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Background Screening for depression and diabetes distress in people with type 2 diabetes (T2DM) in primary care is increasingly recommended but implementation in practice is suboptimal. As health care professionals influence detection practices, their perceptions and experiences of screening recommendations can improve understanding of aspects that work, and those which are difficult to implement. We aim to synthesise the available qualitative evidence on healthcare professionals’ perceived barriers and enablers to recognising possible depression and diabetes distress in people with T2DM using validated screening tools compared to clinical questioning or no screening. Methods Primary qualitative and mixed method studies were identified using systematic database searching of six databases and supplementary searching. We selected ‘best-fit framework synthesis’ to synthesise primary data using the RETREAT (Review question-Epistemology-Time/Timescale-Resources-Expertise-Audience and purpose-Type of Data) framework. We selected the theoretical domains framework (TDF) as the a priori best fit framework as the TDF is derived from existing behaviour change theories. Quality appraisal of primary studies and confidence in the overall review findings will be determined using the CASP (Critical-Appraisal-Skills-Programme) and the GRADE-CERQual (Grading-of-Recommendations-Assessment-Development-and-Evaluation-Confidence-in-the-Evidence-from-Reviews-of-Qualitative-research) respectively. The study is registered on the international Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42019145483). Results Ten primary qualitative studies were identified from five countries; England (n=4), China (n=1), the Netherlands (n=3), Australia (n=1), Canada (n=1). No studies on detection of diabetes-distress were identified. Data extraction and analysis is ongoing. Tentative findings indicate that primary care health professionals experience barriers and enablers to detection unique in T2DM populations; symptom overlap, perceptions of role and responsibilities, the perceived value of screening in the T2DM population, and integrating screening protocols into T2DM review visits. Additional barriers to depression screening in the T2DM population; mental health stigma, patient-clinician relationship, were pertinent to depression screening in primary care populations more generally. Discussion Findings may (1) improve understanding of how depression can be more appropriately identified in people with T2DM in primary care settings from a health care professional perspective, (2) inform the design of future depression screening interventions or (3) inform depression screening recommendations for people with T2DM. The application of recommended qualitative evidence synthesis approaches i.e. RETREAT, GRADE-CERQual, enhances the overall robustness of the study. The protocol is available at https://hrbopenresearch.org/articles/2-26/v2.

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.

Background Evidence-based healthcare innovations require complementary evidence-based implementation strategies to support their translation into practice. Efforts to test, refine and replicate implementation strategies are frustrated by insufficient description. Our aim was to examine the extent to which implementation strategies could be specified using the Behaviour Change Technique (BCT) taxonomy, a behavioural science tool for describing the active ingredients of interventions. Methods The data source was a compilation of 73 implementation strategies, developed through evidence synthesis and expert consensus. The definition of each strategy (n=73) was deductively coded using the BCT Taxonomy, containing 93 discrete techniques. A typology was developed iteratively to categorise the extent of overlap between strategies and BCTs. The number of BCTs per strategy and extent of overlap was estimated. In the next stage, 3 experts will independently rate 1) their level of agreement with the categorisation and 2) level of agreement with the BCT(S) identified within each strategy. Results During preliminary analysis, 87 BCTs were coded across 73 strategies (average 1.2 per strategy). Five types of overlap were identified. For 8% of strategies (n=6), there was direct overlap between the strategy description and BCT (e.g. strategy: remind clinicians/BCT: prompts and cues). For 36% of strategies (n=26), there was at least 1 BCT clearly subsumed under the strategy description which could be used to guide initial operationalisation (e.g. strategy: provide clinical supervision/BCT: restructure social environment). For 26% of strategies (n=19), a BCT(s) was probably subsumed under the strategy given its definition and/or title but other BCTs were possible depending on how the strategy is operationalised (e.g. strategy: visit other implementation sites/BCT: social comparison). For 11% (n=8), there were no BCTs clearly indicated in the strategy definition or title (e.g. strategy: make training dynamic). Finally, 19% of strategies (n=14) did not focus on behaviour change to support implementation (e.g. strategy: access new funding). Conclusion Many implementation strategies require further specification in order to apply them in a setting, relying on assumptions and inference on the part of the intervention developer, be it researcher or practitioner. This creates an opportunity for inconsistent application and limits the potential for replication and synthesis of evidence of effectiveness. This study is the first step towards moving from general descriptions of implementation strategies to full descriptions of their active ingredients. This is essential to understand how strategies at an organisational and professional level can lead to observable changes in individual behaviour.

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 Medication costs are the primary driver of increasing medical expenditure on diabetes. We explore trends in pharmaceutical expenditure on diabetes between 2011 and 2015, examining the impact of newer blood glucose-lowering medications, and estimating the effect of cost-containment measures implemented during this time. Methods Data from a national pharmacy claims database were analysed. Patients dispensed items used in the treatment or management of diabetes were identified. Total expenditure associated with diabetes was calculated by extracting data on all diabetes-related items dispensed to eligible patients. Costs were categorised into two groups; diabetes-specific items include items used directly in the treatment of diabetes and other items include all other condition-related. The impact of two specific cost-containment measures, co-payments and reference pricing, implemented over the study period were assessed using segmented linear regression analyses of interrupted time series. Results Total expenditure varied over the study period, peaking at €216,994,441 in 2012. Expenditure on diabetes-specific items increased steadily by 18% reaching €153,621,477 in 2015, with blood glucose-lowering medications accounting for 73% of this increase. During the same period, expenditure on other items decreased by 32% to €50,835,856. The introduction of reference pricing for atorvastatin in November 2013 resulted in immediate costs savings of €2.4 million per yearly quarter (level change p Conclusion The increasing costs of blood glucose-lowering medications overshadows the effect of cost-containment measures. Innovative policies are required to ensure high quality diabetes care can be provided at an equitable, affordable and sustainable rate.

Background The optimal organisation of emergency and urgent care services (EUCS) is a perennial problem internationally. Similar to other countries, the Health Service Executive in Ireland pursued EUCS reconfiguration in response to quality and safety concerns, unsustainable costs and workforce issues. However, the implementation of reconfiguration has been inconsistent at a regional level. Our aim was to identify the factors that led to this inconsistency. Methods Using a multiple case study design, case study regions were selected based on the extent of emergency department reconfiguration in the region (categorised as full, partial and little/no reconfiguration). Semi-structured interviews were conducted with a purposive sample of stakeholders who were centrally involved in the reconfiguration process in each region. Interview data were supplemented with documentary analysis of proposals for EUCS in each region. Data were analysed using a framework approach, drawing on an existing conceptual framework for major system change. Cross-case analysis was conducted iteratively to identify patterns and differences across the regions. Results Six regions were selected for analysis and 42 interviews were analysed. The impetus to reconfigure ED services was triggered by patient safety events, and to a lesser extent by having a region-specific plan and an obvious starting point for changes. However, the complexity of the next steps and political influence impeded reconfiguration in several regions. Implementation was more strategic in regions that reconfigured later, facilitated by clinical leadership and ‘lead-in time’ to plan and sell changes. Conclusion While the global shift towards centralisation of EUCS is driven by universal challenges, decisions about when, where and how much to implement are influenced by local drivers including context, people and politics. This can contribute to a public perception of inequity and distrust in proposals for major systems change.

Background Valid and reliable estimates for the incremental costs attributable to diabetes at country-level are required to provide more precise estimates of the global cost of diabetes and to encourage and inform national responses to the diabetes epidemic. The most recent estimates for Ireland come from the CODEIRE study which uses data from the years 1999/2000 and employs a sum-all medical approach for a hospital-based sample of people with diabetes. Indirect costs are not estimated We estimate the total costs, direct and indirect, attributable to diabetes in older Irish adults. Methods Adopting a societal perspective and using a prevalence-based approach, we estimate the direct costs (healthcare utilisation and medications) and indirect costs (participation in the labour force and premature mortality) attributable to diabetes in 2013. A human capital approach was used to estimate indirect costs. Where possible, incremental costing methodology was employed. Data sources include a nationally representative cohort study, a national pharmacy claims database and national vital statistics. Results The estimated total cost of diabetes was €536,668,060 (95% CI: 360,172,044–751,720,140); €238,155,072 (95% CI: 192,023,954–278,959,992) in direct costs and €298,512,988 (95% CI: 168,148,090–472,760,148) in indirect costs. People with diabetes were 41% less likely to be employed than those without diabetes (p Conclusion We establish the societal costs attributable to diabetes in older adults in Ireland and therefore identify costs that can be directly targeted by prevention and treatment strategies. Primary, secondary and tertiary prevention of diabetes can result in significant cost savings, not only in terms of direct healthcare costs but also indirect costs.

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 Obesity during pregnancy is associated with a number of complications including gestational diabetes mellitus (GDM). Currently, little is known about guidelines in clinical practice and the challenges faced by heath care professionals (HCPs). The aim of this study was to understand the perceptions, approach and challenges faced by midwives, obstetricians and general practitioners who provide antenatal care to women who are overweight and obese during pregnancy with the view to informing the development of an antenatal lifestyle intervention. Methods Semi-structured interviews were conducted with a purposive sample of health care professionals (HCPs) from Cork University Maternity Hospital (CUMH) (n=10) and with a sample of General Practitioners (GPs) working in primary care in the region (n=7). Data was collected until data saturation occurred. Interviews were digitally recorded and transcribed into NVivo V.10 software. Thematic analysis is on-going. Results Preliminary results identified ‘knowledge of weight management’ and ‘antenatal services’ as key issues. A lack of knowledge was evident involving risks, complications and initiating a conversation around overweight and obesity in pregnancy. Variation exists around what is considered appropriate weight gain and whether HCPs were following any particular guidelines. HCPs expressed concern about the dramatic increase in the number of pregnant women who are overweight and obese and how weight perception has changed in society. Large ‘caseloads’ meant that lifestyle factors were not routinely discussed with the women and furthermore, a lack of communication is very evident between HCPs in the hospital and GPs in terms of the services provided. Conclusion HCPs expressed challenges when communicating with their patients about weight management in pregnancy. By ensuring midwives and other HCPs have the knowledge, skills and opportunity to discuss weight and lifestyle factors with pregnant women, the women, in turn, may be more motivated to maintain healthy behaviour’s during pregnancy.

Background Regular Physical Activity (PA) during pregnancy is associated with a number of health benefits such as preventing pregnancy complications, limiting pregnancy weight gain, and decreasing the risk of gestational diabetes. Despite this, women’s PA levels often reduce or cease during pregnancy. Various factors like body mass index, unemployment, and educational levels have been shown to be associated with PA levels during pregnancy. Using the Screening for Pregnancy Endpoint (SCOPE) data, this study aimed to examine the association of health behaviours and psychological well-being on PA levels in pregnancy using the biopsychosocial model. Methods Nulliparous women with a singleton pregnancy were recruited from a large academic maternity hospital in Cork, Ireland (CUMH) as part of the international SCOPE study. Data was collected at 15±1 week’s gestation including personal information, lifestyle and psychological measures. The outcome of interest was PA categorised as low, moderate or high levels and covariates were selected using the biopsychosocial model including social (age; years of schooling; socioeconomic status), biological (body mass index), behavioural (diet; smoking) and psychological factors (anxiety; response to pregnancy). Univariate and multivariable multinomial logistic regression examined the association between covariates and PA using Stata IC13. Results 1774 pregnant women were recruited to SCOPE and women were classified as having low (22.3%), moderate (54.4%) or high (23.4%) PA levels (n=1766). In the fully adjusted model, preliminary findings indicate that age categories 30–34 years (OR 2.34 [95% CI: 1.26–4.37]),≥35 years (OR 2.06 [95% CI: 1.01–4.19]) compared to those Conclusion Social and behavioural factors appear to be the most influential factors driving PA levels. The results should be used to guide the development of educational campaigns and behaviour change intervention to encourage younger women to be active and to target those with lower education attainment and of lower socioeconomic status.

