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‘Strengthening And Stretching for Rheumatoid Arthritis of the Hands’, or ‘SARAH’ for short, is an evidence-based hand and arm exercise programme for people with rheumatoid arthritis. We already run a programme to train hand therapists, but can we help people with RA to follow SARAH on their own?
Primary care treatment of insomnia: study protocol for a pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy to sleep hygiene (the HABIT trial)
Introduction: Insomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared to sleep hygiene advice. Methods and Analysis: In the HABIT trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over four weekly sessions; total therapy time is approximately 1 hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the insomnia severity index (ISI) at six months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention to treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed. Ethics and dissemination: Ethical approval was granted by the Yorkshire & the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings (on clinical and cost-effectiveness) in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focused on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder.
A randomised controlled trial of extended anticoagulation treatment versus standard treatment for the prevention of recurrent venous thromboembolism (VTE) and post-thrombotic syndrome in patients being treated for a first episode of unprovoked VTE (the ExACT study).
Venous thromboembolism (VTE) is prevalent and impactful, with a risk of death, morbidity and recurrence. Post-thrombotic syndrome (PTS) is a common consequence and associated with impaired quality of life (QoL). The ExACT study was a non-blinded, prospective, multicentred randomised controlled trial comparing extended versus limited duration anticoagulation following a first unprovoked VTE (proximal deep vein thrombosis or pulmonary embolism). Adults were eligible if they had completed ≥3 months anticoagulation (remaining anticoagulated). The primary outcome was time to first recurrent VTE from randomisation. The secondary outcomes included PTS severity, bleeding, QoL and D-dimers. Two-hundred and eighty-one patients were recruited, randomised and followed up for 24 months (mean age 63, male:female 2:1). There was a significant reduction in recurrent VTE for patients receiving extended anticoagulation [2·75 vs. 13·54 events/100 patient years, adjusted hazard ratio (aHR) 0·20 (95% confidence interval (CI): 0·09 to 0·46, P < 0·001)] with a non-significant increase in major bleeding [3·54 vs. 1·18 events/100 patient years, aHR 2·99 (95% CI: 0·81-11·05, P = 0·10)]. Outcomes of PTS and QoL were no different between groups. D-dimer results (on anticoagulation) did not predict VTE recurrence. In conclusion, extended anticoagulation reduced VTE recurrence but did not reduce PTS or improve QoL and was associated with a non-significant increase in bleeding. Results also suggest very limited clinical utility of D-dimer testing on anticoagulated patients.
Views about integrating smoking cessation treatment within psychological services for patients with common mental illness: a multi-perspective qualitative study
<jats:p>Background: Smoking rates are significantly higher in people with mental health problems, compared to those without. Negative attitudes towards smoking cessation are widespread in inpatient settings towards patients with severe and enduring mental illness. It is not clear if the same attitudes operate in psychological services towards people with common mental illness. We aimed to understand the concerns and views that patients, therapists, and smoking cessation practitioners may have about integrating smoking cessation treatment into psychological treatment for common mental illness and how these concerns may be overcome. Methods: Thematic analysis of 23 in-depth interviews. Interviews took place in Improving Access to Psychological Therapies (IAPT) and smoking cessation services in England. Participants were 11 psychological wellbeing practitioners (PWPs), six IAPT patients with common mental illness, and six smoking cessation advisors. Findings: IAPT patients reported psychological benefits from smoking, but also described smoking as a form of therapeutic self-harm. PWPs seem positive towards smoking cessation treatment for people with common mental illness. IAPT PWPs and patients accept evidence that smoking tobacco may harm mental health, and quitting might benefit mental health. PWPs report expertise in helping people with common mental illness to make behavioural changes in the face of mood disturbances and poor motivation. IAPT appears to be a natural environment for smoking cessation intervention. PWPs felt confident to offer smoking cessation treatments to IAPT patients, but thought that a reduction in caseload was required to deliver smoking cessation support in an already pressed service.</jats:p>
Exploring the variation in implementation of a COPD disease management programme and its impact on health outcomes: a post hoc analysis of the RECODE cluster randomised trial.
