'It just wasn't going to be heard': A mixed methods study to compare different ways of involving people with diabetes and health-care professionals in health intervention research.

BACKGROUND: Guidelines recommend involving intervention users in the intervention development process. However, there is limited guidance on how to involve users in a meaningful and effective way. OBJECTIVE: The aim of this Study within a trial was to compare participants' experiences of taking part in one of three types of consensus meetings-people with diabetes-only, combined people with diabetes and health-care professionals (HCPs) or HCP-only meeting. DESIGN: The study used a mixed methods convergent design. Quantitative (questionnaire) and qualitative (observation notes and semi-structured telephone interviews) data were collected to explore participants' experiences. A triangulation protocol was used to compare quantitative and qualitative findings. PARTICIPANTS: People with diabetes (recruited via multiple strategies) were randomly assigned to attend the people with diabetes or combined meeting. HCPs (recruited through professional networks) attended the HCP or combined meeting based on their availability. RESULTS: Sixteen people with diabetes and 15 HCPs attended meetings, of whom 18 participated in a telephone interview. Participants' questionnaire responses suggested similar positive experiences across the three meetings. Observation and semi-structured interviews highlighted differences experienced by participants in the combined meeting relating to: perceived lack of common ground; feeling empowered versus undervalued; needing to feel safe and going off task to fill the void. CONCLUSIONS: The qualitative theme 'needing to feel safe' may explain the dissonance (disagreement) between quantitative and qualitative data. In this study, involving patients and HCPs simultaneously in a consensus process was not found to be as suitable as involving each stakeholder group separately.

What and how do different stakeholders contribute to intervention development? A mixed methods study.

Background: UK Medical Research Council guidelines recommend end-user involvement in intervention development. There is limited evidence on the contributions of different end-users to this process. The aim of this Study Within A Trial (SWAT) was to identify and compare contributions from two groups of end-users - people with diabetes' (PWD) and healthcare professionals' (HCPs), during consensus meetings to inform an intervention to improve retinopathy screening uptake. Methods: A mixed method, explanatory sequential design comprising a survey and three semi-structured consensus meetings was used. PWD were randomly assigned to a diabetes only or combined meeting. HCPs attended a HCP only or combined meeting, based on availability. In the survey, participants rated intervention proposals on acceptability and feasibility. Survey results informed the meeting topic guide. Transcripts were analysed deductively to compare feedback on intervention proposals, suggestions for new content, and contributions to the final intervention. Results: Overall, 13 PWD and 17 HCPs completed the survey, and 16 PWD and 15 HCPs attended meetings. For 31 of the 39 intervention proposals in the survey, there were differences (≥10%) between the proportion of HCPs and PWD who rated proposals as acceptable and/or feasible. End-user groups shared and unique concerns about proposals; both were concerned about informing but not scaring people when communicating risk, while concerns about resources were mostly unique to HCPs and concerns about privacy were mostly unique to PWD.  Fewer suggestions for new intervention content from the combined meeting were integrated into the final intervention as they were not feasible for implementation in general practice. Participants contributed four new behaviour change techniques not present in the original proposals: goal setting (outcome), restructuring the physical environment, material incentive (behaviour) and punishment. Conclusions: Preferences for intervention content may differ across end-user groups, with feedback varying depending on whether end-users are involved simultaneously or separately.

Adoption and Initial Implementation of a National Integrated Care Programme for Diabetes: A Realist Evaluation.

Background: The implementation of models of integrated care for chronic conditions is not well understood. We conducted a realist evaluation to determine how and why the implementation of the National Diabetes Programme in Ireland worked (or not). Methods: Documentary analysis and qualitative interviews with a purposive sample of national stakeholders (n = 19), were used to develop an initial theory on expected programme delivery. We refined this theory using semi-structured interviews (n = 38) with professionals from different clinical disciplines involved in programme implementation. Results: Locally important contexts facilitating implementation included staff experience of delivering diabetes care, capacity, and familiarity with the intended purpose of new clinical posts. The extent to which integrated care was adopted and implemented depended on judgements made by professionals working in these contexts; specifically, judging the relative advantage of the programme and whether to engage in negotiations to legitimize their new roles in diabetes care. Conclusions: Our results highlight the need for adequate preparatory work to raise awareness of and support new roles to implement integrated care, clarification on the core components of new care models, and the development of local service infrastructures to support integrated care.

