Claire Planner

Background: Patient participation in health systems is increasing globally. English general practices have been required to establish patient participation groups (PPGs) since 2015. However, little is known about current PPG coverage and distribution. Aim: To explore the relationship between PPG coverage and quality with general practice deprivation deciles, geographical location, and Care Quality Commission (CQC) ratings. Design and setting: Mixed-methods documentary analysis of quantitative and qualitative data was carried out from general practice CQC reports in Yorkshire and Humber, England. Method: Data were extracted from CQC reports for practices in the most and least deprived areas across three integrated care systems (ICSs). Quantitative data examined PPG coverage by practice deprivation decile, location, and CQC rating. Qualitative thematic analysis assessed PPG quality. Results: Of 122 practices, 99 (81.1%) had a PPG, 16 (13.1%) lacked one, and seven (5.7%) had a partial PPG. Practices in the most deprived areas were significantly less likely to have a PPG than those in the least deprived areas ( P = 0.006). While there were minor differences in PPG coverage between ICS locations, no significant variation was observed based on CQC ratings. PPG activities included workforce adjustments and training, infrastructure, communications, accessibility and appointments, health promotion and education, and fundraising. Conclusion: Practices in the most deprived areas were significantly less likely to have a PPG ( P = 0.006), and their PPGs engaged in different activities compared with those in the least deprived areas. This may exacerbate inequalities as PPGs are one mechanism to support patient participation and improve general practice quality and experience.

Background and aims: Individuals living with severe mental illness such as schizophrenia and bipolar can have significant emotional, cognitive, physical and social challenges. Most people with severe mental illness in the United Kingdom do not receive specialist mental health care. Collaborative care is a system of support that combines clinical and organisational components to provide integrated and person-centred care. It has not been tested for severe mental illness in the United Kingdom. We aimed to develop and evaluate a primary care-based collaborative care model (PARTNERS) designed to improve quality of life for people with diagnoses of schizophrenia, bipolar or other psychoses when compared with usual care. Methods: Phase 1 included studies to (1) understand context: an observational retrospective study of primary and secondary care medical records and an update of the Cochrane review ‘Collaborative care approaches for people with severe mental illness’; (2) develop and formatively evaluate the PARTNERS intervention: a review of literature on collaborative care and recovery, interviews with key leaders in collaborative care and recovery, focus groups with service users and a formative evaluation of a prototype intervention model; and (3) develop trial science work in this area: a core outcome set for bipolar and recruitment methods. In phase 2 we conducted a cluster randomised controlled trial measuring quality of life using the Manchester Short Assessment of Quality of Life and secondary outcomes including time use, recovery and mental well-being; a cost-effectiveness study; and a mixed-methods process evaluation. Public involvement underpinned all of the workstream activity through the study Lived Experience Advisory Panel and the employment of service user researchers in the project team. Results phase 1: The study of records showed that care for individuals under secondary care is variable and substantial and that people are seen every 2 weeks on average. The updated Cochrane review showed that collaborative care interventions were highly variable, and no reliable conclusions can be drawn about effectiveness. The PARTNERS model incorporated change at organisational, practitioner and individual levels. Coaching was selected as the main form of support for individuals’ personal goals. In the formative evaluation, we showed that more intensive supervision and ‘top-up’ training were needed to achieve the desired shifts in practice. A core outcome set was developed for bipolar, and measures were selected for the trial. We developed a stepped approach to recruitment including initial approach and appointment. Results phase 2: The trial was conducted in four areas. In total, 198 participants were recruited from 39 practices randomised. Participants received either the PARTNERS intervention or usual care. The follow-up rate was 86% at 9–12 months. The mean change in overall Manchester Short Assessment Quality of Life score did not differ between the groups [0.25 (standard deviation 0.73) for intervention vs. 0.21 (standard deviation 0.86) for control]. We also found no difference for any secondary measures. Safety outcomes (e.g. crises) did not differ between those receiving and those not receiving the intervention. Although the costs of intervention and usual care were similar, there is insufficient evidence to draw conclusions about the overall cost-effectiveness of PARTNERS. The mixed-methods process evaluation demonstrated that a significant proportion of individuals did not receive the full intervention. This was partly due to care partner absence and participant choice. The in-depth realist informed case studies showed that participants generally appreciated the support, with some describing having a ‘professional friend’ as very important. For some people there was evidence that delivery of the intervention had led to specific personal changes. Strengths and limitations: The phase 1 records study provided insights into usual care that had not been previously documented. The realist informed complex intervention development was both theoretical and pragmatic. The trial continued through the COVID-19 pandemic with high levels of follow-up. The process evaluation had the depth to explore individual changes in participants’ response to the intervention. Weaknesses in the trial methodology included suboptimal implementation, outcome measures that may not have been sensitive to changes patients most appreciated and difficulties collecting some outcomes. Conclusions: While PARTNERS was not shown to be superior to usual care, the change to PARTNERS care was not shown to be unsafe. Full intervention implementation was challenging, but this is to be expected in studies of care that include those with psychosis. Some individuals responded well to the intervention when psychological support in the form of individualised goal setting was flexibly deployed, with evidence that having access to a ‘professional friend’ was experienced as particularly helpful for some individuals. Future work: Key components of the PARTNERS model could be developed further and tested, along with improved supervision in the context of ongoing community mental health care change. Trial registration: This trial is registered as ISRCTN95702682. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: NIHR200625) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information.

Participant recruitment and retention are long-standing problems in clinical trials. Although there are a large number of factors impacting on recruitment and retention, some of the problems may reflect the fact that trial design and delivery is not sufficiently ‘patient-centred’ (i.e., sensitive to patient needs and preferences). Most trials collect process and outcome measures, but it is unclear whether patient experience of trial participation itself is routinely measured. We conducted a structured scoping review of studies reporting standardised assessment of patient experience of participation in a trial. A structured search of Medline, PsycINFO, Embase and CINAHL (Cumulative Index to Nursing and Allied Health Literature) and hand searching of included studies were conducted in 2016. Additional sources included policy documents, relevant websites and experts. We extracted data on trial context (type, date and location) and measure type (number of items and mode of administration), patient experience domains measured, and the results reported. We conducted a narrative synthesis. We identified 22 journal articles reporting on 21 different structured measures of participant experience in trials. None of the studies used a formal definition of patient experience. Overall, patients reported relatively high levels of global satisfaction with the trial process as well as positive outcomes (such as the likelihood of future participation or recommendation of the trial to others). Current published evidence is sparse. Standardised assessment of patient experience of trial participation may provide opportunities for researchers to enhance trial design and delivery. This could complement other methods of enhancing the patient-centredness of trials and might improve recruitment, retention, and long-term patient engagement with trials.

Introduction The increasing prevalence of type 2 diabetes mellitus (T2DM) presents a significant burden on affected individuals and healthcare systems internationally. There is, however, no agreed validated measure to infer diabetes severity from electronic health records (EHRs). We aim to quantify T2DM severity and validate it using clinical adverse outcomes. Methods and analysis Primary care data from the Clinical Practice Research Datalink, linked hospitalisation and mortality records between April 2007 and March 2017 for patients with T2DM in England will be used to develop a clinical algorithm to grade T2DM severity. The EHR-based algorithm will incorporate main risk factors (severity domains) for adverse outcomes to stratify T2DM cohorts by baseline and longitudinal severity scores. Provisionally, T2DM severity domains, identified through a systematic review and expert opinion, are: diabetes duration, glycated haemoglobin, microvascular complications, comorbidities and coprescribed treatments. Severity scores will be developed by two approaches: (1) calculating a count score of severity domains; (2) through hierarchical stratification of complications. Regression models estimates will be used to calculate domains weights. Survival analyses for the association between weighted severity scores and future outcomes—cardiovascular events, hospitalisation (diabetes-related, cardiovascular) and mortality (diabetes-related, cardiovascular, all-cause mortality)—will be performed as statistical validation. The proposed EHR-based approach will quantify the T2DM severity for primary care performance management and inform the methodology for measuring severity of other primary care-managed chronic conditions. We anticipate that the developed algorithm will be a practical tool for practitioners, aid clinical management decision-making, inform stratified medicine, support future clinical trials and contribute to more effective service planning and policy-making. Ethics and dissemination The study protocol was approved by the Independent Scientific Advisory Committee. Some data were presented at the National Institute for Health Research School for Primary Care Research Showcase, September 2017, Oxford, UK and the Diabetes UK Professional Conference March 2018, London, UK. The study findings will be disseminated in relevant academic conferences and peer-reviewed journals.

Background: Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials.Objective: To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials.Design: A modified Delphi process including a two round online survey and a stakeholder consensus meeting.Participants: In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty‐seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting.Results: Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants.Conclusions: The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste.

Smoking is one of the major modifiable risk factors contributing to early mortality for people with serious mental illness. However, only a minority of service users access smoking cessation interventions and there are concerns about the appropriateness of generic stop-smoking services for this group. The SCIMITAR (Smoking Cessation Intervention for Severe Mental Ill-Health Trial) feasibility study explored the effectiveness of a bespoke smoking cessation intervention delivered by mental health workers. This paper reports on the nested qualitative study within the trial. Qualitative semi-structured interviews were conducted with 13 service users receiving the intervention and 3 of the MHSCPs (mental health smoking cessation practitioners) delivering the intervention. Topic guides explored the perceived acceptability of the intervention particularly in contrast to generic stop-smoking services, and perceptions of the implementation of the intervention in practice. Transcripts were analysed using the Constant Comparative Method. Generic services were reported to be inappropriate for this group, due to concerns over stigma and a lack of support from health professionals. The bespoke intervention was perceived positively, with both practitioners and service users emphasising the benefits of flexibility and personalisation in delivery. The mental health background of the practitioners was considered valuable not only due to their increased understanding of the service users’ illness but also due to the more collaborative relationship style they employed. Challenges involved delays in liaising with general practitioners and patient struggles with organisation and motivation, however the MHSCP was considered to be well placed to address these problems. The bespoke smoking cessation intervention was acceptable to service users and the both service users and practitioners reported the value of a protected mental health worker role for delivering smoking cessation to this group. The results have wider implications for understanding how to achieve integrated and personalised care for this high-risk population and further underscore the need for sensitised smoking cessation support for people with serious mental illness. Current Controlled Trials ISRCTN79497236 . Registered 3rd July 2009.

The use of Electronic Health Records databases for medical research has become mainstream. In the UK, increasing use of Primary Care Databases is largely driven by almost complete computerisation and uniform standards within the National Health Service. Electronic Health Records research often begins with the development of a list of clinical codes with which to identify cases with a specific condition. We present a methodology and accompanying Stata and R commands (pcdsearch/Rpcdsearch) to help researchers in this task. We present severe mental illness as an example. We used the Clinical Practice Research Datalink, a UK Primary Care Database in which clinical information is largely organised using Read codes, a hierarchical clinical coding system. Pcdsearch is used to identify potentially relevant clinical codes and/or product codes from word-stubs and code-stubs suggested by clinicians. The returned code-lists are reviewed and codes relevant to the condition of interest are selected. The final code-list is then used to identify patients. We identified 270 Read codes linked to SMI and used them to identify cases in the database. We observed that our approach identified cases that would have been missed with a simpler approach using SMI registers defined within the UK Quality and Outcomes Framework. We described a framework for researchers of Electronic Health Records databases, for identifying patients with a particular condition or matching certain clinical criteria. The method is invariant to coding system or database and can be used with SNOMED CT, ICD or other medical classification code-lists.

Objectives Little is known about service utilisation by patients with severe mental illness (SMI) in UK primary care. We examined their consultation rate patterns and whether they were impacted by the introduction of the Quality and Outcomes Framework (QOF), in 2004. Design Retrospective cohort study using individual patient data collected from 2000 to 2012. Setting 627 general practices contributing to the Clinical Practice Research Datalink, a large UK primary care database. Participants SMI cases (346 551) matched to 5 individuals without SMI (1 732 755) on age, gender and general practice. Outcome measures Consultation rates were calculated for both groups, across 3 types: face-to-face (primary outcome), telephone and other (not only consultations but including administrative tasks). Poisson regression analyses were used to identify predictors of consultation rates and calculate adjusted consultation rates. Interrupted time-series analysis was used to quantify the effect of the QOF. Results Over the study period, face-to-face consultations in primary care remained relatively stable in the matched control group (between 4.5 and 4.9 per annum) but increased for people with SMI (8.8–10.9). Women and older patients consulted more frequently in the SMI and the matched control groups, across all 3 consultation types. Following the introduction of the QOF, there was an increase in the annual trend of face-to-face consultation for people with SMI (average increase of 0.19 consultations per patient per year, 95% CI 0.02 to 0.36), which was not observed for the control group (estimates across groups statistically different, p=0.022). Conclusions The introduction of the QOF was associated with increases in the frequency of monitoring and in the average number of reported comorbidities for patients with SMI. This suggests that the QOF scheme successfully incentivised practices to improve their monitoring of the mental and physical health of this group of patients.

