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IntroductionUp to 80% of patients with respiratory tract infections (RTI) attending healthcare facilities in rural areas of China are prescribed antibiotics, many of which are unnecessary. Since 2009, China has implemented several policies to try to reduce inappropriate antibiotic use; however, antibiotic prescribing remains high in rural health facilities.Methods and analysisA cluster randomised controlled trial will be carried out to estimate the effectiveness and cost effectiveness of a complex intervention in reducing antibiotic prescribing at township health centres in Anhui Province, China. 40 Township health centres will be randomised at a 1:1 ratio to the intervention or usual care arms. In the intervention group, practitioners will receive an intervention comprising: (1) training to support appropriate antibiotic prescribing for RTI, (2) a computer-based treatment decision support system, (3) virtual peer support, (4) a leaflet for patients and (5) a letter of commitment to optimise antibiotic use to display in their clinic. The primary outcome is the percentage of antibiotics (intravenous and oral) prescribed for RTI patients. Secondary outcomes include patient symptom severity and duration, recovery status, satisfaction, antibiotic consumption. A full economic evaluation will be conducted within the trial period. Costs and savings for both clinics and patients will be considered and quality of life will be measured by EuroQoL (EQ-5D-5L). A qualitative process evaluation will explore practitioner and patient views and experiences of trial processes, intervention fidelity and acceptability, and barriers and facilitators to implementation.Ethics and disseminationEthical approval was obtained from the Biomedical Research Ethics Committee of Anhui Medical University (Ref: 20180259); the study has undergone due diligence checks and is registered at the University of Bristol (Ref: 2020-3137). Research findings will be disseminated to stakeholders through conferences and peer-reviewed journals in China, the UK and internationally.Trial registration numberISRCTN30652037.

Backgroundsarcopenia and frailty are associated with increased risk of falls and fractures. This study evaluated the feasibility of assessing sarcopenia and frailty among older people attending fracture clinics.Methodspatients aged 65+ years with an arm fracture attending fracture clinics in one UK city were recruited. Sarcopenia was assessed using gait speed, grip strength, skeletal muscle mass index SMI, SARC-F questionnaire and the European Working Group on Sarcopenia in Older People (EWGSOP) I and II criteria. Frailty was assessed using Fried Frailty Phenotype (FFP), FRAIL scale, PRISMA-7, electronic Frailty Index (e-FI), Clinical Frailty Score (CFS) and Study of Osteoporotic Fracture. The sensitivity and specificity of each tool was calculated against the EWGSOP II criteria (sarcopenia) and FFP (frailty). Patients identified to have either condition were referred for Comprehensive Geriatric Assessment (CGA). Interviews with 13 patients and nine staff explored the acceptability of this process.Resultshundred patients (Mean age 75 years) were recruited. Most sarcopenia and frailty assessments were quick with complete data collection and were acceptable to patients and staff. Sarcopenia was identified among 4–39% participants depending on the tool and frailty among 9–25%. Both conditions were more common among men than women with all tools. The SARC-F and PRISMA-7 had the best sensitivity (100 and 93%, respectively) and specificity (96 and 87%). CGA among 80% of referred participants led to three interventions per participant (e.g. medication changes and investigations).ConclusionSARC-F and PRISMA-7 are recommended for use in fracture clinics to screen for sarcopenia and frailty.

IntroductionCoronavirus disease (Covid-19) has led to a global pandemic since its emergence in December 2019. The majority of research into Covid-19 has focused on transmission, and mortality and morbidity associated with the virus. However, less attention has been given to its impact on health-related quality of life (HRQoL) of patients with Covid-19.MethodsWe searched for original studies published between December 2019 and Jan 2021 in PubMed, Scopus and Medline databases using a specific search strategy. We also explored literature on websites of distinguished public health organisations and hand-searched reference lists of eligible studies. The studies were screened by two reviewers according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) flowchart using pre-determined eligibility criteria. Data were synthesised, analysed descriptively and reported in line with PRISMA guidelines.ResultsIn total, 1276 studies were identified through the search strategy. Of these, 77 studies were selected for full-text reading after screening the studies. After reading full-text, 12 eligible studies were included in this review. The majority of the studies used a generic HRQoL assessment tool; five studies used SF-36, five studies used EQ-5D-5L, and three used pulmonary disease-specific HRQoL tools (two studies used two tools each). The impact of Covid-19 on HRQoL was found to be considerable in both Acute Covid and Long Covid patients. Higher impact on HRQoL was reported in Acute Covid, females, older ages, patients with more severe disease and patients from low-income countries.ConclusionThe impact of Covid-19 on HRQoL of Acute and Long Covid patients is substantial. There was disproportional impact on patients by gender, age, severity of illness and study country. The long-term impact of Covid-19 is still in its initial stage. The findings of the review may be useful to researchers, policymakers, and clinicians caring for people following Covid-19 infection.

