Selective outcome reporting in trials of behavioural health interventions in health psychology and behavioural medicine journals: a review.

Selective outcome reporting can result in overestimation of treatment effects, research waste, and reduced openness and transparency. This review aimed to examine selective outcome reporting in trials of behavioural health interventions and determine potential outcome reporting bias. A review of nine health psychology and behavioural medicine journals was conducted to identify randomised controlled trials of behavioural health interventions published since 2019. Discrepancies in outcome reporting were observed in 90% of the 29 trials with corresponding registrations/protocols. Discrepancies included 72% of trials omitting prespecified outcomes; 55% of trials introduced new outcomes. Thirty-eight percent of trials omitted prespecified and introduced new outcomes. Three trials (10%) downgraded primary outcomes in registrations/protocols to secondary outcomes in final reports; downgraded outcomes were not statistically significant in two trials. Five trials (17%) upgraded secondary outcomes to primary outcomes; upgraded outcomes were statistically significant in all trials. In final reports, three trials (7%) omitted outcomes from the methods section; three trials (7%) introduced new outcomes in results that were not in the methods. These findings indicate that selective outcome reporting is a problem in behavioural health intervention trials. Journal- and trialist-level approaches are needed to minimise selective outcome reporting in health psychology and behavioural medicine.

Improving retrospective intervention descriptions: Lessons learned from research on type 2 diabetes programmes in the United Kingdom and the Republic of Ireland.

In recent years, multiple countries worldwide have implemented behavioural interventions within national healthcare systems. Describing the content of these interventions is critical to improve their implementation, replication, and effectiveness, as well as to advance behavioural science. Tools, such as the Behaviour Change Technique Taxonomy, can enhance the quality of intervention description and reporting. As interventions are frequently developed without the use of such tools, retrospective coding of existing interventions to accurately characterise their content is becoming more common. However, the use of these tools for retrospective coding poses various challenges, the discussion of which has been neglected to date. This commentary discusses the challenges encountered when retrospectively describing the content of five nationally implemented programmes for type 2 diabetes in the United Kingdom and the Republic of Ireland and suggests recommendations to tackle these challenges. We present important methodological, practical, and ethical considerations for researchers to reflect on, relevant to the retrospective description of existing interventions. Specifically, we discuss (i) the importance of positive relationships and collaboration with intervention stakeholders, (ii) the practical and ethical considerations when analysing the content of implemented interventions, (iii) the independence of research teams and the potential for misclassification of intervention content, and (iv) the challenges associated with the analysis of intervention content using behavioural science tools. There is a growing demand for more robust approaches to address the methodological, practical, and ethical challenges associated with such studies. The present commentary describes key issues to be considered by research teams, as well as concrete recommendations to improve the retrospective characterisation of intervention content.

In this commentary, we discuss how researchers can best describe the content of existing behavioural interventions. We talk about the challenges we faced when analysing behavioural interventions for type 2 diabetes prevention and management in the United Kingdom and the Republic of Ireland. Specifically, we reflect on the importance of building good relationships and collaborating with those responsible for developing and/or delivering the interventions, important practical and ethical considerations, dealing with research team independence, and using behavioural science tools to guide the analysis of intervention content. We also share what we have learned from these experiences and some ideas on how to tackle these challenges. Our experiences and lessons can offer valuable insights for future analyses of existing interventions.

Exploring health professionals' knowledge, practices and attitudes regarding gestational diabetes: A cross-sectional Irish national survey.

