Yuqing Zhang1, Ivan D Flórez2, Luis E Colunga Lozano3, Fazila Abu Bakar Aloweni4, Sean Alexander Kennedy5, Aihua Li6, Samantha Craigie7, Shiyuan Zhang8, Arnav Agarwal9, Luciane C Lopes10, Tahira Devji6, Wojtek Wiercioch6, John J Riva11, Mengxiao Wang6, Xuejing Jin6, Yutong Fei12, Paul Alexander6, Gian Paolo Morgano6, Yuan Zhang6, Alonso Carrasco-Labra13, Lara A Kahale14, Elie A Akl15, Holger J Schünemann16, Lehana Thabane6, Gordon H Guyatt17. 1. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Guang'anmen Hospital China Academy of Chinese Medical Science, Xicheng District, Beijing, China. 2. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Pediatrics, University of Antioquia, Medellín, Colombia. 3. Department of Critical Care, Hospital Angeles del Carmen, Guadalajara, Jalisco, Mexico. 4. Nursing Division, Singapore General Hospital, Singapore. 5. Department of Diagnostic Radiology, University of Toronto, Toronto, Ontario, Canada. 6. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. 7. Department of Anesthesiology, Michael G. DeGroote National Pain Centre, Hamilton, Ontario, Canada. 8. Health Economics and Outcomes Research, Medical Affairs, GSK, Mississauga, Ontario, Canada. 9. Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada. 10. Department of Pharmaceutical science, Universidade de Sorocaba, São Paulo, Brazil; Department of Pharmaceutical science, Universidade Estadual Paulista "Julio de Mesquita Filho", São Paulo, Brazil. 11. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada. 12. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Chaoyang Qu, China. 13. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Evidence based dentistry unit and Department of oral and maxillo-facial surgery, Universidad de Chile, Santiago, Región Metropolitana, Chile. 14. Department of Internal Medicine, American University of Beirut, Riad El-Solh, Beirut, Lebanon. 15. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Internal Medicine, American University of Beirut, Riad El-Solh, Beirut, Lebanon. 16. Department of Medicine and Department of Health Research Methods, Evidence, and Impact, Hamilton, Ontario, Canada. 17. Department of Medicine and Department of Health Research Methods, Evidence, and Impact, Hamilton, Ontario, Canada. Electronic address: guyatt@mcmaster.ca.
Abstract
OBJECTIVE: To assess analytic approaches randomized controlled trial (RCT) authors use to address missing participant data (MPD) for patient-important continuous outcomes. STUDY DESIGN AND SETTING: We conducted a systematic survey of RCTs published in 2014 in the core clinical journals that reported at least one patient-important outcome analyzed as a continuous variable. RESULTS: Among 200 studies, 187 (93.5%) trials explicitly reported whether MPD occurred. In the 163 (81.5%) trials that reported the occurrence of MPD, the median and interquartile ranges of the percentage of participants with MPD were 11.4% (2.5%-22.6%).Among the 147 trials in which authors made clear their analytical approach to MPD, the approaches chosen included available data only (109, 67%); mixed-effect models (10, 6.1%); multiple imputation (9, 4.5%); and last observation carried forward (9, 4.5). Of the 163 studies reporting MPD, 16 (9.8%) conducted sensitivity analyses examining the impact of the MPD and (18, 11.1%) discussed the risk of bias associated with MPD. CONCLUSION: RCTs reporting continuous outcomes typically have over 10% of participant data missing. Most RCTs failed to use optimal analytic methods, and very few conducted sensitivity analyses addressing the possible impact of MPD or commented on how MPD might influence risk of bias.
OBJECTIVE: To assess analytic approaches randomized controlled trial (RCT) authors use to address missing participant data (MPD) for patient-important continuous outcomes. STUDY DESIGN AND SETTING: We conducted a systematic survey of RCTs published in 2014 in the core clinical journals that reported at least one patient-important outcome analyzed as a continuous variable. RESULTS: Among 200 studies, 187 (93.5%) trials explicitly reported whether MPD occurred. In the 163 (81.5%) trials that reported the occurrence of MPD, the median and interquartile ranges of the percentage of participants with MPD were 11.4% (2.5%-22.6%).Among the 147 trials in which authors made clear their analytical approach to MPD, the approaches chosen included available data only (109, 67%); mixed-effect models (10, 6.1%); multiple imputation (9, 4.5%); and last observation carried forward (9, 4.5). Of the 163 studies reporting MPD, 16 (9.8%) conducted sensitivity analyses examining the impact of the MPD and (18, 11.1%) discussed the risk of bias associated with MPD. CONCLUSION: RCTs reporting continuous outcomes typically have over 10% of participant data missing. Most RCTs failed to use optimal analytic methods, and very few conducted sensitivity analyses addressing the possible impact of MPD or commented on how MPD might influence risk of bias.
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