A systematic survey on reporting and methods for handling missing participant data for continuous outcomes in randomized controlled trials

Yuqing Zhang; Ivan D Flórez; Luis E Colunga Lozano; Fazila Abu Bakar Aloweni; Sean Alexander Kennedy; Aihua Li; Samantha Craigie; Shiyuan Zhang; Arnav Agarwal; Luciane C Lopes; Tahira Devji; Wojtek Wiercioch; John J Riva; Mengxiao Wang; Xuejing Jin; Yutong Fei; Paul Alexander; Gian Paolo Morgano; Yuan Zhang; Alonso Carrasco-Labra; Lara A Kahale; Elie A Akl; Holger J Schünemann; Lehana Thabane; Gordon H Guyatt

doi:10.1016/j.jclinepi.2017.05.017

A systematic survey on reporting and methods for handling missing participant data for continuous outcomes in randomized controlled trials

J Clin Epidemiol. 2017 Aug:88:57-66. doi: 10.1016/j.jclinepi.2017.05.017. Epub 2017 Jun 3.

Authors

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

Affiliations

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: [email protected].

PMID: 28583378
DOI: 10.1016/j.jclinepi.2017.05.017

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.

Keywords: Analytic approaches; Continuous outcome; Lost to follow-up; MPD; Missing participant data; Randomized controlled trials.

Publication types

Review

MeSH terms

Bias
Data Accuracy*
Humans
Lost to Follow-Up*
Patient Dropouts / statistics & numerical data*
Randomized Controlled Trials as Topic / statistics & numerical data*
Research Design / statistics & numerical data*
Surveys and Questionnaires*