Literature DB >> 31258815

Comparisons between protocols and publications of case-control studies: analysis of potential causes of non-reproducibility and recommendations for enhancing the quality of personalization in healthcare.

Haifeng Hou1,2, Guoyong Ding1, Xuan Zhao1, Zixiu Meng1, Jiangmin Xu3, Zheng Guo2, Yulu Zheng2, Dong Li1, Wei Wang1,2.   

Abstract

BACKGROUND: Selective reporting of results in published case-control studies has been widely suspected, but little comprehensive information on selective reporting is available with regard to case-control studies. We aimed to evaluate the concordance of findings between publications and the protocols of case-control studies and to assess the level of selective reporting of results in case-control studies.
METHODS: The databases of Embase, Medline, Scopus, and Web of Science were searched to identify case-control study protocols published between January 1, 1990 and December 31, 2017. The numbers and characteristics of predefined exposures (or factors) were extracted from the protocols. The reported and unreported factors were both collected from the published studies and protocols. The frequency of selective reporting of results were estimated by identifying the discrepancies of factors between the protocols and the published studies. Study sample size and the extent of selective reporting of factors were measured by a Spearman correlation analysis.
RESULTS: Fourteen protocols with 24 published studies and 159 factors were identified, of which eight protocols (57.1%) had discrepancies between the publications and protocols. The prevalence of incomplete reporting in published case-control studies was 42.9% (6/14), with participant characteristics, anthropometric and laboratory measurement variables more likely to be unreported. A total of 16,835 cases and 56,049 controls were recruited in the 14 protocols of case-control studies (sample size ranges from 428 to 52,596 per study). Sample size had no statistical significance with selective reporting of results (P > 0.05).
CONCLUSION: The study protocols should be publicly available prior to the completion of case-control studies so that the potential bias can be assessed by the readers. Our findings highlight the need for investigators, peer reviewers, and readers to exercise increased awareness and scrutiny due to the undesirable practice of selective reporting of results in medical sciences causing the loss of potentially important information, thus impacting quality of personalized attitude in healthcare in the context of the predictive, preventive, and personalized medicine.

Entities:  

Keywords:  Case-control study; Predictive preventive personalized medicine; Protocol; Publication bias; Quality of healthcare; Selective reporting of results

Year:  2019        PMID: 31258815      PMCID: PMC6562015          DOI: 10.1007/s13167-019-00165-2

Source DB:  PubMed          Journal:  EPMA J        ISSN: 1878-5077            Impact factor:   6.543


  43 in total

1.  Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.

Authors:  An-Wen Chan; Asbjørn Hróbjartsson; Mette T Haahr; Peter C Gøtzsche; Douglas G Altman
Journal:  JAMA       Date:  2004-05-26       Impact factor: 56.272

2.  Clinical trial registration: a statement from the International Committee of Medical Journal Editors.

Authors:  Catherine D DeAngelis; Jeffrey M Drazen; Frank A Frizelle; Charlotte Haug; John Hoey; Richard Horton; Sheldon Kotzin; Christine Laine; Ana Marusic; A John P M Overbeke; Torben V Schroeder; Hal C Sox; Martin B Van Der Weyden
Journal:  JAMA       Date:  2004-09-08       Impact factor: 56.272

3.  Interim review of the Transnational Case-control Study of Oral Contraceptives and Health: approved protocol revisions through September 1995.

Authors:  D M Lewis; A Assmann; L Heinemann; W O Spitzer
Journal:  Pharmacoepidemiol Drug Saf       Date:  1996-01       Impact factor: 2.890

4.  Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research.

Authors:  An-Wen Chan; Karmela Krleza-Jerić; Isabelle Schmid; Douglas G Altman
Journal:  CMAJ       Date:  2004-09-28       Impact factor: 8.262

5.  Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet.

Authors:  Sanaa Al-Marzouki; Ian Roberts; Stephen Evans; Tom Marshall
Journal:  Lancet       Date:  2008-07-19       Impact factor: 79.321

6.  Protocols, probity, and publication.

Authors:  William Summerskill; David Collingridge; Helen Frankish
Journal:  Lancet       Date:  2009-03-21       Impact factor: 79.321

7.  Multicentre international liver tumour study protocol of the case-control study on hepatocellular cancer.

Authors:  L A Heinemann; D B Thomas; M Möhner
Journal:  Pharmacoepidemiol Drug Saf       Date:  1996-05       Impact factor: 2.890

8.  Selective publication of antidepressant trials and its influence on apparent efficacy.

Authors:  Erick H Turner; Annette M Matthews; Eftihia Linardatos; Robert A Tell; Robert Rosenthal
Journal:  N Engl J Med       Date:  2008-01-17       Impact factor: 91.245

9.  Case-control study on analgesics and nephropathy (SAN): protocol.

Authors:  Lothar A J Heinemann; Edeltraut Garbe; Michael Lewis; Fokko van der Woude; Helmut Graf
Journal:  BMC Nephrol       Date:  2005-08-08       Impact factor: 2.388

10.  Individual and occupational risk factors for knee osteoarthritis - study protocol of a case control study.

Authors:  André Klussmann; Hansjuergen Gebhardt; Falk Liebers; Lars Victor von Engelhardt; Andreas Dávid; Bertil Bouillon; Monika A Rieger
Journal:  BMC Musculoskelet Disord       Date:  2008-02-26       Impact factor: 2.362

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.