This study aims to (1) examine the variation in implementation of a 2-year chronic obstructive pulmonary disease (COPD) management programme called RECODE, (2) analyse the facilitators and barriers to implementation and (3) investigate the influence of this variation on health outcomes. Implementation variation among the 20 primary-care teams was measured directly using a self-developed scale and indirectly through the level of care integration as measured with the Patient Assessment of Chronic Illness Care (PACIC) and the Assessment of Chronic Illness Care (ACIC). Interviews were held to obtain detailed information regarding the facilitators and barriers to implementation. Multilevel models were used to investigate the association between variation in implementation and change in outcomes. The teams implemented, on average, eight of the 19 interventions, and the specific package of interventions varied widely. Important barriers and facilitators of implementation were (in)sufficient motivation of healthcare provider and patient, the high starting level of COPD care, the small size of the COPD population per team, the mild COPD population, practicalities of the information and communication technology (ICT) system, and hurdles in reimbursement. Level of implementation as measured with our own scale and the ACIC was not associated with health outcomes. A higher level of implementation measured with the PACIC was positively associated with improved self-management capabilities, but this association was not found for other outcomes. There was a wide variety in the implementation of RECODE, associated with barriers at individual, social, organisational and societal level. There was little association between extent of implementation and health outcomes.
The True Colours remote mood monitoring system was developed over a decade ago by researchers, psychiatrists, and software engineers at the University of Oxford to allow patients to report on a range of symptoms via text messages, Web interfaces, or mobile phone apps. The system has evolved to encompass a wide range of measures, including psychiatric symptoms, quality of life, and medication. Patients are prompted to provide data according to an agreed personal schedule: weekly, daily, or at specific times during the day. The system has been applied across a number of different populations, for the reporting of mood, anxiety, substance use, eating and personality disorders, psychosis, self-harm, and inflammatory bowel disease, and it has shown good compliance. Over the past decade, there have been over 36,000 registered True Colours patients and participants in the United Kingdom, with more than 20 deployments of the system supporting clinical service and research delivery. The system has been adopted for routine clinical care in mental health services, supporting more than 3000 adult patients in secondary care, and 27,263 adolescent patients are currently registered within Oxfordshire and Buckinghamshire. The system has also proven to be an invaluable scientific resource as a platform for research into mood instability and as an electronic outcome measure in randomized controlled trials. This paper aimed to report on the existing applications of the system, setting out lessons learned, and to discuss the implications for tailored symptom monitoring, as well as the barriers to implementation at a larger scale.
BACKGROUND: Although many meta-analyses have examined the association between childhood sexual abuse and subsequent outcomes, the scope, validity, and quality of this evidence has not been comprehensively assessed. We aimed to systematically review existing meta-analyses on a wide range of long-term psychiatric, psychosocial, and physical health outcomes of childhood sexual abuse, and evaluate the quality of the literature. METHODS: In this umbrella review, we searched four databases (PsycINFO, PubMed, Cumulative Index to Nursing and Allied Health Literature, and Global Health) from inception to Dec 31, 2018, to identify meta-analyses of observational studies that examined the association between childhood sexual abuse (before 18 years of age) and long-term consequences (after 18 years). We compared odds ratios (ORs) across different outcomes. We also examined measures of quality, including heterogeneity between studies and evidence for publication bias. This study is registered with PROSPERO, CRD42016049701. FINDINGS: We identified 19 meta-analyses that included 559 primary studies, covering 28 outcomes in 4 089 547 participants. Childhood sexual abuse was associated with 26 of 28 specific outcomes: specifically, six of eight adult psychiatric diagnoses (ORs ranged from 2·2 [95% CI 1·8-2·8] to 3·3 [2·2-4·8]), all studied negative psychosocial outcomes (ORs ranged from 1·2 [1·1-1·4] to 3·4 [2·3-4·8]), and all physical health conditions (ORs ranged from 1·4 [1·3-1·6] to 1·9 [1·4-2·8]). Strongest psychiatric associations with childhood sexual abuse were reported for conversion disorder (OR 3·3 [95% CI 2·2-4·8]), borderline personality disorder (2·9 [2·5-3·3]), anxiety (2·7 [2·5-2·8]), and depression (2·7 [2·4-3·0]). The systematic reviews for two psychiatric outcomes (post-traumatic stress disorder and schizophrenia) and one psychosocial outcome (substance misuse) met high quality standards. Quality was low for meta-analyses on borderline personality disorder and anxiety, and moderate for conversion disorder. Assuming causality, population attributable risk fractions for outcomes ranged from 1·7% (95% CI 0·7-3·3) for unprotected sexual intercourse to 14·4% (8·8-19·9) for conversion disorder. INTERPRETATION: Although childhood sexual abuse was associated with a wide range of psychosocial and health outcomes, systematic reviews on only two psychiatric disorders (post-traumatic stress disorder and schizophrenia) and one psychosocial outcome (substance misuse) were of a high quality. Whether services should prioritise interventions that mitigate developing certain psychiatric disorders following childhood abuse requires further review. Higher-quality meta-analyses for specific outcomes and more empirical studies on the developmental pathways from childhood sexual abuse to later outcomes are necessary. FUNDING: Wellcome Trust.
