Patient reported measures of continuity of care and health outcomes: a systematic review.

BACKGROUND: There is a considerable amount of research showing an association between continuity of care and improved health outcomes. However, the methods used in most studies examine only the pattern of interactions between patients and clinicians through administrative measures of continuity. The patient experience of continuity can also be measured by using patient reported experience measures. Unlike administrative measures, these can allow elements of continuity such as the presence of information or how joined up care is between providers to be measured. Patient experienced continuity is a marker of healthcare quality in its own right. However, it is unclear if, like administrative measures, patient reported continuity is also linked to positive health outcomes. METHODS: Cohort and interventional studies that examined the relationship between patient reported continuity of care and a health outcome were eligible for inclusion. Medline, EMBASE, CINAHL and the Cochrane Library were searched in April 2021. Citation searching of published continuity measures was also performed. QUIP and Cochrane risk of bias tools were used to assess study quality. A box-score method was used for study synthesis. RESULTS: Nineteen studies were eligible for inclusion. 15 studies measured continuity using a validated, multifactorial questionnaire or the continuity/co-ordination subscale of another instrument. Two studies placed patients into discrete groups of continuity based on pre-defined questions, one used a bespoke questionnaire, one calculated an administrative measure of continuity using patient reported data. Outcome measures examined were quality of life (n = 11), self-reported health status (n = 8), emergency department use or hospitalisation (n = 7), indicators of function or wellbeing (n = 6), mortality (n = 4) and physiological measures (n = 2). Analysis was limited by the relatively small number of hetrogenous studies. The majority of studies showed a link between at least one measure of continuity and one health outcome. CONCLUSION: Whilst there is emerging evidence of a link between patient reported continuity and several outcomes, the evidence is not as strong as that for administrative measures of continuity. This may be because administrative measures record something different to patient reported measures, or that studies using patient reported measures are smaller and less able to detect smaller effects. Future research should use larger sample sizes to clarify if a link does exist and what the potential mechanisms underlying such a link could be. When measuring continuity, researchers and health system administrators should carefully consider what type of continuity measure is most appropriate.

Relationship between research activity and general practice performance: cross sectional and longitudinal analyses.

BACKGROUND: Research activity usually improves outcomes by being translated into practice. However, there is developing evidence that research activity itself may improve the overall performance of health care organisations. However, evidence that these relationships represent a causal impact of research activity is less clear. Additionally, the bulk of the existing evidence relates to hospital settings, and it is not known if those relationships would also be found in general practice, where most patient contacts occur. AIM: We sought to (a) test whether there were significant relationships between research activity in general practice and organisational performance (b) test whether those relationships were plausibly causal. DESIGN AND SETTING: We analysed national data between 2008 and 2019 using cross sectional and longitudinal analyses, on general practices in England. METHODS: We used cross-sectional, panel and instrumental variable analyses to explore relationships between research activity (including measures from the NIHR Clinical Research Network and the Royal College of General Practitioners) and practice performance (including clinical quality of care, patient reported experience of care, prescribing quality and hospital admissions) Results: In cross-sectional analyses, research activity was positively associated with several measures of practice performance, including clinical quality of care, patient reported experience of care, and reduced hospital admissions. The associations were generally modest in magnitude. However, longitudinal analyses did not support a reliable causal relationship. CONCLUSION: Similar to findings from hospital settings, research activity in general practice is associated with practice performance. There is less evidence that research is causing those improvements, although this may reflect the limited level of research activity in most practices. We identified no negative impacts, suggesting that research activity is a potential marker of quality and something that high quality practices can deliver alongside their core responsibilities.

Service design for children and young people with common mental health problems: literature review, service mapping and collective case study.

Background: The mental health of children/young people is a growing concern internationally. Numerous reports and reviews have consistently described United Kingdom children's mental health services as fragmented, variable, inaccessible and lacking an evidence base. Little is known about the effectiveness of, and implementation complexities associated with, service models for children/young people experiencing 'common' mental health problems like anxiety, depression, attention deficit hyperactivity disorder and self-harm. Aim: To develop a model for high-quality service design for children/young people experiencing common mental health problems by identifying available services, barriers and enablers to access, and the effectiveness, cost effectiveness and acceptability of such services. Design: Evidence syntheses with primary research, using a sequential, mixed-methods design. Inter-related scoping and integrative reviews were conducted alongside a map of relevant services across England and Wales, followed by a collective case study of English and Welsh services. Setting: Global (systematic reviews); England and Wales (service map; case study). Data sources: Literature reviews: relevant bibliographic databases and grey literature. Service map: online survey and offline desk research. Case study: 108 participants (41 children/young people, 26 parents, 41 staff) across nine case study sites. Methods: A single literature search informed both reviews. The service map was obtained from an online survey and internet searches. Case study sites were sampled from the service map; because of coronavirus disease 2019, case study data were collected remotely. 'Young co-researchers' assisted with case study data collection. The integrative review and case study data were synthesised using the 'weaving' approach of 'integration through narrative'. Results: A service model typology was derived from the scoping review. The integrative review found effectiveness evidence for collaborative care, outreach approaches, brief intervention services and the 'availability, responsiveness and continuity' framework. There was cost-effectiveness evidence only for collaborative care. No service model appeared to be more acceptable than others. The service map identified 154 English and Welsh services. Three themes emerged from the case study data: 'pathways to support'; 'service engagement'; and 'learning and understanding'. The integrative review and case study data were synthesised into a coproduced model of high-quality service provision for children/young people experiencing common mental health problems. Limitations: Defining 'service model' was a challenge. Some service initiatives were too new to have filtered through into the literature or service map. Coronavirus disease 2019 brought about a surge in remote/digital services which were under-represented in the literature. A dearth of relevant studies meant few cost-effectiveness conclusions could be drawn. Conclusions: There was no strong evidence to suggest any existing service model was better than another. Instead, we developed a coproduced, evidence-based model that incorporates the fundamental components necessary for high-quality children's mental health services and which has utility for policy, practice and research. Future work: Future work should focus on: the potential of our model to assist in designing, delivering and auditing children's mental health services; reasons for non-engagement in services; the cost effectiveness of different approaches in children's mental health; the advantages/disadvantages of digital/remote platforms in delivering services; understanding how and what the statutory sector might learn from the non-statutory sector regarding choice, personalisation and flexibility. Study registration: This study is registered as PROSPERO CRD42018106219. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/09/08) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 13. See the NIHR Funding and Awards website for further award information.

