Andrew William Murphy

BACKGROUND Participant recruitment is a persistent barrier to clinical trials, particularly in primary care, where fixed funding timelines intensify pressure to enrol rapidly and traditional clinician-mediated and community-based methods can be slow and resource-intensive. Direct-to-patient (DTP) digital recruitment through social media offers a potential alternative, but real-world evidence in primary care trials requiring rapid enrolment remains limited. OBJECTIVE To evaluate the effectiveness and efficiency of a multi-modal recruitment strategy combining primary care network outreach with DTP social media advertising in achieving enrolment targets within a constrained timeframe in a fully remote primary care digital therapeutic trial, and to describe its impact on recruitment performance, participant retention, and engagement. METHODS The RiSolve study was a single-arm, fully remote primary care trial of a digital therapeutic for women with bothersome overactive bladder symptoms, delivered through the Irish primary care clinical trials network with a target of approximately 45 participants within an eight-week window. Recruitment combined traditional outreach (approximately 150 general practices, urogynaecology units, community and pharmacy promotion, and snowball referral) with DTP paid advertising on Meta (Facebook and Instagram) and Google. The recruitment funnel, campaign metrics (impressions, click-through rate, cost per click, and cost per enrolled participant), and retention (Week 8 completion) were summarised descriptively. RESULTS Of 208 expressions of interest, 204 (98.1%) were generated through social media; none of the 46 enrolled participants were recruited via traditional pathways. The enrolled cohort's mean age (60 years) and body mass index (27.8 kg/m²) were consistent with the population subgroups reported to carry the highest burden of OAB. The target was achieved three weeks ahead of schedule (47 participants consented over five weeks; mean 9.4 per week), with an 83.9% pre-screening-to-consent conversion. The Meta campaign achieved a click-through rate of 1.80% and a cost per click of €0.13 on a spend of €879.08, at €19.11 per enrolled participant. Engagement closely tracked campaign delivery, with 94.7% of expressions of interest recorded while advertising was live. Retention was 82.6% (38/46). CONCLUSIONS A direct-to-patient digital recruitment strategy enabled rapid, cost-efficient enrolment in a fully remote primary care trial, meeting the target ahead of schedule while traditional methods contributed no enrolments. Recruited participants showed high retention, countering concerns that digitally recruited cohorts are difficult to retain. These findings support direct-to-patient digital recruitment as a viable strategy for time-constrained, decentralised primary care trials. Future work should incorporate end-to-end conversion tracking and directly compare recruitment pathways across a range of other therapeutic areas. CLINICALTRIAL ClinicalTrials.gov NCT07206446; https://clinicaltrials.gov/study/NCT07206446

Background: Cardiac rehabilitation (CR) is an evidence-based, multicomponent intervention. However, participation in and reach of CR remain suboptimal globally. Digital CR is a promising alternative to traditional center-based CR, with the potential to increase intervention reach and efficiency. However, efforts to increase the efficiency of digital CR require an understanding of the relative effectiveness of the components of CR, which is currently lacking. The Multiphase Optimization Strategy provides a framework to evaluate the effects of individual components within complex interventions. Objective: This mixed methods study explored the feasibility and acceptability of implementing the procedures of a factorial design and delivering multiple intervention components in preparation for an optimization randomized controlled trial of a digital CR intervention. Methods: Patients attending CR in a community setting were randomized to 1 of 8 experimental conditions in a 2 × 2 × 2 (23) factorial trial design. Each condition received a different combination of three intervention components over a 6-week study period (1) goal setting and self-monitoring, (2) education, and (3) feedback messages. Feasibility was assessed through intervention fidelity (eg, usage statistics) and outcome measure data completeness. Acceptability was measured using the System Usability Scale, a questionnaire, and semistructured interviews based on the Theoretical Framework of Acceptability. Results: A total of 8 participants were recruited and retained in the study. The mean age was 75 (SD 5.6) years, and the majority were female (5/8, 62.5%). The digital CR intervention demonstrated good usability (System Usability Scale score 72.1, SD 19.1), and 83.3% (5/6) of participants found the digital technology acceptable. However, only half (2/4, 50%) found the feedback messages acceptable. Fidelity was high for goal setting/self-monitoring and feedback but lower for education. Qualitative findings indicated that participants held positive attitudes toward the intervention and reported improvements in physical activity, although many expressed a preference for more tailored feedback and 2-way communication. Of the 3 prespecified progression criteria, usability met the “Go” criterion, whereas intervention fidelity, acceptability, and outcome measure data completeness met the “Amend” threshold. Conclusions: This study demonstrated the feasibility of implementing a factorial design and delivering multiple intervention components within a digital CR intervention. While the intervention was generally acceptable, modifications to the education and feedback components are necessary prior to conducting a pilot optimization randomized controlled trial.

