Paddy Gillespie

Background: Young adults living with type 1 diabetes (T1D) often experience sub‐optimal outcomes due to competing life demands, disruptions in care, reduced clinic attendance, and difficulties in self‐management. To improve outcomes among this population, we developed and piloted the D1 Now intervention using a user‐centred and theory‐informed approach. This protocol describes a cluster randomised controlled trial (RCT) to test the effectiveness and cost‐effectiveness of the D1 Now intervention. Methods: A cluster RCT seeking to recruit 348 young adults (aged 18–25) with type 1 diabetes from 12 hospital diabetes centres in Ireland. Centres will be randomised to receive either standard care or the D1 Now intervention, which includes two components: an agenda‐setting tool and a support worker. The primary outcome is the change in HbA1c from baseline to 12‐month follow‐up. Secondary outcomes include participant‐reported psychosocial outcomes, clinical outcomes, self‐management outcomes, and healthcare utilisation. We will collect data through blood samples, online participant surveys, and participant records at baseline and 12 months. Additionally, we will conduct a cost‐effectiveness evaluation and a mixed‐methods process evaluation. Discussion: We anticipate that the D1 Now intervention will be both effective and cost‐effective in improving clinical and psychosocial outcomes for young adults compared to standard care. The findings from the process evaluation will shed light on how the intervention works (or not) and how implementation into health services (if warranted) can be optimised. If effective, D1 Now will offer a sustainable model of care to support engagement and self‐management for young adults living with type 1 diabetes.

Male foetal sex is recognised as an independent risk factor for adverse pregnancy outcomes including preterm birth, neonatal care unit admission and lower

OBJECTIVE: To assess whether initiating metformin at 25 weeks' gestation influences exclusive breastfeeding at 12 weeks postpartum in gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS: We performed a prespecified secondary analysis of the Effectiveness of Metformin in Addition to Usual Care in the Reduction of Gestational Diabetes Effects (EMERGE) trial, a multicenter, double-blind, placebo-controlled randomized study. A total of 535 pregnant women (510 with newly diagnosed GDM) were allocated 1:1 to metformin (titrated to 2.5 g/day) or placebo alongside usual care. Infant feeding was prospectively documented at birth and at 4 and 12 weeks postpartum. The primary outcome was exclusive breastfeeding at 12 weeks (intention to treat). Multivariable logistic regression adjusted for race, education, smoking, booking BMI, health care access markers, and diagnostic oral glucose tolerance test (OGTT) glucose levels. RESULTS: Twelve-week feeding data were available for 476 pregnancies (236 in the metformin group and 240 in the placebo group). Exclusive breastfeeding at 12 weeks was 27% with metformin and 26% with placebo (absolute difference +1.3%; 95% CI –6.3 to 8.7; P = 0.75). The adjusted odds ratio (OR) for metformin versus placebo was 1.24 (95% CI 0.79–1.96; P = 0.36). Feeding patterns shifted from breastfeeding to formula temporally in both groups (P < 0.001), with no treatment-by-time interaction (P = 0.61). Non-Caucasian ethnicity independently predicted exclusive breastfeeding (adjusted OR 2.37; 95% CI 1.27–4.42). CONCLUSIONS: Starting metformin treatment at 25 weeks in the GDM group was not associated with differences in exclusive breastfeeding at 12 weeks postpartum. Where metformin was discontinued at delivery, the results support compatibility of antenatal metformin with breastfeeding objectives. Breastfeeding outcomes were more linked to sociodemographic factors than metabolic ones, highlighting the need for culturally appropriate postpartum support.

Purpose: This paper presents independent associations between complex multimorbidity and health-related quality of life using the EQ-5D-5L instrument s . Identifying the decrements in utility associated with complex multimorbidity is of value for economic evaluation and health technology assessment. Methods: 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. Results: 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% CI − 0.567, − 0.445) relative to those aged 65 years and over with no serious illness. The negative health impact was most pronounced for pain/discomfort and anxiety/depression. Conclusion: This study reported the associative impacts of complex multimorbidity for all EQ-5D-5L dimensions and for health utility overall. The findings highlight the potential impact on health-related quality of life of interventions that can prevent or delay the onset and progression of multimorbidity.

