Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives.

OBJECTIVES: To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials. DESIGN: Qualitative interviews analysed using thematic analysis. SETTING AND PARTICIPANTS: Five professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter). RESULTS: Professionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake 'self-driven' referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials. CONCLUSIONS: Diversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency.

Exploring the experiences of people and family carers from under-represented groups in self-managing Parkinson's disease and their use of digital health to do this.

Introduction: Digital health is thought to enable people to better manage chronic conditions, such as Parkinson's. However, little is known about how people from under-represented groups with chronic conditions use digital health to self-manage. Objective: The objective of our study was to explore the experiences of people and family carers from under-represented groups in self-managing Parkinson's, including their use of digital health to do this. Methods: Semi-structured interviews (n = 18, including four dyadic) were conducted remotely, with 16 people with Parkinson's and six family carers in 2020-2021. Participants were purposively sampled from under-represented groups: belong to an ethnic minority, or having significant physical or sensory impairment. Interviews were audio-recorded, transcribed and analysed using thematic analysis. Results: Three main themes of importance were developed: 'self-management support', 'digital health use to support self-management' and 'identity, attitudes and characteristics'. Participants received medical, psychological, social and practical self-management support. Some participants used digital health resources, e.g., Parkinson's UK website. Digital literacy was the biggest barrier to using digital health, regardless of background, often dependant on previous occupation and confidence. Few ethnic minority participants thought race or culture alters self-management ability and most believed there was no need for digital health interventions to be tailored to an individual's race or culture. Some felt inclusivity was important in terms of diverse images of people. A range of considerations were identified to optimise digital health, such as assistive equipment for people with sensory impairment. Conclusions: Barriers to using digital health for self-management were primarily dependent on personal factors including digital literacy and attitudes but rarely race or culture. We recommend the optimisation of digital health interventions by providing assistive technology at low cost, and visual inclusiveness should be promoted by including images of people from diverse backgrounds.

Using Patient-Reported Outcomes in Dose-Finding Oncology Trials: Surveys of Key Stakeholders and the National Cancer Research Institute Consumer Forum.

BACKGROUND: Patient-reported adverse events may be a useful adjunct for assessing a drug's tolerability in dose-finding oncology trials (DFOT). We conducted surveys of international stakeholders and the National Cancer Research Institute (NCRI) Consumer Forum to understand attitudes about patient-reported outcome (PRO) use in DFOT. METHODS: A 35-question survey of clinicians, trial managers, statisticians, funders, and regulators of DFOT was distributed via professional bodies examining experience using PROs, benefits/barriers, and their potential role in defining tolerable doses. An 8-question survey of the NCRI Consumer Forum explored similar themes. RESULTS: International survey: 112 responses from 15 September-30 November 2020; 103 trialists [48 clinicians (42.9%), 38 statisticians (34.0%), 17 trial managers (15.2%)], 7 regulators (6.3%), 2 funders (1.8%)]. Most trialists had no experience designing (73, 70.9%), conducting (52, 50.5%), or reporting (88, 85.4%) PROs in DFOT. Most agreed that PROs could identify new toxicities (75, 67.0%) and provide data on the frequency (86, 76.8%) and duration (81, 72.3%) of toxicities. The top 3 barriers were lack of guidance regarding PRO selection (73/103, 70.9%), missing PRO data (71/103, 68.9%), and overburdening staff (68/103, 66.0%). NCRI survey: 57 responses on 21 March 2021. A total of 28 (49.1%) were willing to spend <15 min/day completing PROs. Most (55, 96.5%) preferred to complete PROs online. 61 (54.5%) trialists and 57 (100%) consumers agreed that patient-reported adverse events should be used to inform dose-escalation decisions. CONCLUSION: Stakeholders reported minimal experience using PROs in DFOT but broadly supported their use. Guidelines are needed to standardize PRO selection, analysis, and reporting in DFOT.

Medicines management at home during the COVID-19 pandemic: a qualitative study exploring the UK patient/carer perspective.