Background/Objectives: Reducing inappropriate use of antimicrobial agents in healthcare settings is a critical strategy to mitigate the growing threat of antimicrobial resistance. Globally, the highest consumption of antimicrobials in human healthcare originates from antibiotic prescriptions made in General Practice settings. Small group learning has long held a key role in General Practice education, characterized by active participation, common learning goals, and opportunities for reflection. This mode of delivery has been explored as a potential approach to increase appropriate antibiotic prescribing, supported by research indicating that more didactic educational interventions are unlikely to effectively improve physician prescribing behaviours. This systematic review specifically sought to synthesise the evidence on the effectiveness of small group-based, interventions in improving appropriate antibiotic prescribing behaviours in general practice. Methods: A mixed methods systematic review was employed. Studies were eligible if they reported on in-person, small group-based educational interventions to improve antibiotic prescribing among GPs. Full-text screening resulted in 19 eligible studies. Key characteristics, such as study design, intervention content, and outcomes, were extracted. Results: The 19 included studies used single and multi-modal interventions, with 68% focusing on respiratory tract infections. Common topics were patient communication (n = 11) and adherence to prescribing guidelines (n = 8). Most (n = 11) reported positive outcomes like reduced prescribing and were acceptable to GPs. Conclusions: These types of interventions can be effective in increasing the appropriate use of antibiotics in General Practice and are well received by GP participants. However, further research is required on the optimal content delivered in interventions and their associated long-term impact.

Introduction and aims: Objective structured clinical examinations (OSCEs) are an integral part of medical education assessment. The advanced clinical skills (ACS) OSCE examines clinical skills in psychiatry, general practice, obstetrics and gynaecology and paediatrics for fourth-year medical students at the University of Galway. This study compares results between the 2019 OSCE, and two subsequent OSCEs (2020 and 2021) modified to varying degrees secondary to the COVID-19 pandemic. We also examined student’s satisfaction and perspectives regarding both modified OSCEs. Materials and methods: Anonymised results between the 2019 (128 min), 2020 (56 min) and 2021 (96 min) ACS OSCEs were compared, and student feedback pertaining to the 2020 and 2021 OSCEs was analysed. Results: A higher total mean mark OSCE result was achieved at the 2020 OSCE (62.95%) compared to the 2019 (59.35%) and 2021 (58.89%) OSCEs (F = 31.83, p < 0.001), with significantly more first-class honours marks attained in 2020 (11.5%) compared to 2019 and 2021 (both 1%) (p < 0.001). Measures of reliability were consistent across all years. A majority of students in both 2020 and 2021 reported the OSCE to be safe, well-coordinated, and fair, but similar numbers of students from both 2020 and 2021 expressed concern that face masks impeded their communication skills. Conclusion: This study demonstrates the feasibility of conducting a modified reliable OSCE during a pandemic. Conducting a 96-min OSCE demonstrated similar results to the pre-COVID-19 pandemic 128-min OSCE, in contrast to a 56-min OSCE where potentially inflated marks were attained.

BACKGROUND Cardiac rehabilitation (CR) is an evidence-based, multicomponent intervention. However, participation in and reach of CR remain suboptimal globally. Digital CR is a promising alternative to traditional center-based CR, with the potential to increase intervention reach and efficiency. However, efforts to increase the efficiency of digital CR require an understanding of the relative effectiveness of the components of CR, which is currently lacking. The Multiphase Optimization Strategy provides a framework to evaluate the effects of individual components within complex interventions. OBJECTIVE This mixed methods study explored the feasibility and acceptability of implementing the procedures of a factorial design and delivering multiple intervention components in preparation for an optimization randomized controlled trial of a digital CR intervention. METHODS Patients attending CR in a community setting were randomized to 1 of 8 experimental conditions in a 2 × 2 × 2 (23) factorial trial design. Each condition received a different combination of three intervention components over a 6-week study period (1) goal setting and self-monitoring, (2) education, and (3) feedback messages. Feasibility was assessed through intervention fidelity (eg, usage statistics) and outcome measure data completeness. Acceptability was measured using the System Usability Scale, a questionnaire, and semistructured interviews based on the Theoretical Framework of Acceptability. RESULTS A total of 8 participants were recruited and retained in the study. The mean age was 75 (SD 5.6) years, and the majority were female (5/8, 62.5%). The digital CR intervention demonstrated good usability (System Usability Scale score 72.1, SD 19.1), and 83.3% (5/6) of participants found the digital technology acceptable. However, only half (2/4, 50%) found the feedback messages acceptable. Fidelity was high for goal setting/self-monitoring and feedback but lower for education. Qualitative findings indicated that participants held positive attitudes toward the intervention and reported improvements in physical activity, although many expressed a preference for more tailored feedback and 2-way communication. Of the 3 prespecified progression criteria, usability met the “Go” criterion, whereas intervention fidelity, acceptability, and outcome measure data completeness met the “Amend” threshold. CONCLUSIONS This study demonstrated the feasibility of implementing a factorial design and delivering multiple intervention components within a digital CR intervention. While the intervention was generally acceptable, modifications to the education and feedback components are necessary prior to conducting a pilot optimization randomized controlled trial.

Background: Secondary prevention is an important strategy to reduce the burden of cardiovascular disease (CVD), a leading cause of death worldwide. Despite the growing evidence for the effectiveness of digital health interventions (DHIs) for the secondary prevention of CVD, the majority are designed with minimal input from target end users, resulting in poor uptake and usage. Objective: This study aimed to optimize the acceptance and effectiveness of a DHI for the secondary prevention of CVD through co-design, integrating end users’ perspectives throughout. Methods: A theory-driven, person-based approach using co-design was adopted for the development of the DHI, known as INTERCEPT. This involved a 4-phase iterative process using online workshops. In phase 1, a stakeholder team of health care professionals, software developers, and public and patient involvement members was established. Phase 2 involved identification of the guiding principles, content, and design features of the DHI. In phase 3, DHI prototypes were reviewed for clarity of language, ease of navigation, and functionality. To anticipate and interpret DHI usage, phase 4 involved usability testing with participants who had a recent cardiac event (<2 years). To assess the potential impact of usability testing, the System Usability Scale was administered before and after testing. The GUIDED (Guidance for Reporting Intervention Development Studies in Health Research) checklist was used to report the development process. Results: Five key design principles were identified: simplicity and ease of use, behavioral change through goal setting and self-monitoring, personalization, system credibility, and social support. Usability testing resulted in 64 recommendations for the app, of which 51 were implemented. Improvements in System Usability Scale scores were observed when comparing the results before and after implementing the recommendations (61 vs 83; P=.02). Conclusions: Combining behavior change theory with a person-based, co-design approach facilitated the development of a DHI for the secondary prevention of CVD that optimized responsiveness to end users’ needs and preferences, thereby potentially improving future engagement.

BACKGROUND Secondary prevention is an important strategy to reduce the burden of cardiovascular disease (CVD), a leading cause of death worldwide. Despite the growing evidence for the effectiveness of digital health interventions (DHIs) for the secondary prevention of CVD, the majority are designed with minimal input from target end users, resulting in poor uptake and usage. OBJECTIVE This study aimed to optimize the acceptance and effectiveness of a DHI for the secondary prevention of CVD through co-design, integrating end users’ perspectives throughout. METHODS A theory-driven, person-based approach using co-design was adopted for the development of the DHI, known as INTERCEPT. This involved a 4-phase iterative process using online workshops. In phase 1, a stakeholder team of health care professionals, software developers, and public and patient involvement members was established. Phase 2 involved identification of the guiding principles, content, and design features of the DHI. In phase 3, DHI prototypes were reviewed for clarity of language, ease of navigation, and functionality. To anticipate and interpret DHI usage, phase 4 involved usability testing with participants who had a recent cardiac event (<2 years). To assess the potential impact of usability testing, the System Usability Scale was administered before and after testing. The GUIDED (Guidance for Reporting Intervention Development Studies in Health Research) checklist was used to report the development process. RESULTS Five key design principles were identified: simplicity and ease of use, behavioral change through goal setting and self-monitoring, personalization, system credibility, and social support. Usability testing resulted in 64 recommendations for the app, of which 51 were implemented. Improvements in System Usability Scale scores were observed when comparing the results before and after implementing the recommendations (61 vs 83; P=.02). CONCLUSIONS Combining behavior change theory with a person-based, co-design approach facilitated the development of a DHI for the secondary prevention of CVD that optimized responsiveness to end users’ needs and preferences, thereby potentially improving future engagement.