Background: There is a high prevalence of smoking among people who experience severe mental ill health (SMI). Helping people with disorders such as bipolar illness and schizophrenia to quit smoking would help improve their health, increase longevity and also reduce health inequalities. Around half of people with SMI who smoke express an interest in cutting down or quitting smoking. There is limited evidence that smoking cessation can be achieved for people with SMI. Those with SMI rarely access routine NHS smoking cessation services. This suggests the need to develop and evaluate a behavioural support and medication package tailored to the needs of people with SMI.Objective: The objective in this project was to conduct a pilot trial to establish acceptability of the intervention and to ensure the feasibility of recruitment, randomisation and follow-up. We also sought preliminary estimates of effect size in order to design a fully powered trial of clinical effectiveness and cost-effectiveness. The pilot should inform a fully powered trial to compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual general practitioner (GP) care for people with SMI.Design: A pilot pragmatic two-arm individually randomised controlled trial (RCT). Simple randomisation was used following a computer-generated random number sequence. Participants and practitioners were not blinded to allocation.Setting: Primary care and secondary care mental health services in England.Participants: Smokers aged > 18 years with a severe mental illness who would like to cut down or quit smoking.Interventions: A BSC intervention delivered by mental health specialists trained to deliver evidence-supported smoking cessation interventions compared with usual GP care.Main outcome measures: The primary outcome was carbon monoxide-verified smoking cessation at 12 months. Smoking-related secondary outcomes were reduction of number of cigarettes smoked, Fagerstrom test of nicotine dependence and motivation to quit (MTQ). Other secondary outcomes were Patient Health Questionnaire-9 items and Short Form Questionnaire-12 items to assess whether there were improvements or deterioration in mental health and quality of life. We also measured body mass index to assess whether or not smoking cessation was associated with weight gain. These were measured at 1, 6 and 12 months post randomisation.Results: The trial recruited 97 people aged 19–73 years who smoked between 5 and 60 cigarettes per day (mean 25 cigarettes). Participants were recruited from four mental health trusts and 45 GP surgeries. Forty-six people were randomised to the BSC intervention and 51 people were randomised to usual GP care. The odds of quitting at 12 months was higher in the BSC intervention (36% vs. 23%) but did not reach statistical significance (odds ratio 2.9; 95% confidence interval 0.8% to 10.5%). At 3 and 6 months there was no evidence of difference in self-reported smoking cessation. There was a non-significant reduction in the number of cigarettes smoked and nicotine dependence. MTQ and number of quit attempts all increased in the BSC group compared with usual care. There was no difference in terms of quality of life at any time point, but there was evidence of an increase in depression scores at 12 months for the BSC group. There were no serious adverse events thought likely to be related to the trial interventions. The pilot economic analysis demonstrated that it was feasible to carry out a full economic analysis.Conclusions: It was possible to recruit people with SMI from primary and secondary care to a trial of a smoking cessation intervention based around behavioural support and medication. The overall direction of effect was a positive trend in relation to biochemically verified smoking cessation and it was feasible to obtain follow-up in a substantial proportion of participants. A definitive trial of a bespoke cessation intervention has been prioritised by the National Institute for Health Research (NIHR) and the SCIMITAR pilot trial forms a template for a fully powered RCT to examine clinical effectiveness and cost-effectiveness.Trial registration: Current Controlled Trials ISRCTN79497236.Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment, Vol. 19, No. 25. See the NIHR Journals Library website for further project information.