Barriers and enablers to screening and diagnosing diabetes distress and depression in people with type 2 diabetes mellitus: A qualitative evidence synthesis.

AIM: Synthesise qualitative evidence of healthcare professionals' (HCP) experiences of diabetes distress and depression screening in people with type 2 diabetes (T2DM) in primary care to identify HCP barriers and enablers to screening implementation. METHODS: Searched six electronic databases in October 2020 for qualitative studies exploring HCPs' experiences of diabetes distress and depression screening in T2DM populations. Applying a best-fit framework synthesis, data were coded to the theoretical domains framework (TDF), followed by thematic analysis of data that did not fit the TDF. Study quality and confidence in findings were assessed using CASP and GRADE-CERQual respectively. FINDINGS: Of 4942 unique records identified, 10 articles were included. We identified fifteen barriers and enablers in 8 TDF domains and 1 new domain; people with T2DM factors. One barrier (poor awareness about the rationale for screening) and 2 enablers (perceived impacts on T2DM care, receiving financial reimbursement) were assessed as findings of high confidence. CONCLUSION: HCPs experience many barriers and enablers to diabetes distress and depression screening among people with T2DM in primary care. Future interventions and policies should ensure HCPs understand the rationale for screening, highlight the benefits of screening, resource screening appropriately and address HCP group specific barriers.

Correction to: Development of an intervention to facilitate implementation and uptake of diabetic retinopathy screening.

An amendment to this paper has been published and can be accessed via the original article.

Feasibility of an implementation intervention to increase attendance at diabetic retinopathy screening: protocol for a cluster randomised pilot trial.

BACKGROUND: Diabetic retinopathy screening (DRS) leads to the earlier detection of retinopathy and treatment that can prevent or delay the development of diabetes-related blindness. However, uptake continues to be sub-optimal in many countries, including Ireland. Routine management of type 2 diabetes largely takes place in primary care. As such, there may be an opportunity in primary care to introduce interventions to improve DRS uptake. However, few studies test the feasibility of interventions to enhance DRS uptake in this context. Our aim is to investigate the feasibility of an implementation intervention (IDEAs (Improving Diabetes Eye screening Attendance)) delivered in general practice to improve the uptake of the national DRS programme, RetinaScreen. METHODS: The IDEAs study is a cluster randomised pilot trial with an embedded process evaluation and economic evaluation. Following stratification by practice size, eight general practices (clusters) will be randomly allocated to intervention (n = 4) or wait-list control groups (n = 4). The intervention will be delivered for 6 months, after which, it will be administered to wait-list control practices. The intervention is multi-faceted and comprises provider-level components (training, audit and feedback, health care professional prompt, reimbursement) and patient-level components (GP-endorsed reminder with information leaflet delivered opportunistically face-to-face, and systematically by phone and letter). Patient inclusion criteria are type 1 or type 2 diabetes and DRS programme non-attendance. A multi-method approach will be used to determine screening uptake, evaluate the trial and study procedures and examine the acceptability and feasibility of the intervention from staff and patient perspectives. Quantitative and qualitative data will be collected on intervention uptake and delivery, research processes and outcomes. Data will be collected at the practice, health professional and patient level. A partial economic evaluation will be conducted to estimate the cost of delivering the implementation intervention in general practice. Formal continuation criteria will be used to determine whether IDEAs should progress to a definitive trial. DISCUSSION: Findings will determine whether IDEAsis feasible and acceptable and will be used to refine the intervention and study procedures. A definitive trial will determine whether IDEAs is a cost-effective intervention to improve DRS uptake and reduce diabetes-related blindness. TRIAL REGISTRATION: ClinicalTrials.gov NCT03901898. Registered 3rd April 2019.

Development of an intervention to facilitate implementation and uptake of diabetic retinopathy screening.

