Determining the outcomes to measure in research into informed consent for therapy
type: CreativeWork
description: Over the last 25 years, researchers have trialled many different techniques for undertaking the informed consent process for surgery in adults with capacity. Since none of these studies have measured the same outcomes in the same way, we do not know which techniques work best. Furthermore, it appears that the outcomes collected may not be what matters most to patients and doctors. To address these issues, I present the development of a core outcome set for trials of interventions designed to improve consent for surgery. I have developed this core outcome set by: i. investigating which outcomes have been reported in existing research; ii. defining additional outcomes that could be measured through a review of the qualitative literature and a series of semi-structured stakeholder interviews; iii. developing a consent outcomes taxonomy; and iv. determining which outcomes are core through the conduct of an international Delphi survey and a series of consensus webinars. Systematic reviews of existing literature demonstrated that the quality of the informed consent process had largely been evaluated by using recall of consent related information. It was clear from reviewing the protocols of ongoing and planned clinical trials in this field that future research did not plan to evaluate any novel outcomes and again relied on patient recall of information as a marker of quality of the informed consent process. Using the outcomes generated from previous systematic reviews, a qualitative evidence synthesis and the qualitative interviews we asked patient, clinician, consent researcher, bioethicist and lawyer stakeholders to prioritise outcomes for inclusion in a COS. This was conducted over two rounds and included 125 respondents from 8 countries who completed all aspects of both rounds of the survey. Using established consensus building methodology, the survey identified 11 outcomes that met consensus criteria. Many of these had not been reported in existing consent research. …
abstract: Over the last 25 years, researchers have trialled many different techniques for undertaking the informed consent process for surgery in adults with capacity. Since none of these studies have measured the same outcomes in the same way, we do not know which techniques work best. Furthermore, it appears that the outcomes collected may not be what matters most to patients and doctors. To address these issues, I present the development of a core outcome set for trials of interventions designed to improve consent for surgery. I have developed this core outcome set by: i. investigating which outcomes have been reported in existing research; ii. defining additional outcomes that could be measured through a review of the qualitative literature and a series of semi-structured stakeholder interviews; iii. developing a consent outcomes taxonomy; and iv. determining which outcomes are core through the conduct of an international Delphi survey and a series of consensus webinars. Systematic reviews of existing literature demonstrated that the quality of the informed consent process had largely been evaluated by using recall of consent related information. It was clear from reviewing the protocols of ongoing and planned clinical trials in this field that future research did not plan to evaluate any novel outcomes and again relied on patient recall of information as a marker of quality of the informed consent process. Using the outcomes generated from previous systematic reviews, a qualitative evidence synthesis and the qualitative interviews we asked patient, clinician, consent researcher, bioethicist and lawyer stakeholders to prioritise outcomes for inclusion in a COS. This was conducted over two rounds and included 125 respondents from 8 countries who completed all aspects of both rounds of the survey. Using established consensus building methodology, the survey identified 11 outcomes that met consensus criteria. Many of these had not been reported in existing consent research. …
author: Convie, Liam
language: eng
keywords: Informed Consent, Surgery, Core Outcome Set (COS), Qualitative Evidence Synthesis, Thematic Analysis, Qualitative
date published: 2020-7
date modified: 2026-07-24T03:55:18Z
provider: Queen's University Belfast
publisher: Networked Digital Library of Theses and Dissertations
type: WebPage
source organization: Queen's University Belfast