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What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey.

ABSTRACT: To investigate parents' views about deferred consent to inform management of trial disclosure after a child's death.A postal questionnaire survey was sent to members of the Meningitis Research Foundation UK charity, whose child had suffered from bacterial meningitis or meningococcal septicaemia within the previous 5 years. Main outcome measures were acceptability of deferred consent; timing of requesting consent; and the management of disclosure of the trial after a child's death.220 families were sent questionnaires of whom 63 (29%) were bereaved. 68 families responded (31%), of whom 19 (28%) were bereaved. The majority (67%) was willing for their child to be involved in the trial without the trial being explained to them beforehand; 70% wanted to be informed about the trial as soon as their child's condition had stabilised. In the event of a child's death before the trial could be discussed the majority of bereaved parents (66% 12/18) anticipated wanting to be told about the trial at some time. This compared with 37% (18/49) of non-bereaved families (p = 0.06). Parents' free text responses indicated that the word 'trial' held strongly negative connotations. A few parents regarded gaps in the evidence base about emergency treatments as indicating staff lacked expertise to care for a critically ill child. Bereaved parents' free text responses indicated the importance of individualised management of disclosure about a trial following a child's death.Deferred consent is acceptable to the majority of respondents. Parents whose children had recovered differed in their views compared to bereaved parents. Most bereaved parents would want to be informed about the trial in the aftermath of a child's death, although a minority strongly opposed such disclosure. Distinction should be drawn between the views of bereaved and non-bereaved parents when considering the acceptability of different consent processes.

SUBMITTER: Gamble C

PROVIDER: S-EPMC3346812 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey.

Gamble Carrol C Nadel Simon S Snape Dee D McKay Andrew A Hickey Helen H Williamson Paula P Glennie Linda L Snowdon Claire C Young Bridget B

PloS one 20120507 5

<h4>Objective</h4>To investigate parents' views about deferred consent to inform management of trial disclosure after a child's death.<h4>Methods</h4>A postal questionnaire survey was sent to members of the Meningitis Research Foundation UK charity, whose child had suffered from bacterial meningitis or meningococcal septicaemia within the previous 5 years. Main outcome measures were acceptability of deferred consent; timing of requesting consent; and the management of disclosure of the trial aft ...[more]

PMID: 22586456

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Project description:BackgroundLower than expected recruitment and retention rates are common challenges in parenting trials-particularly for community-based trials targeting parents of young children that rely on face-to-face recruitment by frontline workers. Recruitment requires parental informed consent, yet information sheets have been criticized for being lengthy and complex, and particularly challenging for parents with low literacy. Recent innovations include 'talking head' information videos. This paper aims to explore parent perceptions of using a 'talking head' video to support informed consent, recruitment, and retention procedures in parenting trials.MethodsWe conducted semi-structured interviews with a sample of 24 mothers recruited after their final follow-ups in two different parenting trials in Denmark. Before consenting to participate in the trials, parents were invited to view a video of a member of the study team giving information about the study, and again before the interviews for the current study. The audio data was transcribed and thematic analysis was conducted.ResultsWe identified three overarching themes: (1) general impression of the video, (2) thoughts on participation in research, and (3) recruitment and retention. Participants were generally positive in their appraisal of the two talking head informational videos. We found that participants felt that a mix of paper-based and video-based sources of information would enable them to make an informed choice about whether to participate in a research study. We also found that a professionally produced video featuring a key member of the study team produced a feeling of commitment to the study that could impact retention rates.ConclusionsInformational videos are acceptable to parents; however, co-production or participant/patient involvement in the development of such videos is recommended. Informational videos may not increase recruitment but have the potential for improving retention. Key design recommendations are to ensure a 'professional' look to the video, to supplement videos with paper-based information, to keep the length to < 3 min, and for the 'talking head' part to feature a key member of the study team.

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:IntroductionInformed 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 analysisGuided 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 disseminationFormal 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.

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What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey.

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What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey.

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