Pilot and Feasibility Studies

ObjectivesTo investigate the effectiveness of adding a brief vocational advice intervention to usual care in reducing the number of days absent from work over a period of 6 months in adults given a fit note by their general practice. DesignMulticentre, pragmatic, two parallel-arm, randomised controlled trial with health economic analyses and nested qualitative study. A computer-generated stratified block randomisation (ratio 1:1) was used to allocate arms. SettingParticipants will be recruited from general practices in the UK. Participants720 adults consulting in general practice, for any health condition, and receiving a fit note who have been absent from work for more than two-weeks but less than six months. InterventionsParticipants in the intervention arm will be offered usual care and vocational advice delivered by a Vocational Support Worker (VSW) remotely via phone or videoconferencing. Participants in the control arm will be offered usual care. Main outcome measureNumber of days off work over 6 months. Follow-up data collection is via questionnaires at 6 weeks and 6 months. ConclusionsThis paper presents the rationale, design and methods of the Work And Vocational advicE (WAVE) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for patients with work absence. Trial registration: Clinical Trials: NCT04543097 Protocol number: Version 5.1

Male urinary incontinence (UI) is most prevalent in older men, with one in three men aged 65 and above having problems maintaining continence. Addressing health inequalities, male-female disparities in continence services, and low health-seeking behavior among men emphasizes the necessity for co-creating an intervention that empowers them to self-manage their UI. We aim to co-create a self-management intervention with an older men and Health care provider (HCP) group and assess its usability/acceptability among older men with UI. The intervention mapping (IM) framework, a co-creation strategy, will be used to co-create a self-management tool, followed by usability/acceptability testing. The study will be guided by the first four IM steps: the logic model of the problem, the logic model of change, program/intervention design, and program/intervention production, followed by preliminary testing. A participatory group of older men with UI recruited from an existing group of patient partners, and continence care experts will be involved in all steps of the IM process. Usability/acceptability testing will be conducted on a sample of 20 users recruited through seniors associations and retirement living facilities. After accessing the self-management tool for a week, participants will complete a product usability testing scale (aka System Usability Scale-SUS) and/or an acceptability test, depending on the preferred mode(s) of intervention delivery. Data will be analyzed using descriptive statistics. A benchmark overall mean usability score of 70 represents a good/usable product, based on the large database of SUS scores.

BackgroundA study of premature babies, less than 32 weeks gestation, found that the median number of medicines per patient at discharge was 2.5 (range 2 to 7), with 28% of babies discharged on more than 3 medicines (1). Medication administration to infants can cause anxiety and concern for parents/carers who worry about making mistakes. A systematic review of carers for all ages has estimated the administration error rate at home to be between 2 and 33% (2) while a rate of 66.3% was recorded in medication administered to premature infants where parents were responsible for administration (3). It has also been reported that up to 90% of carers will administer a medicine incorrectly at some point (2). The aim of this study is to work with healthcare professionals (HCPs) and parents/carers to co-design resources aimed at improving medication safety and reducing parental anxiety for those giving medications to neonates at home. MethodsWork Package 1: Project management and co-ordination phase: preparation of protocols and survey material and ethics approval applications. Work Package 2: Stakeholder engagement phase, e-surveys and focus groups: An electronic-survey (e-survey) will be developed by a multi-disciplinary study management group (SMG). This will be circulated to HCPs involved in the care of neonates and parents/carers whose babies had recently been discharged from hospital. A small number of parents/carers will be invited to take part in focus groups. Work Package 3: Co-design of resources and quantitative evaluation: Parents/carers willing to co-design educational and information resources to support safe administration of medicines to neonates following discharge will be recruited. A quantitative evaluation of the effect of the resource will be conducted with a new group of caregivers to measure specific outcome(s). DiscussionThis study aims to co-develop, with healthcare professionals (HCPs) and parents/carers, resources aimed at improving medication safety and reducing parental anxiety for those giving medications to neonates at home. Co-development of resources with HCPs and parents, ensures that the project outcomes are relevant and useful, leading to a reduction in parental anxiety. Trial registrationISRCTN registry Ref 17332620

