Understanding local ethnic inequalities in childhood BMI through cross-sectional analysis of routinely collected local data.

BACKGROUND: Local-level analysis of ethnic inequalities in health is lacking, prohibiting a comprehensive understanding of the health needs of local populations and the design of effective health services. Knowledge of ethnic disparities in child weight status is particularly limited by overlooking both the heterogeneity within ethnic groupings; and the complex ecological contexts in which obesity arises. This study aimed to establish whether there was variation in childhood BMI across ethnic groups in Coventry, and the influence of individual, school and neighbourhood contexts, using routinely collected local data. METHODS: National Child Measurement Programme data were compiled for the period 2007/8-2014/15 and combined with routinely collected local data reflecting school performance and demographics, and school and neighbourhood physical environments. Multi-level modelling using Monte Carlo Markov Chain methods was used to account for the clustering of children within schools and neighbourhoods. Ethnic group differences in BMI z-score (zBMI) were explored at 4-5 years and 10-11 years for girls and boys alongside individual, school and neighbourhood covariates. RESULTS: At age 4-5 years (n = 28,407), ethnic group differences were similar for boys and girls, with children from South Asian, White other, Chinese and 'any other' ethnic groups having a significantly lower zBMI, and Black African children having a higher zBMI, versus White British (WB) children. Patterns differed considerably at age 10-11 years (n = 25,763) with marked sex differences. Boys from White other, Bangladeshi and Black African groups had a significantly higher zBMI than WB boys. For girls, only children from Black ethnic groups showed a significantly higher zBMI. Area-level deprivation was the only important school or neighbourhood covariate, but its inclusion did not explain ethnic group differences in child zBMI. CONCLUSION: This analysis contributes to the existing literature by identifying nuanced patterns of ethnic disparities in childhood adiposity in Coventry, supporting the targeting of early obesity prevention for children from Black African groups, as well as girls from Black Caribbean and Black other ethnic backgrounds; and boys from Bangladeshi and White other ethnic backgrounds. It also demonstrates the utility of exploring routinely collected local data sets in building a comprehensive understanding of local population needs.

The Natural History of Full-Thickness Rotator Cuff Tears in Randomized Controlled Trials: A Systematic Review and Meta-analysis.

BACKGROUND: Rotator cuff tears are the most common tendon injury in the adult population, resulting in substantial morbidity. The optimum management for these patients is not known. PURPOSE: To assess the overall treatment response to all interventions in full-thickness rotator cuff tears among patients enrolled in randomized clinical trials. STUDY DESIGN: Systematic review and meta-analysis. METHODS: Randomized controlled trials (RCTs) were identified from a systematic search of Medline, Embase, CINHAL, and the Cochrane Central Register of Controlled Trials. Patients were aged ≥18 years with a full-thickness rotator cuff tear. The primary outcome measure was change in Constant shoulder score from baseline to 52 weeks. A meta-analysis to assess treatment response was calculated via the standardized mean change in scores. RESULTS: A total of 57 RCTs were included. The pooled standardized mean change as compared with baseline was 1.42 (95% CI, 0.80-2.04) at 3 months, 2.73 (95% CI, 1.06-4.40) at 6 months, and 3.18 (95% CI, 1.64-4.71) at 12 months. Graphic plots of treatment response demonstrated a sustained improvement in outcomes in nonoperative trial arms and all operative subgroup arms. CONCLUSION: Patients with full-thickness rotator cuff tears demonstrated a consistent pattern of improvement in Constant score with nonoperative and operative care. The natural history of patients with rotator cuff tears included in RCTs is to improve over time, whether treated operatively or nonoperatively.

Comparison of hip function and quality of life of total hip arthroplasty and resurfacing arthroplasty in the treatment of young patients with arthritis of the hip joint at 5 years.