IntroductionFalls are a major health problem for older people; 35% of people aged 65+ years fall every year, leading to fractures in 10%–15%. Upper limb fractures are often the first sign of osteoporosis and routine screening for osteoporosis is recommended by the National Institute for Health and Care Excellence to prevent subsequent hip fractures. However, both frailty and sarcopenia (muscle weakness) are associated with increased risk of falling and fracture but are not routinely identified in this group. The aim of this study is to evaluate the feasibility of assessing and managing frailty and sarcopenia among people aged 65+ years with an upper limb fracture.Methods and analysisThis study will be conducted in three fracture clinics in one acute trust in England. 100 people aged 65+ years with an upper arm fracture will be recruited and assessed using six validated frailty measures and two sarcopenia tools. The prevalence of the two conditions and the best tools to use will be determined. Those with either condition will be referred to geriatric clinical teams for comprehensive geriatric assessment (CGA). We will document the proportion who are referred for CGA and those who receive CGA. Other outcome measures including falls, fractures and healthcare resource use over 6 months will be collected. In-depth interviews with a purposive sample of patients who undergo the frailty and sarcopenia assessments and healthcare professionals in fracture clinics and geriatric services will be carried out to their acceptability of assessing frailty and sarcopenia in a busy environment.Ethics and disseminationThe study was given the relevant ethical approvals from NHS Research Ethics Committee (REC No: 18/NE/0377), the University Hospital Southampton NHS Foundation Trust, and the University of Southampton, Faculty of Medicine Ethics Committee and Research Governance Office. Findings will be published in scientific journals and presented to local, national and international conferences.Trial registration numberISRCTN13848445

Objective: To compare the efficacy and cost of specialised individually-delivered parent training (PT) for preschool children with attention-deficit/ hyperactivity disorder (ADHD) against generic group-based PT and treatment as usual (TAU). Design: Multi-centre, three-arm parallel group randomised controlled trial. Research Setting: National Health Service Trusts. Participants: Preschool children (33-54 months) fulfilling ADHD research diagnostic criteria. Interventions: New Forest Parenting Programme (NFPP) – 12 week individual, home-delivered ADHD PT programme; Incredible Years (IY) – 12 week group-based, PT programme initially designed for children with behaviour problems. Main outcome measures: Primary outcome - Parent ratings of child’s ADHD symptoms (Swanson, Nolan & Pelham Questionnaire - SNAP-IV). Secondary outcomes - teacher ratings (SNAP-IV) and direct observations of ADHD symptoms and parent/teacher ratings of conduct problems. NFPP, IY and TAU outcomes were measured at baseline (T1) and post-treatment (T2). NFPP and IY outcomes only were measured 6 months post treatment (T3). Researchers, but not therapists or parents, were blind to treatment allocation. Analysis employed mixed effect regression models (multiple imputation). Intervention and other costs were estimated using standardized approaches. Results: NFPP and IY did not differ on parent-rated SNAP-IV, ADHD combined symptoms (mean difference -0.009 95%CI [-0.191, 0.173], p=0.921) or any other measure. Small, non-significant, benefits of NFPP over TAU were seen for parent-rated SNAP-IV, ADHD combined symptoms (-0.189 95%CI [-0.380, 0.003], p=0.053). NFPP significantly reduced parent-rated conduct-problems compared to TAU across scales (p-values.05). The cost per family of providing NFPP in the trial was significantly lower than IY (£1,591 versus £2,103). \ud Conclusions: Although, there were no differences between NFPP and IY with regards clinical effectiveness, individually-delivered NFPP cost less. However, this difference may be reduced when implemented in routine clinical practice. Clinical decisions should take into account parental preferences between delivery approaches. \ud Funding: National Institute of Health Research. \ud Trial Registration: Trial name: COPPI Trial; ISRCTN39288126.

PURPOSE: To determine the maximum rate of false-positive diagnoses that patients and health care professionals were willing to accept in exchange for detection of extracolonic malignancy by using computed tomographic (CT) colonography for colorectal cancer screening. MATERIALS AND METHODS: After obtaining ethical approval and informed consent, 52 patients and 50 health care professionals undertook two discrete choice experiments where they chose between unrestricted CT colonography that examined intra- and extracolonic organs or CT colonography restricted to the colon, across different scenarios. The first experiment detected one extracolonic malignancy per 600 cases with a false-positive rate varying across scenarios from 0% to 99.8%. One experiment examined radiologic follow-up generated by false-positive diagnoses while the other examined invasive follow-up. Intracolonic performance was identical for both tests. The median tipping point (maximum acceptable false-positive rate for extracolonic findings) was calculated overall and for both groups by bootstrap analysis. RESULTS: The median tipping point for radiologic follow-up occurred at a false-positive rate greater than 99.8% (interquartile ratio [IQR], 10 to >99.8%). Participants would tolerate at least a 99.8% rate of unnecessary radiologic tests to detect an additional extracolonic malignancy. The median tipping-point for invasive follow-up occurred at a false-positive rate of 10% (IQR, 2 to >99.8%). Tipping points were significantly higher for patients than for health care professionals for both experiments (>99.8 vs 40% for radiologic follow-up and >99.8 vs 5% for invasive follow-up, both P < .001). CONCLUSION: Patients and health care professionals are willing to tolerate high rates of false-positive diagnoses with CT colonography in exchange for diagnosis of extracolonic malignancy. The actual specificity of screening CT colonography for extracolonic findings in clinical practice is likely to be highly acceptable to both patients and health care professionals. Online supplemental material is available for this article.

IntroductionAutism spectrum disorders (ASDs) are associated with difficulties in social interaction, communication and restricted, repetitive behaviours. Much is known about their community prevalence among adults, data on adult inpatients within an acute mental health setting is lacking.This pilot study aimed to estimate the prevalence of ASDs among adults admitted to acute mental health wards and to examine the association between ASDs and psychiatric and physical comorbidities within this group.Methods and analysisA multiple-phase approach will be used. Phase I will involve testing of 200 patients and corresponding informants, using the autism quotient (AQ), the informant version of the Social Responsiveness Scale, second edition—Adult, the self and informant versions of the Adult Social Behaviour Questionnaire and the EuroQol-5D-5L. Patients with intellectual disability (ID) will bypass Phase I.Phase II will involve diagnostic testing of a subgroup of 40 patients with the Diagnostic Interview for Social and Communication Disorders, the Autism Diagnostic Observation Schedule version 2 and the ASD interview within the Schedules for Clinical Assessment in Neuropsychiatry version 3. 25±5 patients will not have ID and be selected via stratified random sampling according to AQ score; 15±5 patients will have ID. Phase II patients will be interviewed with the Physical Health Conditions and Mental Illness Diagnoses and Treatment sections of the 2014 Adult Psychiatric Morbidity Survey.Prevalence estimates will be based on the proportion of Phase II participants who satisfy the 10th revision of the International Statistical Classification of Diseases and Related Health Problems Diagnostic Criteria for Research (ICD-10-DCR) and the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for ASD, adjusting for selection and non-response. Univariate analysis will be conducted for comorbidities to identify the level of their association with an ASD diagnosis.Ethics and disseminationStudy oversight is provided by the University of Leicester. The National Health Service Health Research Authority have provided written approval. Study results will be disseminated via conference presentations and peer-reviewed publications.Trial registration numberISRCTN27739943

IntroductionLow quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management.Methods and analysisA randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support.Ethics and disseminationThe trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations.Trial registration numberISRCTN96374224; Pre-results.

A wide range of screening technologies is available for colorectal cancer screening. There is demand to discover public preferences for these tests on the rationale that tailoring screening to preferences may improve uptake. This review describes a type of study (conjoint analysis) used to assess people's preferences for colorectal cancer screening tests and critically evaluates research quality using a recently published set of guidelines. Most primary studies assessed preferences for colonoscopy and fecal occult blood testing but newer technologies (e.g., capsule endoscopy) have not yet been evaluated. Although studies often adhered to guidelines, there was limited correspondence between stated preferences and actual screening behavior. Future research should investigate how studies can go beyond the guidelines in order to improve this and also explore how test preferences may differ by important population subgroups.

Aims We wish to assess the clinical and cost-effectiveness of remote monitoring of heart failure patients with cardiac implanted electronic devices. Methods REM-HF is a multicentre, randomized, non-blinded, parallel trial designed to compare weekly remote monitoring-driven management with usual care for patients with cardiac implanted electronic devices (ICD, CRT-D, or CRT-P). The trial is event driven, and the final analysis will be performed when 546 events have been observed or the study is terminated at the interim analysis. We have randomized 1650 patients to be followed up for a minimum of 2 years. Patients will remain in the trial up to study termination. The first patient was randomized in September 2011 and the study is expected to complete in early 2016. The primary combined endpoint is time to first event of all-cause death or unplanned hospitalization for cardiovascular reasons. An economic evaluation will be performed, estimating the cost per quality-adjusted lifeyear, with direct costs estimated from the National Health Service perspective and quality of life assessed by the EQ-5D, Short-Form12, and Kansas City Cardiomyopathy Questionnaires. The study design has been informed by a feasibility study. Conclusion REM-HF is a multicentre randomized study that will provide important data on the effect of remote monitoring-driven management of implanted cardiac devices on morbidity and mortality, as well as the cost-effectiveness of this approach. Trial registration: UKCRN 10383.

BACKGROUND: Guidelines indicate eligibility for lipid lowering drugs, but it is not known to what extent GPs' follow guidelines in routine clinical practice or whether additional clinical factors systematically influence their prescribing decisions. METHODS: A retrospective cohort analysis was undertaken using electronic primary care records from 421 UK general practices. At baseline (May 2008) patients were aged 30 to 74 years, free from cardiovascular disease and not taking lipid lowering drugs. The outcome was prescription of a lipid lowering drug within the next two years. The proportions of eligible and ineligible patients prescribed lipid lowering drugs were reported and multivariable logistic regression models were used to investigate associations between age, sex, cardiovascular risk factors and prescribing. RESULTS: Of 365,718 patients with complete data, 13.8% (50,558) were prescribed lipid lowering drugs: 28.5% (21,101/74,137) of those eligible and 10.1% (29,457/291,581) of those ineligible. Only 41.7% (21,101/50,558) of those prescribed lipid lowering drugs were eligible. In multivariable analysis prescribing was most strongly associated with increasing age (OR for age ≥ 65 years 4.21; 95% CI 4.05-4.39); diabetes (OR 4.49; 95% CI 4.35-4.64); total cholesterol level ≥ 7 mmol/L (OR 2.20; 95% CI 2.12-2.29); and ≥ 4 blood pressure measurements in the past year (OR 4.24; 95% CI 4.06-4.42). The predictors were similar in eligible and ineligible patients. CONCLUSIONS: Most lipid lowering drugs for primary prevention are prescribed to ineligible patients. There is underuse of lipid lowering drugs in eligible patients.

Introduction Self-management of hypertension, including self-monitoring and antihypertensive medication titration, lowers blood pressure (BP) at 1 year compared to usual care. The aim of the current trial is to assess the effectiveness of the Home and Online Management and Evaluation of Blood Pressure (HOME BP) intervention for the self-management of hypertension in primary care. Methods and analysis The HOME BP trial will be a randomised controlled trial comparing BP self-management—consisting of the HOME BP online digital intervention with self-monitoring, lifestyle advice and antihypertensive drug titration—with usual care for people with uncontrolled essential hypertension. Eligible patients will be recruited from primary care and randomised to usual care or to self-management using HOME BP. The primary outcome will be the difference in mean systolic BP (mm Hg) at 12-month follow-up between the intervention and control groups adjusting for baseline BP and covariates. Secondary outcomes (also adjusted for baseline and covariates where appropriate) will be differences in mean BP at 6 months and diastolic BP at 12 months; patient enablement; quality of life, and economic analyses including all key resources associated with the intervention and related services, adopting a broad societal perspective to include NHS, social care and patient costs, considered within trial and modelled with a lifetime horizon. Medication beliefs, adherence and changes; self-efficacy; perceived side effects and lifestyle changes will be measured for process analyses. Qualitative analyses will explore patient and healthcare professional experiences of HOME BP to gain insights into the factors affecting acceptability, feasibility and adherence. Ethics and dissemination This study has received NHS ethical approval (REC reference 15/SC/0082). The findings from HOME BP will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, HOME BP will be directly applicable to UK primary care management of hypertension. Trial registration number [ISRCTN13790648][1]; pre-results. [1]: http://www.isrctn.com/ISRCTN13790648

Background and objective: The SENIORS trial demonstrated that nebivolol is effective in the treatment of heart failure in elderly patients (e.g. ≥70 years). This analysis evaluates the cost effectiveness of nebivolol compared with standard treatment. Methods: An individual patient-simulation model based on a Markov modelling framework was developed to compare costs and outcomes for nebivolol and standard care in patients with heart failure starting treatment at the age of 70 years. Health states were defined by New York Heart Association (NYHA) class and death. At a given NYHA class and a given cycle, patients could die, be hospitalized for cardiovascular disease or remain stable. Risks for these events were derived from individual patient data from the SENIORS trial. The risk of each event in a given cycle was based on the subject’s baseline characteristics and time in the current health state. The economic analysis was conducted from the UK NHS perspective with a lifetime horizon. The costs (€; year 2006 values) considered were drug costs for nebivolol and other cardiac drugs, costs of GP visits, outpatient specialist visits and cardiovascular-related hospitalizations. Univariate and probabilistic sensitivity analysis was conducted. Results: In the baseline analysis, the total cost per patient was €6740 and €9288, and QALYs were 5.194 and 5.843 for patients aged 70 years at the start of treatment for the standard treatment and nebivolol groups, respectively. The probabilistic sensitivity analysis provided an incremental cost-effectiveness ratio of €3926 (95% CI 3731, 4159) per QALY. Conclusions: This analysis indicates that nebivolol appears to be a cost-effective treatment for elderly patients with heart failure compared with standard care.