Gemma Mansell

Objectives Community pharmacies are increasingly recognised as accessible providers of public health services. Integrating cardiovascular health checks and behaviour change strategies with the community pharmacy vaccination service has the potential to improve population health outcomes. This scoping review aims to identify potential pharmacist-led cardiovascular-related services suitable for such integration, and to explore the acceptability and feasibility of pharmacy-led services among both service users and providers. Data sources MEDLINE, EMBASE, CINAHL and Web of Science were systematically searched for UK-based empirical studies published between January 2013 and December 2024. Eligibility criteria Primary studies reporting on pharmacist-led cardiovascular-related interventions (eg, blood pressure monitoring, cholesterol screening, smoking cessation) delivered to adults (≥18 years) in community pharmacy settings and reporting on clinical outcomes, feasibility or acceptability were included. Data extraction and synthesis Data were extracted using a standardised form on Excel and synthesised narratively. Key domains of interest included intervention characteristics, facilitators, barriers, perceived outcomes, delivery mode and intervention content including behavioural change strategies or components to support implementation. Results Of 8322 records screened, 53 studies met the inclusion criteria. Cardiovascular-related interventions were broadly feasible and acceptable to both patients and pharmacy staff. High patient satisfaction was attributed to the accessibility and convenience of pharmacy locations, as well as the ability of pharmacy staff to establish rapport during interactions. Facilitators of service delivery included private consultation spaces, structured training and access to digital screening tools (eg, devices for atrial fibrillation detection). Barriers included workload constraints and limited public awareness of pharmacy services. Five studies described successful integration of lifestyle interventions within pharmacy-based settings, but the long-term clinical outcomes produced by the intervention were rarely reported. Patients valued the convenience and trusted relationships with pharmacists, though concerns about privacy were raised. Pharmacists reported the need for clearer clinical protocols, and multidisciplinary support and training to improve their confidence in delivering health checks as part of their routine work. Conclusions Community pharmacies offer an optimal setting for integrating cardiovascular-related screening interventions with the vaccination service delivered within community pharmacy. Successful implementation will require attention to the identified facilitators including the quality of staff training, competing priorities and optimisation and utilisation of pharmacy space. Future research should prioritise definitive controlled trials and cost-effectiveness analyses to assess long-term health outcomes. Policy action is also needed to support service integration and expand pharmacists’ public health roles within the wider National Health Service.

Background: Accessible occupational health advice is only available to approximately half the United Kingdom population. With rising sickness absence new models for delivering occupational health are required to support employees with health conditions to manage their condition at work. Aim: To determine, in patients consulting in general practice who receive a fit note, whether the addition of a vocational advice intervention to usual primary care leads to fewer days lost from work, and whether vocational advice is cost-effective. Design: Intervention development: Training development using mixed methods and the theoretical framework the Behaviour Change Wheel. Feasibility study: Mixed methods, single-arm feasibility study, with stop/go criteria to assist decision making about progression to full trial. Trial: Multi-centre, two-parallel arm, superiority, randomised controlled trial with health economic analysis and nested qualitative study. Setting: General practices in three geographic areas in England: West Midlands, South London and Wessex. Participants: Patients aged ≥ 18 years, currently in paid employment (full or part-time), current absence from work of at least 2 weeks but not more than 6 consecutive months, with a fit note for any health condition. Interventions: Vocational advice delivered by trained vocational support workers plus usual primary care (intervention arm), compared to usual primary care alone (control arm). Main outcome measures: The outcome of intervention development was a vocational advice intervention and training package. Feasibility study outcomes were ability to recruit and acceptability of the vocational advice intervention to participants. The trial primary outcome was number of days absent from work over 6 months. Results: A vocational advice intervention and training package designed for delivery in primary care using case management and stepped care to support patients absent from work for 2 weeks to 6 months. The feasibility study recruited 19 participants demonstrating the vocational advice intervention could be delivered and was acceptable to participants. Recommendations around automated recruitment and data collection were made which were implemented in the trial. The randomised controlled trial sample size was 720; 130 participants were recruited (66 intervention/64 control) before closing early due to recruitment difficulties. There was no statistically significant difference in days absent over 6 months with a mean of 37 (standard deviation 48) days absence (vocational advice intervention) compared to a mean of 42 (standard deviation 57) days absence (usual primary care alone) and an adjusted incidence rate ratio of 0.913 (80% confidence interval 0.653 to 1.276). Health economic analysis found that productivity losses were also lower in the intervention arm at £5513.84 (standard deviation £7101.43) compared to the control arm at £6146.21 (standard deviation 8431.88). At 6 weeks, the intervention arm had lower mean absenteeism, presenteeism, work productivity loss and activity impairment on the work productivity activity impairment scale than the control arm; again this was not significant. Conclusions and future work: This study resulted in a vocational advice intervention suitable for all health conditions and a training package to support delivery of the intervention. In primary care, delivery was feasible and acceptable to patients. Exploratory analysis indicated some signals of benefit in terms of days absent from work, costs and most other secondary outcome measures. Future work should focus on the delivery of a fully powered randomised controlled trial evaluating an early vocational advice intervention compared to usual primary care to determine the effectiveness and cost-effectiveness of this approach. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17/94/49.

