Background People experiencing homelessness (PEH) are disproportionately affected by frailty, yet few interventions have targeted this syndrome in this population. Aim To assess the feasibility, and potential impact of a combined exercise and nutritional intervention for PEH living with, or at risk of, frailty. Design & setting A single-arm feasibility trial in a GP clinic for PEH in the Republic of Ireland. Method A two-month exercise and nutritional intervention tailored for PEH was offered to potential participants. Individuals with, or at risk of, frailty attending a GP clinic for PEH in the Republic of Ireland were invited to participate. The primary outcome was feasibility, which was assessed using Bowen’s framework. Secondary outcomes were based on potential impact and included frailty scores (Clinical Frailty Scale [CFS] and Survey of Health, Ageing and Retirement in Europe-Frailty Instrument [SHARE-FI]) and weight. A process evaluation explored participant experience. Results Of 124 eligible individuals, 108 (87.1%) enrolled, and 75 (69.4%) completed follow-up. Among those followed up, 70 (93.3%) engaged with at least one component of the intervention, with the majority finding the intervention easy to follow. CFS and SHARE-FI scores improved following the intervention in those followed-up. Conclusion This study supports the feasibility of a primary care-based exercise and nutritional intervention for PEH living with frailty. The intervention appeared to be safe and to improve the frailty status of participants. It can also be used to inform the design of a definitive trial.
BACKGROUND AND OBJECTIVES:Multimorbidity, the coexistence of two or more chronic conditions, affects about 40% of all adults and over half of adults over 60 years. The complexity of multimorbidity (MM) often renders traditional trial designs inadequate, unable to account for the context of interventions, including the interplay of multiple health conditions in daily life. This gap reduces the generalizability and applicability of their results. METHODS:This commentary aims to review the current state of trials targeting or involving patients with MM. Highlighting current limitations and drawing on insights from an international dedicated workshop in Bielefeld, Germany, we identify an ongoing and pressing need for innovative, patient-centered approaches to their design and conduct. RESULTS:We propose a shift toward more holistic and integrative experimental approaches, including developing interventions tailored to the characteristics and needs of patients with MM, establishing relevant outcomes, and enhancing data collection and process evaluation. We specifically advocate for adaptive trial designs, prespecified subgroup analyses, and the incorporation of patient-reported outcomes and experience measures such as burden of care to ensure that research is both comprehensive and reflective of the needs of patients living with MM, their caregivers, and of the clinicians participating in their care. Ethical considerations are discussed in our commentary as well, emphasizing the importance of patient safety, data protection, and informed consent. Finally, we call for the development of specific reporting guidance, such as a SPIRIT extension tailored to MM trials, to help researchers adapt standard protocols to the complex and heterogeneous reality of this population. CONCLUSION:This commentary aims to bridge the gap between research and practice, fostering the development of effective interventions that improve patient outcomes and enhance the quality of care for patients living with MM.
Background Despite the overall decline in smoking prevalence, socioeconomic disparities in smoking quit rates are widening. Financial incentives such as cash or cash-like rewards provided conditional on performance of healthy behaviours, are effective tools to enhance smoking cessation, yet are complex and often designed without community input or theoretical rationale. Hence, we aimed to co-design a theoretically driven and contextually-relevant financial incentive scheme for implementation, with key stakeholder groups including community members and health professionals, in Irish primary care and community services. Methods A mixed-methods approach was utilised with a modified Nominal Group Technique, underpinned by Adams et al.’s (2014) 9-domain incentive framework, over three one-day workshops (n = 59 participants) to elicit ideas and achieve consensus on incentive design. Descriptive statistics were used to identify the highly-ranked ideas, while reflexive thematic analysis was employed to examine the decision-making process focusing on key considerations across various domains of the proposed incentive scheme. Results The incentive design was as follows: 1) Total amount: €400 (Median, IQR: €200–500); 2) Form: voucher; 3) Certainty: definite reward; 4) Target population: adults living in deprived areas who smoke and are in receipt of free primary care services; 5) Target behaviour: validated smoking cessation and clinic attendance; 6,7) Schedule and Frequency: incrementally increasing amount aligned with current services review timepoints; 8) Immediacy: as soon as possible within a week; 9) Provider: smoking cessation advisors. Participants’ key considerations in reaching consensus on each incentive domain were represented by five themes including: acceptability, potential of gaming, operational and administrative demands, fit with existing services workflows, maintaining organisational image, and public scrutiny. Conclusion This is the first study to co-design a stakeholder-informed, and theory-aligned incentive-based scheme to support smoking cessation for people living in deprived areas. A pilot is now underway to test real-life implementation feasibility on smoking cessation outcomes.