ISO-101 is a novel wrist-worn device designed to deliver guided upper-limb isometric counter-manoeuvres via a retractable resistance tether with visual feedback. This proof-of-concept study evaluated feasibility, safety and preliminary efficacy in adults with orthostatic hypotension (OH). In a fixed-sequence, within-participant design, each participant completed three active-stand assessments: unassisted; device activation while supine immediately before standing; and device activation immediately after standing. The primary outcome was the proportion of responders, defined a priori as achieving, with device use versus the unassisted condition, [≥]10 mmHg improvement in any one of resting blood pressure, nadir standing blood pressure at 30- 60 s, or reduction in the orthostatic blood-pressure drop (systolic or diastolic). The study was powered to test the responder proportion against a 20% benchmark derived from standard non-pharmacological care. Seventeen participants were enrolled (mean age 72 years; 77% male) and fourteen completed all assessments. Six of fourteen (43%) met the responder definition, exceeding the benchmark (exact binomial p=0.012). When the device was used immediately after standing, responders showed mean (SD) increases of +22.13 (16.29) mmHg systolic and +19.52 (12.47) mmHg diastolic compared with the unassisted stand; pre-stand activation yielded smaller, non-significant changes. No adverse events occurred. Usability was high, with 88% rating the device easy to use and 69% indicating they would use it in daily life. ISO-101 produced clinically meaningful improvements in orthostatic blood pressure in a substantial subset of patients, supporting progression to larger, controlled evaluations. WHAT IS ALREADY KNOWNO_LIOrthostatic hypotension (OH) is common and clinically significant, yet counter-manoeuvres are often poorly implemented in practice. C_LIO_LIWearable assistance for standardised counter-manoeuvres has not previously been tested in OH. C_LI WHAT THIS STUDY ADDSO_LIIn this proof-of-concept study, ISO-101, a guided wrist-worn device, achieved a clinically meaningful and statistically significant responder rate, exceeding that typically observed with standard care. C_LIO_LIResponders demonstrated marked increases in postural blood pressure, the device was rated as highly usable, and no adverse events were reported. C_LI HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICYO_LIThese findings highlight the potential for wearable-assisted therapy in OH and support the need for further clinical evaluation. C_LI TRIAL REGISTRATION NUMBERClinicalTrials.gov: NCT06039410

IntroductionCompared with the general population, people with serious mental illness (SMI) are 2-3 times more likely to develop type 2 diabetes, have poorer outcomes, and die 15 to 20 years younger, often as a result of long-term physical health conditions. Standard diabetes care does not meet the needs of people with SMI and they are frequently excluded from research, missing out on innovation. As diabetes care increasingly uses technology like continuous glucose monitoring (CGM) it is important to consider the views of people with SMI when new interventions are developed. This is a study protocol to identify candidate components of a structured CGM intervention for people with SMI, including the co-design of a logic model and programme theory. MethodsDrawing on experience-based co-design (EBCD) methods, we propose to collaborate with service-users, carers, and healthcare professionals to undertake early-phase development work for a novel intervention that maximises the potential of CGM to facilitate behaviour change. Fifteen participants will be recruited through existing cohorts and networks in England. The co-design will be informed by existing evidence and based on links between mechanisms of action and behaviour change techniques. Through a series of events (discovery sessions, co-design workshop, celebration event), we will identify candidate components for a prototype intervention ready for further development and testing. A logic model and programme theory will be developed and refined iteratively. DiscussionThe main output of this study will be a logic model and programme theory for a novel prototype intervention, ready for further testing following best practice intervention development, such as the Medical Research Council guidance for the development and evaluation of complex interventions. An intervention that makes CGM accessible for people with SMI has the potential to make a considerable contribution to reducing the profound health inequalities experienced by this population.

The REdressing Long-tErm Antidepressant uSE in general practice (RELEASE) trial is a pragmatic cluster randomized controlled trial (cRCT) that seeks to determine whether a novel multi-strategy intervention that supports safe cessation of long-term antidepressants is superior to Usual Care.1 Pragmatic trials are designed to determine how well interventions work in clinical practice under everyday conditions.2 The multi-strategy intervention has two forms, known as RELEASE and RELEASE+. RELEASE for patients includes direct patient education and resources3 and an invitation to medication review; RELEASE for general practitioners (GPs) includes education, training in the brief intervention (Ask, Advise, Assist) and printable resources via practice management software. RELEASE+ additionally includes for patients links to freely available information online via an App, and for GPs clinical audit and feedback on practice prescribing of antidepressants. Patient directed education material has the potential to support safer prescribing, including in this case improved recognition and management of antidepressant withdrawal symptoms.4, 5 Brief interventions have the potential to change GP prescribing behaviour.6 The primary comparison of interest is whether any RELEASE intervention is superior to Usual Care. A secondary comparison will be between the two types of RELEASE interventions (RELEASE and RELEASE+). The purpose of this document is to minimise bias and ensure transparency and internal validity for the findings of the trial, by defining and making publicly available the analysis approach prior to reviewing or analysing trial data. The statistical analysis plan (SAP) will inform analysis and reporting of the main effectiveness findings of the trial. It provides a detailed description of the primary and secondary trial outcomes and the methods for statistical comparison.

