Conscientious Objection and Refusal to Provide Reproductive Healthcare: a White Paper Examining Prevalence, Health Consequences, and Policy Responses

International Journal of Gynecology and Obstetrics 123 (2013) S41–S56

CONSCIENTIOUS OBJECTION Conscientious objection and refusal to provide reproductive healthcare: A White Paper examining prevalence, health consequences, and policy responses

Wendy Chavkin a,b,c,*, Liddy Leitman a, Kate Polin a; for Global Doctors for Choice aGlobal Doctors for Choice, New York, USA bCollege of Physicians and Surgeons, Columbia University, New York, USA cMailman School of Public Health, Columbia University, New York, USA

ARTICLE INFO ABSTRACT

Keywords: Background: Global Doctors for Choice—a transnational network of physician advocates for reproductive Abortion health and rights—began exploring the phenomenon of conscience-based refusal of reproductive healthcare Assisted reproductive technologies as a result of increasing reports of harms worldwide. The present White Paper examines the prevalence and Conscience-based refusal of care impact of such refusal and reviews policy efforts to balance individual conscience, autonomy in reproductive Conscientious commitment decision making, safeguards for health, and professional medical integrity. Conscientious objection The White Paper draws on medical, public health, legal, ethical, and social sci- Contraception Objectives and search strategy: Policy response ence literature published between 1998 and 2013 in English, French, German, Italian, Portuguese, and Span- Reproductive health services ish. Estimates of prevalence are diﬃcult to obtain, as there is no consensus about criteria for refuser status and no standardized deﬁnition of the practice, and the studies have sampling and other methodologic limitations. The White Paper reviews these data and offers logical frameworks to represent the possible health and health system consequences of conscience-based refusal to provide abortion; assisted reproductive technologies; contraception; treatment in cases of maternal health risk and inevitable pregnancy loss; and prenatal diagnosis. It concludes by categorizing legal, regulatory, and other policy responses to the practice. Conclusions: Empirical evidence is essential for varied political actors as they respond with policies or regulations to the competing concerns at stake. Further research and training in diverse geopolitical settings are required. With dual commitments toward their own conscience and their obligations to patients’ health and rights, providers and professional medical/public health societies must lead attempts to respond to conscience-based refusal and to safeguard reproductive health, medical integrity, and women’s lives. © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

1. Introduction out the potential consequences for the health of patients and the impact on other health providers and health systems; and report How can societies ﬁnd the proper balance between women’s on legal, regulatory, and professional responses. Human rights are rights to receive the reproductive healthcare they need and health- intertwined with health, and we draw upon human rights frame- care providers’ rights to exercise their conscience? Global Doctors works and decisions throughout. We also refer to bedrock bioethical for Choice (GDC)—a transnational network of physician advocates principles that undergird the practice of medicine in general, such for reproductive health and rights (www.globaldoctorsforchoice. as the obligations to provide patients with accurate information, to org)—began exploring the phenomenon of conscience-based refusal provide care conforming to the highest possible standards, and to of reproductive healthcare in response to increasing reports of provide care that is urgently needed. Others have underscored the harms worldwide. The present White Paper addresses the varied consequences of negotiating conscientious objection in healthcare interests and needs at stake when clinicians claim conscientious in terms of secular/religious tension. Our contribution, which com- objector status when providing certain elements of reproductive plements all of this previous work, is to provide the medical and healthcare. (While GDC represents physicians, in the present White public health perspectives and the evidence. We focus on the rights Paper we use the terms providers or clinicians to also address of the provider who conscientiously objects, together with that refusal of care by nurses, midwives, and pharmacists.) As the focus provider’s professional obligations; the rights of the women who is on health, we examine data on the prevalence of refusal; lay need healthcare and the consequences of refusal for their health; and the impact on the health system as a whole. Conscientious objection is the refusal to participate in an activity * Corresponding author: Wendy Chavkin, 60 Haven Avenue B-2, New York, NY that an individual considers incompatible with his/her religious, 10032, USA. Tel.: +1 646 649 9903; fax: +1 646 366 1897. E-mail address: [email protected]; [email protected] moral, philosophical, or ethical beliefs [1]. This originated as op- (W. Chavkin). position to mandatory military service but has increasingly been

Downloaded for Anonymous User (n/a) at University of Southern California from ClinicalKey.com by Elsevier on May 17, 2019. For personal use only. No other uses without permission. Copyright ©2019. Elsevier Inc. All rights reserved. S42 W. Chavkin et al. / International Journal of Gynecology and Obstetrics 123 (2013) S41–S56 raised in a wide variety of contested contexts such as education, reported in a UK study [13] to almost 70% of gynecologists who capital punishment, driver’s license requirements, marriage licenses registered as conscientious objectors to abortion with the Italian for same-sex couples, and medicine and healthcare. While health Ministry of Health [14]. While the impact of the loss of providers providers have claimed conscientious objection to a variety of may be immediate and most obvious in countries in which maternal medical treatments (e.g. end-of-life palliative care and stem cell death rates from pregnancy, delivery, and illegal abortion are high treatment), the present White Paper addresses conscientious objec- and represent major public health concerns, consequences at indi- tion to providing certain components of reproductive healthcare. vidual and systemic levels have also been reported in resource-rich (The terms conscientious objection and conscience-based refusal settings. At the individual level, decreased access to health services of care are used interchangeably throughout.) Refusal to provide brought about by conscientious objection has a disproportionate this care has affected a wide swath of diagnostic procedures and impact on those living in precarious circumstances, or at otherwise treatments, including abortion and postabortion care; components heightened risk, and aggravates inequities in health status. Indeed, of assisted reproductive technologies (ART) relating to embryo ma- too many women, men, and adolescents lack access to essential nipulation or selection; contraceptive services, including emergency reproductive healthcare services because they live in countries with contraception (EC); treatment in cases of unavoidable pregnancy restrictive laws, scant health resources, too few providers and slots loss or maternal illness during pregnancy; and prenatal diagnosis to train more, and limited infrastructure for healthcare and means (PND). to reach care (e.g. roads and transport). The inadequate number Efforts have been made to balance the rights of objecting of providers is further depleted by the “brain drain” when trained providers and other health personnel with those of patients. In- personnel leave their home countries for more comfortable, techni- ternational and regional human rights conventions such as the cally fulfilling, and lucrative careers in wealthier lands [15]. Access Convention on the Elimination of All Forms of Discrimination to reproductive healthcare is additionally compromised when gy- against Women [2], the International Covenant on Civil and Political necologists, anesthesiologists, generalists, nurses, midwives, and Rights (ICCPR) [1], the American Convention on Human Rights [3], pharmacists cite conscientious objection as grounds for refusing to and the European Convention for the Protection of Human Rights provide specific elements of care. and Fundamental Freedoms [4], as well as UN treaty-monitoring The level of resources allocated by the health system greatly bodies [5,6], have recognized both the right to have access to qual- influences the impact caused by the loss of providers due to ity, affordable, and acceptable sexual and reproductive healthcare conscience-based refusal of care. In resource-constrained settings, services and/or the right to freedom of religion, conscience, and where there are too few providers for population need, it is log- thought. The Protocol to the African Charter on Human and Peoples’ ical to assume the following chain of events: further reductions Rights on the Rights of Women in Africa recognizes the right to be in available personnel lead to greater pressure on those remain- free from discrimination based on religion and acknowledges the ing providers; more women present with complications due to right to health, especially reproductive health, as a key human right decreased access to timely services; and complications require [7]. These instruments negotiate these apparently competing rights specialized services such as maternal/neonatal intensive care and by stipulating that individuals have a right to belief but that the more highly trained staff, in addition to incurring higher costs. The freedom to manifest one’s religion or beliefs can be limited in order increased demand for specialized services and staffing burdens and to protect the rights of others. diverts the human and infrastructural resources available for other The ICCPR, a central pillar of human rights that gives legal force priority health conditions. However, it is difficult to disentangle the to the 1948 UN Universal Declaration of Human Rights, states in impact of conscientious objection when it is one of many barriers Article 18(1) that [1]: to reproductive healthcare. It is conceptually and pragmatically complicated to sort the contribution to constrained access to repro- Everyone shall have the right to freedom of thought, ductive care attributable to conscientious objectors from that due conscience and religion. This right shall include freedom to limited resources, restrictive laws, or other barriers. to have or to adopt a religion or belief of his choice, and What are the criteria for establishing objector status and who freedom, either individually or in community with others is eligible to do so? In the military context, conscientious objector and in public or private, to manifest his religion or belief applicants must satisfy numerous procedural requirements and in worship, observance, practice and teaching. must provide evidence that their beliefs are sincere, deeply held, and consistent [16]. These requirements aim to parse genuine Article 18(3), however, states that [1]: objectors from those who conflate conscientious objection with Freedom to manifest one’s religion or beliefs may be political or personal opinion. For example, the true conscientious subject only to such limitations as are prescribed by law objector to military involvement would refuse to fight in any and are necessary to protect public safety, order, health or war, whereas the latter describes someone who disagrees with morals or the fundamental rights and freedoms of others. a particular war but who would be willing to participate in a different, “just” war. Study findings and anecdotal reports from International professional associations such as the World Medi- many countries suggest that some clinicians claim conscientious cal Association (WMA) [8] and FIGO [9]—as well as national medical objection for reasons other than deeply held religious or ethical and nursing societies and groups such as the American Congress convictions. For example, some physicians in Brazil who described of Obstetricians and Gynecologists (ACOG) [10]; Grupo Médico por themselves as objectors were, nonetheless, willing to obtain or el Derecho a Decidir/GDC Colombia [11]; and the Royal College of provide abortions for their immediate family members [17]. A Nursing, Australia [12]—have similarly agreed that the provider’s Polish study described clinicians, such as those referred to as right to conscientiously refuse to provide certain services must be the White Coat Underground, who claim conscientious objection secondary to his or her first duty, which is to the patient. They status in their public sector jobs but provide the same services in specify that this right to refuse must be bounded by obligations to their fee-paying private practices [18]. Other investigations indicate ensure that the patient’s rights to information and services are not that some claim objector status because they seek to avoid being infringed. associated with stigmatized services, rather than because they truly Conscience-based refusal of care appears to be widespread in conscientiously object [19]. many parts of the world. Although rigorous studies are few, esti- Moreover, some religiously affiliated healthcare institutions claim mates range from 10% of OB/GYNs refusing to provide abortions objector status and compel their employees to refuse to provide

Downloaded for Anonymous User (n/a) at University of Southern California from ClinicalKey.com by Elsevier on May 17, 2019. For personal use only. No other uses without permission. Copyright ©2019. Elsevier Inc. All rights reserved. W. Chavkin et al. / International Journal of Gynecology and Obstetrics 123 (2013) S41–S56 S43 legally permissible care [20,21]. The right to conscience is generally refusal on delay in obtaining care for patients and their families, understood to belong to an individual, not to an institution, as society, healthcare providers, and health systems. As such research claims of conscience are considered a way to maintain an indi- has not been conducted, we schematically delineate the logical vidual’s moral or religious integrity. Some disagree, however, and sequence of events if care is refused. argue that a hospital’s mission is analogous to a conscience–identity We then look at responses to conscience-based refusal of care resembling that of an individual, and “warrant[s] substantial def- by transnational bodies, governments, health sector and other erence” [22]. Others dispute this on the grounds that healthcare employers, and professional associations. These responses include institutions are licensed by states, often receive public financing, establishment of criteria for obtaining objector status, required and may be the sole providers of healthcare services in communi- disclosure to patients, registration of objector status, mandatory ties. Wicclair and Charo both argue that, since a license bestows referral to willing providers, and provision of emergency care. We certain rights and privileges on an institution [22–24], “[W]hen draw upon analyses performed by others to categorize the different licensees accept and enjoy these rights and privileges, they incur models used: legislative, constitutional, case law, regulatory, em- reciprocal obligations, including obligations to protect patients from ployment requirements, and professional standards of care. Finally, harm, promote their health, and respect their autonomy” [22]. we provide recommendations for further research and for ways There are also disputes as to whether obligations and rights in which medical and public health organizations could contribute vary if a provider works in the public or private sector. Public to the development and implementation of policies to manage sector providers are employees of the state and have obligations conscientious objection. to serve the public for the greater good, providing the highest The present White Paper draws upon medical, public health, “standard of care,” as codified in the laws and policies of the legal, ethical, and social science literature of the past 15 years in state [22]. The Institute of Medicine in the USA defines standard English, French, German, Italian, Portuguese, and Spanish available of care as “the degree to which health services for individuals in 2013. It is intended to be a state-of-the-art compendium useful and populations increase the likelihood of desired health outcomes for health and other policymakers negotiating the balance of and are consistent with current professional knowledge” and an individual provider’s rights to “conscience” with the systemic identifies safety, effectiveness, patient centeredness, and timeliness obligation to provide care and it will need updating as further as key components [25]. WHO adds the concepts of equitability, evidence and policy experiences accrue. It is intended to highlight accessibility, and efficiency to the list of essential components of the importance of the medical and public health perspectives, quality of care [26]. There are legal precedents limiting the scope employ a human rights framework for provision of reproductive of conscientious objection for professionals who operate as state health services, and emphasize the use of scientific evidence in actors [23]. Some argue that such limitations can be extended to policy deliberations about competing rights and obligations. those who provide health services in the private sector because, as state licensure grants these professions a monopoly on a public 2. Review of the evidence service, the professions have a collective obligation to patients to provide non-discriminatory access to all lawful services [23,27]. 2.1. Methods However, it is more difficult to identify conscience-based refusal of care in the private sector because clinicians typically have We reviewed data regarding the prevalence of conscientious discretion over the services they choose to offer, although the objection and the motivations of objectors in order to assess same professional obligations of providing patients with accurate the distribution and scope of the phenomenon and to have an information and referral pertain. empirical basis for designing respectful and effective responses. An alternative framing is provided by the concept of consci- However, estimates of prevalence are difficult to obtain; there entious commitment to acknowledge those providers whose con- is no consensus about criteria for objector status and, thus, no science motivates them to deliver reproductive health services and standardized definition of the practice. Moreover, it is difficult to who place priority on patient care over adherence to religious doc- assess whether findings in some studies reflect intention or actual trines or religious self-interest [28,29]. Dickens and Cook articulate behavior. The few countries that require registration provide the that conscientious commitment “inspires healthcare providers to most solid evidence of prevalence. overcome barriers to delivery of reproductive services to protect A systematic review could not be performed because the data and advance women’s health” [28]. They assert that, because pro- are limited in a variety of ways (which we describe), making vision of care can be conscience based, full respect for conscience most of them ineligible for inclusion in such a process. We requires accommodation of both objection to participation and searched systematically for data from quantitative, qualitative, and commitment to performance of services such that the latter group ethnographic studies and found that many have non-representative of providers also have the right to not suffer discrimination on the or small samples, low response rates, and other methodologic basis of their convictions [28]. This principle is articulated by FIGO limitations that limit their generalizability. Indeed, the studies [9]; according to the FIGO “Resolution on Conscientious Objection,” reviewed are not comparable methodologically or topically. The “Practitioners have a right to respect for their conscientious convic- majority focus on conscience-based refusal of abortion-related tions in respect both not to undertake and to undertake the delivery care and only a few examine refusal of emergency or other of lawful procedures” [30]. contraception, PND, or other elements of care. Some examine We begin the present White Paper with a review of the limited provider attitudes and practices related to abortion in general, data regarding the prevalence of conscience-based refusal of care while others investigate these in terms of the specific circumstances and objectors’ motivations. Descriptive prevalence data are needed for which people seek the service: for example, financial reasons, in order to assess the distribution and scope of this phenomenon sex selection, failed contraception, rape/incest, fetal anomaly, and and it is necessary to understand the concerns of those who maternal life endangerment. Some rely on closed-ended electronic refuse in order to design respectful and effective responses. We or mail surveys, while others employ in-depth interviews. Most review the data; point out the methodologic, geographic, and focus on physicians; fewer study nurses, midwives, or pharmacists. other limitations; and specify some questions requiring further These investigations are also limited geographically because investigation. Next, we explore the consequences of conscientious more were conducted in higher-income than lower-income coun- objection for patients and for health systems. Ideally, we would tries. Because of both greater resources and more liberalized evaluate empirical evidence on the impact of conscience-based reproductive health laws and policies, many higher-income coun-

Downloaded for Anonymous User (n/a) at University of Southern California from ClinicalKey.com by Elsevier on May 17, 2019. For personal use only. No other uses without permission. Copyright ©2019. Elsevier Inc. All rights reserved. S44 W. Chavkin et al. / International Journal of Gynecology and Obstetrics 123 (2013) S41–S56 tries offer a greater range of legal services and, consequently, described themselves as objectors, most of this group supported more opportunities for objection. Assessment of the impact of abortion for severe fetal anomaly [13]. conscience-based refusal of care in resource-constrained settings Other inconsistencies regarding refusal of care derived from the presents additional challenges because high costs and lack of skilled provider’s familiarity with a patient, experience of stigmatization, providers may dwarf this and other factors that impede access. or opportunism. A Brazilian study reported that Brazilian gynecol- Acknowledging that conscientious objection to reproductive health- ogists were more likely to support abortion for themselves or a care has yet to be rigorously studied, we included all studies we family member than for patients [17]. Physicians in Poland and were able to locate within the past 15 years, and present the Brazil reported reluctance to perform legally permissible abortions cross-cutting themes as topics for future systematic investigation. because of a hostile political atmosphere rather than because of conscience-based objection. The authors also noted that consci- 2.2. Prevalence and attitudes entious objection in the public sphere allowed doctors to funnel patients to private practices for higher fees [19]. The sturdiest estimates of prevalence come from a limited Not surprisingly, higher levels of self-described religiosity were sample of those few places that require objectors to register as associated with higher levels of disapproval and objection regarding such or to provide written notification. 70% of OB/GYNs and 50% of the provision of certain procedures [49]. Additionally, a random anesthesiologists have registered with the Italian Ministry of Health sample of UK general practitioners (GPs) [50], a study of Idaho as objectors to abortion [31]. While Norway and Slovenia require licensed nurses [51], a study of OB/GYNs in a New York hospital some form of registration, neither has reported prevalence data [52], and a cross-sectional survey of OB/GYNs and midwives in [32–34]. Other estimates of prevalence derive from surveys with Sweden [53] found self-reported religiosity to be associated with varied sampling strategies and response rates. In a random sample reluctance to perform abortion. A study of Texas pharmacists found of OB/GYN trainees in the UK, almost one-third objected to abortion the same association regarding refusal to prescribe EC [54]. [35]. 14% of physicians of varied specialties surveyed in Hong Higher acceptance of these contested service components and Kong reported themselves to be objectors [36]. 17% of licensed lower rates of objection were associated with higher levels of Nevada pharmacists surveyed objected to dispensing mifepristone training and experience in a survey of medical students and and 8% objected to EC [37]. A report from Austria describes many physicians in Cameroon and in a qualitative study of OB/GYN regions without providers and a report from Portugal indicates that clinicians in Senegal [55,56]. Similar patterns prevailed in a survey approximately 80% of gynecologists there refuse to perform legal of Norwegian medical students [57] and among pharmacists and abortions [38–40]. OB/GYNs in the USA [45]. Other studies have investigated opinions about abortion and Clinicians’ refusal to provide elements of ART and PND also intention to provide services. A convenience sample of Spanish varied, at times motivated by concerns about their own lack medical and nursing students indicated that most support access to of competence with these procedures. And, while the majority abortion and intend to provide it [41]. A survey of medical, nursing, of Danish OB/GYNs and nurses (87%) in a non-random sample and physician assistant students at a US university indicated that supported abortion and ART, 69% opposed selective reduction [49]. more than two-thirds support abortion yet only one-third intend to A random sample of OB/GYNs from the UK indicated that 18% provide, with the nursing and physician assistant students evincing would not agree to provide a patient with PND [13]. the strongest interest in doing so [42]. The 8 traditional healers Several studies report institutional-level implications conse- interviewed in South Africa were opposed to abortion [43], and an quent to refusal of care. Physicians and nurse managers in hospitals ethnographic study of Senegalese OB/GYNs, midwives, and nurses in Massachusetts said that nurse objection limited the ability to reported that one-third thought the highly restrictive law there schedule procedures and caused delays for patients [58]. Half of should permit abortion for rape/incest, although very few were a stratified random sample of US OB/GYNs practicing primarily willing to provide services (unpublished data). at religiously affiliated hospitals reported conflicts with the hos- Some studies indicate that a subset of providers claim to be con- pital regarding clinical practice; 5% reported these to center on scientious objectors when, in fact, their objection is not absolute. treatment of ectopic pregnancy [59]. 52% of a non-random sample Rather, it reflects opinions about patient characteristics or reasons of regional consultant OB/GYNs in the UK said that insufficient for seeking a particular service. For example, a stratified random numbers of junior doctors are being trained to provide abortions sample of US physicians revealed that half refuse contraception owing to opting out and conscientious objection [35]. A 2011 South and abortion to adolescents without parental consent, although the African report states that more than half of facilities designated law stipulates otherwise [44]. A survey of members of the US pro- to provide abortion do not do so, partly because of conscien- fessional society of pediatric emergency room physicians indicated tious objection, resulting in the persistence of widespread unsafe that the majority supported prescription of EC to adolescents but abortion, morbidity, and mortality [60]. A non-random sample of only a minority had done so [45]. A study of the postabortion Polish physicians reported that institutional, rather than individual, care program in Senegal, intended to reduce morbidity and mor- objection was common [19]. Similar observations have been made tality due to complications from unsafe abortion, found that some about Slovakian hospitals [61]. providers nonetheless delayed care for women they suspected of A few investigations have explored clinician attitudes toward having had an induced abortion (unpublished data). regulation of conscience-based refusal of reproductive healthcare. Willingness to provide abortions varies by clinical context and Two studies from the USA indicate that majorities of family reason for abortion, as demonstrated by a stratified random sample medicine physicians in Wisconsin and a random sample of US of OB/GYN members of the American Medical Association (AMA) physicians believe physicians should disclose objector status to [46]. A survey of family medicine residents in the USA assessing patients [44,47]. A survey of UK consultants revealed that half want prevalence of moral objection to 14 legally available medical the authority to include abortion provision in job descriptions for procedures revealed that 52% supported performing abortion for OB/GYN posts, and more than one-third think objectors should be failed contraception [47]. Despite opposition to voluntary abortion, required to state their reasons [35]. Interviews with a purposive more than three-quarters of OB/GYNs working in public hospitals sample of Irish physicians revealed mixed opinions about the in the Buenos Aires area from 1998 to 1999 supported abortion for obligation of objectors to refer to other willing providers, as well maternal health threat, severe fetal anomaly, and rape/incest [48]. as awareness that women traveled abroad for abortions and related While 10% of a random sample of consultant OB/GYNs in the UK services that were denied at home [62].

