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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) aim to assess the effect of one (or more) unproven health interventions relative to other reference interventions. RCTs sometimes use an ordinal outcome, which is an endpoint that comprises of multiple, monotonically ordered categories that are not necessarily separated by a quantifiable distance. Ordinal outcomes are appealing in clinical settings as specific disease states can represent meaningful categories that may be of clinical importance to researchers. Ordinal outcomes can also retain information and increase statistical power compared to dichotomised outcomes and can allow multiple clinical outcomes to be comprised in a single endpoint. Target parameters for ordinal outcomes in RCTs may vary depending on the nature of the research question, the modelling assumptions and the expertise of the data analyst. The aim of this scoping review is to systematically describe the use of ordinal outcomes in contemporary RCTs. Specifically, we aim to: [Formula: see text] Identify which target parameters are of interest in trials that use an ordinal outcome, and whether these parameters are explicitly defined. [Formula: see text] Describe how ordinal outcomes are analysed in RCTs to estimate a treatment effect. [Formula: see text] Describe whether RCTs that use an ordinal outcome adequately report key methodological aspects specific to the analysis of the ordinal outcome. Results from this review will outline the current state of practice of the use of ordinal outcomes in RCTs. Ways to improve the analysis and reporting of ordinal outcomes in RCTs will be discussed.Methods and analysisWe will review RCTs that are published in the top four medical journals (British Medical Journal, New England Journal of Medicine, The Lancet and the Journal of the American Medical Association) between 1 January 2012 and 31 July 2022 that use an ordinal outcome as either a primary or a secondary outcome. The review will identify articles through a PubMed-specific search strategy. Our review will adhere to guidelines for scoping reviews as described in the PRISMA-ScR checklist. The study characteristics and details of the study design and analysis, including the target parameter(s) and statistical methods used to analyse the ordinal outcome, will be extracted from eligible studies. The screening, review and data extraction will be conducted using Covidence, a web-based tool for managing systematic reviews. The data will be summarised using descriptive statistics.

Project description:IntroductionCancer screening is an integral component of primary care, and providers can play a key role in facilitating screening. While much work has focused on patient interventions, there has been less attention on primary care provider (PCP) interventions. In addition, marginalised patients experience disparities in cancer screening which are likely to worsen if not addressed. The objective of this scoping review is to report on the range, extent and nature of PCP interventions that maximise cancer screening participation among marginalised patients. Our review will target cancers where there is strong evidence to support screening, including lung, cervical, breast and colorectal cancers.Methods and analysisThis is a scoping review conducted in accordance with the framework by Levac et al. Comprehensive searches will be conducted by a health sciences librarian using Ovid MEDLINE, Ovid Embase, Scopus, CINAHL Complete and the Cochrane Central Register of Controlled Trials. We will include peer-reviewed English language literature published from 1 January 2000 to 31 March 2022 that describes PCP interventions to maximise cancer screening participation for breast, cervical, lung and colorectal cancers. Two independent reviewers will screen all articles and identify eligible studies for inclusion in two stages: title and abstract, then full text. A third reviewer will resolve any discrepancies. Charted data will be synthesised through a narrative synthesis using a piloted data extraction form informed by the Template for Intervention Description and Replication checklist.Ethics and disseminationSince this is a synthesis of digitally published literature, no ethics approval is needed for this work. We will target appropriate primary care or cancer screening journals and conference presentations to publish and disseminate the results of this scoping review. The results will also be used to inform an ongoing research study developing PCP interventions for addressing cancer screening with marginalised patients.

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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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