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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.

Background ‘Integrated care’ for chronic conditions is considered central to international health system reform. However, models of integrated care work differently in different circumstances. In Ireland, the National Diabetes Programme aimed to integrate diabetes care across primary, secondary and tertiary settings based on patient complexity through the introduction of new clinical posts and guidance for diabetes care. We conducted a realist evaluation to determine how and why the implementation of the programme worked (or not) across the country. Methods Through documentary analysis and qualitative interviews (n=19) with a purposive sample of national stakeholders, we developed an initial theory on how the programme was expected to work. We then refined this theory in semi-structured interviews (n=39) with professionals purposively sampled to represent different clinical disciplines involved in implementation. We applied a realist logic of analysis and synthesis to iteratively build CMO configurations. Results National stakeholders assumed that: 1) introducing guidance would formalise and standardise how care was provided, 2) that professionals would ‘buy in’ and align their work with new ways of working, and 3) that the new clinical posts would become catalysts for service changes at local level. At a national level, important contexts included varying levels of awareness about the programme, no plan for communicating service changes, and no established approach to implementation or professional oversight. Locally, experience delivering diabetes care, resource demands and familiarity with the intended purpose of the new clinical posts were important contextual factors. The extent to which integrated care was adopted and implemented depended on judgements made by health professionals (GPs, nurses, specialists and podiatrists) working in these contexts, specifically; judging the relative advantage of the programme and whether to engage in negotiations to legitimize their roles in diabetes care. Conclusion Theory-based evaluations are better equipped to deal with the complexity of introducing multi-component interventions into dynamic health systems. This study suggests that, given a disconnect between responsibility for programme design and implementation, in the absence of systematic communication about the nature of changes and lack of clarity around governance and reporting structures, professionals used their judgment to adopt, implement and adapt interventions to match their priorities and circumstances.

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

ObjectivesMultifactorial 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.DesignThis 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.ParticipantsOlder adults (aged 60 and over) who attended community-based multifactorial falls risk assessments.ResultsSixteen 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.ConclusionsThese 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.

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.

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.

Background Intervention development is a critical first step when conducting trials or observational studies. Research suggests that involving multiple stakeholders in this process increases the likelihood of developing interventions that are acceptable, engaging, feasible and effective. However, there is little guidance for researchers on the best ways to involve multiple stakeholders in a meaningful way. The aim of this Study Within A Trial (SWAT) is to identify the most suitable approach to involve patients and healthcare professionals in a consensus process to inform the development of the Improve Diabetes Eye-screening Attendance (IDEA’s) intervention. Methods This is a qualitative study. Three meetings were held to establish consensus on the content and delivery of the intervention. Meeting included 1 patients only, meeting 2 included a combination of patients and healthcare professionals and meeting 3 included healthcare professionals only. Stakeholders were asked to agree on intervention components which target patients and general practices. Each meeting was audio recorded and field notes were taken. After the meeting, semi-structured telephone interviews were carried to explore stakeholders’ experiences of taking part. Data were transcribed verbatim and managed using NVivo V12 software. Thematic analysis was performed to identify themes relating to members’ experiences of taking part. Results All three meetings put forward feasible ideas which were incorporated into the final intervention. Each meeting had ideas which were not put forward by the other groups but were incorporated into the final intervention (Meeting 1=6 ideas, Meeting 2=2 ideas and Meeting 3=5 ideas). Thematic analysis suggests that stakeholders in meetings 1 and 3 felt comfortable expressing their opinions and grateful that they were given the opportunity to be heard. Stakeholders in meeting 2 felt they had to hold back on their opinions as they were aware that the other stakeholder group was in the room. They also felt that their contributions were undervalued by the other stakeholder group. Conclusion Involving patients and healthcare professionals together in a consensus process is not a suitable approach to involvement. This study will guide researchers on the most suitable approach to involve patients and healthcare professionals in a consensus process and will contribute to the evolving literature on the potential impact of involving multiple stakeholders in the intervention development process.

Background Diabetic retinopathy is a common complication of diabetes affecting the blood vessels at the back of the eye. Despite evidence that diabetic retinopathy screening (DRS) is effective, uptake continues to be sub-optimal in many countries, including Ireland. As routine management of type 2 diabetes largely takes place in primary care, it is arguably the best setting in which to implement interventions to improve DRS uptake. This study aims to develop a theory-based implementation intervention to improve uptake. Methods A four-stage systematic development process was undertaken. Target behaviours were identified through a multi-phase sequential mixed methods study involving key stakeholder interviews (n=19), and an audit of screening attendance in two primary care centres. Barriers and enablers to uptake were identified through coding interviews with patients (n=48) and health care professionals (HCP) (n=30) using the Theoretical Domains Framework (TDF). Barriers and enablers were mapped to behaviour change techniques (BCTs) to develop intervention content. The APEASE (affordability, practicability, effectiveness, acceptability, side effects and equity) criteria was used to select the components. Effectiveness was determined through a rapid evidence review. Feasibility, local relevance and acceptability of the intervention were identified through consensus group meetings with patients (n=15) and HCPs (n=16), and key stakeholder consultation, including the national DRS programme. Results Three key behaviours were identified; one HCP-level (registration of patients for screening), and two patient-level (consent for the programme to hold their details, and attendance). Modifiable patient barriers and enablers were associated with six TDF domains. Barriers included confusion between screening and routine eye checks (‘Knowledge’), forgetting (‘Memory, attention, decision processes’), anticipation of a negative result (‘Beliefs about consequences’). Enablers included a recommendation from friends/family or HCPs (‘Social Influences’), recognising the importance of screening for early detection (‘Beliefs about consequences’), ownership over their condition (‘Identity’), and being in a routine of attending tests (‘Beliefs about capabilities’). HCP barriers included the time to register patients which was impeded or supported by practice resources (‘Environmental context and resources’), and a lack information on screening uptake in their local area (‘Knowledge’). Following the consensus meetings, consultation and evidence review, ten BCTs were included and operationalised as an implementation intervention targeting professionals (reimbursement, training, audit/feedback and electronic prompt) and patients (face-to-face/phone reminder messages, GP-endorsed reminder letter and information leaflet). Conclusion A multi-stage process combining theory, consultation of multiple stakeholders and existing evidence, was used to develop a multifaceted implementation intervention, targeting both professional and patients, to increase uptake of DRS. The feasibility of delivering the intervention in primary care will be evaluated through a pilot trial.