While the reviewed literature indicates widespread occurrence and health systems, we build logical models delineating plausible of conscientious objection to providing some elements of reproduc- consequences if a particular component of care is refused. We tive healthcare, it does not offer a rigorously obtained evidentiary provide visual schemata to represent these pathways and we use basis from which to map the global landscape. Assessment of the data and examples of refusal from around the world to ground prevalence of conscientious objection requires ascertainment of the them. number objecting (numerator) and the total count of the rele- We attempt to isolate the impact of conscientious objection for vant population of providers comprising the denominator (e.g. the each of the 5 reproductive health components, although we recog- number of OB/GYNs claiming conscientious objection to providing nize the difficulties of identifying the contributions attributable to EC and the total population of OB/GYNs). Registration of objec- other barriers to access. These include limited resources, inadequate tors, as required by the Italian Ministry of Health, provides such infrastructure, failure to implement policies, sociocultural practices, data. Professional societies could also systematically gather data and inadequate understanding of the relevant law by providers and by surveying members on their practices related to conscience- patients alike. based refusal of care or by including such self-identification on We start from the premise that refusal of care leads to fewer standard mandatory forms. Academic institutions or other research clinicians providing specific services, thereby constraining access to organizations could conduct formal studies or add questions on these services. We posit that those who continue to provide these conscience-based refusal of care to ongoing general surveys of contested services may face stigma and/or become overburdened. clinicians. We specify plausible health outcomes for patients, as well as the Aside from prevalence, there are a host of key questions. Further consequences of refusal for families, communities, health systems, research on motivations of objectors is required in order to bet- and providers. ter understand reasons other than conscience-based objection that may lead to refusal of care. As the studies reviewed indicate, these 3.1. Conscience-based refusal of abortion-related services factors may include desire to avoid stigma, to avoid burdensome administrative processes, and to earn more money by providing The availability of safe and legal abortion services varies greatly services in private practice rather than in public facilities; knowl- by setting. Nearly all countries in the world allow legal abortion edge gaps in professional training; and lack of access to necessary in certain cases (e.g. to save the life of the woman, in cases of supplies or equipment. Qualitative studies would best probe these rape, and in cases of severe fetal anomaly). Few countries prohibit complicated motivations. abortion in all circumstances. While some among these allow the What is the impact of conscience-based refusal of care? In criminal law defense of necessity to permit life-saving abortions, the next section, we outline systemic and biologically plausible Chile, El Salvador, Malta, and Nicaragua restrict even this recourse. sequences of events when specified care components are refused. Other countries with restrictive laws are not explicit or clear about Research is needed to see whether these hold true and have those circumstances in which abortion is allowed [63]. health consequences for women and practical consequences for In many countries, particularly in low-resource areas, access other clinicians and the health system as a whole. Research to legal services is compromised by lack of resources for health could illuminate women’s experiences when refused care—their services, lack of health information, inadequate understanding of understanding, access to safe and unsafe alternatives, emotional the law, and societal stigma associated with abortion [64]. response, and course of action. Investigations on the clinician side There is substantial evidence that countries that provide greater could further explore the experiences of those who do provide access to safe, legal abortion services have negligible rates of services after others have refused to do so. Each of these questions unsafe abortion [65]. Conversely, nearly all of the world’s unsafe is likely to have context-specific answers, so research should take abortions occur in restrictive legal settings. Where access to legal place in varied geopolitical settings, and the contextual nature of abortion services is restricted, women seek services under unsafe the findings must be made clear. circumstances. Approximately 21.6 million of the world’s annual Do clinicians consider conscientious objection to be problem- 46 million induced abortions are unsafe, with nearly all of these atic? What kinds of constraints on provider behavior do clinicians (98%) occurring in resource-limited countries [65,66]. In low- consider appropriate or realistic? When enacted, have such poli- income countries, more than half of abortions performed (56%) cies or regulations been implemented? Have those implemented are unsafe, compared with 6% in high-income areas [66]. Nearly effectively met their purported objectives? What mechanisms one-quarter (more than 5 million) of these result in serious of regulation do women consider reasonable? Do they perceive medical complications that require hospital-based treatment [67, conscience-based refusal of care as a significant barrier to reproduc- 68]; 47,000 women die each year because of unsafe abortion and an tive health services? Could enhanced training and updated medical additional unknown number of women experience complications and nursing school curricula devoted to reproductive health address from unsafe abortions but do not seek care [68]. While the the lack of clinical skills that contributes to refusal of care? Could international health community has sought to mitigate the high further education clarify which services are permitted by law, and rates of maternal morbidity and mortality caused by unsafe abortion under which circumstances, and thus reassure clinicians sufficiently through postabortion care programs [56], the implementation and such that they provide care? Empirical evidence is essential as effectiveness of these have been undermined by conscience-based varied political actors try to respond to these competing concerns refusal of care [24,56,69]. with policies or regulations. We posit that conscience-based refusal of care will have less of an impact at the population level in countries with available safe, 3. Consequences of refusal of reproductive healthcare for legal abortion services than in those where access is restricted. women and for health systems Women living in settings in which legal abortion is widely available and who experience provider refusal will be more likely to find We lay out the potential implications of conscience-based other willing providers offering safe, legal services than women in refusal of care for patients and for health systems in 5 areas settings in which abortion is more highly restricted. We ground of reproductive healthcare—abortion and postabortion care, ART, our model (Fig. 1) in the following examples: (1) in South Africa, contraception, treatment for maternal health risk and unavoidable widespread conscientious objection limits the numbers of willing pregnancy loss, and PND. Because we lack empirical data to providers and, thus, access to safe care, and the number of unsafe explore the impact of conscience-based refusal of care on patients abortions has not decreased since the legalization of abortion in

Fig. 1. Consequences of refusal of abortion-related services.

1996 [70,71]; (2) although Senegal’s postabortion care program nal and fetal outcomes are markedly superior when fewer embryos is meant to mitigate the grave consequences of unsafe abortion, are implanted, the objection to embryo selection/reduction and conscientious objection is, nevertheless, often invoked when abor- cryopreservation promoted by the Catholic Church has reportedly tion is suspected of being induced rather than spontaneous [56] led many physicians to avoid these [78]. Anecdotal reports from (unpublished data). Argentina describe ART physicians’ avoidance of cryopreservation and embryo selection/reduction following the self-appointment of a 3.2. Conscience-based refusal of components of ART lawyer and member of Opus Dei as legal guardian for cryopreserved embryos [78,79]. The only example that illustrates the implications Infertility is a global public health issue affecting approximately of denial of preimplantation genetic diagnosis (PGD) refers to a 8%–15% of couples [72,73], or 50–80 million people [74], worldwide. legal ban, rather than conscience-based refusal of care. Nonetheless, Although the majority of those affected reside in low-resource we use it to describe the potential consequences when such care is countries [72,73], the use of ART is much more likely in high- denied. In 2004, Italy passed a law banning PGD, cryopreservation, resource countries. and gamete donation [80]. This ban compelled a couple who were Access to speciﬁc ART varies by socioeconomic status and ge- both carriers of the gene for β-thalassemia to wait to undergo ographic location, between and within countries. In high-resource amniocentesis and then to have a second-trimester abortion rather countries, the cost of treatment varies greatly depending on the than allow the abnormality to be detected prior to implantation healthcare system and the availability of government subsidy [75]. [80](Fig. 2). For example, in 2006, the price of a standard in vitro fertilization (IVF) cycle ranged from US $3956 in Japan to $12,513 in the USA 3.3. Conscience-based refusal of contraceptive services [76]. After government subsidization in Australia, the cost of IVF averaged 6% of an individual’s annual disposable income; it was The availability of the range of contraceptive methods varies by 50% without subsidization in the USA [77]. In low-income countries, setting, as does prevalence of use [81]. In general, contraceptive despite high rates of infertility, there are few resources available use is correlated with level of income. In 2011, 61.3% of women for ART, and costs are generally prohibitive for the majority of aged 15–49 years, married or in a union, in middle–upper-income the population. Because these economic and infrastructural factors countries were using modern methods, compared with 25% in drive lack of access to ART in low-income countries, we posit that the lowest-resource countries [81,82]. Within countries, access to denial of services owing to conscience-based refusal of care is not a and use of methods also vary. For example, according to the 2003 major contributing factor to limited access in these settings. There- Demographic and Health Survey of Kenya (a cross-sectional study of fore, for the model (Fig. 2), we primarily examine the consequences a nationally representative sample), women in the richest quintile of conscientious objection to components of ART in middle- to were reported to have signiﬁcantly higher odds for using long-term high-income countries. At times, regulations and policies regarding contraceptive methods (intrauterine device, sterilization, implants) ART stem from empirically based concerns, grounded in medical than women in the poorest quintile [82]. evidence, about health outcomes for women and their offspring or The legal status of particular contraceptive methods also varies health system priorities. Our focus, however, is on those instances by setting. In Honduras, Congress passed a bill banning EC, which in which some physicians practice according to moral or religious has not yet been enacted into law [83]. Even when contraception is beliefs, even when these contradict best medical practices. In some legal, lack of basic resources allocated by government programs may Latin American countries, despite the medical evidence that mater- compromise availability of particular methods. High manufacturing

Fig. 2. Consequences of refusal of components of assisted reproductive technologies. costs or steep prices can also undermine access [84]. In other cases, and jeopardize the health of the pregnant woman. However, individual health providers opt not to provide contraception to all the incidence of ectopic pregnancy ranges from 1% to 16% [87– or to certain groups of women. Some providers refuse to provide 90], and 10%–20% of all clinically recognized pregnancies end in speciﬁc methods such as EC or sterilization. In Poland, there is spontaneous abortion [90]. Often, refusal of care in circumstances widespread refusal to provide contraceptive services (J. Mishtal, of maternal health risk occurs in the context of highly restrictive personal communication, April 2012). In Oklahoma, a rape victim abortion laws. We refer to 3 cases from around the world (Fig. 4) was denied EC by a doctor [85], and in Germany a rape victim to highlight this phenomenon in our model. In Ireland in 2012, was denied EC by 2 Catholic hospitals in 2012 [86]. In Fig. 3, Savita Halappanavar, 31, presented at a Galway hospital with we delineate potential implications of conscience-based refusal of ruptured membranes early in the second trimester. She was refused contraceptive services. completion of the inevitable spontaneous abortion, developed sepsis, and subsequently died [91]. Z’s daughter, a young Polish 3.4. Conscience-based refusal of care in cases of risk to maternal health woman, was diagnosed with ulcerative colitis while she was and unavoidable pregnancy loss pregnant [92]. She was repeatedly denied medical treatment; physicians stated that they would not conduct procedures or tests In some circumstances, pregnancy can exacerbate a serious ma- that might result in fetal harm or termination of the pregnancy ternal illness or maternal illness may require treatment hazardous [92]. She developed sepsis, experienced fetal demise, and died. The to a fetus. In these cases, women require access to life-saving treat- only example that illustrates the implications of denial of treatment ment, which may include abortion. Yet women have been denied for ectopic pregnancy derives from legal bans, rather than from appropriate treatment. Women seeking completion of inevitable an example of conscience-based refusal of care. In El Salvador, a pregnancy loss due to ectopic pregnancy or spontaneous abortion total prohibition on abortion has led to physician refusal to treat have also been denied necessary care. ectopic pregnancy [93]; in Nicaragua, the abortion ban results in It is beyond the scope of the present White Paper to deﬁne delay of treatment for ectopic pregnancies, despite law and medical the full range of conditions that may be exacerbated by pregnancy guidelines mandating the contrary [94](Fig. 4).

Fig. 3. Consequences of refusal of contraceptive services.

3.5. Conscience-based refusal of PND 4. Policy responses to manage conscience-based refusal of reproductive healthcare The availability of PND varies greatly by setting—with those in middle–upper-income countries having access to testing for a Here, we review various policy interventions related to variety of genetic conditions and structural anomalies, and fewer conscience-based refusal of care. Initially, we look at the con- having access to a more limited series of testing in low-income text established by human rights standards or human rights bodies countries. Access to PND provides women with information so wherein freedom of conscience is enshrined. The UN Committee on that they can make decisions and/or preparations when severe or Economic, Social and Cultural Rights (CESCR); the UN Committee lethal fetal anomalies are detected. Outcomes for affected neonates on the Elimination of Discrimination against Women (CEDAW); and vary by country resource level; PND enables physicians to plan the UN Human Rights Committee have commented on the need for the level of care needed during delivery and in the neonatal to balance providers’ rights to conscience with women’s rights to period. With PND, families are also afforded the time to secure have access to legal health services [98–104]. CEDAW asserts that the necessary emotional and ﬁnancial resources to prepare for the “it is discriminatory for a country to refuse to legally provide for birth of a child with special needs [95,96]. In settings in which the performance of certain reproductive health services for women” there are fewer resources available for PND, conscientious objection and that, if healthcare providers refuse to provide services on the further restricts women’s access to services. Figure 5 presents basis of conscientious objection, “measures should be introduced pathways and implications of provider conscience-based refusal to to ensure that women are referred to alternative health providers” provide PND services. Because most data on access to PND are [99]. CESCR has called on Poland to take measures to ensure that from high-resource countries, we must project what would happen women enjoy their rights to sexual and reproductive health, in- in lower-income countries. We use the example of R.R., a Polish cluding by “enforcing the legislation on abortion and implementing woman who was repeatedly refused diagnostic tests to assess fetal a mechanism of timely and systematic referral in the event of status after ultrasound detection of a nuchal hygroma [97](Fig. 5). conscientious objection” [104]. The international medical and public health communities, including FIGO in its Ethical Guidelines on Conscientious Objection (2005) [9] and WHO in its updated Safe Abortion Guidelines (2012) [105], have agreed on principles related to the management of

Fig. 4. Consequences of refusal of care in cases of risk to maternal health and unavoidable pregnancy loss.

Fig. 5. Consequences of refusal of prenatal diagnosis. conscientious objection to reproductive healthcare provision. While • Providers have a right to conscientious objection and not to these are non-binding recommendations, they do assert profes- suffer discrimination on the basis of their beliefs. sional standards of care. These include the following: • The primary conscientious duty of healthcare providers is to

treat, or provide benefit and prevent harm to patients; conscien- [33,115]. In Colombia, the Constitutional Court affirmed that con- tious objection is secondary to this primary duty. scientious objection must be grounded in true religious conviction, rather than in a personal judgment of “rightness” [116]. Moreover, the following safeguards must be in place in order to Some of these responses are legally binding through national ensure access to services without discrimination or undue delays: constitutional provisions, legislation, or case law. The European • Providers have a professional duty to follow scientifically and Court of Human Rights (ECHR), whose rulings are legally binding professionally determined definitions of reproductive health for member nations, clarified the obligation of states to orga- services, and not to misrepresent them on the basis of personal nize the practice of conscience-based refusal of care to ensure beliefs. that patients have access to legal services, specifically to abortion • Patients have the right to be referred to practitioners who do [97]. Professional associations and employers have developed other not object for procedures medically indicated for their care. interventions, including job requirements and non-binding recom- • Healthcare providers must provide patients with timely access mendations. In Germany, for example, a Bavarian High Adminis- to medical services, including giving information about the trative Court decision [117], upheld by the Federal Administrative medically indicated options of procedures for care, including Court [118], ruled that it was permissible for a municipality to in- those that providers object to on grounds of conscience. clude ability and willingness to perform abortions as a job criterion. • Providers must provide timely care to their patients when In Norway, employers can refuse to hire objectors and employment referral to other providers is not possible and delay would advertisements may require performance of abortion as a condition jeopardize patients’ health. for employment [112]. In Sweden, Bulgaria, Czech Republic, Finland, • In emergency situations, providers must provide the medically and Iceland, healthcare providers are not legally permitted to con- indicated care, regardless of their own personal objections. scientiously object to providing abortion services [38]. Some require referral to non-objecting providers. For example, in the recent P. These statements support both sides of the tension: the right and S. v. Poland case, the ECHR emphasized the need for referrals to of patients to have access to appropriate medical care and the be put in writing and included in patients’ medical records [119]. right of providers to object, for reasons of conscience, to providing In Argentina [110] and France [120], legislation requires doctors particular forms of care. They underscore the professional obligation who conscientiously object to refer patients to non-objecting prac- of healthcare providers to ensure timely access to care, through titioners. Similar laws exist in Victoria, Australia [121], Colombia provision of accurate information, referral, and emergency care. At [116,122,123], Italy [124], and Norway [115]. Professional and med- the transnational level, human rights consensus documents have ical associations around the world recommend that objectors refer asserted that institutions and individuals are similarly bound by patients to non-objecting colleagues. ACOG in the USA [125] and their obligations to operate according to the bedrock principles El Sindicato Médico in Uruguay [126] recommend that objectors that underpin the practice of medicine, such as the obligations refer patients to other practitioners. The British Medical Association to provide patients with accurate information, to provide care (BMA) specifies that practitioners cannot claim exemption from conforming to the highest possible standards, and to provide care giving advice or performing preparatory steps (including referral) in emergency situations. where the request for an abortion meets legal requirements [127]. At the country level, however, there is no agreement as to The WMA asserts that, if a physician must refuse a certain service whether institutions can claim objector status. For example, Spain on the basis of conscience, s/he may do so after ensuring the [106], Colombia [107], and South Africa [108] have laws stating continuity of medical care by a qualified colleague [128]. FIGO that refusal to perform abortions is always an individual, not an maintains that patients are entitled to referral to practitioners who institutional, decision. Conversely, Argentinian law [109,110] gives do not object [9]. private institutions the ability to object and requires private health Pharmacists’ associations in the USA and UK have made similar centers to register as conscientious objectors with local health recommendations. The American Society of Health-System Phar- authorities. In Uruguay, the Ethical Code does not require the macists asserts that pharmacists and other pharmacy employees institution employing a conscientious objector to provide referral have the right not to participate in therapies they consider to be services, although a newly proposed bill would require such referral morally objectionable but they must make referrals in an objective [111,112]. In the USA, the question of institutional rights and manner [129]; the AMA guidelines state that patients have the right obligations is hotly debated and the situation is complicated and to receive an immediate referral to another dispensing pharmacy unresolved. Currently, federal law forbids agencies receiving federal if a pharmacist invokes conscientious objection [130]. In the UK, funding from discriminating against any healthcare entity that pharmacists must also have in place the means to make a referral refuses to provide abortion services [113]. Yet other federal law to another relevant professional within an appropriate time frame requires institutions providing services for low-income people to [131]. maintain an adequate network of providers and to guarantee that Some jurisdictions mandate registration of objectors or require individuals receive services without additional out-of-pocket cost objectors to provide advance written notice to employers or [114]. government bodies. In Spain, for example, the law requires that International and regional human rights bodies, governments, conscientious objection must be expressed in advance and in courts, and health professional associations have developed vari- written form to the health institution and the government [106]. ous responses to address conscience-based refusal of care. These Italian law also requires healthcare personnel to declare their responses differ as to whose rights they protect: the rights of a conscientious objection to abortion to the medical director of woman to have access to legal services or the rights of a provider the hospital or nursing home in which they are employed and to object based on reasons of conscience. They might also have to the provincial medical officer no later than 1 month after different emphases or targets. Some focus on ensuring an ade- date of commencement of employment [124]. Victoria, Australia quate number of providers for a certain service, some concentrate [118]; Colombia [123]; Norway [115]; Madagascar [132]; and on ensuring that women receive timely referrals to non-objecting Argentina [109] have similar laws. In Norway, the administrative practitioners, and some seek to establish criteria for designation head of a health institution must inform the county municipality as an objector. For example, Norway established a comprehensive of the number of different categories of health personnel who regulatory and oversight framework on conscientious objection are exempted on grounds of conscience [115]. Argentinian law to abortion, which includes ensuring the availability of providers [109] gives private institutions the ability to object, requiring these

Downloaded for Anonymous User (n/a) at University of Southern California from ClinicalKey.com by Elsevier on May 17, 2019. For personal use only. No other uses without permission. Copyright ©2019. Elsevier Inc. All rights reserved. W. Chavkin et al. / International Journal of Gynecology and Obstetrics 123 (2013) S41–S56 S51 institutions to register as conscientious objectors with local health Other measures address the required provision of services when authorities and to guarantee care by referring women to other referral to an alternative provider is not possible. In Norway, for centers. Argentinian law also states that an individual objector example, a doctor is not legally allowed to refuse care unless a cannot provide services in a private health center that s/he objects patient has such reasonable access [115]. FIGO recommends that to the provision of in the public health system [110]. Regulation in “practitioners must provide timely care to their patients when Canada requires pharmacists to ensure that employers know about referral to other practitioners is not possible and delay would their conscientious objector status and to prearrange access to an jeopardize patients’ health and well being, such as by patients alternative source for treatment, medication, or procedure [133]. experiencing unwanted pregnancy” [9]. The Code of Ethics for nurses in Australia also requires disclosure Some interventions obligate the state to ensure services. In to employers [134]. In Northern Ireland, a guidance document by Colombia, for example, the health system is responsible for provid- the Department of Health, Social Services and Public Safety asserts ing an adequate number of providers, and institutions must provide that an objecting provider “should have in place arrangements services even if individuals conscientiously object [107]. The law with practice colleagues, another GP practice, or a Health Social on voluntary sterilization and vasectomies in Argentina obligates Care Trust to whom the woman can be referred” for advice or health centers to ensure the immediate availability of alternative assessment for termination of pregnancy [135]. services when a provider has objected [144]. In Spain, the govern- Other measures require disclosure to patients about providers’ ment will pay for transportation to an alternative willing public status as objectors. For example, the law in the state of Victoria, health facility [106]. Italian law requires healthcare institutions to Australia, requires objectors to inform the woman and refer her ensure that women have access to abortion; regional healthcare to a willing provider [121]. In Argentina, the Technical Guide for entities are obliged to supervise and ensure such access, which may Comprehensive Legal Abortion Care 2010 [109] requires that all include transferring healthcare personnel [125]. In Mexico City, the women be informed of the conscientious objections of medical, public health code was amended to reinforce the duty of healthcare treating, and/or support staff at first visit. Portugal’s medical ethical facilities to make abortion accessible, including their responsibility guidelines encourage doctors to communicate their objection to to limit the scope of conscientious objection [140]. patients [136]. Some measures specify which service providers are eligible to The right to receive information in healthcare, including repro- refuse and when they are allowed to do so. In the UK, for example, ductive health information, is enshrined in international law. For auxiliary staff are not entitled to conscientiously object [145,146]. example, the ECHR determined that denial of services essential to According to the BMA guidelines, refusal to participate in paper- making an informed decision regarding abortion can constitute a work or administration connected with abortion procedures lies violation of the right to be free from inhuman and degrading treat- outside the terms of the conscientious objection clause [127]. In ment [97]. At the national level, laws have mandated disclosure Spain, only health professionals directly involved in termination of of health information to patients. For example, according to the pregnancy have the right to object, and they must provide care South African abortion law, providers, including objectors, must to the woman before and after termination of pregnancy [106]. ensure that pregnant women are aware of their legal rights to Similarly, doctors in Italy are legally required to assist before and abortion [108]. In Spain, women are entitled to receive information after an abortion procedure even if they opt out of the proce- about their pregnancies (including prenatal testing results) from dure itself [124]. Also, medical guidelines in Argentina encourage all providers, including those registered as objectors [106]. In the practitioners to aid before and after legal abortion procedures UK, objectors are legally required to disclose their conscientious even if they are invoking conscientious objection to participation objector status to patients, to tell them they have the right to see in the procedure itself [109]. During the Bush administration, the another doctor, and to provide them with sufficient information to US Department of Health and Human Services extended regulatory enable them to exercise that right [137–139]. “conscience protections” to any individual peripherally participating Professional guidelines have also addressed disclosure of health in a health service [147]. This regulation was contested vigorously information. In Argentina, any delaying tactics, provision of false and retracted almost fully in February 2011 [148,149]. information, or reluctance to carry out treatment by health pro- In Table 1, we lay out some benefits and limitations of policy fessionals and authorities of hospitals is subject to administrative, responses to conscientious objection in order to provide varied civil, and/or criminal actions [109]. FIGO asserts that the ethical actors with a menu of possibilities. As criteria are developed for responsibility of OB/GYNs to prevent harm requires them to provide invoking refusal, it is essential to address the questions of who is patients with timely access to medical services, including giving eligible to object, and to the provision of which services. We have them information about the medically indicated options for their added the categories of “data” and “standardization” as parameters care [9]. in the table in recognition of the scant evidence available and the Some require the provision of services in cases of emergency. resulting inability to methodically assess the scope and efficacy of For example, legislation in Victoria, Australia [121]; Mexico City interventions. Selection of the various options delineated below will [140]; Slovenia [141]; and the UK [138] stipulates that physicians be influenced by the specific sociopolitical and economic context. may not refuse to provide services in cases of emergency and when urgent termination is required. US case law determined 5. Conclusion that a private hospital with a tradition of providing emergency care was still obliged to treat anyone relying on it even after Refusal to provide certain components of reproductive health- its merger with a Catholic institution. This sets the standard for care because of moral or religious objection is widespread and continuity of access after mergers of 2 hospitals with conflicting seems to be increasing globally. Because lack of access to repro- philosophies [142]. Also, ACOG urges clinicians to provide medically ductive healthcare is a recognized route toward adverse health indicated care in emergency situations [125]. In Argentina, technical outcomes and inequalities, exacerbation of this through further guidelines from the Ministry of Health stipulate that institutions depletion of clinicians constitutes a grave global health and rights must provide termination of pregnancy through another provider concern. The limited evidence available indicates that objection at the institution within 5 days or immediately if the situation is occurs least when the law, public discourse, provider custom, and urgent [109]. In the UK, medical standards also prohibit conscience- clinical experience all normalize the provision of the full range of based refusal of care in cases of emergency for nurses and midwives reproductive healthcare services and promote women’s autonomy. [143]. While data on both the prevalence of conscience-based refusal of

Downloaded for Anonymous User (n/a) at University of Southern California from ClinicalKey.com by Elsevier on May 17, 2019. For personal use only. No other uses without permission. Copyright ©2019. Elsevier Inc. All rights reserved. W. Chavkin et al. / International Journal of Gynecology and Obstetrics 123 (2013) S41–S56 S53 care and the consequences for women’s health and health system Conflict of interest function are inadequate, they indicate that refusal is unevenly distributed; that it may have the most severe impact in those parts The authors have no conflicts of interest. of the world least able to sustain further personnel shortages; and that it also affects women in more privileged circumstances. References The present White Paper has laid out the available data and outlined research questions for further management of conscience- [1] International Covenant on Civil and Political Rights, adopted Dec. 16, 1966, based refusal of care. It presents logical chains of consequences G.A. Res. 2200A (XXI), U.N. GAOR, 21st Sess., Supp. No. 16, at 52, U.N. Doc. A/6316 (1966), 999 U.N.T.S. 171 (entered into force March 23, 1976). when refusal compromises access to specific components of re- [2] Convention on the Elimination of All Forms of Discrimination against Women, productive healthcare and categorizes efforts to balance the claims adopted December 18, 1979, G.A. Res. 34/180, U.N. GAOR, 34th Sess., Supp. of objectors with the claims of both those seeking healthcare and No. 46, at 193, U.N. Doc. A/34/46 (entered into force September 3, 1981). the systems obligated to provide these services. We highlight the [3] Organization of American States. American Convention on Human Rights, “Pact of San Jose”, Costa Rica. November 22, 1969. http://www.unhcr.org/ claims of those whose conscience compels them to provide such refworld/docid/3ae6b36510.html. Accessed February 10, 2013. care, despite hardship. As our emphasis is on medicine and science, [4] Council of Europe. European Convention for the Protection of Human Rights we close by considering ways for medical professional and public and Fundamental Freedoms, as amended by Protocols Nos. 11 and 14. health societies to develop and implement policies to manage November 4, 1950, ETS 5. http://www.unhcr.org/refworld/docid/3ae6b3b04. html. Accessed February 10, 2013. conscientious objection. [5] UN Committee on Economic, Social and Cultural Rights (CESCR). General One recommendation is to standardize a definition of the Comment No. 14: The Right to the Highest Attainable Standard of Health practice and to develop eligibility criteria for designation as an (Art. 12 of the Covenant). August 11, 2000, E/C.12/2000/4. http://www. objector. Such designation would have accompanying obligations, refworld.org/docid/4538838d0.html. Accessed May 7, 2013. such as disclosure to employers and patients, and duties to refer, [6] L.C. v. Peru, Communication No. 1153/2003, Human Rights Committee, para. 6.3, U.N. Doc. CCPR/C/85/D/1153/2003 (2005). to impart accurate information, and to provide urgently needed [7] Protocol to the African Charter on Human and Peoples’ Rights on the Rights care. Importantly, professional organizational voices can uphold of Women in Africa, adopted July 11, 2003, 2nd African Union Assembly, conformity with standards of care as the priority professional Maputo, Mozambique (entered into force 2005). commitment of clinicians, thus eliminating refusal as an option [8] World Medical Association. Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects. Adopted 1964. http://www. for the care of ectopic pregnancy, inevitable spontaneous abortion, wma.net/en/30publications/10policies/b3/. Accessed June 15, 2013. rape, and maternal illness. 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7 of 7 2/13/2020, 12:31 PM CHAPTER 1: OPINIONS ON PATIENT-PHYSICIAN RELATIONSHIPS

The Opinions in this chapter are offered as ethics guidance for physicians and are not intended to establish standards of clinical practice or rules of law.