Introduction Multiple long-term conditions (MLTCs), defined as the co-existence of two or more chronic health conditions, are increasingly prevalent across all age groups and disproportionately affect socioeconomically disadvantaged and ethnic minority populations. Trials targeting MLTCs face methodological challenges due to patient heterogeneity, variation in selection of conditions and limitations in design and analysis. These challenges may contribute to the lack of evidence to inform effective interventions for people with MLTCs. This study aims to systematically identify and prioritise key methodological uncertainties in the design, conduct and analysis of future trials aiming to improve health outcomes for people with MLTCs. Methods We will conduct a four-round modified Delphi study involving key interest groups including methodologists, trialists, MLTC researchers, research funders, commissioners, regulators, people with MLTC lived experience and MLTC carers. The process will include two rounds of online questionnaires, one lived-experience meeting (in-person or virtual) and a final virtual consensus meeting. To promote inclusivity and diversity of input, participants may join at any stage. Responses from each round will be analysed and summarised to inform the next stage, with final priorities agreed through structured consensus voting. Expected Outcomes This consensus study will produce a ranked list of methodological research uncertainties to guide future research and clinical trial design, conduct and analysis in MLTCs. Findings will be disseminated through a facilitated online dissemination workshop, academic channels and targeted public engagement activities to support inclusive and relevant MLTC research.
Background: Randomised controlled trials (RCTs) in people with multiple long-term conditions (MLTC) remain limited, and variation in design and analysis may hinder the generation of implementable evidence. This review aimed to characterise methodological approaches, risk of bias, and reporting quality in RCTs targeting MLTC.Methods: MEDLINE, Scopus, CINAHL, and CENTRAL were searched from 1999 to March 2026. RCTs evaluating interventions in adults with MLTC were included. Study selection, data extraction, risk of bias, and adherence to CONSORT 2025 were conducted independently by two reviewers. A narrative synthesis was undertaken.Results: Thirty-nine RCTs (n=13,008 participants; 64% published after 2020) were included. Trials were predominantly two arm parallel designs using individual randomisation, with no use of adaptive or platform designs. Methodological limitations included inconsistent reporting of pre specified analysis plans (56%), limited reporting and handling of missing data, and infrequent assessment of analytical assumptions (23%). Most trials were at moderate to high risk of bias, particularly for performance (92%) and detection bias (41%). Outcome selection was heterogeneous; medication related outcomes were most common, whereas health related quality of life was less frequently prioritised and mortality was not assessed as a primary outcome. Reporting of participant characteristics was limited, with ethnicity reported in only 26% of trials, and patient and public involvement in 18%.Conclusion: RCTs in MLTC remain few and are methodologically underdeveloped, with reliance on traditional designs and inconsistent analytical approaches. Greater adoption of innovative trial designs, improved outcome selection, and more rigorous reporting are needed to strengthen the evidence base and support the development of implementable interventions for this population.
There is currently no explicit, formal framework or tool to guide Health Technology Reassessment (HTR) and disinvestment decision-making in Ireland. This study aimed to explore the views and experiences of stakeholders involved in HTR and disinvestment decision-making in Ireland, with a focus on disinvestment from low-value medicines, and to identify participants' awareness of past and current policies, practices, and perceived opportunities for HTR and disinvestment in Ireland. A qualitative study design was employed with semi-structured interviews conducted with 15 stakeholders drawn across the Irish public health system between May and September 2025. The interviews were recorded, transcribed verbatim and analysed thematically using NVivo 14 software. Three overarching themes and nine subthemes were identified. The three themes were “Understanding HTR and disinvestment”, “Implementing HTR and disinvestment in practice” and “Barriers, enablers and trust”. Participants gave examples of past and present disinvestment-related policies in Ireland and suggested potential triggers for identifying low-value medicines. Across stakeholder groups, the clinical needs of the patient were consistently emphasized as taking precedence over financial costs. This study sought to improve our understanding of the HTR and disinvestment landscape in Ireland but has implications for similar health systems internationally. The findings can inform the development of a tailored HTR and disinvestment framework for Irish decision-making relating to low-value medicines.