Young people living with type 1 diabetes (T1D) navigate daily complex diabetes related tasks as they take on increasing (and eventually full) responsibility for managing their condition, in addition to developing their lives as independent adults. Alongside the need for careful day-to-day diabetes management, the psychosocial burden and mental health impact and stigma are well recognised. Despite advances in psychological care, many young people with diabetes still experience a greater mental health burden than those without diabetes. This study aims to develop a brief and simple intervention for young people with T1D that will support their wellbeing day to day, as required, and grow their ability to live confidently with their condition that requires lifelong meticulous management. This study will consist of qualitative research and collaboration with young people with T1D and their siblings, friends, and peers to co-create a testable intervention. In Part 1, research interviews will be conducted with young people (16-24 years old) with T1D and, where possible, their siblings/peers to understand the day-to-day challenges of type 1 and what a novel intervention should address. Thematic analysis of interviews will inform the generation of a prototype intervention to take into part two, focus group discussions. Focus groups with (i) young people with T1D and, separately (ii) carers (comprising parents, carers, teachers, specialist nurses). Collaborative principles will be used to review, redesign and evolve the intervention to meet user needs. A blend of narrative and thematic analysis will inform the findings and report. Insights from Parts 1 and 2 will shape a user-defined and formatively analysed brief and simple intervention and future study design ready for pilot testing. The aim of this part of the research is to maximise acceptability and usability of a testable intervention by the target population. To aim of the future intervention will be to demonstrate effectiveness in helping young adults to live well with T1D. METADATAThis research is funded by a studentship to the first author, provided by University of Brighton as part of its partnership activities with the National Institute for Health Research (NIHR) Applied Research Collaboration Kent, Surrey, Sussex. The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Ethical approval for this study was provided by Cornwall and Plymouth Research Ethics Committee on behalf of the Health Research Authority and Health and Care Research Wales on 22 Aug 2022 (22/SW/0097). The University of Brighton is the Sponsor (protocol number 2022-9871).

IntroductionAssessing the fidelity of complex behavioural interventions and examining the contextual reasons why such interventions succeed, or fail are important activities but challenging and rarely reported. The Smoking Treatment Optimisation in Pharmacies (STOP) trial is a cluster randomised trial evaluating the effectiveness of a complex intervention to optimise the National Health Service (NHS) Stop Smoking Service delivered in community pharmacies. This complex intervention comprises a training package for pharmacy staff involving motivational interviewing and communication skills aimed at increasing smoking cessation knowledge and proactive client engagement. We report on a process evaluation which was planned alongside the trial to offer findings that will assist in the interpretation of the main trial results and help inform potential implementation in community pharmacy settings on a wider scale. Methods and analysisQuantitative data on recruitment and retention process of pharmacies, pharmacy staff and service users has been collected during the trial along with data on dose and fidelity of the intervention delivery from participating intervention arm pharmacies to identify potential implementation issues. Simulated client data on behaviour change skills and display of intervention materials from both control and intervention pharmacies is being assessed. These data will be combined with qualitative data; including adviser-smoker consultation recordings that provide a snapshot of behaviour skills delivery by stop smoking advisers and semi-structured interviews with pharmacy staff and services users from the intervention arm. DiscussionPublished protocols for process evaluations of complex health interventions are still rare despite increasing funding for this work to facilitate understanding of trial outcomes from an implementation perspective. This mixed methods protocol will contribute to the developing literature around the conduct of process evaluation and the value they add to health services research. Trial registration number ISRCTN16351033. Strengths and limitations of this studyO_LIA planned mixed methods process evaluation that draws together data from different sources to help explain the trial results and establish the feasibility of scaling this complex intervention up in community pharmacy settings. C_LIO_LIA strength is the use of a previously tested mystery shopping method to assess fidelity of skills performance at the pharmacy counter C_LIO_LIThe process evaluation relies on willing pharmacy staff and service users involved in the trial to collect some of the data, which may introduce bias. C_LIO_LIThis paper also provides a detailed example of how to use the MRC framework for process evaluation of complex interventions to design an extensive process evaluation within trial settings. C_LI