1.1 Responsibilities of Physicians & Patients 1.1.1 Patient-Physician Relationships 1.1.2 Prospective Patients 1.1.3 Patient Rights 1.1.4 Patient Responsibilities 1.1.5 Terminating a Patient-Physician Relationship 1.1.6 Quality 1.1.7 Physician Exercise of Conscience 1.1.8 Physician Responsibilities for Safe Patient Discharge from Health Care Facilities

1.2 Special Issues in Patient-Physician Relationships 1.2.1 Treating Self or Family 1.2.2 Disruptive Behavior by Patients 1.2.3 Consultation, Referral & Second Opinions 1.2.4 Use of Chaperones 1.2.5 Sports Medicine 1.2.6 Work-Related & Independent Medical Examinations 1.2.7 Use of Restraints 1.2.8 Gifts from Patients 1.2.9 Use of Remote Sensing & Monitoring Devices 1.2.10 Political Action by Physicians 1.2.11 Ethically Sound Innovation in Medical Practice 1.2.12 Ethical Practice in Telemedicine



1.1.1 Patient-Physician Relationships

The practice of medicine, and its embodiment in the clinical encounter between a patient and a physician, is fundamentally a moral activity that arises from the imperative to care for patients and to alleviate suffering. The relationship between a patient and a physician is based on trust, which gives rise to physicians’ ethical responsibility to place patients’ welfare above the physician’s own self-interest or obligations to others, to use sound medical judgment on patients’ behalf, and to advocate for their patients’ welfare.

A patient-physician relationship exists when a physician serves a patient’s medical needs. Generally, the relationship is entered into by mutual consent between physician and patient (or surrogate).

However, in certain circumstances a limited patient-physician relationship may be created without the patient’s (or surrogate’s) explicit agreement. Such circumstances include:

(a) When a physician provides emergency care or provides care at the request of the patient’s treating physician. In these circumstances, the patient’s (or surrogate’s) agreement to the relationship is implicit. (b) When a physician provides medically appropriate care for a prisoner under court order, in keeping with ethics guidance on court-initiated treatment.

(c) When a physician examines a patient in the context of an independent medical examination, in keeping with ethics guidance. In such situations, a limited patient-physician relationship exists.

AMA Principles of Medical Ethics: I,II,IV,VIII

1.1.2 Prospective Patients

As professionals dedicated to protecting the well-being of patients, physicians have an ethical obligation to provide care in cases of medical emergency. Physicians must also uphold ethical responsibilities not to discriminate against a prospective patient on the basis of race, gender, sexual orientation or gender identity, or other personal or social characteristics that are not clinically relevant to the individual’s care. Nor may physicians decline a patient based solely on the individual’s infectious disease status. Physicians should not decline patients for whom they have accepted a contractual obligation to provide care.

However, physicians are not ethically required to accept all prospective patients. Physicians should be thoughtful in exercising their right to choose whom to serve.

A physician may decline to establish a patient-physician relationship with a prospective patient, or provide specific care to an existing patient, in certain limited circumstances:

(a) The patient requests care that is beyond the physician’s competence or scope of practice; is known to be scientifically invalid, has no medical indication, or cannot reasonably be expected to achieve the intended clinical benefit; or is incompatible with the physician’s deeply held personal, religious, or moral beliefs in keeping with ethics guidance on exercise of conscience.

(b) The physician lacks the resources needed to provide safe, competent, respectful care for the individual. Physicians may not decline to accept a patient for reasons that would constitute discrimination against a class or category of patients

(c) Meeting the medical needs of the prospective patient could seriously compromise the physician’s ability to provide the care needed by his or her other patients. The greater the prospective patient’s medical need, however, the stronger is the physician’s obligation to provide care, in keeping with the professional obligation to promote access to care.

(d) The individual is abusive or threatens the physician, staff, or other patients, unless the physician is legally required to provide emergency medical care. Physicians should be aware of the possibility that an underlying medical condition may contribute to this behavior.

AMA Principles of Medical Ethics: I,VI,VIII,X

1.1.3 Patient Rights

The health and well-being of patients depends on a collaborative effort between patient and physician in a mutually respectful alliance. Patients contribute to this alliance when they fulfill responsibilities they have, to seek care and to be candid with their physicians, for example.

Physicians can best contribute to a mutually respectful alliance with patients by serving as their patients’ advocates and by respecting patients’ rights. These include the right:

(a) To courtesy, respect, dignity, and timely, responsive attention to his or her needs.

(b) To receive information from their physicians and to have opportunity to discuss the benefits, risks, and costs of appropriate treatment alternatives, including the risks, benefits and costs of forgoing treatment. Patients should be able to expect that their physicians will provide guidance about what they consider the optimal course of action for the patient based on the physician’s objective professional judgment.

(c) To ask questions about their health status or recommended treatment when they do not fully understand what has been described and to have their questions answered.

(d) To make decisions about the care the physician recommends and to have those decisions respected. A patient who has decision-making capacity may accept or refuse any recommended medical intervention.

(e) To have the physician and other staff respect the patient’s privacy and confidentiality.

(f) To obtain copies or summaries of their medical records.

(g) To obtain a second opinion.

(h) To be advised of any conflicts of interest their physician may have in respect to their care.

(i) To continuity of care. Patients should be able to expect that their physician will cooperate in coordinating medically indicated care with other health care professionals, and that the physician will not discontinue treating them when further treatment is medically indicated without giving them sufficient notice and reasonable assistance in making alternative arrangements for care.

AMA Principles of Medical Ethics: I,IV,V,VIII,IX

1.1.4 Patient Responsibilities

Successful medical care requires ongoing collaboration between patients and physicians. Their partnership requires both individuals to take an active role in the healing process.

Autonomous, competent patients control the decisions that direct their health care. With that exercise of self-governance and choice comes a number of responsibilities. Patients contribute to the collaborative effort when they:

(a) Are truthful and forthcoming with their physicians and strive to express their concerns clearly. Physicians likewise should encourage patients to raise questions or concerns.

(b) Provide as complete a medical history as they can, including providing information about past illnesses, medications, hospitalizations, family history of illness, and other matters relating to present health.

(c) Cooperate with agreed-on treatment plans. Since adhering to treatment is often essential to public and individual safety, patients should disclose whether they have or have not followed the agreed-on plan and indicate when they would like to reconsider the plan.

(d) Accept care from medical students, residents, and other trainees under appropriate supervision. Participation in medical education is to the mutual benefit of patients and the health care system; nonetheless, patients’ (or surrogates’) refusal of care by a trainee should be respected in keeping with ethics guidance.

(e) Meet their financial responsibilities with regard to medical care or discuss financial hardships with their physicians. Patients should be aware of costs associated with using a limited resource like health care and try to use medical resources judiciously.

(f) Recognize that a healthy lifestyle can often prevent or mitigate illness and take responsibility to follow preventive measures and adopt health-enhancing behaviors.

(g) Be aware of and refrain from behavior that unreasonably places the health of others at risk. They should ask about what they can do to prevent transmission of infectious disease.

(h) Refrain from being disruptive in the clinical setting.

(i) Not knowingly initiate or participate in medical fraud.

(j) Report illegal or unethical behavior by physicians or other health care professionals to the appropriate medical societies, licensing boards, or law enforcement authorities.

AMA Principles of Medical Ethics: I,IV,VI

1.1.5 Terminating a Patient-Physician Relationship

Physicians’ fiduciary responsibility to patients entails an obligation to support continuity of care for their patients. At the beginning of patient-physician relationship, the physician should alert the patient to any foreseeable impediments to continuity of care.

When considering withdrawing from a case, physicians must :

(a) Notify the patient (or authorized decision maker) long enough in advance to permit the patient to secure another physician.

(b) Facilitate transfer of care when appropriate.

AMA Principles of Medical Ethics: I,VI

1.1.6 Quality

As professionals dedicated to promoting the well-being of patients, physicians individually and collectively share the obligation to ensure that the care patients receive is safe, effective, patient centered, timely, efficient, and equitable.

While responsibility for quality of care does not rest solely with physicians, their role is essential. Individually and collectively, physicians should actively engage in efforts to improve the quality of health care by:

(a) Keeping current with best care practices and maintaining professional competence.

(b) Holding themselves accountable to patients, families, and fellow health care professionals for communicating effectively and coordinating care appropriately.

(c) Monitoring the quality of care they deliver as individual practitioners—e.g., through personal case review and critical self-reflection, peer review, and use of other quality improvement tools.

(d) Demonstrating commitment to develop, implement, and disseminate appropriate, well- defined quality and performance improvement measures in their daily practice.

(e) Participating in educational, certification, and quality improvement activities that are well designed and consistent with the core values of the medical profession.

AMA Principles of Medical Ethics: I,V,VII,VIII

1.1.7 Physician Exercise of Conscience

Physicians are expected to uphold the ethical norms of their profession, including fidelity to patients and respect for patient self-determination. Yet physicians are not defined solely by their profession. They are moral agents in their own right and, like their patients, are informed by and committed to diverse cultural, religious, and philosophical traditions and beliefs. For some physicians, their professional calling is imbued with their foundational beliefs as persons, and at times the expectation that physicians will put patients’ needs and preferences first may be in tension with the need to sustain moral integrity and continuity across both personal and professional life.

Preserving opportunity for physicians to act (or to refrain from acting) in accordance with the dictates of conscience in their professional practice is important for preserving the integrity of the medical profession as well as the integrity of the individual physician, on which patients and the public rely. Thus physicians should have considerable latitude to practice in accord with well-considered, deeply held beliefs that are central to their self-identities.

Physicians’ freedom to act according to conscience is not unlimited, however. Physicians are expected to provide care in emergencies, honor patients’ informed decisions to refuse life-sustaining treatment, and respect basic civil liberties and not discriminate against individuals in deciding whether to enter into a professional relationship with a new patient.

In other circumstances, physicians may be able to act (or refrain from acting) in accordance with the dictates of their conscience without violating their professional obligations. Several factors impinge on the decision to act according to conscience. Physicians have stronger obligations to patients with whom they have a patient-physician relationship, especially one of long standing; when there is imminent risk of foreseeable harm to the patient or delay in access to treatment would significantly adversely affect the patient’s physical or emotional well-being; and when the patient is not reasonably able to access needed treatment from another qualified physician.

In following conscience, physicians should:

(a) Thoughtfully consider whether and how significantly an action (or declining to act) will undermine the physician’s personal integrity, create emotional or moral distress for the physician, or compromise the physician’s ability to provide care for the individual and other patients.

(b) Before entering into a patient-physician relationship, make clear any specific interventions or services the physician cannot in good conscience provide because they are contrary to the physician’s deeply held personal beliefs, focusing on interventions or services a patient might otherwise reasonably expect the practice to offer.

(c) Take care that their actions do not discriminate against or unduly burden individual patients or populations of patients and do not adversely affect patient or public trust.

(d) Be mindful of the burden their actions may place on fellow professionals.

(e) Uphold standards of informed consent and inform the patient about all relevant options for treatment, including options to which the physician morally objects.

(f) In general, physicians should refer a patient to another physician or institution to provide treatment the physician declines to offer. When a deeply held, well-considered personal belief leads a physician also to decline to refer, the physician should offer impartial guidance to patients about how to inform themselves regarding access to desired services.

(g) Continue to provide other ongoing care for the patient or formally terminate the patient-physician relationship in keeping with ethics guidance.

AMA Principles of Medical Ethics: I,II,IV,VI,VIII,IX

1.1.8 Physician Responsibilities for Safe Patient Discharge from Health Care Facilities

Physicians’ primary ethical obligation to promote the well-being of individual patients encompasses an obligation to collaborate in a discharge plan that is safe for the patient. As advocates for their patients, physicians should resist any discharge requests that are likely to compromise a patient’s safety. The discharge plan should be developed without regard to socioeconomic status, immigration status, or other clinically irrelevant considerations. Physicians also have a long-standing obligation to be prudent stewards of the shared societal resources with which they are entrusted. That obligation may require physicians to balance advocating on behalf of an individual patient with recognizing the needs of other patients.

To facilitate a patient’s safe discharge from an inpatient unit, physicians should:

(a) Determine that the patient is medically stable and ready for discharge from the treating facility; and

(b) Collaborate with those health care professionals and others who can facilitate a patient discharge to establish that a plan is in place for medically needed care that considers the patient’s particular needs

and preferences. If a medically stable patient refuses discharge, physicians should support the patient’s right to seek further review, including consultation with an ethics committee or other appropriate institutional resource.

AMA Principles of Medical Ethics: I,II,VIII

1.2.1 Treating Self or Family

Treating oneself or a member of one’s own family poses several challenges for physicians, including concerns about professional objectivity, patient autonomy, and informed consent.

When the patient is an immediate family member, the physician’s personal feelings may unduly influence his or her professional medical judgment. Or the physician may fail to probe sensitive areas when taking the medical history or to perform intimate parts of the physical examination. Physicians may feel obligated to provide care for family members despite feeling uncomfortable doing so. They may also be inclined to treat problems that are beyond their expertise or training.

Similarly, patients may feel uncomfortable receiving care from a family member. A patient may be reluctant to disclose sensitive information or undergo an intimate examination when the physician is an immediate family member. This discomfort may particularly be the case when the patient is a minor child, who may not feel free to refuse care from a parent.

In general, physicians should not treat themselves or members of their own families. However, it may be acceptable to do so in limited circumstances:

(a) In emergency settings or isolated settings where there is no other qualified physician available. In such situations, physicians should not hesitate to treat themselves or family members until another physician becomes available.

(b) For short-term, minor problems.

When treating self or family members, physicians have a further responsibility to:

(d) Recognize that if tensions develop in the professional relationship with a family member, perhaps as a result of a negative medical outcome, such difficulties may be carried over into the family member’s personal relationship with the physician.

(e) Avoid providing sensitive or intimate care especially for a minor patient who is uncomfortable being treated by a family member.

(f) Recognize that family members may be reluctant to state their preference for another physician or decline a recommendation for fear of offending the physician.

AMA Principles of Medical Ethics: I,II,IV

1.2.2 Disruptive Behavior by Patients

The relationship between patients and physicians is based on trust and should serve to promote patients’ well-being while respecting their dignity and rights.

Disrespectful or derogatory language or conduct on the part of either physicians or patients can undermine trust and compromise the integrity of the patient-physician relationship. It can make members of targeted groups reluctant to seek care, and create an environment that strains relationships among patients, physicians, and the health care team.

Trust can be established and maintained only when there is mutual respect. Therefore, in their interactions with patients, physicians should:

(a) Recognize that derogatory or disrespectful language or conduct can cause psychological harm to those they target.

(b) Always treat their patients with compassion and respect.

Terminate the patient-physician relationship with a patient who uses derogatory language or acts in a prejudicial manner only if the patient will not modify the conduct. In such cases, the physician should arrange to transfer the patient’s care.

AMA Principles of Medical Ethics: I,II,VI,IX

1.2.3 Consultation, Referral & Second Opinions

Physicians’ fiduciary obligation to promote patients’ best interests and welfare can include consulting other physicians for advice in the care of the patient or referring patients to other professionals to provide care.

When physicians seek or provide consultation about a patient’s care or refer a patient for health care services, including diagnostic laboratory services, they should:

(a) Base the decision or recommendation on the patient’s medical needs, as they would for any treatment recommendation, and consult or refer the patient to only health care professionals who have appropriate knowledge and skills and are licensed to provide the services needed.

(b) Share patients’ health information in keeping with ethics guidance on confidentiality.

(c) Assure the patient that he or she may seek a second opinion or choose someone else to provide a recommended consultation or service. Physicians should urge patients to familiarize themselves with any restrictions associated with their individual health plan that may bear on their decision, such as additional out-of-pocket costs to the patient for referrals or care outside a designated panel of providers.

(d) Explain the rationale for the consultation, opinion, or findings and recommendations clearly to the patient.

(e) Respect the terms of any contractual relationships they may have with health care organizations or payers that affect referrals and consultation.

Physicians may not terminate a patient-physician relationship solely because the patient seeks recommendations or care from a health care professional whom the physician has not recommended.

AMA Principles of Medical Ethics: IV,V,VI

1.2.4 Use of Chaperones

Efforts to provide a comfortable and considerate atmosphere for the patient and the physician are part of respecting patients’ dignity. These efforts may include providing appropriate gowns, private facilities for undressing, sensitive use of draping, and clearly explaining various components of the physical examination. They also include having chaperones available. Having chaperones present can also help prevent misunderstandings between patient and physician.

Physicians should:

(a) Adopt a policy that patients are free to request a chaperone and ensure that the policy is communicated to patients.

(b) Always honor a patient’s request to have a chaperone.

(c) Have an authorized member of the health care team serve as a chaperone. Physicians should establish clear expectations that chaperones will uphold professional standards of privacy and confidentiality.

(d) In general, use a chaperone even when a patient’s trusted companion is present.

(e) Provide opportunity for private conversation with the patient without the chaperone present. Physicians should minimize inquiries or history taking of a sensitive nature during a chaperoned examination.

AMA Principles of Medical Ethics: I,IV

1.2.5 Sports Medicine

Many professional and amateur athletic activities, including contact sports, can put participants at risk of injury. Physicians can provide valuable information to help sports participants, dancers, and others make informed decisions about whether to initiate or continue participating in such activities.

Physicians who serve in a medical capacity at athletic, sporting, or other physically demanding events should protect the health and safety of participants.

In this capacity, physicians should:

(a) Base their judgment about an individual’s participation solely on medical considerations.

(b) Not allow the desires of spectators, promoters of the event, or even the injured individual to govern a decision about whether to remove the participant from the event.

AMA Principles of Medical Ethics: I,VII

1.2.6 Work-Related & Independent Medical Examinations

Physicians who are employed by businesses or insurance companies, or who provide medical examinations within their realm of specialty as independent contractors, to assess individuals’ health or disability face a conflict of duties. They have responsibilities both to the patient and to the employer or third party.

Such industry-employed physicians or independent medical examiners establish limited patient-physician relationships. Their relationships with patients are confined to the isolated examination; they do not monitor patients’ health over time, treat them, or carry out many other duties fulfilled by physicians in the traditional fiduciary role.

In keeping with their core obligations as medical professionals, physicians who practice as industry- employed physicians or independent medical examiners should:

(a) Disclose the nature of the relationship with the employer or third party and that the physician is acting as an agent of the employer or third party before gathering health information from the patient.

(b) Explain that the physician’s role in this context is to assess the patient’s health or disability independently and objectively. The physician should further explain the differences between this practice and the traditional fiduciary role of a physician.

(d) Inform the patient about important incidental findings the physician discovers during the examination. When appropriate, the physician should suggest the patient seek care from a qualified physician and, if requested, provide reasonable assistance in securing follow-up care.

AMA Principles of Medical Ethics: I

1.2.7 Use of Restraints

All individuals have a fundamental right to be free from unreasonable bodily restraint. At times, however, health conditions may result in behavior that puts patients at risk of harming themselves. In such situations, it may be ethically justifiable for physicians to order the use of chemical or physical restraint to protect the patient.

Except in emergencies, patients should be restrained only on a physician’s explicit order. Patients should never be restrained punitively, for convenience, or as an alternate to reasonable staffing.

Physicians who order chemical or physical restraints should:

(a) Use best professional judgment to determine whether restraint is clinically indicated for the individual patient.

(b) Obtain the patient’s informed consent to the use of restraint, or the consent of the patient’s surrogate

when the patient lacks decision-making capacity. Physicians should explain to the patient or surrogate:

(i) why restraint is recommended;

(ii) what type of restraint will be used;

(iii) length of time for which restraint is intended to be used.

(c) Regularly review the need for restraint and document the review and resulting decision in the patient’s medical record.

In certain limited situations, when a patient poses a significant danger to self or others, it may be appropriate to restrain the patient involuntarily. In such situations, the least restrictive restraint reasonable should be implemented and the restraint should be removed promptly when no longer needed.

AMA Principles of Medical Ethics: I,IV

1.2.8 Gifts from Patients

Patients offer gifts to a physician for many reasons. Some gifts are offered as an expression of gratitude or a reflection of the patient’s cultural tradition. Accepting gifts offered for these reasons can enhance the patient-physician relationship.

Other gifts may signal psychological needs that require the physician’s attention. Some patients may offer gifts or cash to secure or influence care or to secure preferential treatment. Such gifts can undermine physicians’ obligation to provide services fairly to all patients; accepting them is likely to damage the patient-physician relationship.

The interaction of these factors is complex and physicians should consider them sensitively before accepting or declining a gift.

Physicians to whom a patient offers a gift should:

(a) Be sensitive to the gift’s value relative to the patient’s or physician’s means. Physicians should decline gifts that are disproportionately or inappropriately large, or when the physician would be uncomfortable to have colleagues know the gift had been accepted.

(b) Not allow the gift or offer of a gift to influence the patient’s medical care.

(c) Decline a bequest from a patient if the physician has reason to believe accepting the gift would present an emotional or financial hardship to the patient’s family.

(d) Physicians may wish to suggest that the patient or family make a charitable contribution in lieu of the bequest, in keeping with ethics guidance.

AMA Principles of Medical Ethics: I,II

1.2.9 Use of Remote Sensing & Monitoring Devices

Sensing and monitoring devices can benefit patients by allowing physicians and other health care professionals to obtain timely information about the patient’s vital signs or health status without

requiring an in-person, face-to-face encounter. Implantable devices can also enable physicians to identify patients rapidly and expedite access to patients’ medical records. Devices that transmit patient information wirelessly to remote receiving stations can offer convenience for both patients and physicians, enhance the efficiency and quality of care, and promote increased access to care, but also raise concerns about safety and the confidentiality of patient information.

Individually, physicians who employ remote sensing and monitoring devices in providing patient care should:

(a) Determine whether using one or more such devices is appropriate in light of individual patients’ medical needs and circumstances, including patients’ ability to use the chosen device appropriately.

