Preventing Malpractice and Medical Litigation in Digestive Interventional Endoscopy by the Use of Empirical Models for the Informed Consent

Preventing malpractice and medical litigation in digestive interventional endoscopy by the use of empirical models for the informed consent

Elena Toader1, Gheorghe G. Balan1,*, Gabriel Constantinescu2, Diana Bulgaru-Iliescu1

______Abstract: Informed consent contributed to universal assurance of patient self determination. Patients have the right to be fully informed about their health status and therefore they may refuse and stop any medical intervention. The importance and role of the informed consent should be seen also as a factor promoting quality in healthcare and therefore preventing medical litigation and malpractice. The aim of our study is to provide empirical models for informed consent in interventional endoscopy as such empirical models could contribute to a higher level of quality healthcare assurance and subsequently a lower index of medical litigation and malpractice claims in endoscopy. Methods. All the data used in investigation was collected from available sources and therefore rely on a mini-review of the literature. The literature was screened by searching for a set of keywords in various medical databases in September 2018. The analysis of the literature allows obtaining empirical models that need to be confirmed by various alternative hypotheses, namely logical interconnections between various social dimensions in need of an inter-party regulation clause. Results and discussions. Empirical modeling includes various circumstances like emergency endoscopy, therapeutic endoscopy in children, follow-up procedures after therapeutic endoscopy, unexpected findings and intra-procedural need for special care, therapeutic ERCP and infection control in patients with biliary obstruction in need for endoscopic stenting, diagnostic EUS and the need for fine needle aspiration and fine needle biopsy, withdrawal of consent and advanced decisions to refuse treatment or waiver consent, tissue sampling during endoscopy, media documentation of the procedure, live-endoscopy settings, or trainees participating at the procedure. Referring to such models is surely not exhaustive but should be applied by practitioners when the case allows it. Nevertheless, general principles of informed consenting should always be applied. Conclusion. The models developed are characterized by validation and sustainability and using such models may strengthen the idea that proper informed consent models could play an important role in the quality and safety assurance of interventional digestive endoscopy procedures therefore lowering the overall prevalence of medical litigation and malpractice. Key Words: malpractice, gastrointestinal endoscopy, self determination, autonomy, model.

INTRODUCTION after finding out about their true condition or prognosis [1]. The concept of modeling the informed consent is not Physicians have a duty to inform, patients a new one, one of the first models dating back to the 14th have a right to refuse. This has been perhaps the most century and being regarded to nowadays as one of the first important principle of medical law and ethics regarding documents aiming rather to protect physicians than to the paradigm of informed consent. The medical profession promote patient autonomy [2]. The 20th century has, on has traditionally been governed by a paternalistic approach the other side, been characterized by the utmost proposing to patient management, one of the Hippocratic principal and valuing the patients’ right of self-determination. In this thoughts stating that in some cases the doctor has to deftly respect, patties have to be given information first about comfort the patient without disclosure of the real meaning their rights under applicable state laws and subsequently of his illness because there are many patients who turn worse about their medical condition in order to be able to take

1) “Grigore T. Popa” University of Medicine and Pharmacy, Iasi, Romania * Corresponding author: E-mail: [email protected] 2) “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania

429 Toader E. et al. Preventing malpractice and medical litigation in digestive interventional endoscopy informed decisions [3]. Such rights have been extensively to discrimination and polarization of practice when described in the Patient Self Determination Act adopted recorded in relationship with several populations of in 1990 by the United States Congress and generally refer patients especially those vulnerable or with special needs. to [4]: (i) the right to participate in and direct their own As currently medical practice is increasingly guided by healthcare decisions, (ii) the right to accept or refuse political strategies, difficulties in the challenge of existing medical and surgical treatment, (iii) the right to prepare paradigms are common. On the other hand, one of the an advance directive, and (iv) the right to be informed on main interests of professional communities is to prevent the hospital policies governing patient self-determination. medical litigation and malpractice claims [10-12]. A Such legal codification for patient self-determination has, proper appliance of the informed consent documents for the first time introduced the legal protection of patient followed by high quality communication could positively autonomy, otherwise a valued fundamental ethical principle contribute in such a direction. Therefore, the aim of our that marked the decline of the traditional paternalistic study is to provide empirical models for informed consent approaches. Another very important consequence of to be used in interventional endoscopy procedures when such legal statute is the subsequent ability of patients to dealing with such either vulnerable patients or patients pursue their interest in courts of law by suing health with special needs. Secondary, through their appliance, care professionals if their expressed wishes on medical such empirical models could contribute to a higher procedures have been either ignored or misinterpreted. level of quality healthcare assurance in the endoscopy Moreover such litigation actions known as the Nuremberg suite and to better cohesion of personal credentialing, trials led to the expansion of patient autonomy also in what subsequently lowering the chance for malpractice claims medical research is concerned [5]. Hence, the need for and litigation. universal assurance of patient self determination through the informed consent process has been met through METHODS the 1994 World Health Organization constitutional declaration of patients’ rights stating that patients have All the data used in investigation was collected the right to be fully informed about their health status, the from available sources and therefore rely on a mini-review diagnosis, prognosis and progress of treatment, including of the literature. The literature was screened by searching the medical facts about their condition, the proposed for a set of keywords in various medical databases in medical procedures, the potential risks and benefits, the September 2018. The keywords were selected from the alternatives to the proposed intervention and the effect of MeSH Database: informed consent, consent forms, non-treatment [6]. The patient has therefore the right to gastrointestinal endoscopy, endosonography, endoscopic refuse and stop any medical intervention. Not the least, retrograde cholangiopancreatography, autonomy, the importance and role of the informed consent should paternalism. Literature databases included: EBSCO be seen also as a factor promoting quality in healthcare, as Academic Search Complete, Oxford Journals, Science recognized also by the European Union, and thus the need Direct, Springer Link, ProQuest, Web of Science, Scopus, of efforts taken to act for the sustainable benefit of future Wiley Journals, Taylor & Francis, Medline, Cochrane generations. Library. Duplication articles were excluded after first Informed consent generally for gastrointestinal search workup. Final selection of the articles included endoscopy and particularly for interventional procedures only those works that define, enounce, or suggest is an essential part for quality assurance in endoscopy- empirical forms of consent in various topics related to the related medical care. As endoscopy-related procedures field of interventional digestive endoscopy procedures. In become more and more invasive and both clinically this way, the analysis of the literature strives to highlight and technically challenging, the informed consent that obtaining empirical models for the informed consent begins to be seen as a tool for protecting all parties clauses needs to be confirmed by various alternative involved [7], namely: (i) the patient for understanding hypotheses. Such hypotheses are logical interconnections the medical condition and personally determining it’s between various social dimensions in need of an inter- best management, and (ii) the endoscopist and medical party regulation clause. A null interconnection defined institution providing opting out from liability secondary by the absence of correlation between studies led to to out-of-control complications. Despite the fact that the exclusion of the work. Consequently, generating an both patient self determination and protection of empirical model resided not in summing up previous informed consent principles in endoscopy have generally models from the literature but creation of socially, legally and uniformly been regarded to as important pillars of and professionally applicable models. quality and credentialing value, there are numerous studies pointing out that informed consent seen as a Assessment of the literature. The core curriculum process is often poorly done or even altogether neglected of informed consent by many endoscopy practitioners [8, 9], thus leading The first aspect reviewed in the literature was a first to low-quality of care, and even more importantly proper definition for the informed consent, as a legal and

