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      Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders’ views in South Wales

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          Abstract

          Background

          Care home residents, especially those lacking capacity to provide consent for themselves, are frequently excluded from research, thus limiting generalisability of study findings. We set out to explore stakeholders’ views about the ethical and practical challenges associated with recruiting care home residents into research studies.

          Methods

          Qualitative individual interviews with care home residents (n = 14), their relatives (n = 14), and general practitioners (GPs) (n = 10), and focus groups (n = 2) with care home staff. Interviews focused on the issues of older adults consenting to research in care homes, including advanced consent, in general and through reference to a particular study on the use of probiotics to prevent Antibiotic Associated Diarrhoea. Data were analysed using a thematic approach incorporating themes that had been identified in advance, and themes derived from the data. Researchers discussed evidence for themes, and reached consensus on the final themes.

          Results

          Respondents were generally accepting of low risk observational studies and slightly less accepting of low risk randomised trials of medicinal products. Although respondents identified some practical barriers to informed consent, consenting arrangements were considered workable. Residents and relatives varied in the amount of detail they wanted included in information sheets and consent discussions, but were generally satisfied that an advanced consent model was acceptable and appropriate. Opinions differed about what should happen should residents lose capacity during a research study.

          Conclusions

          Research staff should be mindful of research guidance and ensure that they have obtained an appropriate level of informed consent without overwhelming the participant with unnecessary detail. For research involving medicinal products, research staff should also be more explicit when recruiting that consent is still valid should an older person lose capacity during a trial provided the individual did not previously state a wish to be withdrawn if they lose capacity, and provided they do not indicate objection or resistance after loss of capacity.

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          Most cited references17

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          Improvement of informed consent and the quality of consent documents.

          Guidelines on informed consent intend to protect patients and promote ethical research conduct. To give informed consent, individuals should understand the purpose, process, risks, benefits, and alternatives to research (or a proposed clinical intervention) and make a free, voluntary decision about whether to participate. Many participants have incomplete understanding of various features of clinical trials. Issues associated with the length, format, and language of documents for written informed consent are common. Here, we analyse the written consent form, particularly in the context of clinical research, and the discussions that take place between clinician or investigator and patient. We review strategies to improve consent forms, particularly the use of plain language. Recommendations are made on discussions between investigator and patient to improve participant comprehension and satisfaction with the informed-consent process.
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            Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial.

            To explore trial participants' understandings of randomisation. In this exploratory study, which used qualitative research methods, in-depth, semistructured interviews were carried out with 20 participants from the CLasP randomised controlled trial. Interviews were recorded on audio tape and fully transcribed. Data were analysed by comparing transcripts and describing emergent themes, using a grounded theory approach. The CLasP study comprises three linked multicentre, pragmatic randomised controlled trials evaluating the effectiveness and cost effectiveness of laser therapy, standard surgery, and conservative management for men with lower urinary tract symptoms or urinary retention, or both, related to benign prostatic disease. 20 participants in the CLasP study were interviewed. Sampling was purposeful: men were included from each of the treatment arms, the two major centres, and at different points in the trial. Interviews used a checklist of topics to encourage participants to describe their experiences. Narratives concerning randomisation were compared to identify common themes, retaining the context of the discussion to allow detailed interpretation. Most participants recalled and described aspects of randomisation, such as the involvement of chance, comparison, and concealed allocation. Many found the concept of randomisation difficult, however, and developed alternative lay explanations to make sense of their experiences. Inaccurate patient information and lay interpretations of common trial terms caused confusion. The provision of clear and accurate patient information is important, but this alone will not ensure consistent interpretation of concepts such as randomisation. Patients may need to discuss the purposes of randomisation in order to understand them fully enough to give truly informed consent.
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              Recruitment of frail older people to research: lessons learnt through experience.

              With the emphasis on the need for clinical governance and evidence-based practice in the healthcare industry there is increasing pressure on researchers to provide tangible research evidence of the effectiveness of new treatments, interventions and services. Recruiting an adequate size of sample is an important factor in the success or otherwise of a study to answer the research question. Difficulty in the recruitment of older people to research is widely acknowledged. However, much can be achieved to maximize the success of this process. This paper describes and explores our experience of recruiting frail, older people to research, with particular emphasis on ensuring quality in the process of research related to ethical practice. Recruitment of frail older people to research can be a complex process in which the awareness and integrity of the researcher is key in upholding the principle of nonexploitation. It is important not to underestimate this difficulty and to ensure that the data collection period is sufficient to recruit adequate numbers. There is a need to continue to develop and refine recruitment skills and strategies to maximize the involvement of frail older people to research while protecting their right to refuse.
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                Author and article information

                Contributors
                Journal
                Trials
                Trials
                Trials
                BioMed Central
                1745-6215
                2013
                9 August 2013
                : 14
                : 247
                Affiliations
                [1 ]Institute of Primary Care and Public Health, School of Medicine, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff CF14 4XNWales, UK
                [2 ]South East Wales Trials Unit, School of Medicine, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, CF14 4XNWales, UK
                Author notes
                the PAAD study team
                Article
                1745-6215-14-247
                10.1186/1745-6215-14-247
                3750808
                23937972
                5312faee-0eeb-481e-bab1-31e94566b14f
                Copyright © 2013 Wood et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 15 January 2013
                : 24 July 2013
                Categories
                Research

                Medicine
                consent,older adults,qualitative research,mental capacity,ethics,recruitment,common infections
                Medicine
                consent, older adults, qualitative research, mental capacity, ethics, recruitment, common infections

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