TY - JOUR
T1 - Missing data in randomized controlled trials testing palliative interventions pose a significant risk of bias and loss of power:
T2 - a systematic review and meta-analyses
AU - Hussain, Jamilla A
AU - White, Ian R
AU - Langan, Dean
AU - Johnson, Miriam J
AU - Currow, David C
AU - Torgerson, David J
AU - Bland, Martin
N1 - Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.
PY - 2016/6
Y1 - 2016/6
N2 - OBJECTIVES: To assess the risk posed by missing data (MD) to the power and validity of trials evaluating palliative interventions.STUDY DESIGN AND SETTING: A systematic review of MD in published randomized controlled trials (RCTs) of palliative interventions in participants with life-limiting illnesses was conducted, and random-effects meta-analyses and metaregression were performed. CENTRAL, MEDLINE, and EMBASE (2009-2014) were searched with no language restrictions.RESULTS: One hundred and eight RCTs representing 15,560 patients were included. The weighted estimate for MD at the primary endpoint was 23.1% (95% confidence interval [CI] 19.3, 27.4). Larger MD proportions were associated with increasing numbers of questions/tests requested (odds ratio [OR], 1.19; 95% CI 1.05, 1.35) and with longer study duration (OR, 1.09; 95% CI 1.02, 1.17). Meta-analysis found evidence of differential rates of MD between trial arms, which varied in direction (OR, 1.04; 95% CI 0.90, 1.20; I(2) 35.9, P = 0.001). Despite randomization, MD in the intervention arms (vs. control) were more likely to be attributed to disease progression unrelated to the intervention (OR, 1.31; 95% CI 1.02, 1.69). This was not the case for MD due to death (OR, 0.92; 95% CI 0.78, 1.08).CONCLUSION: The overall proportion and differential rates and reasons for MD reduce the power and potentially introduce bias to palliative care trials.
AB - OBJECTIVES: To assess the risk posed by missing data (MD) to the power and validity of trials evaluating palliative interventions.STUDY DESIGN AND SETTING: A systematic review of MD in published randomized controlled trials (RCTs) of palliative interventions in participants with life-limiting illnesses was conducted, and random-effects meta-analyses and metaregression were performed. CENTRAL, MEDLINE, and EMBASE (2009-2014) were searched with no language restrictions.RESULTS: One hundred and eight RCTs representing 15,560 patients were included. The weighted estimate for MD at the primary endpoint was 23.1% (95% confidence interval [CI] 19.3, 27.4). Larger MD proportions were associated with increasing numbers of questions/tests requested (odds ratio [OR], 1.19; 95% CI 1.05, 1.35) and with longer study duration (OR, 1.09; 95% CI 1.02, 1.17). Meta-analysis found evidence of differential rates of MD between trial arms, which varied in direction (OR, 1.04; 95% CI 0.90, 1.20; I(2) 35.9, P = 0.001). Despite randomization, MD in the intervention arms (vs. control) were more likely to be attributed to disease progression unrelated to the intervention (OR, 1.31; 95% CI 1.02, 1.69). This was not the case for MD due to death (OR, 0.92; 95% CI 0.78, 1.08).CONCLUSION: The overall proportion and differential rates and reasons for MD reduce the power and potentially introduce bias to palliative care trials.
U2 - 10.1016/j.jclinepi.2015.12.003
DO - 10.1016/j.jclinepi.2015.12.003
M3 - Article
C2 - 26718729
SN - 0895-4356
VL - 74
SP - 57
EP - 65
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -