Severe pectus excavatum (PE) may impair cardiopulmonary and physical function. The effectiveness of surgical treatment to correct PE and restore physical function is widely debated due to a lack of high-quality comparative evidence. The RESTORE trial aims to determine the clinical and cost-effectiveness of corrective surgery for severe PE compared with conservative management for the first time in a randomised controlled trial (RCT).

RESTORE is a pragmatic, multicentre, RCT with an embedded observational cohort. 200 participants aged ≥12 years with severe PE will be recruited at around 12 National Health Service cardiothoracic surgical centres in England. Participants will be randomised 1:1 to receive either surgery within 3 months of randomisation (intervention arm) or no surgery until after the primary outcome measurement at 1 year (comparator arm). The primary outcome is change in physical functioning from baseline to 1 year as measured by the Short Form Health Survey (SF-36v2) physical function score. The primary economic outcome is cost-effectiveness. The key secondary outcome is change in % predicted VO_2peak at 1 year measured by cardiopulmonary exercise test (CPET). Outcomes will be assessed at 1 year post-randomisation in the comparator arm and 1 year post-surgery in the intervention arm. The primary analyses will be undertaken on an intention-to-treat population using a linear mixed-effects model, adjusted for stratification variables via a binary covariate. Other secondary outcomes will include change from baseline of cardiopulmonary function (CPET and spirometry), health-related quality of life using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) and SF-36v2 questionnaires, Hospital Anxiety and Depression Scale and disease specific symptoms (Phoenix Comprehensive Assessment for Pectus Excavatum Symptoms and Pectus Excavatum Evaluation Questionnaire). Adverse events, complications from surgery and operative technical success (Haller and Compression Indices from preoperative and postoperative CT scans) will also be assessed. Health economic analysis will estimate the incremental cost per quality adjusted life year at 1 year.

The trial was approved by East of Scotland Research and Ethics Service (24/ES/0034). Participants who are ≥16 years of age will be required to provide written informed consent. For participants

ISRCTN11359779.

Dietary modification, particularly low-carbohydrate diet, and diabetes self-management education (DSME) have shown promise in improving glycaemic control among persons with type 2 diabetes mellitus (T2DM). However, real-world evidence from India is limited. This protocol describes the methods of a cluster randomised trial to determine the effectiveness and feasibility of adopting a low-carbohydrate diet among persons with T2DM.

Our cluster-randomised trial with a mixed-method process evaluation will use computer-generated block randomisation sequence to randomise Urban Primary Health Centres (UPHCs) (n=16) to either continue delivering the usual guideline-based care under the National Programme for Prevention and Control of Non-Communicable Diseases (NPNCD) or our study intervention. The study intervention will comprise a personalised nutrition counselling focusing on (i) low-carbohydrate diet (

We will include persons with T2DM, over the age of 30 years and above, irrespective of comorbidities, registered in the selected UPHC under care for diabetes for at least a month and with an glycated haemoglobin (HbA1c) level ≥6.5% during the screening test. We will collect data electronically using semistructured questionnaires and measure HbA1c, blood pressure, lipid profile, serum creatinine and body weight at baseline, 3, 6, 9 and 12 months after enrolment. We will use a difference in difference analysis, adjusted for clustering, to compare the change in HbA1c at the follow-up visits compared with baseline across the two study arms. We will conduct both intention-to-treat and per-protocol analysis, exploring reasons for differences in effect size.

The study protocol was reviewed and approved by the Scientific Advisory Committee/Institutional Human Ethics Committee of the research institution (NIE/IHEC/202302-03). The findings of this study will be disseminated through publication in peer-reviewed journals.

Clinical Trials Registry-India (CTRI/2024/02/062202).

Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis, health outcomes have improved. This paper evaluates the health system costs and the health-related quality of life implications of these guidelines.

A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015.

Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months.

Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS) and the EuroQoL; healthcare costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life Years (QALYs) were calculated from the EQ-5D utility scores. Cost–utility analysis was performed using the NHS and Social Care perspective.

A total of 49 patients were included; 35 were treated within 48 hours, ‘early’ (median (IQR) 8.25 [3.7–20.5]) and 14 were treated after 48 hours ‘delayed’ (median (IQR) 93.9 [66.7–100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared with 4 (29%) in the delayed group. According to GOS, 10 (29%) had a good recovery in the early treatment group, but only 1 (7%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p

This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment.