John Macleod

Background: The Additional Roles Reimbursement Scheme (ARRS), introduced by NHS England in 2019, aimed to expand the workforce, promote multidisciplinary team-based care, and improve patient outcomes. Aim: To examine changes in consultation rates and outcomes in relation to ARRS implementation, and compare outcomes across primary care roles. Design and setting: Longitudinal cohort study using the Clinical Practice Research Datalink (CPRD) AURUM, analysing 12 170 079 consultations (2015–2021) from 600 000 randomly sampled patients at 400 English practices. Method: Joinpoint regression modelled trends in age- and sex-standardised consultation rates, further consultations within 1–14 days, prescribing, and referrals. Multilevel regression compared outcomes between diagnostic-capable roles and GPs. Results: Most consultations remained GP- or nurse-led, but rates with direct patient care (DPC)-ARRS-eligible roles increased, particularly for pharmacists, physiotherapists, and nursing associates. For paramedics and mental health practitioners, growth preceded formal ARRS inclusion, suggesting the scheme accelerated rather than initiated expansion. Most DPC-ARRS-eligible roles were consulted more frequently in less deprived areas, except physiotherapists. Compared with GPs, most DPC-ARRS-eligible roles delivered more consultations face to face (except pharmacists), had lower prescribing (except advanced nurse practitioners) and referral rates, and higher further consultation rates with a diagnostic-capable clinician within 1–14 days (except pharmacists). However, all DPC-ARRS-eligible roles had lower odds of a further consultation specifically with a GP. Conclusion: ARRS has supported and accelerated the diversification of the primary care skill mix. Patterns of consultation activity suggest an expansion of overall primary care capacity with some redistribution of workload across the multidisciplinary team, rather than a direct reduction in GP workload.

Background: The Additional Roles Reimbursement Scheme (ARRS) launched in England in 2019 to expand the multidisciplinary primary care workforce, but its impact on workload since implementation is unclear. Aim: To examine changes in workload complexity associated with ARRS implementation. Design and setting: A longitudinal cohort study was conducted, which used the Clinical Practice Research Datalink (CPRD) Aurum. In total, 3 530 628 consultations were analysed involving GPs, nurses, or direct patient care (DPC)-ARRS roles for 420 986 patients from 369 English practices in 2018 and 2021. Method: Multilevel logistic regression assessed associations between 17 patient and consultation complexity factors and being seen by a DPC-ARRS role, adjusting for year, age, sex, region, deprivation, and consultation mode. Results: Complex consultations with DPC-ARRS-eligible roles increased from 15.8% in 2018 to 18.8% in 2021. Diagnostically capable ARRS roles were more likely than GPs to conduct the first consultation after diabetes diagnosis (odds ratio [OR] 1.4, 95% confidence interval [CI] = 1.3 to 1.5) and consultations with ≥2 preventive tasks (OR 5.6, 95% CI = 5.5 to 5.8), but less likely to manage chronic pain (OR 0.8, 95% CI = 0.7 to 0.9), dementia (OR 0.4, 95% CI = 0.3 to 0.4), mental illness (OR 0.4, 95% CI = 0.3 to 0.5), learning disabilities (OR 0.3, 95% CI = 0.3 to 0.4), consultations with ≥3 medicines prescribed (OR 0.6, 95% CI = 0.5 to 0.6), consultations resulted in emergency admission (OR 0.7, 95% CI = 0.6 to 0.8), and consultations with ≥2 diagnoses coded (OR 0.5, 95% CI = 0.5 to 0.5). Patients with interpreter needs (OR 1.2, 95% CI = 1.1 to 1.3), experiencing recent homelessness (OR 1.4, 95% CI = 1.1 to 1.7), or ≥3 long-term conditions (OR 1.1, 95% CI = 1.1 to 1.1) were more likely to be seen by diagnostic ARRS staff. Conclusion: Following ARRS implementation, primary care activity was delivered by a broader workforce managing increasingly complex care. Further research should assess the safety, quality, and system impacts of ARRS roles.

Background: Care-experienced young people (CEYP) have higher rates of PTSD than their peers; however, their post-traumatic stress disorder (PTSD) symptoms are often missed. The Child Revised Impact of Events Scale (8 items; CRIES-8) is a well-validated and widely available screening tool, which could identify children at risk of PTSD.Objective: This project aimed to understand barriers and facilitators for the use of the CRIES-8 with CEYP accessing mental health services, as a means of increasing their access to evidence-based support.Methods: We recruited 243 mental health professionals from 28 mental health teams across England and provided training in the CRIES-8 and cognitive therapy for PTSD. Focus groups and interviews were conducted approximately every three months for 12-18 months, as well as a brief one-off questionnaire about implementation completed 6-9 months post-training. Qualitative data were analysed via thematic analysis.Results: While 80% of the sample did use the CRIES-8, only 50% used it with CEYP, and overall use was sporadic and inconsistent. The main barriers included capacity, CEYP access to mental health services, and professionals' beliefs around diagnoses and routine outcome measures, particularly for CEYP. Flexibility and proactivity amongst the team were important facilitators. In practice, there were a variety of methods to implement the CRIES-8, each with a different impact on service resources and the young person completing it.Conclusions Further service-based research to develop and test methods to address the identified barriers is essential to ensure that CEYP receive access to best-evidenced, needs-matched treatments.

Background: Clinically coded long COVID cases in electronic health records (EHRs) are incomplete, despite reports of rising cases of long COVID. Aim: To determine patient characteristics associated with clinically coded long COVID. Design & setting: With the approval of NHS England, we conducted a cohort study using EHRs within the OpenSAFELY-TPP platform in England, to study patient characteristics associated with clinically coded long COVID from 29 January 2020 to 31 March 2022. Method: We summarised the distribution of characteristics for people with clinically coded long COVID. We estimated age–sex adjusted hazard ratios (aHRs) and fully aHRs for coded long COVID. Patient characteristics included demographic factors, and health behavioural and clinical factors. Results: Among 17 986 419 adults, 36 886 (0.21%) were clinically coded with long COVID. Patient characteristics associated with coded long COVID included female sex, younger age (aged <60 years), obesity, living in less deprived areas, ever smoking, greater consultation frequency, and history of diagnosed asthma, mental health conditions, pre-pandemic post-viral fatigue, or psoriasis. These associations were attenuated following two doses of COVID-19 vaccines compared with before vaccination. Differences in the predictors of coded long COVID between the pre-vaccination and post-vaccination cohorts may reflect the different patient characteristics in these two cohorts rather than the vaccination status. Incidence of coded long COVID was higher in those with hospitalised COVID-19 than with those with non-hospitalised COVID-19. Conclusion: We identified variation in coded long COVID by patient characteristic. Results should be interpreted with caution as long COVID was likely under-recorded in EHRs.

Background: Testing for HIV, linkage to treatment and access to pre-exposure prophylaxis (PrEP) (medication which reduces the risk of acquiring HIV) is essential for early HIV diagnosis, treatment, and prevention. General practice could play a key role in maximising H IV testing opportunities and supporting access to PrEP. Aim: To develop an intervention for general practice to increase HIV testing and facilitate access to PrEP. Design and setting: A person-based approach (PBA) intervention development study using the Capability, Opportunity, Motivation, Behaviour (COM-B) Model in South West England. Method: A scoping review and semi-structured interviews with healthcare professionals (HCPs) and local organisation representatives with an interest in HIV prevention/healthcare) were conducted to understand the challenges and find potential solutions to increase HIV testing and facilitate access to PrEP in general practice. Intervention development used focus groups with HCPs and the public. Purposive sampling ensured diversity of practices and participants. Data was analysed using the PBA table of planning and CLIP-Q approach. Results: Barriers identified included lack of clinician knowledge of HIV and PrEP, concern about stretched resources and a lack of systematic testing methods. Proposed strategies included simpler testing methods to normalise testing and reduce HIV stigma. The intervention developed consists of: education, a prompt to test, simplified and standardised testing and PrEP signposting processes, patient information, and practice champions. Conclusion: Research is needed to explore the feasibility and the effectiveness of this multicomponent intervention to increase testing and access to PrEP within general practice. Funding barriers also need to be addressed. How this fits in: General practice could play a key role in maximising HIV testing opportunities and supporting access to pre-exposure prophylaxis (PrEP). Opportunities to carry out HIV testing continue to be missed in general practice leading to late HIV diagnosis which is associated with reduced life expectancy, increased mortality and greater treatment costs. Patient acceptability for HIV testing is high but testing rates are low and variable and patients experience barriers to accessing PrEP through sexual health clinics. This research reports the development of a multi-faceted approach to increase HIV testing and access to PrEP in general practice using the person-based approach. This included investigating public and healthcare professional perceptions about a range of approaches including training, opt-out testing, and the provision of decision-making aids. Targeting capability, opportunity and motivation barriers the intervention encompasses HIV and PrEP education and training, and the provision of simpler and systematic approaches to testing.

Design: Parallel-group randomised controlled trial. Methods: Participants: Adolescents aged 11–17 years, diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome and with no local specialist treatment centre, were referred to a specialist service in South West England. Interventions: Fatigue In Teenagers on the interNET in the National Health Service is a web-based myalgic encephalomyelitis/chronic fatigue syndrome-focused cognitive–behavioural therapy programme for adolescents, supported by individualised written, asynchronous electronic consultations with a clinical psychologist/cognitive–behavioural therapy practitioner. The comparator was videocall-delivered activity management with a myalgic encephalomyelitis/chronic fatigue syndrome clinician. Both treatments were intended to last 6 months. Objectives: Estimate the effectiveness of Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management for paediatric myalgic encephalomyelitis/chronic fatigue syndrome. Estimate the effectiveness of Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management for those with mild/moderate comorbid mood disorders. From a National Health Service perspective, estimate the cost-effectiveness of Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management over a 12-month horizon. Primary Outcome: 36-item Short Form Health Survey Physical Function subscale at 6 months post randomisation. Randomisation: Web-based, using minimisation with a random component to balance allocated groups by age and gender. Blinding: While the investigators were blinded to group assignment, this was not possible for participants, parents/carers and therapists. Results: The treatment of 314 adolescents was randomly allocated, 155 to Fatigue In Teenagers on the interNET in the National Health Service. Mean age was 14 years old and 63% were female. Primary outcome: At 6 months, participants allocated to Fatigue In Teenagers on the interNET in the National Health Service were more likely to have improved physical function (mean 60.5, standard deviation 29.5, n = 127) compared to Activity Management (mean 50.3, standard deviation 26.5, n = 138). The mean difference was 8.2 (95% confidence interval 2.7 to 13.6, p = 0.003). The result was similar for participants meeting the National Institute for Health and Care Excellence 2021 diagnostic criteria. Secondary outcomes: Fatigue In Teenagers on the interNET in the National Health Service participants attended, on average, half a day more school per week at 6 months than those allocated Activity Management, and this difference was maintained at 12 months. There was no strong evidence that comorbid mood disorder impacted upon the relative effectiveness of the two interventions. Similar improvement was seen in the two groups for pain and the Clinical Global Impression scale, with a mixed picture for fatigue. Both groups continued to improve, and no clear difference in physical function remained at 12 months [difference in means 4.4 (95% confidence interval −1.7 to 10.5)]. One or more of the pre-defined measures of a worsening condition in participants during treatment, combining therapist and patient reports, were met by 39 (25%) participants in the Fatigue In Teenagers on the interNET in the National Health Service group and 42 (26%) participants in the Activity Management group. A small gain was observed for the Fatigue In Teenagers on the interNET in the National Health Service group compared to Activity Management in quality-adjusted life-years (0.002, 95% confidence interval −0.041 to 0.045). From an National Health Service perspective, the costs were £1047.51 greater in the Fatigue In Teenagers on the interNET in the National Health Service group (95% confidence interval £624.61 to £1470.41). At a base cost-effectiveness threshold of £20,000 per quality-adjusted life-year, the incremental cost-effectiveness ratio was £457,721 with incremental net benefit of −£1001 (95% confidence interval −£2041 to £38). Conclusion: At 6 months post randomisation, compared with Activity Management, Fatigue In Teenagers on the interNET in the National Health Service improved physical function and school attendance. The additional cost of Fatigue In Teenagers on the interNET in the National Health Service and limited sustained impact mean it is unlikely to be cost-effective. Trial registration: This trial is registered as ISRCTN18020851. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/192/109) and is published in full in Health Technology Assessment; Vol. 28, No. 70. See the NIHR Funding and Awards website for further award information.

Background: Human papillomavirus (HPV) vaccination has been offered in over a hundred countries worldwide (including the United Kingdom, since September 2008). Controversy around adverse effects persists, with inconsistent evidence from follow-up of randomized controlled trials and confounding by indication limiting the conclusions drawn from larger-scale observational studies. This study aims to estimate the association between receiving a quadrivalent HPV vaccine and the reporting of short-term adverse effects and to demonstrate the utility of regression discontinuity design for examining side effects in routine data. Methods: We applied a novel regression discontinuity approach to a retrospective population-based cohort using primary care data from the UK Clinical Practice Research Datalink linked to hospital and social deprivation data. We examined the new onset of gastrointestinal, neuromuscular, pain, and headache/migraine symptoms using READ and International Classification of Diseases, tenth revision diagnostic codes. For each year between 2012 and 2017, we compared girls in school year 8 (born July/August) who were eligible to receive the vaccine with girls in year 7 (born September/October) who were not eligible. Results: Of the 21,853 adolescent girls in the cohort, 10,881 (50%) were eligible for HPV vaccination. There was no evidence of increased new gastrointestinal symptoms (adjusted odds ratio [OR]: 0.99; 95% confidence interval [CI]: 0.85, 1.15), headache/migraine symptoms (OR: 0.84; 95% CI: 0.70, 1.01), or pain symptoms (OR: 1.05; 95% CI: 0.95, 1.16) when comparing those eligible and ineligible for HPV vaccination. Conclusion: This study found no evidence that HPV vaccination eligibility is associated with reporting short-term adverse effects among adolescent girls.

Background: The Additional Roles Reimbursement Scheme (ARRS) was introduced by NHS England in 2019 alongside primary care networks (PCNs), with the aims of increasing the workforce and improving patient outcomes. Aim: To describe the uptake of direct patient care (DPC)-ARRS roles and its impact on patients’ experiences. Design and setting: An ecological study using 2020–2023 PCN and practice workforce data, registered patient characteristics, the General Practice Patient Survey, and the Quality and Outcomes Framework (QOF). Method: Descriptive statistics with associations were examined using quantile and linear regression. Results: By March 2023, 17 588 full-time equivalent (FTE) DPC-ARRS roles were commissioned by 1223 PCNs. PCNs with fewer constituent practices had more DPC-ARRS roles per population ( P P = 0.005). DPC-ARRS commissioning did not vary with age, sex, or deprivation characteristics of practice populations. DPC-ARRS roles were associated with small increases in patient satisfaction (0.8 percentage points increase in patients satisfied per one DPC-ARRS FTE) and perceptions of access (0.7 percentage points increase in patients reporting ‘good’ experience of making an appointment per one DPC-ARRS FTE), but not with overall QOF achievement. Conclusion: The commissioning of DPC-ARRS roles was associated with small increases in patient satisfaction and perceptions of access, but not with QOF achievement. DPC-ARRS roles were employed in areas with more GPs rather than compensating for a shortage of doctors. Single-practice PCNs commissioned more roles per registered population, which may be advantageous to single-practice PCNs. Further evaluation of the scheme is warranted.

Background The Additional Roles Reimbursement Scheme (ARRS) was introduced by NHS England in 2020 alongside Primary Care Networks (PCNs) with aims of increasing the workforce and improving patient outcomes. Aim Describe the uptake of direct-patient care (DPC)-ARRS roles and its impact on patients’ experiences. Design and Setting Ecological study using 2020-2023 PCN and Practice workforce data, registered patient characteristics, the General Practice Patient Survey, and the Quality and Outcomes Framework (QOF). Methods Descriptive statistics with associations examined using quantile and linear regression. Results By March 2023, 17,588 FTE DPC-ARRS roles were commissioned by 1,223 PCNs. PCNs with fewer constituent practices had more DPC-ARRS roles per population (pConclusions The commissioning of DPC-ARRS roles was associated with small increases in patient satisfaction and perceptions of access, but not with QOF achievement. DPC-ARRS roles were employed in areas with more GPs rather than compensating for a shortage of doctors. Single practice PCNs commissioned more roles per registered population, which may be advantageous to single practice PCNs. Further evaluation of the scheme is warranted. How this fits in Primary Care Networks (PCNs) commissioning of non-GP direct-patient care (DPC) roles via the Additional Roles Reimbursement Scheme (ARRS) has expanded rapidly, with an allocated budget of £110m in 2019/2020 employing 279 full time equivalent (FTE) DPC-ARRS staff in March 2020, to £1,027m in 2022/2023, employing 17,588 FTE DPC-ARRS staff in March 2023. Previous research, using NHS England data prior to 2020, had reported associations between increased Healthcare Associate Professionals employment and reductions in patient satisfaction and perceptions of access, with no impact on Quality and Outcomes Framework (QOF) achievement, but it was not known if these trends remained after the implementation of ARRS. This study found a small increase in both overall patient satisfaction and perceptions of access, which equates to approximately 240-400 patients satisfied with their care and 210-350 patients able to make appointments for each FTE in ARRS roles employed in a typical PCN (30,000-50,000 patients), but no association with overall QOF achievement. Further evaluation is required to identify if the observed associations can be attributed to the ARRS roll-out and if this represents value for money.

Background Fit notes (“sick notes”) are issued by general practitioners (GPs) when a person can’t work for health reasons and is an indication of the public health and economic burden for people recovering from COVID-19. Methods With NHS England approval, we used routine clinical data from >24 million patients to compare fit note incidence in people 18-64 years with and without evidence of COVID-19 in 2020, 2021 and 2022. We fit Cox regression models to estimate adjusted hazard ratios, overall and by time post-diagnosis and within demographic subgroups. Results We identified 365,421, 1,206,555 and 1,321,313 people with evidence of COVID-19 in 2020, 2021 and 2022. The fit note rate was 4.88 per 100 person-months (95%CI 4.83-4.93) in 2020, 2.66 (95%CI 2.64-2.67) in 2021, and 1.73 (95%CI 1.72-1.73) in 2022. Compared with the age, sex and region matched general population, the hazard ratio (HR) adjusted for demographics and clinical characteristics over the follow-up period was 4.07 (95%CI 4.02-4.12) in 2020 decreasing to 1.57 (95%CI 1.56-1.58) in 2022. The HR was highest in the first 30 days post-diagnosis in all years. Conclusions Despite likely underestimation of the fit note rate, we identified a considerable increase among people with COVID-19, even in an era when most people are vaccinated. Most fit notes are associated with the acute phase of the disease, but the increased risk several months post-diagnosis provides further evidence of the long-term impact. Evidence before this study We searched Pubmed from 1 March 2020 to 30 June 2023 using the following search terms: (“COVID-19” OR “SARS-CoV-2” OR “coronavirus”) AND (“United Kingdom” OR “England” OR “Britain” OR “Scotland” OR “Wales”) AND (“fit note” OR “sick note” OR “sick leave” OR “sickness absence”). We also searched the reference list of relevant articles. We included both peer-reviewed research studies and grey literature that quantified receipt of fit notes or sick leave during the COVID-19 pandemic. We found two peer-reviewed studies and one briefing by an independent think tank. A study of 959,356 National Health Service (NHS) employees in England quantified receipt of non-COVID-19 related fit notes during the first wave of the pandemic. They found that the overall fit note rate was lower in 2020 compared with 2019. However, increases in the number of people receiving fit notes were observed for respiratory, infectious disease, and mental health conditions. The second study of 15,931 domiciliary care workers in Wales between Mar 2020 and Nov 2021 found that 15% had been issued a fit note over the study period. Fit notes were more common among women, people ≥45 years, and those with comorbidities. The briefing found that the percentage of sickness absence days taken by NHS employees was higher in 2022 (5.6%) compared with 2019 (4.3%), with a particular increase in absences due to mental health and infectious diseases. In 2022, 18% of sickness absence days were attributable to COVID-19. Added value of this study This study is the first to quantify changes in fit note rate since the start of the COVID-19 pandemic among people with a reported SARS-CoV-2 infection and how this compares with the general population in the UK. We found that people with evidence of SARS-CoV-2 infection had a higher fit note rate than the general population, even after adjusting for demographics and clinical characteristics. While this increased risk was greatest in 2020 (hazard ratio [HR] = 4.07, 95%CI 4.02-4.12), it continued to a lesser extent even into 2022 (HR = 1.57, 95%CI 1.56-1.58). The fit note rate was greatest in the first 30 days post-diagnosis, suggesting that most sick leave is associated with the acute phase. In subgroup analyses, the groups with the greatest relative increased risk changed over the years. People aged 18-24 years had a larger relative increased risk of fit notes (as measured by HR) in 2022 than 2021, when compared with the general population in each year. Additionally, while in 2020 and 2021 the HR increased along with lessening deprivation, this effect dissipated in 2022. In contrast, people hospitalised with COVID-19 were less likely to be issued a fit note than the pneumonia cohort, suggesting the long-term effects may be similar to comparable severe respiratory infections for severe cases resulting in hospitalisation. Implications of all the available evidence While we have likely underestimated the fit note rate due to overcounting of people in the workforce and misclassification of COVID-19 status, we still identified a substantial