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. 2020 Sep 24:3:36.
doi: 10.12688/hrbopenres.13068.2. eCollection 2020.

A protocol for a systematic review investigating the factors influencing the statistical planning, design, conduct, analysis and reporting of trials

Marina Zaki  1   2 , Marie Galligan  3 , Lydia O'Sullivan  2   3 , Declan Devane  2   4   5 , Eilish McAuliffe  1
Affiliations

A protocol for a systematic review investigating the factors influencing the statistical planning, design, conduct, analysis and reporting of trials

Marina Zaki et al. HRB Open Res. .

Abstract

Trials can be defined as prospective human research studies to test the effectiveness and safety of interventions, such as medications, surgeries, medical devices and other interventions for the management of patient care. Statistics is an important and powerful tool in trials. Inappropriately designed trials and/or inappropriate statistical analysis produce unreliable results, with limited clinical use. The aim of this systematic literature review is to identify, describe and synthesise factors contributing to or influencing the statistical planning, design, conduct, analysis and reporting of trials. This protocol will describe the methodological approach taken for the following: conducting a systematic and comprehensive search for relevant articles, applying eligibility criteria for the inclusion of such articles, extracting data and information, appraising the quality of the articles, and thematically synthesizing the data to illuminate the key factors influencing statistical aspects of trials.

Keywords: Clinical trials; protocol; statistics; systematic review.

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Conflict of interest statement

No competing interests were disclosed.

References

    1. Adams-Huet B, Ahn C: Bridging clinical investigators and statisticians: writing the statistical methodology for a research proposal. J Investig Med. 2009;57(8):818–824. 10.2310/JIM.0b013e3181c2996c - DOI - PMC - PubMed
    1. Altman DG: 'Statistics and ethics in medical research: Misuse of statistics is unethical' BMJ. 1980;281(6249):1182–4. 10.1136/bmj.281.6249.1182 - DOI - PMC - PubMed
    1. Booth A: Searching for qualitative research for inclusion in systematic reviews: a structured methodological review. Syst Rev. 2016;5:74. 10.1186/s13643-016-0249-x - DOI - PMC - PubMed
    1. Krishnankutty B, Bellary S, Kumar NBR, et al. : 'Data management in clinical research: An overview', Indian J Pharmacol. 2012;44(2):168–172. 10.4103/0253-7613.93842 - DOI - PMC - PubMed
    1. Moher D, Liberati A, Tetzlaff J, et al. : Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med. 2009;6(7):e1000097. 10.1371/journal.pmed.1000097 - DOI - PMC - PubMed

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