Economic evaluation of the OSAC randomised controlled trial: oral corticosteroids for non-asthmatic adults with acute lower respiratory tract infection in primary care.

OBJECTIVE: To estimate the costs and outcomes associated with treating non-asthmatic adults (nor suffering from other lung-disease) presenting to primary care with acute lower respiratory tract infection (ALRTI) with oral corticosteroids compared with placebo. DESIGN: Cost-consequence analysis alongside a randomised controlled trial. Perspectives included the healthcare provider, patients and productivity losses associated with time off work. SETTING: Fifty-four National Health Service (NHS) general practices in England. PARTICIPANTS: 398 adults attending NHS primary practices with ALRTI but no asthma or other chronic lung disease, followed up for 28 days. INTERVENTIONS: 2× 20 mg oral prednisolone per day for 5 days versus matching placebo tablets. OUTCOME MEASURES: Quality-adjusted life years using the 5-level EuroQol-5D version measured weekly; duration and severity of symptom. Direct and indirect resources related to the disease and its treatment were also collected. Outcomes were measured for the 28-day follow-up. RESULTS: 198 (50%) patients received the intervention (prednisolone) and 200 (50%) received placebo. NHS costs were dominated by primary care contacts, higher with placebo than with prednisolone (£13.11 vs £10.38) but without evidence of a difference (95% CI £3.05 to £8.52). The trial medication cost of £1.96 per patient would have been recouped in prescription charges of £4.30 per patient overall (55% participants would have paid £7.85), giving an overall mean 'profit' to the NHS of £7.00 (95% CI £0.50 to £17.08) per patient. There was a quality adjusted life years gain of 0.03 (95% CI 0.01 to 0.05) equating to half a day of perfect health favouring the prednisolone patients; there was no difference in duration of cough or severity of symptoms. CONCLUSIONS: The use of prednisolone for non-asthmatic adults with ALRTI, provided small gains in quality of life and cost savings driven by prescription charges. Considering the results of the economic evaluation and possible side effects of corticosteroids, the short-term benefits may not outweigh the long-term harms. TRIAL REGISTRATION NUMBERS: EudraCT 2012-000851-15 and ISRCTN57309858; Pre-results.

Cost-effectiveness of a patient-centred approach to managing multimorbidity in primary care: a pragmatic cluster randomised controlled trial.

OBJECTIVE: Patients with multiple chronic health conditions are often managed in a disjointed fashion in primary care, with annual review clinic appointments offered separately for each condition. This study aimed to determine the cost-effectiveness of the 3D intervention, which was developed to improve the system of care. DESIGN: Economic evaluation conducted alongside a pragmatic cluster-randomised trial. SETTING: General practices in three centres in England and Scotland. PARTICIPANTS: 797 adults with three or more chronic conditions were randomised to the 3D intervention, while 749 participants were randomised to receive usual care. INTERVENTION: The 3D approach: comprehensive 6-monthly general practitioner consultations, supported by medication reviews and nurse appointments. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary economic evaluation assessed the cost per quality-adjusted life year (QALY) gained from the perspective of the National Health Service (NHS) and personal social services (PSS). Costs were related to changes in a range of secondary outcomes (QALYs accrued by both participants and carers, and deaths) in a cost-consequences analysis from the perspectives of the NHS/PSS, patients/carers and productivity losses. RESULTS: Very small increases were found in both QALYs (adjusted mean difference 0.007 (-0.009 to 0.023)) and costs (adjusted mean difference £126 (£-739 to £991)) in the intervention arm compared with usual care after 15 months. The incremental cost-effectiveness ratio was £18 499, with a 50.8% chance of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY (55.8% at £30 000 per QALY). CONCLUSIONS: The small differences in costs and outcomes were consistent with chance, and the uncertainty was substantial; therefore, the evidence for the cost-effectiveness of the 3D approach from the NHS/PSS perspective should be considered equivocal. TRIAL REGISTRATION NUMBER: ISCRTN06180958.

Qualitative assessment of the primary care outcomes questionnaire: a cognitive interview study.

