Site visits to initiate recruitment in a clinical trial: Does it matter who conducts the visit? Protocol for implementation in trials

The Study Within A Trial (SWAT) programme exists to ‘embed research within research, so as to resolve uncertainties about the different ways of designing, conducting, analysing and interpreting evaluations of health and social care’ (1). Published in this journal in 2013, a template for the first SWAT protocol outlined an investigation into the effects of site visits by the Principal Investigator on recruitment in multi-centre randomized controlled trials (1). We have now designed a SWAT protocol to extend this question and ask ‘does it matter who conducts the site visit?’ Our aim is to provide a protocol which trials can implement to address this research question

Co-designing a mental health training curriculum for staff in the vision impairment sector

Depression and anxiety are common in people with congenital and acquired vision impairment but often go unaddressed. Staff from a variety of professions and roles in the sight impairment sector are well placed to identify mental health issues and signpost individuals for support. However, many of these individuals need training to do this competently. The aim of this project was to develop a mental health training curriculum for staff. We used a seven-step method involving staff and service users from national sight loss charities & local authority and university researchers. The result was a curriculum containing five modules covering an introduction to mental wellbeing, the use of a standardised depression and anxiety screening tool, referral and support options and implementation issues to consider. Future work involves developing the curriculum into an online training programme for wide dissemination across the sight loss sector

Effective approaches to public involvement in care home research: a systematic review and narrative synthesis

Background Public involvement (often referred to as patient and public involvement or PPI) integrates the voices of the public in health and care research. However, groups such as care home residents are often excluded from involvement opportunities due to the complexities of involving people with additional care and communication needs. Despite a range of approaches being used, there is little understanding about how best to incorporate their experiences, and those of other care home stakeholders, into the design and conduct of research. Objective A systematic review was conducted to identify PPI methods that better meet the specific needs of care home stakeholders. This was undertaken by (1) outlining effective PPI approaches used in care home research and the key stakeholders involved; (2) describing the role of PPI in different care home contexts and (3) identifying stakeholders’ experiences and attitudes towards PPI in care homes. Methods Databases CINAHL, Embase, MEDLINE, PsycINFO and Scopus were searched for English language papers from inception to November 2021. A narrative synthesis approach was utilised to organise the extracted data into five themes. Results The search initially yielded 2314 articles (following de-duplication), with 27 meeting the inclusion criteria. Articles reported a range of input from stakeholders (including residents, staff, relatives and community stakeholders), with the impact of PPI varying according to the type of care establishment and research context. The experiences and reflections of stakeholders’ about their involvement in care home research varied, with some studies offering first-hand accounts compared with summaries from researchers. Some articles explicitly evaluated the effectiveness of the PPI approach using specific outcome measures whilst others indirectly described the impact of their approach. Five themes were identified as characterising an effective PPI approach: (1) valuing stakeholders’ perspectives, (2) awareness of the multi-faceted research context, (3) ensuring inclusivity and transparency, (4) maintaining flexibility and adaptability and (5) utilising resources and wider support. Conclusion Effective PPI in care home research requires researchers to create person-centred opportunities to adequately involve groups with physical and cognitive impairments. The findings led to the creation of evidence-based practical recommendations to support future involvement opportunities and help researchers develop strategies for inclusive opportunities for involvement

Barriers to integrating routine depression screening into community low vision rehabilitation services: a mixed methods study

Background:Undetected depression is common in people withlow vision and depression screening has beenrecommended. However, depression screening is a complex procedure for which low vision practitioners need training. Thisstudy examined the integration of routine depression screening, using two questions, and referral pathways into a nationallow vision service in Wales at 6 months following practitioner training, and identified key barriers to implementation.Methods:This pre-post single group study employed a convergent mixed methods design to collect quantitativequestionnaire and qualitative interview data on low vision practitioners’clinical practice and perceived barriers toimplementing depression screening. Forty practitioners completed questionnaires pre-, immediately post- and 6 monthspost-training and nine engaged in interviews 6 months post-training. Ordinal questionnaire scores were Rasch-transformedinto interval-level data before linear regression analyses were performed to determine the change in scores over time andthe association between perceived barriers and clinical practice. Thematic Analysis was applied to the interviews and thenarrative results merged withthe questionnaire findings.Results:Before training, only one third of practitioners (n= 15) identified depression in low vision patients, increasing toover 90% (n= 37) at 6 months post-training, with a corresponding increase in those using validated depression screeningquestions from 10% (n= 4) to 80% (n= 32). Six months post-training, practitioners reported taking significantly moreaction in response to suspected depression (difference in means = 2.77, 95% CI 1.93 to 3.61,p< 0.001) and perceived lessbarriers to addressing depression (difference in means =−0.95, 95% CI−1.32 to−0.59,p<0.001).However,thescreening questions were not used consistently. Some barriers to implementation remained, including perceived patientreluctance to discuss depression, time constraints and lack of confidence in addressing depression.Conclusions:The introduction of depression screening service guidelines and training successfully increased the numberof low vision practitioners identifying and addressing depression. However, standardized screening of all low visionattendees has not yet been achieved and several barriers remain. Healthcare services need to address these barriers whenconsidering mental health screening, and further research could focus on the process from the patients’perspective, todetermine the desire for and acceptability of screening

