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.

Background:Plantar heel pain (PHP) is the most common soft tissue foot condition and impairs mobility, physical function, ability to work, and quality of life. Systematic reviews highlight a need for high-quality randomised controlled trials (RCTs) of exercises and orthoses for PHP. Objectives:To determine the clinical and cost-effectiveness of individualised exercises and/or prefabricated foot orthoses plus self-management advice (SMA) compared to SMA alone in adults with PHP. Methods:A multi-centre four-arm two-stage adaptive parallel-group RCT with internal pilot. Up to 696 participants aged ≥18 years with PHP will be identified from general practice, physiotherapy/podiatry referrals and self-referral, and randomised 1:1:1:1 to: (1) SMA (control), (2) SMA plus individualised exercises, (3) SMA plus prefabricated foot orthoses, or (4) SMA plus individualised exercises and prefabricated foot orthoses. Outcomes will be collected by SMS text-message (weekly during weeks 1-12, monthly during months 4-12) and questionnaires at 12 weeks and 6 and 12 months. The primary outcome is change in PHP intensity (0-10 numeric rating scale) between baseline and the average over 6-12 weeks. Interim analysis when 348 participants have completed the primary outcome assessment will inform adaptation, where interventions may be dropped or the trial stopped early (for efficacy or futility). The main between-group comparison for the primary outcome will be undertaken using linear mixed modelling. Secondary outcomes will examine i) short-term pain trajectories over weeks 1-12, ii) pain at 6 and 12 months, and monthly from 3-12 months, iii) first step pain, physical function, global rating of change, pain self-efficacy, illness perceptions, ability to work, and treatment satisfaction at 12 weeks, 6 and 12 months, iv) cost-effectiveness. Patient and public partner involvement is embedded throughout. Discussion:The TREADON multi-arm multi-stage RCT will provide new evidence on the clinical and cost-effectiveness of individualised exercises and prefabricated foot orthoses for people with PHP. Trial registration:ISRCTN 12418153. Registration date 06 December 2022 https://doi.org/10.1186/ISRCTN12418153.

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 Opioids offer limited long-term benefits and carry significant risks. We developed the PROMPPT intervention to address challenges in implementing effective person-centred review and safe opioid tapering in UK primary care. PROMPPT comprises a primary care review, led by clinical pharmacists working in general practices as part of the multidisciplinary team, and an associated training package. This trial will evaluate (1) the effectiveness of PROMPPT in supporting people with persistent non-cancer pain to safely reduce opioids, where appropriate, without increasing pain/pain-related interference, and (2) cost-effectiveness compared with usual primary care. Methods Design and setting: cluster randomised controlled trial, with internal pilot, in 38 general practices across England. Participants: patients ≥18 years prescribed one or more opioids ≥6 months for persistent pain who consent to participate in a questionnaire study. Exclusions: acute pain, cancer pain, end-of-life care, dementia, severe mental illness or otherwise vulnerable, and current substance misuse treatment. Practices are randomly allocated (1:1) to either: invite participants for a PROMPPT review with a trained practice pharmacist, and follow-up as needed, or continue usual primary care review for patients who are prescribed opioids. Co-primary outcomes, measured at 12 months, are (1) reduction in self-reported opioid use (≥25% reduction in daily morphine equivalent dose from their baseline) and (2) non-inferiority of the Brief Pain Inventory total score. The trial includes an economic evaluation (within trial and longer-term cost-utility analyses) and a mixed methods process evaluation. Analysis of consultation audio-recordings, case report forms (including an intervention delivery template), acceptability questionnaires and semi-structured interviews will explore how PROMPPT was delivered and received, and how context affected implementation and outcomes. Conclusion The PROMPPT trial will assess whether review by trained clinical pharmacists working in general practices can support safe opioid reduction without compromising pain management and quality of life. Trial registration ISRCTN 45616481, 13/05/2022 https://doi.org/10.1186/ISRCTN45616481

