ORIGINAL ARTICLE
Identifying essential information to support patient decision-making regarding participation in cancer clinical trials: A Delphi study
Correction(s) for this article
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Corrigendum
- Volume 29Issue 2European Journal of Cancer Care
- First Published online: March 23, 2020
Chi-Yin Kao,
Sanchia Aranda,
Mei Krishnasamy,
Bridget Hamilton,
Corresponding Author
Chi-Yin Kao
Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Correspondence
Chi-Yin Kao, Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Email: [email protected]
Search for more papers by this authorSanchia Aranda
Cancer Council Australia, Sydney, New South Wales, Australia
Department of Nursing, Melbourne School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia
Search for more papers by this authorMei Krishnasamy
Department of Nursing, Melbourne School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia
Search for more papers by this authorBridget Hamilton
Department of Nursing, Melbourne School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia
Search for more papers by this authorChi-Yin Kao,
Sanchia Aranda,
Mei Krishnasamy,
Bridget Hamilton,
Corresponding Author
Chi-Yin Kao
Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Correspondence
Chi-Yin Kao, Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Email: [email protected]
Search for more papers by this authorSanchia Aranda
Cancer Council Australia, Sydney, New South Wales, Australia
Department of Nursing, Melbourne School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia
Search for more papers by this authorMei Krishnasamy
Department of Nursing, Melbourne School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia
Search for more papers by this authorBridget Hamilton
Department of Nursing, Melbourne School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia
Search for more papers by this authorAbstract
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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