Evidence map›Paper›PMID 28259174›Full record

ArticleTrials2017

Analysis of cluster randomised stepped wedge trials with repeated cross-sectional samples.

Karla Hemming, Monica Taljaard, Andrew Forbes

Registry-linked trialAbstract read
In one paragraph

Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05358522 (Learning Health System Clinician Feedback Using Patient-reported Data to Increase Implementation of Post-operative Opioid Prescribing Guidelines), which is not on this map. Cited by 105 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
105citing papers in PubMed, 2 pooled it
–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.

NCT05358522 nacompletednot on this mapstarted 2022, after this paper: background citation

Learning Health System Clinician Feedback Using Patient-reported Data to Increase Implementation of Post-operative Opioid Prescribing Guidelines: a Stepped-wedge Cluster Randomized Trial

TypeinterventionalSponsorUniversity of PennsylvaniaRan2022 to 2023Enrolled26,562ConditionsSurgery, Opioid Use, Opioid Misuse, Prescription Opioid MisuseArmsOpioid Prescribing Report Cards
3 · Its place in the literature

Who cites it

105 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  9. Fracture liaison service (FLS) is associated with lower subsequent fragility fracture risk and mortality: NoFRACT (the Norwegian capture the fracture initiative).Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
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  13. Opportunistic Treatment of Hepatitis C Infection Among Hospitalized People Who Inject Drugs (OPPORTUNI-C): A Stepped Wedge Cluster Randomized Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
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  15. Effectiveness and Cost of an Enhanced Mailed Fecal Test Outreach Colorectal Cancer Screening Program: Findings from the PROMPT Stepped-Wedge Trial.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2023
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  20. Random effect misspecification in stepped wedge designs.Clinical trials (London, England) · 2022
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45 more citing papers are in PubMed but not listed here.

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

3 authors.

Karla HemmingInstitute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. k.hemming@bham.ac.uk.
Monica TaljaardClinical Epidemiology Program, Ottawa Hospital Research Institute, 1053 Carling Avenue, Ottawa, ON, K1Y4E9, Canada.
Andrew ForbesSchool of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.

Funding

Department of Health WMCLAHRC-2014-1
6 · The paper itself

Abstract

backgroundThe stepped wedge cluster randomised trial (SW-CRT) is increasingly being used to evaluate policy or service delivery interventions. However, there is a dearth of trials literature addressing analytical approaches to the SW-CRT. Perhaps as a result, a significant number of published trials have major methodological shortcomings, including failure to adjust for secular trends at the analysis stage. Furthermore, the commonly used analytical framework proposed by Hussey and Hughes makes several assumptions.

methodsWe highlight the assumptions implicit in the basic SW-CRT analytical model proposed by Hussey and Hughes. We consider how simple modifications of the basic model, using both random and fixed effects, can be used to accommodate deviations from the underlying assumptions. We consider the implications of these modifications for the intracluster correlation coefficients. In a case study, the importance of adjusting for the secular trend is illustrated.

resultsThe basic SW-CRT model includes a fixed effect for time, implying a common underlying secular trend across steps and clusters. It also includes a single term for treatment, implying a constant shift in this trend under the treatment. When these assumptions are not realistic, simple modifications can be implemented to allow the secular trend to vary across clusters and the treatment effect to vary across clusters or time. In our case study, the naïve treatment effect estimate (adjusted for clustering but unadjusted for time) suggests a beneficial effect. However, after adjusting for the underlying secular trend, we demonstrate a reversal of the treatment effect.

conclusionDue to the inherent confounding of the treatment effect with time, analysis of a SW-CRT should always account for secular trends or risk-biased estimates of the treatment effect. Furthermore, the basic model proposed by Hussey and Hughes makes a number of important assumptions. Consideration needs to be given to the appropriate model choice at the analysis stage. We provide a Stata code to implement the proposed analyses in the illustrative case study.

Indexed as

Research DesignAmnionCluster AnalysisConfounding Factors, EpidemiologicData Interpretation, StatisticalFemaleHumansLabor, InducedModels, StatisticalMulticenter Studies as TopicParturitionPregnancyRandomized Controlled Trials as TopicTime FactorsAnalysisCluster randomised trialSecular trendsStepped wedge

Identifiers

PMID28259174
PMCPMC5336660

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.