BACKGROUND: Globally, general practice faces recruitment and retention challenges as many countries struggle to meet the rising demand for primary care. Ireland also faces increased demand for primary care as a result of its ageing population, increased incidence of chronic illness and greater patient complexity. Significantly more GPs will be needed to meet this increased demand. Further challenges facing Ireland’s GP workforce include the fact that one quarter of GPs in Ireland are aged over 60 years old and changing working patterns by GPS which have seen GPs reduce their patient-facing hours. Work intensity is one of the factors driving GPs to change their working patterns. This paper identifies the key sources of work intensity in general practice in Ireland and considers how to improve GPs’ experiences of work with a view to improving GP wellbeing and retention. METHODS: The study used a qualitative method of remote ethnography, with 20 participant GPs. Each GP participated in two semi-structured interviews and an eight-week instant messaging conversation via Threema. Ethical approval was granted by the institutional ethics committee and data collection took place from October 2024 to July 2025. RESULTS: Participant GPs described a high level of work intensity, describing a “relentless” pace, long hours, and little opportunity for breaks. Sources of work intensity included GPs’ expanded scope of care, increased patient complexity, patient demands and the administrative workload. Participant GPs highlighted practice-level strategies that might reduce work intensity, including protected administrative time, and longer appointment times for complex patients. The results of the study are discussed in the context of the individual, organisational, and system-level solutions that may be deployed to address work intensity in general practice. CONCLUSIONS: General practice in Ireland is under considerable pressure, with increased work intensity driven by multiple sources. In response targeted strategies are necessary to reduce intensity and improve GPs’ experiences of work. In order to protect GP wellbeing, improve GP retention and secure the future sustainability of the GP workforce, the causes of work intensity must be better understood and factored into GP workforce planning.
OBJECTIVES:While rapid health technology assessments (HTA) are important for decision makers, there is no universally accepted definition or standardized methods. The objective of this study was to analyze the content and conduct of published rapid and mini-HTA reports. METHODS:We conducted a cross-sectional analysis of rapid and mini-HTA reports identified from the International HTA Database (2014-April 2024) and supplementary searches of HTA agency websites. We extracted descriptive data on rapid HTA products; specifically, which traditional HTA domains were included or omitted, evidence synthesis methods, and approaches to interest-holder (formerly known as stakeholder) engagement. Data analysis was conducted in Stata. RESULTS:We included 203 rapid HTA reports. Most frequently included HTA domains were clinical effectiveness (99 percent) and safety (82.3 percent). Legal aspects (12.3 percent) and budget impact analyses (10.8 percent) were less frequently reported. Across reports reviewing clinical effectiveness (n = 201), generic literature searches were the most predominantly self-reported evidence synthesis method (37.8 percent), with updates (1.5 percent) and overviews (2 percent) of systematic reviews less common. Cost-utility analyses were the most commonly self-reported form of economic evaluation (36.2 percent). Additionally, public consultations (68 percent) were the most commonly reported ways to engage with interest holders. CONCLUSION:Our analysis highlights variations across rapid HTA reports and will contribute to wider research aiming to establish a clearer definition and framework of rapid HTAs and inform when and how rapid HTAs are performed. Clearer reporting and justification of simplifications in rapid HTA reports are needed.
This paper presents independent associations between complex multimorbidity and health-related quality of life using the EQ-5D-5L instruments. Identifying the decrements in utility associated with complex multimorbidity is of value for economic evaluation and health technology assessment. Data from the population normative dataset from the Irish EQ-5D-5L study were combined with baseline data from the SPPiRE (Supporting Prescribing in Older Adults with Multimorbidity in Irish Primary Care) randomised controlled trial. The trial included an Irish cohort aged 65+ with complex multimorbidity. For the analysis, the estimation sample consisted of 364 individuals from the SPPiRE complex multimorbidity sample, along with 116 individuals aged 65+ from the general population who did not report having any serious illness. A multivariate ordered probit regression model was used to estimate the independent associations between complex multimorbidity and the five EQ-5D-5L dimensions. Complex multimorbidity was independently associated with a lower probability of reporting no problems for all five EQ-5D-5L dimensions, and a higher probability of reporting the most extreme response for all five dimensions. The loss in health utility associated with complex multimorbidity was estimated to be − 0.506 (95
Background:Guidelines are essential tools for improving healthcare decision-making. Over the last few decades there has been substantial investment in developing international standards and frameworks to support the technical or methodological aspects of making recommendations. However, exploration of the social processes involved has been more limited. Objective:To explore the perspectives and experiences of stakeholders on the social processes of developing recommendations in decision-making contexts in Ireland. Methods:A descriptive qualitative study using data from 14 semi-structured interviews was conducted with former guideline development group and expert advisory group members via MS Teams (February-August 2024). Interviewees included clinicians, methodologists and managers. Interviews were transcribed verbatim, analysed thematically and reported in accordance with the Standards for Reporting Qualitative Research. Findings:Voices was identified as a central theme. Strong voices and hierarchies may influence decision-making, leveraging pre-existing hierarchies of professions and hierarchies of evidence. This can be exacerbated when a chair embodies this hierarchy. Our data highlighted a lack of alignment of goals and expectations between the chair and patient voices which, at times, could dominate group discussions. Methods for mitigating dominant voices included forming groups through combinations of personal and professional networks, multidisciplinary voices, briefing and debriefing patient and public representatives, and anchoring the discussion within the evidence and frameworks. Conclusions:The study highlights the varied voices and social structures shaping the evidence to recommendation journey, with mechanisms to mitigate against dominance within guideline development processes.
