scholarly journals Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046913
Author(s):  
Rowa Taha ◽  
Paul Leighton ◽  
Chris Bainbridge ◽  
Alan Montgomery ◽  
Tim Davis ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Data Collection ◽  
Outcome Measures ◽  
Text Messages ◽  
Retention Rates ◽  
Efficient Treatment ◽  
Shaft Fractures ◽  
Metacarpal Shaft ◽  
Patient Reported ◽  
Non Surgical Treatment

IntroductionMetacarpal shaft fractures (MSF) are common traumatic hand injuries that usually affect young people of working age. They place a significant burden on healthcare resources and society; however, there is a lack of evidence to guide their treatment. Identifying the most beneficial and cost-efficient treatment will ensure optimisation of care and provide economic value for the National Health Service. The aim of this study is to assess the feasibility of a randomised controlled trial comparing surgical and non-surgical treatment for MSF in adults.Methods and analysisThis is a multicentre prospective cohort study, with a nested qualitative study consisting of patient interviews and focus groups, and an embedded factorial randomised substudy evaluating the use of text messages to maximise data collection and participant retention. The outcomes of interest include eligibility, recruitment and retention rates, completion of follow-up, evaluation of primary outcome measures, calculation of the minimal clinically important difference (MCID) for selected outcome measures and establishing the feasibility of data collection methods and appropriate time-points for use in a future trial. Data will be captured using a secure online data management system. Data analyses will be descriptive and a thematic inductive analysis will be used for qualitative data. Minimum clinically important effects for each patient-reported outcome measure will be estimated using anchor-based responsiveness statistics and distribution-based methods.Ethics and disseminationThis study has received ethical approval from the Research Ethics Committee and the Health Research Authority (REC reference 20/EE/0124). Results will be made available to patients, clinicians, researchers and the funder via peer-reviewed publications and conference presentations. Social media platforms, local media and feedback from the Patient Advisory Group will be used to maximise circulation of findings to patients and the public.Trial registration numberISRCTN13922779.

Surgical Versus Non-Surgical Treatment of Humeral Shaft Fractures Compared By a Patient Reported Outcome: The Scandinavian Humeral Diaphyseal Fracture Trial (SHAFT) - A Study Protocol For a Pragmatic Randomized Clinical Trial

2021 ◽  
Author(s):  
Dennis Karimi ◽  
Stig Brorson ◽  
Kaare S. Midtgaard ◽  
Tore Fjalestad ◽  
Aksel Paulsen ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Controlled Trial ◽  
Patient Reported Outcome ◽  
Humeral Shaft ◽  
Major Adverse Cardiovascular Events ◽  
Dash Score ◽  
Humeral Shaft Fractures ◽  
Shaft Fractures ◽  
Patient Reported ◽  
Non Surgical Treatment

Abstract Background: The outcome of non-surgical treatment is generally good, but the treatment course can be long and painful with approximately a quarter of the patients acquiring a nonunion. Both surgical and non-surgical treatment can have disabling consequences such as nerve injury, infection and nonunion. The purpose of the study is to compare patient reported outcome after surgical and non-surgical treatment for humeral shaft fractures. Methods: A pragmatic randomized controlled trial is planned with two study groups (SHAFT-Y and SHAFT-E). A total of 287 eligible acute humeral shaft fractures are scheduled to be recruited and randomly allocated to surgical or non-surgical treatment with the option of early crossover due to delayed union. The surgical method within the allocation is decided by the surgeon. The primary outcome is the Disability of Arm, Shoulder and Hand (DASH) score at 52 weeks, and is assessor blinded. The secondary outcomes are DASH score, EQ-5D-5L, pain assessed by visual analogue score, Constant-Murley score including elbow range of motion and anchor-questions collected at all timepoints throughout the trial. All complications will be reported including; infection, nerve or vascular injury, surgical revisions (implant malpositioning, hardware failure, aseptic loosening and peri-implant fracture), major adverse cardiovascular events, and mortality. Patients declining randomization will be asked to enroll into an observational cohort with same outcomes and post-treatment regimes. Discussion: SHAFT will provide information on the effectiveness of two standard treatments for humeral shaft fractures, while taking the dilemmas within the population into account. Trial registration: Clinicaltrials.gov, NCT04574336. Registered on 5 October 2020.

scholarly journals Patient-reported outcomes after surgical and non-surgical treatment of proximal hamstring avulsions in middle-aged patients

2019 ◽  
Vol 5 (1) ◽  
pp. e000511 ◽  
Author(s):  
Elsa Pihl ◽  
Olof Skoldenberg ◽  
Hans Nasell ◽  
Sven Jonhagen ◽  
Paula Kelly Pettersson ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Treatment Algorithm ◽  
Hamstring Injury ◽  
Middle Aged ◽  
Mri Findings ◽  
Aged Patients ◽  
Patient Reported ◽  
Proximal Hamstring ◽  
Non Surgical Treatment