AIM: Gestational diabetes confers short- and long-term risk of mother and offspring health complications. Healthcare professionals such as endocrinologists, diabetes nurses, dietitians, midwives and general practitioners provide gestational diabetes care. We sought to explore healthcare professionals' perspectives on gestational diabetes care during pregnancy and postpartum. METHODS: Healthcare professionals in the Republic of Ireland, whose role included gestational diabetes care were invited to complete an online 20-item survey between June and September 2022. Social media, professional organisations and personal networks were used for recruitment. Questions included guideline use, postpartum diabetes screening and advice practices. Analyses were performed using SPSS statistical software and free text was coded using NVivo. RESULTS: Seventeen healthcare professions across primary and secondary care settings participated (n = 127). No differences were noted between groups (medical, nursing/midwifery, allied health/other); therefore, findings were reported as a single group. Healthcare professionals reported using multiple different guidelines to support gestational diabetes management (n = 14). The most cited were 'Health Service Executive guidelines' (24.5%), 'local guidelines' (13.2%) and National Institute for Clinical Excellence guidelines (11.3%); 12.3% cited uncertainty, and 27.5% reported not to follow any named guidelines. For postpartum follow-up, 39% felt clear guidelines were available to support practice, 37% felt appropriate systems were in place and 29% reported effective communication between primary and secondary care services. Qualitative findings emphasised a desire for improved communication between systems, participants and providers, clear interdisciplinary guidelines, and adequate resourcing for gestational diabetes management and postpartum diabetes prevention, including comprehensive support and follow-up. CONCLUSION: System-level challenges and ineffective communication across settings are barriers to optimum postpartum care. Nationally agreed guidelines for best practice gestational diabetes management including postpartum diabetes prevention are needed.

Using behavioral science to increase core outcome set use in trials.

OBJECTIVES: Core outcome sets (COS) are agreed sets of outcomes for use in clinical trials, which can increase standardization and reduce heterogeneity of outcomes in research. Using a COS, or not, is a behavior that can potentially be increased using behavioral strategies. The aim of this study was to identify behavioral intervention components to potentially increase use of COS in trials. METHODS: This project was informed by the Behavior Change Wheel framework. Two reviewers extracted barriers and facilitators to COS use from four recently published studies examining COS use in trials. Barriers and facilitators were coded to the Capability, Opportunity, Motivation-Behavior (COM-B) model, which forms part of the Behavior Change Wheel. COM-B findings were mapped to intervention functions by two reviewers, and then mapped to behavior change techniques (BCTs). Full-team Affordability, Practicability, Effectiveness/Cost-effectiveness, Acceptability, Side effects/Safety, Equity ratings were used to reach consensus on intervention functions and BCTs. BCTs were operationalized using examples of tangible potential applications and were categorized based on similarity. RESULTS: Barriers and facilitators were identified for all capability, opportunity and motivation aspects of the COM-B model. Five intervention functions (education, training, enablement, persuasion, and modeling) and 15 BCTs were identified. Thirty-six BCT examples were developed, including providing information on benefits of COS for health research, and information choosing COS. BCT examples are categorized by approaches related to "workshops," "guidance," "audio/visual resources," and "other resources." CONCLUSION: Study findings represent diverse ways to potentially increase COS use in trials. Future work is needed to examine effects of these behavioral intervention components on COS use. If effective, increased use of COS can improve outcome reporting and minimize outcome heterogeneity and research waste.

Still face in pet dogs (Canis familiaris).

Dogs are able to cooperate in reciprocal exchange with humans but little is known about the extent of these abilities (Range & Virányi, 2015). In the Still Face paradigm, infants reply to a sudden nonreciprocal facial expression with gaze aversion and an increase in re-engagement and distress behaviors (E. Tronick et al., 1978). We directly adapted this method; the dog's owner talked to the dog, then abruptly switched to a still, neutral face, maintaining eye contact. In Study 1 (N = 20), we found that dogs showed a significant decrease in the amount of looking at the owner in the Still Face phase, paralleling the results found in gaze aversion in infants, and they performed fewer pawing and vocalizations toward the person in the Still Face phase. In Study 2 (N = 60), we included one condition of continuous physical contact, and one condition that was a direct replication of the initial study without physical contact. Similar to human infants, we found a significant decrease in looking from the Interaction phase to the Still Face phase. However, in contrast to human infants, re-engagement and stress behaviors were higher in the Interaction phase than the Still Face phase. Looking and re-engagement behaviors differed based on the condition, with a smaller difference between phases in the Petting condition. These results suggest that dogs are capable of perceiving these small changes in human affect. However, unlike human infants, dogs seem to have greater expectations about physical interactions than verbal interactions, as they reacted more strongly to an Interaction phase without physical contact than the Still Face. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Behaviour change techniques and intervention characteristics in digital cardiac rehabilitation: a systematic review and meta-analysis of randomised controlled trials.

Evidence suggests that digitally delivered cardiac rehabilitation (CR) is likely to be an effective alternative to centre-based CR. However, there is limited understanding of the behaviour change techniques (BCTs) and intervention characteristics included in digital CR programmes. This systematic review aimed to identify the BCTs and intervention characteristics that have been used in digital CR programmes, and to study those associated with effective programmes. Twenty-five randomised controlled trials were included in the review. Digital CR was associated with significant improvements in daily steps, light physical activity, medication adherence, functional capacity, and low-density lipoprotein-cholesterol when compared to usual care, and produced effects on these outcomes comparable to centre-based CR. The evidence for improved quality of life was mixed. Interventions that were effective at improving behavioural outcomes frequently employed BCTs relating to feedback and monitoring, goals and planning, natural consequences, and social support. Completeness of reporting on the TIDieR checklist across studies ranged from 42% to 92%, with intervention material descriptions being the most poorly reported item. Digital CR appears effective at improving outcomes for patients with cardiovascular disease. The integration of certain BCTs and intervention characteristics may lead to more effective interventions, however better intervention reporting is required.

Understanding how self-management education and support programmes for type 2 diabetes are expected to change behaviour: A document analysis of two programmes.

AIMS: Attendance at diabetes self-management education and support (DSMES) programmes for type 2 diabetes is associated with positive outcomes, but the impact on some outcomes is inconsistent and tends to decline over time. Understanding the active ingredients of effective programmes is essential to optimise their effectiveness. This study aimed to (1) retrospectively identify behaviour change techniques (BCTs), mechanisms of action (MoAs) and intervention functions in two DSMES programmes, the Community-Oriented Diabetes Education and the Diabetes Education and Self-Management for Ongoing and Newly Diagnosed and (2) examine variation in content between programmes. METHODS: A multiple case study approach, including a documentary analysis of the programme materials, was conducted. Materials were coded using the BCT Taxonomy v1, the Mode of Delivery Ontology v1 and the Intervention Source Ontology v1. The Behaviour Change Wheel guidance and the Theory and Techniques tool were used to identify intervention functions and MoAs. Programme stakeholders provided feedback on the findings. RESULTS: Thirty-four BCTs were identified across the programmes, with 22 common to both. The identified BCTs were frequently related to 'goals and planning', 'feedback and monitoring' and 'natural consequences'. BCTs were linked with 15 MoAs, predominantly related to reflective motivation ('beliefs about capabilities' and 'beliefs about consequences') and psychological capability ('knowledge'). BCTs served six intervention functions, most frequently 'education', 'enablement' and 'persuasion'. CONCLUSIONS: Although both programmes included several BCTs, some BCTs were rarely or never used. Additional BCTs could be considered to potentially enhance effectiveness by addressing a wider range of barriers.

Exploring patient experiences of participating in digital cardiac rehabilitation: A qualitative study.

OBJECTIVE: Digital cardiac rehabilitation (CR) has emerged as a promising alternative to in-person CR. Understanding patients' experiences and perceptions can provide valuable insights into what makes these programmes successful and identify opportunities for improvement. This study aimed to explore patients' experiences of digital CR and to understand the factors that make these programmes successful. DESIGN: A qualitative approach was taken. METHODS: From March to August 2022, we conducted semi-structured interviews with patients who were referred to one of two digital CR programmes offered on the island of Ireland. Interviews were audio-recorded, transcribed verbatim and analysed using reflexive thematic analysis. A public and patient involvement panel guided the recruitment strategy and assisted with data analysis. RESULTS: Eleven patients, predominantly male (82%) and with a mean age of 64 (range 50-75), participated in the study. Five themes were developed: (1) Empowered patients; (2) Controlling the recovery; (3) At home but not alone; (4) The world at your (digital) doorstep and; (5) Challenges of interacting online. Participants reported that digital CR equipped them with the necessary tools and support to modify their lifestyle and effectively manage their recovery. However, the opportunities for social interaction were limited and communicating online was not always straightforward. CONCLUSIONS: Participants reported that digital CR guided them towards recovery and improved their sense of empowerment and control. However, the limited opportunities for social interaction may represent a challenge for patients seeking social support.

Maternity Dietitians' Perspectives on Delivering Gestational Diabetes Care, and Postpartum Follow-Up in Ireland: A Qualitative Study.

BACKGROUND: Medical nutrition therapy is recognized as the cornerstone to optimal glycemic management of gestational diabetes (GDM) during pregnancy and registered dietitian nutritionists (RDNs) are central to delivery of this, yet data are lacking on their views of the barriers and enablers to performing this role. OBJECTIVE: This qualitative study aimed to explore the perspectives of RDNs providing medical nutrition therapy to people with GDM across the Republic of Ireland. DESIGN: Focus groups and semistructured interviews were conducted with RDNs from maternity settings whose roles included providing dietetics services to people with GDM. PARTICIPANTS AND SETTING: Five focus groups and 2 semistructured interviews were conducted with 16 RDNs from 13 maternity sites, whose roles included medical nutrition therapy to people with GDM, in Ireland in February to March 2021. A topic guide addressing GDM management, postpartum care, and future type 2 diabetes prevention was followed. DATA ANALYSIS: Data from focus groups and interviews were analyzed using reflexive thematic analysis. RESULTS: RDNs collectively viewed their role as central to supporting people with GDM. Three themes were generated: Theme 1-a complex layered role-addressed complexities in dietetics practice. Theme 2 highlighted challenges in providing optimum care with sub themes of huge changes with COVID-19, care is not equal, and no defined postpartum pathway. Theme three reported on framing future health needs through sub themes of the 6-week check is a missed opportunity, people need to understand their risk, and more integrated care and type 2 diabetes prevention is needed. CONCLUSIONS: RDNs recognize the need for continuity of care in pregnancy and postpartum for people diagnosed with GDM. However, perceived disparities in allocation of dietetics services for GDM and an absence of agreed care pathways were seen as barriers to optimum care. Collaboration and communication across primary and secondary care settings are essential and require improvement.

Barriers and enablers to maintaining self-management behaviours after attending a self-management support intervention for type 2 diabetes: a systematic review and qualitative evidence synthesis.

Attendance at type 2 diabetes self-management interventions is associated with improved outcomes. However, difficulties maintaining self-management behaviours attenuate long-term impact. This review aimed to identify and synthesise qualitative research on barriers and enablers to maintaining type 2 diabetes self-management behaviours after attending a self-management intervention. Eight electronic databases were searched to identify relevant peer-reviewed and grey literature studies. Data were synthesised using the best-fit framework synthesis approach guided by the themes and constructs identified by Kwasnicka et al. (2016) on their review of theoretical explanations for behaviour change maintenance. Study methodological limitations and confidence in findings were assessed using an adapted version of the Critical Appraisal Skills Programme (CASP) tool and the GRADE-CERQual approach respectively. Eleven articles reporting on 10 studies were included. Twenty-eight barriers and enablers were coded to the a priori themes. Barriers were commonly coded to the themes self-regulation, resources, and environmental and social influences. Enablers were commonly coded to the themes habits and maintenance motives. Methodological limitations of included studies varied, leading to moderate or low confidence in most findings. Interventions may improve behavioural maintenance by providing post-intervention support, promoting positive behaviour change motives, self-regulation, habit formation, and facilitating access to resources and support.

A qualitative investigation into the perceptions and experiences of the stigma attached to gestational diabetes mellitus among women in Denmark.

AIM: The aim of this study was to explore the perceptions of women with gestational diabetes mellitus (GDM) in Denmark, with a particular focus on GDM-specific stigma. METHOD: We conducted semi-structured interviews with 20 women with GDM from January to May 2022. All interviews were transcribed and analysed abductively using Braun and Clarke's framework for applied reflexive analysis. RESULTS: Five themes were identified, 1) victim-blaming narrative, 2) identity threat, 3) non-disclosure and anticipated stigma, 4) stigma in a clinical setting, and 5) stigma reduction in a clinical setting. Additionally, intersectionality was identified between GDM-specific stigma, notions of how to be a good mother, and stigma associated with having type 2 diabetes mellitus and overweight. Implications of GDM-specific stigma included suboptimal GDM care and management, i.e., not attending screening for GDM, and not wanting to disclose the diagnosis. CONCLUSION: The impact of GDM-specific stigma on the informants' lives included some informants not accepting all services provided by the healthcare system, and some not wanting to identify with the diagnosis. These findings may help inform both healthcare personnel and future health promotion interventions to minimize the reproduction of a victim-blaming narrative and thereby promote well-being among women with GDM.

Reply to: "The partner-an underutilized facilitator to support healthy gestational weight gain".

Facilitators and barriers influencing weight management behaviours were identified in our meta-synthesis of qualitative research entitled "Facilitators and barriers influencing weight management behaviours during pregnancy: a meta-synthesis of qualitative research". This manuscript is in response to the letter submitted by Sparks et al. regarding that work. The authors highlight the importance of including partners into intervention design when addressing weight management behaviours. We agree with the authors that it is important to include partners into intervention design and further research is granted to identify facilitators and barriers affecting their influence over women. As per our findings, the influence of the social context goes beyond the partner and we suggest that future interventions should address other relevant people in women's contexts such as parents, other relatives, and close friends.

A systematic review of behaviour change techniques used in the context of stillbirth prevention.

BACKGROUND: Stillbirth is one of the most devastating pregnancy outcomes that families can experience. Previous research has associated a wide range of risk factors with stillbirth, including maternal behaviours such as substance use, sleep position and attendance and engagement with antenatal care. Hence, some preventive efforts have been focused on tackling the behavioural risk factors for stillbirth. This study aimed to identify the Behaviour Change Techniques (BCTs) used in behaviour change interventions tacking behavioural risk factors for stillbirth such as substance use, sleep position, unattendance to antenatal care and weight management. STUDY DESIGN: A systematic review of the literature was conducted in June 2021 and updated in November 2022 in five databases: CINHAL, Psyhinfo, SociIndex, PubMed and Web of Science. Studies published in high-income countries describing interventions designed in the context of stillbirth prevention, reporting stillbirth rates and changes in behaviour were eligible for inclusion. BCTs were identified using the Behaviour Change Technique Taxonomy v1. RESULTS: Nine interventions were included in this review identified in 16 different publications. Of these, 4 interventions focused on more than one behaviour (smoking, monitoring fetal movements, sleep position, care-seeking behaviours), one focused on smoking, three on monitoring fetal movements and one on sleep position. Twenty-seven BCTs were identified across all interventions. The most commonly used was "Information about health consequences" (n = 7/9) followed by "Adding objects to the environment" (n = 6/9). One of the interventions included in this review has not been assessed for efficacy yet, of the remaining eight, three showed results in the reduction of stillbirth rates. and four interventions produced behaviour change (smoking reductions, increased knowledge, reduced supine sleeping time). CONCLUSIONS: Our findings suggest that interventions designed to date have limited effects on the rates of stillbirth and utilise a limited number of BCTs which are mostly focused on information provision. Further research is necessary to design evidence base behaviour change interventions with a greater focus to tackle all the other factors influencing behaviour change during pregnancy (e.g.: social influence, environmental barriers).

Pet dogs (Canis familiaris) re-engage humans after joint activity.

Joint intentionality, the mutual understanding of shared goals or actions to partake in a common task, is considered an essential building block of theory of mind in humans. Domesticated dogs are unusually adept at comprehending human social cues and cooperating with humans, making it possible that they possess behavioral signatures of joint intentionality in interactions with humans. Horschler and colleagues (Anim Behav 183: 159-168, 2022) examined joint intentionality in a service dog population, finding that upon interruption of a joint experience, dogs preferentially re-engaged their former partner over a passive bystander, a behavior argued to be a signature of joint intentionality in human children. In the current study, we aimed to replicate and extend these results in pet dogs. One familiar person played with the dog and then abruptly stopped. We examined if dogs would preferentially re-engage the player instead of a familiar bystander who was also present. Consistent with the findings of Horschler and colleagues (Anim Behav 183: 159-168, 2022), pet dogs preferentially gazed toward and offered the toy to the player significantly more than the familiar bystander. However, no difference was observed in physical contact. These findings provide preliminary evidence for behavioral signatures of joint intentionality in pet dogs, but future work is needed to understand whether this phenomenon extends to other contexts.