BACKGROUND: The Primary Care Outcomes Questionnaire (PCOQ) is a new patient-reported outcome measure designed specifically for primary care. This paper describes the developmental process of improving the item quality and testing the face validity of the PCOQ through cognitive interviews with primary care patients. METHODS: Two formats of the PCOQ were developed and assessed: the PCOQ-Status (which has an adjectival scale) and the PCOQ-Change (which has the same items as the PCOQ-Status, but a transitional scale). Three rounds of cognitive interviews were held with twenty patients from four health centres in Bristol. Patients seeking healthcare were recruited directly by their GP or practice nurse, and others not currently seeking healthcare were recruited from patient participation groups. An adjusted form of Tourangeau's model of cognitive processing was used to identify problems. This contained four categories: general comprehension, temporal comprehension, decision process, and response process. The resultant pattern of problems was used to assess whether the items and scales were working as intended, and to make improvements to the questionnaires. RESULTS: The problems identified in the PCOQ-Status reduced from 41 in round one to seven in round three. It was noted that the PCOQ-Status seemed to be capturing a subjective view of health which might not vary with age or long-term conditions. However, as it is designed to be evaluative (measuring change over time) as opposed to discriminative (measuring change between different groups of people), this does not present a problem for validity. The PCOQ-Status was both understood by patients and was face valid. The PCOQ-Change had less face validity, and was misunderstood by three out of six patients in round 1. It was not taken forward after this round. CONCLUSIONS: The cognitive interviews successfully contributed to the development of the PCOQ. Through this study, the PCOQ-Status was found to be well understood by patients, and it was possible to improve comprehension through each round of interviews. The PCOQ-Change was poorly understood and, given that this corroborates existing research, this may call into question the use of transitional questionnaires generally.

Choice of Moisturiser for Eczema Treatment (COMET): feasibility study of a randomised controlled parallel group trial in children recruited from primary care.

OBJECTIVES: To determine the feasibility of a randomised controlled trial of 'leave on' emollients for children with eczema. DESIGN: Single-centre, pragmatic, 4-arm, observer-blinded, parallel, randomised feasibility trial. SETTING: General practices in the UK. PARTICIPANTS: Children with eczema aged 1 month to <5 years. OUTCOME MEASURES: Primary outcome-proportion of parents who reported use of the allocated study emollient every day for the duration of follow-up (12 weeks). Other feasibility outcomes-participant recruitment and retention, data collection and completeness and blinding of observers to allocation. INTERVENTIONS: Aveeno lotion, Diprobase cream, Doublebase gel, Hydromol ointment. RESULTS: 197 children were recruited-107 by self-referral (mainly via practice mail-outs) and 90 by inconsultation (clinician consenting and randomising) pathways. Participants recruited inconsultation were younger, had more severe Patient-Oriented Eczema Measure scores and were more likely to withdraw than self-referrals. Parents of 20 (10%) of all the randomised participants reported using the allocated emollient daily for 84 days. The use of other non-study emollients was common. Completeness of data collected by parent-held daily diaries and at monthly study visits was good. Daily diaries were liked (81%) but mainly completed on paper rather than via electronic ('app') form. Major costs drivers were general practitioner consultations and eczema-related prescriptions. Observer unblinding was infrequent, and occurred at the baseline or first follow-up visit through accidental disclosure. CONCLUSIONS: It is feasible in a primary care setting to recruit and randomise young children with eczema to emollients, follow them up and collect relevant trial data, while keeping observers blinded to their allocation. However, reported use of emollients (study and others) has design implications for future trials. TRIAL REGISTRATION NUMBER: ISRCTN21828118/EudraCT2013-003001-26.

Cost-effectiveness of telehealth for patients with depression: evidence from the Healthlines randomised controlled trial.

BACKGROUND: Depression is a prevalent long-term condition that is associated with substantial resource use. Telehealth may offer a cost-effective means of supporting the management of people with depression. AIMS: To investigate the cost-effectiveness of a telehealth intervention ('Healthlines') for patients with depression. METHOD: A prospective patient-level economic evaluation conducted alongside a randomised controlled trial. Patients were recruited through primary care, and the intervention was delivered via a telehealth service. Participants with a confirmed diagnosis of depression and PHQ-9 score ≥10 were recruited from 43 English general practices. A series of up to 10 scripted, theory-led, telephone encounters with health information advisers supported participants to effect a behaviour change, use online resources, optimise medication and improve adherence. The intervention was delivered alongside usual care and was designed to support rather than duplicate primary care. Cost-effectiveness from a combined health and social care perspective was measured by net monetary benefit at the end of 12 months of follow-up, calculated from incremental cost and incremental quality-adjusted life years (QALYs). Cost-consequence analysis included cost of lost productivity, participant out-of-pocket expenditure and the clinical outcome. RESULTS: A total of 609 participants were randomised - 307 to receive the Healthlines intervention plus usual care and 302 to receive usual care alone. Forty-five per cent of participants had missing quality of life data, 41% had missing cost data and 51% of participants had missing data on either cost or utility, or both. Multiple imputation was used for the base-case analysis. The intervention was associated with incremental mean per-patient National Health Service/personal social services cost of £168 (95% CI £43 to £294) and an incremental QALY gain of 0.001 (95% CI -0.023 to 0.026). The incremental cost-effectiveness ratio was £132 630. Net monetary benefit at a cost-effectiveness threshold of £20 000 was -£143 (95% CI -£164 to -£122) and the probability of the intervention being cost-effective at this threshold value was 0.30. Productivity costs were higher in the intervention arm, but out-of-pocket expenses were lower. CONCLUSIONS: The Healthlines service was acceptable to patients as a means of condition management, and response to treatment after 4 months was higher for participants randomised to the intervention. However, the positive average intervention effect size was modest, and incremental costs were high relative to a small incremental QALY gain at 12 months. The intervention is not likely to be cost-effective in its current form. DECLARATION OF INTEREST: None. COPYRIGHT AND USAGE: © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence.