In this research study, we explored services for children and young people with 'common' mental health problems like depression, anxiety and self-harm. We aimed to find out what services exist, how children/young people and families find out about and access these services, what the services actually do, whether they are helpful and whether they offer value for money. We looked at the international literature (reports and research papers) to identify different approaches to providing support, and to find out whether certain approaches worked better than others and whether children/young people and families preferred some approaches over others. The literature provided very little information about the value for money of services. We also carried out a survey and used the internet to identify 154 relevant services in England and Wales. To explore services in more detail, and hear directly from those using them, we planned to visit 9 of the 154 services to interview children/young people, parents and staff. Unfortunately, coronavirus disease 2019 stopped us directly visiting the nine services and so we conducted phone and video interviews instead. We still managed to speak to, and hear the experiences of, more than 100 people (including children/young people and parents). We combined information from the literature with information from the interviews to create an evidence-based 'model' of what services should look like. This model considers some basic things like how quickly children/young people could access a service, what information was available, the importance of confidentiality and whether staff make the service fit with the child/young person's needs and interests. It also considers whether the service helps children/young people learn skills to manage their mental health and whether staff at a service work well together. We hope our model will help existing and new services improve what they offer to children/young people and families.

Impact of research activity on performance of general practices: a qualitative study.

BACKGROUND: There is evidence that engaging in research is directly associated with better performance. If this relationship is to be strengthened, it is necessary to understand the mechanisms which might underlie that relationship. AIM: To explore the perspectives of staff and wider stakeholders about mechanisms by which research activity might impact on the performance of general practices. DESIGN & SETTING: Qualitative study using semi-structured interviews with general practice professionals and wider stakeholders in England. METHOD: Individual interviews with 41 purposively sampled staff in 'research ready' or 'research active' general practices and 21 other stakeholders. Interviews were independently coded by three researchers using a Framework approach. RESULTS: Participants described potential 'direct' and 'indirect' impacts on their work. 'Direct' impacts included research changing practice work (eg, additional records searches for particular conditions), bringing in additional resources (eg, access to investigations or staff) and improving relationships with patients. 'Indirect' impacts included job satisfaction (eg, perception of practice as a centre of excellence and innovation, and the variety afforded by research activity reducing burnout) and staff recruitment (increasing the attractiveness of the practice as a place to work). Respondents identified few negative impacts. CONCLUSIONS: Staff and stakeholders identified a range of potential impacts of research activity on practice performance, with impacts on their working lives most salient. Negative impacts were not generally raised. Nevertheless, respondents generally discussed potential impacts rather than providing specific examples of those impacts. This may reflect the type of research activity conducted in general practice, often led by external collaborators.

Inpatient-level care at home delivered by virtual wards and hospital at home: a systematic review and meta-analysis of complex interventions and their components.

BACKGROUND: Technology-enabled inpatient-level care at home services, such as virtual wards and hospital at home, are being rapidly implemented. This is the first systematic review to link the components of these service delivery innovations to evidence of effectiveness to explore implications for practice and research. METHODS: For this review (registered here https://osf.io/je39y ), we searched Cochrane-recommended multiple databases up to 30 November 2022 and additional resources for randomised and non-randomised studies that compared technology-enabled inpatient-level care at home with hospital-based inpatient care. We classified interventions into care model groups using three key components: clinical activities, workforce, and technology. We synthesised evidence by these groups quantitatively or narratively for mortality, hospital readmissions, cost-effectiveness and length of stay. RESULTS: We include 69 studies: 38 randomised studies (6413 participants; largely judged as low or unclear risk of bias) and 31 non-randomised studies (31,950 participants; largely judged at serious or critical risk of bias). The 69 studies described 63 interventions which formed eight model groups. Most models, regardless of using low- or high-intensity technology, may have similar or reduced hospital readmission risk compared with hospital-based inpatient care (low-certainty evidence from randomised trials). For mortality, most models had uncertain or unavailable evidence. Two exceptions were low technology-enabled models that involve hospital- and community-based professionals, they may have similar mortality risk compared with hospital-based inpatient care (low- or moderate-certainty evidence from randomised trials). Cost-effectiveness evidence is unavailable for high technology-enabled models, but sparse evidence suggests the low technology-enabled multidisciplinary care delivered by hospital-based teams appears more cost-effective than hospital-based care for those with chronic obstructive pulmonary disease (COPD) exacerbations. CONCLUSIONS: Low-certainty evidence suggests that none of technology-enabled care at home models we explored put people at higher risk of readmission compared with hospital-based care. Where limited evidence on mortality is available, there appears to be no additional risk of mortality due to use of technology-enabled at home models. It is unclear whether inpatient-level care at home using higher levels of technology confers additional benefits. Further research should focus on clearly defined interventions in high-priority populations and include comparative cost-effectiveness evaluation. TRIAL REGISTRATION: https://osf.io/je39y .

Factors affecting the experience of joined-up, continuous primary care in the absence of relational continuity: an observational study.

