Adequacy of measures of informed consent in medical practice: A systematic review.

As a critical component of medical practice, it is alarming that patient informed consent does not always reflect (1) adequate information provision, (2) comprehension of provided information, and (3) a voluntary decision. Consequences of poor informed consent include low patient satisfaction, compr...

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Autores principales:	Kerry A Sherman, Christopher Jon Kilby, Melissa Pehlivan, Brittany Smith
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/e693bd3b531b4a42a990df7c70acf54c
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spelling	oai:doaj.org-article:e693bd3b531b4a42a990df7c70acf54c2021-11-25T06:19:01ZAdequacy of measures of informed consent in medical practice: A systematic review.1932-620310.1371/journal.pone.0251485https://doaj.org/article/e693bd3b531b4a42a990df7c70acf54c2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0251485https://doaj.org/toc/1932-6203As a critical component of medical practice, it is alarming that patient informed consent does not always reflect (1) adequate information provision, (2) comprehension of provided information, and (3) a voluntary decision. Consequences of poor informed consent include low patient satisfaction, compromised treatment adherence, and litigation against medical practitioners. To ensure a well-informed, well-comprehended, and voluntary consent process, the objective and replicable measurement of these domains via psychometrically sound self-report measures is critical. This systematic review aimed to evaluate the adequacy of existing measures in terms of the extent to which they assess the three domains of informed consent, are psychometrically sound and acceptable for use by patients. Extensive searching of multiple databases (PsychINFO, PubMed, Sociological Abstracts, CINAHL, AMED) yielded 10,000 potential studies, with 16 relevant scales identified. No existing scale was found to measure all three consent domains, with most only narrowly assessing aspects of any one domain. Information provision was the most frequently assessed domain, followed by comprehension, and then voluntariness. None of the identified scales were found to have adequate evidence for either high quality psychometric properties or patient user acceptability. No existing scale is fit for purpose in comprehensively assessing all domains of informed consent. In the absence of any existing measure meeting the necessary criteria relating to information, comprehension and voluntariness, there is an urgent need for a new measure of medical consent to be developed that is psychometrically sound, spans all three domains and is acceptable to patients and clinicians alike. These findings provide the impetus and justification for the redesign of the informed consent process, with the aim to provide a robust, reliable and replicable process that will in turn improve the quality of the patient experience and care provided.Kerry A ShermanChristopher Jon KilbyMelissa PehlivanBrittany SmithPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 5, p e0251485 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Kerry A Sherman Christopher Jon Kilby Melissa Pehlivan Brittany Smith Adequacy of measures of informed consent in medical practice: A systematic review.
description	As a critical component of medical practice, it is alarming that patient informed consent does not always reflect (1) adequate information provision, (2) comprehension of provided information, and (3) a voluntary decision. Consequences of poor informed consent include low patient satisfaction, compromised treatment adherence, and litigation against medical practitioners. To ensure a well-informed, well-comprehended, and voluntary consent process, the objective and replicable measurement of these domains via psychometrically sound self-report measures is critical. This systematic review aimed to evaluate the adequacy of existing measures in terms of the extent to which they assess the three domains of informed consent, are psychometrically sound and acceptable for use by patients. Extensive searching of multiple databases (PsychINFO, PubMed, Sociological Abstracts, CINAHL, AMED) yielded 10,000 potential studies, with 16 relevant scales identified. No existing scale was found to measure all three consent domains, with most only narrowly assessing aspects of any one domain. Information provision was the most frequently assessed domain, followed by comprehension, and then voluntariness. None of the identified scales were found to have adequate evidence for either high quality psychometric properties or patient user acceptability. No existing scale is fit for purpose in comprehensively assessing all domains of informed consent. In the absence of any existing measure meeting the necessary criteria relating to information, comprehension and voluntariness, there is an urgent need for a new measure of medical consent to be developed that is psychometrically sound, spans all three domains and is acceptable to patients and clinicians alike. These findings provide the impetus and justification for the redesign of the informed consent process, with the aim to provide a robust, reliable and replicable process that will in turn improve the quality of the patient experience and care provided.
format	article
author	Kerry A Sherman Christopher Jon Kilby Melissa Pehlivan Brittany Smith
author_facet	Kerry A Sherman Christopher Jon Kilby Melissa Pehlivan Brittany Smith
author_sort	Kerry A Sherman
title	Adequacy of measures of informed consent in medical practice: A systematic review.
title_short	Adequacy of measures of informed consent in medical practice: A systematic review.
title_full	Adequacy of measures of informed consent in medical practice: A systematic review.
title_fullStr	Adequacy of measures of informed consent in medical practice: A systematic review.
title_full_unstemmed	Adequacy of measures of informed consent in medical practice: A systematic review.
title_sort	adequacy of measures of informed consent in medical practice: a systematic review.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/e693bd3b531b4a42a990df7c70acf54c
work_keys_str_mv	AT kerryasherman adequacyofmeasuresofinformedconsentinmedicalpracticeasystematicreview AT christopherjonkilby adequacyofmeasuresofinformedconsentinmedicalpracticeasystematicreview AT melissapehlivan adequacyofmeasuresofinformedconsentinmedicalpracticeasystematicreview AT brittanysmith adequacyofmeasuresofinformedconsentinmedicalpracticeasystematicreview
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Adequacy of measures of informed consent in medical practice: A systematic review.

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