430 Romanian Journal of Legal Medicine Vol. XXVI, No 4(2018) ethical mandate before any diagnostic or interventional are declined. Such statements represent the fundamentals procedure in gastrointestinal endoscopy. The law regarding what information is required for a proper defines informed consent as the decision of a sound informed consent delivery in interventional endoscopy. minded adult on which, if any, of the available forms On the other hand, as we have previously demonstrated, of treatment or diagnosis to undergo [13]. Informed every informed consent form may be characterized consent should be well differentiated from consent seen by special information patterns that even treated as as a permission or approval as opposed to assault or subsidiary; they may act as important behavior control battery meaning unpermitted physical contact or the fear mechanisms and influence decisions of patients [17, 18]. of such unwilling contact [14]. The concept of informed Another important aspect is related to who may consent is therefore defined by the fact that it requires consent, what are the exceptions for obtaining informed sharing enough information in order for the patient to consent, and the bases for refusal of treatment or act autonomous in the decision to undertake or not a withdrawal of consent. Only legally competent patients certain endoscopic procedure baring certain risks and may consent and in this respect state definitions may benefits opposed to some alternatives for diagnosis or vary. Generally, competence is acquired by reaching treatment. The American Society of Gastrointestinal an age level (i.e. adulthood, in most countries after 18 Endoscopy (ASGE) has thus issued guidelines on how years of age) and by the absence of any temporary or specific information should be disclosed; who should continuous lack of ability to discern. In either children provide such information and the documentation and or adult patients definitively lacking capacity to discern timing that such process should be characterized by legal guardians are entitled to give consent. General [15]. In this respect, informed consent appears to be the exceptions applicable also in interventional endoscopy balanced process that connects the quantity and quality are those triggered by need of emergency care doubled by of disclosure and the attributes of the personally assumed an inability to either obtain the patient’s informed consent decision. or to contact legal guardians or, dependent on state laws, In what the quantity and quality of disclosure the closest of relatives. Such situation can frequently are concerned, there are several aspects that should be arise in either pediatric patients or adult incapacitated included in informed consent clauses on gastrointestinal (comatose or neurologically impaired, found in shock interventional endoscopy. The core statements of and with advanced life support, etc.) in need of urgent disclosure include [15, 16]: (i) the clinically debated therapeutic endoscopy i.e. for hemostasis or emergency medical diagnosis and test results that are indication ERCP in a time interval insufficient for bringing surrogate for a certain therapeutic endoscopic procedure (i.e. decision maker. State law should properly determine colorectal polyps, common bile duct stones, unresectable specific conditions for emergency care and definition pancreatic tumors, gastrointestinal bleedings etc.); (ii) of surrogate decider [15]. Therapeutic privilege, waiver the nature of the proposed interventional diagnostic or and legal mandate are other circumstances in which therapeutic procedure (i.e. colonoscopy and polipectomy, informed consent may not be obtained secondary endosonography and fine needle biopsy, endoscopic to classic principles. Therapeutic privilege refers to retrograde cholangiopancreatography (ERCP), etc.); (iii) deliberate withholding information when considered the reason the procedure is being suggested, namely the that information would harm the patient or diminish the outcome expected from the interventional process carried goals of informed consent [19] but is subject to various out throughout the endoscopic procedure (colorectal state legal definitions and in the setting of interventional cancer prophylaxis, control of bleeding and prophylaxis endoscopy procedures such a privilege may likely refer to of bleeding recurrence, therapy of obstruction-related the diagnosis or outcome after the procedure. Frequently, cholangitis, positive histological diagnosis of pancreatic a patient may opt not to be informed. Withholding tumors, etc.); (iv) the benefits strictly dependent on the information from patients at their request is an exception outcome of the procedure and it’s prophylactic value; (v) to informed consent which is in many states empowered The risks and complications of the procedure, including by law and is referred to as a waiver [15, 19]. Naming their cited incidence and severity above 1%, the rarer a surrogate decision maker is mandatory in such cases. events could not on the first hand be physically foreseen Such a decider may be enforced also by a judicial and on the other hand would not be material to the order commonly known as a legal mandate. Refusal of decision making process (i.e. bleeding and perforation endoscopic treatment can be expressed at any moment could be adverse events for polipectomy but stroke before or even during the procedure in unsedated legally secondary to over sedation although possible could not competent patients. Such refusal should be delivered to be influencing the informed character of the decision the doctor [3]. Exceptionally, consent can be withdrawn mainly because of its low incidence in endoscopy related also after administration of sedation when patients sedation); (vi) reasonable and feasible alternatives to the is still conscious, as concluded in a British survey of proposed procedure namely surgery; (vii) the patient’s gastroenterologists regarding stopping a colonoscopy prognosis if interventional endoscopy or it’s alternatives under moderate sedation at the special request of the