ObjectivesIn the literature on proximal hamstring avulsions, only two studies report the outcomes of non-surgically treated patients. Our objective was to compare subjective recovery after surgical and non-surgical treatment of proximal hamstring avulsions in a middle-aged cohort.MethodsWe included 47 patients (33 surgically and 14 non-surgically treated) with a mean (SD) age of 51 (±9) years in a retrospective cohort study. Follow-up time mean (SD) of 3.9 (±1.4) years. The outcome variables were the Lower Extremity Functional Scale (LEFS) and questions from the Proximal Hamstring Injury Questionnaire. Outcome variables were adjusted in regression models for gender, age, American Society of Anestesiologits (ASA) classification and MRI findings at diagnosis.ResultsThe baseline characteristics showed no differences except for the MRI result, in which the surgically treated group had a larger proportion of tendons retracted ≥ 2 cm. The mean LEFS score was 74 (SD±12) in the surgically treated cohort and 72 (SD±16) in the non-surgically treated cohort. This was also true after adjusting for confounders. The only difference in outcome at follow-up was the total hours performing physical activity per week, p=0.02; surgically treated patients reported 2.5 hours or more (5.2 vs 2.7).ConclusionThis study on middle-aged patients with proximal hamstring avulsions was unable to identify any difference in patient-reported outcome measures between surgically and non-surgically treated patients. The vast majority of patients treated surgically had complete proximal hamstring avulsions with ≥ 2 cm of retraction. We conclude that to obtain an evidence-based treatment algorithm for proximal hamstring avulsions studies of higher scientific level are needed.

scholarly journals A Systematic Review of Treatment Interventions for Metacarpal Shaft Fractures in Adults

Hand ◽  
2020 ◽  
pp. 155894472097436
Author(s):  
Rowa H. M. Taha ◽  
Douglas Grindlay ◽  
Sandeep Deshmukh ◽  
Alan Montgomery ◽  
Tim R. C. Davis ◽  
...  
Keyword(s):  
Systematic Review ◽  
Best Practice ◽  
Treatment Modalities ◽  
Eligibility Criteria ◽  
Efficient Treatment ◽  
Shaft Fractures ◽  
Metacarpal Shaft ◽  
Wide Variability ◽  
Cost Efficient ◽  
Meta Analyses

Metacarpal shaft fractures are common hand injuries that predominantly affect younger patients. There is wide variability in their treatment with no consensus on best practice. We performed a systematic review to assess the breadth and quality of available evidence supporting different treatment modalities for metacarpal shaft fractures of the finger digits in adults. A comprehensive search was conducted across multiple databases, in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 1600 records were identified; 7 studies fulfilled eligibility criteria and were included. No randomized controlled trials directly comparing surgery with nonsurgical treatment were found. One retrospective study compared nonsurgical with surgical treatment, whereas 6 compared surgical or nonsurgical treatments. Considerable heterogeneity between studies along with a high or critical risk of bias restricts direct comparison and conclusions. There is a lack of high-quality evidence to guide treatment, supporting the need for well-designed, multicenter trials to identify the most effective and cost-efficient treatment for metacarpal shaft fractures in adults.

Proximal hamstring tendon avulsion: state of the art

2020 ◽  
pp. jisakos-2019-000420
Author(s):  
Pablo Bertiche ◽  
Nicholas Mohtadi ◽  
Denise Chan ◽  
Per Hölmich
Keyword(s):  
Surgical Treatment ◽  
State Of The Art ◽  
Treatment Options ◽  
Diagnostic Testing ◽  
Biceps Femoris ◽  
Hamstring Tendon ◽  
Ischial Tuberosity ◽  
Patient Reported ◽  
Proximal Hamstring ◽  
Non Surgical Treatment

Complete proximal hamstring tendon avulsions from the ischial tuberosity, though infrequent, are the most severe type of hamstring muscle injury in the field of sport medicine. These serious injuries are commonly associated with a delayed or even misdiagnosis, despite obvious clinical findings. The published literature favours surgical repair even though the studies represent lower levels of evidence. Non-surgical treatment is a viable option for lower physical demand patients. This state-of-the-art article reviews the relevant anatomy, the clinical assessment including specific physical examination signs and diagnostic testing in patients suspected of a proximal hamstring avulsion. Up-to-date evidence is reviewed to address surgical and non-surgical treatment options and outcome assessment. The authors provide a detailed description of what would be considered the current worldwide standard of care; an open, suture-anchor-based repair of the avulsed tendon complex (semitendinosus, long head of biceps femoris and semimembranosus) securely to the ischial tuberosity. Also included are surgical tips and tricks, with advice on postsurgical management and rehabilitation. Future perspectives should involve higher quality, prospective research to better define the indications for surgery, evaluate the emerging role of endoscopic repair and disclose complications along with measuring patient-reported outcomes.

