Proceedings of the First International Conference on Stepped Wedge Trial Design : York, UK, 10 March 2016.

Mona Kanaan,Karla Hemming,Shona Methven,Fumihito Takanashi,Graeme Maclennan,Elaine Nicholls,Martyn Lewis,Lingyu Li,Vivian H Lyons,Antonio Gasparrini,Fergus Caskey,Anna Casula,Calum Davey,Alan Girling,Monica Taljaard,Richard Hooper,Steven Teerenstra,Andrew Finney,Siladitya Bhattacharya,Andrew Forbes,Adam Finn,Clare Jinks,Erik Lenguerrand,Ada Keding,Simon Crouch,Gian Luca Di Tanna,Sandra Eldridge,Noreen Dadirai Mdege,Tim Draycott,Hannah Christensen,John Norrie,Catriona Keerie ,Margaret T May ,Karen Smith ,James P Hughes ,Katherine Fielding ,Stephanie J Macneill ,Laura J Gray ,Ra Parker ,Alexander M Aiken ,Ja Thompson ,A E Maxwell ,Ag Rudd ,Rustam Al‐Shahi Salman ,Christopher J Weir ,Mills Nl ,Esther De Hoop ,James Hargreaves ,J N S Matthews ,Nicholas M Selby ,Caroline Kristunas ,A Shah ,Ms Dennis ,Fiona Strachan ,Richard Hayes ,Valerie Tan ,León Danon ,Christian Mallen ,Sarah Lawton ,Emma L Healey ,Ali Rowhani‐Rahbar

doi:10.1186/s13063-016-1436-8

Abstract

Table of contentsI1 IntroductionMona Kanaan, Noreen Dadirai Mdege, Ada KedingO1 The HiSTORIC trial: a hybrid before-and-after and stepped wedge designRA Parker, N Mills, A Shah, F Strachan, C Keerie, CJ WeirO2 Stepped wedge trials with non-uniform correlation structureAndrew Forbes, Karla HemmingO3 Challenges and solutions for the operationalisation of the ENHANCE study: a pilot stepped wedge trial within a general practice settingSarah A Lawton, Emma Healey, Martyn Lewis, Elaine Nicholls, Clare Jinks, Valerie Tan, Andrew Finney, Christian D Mallen, on behalf of the ENHANCE Study TeamO4 Early lessons from the implementation of a stepped wedge trial design investigating the effectiveness of a training intervention in busy health care settings: the Thistle studyErik Lenguerrand, Graeme MacLennan, John Norrie, Siladitya Bhattacharya, Tim Draycott, on behalf of the Thistle groupO5 Sample size calculation for longitudinal cluster randomised trials: a unified framework for closed cohort and repeated cross-section designsRichard Hooper, Steven Teerenstra, Esther de Hoop, Sandra EldridgeO6 Restricted randomisation schemes for stepped-wedge studies with a cluster-level covariateAlan Girling, Monica TaljaardO7 A flexible modelling of the time trend for the analysis of stepped wedge trials: results of a simulation studyGian Luca Di Tanna, Antonio GasparriniP1 Tackling acute kidney injury – a UK stepped wedge clinical trial of hospital-level quality improvement interventionsAnna Casula, Fergus Caskey, Erik Lenguerrand, Shona Methven, Stephanie MacNeill, Margaret May, Nicholas SelbyP2 Sample size considerations for quantifying secondary bacterial transmission in a stepped wedge trial of influenza vaccineLeon Danon, Hannah Christensen, Adam Finn, Margaret MayP3 Sample size calculation for time-to-event data in stepped wedge cluster randomised trialsFumihito Takanashi, Ada Keding, Simon Crouch, Mona KanaanP4 Sample size calculations for stepped-wedge cluster randomised trials with unequal cluster sizesCaroline A. Kristunas, Karen L. Smith, Laura J. GrayP5 The design of stepped wedge trials with unequal cluster sizesJohn N.S. MatthewsP6 Promoting Recruitment using Information Management Efficiently (PRIME): a stepped wedge SWAT (study-within-a-trial)R Al-Shahi Salman, RA Parker, A Maxwell, M Dennis, A Rudd, CJ WeirP7 Implications of misspecified mixed effect models in stepped wedge trial analysis: how wrong can it be?Jennifer A Thompson, Katherine L Fielding, Calum Davey, Alexander M Aiken, James R Hargreaves, Richard J HayesS1 Stepped Wedge Designs with Multiple InterventionsVivian H Lyons, Lingyu Li, James Hughes, Ali Rowhani-RahbarS2 Analysis of the cross-sectional stepped wedge cluster randomised trialKarla Hemming, Monica Taljaard, Andrew Forbes

Highlights

Introduction MonaKanaan, Noreen Dadirai Mdege, Ada Keding Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK Correspondence: Mona Kanaan – Department of Health Sciences, University of York, York, North Yorkshire, YO10 5DD, UK Trials 2016, 17(Suppl 1):I1The First International Conference on the Stepped Wedge Trial Design was hosted by the York Trials Unit, Department of Health Sciences, University of York on 10 March 2016
The study design consists of a hybrid before-and-after and stepped wedge trial design
The stepped wedge component enables us to make cross-sectional comparisons as well as within-site comparisons; the before-and-after component allows us to completely adjust for seasonal effects and evaluate the intervention when it is fully embedded into normal practice

Summary

Introduction

The ENHANCE pilot trial aims to examine the feasibility and acceptability of an integrated approach to Long Term Condition (LTC) management by tackling the under-diagnosis and under-management of osteoarthritis (OA) related pain and anxiety &/or depression in patients aged 45 years and over with other LTCs in primary care, using a stepped wedge trial design This abstract describes some of the challenges faced in operationalising this trial design within general practice, together with solutions that have been implemented. There is increasing methodological literature on design, sample size calculations and analyses of stepped wedge trials (SWT). Stepped wedge cluster randomised trial (SWCRT) designs are increasingly popular for the evaluation of health interventions. This study aimed to evaluate sample size and statistical power for SWCRTs that measure time-to-event data. Stepped wedge cluster randomised trials (SW-CRT) are novel study designs increasingly used to evaluate policy or service delivery treatments. A recent systematic review identified that 67 % of published SWCRTs failed to adjust for secular trends at the analysis stage

Objectives

Methods

Results

Conclusion