Background and objectives: To describe exploratory findings and lessons learned from the discontinued WAVE trial, which sought to determine the effectiveness and costs of adding an early vocational advice intervention to usual primary care on number of days of sickness absence over 6 months. Methods: Pragmatic, multicentre, two-parallel arm, superiority, randomised controlled trial with health economic analysis in 10 general practices in England, with nested qualitative interviews. Population: Adults with fit notes for any health condition, absent from work ≥ 2 weeks and ≤ 6 months were invited to participate. Intervention and comparator: Participants were randomised (1 : 1) to usual primary care with/without vocational advice delivered by trained Vocational Support Workers. The planned sample size was 720, the first 4 months of recruitment served as an internal pilot phase and the primary outcome was self-reported days of work absence over 6 months. Results: One hundred and thirty participants were recruited from 7955 invitations (May 2022–May 2023) before trial closure (64 usual care, 66 usual care plus vocational advice). Exploratory analysis of 125 participants (with outcome data) indicated small additional benefits of the vocational advice intervention over usual care [mean days absence = 37.86 (standard deviation = 48.76) vs. usual care = 42.66 (standard deviation = 57.67), incidence rate ratio = 0.913, 80% confidence interval (0.653 to 1.276)]. The vocational advice intervention was delivered remotely [mean = 4.8 contacts (range 1–12)]. Partial health economic evaluation found lower work productivity losses at 6 months after vocational advice intervention (£5513.84, standard deviation = £7101.43) compared to usual care (£6146.21, standard deviation = £8431.88). Conclusions, limitations and future work: Exploratory analysis indicated a signal of effect, with differences in the number of days absent from work, costs and secondary outcomes. Key lessons learned included the need for closer working with primary care teams and more flexible recruitment methods. A future fully powered randomised controlled trial of vocational advice intervention added to usual primary care is needed to determine the effectiveness and cost-effectiveness. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17/94/49.

Objectives: Most patients with health conditions necessitating time off work consult in primary care. Offering vocational advice (VA) early within this setting may help them to return to work and reduce sickness absence. Previous research shows the benefits of VA interventions for musculoskeletal pain in primary care, but an intervention for a much broader primary care patient population has yet to be tested. The Work And Vocational advicE feasibility study tested patient identification and recruitment methods, explored participants’ experiences of being invited to the study and their experiences of receiving VA. Design: A mixed method, single arm feasibility study comprising both quantitative and qualitative analysis of recruitment and participation in the study. Setting: Primary care. Methods: The study included participant follow-up by fortnightly Short Message Service text and 6-week questionnaire. Stop/go criteria focus on recruitment and intervention engagement. The semistructured interviews explored participants’ experiences of recruitment and receipt and engagement with the intervention. Results: 19 participants were recruited (4.3% response rate). Identification of participants via retrospective fit-note searches was reasonably successful (13/19 (68%) identified), recruitment stop/go criteria were met with ≥50% of those eligible and expressing an interest recruited. The stop/go criterion for intervention engagement was met with 16/19 (86%) participants having at least one contact with a vocational support worker. Five participants were interviewed; they reported positive experiences of recruitment and felt the VA intervention was acceptable. Conclusion: This study demonstrates that delivering VA in primary care is feasible and acceptable. To ensure a future trial is feasible, recruitment strategies and data collection methods require additional refinement. Trial registration number: NCT04543097 .