Background Falls are one of the most serious and common threats facing older adults. Multifactorial falls risk assessment can reduce the rate of falls among community dwelling older adults and is recommended as a first step in the early detection and management of risk factors. It is used as a gateway for older people to access evidence-based interventions targeting their individual risk factors. However, effective interventions will only reduce the rate and risk of falls if there is a high level of uptake in the population and suboptimal uptake is a common challenge. The aim of this study is to understand the reasons for the patterns of uptake of multifactorial fall risk assessment clinics in the community. Methods A convergent mixed methods study design was used. Data on attendance/non-attendance during the first 12 months at each clinic (n=4) were extracted from a centralised administrative database. Semi-structured interviews (n-16) were conducted with a purposive sample of people who attended a clinic (criteria: male/female, age: 55–69, 70–79, 80+, and clinic), selected from those who had opted in during a preceding service-user experience survey. Administrative data were analysed descriptively using STATA (v13) software. Thematic analysis was performed and themes were mapped onto the Theoretical Domains Framework (TDF). Data were merged during analysis and interpretation using qualitative themes to expand on the patterns emerging in the quantitative data. Results Of the 588 older adults invited, 484 attended the assessment which resulted in an uptake rate of 82.3% (range: 77.5–86.1). Reasons for attending were summarised into themes which mapped onto 10 theoretical domains. Key themes identified were always attending medical appointments and adhering to medical advice (social/professional role and identity), having a positive attitude towards health services (optimism), being linked in with health professionals and community services (environmental context and resources) and having strong social support from family and friends (social influences). Other themes included understanding what the clinic was about (knowledge), having a fear of falling (emotion), supposing the benefits of attending (beliefs about consequences) and wanting to prevent further falls (goals). Conclusion The results suggest older people attend fall prevention services if they have existing (positive) links to health services and are well supported in their homes and communities. To improve the spread of fall prevention programmes, there is a need to reach older adults who are less well supported.

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 to achieve consensus, 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 dissemination method as developed by lead study site in Glasgow, Scotland). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two dissemination methods. Results Patients want to receive results of clinical trials, with qualitative findings of perspectives and preferences 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 by researchers, trial participants and adult literacy experts. One hundred and one TRUST participants were then randomised to receive the patient-preferred result method or the standard dissemination method. 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 dissemination methods. Conclusion Patient and Public Involvement (PPI) is advocated for every step of the trial process. We have demonstrated that it is feasible to do this 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.

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 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.

Background Implementation strategies are needed to ensure that evidence-based healthcare interventions are adopted successfully. However, strategies are generally poorly described and those used in everyday practice are seldom reported formally or fully understood. Characterising the active ingredients of existing strategies is necessary to test and refine implementation. We examined whether an implementation strategy, delivered across multiple settings targeting different stakeholders to support a fall prevention programme, could be characterised using the Behaviour Change Technique (BCT) Taxonomy. Methods Data sources included project plans, promotional material, interviews with a purposive sample of stakeholders involved in the strategy’s design and delivery and observations of staff training and information meetings. Data were analysed using TIDieR to describe the strategy and determine the levels at which it operated (organisational, professional, patient). The BCT Taxonomy identified BCTs which were mapped to intervention functions. Data were coded by three researchers and finalised through consensus. Results We analysed 22 documents, 6 interviews and 4 observation sessions. Overall, 21 out a possible 93 BCTs were identified across the three levels. At an organisational level, identifiable techniques tended to be broadly defined; the most common BCT was restructuring the social environment. While some activities were intended to encourage implementation, they did not have an immediate behavioural target and could not be coded using BCTs. The largest number and variety of BCTs were used at the professional level to target the multidisciplinary teams delivering the programme and professionals referring to the programme. The main BCTs targeting the multidisciplinary team were instruction on how to perform the (assessment) behaviour and demonstration of (assessment) behaviour; the main BCT targeting referrers was adding objects to the environment. At the patient level, few BCTs were used to target attendance. Conclusion In this study, several behaviour change techniques were evident at the individual professional level; however, fewer techniques were identifiable at an organisational level. The BCT Taxonomy was useful for describing components of a multilevel implementation strategy that specifically target behaviour change. To fully and completely describe an implementation strategy, including components that involve organisational or systems level change, other frameworks may be needed. Electronic supplementary material The online version of this article (10.1186/s13012-018-0798-6) contains supplementary material, which is available to authorized users.

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.

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. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2148-4) contains supplementary material, which is available to authorized users.

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. Keywords: Public and patient involvement, PPI, Study within a trial, SWAT, Clinical trial result dissemination, End of trial results, Trial results