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Printed summaries sent by post ensure the highest number of participants receive trial results.

Uptake of interventions to communicate results of a phase III randomised controlled trial to participants: early results from the Show RESPECT study (ISRCTN96189403)

Annabelle South1, Cara Purvis1, Ania Spurdens1, Liz James1, Carlos Diaz Montana1, Matt Sydes1, Katie Gillies2, Sierra Santana1, William J. Cragg1,3, Nalinie Joharatnam-Hogan1, Archie MacNair1, Andrew Copas1

1MRC Clinical Trials Unit at UCL, 2Health Services Research Unit, University of Aberdeen, 3Leeds Institute of Clinical Trials Research, University of Leeds

 

Introduction

  • Most participants want to be offered the results of trials they have taken part in
  • Many are not offered results
  • There are many challenges to sharing results with participants
  • Show RESPECT tested three approaches to communicating trial results to UK participants of ICON8, a phase III ovarian cancer chemotherapy RCT

Methods

  • Cluster randomised factorial study within the ICON8 trial
  • 43 UK hospitals randomised to share results with 384 participants using combinations of approaches
  • Link tracking used to measure uptake of webpages & email
  • Logs kept by sites used to measure distribution of printed summaries

 

Show RESPECT interventions

The basic webpage

  • View the page here
  • Follows the structure and ‘friendly’ versions of the headings for lay summaries mandated by the European Parliament Regulation (EU) No 536/2014 Article 37 (4)
  • Written in Plain English
  • Clear headings
  • Body text 12pt Arial
  • Black text against white background

The enhanced webpage

  • View the page here
  • Structure adapted from MRCT Center Guidance and Toolkit and CISCRP template
  • Written in Plain English
  • Clear headings
  • Body text 12pt Arial
  • Black text against white background
  • Links to further information and support
  • Short video of clinician explaining results
  • Diagram & graph
  • FAQ section where participants can send in questions

The printed summary

  • Structure adapted from MRCT Center Guidance and Toolkit and CISCRP template
  • Written in Plain English
  • Clear, coloured headings
  • Body text 12pt Arial
  • Black text against white background
  • Diagram & graph
  • Printed as an A4 booklet on 150gsm paper

The email list

  • Implemented using Mailman (list hosting) and MailChimp (email design)
  • Structure adapted from MRCT Center Guidance and Toolkit and CISCRP template
  • Written in Plain English
  • Clear, coloured headings
  • Body text 12pt Arial
  • Black text against white background
  • Diagram & graph
  • Links to further information and support
  • FAQ section where participants can send in questions