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Professor Richard McManus elected Statutory Chair in Primary Care
Risk of bias in routine mental health outcome data: the case of Health of the Nation Outcome Scales
BackgroundRoutine outcome data in secondary mental health services have significant potential for service planning, evaluation and research. Expanding the collection and use of these data is an ongoing priority in the National Health Service (NHS), but inconsistent use threatens their validity and utility. If recording is more likely among certain patient groups or at specific stages of treatment, measured outcomes may be biased and unreliable.ObjectiveThe objective is to assess the scale, determinants and implications of incomplete routine outcome measurement in a secondary mental health provider, using the example of the widely collected Health of the Nation Outcome Scores (HoNOS).MethodsA retrospective cohort study was conducted using routine HoNOS assessments and episodes of care for patients receiving secondary mental healthcare from an NHS Trust in Southeast England between 2016 and 2022 (n=30 341). Associations among demographic, clinical and service factors, and rates and timings of HoNOS assessments were explored with logistic regressions. Relationships between total HoNOS scores and related mental health outcomes (costs, relapse and improvement between assessments) were estimated after adjusting for the likelihood of assessment.Findings66% of patients (n=22 288) had a recorded HoNOS assessment. Of the distinct episodes of care for these patients (n=65 439), 43% (n=28 170) were linked to any assessment, 25% (n=16 131) were linked to an initial baseline assessment, while 4.7% (n=3 094) were linked to multiple HoNOS assessments, allowing for evaluation of clinical progress. Likelihood and timing of assessment were significantly associated with a range of factors, including service type, diagnosis, ethnicity, age and gender. After adjusting for observed factors determining the likelihood of assessment, the strength of association between HoNOS scores and overall costs was significantly reduced.ConclusionMost of the activity observed in this study cannot be evaluated with HoNOS. HoNOS assessments are highly unlikely to be missing at random. Without approaches to correct for substantial gaps in routine outcome data, evaluations based on these may be systematically biased, limiting their usefulness for service-level decision-making.Clinical implicationsRoutine outcome collection must increase significantly to successfully implement proposed strategies for outcome assessment in community mental healthcare without inconsistent records undermining the use of resulting data.
Preferences for multi-cancer tests (MCTs) in primary care: discrete choice experiments of general practitioners and the general public in England.
BACKGROUND: Multi-Cancer tests (MCTs) hold potential to detect cancer across multiple sites and some predict the origin of the cancer signal. Understanding stakeholder preferences for MCTs could help to develop appealing MCTs, encouraging their adoption. METHODS: Discrete Choice Experiments (DCEs) conducted online in England. RESULTS: GPs (n = 251) and the general public (n = 1005) preferred MCTs that maximised negative predictive value, positive predictive value, and could test for a larger number of cancer sites. A reduction of the NPV of 4.0% was balanced by a 12.5% increase in the PPV for people and a 32.5% increase in PPV for GPs. People from ethnic minority backgrounds placed less importance on whether MCTs can detect multiple cancers. People with more knowledge and experience of cancer placed substantial importance on the MCT being able to detect cancer at an early stage. Both GPs and members of the public preferred the MCT reported in the SYMPLIFY study to FIT, PSA, and CA125, and preferred the SYMPLIFY MCT to 91% (GPs) and 95% (people) of 2048 simulated MCTs. CONCLUSIONS: These findings provide a basis for designing clinical implementation strategies for MCTs, according to their performance characteristics.
A Cluster Randomized Controlled Trial of Social Workers in Schools (SWIS) in England
Purpose: “Social Workers in Schools” (SWIS) is a school-based intervention aiming to reduce the need for children to receive child protection services in England. This article reports the findings of a randomized controlled trial (RCT) designed to evaluate SWIS. Method: The study was a two-arm pragmatic cluster RCT with an embedded process and economic evaluation. The intervention physically located social workers within schools. The primary outcome was the rate of child protection inquiries and secondary outcomes included care entry and educational outcomes. Results: 278,858 students in 268 schools were randomized to the intervention (136 schools) or control arm (132 schools). We found no statistically significant effects on primary or secondary outcomes. SWIS was implemented well and positively perceived. Discussion: SWIS appears ineffective in reducing the need for statutory services. The study demonstrates it is possible to conduct a large-scale school-based social work RCT. The study was registered at https://www.isrctn.com/, ref: ISRCTN90922032.
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.
Sleep regularity index as a novel indicator of sleep disturbance in stroke survivors: a secondary data analysis
Sleep disturbance is common but often overlooked after stroke. Regular sleep is increasingly recognised as important for overall health, yet little is known about how sleep regularity changes after stroke. This study examined differences in the Sleep Regularity Index (SRI) between stroke survivors and healthy controls using actigraphy data from an existing dataset (~ 1 week per participant). Data were analysed for 162 stroke survivors (mean age 61 ± 14 years, 5 ± 5 years post-stroke, 89 males) and 60 controls (mean age 57 ± 17 years, 32 males). Stroke survivors had significantly lower SRI scores than controls (p = 0.001), indicating less regular sleep. In the stroke group, higher SRI correlated with longer total sleep time (p = 0.003) and better self-reported sleep quality (p = 0.001) but not with other sleep metrics. Lower SRI was associated with worse depressive symptoms (p = 0.006) and lower quality of life (p = 0.001) but not with disability (p = 0.886) or time since stroke (p = 0.646). These findings suggest that sleep regularity is disrupted post-stroke and may influence well-being. Future research should explore interventions to improve sleep regularity and related health outcomes in stroke survivors.
Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial
Background: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented. Methods: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563). Findings: Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19–88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference –3·05, 95% CI –3·83 to –2·28; p<0·0001; Cohen's d –0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention. Interpretation: Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder. Funding: The National Institute for Health and Care Research Health Technology Assessment Programme.
Improving sleep after stroke: A randomised controlled trial of digital cognitive behavioural therapy for insomnia
Stroke is frequently accompanied by long-term sleep disruption. We therefore aimed to assess the efficacy of digital cognitive behavioural therapy for insomnia to improve sleep after stroke. A parallel group randomised controlled trial was conducted remotely in participant's homes/online. Randomisation was online with minimisation of between-group differences in age and baseline Sleep Condition Indicator-8 score. In total, 86 community-dwelling stroke survivors consented, of whom 84 completed baseline assessments (39 female, mean 5.5 years post-stroke, mean 59 years old), and were randomised to digital cognitive behavioural therapy or control (sleep hygiene information). Follow-up was at post-intervention (mean 75 days after baseline) and 8 weeks later. The primary outcome was self-reported insomnia symptoms, as per the Sleep Condition Indicator-8 (range 0–32, lower numbers indicate more severe insomnia, reliable change 7 points) at post-intervention. There were significant improvements in Sleep Condition Indicator-8 for digital cognitive behavioural therapy compared with control (intention-to-treat, digital cognitive behavioural therapy n = 48, control n = 36, 5 imputed datasets, effect of group p ≤ 0.02, (Formula presented.) = 0.07–0.12 [medium size effect], pooled mean difference = −3.35). Additionally, secondary outcomes showed shorter self-reported sleep-onset latencies and better mood for the digital cognitive behavioural therapy group, but no significant differences for self-efficacy, quality of life or actigraphy-derived sleep parameters. Cost-effectiveness analysis found that digital cognitive behavioural therapy dominates over control (non-significant cost savings and higher quality-adjusted life years). No related serious adverse events were reported to the researchers. Overall, digital cognitive behavioural therapy for insomnia effectively improves sleep after stroke. Future research is needed to assess earlier stages post-stroke, with a longer follow-up period to determine whether it should be included as part of routine post-stroke care. Clinicaltrials.gov NCT04272892.
The Pandemic EVIDENCE Collaboration (EVidence-Informed DevelopmEnt of Non-PharmaCological IntErventions) Pillar 3: Practice and Policy
Slide presentation Pillar 3: Practice and Policy
The Pandemic EVIDENCE Collaboration (EVidence-Informed DevelopmEnt of Non-PharmaCological IntErventions) Pillar 2: Interventions and Evidence
Slide Presentation Pillar 2: Interventions and Evidence
Understanding the inclusion and participation of adults from Black African Diaspora Communities (BAFDC) in health and care research in the UK: a realist review protocol
Introduction People from Black African Diaspora Communities (BAFDC) experience poorer health outcomes, have many long-term conditions and are persistently under-represented in health and care research. There is limited focus on programmes, or interventions that support inclusion and participation of people from BAFDC in research. Through coproduction, this realist review seeks to provide a programme theory explaining what context and mechanisms may be required, to produce outcomes that facilitate inclusion and participation for people from BAFDC in health and care research, in the UK. Methods and analysis A group of people from BAFDC with lived and professional experience, representing all levels of the health and care research system, will coproduce a realist review with a team of African-Caribbean, white British and white British of Polish origin health and care researchers. They will follow Pawson’s five steps: (1) shaping the scope of the review; (2) searching for evidence; (3) document selection and appraisal; (4) data extraction and (5) data synthesis. The coproduction group will help to map the current landscape, identifying key issues that may inhibit or facilitate inclusion. Data will be extracted, analysed and synthesised following realist logic analysis, identifying and explaining how context and mechanisms are conceptualised in the literature and the types of contextual factors that exist and impact on inclusion and participation. Findings will be reported in accordance with Realist and Meta-narrative Evidence Synthesis Evolving Standards . Ethics and dissemination The coproduction group will agree an ethical approach considering accountability, responsibility and power dynamics, by establishing a terms of reference, taking a reflexive approach and coproducing an ethical framework. Findings will be disseminated to BAFDC and the research community through arts-based methods, peer-reviewed publications and conference presentations, agreeing a coproduced strategy for dissemination. Ethical review is not required.
Co-producing an online patient public community research hub: a qualitative study exploring the perspectives of national institute for health research (NIHR) research champions in England.
BackgroundPatient and Public Involvement and Engagement (PPIE) should be embedded as part of researchers' everyday practice. However, this can be challenging. Creating a digital presence for PPIE as part of Higher Education Institutes' (HEIs) infrastructure may be one way of supporting this. This can support how information is made available to patients and members of the public, but relatively little is known about how HEIs can best do this. Our aim was to develop a university website for patients and members of the public to learn about ways to get actively involved in research and be able to access the results of health and social care research.MethodsThis project involved working as partners with five National Institute for Health and Care Research (NIHR) Research Champions. NIHR Research Champions are volunteers who raise awareness and share experiences about health and social care research. Content of a prototype Patient Public Community Research Hub website was co-produced with the Research Champions, and then 15 NIHR Research Champions from across England were asked for their views about the website.FindingsThe information collected told us that the Patient Public Community Research Hub was viewed as being beneficial for increasing visibility of PPIE opportunities and sharing the findings of studies though needs further work: to make the information more user-friendly; to improve the methods for directing people to the site and to create new ways of connecting with people. It provides a foundation for further co-development and evaluation. A set of recommendations has been developed that may be of benefit to other HEIs and organisations who are committed to working with patients and members of the public.
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