Background Plantar heel pain (PHP) is the most common soft tissue foot condition and impairs mobility, physical function, ability to work, and quality of life. Systematic reviews highlight a need for high-quality randomised controlled trials (RCTs) of exercises and orthoses for PHP. Objectives To determine the clinical and cost-effectiveness of individualised exercises and/or prefabricated foot orthoses plus self-management advice (SMA) compared to SMA alone in adults with PHP. Methods A multi-centre four-arm two-stage adaptive parallel-group RCT with internal pilot. Up to 696 participants aged ≥18 years with PHP will be identified from general practice, physiotherapy/podiatry referrals and self-referral, and randomised 1:1:1:1 to: (1) SMA (control), (2) SMA plus individualised exercises, (3) SMA plus prefabricated foot orthoses, or (4) SMA plus individualised exercises and prefabricated foot orthoses. Outcomes will be collected by SMS text-message (weekly during weeks 1–12, monthly during months 4–12) and questionnaires at 12 weeks and 6 and 12 months. The primary outcome is change in PHP intensity (0–10 numeric rating scale) between baseline and the average over 6–12 weeks. Interim analysis when 348 participants have completed the primary outcome assessment will inform adaptation, where interventions may be dropped or the trial stopped early (for efficacy or futility). The main between-group comparison for the primary outcome will be undertaken using linear mixed modelling. Secondary outcomes will examine i) short-term pain trajectories over weeks 1–12, ii) pain at 6 and 12 months, and monthly from 3–12 months, iii) first step pain, physical function, global rating of change, pain self-efficacy, illness perceptions, ability to work, and treatment satisfaction at 12 weeks, 6 and 12 months, iv) cost-effectiveness. Patient and public partner involvement is embedded throughout. Discussion The TREADON multi-arm multi-stage RCT will provide new evidence on the clinical and cost-effectiveness of individualised exercises and prefabricated foot orthoses for people with PHP. Trial registration ISRCTN 12418153. Registration date 06 December 2022 https://doi.org/10.1186/ISRCTN12418153

BACKGROUND:Chronic breathlessness poses significant burden for individuals and healthcare systems. Effective symptom-directed approaches, such as breathing and relaxation techniques, require medical optimisation of the underlying long-term condition causing breathlessness. We previously identified nine, predominantly cardiorespiratory, long-term conditions contributing to the greatest burden of breathlessness in primary care. AIM:Develop checklists to support primary care in delivering optimal, evidence-based management of conditions causing chronic breathlessness. DESIGN & SETTING:Synthesis of national guidance and stakeholder workshops, using a co-design approach. METHOD:Desktop review of national guidance relating to management of each condition was synthesised as the basis for the checklists. Virtual workshops and interviews were conducted to further adapt checklist content with stakeholders (primary care staff, clinical specialists and representatives from national speciality groups). Workshops were recorded and facilitated by a qualitative researcher with clinical experience. Insights from workshop data were incorporated to produce draft checklists for verification by workshop participants. Checklist contents were refined and agreed in consultation with national specialist groups. Electronic patient record templates were developed to operationalise the checklists. RESULTS:Twenty-two national guidelines were reviewed and synthesised into the checklist drafts. Six virtual workshops and nine individual interviews were conducted with 30 key stakeholders (five GP, four nurses, six physiotherapists, three pharmacists, three dieticians, nine physicians). Participants directed the checklist format to include safety netting, key diagnostic checks and optimal management. CONCLUSION:Short pragmatic evidence-based checklists were developed for use in primary care to support primary care clinicians in managing the main conditions contributing to chronic breathlessness.

Given the poor long-term effectiveness of opioids for persistent non-cancer pain, and their potential for harm, evidence-based interventions to address opioid overprescribing for persistent pain are needed. This study aimed to explore the acceptability and feasibility of a primary care practice pharmacist-led intervention (PROMPPT review) for patients prescribed opioids for persistent pain and the feasibility of evaluating PROMPPT in a definitive trial. A single-arm study, with mixed methods process evaluation, was conducted in four English primary care practices. Adults prescribed opioids for ≥ 6 months were invited to participate in the Management of Opioids and Persistent Pain (MOPP) study by completing baseline and 3-month follow-up questionnaires. Practices invited a representative sample of MOPP participants to schedule a PROMPPT review, eight of which were audio-recorded. Following the review, pharmacists completed intervention delivery templates, and participants were sent an Acceptability Questionnaire and invited to consent to an interview. Between November 2020 and May 2021, 148 participants were recruited to the MOPP study. Of these, 123 (83 ISRCTN87628403 , registered 31 July 2020

