Riaz Qureshi1, Evan Mayo-Wilson2, Tianjing Li3. 1. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. 2. Department of Epidemiology and Biostatistics, Indiana University School of Public Health, Bloomington, ID, USA. 3. Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA. Electronic address: tianjing.li@cuanschutz.edu.
Abstract
OBJECTIVE: Most systematic reviews of interventions focus on potential benefits. Common methods and assumptions that are appropriate for assessing benefits can be inappropriate for harms. This paper provides a primer on researching harms, particularly in systematic reviews. STUDY DESIGN AND SETTING: Commentary describing challenges with assessing harm. RESULTS: Investigators should be familiar with various terminologies used to describe, classify, and group harms. Published reports of clinical trials include limited information about harms, so systematic reviewers should not depend on these studies and journal articles to reach conclusions about harms. Visualizations might improve communication of multiple dimensions of harms such as severity, relatedness, and timing. CONCLUSION: The terminology, classification, detection, collection, and reporting of harms create unique challenges that take time, expertise, and resources to navigate in both primary studies and evidence syntheses. Systematic reviewers might reach incorrect conclusions if they focus on evidence about harms found in published reports of randomized trials of a particular health problem. Systematic reviews could be improved through better identification and reporting of harms in primary studies and through better training and uptake of appropriate methods for synthesizing evidence about harms.
OBJECTIVE: Most systematic reviews of interventions focus on potential benefits. Common methods and assumptions that are appropriate for assessing benefits can be inappropriate for harms. This paper provides a primer on researching harms, particularly in systematic reviews. STUDY DESIGN AND SETTING: Commentary describing challenges with assessing harm. RESULTS: Investigators should be familiar with various terminologies used to describe, classify, and group harms. Published reports of clinical trials include limited information about harms, so systematic reviewers should not depend on these studies and journal articles to reach conclusions about harms. Visualizations might improve communication of multiple dimensions of harms such as severity, relatedness, and timing. CONCLUSION: The terminology, classification, detection, collection, and reporting of harms create unique challenges that take time, expertise, and resources to navigate in both primary studies and evidence syntheses. Systematic reviewers might reach incorrect conclusions if they focus on evidence about harms found in published reports of randomized trials of a particular health problem. Systematic reviews could be improved through better identification and reporting of harms in primary studies and through better training and uptake of appropriate methods for synthesizing evidence about harms.
Authors: Daniela R Junqueira; Rachel Phillips; Liliane Zorzela; Su Golder; Yoon Loke; David Moher; John P A Ioannidis; Sunita Vohra Journal: J Clin Epidemiol Date: 2021-05-10 Impact factor: 6.437
Authors: Evan Mayo-Wilson; Tianjing Li; Nicole Fusco; Lorenzo Bertizzolo; Joseph K Canner; Terrie Cowley; Peter Doshi; Jeffrey Ehmsen; Gillian Gresham; Nan Guo; Jennifer A Haythornthwaite; James Heyward; Hwanhee Hong; Diana Pham; Jennifer L Payne; Lori Rosman; Elizabeth A Stuart; Catalina Suarez-Cuervo; Elizabeth Tolbert; Claire Twose; Swaroop Vedula; Kay Dickersin Journal: J Clin Epidemiol Date: 2017-08-24 Impact factor: 6.437
Authors: JoAnn E Manson; Rowan T Chlebowski; Marcia L Stefanick; Aaron K Aragaki; Jacques E Rossouw; Ross L Prentice; Garnet Anderson; Barbara V Howard; Cynthia A Thomson; Andrea Z LaCroix; Jean Wactawski-Wende; Rebecca D Jackson; Marian Limacher; Karen L Margolis; Sylvia Wassertheil-Smoller; Shirley A Beresford; Jane A Cauley; Charles B Eaton; Margery Gass; Judith Hsia; Karen C Johnson; Charles Kooperberg; Lewis H Kuller; Cora E Lewis; Simin Liu; Lisa W Martin; Judith K Ockene; Mary Jo O'Sullivan; Lynda H Powell; Michael S Simon; Linda Van Horn; Mara Z Vitolins; Robert B Wallace Journal: JAMA Date: 2013-10-02 Impact factor: 56.272