Online patient feedback as a measure of quality in primary care: a multimethod study using correlation and qualitative analysis
<jats:sec><jats:title>Objectives</jats:title><jats:p>To ascertain the relationship between online patient feedback and the General Practice Patient Survey (GPPS) and the Friends and Family Test (FFT). To consider the potential benefit it may add by describing the content of public reviews found on NHS Choices for all general practices in one Clinical Commissioning Group in England.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Multimethod study using correlation and thematic analysis.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>1396 public online reviews and ratings on NHS Choices for all General Practices (n=70) in Oxfordshire Clinical Commissioning Group in England.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Significant moderate correlations were found between the online patient feedback and the GPPS and the FFT. Three themes were developed through the qualitative analysis: (1) online feedback largely provides positive reinforcement for practice staff; (2) online feedback is used as a platform for suggesting service organisation and delivery improvements; (3) online feedback can be a source of insight into patients’ expectations of care. These themes illustrate the wide range of topics commented on by patients, including their medical care, relationships with various members of staff, practice facilities, amenities and services in primary care settings.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>This multimethod study demonstrates that online feedback found on NHS Choices is significantly correlated with established measures of quality in primary care. This suggests it has a potential use in understanding patient experience and satisfaction, and a potential use in quality improvement and patient safety. The qualitative analysis shows that this form of feedback contains helpful information about patients’ experiences of general practice that provide insight into issues of quality and patient safety relevant to primary care. Health providers should offer patients multiple ways of offering feedback, including online, and should have systems in place to respond to and act on this feedback.</jats:p></jats:sec>
Mobile phone text-messaging interventions aimed to prevent cardiovascular diseases (Text2PreventCVD): systematic review and individual patient data meta-analysis.
Background: A variety of small mobile phone text-messaging interventions have indicated improvement in risk factors for cardiovascular disease (CVD). Yet the extent of this improvement and whether it impacts multiple risk factors together is uncertain. We aimed to conduct a systematic review and individual patient data (IPD) meta-analysis to investigate the effects of text-messaging interventions for CVD prevention. Methods: Electronic databases were searched to identify trials investigating a text-messaging intervention focusing on CVD prevention with the potential to modify at least two CVD risk factors in adults. The main outcome was blood pressure (BP). We conducted standard and IPD meta-analysis on pooled data. We accounted for clustering of patients within studies and the primary analysis used random-effects models. Sensitivity and subgroup analyses were performed. Results: Nine trials were included in the systematic review involving 3779 participants and 5 (n=2612) contributed data to the IPD meta-analysis. Standard meta-analysis showed that the weighted mean differences are as follows: systolic blood pressure (SBP), -4.13 mm Hg (95% CI -11.07 to 2.81, p<0.0001); diastolic blood pressure (DBP), -1.11 mm Hg (-1.91 to -0.31, p=0.002); and body mass index (BMI), -0.32 (-0.49 to -0.16, p=0.000). In the IPD meta-analysis, the mean difference are as follows: SBP, -1.3 mm Hg (-5.4 to 2.7, p=0.5236); DBP, -0.8 mm Hg (-2.5 to 1.0, p=0.3912); and BMI, -0.2 (-0.8 to 0.4, p=0.5200) in the random-effects model. The impact on other risk factors is described, but there were insufficient data to conduct meta-analyses. Conclusion: Mobile phone text-messaging interventions have modest impacts on BP and BMI. Simultaneous but small impacts on multiple risk factors are likely to be clinically relevant and improve outcome, but there are currently insufficient data in pooled analyses to examine the extent to which simultaneous reduction in multiple risk factors occurs. PROSPERO registration number: CRD42016033236.