BACKGROUND: 'Implementation interventions' refer to methods used to enhance the adoption and implementation of clinical interventions such as diabetic retinopathy screening (DRS). DRS is effective, yet uptake is often suboptimal. Despite most routine management taking place in primary care and the central role of health care professionals (HCP) in referring to DRS, few interventions have been developed for primary care. We aimed to develop a multifaceted intervention targeting both professionals and patients to improve DRS uptake as an example of a systematic development process combining theory, stakeholder involvement, and evidence. METHODS: First, we identified target behaviours through an audit in primary care of screening attendance. Second, we interviewed patients (n = 47) and HCP (n = 30), to identify determinants of uptake using the Theoretical Domains Framework, mapping these to behaviour change techniques (BCTs) to develop intervention content. Thirdly, we conducted semi-structured consensus groups with stakeholders, specifically users of the intervention, i.e. patients (n = 15) and HCPs (n = 16), regarding the feasibility, acceptability, and local relevance of selected BCTs and potential delivery modes. We consulted representatives from the national DRS programme to check intervention 'fit' with existing processes. We applied the APEASE criteria (affordability, practicability, effectiveness, acceptability, side effects, and equity) to select the final intervention components, drawing on findings from the previous steps, and a rapid evidence review of operationalised BCT effectiveness. RESULTS: We identified potentially modifiable target behaviours at the patient (consent, attendance) and professional (registration) level. Patient barriers to consent/attendance included confusion between screening and routine eye checks, and fear of a negative result. Enablers included a recommendation from friends/family or professionals and recognising screening importance. Professional barriers to registration included the time to register patients and a lack of readily available information on uptake in their local area/practice. Most operationalised BCTs were acceptable to patients and HCPs while the response to feasibility varied. After considering APEASE, the core intervention, incorporating a range of BCTs, involved audit/feedback, electronic prompts targeting professionals, HCP-endorsed reminders (face-to-face, by phone and letter), and an information leaflet for patients. CONCLUSIONS: Using the example of an intervention to improve DRS uptake, this study illustrates an approach to integrate theory with user involvement. This process highlighted tensions between theory-informed and stakeholder suggestions, and the need to apply the Theoretical Domains Framework (TDF)/BCT structure flexibly. The final intervention draws on the trusted professional-patient relationship, leveraging existing services to enhance implementation of the DRS programme. Intervention feasibility in primary care will be evaluated in a randomised cluster pilot trial.

'I've always done what I was told by the medical people': a qualitative study of the reasons why older adults attend multifactorial falls risk assessments mapped to the Theoretical Domains Framework.

OBJECTIVES: Multifactorial falls risk assessments reduce the rate of falls in older people and are recommended by international guidelines. Despite their effectiveness, their potential impact is often constrained by barriers to implementation. Attendance is an issue. The aim of this study was to explore why older people attend community-based multifactorial falls risk assessment clinics, and to map these reasons to a theoretical framework. DESIGN: This is a qualitative study. Semi-structured interviews were conducted and analysed thematically. Each theme and subtheme were then mapped onto the Theoretical Domains Framework (TDF) to identify the determinants of behaviour. PARTICIPANTS: Older adults (aged 60 and over) who attended community-based multifactorial falls risk assessments. RESULTS: Sixteen interviews were conducted. Three main themes explained participants' reasons for attending the multifactorial risk assessment; being that 'type of person', being 'linked in' with health and community services and having 'strong social support'. Six other themes were identified, but these themes were not as prominent during interviews. These were knowing what to expect, being physically able, having confidence in and being positive towards health services, imagining the benefits given previous positive experiences, determination to maintain or regain independence, and being 'crippled' by the fear of falling. These themes mapped on to nine TDF domains: 'knowledge', 'skills', 'social role and identity', 'optimism', 'beliefs about consequences', 'goals', 'environmental context and resources', 'social influences' and 'emotion'. There were five TDF domains that were not relevant to the reasons for attending. CONCLUSIONS: These findings provide theoretically based factors that influence attendance which can be used to inform the development of interventions to improve attendance to falls prevention programmes.

Understanding the uptake of a national retinopathy screening programme: An audit of patients with diabetes in two large primary care centres.