Harnessing digital health to optimise the delivery of guideline-based cardiac rehabilitation during COVID-19: an observational study.

BACKGROUND: The COVID-19 pandemic accelerated the uptake of digital health interventions for the delivery of cardiac rehabilitation (CR). However, there is a need to evaluate these interventions. METHODS: We examined the impact of an evidence-based, digital CR programme on medical, lifestyle and psychosocial outcomes. Delivered by an interdisciplinary team of healthcare professionals, the core components of this 12-week programme included lifestyle modification, medical risk factor management, psychosocial and behavioural change support. To support self-management, patients were provided with a Fitbit, a home blood pressure (BP) monitor and an interactive workbook. Patients received access to a bespoke web-based platform and were invited to attend weekly, online group-based supervised exercise sessions and educational workshops. Outcomes were assessed at baseline, end of programme and at 6-month follow-up. RESULTS: Over a 3-month period, 105 patients (88% with coronary heart disease) were referred with 74% (n=77) attending initial assessment. Of these, 97% (n=75) enrolled in the programme, with 85% (n=64) completing the programme, 86% (n=55) of completers attended 6-month follow-up. Comparing baseline to end of programme, we observed significant improvements in the proportion of patients meeting guideline-recommended targets for physical activity (+68%, p<0.001), BP (+44%, p<0.001) and low-density lipoprotein cholesterol (+27%, p<0.001). There were significant reductions in mean weight (-2.6 kg, p<0.001). Adherence to the Mediterranean diet score improved from 5.2 to 7.3 (p<0.001). Anxiety and depression levels (Hospital Anxiety and Depression score) both reduced by more than 50% (p<0.001). The majority of these improvements were sustained at 6-month follow-up. CONCLUSION: Outcomes from this study suggest that interdisciplinary digital CR programmes can be successfully implemented and help patients achieve guideline recommended lifestyle, medical and therapeutic targets.

Exploring barriers and enablers to the delivery of Making Every Contact Count brief behavioural interventions in Ireland: A cross-sectional survey study.

OBJECTIVES: The public health impact of the Irish Making Every Contact Count (MECC) brief intervention programme is dependent on delivery by health care professionals. We aimed to identify enablers and modifiable barriers to MECC intervention delivery to optimize MECC implementation. DESIGN: Online cross-sectional survey design. METHODS: Health care professionals (n = 4050) who completed MECC eLearning were invited to complete an online survey based on the Theoretical Domains Framework (TDF). Multiple regression analysis identified predictors of MECC delivery (logistic regression to predict delivery or not; linear regression to predict frequency of delivery). Data were visualized using Confidence Interval-Based Estimates of Relevance (CIBER). RESULTS: Seventy-nine per cent of participants (n = 283/357) had delivered a MECC intervention. In the multiple logistic regression (Nagelkerke's R2  = .34), the significant enablers of intervention delivery were 'professional role' (OR = 1.86 [1.10, 3.15]) and 'intentions/goals' (OR = 4.75 [1.97, 11.45]); significant barriers included 'optimistic beliefs about consequences' (OR = .41 [.18, .94]) and 'negative emotions' (OR = .50 [.32, .77]). In the multiple linear regression (R2  = .29), the significant enablers of frequency of MECC delivery were 'intentions/goals' (b = 10.16, p = .02) and professional role (b = 6.72, p = .03); the significant barriers were 'negative emotions' (b = -4.74, p = .04) and 'barriers to prioritisation' (b = -5.00, p = .01). CIBER analyses suggested six predictive domains with substantial room for improvement: 'intentions and goals', 'barriers to prioritisation', 'environmental resources', 'beliefs about capabilities', 'negative emotions' and 'skills'. CONCLUSION: Implementation interventions to enhance MECC delivery should target intentions and goals, beliefs about capabilities, negative emotions, environmental resources, skills and barriers to prioritization.

Using a digital health intervention "INTERCEPT" to improve secondary prevention in coronary heart disease (CHD) patients: protocol for a mixed methods non-randomised feasibility study.

Background: Digital health interventions (DHIs) are increasingly used for the secondary prevention of cardiovascular disease (CVD). The aim of this study is to determine the feasibility of "INTERCEPT", a co-designed DHI developed to improve secondary prevention in hospitalised coronary heart disease patients (CHD). Methods: This non-randomised feasibility study will be conducted using a mixed methods process evaluation with a sample of 40 patients in an acute hospital setting. Informed by behaviour change theory, the Intercept application (I-App) integrates a smartphone interface, health care professional portal, a fitness wearable and a blood pressure monitor. I-App is designed to support and motivate patients to set goals, self-monitor lifestyle and medical risk factors, and manage their medications, with the health care professional portal enabling monitoring and communication with patients. Using convenience sampling, eligible patients will be recruited in two phases, a pre-implementation phase and an implementation phase. During the pre-implementation phase participants will not immediately receive the I-App but will be invited to receive the I-App at 3 months follow-up. This will enable early learning about the processes of recruitment and conducting the assessment prior to full scale deployment of the I-App. During the implementation phase, participants will be invited to download the I-App to their smartphone prior to hospital discharge. Qualitative interviews will be conducted among a subset of patients and health care professionals to gain a greater insight into their experience of using the I-App. Primary outcomes will be assessed at baseline and 3-month follow-up. Using pre-defined feasibility criteria, including recruitment, retention and engagement rates, together with data on intervention acceptability, will determine the appropriateness of progressing to a definitive trial. Discussion: This study will provide important insights to help inform the feasibility of conducting a definitive trial of "INTERCEPT" among coronary heart disease patients in a critical health care setting.

Supporting GPs and people with hypertension to maximise medication use to control blood pressure: Protocol for a pilot cluster RCT of the MIAMI intervention.

Background: Hypertension is one of the most important risk factors for stroke and heart disease. Recent international guidelines have stated that 'poor adherence to treatment - in addition to physician inertia - is the most important cause of poor blood pressure control'. The MaxImising Adherence, Minimising Inertia (MIAMI) intervention, which has been developed using a systematic, theoretical, user-centred approach, aims to support general practitioners (GPs) and people with hypertension to maximise medication use, through the facilitation of adequate information exchange within consultations about long-term antihypertensive medication use and adherence skill development. The aim of the MIAMI pilot cluster randomised controlled trial (RCT) is to gather and analyse feasibility data to allow us to (1) refine the intervention, and (2) determine the feasibility of a definitive RCT. Methods: GP practices (n = 6) will be recruited and randomised to the intervention arm (n = 3) or usual care control arm (n = 3). Each practice will recruit 10 patient participants. For a patient to be eligible they must have a diagnosis of hypertension, be on two or more anti-hypertensive medications, must not be achieving recommended blood pressure levels, and be over the age of 65 years. Participants in the intervention arm will meet their GP and receive the MIAMI intervention twice over three months. Quantitative data collection will take place at baseline and three month follow up. A pilot health economic analysis and a qualitative sub-study will also be incorporated into the study. Discussion: This pilot cluster RCT of the MIAMI intervention will allow us to gather valuable acceptability and feasibility data to further refine the intervention so it optimally designed for both GP and patient use. In particular, the qualitative component will provide an insight into GP and patient experiences of using the intervention.

Obesity in Adults: A 2022 Adapted Clinical Practice Guideline for Ireland.

BACKGROUND: This Clinical Practice Guideline (CPG) for the management of obesity in adults in Ireland, adapted from the Canadian CPG, defines obesity as a complex chronic disease characterised by excess or dysfunctional adiposity that impairs health. The guideline reflects substantial advances in the understanding of the determinants, pathophysiology, assessment, and treatment of obesity. SUMMARY: It shifts the focus of obesity management toward improving patient-centred health outcomes, functional outcomes, and social and economic participation, rather than weight loss alone. It gives recommendations for care that are underpinned by evidence-based principles of chronic disease management; validate patients' lived experiences; move beyond simplistic approaches of "eat less, move more" and address the root drivers of obesity. KEY MESSAGES: People living with obesity face substantial bias and stigma, which contribute to increased morbidity and mortality independent of body weight. Education is needed for all healthcare professionals in Ireland to address the gap in skills, increase knowledge of evidence-based practice, and eliminate bias and stigma in healthcare settings. We call for people living with obesity in Ireland to have access to evidence-informed care, including medical, medical nutrition therapy, physical activity and physical rehabilitation interventions, psychological interventions, pharmacotherapy, and bariatric surgery. This can be best achieved by resourcing and fully implementing the Model of Care for the Management of Adult Overweight and Obesity. To address health inequalities, we also call for the inclusion of obesity in the Structured Chronic Disease Management Programme and for pharmacotherapy reimbursement, to ensure equal access to treatment based on health-need rather than ability to pay.

The multimorbidity collaborative medication review and decision making (MyComrade) study: a pilot cluster randomised trial in two healthcare systems.

BACKGROUND: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. AIM: The pilot study aimed to assess the feasibility of a definitive trial of the MyComrade intervention across two healthcare systems (Republic of Ireland (ROI) and Northern Ireland (NI)). DESIGN: A pilot cluster-randomised controlled trial was conducted (clustered at general practice level), using specific progression criteria and a process evaluation framework. SETTING: General practices in the ROI and NI. PARTICIPANTS: Eligible practices were those in defined geographical areas who had GP's and Practice Based Pharmacists (PBP's) (in NI) willing to conduct medication reviews. Eligible patients were those aged 18 years and over, with multi morbidity and on ten or more medications. INTERVENTION: The MyComrade intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care, using a planned collaborative approach guided by an agreed checklist, within a specified timeframe. OUTCOME MEASURES: Feasibility outcomes, using pre-determined progression criteria, assessed practice and patient recruitment and retention and intervention acceptability and fidelity. Anonymised patient-related quantitative data, from practice medical records and patient questionnaires were collected at baseline, 4 and 8 months, to inform potential outcome measures for a definitive trial. These included (i) practice outcomes-completion of medication reviews; (ii) patient outcomes-treatment burden and quality of life; (iii) prescribing outcomes-number and changes of prescribed medications and incidents of potentially inappropriate prescribing; and (iv) economic cost analysis. The framework Decision-making after Pilot and feasibility Trials (ADePT) in conjunction with a priori progression criteria and process evaluation was used to guide the collection and analysis of quantitative and qualitative data. RESULTS: The recruitment of practices (n = 15) and patients (n = 121, mean age 73 years and 51% female), representing 94% and 38% of a priori targets respectively, was more complex and took longer than anticipated; impacted by the global COVID-19 pandemic. Retention rates of 100% of practices and 85% of patients were achieved. Both practice staff and patients found the intervention acceptable and reported strong fidelity to the My Comrade intervention components. Some practice staff highlighted concerns such as poor communication of the reviews to patients, dissatisfaction regarding incentivisation and in ROI the sustainability of two GPs collaboratively conducting the medication reviews. Assessing outcomes from the collected data was found feasible and appropriate for a definitive trial. Two progression criteria met the 'Go' criterion (practice and patient retention), two met the 'Amend' criterion (practice recruitment and intervention implementation) and one indicated a 'Stop - unless changes possible' (patient recruitment). CONCLUSION: The MyComrade intervention was found to be feasible to conduct within two different healthcare systems. Recruitment of participants requires significant time and effort given the nature of this population and the pairing of GP and pharmacist may be more sustainable to implement in routine practice. TRIAL REGISTRATION: Registry: ISRCTN, ISRCTN80017020 ; date of confirmation 4/11/2019; retrospectively registered.