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Advanced consent for participation in acute care randomised control trials: protocol for a scoping review.

ABSTRACT: INTRODUCTION:Informed consent is essential to clinical research, though obtaining informed consent for participation in research for emergency conditions is challenging. Adapted consent methods include consent from a substitute-decision maker, deferral of consent and waiver of consent. A novel approach is to use advanced consent, where a potential participant provides consent in the present in the event that they become eligible for enrolment into a future study. This scoping review will map and synthesise the literature on the use of advanced consent for participation and enrolment in randomised control trials for emergency conditions. METHODS AND ANALYSIS:Guided by Arksey and O'Malley's scoping review methodology framework, we will search electronic databases (Medline, Embase, Web of Science and the Cochrane Register of Clinical Trials), the grey literature sources and reference lists of relevant studies. Eligible studies will include English language articles that discuss, examine or employ the use of advanced consent for enrolment in randomised control trials, specifically related to emergency conditions or emergency treatment. Diverse types of articles will be eligible for inclusion, including peer-reviewed qualitative and quantitative studies such as randomised control trials, observational studies, surveys, systematic reviews, as well as narrative reviews and ethics papers. Studies will be screened by two independent reviewers to determine eligibility for inclusion. Data on bibliographic information, study characteristics and methodology, and reported results, specifically author disposition, will be extracted and described using qualitative analysis. ETHICS AND DISSEMINATION:Formal ethics review is not required as primary data will not be collected. The findings of this study will be disseminated through a peer-reviewed publication. The findings of this study will help identify knowledge gaps that may guide areas for future research and may aid in the design of future clinical trials using advanced consent.

SUBMITTER: Niznick N

PROVIDER: S-EPMC7569993 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Advanced consent for participation in acute care randomised control trials: protocol for a scoping review.

Niznick Naomi N Lun Ronda R Dewar Brian B Dowlatshahi Dar D Shamy Michel M

BMJ open 20201016 10

<h4>Introduction</h4>Informed consent is essential to clinical research, though obtaining informed consent for participation in research for emergency conditions is challenging. Adapted consent methods include consent from a substitute-decision maker, deferral of consent and waiver of consent. A novel approach is to use advanced consent, where a potential participant provides consent in the present in the event that they become eligible for enrolment into a future study. This scoping review will ...[more]

PMID: 33067291

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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.

Project description:IntroductionRandomised controlled trials (RCTs) are widely viewed to generate the most reliable medical knowledge. However, RCTs are not always scientifically necessary and therefore not always ethical. Unfortunately, it is not clear when an RCT is not necessary or how this should be established. This study seeks to systematically catalogue justifications offered throughout the medical and ethics literature for performing randomisation within clinical trials.Methods and analysisWe will systematically search electronic databases of the medical literature including MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov; databases of philosophical literature including Philosopher's Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE, National Reference Centre for Bioethics; the library catalogue at the University of Ottawa; bibliographies of retrieved papers; and the grey literature. We will also pursue suggestions from experts in the fields of medical ethics, philosophy and clinical trial methodology. Article screening, selection and data extraction will be performed by two independent reviewers based on prespecified inclusion/exclusion criteria. A third reviewer will be consulted to resolve any discrepancies. We will then extract the reasons given to justify randomisation using methodology established to extract data in a defensible, systematic manner. We will track the reasons given, their frequency of use and changes over time. Finally, using grounded theory, we will combine the reasons into broader themes. These themes will form the foundation of our subsequent analysis from qualitative and quantitative perspectives. This review will map existing arguments that clinicians, ethicists and philosophers use to ethically justify randomisation in clinical trials.Ethics and disseminationNo research ethics board approval is necessary because we are not examining patient-level data. This protocol complies with the reported guidance for conducting systematic scoping reviews. The findings of this paper will be disseminated via presentations and academic publication. In a subsequent phase of this research, we hope to engage with stakeholders and translate any recommendations derived from our findings into operational guidelines.

Project description:IntroductionCricket is a popular sport played by 2.5 billion people of all ages and abilities. However, cricket participation is decreasing in the UK, despite an increased focus of governments on increasing sport participation to enhance public health. Understanding the health benefits and mitigating the health risks of cricket participation may help cricket organisations promote cricket participation while optimising the long-term health of cricket participants. Currently, there is no literature review on the relationship between cricket participation, health and well-being; thus, this relationship remains unclear. Therefore, the aims of this scoping review were (1) to investigate the relationship between cricket participation, health and well-being and (ii) to identify the research gaps related to cricket, health and well-being.Methods and analysisDue to the broad nature of our research question and the large number of health outcomes assessed within the cricket literature and to facilitate identification of research gaps, a scoping review methodology was used. The methodology of this paper was informed by previous scoping review protocols and best practice methodological frameworks. MEDLINE, CINAHL, Embase, Scopus, PsycINFO, SPORTDiscus, Cochrane Library, EBSCO, Web of Science and PEDro and grey literature sources (Google Scholar, ClinicalTrials.gov, ISRCTN Registry and ProQuest) will be systematically searched. Studies that assess a construct related to health and/or well-being in current and/or former cricketers from all ages and standards of play will be eligible. Two reviewers will independently screen full texts of identiﬁed studies for eligibility and will perform data extraction. Results will be presented in tabular and graphical forms and will be reported descriptively.Ethics and disseminationThis research is exempt from ethics approval due to the data being available through published and public available resources. Results will be published in a peer-reviewed sports and exercise medicine journal regardless of positive or negative findings. In addition, results will be disseminated through multiple platforms, including conference presentations and social media using multimedia resources (eg, infographics, animations, videos, podcasts and blogs), to engage stakeholder groups, including cricketers, cricket coaches, sporting bodies, sports medicine professionals and policy makers. There findings will inform clinical decision making, policy changes and future research agendas.

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Advanced consent for participation in acute care randomised control trials: protocol for a scoping review.

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Advanced consent for participation in acute care randomised control trials: protocol for a scoping review.

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