OBJECTIVES: To explore home medicine practices and safety for people shielding and/or over the age of 70 during the COVID-19 pandemic and to create guidance, from the patient/carer perspective, for enabling safe medicine practices for this population. METHODS: Semi-structured interviews were carried out with 50 UK participants who were shielding and/or over the age of 70 and who used medicines for a long-term condition, using telephone or video conferencing. Participants were recruited through personal/professional networks and through patient/carer organisations. Participants were asked about their experiences of managing medicines during the pandemic and how this differed from previous practices. Data were analysed using inductive thematic analysis. KEY FINDINGS: Patients' and their families' experiences of managing medicines safely during the pandemic varied greatly. Analysis suggests that this was based on the patient's own agency, the functioning of their medicines system pre-pandemic and their relationships with family, friends, community networks and pharmacy staff. Medicine safety issues reported included omitted doses and less-effective formulations being used. Participants also described experiencing high levels of anxiety related to obtaining medicines, monitoring medicines and feeling at risk of contracting COVID-19 while accessing healthcare services for medicine-related issues. Effects of the pandemic on medicines adherence were reported to be positive by some and negative by others. CONCLUSIONS: Pharmacy staff have a key role to play by establishing good relationships with patients and their families, working with prescribers to ensure medicines systems are as joined up as possible, and signposting to community networks that can help with medicines collection.

How can patient-held lists of medication enhance patient safety? A mixed-methods study with a focus on user experience.

BACKGROUND: Patients often carry medication lists to mitigate information loss across healthcare settings. We aimed to identify mechanisms by which these lists could be used to support safety, key supporting features, and barriers and facilitators to their use. METHODS: We used a mixed-methods design comprising two focus groups with patients and carers, 16 semistructured interviews with healthcare professionals, 60 semistructured interviews with people carrying medication lists, a quantitative features analysis of tools available for patients to record their medicines and usability testing of four tools. Findings were triangulated using thematic analysis. Distributed cognition for teamwork models were used as sensitising concepts. RESULTS: We identified a wide range of mechanisms through which carrying medication lists can improve medication safety. These included improving the accuracy of medicines reconciliation, allowing identification of potential drug interactions, facilitating communication about medicines, acting as an aide-mémoire to patients during appointments, allowing patients to check their medicines for errors and reminding patients to take and reorder their medicines. Different tools for recording medicines met different needs. Of 103 tools examined, none met the core needs of all users. A key barrier to use was lack of awareness by patients and carers that healthcare information systems can be fragmented, a key facilitator was encouragement from healthcare professionals. CONCLUSION: Our findings suggest that patients and healthcare professionals perceive patient-held medication lists to have a wide variety of benefits. Interventions are needed to raise awareness of the potential role of these lists in enhancing patient safety. Such interventions should empower patients and carers to identify a method that suits them best from a range of options and avoid a 'one size fits all' approach.

Comments on: involving service users in the qualitative analysis of patient narratives to support healthcare quality improvement.

PLAIN ENGLISH SUMMARY: Some previous researchers (Locock et al) have written about what may be the best way for public contributors to be involved in data analysis in research projects. Their experience has been that giving public contributors large amounts of text to read is not the best use of their time and experience. They have recommended that a better approach would be for a researcher to meet with a group of users at the start of analysis, to discuss what to look out for. However, as another patient group that has been involved in analysis, we think differently. The approach we used was to be more fully involved in the project over a longer time period. Analysis tasks were broken down into stages to make it easier for those taking part. We found that this allowed us to take part fully without placing too much burden on us. We found that our approach was workable and successful and see no reason why it could not be applied in other circumstances. ABSTRACT: In this journal, Locock et al. have suggested that service users should not be overburdened with large amounts of data, and that eliciting users' reflections on their experience at the start of analysis and using this as a guide to direct researcher attention during the remainder of the process may work better. As public contributors that have been involved in analysis we suggest an alternative approach in this brief letter, based on our own experiences.