Cost-effectiveness modelling of telehealth for patients with raised cardiovascular disease risk: evidence from a cohort simulation conducted alongside the Healthlines randomised controlled trial.

OBJECTIVES: To investigate the long-term cost-effectiveness (measured as the ratio of incremental NHS cost to incremental quality-adjusted life years) of a telehealth intervention for patients with raised cardiovascular disease (CVD) risk. DESIGN: A cohort simulation model developed as part of the economic evaluation conducted alongside the Healthlines randomised controlled trial. SETTING: Patients recruited through primary care, and intervention delivered via telehealth service. PARTICIPANTS: Participants with a 10-year CVD risk ≥20%, as measured by the QRISK2 algorithm, and with at least 1 modifiable risk factor, individually randomised from 42 general practices in England. INTERVENTION: A telehealth service delivered over a 12-month period. The intervention involved a series of responsive, theory-led encounters between patients and trained health information advisors who provided access to information resources and supported medication adherence and coordination of care. PRIMARY AND SECONDARY OUTCOME MEASURES: Cost-effectiveness measured by net monetary benefit over the simulated lifetime of trial participants from a UK National Health Service perspective. RESULTS: The probability that the intervention was cost-effective depended on the duration of the effect of the intervention. The intervention was cost-effective with high probability if effects persisted over the lifetime of intervention recipients. The probability of cost-effectiveness was lower for shorter durations of effect. CONCLUSIONS: The intervention was likely to be cost-effective under a lifetime perspective. TRIAL REGISTRATION NUMBER: ISRCTN27508731; Results.

Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial.

OBJECTIVES: To investigate the cost-effectiveness of a telehealth intervention for primary care patients with raised cardiovascular disease (CVD) risk. DESIGN: A prospective within-trial patient-level economic evaluation conducted alongside a randomised controlled trial. SETTING: Patients recruited through primary care, and intervention delivered via telehealth service. PARTICIPANTS: Adults with a 10-year CVD risk ≥20%, as measured by the QRISK2 algorithm, with at least 1 modifiable risk factor. INTERVENTION: A series of up to 13 scripted, theory-led telehealth encounters with healthcare advisors, who supported participants to make behaviour change, use online resources, optimise medication and improve adherence. Participants in the control arm received usual care. PRIMARY AND SECONDARY OUTCOME MEASURES: Cost-effectiveness measured by net monetary benefit at the end of 12 months of follow-up, calculated from incremental cost and incremental quality-adjusted life years (QALYs). Productivity impacts, participant out-of-pocket expenditure and the clinical outcome were presented in a cost-consequences framework. RESULTS: 641 participants were randomised-325 to receive the telehealth intervention in addition to usual care and 316 to receive only usual care. 18% of participants had missing data on either costs, utilities or both. Multiple imputation was used for the base case results. The intervention was associated with incremental mean per-patient National Health Service (NHS) costs of £138 (95% CI 66 to 211) and an incremental QALY gain of 0.012 (95% CI -0.001 to 0.026). The incremental cost-effectiveness ratio was £10 859. Net monetary benefit at a cost-effectiveness threshold of £20 000 per QALY was £116 (95% CI -58 to 291), and the probability that the intervention was cost-effective at this threshold value was 0.77. Similar results were obtained from a complete case analysis. CONCLUSIONS: There is evidence to suggest that the Healthlines telehealth intervention was likely to be cost-effective at a threshold of £20 000 per QALY. TRIAL REGISTRATION NUMBER: ISRCTN27508731; Results. Prospectively registered 05 July 2012.

Using willingness-to-pay to establish patient preferences for cancer testing in primary care.

BACKGROUND: Shared decision making is a stated aim of several healthcare systems. In the area of cancer, patients' views have informed policy on screening and treatment but there is little information about their views on diagnostic testing in relation to symptom severity. METHODS: We used the technique of willingness-to-pay to determine public preferences around diagnostic testing for colorectal, lung, and pancreatic cancer in primary care in the UK. Participants were approached in general practice waiting rooms and asked to complete a two-stage electronic survey that described symptoms of cancer, the likelihood that the symptoms indicate cancer, and information about the appropriate diagnostic test. Part 1 asked for a binary response (yes/no) as to whether they would choose to have a test if it were offered. Part 2 elicited willingness-to-pay values of the tests using a payment scale followed by a bidding exercise, with the aim that these values would provide a strength of preference not detectable using the binary approach. RESULTS: A large majority of participants chose to be tested for all cancers, with only colonoscopy (colorectal cancer) demonstrating a risk gradient. In the willingness-to-pay exercise participants placed a lower value on an X-ray (lung cancer) than the tests for colorectal or pancreatic cancer and X-ray was the only test where risk was clearly related to the willingness-to-pay value. CONCLUSION: Willingness-to-pay values did not enhance the binary responses in the way intended; participants appeared to be motivated differently when responding to the two parts of the questionnaire. More work is needed to understand how participants perceive risk in this context and how they respond to questions about willingness-to-pay. Qualitative methods could provide useful insights.

Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial.

OBJECTIVE:  To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies. DESIGN:  Pragmatic, multicentre, randomised controlled trial. SETTING:  42 general practices in three areas of England. PARTICIPANTS:  Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score. INTERVENTIONS:  Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone. MAIN OUTCOME MEASURES:  The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked. RESULTS:  50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic -2.7 mm Hg (95% confidence interval -4.7 to -0.6 mm Hg), mean diastolic -2.8 (-4.0 to -1.6 mm Hg); weight -1.0 kg (-1.8 to -0.3 kg), and body mass index -0.4 ( -0.6 to -0.1) but not cholesterol -0.1 (-0.2 to 0.0), smoking status (adjusted odds ratio 0.4, 0.2 to 1.0), or overall cardiovascular risk as a continuous measure (-0.4, -1.2 to 0.3)). The intervention was associated with improvements in diet, physical activity, drug adherence, and satisfaction with access to care, treatment received, and care coordination. One serious related adverse event occurred, when a participant was admitted to hospital with low blood pressure. CONCLUSIONS:  This evidence based telehealth approach was associated with small clinical benefits for a minority of people with high cardiovascular risk, and there was no overall improvement in average risk. The Healthlines service was, however, associated with improvements in some risk behaviours, and in perceptions of support and access to care.Trial registration Current Controlled Trials ISRCTN 27508731.

Improving the management of multimorbidity in general practice: protocol of a cluster randomised controlled trial (The 3D Study).

INTRODUCTION: An increasing number of people are living with multimorbidity. The evidence base for how best to manage these patients is weak. Current clinical guidelines generally focus on single conditions, which may not reflect the needs of patients with multimorbidity. The aim of the 3D study is to develop, implement and evaluate an intervention to improve the management of patients with multimorbidity in general practice. METHODS AND ANALYSIS: This is a pragmatic two-arm cluster randomised controlled trial. 32 general practices around Bristol, Greater Manchester and Glasgow will be randomised to receive either the '3D intervention' or usual care. 3D is a complex intervention including components affecting practice organisation, the conduct of patient reviews, integration with secondary care and measures to promote change in practice organisation. Changes include improving continuity of care and replacing reviews of each disease with patient-centred reviews with a focus on patients' quality of life, mental health and polypharmacy. We aim to recruit 1383 patients who have 3 or more chronic conditions. This provides 90% power at 5% significance level to detect an effect size of 0.27 SDs in the primary outcome, which is health-related quality of life at 15 months using the EQ-5D-5L. Secondary outcome measures assess patient centredness, illness burden and treatment burden. The primary analysis will be a multilevel regression model adjusted for baseline, stratification/minimisation, clustering and important co-variables. Nested process evaluation will assess implementation, mechanisms of effectiveness and interaction of the intervention with local context. Economic analysis of cost-consequences and cost-effectiveness will be based on quality-adjusted life years. ETHICS AND DISSEMINATION: This study has approval from South-West (Frenchay) National Health Service (NHS) Research Ethics Committee (14/SW/0011). Findings will be disseminated via final report, peer-reviewed publications and guidance to healthcare professionals, commissioners and policymakers. TRIAL REGISTRATION NUMBER: ISRCTN06180958; Pre-results.

Long-term effectiveness and cost-effectiveness of cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: follow-up of the CoBalT randomised controlled trial.

BACKGROUND: Cognitive behavioural therapy (CBT) is an effective treatment for people whose depression has not responded to antidepressants. However, the long-term outcome is unknown. In a long-term follow-up of the CoBalT trial, we examined the clinical and cost-effectiveness of cognitive behavioural therapy as an adjunct to usual care that included medication over 3-5 years in primary care patients with treatment-resistant depression. METHODS: CoBalT was a randomised controlled trial done across 73 general practices in three UK centres. CoBalT recruited patients aged 18-75 years who had adhered to antidepressants for at least 6 weeks and had substantial depressive symptoms (Beck Depression Inventory [BDI-II] score ≥14 and met ICD-10 depression criteria). Participants were randomly assigned using a computer generated code, to receive either usual care or CBT in addition to usual care. Patients eligible for the long-term follow-up were those who had not withdrawn by the 12 month follow-up and had given their consent to being re-contacted. Those willing to participate were asked to return the postal questionnaire to the research team. One postal reminder was sent and non-responders were contacted by telephone to complete a brief questionnaire. Data were also collected from general practitioner notes. Follow-up took place at a variable interval after randomisation (3-5 years). The primary outcome was self-report of depressive symptoms assessed by BDI-II score (range 0-63), analysed by intention to treat. Cost-utility analysis compared health and social care costs with quality-adjusted life-years (QALYs). This study is registered with isrctn.com, number ISRCTN38231611. FINDINGS: Between Nov 4, 2008, and Sept 30, 2010, 469 eligible participants were randomised into the CoBalT study. Of these, 248 individuals completed a long-term follow-up questionnaire and provided data for the primary outcome (136 in the intervention group vs 112 in the usual care group). At follow-up (median 45·5 months [IQR 42·5-51·1]), the intervention group had a mean BDI-II score of 19·2 (SD 13·8) compared with a mean BDI-II score of 23·4 (SD 13·2) for the usual care group (repeated measures analysis over the 46 months: difference in means -4·7 [95% CI -6·4 to -3·0, p<0·001]). Follow-up was, on average, 40 months after therapy ended. The average annual cost of trial CBT per participant was £343 (SD 129). The incremental cost-effectiveness ratio was £5374 per QALY gain. This represented a 92% probability of being cost effective at the National Institute for Health and Care Excellence QALY threshold of £20 000. INTERPRETATION: CBT as an adjunct to usual care that includes antidepressants is clinically effective and cost effective over the long-term for individuals whose depression has not responded to pharmacotherapy. In view of this robust evidence of long-term effectiveness and the fact that the intervention represented good value-for-money, clinicians should discuss referral for CBT with all those for whom antidepressants are not effective. FUNDING: National Institute for Health Research Health Technology Assessment.

Factors influencing parents' decision-making when sending children with respiratory tract infections to nursery.

BACKGROUND: Many families rely on formal day care provision, which can be problematic when children are unwell. Attendance in these circumstances may impact on the transmission of infections in both day care and the wider community. METHODS: Thirty-one semi-structured interviews were conducted to investigate how parents make decisions about nursery care when children are unwell. Topics for discussion included: illness attitudes, current practice during childhood illness and potential nursery policy changes that could affect decision-making. RESULTS: A combination of illness perceptions and external factors affected decision-making. Parents: (i) considered the severity of respiratory and non-respiratory symptoms differently, and stated that while most other contagious illnesses required nursery exclusion, coughs/colds did not; (ii) said decisions were not solely based on nursery policy, but on practical challenges such as work absences, financial penalties and alternative care availability; (iii) identified modifiable nursery policy factors that could potentially help parents keep unwell children at home, potentially reducing transmission of infectious illness. CONCLUSIONS: Decision-making is a complex interaction between the child's illness, personal circumstance and nursery policy. Improving our understanding of the modifiable aspects of nursery policies and the extent to which these factors affect decision-making could inform the design and implementation of interventions to reduce the transmission of infectious illness and the associated burden on NHS services.

The CHICO (Children's Cough) Trial protocol: a feasibility randomised controlled trial investigating the clinical and cost-effectiveness of a complex intervention to improve the management of children presenting to primary care with acute respiratory tract infection.

INTRODUCTION: While most respiratory tract infections (RTIs) will resolve without treatment, many children will receive antibiotics and some will develop severe symptoms requiring hospitalisation. There have been calls for evidence to reduce uncertainty regarding the identification of children who will and will not benefit from antibiotics. The aim of this feasibility trial is to test recruitment and the acceptance of a complex behavioural intervention designed to reduce antibiotic prescribing, and to inform how best to conduct a larger trial. METHODS AND ANALYSIS: The CHICO (Children's Cough) trial is a single-centre feasibility cluster randomised controlled trial (RCT) comparing a web-based, within-consultation, behavioural intervention with usual care for children presenting to general practitioner practices with RTI and acute cough. The trial aims to recruit at least 300 children between October 2014 and April 2015, in a single area in South West England. Following informed consent, demographic information will be recorded, and symptoms and signs measured. Parents/carers of recruited children will be followed up on a weekly basis to establish symptom duration, resource use and cost of the illness to the parent until the child's cough has resolved or up to 8 weeks, whichever occurs earlier. A review of medical notes, including clinical history, primary care reconsultations and hospitalisations will be undertaken 2 months after recruitment. The trial feasibility will be assessed by: determining acceptability of the intervention to clinicians and parent/carers; quantifying differential recruitment and follow-up; determining intervention fidelity; the success in gathering the data necessary to conduct a cost-effectiveness analysis; and collecting data about antibiotic prescribing rates to inform the sample size needed for a fully powered RCT. ETHICS AND DISSEMINATION: The study was approved by the North West-Haydock Research Ethics Committee, UK (reference number: 14/NW/1034). The findings from this feasibility trial will be disseminated through research conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN23547970.

Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial.

BACKGROUND: Eczema is common in children and in the UK most cases are managed in primary care. The foundation of all treatment is the regular use of leave-on emollients to preserve and restore moisture to the skin. This not only improves comfort but may also reduce the need for rescue treatment for 'flares', such as topical corticosteroids. However, clinicians can prescribe many different types of emollient and there is a paucity of evidence to guide this choice. One reason for this may be the challenges of conducting a clinical trial: are parents or carers of young children willing to be randomly allocated an emollient and followed up for a meaningful amount of time? DESIGN: This is a single-centre feasibility study of a pragmatic, four-arm, single-masked, randomized trial. Children with eczema who are eligible (from 1 month to less than 5 years of age, not known to be sensitive or allergic to any of study emollients or their constituents) are recruited via their general practices. Participants are allocated Aveeno® lotion, Diprobase® cream, Doublebase® gel or Hydromol® ointment via a web-based system, using a simple randomization process in a 1:1:1:1 fashion. Researchers are masked to the study emollient. Participants are assessed at baseline and followed up for 3 months. Data are collected by daily diaries, monthly researcher visits and review of electronic medical records. Because this is a feasibility study, a formal sample size calculation for the estimation of treatment effectiveness has not be made but we aim to recruit 160 participants. DISCUSSION: Recruitment is on-going. At the end of the study, as well as being able to answer the question, 'Is it is possible to recruit and retain children with eczema from primary care into a four-arm randomized trial of emollients?', we will also have collected important data on the acceptability and effectiveness of four commonly used emollients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN21828118 and Clinical Trials Register EudraCT2013-003001-26.

Can oral corticosteroids reduce the severity or duration of an acute cough, and the associated National Health Service and societal costs, in adults presenting to primary care? Study protocol for a randomised controlled trial.

BACKGROUND: Acute lower respiratory tract infection (LRTI) is one of the most common conditions managed internationally and is costly to health services and patients. Despite good evidence that antibiotics are not effective for improving the symptoms of uncomplicated LRTI, they are widely prescribed, contributing to antimicrobial resistance. Many of the symptoms observed in LRTI are mediated by inflammatory processes also observed in exacerbations of asthma, for which there is strong evidence of corticosteroid effectiveness. The primary aim of the OSAC (Oral Steroids for Acute Cough) Trial is to determine whether oral prednisolone (40 mg daily for 5 days) can reduce the duration of moderately bad (or worse) cough and the severity of all its associated symptoms on days 2 to 4 post-randomisation (day 1 is trial entry) by at least 20% in adults ≥18 years with acute LRTI presenting to primary care. METHODS/DESIGN: OSAC is a two-arm, multi-centre, placebo-controlled, randomised superiority trial. The target sample size is 436 patients, which allows for a 20% dropout rate. Patients will be recruited from primary care sites (General Practitioner surgeries) across England and followed up until symptom resolution. The two primary clinical outcomes are the duration of moderately bad (or worse) cough, and the severity of all its associated symptoms on days 2 to 4 post-randomisation. Secondary outcomes include: antibiotic consumption; symptom burden; adverse events; participant satisfaction with treatment and intention to consult for future similar illnesses. A parallel economic evaluation will investigate the cost-effectiveness of the intervention. DISCUSSION: Results from the OSAC trial will increase knowledge regarding the clinical and cost-effectiveness of corticosteroids for LRTI, and will establish the potential of a new treatment option that could substantially improve patient health. We have chosen a relatively high 'efficacy dose' as this will enable us to decide on the potential for further research into lower dose oral and/or inhaled corticosteroids. This trial will also contribute to a growing body of research investigating the natural course of this very common illness, as well as the effects of steroids on the undesirable inflammatory symptoms associated with infection. TRIAL REGISTRATION: Current Controlled Trials ISRCTN57309858 (31 January 2013).

TElehealth in CHronic disease: mixed-methods study to develop the TECH conceptual model for intervention design and evaluation.

OBJECTIVE: To develop a conceptual model for effective use of telehealth in the management of chronic health conditions, and to use this to develop and evaluate an intervention for people with two exemplar conditions: raised cardiovascular disease risk and depression. DESIGN: The model was based on several strands of evidence: a metareview and realist synthesis of quantitative and qualitative evidence on telehealth for chronic conditions; a qualitative study of patients' and health professionals' experience of telehealth; a quantitative survey of patients' interest in using telehealth; and review of existing models of chronic condition management and evidence-based treatment guidelines. Based on these evidence strands, a model was developed and then refined at a stakeholder workshop. Then a telehealth intervention ('Healthlines') was designed by incorporating strategies to address each of the model components. The model also provided a framework for evaluation of this intervention within parallel randomised controlled trials in the two exemplar conditions, and the accompanying process evaluations and economic evaluations. SETTING: Primary care. RESULTS: The TElehealth in CHronic Disease (TECH) model proposes that attention to four components will offer interventions the best chance of success: (1) engagement of patients and health professionals, (2) effective chronic disease management (including subcomponents of self-management, optimisation of treatment, care coordination), (3) partnership between providers and (4) patient, social and health system context. Key intended outcomes are improved health, access to care, patient experience and cost-effective care. CONCLUSIONS: A conceptual model has been developed based on multiple sources of evidence which articulates how telehealth may best provide benefits for patients with chronic health conditions. It can be used to structure the design and evaluation of telehealth programmes which aim to be acceptable to patients and providers, and cost-effective.

Effectiveness of PhysioDirect telephone assessment and advice services for patients with musculoskeletal problems.

STUDY QUESTION: Are PhysioDirect services, based on initial telephone assessment and advice from a physiotherapist, as effective as usual care involving patients waiting for a face-to-face appointment? SUMMARY ANSWER: Patients allocated to PhysioDirect received treatment more quickly than those allocated to usual care, and had equivalent clinical outcomes.

Changing eating behaviours to treat childhood obesity in the community using Mandolean: the Community Mandolean randomised controlled trial (ComMando)--a pilot study.

BACKGROUND: Around one in five children in England is obese when they leave primary school. Thus far, it has not been demonstrated that primary care interventions to manage childhood obesity can achieve significant weight reduction. Training obese children to eat more slowly as an adjunct to other healthy lifestyle behaviour change has been shown to increase weight reduction in a hospital setting. OBJECTIVES: This pilot study aimed to test recruitment strategies, treatment adherence, clinic attendance and participants' experiences of using a device [Mandolean® (previously Mandometer®, Mikrodidakt AB, Lund, Sweden)] to slow down speed of eating as an adjunct to dietary and activity advice in treating obesity in primary school-aged children. DESIGN: A two-arm, parallel, randomised controlled trial with a qualitative study embedded within the pilot. Randomisation occurred after informed consent and baseline measures were collected. Participants were randomised by the Bristol Randomised Trials Collaboration randomisation service with allocation stratified by hub and minimised by age of the child, gender, and baseline body mass index (BMI) standard deviation score (BMI z-value) of the child, and by BMI of the study parent (obese/not obese). SETTING: General practices across Bristol, North Somerset and South Gloucestershire primary care trusts. PARTICIPANTS: Children (BMI ≥ 95th percentile) aged 5-11 years and their families. INTERVENTION: Standard care comprised dietary and activity advice by trained practice nurses. Adjunctive Mandolean training (the intervention) educated participants to eat meals more slowly and to rate levels of fullness (satiety). Mandolean is a small computer device attached to a weighing scale that provides visual and oral feedback during meals while generating a visual representation of levels of satiety during the meal. Participants were encouraged to eat their main meal each day from the Mandolean. One parent was also given a Mandolean to use when eating with the child. OUTCOME MEASURES: Outcomes for the pilot were recruitment of 36 families to the trial in the 9-month pilot phase, that meals would be eaten at least five times a week off a Mandolean by 90% of patients randomised to the intervention arm, that 80% of patients in both arms would attend the weight management clinic appointment 3 months post randomisation and that > 60% of children using Mandolean would demonstrate a reduction in speed of eating from baseline within 3 months of randomisation. RESULTS: None of the criteria for progression to the main trial were reached. Despite numerous pathways being available for referral, only 21 (13 to standard care, eight to intervention arm; 58%) of the target 36 families were recruited in the pilot phase. Less than 20% of those randomised to Mandolean used the device at least five times a week. The > 60% target for slowing down of eating speed by 3 months was unmet. Attendance at the weight management clinic in general practice hubs for both arms of the study at 3 months was 44% against a target of 80%. CONCLUSIONS: This pilot trial failed to meet its objectives in terms of recruitment, treatment adherence, demonstration of a reduction in speed of eating in sufficient numbers of children, and attendance at follow-up appointments. Despite a high prevalence of childhood obesity in the geographical area and practices signing up for the trial, this study, like many others, demonstrates a failure of families to engage with and respond to primary care weight management interventions. We need to understand why the target population seems inured to the health message that childhood obesity is a significant health-care issue and identify the barriers to seeking help and then acting on positive health behaviour retraining. Only when we have fully understood the general public's perceptions of childhood obesity and have identified ways of engaging target populations can we hope to develop interventions that can work in a primary or community-based setting. TRIAL REGISTRATION: Current Controlled Trials ISRCTN90561114. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 47. See the NIHR Journals Library website for further project information.

Clinical effectiveness and cost-effectiveness of cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: the CoBalT randomised controlled trial.

BACKGROUND: Only one-third of patients with depression respond fully to treatment with antidepressant medication. However, there is little robust evidence to guide the management of those whose symptoms are 'treatment resistant'. OBJECTIVE: The CoBalT trial examined the clinical effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment-resistant depression (TRD) compared with usual care alone. DESIGN: Pragmatic, multicentre individually randomised controlled trial with follow-up at 3, 6, 9 and 12 months. A subset took part in a qualitative study investigating views and experiences of CBT, reasons for completing/not completing therapy, and usual care for TRD. SETTING: General practices in Bristol, Exeter and Glasgow, and surrounding areas. PARTICIPANTS: Patients aged 18-75 years who had TRD [on antidepressants for ≥ 6 weeks, had adhered to medication, Beck Depression Inventory, 2nd version (BDI-II) score of ≥ 14 and fulfilled the International Classification of Diseases and Related Health Problems, Tenth edition criteria for depression]. Individuals were excluded who (1) had bipolar disorder/psychosis or major alcohol/substance abuse problems; (2) were unable to complete the questionnaires; or (3) were pregnant, as were those currently receiving CBT/other psychotherapy/secondary care for depression, or who had received CBT in the past 3 years. INTERVENTIONS: Participants were randomised, using a computer-generated code, to usual care or CBT (12-18 sessions) in addition to usual care. MAIN OUTCOME MEASURES: The primary outcome was 'response', defined as ≥ 50% reduction in depressive symptoms (BDI-II score) at 6 months compared with baseline. Secondary outcomes included BDI-II score as a continuous variable, remission of symptoms (BDI-II score of < 10), quality of life, anxiety and antidepressant use at 6 and 12 months. Data on health and social care use, personal costs, and time off work were collected at 6 and 12 months. Costs from these three perspectives were reported using a cost-consequence analysis. A cost-utility analysis compared health and social care costs with quality adjusted life-years. RESULTS: A total of 469 patients were randomised (intervention: n = 234; usual care: n = 235), with 422 participants (90%) and 396 (84%) followed up at 6 and 12 months. Ninety-five participants (46.1%) in the intervention group met criteria for 'response' at 6 months compared with 46 (21.6%) in the usual-care group {odds ratio [OR] 3.26 [95% confidence interval (CI) 2.10 to 5.06], p < 0.001}. In repeated measures analyses using data from 6 and 12 months, the OR for 'response' was 2.89 (95% CI 2.03 to 4.10, p < 0.001) and for a secondary 'remission' outcome (BDI-II score of < 10) 2.74 (95% CI 1.82 to 4.13, p < 0.001). The mean cost of CBT per participant was £ 910, the incremental health and social care cost £ 850, the incremental QALY gain 0.057 and incremental cost-effectiveness ratio £ 14,911. Forty participants were interviewed. Patients described CBT as challenging but helping them to manage their depression; listed social, emotional and practical reasons for not completing treatment; and described usual care as mainly taking medication. CONCLUSIONS: Among patients who have not responded to antidepressants, augmenting usual care with CBT is effective in reducing depressive symptoms, and these effects, including outcomes reflecting remission, are maintained over 12 months. The intervention was cost-effective based on the National Institute for Health and Care Excellence threshold. Patients may experience CBT as difficult but effective. Further research should evaluate long-term effectiveness, as this would have major implications for the recommended treatment of depression. TRIAL REGISTRATION: Current Controlled Trials ISRCTN38231611.

Keep it simple? Predicting primary health care costs with clinical morbidity measures.

Models of the determinants of individuals' primary care costs can be used to set capitation payments to providers and to test for horizontal equity. We compare the ability of eight measures of patient morbidity and multimorbidity to predict future primary care costs and examine capitation payments based on them. The measures were derived from four morbidity descriptive systems: 17 chronic diseases in the Quality and Outcomes Framework (QOF); 17 chronic diseases in the Charlson scheme; 114 Expanded Diagnosis Clusters (EDCs); and 68 Adjusted Clinical Groups (ACGs). These were applied to patient records of 86,100 individuals in 174 English practices. For a given disease description system, counts of diseases and sets of disease dummy variables had similar explanatory power. The EDC measures performed best followed by the QOF and ACG measures. The Charlson measures had the worst performance but still improved markedly on models containing only age, gender, deprivation and practice effects. Comparisons of predictive power for different morbidity measures were similar for linear and exponential models, but the relative predictive power of the models varied with the morbidity measure. Capitation payments for an individual patient vary considerably with the different morbidity measures included in the cost model. Even for the best fitting model large differences between expected cost and capitation for some types of patient suggest incentives for patient selection. Models with any of the morbidity measures show higher cost for more deprived patients but the positive effect of deprivation on cost was smaller in better fitting models.