Higher education institutions (HEIs) play a crucial role in developing healthier communities through diverse functions including research, education, operations, culture, advocacy and civic engagement. However, the implementation of a 'settings-based approach' to a comprehensive campus-wide health promotion strategy remains challenging due to the diverse and complex nature of HEI organisational structures. Toolkits have been developed to guide HEIs in evaluating their health promotion approaches but, to our knowledge, no comprehensive review of these toolkits has been conducted. This scoping review, with a narrative synthesis, sought to identify, map and compare available toolkits, assessing their comprehensiveness in supporting health promotion. Following a search of five online databases and pertinent grey literature, six toolkits were identified that were examined using a 58-item checklist to assess how each toolkit addresses health promotion domains within HEIs. Our narrative synthesis identifies areas of universal coverage, such as the integration of health into HEI policies and context-specific initiatives, including support for minority groups. Across toolkits, governance/leadership integration and monitoring and evaluation were consistently represented, with strong emphasis on mental health and physical activity. Coverage of areas, such as substance use, sexual health, disability-friendly services and indigenous/minority inclusion, was less consistent - highlighting differences in how comprehensive toolkits address equity-focused and specialised components of health promotion. Our analysis offers valuable insights for the ongoing assessment and refinement of health promotion strategies in HEIs globally, aiming to enhance their capacity to cultivate healthy, inclusive and sustainable campus environments.
Obesity is a leading risk factor for premature morbidity and mortality, and an increasing public health challenge. This review aimed to systematically identify and appraise national and international clinical guidelines for the management of obesity in adults. We systematically searched MEDLINE, CINAHL, Embase, and PsycINFO from 01/01/2019 to 06/01/2025. We conducted supplementary searches on websites of clinical guideline-producing organizations and other relevant institutional and evidence-based clinical resources. We included national and international guidelines on the management of obesity in adults aged ≥ 18 years that included recommendations on prespecified primary topics of interest, clearly stated the systematic approach and evidence base underpinning recommendations, and included a rating of the quality of evidence. The Appraisal of Guidelines for Research and Evaluation (AGREE) II tool and appraisal using the mEaningful VOice in the design and deLiVery of care (EVOLVE) framework were employed by two reviewers independently. Data were extracted by one reviewer, checked by another, and narratively synthesized. We identified 10 eligible clinical guidelines. The mean overall AGREE II score was 4.9/7 (SD: 1.22). Patients were involved in highlighting preferences, panel membership, reviewing drafts, and consensus meetings in most guidelines, and formulating/prioritizing questions, priority setting, and dissemination in a minority. The 2025 National Institute of Health and Care Excellence guideline on "Overweight and Obesity Management" displayed the most extensive scope and highest overall AGREE II score (7/7). This review will inform adaptation, as part of an ADAPTE process, for a prioritized National Clinical Guideline on the management of obesity in adults in Ireland.
INTRODUCTION:Exercise is a safe, effective intervention for improving health-related outcomes in people living with chronic conditions and multimorbidity. ExWell Medical is a community-based, medically designed group exercise programme for people living with chronic conditions in Ireland. AIMS:We aimed to evaluate the longitudinal association of ExWell with health-related outcomes and to explore the association of these outcomes with programme adherence. METHODS:We employed a prospective cohort study design. All participants attending an ExWell Medical induction in the Dublin/Kildare regions January-September 2023 were invited to participate. At baseline, 12 and 24 weeks we collected data on socio-demographics; health status, health behaviours; measures of physical function, patient-reported outcomes. RESULTS:Of the 2219 patients referred to ExWell, 1364 attended an induction and 1289 agreed to participate, mean age 69 years (SD: 10.90 CI: 68.84-70.06), 60% female, living with a mean of 3.29 (SD: 2.17 CI: 3.17-3.40) chronic conditions. 725 (56%) completed assessments at the primary endpoint (24 weeks). There were significant improvements in body mass index, gait speed, a range of timed tests, health related quality of life, self-efficacy, stages of adopting exercise, a modest reduction in alcohol consumption, no significant change in smoking, an increase in physical activity but not sufficient to meet current guidelines, with programme adherence significantly associated with better outcomes. There were no improvements in grip strength, fear of falling, pain, smoking prevalence. CONCLUSION:Participation in the ExWell programme was associated with significant improvements in some health-related outcomes in community-dwelling adults living with one or more chronic conditions.