Background There is a need to reduce delays to diagnosis for chronic breathlessness to improve patient outcomes.Objective To conduct a mixed-methods feasibility study of a larger cluster randomised controlled trial (cRCT) investigating a structured symptom-based diagnostic approach versus usual care for chronic breathlessness in primary care.Methods 10 general practitioner practices were cluster randomised to a structured diagnostic approach for chronic breathlessness including early parallel investigations (intervention) or usual care. Adults over 40 years old at participating practices were eligible if presenting with chronic breathlessness without an existing explanatory diagnosis. The primary feasibility outcomes were participant recruitment and retention rate at 1 year. Secondary outcomes included number of investigations at 3 months, and investigations, diagnoses and patient-reported outcome measures (PROMs) at 1 year. Semistructured interviews were completed with patients and clinicians, and analysed using thematic analysis.Results Recruitment rate was 32% (48/150): 65% female, mean (SD) age 66 (11) years, body mass index 31.2 kg/m2 (6.5), median (IQR) Medical Research Council dyspnoea 2 (2–3). Retention rate was 85% (41/48). At 3 months, the intervention group had a median (IQR) of 8 (7–9) investigations compared with 5 (3–6) investigations with usual care. 11/25 (44%) patients in the intervention group had coded diagnosis for breathlessness at 12 months compared with 6/23 (26%) with usual care. Potential improvements in symptom burden and quality of life were observed in the intervention group above usual care.Conclusions A cRCT investigating a symptom-based diagnostic approach for chronic breathlessness is feasible in primary care showing potential for timely investigations and diagnoses, with PROMs potentially indicating patient-level benefit. A further refined fully powered cRCT with health economic analysis is needed.

Variation between general practices in the rate of consultations for musculoskeletal pain conditions may signal important differences in access to primary care, perceived usefulness, or available alternative sources of care; however, it might also just reflect differences in underlying 'need' between practices' registered populations. In a study of 30 general practices in Staffordshire, we calculated the proportion of adults consulting for a musculoskeletal pain condition, then examined this in relation to selected practice and population characteristics, including the estimated prevalence of self-reported musculoskeletal problems and chronic pain in each practices' registered population. Between September 2021 and July 2022, 18,388 adults were consulted for a musculoskeletal pain condition. After controlling for length of recruitment, time of year, and age-sex structure, the proportion consulting varied up to two-fold between practices but was not strongly associated with the prevalence of self-reported long-term musculoskeletal problems, chronic pain, and high-impact chronic pain.

Objectives To estimate the direction and magnitude of socioeconomic inequalities in outcome, experience and care among adults consulting for a musculoskeletal pain condition.Design Multicentre, prospective observational cohort with repeated measures at three waves (baseline, 3 months and 6 months after index consultation).Setting 30 general practices in North Staffordshire and Stoke-on-Trent, England.Participants 1875 consecutive, eligible, consenting patients, aged 18 years and over, presenting with a relevant SNOMED CT-coded musculoskeletal pain condition between September 2021 and July 2022.Interventions Standard care.Primary and secondary outcome measures Primary outcome was patient-reported pain and function using the Musculoskeletal Health Questionnaire (MSK-HQ score, 0–56). Secondary outcomes were patient experience (overall dissatisfaction with consultation experience, dichotomised) and an indicator of care received (opioid prescription within 14 days of index consultation). Using multilevel models, we examined inequalities in primary and secondary outcomes by area deprivation (Index of Multiple Deprivation derived from patient residential postcode), before and after adjusting for sociodemographic and survey administration variables, clinical case-mix and selected practice-level covariates.Results Compared with patients from the least deprived neighbourhoods, patients from the most deprived neighbourhoods had significantly poorer MSK-HQ scores at baseline (mean 22.6 (SD 10.4) vs 27.6 (10.1)). At 6 months, the inequality gap in MSK-HQ score widened (difference in mean score after adjustment for all covariates: 1.94; 95% CI: −0.70 to 4.58). Opioid prescription was more common for patients living in the most deprived neighbourhoods (30% vs 19%; fully adjusted OR: 0.69; 95% CI: 0.44 to 1.08). Only 6% of patients overall reported being dissatisfied with their consultation. Analysis of multiply imputed data produced a similar pattern of findings to complete-case analysis.Conclusions Substantial inequalities in the chronicity, severity and complexity of musculoskeletal pain problems are already present at the time of accessing care. Inequalities in pain and function do not reduce after accessing care and may even widen slightly.Trial registration number ISRCTN18132064; Results.

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.

