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2016 ; 6
(6
): e011188
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Reporting of planned statistical methods in published surgical randomised trial
protocols: a protocol for a methodological systematic review
#MMPMID27259528
Madden K
; Arseneau E
; Evaniew N
; Smith CS
; Thabane L
BMJ Open
2016[Jun]; 6
(6
): e011188
PMID27259528
show ga
INTRODUCTION: Poor reporting can lead to inadequate presentation of data,
confusion regarding research methodology used, selective reporting of results,
and other misinformation regarding health research. One of the most recent
attempts to improve quality of reporting comes from the Standard Protocol Items:
Recommendations for Interventional Trials (SPIRIT) Group, which makes
recommendations for the reporting of protocols. In this report, we present a
protocol for a systematic review of published surgical randomised controlled
trial (RCT) protocols, with the purpose of assessing the reporting quality and
completeness of the statistical aspects. METHODS: We will include all published
protocols of randomised trials that investigate surgical interventions. We will
search MEDLINE, EMBASE, and CENTRAL for relevant studies. Author pairs will
independently review all titles, abstracts, and full texts identified by the
literature search, and extract data using a structured data extraction form. We
will extract the following: year of publication, country, sample size,
description of study population, description of intervention and control, primary
outcome, important methodological qualities, and quality of reporting of planned
statistical methods based on the SPIRIT guidelines. ETHICS AND DISSEMINATION: The
results of this review will demonstrate the quality of statistical reporting of
published surgical RCT protocols. This knowledge will inform recommendations to
surgeons, researchers, journal editors and peer reviewers, and other knowledge
users that focus on common deficiencies in reporting and how to rectify them.
Ethics approval for this study is not required. We will disseminate the results
of this review in peer-reviewed publications and conference presentations, and at
a doctoral independent study of oral defence.