Background In Ireland, more Diabetes Nurse Specialists (DNSs) have been introduced into the community as part of a national programme to standardise and improve diabetes care. DNSs support the delivery of a new model of care whereby uncomplicated type 2 diabetes (T2DM) is managed in primary care, and complicated T2DM is managed between primary and secondary care. Historically diabetes care in Ireland has often been delivered in an unstructured way, lacking integration between primary and secondary care. Given this context we wanted to understand the challenges faced by community-based DNSs in delivering a standardised service. Methods We purposively sampled DNSs from community-based respondents to a national survey (n=25) according to four administrative regions of the national health service. We conducted focus groups and interviews using a semi-structured topic guide. Interviews were digitally recorded and transcribed into NVivo V.11 software for coding and analysis. Data analysis is on-going using thematic analysis. Results Sixteen DNSs participated in 2 focus groups, and 8 interviews. Preliminary analysis suggested elements of the role presented a challenge. As DNSs require their Collaborative Practice Agreement to be signed off by each GP using their service, they were currently unable to prescribe in the community. Despite describing this as ‘frustrating’, DNSs suggested that prescribing could remove opportunities for relationship-building with GPs through discussion of medications. In the community, DNSs lacked the safety net of the hospital team to check things with, and had to work more autonomously, described as ‘daunting’. Role understanding by other staff was another challenge; DNSs felt managers did not understand how the community role should work, which created difficulty when negotiating aspects of the role, including flexible working hours. The lack of a shared record between settings meant patient information from hospital appointments was not readily accessible by DNSs at GP practices and vice versa. This made patient follow-up and case discussion difficult when DNSs were off-site. The absence of administrative support in the role, considered ‘crucial’, was also highlighted. Further interviews with community DNSs are ongoing. Conclusion Community-based DNSs faced challenges presented by aspects of their role, their relationship with other staff, their work environment, and the available organisational infrastructure and resources. Although recent policy reforms in Ireland have focused on improving the integrated management of diabetes in the community, findings from this study suggest DNSs may need to be better supported to ensure delivery of a standardised model of diabetes care.

Background Limited data exists, internationally and in Ireland, on long-term outcomes among people with diabetes who are managed in primary care. The Midlands Diabetes Structured Care Programme encompasses evidence-based strategies to structure diabetes management within general practice: patient registration and recall, regular diabetes review visits, active role of the practice nurse in ongoing management, multidisciplinary specialist access, professional education, and remuneration. Our aim was to examine clinical outcome targets, complications and mortality among patients with diabetes enrolled in the programme since its establishment in 1998. Methods Data were collected in 1999, 2003, 2008 and 2015, on outcomes (clinical parameters, complications and mortality) among patients with diabetes (≥18 years) registered with participating practices. Data were extracted from patient notes by clinical nurse specialists using a paper-based data collection form. Cause and date of death were obtained from national death records. Using Stata, chi-square tests were used to test differences in clinical outcomes over time. Cox proportional hazards regression was used to examine the association of baseline factors and mortality. Results Patients from 1999 (n=376), were followed up in 2003 (n=229), 2008 (n=96) and 2016 (n=376).The proportion of patients with a recommended blood pressure target ( Discussion Improvements in the clinical profile of patients enrolled in the programme since its introduction suggests primary-care-led integrated diabetes management can perform favourably in the long-term. However, the high incidence of macrovascular complications, prevalence of retinopathy and mortality rate indicates the importance of effective management.