OBJECTIVE: To compare the medium-term clinical effectiveness of total hip arthroplasty and resurfacing arthroplasty. DESIGN: Single centre, two-arm, parallel group, assessor blinded, randomised controlled trial with 1:1 treatment allocation. SETTING: A large teaching hospital in England. PARTICIPANTS: 122 patients older than 18 years with severe arthritis of the hip joint, suitable for resurfacing arthroplasty of the hip. Patients were excluded if they were considered to be unable to adhere to trial procedures or complete questionnaires. INTERVENTIONS: Total hip arthroplasty (replacement of entire femoral head and neck); hip resurfacing arthroplasty (replacement of the articular surface of femoral head only, femoral neck remains intact). Both procedures replaced the articular surface of the acetabulum. OUTCOMES: The outcome measures were hip function assessed using the Oxford Hip Score (OHS) and health-related quality of life assessed using the EuroQol (EQ-5D). Patients were followed up annually for a minimum of 5 years. Outcome data were modelled using the generalised estimating equation methodology to explore temporal variations during follow-up. RESULTS: 60 patients were randomly assigned to hip resurfacing arthroplasty and 62 to total hip arthroplasty. 95 (78%) of the 122 original study participants provided data at 5 years. There was a small decrease in both hip functions and quality of life in both groups of patients each year during the 5-year follow-up period. However, there was no evidence of a significant difference between treatments group in the OHS (P=0.333) or the EQ-5D (P=0.501). CONCLUSIONS: We previously reported no difference in outcome in the first year after surgery. The current medium-term results also show no evidence of a difference in hip function or health-related quality of life in the 5 years following a total hip arthroplasty versus resurfacing arthroplasty. TRIAL REGISTRATION NUMBER: ISRCTN33354155. UKCRN 4093.

A comparison of electronic and manual dynamometry and goniometry in patients with fracture of the distal radius and healthy participants.

UNLABELLED: The purpose of this study was to assess the intra-rater and inter-rater reliability of electronic and manual dynamometry and goniometry in healthy volunteers, and the inter-instrument reliability in the assessment of healthy volunteers and patients recovering after a fracture of the distal radius. Grip strength, grip fatigue, pinch strength and range of motion were assessed in all participants with both the manual and electronic instruments by two physiotherapists and orthopaedic specialist trainee. The measures of dynamometry demonstrated excellent reliability (intra-class correlation coefficient >0.90), with the instruments found to be interchangeable with the exception of the grip fatigue. Variable intra-rater and inter-rater reliability was demonstrated with all planes of movement for the goniometry measures regardless of the instrument used. The results of this study support the continued use of dynamometry in the clinical setting, but raise questions regarding the use of goniometry measurements. LEVEL OF EVIDENCE: Diagnostic level III.

UK Fixation of Distal Tibia Fractures (UK FixDT): protocol for a randomised controlled trial of 'locking' plate fixation versus intramedullary nail fixation in the treatment of adult patients with a displaced fracture of the distal tibia.

INTRODUCTION: The treatment of displaced, extra-articular fractures of the distal tibia remains controversial. These injuries are difficult to manage due to limited soft tissue cover, poor vascularity of the area and proximity to the ankle joint. Surgical treatment options are expanding and include locked intramedullary nails, plate and screw fixation and external fixator systems. The nail and plate options are most commonly used in the UK, but controversy exists over which treatment is most clinically and cost-effective. In this multicentre randomised controlled trial we aim to assess ratings of disability 6 months postinjury in patients who have sustained a distal tibia fracture treated with either an intramedullary nail or plate and locking screw fixation. METHODS AND ANALYSIS: Adult patients presenting at trial centres with an acute fracture of the distal tibia will be considered for inclusion. A total of 320 patients will provide 90% power to detect a difference of 8 points in Disability Rating Index (DRI) score at 6 months at the 5% level. The randomisation sequence is stratified by trial centre and age, and administered via web-based service with 1:1 treatment allocation. Baseline demographic and pre-injury functional data and radiographs will be collected using the DRI, Olerud and Molander, and EuroQol EQ-5D questionnaire. Clinical assessment, early complications and radiographs will be recorded at 6-8 weeks. Functional outcome, health-related quality of life and resource use will be collected at 3, 6 and 12 months postoperatively. The main analysis will investigate differences in DRI 6 months postsurgery, between the two treatment groups, on an intention-to-treat basis. Tests will be two-sided and considered to provide evidence for a significant difference if p values are <0.05. ETHICS AND DISSEMINATION: NRES Committee West-Midlands, 6/11/2012 (ref:12/WM/0340). The results of the trial will be disseminated via peer-reviewed publications and presentations at relevant conferences. TRIAL REGISTRATION NUMBER: ISRCTN99771224.

