Dataset Information

Patient and Caregiver Experiences of Participating in Parkinson's Disease Clinical Trials: A Systematic Review of Qualitative Studies.

ABSTRACT:

Background

Older people experience multiple barriers to enrolment in clinical trials. Caregivers play an important role in supporting patients with Parkinson's disease. Understanding the experiences of patients and caregivers who participate in trials is important to inform the design of future studies and identify problems with recruitment and retention.

Objective

To systematically review and synthesize qualitative studies exploring the experiences of participating in clinical trials from the perspectives of patients with Parkinson's disease and their caregivers.

Methods

Two reviewers independently searched the following databases: MEDLINE, Embase, PsycInfo, Cochrane, and CINAHL. The reference lists of all selected papers were screened for additional studies. Articles meeting predefined eligibility criteria were included in the synthesis. Methodological quality of each study was assessed using the Critical Appraisal Skills Programme (CASP) Qualitative Checklist. Included study findings were synthesized using the principles of thematic analysis.

Results

Eleven studies were included. Five key themes were identified: positive experiences of participating in research, assessment completion, motivators, enablers, and barriers. Positive experiences of participating in studies were linked to social interaction with other patients, building trust with the researchers, and expertise of the research team.

Conclusions

This review supports literature highlighting the important role of caregivers in supporting patients with Parkinson's disease. Future studies are needed to further examine their perspectives on participating in research.

SUBMITTER: Gorzynska O

PROVIDER: S-EPMC9035084 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

Patient and Caregiver Experiences of Participating in Parkinson's Disease Clinical Trials: A Systematic Review of Qualitative Studies.

Gorzynska Olivia O McGoohan Katie K Velayudhan Latha L

Archives of clinical neuropsychology : the official journal of the National Academy of Neuropsychologists 20220201 3

<h4>Background</h4>Older people experience multiple barriers to enrolment in clinical trials. Caregivers play an important role in supporting patients with Parkinson's disease. Understanding the experiences of patients and caregivers who participate in trials is important to inform the design of future studies and identify problems with recruitment and retention.<h4>Objective</h4>To systematically review and synthesize qualitative studies exploring the experiences of participating in clinical tr ...[more]

PMID: 34673913

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Project description:BackgroundFundamental to the success of clinical research that involves human participants is the quality of the data that is generated. To ensure data quality, clinical trials must comply with the Good Clinical Practice guideline which recommends data monitoring. To date, the guideline is broad, requires technology for enforcement, follows strict industry standards, mostly designed for drug-registration trials and based on informal consensus. It is also unknown what challenges clinical trials and researchers face in implementing data monitoring procedures. Thus, this study aimed to describe researcher experiences with data quality monitoring in clinical trials.MethodsWe conducted semi-structured telephone interviews following a guided-phenomenological approach. Participants were recruited from the Australian and New Zealand Clinical Trials Registry and were researchers affiliated with a listed clinical study. Each transcript was analysed with inductive thematic analysis before thematic categorisation of themes from all transcripts. Primary, secondary and subthemes were categorised according to the emerging relationships.ResultsData saturation were reached after interviewing seven participants. Five primary themes, two secondary themes and 21 subthemes in relation to data quality monitoring emerged from the data. The five primary themes included: education and training, ways of working, working with technology, working with data, and working within regulatory requirements. The primary theme 'education and training' influenced the other four primary themes. While 'working with technology' influenced the 'way of working'. All other themes had reciprocal relationships. There was no relationship reported between 'working within regulatory requirements' and 'working with technology'. The researchers experienced challenges in meeting regulatory requirements, using technology and fostering working relationships for data quality monitoring.ConclusionClinical trials implemented a variety of data quality monitoring procedures tailored to their situation and study context. Standardised frameworks that are accessible to all types of clinical trials are needed with an emphasis on education and training.

Project description:BackgroundEarly diagnosis and intervention for people with dementia is increasingly considered a priority, but practitioners are concerned with the effects of earlier diagnosis and interventions on patients and caregivers. This systematic review evaluates the qualitative evidence about how people accommodate and adapt to the diagnosis of dementia and its immediate consequences, to guide practice.Methods and findingsWe systematically reviewed qualitative studies exploring experiences of community-dwelling individuals with dementia, and their carers, around diagnosis and the transition to becoming a person with dementia. We searched PubMed, PsychINFO, Embase, CINAHL, and the British Nursing Index (all searched in May 2010 with no date restrictions; PubMed search updated in February 2012), checked reference lists, and undertook citation searches in PubMed and Google Scholar (ongoing to September 2011). We used thematic synthesis to identify key themes, commonalities, barriers to earlier diagnosis, and support identified as helpful. We identified 126 papers reporting 102 studies including a total of 3,095 participants. Three overarching themes emerged from our analysis: (1) pathways through diagnosis, including its impact on identity, roles, and relationships; (2) resolving conflicts to accommodate a diagnosis, including the acceptability of support, focusing on the present or the future, and the use or avoidance of knowledge; and (3) strategies and support to minimise the impact of dementia. Consistent barriers to diagnosis include stigma, normalisation of symptoms, and lack of knowledge. Studies report a lack of specialist support particularly post-diagnosis.ConclusionsThere is an extensive body of qualitative literature on the experiences of community-dwelling individuals with dementia on receiving and adapting to a diagnosis of dementia. We present a thematic analysis that could be useful to professionals working with people with dementia. We suggest that research emphasis should shift towards the development and evaluation of interventions, particularly those providing support after diagnosis.

Dataset Information

Patient and Caregiver Experiences of Participating in Parkinson's Disease Clinical Trials: A Systematic Review of Qualitative Studies.

Background

Objective

Methods

Results

Conclusions

Publications

Patient and Caregiver Experiences of Participating in Parkinson's Disease Clinical Trials: A Systematic Review of Qualitative Studies.

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