Peer reviewed evaluation of registered end-points of randomised trials (the PRE-REPORT study): protocol for a stepped-wedge, cluster-randomised trial

IntroductionClinical trials are critical to the advancement of medical knowledge. However, the reliability of trial conclusions depends in part on consistency between pre-planned and reported study outcomes. Unfortunately, selective outcome reporting, in which outcomes reported in published manuscripts differ from pre-specified study outcomes, is common. Trial registries such as ClinicalTrials.gov have the potential to help identify and stop selective outcome reporting during peer review by allowing peer reviewers to compare outcomes between registry entries and submitted manuscripts. However, the persistently high rate of selective outcome reporting among published clinical trials indicates that the current peer review process at most journals does not effectively address the problem of selective outcome reporting.Methods and analysisPRE-REPORT is a stepped-wedge cluster-randomised trial that will test whether providing peer reviewers with a summary of registered, pre-specified primary trial outcomes decreases inconsistencies between prospectively registered and published primary outcomes. Peer reviewed manuscripts describing clinical trial results will be included. Eligible manuscripts submitted to each participating journal during the study period will comprise each cluster. After an initial control phase, journals will transition to the intervention phase in random order, after which peer reviewers will be emailed registry information consisting of the date of registration and any prospectively defined primary outcomes. Blinded outcome assessors will compare registered and published primary outcomes for all included trials. The primary PRE-REPORT outcome is the presence of a published primary outcome that is consistent with a prospectively defined primary outcome in the study’s trial registry. The primary outcome will be analysed using a mixed effect logistical regression model to compare results between the intervention and control phases.Ethics and disseminationThe Cooper Health System Institutional Review Board determined that this study does not meet criteria for human subject research. Findings will be published in peer-reviewed journals.Trial registration numberISRCTN41225307; Pre-results.

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Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application

BMJ Open ◽

10.1136/bmjopen-2019-033640 ◽

2020 ◽

Vol 10 (6) ◽

pp. e033640 ◽

Cited By ~ 1

Author(s):

R I Helou ◽

Gaud Catho ◽

Annabel Peyravi Latif ◽

Johan Mouton ◽

M Hulscher ◽

...

Keyword(s):

Antimicrobial Stewardship ◽

Professional Training ◽

Primary Outcome ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Great Promise ◽

Antimicrobial Use ◽

Stepped Wedge ◽

Cluster Randomised ◽

The Impact

IntroductionWith the widespread use of electronic health records and handheld electronic devices in hospitals, informatics-based antimicrobial stewardship interventions hold great promise as tools to promote appropriate antimicrobial drug prescribing. However, more research is needed to evaluate their optimal design and impact on quantity and quality of antimicrobial prescribing.Methods and analysisUse of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland. Secondary outcomes will include antimicrobial use metrics, clinical and process outcomes. A multicentre stepped-wedge cluster randomised trial will randomise entities defined as wards or specialty regarding time of introduction of the intervention. We will include 36 hospital entities with seven measurement periods in which the primary outcome will be measured in 15 participating patients per time period per cluster. At participating wards, patients of at least 18 years of age using antimicrobials will be included. After a baseline period of 2-week measurements, six periods of 4 weeks will follow in which the intervention is introduced in 6 wards (in three hospitals) until all 36 wards have implemented the intervention. Thereafter, we allow use of the app by everyone, and evaluate the sustainability of the app use 6 months later.Ethics and disseminationThis protocol has been approved by the institutional review board of each participating centre. Results will be disseminated via media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.Trial registration numberClinicalTrials.gov registry (NCT03793946). Stage; pre-results.

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Correction: Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial

PLoS Medicine ◽

10.1371/journal.pmed.1002993 ◽

2019 ◽

Vol 16 (12) ◽

pp. e1002993

Author(s):

Nina Østerås ◽

Tuva Moseng ◽

Leti van Bodegom-Vos ◽

Krysia Dziedzic ◽

Ibrahim Mdala ◽

...

Keyword(s):

Primary Healthcare ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Structured Model ◽

Cluster Randomised

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Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial

PLoS Medicine ◽

10.1371/journal.pmed.1002175 ◽

2016 ◽

Vol 13 (11) ◽

pp. e1002175 ◽

Cited By ~ 54

Author(s):

Badara Cissé ◽

El Hadj Ba ◽

Cheikh Sokhna ◽

Jean Louis NDiaye ◽

Jules F. Gomis ◽

...

Keyword(s):

Randomised Trial ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Cluster Randomised ◽

Seasonal Malaria Chemoprevention

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Improving quality of care during childbirth in primary health centres: a stepped-wedge cluster-randomised trial in India

BMJ Global Health ◽

10.1136/bmjgh-2018-000907 ◽

2018 ◽

Vol 3 (5) ◽

pp. e000907 ◽

Cited By ~ 3

Author(s):

Ramesh Agarwal ◽

Deepak Chawla ◽

Minakshi Sharma ◽

Shyama Nagaranjan ◽

Suresh K Dalpath ◽

...

Keyword(s):

Quality Of Care ◽

Management Strategy ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Primary Health ◽

Cluster Randomised ◽

Primary Health Centres ◽

Health Centres

BackgroundLow/middle-income countries need a large-scale improvement in the quality of care (QoC) around the time of childbirth in order to reduce high maternal, fetal and neonatal mortality. However, there is a paucity of scalable models.MethodsWe conducted a stepped-wedge cluster-randomised trial in 15 primary health centres (PHC) of the state of Haryana in India to test the effectiveness of a multipronged quality management strategy comprising capacity building of providers, periodic assessments of the PHCs to identify quality gaps and undertaking improvement activities for closure of the gaps. The 21-month duration of the study was divided into seven periods (steps) of 3 months each. Starting from the second period, a set of randomly selected three PHCs (cluster) crossed over to the intervention arm for rest of the period of the study. The primary outcomes included the number of women approaching the PHCs for childbirth and 12 directly observed essential practices related to the childbirth. Outcomes were adjusted with random effect for cluster (PHC) and fixed effect for ‘months of intervention’.ResultsThe intervention strategy led to increase in the number of women approaching PHCs for childbirth (26 vs 21 women per PHC-month, adjusted incidence rate ratio: 1.22; 95% CI 1.17 to 1.28). Of the 12 practices, 6 improved modestly, 2 remained near universal during both intervention and control periods, 3 did not change and 1 worsened. There was no evidence of change in mortality with a majority of deaths occurring either during referral transport or at the referral facilities.ConclusionA multipronged quality management strategy enhanced utilisation of services and modestly improved key practices around the time of childbirth in PHCs in India.Trial registration numberCTRI/2016/05/006963.

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