BACKGROUND:Healthcare accounts for up to 5% of worldwide carbon emissions and costs global economies an estimated $9 trillion annually. Primary care accounts for up to one-fifth of all NHS carbon emissions, with musculoskeletal (MSK) pain accounting for 14%-30% of all primary care consultations. METHOD:A cost-carbon calculator model was used to undertake a retrospective economic and environmental analysis of resource use for non-inflammatory MSK pain primary care consulters. Data used to populate the model was derived from Electronic Health Records and patient surveys collected during The Multi-level Integrated Data for Musculoskeletal Health Intelligence and ActionS GP Study. The model was utilised to estimate the mean (with 95%CI's) cost and carbon output per MSK consulter, while also examining variations at two levels: (a) the Primary Care Network (PCN), and (b) the consulter's index MSK pain site. RESULTS:One thousand eight hundred seventy-five individuals from 30 NHS primary care practices across 13 PCNs were eligible for EHR and survey data analysis. The mean carbon and cost output per person (over 6 months) was 46.91 kg CO2e (95% CIs; 45.02, 48.81 kg CO2e) and £182.65 (95% CIs; £178.69, £190.62), respectively, with substantial variation observed across PCNs. The resource category with the highest carbon footprint was consistently pharmacological intervention across all PCNs. Individuals who consulted for multisite/widespread pain and back pain had the highest mean carbon and cost output respectively. CONCLUSION:This is the first study, we are aware of, that presents data on both the environmental and economic impact of the primary care of non-inflammatory MSK pain. Future work should focus on benchmarking the cost and carbon output of MSK care pathways and standardising methods that are implemented to influence sustainable practice and policy development.

Waste landfill sites are associated with gaseous emissions and this air pollution can cause unpleasant smells (“malodour”). This causes concerns about its impact on the health of the local population. This study assessed change in general practice consultation behaviour during a period of increased complaints associated with air pollution at a UK landfill site. The study period was October 2020 to December 2021. The age-sex standardised prevalence and incidence of consultations for mental health, respiratory, and other symptoms hypothesised to be impacted by the air pollution issues were determined and compared between: (i) 6 practices located close to the landfill site (zone A), (ii) 6 practices located a mid-distance from the site (zone B), (iii) 6 practices located further away and expected to have had less impact (zone C). There was an increased consultation for mental health problems in practices nearest to the landfill site compared to those furthest away, however, consultation frequencies for respiratory and other potentially associated symptoms were lower and likelihood of consultation was consistently highest in practices located in zone B. This study showed limited evidence of an increase in recorded primary healthcare contacts for conditions and symptoms hypothesised to be connected to air pollution. It highlighted the challenges of examining impact of air pollution on the health of local populations. Since this study focussed on coded consultations in primary care and not symptoms present in the general population, an impact on the health of individuals cannot be ruled out.

Background Waste landfill sites are associated with gaseous emissions and this air pollution can cause unpleasant smells (malodour). This causes concerns about its impact on the health of the local population. This study assessed change in general practice consultation behaviour during a period of increased complaints associated with air pollution at a landfill site in the UK. Methods The study period was October 2020 to December 2021. The age-sex standardised prevalence and incidence of consultations for mental health, respiratory, and other symptoms hypothesised to be impacted by the air pollution issues were determined and compared between: i) 6 practices located close to the landfill site (zone A), ii) 6 practices located a mid-distance from the site (zone B), iii) 6 practices located further away and expected to have had less impact (zone C). Results Whilst there was an increased consultation for mental health problems in practices nearest to the landfill site compared to those furthest away, consultation frequencies for respiratory and other potentially associated symptoms were lower and likelihood of consultation was consistently highest in practices located in zone B. Conclusion This study did not show an increase in recorded primary healthcare contacts for conditions and symptoms hypothesised to be connected to air pollution. It highlighted the challenges of examining the impact of air pollution on the health of local populations. Since this study focussed on coded consultations in primary care and not symptoms present in the general population, an impact on the health of individuals cannot be ruled out. ### Competing Interest Statement Funding for the study was obtained from Staffordshire County Council ### Funding Statement The study was funded by Staffordshire County Council. SM, CDM and KPJ are partly funded by the National Institute for Health and Care Research (NIHR) Applied Research Collaboration West Midlands. CDM is also part funded by the NIHR School for Primary Care Research. CB is funded by an NIHR Clinical Lectureship. The views expressed are those of the authors and not necessarily those of the NIHR, NHS or the Department of Health and Social Care. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Keele University Research Ethics Committee (REC Project Reference 0138) and the Health Research Authority (HRA) (Reference: 22/PR/0078) gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The datasets underlying this article cannot be shared publicly due to privacy of individuals as they refer to individual consultation records. However summarised data are available from the corresponding author on reasonable request.

