Reporting quality of stepped wedge design randomized trials: a systematic review protocol.

Alex Thabane, Brittany B Dennis, Olga Gajic-Veljanoski, James Paul, Lehana Thabane

Abstract read

In one paragraph

Article in Clinical epidemiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it

0cells of the map it votes in

4citing papers in PubMed

–field-weighted citation impact

1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE).BMJ open · 2022
Article
Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects.Trials · 2020
Article
Enhancing research publications and advancing scientific writing in health research collaborations: sharing lessons learnt from the trenches.Journal of multidisciplinary healthcare · 2018
Article
The reporting quality of abstracts of stepped wedge randomized trials is suboptimal: A systematic survey of the literature.Contemporary clinical trials communications · 2017
Review

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Alex ThabaneLife Sciences Program, Queen's University, Kingston, ON, Canada; Department of Anesthesia, McMaster University Hamilton ON.

Brittany B DennisDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton ON, Canada; St. George's University of London, London England, UK.

Olga Gajic-VeljanoskiDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton ON, Canada; Department of Medicine, McMaster University, Hamilton ON, Canada; Hamilton Health Sciences, St. Peter's Hospital, Hamilton, ON Canada.

James PaulDepartment of Anesthesia, McMaster University Hamilton ON; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton ON, Canada.

Lehana ThabaneDepartment of Anesthesia, McMaster University Hamilton ON; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton ON, Canada; Population Health Research Institute, Hamilton Health Sciences; Department of Pediatrics, McMaster University, Hamilton, ON, Canada; Centre for Evaluation of Medicine; Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStepped wedge design (SWD) is a cluster randomized controlled trial (RCT) design that sequentially rolls out intervention to all clusters at varying time points. Being a relatively new design method, reporting quality has yet to be explored, and this review will seek to fill this gap in knowledge.

objectivesThe objectives of this review are: 1) to assess the quality of SWD trial reports based on the CONSORT guidelines or CONSORT extension to cluster RCTs; 2) to assess the completeness of reporting of SWD trial abstracts using the CONSORT extension for abstracts; 3) to assess the reporting of sample size details in SWD trial reports or protocols; 4) to assess the completeness of reporting of SWD trial protocols according to SPIRIT guidelines; 5) to assess the consistency between the trial registration information and final SWD trial reports; and 6) to assess the consistency of what is reported in the abstracts and main text of the SWD trial reports. We will also explore factors that are associated with the completeness of reporting.

methodsWe will search MEDLINE, EMBASE, Web of Science, CINAHL, and PsycINFO for all randomized controlled trials utilizing SWD. Details from eligible papers will be extracted in duplicate. Demographic statistics obtained from the data extraction will be analyzed to answer the primary objectives pertaining to the reporting quality of several aspects of a published paper, as well as to explore possible temporal trends and consistency between abstracts, trial registration information, and final published articles. DISCUSSION: Findings from this review will establish the reporting quality of SWD trials and inform academics and clinicians on their completeness and consistency. Results of this review will influence future trials and improve the overall quality and reporting of SWD trials.

Indexed as

cluster randomized trialquality of reportingrandomized controlled trialstepped wedgestepped wedge designsystematic review

Identifiers

PMID27468249

DOI10.2147/CLEP.S103098

PMCPMC4944926

What OpenQuestion holds

Textmetadata

LicenceCC BY-NC

Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.