(b) Explain how the device(s) will be used in the patient’s care and what will be expected of the patient in using the technology, and disclose any limitations, risks, or medical uncertainties associated with the device(s) and data transmission.

Collectively, physicians should:

(d) Support research into the safety, efficacy, and possible non-medical uses of remote sensing and monitoring devices, including devices intended to transmit biometric data and implantable radio frequency ID devices.

(e) Advocate for appropriate oversight of remote sensing and monitoring devices.

AMA Principles of Medical Ethics: I,III,V

1.2.10 Political Action by Physicians

Like all Americans, physicians enjoy the right to advocate for change in law and policy, in the public arena, and within their institutions. Indeed, physicians have an ethical responsibility to seek change when they believe the requirements of law or policy are contrary to the best interests of patients. However, they have a responsibility to do so in ways that are not disruptive to patient care.

Physicians who participate in advocacy activities should:

(a) Ensure that the health of patients is not jeopardized and that patient care is not compromised.

(b) Avoid using disruptive means to press for reform. Strikes and other collection actions may reduce access to care, eliminate or delay needed care, and interfere with continuity of care and should not be used as a bargaining tactic. In rare circumstances, briefly limiting personal availability may be appropriate as a means of calling attention to the need for changes in patient care. Physicians should be aware that some actions may put them or their organizations at risk of violating antitrust laws or laws pertaining to medical licensure or malpractice.

(c) Avoid forming workplace alliances, such as unions, with workers who do not share physicians’ primary and overriding commitment to patients.

(d) Refrain from using undue influence or pressure colleagues to participate in advocacy activities and should not punish colleagues, overtly or covertly, for deciding not to participate.

AMA Principles of Medical Ethics: I,III,VI

1.2.11 Ethically Sound Innovation in Medical Practice

Innovation in medicine can range from improving an existing intervention, to introducing an innovation in one’s own clinical practice for the first time, to using an existing intervention in a novel way or translating knowledge from one clinical context into another. Innovation shares features with both research and patient care, but is distinct from both.

When physicians participate in developing and disseminating innovative practices, they act in accord with professional responsibilities to advance medical knowledge, improve quality of care, and promote the well-being of individual patients and the larger community. Similarly, these responsibilities are honored when physicians enhance their own practices by expanding the range of techniques and interventions they offer to patients.

Individually, physicians who are involved in designing, developing, disseminating, or adopting innovative modalities should:

(a) Innovate on the basis of sound scientific evidence and appropriate clinical expertise.

(b) Seek input from colleagues or other medical professionals in advance or as early as possible in the course of innovation.

(c) Design innovations so as to minimize risks to individual patients and maximize the likelihood of application and benefit for populations of patients.

(d) Be sensitive to the cost implications of innovation; and

(e) Be aware of influences that may drive the creation and adoption of innovative practices for reasons other than patient or public benefit.

When they offer existing innovative diagnostic or therapeutic services to individual patients, physicians must:

(f) Base recommendations on patients’ medical needs.

(g) Refrain from offering such services until they have acquired appropriate knowledge and skills.

(h) Recognize that in this context informed decision making requires the physician to disclose:

(i) how a recommended diagnostic or therapeutic service differs from the standard therapeutic approach if one exists;

(ii) why the physician is recommending the innovative modality;

(iii) what the known or anticipated risks, benefits, and burdens of the recommended therapy and alternatives are;

(iv) what experience the professional community in general and the physician individually has had to date with the innovative therapy; and (v) what conflicts of interest the physician may have with respect to the recommended therapy.

(i) Discontinue any innovative therapies that are not benefiting the patient; and

(j) Be transparent and share findings from their use of innovative therapies with peers in some manner.

To promote patient safety and quality, physicians should share both immediate or delayed positive and negative outcomes.

To promote responsible innovation, the medical profession should:

(k) Require that physicians who adopt innovative treatment or diagnostic techniques into their practice have appropriate knowledge and skills.

(l) Provide meaningful professional oversight of innovation in patient care; and

(m) Encourage physician-innovators to collect and share information about the resources needed to implement their innovative therapies effectively.

AMA Principles of Medical Ethics: V,VIII

1.2.12 Ethical Practice in Telemedicine

Innovation in technology, including information technology, is redefining how people perceive time and distance. It is reshaping how individuals interact with and relate to others, including when, where, and how patients and physicians engage with one another.

Telehealth and telemedicine span a continuum of technologies that offer new ways to deliver care. Yet as in any mode of care, patients need to be able to trust that physicians will place patient welfare above other interests, provide competent care, provide the information patients need to make well-considered decisions about care, respect patient privacy and confidentiality, and take steps to ensure continuity of care. Although physicians’ fundamental ethical responsibilities do not change, the continuum of possible patient-physician interactions in telehealth/telemedicine give rise to differing levels of accountability for physicians.

All physicians who participate in telehealth/telemedicine have an ethical responsibility to uphold fundamental fiduciary obligations by disclosing any financial or other interests the physician has in the telehealth/telemedicine application or service and taking steps to manage or eliminate conflicts of interests. Whenever they provide health information, including health content for websites or mobile health applications, physicians must ensure that the information they provide or that is attributed to them is objective and accurate.

Similarly, all physicians who participate in telehealth/telemedicine must assure themselves that telemedicine services have appropriate protocols to prevent unauthorized access and to protect the security and integrity of patient information at the patient end of the electronic encounter, during transmission, and among all health care professionals and other personnel who participate in the telehealth/telemedicine service consistent with their individual roles.

Physicians who respond to individual health queries or provide personalized health advice electronically through a telehealth service in addition should:

(a) Inform users about the limitations of the relationship and services provided.

(b) Advise site users about how to arrange for needed care when follow-up care is indicated.

(c) Encourage users who have primary care physicians to inform their primary physicians about the online health consultation, even if in-person care is not immediately needed.

Physicians who provide clinical services through telehealth/telemedicine must uphold the standards of professionalism expected in in-person interactions, follow appropriate ethical guidelines of relevant specialty societies and adhere to applicable law governing the practice of telemedicine. In the context of telehealth/telemedicine they further should:

(d) Be proficient in the use of the relevant technologies and comfortable interacting with patients and/or surrogates electronically.

(e) Recognize the limitations of the relevant technologies and take appropriate steps to overcome those limitations. Physicians must ensure that they have the information they need to make well-grounded clinical recommendations when they cannot personally conduct a physical examination, such as by having another health care professional at the patient’s site conduct the exam or obtaining vital information through remote technologies.

(f) Be prudent in carrying out a diagnostic evaluation or prescribing medication by:

(i) establishing the patient’s identity; (ii) confirming that telehealth/telemedicine services are appropriate for that patient’s individual situation and medical needs; (iii) evaluating the indication, appropriateness and safety of any prescription in keeping with best practice guidelines and any formulary limitations that apply to the electronic interaction; and (iv) documenting the clinical evaluation and prescription.

(g) When the physician would otherwise be expected to obtain informed consent, tailor the informed consent process to provide information patients (or their surrogates) need about the distinctive features of telehealth/telemedicine, in addition to information about medical issues and treatment options. Patients and surrogates should have a basic understanding of how telemedicine technologies will be used in care, the limitations of those technologies, the credentials of health care professionals involved, and what will be expected of patients for using these technologies.

(h) As in any patient-physician interaction, take steps to promote continuity of care, giving consideration to how information can be preserved and accessible for future episodes of care in keeping with patients’ preferences (or the decisions of their surrogates) and how follow-up care can be provided when needed. Physicians should assure themselves how information will be conveyed to the patient’s primary care physician when the patient has a primary care physician and to other physicians currently caring for the patient.

Collectively, through their professional organizations and health care institutions, physicians should:

(i) Support ongoing refinement of telehealth/telemedicine technologies, and the development and implementation of clinical and technical standards to ensure the safety and quality of care.

(j) Advocate for policies and initiatives to promote access to telehealth/telemedicine services for all patients who could benefit from receiving care electronically.

(k) Routinely monitor the telehealth/telemedicine landscape to:

(i) identify and address adverse consequences as technologies and activities evolve; and (ii) identify and encourage dissemination of both positive and negative outcomes.

AMA Principles of Medical Ethics: I,IV,VI,IX

Code of Professional Ethics of the American College of Obstetricians and Gynecologists

Obstetrician–gynecologists, as members of the medical profession, have ethical responsibilities not only to patients, but also to society, to other health professionals and to themselves. The following ethical foundations for professional activities in the field of obstetrics and gynecology are the supporting structures for the Code of Conduct. The Code implements many of these foundations in the form of rules of ethical conduct. Certain documents of the American College of Obstetricians and Gynecologists also provide additional ethical rules, including documents addressing the following issues: seeking and giving consultation, informed consent, sexual misconduct, patient testing, relationships with industry, commercial enterprises in medical practice, and expert testimony. Noncompliance with the Code, including the above-referenced documents, may affect an individual’s initial or continuing Fellowship in the American College of Obstetricians and Gynecologists. These documents may be revised or replaced periodically, and Fellows should be knowledgeable about current information. Ethical Foundations I. The patient–physician relationship: The welfare of the patient (beneficence) is central to all considerations in the patient–physician relationship. Included in this relationship is the obligation of physicians to respect the rights of patients, colleagues, and other health professionals. The respect for the right of individual patients to make their own choices about their health care (autonomy) is fundamental. The principle of justice requires strict avoidance of discrimination on the basis of race, color, religion, national origin, sexual orientation, perceived gender, and any basis that would constitute illegal discrimination (justice). II. Physician conduct and practice: The obstetrician–gynecologist must deal honestly with patients and colleagues (veracity). This includes not misrepresenting himself or herself through any form of communication in an untruthful, misleading, or deceptive manner. Furthermore, maintenance of medical competence through study, application, and enhancement of medical knowledge and skills is an obligation of practicing physicians. Any behavior that diminishes a physician’s capability to practice, such as substance abuse, must be immediately addressed and rehabilitative services instituted. The physician should modify his or her practice until the dimin- ished capacity has been restored to an acceptable standard to avoid harm to patients (nonmaleficence). All physicians are obligated to respond to evidence of questionable conduct or unethical behavior by other physicians through appropriate procedures established by the relevant organization. III. Avoiding conflicts of interest: Potential conflicts of interest are inherent in the practice of medicine. Physicians are expected to recognize such situations and deal with them through public disclosure. Conflicts of interest should be resolved in accordance with the best interest of the patient, respecting a woman’s autonomy to make health care decisions. The physician should be an advocate for the patient through public disclosure of conflicts of interest raised by health payer policies or hospital policies. 409 12th Street, SW PO Box 96920 IV. Professional relations: The obstetrician–gynecologist should respect and cooperate with Washington, DC 20090-6920 other physicians, nurses, and health care professionals. 2 Code of Professional Ethics

V. Societal responsibilities: The obstetrician–gynecologist has a continuing responsibility to society as a whole and should support and participate in activities that enhance the community. As a member of society, the obstetrician–gynecologist should respect the laws of that society. As professionals and members of medical societies, physicians are required to uphold the dignity and honor of the profession. Code of Conduct I. Patient–Physician Relationship 1. The patient–physician relationship is the central focus of all ethical concerns, and the welfare of the patient must form the basis of all medical judgments. 2. The obstetrician–gynecologist should serve as the patient’s advocate and exercise all reasonable means to ensure that the most appropriate care is provided to the patient. 3. The patient–physician relationship has an ethical basis and is built on confidentiality, trust, and honesty. If no patient–physician relationship exists, a physician may refuse to provide care, except in emergencies. Once the patient–physician relationship exists, the obstetrician–gynecologist must adhere to all applicable legal or contractual constraints in dissolving the patient–physician relationship. 4. Sexual misconduct on the part of the obstetrician–gynecologist is an abuse of professional power and a violation of patient trust. Sexual contact or a romantic relationship between a physician and a current patient is always unethical. 5. The obstetrician–gynecologist has an obligation to obtain the informed consent of each patient. In obtaining informed consent for any course of medical or surgical treatment, the obstetrician–gynecologist must present to the patient, or to the person legally responsible for the patient, pertinent medical facts and recommendations consistent with good medical practice. Such information should be presented in reasonably under- standable terms and include alternative modes of treatment and the objectives, risks, benefits, possible complications, and anticipated results of such treatment. 6. It is unethical to prescribe, provide, or seek compensation for therapies that are of no benefit to the patient. 7. The obstetrician–gynecologist must respect the rights and privacy of patients, colleagues, and others and safeguard patient information and confidences within the limits of the law. If during the process of providing information for consent it is known that results of a particular test or other information must be given to governmental authorities or other third parties, that must be explained to the patient. 8. The obstetrician–gynecologist must not discriminate against patients on the basis of race, color, religion, national origin, sexual orientation, perceived gender, and any basis that would constitute illegal discrimination.

II. Physician Conduct and Practice 1. The obstetrician–gynecologist should recognize the boundaries of his or her particular competencies and expertise and must provide only those services and use only those techniques for which he or she is qualified by education, training, and experience.

2. The obstetrician–gynecologist should participate in continuing medical education activities to maintain current scientific and professional knowledge relevant to the medical services he or she renders. The obstetrician–gynecologist should provide medical care involving new therapies or techniques only after undertaking appropriate training and study. Code of Professional Ethics 3

3. In emerging areas of medical treatment where recognized medical guidelines do not exist, the obstetrician–gynecologist should exercise careful judgment and take appropriate precautions to protect patient welfare. 4. The obstetrician–gynecologist must not publicize or represent himself or herself in any untruthful, misleading, or deceptive manner to patients, colleagues, other health care professionals, or the public. 5. The obstetrician–gynecologist who has reason to believe that he or she is infected with a bloodborne pathogen or other serious infectious agent that might be communicated to patients should voluntarily be tested for the protection of his or her patients. In making decisions about patient-care activities, a physician infected with such an agent should adhere to the fundamental professional obligation to avoid harm to patients. 6. The obstetrician–gynecologist should not practice medicine while impaired by alcohol, drugs, or physical or mental disability. The obstetrician–gynecologist who experiences substance abuse problems or who is physically or emotionally impaired should seek appropriate assistance to address these problems and must limit his or her practice until the impairment no longer affects the quality of patient care.

III. Conflicts of Interest 1. Potential conflicts of interest are inherent in the practice of medicine. Conflicts of interest should be resolved in accordance with the best interest of the patient, respecting a woman’s autonomy to make health care decisions. If there is an actual or potential conflict of interest that could be reasonably construed to affect significantly the patient’s care, the physician must disclose the conflict to the patient. The physician should seek consultation with colleagues or an institutional ethics committee to determine whether there is an actual or potential conflict of interest and how to address it. 2. Commercial promotions of medical products and services may generate bias unrelated to product merit, creating or appearing to create inappropriate undue influence. The obstetrician–gynecologist should be aware of this potential conflict of interest and offer medical advice that is as accurate, balanced, complete, and devoid of bias as possible. 3. The obstetrician–gynecologist should prescribe drugs, devices, and other treatments solely on the basis of medical considerations and patient needs, regardless of any direct or indirect interests in or benefit from a pharmaceutical firm or other supplier. 4. When the obstetrician–gynecologist receives anything of substantial value, including royalties, from companies in the health care industry, such as a manufacturer of phar- maceuticals and medical devices, this fact should be disclosed to patients and colleagues when material. 5. Financial and administrative constraints may create disincentives to treatment otherwise recommended by the obstetrician–gynecologist. Any pertinent constraints should be disclosed to the patient.

IV. Professional Relations 1. The obstetrician–gynecologist’s relationships with other physicians, nurses, and health care professionals should reflect fairness, honesty, and integrity, sharing a mutual respect and concern for the patient. 2. The obstetrician–gynecologist should consult, refer, or cooperate with other physicians, health care professionals, and institutions to the extent necessary to serve the best interests of their patients. 4 Code of Professional Ethics

V. Societal Responsibilities 1. The obstetrician–gynecologist should support and participate in those health care programs, practices, and activities that contribute positively, in a meaningful and cost-effective way, to the welfare of individual patients, the health care system, or the public good. 2. The obstetrician–gynecologist should respect all laws, uphold the dignity and honor of the profession, and accept the profession’s self-imposed discipline. The professional competence and conduct of obstetrician–gynecologists are best examined by professional associations, hospital peer-review committees, and state medical and licensing boards. These groups deserve the full participation and cooperation of the obstetrician– gynecologist. 3. The obstetrician–gynecologist should strive to address through the appropriate procedures the status of those physicians who demonstrate questionable competence, impairment, or unethical or illegal behavior. In addition, the obstetrician–gynecologist should cooperate with appropriate authorities to prevent the continuation of such behavior. 4. The obstetrician–gynecologist must not knowingly offer testimony that is false. The obstetrician–gynecologist must testify only on matters about which he or she has knowledge and experience. The obstetrician–gynecologist must not knowingly misrepresent his or her credentials. 5. The obstetrician–gynecologist testifying as an expert witness must have knowledge and experience about the range of the standard of care and the available scientific evidence for the condition in question during the relevant time and must respond accurately to questions about the range of the standard of care and the available scientific evidence. 6. Before offering testimony, the obstetrician–gynecologist must thoroughly review the medical facts of the case and all available relevant information.

7. The obstetrician–gynecologist serving as an expert witness must accept neither disproportionate compensation nor compensation that is contingent upon the outcome of the litigation.

Copyright December 2018 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC 20090-6920. This document provides rules for ethical conduct for obstetricians and gynecologists. ~-/"-,-_ -_-_/- -_ - -- < __ - : --_ - - _- ACOG tfil')~[~ IT"Jiel= ().ffllll>N

Number 385 • November 2007 The Limits of Conscientious Refusal in Reproductive Medicine

Committee on Ethics ABSTRACT: Health care providers occasionally may find that providing indicated, even standard, care would present for them a personal moral problem-a conflict of con Reaffirmed 2019 science-particularly in the field of reproductive medicine. Although respect for con science is important, conscientious refusals should be limited if they constitute an imposition of rel'1gious or moral beliefs on patients, negatively affect a patient's health, are based on scientific misinformation, or create or reinforce racial or socioeconomic inequalities. Conscientious refusals that conflict with patient well-being should be accom modated only if the primary duty to the patient can be fulfilled. All health care providers must provide accurate and unbiased information so that patients can make informed deci sions. Where conscience implores physicians to deviate from standard practices, they must provide potential patients with accurate and prior notice of their personal moral com mitments. Physici@ns and other health care providers have the duty to refer patients in a timely manner to other providers if they do not feel that they can in conscience provide the standard reproductive services that patients request. In resource-poor areas, access to safe and legal reproductive services should be maintained. Providers with moral or reli gious objections should either practice in proximity to individuals who do not share their views or ensure that referral processes are in place. In an emergency in which referral is not possible or might negatively have an impact on a patient's physical or mental health, providers have an obligation to provide medically indicated and requested care.

Physicians and other providers may not contraception, arguing that dispensing the always agree with the decisions patients make medication was a "violation of morals" (2). about their own health and health care. Such In Virginia, a 42-year-old mother of two was differences are expected-and, indeed, refused a prescription for emergency contra underlie the American model of informed ception, became pregnant, and ultimately consent and respect for patient autonomy. underwent an abortion she tried to prevent Occasionally, however, providers anticipate by requesting emergency contraception (3). that providing indicated, even standard, care In California, a physician refused to perform would present for them a personal moral intrauterine insemination for a lesbian cou problem-a conflict of conscience, It1 such ple, prompted by religious beliefs and disap cases, some providers claim a right to refuse proval of lesbians having children (4). In to provide certain services, refuse to refer Nebraska, a 19-yeat-old woman with a. life patients to another provider for these servic threatening pulmonary embolism at 10 weeks es, or even decline to inform patients of their of gestation was refused a first-trimester preg existing options (1). nancy termination when admitted to a reli Conscientious refusals have been partic giously affiliated hospital and was ultimately ularly widespread in the arena of reproduc transferred by ambulance to another facility The American College tive medicine, in which there are deep to undergo the procedure (5). At the heart of of Obstetricians divisions regarding the moral acceptability of each of these examples of refusal is a claim of ·and Gynecologists pregnancy termination and contraception. In conscience-a claim that to provide certain Womens Health Care Texas, for example, a pharmacist rejected a services would compromise the moral Physicians rape victim's prescription for emergency integrity of a provider or institution. In this opinion, the American College of Obste external authority violate the goals of medicine and his or tricians and Gynecologists (ACOG) Committee on Ethics her fiduciary obligations to the patient. Established clini considers the issues raised by conscientious refusals in cal norms may come into conflict with guidelines imposed reproductive medicine and outlines a framework for by law, regulation, or public policy. For example, policies defining the ethically appropriate limits of conscientious that mandate physician reporting of undocumented refusal in reproductive health contexts. The committee patients to immigration authorities conflict with norms begins by offering a definition of conscience and describ such as privacy and confidentiality and the primary prin ing what might constitute an authentic claim of con ciple of nonmaleficence that govern the provider-patient science. Next, it discusses the limits of conscientious relationship (10). Such challenges to integrity can result in refusals, describing how claims of conscience should be considerable moral distress for providers and are best met weighed in the context of other values critical to the eth through organized advocacy on the part of professional ical provision of health care. It then outlines options for organizations (11, 12). When threats to patient well-being public policy regarding conscientious refusals in repro and the health care professional's integrity are at issue, ductive medicine. Finally, the committee proposes a series some individual providers find a conscience-based refusal of recommendations that maximize accommodation of to comply with policies and acceptance of any associated an individual's religious or moral beliefs while avoiding professional and personal consequences to be the only imposition of these beliefs on others or interfering with morally tenable course of action (10). the safe, timely, and financially feasible access to repro Claims of conscience are not always genuine. They ductive health care that all women deserve. may mask distaste for certain procedures, discriminatory attitudes, or other self-interested motives (13). Providers Defining Conscience who decide not to perform abortions primarily because In this effort to reconcile the sometimes competing they find the procedure unpleasant or because they fear demands of religious or moral freedom and reproductive criticism from those in society who advocate against it do rights, it is important to characterize what is meant by not have a genuine claim of conscience. Nor do providers conscience. Conscience has been defined as the private, who refuse to provide care for individuals because of fear constant, ethically attuned part of the human character. It of disease transmission to themselves or other patients. operates as an internal sanction that comes into play Positions that are merely self-protective do not constitute through critical reflection about a certain action or inac the basis for a genuine claim of conscience. Furthermore, tion (6). An appeal to conscience would express a senti the logic of conscience, as a form of self-reflection on and ment such as "If I were to do 'x,' I could not live with judgment about whether one's own acts are obligatory or myself/I would hate myself/I wouldn't be able to sleep at prohibited, means that it would be odd or absurd to say "I night:' According to this definition, not to act in accor would have a guilty conscience if she did 'x."' Although dance with one's conscience is to betray oneself-to risk some have raised concerns about complicity in the con personal wholeness or identity. Thus, what is taken seri text of referral to another provider for requested medical ously and is the specific focus of this document is not sim care, the logic of conscience entails that to act in accor ply a broad claim to provider autonomy (7), but rather the dance with conscience, the provider need not rebuke particular claim to a provider's right to protect his or her other providers or obstruct them from performing an act moral integrity-to uphold the "soundness, reliability, (8). Finally, referral to another· provider need not be wholeness and integration of [one's] moral character" (8). conceptualized as a repudiation or compromise of one's Personal conscience, so conceived, is not merely a own values, but instead can be seen as an acknowledg source of potential conflict. Rather, it has a critical and ment of both the widespread and thoughtful disagree useful place in the practice of medicine. In many cases, it ment among physicians and society at large and the moral can foster thoughtful, effective, and humane care. Ethical sincerity of others with whom one disagrees (14). decision making in medicine often touches on individu The authenticity of conscience can be assessed als' deepest identity-conferring beliefs about the nature through inquiry into 1) the extent to which the underly and meaning of creating and sustaining life (9). Yet, con ing values asserted constitute a core component of a science also may conflict with professional and ethical provider's identity, 2) the depth of the provider's reflec standards and result in inefficiency, adverse outcomes, tion on the issue at hand, and 3) the likelihood that the violation of patients' rights, and erosion of trust if, for provider will experience guilt, shame, or loss of self example, one's conscience limits the information or care respect by performing the act in question (9). It is the provided to a patient. Finding a balance between respect genuine claim of conscience that is considered next, in the for conscience and other important values is critical to context of the values that guide ethical health care. th~ ethical practice of medicine. In some circumstances, respect for conscience must Defining Limits for Conscientious be weighed against respect for particular social values. Refusal Challenges to a health care professional's integrity may Even when appeals to conscience are genuine, when a occur when a practitioner feels that actions required by an provider's moral integrity is truly at stake, there are clear-