Examining Development Processes for Text Messaging Interventions to Prevent Cardiovascular Disease: Systematic Literature Review.
BACKGROUND: Interventions delivered by mobile phones have the potential to prevent cardiovascular disease (CVD) by supporting behavior change toward healthier lifestyles and treatment adherence. To allow replication and adaptation of these interventions across settings, it is important to fully understand how they have been developed. However, the development processes of these interventions have not previously been systematically examined. OBJECTIVE: This study aimed to systematically describe and compare the development process of text messaging interventions identified in the Text2PreventCVD systematic review. METHODS: We extracted data about the development process of the 9 interventions identified in the Text2PreventCVD systematic review. Data extraction, which was guided by frameworks for the development of complex interventions, considered the following development stages: intervention planning, design, development, and pretesting. Following data extraction, we invited the developers of the interventions to contribute to our study by reviewing the accuracy of the extracted data and providing additional data not reported in the available publications. RESULTS: A comprehensive description of the development process was available for 5 interventions. Multiple methodologies were used for the development of each intervention. Intervention planning involved gathering information from stakeholder consultations, literature reviews, examination of relevant theory, and preliminary qualitative research. Intervention design involved the use of behavior change theories and behavior change techniques. Intervention development involved (1) generating message content based on clinical guidelines and expert opinions; (2) conducting literature reviews and primary qualitative research to inform decisions about message frequency, timing, and level of tailoring; and (3) gathering end-user feedback concerning message readability, intervention acceptability, and perceived utility. Intervention pretesting involved pilot studies with samples of 10 to 30 participants receiving messages for a period ranging from 1 to 4 weeks. CONCLUSIONS: The development process of the text messaging interventions examined was complex and comprehensive, involving multiple studies to guide decisions about the scope, content, and structure of the interventions. Additional research is needed to establish whether effective messaging systems can be adapted from work already done or whether this level of development is needed for application in other conditions and settings.
Accurately reflecting uncertainty when using patient-level simulation models to extrapolate clinical trial data
Introduction: Patient-level simulation models facilitate extrapolation of clinical trial data, whilst allowing for heterogeneity, prior history, and non-linearity. However, combining different types of uncertainty around within-trial and extrapolated results remains challenging. Methods: We tested four methods to combine parameter uncertainty (around the regression coefficients used to predict future events) with sampling uncertainty (uncertainty around mean risk factors within the finite sample whose outcomes are being predicted and the effect of treatment on these risk factors). We compared these four methods using a simulation study based on an economic evaluation extrapolating the AFORRD randomised controlled trial using the UK Prospective Diabetes Study Outcomes Model version 2. This established type 2 diabetes model predicts patient-level health outcomes and costs. Results: 95% confidence intervals around life-years gained gave 25% coverage when sampling uncertainty was excluded (i.e. 25% of 95% confidence intervals contained the “true” value). Allowing for sampling uncertainty as well as parameter uncertainty widened confidence intervals by 6.3-fold and gave 96.3% coverage. Methods adjusting for baseline risk factors that combine sampling and parameter uncertainty overcame the bias that can result from between-group baseline imbalance and gave confidence intervals around 50% wider than those just considering parameter uncertainty, with 99.8% coverage. Conclusions: Analyses extrapolating data for individual trial participants should include both sampling uncertainty and parameter uncertainty and should adjust for any imbalance in baseline covariates.