Background: Young adults living with type 1 diabetes (T1D) often experience sub-optimal outcomes due to competing life demands, disruptions in care, reduced clinic attendance, and difficulties in self-management. To improve outcomes among this population, we developed and piloted the D1 Now intervention using a user-centred and theory-informed approach. This protocol describes a cluster randomised controlled trial (RCT) to test the effectiveness and cost-effectiveness of the D1 Now intervention. Methods: A cluster RCT seeking to recruit 348 young adults (aged 18–25) with T1D from 12 hospital diabetes centres in Ireland. Centres will be randomised to receive either standard care or the D1 Now intervention, which includes two components: an agenda-setting tool and a support worker. The primary outcome is the change in HbA1c from baseline to 12-month follow-up. Secondary outcomes include patient-reported psychosocial outcomes, clinical outcomes, self-management outcomes and healthcare utilisation. We will collect data through blood samples, online patient surveys, and patient records at baseline and 12 months. Additionally, we will conduct a cost-effectiveness evaluation and a mixed-methods process evaluation. Discussion: We anticipate that the D1 Now intervention will be both effective and cost-effective in improving clinical and psychosocial outcomes for young adults compared to standard care. The findings from the process evaluation will shed light on how the intervention works (or not) and how implementation into health services (if warranted) can be optimised. If effective, D1 Now will offer a sustainable model of care to support engagement and self-management for young adults living with T1D. Trial registration: ISRCTN Identifier: ISRCTN28944606 . Date applied 01 May 2025

Aims: To investigate the cost‐effectiveness of early initiation of metformin and usual care for gestational diabetes mellitus (GDM). Methods: Economic evaluation from a healthcare perspective, based on the EMERGE randomised controlled trial. In total, 535 women with GDM were randomised to placebo in addition to usual care or metformin in addition to usual care. Economic outcomes included incremental healthcare costs and quality adjusted life years ( QALYs ) and expected cost‐effectiveness at cost‐effectiveness threshold values of €20,000, €45,000 and €100,000 per QALY gained. Uncertainty was explored using parametric, non‐parametric, deterministic and probabilistic methods and heterogeneity using subgroup analysis. Results: On average, relative to the placebo arm, the early metformin arm was associated with non‐statistically significant mean increases of €193.07 (95% CI : −€789.88, €1176.01; p = 0.700) and 0.002 QALYs (95% CI : −0.009, 0.013; p = 0.771). In terms of expected cost‐effectiveness at threshold values of €20,000, €45,000 and €100,000 per QALY gained, the probability of the early metformin arm being more cost‐effective was estimated at 0.423, 0.452 and 0.524. Exploratory subgroup analyses provided more favourable but not definitive evidence in favour of the early metformin arm for cohorts with previous GDM and previous caesarean section. Conclusions: We do not find definitive evidence that early initiation of metformin in addition to usual care for GDM was more cost‐effective than usual care alone. The clinical and economic evidence may be considered equivocal, but worthy of further examination.

Background: Latch On’s objective was to achieve improved breastfeeding rates in women with raised body mass indices using a multicomponent breastfeeding support intervention. Methods: A hybrid type 1 implementation-effectiveness trial with mixed-methods process and health economics analyses were conducted. Data collection included stakeholder questionnaires, interviews, focus groups, fidelity data, participant and health system costs. Results: The intervention was delivered with fidelity but the high breastfeeding rates at 3 months were not different between intervention and usual care. Participants receiving the minimum intervention dose were more likely to initiate breastfeeding (P = 0.045) and be breastfeeding at hospital discharge (P = 0.01) compared with participants below the threshold. Participant exit interview themes highlighted the importance of improving breastfeeding support to women, the effect of COVID-19 on the breastfeeding experience, and found that the intervention improved the experience of establishing breastfeeding. The intervention cost €157 per participant, with no other cost difference between groups. Process analysis found that follow-up breastfeeding services continued in half of sites after study completion. Conclusions: This low-cost intervention resulted in a more enjoyable breastfeeding experience for participants and changed practice in some study sites. The intervention dose received may impact effectiveness, but further research is needed to provide definitive evidence of clinical and cost effectiveness.