Background: Diabetic retinopathy (DR) affects 8.2% of the Irish population with type 2 diabetes over 50 years and is one of the leading causes of blindness among working-age adults. Regular diabetic retinopathy screening (DRS) can reduce the risk of sight loss. In 2013, the new national screening programme (RetinaScreen) was introduced in Ireland. Maximising DRS uptake (consent to participate in the programme and attendance once invited) is a priority, therefore it is important to identify characteristics which determine DRS uptake among those with diabetes in Ireland. We report uptake in an Irish primary care population during the initial phase of implementation of RetinaScreen and investigate factors which predict consenting to participate in the programme. Methods:  In two primary care practices, data were extracted from records of people with diabetes (type 1 and type 2) aged ≥18 years who were eligible to participate in RetinaScreen between November 2013 and August 2015. Records were checked for a RetinaScreen letter. RetinaScreen were contacted to establish the status of those without a letter on file. Multivariable Poisson regression was used to examine associations between socio-demographic variables and consenting. Adjusted incident rate ratios (IRR) with 95% CI were generated as a measure of association. Results: Of 722 people with diabetes, one fifth (n=141) were not registered with RetinaScreen. Of 582 who were registered, 63% (n=365) had participated in screening. Most people who consented subsequently attended (n=365/382, 96%). People who had attended another retinopathy screening service were less likely to consent (IRR 0.65 [95%CI 0.5-0.8]; p<0.001). Other predictors were not significantly associated with consent. Conclusions: Over one third of people eligible to participate in RetinaScreen had not consented. Research is needed to understand barriers and enablers of DRS uptake in the Irish context. Implementing strategies to improve DRS uptake (consent and attendance) should be a priority.

Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience.

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including 'acknowledgement of individual contribution', 'contributing for a collective benefit' and 'receiving accessible and easy to understand results'. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group.  There were no differences in patient understanding between the two methods.  Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients' final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.

Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study.

BACKGROUND: In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a 'gold standard', validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists' readiness and ability to perform RBM. The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland. METHODS: This is a mixed-methods, explanatory sequential design, with quantitative survey followed by semistructured interviews. Academic clinical researchers (N = 132) working in Ireland were surveyed to examine their use and perceptions of RBM. A purposive sample of survey participants (n = 22) were then interviewed to gain greater insight into the quantitative findings. The survey and interview data were merged to generate a list of perceived barriers and facilitators to RBM implementation, with suggestions for, and solutions to, these issues. RESULTS: Survey response rate was 49% (132/273). Thirteen percent (n = 18) of responders were not familiar with the term risk-based monitoring and less than a quarter of respondents (21%, n = 28) had performed RBM in a clinical trial. Barriers to RBM implementation included lack of RBM knowledge/training, increased costs caused by greater IT demands, increased workload for trial staff and lack of evidence to support RBM as an effective monitoring approach. Facilitators included participants' legal obligation to perform RBM under the new ICH-GCP guidelines, availability of RBM guidance and perception of cost savings by performing RBM in future trials. CONCLUSION: The results of this study demonstrate a need for training and regulatory-endorsed guidelines to support the implementation of RBM in academic-led clinical trials. The study provides valuable insights to inform interventions and strategies by policy-makers and clinical trial regulators to improve RBM uptake.

Study within a trial (SWAT) protocol. Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience.

INTRODUCTION: Dissemination of results of randomised controlled trials is traditionally limited to academic and professional groups rather than clinical trial participants. While there is increasing consensus that results should be communicated to trial participants, there is a lack of evidence on the most appropriate methods of dissemination. This study within a trial (SWAT) aims to address this gap by using a public and patient involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving trial results of the Thyroid Hormone Replacement for Subclinical Hypothyroidism Trial (TRUST). METHODS: An experimental (intervention) study will be conducted using mixed methods to inform the development of and evaluation of a patient-preferred method of communication of trial results. The study will involve three consecutive phases. In the first phase, focus groups of trial participants will be conducted to identify a patient-preferred method of receiving trial results. The method will be developed and then assessed and refined by a patient and public expert group. In the second phase participants will be randomly assigned to the intervention (patient-preferred method) and comparison groups (standard dissemination method as developed by the lead study site in Glasgow, Scotland). In the third phase, a quantitative questionnaire will be used to measure and compare patient understanding of trial results between the two groups. DISCUSSION: This protocol provides a template for other trialists who wish to enhance patient and public involvement and additionally, will provide empirical evidence on how trialists should best disseminate study results to their participants.