2 ACOG Committee Opinion No. 385 ly limits to the degree to which appeals to conscience may appropriate reproductive health care. Providing com justifiably guide decision making. Although respect for plete, scientifically accurate information about options conscience is a value, it is only a prima facie value, which for reproductive health, including contraception, sterili means it can and should be overridden in the interest of zation, and abortion, is fundamental to respect for patient other moral obligations that outweigh it in a given cir autonomy and forms the basis of informed decision mak cumstance. Professional ethics requires that health be ing in reproductive medicine. Providers refusing to pro delivered in a way that is respectful of patient autonomy, vide such information on the grounds of moral or timely and effective, evidence based, and nondiscrimina religious objection fail in their fundamental duty to tory. By virtue of entering the profession of medicine, enable patients to make decisions for themselves. When physicians accept a set of moral values-and duties--that the potential for imposition and breach of autonomy is are central to medical practice (15). Thus, with profes high due either to controlling constraints on medication sional privileges come professional responsibilities to or procedures or to the provider's withholding of infor patients, which must precede a provider's personal inter mation critical to reproductive decision making, consci ests (16). When conscientious refusals conflict with moral entious refusal cannot be justified. obligations that are central to the ethical practice of med icine, ethical care requires either that the physician pro 2. Effect on Patient Health vide care despite reservations or that there be resources in A second important consideration in evaluating consci place to allow the patient to gain access to care in the pre entious refusal is the impact such a refusal might have on sence of conscientious refusal. In the following sections, well-being as the patient perceives it-in particular, the four criteria are highlighted as important in determining potential for harm. For the purpose of this discussion, appropriate limits for conscientious refusal in reproduc harm refers to significant bodily harm, such as pain, dis tive health contexts. ability, or death or a patient's conception of well-being. Those who choose the profession of medicine (like those 1. Potential for Imposition who choose the profession oflaw or who are trustees) are The first important consideration in defining limits for bound by special fiduciary duties, which oblige physicians conscientious refusal is the degree to which a refusal con to act in good faith to protect patients' health-particu stitutes an imposition on patients who do not share the larly to the extent that patients' health interests conflict objector's beliefs. One of the guiding principles in the with physicians' personal or self-interest (16). Although practice of medicine is respect for patient autonomy, conscientious refusals stem in part from the commitment a principle that holds that persons should be free to to "first, do no harm," their result can be just the opposite. choose and act without controlling constraints imposed For example, religiously based refusals to perform tubal by others. To respect a patient's autonomy is to respect her sterilization at the time of cesarean delivery can place a capacities and perspectives, including her right to hold woman in harm's way-either by putting her at risk for certain views, make certain choices, and take certain an undesired or unsafe pregnancy or by necessitating an actions based on personal values and beliefs (17). Respect additional, separate sterilization procedure with its atten involves acknowledging decision-making rights and act dant and additional risks. ing in a way that enables patients to make choices for Some experts have argued that in the context of preg themselves. Respect for autonomy has particular impor nancy, a moral obligation to promote fetal well-being also tance in reproductive decision making, which involves should justifiably guide care. But even though views private, personal, often pivotal decisions about sexuality about the moral status of the fetus and the obligations and childbearing. that status confers differ widely, support of such moral It is not uncommon for conscientious refusals to pluralism does not justify an erosion of clinicians' basic result in imposition of religious or moral beliefs on a obligations to protect the safety of women who are, pri patient who may not share these beliefs, which may marily and unarguably, their patients. Indeed, in the vast undermine respect for patient autonomy. Women's majority of cases, the interests of the pregnant woman informed requests for contraception or sterilization, for and fetus converge. For situations in which their interests example, are an important expression of autonomous diverge, the pregnant woman's autonomous decisions choice regarding reproductive decision making. Refusals should be respected (18). Furthermore, in situations "in to dispense contraception may constitute a failure which maternal competence for medical decision making to respect women's capacity to decide for themselves is impaired, health care providers should act in the best whether and under what circumstances to become interests of the woman first and her fetus second" ( 19). pregnant. Similar issues arise when patients are unable to 3. Scientific Integrity obtain medication that has been prescribed by a physi The third criterion for evaluating authentic conscientious cian. Although pharmacist conduct is beyond the scope of refusal is the scientific integrity of the facts supporting the this document, refusals by other professionals can have an objector's claim. Core to the practice of medicine is a important impact on a physician's efforts to provide commitment to science and evidence-based practice.

ACOG Committee Opinion No. 385 3 Patients rightly expect care guided by best evidence as manner. One conception of justice, sometimes referred to well as information based on rigorous science. When con as the distributive paradigm, calls for fair allocation of scientious refusals reflect a misunderstanding or mistrust society's benefits and burdens. Persons intending consci of science, limits to conscientious refusal should be entious refusal should consider the degree to which they defined, in part, by the strength or weakness of the science create or reinforce an unfair distribution of the benefits of on which refusals are based. In other words, claims of reproductive technology. For instance, refusal to dispense conscientious refusal should be considered invalid when contraception may place a disproportionate burden on the rationale for a refusal contradicts the body of scien disenfranchised women in resource-poor areas. Whereas tific evidence. a single, affluent professional might experience such a The broad debate about refusals to dispense emer refusal as inconvenient and seek out another physician, a gency contraception, for example, has been complicated young mother of three depending on public transporta by misinformation and a prevalent belief that emergency tion might find such a refusal to be an insurmountable contraception acts primarily by preventing implantation barrier to medication because other options are not real (20). However, a large body of published evidence sup istically available to her. She thus may experience loss of ports a different primary mechanism of action, namely control of her reproductive fate and quality of life for her the prevention of fertilization. A review of the literature self and her children. Refusals that unduly burden the indicates that Plan B can interfere with sperm migration most vulnerable of society violate the core commitment and that preovulatory use of Plan B suppresses the to justice in the distribution of health resources. luteinizing hormone surge, which prevents ovulation or Anothet conception of justice is concerned with leads to the release of ova that are resistant to fertilization. matters of oppression as well as distribution (24). Thus, Studies do not support a major postfertilization mecha the impact of conscientious refusals on oppression of cer nism of action (21). Although even a slight possibility of tain groups of people should guide limits for claims of postfertilization events may be relevant to some women's conscience as well. Consider, for instance, refusals to decisions about whether to use contraception, provider provide infertility services to same-sex couples. It is likely refusals to dispense emergency contraception based on that such couples would be able to obtain infertility ser unsupported beliefs about its primary mechanism of vices from another provider and would not have their action should not be justified. health jeopardized, per se. Nevertheless, allowing physi In the context of the morally difficult and highly con cians to discriminate on the basis of sexual orientation tentious debate about pregnancy termination, scientific would constitute a deeper insult, namely reinforcing the integrity is one of several important considerations. For scientifically unfounded idea that fitness to parent is example, some have argued against providing access to based on sexual orientation, and, thus, reinforcing the abortion based on claims that induced abortion is associ oppressed status of same-sex couples. The concept of ated with an increase in breast cancer risk; however, a oppression raises the implications of all conscientious 2003 U.S. National Cancer Institute panel concluded that refusals for gender justice in general. Legitimizing refusals there· is well-established epidemiologic evidence that in reproductive contexts may reinforce the tendency to induced abortion and breast cancer are not associated value women primarily with regard to their capacity for (22). Refusals to provide abortion should not be justified reproduction while ignoring their interests and rights on the basis of unsubstantiated health risks to women. as people more generally. As the place of conscience Scientific integrity is particularly important at the in reproductive medicine is considered, the impact of level of public policy, where unsound appeals to science permissive policies toward conscientious refusals on the may have masked an agenda based on religious beliefs. status of women must be considered seriously as well. Delays in granting over-the-counter status for emergency Some might say that it is not the job of a physician to contraception are one such example. Critics of the U.S. "fix" social inequities. However, it is the responsibility, Food and Drug Administration's delay cited deep flaws in whenever possible, of physicians as advocates for patients' the science and evidence used to justify the delay, flaws needs and rights not to create or reinforce racial or socio these critics argued were indicative of unspoken and mis economic inequalities in society. Thus, refusals that create placed value judgments (23 ). Thus, the scientific integrity or reinforce such inequalities should raise significant of a claim of refusal is an important metric in determin caution. ing the acceptability of conscience-based practices or Institutional and Organizational policies. Responsibilities 4. Potential for Discrimination Given these limits, individual practitioners may face diffi Finally, conscientious refusals should be evaluated on the cult decisions about adherence to conscience in the con basis of their potential for discrimination. Justice is a text of professional responsibilities. Some have offered, complex and important concept that requires medical however, that "accepting a collective obligation does not professionals and policy makers to treat individuals fairly mean that all members of the profession are forced to vio and to provide medical services in a nondiscriminatory late their own consciences" (1). Rather, institutions and

ACOG Committee Opinion No. 385 4 professional organizations should work to create and science provide the standard reproductive services maintain organizational structures that ensure nondis that their patients request. criminatory access to all professional services and mini 5. In an emergency in which referral is not possible or mize the need for individual practitioners to act in might negatively affect a patient's physical or mental opposition to their deeply held beliefs. This requires at the health, providers have an obligation to provide med very least that systems be in place for counseling and ically indicated and requested c.are regardless of the referral, particularly in resource-poor areas where consci provider's personal moral objections. entious refusals have significant potential to limit patient 6. In resource-poor areas, access to safe and legal repro choice, and that individuals and institutions "act affirma ductive services should be maintained. Conscien tively to protect patients from unexpected and disruptive tious refusals that undermine access should raise denials of service" (13 ). Individuals and institutions significant caution. Providers with moral or religious should support staffing that does not place practitioners objections should either practice in proximity to or facilities in situations in which the harms and thus individuals who do not share their views or ensure conflicts from conscientious refusals are likely to arise. that referral processes are in place so that patients For example, those who feel it improper to prescribe have access to the service that the physician does not emergency contraception should not staff sites, such as wish to provide. Rights to withdraw from caring for emergency rooms, in which such requests are likely to an individual should not be a pretext for interfering arise, and prompt disposition of emergency contra with patients' rights to health care services. ception is required and often integral to professional practice. Similarly, institutions that uphold doctrinal 7. Lawmakers should advance policies that balance pro objections should not position themselves as primary tection of providers' consciences with the critical providers of emergency care for victims of sexual assault; goal of ensuring timely, effective, evidence-based, when such patients do present for care, they should be and safe access to all women seeking reproductive given prophylaxis. Institutions should work toward struc services. tures that reduce the impact on patients of professionals' refusals to provide standard reproductive services. References 1. Charo RA. The celestial fire of conscience-refusing to Recommendations deliver medical care. N Engl J Med 2005;352:2471-3. Respect for conscience is one of many values important to 2. Denial of rape victim's pills raises debate: moral, legal ques the ethical practice of reproductive medicine. Given this tions surround emergency contraception, New York (NY): framework for analysis, the ACOG Committee on Ethics Associated Press; 2004, Available at: http://www.msnbc. proposes the following recommendations, which it msn.com/id/4359430. Retrieved July 10, 2007. believes maximize respect for health care professionals' 3. L D. What happens when there is no plan B? Washington consciences without compromising the health and well Post; June 4, 2006. p. Bl. Available at: http://www. being of the women they serve. washingtonpost.com/wp-dyn/content/article/2006/06/02/ AR2006060201405.html. Retrieved July 10, 2007. 1. In the provision of reproductive services, the 4. Weil E. Breeder reaction: does everyone now have a right patient's well-being must be paramount. Any consci to bear children? Mother Jones 2006;31(4):33-7. Available entious refusal that conflicts with a patient's well at: http://www.motherjones.com/news/feature/2006/07 / being should be accommodated only if the primary breeder_reaction.html. Retrieved July 10, 2007. duty to the patient can be fulfilled. 5. American Civil Liberties Union. Religious refusals and 2. Health care providers must impart accurate and unbi reproductive rights: ACLU Reproductive Freedom Project. ased information so that patients can make informed New York (NY): ACLU; 2002. Available at: http://www.aclu. decisions about their health care. They must disclose org/FilesPDFs/ACF911.pdf. Retrieved July 10, 2007. scientifically accurate and professionally accepted 6. Childress JF. Appeals to conscience, Ethics 1979;89:315-35. characterizations of reproductive health services. 7. Wicclair MR. Conscientious objection in medicine. 3. Where conscience implores physicians to deviate Bioethics 2000;14:205-27. from standard practices, including abortion, sterili- 8. Beauchamp TL, Childress JF. Principles of biomedical ethics . . zation, and provision of contraceptives, they must 5th ed. New York (NY): Oxford University Press; 2001. provide potential patients with accurate and prior 9, Benjamin M. Conscience. In: Reich WT, editor. Encyclo notice of their personal moral commitments. In the pedia of bioethics. New York (NY): Simon & Schuster process of providing prior notice, physicians should Macmillan; 1995. p. 469-73. not use their professional authority to argue or advo 10. Ziv TA, Lo B. Denial of care to illegal immigrants. cate these positions. Proposition 187 in California. N Engl J Med 1995;332: 4. Physicians and other health care professionals have 1095-8, the duty to refer patients in a timely manner to other 11. American College of Obstetricians and Gynecologists. Code providers if they do not feel that they can in con- of professional ethics of the American College of Obste-

5 ACOG Committee Opinion No. 385 tricians and Gynecologists. Washington, DC: ACOG; 2004. www.figo.org/docs/Ethics%20Guidelines.pdf. Retrieved Available at: http://www.acog.org/from_home/acogcode. July 10, 2007. pdf. Retrieved July 10, 2007. 20. Cantor J, Baum K. The limits of conscientious objection 12. American Medical Association. Principles of medical ethics. may pharmacists refuse to fill prescriptions for emergency In: Code of medical ethics of the American Medical contraception? N Engl J Med 2004;351:2008-12. Association: current opinions with annotations. 2006-2007 21. Davidoff F, Trussell J. Plan B and the politics of doubt. ed. Chicago (IL): AMA; 2006. p. xv. JAMA 2006;296: 1775-8. 13. Dresser R. Professionals, conformity, and conscience. 22. Induced abortion and breast cancer risk. ACOG Committee Hastings Cent Rep 2005;35:9-10. Opinion No. 285. American College of Obstetricians and 14. Blustein J. Doing what the patient orders: maintaining Gynecologists. Obstet Gynecol 2003;102:433-5. · integrity in the doctor-patient relationship. Bioethics 23. Grimes DA. Emergency contraception: politics trumps sci 1993;7:290-314. ence at the U.S. Food and Drug Administration. Obstet 15. Brody H, Miller FG. The internal morality of medicine: Gynecol 2004;104:220-1. explication and application to managed care. J Med Philos 24. Young IM, Justice and the politics of difference. Princeton l 998;23:384-410. (NJ): Princeton University Press; 1990. 16. Dickens BM, Cook RJ. Conflict of interest: legal and ethical aspects. Int J Gynaecol Obstet 2006;92:192-7. 17. Faden RR, Beauchamp TL. A history and theory of Copyright © November 2007 by the American College of Obstet· informed consent. New York (NY): Oxford University ricians and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC 20090-6920. All rights reserved. No part of this pub Press; 1986. lication may be reproduced, stored in a retrieval system, posted on 18. Maternal decision making, ethics, and the law. ACOG the Internet, or transmitted, in any form or by any means, electronic, Committee Opinion No. 321. American College of mechanical, photocopying, recording, or otherwise, without prior writ ten permission from the publisher. Requests for authorization to make Obstetricians and Gynecologists. Obstet Gynecol 2005;106: photocopies should be directed to: Copyright Clearance Center, 222 1127-37. Rosewood Drive, Danvers, MA 01923, (978) 750-8400. 19. International Federation of Gynecology and Obstetrics. The limits of conscientious refusal in reproductive medicine. AGOG Ethical guidelines regarding interventions for fetal well Committee Opinion No. 385. American College of Obstetricians and being. In: Ethical issues in obstetrics and gynecology. Gynecologists. Obstet Gynecol 2007; 11 O: 1203-8. London (UK): FIGO; 2006. p. 56-7. Available at: http:// ISSN 1074-861X GUTTMACHER POLICY REVIEW GPR | 2018 Vol. 21 REPRODUCTIVE HEALTH IN CRISIS: A SPECIAL SERIES

Unbiased Information on and Referral for All Pregnancy Options Are Essential to Informed Consent in Reproductive Health Care

By Kinsey Hasstedt HIGHLIGHTS patient’s ability to give informed consent to care is a bedrock principle of modern • One aspect of ensuring informed consent in reproductive medical practice in the United States. The health care requires that women be offered complete, Aprinciple of informed consent centers accurate and unbiased information on all pregnancy on an individual’s well-being and right to self- options—including parenting, adoption and abortion—and determination, and requires that patients be given referrals for additional services as needed. all relevant information on their condition and • The right to provide informed consent has long been possible treatment options or outcomes in order threatened by antiabortion policymakers and advocates to make voluntary decisions about their care, in seeking to keep women from receiving factual information conjunction with their health care providers. about abortion and referral for abortion services.

Informed consent is deeply rooted in legal, ethi- • Restricting comprehensive counseling and referrals for all pregnancy options seriously jeopardizes women’s health cal and medical standards developed over the and well-being. course of decades. Major U.S. professional medical organizations have defined what informed consent means in practice. The American Medical Association, for example, states in its Code of term, and then choosing either parenting or adop- Medical Ethics that clinicians should “present tion. Such ideologically driven interventions would relevant information accurately and sensitively, clearly undermine women’s ability to provide truly in keeping with the patient’s preferences”1 and informed consent to their own reproductive health asserts that “withholding information without care, with damaging consequences for their health the patient’s knowledge or consent is ethically and well-being. unacceptable.”2 Nondirective pregnancy options counseling and Policymakers and advocates opposed to abortion referral is essential for informed consent. The have long sought to undermine this fundamental guidelines of a number of leading professional standard of care, particularly when it comes to medical organizations specifically address the women’s right to complete, medically accurate need for comprehensive, unbiased information and unbiased information and resources for all on and referral for all of a woman’s pregnancy of their pregnancy options—often referred to as options—parenting, adoption or abortion—as a “nondirective pregnancy options counseling and fundamental component of a patient’s right to referral.” Specifically, abortion foes aim to force self-determination. clinicians to inappropriately withhold information about abortion and referral for abortion services. In 2015, the American College of Obstetricians and This means women would only receive informa- Gynecologists (ACOG) reaffirmed a 2009 com- tion on and resources for carrying a pregnancy to mittee opinion stressing that patient autonomy

Guttmacher Policy Review | Vol. 21 | 2018 www.guttmacher.org 1 is especially critical when it comes to women’s A position statement issued in 1989 and reaf- sexual and reproductive health. ACOG asserts that firmed in 2016 by the Association of Women’s all providers, even those who personally object Health, Obstetric and Neonatal Nurses supports to abortion, “must provide the patient with accu- and promotes a patient’s right to “evidence-based, rate and unbiased information about her medical accurate, and complete information and access to options and make appropriate referrals.”3 ACOG the full range of reproductive health care services,” further notes that “informed consent includes and specifically opposes policies that limit health freedom from external coercion, manipulation, care professionals’ ability to counsel patients on or infringement of bodily integrity.” In its most their pregnancy options and to provide referrals if recent Guidelines for Women’s Health Care, ACOG needed.7 expressly addresses nondirective options counseling for women experiencing unintended preg- Collectively, these organizations echo the nancy, recommending that all patients, including President’s Commission for the Study of Ethical adolescents, “should be counseled about [their] Problems in Medicine and Biomedical and options: continuing the pregnancy to term and Behavioral Research, which consisted of leading raising the infant, continuing the pregnancy to experts in research, law, medicine and medical term and placing the infant for legal adoption, or ethics. The commission issued a seminal 1982 terminating the pregnancy.”4 These guidelines also report on the ethical and legal implications of advise that providers follow a patient’s wishes informed consent that concluded patients must regarding any resources that should be offered be able to make decisions voluntarily and must to her partner and, if the patient is a dependent be provided with “all relevant information regard- adolescent, what information should be shared ing their condition and alternative treatments.” with her parents (in accordance with relevant state Moreover, the commission advised health care law). professionals not to withhold or distort information with the intent to influence patients’ deci- The American Academy of Pediatrics (AAP) is simi- sions: “A choice that has been coerced, or that larly explicit in its policy regarding counseling and resulted from serious manipulation of a person’s referral for adolescents, which states that pediatri- ability to make an intelligent and informed deci- cians “should be able to make a timely diagnosis sion, is not the person’s own free choice.”8 and to help the adolescent understand her options and act on her decision to continue or terminate Federal guidelines uphold nondirective pregnancy her pregnancy.”5 The organization further declares options counseling and referral. The most notable that practitioners are not entitled to let their own example is the Title X national family planning pro- views diminish this standard of care, and that an gram. Administered by the U.S. Office of Population adolescent who is pregnant deserves to be sup- Affairs (OPA), Title X has been the only federal ported regardless of her decision. program dedicated to advancing the availability of high-quality family planning services in the United The American Academy of Physician Assistants States since its inception in 1970. The statute, regu- (AAPA) states in its Guidelines for Ethical Conduct lations and programmatic guidelines that govern that clinicians have a “duty to protect and foster Title X effectively set the standard for publicly fund- an individual patient’s free and informed choices,” ed family planning care across the country. and to assist each patient “in making decisions that account for medical, situational, and personal Voluntary participation and freedom from factors.”6 Specifically on reproductive decision coercion—key aspects of informed consent— making, AAPA’s guidelines state that clinicians are cornerstones of the Title X program. Sites “have an ethical obligation to provide balanced supported by Title X funding are explicitly required and unbiased clinical information about reproduc- to offer any client who needs it “neutral, factual tive health care,” even if that means referring the information and nondirective counseling” on any patient to another provider if the clinician’s values of the full scope of pregnancy options, including conflict with the patient’s care. “prenatal care and delivery; infant care, foster

Guttmacher Policy Review | Vol. 21 | 2018 www.guttmacher.org 2 care, or adoption; and pregnancy termination.”9 President Reagan and his administration were Title X providers must also offer “referral upon moved by antiabortion activists’ unfounded but request” for services related to any of these sustained allegations of misuse of Title X dollars. options. Only the client gets to decide which In response, the administration issued regulations, pregnancy options she wants to learn more about finalized in 1988, that were designed to prohibit and which ones do not match her needs. Informed clinicians at any Title X–funded site from provid- consent in the Title X context also includes ing abortion counseling or referral—even when providing patients with access to a broad array of expressly requested by a client.11 contraceptive methods (see “Why Family Planning Policy and Practice Must Guarantee a True Choice Commonly referred to as the “domestic gag rule,” of Contraceptive Methods,” 2017). this administrative rule—which was held up in court for years—would have made receipt of Title X In practice, this means that Title X providers must funds contingent on clinicians providing incom- offer comprehensive counseling and resources that plete and biased information to their patients. are responsive to each client’s needs. According While barred from discussing abortion, they would to clinical recommendations on providing quality have been expressly required to provide informa- family planning services—published in 2014 by the tion on and referral for prenatal care. The rule Centers for Disease Control and Prevention and also included detailed requirements to financially OPA—family planning providers (including but not and physically separate Title X–supported activi- limited to those funded by the Title X program) ties from abortion-related services, and restricted should follow the most current recommendations Title X–funded sites’ ability to advocate for or “pro- on pregnancy testing and counseling from lead- mote” abortion access. Collectively, these regula- ing medical associations, specifically citing ACOG tions would have forced safety-net family planning and AAP (see above).10 The family planning guide- providers to choose between receiving Title X fund- lines additionally recommend that these discus- ing and providing high-quality services that uphold sions address the client’s medical history and her the principles of informed consent. personal goals about whether and when to have children, and advise that a client’s confidentiality Ultimately, however—following years of lawsuits, must be guaranteed upon her request. Staff must congressional intercession and a reinterpretation also be knowledgeable about other providers or of the rules under President George H.W. Bush— organizations to which they can refer clients for these harmful restrictions were in effect for only services ranging from abortion to prenatal care to a few months, and confusion surrounded their adoption services, and do everything possible to implementation.12 President Clinton suspended expedite those referrals, including making provider the restrictions almost immediately after taking listings available and contacting the referral site office,13 and the Reagan-era regulations were on the client’s behalf, if so requested. In order to formally reversed through subsequent federal provide such client-centered care, staff must be agency rulemaking.14 trained and able to have conversations on all pregnancy options that are respectful, nonjudgmental At the state level, policymakers have long tried to and based on the medical evidence, and work col- restrict women’s right to full and unbiased infor- laboratively with the client to establish a plan that mation when it comes to abortion. A small number matches her decision. of court decisions have struck down state laws prohibiting providers’ use of public funds for abor- Abortion foes have long attacked women’s right tion counseling and referral as part of nondirec- to nondirective pregnancy options counseling tive pregnancy options counseling.15,16 Still, some and referral. The most significant federal-level states have been able to enact restrictions: Four attack targeted Title X–supported providers and the (Arkansas, Michigan, Ohio and Wisconsin) cur- women who rely on them. Even though grantees rently prohibit the use of public funds for abortion have been prohibited from using Title X funds to counseling and referral, although all make excep- pay for abortions since the program was enacted, tions for the nondirective care required under

