Mini-Stern Trial: A randomised trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Objective Aortic valve replacement (AVR) can be performed either through full median sternotomy (FS) or upper mini-sternotomy (MS). The Mini-Stern trial aimed to establish whether MS leads to quicker postoperative recovery and shorter hospital stay after first-time isolated AVR. Methods This pragmatic, open-label, parallel RCT compared MS with FS for first-time isolated AVR in two UK NHS hospitals. Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR, analysed in the intent-to-treat population. Results In this RCT, 222 patients were recruited and randomised (118 MS, 104 FS). Compared to FS patients, MS patients had longer hospital stay (mean 9.5 vs. 8.6 days) and took longer to achieve fitness for discharge home (mean 8.5 vs. 7.5 days). Adjusting for valve type, sex and surgeon, hazard ratios (HR) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0.874, 95% CI 0.668-1.143, p-value 0.3246) or time to fitness for discharge (HR 0.907, 95% CI 0.688-1.197, p-value 0.4914). During mean follow up of 760 days (MS:745 and FS:777 days), 12 (10%) MS and 7 (7%) FS patients died (HR 1.871, 95% CI 0.723-4.844, p-value 0.1966). Average extra cost for MS was £1,714, during the first 12 months after AVR. Conclusions Compared to FS for AVR, MS did not result in shorter hospital stay, faster recovery or improved survival and was not cost-effective. MS approach is not superior to FS for performing AVR

Optimal primary care management of clinical osteoarthritis and joint pain in older people: a mixed-methods programme of systematic reviews, observational and qualitative studies, and randomised controlled trials

Background Osteoarthritis (OA) is the most common long-term condition managed in UK general practice. However, care is suboptimal despite evidence that primary care and community-based interventions can reduce OA pain and disability. Objectives The overall aim was to improve primary care management of OA and the health of patients with OA. Four parallel linked workstreams aimed to (1) develop a health economic decision model for estimating the potential for cost-effective delivery of primary care OA interventions to improve population health, (2) develop and evaluate new health-care models for delivery of core treatments and support for self-management among primary care consulters with OA, and to investigate prioritisation and implementation of OA care among the public, patients, doctors, health-care professionals and NHS trusts, (3) determine the effectiveness of strategies to optimise specific components of core OA treatment using the example of exercise and (4) investigate the effect of interventions to tackle barriers to core OA treatment, using the example of comorbid anxiety and depression in persons with OA. Data sources The North Staffordshire Osteoarthritis Project database, held by Keele University, was the source of data for secondary analyses in workstream 1. Methods Workstream 1 used meta-analysis and synthesis of published evidence about effectiveness of primary care treatments, combined with secondary analysis of existing longitudinal population-based cohort data, to identify predictors of poor long-term outcome (prognostic factors) and design a health economic decision model to estimate cost-effectiveness of different hypothetical strategies for implementing optimal primary care for patients with OA. Workstream 2 used mixed methods to (1) develop and test a ‘model OA consultation’ for primary care health-care professionals (qualitative interviews, consensus, training and evaluation) and (2) evaluate the combined effect of a computerised ‘pop-up’ guideline for general practitioners (GPs) in the consultation and implementing the model OA consultation on practice and patient outcomes (parallel group intervention study). Workstream 3 developed and investigated in a randomised controlled trial (RCT) how to optimise the effect of exercise in persons with knee OA by tailoring it to the individual and improving adherence. Workstream 4 developed and investigated in a cluster RCT the extent to which screening patients for comorbid anxiety and depression can improve OA outcomes. Public and patient involvement included proposal development, project steering and analysis. An OA forum involved public, patient, health professional, social care and researcher representatives to debate the results and formulate proposals for wider implementation and dissemination. Results This programme provides evidence (1) that economic modelling can be used in OA to extrapolate findings of cost-effectiveness beyond the short-term outcomes of clinical trials, (2) about ways of implementing support for self-management and models of optimal primary care informed by National Institute for Health and Care Excellence recommendations, including the beneficial effects of training in a model OA consultation on GP behaviour and of pop-up screens in GP consultations on the quality of prescribing, (3) against adding enhanced interventions to current effective physiotherapy-led exercise for knee OA and (4) against screening for anxiety and depression in patients with musculoskeletal pain as an addition to current best practice for OA. Conclusions Implementation of evidence-based care for patients with OA is feasible in general practice and has an immediate impact on improving the quality of care delivered to patients. However, improved levels of quality of care, changes to current best practice physiotherapy and successful introduction of psychological screening, as achieved by this programme, did not substantially reduce patients’ pain and disability. This poses important challenges for clinical practice and OA research. Limitations The key limitation in this work is the lack of improvement in patient-reported pain and disability despite clear evidence of enhanced delivery of evidence-based care. Future work recommendations (1) New thinking and research is needed into the achievable and desirable long-term goals of care for people with OA, (2) continuing investigation into the resources needed to properly implement clinical guidelines for management of OA as a long-term condition, such as regular monitoring to maintain exercise and physical activity and (3) new research to identify subgroups of patients with OA as a basis for stratified primary care including (i) those with good prognosis who can self-manage with minimal investigation or specialist treatment, (ii) those who will respond to, and benefit from, specific interventions in primary care, such as physiotherapy-led exercise, and (iii) develop research into effective identification and treatment of clinically important anxiety and depression in patients with OA and into the effects of pain management on psychological outcomes in patients with OA. Trial registration Current Controlled Trials ISRCTN06984617, ISRCTN93634563 and ISRCTN40721988. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research Programme and will be published in full in Programme Grants for Applied Research Programme; Vol. 6, No. 4. See the NIHR Journals Library website for further project information. </jats:sec