BACKGROUND: There is an international trend towards the at-scale provision of primary care services, with such services often provided in different settings by a clinician unfamiliar to the patient. It is often assumed that, in the absence of relational continuity, any competent clinician can deliver joined-up, continuous care if they have access to clinical notes. AIM: To explore the factors that affect the potential for providing joined-up, continuous care in a system where care is delivered away from a patient's regular practice, by a different organisation and set of staff. DESIGN AND SETTING: Case studies of two extended-access providers in the north of England. METHOD: Case studies were carried out between September 2021 and January 2022 in two sites. Data collected included observations of patient-healthcare professional interactions, interviews with staff and patients, and documentation. Analysis took place using a constant comparison approach. Data were coded. A model of the factors affecting continuity was constructed. RESULTS: The potential for joined-up, continuous care appears dependent on staff, patient, and system factors. This includes diverse elements such as the attitude of clinicians to care coordination and the ability of an organisation to retain staff. CONCLUSION: Healthcare systems increasingly rely on the assumption that any competent clinician can deliver joined-up, continuous care if they have access to clinical notes. This appears not to be the case. This study presents a model of factors affecting the patient's experience of continuity. The model needs validating in in-hours general practice and other settings.

Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme.

Background: Randomised controlled trials ('trials') are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to improve recruitment and retention. However, relatively few of these have been conducted. Objectives: PROMoting THE Use of Studies Within A Trial aimed to facilitate at least 25 Studies Within A Trial evaluating recruitment or retention strategies. We share our experience of delivering the PROMoting THE Use of Studies Within A Trial programme, and the lessons learnt for undertaking randomised Studies Within A Trial. Design: A network of 10 Clinical Trials Units and 1 primary care research centre committed to conducting randomised controlled Studies Within A Trial of recruitment and/or retention strategies was established. Promising recruitment and retention strategies were identified from various sources including Cochrane systematic reviews, the Study Within A Trial Repository, and existing prioritisation exercises, which were reviewed by patient and public members to create an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding and receive support from the PROMoting THE Use of Studies Within A Trial team to undertake Studies Within A Trial. We also tested the feasibility of undertaking co-ordinated Studies Within A Trial, across multiple host trials simultaneously. Setting: Clinical trials unit-based trials recruiting or following up participants in any setting in the United Kingdom were eligible. Participants: Clinical trials unit-based teams undertaking trials in any clinical context in the United Kingdom. Interventions: Funding of up to £5000 and support from the PROMoting THE Use of Studies Within A Trial team to design, implement and report Studies Within A Trial. Main outcome measures: Number of host trials funded. Results: Forty-two Studies Within A Trial were funded (31 host trials), across 12 Clinical Trials Units. The mean cost of a Study Within A Trial was £3535. Twelve Studies Within A Trial tested the same strategy across multiple host trials using a co-ordinated Study Within A Trial design, and four used a factorial design. Two recruitment and five retention strategies were evaluated in more than one host trial. PROMoting THE Use of Studies Within A Trial will add 18% more Studies Within A Trial to the Cochrane systematic review of recruitment strategies, and 79% more Studies Within A Trial to the Cochrane review of retention strategies. For retention, we found that pre-notifying participants by card, letter or e-mail before sending questionnaires was effective, as was the use of pens, and sending personalised text messages to improve questionnaire response. We highlight key lessons learnt to guide others planning Studies Within A Trial, including involving patient and public involvement partners; prioritising and selecting strategies to evaluate and elements to consider when designing a Study Within A Trial; obtaining governance approvals; implementing Studies Within A Trial, including individual and co-ordinated Studies Within A Trials; and reporting Study Within A Trials. Limitations: The COVID-19 pandemic negatively impacted five Studies Within A Trial, being either delayed (n = 2) or prematurely terminated (n = 3). Conclusions: PROMoting THE Use of Studies Within A Trial significantly increased the evidence base for recruitment and retention strategies. When provided with both funding and practical support, host trial teams successfully implemented Studies Within A Trial. Future work: Future research should identify and target gaps in the evidence base, including widening Study Within A Trial uptake, undertaking more complex Studies Within A Trial and translating Study Within A Trial evidence into practice. Study registration: All Studies Within A Trial in the PROMoting THE Use of Studies Within A Trial programme had to be registered with the Northern Ireland Network for Trials Methodology Research Study Within A Trial Repository. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/55/80) and is published in full in Health Technology Assessment; Vol. 28, No. 2. See the NIHR Funding and Awards website for further award information.

A Study Within A Trial is a research study nested inside a larger 'host trial', promoting the use of Studies Within A Trial aimed to do Study Within A Trial routine practice in clinical trial units by funding and supporting at least 25 Studies Within A Trial. The best way to test health and social care treatments is to do a randomised controlled trial ('trial'), where some patients get the treatment being tested and some do not. The results of different groups are compared to see if the treatment improves care. Recruiting patients and keeping them involved in trials is often very difficult. Research teams often do not know how best to recruit and keep patients engaged as the methods have not been tested to see if they work. The best way to test these methods is by doing a Study Within A Trial. We test a programme of Studies Within A Trial for recruiting and keeping patients engaged in trials. Trial teams were able to apply for funding of up to £5000 and receive support from Promoting the use of Study Within A Trial team to do Studies Within A Trial. We used our experience of doing Studies Within A Trial to outline lessons learnt for doing Studies Within A Trial. We funded 42 Studies Within A Trial and gave teams necessary advice to do them. We significantly increased the knowledge for both recruitment and retention strategies, and found 'pre-notifying' before sending questionnaires, sending pens and personalised text messages were all effective for increasing responses by participants. We tested Studies Within A Trial across several different trials at the same time to find out more quickly whether their methods worked. We highlight key lessons learnt to guide others doing Studies Within A Trial, including involving patient partners; picking the right strategy to test; getting ethical approvals; how to do and report Studies Within A Trial. Promoting the use of studies within a trial was successful and supported more Studies Within A Trial than planned. We hope our experience will support those doing Studies Within A Trial in the future.

A primary care research agenda for multiple long-term conditions: a Delphi study.

BACKGROUND: Multiple long-term conditions (MLTC), also known as multimorbidity, has been identified as a priority research topic globally. Research priorities from the perspectives of patients and research funders have been described. Although most care for MLTC is delivered in primary care, the priorities of academic primary care have not been identified. AIM: To identify and prioritise the academic primary care research agenda for MLTC. DESIGN AND SETTING: This was a three-phase study with primary care MLTC researchers from the UK and other high-income countries. METHOD: The study consisted of: an open-ended survey question, a face-to-face workshop to elaborate questions with researchers from the UK and Ireland, and a two-round Delphi consensus survey with international multimorbidity researchers. RESULTS: Twenty-five primary care researchers responded to the initial open-ended survey and generated 84 potential research questions. In the subsequent workshop discussion (n = 18 participants), this list was reduced to 31 questions. The longlist of 31 research questions was included in round 1 of the Delphi; 27 of the 50 (54%) round 1 invitees and 24 of the 27 (89%) round 2 invitees took part in the Delphi. Ten questions reached final consensus. These questions focused broadly on addressing the complexity of the patient group with development of new models of care for multimorbidity, and methods and data development. CONCLUSION: These high-priority research questions offer funders and researchers a basis on which to build future grant calls and research plans. Addressing complexity in this research is needed to inform improvements in systems of care and for disease prevention.

Safer Patients Empowered to Engage and Communicate about Health (SPEECH) in primary care: a feasibility study and process evaluation of an intervention for older people with multiple long-term conditions (multimorbidity).

BACKGROUND: Older people with multiple long-term conditions (multimorbidity) (MLTC-M) experience difficulties accessing and interacting with health and care services. Breakdowns in communication between patients and staff can threaten patient safety. To improve communication and reduce risks to patient safety in primary care, we developed an intervention: Safer Patients Empowered to Engage and Communicate about Health (SPEECH). SPEECH comprises a booklet for patients and an associated guide for staff. The booklet is designed to provide patients with information about staff and services, skills to prepare and explain, and confidence to speak up and ask. METHODS: A single-arm mixed methods feasibility study with embedded process evaluation. General practices in the North West of England were recruited. Participating practices invited patients aged 65+ with MLTC-M who had an appointment scheduled during the study period. Patients were asked to complete questionnaires at baseline and follow-up (four to eight weeks after being sent the patient booklet), including the Consultation and Relational Empathy measure, Empowerment Scale, Multimorbidity Treatment Burden Questionnaire, and Primary Care Patient Measure of Safety. Staff completed questionnaires at the end of the study period. A sub-sample of patients and staff were interviewed about the study processes and intervention. Patients and the public were involved in all aspects of the study, from generation of the initial idea to interpretation of findings. RESULTS: Our target of four general practices were recruited within 50 days of the study information being sent out. A fifth practice was recruited later to boost patient recruitment. We received expressions of interest from 55 patients (approx. 12% of those invited). Our target of 40 patient participants completed baseline questionnaires and were sent the SPEECH booklet. Of these, 38 (95%) completed follow-up. Patients found the intervention and study processes acceptable, and staff found the intervention acceptable and feasible to deliver. CONCLUSIONS: Our findings suggest the intervention is acceptable, and it would be feasible to deliver a trial to assess effectiveness. Prior to further evaluation, study processes and the intervention will be updated to incorporate suggestions from participants. TRIAL REGISTRATION: The study was registered on the ISRCTN registry (ISRCTN13196605: https://doi.org/10.1186/ISRCTN13196605 ).

PeRsOnaliSed care Planning for oldER people with frailty (PROSPER): protocol for a randomised controlled trial.

BACKGROUND: Frailty is common in older age and is characterised by loss of biological reserves across multiple organ systems. These changes associated with frailty mean older people can be vulnerable to sudden, dramatic changes in health because of relatively small problems. Older people with frailty are at increased risk of adverse outcomes including disability, hospitalisation, and care home admission, with associated reduction in quality of life and increased NHS and social care costs. Personalised Care Planning offers an anticipatory, preventative approach to supporting older adults to live independently for longer, but it has not been robustly evaluated in a population of older adults with frailty. METHODS: Following an initial feasibility study, this multi-centre, individually randomised controlled trial aims to establish whether personalised care planning for older people improves health-related quality of life. It will recruit 1337 participants from general practices across Yorkshire and Humber and Mid-Mersey in the North of England. Eligible patients will be aged 65 and over with an electronic frailty index score of 0.21 or above, living in their own homes, without severe cognitive impairment and not in receipt of end-of-life care. Following confirmation of eligibility, informed consent and baseline data collection, participants will be individually randomised to the PeRsOnaliSed care Planning for oldER people with frailty (PROSPER) intervention or usual care in a 2.6:1 allocation ratio. Participants will not be blinded to allocation, but data collection and analysis will be blinded. The intervention will be delivered over 12 weeks by a Personal Independence Co-ordinator worker based within a voluntary sector organisation, Age UK. The primary outcomes are health-related quality of life, measured using both the physical and mental components of the Short-Form 12 Item Health Questionnaire at 12 months after randomisation. Secondary outcomes comprise activities of daily living, self-management capabilities and loneliness, admission to care homes, hospitalisations, and health and social care resource use at 12 months post randomisation. Parallel cost-effectiveness and process evaluations will be conducted alongside the trial. DISCUSSION: The PROSPER study will evaluate the effectiveness and cost-effectiveness of a personalised care planning approach for older people with frailty and inform the process of its implementation. TRIAL REGISTRATION: ISRCTN16123291 .  Registered on  28 August 2020.

Users' views on the use of a smartwatch app to collect daily symptom data in individuals with multiple long-term conditions (Multimorbidity): A qualitative study.

Introduction: Long-term conditions are a major burden on health systems. One way to facilitate more research and better clinical care among patients with long-term conditions is to collect accurate data on their daily symptoms (patient-generated health data) using wearable technologies. Whilst evidence is growing for the use of wearable technologies in single conditions, there is less evidence of the utility of frequent symptom tracking in those who have more than one condition. Aims: To explore patient views of the acceptability of collecting daily patient-generated health data for three months using a smartwatch app. Methods: Watch Your Steps was a longitudinal study which recruited 53 patients to track over 20 symptoms per day for a 90-day period using a study app on smartwatches. Semi-structured interviews were conducted with a sub-sample of 20 participants to explore their experience of engaging with the app. Results: In a population of older people with multimorbidity, patients were willing and able to engage with a patient-generated health data app on a smartwatch. It was suggested that to maintain engagement over a longer period, more 'real-time' feedback from the app should be available. Participants did not seem to consider the management of more than one condition to be a factor in either engagement or use of the app, but the presence of severe or chronic pain was at times a barrier. Conclusion: This study has provided preliminary evidence that multimorbidity was not a major barrier to engagement with patient-generated health data via a smartwatch symptom tracking app.

A collaboratively produced model of service design for children and young people with common mental health problems.

BACKGROUND: Little is known about the effectiveness of, and implementation complexities associated with, service delivery models for children and young people (CYP) experiencing 'common' mental health problems such as anxiety, depression, behavioural difficulties and self-harm. This paper outlines how a model for high-quality service design for this population group was developed by identifying available services, their effectiveness, cost-effectiveness and acceptability, and the barriers and enablers to access. METHODS: Sequential, mixed-methods design, combining evidence syntheses (scoping and integrative reviews of the international literature) with primary research (a collective case study in England and Wales). Data from these two elements were collaboratively synthesised in a subsequent model-building phase. RESULTS: The scoping review yielded a service model typology. The integrative review found effectiveness evidence only for four models: collaborative care (the only service model to also have cost-effectiveness evidence), outreach approaches, brief intervention services and an organisational framework called 'Availability, Responsiveness and Continuity'. No service model seemed more acceptable than others. Three case study themes were identified: pathways to support; service engagement; and learning and understanding. The model-building phase identified rapid access, learning self-care skills, individualised support, clear information, compassionate and competent staff and aftercare planning as core characteristics of high-quality services. These characteristics were underpinned by four organisational qualities: values that respect confidentiality; engagement and involvement; collaborative relationships; and a learning culture. CONCLUSIONS: A consistent organisational evidence-base for service design and delivery in CYP's mental health spanning many years appears to have had little impact on service provision in England and Wales. Rather than impose - often inflexible and untested - specific local or national models or frameworks, those commissioning, designing and delivering mental health services for CYP should (re)focus on already known, fundamental components necessary for high-quality services. These fundamental components have been integrated into a collaboratively produced general model of service design for CYP with common mental health problems. While this general model is primarily focused on British service provision, it is broad enough to have utility for international audiences.

Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D pilot): results of a feasibility randomised trial.

BACKGROUND: The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection. METHODS: A multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months. RESULTS: The trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60-80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants. CONCLUSION: The feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable. TRIAL REGISTRATION: ISCTRN ISRCTN13404264. Registered on 10 October 2018.

Risk factors for deaths of despair in England: An ecological study of local authority mortality data.

Deaths of Despair (DoD) are socially patterned fatalities encompassing those attributable to drug and alcohol misuse and suicide. DoD occur much more frequently in socially deprived communities. This ecological study aimed to yield new knowledge on the spatial distribution of DoD, and socioeconomic factors that predict DoD risk in England. Via ICD-10 coding, deaths nationally during 2019-2021 were classified to non-overlapping categories of drug-related death, alcohol-specific death, and suicide. The proportion of DoD from each of these causes was calculated and age standardised DoD rates were generated for local authorities. A multivariable regression model for DoD risk was developed using 25 socioeconomic indicators. In 2019-2021, an estimated 46,200 people lost their lives due to DoD. Rates were higher in the North and in coastal areas (p < 0.001), ranging regionally from 25.1/100,000 (SD 6.3) in London to 54.7/100,000 (SD 9.5) in the North East. Alcohol-specific deaths were the largest contributor of DoD, accounting for 44.1% (95%CI 43.5-44.8%) of all such deaths. Living in the North, unemployment, White British ethnicity, living alone, economic inactivity, employment in elementary occupations, and living in urban areas were significantly associated with elevated DoD risk. DoD in England are spatially patterned, with northern regions experiencing a much higher burden of mortality from these avoidable causes. This study provides novel insights into the area-level factors associated with DoD in England. Potential ecological error is a key limitation.

Nurse-delivered sleep restriction therapy in primary care for adults with insomnia disorder: a mixed-methods process evaluation.

BACKGROUND: Sleep restriction therapy (SRT) is a behavioural therapy for insomnia. AIM: To conduct a process evaluation of a randomised controlled trial comparing SRT delivered by primary care nurses plus a sleep hygiene booklet with the sleep hygiene booklet only for adults with insomnia disorder. DESIGN AND SETTING: A mixed-methods process evaluation in a general practice setting. METHOD: Semi-structured interviews were conducted in a purposive sample of patients receiving SRT, the practice nurses who delivered the therapy, and also GPs or practice managers at the participating practices. Qualitative data were explored using framework analysis, and integrated with nurse comments and quantitative data, including baseline Insomnia Severity Index score and serial sleep efficiency outcomes to investigate the relationships between these. RESULTS: In total, 16 patients, 13 nurses, six practice managers, and one GP were interviewed. Patients had no previous experience of behavioural therapy, needed flexible appointment times, and preferred face-to-face consultations; nurses felt prepared to deliver SRT, accommodating patient concerns, tailoring therapy, and negotiating sleep timings despite treatment complexity and delays between training and intervention delivery. How the intervention produced change was explored, including patient and nurse interactions and patient responses to SRT. Difficulties maintaining SRT, negative attitudes towards treatment, and low self-efficacy were highlighted. Contextual factors, including freeing GP time, time constraints, and conflicting priorities for nurses, with suggestions for alternative delivery options, were raised. Participants who found SRT a positive process showed improvements in sleep efficiency, whereas those who struggled did not. CONCLUSION: SRT was successfully delivered by practice nurses and was generally well received by patients, despite some difficulties delivering and applying the intervention in practice.

The effectiveness and acceptability of multimedia information when recruiting children and young people to trials: the TRECA meta-analysis of SWATs.

Background: The information provided to potential trial participants plays a crucial role in their decision-making. Printed participant information sheets for trials have received recurrent criticism as being too long and technical, unappealing and hard to navigate. An alternative is to provide information through multimedia (text, animations, video, audio, diagrams and photos). However, there is limited evidence on the effects of multimedia participant information on research recruitment rates, particularly in children and young people. Objectives: The study objectives were as follows: 1. to develop template multimedia information resources through participatory design, for use when recruiting children and young people to trials 2. to evaluate the multimedia information resources in a series of Studies Within A Trial, to test their effects on recruitment and retention rates, and participant decision-making, by comparing the provision of multimedia information resources instead of printed participant information sheets, and comparing the provision of multimedia information resources in addition to printed participant information sheets. Design: Two-phase study: 1. multimedia information resources development including qualitative study; user testing study; readability metrics; enhanced patient and public involvement 2. multimedia information resources' evaluation comprising Studies Within A Trial undertaken within host trials recruiting children and young people. Setting: United Kingdom trials involving patients aged under 18. Participants: Development phase: n = 120 (children and young people, parents, clinicians, trial personnel). Evaluation phase: n = 1906 (children and young people being asked to take part in trials). Interventions: Multimedia information resources (comprising text, audio, 'talking heads' video, trial-specific and trial-generic animations). Printed participant information sheets. Main outcome measures: Primary outcome: trial recruitment rate comparing multimedia information resource-only with printed participant information sheet-only provision. Secondary outcomes: trial recruitment rate comparing combined multimedia information resource and printed participant information sheet with printed participant information sheet-only provision; trial retention rate; quality of participant decision-making. Results for each trial were calculated and combined in a two-stage random-effects meta-analysis. Results: Phase 1 generated two multimedia information resource templates: (1) for children aged 6-11 years; (2) for children aged 12-18 years and parents. In the Phase 2 Studies Within A Trial the multimedia information resources improved trial recruitment, when compared to printed information alone [odds ratio (OR) = 1.54; 95% confidence interval (CI) 1.05 to 2.28; p = 0.03; I2 = 0%]. When printed participant information sheet-only provision was compared to combined multimedia information resource and printed participant information sheet provision, there was no effect on trial recruitment (OR = 0.89; 95% CI 0.53 to 1.50; I2 = 0%). There were no differences between multimedia information resource and printed participant information sheet on trial retention or participant decision-making quality. In a study within a hypothetical trial setting, multimedia information resource-only provision produced higher ratings of 'information was easy to understand' (Z = 3.03; p = 0.003) and 'I had confidence in decision-making' (Z = 2.00; p = 0.044) than printed participant information sheet-only provision. Limitations: It was not possible to include data from three Studies Within A Trial in the meta-analysis due to limited sample size, and questionnaire return rates were low, which reduced the strength of the findings. Conclusions: Use of multimedia information increased the rate of recruitment to trials involving children and young people compared to standard patient information sheets. Future work: There should be further evaluation of the effects of multimedia information on recruitment to trials involving children and young people. It would be valuable to assess any impacts of multimedia information resources on communication between trial recruiters, children and young people, and parents. Study registration: This trial is registered as TRECA ISRCTN 73136092 and Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT 97). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 14/21/21) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 24. See the NIHR Funding and Awards website for further award information.

Clinical trials are important to National Health Service care, but it can be difficult to recruit enough people. We do not know enough about how to improve recruitment, especially when trying to recruit children and young people. People are normally told about a trial through printed information, which is often long and complex. Multimedia information (text, audio, cartoons and video) might be a better way of telling people. It is important to test whether multimedia interventions can help. One way of doing this is to run a 'Study Within A Trial' where people receive information in different ways. We created two multimedia interventions, one for parents and young people being asked for consent, and a simpler one for younger children. Some content applied to all trials, and some about the specific trial people were being asked to consider. We designed these by working closely with children and young people, parents and healthcare staff. We tested the multimedia information in six trials (although only three gave us enough data). Children, young people and their parents saw either standard printed information or our multimedia information. We then collected data on their decision-making, trial recruitment and whether people stayed in the trial. Children and young people who saw multimedia information were more likely to be recruited than those who received standard printed information. Once recruited to a trial, people given multimedia or printed information were similarly likely to remain in the trial. People's views on multimedia and printed information were also similar, but this finding could have been affected by small numbers of people returning questionnaires. Our study provides evidence that multimedia information can be used in trials with children and young people and that it increases the number of people who agree to take part, but further work is needed.

Patient reported outcomes and recruitment rates following the introduction of principled patient information leaflets (PrinciPILs): Protocol for a meta-analysis.

Background: The way potential benefits and harms of trial interventions are shared within patient information leaflets (PILs) varies widely and may cause unnecessary harms ("nocebo effects"). The aim of this meta-analysis will be to evaluate the influence on recruitment rates and early effects on patient reported adverse events of principled patient information leaflets (PrinciPILs) compared with standard PILs. Methods: Eligible studies will include those that report the effects on recruitment and patient reported adverse events of PrinciPILs compared to standard PILs. We will include in this meta-analysis all the standard PILs in studies within trials (SWATs) of PrinciPILs that were developed as part of the Medical Research Council (MRC) funded PrinciPIL project. By publishing this as a living meta-analysis, we will allow the meta-analysis to be updated with future SWATs of PrinciPILs. We will use the Cochrane Risk of Bias tool to evaluate the risk of bias for each outcome. We will report the total number of studies and participants analysed and the characteristics of included studies (including details of intervention, comparators, outcomes). For dichotomous data, we will calculate the risk difference and the risk ratio (RR) and 95% confidence intervals (CIs). For continuous outcomes we will use weighted mean differences with 95% CIs or standardized mean differences with 95% CIs. We will investigate heterogeneity by visually inspecting the forest plot and by considering the I 2 test result. We will assess the certainty warranted for each outcome using the Grading of Recommendations Assessment Development and Evaluation (GRADE). Ethics approval is not applicable since no original data will be collected. The results will be disseminated through peer-reviewed publication and conference presentations. Discussion: We will discuss the limitations of the meta-analysis including study risk of bias, inconsistency, heterogeneity, and imprecision. A general interpretation of the results and important implications will be provided.

People who take part in randomised trials need to understand the risks as well as the benefits of taking part. Most 'patient information leaflets' (PILs) that describe trial treatments include information about harms. Yet only some PILs contain information about potential benefits. This variation is confusing. Also, the over-emphasis on harms can cause "nocebo" effects, which are the harms caused by expecting something bad to happen. To solve these problems, we have developed seven principles that ensure that information about potential benefits and harms in PILs is balanced and consistent. We will now compare PILs that have been developed according to our principles (we call these 'PrinciPILs') with PILs that have not been developed with our principles. We will test whether PrinciPILs reduce nocebo effects and improve trial recruitment. Here we have described our plans to test the effect of PrinciPILs in a few trials.

The individual contribution and relative importance of self-management and quality of care on glycaemic control in type 2 diabetes / Contribución individual e importancia relativa del auto-cuidado y la calidad de la atención en el control glucémico de la diabetes tipo 2

Abstract: Objective: To evaluate the relative importance of selfmanagement (SM) and quality of care (QoC) inpredicting glycaemic control in patients with type 2 diabetes. Materials and methods: A longitudinal cohort study was conducted in 204 adults diagnosed with type 2 diabetes. Self-management and quality of care were measured at baseline. HbA1c was measured at baseline and at six-month follow-up. Results: None of the measures of self-management were significantly associated with HbA1c.Treatment intensification (TI) (a proxy for quality of care) resulted in lower HbA1c at follow-up. Other variables were associated with HbA1c at follow-up: HbA1c at baseline, age, diabetes duration, and combination of oral glucose-lowering medications. An exploratory analysis showed that patients who did not receive treatment intensification but performed more self-management behaviours had lower HbA1c levels at follow-up. Conclusion: Treatment intensification might be more important for glycaemic control than self-management but the interaction between treatment intensification and self-management needs further research.

Resumen: Objetivo: Evaluar la importancia relativa del autocuidado (AU) y calidad de la atención (CA) para predecir control glucémico en diabetes mellitus tipo 2 (DM2). Material y métodos: Estudio longitudinal en 204 adultos con DM2. AU y CA evaluados en la medición basal. HbA1c evaluada en la medición basal y a los seis meses. Resultados: A los seis meses, ninguna de las mediciones de AU se asoció significativamente con HbA1c. La intensificación en el tratamiento (IT) (proxy de CA) se asoció con disminución de HbA1c. Otras variables asociadas con HbA1c: HbA1c en medición basal, edad, duración de diabetes, y combinación de anti-hiperglucemiantes. En un análisis exploratorio, los participantes que no recibieron IT pero desempeñaron más conductas de AU tuvieron niveles más bajos de HbA1c. Conclusión: IT parece ser más importante para el control glucémico que AU, pero la interacción entre IT y conductas de AU se deben estudiar con más profundidad.

Social support network, mental health and quality of life: a cross-sectional study in primary care / Rede de apoio social, saúde mental e qualidade de vida: um estudo transversal na atenção primária / Red de apoyo social, salud mental y calidad de vida: un estudio transversal en la atención primaria

The objective of this study was to identify the association between emotional distress and social support networks with quality of life in primary care patients. This was a cross-sectional study involving 1,466 patients in the cities of São Paulo and Rio de Janeiro, Brazil, in 2009/2010. The General Health Questionnaire, the Hospital Anxiety and Depression Scale and the brief version of the World Health Organization Quality of Life Instrument were used. The Social Support Network Index classified patients with the highest and lowest index as socially integrated or isolated. A bivariate analysis and four multiple linear regressions were conducted for each quality of life outcome. The means scores for the physical, psychological, social relations, and environment domains were, respectively, 64.7; 64.2; 68.5 and 49.1. In the multivariate analysis, the psychological domain was negatively associated with isolation, whereas the social relations and environment domains were positively associated with integration. Integration and isolation proved to be important factors for those in emotional distress as they minimize or maximize negative effects on quality of life.