Hypertension, or high blood pressure, is a key modifiable risk factor for heart disease and stroke. International guidelines have highlighted ‘poor adherence to treatment’ and ‘physician inertia’ as major barriers to effective blood pressure management. The Maximising Adherence, Minimising Inertia (MIAMI) intervention, a theory-based complex intervention, supports General Practitioners (GPs) and people with hypertension in maximising medication use to manage blood pressure. This pilot cluster randomised control trial (RCT) aimed to collect and analyse feasibility data to refine the MIAMI intervention and assess the feasibility of a definitive RCT. A pilot cluster RCT with a MIAMI intervention arm and usual care control arm was conducted. Quantitative data collection consisting of clinical measures and a self-report questionnaire took place at baseline and twelve week follow up. Semi-structured interviews with GP and patient participants were conducted. Fidelity (as measured by a protocol checklist and through qualitative interviews) and health economics costings were assessed. Six GP practices (intervention arm n = 3, control arm n = 3) and 52 patients (intervention arm n = 25, control arm n = 27) took part. All six GP practices and 92% of patients were retained. Fidelity, as measured by a checklist and through qualitative interviews, was good but three deviations from protocol were identified. Outcomes and measures used were acceptable. The implementation cost of the MIAMI intervention was estimated at €490 per participant. The qualitative data demonstrated that the intervention was considered acceptable and feasible by both GP and patient participants, except for the urine test component, which GPs found difficult to incorporate into practice due to logistical challenges. The MIAMI intervention was considered largely acceptable and feasible. Some changes to both intervention components and trial processes are required but with these in place a definitive RCT could be considered worthwhile. ISRCTN registry, ISRCTN85009436, registered 17/1/23.

Background: Evidence on the cost effectiveness of deprescribing in multimorbidity is limited. Objective: To investigate the cost effectiveness of a general practitioner (GP) delivered, individualised medication review to reduce polypharmacy and potentially inappropriate prescribing in older patients with multimorbidity in Irish primary care. Methods: Within trial economic evaluation, from a healthcare perspective and based on a cluster randomised controlled trial with a 6 month follow up and 403 patients (208 Intervention and 195 Control) recruited between April 2017 and December 2019. Intervention GPs used the SPPiRE website which contained educational materials and a template to support a web-based individualised medication review. Control GPs delivered usual care. Incremental costs, quality adjusted life years (QALYs) generated using the EQ-5D-5L instrument, and expected cost effectiveness were estimated using multilevel modelling and multiple imputation techniques. Uncertainty was explored using parametric, deterministic and probabilistic methods. Results: On average, the SPPiRE intervention was dominant over usual care, with non-statistically significant mean cost savings of €410 (95% confidence interval (CI): − 2211, 1409) and mean health gains of 0.014 QALYs (95% CI − 0.011, 0.039). At cost effectiveness threshold values of €20,000 and €45,000 per QALY, the probability of SPPiRE being cost effective was 0.993 and 0.988. Results were sensitive to missing data and data collection period. Conclusions: The study observed a pattern towards dominance for the SPPiRE intervention, with high expected cost effectiveness. Notably, observed differences in costs and outcomes were consistent with chance, and missing data and related uncertainty was non trivial. The cost effectiveness evidence may be considered promising but equivocal. Trial registration: ISRCTN: 12752680, 20th October 2016.