Guttmacher Policy Review | Vol. 21 | 2018 www.guttmacher.org 3 Title X.17 Lawmakers in other states have proposed Women choosing to carry pregnancies to term similar policies as part of a broader resurgence of benefit from initiating prenatal care early on, in state-based family planning funding restrictions order to promote healthy pregnancies and births. (see “Recent Funding Restrictions on the U.S. For women who choose to terminate, abortion is Family Planning Safety Net May Foreshadow What particularly safe when obtained in the first trimes- Is to Come,” 2016). ter of pregnancy.23 Moreover, it often becomes more difficult for a woman to obtain an abortion Restricting pregnancy options counseling and as pregnancy progresses due to a lack of provid- referral harms women. Biasing the information ers and increased cost, and her mental health may and resources available on pregnancy options suffer as she undergoes forced delays in care.24–26 could coerce women into unwanted medical decisions and care, and it ultimately threatens their Fourth, denying or delaying a woman’s decision to health and well-being in a number of ways. terminate a pregnancy can be particularly harmful for women with certain medical conditions. For First, forcing clinicians to deny patients the full instance, in statements opposing the Title X gag scope of information and referral represents rule, a number of professional medical associa- unacceptable and damaging governmental tions described how not being able to make a fully interference in the provider-patient relationship, informed decision on how to proceed with a preg- and stands in sharp conflict with women’s right to nancy would be especially harmful for women self-determination—and to abortion, as articulated with severe diabetes, heart conditions, HIV/AIDS in Roe v. Wade. ACOG describes informed consent and estrogen-dependent tumors—all conditions as a communicative process ultimately “governed that could be exacerbated by continuing a preg- by the ethical requirement of truth-telling.”3 ACOG nancy.27 In the words of an ACOG statement decry- also points to “the historical imbalance of power ing such obstruction of care: “That’s unethical. It’s in gender relations and in the physician-patient bad medicine. And it’s inhumane.”28 relationship…and the intersection of gender bias with race and class bias” that are particularly Finally, limiting pregnancy options counseling and present in obstetrics and gynecology, and in referral in the context of publicly funded programs reproductive health care broadly.3 Forcing providers would further entrench existing health disparities. to sabotage the rapport they have built with patients Women who rely on publicly funded programs may cause those patients to retreat, possibly are disproportionately low-income, young or oth- from seeking health care for other needs; this erwise underserved,29 and forcing subpar care on may be particularly true for women of color, low- them is unethical—a point that many policymak- income women and others who have historically ers made in opposing the domestic gag rule. In experienced coercive treatment in the context of 1992, for example, former Senate Majority Leader reproductive health care.18,19 George Mitchell said, “A society like ours, based upon the fundamental principle of equality, ought Second, limiting information and referrals only to not tolerate, let alone encourage, even less insist those related to carrying a pregnancy to term mis- upon a system in which there are two standards of leadingly suggests that pregnancy and childbirth care: One for the wealthy, the affluent, the power- are a woman’s safest options. In fact, pregnancy ful; and another, lower standard, for the poor.”30 and delivery are decidedly riskier than abortion.20–22 Being able to appropriately compare the And yet, such ideologically motivated threats safety of one’s medical options is a central compo- persist today. The Trump administration, Congress nent of informed consent. and state governments across the country are controlled by antiabortion policymakers intent Third, denying a woman information about and on limiting access to unbiased information on access to the full range of options once she knows and resources to obtain abortion services. These that she is pregnant interferes with her ability to attempts clearly go against ethical and legal obtain additional services in a timely manner. requirements on informed consent. Pregnancy

Guttmacher Policy Review | Vol. 21 | 2018 www.guttmacher.org 4 options counseling does not—and should not— 16. Planned Parenthood Association Chicago Area v. Kempiners, 568 involve advocacy of any one option. Rather, F.Supp. 1490 (N.D. IL 1983). clinicians are obligated to assist and support all 17. Guttmacher Institute, State family planning funding restrictions, State Laws and Policies (as of January 2018), women in exploring all options so they can make 2018, https://www.guttmacher.org/state-policy/explore/ their own, fully informed reproductive health state-family-planning-funding-restrictions. 18. Center for Reproductive Rights (CRR), National Latina Institute for choices free from coercion. Ensuring this standard Reproductive Justice and SisterSong Women of Color Reproductive of care is essential to advancing women’s right to Justice Collective, Reproductive Injustice: Racial and Gender Discrimination in U.S. Health Care, New York: CRR, 2014, https:// self-determination, healthy reproductive lives and www.reproductiverights.org/document/reproductive-injustice-racial- overall well-being. n and-gender-discrimination-in-us-health-care. 19. Gold RB, Guarding against coercion while ensuring access: a delicate balance, Guttmacher Policy Review, 2014, 17(3):8–14, https://www.guttmacher.org/gpr/2014/09/ guarding-against-coercion-while-ensuring-access-delicate-balance. 20. World Health Organization (WHO), United Nations Children’s Fund, REFERENCES United Nations Population Fund, World Bank and United Nations 1. American Medical Association (AMA), Opinion Population Division, Trends in Maternal Mortality: 1990 to 2013, 2.1.1: Informed consent, Code of Medical Ethics, Geneva: WHO, 2014, http://www.who.int/reproductivehealth/ 2016, https://www.ama-assn.org/delivering-care/ publications/monitoring/maternal-mortality-2013/en/. code-medical-ethics-consent-communication-decision-making. 21. Guttmacher Institute, Induced abortion in the United States, 2. AMA, Opinion 2.1.3: Withholding information from patients, Code Fact Sheet, New York: Guttmacher Institute, 2017, https://www. of Medical Ethics, 2016, https://www.ama-assn.org/delivering-care/ guttmacher.org/fact-sheet/induced-abortion-united-states. code-medical-ethics-consent-communication-decision-making 22. Raymond EG and Grimes DA, The comparative safety of legal 3. American College of Obstetricians and Gynecologists (ACOG), induced abortion and childbirth in the United States, Obstetrics & Informed consent, Committee Opinion No. 439, Obstetrics Gynecology, 2012, 119(2):215–219, https://www.ncbi.nlm.nih.gov/ & Gynecology, 2009, 114(2):401–408, https://www.acog. pubmed/22270271. org/Resources-And-Publications/Committee-Opinions/ 23. Weitz TA et al., Safety of aspiration abortion performed by nurse Committee-on-Ethics/Informed-Consent. practitioners, certified nurse midwives, and physician assistants 4. ACOG, Guidelines for Women’s Health Care: A Resource Manual, under a California legal waiver, American Journal of Public Health, fourth ed., Washington, DC: ACOG, 2014. 2013, 103(3):454–461, https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC3673521/. 5. Committee on Adolescence, American Academy of Pediatrics, Counseling the adolescent about pregnancy options, Pediatrics, 24. Jerman J and Jones RK, Secondary measures of access to 1998, 101(5):938–940. abortion services in the United States, 2011 and 2012: gestational age limits, cost, and harassment, Women’s Health Issues, 2014, 6. American Academy of Physician Assistants, Guidelines for Ethical 24(4):e419–e424, https://www.guttmacher.org/article/2014/07/ Conduct for the PA Profession, 2013, https://www.aapa.org/wp- secondary-measures-access-abortion-services-united-states-2011- content/uploads/2017/02/16-EthicalConduct.pdf. and-2012-gestational. 7. Association of Women’s Health, Obstetric and Neonatal Nurses 25. Jones RK, Upadhyay UD and Weitz TA, At what cost? Payment (AWHONN), AWHONN position statement: Health care decision for abortion care by U.S. women, Women’s Health Issues, 2013, making for reproductive care, Journal of Obstetric, Gynecologic & 23(3):e173–e178, https://www.guttmacher.org/article/2013/05/ Neonatal Nursing, 2016, 45(5):718, http://www.jognn.org/article/ what-cost-payment-abortion-care-us-women. S0884-2175(16)30229-5/fulltext. 26. Jerman J et al., Barriers to abortion care and their consequences for 8. President’s Commission for the Study of Ethical Problems in patients traveling for services: qualitative findings from two states, Medicine and Biomedical and Behavioral Research, Making Health Perspectives on Sexual and Reproductive Health, 2017, 49(2):95– Care Decisions: A Report on the Ethical and Legal Implications 102, https://www.guttmacher.org/journals/psrh/2017/04/barriers- of Informed Consent in the Patient-Practitioner Relationship, abortion-care-and-their-consequences-patients-traveling-services. Washington, DC: U.S. Government Printing Office, 1982, https:// repository.library.georgetown.edu/handle/10822/559354. 27. Letter from American Academy of Nurse Practitioners et al. to Deputy Assistant Secretary for Population Affairs, HHS, Nov. 1, 9. 42 CFR 59.5. 1987. 10. Gavin L et al., Providing quality family planning services: 28. Graham JJ, Statement by the American College of Obstetricians recommendations of CDC and the U.S. Office of Population and Gynecologists on Title X regulations, Feb. 2, 1988. Affairs, Morbidity and Mortality Weekly Report, 2014, Vol. 63, No. RR-4, https://www.hhs.gov/opa/guidelines/clinical-guidelines/quality- 29. Fowler CI et al., Title X Family Planning Annual Report: 2016 family-planning/index.html. National Summary, Research Triangle Park, NC: RTI International, 2017, https://www.hhs.gov/opa/title-x-family-planning/fp-annual- 11. 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Guttmacher Policy Review | Vol. 21 | 2018 www.guttmacher.org 5 REVIEW ARTICLE

Client Preferences for Contraceptive Counseling: A Systematic Review EdithD1XX Fox, MPH,D2XX 1 ArleneD3XX Reyna, MD,D4XX 1 NikitaD5XX M. Malcolm, MPH,D6XX 2 RachelD7XX B. Rosmarin, MPH,D8XX 2 LaurenD9XX B. Zapata, PhD,D10XX MSPH,3 BrittniD1XX N. Frederiksen, PhD,D12XX MPH,4 SusanD13XX B. Moskosky, MS,D14XX 4 ChristineD15XX Dehlendorf, MD,D16XX MAS1,5,6

Context: Providers can help clients achieve their personal reproductive goals by providing high- quality, client-centered contraceptive counseling. Given the individualized nature of contraceptive decision making, provider attention to clients’ preferences for counseling interactions can enhance client centeredness. The objective of this systematic review was to summarize the evidence on what preferences clients have for the contraceptive counseling they receive. Evidence acquisition: This systematic review is part of an update to a prior review series to inform contraceptive counseling in clinical settings. Sixteen electronic bibliographic databases were searched for studies related to client preferences for contraceptive counseling published in the U.S. or similar settings from March 2011 through November 2016. Because studies on client preferences were not included in the prior review series, a limited search was conducted for earlier research published from October 1992 through February 2011. Evidence synthesis: In total, 26 articles met inclusion criteria, including 17 from the search of literature published March 2011 or later and nine from the search of literature from October 1992 through February 2011. Nineteen articles included results about client preferences for information received during counseling, 13 articles included results about preferences for the decision-making process, 13 articles included results about preferences for the relationship between providers and clients, and 11 articles included results about preferences for the context in which contraceptive counseling is delivered. Conclusions: Evidence from the mostly small, qualitative studies included in this review describes preferences for the contraceptive counseling interaction. Provider attention to these preferences may improve the quality of family planning care; future research is needed to explore interventions designed to meet preferences.

Theme information: This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Ofﬁce of Population Affairs, U.S. Department of Health and Human Services. Am J Prev Med 2018;(55):691À702. © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

From the 1Department of Family and Community Medicine, University of CONTEXT California, San Francisco, San Francisco, California; 2Atlas Research, Wash- ington, District of Columbia; 3Division of Reproductive Health, Centers for ontraceptive counseling is a common healthcare Disease Control and Prevention, Atlanta, Georgia; 4Ofﬁce of Population experience in the U.S.1 The National Survey of Affairs, HHS, Washington, District of Columbia; 5Department of Obstetrics, Family Growth, a nationally representative sur- Gynecology, and Reproductive Sciences, University of California, San Fran- C cisco, California; and 6Department of Epidemiology and Biostatistics, Uni- vey of women of reproductive age, has found that more versity of California, San Francisco, San Francisco, California than 50% of sexually active women report receiving a Address correspondence to: Edith Fox, MPH, Department of Family and family planning service related to birth control in the Community Medicine, University of California, San Francisco, 995 Potrero past 12 months.1 Contraceptive counseling delivered Ave., Building 80, 3rd Floor, San Francisco CA 94110. E-mail: [email protected]. during this care presents a key opportunity for health- 0749-3797/$36.00 care providers to help clients achieve their personal https://doi.org/10.1016/j.amepre.2018.06.006

© 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights Am J Prev Med 2018;55(5):691À702 691 reserved. 692 Fox et al / Am J Prev Med 2018;55(5):691À702 reproductive goals, as well as contribute to clients’ “What are clients’ preferences with regard to contraceptive improved relationships with providers and the health- counseling approaches in the family planning setting?” was added care system. Quality contraceptive counseling has been during this review update process, in keeping with QFP’s empha- À found to be associated with contraceptive continuation2 sis on the importance of client-centered care. Although KQs 1 5 address the outcomes and implementation of counseling interven- and to help build trust between clients and providers.3 tions, KQ 6 is a unique addition in its explicit focus on describing In addition, provision of quality, client-centered client preferences. This review describes the evidence for KQ 6. counseling that focuses on client experiences, values, For the review series, 16 electronic bibliographic databases 4 and preferences is an ethical goal in and of itself. were searched for studies related to KQs 1À6 published from Providing Quality Family Planning Services (QFP), March 2011 through November 2016. Because KQ 6 was not published by the Centers for Disease Control and Preven- included in the prior review, a limited search was conducted of tion (CDC) and the Office of Population Affairs in 2014, ten electronic bibliographic databases for earlier research pub- identifies client centeredness as a core aspect of quality lished from October 1992 through February 2011 (six of the 16 5 fi “ databases used for the latter time period were unavailable because care. The QFP de nes client-centered care as care [that] of institutional barriers). October 1992 was selected as the begin- is respectful of, and responsive to, individual client prefer- ning date because that is when the Food and Drug Administration ences, needs, and values; client values guide all clinical approved injectable contraception for use, marking a shift in the decisions.” The National Academy of Medicine’s recogni- range of available contraceptive options, and thus a potential tion of the importance of patient centeredness throughout change in counseling preferences. Although fewer databases were health care6 informed the QFP’s emphasis on client cen- used for the limited search, the conclusion was drawn that these fi teredness. Client-centered care is particularly important databases were suf cient, given that the six excluded databases had not yielded any relevant articles in the search of literature in in contraceptive counseling because of the personal nature the latter time period. of reproductive decisions and the complex individual, Search terms were developed for the updated review series social, and cultural factors that may influence contracep- (Appendix Table 2, available online), which were used to identify tive method selection and use. potential articles related to KQs 1À6 from March 2011 through Research suggests a need for improvement in the pro- November 2016; the search terms were revised to be specificto vision of client-centered contraceptive counseling. KQ 6 in the search of literature published prior to 2011. Women have reported dissatisfaction with contraceptive counseling in general, and specifically with the informa- Selection of Studies À fi tion and decision support they receive.3,7 9 Understand- Inclusion parameters de ned a priori required that studies be (1) conducted in the U.S., Canada, Australia, New Zealand, or Euro- ing client preferences for contraceptive counseling and pean countries categorized as “very high” on the Human Develop- tailoring the interaction accordingly is essential to pro- ment Index13; (2) written in English; and (3) available as full-text viding client-centered care. Efforts in this area are espe- articles (e.g., not abstracts from conference presentations). Specific cially important considering challenges that may hinder to this review, additionally, studies must have examined client the delivery of client-centered care, such as time con- preferences among women of reproductive age (15À45 years) and straints and competing medical priorities during visits.10 must have been related to client preferences for contraceptive To inform recommendations included in the QFP, counseling delivered in a clinical setting. All study designs were included. CDC and Office of Population Affairs conducted a series Two authors reviewed titles and abstracts of identified articles. of systematic reviews on contraceptive counseling and Inter-reviewer agreement on exclusion decisions was assessed education during 2010À2011. Efforts to update this using k statistics, ensuring a statistic of 0.8 or higher. Full-text series began in 2015. Building on the value QFP places articles were retrieved if they did not meet exclusion criteria at the on client-centered family planning care, the updated title and abstract review stage. Study characteristics and findings series includes explicit attention to client preferences for from articles meeting the inclusion criteria for this review were contraceptive counseling. The objective of this report is abstracted. The quality of each piece of evidence was assessed to summarize the evidence on these client preferences. using the grading system developed by the U.S. Preventive Serv- ices Task Force.14 EVIDENCE ACQUISITION The methodology for conducting this systematic review was simi- EVIDENCE SYNTHESIS lar to the approach used in the reviews in the prior series and has For the review series, a search was conducted of litera- 11 fl been described elsewhere. Brie y, six key questions (KQs) were ture related to all KQs 1À6 published March 2011 or developed (Appendix Table 1, available online) and an analytic later. This review included only those articles addressing framework applied to show the relationships between the popula- À tion, intervention, and outcomes of interest (Figure 1). KQs 1À5 KQ 6. The search for literature related to all KQs 1 6 were included in the prior review on contraceptive counseling12 yielded 24,953 citations (Figure 2). Of these, 10,157 were and are addressed elsewhere in this issue. KQ 6, which asks, excluded as duplicates. Titles and abstracts were

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Figure 1. Analytic framework for systematic review on contraceptive counseling and education. KQ, key question.

reviewed for 14,796 citations, and 14,591 were excluded, preferences for contraceptive counseling among clients primarily because they described research conducted across the reproductive age range (15À45 years). outside the U.S. or similar setting, were unrelated to In the search for literature relevant to KQ 6 pub- family planning, were not original research, or did not lished prior to 2011, results included 13,313 citations describe a contraceptive counseling intervention or cli- (Figure 2). Of these, 3,375 were excluded as duplicates, ent preferences. Full-text articles were reviewed for 205 and 9,938 citations were included in the review of records. Seventeen articles were identified as addressing titles and abstracts. Of these, 9,880 citations were KQ 6, in that they described aspects of care for which cli- excluded, primarily for the same reasons citations ents expressed a preference or which were associated were excluded in the search of literature published with greater patient satisfaction or perceived quality of since 2011. There were 58 full-text articles reviewed; care. Another review in this issue examines outcomes the nine articles that met inclusion criteria were associated with youth-friendly services.15 Although there abstracted and results were integrated with results of is a minor overlap in findings (specifically regarding the 17 articles published since 2011, for a total of 26 importance of positive provider interactions and confi- articles describing client preferences published from dential services for youth), these two reviews provide October 1992 through November 2016. Two articles uniquely useful bodies of evidence on (1) any family describe results from the same study and are discussed planning services designed specifically for youth and (2) together in Evidence Synthesis.16,17

November 2018 694 Fox et al / Am J Prev Med 2018;55(5):691À702

Figure 2. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) ﬂow chart for literature published March 1, 2011, through November 30, 2016, and limited search of earlier literature. KQ, key question.

Appendix Table 3 (available online) describes key survey or questionnaire (sample sizes ranging from 15 to characteristics, research questions, results, design, and 59 women),7,35,36 and one study used additional data study quality of the 26 included articles. Twelve studies from a chart review (n=7,801 women).37 One clinical (from 13 articles) used qualitative methods to under- trial of a counseling intervention (n=814 women) stand client preferences for contraceptive counseling, assessed client preferences as a secondary outcome.38 À with sample sizes ranging from 14 to 42 women.3,16 27 Female clients or potential clients of family planning Five studies used quantitative surveys to obtain descrip- services were the population for all studies, with nine tive information of counseling preferences (sample sizes studies assessing preferences of adolescent clients speciﬁ- À ranging from 57 to 1,852 women).28 32 Three studies cally.18,20,21,23,24,27,29,36,37 Other studies focused on used surveys to examine associations between various women seeking prenatal and postpartum care,16,17,30 factors and client preference, satisfaction, or perception Latina immigrant women,19 young women who had of high quality of care (sample sizes ranging from 748 to experienced pregnancy,36 college students,21 homeless 1,741 women).9,33,34 Four studies used mixed methods. women,35 women seeking abortion,28,31 and women or Three of these studies had qualitative components and a adolescents seeking emergency care.20,29,38 Four studies

www.ajpmonline.org Fox et al / Am J Prev Med 2018;55(5):691À702 695 sought to assess differences in preferences between and colleagues,3 some participants indicated the desire Latina, black, and white participants.3,9,25,31 to review written information before a visit to formulate Seventeen studies (from 18 articles) were conducted in questions for their provider. Likewise, Marshall et al.22 À À À À urban settings in the U.S.3,16 20,22 25,29 31,35 38 Three found that clients liked using an electronic contraceptive studies about adolescents were conducted in secondary decision support tool before a visit, with some partici- school settings,23,27,37 and one study was conducted on a pants expressing desire to use the tool during or after the suburban college campus.21 Six studies had geographi- visit, as well. In two interview studies, participants cally diverse samples (including urban, suburban, and described preference for seeing written materials during rural participants) in multiple states or counties in the their visit.25,30 In Dasari and colleagues,35 participants À U.S.,7,9,28,32 34 including two with nationally representa- liked receiving written materials to take with them after tive samples.9,32 Two studies were conducted in midsized visits. Participants in four qualitative studies liked to cities in Western Europe.26,27 Studies generally had access information from web sources that could comple- moderate risk for bias and low generalizability to the ment counseling.3,16,18,20 predefined target population of women of reproductive Participants in two qualitative studies and a clinical age in the U.S. trial preferred verbal over written communication about During evidence synthesis, it was inductively deter- contraception.23,29,38 Adolescent participants in the mined that results aligned with four domains for client study by Sangraula et al.23 preferred verbal communica- preferences. Results are organized according to these tion specifically because of confidentiality concerns. domains. Three domains are derived from Dehlendorf In seven studies, clients reported liking the use of À À et al.,3 including (1) contraceptive information received visual models and aids during counseling.16 18,23 25,34,35 in counseling; (2) the decision-making process; and (3) Dasari and colleagues35 showed participants a chart of the relationship between providers and clients. An addi- contraceptive method efficacy.39 Participants reported tional domain was addressed by a subset of studies: (4) liking the visual model and that it made it easier to com- the context in which contraceptive counseling is deliv- pare method efficacy. In three studies, adolescent users ered (e.g., where, when, and with whom counseling con- of long-acting reversible contraception (LARC) said they versations occur). Findings are described by domain and appreciated seeing models depicting LARC inser- subdomain below. Table 1 depicts article findings by tion.18,23,24 Participants in the study by Becker et al.25 domain and subdomain. appreciated seeing contraceptive method samples as visual aids. The survey study by Pilgrim and colleagues34 Domain 1: Contraceptive Information with Title X clients found that those who were not coun- Sixteen articles (from 15 studies) indicated client pre- seled using visual aids had lower odds of agreeing they ference for receipt of detailed information about con- received high quality care, compared with those coun- À À traceptive methods.3,7,16 20,22 25,27,30,32,33,35 Eight seled using visual aids (AOR=0.25, p<0.05). studies (from nine articles) emphasized the importance to clients of personalized contraceptive information Domain 2: The Decision-Making Process that met their individual needs and prefer- Five studies explicitly described the importance of À ences.7,16 18,20,22,25,27,32 Studies reported on varied client respect for patient autonomy in contraceptive decision priorities for contraceptive information. Information on making.16,23,25,26,31 In one study, clients reported a side effects was most frequently reported as important to higher value for autonomy in contraceptive decisions clients.3,16,18,19,23,25,27,35 Other types of information versus other healthcare decisions.31 desired included method efficacy,19,35 how to use a In the study by Pilgrim et al.,34 clients who reported method,25 the mechanism of pregnancy prevention,23 that the provider mostly made the contraceptive decision and corrections to contraceptive misinformation.18,20,23 had lower odds of agreeing that they received high-qual- In two studies, adolescent participants expressed a need ity care, compared with those who made the decision not to be overwhelmed with too much information.23,27 alone (AOR=0.14, p<0.05). There was no significant dif- Twelve studies included results on client preferences ference between clients who made the decision together for modes of communication for contraceptive with their provider and those who made the decision À information.3,16 18,20,22,23,25,27,29,30,35,38 In eight qualita- alone. In the study by Dehlendorf and colleagues,3 black tive and mixed-methods studies, participants expressed and Spanish-speaking Latina participants (as compared wanting to receive written information to complement with white and English-speaking Latina participants) felt À verbal information from providers.3,16 18,20,22,25,27,35 it was appropriate for providers to express a method This information could be delivered at several opportu- preference only if requested by the patient or if clearly nities surrounding the visit. In the study by Dehlendorf justified.

