Making a decision about trial participation : the feasibility of measuring deliberation during the informed consent process for clinical trials

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Decision aids for randomised controlled trials : a qualitative exploration of stakeholders' views

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. Funding: This work was supported by personal fellowship award (to KG) from the Chief Scientist Office of the Scottish Governments Health and Social Care Directorates, grant number [PDF/09/01]. The Health Services Research Unit is supported by a core grant from the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.Peer reviewedPublisher PD

A systematic review of risk communication in clinical trials : how does it influence decisions to participate and what are the best methods to improve understanding in a trial context?

The data underlying the results presented in the study are available from the published papers. Included studies available here: Reference 22 - DOI: 10.1177/009286150604000302 Reference 23 - DOI: 10.1542/peds.2009-1796 Reference 24 - DOI: 10.1177/1740774515585120 Reference 25 - DOI: 10.1017/S1357530902000558 Reference 26 - DOI: 10.1097/00000539-200302000-00037 Reference 27 - DOI: 10.1186/1472-6947-10-55 Reference 28 - DOI: 10.1177/014107689008300710. The authors would like to acknowledge Cynthia Fraser for help designing and running the search strategies and Paul Manson for updating the search.Peer reviewedPublisher PD

Development and evaluation of decision aids for people considering taking part in a clinical trial : a conceptual framework

Funding This research was supported by the MRC Methodology Fellowship (KG MR/L01193X/1. The Health Services Research Unit, University of Aberdeen, receives core funding from the Chief Scientist Office of the Scottish Government Health and Social Care Directorate. Authors’ contributions KG and MC conceived the idea for the article. KG wrote the first draft of the manuscript. KG and MC contributed to further development of the manuscript. Both reviewed and approved the final manuscript.Peer reviewedPublisher PD

Determining information for inclusion in a decision-support intervention for clinical trial participation : A modified Delphi approach

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Evaluation of interventions for informed consent for randomised controlled trials (ELICIT) : protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Acknowledgements This work was supported by personal fellowship award (to KG) from the Medical Research Council’s Strategic Skills Methodology programme. The Health Services Research Unit is supported by a core grant from the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. PW is funded by a UK Medical Research Council Hub for Trials Methodology Research Network grant G0800792. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Chief Scientist Office, MRC or the Department of Health.Peer reviewedPublisher PD

An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations

Acknowledgments The authors would like to acknowledge the trial participants, Surgeons and Research Nurses for agreeing to be audio-recorded as part of the main trial. Thanks also to Professor Craig Ramsay and Mr Irfan Ahmed the Chief Investigators of the trial. Thanks also to Karen Innes the Trial Manager and Becky Bruce the Data Coordinator for their support of the study. Ethics approval and consent to participate: This study was approved through the parent trial from NHS North of Scotland Research Ethics Committee (16/NS/0053). Informed consent was obtained from all participants. Declarations of interest: None. Role of funding source: KG held a Medical Research Council UK Methodology Fellowship during the delivery of this project (MR/L01193X/1). The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish.Peer reviewedPostprin

Surgeons' and methodologists' perceptions of utilising an expertise-based randomised controlled trial design : A qualitative study

Acknowledgements The authors would like to acknowledge the interviewees for giving up the time to take part in the interviews and Sharon McCann for her guidance when setting up the study. Funding Jonathan Cook held a Medical Research Council (MRC) UK methodology (G1002292) fellowship which supported this study. Katie Gilles holds a MRC UK methodology fellowship (MR/L01193X/1). The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish.Peer reviewedPublisher PD

Using a behavioural approach to explore the factors that affect questionnaire return within a clinical trial : a qualitative study based on the Theoretical Domains Framework

Funding This research is funded by the Chief Scientist Office of the Scottish Government’s Health and Social Care Department (HIPS/16/46). KG held a Medical Research Council UK Methodology Fellowship during the delivery of this project (MR/L01193X/1). The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish. in a recent paper. Acknowledgements The authors would like to thank the patients for volunteering their time to participate in this study and to Rebecca Bruce and Karen Innes for facilitating recruitment.Peer reviewedPublisher PD

Relative importance of informational items in Participant Information Leaflets for trials : a Q-Methodology approach

Acknowledgements: The authors would like to thank the stakeholders who participated in the study for their time. Funding: This work was supported by personal fellowship award (to KG) from the Medical Research Council Strategic Skills Methodology Fellowship (MRC MR/ L01193X/1). KI and SC were supported by awards from the National Institute for Health Research Health Technology Assessment Programme (HTA ref 14/192/71, HTA ref 11/58/15). The Health Services Research Unit is supported by a core grant from the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.Peer reviewedPublisher PD