O estudo teve como objetivo identificar a associação entre sofrimento emocional e redes de apoio social com qualidade de vida em pacientes de atenção primária. O estudo transversal incluiu 1.466 pacientes nas cidades de São Paulo e Rio de Janeiro, Brasil, entre 2009 e 2010. Foram utilizados o General Health Questionnaire, a Hospital Anxiety and Depression Scale e a versão breve do World Health Organization Quality of Life Instrument. O Índice de Redes Sociais de Apoio classificou os pacientes com as pontuações mais altas e baixas como sendo socialmente integrados ou isolados, respectivamente. Para cada resultado de qualidade vida, foram realizadas uma análise bivariada e quatro regressões lineares múltiplas. As médias para os domínios físico, psicológico, social e ambiental foram, respectivamente: 64,7; 64,2; 68,5 e 49,1. Na análise multivariada, o domínio psicológico mostrou associação negativa com o isolamento, enquanto os domínios social e ambiental foram associados positivamente com a integração. A integração e o isolamento apareceram como fatores importantes para aqueles com sofrimento emocional, já que minimizam ou maximizam os efeitos negativos sobre qualidade de vida.

El estudio tuvo como objetivo identificar la asociación entre sufrimiento emocional y redes de apoyo social con la calidad de vida en pacientes de atención primaria. El estudio transversal incluyó a 1.466 pacientes en las ciudades de São Paulo y Río de Janeiro, Brasil, entre 2009 y 2010. Se utilizaron el General Health Questionnaire, la Hospital Anxiety and Depression Scale y la versión breve del World Health Organization Quality of Life Instrument. El Índice de Redes Sociales de Apoyo clasificó a los pacientes con las puntuaciones más altas y bajas como estando socialmente integrados o aislados, respectivamente. Para cada resultado de calidad vida, se realizó un análisis bivariado y cuatro regresiones lineales múltiples. Las medias para los dominios físico, psicológico, social y ambiental fueron, respectivamente: 64,7; 64,2; 68,5 y 49,1. En el análisis multivariado, el dominio psicológico mostró una asociación negativa con el aislamiento, mientras los dominios social y ambiental se asociaron positivamente con la integración. La integración y el aislamiento aparecieron como factores importantes para aquellos con sufrimiento emocional, ya que minimizan o maximizan los efectos negativos sobre la calidad de vida.

Brazilian multicentre study of common mental disorders in primary care: rates and related social and demographic factors / Estudo multicêntrico brasileiro sobre transtornos mentais comuns na atenção primária: prevalência e fatores sociodemográficos relacionados / Estudio brasileño multicéntrico de trastornos mentales comunes en atención primaria: prevalencia y factores sociodemográficos relacionados

Mental health problems are common in primary health care, particularly anxiety and depression. This study aims to estimate the prevalence of common mental disorders and their associations with socio-demographic characteristics in primary care in Brazil (Family Health Strategy). It involved a multicenter cross-sectional study with patients from Rio de Janeiro, São Paulo, Fortaleza (Ceará State) and Porto Alegre (Rio Grande do Sul State), assessed using the General Health Questionnaire (GHQ-12) and the Hospital Anxiety and Depression Scale (HAD). The rate of mental disorders in patients from Rio de Janeiro, São Paulo, Fortaleza and Porto Alegre were found to be, respectively, 51.9%, 53.3%, 64.3% and 57.7% with significant differences between Porto Alegre and Fortaleza compared to Rio de Janeiro after adjusting for confounders. Prevalence proportions of mental problems were especially common for females, the unemployed, those with less education and those with lower incomes. In the context of the Brazilian government's moves towards developing primary health care and reorganizing mental health policies it is relevant to consider common mental disorders as a priority alongside other chronic health conditions.

Problemas de saúde mental são comuns na atenção primária e são geralmente relacionados à ansiedade e à depressão. Este estudo tem o objetivo de avaliar a taxa de transtornos mentais comuns e suas associações com características sociodemográficas em unidades de saúde da família. É um estudo multicêntrico, transversal, com os usuários da atenção primária do Rio de Janeiro, São Paulo, Fortaleza (Ceará) e Porto Alegre (Rio Grande do Sul), Brasil. Utilizou-se o General Health Questionnaire (GHQ-12) e o Hospital Anxiety and Depression Scale (HAD). A taxa de transtornos mentais nos usuários do Rio de Janeiro, São Paulo, Fortaleza e Porto Alegre foram, respectivamente, 51,9%, 53,3%, 64,3% e 57,7%, com diferenças significativas entre Porto Alegre e Fortaleza comparando-se ao Rio de Janeiro. Problemas de saúde mental foram especialmente altos em mulheres, desempregados, em pessoas com baixa escolaridade e com baixa renda. Dadas as iniciativas do governo brasileiro para o desenvolvimento os cuidados primários e para reorganização da política pública de saúde mental, é importante considerar os transtornos mentais comuns como uma prioridade tal como outras morbidades crônicas.

Los problemas de salud mental son comunes en la atención primaria y están relacionados con la ansiedad y la depresión. Este estudio tiene como objetivo evaluar las tasas de trastornos mentales comunes y sus asociaciones con las características sociodemográficas de los usuarios de la atención primaria. Se trata de un estudio multicéntrico, transversal, con usuarios de Río de Janeiro, São Paulo, Fortaleza y Porto Alegre, Brasil. Se utilizó el General Health Questionnaire (GHQ-12) y el Hospital Anxiety and Depression Scale (HAD). La tasa de trastornos mentales en pacientes de Río de Janeiro, São Paulo, Fortaleza (Ceará) y Porto Alegre (Río Grande do Sul) fueron, respectivamente, 51,9%, 53,3%, 64,3% y 57,7%, con diferencias significativas entre Porto Alegre y Fortaleza. Los problemas de salud mental fueron especialmente altos en las mujeres, desempleados, personas con bajo nivel educativo y quienes tienen bajos ingresos. Teniendo en cuenta los esfuerzos del gobierno brasileño para el desarrollo de la atención primaria y las políticas para la reorganización de la salud mental es importante considerar los trastornos mentales como una prioridad junto a otras afecciones crónicas.