Measurement properties of the Disability Rating Index in patients undergoing hip replacement.

OBJECTIVE: The aim of this study was to establish and validate the measurement properties of the Disability Rating Index (DRI) in a population of adults undergoing hip replacement. METHODS: One hundred and twenty-six adults participating in a randomized controlled trial completed the Oxford Hip Score, Harris Hip Score, DRI and EuroQol Group-Five Dimensions (EQ-5D) questionnaires at four time points. The structural validity of the DRI was assessed using principal component analysis. Cronbach's α was used to determine the internal consistency and scale reliability was also assessed. Correlation between the DRI and the other functional and health-related quality of life scales was used to check criterion validity. DRI responsiveness was estimated and the interpretability of the scale was also assessed by checking for edge effects. RESULTS: Results of analyses showed that the DRI was internally consistent (Cronbach's α = 0.92), had good association with both function-specific and general health-related quality of life scores and was sensitive to change (smallest detectable change = 2.7). No evidence of edge effects was found. Furthermore, structural assessment of the DRI revealed two novel subscales representing simple tasks and difficult tasks. CONCLUSIONS: The DRI is structurally valid, responsive and concurs with functional assessment in adults undergoing hip replacement.

Total hip arthroplasty versus resurfacing arthroplasty in the treatment of patients with arthritis of the hip joint: single centre, parallel group, assessor blinded, randomised controlled trial.

OBJECTIVES: To compare the clinical and cost effectiveness of total hip arthroplasty with resurfacing arthroplasty in patients with severe arthritis of the hip. DESIGN: Single centre, two arm, parallel group, assessor blinded, randomised controlled trial with 1:1 treatment allocation. SETTING: One large teaching hospital in the United Kingdom. PARTICIPANTS: 126 patients older than 18 years with severe arthritis of the hip joint, suitable for resurfacing arthroplasty of the hip. Patients were excluded if they were considered to be unable to adhere to trial procedures or complete questionnaires. INTERVENTIONS: Total hip arthroplasty (replacement of entire femoral head and neck); hip resurfacing arthroplasty (replacement of the articular surface of femoral head only, femoral neck remains intact). Both procedures replaced the articular surface of the acetabulum. MAIN OUTCOME MEASURES: Hip function at 12 months after surgery, assessed using the Oxford hip score and Harris hip score. Secondary outcomes were quality of life, disability rating, physical activity level, complications, and cost effectiveness. RESULTS: 60 patients were randomly assigned to hip resurfacing arthroplasty and 66 to total hip arthroplasty. Intention to treat analysis showed no evidence for a difference in hip function between treatment groups at 12 months (t test, P=0.242 and P=0.070 for Oxford hip score and Harris hip score, respectively); 95% of follow-up data was available for analysis. Mean Oxford hip score was 40.4 (95% confidence interval 37.9 to 42.9) in the resurfacing group and 38.2 (35.3 to 41.0) in the total arthroplasty group (estimated treatment effect size 2.23 (-1.52 to 5.98)). Mean Harris hip score was 88.4 (84.4 to 92.4) in the resurfacing group and 82.3 (77.2 to 87.5) in the total arthroplasty group (6.04 (-0.51 to 12.58)). Although we saw no evidence of a difference, we cannot definitively exclude clinically meaningful differences in hip function in the short term. Overall complication rates did not differ between treatment groups (P=0.291). However, we saw more wound complications in the total arthroplasty group (P=0.056) and more thromboembolic events in the resurfacing group (P=0.049). CONCLUSIONS: No evidence of a difference in hip function was seen in patients with severe arthritis of the hip, one year after receiving a total hip arthroplasty versus resurfacing arthroplasty. The long term effects of these interventions remain uncertain. TRIAL REGISTRATION: Current Controlled Trials ISRCTN33354155, UKCRN 4093.

