Home-based rehabilitation programme compared with traditional physiotherapy for patients at risk of poor outcome after knee arthroplasty: the CORKA randomised controlled trial.

OBJECTIVES: To evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy. DESIGN: A prospective, single-blind, two-arm randomised controlled superiority trial. SETTING: 14 National Health Service physiotherapy departments in the UK. PARTICIPANTS: 621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool. INTERVENTIONS: A multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy. MAIN OUTCOME MEASURES: The primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance. RESULTS: 621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4-7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2-6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points; 95% CI -0.89 to 1.88; p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months.There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions. CONCLUSIONS: The CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group. TRIAL REGISTRATION NUMBER: ISRCTN13517704.

Exploratory Efficacy of Calcium-Vitamin D Milk Fortification and Periodontal Therapy on Maternal Oral Health and Metabolic and Inflammatory Profile.

In this 2 × 2 factorial, outcome-assessor blinded, feasibility randomised trial we explored the effect of a non-pharmaceutical multi-component intervention on periodontal health and metabolic and inflammatory profiles among pregnant women with periodontitis receiving prenatal care in a Brazilian public health centre. 69 pregnant women (gestational age ≤20 weeks, T0) were randomly allocated into four groups: (1) fortified sachet (vitamin D and calcium) and powdered milk plus periodontal therapy during pregnancy (early PT) (n = 17); (2) placebo sachet and powdered milk plus early PT (n = 15); (3) fortified sachet and powdered milk plus late PT (after delivery) (n = 19); (4) placebo sachet and powdered milk plus late PT (n = 18). Third trimester (T1) and 6-8 weeks postpartum (T2) exploratory outcomes included periodontal health (% sites with bleeding on probing (BOP)), glucose, insulin, C-Reactive Protein, serum calcium and vitamin D. The mean BOP was significantly reduced in the early PT groups, while BOP worsened in the late PT groups. No significant effect of fortification on BOP was observed. Changes in glucose levels and variation on birthweight did not differ among groups This feasibility trial provides preliminary evidence for estimating the minimum clinically important differences for selected maternal outcomes. A large-scale trial to evaluate the interventions' clinical benefits and cost-effectiveness is warranted.

Impact of a short version of the CONSORT checklist for peer reviewers to improve the reporting of randomised controlled trials published in biomedical journals: study protocol for a randomised controlled trial.

INTRODUCTION: Transparent and accurate reporting is essential for readers to adequately interpret the results of a study. Journals can play a vital role in improving the reporting of published randomised controlled trials (RCTs). We describe an RCT to evaluate our hypothesis that asking peer reviewers to check whether the most important and poorly reported CONsolidated Standards of Reporting Trials (CONSORT) items are adequately reported will result in higher adherence to CONSORT guidelines in published RCTs. METHODS AND ANALYSIS: Manuscripts presenting the primary results of RCTs submitted to participating journals will be randomised to either the intervention group (peer reviewers will receive a reminder and short explanation of the 10 most important and poorly reported CONSORT items; they will be asked to check if these items are reported in the submitted manuscript) or a control group (usual journal practice). The primary outcome will be the mean proportion of the 10 items that are adequately reported in the published articles. Peer reviewers and manuscript authors will not be informed of the study hypothesis, design or intervention. Outcomes will be assessed in duplicate from published articles by two data extractors (at least one blinded to the intervention). We will enrol eligible manuscripts until a minimum of 83 articles per group (166 in total) are published. ETHICS AND DISSEMINATION: This pragmatic RCT was approved by the Medical Sciences Interdivisional Research Ethics Committee of the University of Oxford (R62779/RE001). If this intervention is effective, it could be implemented by all medical journals without requiring large additional resources at journal level. Findings will be disseminated through presentations in relevant conferences and peer-reviewed publications. This trial is registered on the Open Science Framework (https://osf.io/c4hn8).

Cast versus functional brace in the rehabilitation of patients treated non-operatively for a rupture of the Achilles tendon: protocol for the UK study of tendo achilles rehabilitation (UK STAR) multi-centre randomised trial.

