Development and refinement of the WAItE: a new obesity-specific quality of life measure for adolescents

Background: Few weight-specific outcome measures, developed specifically for obese and overweight adolescents, exist and none are suitable for the elicitation of utility values used in the assessment of cost effectiveness. Objectives: The development of a descriptive system for a new weight-specific measure. Methods: Qualitative interviews were conducted with 31 treatment-seeking (above normal weight status) and non-treatment-seeking (school sample) adolescents aged 11–18 years, to identify a draft item pool and associated response options. 315 eligible consenting adolescents, aged 11–18 years, enrolled in weight management services and recruited via an online panel, completed two version of a long-list 29-item descriptive system (consisting of frequency and severity response scales). Psychometric assessments and Rasch analysis were applied to the draft 29-item instrument to identify a brief tool containing the best performing items and associated response options. Results: Seven items were selected, for the final item set; all displayed internal consistency, moderate floor effects and the ability to discriminate between weight categories. The assessment of unidimensionality was supported (t test statistic of 0.024, less than the 0.05 threshold value). Conclusions: The Weight-specific Adolescent Instrument for Economic-evaluation focuses on aspects of life affected by weight that are important to adolescents. It has the potential for adding key information to the assessment of weight management interventions aimed at the younger population

Valuing selected WAItE health states using the Time Trade-Off methodology: findings from an online interviewer-assisted remote survey

\ua9 2024, The Author(s).Purpose: The Weight-Specific Adolescent Instrument for Economic Evaluation (WAItE) is a physical weight-specific patient reported outcome measure for use in adolescence. The purpose of this study was to use the Time Trade-Off (TTO) methodology, administered using an online interviewer-assisted remote survey, to obtain utility values for several health states from the WAItE descriptive system from a sample of the UK adult general population. Methods: The adult sample was gathered using a market research company and a sample of local residents. All participants completed the same interviewer-assisted remote survey, which included rating WAItE states of varying impairment using the TTO. Results: 42 adults completed the survey. Utility values were gathered for four health states, ranging from low impairment to the most severe health from the WAItE descriptive system (the Pits state). Consistent orderings of the WAItE health states were observed; the health state with the lowest level of impairment was valued highest and the Pits state was valued lowest. Several respondents (n = 7, 17%) considered the Pits state to be worse than death; however, the mean value of this health state was 0.23. Conclusions: The utility value of the Pits state relative to death generated from this study will be used to anchor latent values for WAItE health states generated from a Discrete Choice Experiment onto the 0 = death, 1 = full health Quality Adjusted Life Year (QALY) scale as part of a valuation study for the WAItE in the UK population. This study also provides further evidence that interviewer-assisted digital studies are feasible for collecting TTO data

The Segond fracture occurs at the site of lowest sub-entheseal trabecular bone volume fraction on the tibial plateau.

In a series of human cadaveric experiments, Dr. Paul Segond first described the avulsion injury occurring at the anterolateral tibial plateau that later took his name. The fracture is thought to arise as a consequence of excessive tibia internal rotation which often also elicits damage to other connective tissue of the knee. The exact mechanism behind the avulsion is, however, unclear. A number of ligamentous structures have been proposed in separate studies to insert into the Segond fragment. Suggestions include the iliotibial band (ITB), biceps femoris and the controversial 'anterolateral ligament' (ALL). Despite increasing knowledge of tibial plateau bony microarchitecture in both healthy and disease states, no studies have yet, to our knowledge, considered the role of tibial sub-entheseal bone structure in pathogenesis of the Segond fracture. The goal of this study was thus to elucidate the differences in trabecular properties at regions across the tibial plateau in order to provide an explanation for the susceptibility of the anterolateral region to avulsion injury. Twenty human tibial plateaus from cadaveric donors were dissected and imaged using a Nikon-XTH225-μCT scanner with <80 μm isotropic voxel size. Scans were reconstructed using MicroView 3D Image Viewer and Analysis Tool. Subsequent virtual biopsy at ten anatomically defined regions of interest (ROI) generated estimates of bone volume fraction ('bone volume divided by total volume' (BV/TV)). The overall mean BV/TV value across all 20 tibiae and all 10 ROIs was 0.271. Univariate repeated-measurements ANOVA demonstrated that BV/TV values differed between ROIs. BV/TV values at the Segond site (Sα, Sβ or Sγ) were lower than all other ROIs at 0.195, 0.192 and 0.193, respectively. This suggests that, notwithstanding inter- and intra-specimen variation, the Segond site tends to have a lower trabecular bone volume fraction than entheseal sites elsewhere on the tibia. Since BV/TV correlates with tensile and torsional strength, the lower BV/TV at the Segond site could equate to a region of local weakness in certain individuals which predisposes them to an avulsion injury following the application of force from excessive internal rotation. The low BV/TV recorded at the Segond site also challenges the idea that the fracture occurs due to pull from a discrete 'anterolateral ligament', as the tension exerted focally would be expected to elicit a hypertrophic response in line with Frost's Mechanostat hypothesis. Our data would instead agree with the aforementioned reports of the fibrous band at the Segond site being part of a broader insertion of an 'anterolateral complex'

Implementing a weight-specific quality-of-life tool for young people in primary health care: a qualitative study

Background Obesity is thought to be one of the most serious global public health challenges of the 21st century. The primary care setting is important in terms of the diagnosis, education, and management of obesity in children and young people. This study explored the views of primary care clinicians on the implementation of a quality-of-life (QoL) tool to help young people and their families identify the impact of weight on QoL. Aim To assess the acceptability and feasibility of implementing the Weight-specific Adolescent Instrument for Economic-evaluation (WAItE) QoL tool for young people aged 11–18 years in primary care. Design & setting Qualitative study in Northern England, UK Method One-to-one, semi-structured interviews were conducted with a purposive sample of primary healthcare clinicians working in practices located in areas of varying deprivation in Northern England, UK. Interview transcripts were coded and analysed using framework analysis in NVivo (version 10). Results Participants (n = 16 GPs; n = 4 practice nurses) found the WAItE tool acceptable for them and their patients, and believed it was feasible for use in routine clinical practice. It was important to primary care clinicians that the tool would provide an overall QoL score that would be easy for GPs and nurses to interpret, to help them identify patients most in need of specialist help. Conclusion This study has developed a platform for further research around QoL in young people who are overweight and obese. A future feasibility study will focus on implementing the tool in a small number of primary healthcare practices

Continuous low-dose antibiotic prophylaxis for adults with repeated urinary tract infections (AnTIC): a randomised, open-label trial

Funder: UK National Institute for Health Research. Open Access funded by Department of Health UK Acknowledgments We thank all the participants for their commitment to the study, Sheila Wallace for updating the systematic review, members of the Trial Steering Committee and members of the Data Monitoring Committee for their valuable guidance. We thank the National Health Service organisations, principal investigators and local research staff who hosted and ran the study at site. We thank the Health Technology Assessment Programme of the UK NIHR for funding the study (no. 11/72/01). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the UK Government Department of Health. A full report of the study30 has been published by the NIHR Library.Peer reviewedPublisher PD

Continuous low-dose antibiotic prophylaxis to prevent urinary tract infection in adults who perform clean intermittent self-catheterisation: the AnTIC RCT

Peer reviewedPublisher PD

Development of a new quality of life measure for Duchenne muscular dystrophy using mixed methods

Objective Based on concerns over existing patient reported outcome measures (PROMs) for assessing quality of life (QoL) in Duchenne muscular dystrophy (DMD), we describe the mixed methods development of a new QoL PROM for use in boys and men with DMD: the DMD-QoL. Methods The DMD-QoL was developed in 3 stages. First, draft items were generated from 18 semi-structured qualitative interviews with boys and men with DMD, analysed using framework analysis. Second, cognitive debriefing interviews with patients (n = 10), clinicians (n = 8), and patients' parents (n = 10) were undertaken and a reduced item set selected and refined. Third, psychometric data on the draft items from a cross-sectional online survey (n = 102), and stakeholder input from patients and patients' parents, was used to produce the final questionnaire. Patient and public involvement and engagement was embedded throughout the process. Results From an initial draft of 47 items, a revised set of 27 items was produced at stage 2, and this set was further refined at stage 3 to generate the DMD-QoL, a 14-item QoL PROM. The DMD-QoL is designed for use from 7 years of age by proxy report and from 10 years of age by self or proxy report. The final measure showed good psychometric properties. Conclusions The DMD-QoL is a new 14-item QoL PROM for boys and men with DMD, with demonstrable content and face validity

Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction

Background Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited. Aims To establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum. Methods/design A multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. Eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the NOSE questionnaire. Surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. Medical management comprises a nasal saline spray followed by a fluorinated steroid spray daily for six months. The recruitment target is 378 patients, recruited from up to 17 sites across Scotland, England and Wales. Randomisation will be on a 1:1 basis, stratified by gender and severity (NOSE score). Participants will be followed up for 12 months post randomisation. The primary outcome measure is the total SNOT-22 score at 6 months. Clinical and economic outcomes will be modelled against baseline severity (NOSE scale) to inform clinical decision-making. The study includes a recruitment enhancement process, and an economic evaluation. Discussion The NAIROS trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. Identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit