Gordon H Guyatt1, Shanil Ebrahim2, Pablo Alonso-Coello3, Bradley C Johnston4, Alexander G Mathioudakis5, Matthias Briel6, Reem A Mustafa7, Xin Sun8, Stephen D Walter9, Diane Heels-Ansdell9, Ignacio Neumann10, Lara A Kahale11, Alfonso Iorio1, Joerg Meerpohl12, Holger J Schünemann1, Elie A Akl13. 1. Department of Health Research Methods, Evidence and Impact, McMaster University, 1200 Main St. West, Hamilton L8S 4K1, Canada; Department of Medicine, McMaster University, 1200 Main St. West, Hamilton L8S 4K1, Canada. 2. Department of Health Research Methods, Evidence and Impact, McMaster University, 1200 Main St. West, Hamilton L8S 4K1, Canada; Systematic Overviews through Advancing Research Technology (SORT), Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, 555 University Ave, Toronto, ON M5G 1X8, Canada. 3. Department of Health Research Methods, Evidence and Impact, McMaster University, 1200 Main St. West, Hamilton L8S 4K1, Canada; Iberoamerican Cochrane Centre, CIBERESP-IIB Sant Pau, Casa de Convalescéncia, 4 th floor, C. Sant Antoni Maria Claret 171, Barcelona 08041, Spain. 4. Department of Health Research Methods, Evidence and Impact, McMaster University, 1200 Main St. West, Hamilton L8S 4K1, Canada; Systematic Overviews through Advancing Research Technology (SORT), Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, 555 University Ave, Toronto, ON M5G 1X8, Canada; Department of Anesthesia and Pain Medicine, The Hospital for Sick Children, University of Toronto, 555 University Ave, Toronto, ON M5G 1X8, Canada; Institute for Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, 155 College St, Toronto, ON M5T 3M7, Canada. 5. Iberoamerican Cochrane Centre, CIBERESP-IIB Sant Pau, Casa de Convalescéncia, 4 th floor, C. Sant Antoni Maria Claret 171, Barcelona 08041, Spain. 6. Department of Health Research Methods, Evidence and Impact, McMaster University, 1200 Main St. West, Hamilton L8S 4K1, Canada; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Hebelstrasse 10, Basel 4056, Switzerland. 7. Department of Health Research Methods, Evidence and Impact, McMaster University, 1200 Main St. West, Hamilton L8S 4K1, Canada; Department of Internal Medicine, Kansas University Medical Center, 3901 Rainbow Blvd, Kansas City, KS MS3002, USA. 8. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China. 9. Department of Health Research Methods, Evidence and Impact, McMaster University, 1200 Main St. West, Hamilton L8S 4K1, Canada. 10. Department of Internal Medicine, Pontificia Universidad Catolica de Chile, Av Libertador Bernardo O'Higgins 340, Santiago, Región Metropolitana, Chile. 11. Department of Internal Medicine, American University of Beirut, Riad-El-Solh Beirut, Beirut 1107 2020, Lebanon. 12. Cochrane Germany, Medical Center-University of Freiburg, Breisacher Strasse 153, Freiburg 79110, Germany; Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité-U1153, Inserm/Université Paris Descartes, Cochrane France, Hôpital Hôtel-Dieu, 1 place du Parvis Notre Dame, Paris Cedex 04 75181, France. 13. Department of Health Research Methods, Evidence and Impact, McMaster University, 1200 Main St. West, Hamilton L8S 4K1, Canada; Department of Internal Medicine, American University of Beirut, Riad-El-Solh Beirut, Beirut 1107 2020, Lebanon. Electronic address: ea32@aub.edu.lb.
Abstract
OBJECTIVE: To provide GRADE guidance for assessing risk of bias across an entire body of evidence consequent on missing data for systematic reviews of both binary and continuous outcomes. STUDY DESIGN AND SETTING: Systematic survey of published methodological research, iterative discussions, testing in systematic reviews, and feedback from the GRADE Working Group. RESULTS: Approaches begin with a primary meta-analysis using a complete case analysis followed by sensitivity meta-analyses imputing, in each study, data for those with missing data, and then pooling across studies. For binary outcomes, we suggest use of "plausible worst case" in which review authors assume that those with missing data in treatment arms have proportionally higher event rates than those followed successfully. For continuous outcomes, imputed mean values come from other studies within the systematic review and the standard deviation (SD) from the median SDs of the control arms of all studies. CONCLUSIONS: If the results of the primary meta-analysis are robust to the most extreme assumptions viewed as plausible, one does not rate down certainty in the evidence for risk of bias due to missing participant outcome data. If the results prove not robust to plausible assumptions, one would rate down certainty in the evidence for risk of bias.
OBJECTIVE: To provide GRADE guidance for assessing risk of bias across an entire body of evidence consequent on missing data for systematic reviews of both binary and continuous outcomes. STUDY DESIGN AND SETTING: Systematic survey of published methodological research, iterative discussions, testing in systematic reviews, and feedback from the GRADE Working Group. RESULTS: Approaches begin with a primary meta-analysis using a complete case analysis followed by sensitivity meta-analyses imputing, in each study, data for those with missing data, and then pooling across studies. For binary outcomes, we suggest use of "plausible worst case" in which review authors assume that those with missing data in treatment arms have proportionally higher event rates than those followed successfully. For continuous outcomes, imputed mean values come from other studies within the systematic review and the standard deviation (SD) from the median SDs of the control arms of all studies. CONCLUSIONS: If the results of the primary meta-analysis are robust to the most extreme assumptions viewed as plausible, one does not rate down certainty in the evidence for risk of bias due to missing participant outcome data. If the results prove not robust to plausible assumptions, one would rate down certainty in the evidence for risk of bias.
Authors: Ning Liang; De Zhao Kong; Si Si Ma; Chun Li Lu; Ming Yang; Lu Da Feng; Chen Shen; Ruo Han Diao; Ling Jun Cui; Xing Yu Lu; Dimitrinka Nikolova; Janus C Jakobsen; Christian Gluud; Jian Ping Liu Journal: Cochrane Database Syst Rev Date: 2019-04-03
Authors: Shahnaz Sultan; Rebecca L Morgan; M Hassan Murad; Yngve Falck-Ytter; Philipp Dahm; Holger J Schünemann; Reem A Mustafa Journal: J Gen Intern Med Date: 2019-11-14 Impact factor: 5.128
Authors: Lara A Kahale; Maram B Hakoum; Ibrahim G Tsolakian; Charbel F Matar; Maddalena Barba; Victor E D Yosuico; Irene Terrenato; Francesca Sperati; Holger Schünemann; Elie A Akl Journal: Cochrane Database Syst Rev Date: 2017-12-29
Authors: Ariel Izcovich; Juan M Criniti; Federico Popoff; Liming Lu; Jiaming Wu; Walter Ageno; Daniel M Witt; Michael R Jaff; Sam Schulman; Veena Manja; Peter Verhamme; Gabriel Rada; Yuqing Zhang; Robby Nieuwlaat; Wojtek Wiercioch; Holger J Schünemann; Ignacio Neumann Journal: Blood Adv Date: 2020-04-14
Authors: Sadia Janjua; Alexander G Mathioudakis; Rebecca Fortescue; Ruth Ae Walker; Sahar Sharif; Christopher Jd Threapleton; Sofia Dias Journal: Cochrane Database Syst Rev Date: 2021-01-15
Authors: Joshua Z Goldenberg; Matthew Brignall; Michelle Hamilton; Jennifer Beardsley; Richard D Batson; Jason Hawrelak; Brad Lichtenstein; Bradley C Johnston Journal: Cochrane Database Syst Rev Date: 2019-11-12
Authors: Alexander G Mathioudakis; Michael Miligkos; Cristina Boccabella; Gioulinta S Alimani; Adnan Custovic; A Deschildre; Francine Monique Ducharme; Omer Kalayci; Clare Murray; Antonio Nieto Garcia; Wanda Phipatanakul; David Price; Aziz Sheikh; Ioana Octavia Agache; Leonard Bacharier; Apostolos Beloukas; Andrew Bentley; Matteo Bonini; Jose A Castro-Rodriguez; Giuseppe De Carlo; Timothy Craig; Zuzana Diamant; Wojciech Feleszko; Tim Felton; James E Gern; Jonathan Grigg; Gunilla Hedlin; Elham M Hossny; Despo Ierodiakonou; Tuomas Jartti; Alan Kaplan; Robert F Lemanske; Peter N Le Souëf; Mika J Mäkelä; Georgios A Mathioudakis; Paolo Matricardi; Marina Mitrogiorgou; Mario Morais-Almeida; Karthik Nagaraju; Effie Papageorgiou; Helena Pité; Paulo M C Pitrez; Petr Pohunek; Graham Roberts; Ioanna Tsiligianni; Stephen Turner; Susanne Vijverberg; Tonya A Winders; Gary Wk Wong; Paraskevi Xepapadaki; Heather J Zar; Nikolaos G Papadopoulos Journal: BMJ Open Date: 2021-07-02 Impact factor: 2.692