431 Toader E. et al. Preventing malpractice and medical litigation in digestive interventional endoscopy patient [20]. Such circumstances are subject to debate are obtained through modeling of the informational especially in what the mental ability to discern of such component of informed consent by using opportunity patients is concerned. variables [27]. On the other hand, current studies show Not the least, especially related to interventional that designing informed consent is done in most cases endoscopy procedures, certain special features have been by using classic principles of ethics rather that normative described on where and when informed consent should ethics [28], therefore generating high variability, be taken. With the exception of emergency endoscopy, inconclusive and incomplete information and even patients should be given informed consent forms disinformation. Thus, our approach could be validated by during a medical visit that allows them time to ask the not only by the need given lack of anterior studies but also endoscopist and team questions and to think about the by principles of deontological and consequential theories decision. Generally, written informed consent forms according to which risk/benefit ratios should be evaluated should be offered to patients at least several days before singularly rather that generally and opportunistic the endoscopic procedure, otherwise the patient should assumption of risks does not protect against litigation be given the opportunity to talk with the endoscopist when done generally and interpersonally. before the procedure if same-day informed consent is Secondary, multiple authors suggest that applied. It is therefore undesirable to take consent in the informed consent should be well connected to patients’ endoscopy room immediately before the procedure and needs especially in particular situations either triggered healthcare providers should take measures against such by the vulnerability of patients or complexity of the a situation and offer a suitable protocol for allowing both procedure [29]. Thus, in a consequential approach, patients and endoscopy teams enough time and space to referring to the mental and psychological capacity of properly receive and offer informed consent [7, 21]. In patients during designing informed consent clauses this respect, postal consent may be a desirable alternative should always be performed [30], especially for highly to endoscopy suit consenting [21]. interventional procedures. On the other hand, numerous Given the complexity of both theoretical and epidemiological, empirical, single- or multicenter trials legal aspects regarding general informed consent have attempted to ethically modernize informed consent requirements, we find important to stress that the forms [31-34]. The common downside of such studies is majority of legal issues related to informed consent the excessive ethical orientation on classical principles like arise from either unclear informed consent clauses and autonomy, beneficence, social order, etc., hence referring forms, the lack of documentation, the lack of time for to the same deontological, utilitarian, and consequential properly discussing the procedure details with patients ethical values rather than a patient oriented normative and the absence of proper and qualitative investigation ethics. Consequently, designing informed consent models prior to therapeutic endoscopy. Thus, in most cases it is for patient undergoing invasive endoscopic procedures to be considered that good communication and a proper could bring together normative ethical principles and and honest practitioner-patient relationship is the gold intrinsic features of the endoscopy procedure creating standard for quality consenting. a patient orientated approach. Parallel models can scarcely be found in literature generally referring to risk Arguments for empirical modeling. Discussions stratification and probabilistic provisions [35, 36]. The inference of different and frequently Not the least, informed consent is generally contrasting data related to informed consent in regarded to as a quality indicator for gastrointestinal interventional endoscopy is explained by aiming endoscopy procedures [37-41]. Thus, procedural to extract as much information as possible from a standards should be referred to also in informed consent variety of practical situations that are in most cases clauses leading consequently to the need for consent either unpredictable or with a clear patient-dependent modeling. Examples in this respect include mainly prognosis. Such uncertainty affects the robustness of data personal risk stratification (i.e. patient-dependent risk when referring to informed consent clauses. Therefore, factors), adapting post-procedural recovery times, risk the alternative of empirical modeling seems to be useful of malignant dissemination, post-procedural need for as endoscopy procedures tend to be more and more surgery, etc. Designing special features for informed complex, invasive, and with a patient oriented approach consent forms seems therefore mandatory. Moreover, rather than using standard techniques [22-24]. different approaches could be related to when and in what One of the first arguments for empirical format should information best be provided, the patient modeling of clauses is raising the efficacy of complete and being able to elect possible alternatives [42] in order rightful information and disclosure generating a double to maximize personal comprehension of information. protection standard: that of the patient and of healthcare Subsequently, the manner in which risk of endoscopy is professionals [25]. Subsequently, the quality of care may best presented to the patient may be subject to modeling as be given higher standards and patients would feel more patients may prefer either precise epidemiological data or safe and comfortable during endoscopy [26]. Such results overall estimations strictly related to possible alternatives