Facet joint injections for people with persistent non-specific low back pain (Facet injection study) : A feasibility study for a randomised controlled trial

All NIHR Journals Library reports have been produced under the terms of a commissioning contract issued by the Secretary of State for Health. Reports may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Permission to reproduce material from a published report is covered by the UK government’s non-commercial licence for public sector information. Applications for commercial reproduction should be addressed to the editorial office at: [email protected]: The National Institute for Health and Care Excellence (NICE) 2009 guidelines for persistent low back pain (LBP) do not recommend the injection of therapeutic substances into the back as a treatment for LBP because of the absence of evidence for their effectiveness. This feasibility study aimed to provide a stable platform that could be used to evaluate a randomised controlled trial (RCT) on the clinical effectiveness and cost-effectiveness of intra-articular facet joint injections (FJIs) when added to normal care. Objectives: To explore the feasibility of running a RCT to test the hypothesis that, for people with suspected facet joint back pain, adding the option of intra-articular FJIs (local anaesthetic and corticosteroids) to best usual non-invasive care is clinically effective and cost-effective. Design: The trial was a mixed design. The RCT pilot protocol development involved literature reviews and a consensus conference followed by a randomised pilot study with an embedded mixed-methods process evaluation. Setting: Five NHS acute trusts in England. Participants: Participants were patients aged ≥ 18 years with moderately troublesome LBP present (> 6 months), who had failed previous conservative treatment and who had suspected facet joint pain. The study aimed to recruit 150 participants (approximately 30 per site). Participants were randomised sequentially by a remote service to FJIs combined with ‘best usual care’ (BUC) or BUC alone. Interventions: All participants were to receive six sessions of a bespoke BUC rehabilitation package. Those randomised into the intervention arm were, in addition, given FJIs with local anaesthetic and steroids (at up to six injection sites). Randomisation occurred at the end of the first BUC session. Main outcome measures: Process and clinical outcomes. Clinical outcomes included a measurement of level of pain on a scale from 0 to 10, which was collected daily and then weekly via text messaging (or through a written diary). Questionnaire follow-up was at 3 months. Results: Fifty-two stakeholders attended the consensus meeting. Agreement informed several statistical questions and three design considerations: diagnosis, the process of FJI and the BUC package and informing the design for the randomised pilot study. Recruitment started on 26 June 2015 and was terminated by the funder (as a result of poor recruitment) on 11 December 2015. In total, 26 participants were randomised. Process data illuminate some of the reasons for recruitment problems but also show that trial processes after enrolment ran smoothly. No between-group analysis was carried out. All pain-related outcomes show the expected improvement between baseline and follow-up. The mean total cost of the overall treatment package (injection £419.22 and BUC £264.00) was estimated at £683.22 per participant. This is similar to a NHS tariff cost for a course of FJIs of £686.84. Limitations: Poor recruitment was a limiting factor. Conclusions: This feasibility study achieved consensus on the main challenges in a trial of FJIs for people with persistent non-specific low back pain.Peer reviewe

Early Observations on the impact of the COVID-19 Lockdown on Air Quality Trends across the UK

UK government implemented national lockdown in response to COVID-19 on the 23-26 March 2020. As elsewhere in Europe and Internationally, associated restrictions initially limited individual mobility and workplace activity to essential services and travel, and significant air quality benefits were widely anticipated. Here, break-point/segment methods are applied to air pollutant time-series from the first half of 2020 to provide an independent estimate of the timings of discrete changes in NO, NO2, NOx, O3, PM10 and PM2.5 time-series from Automatic Urban Rural Network (AURN) monitoring stations across the UK. NO, NO2 and NOx all exhibit abrupt decreases at the time the UK locked down of (on average) 7.6 to 17 μg.m-3 (or 32 to 50%) at Urban Traffic stations and 4 to 5.7 μg.m-3 (or 26 to 46%) at Urban Background stations. However, after the initial abrupt reduction, gradual increases were then observed through lockdown. This suggests that the return of vehicles to the road during early lockdown has already offset much of the air quality improvement seen when locking down (provisional estimate 50 to 70% by 01 July). While locking down O3 increased (7 to 7.4 μg.m-3 or 14 to 17% at Urban stations) broadly in line with NO2 reductions, but later changes suggest significant non-lockdown contributions to O3 during the months that followed. Increases of similar magnitudes were observed for both PM10 (5.9 to 6.3 μg.m-3) and PM2.5 (3.9 to 5.0 μg.m-3) at both Rural and Urban stations alike, but the distribution of changes suggests the lockdown was not an obvious direct source of changes in levels of either of these species during this period, and that more complex contributions, e.g. from resuspension and secondary aerosol, may be more likely major drivers for these changes