AimsThe primary aim is to determine the concentration of metformin in the plasma of breastfed infants to lactating women being treated for type 2 diabetes. The secondary aim is to determine the concentration of metformin in breast milk and maternal plasma and the milk-to-plasma ratio of the mothers and to calculate the average daily infant dose (ADID) and relative infant dose (RID). MethodsThe study has a low intervention clinical trial design in the sense that breast milk and blood will be collected merely to study excretion of metformin into breastmilk and transferal to her child. Participation in the study will not decide or in any other way interfere with patients treatment as prescribed by their physician. Only patients that already have been assigned treatment with metformin by their physician will be approached and asked for participation. All procedures for blood collection will follow established clinical routines at the clinical sites. The sampling will take place {approx} 6-8 weeks postpartum. The study has been approved as a low-intervention clinical trial by the Swedish Medical Product Agency (Publicly available in CTIS (EU CT no. 2022-501693-19-00 and registered in EUPAS 105190) which includes an approval by the Swedish Ethical Review Authority. The date for the ethics approval is 17 February 2023 ResultsUp to date (24 February) 18 women and infants have been recruited and sampled. Recruitment is ongoing. ConclusionsAn evaluation of pharmacokinetic results as well as clinical experiences related to recruitment and sampling will be systematically conducted upon completion of the study, which is estimated to conclude by the end of 2025. Preliminary experiences suggest that the primary challenge for a study of this nature is recruiting a sufficient number of participants. HighlightsWith as few as 5% of available medications being adequately monitored, tested and labelled with safety information for use in breastfeeding women there is a great need to monitor and evaluate the potential risk of transfer of medicines to the infant. We demonstrate here how a low-intervention clinical trial may be designed in order to provide evidence of transfer.

BackgroundPharmacies in the UK are increasingly implementing a self-selection model for Pharmacy medicines (PMEDs) in physical pharmacies and allowing their purchase from online pharmacies. This model potentially weakens the additional level of protection recommended by the Medicines and Healthcare products Regulatory Agency (MHRA) by removing the opportunity for intervention, possibly risking patient harm. ObjectiveTo assess the risks and benefits associated with a PMEDs self-selection model in pharmacy settings. MethodsA systematic search was conducted across three databases (PubMed/Medline, Embase, and Cochrane Library) from 01/10/2024 to 22/10/2024. The search terms comprised Medical Subject Headings (MeSH) terms and free text with wildcard truncations. Only studies published from 01/2014 - 10/2024 and published in English were eligible for inclusion. Studies identified (were exported to Excel, where duplicates were removed . The Mixed Methods Appraisal Tool (MMAT) was used to assess the quality of all included studies. ResultsA total of 55 studies of the 104 initially screened were included in the review. The country most frequently reported on was Australia (10/55; 18%), followed by multi-location/global studies (9/55; 16%). The majority (30/55; 55%) of studies focussed on the views and experiences of pharmacy professionals, and approximately a quarter (13/55; 24%) focussed on patient views, experiences, or behaviours. The benefits identified from the included literature were relatively consistent, focussing on access to care, reducing pressure on health systems, and improved patient autonomy. However, the list of risks identified was far more heterogenous, covering a range of themes, including, adverse effects of medication, inappropriate use of medication, and reduced intervention opportunities, and self-diagnoses delaying required care. The risks associated with medication self-selection were more frequently discussed when compared with benefits. ConclusionsAlthough this review identified risks and benefits associated with medication self-selection more broadly, none of the included publications solely discussed PMEDs. More research is needed to fully understand the risks and benefits of the self-selection model for this classification of medicines.

BackgroundEffective management of type 2 diabetes is an increasing challenge for health services globally. Integrated care, targeted at increasing capacity in primary care for earlier intervention in type 2 diabetes, may reduce adverse health outcomes, with benefits accrued over time. This protocol aims to describe a causal approach for the evaluation of a specialist-led integrated model of care delivered in Australian general practices, using linked administrative health data. MethodsThis protocol outlines an observational cohort study using the Lumos data asset (New South Wales Health), linking general practice and hospital data. It follows the target trial framework, emulating a parallel cluster-randomised trial, and applies the estimands framework proposed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. It describes the data structure and statistical analysis plan required for causal inference. The primary causal estimand is the effect of the Diabetes Alliance Program Plus, an integrated care intervention, on all-cause hospitalisation rates for adults actively attending general practice with current or newly diagnosed type 2 diabetes over a 5-year follow-up period. DiscussionThis protocol applies the target trial framework to emulate a parallel cluster-randomized trial of the Diabetes Alliance Program Plus using linked administrative data. This approach addresses confounding and selection bias inherent in observational evaluations of practice-level interventions and will generate robust real-world evidence to inform policy regarding type 2 diabetes management in primary care settings. Trial registrationACTRN12622001438741; 10th November 2022, retrospectively registered: https://www.anzctr.org.au/ACTRN12622001438741.aspx.