432 Romanian Journal of Legal Medicine Vol. XXVI, No 4(2018)

[42, 43]. Presenting media coverage for explaining in subgroups of patients, as stressed also by Zuckermann procedure techniques and extensive use of checklists may et al., Everett et al., Baron et al., and Valori et al. [15, 21, also contribute to a higher quality of information [21, 32- 38, 47], we recommend: (i) given the high complication 44]. rates to be expected even in current settings, specific epidemiology of adverse events should be cited; (ii) Empirical models of informed consent clauses statement that there are unique and non-foreseeable Given the complexity of situations in need complications of ERCP that can occur independent on of empirical models for consenting, we established a the standard character of the procedure; (iii) developing a schematic and compact exposure that allows statement checklist of patient-related risk factors for adverse events of information in a conjunctive manner, with special including possible ongoing pregnancy; (iv) statement recommendations sustained by the opinion of authors on regarding the relatively high rate of infectious adverse each topic. There are multiple special situations specific events due to the special design of duodenoscopes and for the interventional endoscopy practice that need model the physical inability to obtain 100% reprocessing rates, clauses for the informed consent. Such models are surely especially involving patients with biliary obstruction in not exhaustive but should be applied by practitioners need for endoscopic stenting; (v) statement regarding when the case allows it. the possible need for oro-tracheal intubation, blood In the case of emergency endoscopy, as suggested transfusion and surgery immediately after ERCP; (vi) by Everett et al. and Pereira et al. [21, 26]: (i) stating that statement regarding the possible need for repeated ERCP this is an emergency procedure and the medical setting procedures or surgery at a certain time interval after involved; (ii) mentioning whether at least verbal consent ERCP; has been given; (iii) if either written or verbal consent In the case of diagnostic endoscopic ultrasound cannot be obtained, special documentation must be (EUS) procedures especially about the need for fine involved and signed by at least 3 healthcare professionals. needle aspiration (FNA) and fine needle biopsy (FNB), Such procedure must not obliterate future personal as suggested by Rizik et al., Valori et al., or Wani et al. options of patients. [39, 47, 49] we recommend inclusion of: (i) informative When performing therapeutic endoscopy in statement on the diagnostic accuracy of the procedure children, as outlined also by Everett et al., Maaskand et in particular pathologic settings; (ii) acknowledgement al., and also by courts of law [21, 45, 46], we recommend: of the unpredictable risk for malignant dissemination (i) stating that this is a therapeutic procedure for children; of the puncture tract in both FNA and FNB; (iii) special (ii) registration of competence of the endoscopist to statement regarding the potential infectious adverse events perform such procedure; (iii) describing special situations especially in high risk patients; (iv) advance directives on regarding competent children aged depending on state the potential therapeutic maneuvers following FNA or rules; (iv) express mention for the identity of caregiver, FNB including drainage and lumen apposing metal stents guardian or surrogate decision maker. with a special acknowledgement on adverse events and In what follow-up procedures after therapeutic costs. endoscopy are concerned it is advisable, as stated by Everett Regarding the potential withdrawal of consent et al., Valori et al., and also by providers’ associations, to and advanced decisions to refuse treatment or waiver promote [21, 47, 48]: (i) take advance consent for the consent, as suggested by Choctaw, Axon et al., Zuckerman perspective of all surveillance endoscopic procedures, et al., and Everett et al. [3, 7, 15, 21], we consider important dependent on state regulations. Patient should be aware of clauses the following: (i) clearly stating the right of a the follow-up plan; (ii) state the possible new information patient to object during an endoscopic procedure, so that that would influence surveillance intervals and risks; the procedure should be stopped at any moment if there is (iii) agree to adhere to follow-up plan and to inform the no harm for the patient; (ii) foreseeing special situations endoscopy team of the precise new situations arisen. in which stopping the procedure may do harm: lack of Unexpected findings and intra-procedural need hemostasis, inability to close mucosal defects, partial for special care require special informed consent clauses, resection of tumors, etc.; (iii) including the possibility as outlined also by Everett et al. and healthcare providers’ to restart the procedure either during the same session associations [21, 48], i.e.: (i) extending consent before the or after due appointment; (iv) clearly naming situations procedure for treatment or intra-procedural steps that in which capacity is lacking, so that it may be justified can reasonably occur during the procedure; (ii) consent to continue in the person’s best interests, i.e. moderate should be extended to all complications including or deep sedation, temporary discomfort or prior lack of sedation induced adverse events that need immediate care ability to discern dependent on state law. so that abstinence to act may cause immediate damage; As a very common integrative part of Therapeutic ERCP complications, known as interventional procedures, tissue sampling during a field of great risk for medical litigation with a recent endoscopy, as recommended by Everett et al. [21], needs additional risk in infection control situations especially special clause insertion among which: (i) special and

