Background Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel. Objective To assess both the clinical effectiveness and the cost-effectiveness of lightweight fibreglass casts in the management of heel ulcers. Design A pragmatic, multicentre, parallel, observer-blinded randomised controlled trial. A central randomisation centre used a computer-generated random number sequence to allocate participants to groups. Setting Thirty-five specialist diabetic foot secondary care centres in the UK. Those recruited were aged ≥ 18 years and had diabetes mellitus complicated by ulcers of the heel of grades 2–4 on the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel scale. Participants In total, 509 participants [68% male, 15% with type 1 diabetes mellitus, mean age 67.5 years (standard deviation 12.4 years)] were randomised 1 : 1 to the intervention (n = 256) or the control (n = 253) arm. The primary outcome data were available for 425 participants (212 from the intervention arm and 213 from the control arm) and exceeded the total required; attrition was 16.5%. The median ulcer area at baseline was 275 mm2 [interquartile range (IQR) 104–683 mm2] in the intervention group and 206 mm2 (IQR 77–649 mm2) in the control group. There were no differences between the two groups at baseline in any parameter, neither in relation to the participant nor in relation to their ulcer. Interventions The intervention group received usual care supplemented by the addition of an individually moulded, lightweight, fibreglass heel cast. The control group received usual care alone. The intervention phase continued either until the participant’s ulcer had healed (maintained for 28 days) or for 24 weeks, whichever occurred first. During this intervention phase, the participants were reviewed every 2 weeks, and the fibreglass casts were replaced when they were no longer usable. Main outcome measures The primary outcome measure was ulcer healing (confirmed by a blinded observer and maintained for 4 weeks) within 24 weeks. Other outcome measures included the time taken for the ulcer to heal, the percentage reduction in the cross-sectional area, the reduction in local pain, amputation, survival and health economic analysis. The study was powered to define a difference in healing of 15% (55% intervention vs. 40% control). Results Forty-four per cent (n = 94) of the intervention group healed within 24 weeks, compared with 37% (n = 80) of the control participants (odds ratio 1.42, 95% confidence interval 0.95 to 2.14; p = 0.088), using an intention-to-treat analysis. No differences were observed between the two groups for any secondary outcome. Limitations Although the component items of care were standardised, because this was a pragmatic trial, usual care was not uniform. There was some evidence of a small excess of adverse events in the intervention group; however, non-blinded observers documented these events. There was no excess of adverse device effects. Conclusions There may be a small increase in healing with the use of a heel cast, but the estimate was not sufficiently precise to provide strong evidence of an effect. There was no evidence of any subgroup in which the intervention appeared to be particularly effective. A health economic analysis suggested that it is unlikely that the intervention represents good value for money. The provision of a lightweight heel cast may be of benefit to some individuals, but we have found no evidence to justify the routine adoption of this in clinical practice. Future work It is unlikely that further study of this intervention will have an impact on usual clinical care, and so future efforts should be directed towards other interventions designed to improve the healing of ulcers in this population. Trial registration Current Controlled Trials ISRCTN62524796. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 34. See the NIHR Journals Library website for further project information.

BackgroundUnloading knee braces can provide good short-term pain relief for some patients with unicompartmental osteoarthritis (UOA). Their cost is relatively small compared with surgical interventions. However, no previous studies have reported their use over a duration of 5 years or more.MethodsUp to 8 years of prospective data were collected from 63 patients who presented with UOA. After conservative management with analgesia and physiotherapy, patients were offered an unloading brace. EQ-5D (EuroQol five dimensions) questionnaires were collected at baseline and after wearing the brace. Cost and quality-adjusted life years (QALYs) were compared with a total knee replacement (TKR) with an 8-month waiting duration and 8 years of results.ResultsPatients experienced a mean increase in EQ-5D of 0.42 with an average duration of wear of 26.1 months resulting in an increase of 0.44 in QALYs with a mean cost of £625. The adoption of an unloader knee brace was found to be a short-term cost-effective treatment option with an 8-month incremental cost effectiveness ratio of £9599. Compared with no treatment, the unloader knee brace can be considered cost effective at 4 months or more. At 8 years follow-up, the unloader knee brace demonstrated QALYs gain of 0.43 and with an incremental cost-effectiveness ratio of -£6467 compared with TKR.ConclusionUnloading knee braces are cost effective for the management of UOA. These findings strongly support the undertaking of further research into the long-term impact of unloading knee brace. The unloader knee brace has benefits to the National Health Service for capacity, budget, waiting list duration, frequency of surgery and reducing the required severity of surgical intervention.

BackgroundCold homes and fuel poverty contribute to health inequalities in ways that could be addressed through energy efficiency interventions.ObjectivesTo determine the health and psychosocial impacts of energy performance investments in low-income areas, particularly hospital admissions for cardiorespiratory conditions, prevalence of respiratory symptoms and mental health status, hydrothermal conditions and household energy use, psychosocial outcomes, cost consequences to the health system and the cost utility of these investments.DesignA mixed-methods study comprising data linkage (25,908 individuals living in 4968 intervention homes), a field study with a controlled pre-/post-test design (intervention,n = 418; control,n = 418), a controlled multilevel interrupted time series analysis of internal hydrothermal conditions (intervention,n = 48; control,n = 40) and a health economic assessment.SettingLow-income areas across Wales.ParticipantsResidents who received energy efficiency measures through the intervention programme and matched control groups.Main outcome measuresPrimary outcomes – emergency hospital admissions for cardiorespiratory conditions, self-reported respiratory symptoms, mental health status, indoor air temperature and indoor relative humidity. Secondary outcomes – emergency hospital admissions for chronic obstructive pulmonary disease-related cardiorespiratory conditions, excess winter admissions, health-related quality of life, subjective well-being, self-reported fuel poverty, financial stress and difficulties, food security, social interaction, thermal satisfaction and self-reported housing conditions.MethodsAnonymously linked individual health records for emergency hospital admissions were analysed using mixed multilevel linear models. A quasi-experimental controlled field study used a multilevel repeated measures approach. Controlled multilevel interrupted time series analyses were conducted to estimate changes in internal hydrothermal conditions following the intervention. The economic evaluation comprised cost–consequence and cost–utility analyses.Data sourcesThe Patient Episode Database for Wales 2005–14, intervention records from 28 local authorities and housing associations, and scheme managers who delivered the programme.ResultsThe study found no evidence of changes in physical health. However, there were improvements in subjective well-being and a number of psychosocial outcomes. The household monitoring study found that the intervention raised indoor temperature and helped reduce energy use. No evidence was found of substantial increases in indoor humidity levels. The health economic assessment found no explicit cost reductions to the health service as a result of non-significant changes in emergency admissions for cardiorespiratory conditions.LimitationsThis was a non-randomised intervention study with household monitoring and field studies that relied on self-response. Data linkage focused on emergency admissions only.ConclusionAlthough there was no evidence that energy performance investments provide physical health benefits or reduce health service usage, there was evidence that they improve social and economic conditions that are conducive to better health and improved subjective well-being. The intervention has been successful in reducing energy use and improving the living conditions of households in low-income areas. The lack of association of emergency hospital admissions with energy performance investments means that we were unable to evidence cost saving to health-service providers.Future workOur research suggests the importance of incorporating evaluations with follow-up into intervention research from the start.FundingThe National Institute for Health Research Public Health Research programme.

Objective Examine the health and economic impact of extending screening intervals in people with Type 2 diabetes (T2DM) and Type 1 diabetes (T1DM) without diabetes-related retinopathy (DR). Setting Diabetic Eye Screening Wales (DESW). Study design Retrospective observational study with cost-utility analysis (CUA) and Decremental Cost-Effectiveness Ratios (DCER) study. Intervention Biennial screening versus usual care (annual screening). Inputs Anonymised data from DESW were linked to primary care data for people with two prior screening events with no DR. Transition probabilities for progression to DR were estimated based on a subset of 26,812 and 1232 people with T2DM and T1DM, respectively. DCER above £20,000 per QALY was considered cost-effective. Results The base case analysis DCER results of £71,243 and £23,446 per QALY for T2DM and T1DM respectively at a 3.5% discount rate and £56,822 and £14,221 respectively when discounted at 1.5%. Diabetes management represented by the mean HbA 1c was 7.5% for those with T2DM and 8.7% for T1DM. Sensitivity analysis Extending screening to biennial based on HbA 1c , being the strongest predictor of progression of DR, at three levels of HbA 1c 6.5%, 8.0% and 9.5% lost one QALY saving the NHS £106,075; £58,653 and £31,626 respectively for T2DM and £94,696, £37,646 and £11,089 respectively for T1DM. In addition, extending screening to biennial based on the duration of diabetes > 6 years for T2DM per QALY lost, saving the NHS £54,106 and for 6-12 and > 12 years for T1DM saving £83,856, £23,446 and £13,340 respectively. Conclusions Base case and sensitivity analyses indicate biennial screening to be cost-effective for T2DM irrespective of HbA 1c and duration of diabetes. However, the uncertainty around the DCER indicates that annual screening should be maintained for those with T1DM especially when the HbA 1c exceeds 80 mmol/mol (9.5%) and duration of diabetes is greater than 12 years.

Background Children with hearing loss associated with otitis media with effusion (OME) are commonly managed through surgical intervention, hearing aids or watchful waiting. A safe, inexpensive, effective medical treatment would enhance treatment options. Small, poorly conducted trials have found a short-term benefit from oral steroids. Objective To determine the clinical effectiveness and cost-effectiveness of a 7-day course of oral steroids in improving hearing at 5 weeks in children with persistent OME symptoms and current bilateral OME and hearing loss demonstrated by audiometry. Design Double-blind, individually randomised, placebo-controlled trial. Setting Ear, nose and throat outpatient or paediatric audiology and audiovestibular medicine clinics in Wales and England. Participants Children aged 2–8 years, with symptoms of hearing loss attributable to OME for at least 3 months, a diagnosis of bilateral OME made on the day of recruitment and audiometry-confirmed hearing loss. Interventions A 7-day course of oral soluble prednisolone, as a single daily dose of 20 mg for children aged 2–5 years or 30 mg for 6- to 8-year-olds, or matched placebo. Main outcome measures Acceptable hearing at 5 weeks from randomisation. Secondary outcomes comprised acceptable hearing at 6 and 12 months, tympanometry, otoscopic findings, health-care consultations related to OME and other resource use, proportion of children who had ventilation tube (grommet) surgery at 6 and 12 months, adverse effects, symptoms, functional health status, health-related quality of life, short- and longer-term cost-effectiveness. Results A total of 389 children were randomised. Satisfactory hearing at 5 weeks was achieved by 39.9% and 32.8% in the oral steroid and placebo groups, respectively (absolute difference of 7.1%, 95% confidence interval –2.8% to 16.8%; number needed to treat = 14). This difference was not statistically significant. The secondary outcomes were consistent with the picture of a small or no benefit, and we found no subgroups that achieved a meaningful benefit from oral steroids. The economic analysis showed that treatment with oral steroids was more expensive and accrued fewer quality-adjusted life-years than treatment as usual. However, the differences were small and not statistically significant, and the sensitivity analyses demonstrated large variation in the results. Conclusions OME in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. Discussions about watchful waiting and other interventions will be enhanced by this evidence. The findings of this study suggest that any benefit from a short course of oral steroids for OME is likely to be small and of questionable clinical significance, and that the treatment is unlikely to be cost-effective and, therefore, their use cannot be recommended. Future work Studies exploring optimal approaches to sharing natural history data and enhancing shared decision-making are needed for this condition. Trial registration Current Controlled Trials ISRCTN49798431 and EudraCT 2012-005123-32. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 61. See the NIHR Journals Library website for further project information.