Background Trials in occupational populations, such as surgeons, face feasibility challenges due to high workload, restricted availability, and clinical heterogeneity, which may compromise recruitment, adherence, and retention. Objective To prespecify the feasibility framework and progression criteria for an internal pilot phase embedded within a pragmatic randomized controlled trial (RCT) comparing Mechanical Diagnosis and Therapy with generalized exercise in surgeons with chronic spinal pain. Design Protocol for a prespecified internal pilot phase embedded within a pragmatic, two-arm, parallel-group RCT. Methods The internal pilot will include the first four months of recruitment and aims to randomize at least 12 participants. Feasibility will be assessed across predefined domains, i.e., recruitment, eligibility, consent, intervention uptake, adherence, retention, data completeness, and treatment fidelity. Each domain is operationally defined and linked to prespecified progression criteria to ensure interpretability and decision-making utility. Criteria will be interpreted collectively to guide trial continuation. A minimal qualitative process evaluation will be embedded. Ethics and dissemination The host trial has received ethical approval (N-20240046) and is registered at ClinicalTrials.gov (NCT07293130). The findings from the internal pilot will be reported in a separate feasibility manuscript.

Procedures carried out in acute care settings, such as emergency departments (EDs), are among the most common sources of acute pain experienced by children. Such procedures may include intravenous insertions (IVs), venipuncture, and wound irrigation and repair. Inadequately managed procedural pain can cause negative short-term and long-term implications for children, ranging from anxiety to aversion to healthcare. Parents have repeatedly expressed that they do not have the necessary tools to comfort or distract their child during uncomfortable medical procedures. As such, the purpose of this study was to work with parents to develop and evaluate two digital tools for pediatric procedural pain. A whiteboard animation video and interactive infographic were developed following a systematic review and interview with parents. Prototypes were tested in five ED waiting rooms in two Canadian provinces. Sites included those in urban, rural, and remote settings. Overall, parents rated the tools highly, suggesting that engaging with parents to develop arts-based digital tools is a highly effective method in ensuring that parents can understand and utilize complex health information. Author ContributionsThis study was conducted under the supervision of Drs. Shannon D. Scott (SDS) and Lisa Hartling (LH), PIs for translation Evidence in Child Health to enhance Outcomes (ECHO) Research and the Alberta Research Centre for Health Evidence (ARCHE), respectively. Both PIs designed the research study and obtained research funding through Translating Emergency Knowledge for Kids (TREKK) Networks of Centres of Excellence of Canada (NCE). SDS designed and supervised all aspects of tool development and evaluation. LH co-designed and supervised the qualitative study involving interviews with parents and systematic review of parent experiences and information needs. Tony An developed the infographic. Kassi Shave conducted and analyzed qualitative interviews with parents. Anne Le (AL) conducted usability testing. AL analyzed usability data. All authors contributed to the writing of this technical report and provided substantial feedback. This work was funded by: Networks of Centres of ExcellenceO_LIKlassen, T., Hartling, L., Jabbour, M., Johnson, D., & Scott, S.D. (2015). Translating emergency knowledge for kids (TREKK). Networks of Centres of Excellence of Canada Knowledge Mobilization Renewal ($1,200,000). January 2016 - December 2019. C_LI Women and Childrens Health Research Institute (WCHRI)O_LIScott, S.D & Hartling L. (2016). Translating Emergency Knowledge for Kids renewal. Women and Childrens Health Research Institute (matched dollars, $150,000). April 2016 - December 2019. C_LI This report should be cited asLe, A., Hartling, L., Scott, S.D. (2021). The development and usability testing of two arts-based knowledge translation tools for pediatric procedural pain. Technical Report. ECHO Research, University of Alberta. Available at: http://www.echokt.ca/research/technical-reports/

BackgroundThe Community and Hospital cAre Bundle to improve the medical treatment of cLaudIcation and critical limb iSchaemia (CHABLIS) study is a prospective mixed-methods study across NHS hospitals and primary care networks, which aims to determine the feasibility of using a complex intervention in the form of a care bundle, consisting of checklists, leaflets and letters, called the LEGS intervention (LEaflet Gp letter Structured checklist), to improve the care of patients with peripheral arterial disease (PAD). The aim of this qualitative study was to gain an understanding of the acceptability of the provision and delivery of the LEGS intervention, by patients, general practitioners and secondary care clinicians. Engaging stakeholders in these conversations provides insights for future intervention refinement, uptake and implementation. MethodsThis qualitative study was embedded within the CHABLIS study. Twenty-five semi-structured telephone interviews were conducted with i) patients who had received the intervention (n=11), ii) secondary care clinicians responsible for delivering the intervention (n=8), and iii) general practitioners (n=6). Data were initially analysed using inductive descriptive thematic analysis. The consolidated framework for implementation research was then used as a matrix to explore patterns in the data and to map connections between the three participant groups. Lastly, interpretive analysis allowed for refining, and a final coding frame was developed. ResultsFour overarching themes were identified: i) The potential to make a difference, ii) A solution to address the gap in no mans land, iii), Prioritising and making it happen and iv) Personalised information and supportive conversations for taking on the advice. The intervention was viewed as an opportunity to meet patient needs, and to develop shared primary and secondary care working practices. The impetus for prioritising and delivering the intervention was further driven by its flexibility and adaptability to be tailored to the individual and to the environment. ConclusionsThe LEGS intervention can be tailored for use at early and late stages of PAD, can be provided across primary and secondary care settings, and provides an opportunity to promote shared working across the primary-secondary care interface. Contributions to the literatureO_LIPrimary and secondary care providers acknowledged the need for an intervention to support them to deliver guideline-based PAD treatment, and to target the intervention earlier in the PAD treatment pathway. C_LIO_LIA gap was identified in terms of support for patients and providers between the time of diagnosis of early-stage PAD (e.g., claudication) and a subsequent potential diagnosis of advanced PAD. The LEGS intervention can be used to fill this gap by enabling providers to support patients to receive help, education, support, or appropriate medication to address their condition. C_LIO_LIPatient-provider interactions that promote shared decision-making and that support patient preference are also important determinants in the success of implementation. C_LI