433 Toader E. et al. Preventing malpractice and medical litigation in digestive interventional endoscopy express consent given according to state law for tissue of special situations, general principles of informed and/or cell samples; and (ii) special information about: consenting should always be applied. Thus, informed manipulation and property of samples, storage, use for consent documents and clauses should be regarded to as a further research or genetic analysis, and destruction of combination of disclosure and personal decision making samples. Subsequently, media documentation of the involving several fundamental components that promote procedure should be delineated during informed consent adequate disclosure: (i) the type of endoscopic procedure, documents by [7, 21]: (i) allowing healthcare practitioners (ii) the necessity of such procedure, (iii) its known to take photos or videos during endoscopy procedure; (ii) risks and benefits, and (iv) its reasonable alternatives. establishing the extent and the property of such media Furthermore, the team involved should assure proper coverage including further use of imagery in accordance documentation of both informed consenting and to patient/professional confidentiality; (iii) giving clear informed refusal prior to endoscopy and should design permission to use such documentation for second opinion special documentation for the recognized exceptions visits and follow-up; (iv) developing special consent for to the informed consent process including emergency, using imagery in teaching or assessment, without seeking therapeutic privilege, waiver, and legal mandate [15]. additional consent after assuring patient anonymity. Live-endoscopy settings are new and fashionable CONCLUSIONS circumstances in which special and additional information should be given to patients, as expressed by Dinis-Ribeiro Our study has successfully reached its objectives et al. [50] especially on the following topics: (i) live in what sound argumentation and socio-professional transmission of cases should involve special consent; (ii) basis development for empirical models of informed at every moment the patient must consent to the identity consent are concerned, with a particular appliance in of the healthcare provider involved in the procedure; interventional gastrointestinal endoscopy procedures. (iii) if the procedure is part of a live endoscopy congress Hence, the models developed are characterized by or meeting, especially if such event involves the use of validation and sustainability according to the literature alternative or innovative procedure steps and maneuvers, assessment performed. Therefore, using such models special and express consent should be obtained; (iv) clear may strengthen the idea that proper informed consent definition of the healthcare providers and institution models could play an important role in the quality and responsible for the management and outcome of patients; safety assurance of interventional digestive endoscopy (5) clear definition of the technology used in such a procedures subsequently contributing to lower indexes setting. for medical litigation and malpractice claims. Secondary, When trainees participate in interventional such practices may elevate the quality of the professional- endoscopy procedures, as stated by Everett et al. [21], patient relationship thus having a positive impact on the it is to be considered that: (i) patients should expressly overall patient quality of life. However, due to the lack allow participation of either students or trainees in of similar studies on empirical modeling, although clear performing the procedure; (ii) best practice, guideline and sound, the findings of our study are awaiting parallel and recommendation standards should be assured; (iii) results that may contribute to a best-of-care match of patients should give consent after being informed of the such informed consent models with various patient- or exact competence of the medical team involved including procedure-related circumstances. trainees, and all endoscopists and nurses should be documented on the report; Conflict of interest. The authors declare that Nevertheless, independently on the occurrence there is no conflict of interest.

References 1. Dunkas N. The Works of Hippocrates. Athens: Diachronic Publications, Inc; 1998. 2. Leclercq WK, Keulers BJ, Scheltinga MR, Spauwen PH, van der Wilt GJ. A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions. World journal of surgery. 2010;34(7):1406-1415. 3. Choctaw WT. Avoiding Medical Malpractice: A Physician's Guide to the Law. New York: Springer Science + Business Media; 2008. 4. US Congress. Patient Self-Determination Act. Omnibus Budget Reconciliation Act (OBRA), Pub L, 101-508; 1990. 5. Pappworth MH. "Human guinea pigs"--a history. BMJ: British Medical Journal. 1990;301(6766):1456. 6. World Health Organization. (1995). Constitution of the world health organization. 7. Axon AE, Axon ATR. Informed Consent for Gastrointestinal Endoscopy. In: Wallace MB, Fockens P, Sung JJ-Y. Gastroenterological Endoscopy. Third Edition. Stuttgart: Theime; 2018. 8. Triantafyllou K, Stanciu C, Kruse A, Malfertheiner P, Axon A, Ladas SD. Informed consent for gastrointestinal endoscopy: a 2002 ESGE survey. Digestive Diseases. 2002;20(3-4):280-283. 9. Kopacova M, Bures J. Informed consent for digestive endoscopy. World journal of gastrointestinal endoscopy. 2012;4(6):227. 10. Tevanov L, Liciu E, Chirila MO, Dusca A, Ulici A. The use of 3D printing in improving patient-doctor relationship and malpractice prevention. Romanian Journal of Legal Medicine 2017;25(3):279-282.