BACKGROUND:Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack). METHODS:Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486. FINDINGS:Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference -0·5 [97·5% CI -1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (-0·6 [-1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care. INTERPRETATION:The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice. FUNDING:National Institute for Health and Care Research Health Technology Assessment (16/111/78).

ObjectivesTo investigate the usefulness of using automated appointment check-in screens to collect brief research data from patients, prior to their general practice consultation.DesignA descriptive, cross-sectional study.SettingNine general practices in the West Midlands, UK. Recruitment commenced in Autumn 2018 and was concluded by 31 March 2019.ParticipantsAll patients aged 18 years and above, self-completing an automated check-in screen prior to their general practice consultation, were invited to participate during a 3-week recruitment period.Primary and secondary outcome measuresThe response rate to the use of the automated check-in screen as a research data collection tool was the primary outcome measure. Secondary outcomes included responses to the two research questions and an assessment of impact of check-in completion on general practice operationalisationResultsOver 85% (n=9274) of patients self-completing an automated check-in screen participated in the Automated Check-in Data Collection Study (61.0% (n=5653) women, mean age 55.1 years (range 18–98 years, SD=18.5)). 96.2% (n=8922) of participants answered a ‘clinical’ research question, reporting the degree of bodily pain experienced during the past 4 weeks: 32.9% (n=2937) experienced no pain, 28.1% (n=2507) very mild or mild pain and 39.0% (n=3478) moderate, severe or very severe pain. 89.3% (n=8285) of participants answered a ‘non-clinical’ research question on contact regarding future research studies: 46.9% (n=3889) of participants responded ‘Yes, I’d be happy for you to contact me about research of relevance to me’.ConclusionsUsing automated check-in facilities to integrate research into routine general practice is a potentially useful way to collect brief research data from patients. With the COVID-19 pandemic initiating an extensive digital transformation in society, now is an ideal time to build on these opportunities and investigate alternative, innovative ways to collect research data.Trial registration numberISRCTN82531292.

Background Usual primary care for patients with musculoskeletal pain varies widely and treatment outcomes are suboptimal. Stratified care involves targeting treatments according to patient subgroups, in the hope of maximising treatment benefit and reducing potential harm or unnecessary interventions. This programme developed a new prognostic stratified primary care approach, where treatments are matched to a patient’s risk of future persistent pain and disability based on a prognostic tool, and compared this with usual care. Objectives In four linked work packages, we refined and validated a prognostic tool [the Keele STarT MSK (Subgrouping for Targeted Treatment for Musculoskeletal pain) Tool] to identify risk of poor outcome and defined cut-off scores to distinguish patient risk subgroups (work package 1); defined and agreed new matched treatment options for each risk subgroup and developed a support package for delivery of stratified care (work package 2); tested the feasibility of delivering the stratified approach through a pilot randomised controlled trial and externally validated the prognostic tool (work package 3); and tested the effectiveness of the approach by comparing the clinical effectiveness and cost-effectiveness of stratified primary care with that of usual care through a cluster randomised controlled trial with embedded health economic and qualitative studies (work package 4). Setting General practices and linked musculoskeletal services in the West Midlands of England, UK. Participants Adults registered with participating practices consulting with back, neck, shoulder, knee or multisite musculoskeletal pain, and clinicians involved in managing these patients. Design The programme included the following work packages: work package 1 – a prospective cohort study in 12 practices; work package 2 – an evidence synthesis, consensus group workshops and qualitative studies; work package 3 – a cluster feasibility and pilot trial in eight practices; and work package 4 – a main cluster randomised controlled trial in 24 practices, with health economic analyses and process evaluation. Interventions Stratified care comprised training general practitioners to use the tool and match patients to treatment options depending on their risk subgroup. Usual care comprised usual non-stratified primary care without formal stratification tools. Main outcome measures Cohort primary end points included function (Short Form questionnaire-36 items physical component score) and pain intensity (numerical rating scale). The trial primary end point for patient outcomes was pain intensity (monthly for 6 months) (0–10 numerical rating scale). An audit of primary care electronic medical records evaluated the impact of stratified care on clinical decision-making regarding patient management. Results Work package 1 – the cohort study (n = 1890 patients) refined and validated a new 10-item tool with which to stratify patients with the five most common musculoskeletal pain presentations. The tool subgroups patients into three strata with different characteristics and prognoses. Work package 2: 17 treatment options were recommended – four for patients at low risk, 10 for patients at medium risk and 15 for patients at high risk. Work package 3: the feasibility and pilot trial included 524 patients, and the learning led to amendments to several tool items and a reduced set of treatments (14 in total). Work package 4: in the main trial, 1211 patients consented to data collection (534 in stratified care, 677 in usual care). Stratified primary care did not lead to statistically significant differences in the primary patient outcome of pain intensity [stratified care mean 4.4 (standard deviation 2.3) vs. usual care mean 4.6 (standard deviation 2.4); adjusted mean difference –0.16, 95% confidence interval –0.65 to 0.34; p = 0.535]. Where differences were observed, these were largely isolated to patients at high risk of poor outcome (the smallest subgroup), in favour of stratified care. Positive differences were, however, observed in general practitioner clinical decision-making, with increased provision of written self-management information and referrals to physiotherapy, plus reductions in prescription medication. The economic evaluation demonstrated that costs of care were similar across trial arms (£6.85, 95% confidence interval –£107.82 to £121.54 more for stratified care), with incremental quality-adjusted life-years of 0.0041 (95% confidence interval –0.0013 to 0.0094), representing a net quality-adjusted life-year gain. Stratified care was associated with an incremental cost-effectiveness ratio of £1670 per additional quality-adjusted life-year gained. At a willingness-to-pay threshold (λ) of £20,000 per quality-adjusted life-year, the incremental net monetary benefit was £132 and the probability of stratified care being cost-effective was approximately 73%. The very small differences suggest caution in the interpretation of this result. The qualitative findings revealed that general practitioners felt stratified care had a positive role in informing clinical decision-making, helped them to give greater attention to psychosocial issues and take a more functional approach, and facilitated negotiations with patients about treatment options such as imaging. Limitations The randomised controlled trial was not powered to detect differences between stratified and usual care for patients in each risk subgroup (low, medium and high) nor with each different musculoskeletal pain presentation. The stratified care electronic medical record template ‘fired’ only once per patient. Conclusions The Keele STarT MSK Tool is a valid instrument with which to discriminate between, and predict outcomes of, primary care patients with musculoskeletal pain. Although the randomised trial showed no significant benefit in patient-reported outcomes compared with usual care, some aspects of clinical decision-making improved and the approach was cost-effective. Future work The Keele STarT MSK Tool has been shared with over 1000 tool license requestees, leading to other work. Trial data sets have also led to other work, developing personalised prognostic models for back and neck pain patients (the European Union-funded Back-UP project). The challenge remains how to improve outcomes for primary care patients with musculoskeletal pain. Trial registration This trial is registered as ISRCTN15366334. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 11, No. 4. See the NIHR Journals Library website for further project information.

Two recruitment strategies for research were compared to prospectively identify patients with breathlessness who are awaiting a diagnosis in primary care. The first method utilised searches of the electronic patient record (EPR), the second method involved an electronic template triggered during a consultation. Using an electronic template triggered at the point of consultation increased recruitment to prospective research approximately nine-fold compared with searching for symptom codes and study mailouts.

Introduction: Earlier diagnosis and treatment may improve health-related outcomes for adults with chronic breathlessness. Aims: To investigate the impact of a structured diagnostic pathway versus usual care for adults with chronic breathlessness. Methods: Ten family practices were cluster randomised to a structured diagnostic pathway including a panel of early investigations (intervention group [IG]) or usual care (UC). Patients were opportunistically recruited if eligible: ≥40 years old, first presentation of chronic breathlessness and no prior diagnosis for symptoms. Patient reported outcome measures (PROMs) for breathlessness, mental health and health-related quality of life were collected at baseline and 12 months. Results: 48 patients (65% female, mean [SD] age 66[11] years, BMI 31.2[6.5], median [IQR] MRC dyspnoea scale 2 [2-3]) were recruited Nov 2019 to Feb 2021. 40/48 (83%) participants returned questionnaires at 12 months: n=19 UC, n=21 IG. The IG had a median (IQR) of 8 (7-9) tests compared with 5 (3-6) tests in UC within three months. A comparison of the PROMs between groups are shown in Figure 1. Conclusion: In this feasibility study, the IG underwent more investigations compared with UC and results indicate patient level benefit. However, the IG were more symptomatic at baseline. An adequately powered clinical trial is needed to investigate further.