The research to practice continuum: Development of an evidence-based visual aid to improve informed consent for procedural sedation.
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ABSTRACT:
SUBMITTER: Bellolio MF
PROVIDER: S-EPMC5978431 | biostudies-literature | 2017 Oct
REPOSITORIES: biostudies-literature
Publications
The research to practice continuum: Development of an evidence-based visual aid to improve informed consent for procedural sedation.
Bellolio M Fernanda MF E Silva Lucas Oliveira J LOJ Puls Henrique Alencastro HA Hargraves Ian G IG Cabrera Daniel D
Journal of clinical and translational science 20171001 5
In order to fully participate in informed consent, patients must understand what it is that they agreeing, or not agreeing, to. In most cases, patients look to their clinicians to help develop the appropriate understanding required to give informed consent. Using a visual aid as an adjunct to risk communication in a stressful setting as the Emergency Department has a clear potential in facilitating the communication process. ...[more]
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Project description:Background: Informed consent is a basic ethical requirement of clinical research, yet deficiencies have been documented in the comprehension of its components among trial participants. Pregnancy research is sparsely conducted. Assessment of understanding of the informed consent among pregnant women suffering from Gestational Diabetes Mellitus enrolled in a randomized controlled trial, and their experiences was planned. Methodology: A prospective observational cohort study was conducted among participants of EMERGE clinical trial at the University Hospital, Galway. Willing participants allowed observation of their consent encounters. They completed the standard QuIC questionnaire at follow up visits for assessment of objective and subjective understanding of informed consent, and reasons to participate and level of satisfaction. Data was entered and analysed using Microsoft Office Excel and Minitab version 18. Results: The most commonly asked questions asked in the twenty consent encounters observed were focused upon the safety of the study drug for the developing foetuses and women. The general attitude of the women was positive towards participation. The mean objective understanding score was 72.43 ± 7 and the subjective understanding score was 91.67 ± 8.68 (out of 100). Critical components of consent like voluntarism, randomisation, withdrawal, and benefit to others were well understood. The domains related to nonstandard nature of treatment, additional risks/discomforts and compensation were poorly understood. The women cited the desire to provide benefit to future patients as the most common reason to participate, and most were satisfied with the consent process. Conclusion: Comprehension of informed consent is good in most aspects, but the grasp of certain concepts is poor among the pregnant women. Efforts are needed to improve informed consent through engagement of investigators, research nurses and possibly, the use of a decision aid.
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Project description:IntroductionEarly phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures-this is reflected in the increasing length of participant information sheets (PIS). Informed consent for early phase clinical trials has been contentious due to the potential ethical issues associated with performing experimental research on a terminally ill population which has exhausted standard treatment options. Empirical studies have demonstrated significant gaps in patient understanding regarding the nature and intent of these trials. This study aims to test whether enhanced informed consent for patient education can improve patient scores on a validated questionnaire testing clinical trial comprehension.Methods and analysisThis is a randomised controlled trial that will allocate patients who are eligible to participate in one of four investigator-initiated clinical trials at the Royal Marsden Drug Development Unit to either a standard arm or an experimental arm, stratified by age and educational level. The standard arm will involve the full length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A and B (QuIC-A and QuIC-B). The experimental arm will involve the full length trial PIS, exposure to a two-page study aid and 10 online educational videos, followed by administration of the QuIC-A and QuIC-B. The primary endpoint will be the difference (using a one-sided two-sample t-test) in the QuIC-A score, which measures objective understanding, between the standard and experimental arm. Accrual target is at least 17 patients per arm to detect an 8 point difference (80% power, alpha 0.05).Ethics and disseminationEthics approval was granted by the National Health Service Health Research Authority on 15 June 2020-IRAS Project ID 277065, Protocol Number CCR5165, REC Reference 20/EE/0155. Results will be disseminated via publication in a relevant journal.Trial registration numberNCT04407676; Pre-results.
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Project description:Methods to obtain informed consent digitally or electronically may increase the participation of racially and geographically diverse pregnant women in prospective research, which is essential to improve the evidence base for maternity care. We evaluated the feasibility and utility of e-consent in the first year of a multiyear clinical trial involving pregnant women. Of the 86 women screened, 71 were eligible, 65 (93% of eligible) agreed to review the e-consent form, and 61 (86% of eligible) completed the e-consent process. Of the interested women who were sent the e-consent link, all were able to complete the e-consent process, even those who reported low health literacy. Women of all racial and ethnic groups were equally likely to consent, and the sample of women who consented was consistent with practice demographics. E-consent is feasible and easy to use with pregnant women and may expedite enrollment of a representative sample.
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Project description:BackgroundWe assessed potential consent bias in a cohort of > 40,000 adult patients asked by mail after hospitalization to consent to the use of past, present and future clinical and biological data in an ongoing 'general consent' program at a large tertiary hospital in Switzerland.MethodsIn this retrospective cohort study, all adult patients hospitalized between April 2019 and March 2020 were invited to participate to the general consent program. Demographic and clinical characteristics were extracted from patients' electronic health records (EHR). Data of those who provided written consent (signatories) and non-responders were compared and analyzed with R studio.ResultsOf 44,819 patients approached, 10,299 (23%) signed the form. Signatories were older (median age 54 [IQR 38-72] vs. 44 years [IQR 32-60], p < .0001), more comorbid (2614/10,299 [25.4%] vs. 4912/28,676 [17.1%] with Charlson comorbidity index ≤ 4, p < .0001), and more often of Swiss nationality (6592/10,299 [64%] vs. 13,813/28,676 [48.2%], p < .0001).ConclusionsOur results suggest that actively seeking consent creates a bias and compromises the external validity of data obtained via 'general consent' programs. Other options, such as opt-out consent procedures, should be further assessed.
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