Assessment of Diagnostic and Screening Tests
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Preventive Health Care
PREVENTIVE HEALTH CARE DANA BARTLETT, BSN, MSN, MA, CSPI Dana Bartlett is a professional nurse and author. His clinical experience includes 16 years of ICU and ER experience and over 20 years of as a poison control center information specialist. Dana has published numerous CE and journal articles, written NCLEX material, written textbook chapters, and done editing and reviewing for publishers such as Elsevire, Lippincott, and Thieme. He has written widely on the subject of toxicology and was recently named a contributing editor, toxicology section, for Critical Care Nurse journal. He is currently employed at the Connecticut Poison Control Center and is actively involved in lecturing and mentoring nurses, emergency medical residents and pharmacy students. ABSTRACT Screening is an effective method for detecting and preventing acute and chronic diseases. In the United States healthcare tends to be provided after someone has become unwell and medical attention is sought. Poor health habits play a large part in the pathogenesis and progression of many common, chronic diseases. Conversely, healthy habits are very effective at preventing many diseases. The common causes of chronic disease and prevention are discussed with a primary focus on the role of health professionals to provide preventive healthcare and to educate patients to recognize risk factors and to avoid a chronic disease. nursece4less.com nursece4less.com nursece4less.com nursece4less.com 1 Policy Statement This activity has been planned and implemented in accordance with the policies of NurseCe4Less.com and the continuing nursing education requirements of the American Nurses Credentialing Center's Commission on Accreditation for registered nurses. It is the policy of NurseCe4Less.com to ensure objectivity, transparency, and best practice in clinical education for all continuing nursing education (CNE) activities. -
FORMULAS from EPIDEMIOLOGY KEPT SIMPLE (3E) Chapter 3: Epidemiologic Measures
FORMULAS FROM EPIDEMIOLOGY KEPT SIMPLE (3e) Chapter 3: Epidemiologic Measures Basic epidemiologic measures used to quantify: • frequency of occurrence • the effect of an exposure • the potential impact of an intervention. Epidemiologic Measures Measures of disease Measures of Measures of potential frequency association impact (“Measures of Effect”) Incidence Prevalence Absolute measures of Relative measures of Attributable Fraction Attributable Fraction effect effect in exposed cases in the Population Incidence proportion Incidence rate Risk difference Risk Ratio (Cumulative (incidence density, (Incidence proportion (Incidence Incidence, Incidence hazard rate, person- difference) Proportion Ratio) Risk) time rate) Incidence odds Rate Difference Rate Ratio (Incidence density (Incidence density difference) ratio) Prevalence Odds Ratio Difference Macintosh HD:Users:buddygerstman:Dropbox:eks:formula_sheet.doc Page 1 of 7 3.1 Measures of Disease Frequency No. of onsets Incidence Proportion = No. at risk at beginning of follow-up • Also called risk, average risk, and cumulative incidence. • Can be measured in cohorts (closed populations) only. • Requires follow-up of individuals. No. of onsets Incidence Rate = ∑person-time • Also called incidence density and average hazard. • When disease is rare (incidence proportion < 5%), incidence rate ≈ incidence proportion. • In cohorts (closed populations), it is best to sum individual person-time longitudinally. It can also be estimated as Σperson-time ≈ (average population size) × (duration of follow-up). Actuarial adjustments may be needed when the disease outcome is not rare. • In an open populations, Σperson-time ≈ (average population size) × (duration of follow-up). Examples of incidence rates in open populations include: births Crude birth rate (per m) = × m mid-year population size deaths Crude mortality rate (per m) = × m mid-year population size deaths < 1 year of age Infant mortality rate (per m) = × m live births No. -
Primary Screening for Breast Cancer with Conventional Mammography: Clinical Summary
Primary Screening for Breast Cancer With Conventional Mammography: Clinical Summary Population Women aged 40 to 49 y Women aged 50 to 74 y Women aged ≥75 y The decision to start screening should be No recommendation. Recommendation Screen every 2 years. an individual one. Grade: I statement Grade: B Grade: C (insufficient evidence) These recommendations apply to asymptomatic women aged ≥40 y who do not have preexisting breast cancer or a previously diagnosed high-risk breast lesion and who are not at high risk for breast cancer because of a known underlying genetic mutation Risk Assessment (such as a BRCA1 or BRCA2 gene mutation or other familial breast cancer syndrome) or a history of chest radiation at a young age. Increasing age is the most important risk factor for most women. Conventional digital mammography has essentially replaced film mammography as the primary method for breast cancer screening Screening Tests in the United States. Conventional digital screening mammography has about the same diagnostic accuracy as film overall, although digital screening seems to have comparatively higher sensitivity but the same or lower specificity in women age <50 y. For women who are at average risk for breast cancer, most of the benefit of mammography results from biennial screening during Starting and ages 50 to 74 y. While screening mammography in women aged 40 to 49 y may reduce the risk for breast cancer death, the Stopping Ages number of deaths averted is smaller than that in older women and the number of false-positive results and unnecessary biopsies is larger. The balance of benefits and harms is likely to improve as women move from their early to late 40s. -
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests Document Issued On: March 13, 2007
Guidance for Industry and FDA Staff Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests Document issued on: March 13, 2007 The draft of this document was issued on March 12, 2003. For questions regarding this document, contact Kristen Meier at 240-276-3060, or send an e-mail to [email protected]. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Diagnostic Devices Branch Division of Biostatistics Office of Surveillance and Biometrics Contains Nonbinding Recommendations Preface Public Comment Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be submitted to http://www.fda.gov/dockets/ecomments. When submitting comments, please refer to Docket No. 2003D-0044. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet at: http://www.fda.gov/cdrh/osb/guidance/1620.pdf. You may also send an e-mail request to [email protected] to receive an electronic copy of the guidance or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1620 to identify the guidance you are requesting. Contains Nonbinding Recommendations Table of Contents 1. Background....................................................................................................4 -
Estimated HIV Incidence and Prevalence in the United States
Volume 26, Number 1 Estimated HIV Incidence and Prevalence in the United States, 2015–2019 This issue of the HIV Surveillance Supplemental Report is published by the Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, Atlanta, Georgia. Estimates are presented for the incidence and prevalence of HIV infection among adults and adolescents (aged 13 years and older) based on data reported to CDC through December 2020. The HIV Surveillance Supplemental Report is not copyrighted and may be used and reproduced without permission. Citation of the source is, however, appreciated. Suggested citation Centers for Disease Control and Prevention. Estimated HIV incidence and prevalence in the United States, 2015–2019. HIV Surveillance Supplemental Report 2021;26(No. 1). http://www.cdc.gov/ hiv/library/reports/hiv-surveillance.html. Published May 2021. Accessed [date]. On the Web: http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html Confidential information, referrals, and educational material on HIV infection CDC-INFO 1-800-232-4636 (in English, en Español) 1-888-232-6348 (TTY) http://wwwn.cdc.gov/dcs/ContactUs/Form Acknowledgments Publication of this report was made possible by the contributions of the state and territorial health departments and the HIV surveillance programs that provided surveillance data to CDC. This report was prepared by the following staff and contractors of the Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC: Laurie Linley, Anna Satcher Johnson, Ruiguang Song, Sherry Hu, Baohua Wu, H. -
Understanding Relative Risk, Odds Ratio, and Related Terms: As Simple As It Can Get Chittaranjan Andrade, MD
Understanding Relative Risk, Odds Ratio, and Related Terms: As Simple as It Can Get Chittaranjan Andrade, MD Each month in his online Introduction column, Dr Andrade Many research papers present findings as odds ratios (ORs) and considers theoretical and relative risks (RRs) as measures of effect size for categorical outcomes. practical ideas in clinical Whereas these and related terms have been well explained in many psychopharmacology articles,1–5 this article presents a version, with examples, that is meant with a view to update the knowledge and skills to be both simple and practical. Readers may note that the explanations of medical practitioners and examples provided apply mostly to randomized controlled trials who treat patients with (RCTs), cohort studies, and case-control studies. Nevertheless, similar psychiatric conditions. principles operate when these concepts are applied in epidemiologic Department of Psychopharmacology, National Institute research. Whereas the terms may be applied slightly differently in of Mental Health and Neurosciences, Bangalore, India different explanatory texts, the general principles are the same. ([email protected]). ABSTRACT Clinical Situation Risk, and related measures of effect size (for Consider a hypothetical RCT in which 76 depressed patients were categorical outcomes) such as relative risks and randomly assigned to receive either venlafaxine (n = 40) or placebo odds ratios, are frequently presented in research (n = 36) for 8 weeks. During the trial, new-onset sexual dysfunction articles. Not all readers know how these statistics was identified in 8 patients treated with venlafaxine and in 3 patients are derived and interpreted, nor are all readers treated with placebo. These results are presented in Table 1. -
Understanding the Randomized Controlled Trials By
Breast Cancer Screening: Understanding the Randomized Controlled Trials By: Phoebe Freer, MD, Linda Moy, MD, FSBI, Wendy DeMartini, MD, FSBI, and the Screening Leadership Group Screening mammography has been shown to decrease breast cancer mortality across multiple trials, and across many different study designs. Despite this, some opponents continue to question the value of mammography. Thus, it is increasingly important that breast imaging care providers understand the nature and results of the randomized controlled trials (RCTs), which have definitively demonstrated that screening mammography in women 40-74 years of age decreases deaths from breast cancer. Cancer localized in the breast is not what causes death; it is breast cancer spread (metastasis) to other organs that causes mortality. The goal of mammographic screening (and other breast cancer screening tests) is to detect breast cancer earlier than it would otherwise manifest clinically, when it is less likely to have spread. Data clearly show that detection of breast cancers at smaller sizes and lower stages is associated with better patient outcomes from lower morbidity and reduced breast cancer deaths. RCTs are the gold standard for proving that early detection with mammography decreases mortality from breast cancer. It is important to understand that the key evidence measure is the breast cancer death rate observed in the experimental group (women invited to have screening mammography) compared to that in the control group (women not invited to have screening mammography). It is not sufficient to use survival time (the time of discovery of the cancer to the date of death) between the groups, as this may reflect “lead-time” bias, in which a cancer is found earlier so survival time appears longer, but the date of death is not altered. -
Ethics of Vaccine Research
COMMENTARY Ethics of vaccine research Christine Grady Vaccination has attracted controversy at every stage of its development and use. Ethical debates should consider its basic goal, which is to benefit the community at large rather than the individual. accines truly represent one of the mira- include value, validity, fair subject selection, the context in which it will be used and Vcles of modern science. Responsible for favorable risk/benefit ratio, independent acceptable to those who will use it. This reducing morbidity and mortality from sev- review, informed consent and respect for assessment considers details about the pub- eral formidable diseases, vaccines have made enrolled participants. Applying these princi- lic health need (such as the prevalence, bur- substantial contributions to global public ples to vaccine research allows consideration den and natural history of the disease, as health. Generally very safe and effective, vac- of some of the particular challenges inherent well as existing strategies to prevent or con- cines are also an efficient and cost-effective in testing vaccines (Box 1). trol it), the scientific data and possibilities way of preventing disease. Yet, despite their Ethically salient features of clinical vac- (preclinical and clinical data, expected brilliant successes, vaccines have always been cine research include the fact that it involves mechanism of action and immune corre- controversial. Concerns about the safety and healthy subjects, often (or ultimately) chil- lates) and the likely use of the vaccine (who untoward effects of vaccines, about disturb- dren and usually (at least when testing effi- will use and benefit from it, safety, cost, dis- ing the natural order, about compelling indi- cacy) in very large numbers. -
Disease Incidence, Prevalence and Disability
Part 3 Disease incidence, prevalence and disability 9. How many people become sick each year? 28 10. Cancer incidence by site and region 29 11. How many people are sick at any given time? 31 12. Prevalence of moderate and severe disability 31 13. Leading causes of years lost due to disability in 2004 36 World Health Organization 9. How many people become sick each such as diarrhoeal disease or malaria, it is common year? for individuals to be infected repeatedly and have several episodes. For such conditions, the number The “incidence” of a condition is the number of new given in the table is the number of disease episodes, cases in a period of time – usually one year (Table 5). rather than the number of individuals affected. For most conditions in this table, the figure given is It is important to remember that the incidence of the number of individuals who developed the illness a disease or condition measures how many people or problem in 2004. However, for some conditions, are affected by it for the first time over a period of Table 5: Incidence (millions) of selected conditions by WHO region, 2004 Eastern The Mediter- South- Western World Africa Americas ranean Europe East Asia Pacific Tuberculosisa 7.8 1.4 0.4 0.6 0.6 2.8 2.1 HIV infectiona 2.8 1.9 0.2 0.1 0.2 0.2 0.1 Diarrhoeal diseaseb 4 620.4 912.9 543.1 424.9 207.1 1 276.5 1 255.9 Pertussisb 18.4 5.2 1.2 1.6 0.7 7.5 2.1 Measlesa 27.1 5.3 0.0e 1.0 0.2 17.4 3.3 Tetanusa 0.3 0.1 0.0 0.1 0.0 0.1 0.0 Meningitisb 0.7 0.3 0.1 0.1 0.0 0.2 0.1 Malariab 241.3 203.9 2.9 8.6 0.0 23.3 2.7 -
Evidence Synthesis Number 197 Screening for Hypertension in Adults
Evidence Synthesis Number 197 Screening for Hypertension in Adults: A Systematic Evidence Review for the U.S. Preventive Services Task Force Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. HHSA-290-2015-000017-I-EPC5, Task Order No. 5 Prepared by: Kaiser Permanente Research Affiliates Evidence-based Practice Center Kaiser Permanente Center for Health Research Portland, OR Investigators: Janelle M. Guirguis-Blake, MD Corinne V. Evans, MPP Elizabeth M. Webber, MS Erin L. Coppola, MPH Leslie A. Perdue, MPH Meghan Soulsby Weyrich, MPH AHRQ Publication No. 20-05265-EF-1 June 2020 This report is based on research conducted by the Kaiser Permanente Research Affiliates Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA-290-2015-000017-I-EPC5, Task Order No. 5). The findings and conclusions in this document are those of the authors, and do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decision makers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information (i.e., in the context of available resources and circumstances presented by individual patients). -
Should the Randomistas (Continue To) Rule?
Should the Randomistas (Continue to) Rule? Martin Ravallion Abstract The rising popularity of randomized controlled trials (RCTs) in development applications has come with continuing debates on the pros and cons of this approach. The paper revisits the issues. While RCTs have a place in the toolkit for impact evaluation, an unconditional preference for RCTs as the “gold standard” is questionable. The statistical case is unclear on a priori grounds; a stronger ethical defense is often called for; and there is a risk of distorting the evidence-base for informing policymaking. Going forward, pressing knowledge gaps should drive the questions asked and how they are answered, not the methodological preferences of some researchers. The gold standard is the best method for the question at hand. Keywords: Randomized controlled trials, bias, ethics, external validity, ethics, development policy JEL: B23, H43, O22 Working Paper 492 August 2018 www.cgdev.org Should the Randomistas (Continue to) Rule? Martin Ravallion Department of Economics, Georgetown University François Roubaud encouraged the author to write this paper. For comments the author is grateful to Sarah Baird, Mary Ann Bronson, Caitlin Brown, Kevin Donovan, Markus Goldstein, Miguel Hernan, Emmanuel Jimenez, Madhulika Khanna, Nishtha Kochhar, Andrew Leigh, David McKenzie, Berk Özler, Dina Pomeranz, Lant Pritchett, Milan Thomas, Vinod Thomas, Eva Vivalt, Dominique van de Walle and Andrew Zeitlin. Staff of the International Initiative for Impact Evaluation kindly provided an update to their database on published impact evaluations and helped with the author’s questions. Martin Ravallion, 2018. “Should the Randomistas (Continue to) Rule?.” CGD Working Paper 492. Washington, DC: Center for Global Development. -
Prevalence and Determinants of Vaccine Hesitancy and Vaccines Recommendation Discrepancies Among General Practitioners in French-Speaking Parts of Belgium
Article Prevalence and Determinants of Vaccine Hesitancy and Vaccines Recommendation Discrepancies among General Practitioners in French-Speaking Parts of Belgium Cathy Gobert 1, Pascal Semaille 2, Thierry Van der Schueren 3 , Pierre Verger 4 and Nicolas Dauby 1,5,6,* 1 Department of Infectious Diseases, CHU Saint-Pierre, Université Libre de Bruxelles (ULB), 1000 Bruxelles, Belgium; [email protected] 2 Department of General Medicine, Université Libre de Bruxelles (ULB), 1070 Bruxelles, Belgium; [email protected] 3 Scientific Society of General Practice, 1060 Bruxelles, Belgium; [email protected] 4 Southeastern Health Regional Observatory (ORS PACA), 13005 Marseille, France; [email protected] 5 School of Public Health, Université Libre de Bruxelles (ULB), 1070 Bruxelles, Belgium 6 Institute for Medical Immunology, Université Libre de Bruxelles (ULB), 1070 Bruxelles, Belgium * Correspondence: [email protected] Abstract: General practitioners (GPs) play a critical role in patient acceptance of vaccination. Vaccine hesitancy (VH) is a growing phenomenon in the general population but also affects GPs. Few data exist on VH among GPs. The objectives of this analysis of a population of GPs in the Belgian Wallonia-Brussels Federation (WBF) were to: (1) determine the prevalence and the features of VH, (2) identify the correlates, and (3) estimate the discrepancy in vaccination’s behaviors between the GPs’ children and the recommendations made to their patients. An online survey was carried out Citation: Gobert, C.; Semaille, P.; Van among the population of general practitioners practicing in the WBF between 7 January and 18 der Schueren, T.; Verger, P.; Dauby, N. March 2020. A hierarchical cluster analysis was carried out based on various dimensions of vaccine Prevalence and Determinants of hesitancy: perception of the risks and the usefulness of vaccines as well as vaccine recommendations Vaccine Hesitancy and Vaccines for their patients.