INTRODUCTION: Achilles tendon rupture affects over 11 000 people yearly in the UK, and the incidence is increasing. Controversy remains with regard to the best rehabilitation strategy for these patients. In operatively treated patients, functional bracing provides better outcomes compared with plaster casts. However, the role of functional bracing in non-operatively managed patients is unclear. This is the protocol for a multicentre randomised trial of plaster cast immobilisation versus functional bracing for patients with a non-operatively managed Achilles tendon rupture. METHODS AND ANALYSIS: All adults presenting with a primary rupture of the Achilles tendon will be screened. Non-operatively treated patients will be eligible to take part in the trial. Broad eligibility criteria will ensure that the results of the study can be generalised to the wider patient population. Randomisation will be on a 1:1 basis. Both rehabilitation strategies are widely used within the National Health Service. Standardised protocols will be followed, and details of plaster material and brace will be as per the site's usual practice.A minimum of 330 patients will be randomised to obtain 90% power to detect a difference of 8 points in Achilles Tendon Total Rupture Score at 9 months. Quality of life and resource use will be collected at 3, 6 and 9 months. The differences between treatment groups will be assessed on an intention-to-treat basis. The results of the trial-based economic evaluation will be expressed in terms of incremental cost per quality-adjusted life-year gained. ETHICS AND DISSEMINATION: The National Research Ethic Committee approved this study on 18 March 2016 (16/SC/0109).The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of the trial (summer 2019). The results of this trial will substantially inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury. This study has been registered on the International Standard Randomised Controlled Trial Number registry with reference no ISRCTN62639639.

Clinical and cost-effectiveness of progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: protocol for a 2x2 factorial randomised controlled trial (the GRASP trial).

INTRODUCTION: Shoulder pain is very common, with around 70% of cases due to disorders of the rotator cuff. Despite widespread provision of physiotherapy, there is uncertainty about which type of exercise and delivery mechanisms are associated with best outcomes. There is also uncertainty around the long-term benefits and harms of corticosteroid injection therapy, which is often used in addition to physiotherapy. The Getting it Right: Addressing Shoulder Pain trial will assess the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. METHODS AND ANALYSIS: We are conducting a large multicentre randomised controlled trial (2×2 factorial design). We will recruit adults ≥18 years with a new episode of shoulder pain attributable to a rotator cuff disorder as per British Elbow and Shoulder Society guidelines, not currently receiving physiotherapy or being considered for surgery, from at least eight UK National Health Service primary care-based musculoskeletal and related physiotherapy services. Participants (n=704) will be randomised (centralised computer-generated 1:1:1:1 allocation ratio) to one of four interventions: (1) progressive exercise (≤6 physiotherapy sessions); (2) best practice advice (one physiotherapy session); (3) corticosteroid injection then progressive exercise (≤6 sessions) or (4) corticosteroid injection then best practice advice (one session). The primary outcome is the mean difference in Shoulder Pain and Disability Index (SPADI) total score at 12 months. Secondary outcomes are: pain and function SPADI subdomains; health-related quality of life (Five-Level version of the EuroQol EQ-5D-5L); sleep disturbance; return to activity; global impression of change; health resource use; out-of-pocket expenses; work disability. A parallel within-trial economic evaluation will be conducted. The primary analysis will be intention to treat. ETHICS AND DISSEMINATION: Research Ethics Committee approval (REC: 16/SC/0508) has been obtained. Results of the main trial and secondary outcomes will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN16539266; EudraCT number: 2016-002991-28.

Systematic Review of the Methodological Quality of Studies Aimed at Creating Gestational Weight Gain Charts.

A range of adverse outcomes is associated with insufficient and excessive maternal weight gain in pregnancy, but there is no consensus regarding what constitutes optimal gestational weight gain (GWG). Differences in the methodological quality of GWG studies may explain the varying chart recommendations. The goal of this systematic review was to evaluate the methodological quality of studies that aimed to create GWG charts by scoring them against a set of predefined, independently agreed-upon criteria. These criteria were divided into 3 domains: study design (12 criteria), statistical methods (7 criteria), and reporting methods (4 criteria). The criteria were broken down further into items, and studies were assigned a quality score (QS) based on these criteria. For each item, studies were scored as either high (score = 0) or low (score = 1) risk of bias; a high QS correlated with a low risk of bias. The maximum possible QS was 34. The systematic search identified 12 eligible studies involving 2,268,556 women from 9 countries; their QSs ranged from 9 (26%) to 29 (85%) (median, 18; 53%). The most common sources for bias were found in study designs (i.e., not prospective); assessments of prepregnancy weight and gestational age; descriptions of weighing protocols; sample size calculations; and the multiple measurements taken at each visit. There is wide variation in the methodological quality of GWG studies constructing charts. High-quality studies are needed to guide future clinical recommendations. We recommend the following main requirements for future studies: prospective design, reliable evaluation of prepregnancy weight and gestational age, detailed description of measurement procedures and protocols, description of sample-size calculation, and the creation of smooth centile charts or z scores.