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Table 1. Summary of Client Preferences for Contraceptive Counseling

Domain 1: Contraceptive Domain 2: Domain 3: ProviderÀclient Domain 4: Context in which counseling information Decision-making process relationship is provided

Visual Preferences for Total Preferred models Respect Positive provider Preferred sub-domains Author Comprehensive and modes of and for client Provider interpersonal Continuity of Assurance of professions and Female timing of addressed and year relevant information communication aids autonomy involvement dynamic care conﬁdentiality settings providers counseing in study Becker and &&&3 Tsui (2008)9 Becker et al. &&&& &&& & 8 (2009)25 2018;55(5):691 Med Prev J Am / al et Fox Brown et al. &&& && 5 (2013)18 Carvajal et al. &&&&& 5 (2017)19 Chernick et al. && & 3 (2016)20 Dasari et al. &&&& 4 (2016)35 Dehlendorf && 2 et al. (2010)31 Dehlendorf && &&&& 6 et al. (2013)3 Guendelman && 2 7 À

et al. (2000) 702 Hickey and && 2 White (2015)21 Johnson et al. && 2 (2015)36 Lowe (2005)26 &&&3 Marshall et al. && & 3 (2017)22 Matulich et al. & 1 (2014)28 www.ajpmonline.org Mollen et al. & & 2 (2013)29 Peremans && && 4 et al. (2000)27

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Table 1. Summary of Client Preferences for Contraceptive Counseling (continued)

Domain 1: Contraceptive Domain 2: Domain 3: ProviderÀclient Domain 4: Context in which counseling information Decision-making process relationship is provided

Visual Preferences for Total

Preferred models Respect Positive provider Preferred sub-domains 2018;55(5):691 Med Prev J Am / al et Fox Author Comprehensive and modes of and for client Provider interpersonal Continuity of Assurance of professions and Female timing of addressed and year relevant information communication aids autonomy involvement dynamic care confidentiality settings providers counseing in study Pilgrim et al. && & 3 (2014)34 Rubin et al. && & 3 (2016)24 Sangraula &&&& & & 6 et al. (2017)23 Schwarz et al. & 1 (2013)38 Soleimanpour &&& 3 et al. (2010)37 Sonenstein & & 2 et al. (1995)32 À 702 Weisman et al. & 1 (2002)33 Yee and Simon &&&& & &6 (2011)16,17 Yee et al. && & 3 (2015)30 Total studies 15 12 7 11 5 9 3 7 7 4 3 addressing sub-domain 697 698 Fox et al / Am J Prev Med 2018;55(5):691À702 Mirroring the importance of autonomy, participants Tsui9 comparing client preferences of different racial/ disliked provider pressure in their contraceptive deci- ethnic groups, English- and Spanish-speaking Latina sions. Eight of the included studies addressed the topic participants were more likely than white or black partici- of pressure, and in all eight studies, clients preferred that pants to value continuity of care with their family providers not pressure them to choose a particular planning provider. method.3,7,17,19,22,23,25,35 Six qualitative studies with adolescents and young Two studies examined women of color’s preferences women found a preference for assurance of confidential À related to directive counseling by exploring previous services.19 21,23,36,37 Latina participants younger than negative experiences of counseling.17,19 In the interview age 18 years in the study by Carvajal et al.19 were espe- study by Yee and Simon,17 the sample of women of color cially concerned about confidentiality, compared with described having negative experiences when counseling participants older than 18 years, and equated confidenti- felt coercive, restrictive, or overbearing, and some con- ality of services with trust in provider. One additional nected these experiences to racial discrimination. In the interview study found confidentiality was generally study by Carvajal et al.19 with Latina immigrant women, important to women of reproductive age.25 participants disliked counseling that was paternalistic and focused on specific methods, and connected negative experiences to ethnic bias among providers. Domain 4: The Context in Which Contraceptive Although results emphasized the importance of prior- Counseling Is Provided itizing patient autonomy, five studies exploring client Seven studies included results on the preferred types of preferences for provider involvement in decision making providers or settings where contraceptive counseling indicated that some involvement may be desirable to occurs.9,21,26,27,29,32,37 Three studies addressed the receipt some clients.3,18,19,31,34 One specific approach to of counseling in school settings.23,27,37 In one study using counseling discussed in three studies was shared decision focus groups with high school students, participants making.3,19,31 In this model of counseling, the provider expressed that they liked school health centers because contributes his or her medical knowledge, while the cli- they found accessing care easier in schools than in out- ent provides expertise on his or her own values and pref- side settings.37 They also liked that the services were erences.40 All three studies emphasized that clients confidential and free, and they felt that the staff at school preferred to then make the final contraceptive decision health centers were youth-friendly and non-judgmen- themselves.3,19,31 tal.37 By contrast, in another study with secondary school students27 and one study with college students,21 Domain 3: The Provider–Client Relationship participants preferred to learn about contraception from Nine studies (from ten articles) indicated the importance their own family physicians or gynecologists, and not of positive interpersonal dynamics between clients and from school health centers. In the study with secondary À À providers.3,16 19,23 25,36,37 Participants appreciated rela- school students, which was conducted in Belgium, this tionships with providers involving trust, patience, and was due to existing relationships with these doctors.27 In listening. In six qualitative studies, including three with the study with college students in the U.S., this was due adolescents, participants preferred providers to be to a concern that confidentiality could be compromised friendly with clients.3,16,18,23,25,37 Two qualitative studies in the school healthcare setting.21 found that clients saw positive relationships with pro- Participants in the study by Sonenstein and viders as facilitators to learning information and receiv- colleagues32 preferred private physicians to HMOs or ing decision support during counseling.16,24 Adolescent family planning or other clinics. In the survey study participants in three studies,23,36,37 including one study by Becker and Tsui,9 black and English-speaking specifically with young women who had experienced Latina participants were more likely to prefer receiv- pregnancy,36 particularly valued non-judgmental atti- ing contraceptive counseling in a general care setting, tudes from their providers. Women in the interview compared with a family planning setting, than were study by Becker and colleagues25 likewise emphasized white participants (62%, 61%, and 50%, respectively, the importance of non-judgmental provider attitudes p<0.05). Although Spanish-speaking Latinas were when providers questioned clients about sexual behav- most likely to prefer a general healthcare setting ior. In the interview study by Yee and Simon,17 partici- (69%), this was not significantly different from the pants described poor counseling as impersonal and reference group of white clients in multivariate analy- uncaring. sis.9 By contrast, participants in one study in Britain Women expressed a preference for continuity of care preferred receiving care in a family planning clinic in three studies.3,9,25 In the survey study by Becker and over a general care setting, because they perceived

www.ajpmonline.org Fox et al / Am J Prev Med 2018;55(5):691À702 699 the family planning clinic was more focused on including but not limited to information on side effects women’s experiences.26 and method efficacy. This evidence suggests that to Finally, in the study by Mollen et al.29 examining ado- improve the client centeredness of counseling, providers lescent preferences for learning about emergency contra- might use tailored approaches to elucidate what infor- ception in emergency departments, participants mation is most valuable to clients and deliver personal- preferred learning from a doctor or nurse rather than a ized counseling. Customizing the discussion in this way peer counselor. They also preferred for education to may also address time constraints that may affect occur when seeking care related to sexual activity, but counseling quality.10 Future research should explore not when seeking care for reasons unrelated to sexual how tailored approaches, such as decision aids and stan- activity. dardized questions to elicit client preferences, may Four studies indicated participant preference for impact patient experience. À female over male providers.9,25 27 In the study by Clients had varied preferences for modes of commu- Lowe,26 participants preferred female providers nication. Clients generally valued receiving written or because of their perceived personal knowledge of con- electronic information supplementing verbal À traception. The interview study by Becker and col- information.3,16 18,20,22,25,27,35 Visual aids were also use- À À leagues25 also found a preference for female providers ful to clients.16 18,23 25,34,35 The availability of multiple because of participant perception of superior knowl- forms of written and visual information before, during, edge among female providers compared with male and after visits may accommodate clients’ various prefer- providers, and participants’ greater comfort with ences. female providers than male providers. In surveys, Twelve studies (from 13 articles) reported preferences English- and Spanish-speaking Latinas had higher related to the contraceptive decision-making proc- À odds of preferring a female provider compared with ess.3,7,16 19,22,23,25,26,31,34,35 Clients valued respect for their white and black clients.9 autonomy in making the final decision about contracep- Three studies focused on preferences for the timing of tion16,23,25,31 and emphasized dislike for provider pres- counseling in relation to other reproductive health sure.3,7,17,19,20,22,23,25,35 This domain may be particularly care.16,28,30 In the study by Yee et al.30 of women who salient for women of color, given that racial/ethnic bias in had received prenatal and postpartum care, 84% of par- the promotion of highly effective methods, such as LARC, ticipants reported a preference for contraceptive has been documented42 and that two included studies counseling both before and after delivery. Participants in report perceived racial/ethnic discrimination in contracep- a similar population indicated in interviews that they tive counseling among women of color.17,19 Finally, multi- preferred provider-initiated counseling throughout the ple studies documented some clients desired some prenatal period, to give clients multiple opportunities to provider engagement in the decision-making process, with make a decision and “plan ahead.”16 In the survey study emphasis on the client making the final decision.3,16,19,23,34 by Matulich and colleagues28 with abortion clients in This finding is consistent with results from a study pub- Northern California, 64% did not want to talk about lished after the end date for this review (November 30, contraception on the day of their abortion procedure, 2016), which found that patients who reported experienc- with about half reporting this was because they already ing shared decision making were most satisfied with their knew what method they wanted to use. counseling, compared with those who reported making the contraceptive decision by themselves, or who reported 43 DISCUSSION the provider making the decision. Twelve studies (from 13 articles) indicated client pref- This review included 26 articles describing 25 studies erences for positive interpersonal dynamics with their À À related to client preferences for contraceptive counseling, providers.3,9,16 21,23 25,36,37 Confidentiality was also including 17 articles published in March 2011 or later. important in the counseling relationship, especially to À A growing number of studies have addressed this topic adolescents.19 21,23,36,37 Although a positive relationship in the years since 2011, in keeping with an increasing between medical professionals and those they care for is focus on patient centeredness in health care generally41 of value in all aspects of medical care, these results and family planning specifically.5 underscore their particular importance in the context of Eighteen studies (from 19 articles) provided informa- the personal and intimate decision-making process tion on clients’ preferences for receiving contraceptive around contraception. À À À information.3,7,16 20,22 25,27,29,30,32 35,38 Results empha- Finally, 11 studies included information on the À sized the value of comprehensive, personalized informa- context in which counseling is provided.9,16,21,25 30,32,37 tion to meet the needs and preferences of clients, Clients had varied preferences for the context of care,

November 2018 700 Fox et al / Am J Prev Med 2018;55(5):691À702 including receiving counseling inside or outside of the experience of contraceptive counseling for family school settings,23,27,37 in family planning or more general planning clients in the U.S. À care settings,9,21,26,27,29,32 from female providers,9,25 27 and alongside other reproductive healthcare serv- 16,28,30 ACKNOWLEDGMENTS ices. These results point to the importance of having diverse family planning providers and environments The authors thank Lorrie Gavin, formerly Senior Health Scientist to meet clients’ needs. at the Office of Population Affairs, for spearheading the devel- Contraceptive care in the prenatal and postpartum opment of the 2014 Providing Quality Family Planning Services Recommendations and the updated systematic reviews for sup- period was well received by clients.16,30 Contraceptive porting the recommendations. counseling on the day of abortion was not desired by a 28 This product was supported, in part, by contracts between majority of clients in one study. Future research could the Office of Population Affairs and Atlas Research, Inc. (Nos. explore how best to meet the contraceptive needs of cli- HHSP233201500126I, HHSP233201450040A). The findings ents seeking abortion and when contraceptive counsel- and conclusions in this report are those of the authors and ing is best provided in that context. do not necessarily represent the official position of the Office A strength of this review is its comprehensive inclu- of Population Affairs or the Centers for Disease Control and sion of studies of any design. This allowed for the inclu- Prevention. No financial or other disclosures of conflicts of interest were sion of a diverse range of studies on client preferences reported by the authors of this paper. for counseling, many including rich qualitative data. When synthesized in a review, this information offers insights to inform future programmatic efforts, interven- THEME NOTE tions, and research. This article is part of a theme issue entitled Updating the Sys- tematic Reviews Used to Develop the U.S. Recommendations Limitations for Providing Quality Family Planning Services, which is spon- A limitation of many of the included qualitative stud- sored by the Office of Population Affairs, U.S. Department of ies is small sample size, and results have limited gen- Health and Human Services. eralizability to the broader population of women of reproductive age. Some of these small studies offer SUPPLEMENTAL MATERIAL valuable evidence on specific populations, such as women of color and Latina immigrant women. There Supplemental materials associated with this article can be is a lack of evidence, however, on preferences among found in the online version at https://doi.org/10.1016/j. other specific populations with particular needs, such amepre.2018.06.006. as incarcerated women; women who use substances; lesbian, gay, bisexual, transgender, and queer clients; REFERENCES those in rural settings; and immigrant and refugee 1. Borrero S, Schwarz EB, Creinin M, Ibrahim S. The impact of race and clients. An additional limitation is that included stud- ethnicity on receipt of family planning services in the United States. J ies generally had moderate risk for bias. This was Womens Health (Larchmt). 2009;18(1):91–96. https://doi.org/10.1089/ largely due to common recruitment methods for jwh.2008.0976. qualitative research (e.g., by flyer, conducting activi- 2. Dehlendorf C, Henderson JT, Vittinghoff E, et al. 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Urban minority women’s perceptions of and prefer- among reproductive age women at an abortion clinic. Patient Educ ences for postpartum contraceptive counseling. J Midwifery Womens Couns. 2010;81(3):343–348. https://doi.org/10.1016/j.pec.2010.06.021. Health. 2011;56(1):54–60. https://doi.org/10.1111/j.1542-2011.2010. 32. Sonenstein FL, Ku L, Schulte MM. Reproductive health care delivery. 00012.x. Patterns in a changing market. West J Med. 1995;163(3 suppl 1):7–14. 17. Yee LM, Simon MA. Perceptions of coercion, discrimination and 33. Weisman CS, Maccannon DS, Henderson JT, Shortridge E, Orso CL. other negative experiences in postpartum contraceptive counseling for Contraceptive counseling in managed care: preventing unintended low-income minority women. J Health Care Poor Underserved. pregnancy in adults. Womens Health Issues. 2002;12(2):79–95. https:// 2011;22(4):1387–1400. https://doi.org/10.1353/hpu.2011.0144. doi.org/10.1016/S1049-3867(01)00147-5. 18. 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Sex Reprod Healthc. 2015;6(1):28–32. https://doi.org/ 10.2105/AJPH.2009.186833. 10.1016/j.srhc.2014.09.008. 38. Schwarz EB, Burch EJ, Parisi SM, et al. Computer-assisted provision of 22. Marshall C, Nuru-Jeter A, Guendelman S, Mauldon J, Raine-Bennett hormonal contraception in acute care settings. Contraception. 2013;87 T. Patient perceptions of a decision support tool to assist with young (2):242–250. https://doi.org/10.1016/j.contraception.2012.07.003. women’s contraceptive choice. Patient Educ Couns. 2017;100(2):343– 39. Centers for Disease Control and Prevention (CDC). Effectiveness of 348. https://doi.org/10.1016/j.pec.2016.08.022. family planning methods. www.cdc.gov/reproductivehealth/contra- 23. Sangraula M, Garbers S, Garth J, Shakibnia EB, Timmons S, Gold MA. ception/unintendedpregnancy/pdf/Family-Planning-Methods-2014. Integrating long-acting reversible contraception services into New pdf. Published 2014. Accessed September 16, 2017.

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40. Charles C, Gafni A, Whelan T. Shared decision-making in the medical 42. Gomez AM, Fuentes L, Allina A. Women or LARC ﬁrst? Reproductive encounter: what does it mean? (Or it takes at least two to tango). Soc autonomy and the promotion of long-acting reversible contraceptive Sci Med. 1997;44(5):681–692. https://doi.org/10.1016/S0277-9536(96) methods. Perspect Sex Reprod Health. 2014;46(3):171–175. https://doi. 00221-3. org/10.1363/46e1614. 41. Epstein RM, Street RL. The values and value of patient-centered 43. Dehlendorf C, Grumbach K, Schmittdiel JA, Steinauer J. Shared deci- care. Ann Fam Med. 2011;9(2):100–103. https://doi.org/10.1370/ sion making in contraceptive counseling. Contraception. 2017;95 afm.1239. (5):452–455. https://doi.org/10.1016/j.contraception.2016.12.010.

www.ajpmonline.org REVIEW ARTICLE

Impact of Contraceptive Education on Knowledge and Decision Making: An Updated Systematic Review KarenD1XX Pazol, PhD,D2XX MPH,1 LaurenD3XX B. Zapata, PhD,D4XX MSPH,1 ChristineD5XX Dehlendorf, MD,D6XX MAS,2,3,4 NikitaD7XX M. Malcolm, MPH,D8XX 5 RachelD9XX B. Rosmarin, MPH,D10XX 5 BrittniD1XX N. Frederiksen, PhD,D12XX MPH6

Context: Educational interventions can help individuals increase their knowledge of available contraceptive methods, enabling them to make informed decisions and use contraception correctly. This review updates a previous review of contraceptive education.

Evidence acquisition: Multiple databases were searched for articles published March 2011 −November 2016. Primary outcomes were knowledge, participation in and satisfaction/comfort with decision making, attitudes toward contraception, and selection of more effective methods. Sec- ondary outcomes included contraceptive behaviors and pregnancy. Excluded articles described interventions that had no comparison group, could not be conducted feasibly in a clinic setting, or were conducted outside the U.S. or similar country. Evidence synthesis: A total of 24,953 articles were identified. Combined with the original review, 37 articles met inclusion criteria and described 31 studies implementing a range of educational approaches (interactive tools, written materials, audio/videotapes, and text messages), with and without healthcare provider feedback, for a total of 36 independent interventions. Of the 31 interventions for which knowledge was assessed, 28 had a positive effect. Fewer were assessed for their effect on attitudes toward contraception, selection of more effective methods, contraceptive behaviors, or pregnancy—although increased knowledge was found to mediate additional outcomes (positive attitudes toward contraception and contraceptive continuation). Conclusions: This systematic review is consistent with evidence from the broader healthcare field in suggesting that a range of interventions can increase knowledge. Future studies should assess what aspects are most effective, the benefits of including provider feedback, and the extent to which educational interventions can facilitate behavior change and attainment of reproductive health goals. Theme information: This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services. Am J Prev Med 2018;55(5):703−715. © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

CONTEXT From the 1Division of Reproductive Health, Centers for Disease Control 2 espite the availability of a wide variety of effec- and Prevention, Atlanta, Georgia; Department of Family and Community 1 Medicine, University of California, San Francisco (UCSF), San Francisco, tive contraceptive methods, nearly half of all California; 3Obstetrics, Gynecology and Reproductive Sciences, UCSF, San 2 pregnancies in the U.S. are unintended. Unin- Francisco, California; 4Epidemiology and Biostatistics, UCSF, San D 5 tended pregnancy primarily occurs in women who do Francisco, California; Atlas Research, Washington, District of Columbia; 6 not use any contraception or use contraception incor- and Ofﬁce of Population Affairs, HHS, Rockville, Maryland 3,4 Address correspondence to: Karen Pazol, PhD, MPH, Division of rectly or inconsistently. Contraceptive counseling Reproductive Health, Centers for Disease Control and Prevention, 4770 provided by trained healthcare professionals may Buford Highway, MS F-74, Atlanta GA 30341. E-mail: [email protected]. help sexually active individuals and couples identify 0749-3797/$36.00 https://doi.org/10.1016/j.amepre.2018.07.012

© 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights Am J Prev Med 2018;55(5):703−715 703 reserved. 704 Pazol et al / Am J Prev Med 2018;55(5):703−715 contraceptive methods that are the most appropriate and and correct and continued use of contraception.18 That effective for their lifestyle and preferences. An essential review informed the development of the 2014 recom- component of the counseling process is education. Con- mendations, Providing Quality Family Planning Serv- traceptive education aims to provide clients the informa- ices: Recommendations of CDC and the U.S. Office of tion they need to make informed decisions about their Population Affairs.19 The objective of this updated use of contraception and correctly use the contraceptive review is to summarize the body of evidence that was methods they have selected. published subsequently. The importance of contraceptive education can be seen in the impact of knowledge on method selection and cor- EVIDENCE ACQUISITION rect and consistent use of contraception. Many women indicate contraceptive effectiveness is among the most Definition of Contraceptive Education − fi important considerations for selecting a method5 9;con- This review complements ndings of the accompanying review on 20 fi sistent with this priority, better knowledge of contraceptive contraceptive counseling, de ned as an interactive process between a provider and client intended to help the client achieve a effectiveness is associated with adoption of more effective 10,11 reproductive health goal. This education review focuses more nar- methods. Conversely, inadequate knowledge of contra- rowly on the process of helping clients increase their knowledge ception is associated with incorrect perceptions of the risks of contraception so they can make informed decisions about using and side effects of contraceptive methods, incorrect or contraception, and then correctly and consistently use their cho- − inconsistent use, and method discontinuation.12 15 sen method. Despite the importance of education, gaps in contraceptive knowledge are frequently documented.11,16,17 Development of Key Questions and Search Strategy In 2011, the Centers for Disease Control and Preven- This systematic review is reported according to the PRISMA checklist.21 The approach used was similar to that implemented tion (CDC) and the U.S. Office of Population Affairs in previous reviews22 guided by an analytic framework showing conducted a systematic review to better understand the the logical relationships between the population of interest, the aspects of educational interventions that can promote interventions, and the outcomes of interest (Figure 1). This review acquisition of knowledge for informed decision making of education interventions primarily focused on short-term

Figure 1. Analytic framework for systematic review of impact of contraceptive education. KQ, key question.

www.ajpmonline.org Pazol et al / Am J Prev Med 2018;55(5):703−715 705 Table 1. Key Questions for Systematic Review on Impact of Education Interventions

KQ no. Question 1 Does contraceptive education increase comprehension of risks and benefits of contraceptive choices, including potential side effects, method effectiveness, and correct method use? 2 Does contraceptive education increase participation in the decision-making process? 3 Does contraceptive education increase satisfaction/comfort with services and decision making? 4 Does contraceptive education increase positive attitudes about contraception? 5 Does contraceptive education increase selection of more as compared with less effective methods? 6 What are the barriers and facilitators for clinics or clients related to the provision or receipt of education? 7 Are there any unintended negative consequences associated with contraceptive education? Note: The key questions are put into context by the analytic framework presented in Figure 1. KQ, key question. outcomes related to contraceptive knowledge and decision mak- enhanced interventions, a healthcare provider/educator interacted ing; studies were excluded if the intervention they described with the intervention to help participants in at least one group focused only on skills or behaviors. Of seven key questions (KQs; understand or use the information presented. By contrast, in pro- Table 1), the first five (KQ1−KQ5) asked whether educational vider-independent interventions a healthcare provider/educator interventions affected the following: contraceptive knowledge, did not go beyond the standard of care to facilitate participant including correct method use, risks and benefits, side effects, and understanding; the participant received the intervention either method effectiveness; participation in decision making; satisfac- before or after, rather than during their appointment, and pro- tion/comfort with services and decision making; attitudes toward viders were given no specific instructions to help participants contraception; and for interventions providing education on the understand or make use of information. Studies were classified as full range of methods, selection of more versus less effective meth- evaluating more than one intervention if they included distinct ods (KQ5). KQ6 was expanded from a focus in the original review mediums (e.g., written materials versus audio/video) or a pro- on health literacy and asked if there were any barriers or facilita- vider-independent and a provider-enhanced intervention, each of tors for clinics/clients; KQ7 was added to address unintended con- which was separately compared with a control arm. sequences. The search strategy included terms common to the other systematic reviews in this series on contraceptive counseling, Assessment of Study Quality and Data Synthesis Study quality was assessed using a modification of the grading sys- reminder systems, and patient preferences for contraceptive 24 counseling. Articles were identified from 16 electronic databases tem developed by the U.S. Preventive Services Task Force. Stud- fi (Appendix Table 1, available online), and supplemented by ies were rst rated based on the U.S. Preventive Services Task fi hand searches of the bibliographies of identified articles. The Force evidence scale and then speci c criteria were used to judge initial and updated reviews identified articles published whether the study had high, moderate, or low risk for bias. between January 1985−February 2011 and March 2011− Data synthesis was primarily qualitative. Meta-analysis was not November 2017, respectively. performed because of the large degree of heterogeneity across Retrieval and inclusion criteria were developed a priori. studies with respect to study design, study populations, lengths of Included studies were conducted in a clinic-based setting where follow-up, and outcomes measured. family planning services: were provided or assessed an interven- Evidence from the initial and updated systematic reviews tion that could be implemented feasibly in a clinic-based setting (Figure 2), including primary and secondary outcomes, is summa- (e.g., not a multisession course series); contained a comparison rized in Figure 3 and presented in detail in Appendix Table 2 group; were conducted in the U.S., Canada, Australia, New Zea- (available online). Primary outcomes from the review update are land, or a European country categorized as “very high” on the further discussed in the text. Human Development Index23; and addressed at least one KQ. Studies focusing primarily on sexually transmitted infections were included only if they incorporated education on condom use to EVIDENCE SYNTHESIS prevent pregnancy. For studies meeting inclusion criteria, out- Search Results comes of interest to other systematic reviews in this series (i.e., The systematic review identified 14,796 unique abstracts. behavioral outcomes, such as contraceptive use, and long-term From the title and abstract review, 14,591 articles were outcomes, such as pregnancy) also were evaluated because of their potential to be mediated by knowledge. Outcomes related to the excluded and 205 were retrieved; 17 met inclusion crite- 25−41 KQs were considered primary outcomes; all other outcomes were ria. However, because three studies including the considered secondary outcomes. same population and intervention were described in multiple articles,25,29,30,32,34,39 thesearticleswerecountedas Data Abstraction 14 independent studies. Hand searches of references from fi 42 Detailed information was abstracted by a team of four abstractors included articles identi ed one additional article provid- 25,32 and reviewed by two authors for relevance to contraceptive educa- ing further details on a study from the review update, tion; differences were reconciled by consensus. In provider- and one article,43 providing further details on a study