Objective The SupportBack 2 randomised controlled trial (RCT) compared the clinical and cost-effectiveness of an internet intervention supporting self-management versus usual primary care in reducing low back pain (LBP)-related disability. In this study, we aimed to identify and understand key processes and potential mechanisms underlying the impact of the intervention. Design This was a nested qualitative process evaluation of the SupportBack 2 RCT (ISRCTN: 14736486 pre-results). Setting Primary care in the UK (England). Participants 46 trial participants experiencing LBP without indicators of serious spinal pathologies (eg, fractures, infection) took part in telephone interviews at either 3 (n=15), 6 (n=14) or 12 months (n=17) post randomisation. Five physiotherapists who provided telephone support for the internet intervention also took part in telephone interviews. Intervention An internet intervention ‘SupportBack’ supporting self-management of LBP primarily through physical activity and exercise delivered in addition to usual care, with and without physiotherapist telephone support. Analysis Data were analysed thematically, applying a realist logic to develop context-mechanism-outcome configurations. Results Four explanatory themes were developed, with five context-mechanism-outcome configurations. Where benefit was reported, SupportBack appeared to work by facilitating a central associative process where participants linked increases in physical activity or exercise with improvements in LBP, then continued to use physical activity or exercise as key regulatory strategies. Participants who reported little or no benefit from the intervention appeared to experience several barriers to this associative process, including negative expectations, prohibitive beliefs about the cause of LBP or functional limitations preventing engagement. Physiotherapists appeared to provide accountability and validation for some; however, the remote telephone support that lacked physical assessment was viewed as limiting its potential value. Conclusions Digital interventions targeting physical activity and exercise to support LBP self-management may rely on mechanisms that are easily inhibited in complex, heterogeneous populations. Future research should focus on identifying and removing barriers that may limit the effectiveness of digital self-management support for LBP.

Objectives: Most patients with health conditions necessitating time off work consult in primary care. Offering vocational advice (VA) early within this setting may help them to return-to-work (RTW) and reduce sickness absence. Previous research shows the benefits of VA interventions for musculoskeletal pain in primary care, but an intervention for a much broader primary care patient population has yet to be tested. The WAVE feasibility study tested patient identification and recruitment methods, explored participants’ experiences of being invited to the study and their experiences of receiving VA. Design: A mixed method, single arm feasibility study comprising both quantitative and qualitative analysis of recruitment and participation in the study. Setting: Primary care Methods: The study included participant follow-up by fortnightly SMS text and 6-week questionnaire. Stop/go criteria focused on recruitment and intervention engagement. The semi-structured interviews explored participants experiences of recruitment and receipt and engagement with the intervention. Results: Nineteen participants were recruited (4.3% response rate). Identification of participants via retrospective fit-note searches was reasonably successful (13/19 (68%) identified), recruitment stop/go criteria were met with >50% of those eligible and expressing an interest recruited. The stop/go criterion for intervention engagement was met with 16/19 (86%) participants having at least one contact with a Vocational Support Worker (VSW). Five participants were interviewed; they reported positive experiences of recruitment and felt the VA intervention was acceptable. Conclusion: This study demonstrates that delivering VA in primary care is feasible and acceptable. To ensure a future trial is feasible, recruitment strategies and data collection methods require additional refinement. Trial registration: Clinical Trials: NCT04543097 Protocol number: Version 5.1 Article summary: - This is the first study to test the feasibility of delivering a VA intervention to patients who present in primary care, regardless of their health condition. - The study used mixed methods to fully explore feasibility of the delivery of a full trial - The findings can usefully inform the development of the methods for a future trial to ensure that it meets the needs of participants in supporting them to return-to-work after a period of absence

