Impact of missing participant data for dichotomous outcomes on pooled effect estimates in systematic reviews: A protocol for a methodological study
Por:
Akl E.A., Kahale L.A., Agarwal A., Al-Matari N., Ebrahim S., Alexander P.E., Briel M., Brignardello-Petersen R., Busse J.W., Diab B., Iorio A., Kwong J., Li L., Lopes L.C., Mustafa R., Neumann I., Tikkinen K.A.O., Vandvik P.O., Zhang Y., Alonso-Coello P., Guyatt G.
Publicada:
1 ene 2014
Resumen:
Background: There is no consensus on how authors conducting meta-analysis should deal with trial participants with missing outcome data. The objectives of this study are to assess in Cochrane and non-Cochrane systematic reviews: (1) which categories of trial participants the systematic review authors consider as having missing participant data (MPD), (2) how trialists reported on participants with missing outcome data in trials, (3) whether systematic reviewer authors actually dealt with MPD in their meta-analyses of dichotomous outcomes consistently with their reported methods, and (4) the impact of different methods of dealing with MPD on pooled effect estimates in meta-analyses of dichotomous outcomes. Methods/Design: We will conduct a methodological study of Cochrane and non-Cochrane systematic reviews. Eligible systematic reviews will include a group-level meta-analysis of a patient-important dichotomous efficacy outcome, with a statistically significant effect estimate. Teams of two reviewers will determine eligibility and subsequently extract information from each eligible systematic review in duplicate and independently, using standardized, pre-piloted forms. The teams will then use a similar process to extract information from the trials included in the meta-analyses of interest. We will assess first which categories of trial participants the systematic reviewers consider as having MPD. Second, we will assess how trialists reported on participants with missing outcome data in trials. Third, we will compare what systematic reviewers report having done, and what they actually did, in dealing with MPD in their meta-analysis. Fourth, we will conduct imputation studies to assess the effects of different methods of dealing with MPD on the pooled effect estimates of meta-analyses. We will specifically calculate for each method (1) the percentage of systematic reviews that lose statistical significance and (2) the mean change of effect estimates across systematic reviews. Discussion: The impact of different methods of dealing with MPD on pooled effect estimates will help judge the associated risk of bias in systematic reviews. Our findings will inform recommendations regarding what assumptions for MPD should be used to test the robustness of meta-analytical results. © 2014 Akl et al.
Filiaciones:
Akl E.A.:
Department of Internal Medicine, Clinical Epidemiology Unit, American University of Beirut Medical Center, PO Box: 11-0236, Riad-El-Solh, Beirut, 1107, 2020, Lebanon
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
Kahale L.A.:
Department of Internal Medicine, Clinical Epidemiology Unit, American University of Beirut Medical Center, PO Box: 11-0236, Riad-El-Solh, Beirut, 1107, 2020, Lebanon
Agarwal A.:
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
Al-Matari N.:
Department of Internal Medicine, Clinical Epidemiology Unit, American University of Beirut Medical Center, PO Box: 11-0236, Riad-El-Solh, Beirut, 1107, 2020, Lebanon
Ebrahim S.:
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
Department of Anesthesia, McMaster University, Hamilton, Canada
Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, United States
Alexander P.E.:
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
Briel M.:
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Hebelstrasse 10, Basel, 4031, Switzerland
Brignardello-Petersen R.:
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
Evidence Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile
Busse J.W.:
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
Department of Anesthesia, McMaster University, Hamilton, Canada
The Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Canada
Diab B.:
Department of Internal Medicine, Clinical Epidemiology Unit, American University of Beirut Medical Center, PO Box: 11-0236, Riad-El-Solh, Beirut, 1107, 2020, Lebanon
Iorio A.:
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
Department of Medicine, McMaster University, Hamilton, Canada
Kwong J.:
Clinical Research and Evaluation Unit, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China
Li L.:
Clinical Research and Evaluation Unit, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China
Lopes L.C.:
Pharmaceutical Sciences Post graduate Course, University of Sorocaba, UNISO, Sorocaba, Sao Paulo, Brazil
Mustafa R.:
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
Departments of Medicine and Biomedical and Health Informatics, University of Missouri-Kansas City, Kansas, United States
Neumann I.:
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
Department of Internal Medicine, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile
Tikkinen K.A.O.:
Departments of Urology and Public Health, Helsinki University Central Hospital and University of Helsinki, Helsinki, Finland
Vandvik P.O.:
Norwegian Knowledge Centre for the Health Services, Oslo, Norway
Department of Medicine, Innlandet Hospital Trust, Gjøvik, Norway
Zhang Y.:
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
Alonso-Coello P.:
Iberoamerican Cochrane Centre, Institute of Biomedical Research (IIB Sant Pau), Barcelona, Spain
Guyatt G.:
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
Department of Medicine, McMaster University, Hamilton, Canada
All Open Access, Gold
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