BackgroundRecruiting and retaining participants in sarcopenia trials is challenging due to barriers in diagnosis, case-finding, exclusion criteria, frailty and drop-out. We describe and evaluate processes used by the MET-PREVENT randomised controlled trial to improve recruitment and retention. MethodsMET-PREVENT was a two-centre, double-blinded, placebo-controlled trial examining the efficacy of metformin in patients with probable sarcopenia and either pre frailty or frailty. A telephone pre-screening step used the SARC-F questionnaire to identify those at risk of sarcopenia. The study was designed to maximise inclusion; and all study assessments could be conducted in participants homes or at a clinical research facility according to participant preference. Outcome measures were chosen to be simple and quick to collect with low burden to participants. Data on absolute numbers approached and randomised from a range of recruitment channels were analysed along with percentage conversion from approach to randomisation. The relationship between baseline factors at prescreening and conversion to randomisation (age, sex, use of walking aids, SARC-F score) was analysed to evaluated. Results1630 people were approached and 268 people expressed interest in participation - of whom 214/268 (80%) underwent telephone pre-screening and 112/214 (42%) progressed to face-to-face screening.72/112 (64%) were randomised and 70/72 (97%) completed the trial. Recruitment took place from secondary care geriatric medicine clinics and via primary care mailshots; routes where patients had already had muscle strength recorded showed greater recruitment efficiency than those that did not. At face-to-face screening, SARC-F scores of 1 to 4 showed lower efficiency of recruitment compared to 5+ (49/82 [60%] vs 23/30 [77%] respectively) but accounted for most recruits (49/72 [68%]); age and sex were not associated with differences in recruitment. The majority (148/214 [69%]) of potential participants at prescreening expressed a preference for home visits; 101/112 (90%) undertook the screening visit at home and 45/72 (63%) of those randomised undertook either or both outcome visits at home. ConclusionA package of innovations in participant identification, recruitment processes and study visits enabled recruitment to target and the achievement of very high retention rates for a condition where it has traditionally been challenging to conduct clinical trials. Trial registrationISRCTN29932357

BackgroundGlycated haemoglobin (HbA1c) targets are commonly used to guide patient management in diabetes to reduce future risk of diabetes complications, but little is known of the psychological impact of HbA1c target-setting. We explored the feasibility of undertaking a conclusive study evaluating the impact of setting explicit HbA1c targets in adults with diabetes. MethodsA randomised, mixed-methods study design was used to quantitatively and qualitatively evaluate the psychometric and biomedical impact of intensified or relaxed glycaemic targets in adults with diabetes. Alongside baseline measurement of HbA1c, blood pressure and body mass index, patients completed baseline validated psychometric questionnaires (EuroQoL-5D-5L, Problem Areas In Diabetes, Summary of Diabetes Self-Care Activities, Well-Being Quetionnaire-12, Diabetes Empowerment Scale-Long Form) and were randomised 1:1. Participants in group A received explicit HbA1c target intervention targets 5 mmol/mol above current HbA1c. Participants in group B received explicit HbA1c targets 5 mmol/mol below current HbA1c. Rates of eligibility, recruitment, retention and questionnaire response were recorded. Outcomes were re-measured 3-months post-intervention. Patients and healthcare professionals attended semi-structured interviews for qualitative evaluation. ResultsFifty participants were recruited. Withdrawal rate was 34% (n=17). Endpoint evaluation revealed no significant between-group differences in patient-reported outcome measures or HbA1c levels. Overall, levels of distress (-4.4, p=.009), self-efficacy (.25 [.09-.41], p=.004) and subsequent HbA1c readings (-2.8 [-5.0--.7], p=.012) improved, with non-significant changes seen in health-related quality of life, wellbeing, and self-care. Patients and healthcare professional interviews demonstrated study acceptability alongside specific motivators (e.g., target achievability, hypoglycaemia avoidance) and demotivators (e.g., lack of understanding, lack of target achievability) for striving to reach glycaemic targets. Combined qualitative data from patient and healthcare professional interviews and quantitative study aspects triangulated, enhancing data trustworthiness, and informing future hypotheses and methodologies. DiscussionThis mixed-methods study demonstrates feasibility and provides a novel insight into the psychological implications of HbA1c target-setting. Trial registrationThe study is registered with the ISRCTN (registration number: 12461724; date registered: 11th June 2021).