434 Romanian Journal of Legal Medicine Vol. XXVI, No 4(2018)

11. Eş H, Özer Y, Liman Z, Şanlı AN. General surgery malpractice claims in Turkey. Romanian Journal of Legal Medicine 2017;25(3):272-278. 12. Nica AS, Constantinovici M, Miclaus R. Ethical issues in rehabilitation of the post-traumatic patient. Romanian Journal of Legal Medicine 2017;25(3):309-313. 13. Montgomery v Lanarkshire Health Board. 2015. UKSC 11. 14. Citrus Valley Health Parteners. Principles of Consent. Risk Management News. 2000. 15. Standards of Practice Committee, Zuckerman MJ, Shen B, Harrison ME 3rd, Baron TH, Adler DG, Davila RE, Gan SI, Lichtenstein DR, Qureshi WA, Rajan E, Fanelli RD, Van Guilder T. Informed consent for GI endoscopy. Gastrointestinal endoscopy. 2007;66(2):213-218. 16. Barry R, Furrow TL, Greaney SH, et al. Health law, 2nd ed. St. Paul (Minn): West Group; 2000. 17. Balan GG, Trifan A, Savin C, Balan A, Gologan E. Beneficence and Behavior Control: Ethical Dilemmas in Gastroenterology. Revista de Cercetare si Interventie Sociala 2015;55. 18. Toader E, Balan GG, Iliescu DB, Perju-Dumbrava D. Ethical and legal medicine aspects related to hepatic encephalopathy. Romanian Journal of Legal Medicine 2017;25(1):125-127. 19. Meisel A, Kuczewski M. Legal and ethical myths about informed consent. Archives of Internernal Medicine 1996;156:2521-2526. 20. Ward B, Shah S, Kirwan P, Mayberry JF. Issues of consent in colonoscopy: if a patient says ‘‘stop’’ should we continue? J R Soc Med 1999;92:132-133. 21. Everett SM, Griffiths H, Nandasoma U, Ayres K, Bell G, Cohen M, Thomas-Gibson S, Thomson M, Naylor KM. Guideline for obtaining valid consent for gastrointestinal endoscopy procedures. Gut 2016;gutjnl-2016. 22. Constantinescu G, Sandru V, Ilie M, Nedelcu C, Tincu R, Popa B. Treatment of malignant esophageal fistulas: fluoroscopic placement of esophageal SEMS, endoscopically-assisted through surgical gastrostomy: a case report. Journal of Gastrointestinal and Liver Diseases 2016;25(2): 249. 23. Popa B, Ilie M, Plotogea O, Olteanu I, Turculet C, Constantinescu G. Ultrasound-guided drainage of walled-off pancreatic necrosis. Case report. Medical ultrasonography 2015;17(2):259-261. 24. Popa B, Ilie M, Sandru V, Hortopan M, Beuran M, Constantinescu G. Endoscopic resection of a giant colonic lipoma causing severe anemia. Journal of Gastrointestinal and Liver Diseases 2015;24(2):142. 25. Lloyd A, Hayes P, Bell PR, Naylor AR. The role of risk and benefit perception in informed consent for surgery. Medical decision making 2001;21(2):141-149. 26. Pereira SP, Hussaini SH, Wilkinson ML. Informed consent for upper gastrointestinal endoscopy. Gut 1995;37(1):151-153. 27. Kramer AD, Guillory JE, Hancock JT. Experimental evidence of massive-scale emotional contagion through social networks. Proceedings of the National Academy of Sciences, 2014;201320040. 28. Manson NC, O'Neill O. Rethinking informed consent in bioethics. Cambridge: Cambridge University Press, 2007. 29. Sudore RL, Landefeld CS, Williams BA, Barnes DE, Lindquist K, Schillinger D. Use of a modified informed consent process among vulnerable patients: a descriptive study. Journal of general internal medicine, 2006;21(8):867-873. 30. Roberts LW. Informed consent and the capacity for voluntarism. American Journal of Psychiatry 2002;159(5):705-712. 31. Warner J, McCarney R, Griffin M, Hill K, Fisher P. Participation in dementia research: rates and correlates of capacity to give informed consent. Journal of medical ethics 2008;34(3):167-170. 32. Okai D, Owen G, McGuire H, Singh S, Churchill R, Hotopf M. Mental capacity in psychiatric patients: systematic review. The British Journal of Psychiatry 2007;191(4):291-297. 33. Fisher CB. Goodness of fit ethic for informed consent to research involving adults with mental retardation and developmental disabilities. Mental retardation and developmental disabilities research reviews 2003;9(1):27-31. 34. Dunn LB, Nowrangi MA, Palmer BW, Jeste DV, Saks ER. Assessing decisional capacity for clinical research or treatment: a review of instruments. American Journal of Psychiatry 2006;163(8):1323-1334. 35. Bilimoria KY, Liu Y, Paruch JL, Zhou L, Kmiecik TE, Ko CY, Cohen ME. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. Journal of the American College of Surgeons 2013;217(5):833-842. 36. Agre P, Campbell FA, Goldman BD, Boccia ML, Kass N, McCullough LB, Merz JF, Miller SM, Mintz J, Rapkin B, Sugarman J, Sorenson J, Wirshing D. Improving informed consent: the medium is not the message. IRB: Ethics & Human Research 2003;25(5):S11-S19. 37. Baron TH, Petersen BT, Mergener K, Chak A, Cohen J, Deal SE, Hoffinan B, Jacobson BC, Petrini JL, Safdi MA, Faigel DO, Pike IM; ASGE/ ACG Taskforce on Quality in Endoscopy. Quality indicators for endoscopic retrograde cholangiopancreatography. Am J Gastroenterol. 2006;101(4):892-897. 38. Faigel DO, Pike IM, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Petrini JL, Rex DK, Safdi MA; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for gastrointestinal endoscopic procedures: an introduction. Am J Gastroenterol. 2006;101(4):866-872. 39. Rizk MK, Sawhney MS, Cohen J, Pike IM, Adler DG, Dominitz JA, Lieb JG 2nd, Lieberman DA, Park WG, Shaheen NJ, Wani S. Quality indicators common to all GI endoscopic procedures. Am J Gastroenterol. 2015;110(1):48-59. 40. Armstrong D, Barkun A, Bridges R, Carter R, de Gara C, Dube C, Enns R, Hollingworth R, Macintosh D, Borgaonkar M, Forget S, Leontiadis G, Meddings J, Cotton P, Kuipers EJ; Canadian Association of Gastroenterology Safety and Quality Indicators in Endoscopy Consensus Group. Canadian Association of Gastroenterology consensus guidelines on safety and quality indicators in endoscopy. Can J Gastroenterol. 2012;26(1):17-31. 41. Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for colonoscopy. Am J Gastroenterol. 2006;63(4):S16-S28. 42. Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: Advancing guideline development, reporting and evaluation in healthcare. CMAJ 2010;182:E839–42. 43. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360:491–499. 44. Matharoo M, Thomas-Gibson S, Haycock A, Sevdalis N. Implementation of an endoscopy safety checklist. Frontline Gastroenterol 2014;5:260–265.

435 Toader E. et al. Preventing malpractice and medical litigation in digestive interventional endoscopy

45. Gillick v West Norfolk and Wisbech AHA [1986] AC 112. 46. Maaskant JM, Vermeulen H, Apampa B, Fernando B, Ghaleb MA, Neubert A, Thayyil S, Soe A. Interventions for reducing medication errors in children in hospital. Cochrane Database Syst Rev 2015: doi:10.1002/14651858.CD006208.pub3. 47. Valori R, Cortas G, de Lange T, Balfaqih OS, de Pater M, Eisendrath P, Falt P, Koruk I, Ono A, Rustemović N, Schoon E, Veitch A, Senore C, Bellisario C, Minozzi S, Bennett C, Bretthauer M, Dinis-Ribeiro M, Domagk D, Hassan C, Kaminski MF, Rees CJ, Spada C, Bisschops R, Rutter M. Performance measures for endoscopy services: A European Society of Gastrointestinal Endoscopy (ESGE) quality improvement initiative. Endoscopy 2018. 48. Reference guide to consent for examination or treatment (second edition), https://www.gov.uk/government/publications/reference-guide- to-consent-for-examination-or-treatment-second-edition, accessed December 2018. 49. Wani S, Wallace MB, Cohen J, Pike IM, Adler DG, Kochman ML, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Tokar JL. Quality indicators for EUS. Am J Gastroenterol. 2015;110(1):102-113. 50. Dinis-Ribeiro M, Hassan C, Meining A, Aabakken L, Fockens P. Live endoscopy events (LEEs): European Society of Gastrointestinal Endoscopy Position Statement–Update 2014. Endoscopy 2015;47(01):80-86.

436