Training results in increased practitioner confidence and identification of depression in people with low vision: a mixed methods study

Purpose The prevalence of depression in people with low vision is high and often goes undiagnosed. There is the potential for those who provide low vision services to perform concurrent depression screening. However, prior training in depression identification and suitable referral pathways is required. The aims of this study were: (1) to assess the impact of a training programme on practitioners’ confidence and behaviour in addressing depression in patients with low vision, and (2) to review the training programme and identify areas for further development. Methods A convergent mixed methods approach was used. Questionnaires were completed by practitioners pre‐, immediately post‐ and 6 months post‐ training (n = 40) to assess practitioner confidence in approaching depression in patients with low vision. Qualitative interviews were performed with a subset of practitioners 6 months post‐training (n = 9). Additionally, routine data from the Low Vision Service Wales (LVSW) database was used to determine the change in the number of practitioners identifying depression in patients, and the change in the number of patients identified at risk of depression 6 months post‐training. Results Of the 148 practitioners who completed low vision assessments pre‐ and post‐training, 28 (18.9%) documented risk of depression in their patients pre‐training, which increased substantially to 65 (43.9%) post‐training (p < 0.0001). Mixed methods analysis confirmed increased documentation of depressive symptoms by practitioners. Practitioner confidence increased following training, with 92.3% feeling more confident to approach emotional issues with patients and 92.2% intending to use the recommended screening tool to identify depression. Interviews provided insight into areas where confidence was still lacking. Quantitative questionnaires revealed that training content was considered appropriate by 91% of participants. Interviews confirmed these findings while expanding upon possibilities for programme improvement. Conclusions Training for depression screening was found to be time‐efficient and acceptable for LVSW practitioners and shown to increase practitioner confidence in the identification of depression. Additionally, the programme changed behaviour, resulting in an increase in the identification of depression in patients with low vision. However, this is a complex topic and ongoing development is required to embed depression screening as an integral part of low vision services

Depressive symptoms in people with vision impairment: a cross-sectional study to identify who is most at risk

Objective: To identify the risk factors for significant depressive symptoms in people with visual impairment in England and Wales to provide information on who is most at risk and to whom support services could be targeted in future. Design: A cross-sectional study using baseline data from a pragmatic randomised controlled trial. Setting and participants: 990 participants aged 18 or over attending 1 of 14 low-vision rehabilitation primary care optometry-based clinics in South Wales or two hospital clinics in London. Outcome measure: A score of ≥6 on the Geriatric Depression Scale-15 was classed as clinically significant depressive symptoms. Results: In a multivariable logistic regression model, significant depressive symptoms were associated with age (adjusted OR (AOR)=0.82, 95% CI: 0.66 to 0.90, p&lt;0.001), ethnicity (AOR non-white compared with white=1.72, 95% CI: 1.05 to 2.81, p=0.031), total number of eye conditions (AOR for two vs one condition=0.98, 95% CI: 0.67 to 1.43; three or more vs one condition=0.34, 95% CI: 0.15 to 0.75, p=0.026), self-reported health (AOR for excellent vs poor=0.01, 95% CI: 0.00 to 0.12; very good vs poor=0.06, 95% CI: 0.03 to 0.13; good vs poor=0.14, 95% CI: 0.08 to 0.24; fair vs poor=0.28, 95% CI: 0.18 to 0.46, p&lt;0.001) and self-reported visual functioning (AOR=1.45, 95% CI: 1.31 to 1.61, p&lt;0.001). Conclusion: Younger age, a non-white ethnicity, fewer eye conditions and poorer self-reported health and visual function are risk factors for significant depressive symptoms in this population. Trial registration number: ISRCTN46824140; Pre-results

Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK

Background: Explainer animations are a means to communicate aspects of clinical trials to participants in a more engaging and accessible way. Delivered well these have the potential to enhance recruitment and retention. The range of media technology used to deliver this material is expanding rapidly but is highly fragmented. Usage of explainer animations across the UK is unknown, the aim of this research was to determine current usage across the 52 registered UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs) to understand the current landscape and any barriers that could be preventing wider uptake of this functionality. Methods: A survey link was emailed to all UKCRC CTU Directors and Trial Management Leads to ascertain current usage of explainer animations within their CTU. The survey ran between 01 February 2023 and 07 March 2023. Results: Responses were received from 35 CTUs—representing a response rate of 67%. 24 CTUs (69%) reported that they had created/used at least one explainer animation within their unit, although the usage, cost, length and production activities varied among the units. Conclusions: The survey showed that a high proportion of the UKCRC CTUs have used explainer animations to provide information to participants about clinical studies. For those not using the technology yet, the most common reasons cited were a lack of expertise, lack of resources and costs to produce them. One of the desired outcomes of this project is the creation of a free-to-use library of animations to encourage wider uptake and avoid duplication

Depression in Visual Impairment Trial (DEPVIT): A Randomized Clinical Trial of Depression Treatments in People With Low Vision

Purpose: The purpose of this study was to compare two interventions for depression, problem solving treatment (PST) and referral to the patient\u27s physician, with a waiting-list control group in people with sight loss and depressive symptoms. Methods: This was an assessor-masked, exploratory, multicenter, randomized clinical trial, with concurrent economic analysis. Of 1008 consecutive attendees at 14 low-vision rehabilitation centers in Britain, 43% (n = 430) screened positive for depressive symptoms on the Geriatric Depression Scale and 85 of these attendees participated in the trial. Eligible participants were randomized in the ratio 1:1:1 to PST, referral to their physician, or a waiting-list control arm. PST is a manualized talking intervention delivered by a trained therapist who teaches people over six to eight sessions to implement a seven-step method for solving their problems. Referral to the physician involved sending a referral letter to the person\u27s physician, encouraging him or her to consider treatment according to the stepped care protocol recommended by the U.K.\u27s National Institute of Health and Care Excellence. The primary outcome was change in depressive symptoms (6 months after baseline) as determined by the Beck Depression Inventory. Results: At 6 months, Beck Depression Inventory scores reduced by 1.05 (SD 8.85), 2.11 (SD 7.60), and 2.68 (SD 7.93) in the waiting-list control, referral, and PST arms, respectively. The cost per patient of the PST intervention was £1176 in Wales and £1296 in London. Conclusions: Depressive symptoms improved most in the PST group and least in the control group. However, the change was small and the uncertainty of the measurements relatively large

Normalisation process theory and the implementation of a new glaucoma clinical pathway in hospital eye services: perspectives of doctors, nurses and optometrists

Background Normalisation process theory reports the importance of contextual integration in successfully embedding novel interventions, with recent propositions detailing the role that ‘plasticity’ of intervention components and ‘elasticity’ of an intended setting contribute. We report on the introduction of a clinical pathway assessing patient non-responsiveness to treatment for glaucoma and ocular hypertension. The aim of this study was to assess the feasibility of implementing the Cardiff Model of Glaucoma Care into hospital eye services, identifying any issues of acceptability for staff through the filter of normalisation process theory. Methods A prospective observational study was undertaken in four hospital eye services. This incorporated detailed qualitative semi-structured interviews with staff (n = 8) to gather their perceptions on the intervention’s usefulness and practicality. In addition, observational field notes of patient and staff consultations (n = 88) were collected, as well as broader organisational observations from within the research sites (n = 52). Data collection and analysis was informed by the normalisation process theory framework. Results Staff reported the pathway led to beneficial knowledge on managing patient treatment, but the model was sometimes perceived as overly prescriptive. This perception varied significantly based on the composition of clinics in relation to staff experience, staff availability and pre-existing clinical structures. The most commonly recounted barrier came in contextually integrating into sites where wider administrative systems were inflexible to intervention components