Background and objectivesType 1 diabetes (T1D) is a largely self-managed condition that requires ongoing daily tasks and decisions. Many people living with T1D in Canada manage it alone, which can feel very isolating and negatively affect physical and mental health. Connecting with other people in similar situations may help to reduce the potential burden associated with managing this health condition. We aim to co-develop and evaluate a virtual peer support program called CommuniT1D, led by people with T1D, to improve the overall wellbeing of people across Canada whose lives are affected by T1D. Methods and analysisUsing a community-based participatory design and action research approach and a realist evaluation framework, we will first co-develop CommuniT1D by working together as a group of people with T1D, researchers, and clinicians. Over two thirds of steering committee members live with T1D (their own or their childs.) This collective lived expertise is complemented by experts in mental health, social support, health services research, and other relevant fields. Once the program is ready to welcome members, we will work with our partner organizations, networks, and use tailored ads to recruit CommuniT1D peer leaders and members. We will then form virtual peer support groups of people with shared lived experience. Within the program, we will hold monthly small group meetings led by peer leaders via an online platform. We will also hold monthly large webinars open to all CommuniT1D members and other interested people. To evaluate CommuniT1D, we will conduct surveys at baseline and every 6 months, collecting data about diabetes distress, life challenges, quality of life, wellbeing, management indicators, and access and use of management tools and services. We will analyze quantitative data using repeated measures analysis of variance. We will also conduct individual interviews with CommuniT1D members and peer leaders at two time points. We will analyze interview data thematically, and create a logic model by triangulating results from qualitative and quantitative analyses, applying a realist evaluation lens. DiscussionPeer support may help people with T1D feel less alone and better supported. This protocol outlines the design of a virtual peer support program called CommuniT1D to improve the wellbeing of people whose lives are affected by T1D in Canada. We hope that this program will help better equip people with T1D to cope with T1D-related stressors, thus improving the lives of people with T1D in Canada.

Background"Nature prescriptions" are gaining popularity as a form of social prescribing and in response to calls for sustainable healthcare. Our review and meta-analysis appraised evidence of effectiveness of nature prescriptions on various health outcomes. In doing so, we sought to determine the factors that are critical for the success of nature prescriptions, based on Social Cognitive Theory. MethodsThis is a scoping review with a nested meta-analysis for a subset of outcomes. Five databases were searched up to July 25, 2021. Randomised and non-randomised controlled studies featuring a nature prescription (i.e. an instruction or organised programme, by a health or social provider, to promote spending time in nature) are included. All health outcomes are eligible, but only key pre-specified outcomes are qualified for meta-analysis. Two reviewers independently conducted all steps of study selection; one reviewer conducted data collection and risk of bias assessment. Summary data was extracted from published reports for analysis. Random-effect models for meta-analysis were conducted using Review Manager 5.4.1. FindingsWe identified 86 unique studies (116 reports), of which 26 studies contributed data to meta-analysis. Compared to control, nature prescription programmes resulted in a greater reduction in systolic blood pressure (MD = -4{middle dot}9mmHg [-9{middle dot}6 to -0{middle dot}1], I2=65%) and diastolic blood pressure (MD = -3{middle dot}6mmHg [-7{middle dot}4 to 0{middle dot}1], I2=67%). They also had a moderate-to-large effect on depression scores (SMD=0{middle dot}5 [0{middle dot}2 to 0{middle dot}8], I2=79%) and anxiety score (SMD=0{middle dot}6 [0{middle dot}1 to 1{middle dot}2], I2=90%). Lastly, they resulted in a greater increase in daily step counts (MD = 900 steps [790-1010], I2=0%), but did not improve weekly time of moderate physical activities (MD = 25{middle dot}9 minutes [-10{middle dot}3 to 62{middle dot}1], I2=53%). Most studies have moderate to high risk of bias, principally due to non-blinding nature of the interventions, small sample size and lack of analysis plan to rule out risks of bias. InterpretationNature prescription programmes may provide cardiometabolic and mental health benefits and increase physical activity. Effective nature prescription programmes can select from a range of natural settings, activities and might be implemented via social and community channels, besides health providers. The Social Cognition Theory is useful in designing future nature prescription programmes. FundingThis work was supported by the Hort Frontiers Green Cities Fund, part of the Hort Frontiers strategic partnership initiative developed by Hort Innovation, with co-investment from the University of Wollongong (UOW) Faculty of Social Sciences, the UOW Global Challenges initiative and contributions from the Australian Government (project number #GC15005). T.A-B. was supported by a National Health and Medical Research Council Boosting Dementia Research Leader Fellowship (#1140317). X.F. was supported by a National Health and Medical Research Council Career Development Fellowship (#1148792). O_TEXTBOXPanel: Research in context Evidence before this studyExtensive evidence indicates contact with nature is associated with social, mental and physical health. However, little evidence exists on the effectiveness of nature prescriptions, which involve a health provider (e.g. general practitioner) recommending a patient to spend a fixed amount of time a week in a natural setting (e.g. a park). Other studies have attempted to evaluate the benefits of food prescription or green prescription programmes, which do not necessarily involve nature exposure. Only one systematic review on nature prescriptions has been conducted to date, which is a qualitative review without meta-analysis. The review concluded that the evidence (studies up to June 2019) was too sparse to discern any clear evidence of health impacts. There was insufficient information to assess the risk of bias or quality of evidence in the review. Moreover, the review included only nature prescriptions dispensed in outpatient settings, which left out prescription programmes implemented by other institutions, such as welfare centres, social services, universities or workplaces. Added value of this studyOur review is the first to provide comprehensive appraisal including meta-analysis of the effectiveness of nature prescription programs on multiple health outcomes. The scoping review identified a range of promising nature-based interventions that were dispensed outside the clinic setting and did not self-label as a nature prescription, but would be effective as one. The nested meta-analyses on key outcomes demonstrated positive benefits on blood pressure, symptoms of depression and anxiety, and physical activity levels. Implications of all the available evidenceOur findings suggest that an effective nature prescription programme can select from a range of natural settings, activities and can be implemented via social and community channels, in addition to health providers. In addition, we also demonstrated that the Social Cognition Theory framework is useful in designing future nature prescription programmes. C_TEXTBOX

IntroductionWarfarin is a narrow therapeutic index drug that requires frequent monitoring using the international normalized ratio (INR). Current clinic-based INR monitoring models lead to suboptimal warfarin management. Warfarin patient self-management (PSM) has consistently demonstrated superior efficacy compared to clinic-based management but is virtually unused in the US healthcare system. The objective of this study is to implement PSM in the US healthcare system using strategies developed to overcome previously identified barriers associated with PSM underutilization as well as potential PSM facilitators. Methods and analysisWe aim to implement PSM with 150 adult patients at four sites using strategies developed to address barriers to PSM specific to the US healthcare system. Implementation strategies will be guided by the Consolidated Framework for Implementation Research and the Quality Implementation Framework supported by Rapid Cycle Research Methodology. A type III hybrid implementation-effectiveness study design will be used to assess PSM implementation strategy outcomes while also gathering information on PSM clinical outcomes centered on the five elements of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). This study will be approved by the ethics boards at all participating sites. DiscussionWe plan to disseminate the results of this research program examining the feasibility of PSM in US anticoagulation management services in scientific journals and conferences, as well as making elements of the PSM implementation toolkit publicly and freely available. Trial Registration: ClinicalTrials.gov Identifier: NCT04766216

AimTo outline the opportunities and barriers when using hairdressing salons as a novel site for enhancing cardiovascular risk factor assessment and management in women. MethodsA process evaluation nested within a cluster-randomised trial, Hairdressers for Health. The trial evaluated a nudge intervention advising women [≥]45years attending hairdressing salons to undertake a Heart Health Check with their General Practitioner. The UK Medical Research Council process evaluation framework was used to guide the design, data collection and analysis. Nineteen interviews were conducted with nine hairdressers, nine study participants and a project officer. Thematic analysis assessed recruitment, reach, acceptability, and adoption. Characteristics of the salons and participants were analysed using descriptive statistics. ResultsRecruitment of the planned 88 metropolitan and 28 regional salons for the trial was challenging, requiring resource-intensive face-to-face visits. The nudge intervention was well accepted by participants, and salons were perceived to be an appropriate setting to effectively reach women. Adoption of the study by salons was limited with only 54 of the 116 salons recruiting participants (total recruited 239, range 1-22 participants per salon). Barriers to participant recruitment included technological constraints while using a decentralised online recruitment and data collection platform, client preferences and privacy concerns. Established hairdresser-client relationships in smaller salons facilitated greater client participation and was perceived as a good mechanism for health promotion. ConclusionsCardiovascular health prevention messaging for women in salons was acceptable to hairdressers and clients. Designing the study to make better use of hairdresser-client personal relationships may have improved project implementation. Trial RegistrationACTRN12621001740886