Identifying essential information to support patient decision-making regarding participation in cancer clinical trials

A Delphi study

Chi-Yin Kao, Sanchia Aranda, Mei Krishnasamy, Bridget Hamilton

Research output: Contribution to journalArticle

Abstract

Purposes: This research set out to contribute to ongoing efforts to improve the quality of informed consent information provided to patients by specifically focusing on establishing consensus with regard to essential information to enhance the informed consent process. Design and Methods: A Delphi consensus method was used to conduct three rounds of online surveys. Five groups of experts directly or indirectly involved in the informed consent process were invited to participate: patients, family members/friends, physicians, other health professionals and other key informants, including ethicists, contract research staff and pharmaceutical company staff. Findings: Of 156 eligible participants, 101 participants (64.7%) completed all three rounds. In round 1, 994 information items were reported and generated into 74 statements. These were grouped under eight headings essential to the informed consent process. In rounds 2 and 3, the list was reduced to 15 statements representing consensus on essential information to be included in a summarised patient information document to support decision-making regarding trial participation. Risks and discomforts, participation requirements and trial governance were identified as important considerations. Conclusions: The 15 essential statements identified in this study could be used as components of a summarised information sheet given to potential cancer clinical trial participants, as an adjunct to the informed consent process. A robust evaluation of the impact of these statements on the quality of the informed consent process is needed.

Original languageEnglish
Article numbere12954
JournalEuropean Journal of Cancer Care
Volume27
Issue number6
DOIs
Publication statusPublished - 2018 Nov 1

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Delphi Technique
Informed Consent
Decision Making
Clinical Trials
Neoplasms
Consensus
Ethicists
Contracts
Physicians
Health
Research

All Science Journal Classification (ASJC) codes

  • Oncology

Cite this

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title = "Identifying essential information to support patient decision-making regarding participation in cancer clinical trials: A Delphi study",
abstract = "Purposes: This research set out to contribute to ongoing efforts to improve the quality of informed consent information provided to patients by specifically focusing on establishing consensus with regard to essential information to enhance the informed consent process. Design and Methods: A Delphi consensus method was used to conduct three rounds of online surveys. Five groups of experts directly or indirectly involved in the informed consent process were invited to participate: patients, family members/friends, physicians, other health professionals and other key informants, including ethicists, contract research staff and pharmaceutical company staff. Findings: Of 156 eligible participants, 101 participants (64.7{\%}) completed all three rounds. In round 1, 994 information items were reported and generated into 74 statements. These were grouped under eight headings essential to the informed consent process. In rounds 2 and 3, the list was reduced to 15 statements representing consensus on essential information to be included in a summarised patient information document to support decision-making regarding trial participation. Risks and discomforts, participation requirements and trial governance were identified as important considerations. Conclusions: The 15 essential statements identified in this study could be used as components of a summarised information sheet given to potential cancer clinical trial participants, as an adjunct to the informed consent process. A robust evaluation of the impact of these statements on the quality of the informed consent process is needed.",
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Identifying essential information to support patient decision-making regarding participation in cancer clinical trials : A Delphi study. / Kao, Chi-Yin; Aranda, Sanchia; Krishnasamy, Mei; Hamilton, Bridget.

In: European Journal of Cancer Care, Vol. 27, No. 6, e12954, 01.11.2018.

Research output: Contribution to journalArticle

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