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Figure 2. Flow diagram—process of identifying studies included. from the original review.44 Together with evidence from addition to being assessed for their effects on the a priori the original review,18 31 studies described in 37 articles outcomes of interest (Figure 3), for three interventions, − are included in this review update (Figure 2).25 61 knowledge gains were evaluated for their further effect Of the included studies, 17 were RCTs, of which nine on these outcomes, including positive attitudes toward were classified as having low,27,29,30,33,43,44,47,49,52,53,58,60 oral contraceptives (OCs)41 and long-acting reversible six moderate,25,26,31,32,35,40,42,46 and two high38,51 risk for contraceptives (LARC),33 intention to use OCs,41 and bias. Three were non-RCTs with separate groups of continued use of OCs.25,42 intervention and control participants; of these, two were classified as having moderate45,54 and one high57 risk for Knowledge bias. Nine used a pre-/post-test study design, of which The review update identified 12 interventions25,27,28,31 − three were classified as having moderate36,37,41 and six 42 assessed for their effect on knowledge (KQ1), includ- high28,50,55,56,59,61 risk for bias. Two final studies, also ing knowledge of correct method use, risks and benefits, with high risk for bias, used a sequential cohort analysis side effects, and method effectiveness; of these, ten had a − in which one set of participants was studied prior to significant positive effect.25,27,28,31 37,39,41,42 Details are implementation of an intervention and was compared described separately for provider-independent and pro- with another set of participants studied during the inter- vider-enhanced interventions. vention period.34,39,48 Provider-independent interventions. The review Of the 31 studies identified, five included two inter- update identified seven provider-independent interven- − − ventions (one included a written intervention and an tions.25,28,31 33,38,40 42 Of these, three were non-interac- audio/video intervention46; four included a provider- tive, assessing either a video,28 written materials,41 or independent and a provider-enhanced interven- text messages25,32,42; all three had a significant positive tion29,30,43,44,47,52,53) that were each separately compared effect. The first28 used a pre-/post-test analysis to assess with a control arm, for a total of 36 interventions. In the effect of a single online video session; the video was

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Figure 3. Summary of evidence from systematic review on contraceptive education. aIncludes decision aids, computer games, Facebook page, and smart phone apps. bMaterials provided or read as a script. cInterventions described in Kirby et al. 198949; Paperny and Starn 198954; Reis and Tymchyshyn 199256;O’Donnell et al. 199552,53; Smith and Whitfield 199559; Deijen and Kornaat 199746; Little 1998,44 200143; DeLamater et al. 200047; Lindenberg et al. 200250; Johnson et al. 200348; Mason et al. 200351; Steiner et al. 200360; Roberto et al. 200757; Schwarz et al. 200858; Castano et al. 201225; Hall et al. 2013,32 201442; Garbers et al. 201229,30; Vogt and Schaefer 201241; Schwarz et al. 201338; Gilliam et al. 201431;Kofinas et al. 201433; Davidson et al. 201526; Garbers et al. 201528; and Sridhar et al. 2015.40 dInterventions described in: O’Donnell et al. 199552,53; Little et al. 1998,44 200143; Chewning et al. 199945; DeLamater et al. 200047; Pedrazzini et al. 200055; Whitaker et al. 201061; Ragland et al. 201136; Garbers et al. 201229,30; Schwarz et al. 201439; Lee et al. 201534; Ragland et al. 201537; de Reilhac et al. 201627; and Michie et al. 2016.35 eInterventions described in: Kirby et al. 198949; Paperny and Starn 198954; Reis and Tymchyshyn 199256;O’Donnell et al. 199552,53; Smith and Whitfield 199559; Deijen and Kornaat 199746; Little 1998,44 200143; DeLamater et al. 200047; Lindenberg et al. 200250; Mason et al. 200351; Steiner et al. 200360; Roberto et al. 200757; Schwarz et al. 200858; Castano et al. 201225; Hall et al. 2013,32 201442; Vogt and Schaefer 201241; Schwarz et al. 201338; Gilliam et al. 201431;Kofinas et al. 201433; Garbers et al. 201528; and Sridhar et al. 2015.40 fInterventions described in O’Donnell et al. 199552,53; Little et al. 1998,44 200143; Chewning et al. 199945; DeLamater et al. 200047; Pedrazzini et al. 200055; Ragland et al. 201136; Schwarz et al. 201439; Lee et al. 201534; Ragland et al. 201537; de Reilhac et al. 201627; and Michie et al. 2016.35 gInterventions described in Johnson et al. 200348; Mason et al. 200351; Steiner et al. 200360;Kofinas et al. 201433; Davidson et al. 201526; and Sridhar et al. 2015.40 hIntervention described in: Schwarz et al. 201439; Lee et al. 2015.34 iIndicates intervention had a marginally significant effect on this outcome (0.05

November 2018 708 Pazol et al / Am J Prev Med 2018;55(5):703−715 based on social and cognitive theories and provided based on CDC’s U.S. Medical Eligibility Criteria; it information on intrauterine devices (IUDs). Immedi- allowed participants to explore their contraceptive ately following the video, participants showed an options and then request a prescription if they wanted a increase from baseline in their knowledge that the IUD method requiring one; control participants were pro- is more effective than the pill (p<0.001) and that women vided a similar tool with information on chlamydia who have never had a child can use an IUD (p<0.001). infection. Immediately following use of their respective The second intervention41 also used a pre-/post-test tools, intervention and control participants did not differ analysis to examine knowledge among participants who in their knowledge of relative method effectiveness received a comprehensive information brochure on OCs (LARC versus tubal ligation, p=0.26; patch/ring versus using either a standard evidence-based or a mental mod- birth control pills, p=0.16), or the effectiveness of con- els approach. Participants receiving either type of bro- doms for preventing pregnancy (p=0.49). The second chure were combined into one group for analysis, which tool40 was a smartphone app that allowed participants to showed an increase in knowledge from baseline to access information on a range of contraceptive options. immediate post-test (p<0.001), and from baseline to 3 Control participants received standard-of-care counsel- months (p<0.001). The third intervention25,32,42 was ing from a health educator. Mean scores for knowledge evaluated through an RCT and used daily text messages related to the participant’s selected method did not differ to address key domains of information for OCs (mecha- between the intervention and control groups immedi- nism of action, effectiveness, use, side effects, risks, and ately post-intervention (p=0.30). benefits). From baseline to 6 months, knowledge scores In combination with the original review,18 21 pro- increased 7% in the intervention versus 3% in the con- vider-independent interventions were evaluated for their trol group (p<0.001). While the groups were similar at effect on knowledge. Only one50 of 1425,28,41,43,44,46,47,49 − − baseline, at 6 months intervention participants had 53,58 60 non-interactive and two38,40 of higher scores related to mechanisms of action (p=0.004); seven31,33,38,40,54,56,57 interactive interventions did not side effects (p=0.03); effectiveness (p<0.001); and poten- have a positive effect on at least one outcome (Figure 3; tial OC benefits (p<0.001). Appendix Table 2, available online). Only one study The remaining four provider-independent interven- compared delivery of the same information in an inter- tions were interactive tools, each evaluated through an active and a non-interactive format, with participants in RCT.31,33,38,40 Of these, two had a significant positive the interactive group showing greater knowledge gains.33 effect.31,33 The first31 was based on the theory of planned Provider-enhanced interventions. The review update behavior and was intended to fill gaps in knowledge of identified five provider-enhanced interventions evalu- − LARC, while also providing information on the full ated for their effect on knowledge.27,34 37,39 Of these, range of methods. Knowledge among intervention par- one included a video intervention35 and four used writ- ticipants increased from baseline to immediate post- ten materials delivered as a script from a healthcare pro- intervention (p=0.001).31 The second33 presented infor- vider.27,34,36,37,39 The video intervention,35 evaluated mation from American College of Obstetricians and through an RCT, was a 9-minute DVD presenting infor- Gynecologists contraceptive education pamphlets mation on Nexplanon to abortion patients considering through an interactive Facebook page with videos, dia- use of this method for the first time. During their grams, and games; control participants were given the appointment, intervention participants viewed the DVD same amount of time to review the education pamphlets and were then given the opportunity to ask their pro- on the American College of Obstetricians and Gynecolo- vider questions. Immediately post-intervention, a higher gists webpage. Although control participants had higher percentage of intervention versus control participants knowledge scores at baseline (p=0.04), Facebook partici- correctly responded to the effect of implants on mood pants showed greater knowledge gains (p<0.001) and and skin changes (p=0.004), although they did not differ higher post-test scores (p<0.001). Of the two interactive in knowledge related to duration of effectiveness, mecha- tools that did not have a significant effect, the first38 was nisms of action, or return to fertility.

sInterventions described in Kirby et al. 198949; DeLamater et al. 200047; and Schwarz et al. 2008.58 tIntervention described in DeLamater et al. 2000.47 uInterventions described in Deijen and Kornaat 199746; Garbers et al. 201229; and Castano et al. 201225; Hall et al. 2013,32 2014.42 vInterventions described in Chewning et al. 199945; Garbers et al. 201229; and Michie et al. 2016.35 wIntervention described in Schwarz et al. 2008.58 xIntervention described in Chewning et al. 1999.45 KQ, key question.

www.ajpmonline.org Pazol et al / Am J Prev Med 2018;55(5):703−715 709 The first provider-enhanced intervention using writ- independent interventions assessed through an ten materials27 also was evaluated through an RCT. RCT,26,33,40 and one was a provider-enhanced interven- Providers used a checklist to deliver information deter- tion assessed through a sequential cohort analysis.34,39 mined through a Delphi interview process of 100 gyne- Of the provider-independent interventions, the first33 cologists to be essential for women considering OCs for found that intervention participants given the opportu- the first time. Compared with the control group, the nity to interact with a Facebook page, versus control par- intervention group had a higher median knowledge ticipants allowed to view pamphlets with the same score (p<0.001), and for 15 of 22 questions, a higher information, had higher composite scores for satisfaction percentage of participants with correct responses (range with the counseling they received (p<0.001). By con- by response, p<0.05−p<0.0001). The next two interven- trast, the second intervention40 found a lower percentage tions36,37 similarly included the use of a flip chart to of intervention participants using a smartphone app, deliver information about emergency contraception dur- versus control participants receiving standard-of-care ing a 5-minute session; the first36 was delivered in the counseling from a health educator, who reported they waiting room of a women’s clinic, and the second37 was were very satisfied with the counseling they received delivered at a grocery store pharmacy; both were evalu- (p<0.001). The third provider-independent interven- ated through a pre-/post-test analysis. With the clinic- tion26 was a video informed by the transtheoretical based intervention, knowledge scores increased from model of behavioral change designed to increase aware- baseline to immediate post-test (p<0.001), and remained ness and dispel misconceptions about LARC. Interven- elevated at 1−5 months (p-value not reported). With the tion and control participants did not differ as to whether pharmacy-based intervention, knowledge scores also they reported that they had been given sufficient infor- increased from baseline to immediate post-test mation (p=0.94); they had been able to make their own (p<0.001); at 1−3 months follow-up, knowledge scores decision (p=0.21); staff had respected their decision remained higher than at baseline (p=0.014), although (p=0.54); or that they were satisfied with their decision they were lower than immediate post-test scores (p=0.94) and counseling received (p=0.82). The one pro- (p<0.001). The final provider-enhanced intervention vider-enhanced intervention assessed for its effect on using written materials34,39 was evaluated through a satisfaction was the sequential cohort analysis that was sequential cohort analysis. During, but not prior to, the previously described.34,39 In this analysis, a higher per- intervention period, providers used a checklist as a centage of participants in the intervention versus the reminder to ask patients seeking walk-in services for pre-intervention cohort, having been read a short script pregnancy testing or emergency contraception about on LARC effectiveness, reported that all their questions their pregnancy intentions and any unprotected sex in about birth control had been answered (p<0.001), and the past week. Providers then read a short script describ- that they were satisfied with the discussion (p=0.03). ing the effectiveness of LARCs relative to other methods, In combination with the original review,18 seven and offered participants emergency contraception or interventions were assessed for their effect on satis- same-day LARC insertion, as appropriate. Immediately faction/comfort with services and decision making following their appointment, participants in the inter- (Figure 3, Appendix Table 2, available online). Find- vention versus the pre-intervention cohort had greater ings remained mixed. Six of the seven interventions knowledge of LARC effectiveness and duration relative were provider-independent interventions, with three to other methods (p<0.05, both outcomes). However, finding a significant positive effect,33,48,60 two finding findings related to knowledge of the reversibility of no effect,26,51 and one finding a significant negative LARCs were mixed, as were findings related to knowl- effect40; only one provider-enhanced intervention was edge at 3 months. identified.34,39 In combination with the original review,18 a total of ten provider-enhanced interventions were assessed for Positive Attitudes Toward Contraception their effect on knowledge; all ten had a significant posi- Two provider-independent interventions were identi- tive effect (Figure 3, Appendix Table 2, available fied in the review update that assessed attitudes − − online).27,34 37,39,43 45,47,52,55 toward contraception (KQ4), both with a positive effect. The first,41 evaluated through a pre-/post-test Satisfaction/Comfort With Services and Decision analysis of a comprehensive information brochure, as Making described earlier, resulted in an immediate post-test Four interventions in the review update were assessed increase in participants’ scores for a positive attitude for their effect on satisfaction/comfort with services and about OCs (p<0.001); although scores dropped after decision making (KQ3): three were provider- 3 months, they remained higher than at baseline

November 2018 710 Pazol et al / Am J Prev Med 2018;55(5):703−715 (p=0.036). Moreover, the increase was positively asso- of selecting an effective method (generic vs control: ciated with knowledge scores, both immediately post- OR=1.74, 95% CI=1.35, 2.25; tailored vs control: test (r=0.284, p=0.001) and at the 3-month follow-up OR=1.56, 95% CI=1.23, 1.98). (r=0.206, p=0.022). The second intervention,33 also No studies from the original review18 evaluated the described earlier, resulted in a significantly greater effect of educational interventions on selection of more proportion of participants in the interactive Facebook effective methods. group expressing a preference for implants in particular (p<0.01), or LARC in general (p<0.01). More- Educational Attainment as a Facilitator or Barrier over, knowledge was again an important factor. For The review update identified four interventions (two both study arms combined, greater increases in provider-independent32,43 and two provider- knowledge (4%, 12%, 24%, and 36%) were associated enhanced36,43), assessed through two RCTs32,43 and one with a greater increase in the RR of stating a prefer- pre-/post-test analysis,36 that asked whether a partici- ence for LARC (RRs: 1.06, 1.19, 1.43, and 1.71, pant’s education level impacted knowledge gains (KQ6; respectively, 95% CIs in Appendix Table 2, available Figure 3, Appendix Table 2, available online). One study online). assessed the interaction of patient education with use of 18 In combination with the original review, six differ- text messages,32 one with written materials delivered by ent interventions assessed the effect of educational tools a provider using a flip chart,36 and one with use of either on attitudes toward contraception (Figure 3, Appendix a summary card or full-length brochure, delivered with Table 2, available online). Except for one intervention or without interactive questions delivered by a pro- 46 using written materials alone, each had a positive vider.43 With three of the interventions, knowledge gains 33,41,46,58,61 effect. were similar across education categories (text messages: p=0.49; summary card or full-length brochure without Selection of More Effective Contraceptive Methods interactive questions: p=0.9; or with interactive ques- The review update identified four interventions, assessed tions: p=0.6).32,43 Education interacted with the final 30,31,40 through three RCTs that addressed the selection intervention in which providers delivered information of more versus less effective contraceptive methods and using a flip chart: Increases in knowledge were greater also provided education on the full range of contracep- for participants with a high school education versus tive options (KQ5; Figure 3, Appendix Table 2, available those with some college education or above (136% vs online). Two of these interventions were provider-inde- 51%, p=0.016).36 pendent interactive tools described previously: one filled No studies from the original review18 assessed the gaps in knowledge of LARC, while also providing infor- effect of educational attainment on knowledge gains. mation on the full range of contraceptive options,31 and the other presented methods in the order of effective- DISCUSSION ness.40 Neither resulted in differences in LARC uptake among intervention versus control participants (Gilliam The initial and updated reviews identified 31 indepen- et al.31: p=0.77, Sridhar and colleagues40: p=0.75). The dent educational interventions using a variety of final study30 found a positive effect of both a provider- mediums (i.e., written materials, audio/videotapes, text independent and a provider-enhanced intervention. messages, and interactive tools) assessed for their effect − − − This study assessed a computer-based contraceptive on knowledge.25,27,28,31 47,49 52,54 60 All but three38,40,50 assessment module in which intervention participants of the 31 interventions had a significant positive effect, − − received either a generic list of methods (provider-inde- and 1625,27,32,33,35,42 44,46,47,49,52 54,58,60 of those with a pendent), or a list of methods tailored to their responses, positive effect were evaluated through RCTs character- which they were instructed to share with their healthcare ized by low/moderate risk for bias. These findings are provider (provider-enhanced). Among participants in consistent with the initial review18 and other systematic the control group who were not exposed to any tool, reviews from the broader healthcare field,62,63 in suggest- 65% selected an effective method (i.e., injectables, pills, ing a wide range of educational interventions can help patches, or rings), and 15% selected a highly effective increase client understanding. method (i.e., IUD or implant); in comparison to these Although the original review18 did not identify any percentage for the control group, selection of effective interventions assessed for their interaction with client and highly effective methods, respectively, was greater in educational attainment, the review update identified both the generic (78% and 24%, p<0.001) and tailored four such interventions. With three,32,36,43 increases in information arm (75% and 22%, p<0.001), and both knowledge did not differ by educational attainment; the intervention arms had increased odds relative to controls benefit of the fourth was greater for participants with

www.ajpmonline.org Pazol et al / Am J Prev Med 2018;55(5):703−715 711 less versus more education.36 Although the educational participants who attended a face-to-face session with a level targeted by these interventions was not described, it health educator, versus those who received similar infor- is possible they were effective across educational levels mation through a video, made greater knowledge gains because they were designed for individuals with lower relative to controls.47 In the second, participants who levels of educational attainment. This would be consis- received either a simplified tool or a standard leaflet tent with recommendations from evidence-based tool showed increases in knowledge relative to controls; how- kits from the broader healthcare field suggesting that ever, although the increase relative to controls was even health education materials be easy to interpret by clients greater when the simplified tool was paired with interac- − with a fourth- to sixth-grade reading level,64 66 and that tive questions from a provider, there was no additive certain basic strategies can be used to simplify informa- effect with the standard leaflet.44 In the third RCT, the tion and promote comprehension for all clients. These addition of a facilitator-led discussion session was no strategies include appropriately presenting numeric more effective than a videotape alone for increasing quantities (e.g., by using common denominators and knowledge relative to controls,52 but did result in a natural frequencies, such as “1 in 100 versus 5 in higher proportion of participants redeeming vouchers − 100”),67 79 limiting the amount of information pre- for free condoms.53 The final RCT, described above,30 sented, and highlighting important facts by placing them found that a contraceptive assessment tool was similarly − first.80 82 Given the initial review identified only two effective at promoting selection of more effective meth- studies that assessed the use of such strategies for simpli- ods with and without provider enhancement. However, fying the presentation of information (both of which only participants in the provider enhanced group had mixed results),44,60 and no additional studies were showed higher odds relative to controls of using their identified in the review update, more detailed research selected method correctly and continuing at 4 months.29 specific to contraception is warranted. One reason for the mixed results on provider feedback Few conclusions can be drawn with respect to the sec- may be that educational tools by themselves are only ondary outcomes. For intentions to use contraception, effective for some types of learning. Research from other the one secondary outcome considered a short-term out- areas of health care has demonstrated the effectiveness − come in the accompanying reviews, there was a positive of active learning techniques.84 87 Such learning can be effect in all but one35 of six interventions.28,35,41,49,52,53 readily incorporated into interactive tools, many of However, with respect to medium- and long-term out- which have been developed recently for contraception comes (i.e., contraceptive use, including correct, consis- and included in this review, with mixed results.29 − tent, or continued use, and pregnancy), a positive effect 31,33,38,40 However, these tools may not enhance more was found in a smaller proportion of interventions, complex interactions. For instance, the teach-back which may be because broader counseling interventions method, in which clients restate the most important are needed to address outcomes associated with behav- messages in their own words, has been shown to ensure ioral change and reproductive health goals.83 Nonethe- comprehension,88,89 and was recently used to lower IUD less, with three interventions, knowledge mediated discontinuation rates.90 Similarly, interactive tools by additional outcomes of interest, including positive atti- themselves may not be sufficient for other components tudes toward OCs41 or LARCs,33 intentions to use of counseling that build upon knowledge, such as skill OCs,41 and continued use of OCs.25,42 building or evaluating options in light of individual Finally, this update adds to evidence about the extent needs and preferences. More recently, contraceptive to which educational interventions are more effective decision aids have been developed as provider tools for with input from a health provider/educator. With improving contraceptive counseling.91,92 Research is respect to knowledge (KQ1), all ten provider-enhanced needed to assess whether contraceptive decision aids versus 18 of 21 provider-independent interventions had developed for this purpose can further promote satisfac- a significant positive effect. However, for satisfaction/ tion with services, and attainment of behavioral and comfort with decision making and services (KQ3), posi- reproductive health goals. tive attitudes (KQ4), and selection of more effective methods (KQ5), only one provider-enhanced interven- Limitations tion was identified, thus providing little basis for com- This evidence summarizing the impact of educational parison. Of note, however, four RCTs with low risk for interventions has several limitations, which should be bias (three from the original review44,47,52,53 and one considered when interpreting the evidence. Although from the review update29,30) were identified comparing several high-quality studies were identified for assessing the same intervention with and without feedback from a the impact of educational interventions on knowledge, healthcare provider. Results were mixed. In the first, fewer were identified for the remaining primary

November 2018 712 Pazol et al / Am J Prev Med 2018;55(5):703−715 outcomes targeted by contraceptive education. Seven SUPPLEMENTAL MATERIAL studies assessed satisfaction/comfort with services and Supplemental materials associated with this article can be decision making, of which four were RCTs with low/ found in the online version at doi:10.1016/j.amepre.2018. 26,33,40,60 moderate risk, and three had high risk for 07.012. bias.34,39,48,51 Of the five studies assessing positive attitudes toward contraception, three were RCTs with low/ moderate risk for bias,33,46,58 and two had a high risk for REFERENCES 41,61 bias or a less rigorous design. Only three studies 1. Hatcher R, Trussell J, Nelson A, Cates W, Kowal D, Policar M. Con- were identified that assessed selection of more effective traceptive Technology. Atlanta, GA: Ardent Media, 2011. methods, although all were RCTs with low/moderate 2. Finer LB, Zolna MR. 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