Background
Objectives
Methods
Search methods for identification of methodological research projects
Data collection and analysis
Selection of methodological research projects
Data extraction and management
Assessment of study quality in included methodological research projects
Outcome measures
Unit of analysis issues
Dealing with missing data
Assessment of heterogeneity
Assessment of reporting biases
Data synthesis
Subgroup analysis and investigation of potential risk factors for non-publication
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Type of research study (clinical vs. animal vs. lab research).
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Design of clinical studies (RCT vs. CCT vs. observational studies vs. case reports). If some of these subgroups are not reported separately, we will consider combining groups (RCT vs. other designs).
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Funding source (private vs. public vs. both vs. not stated).
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Country of origin of lead investigator (grouped by continent).
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Rank of lead investigator (full professor vs. associate/assistant professor vs. not stated).
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Sex of lead investigator (male vs. female).
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Sample size (below vs. above median or mean sample size of included studies).
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Multicenter vs. single center study.
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National vs. international study.
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English vs. non-English publication.
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Significant positive results vs. significant negative results vs. non-significant results (as defined by primary investigator of methodological research project).
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Clinically relevant results (positive) vs. clinically relevant results (negative) vs. unclear clinical effect
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Study quality as defined in included primary studies (for example, risk of bias).
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Presentation type (oral vs. poster) (abstract aspect only).
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Acceptance for presentation at a scientific conference (abstract aspect only).
Sensitivity analysis
Discussion
Appendix
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Appendix A: Search Strategy for OvidSP MEDLINE
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Appendix B: OPEN Consortium
Appendix A
A. Search Strategy for OvidSP MEDLINE (search strategy will be adapted for other databases)
A.1. Trial registries
A.2. Research ethics committees
A.3. Abstracts
Appendix B
B. OPEN Consortium
Contributor
|
Participating Institution
|
Antes, Gerd | German Cochrane Center, Institute of Medical Biometry and Medical Informatics University Medical Center, Freiburg, Germany |
Bassler, Dirk | Center for Pediatric Clinical Studies, University Medical Center Tuebingen, Germany |
Bertele, Vittorio | Department of Epidemiology, Mario Negri Institute for Pharmacological Research, Italy |
Bonfill, Xavier | The Clinical Epidemiology & Public Health Department at the Hospital de la Santa Creu i Sant Pau, Spain |
Bouesseau, Marie-Charlotte | World Health Organization, Geneva, Switzerland |
Boutron, Isabelle | INSERM U738 research unit, Paris Descartes University, Paris, France |
Gallus, Silvano | Department of Epidemiology, Mario Negri Institute for Pharmacological Research, Italy |
Garattini, Silvio | Department of Epidemiology, Mario Negri Institute for Pharmacological Research, Italy |
Ghassan, Karam | World Health Organization, Geneva, Switzerland |
La Vecchia, Carlo | Department of Epidemiology, Mario Negri Institute for Pharmacological Research, Italy |
Lang, Britta | German Cochrane Center, Institute of Medical Biometry and Medical Informatics University Medical Center, Freiburg, Germany |
Littmann, Jasper | CELLS (Centre for Ethics and Law in Life Sciences), Hannover Medical Scholl, Hannover, Germany |
Kleijnen, Jos | Kleijnen Systematic Reviews Ltd., York, United Kingdom |
Kulig, Michael | Federal Joint Committee, Berlin, Germany |
Malicki, Mario | University of Split School of Medicine, Split, Croatia |
Marusic, Ana | University of Split School of Medicine, Split, Croatia |
Meerpohl, Joerg | German Cochrane Center, Institute of Medical Biometry and Medical Informatics University Medical Center, Freiburg, Germany |
Pardo, Hector | The Clinical Epidemiology & Public Health Department at the Hospital de la Santa Creu i Sant Pau, Spain |
Perleth, Matthias | Federal Joint Committee, Berlin, Germany |
Ravaud, Philippe | INSERM U738 research unit, Paris Descartes University, Paris, France |
Reis, Andreas | World Health Organization, Geneva, Switzerland |
Schmucker, Christine | German Cochrane Center, Institute of Medical Biometry and Medical Informatics University Medical Center, Freiburg, Germany |
Schwarzer, Guido | German Cochrane Center, Institute of Medical Biometry and Medical Informatics University Medical Center, Freiburg, Germany |
Strech, Daniel | CELLS (Centre for Ethics and Law in Life Sciences), Hannover Medical Scholl, Hannover, Germany |
Trinquart, Ludovic | INSERM U738 research unit, Paris Descartes University, Paris, France |
Urrútia, Gerard | The Clinical Epidemiology & Public Health Department at the Hospital de la Santa Creu i Sant Pau, Spain |
Von Elm, Erik | German Cochrane Center, Institute of Medical Biometry and Medical Informatics University Medical Center, Freiburg, Germany Cochrane Switzerland, IUMSP, University Hospital Lausanne, Lausanne, Switzerland |
Wager, Elizabeth | Sideview, Princes Risborough, United Kingdom |
Wieland, Alexandra | Federal Joint Committee, Berlin, Germany |
Wolff, Robert | Kleijnen Systematic Reviews Ltd., York, United Kingdom |