A statistical framework for quantifying clinical equipoise for individual cases during randomized controlled surgical trials.

BACKGROUND: Randomised controlled trials are being increasingly used to evaluate new surgical interventions. There are a number of problematic methodological issues specific to surgical trials, the most important being identifying whether patients are eligible for recruitment into the trial. This is in part due to the diversity in practice patterns across institutions and the enormous range of available interventions that often leads to a low level of agreement between clinicians about both the value and the appropriate choice of intervention. We argue that a clinician should offer patients the option of recruitment into a trial, even if the clinician is not individually in a position of equipoise, if there is collective (clinical) equipoise amongst the wider clinical community about the effectiveness of a proposed intervention (the clinical equipoise principle). We show how this process can work using data collected from an ongoing trial of a surgical intervention. RESULTS: We describe a statistical framework for the assessment of uncertainty prior to patient recruitment to a clinical trial using a panel of expert clinical assessors and techniques for eliciting, pooling and modelling of expert opinions. The methodology is illustrated using example data from the UK Heel Fracture Trial. The statistical modelling provided results that were clear and simple to present to clinicians and showed how decisions regarding recruitment were influenced by both the collective opinion of the expert panel and the type of decision rule selected. CONCLUSIONS: The statistical framework presented has potential to identify eligible patients and assist in the simplification of eligibility criteria which might encourage greater participation in clinical trials evaluating surgical interventions.

In-shoe plantar pressures within ankle-foot orthoses: implications for the management of achilles tendon ruptures.

BACKGROUND: Advances in the management of Achilles tendon rupture have led to the development of immediate weightbearing protocols. These vary regarding which ankle-foot orthoses (AFOs) are used and the number of inserted heel wedges used within them. PURPOSE: This study was conducted to evaluate plantar pressure measurements and temporal gait parameters within different AFOs, using different numbers of heel wedges. STUDY DESIGN: Controlled laboratory study. METHODS: Fifteen healthy participants were evaluated using 3 different AFOs, with 4 different levels of inserted heel wedges. Therefore, a total of 12 conditions were evaluated, in a sequence that was randomly allocated to each participant. Pressure and temporal gait parameters were measured using an in-shoe F-Scan pressure system, and range of movement was measured using an electrogoniometer. RESULTS: Ankle-foot orthoses that were restrictive in design, combined with a higher number of inserted heel wedges, reduced forefoot pressures, increased heel pressures, and decreased the amount of time spent in the terminal stance and preswing phase of the gait cycle (P = .029, .002, and .001). CONCLUSION: The choice of AFO design and the number of inserted heel wedges have a significant effect on plantar pressure measurements and temporal gait parameters. The implications of these changes need to be applied to the clinical management of acute Achilles tendon ruptures. This clinical management requires a balance between protected weightbearing and functional loading, requiring further research within a clinical context. CLINICAL RELEVANCE: The biomechanical data from this research imply that a carbon-fiber AFO, with 1 heel raise, protects against excessive dorsiflexion while facilitating the restoration of near-normal gait parameters. This could lead to an accelerated return to function, avoiding the effects of disuse atrophy. This is in contrast to the rigid rocker-bottom AFO design with a greater number of heel-wedge inserts. However, research within a clinical context would be required to ascertain if these biomechanical advantages translate into a functional benefit for patients. The results should also be considered in relation to the amount of force a healing Achilles tendon can withstand.