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A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research.
Li, Guowei; Abbade, Luciana P F; Nwosu, Ikunna; Jin, Yanling; Leenus, Alvin; Maaz, Muhammad; Wang, Mei; Bhatt, Meha; Zielinski, Laura; Sanger, Nitika; Bantoto, Bianca; Luo, Candice; Shams, Ieta; Shahid, Hamnah; Chang, Yaping; Sun, Guangwen; Mbuagbaw, Lawrence; Samaan, Zainab; Levine, Mitchell A H; Adachi, Jonathan D; Thabane, Lehana.
Afiliação
  • Li G; Department of Health Research Methods, Evidence, and Impact, McMaster University, St. Joseph's Healthcare, Hamilton, 501-25 Charlton Avenue East, Hamilton, ON, L8N 1Y2, Canada. lig28@mcmaster.ca.
  • Abbade LPF; St. Joseph's Healthcare Hamilton, McMaster University, Hamilton, ON, Canada. lig28@mcmaster.ca.
  • Nwosu I; Centre for Evaluation of Medicines, Programs for Assessment of Technology in Health (PATH) Research Institute, McMaster University, Hamilton, ON, Canada. lig28@mcmaster.ca.
  • Jin Y; Department of Dermatology and Radiotherapy, Botucatu Medical School, Universidade Estadual Paulista, UNESP, São Paulo, Brazil.
  • Leenus A; Department of Health Research Methods, Evidence, and Impact, McMaster University, St. Joseph's Healthcare, Hamilton, 501-25 Charlton Avenue East, Hamilton, ON, L8N 1Y2, Canada.
  • Maaz M; Department of Health Research Methods, Evidence, and Impact, McMaster University, St. Joseph's Healthcare, Hamilton, 501-25 Charlton Avenue East, Hamilton, ON, L8N 1Y2, Canada.
  • Wang M; Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Bhatt M; Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Zielinski L; Department of Health Research Methods, Evidence, and Impact, McMaster University, St. Joseph's Healthcare, Hamilton, 501-25 Charlton Avenue East, Hamilton, ON, L8N 1Y2, Canada.
  • Sanger N; Department of Health Research Methods, Evidence, and Impact, McMaster University, St. Joseph's Healthcare, Hamilton, 501-25 Charlton Avenue East, Hamilton, ON, L8N 1Y2, Canada.
  • Bantoto B; McMaster Integrative Neuroscience Discovery and Study, McMaster University, Hamilton, ON, Canada.
  • Luo C; Medical Sciences, McMaster University, Hamilton, ON, Canada.
  • Shams I; Integrated Sciences, McMaster University, Hamilton, ON, Canada.
  • Shahid H; Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
  • Chang Y; Psychology, Neuroscience and Behaviour, McMaster University, Hamilton, ON, Canada.
  • Sun G; Arts and Science, McMaster University, Hamilton, ON, Canada.
  • Mbuagbaw L; Department of Health Research Methods, Evidence, and Impact, McMaster University, St. Joseph's Healthcare, Hamilton, 501-25 Charlton Avenue East, Hamilton, ON, L8N 1Y2, Canada.
  • Samaan Z; Department of Health Research Methods, Evidence, and Impact, McMaster University, St. Joseph's Healthcare, Hamilton, 501-25 Charlton Avenue East, Hamilton, ON, L8N 1Y2, Canada.
  • Levine MAH; Department of Health Research Methods, Evidence, and Impact, McMaster University, St. Joseph's Healthcare, Hamilton, 501-25 Charlton Avenue East, Hamilton, ON, L8N 1Y2, Canada.
  • Adachi JD; St. Joseph's Healthcare Hamilton, McMaster University, Hamilton, ON, Canada.
  • Thabane L; Department of Health Research Methods, Evidence, and Impact, McMaster University, St. Joseph's Healthcare, Hamilton, 501-25 Charlton Avenue East, Hamilton, ON, L8N 1Y2, Canada.
BMC Med Res Methodol ; 18(1): 9, 2018 01 11.
Article em En | MEDLINE | ID: mdl-29325533
ABSTRACT

BACKGROUND:

Prospective study protocols and registrations can play a significant role in reducing incomplete or selective reporting of primary biomedical research, because they are pre-specified blueprints which are available for the evaluation of, and comparison with, full reports. However, inconsistencies between protocols or registrations and full reports have been frequently documented. In this systematic review, which forms part of our series on the state of reporting of primary biomedical, we aimed to survey the existing evidence of inconsistencies between protocols or registrations (i.e., what was planned to be done and/or what was actually done) and full reports (i.e., what was reported in the literature); this was based on findings from systematic reviews and surveys in the literature.

METHODS:

Electronic databases, including CINAHL, MEDLINE, Web of Science, and EMBASE, were searched to identify eligible surveys and systematic reviews. Our primary outcome was the level of inconsistency (expressed as a percentage, with higher percentages indicating greater inconsistency) between protocols or registration and full reports. We summarized the findings from the included systematic reviews and surveys qualitatively.

RESULTS:

There were 37 studies (33 surveys and 4 systematic reviews) included in our analyses. Most studies (n = 36) compared protocols or registrations with full reports in clinical trials, while a single survey focused on primary studies of clinical trials and observational research. High inconsistency levels were found in outcome reporting (ranging from 14% to 100%), subgroup reporting (from 12% to 100%), statistical analyses (from 9% to 47%), and other measure comparisons. Some factors, such as outcomes with significant results, sponsorship, type of outcome and disease speciality were reported to be significantly related to inconsistent reporting.

CONCLUSIONS:

We found that inconsistent reporting between protocols or registrations and full reports of primary biomedical research is frequent, prevalent and suboptimal. We also identified methodological issues such as the need for consensus on measuring inconsistency across sources for trial reports, and more studies evaluating transparency and reproducibility in reporting all aspects of study design and analysis. A joint effort involving authors, journals, sponsors, regulators and research ethics committees is required to solve this problem.
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Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Bases de Dados Bibliográficas / Pesquisa Biomédica / Relatório de Pesquisa Tipo de estudo: Guideline / Observational_studies / Prognostic_studies / Systematic_reviews Limite: Humans Idioma: En Revista: BMC Med Res Methodol Assunto da revista: MEDICINA Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Canadá
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Bases de Dados Bibliográficas / Pesquisa Biomédica / Relatório de Pesquisa Tipo de estudo: Guideline / Observational_studies / Prognostic_studies / Systematic_reviews Limite: Humans Idioma: En Revista: BMC Med Res Methodol Assunto da revista: MEDICINA Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Canadá