Background: Low back pain is highly prevalent and a leading cause of disability. Internet-delivered interventions may provide rapid and scalable support for behavioural self-management. There is a need to determine the effectiveness of highly accessible, internet-delivered support for self-management of low back pain. Objective: To determine the clinical and cost-effectiveness of an accessible internet intervention, with and without physiotherapist telephone support, on low back pain-related disability. Design: A multicentre, pragmatic, three parallel-arm randomised controlled trial with parallel economic evaluation. Setting: Participants were recruited from 179 United Kingdom primary care practices. Participants: Participants had current low back pain without indicators of serious spinal pathology. Interventions: Participants were block randomised by a computer algorithm (stratified by severity and centre) to one of three trial arms: (1) usual care, (2) usual care + internet intervention and (3) usual care + internet intervention + telephone support. ‘SupportBack’ was an accessible internet intervention. A physiotherapist telephone support protocol was integrated with the internet programme, creating a combined intervention with three brief calls from a physiotherapist. Outcomes: The primary outcome was low back pain-related disability over 12 months using the Roland–Morris Disability Questionnaire with measures at 6 weeks, 3, 6 and 12 months. Analyses used repeated measures over 12 months, were by intention to treat and used 97.5% confidence intervals. The economic evaluation estimated costs and effects from the National Health Service perspective. A cost–utility study was conducted using quality-adjusted life-years estimated from the EuroQol-5 Dimensions, five-level version. A cost-effectiveness study estimated cost per point improvement in the Roland–Morris Disability Questionnaire. Costs were estimated using data from general practice patient records. Researchers involved in data collection and statistical analysis were blind to group allocation. Results: Eight hundred and twenty-five participants were randomised (274 to usual primary care, 275 to usual care + internet intervention and 276 to the physiotherapist-supported arm). Follow-up rates were 83% at 6 weeks, 72% at 3 months, 70% at 6 months and 79% at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 internet intervention, 242 telephone support). There was a small reduction in the Roland–Morris Disability Questionnaire over 12 months compared to usual care following the internet intervention without physiotherapist support (adjusted mean difference of −0.5, 97.5% confidence interval −1.2 to 0.2; p = 0.085) and the internet intervention with physiotherapist support (−0.6, 97.5% confidence interval −1.2 to 0.1; p = 0.048). These differences were not statistically significant at the level of 0.025. There were no related serious adverse events. Base-case results indicated that both interventions could be considered cost-effective compared to usual care at a value of a quality-adjusted life-year of £20,000; however, the SupportBack group dominated usual care, being both more effective and less costly. Conclusions: The internet intervention, with or without physiotherapist telephone support, did not significantly reduce low back pain-related disability across 12 months, compared to usual primary care. The interventions were safe and likely to be cost-effective. Balancing clinical effectiveness, cost-effectiveness, accessibility and safety findings will be necessary when considering the use of these interventions in practice. Trial registration: This trial is registered as ISRCTN14736486. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/111/78) and is published in full in Health Technology Assessment; Vol. 29, No. 7. See the NIHR Funding and Awards website for further award information.

Objectives: To 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. Design: Multicentre, 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. Setting: Participants will be recruited from general practices in the UK. Participants: 720 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. Interventions: Participants 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 measure: Number of days off work over 6 months. Follow-up data collection is via questionnaires at 6 weeks and 6 months. Conclusions: This 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

Objective: To investigate whether early changes in fear of movement (kinesiophobia), self‐efficacy and catastrophizing were mediators of the relationship between allocation to the pre‐habilitation intervention and later changes in health outcomes.Methods: The original pre‐habilitation trial (PREPARE, ISRCTN17115599) recruited 118 participants awaiting lumbar fusion surgery, half of whom received a prehabilitation intervention designed based on the modified fear‐avoidance model and half of whom received usual care. Mediation analysis was performed to test each mediator separately. Analysis was performed on each outcome of interest separately (Oswestry disability index, patient‐specific function, EQ general health and moderate/vigorous physical activity). Mediation analysis was carried out using PROCESS. Beta coefficients and bootstrapped 95% CIs were used to interpret the results.Results: None of the potential mediators was found to mediate the relationship between allocation to the intervention and 3‐month scores on any of the health outcomes tested.Conclusions: Screening patients for higher levels of catastrophizing and fear avoidance and lower levels of self‐efficacy could help ensure only the patients who are most likely to benefit from the intervention are included.Significance: Prehabilitation interventions for spinal fusion surgery have been found to improve health outcomes for patients. Theory‐based interventions that target key mechanisms are more effective at improving outcomes than non‐theory‐based interventions. While no mediating effects were found for this particular intervention, the analysis suggests that the underlying theoretical model and treatment targets are appropriate and could drive improvement if more strongly targeted.