scholarly journals A snapshot of “real world” current neuro-oncology practice in ten UK centres participating in the Tessa Jowell BRAIN MATRIX platform study

2021 ◽  
Vol 23 (Supplement_4) ◽  
pp. iv17-iv18
Author(s):  
Victoria Wykes ◽  
John R Apps ◽  
Joshua Savage ◽  
Sara Meade ◽  
Ute Pohl ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Data Collection ◽  
Outcome Measures ◽  
Real World ◽  
Life Assessment ◽  
Molecular Diagnostic ◽  
Categorical Variables ◽  
Patient Reported ◽  
Oncology Practice

Abstract Aims The TJBM Platform Study (https://www.birmingham.ac.uk/research/crctu/trials/brain-matrix) is a programme of work aimed at improving the knowledge of, and treatment for, glioma. The study will develop a backbone infrastructure for a molecular diagnostic pathway, particularly epigenetic classification and whole genome sequencing (WGS), and a data-repository of disease imaging, including real-time centralised Response Assessment in Neuro-Oncology (RANO) review, treatment and outcome data. Developed with the involvement of patients and relatives, patient reported outcome measures (PROMs), particularly quality of life assessment will be collected for patients. We present the feasibility data collected from the initial ten UK centres selected to participate in the TJBM study. This presents an opportunity to understand current local neuro-oncology practice, identify differences between services and chances to optimise these, bearing in mind the heterogeneity in our patient populations, staff and hospital facilities. Method Ten UK centres were selected to participate in the TJBM platform study, and each centre completed a multi-disciplinary feasibility questionnaire to facilitate participation and collaboration across the centres. Data were collected from hospital electronic MDT (Multi-Disciplinary Team) records, clinic letters, operative and imaging notes, MDT or personal experience. Continuous variables were reported using medians and ranges due to the non-normality of the data and categorical variables were reported as numbers and percentages. Tables and bar charts were generated to display relevant data. Analysis and plots were generated using Microsoft Excel sheets and SPSS (IBM) version 26. Results Work load Between 2016-2018 service provision redistribution reflects a trend towards higher volume centres. Overall, glioma workload within ten TJBM centres has remained stable (Figure 1). Imaging All TJBM centres have good access to imaging techniques and neuroradiology expertise, including relevant ‘advanced’ imaging. All have RANO capability, although not widely used clinically. Neurosurgery All centres have access to 5 ALA, perform awake craniotomy for language assessment and motor/sensory mapping are typically performed asleep, with subtle variation in techniques. Pathology Despite molecular analysis advances, current practice is limited to the evaluation of formalin embedded tissue by traditional morphology/ immuno-histochemical staining, with limited targeted testing of specific genetic changes (Figure 2). Clinical oncology Oncology treatments for glioma were as per NICE guidance with some minor local variation. The data has informed the development of the TJBM protocol, an overview of which will be presented (Figure 3). Conclusion Through systematic real-world data collection the TJBM platform study will provide a detailed understanding of practice within the UK, linked to molecular tumour genotype, treatment response outcome measures, and also regular quality of life assessments. Use of the platform infrastructure, will facilitate trials and add-on observational and biological studies to obtain rapid, efficient, and cost-effective data collection, and integrate findings with comprehensive molecular biological profiling and radiological features, thereby reducing the time and administrative burdens in trial delivery. This infrastructure will help establish a trial-competent network on which future research and collaborations can be based. Academic and industry partners will be able to use the TJBM platform through collaboration, overseen by a strong governance framework. This will maximise the opportunities and abilities to translate advances into trials and patient benefit.

scholarly journals Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA): protocol for a prospective observational study

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Onosi S. Ifesemen ◽  
Daniel F. McWilliams ◽  
Eamonn Ferguson ◽  
Richard Wakefield ◽  
Kehinde Akin-Akinyosoye ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Outcome Measures ◽  
Central Sensitization ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Text Messages ◽  
Self Report ◽  
Pain Mechanisms ◽  
Link Type ◽  
Patient Reported

Abstract Background Pain and fatigue are persistent problems in people with rheumatoid arthritis. Central sensitisation (CS) may contribute to pain and fatigue, even when treatment has controlled inflammatory disease. This study aims to validate a self-report 8-item questionnaire, the Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA) questionnaire, developed to measure central pain mechanisms in RA, and to predict patient outcomes and response to treatment. A secondary objective is to explore mechanisms linking CS, pain and fatigue in people with RA. Methods/design This is a prospective observational cohort study recruiting 250 adults with active RA in secondary care. The CAP-RA questionnaire, demographic data, medical history, and patient reported outcome measures (PROMs) of traits associated with central sensitization will be collected using validated questionnaires. Quantitative sensory testing modalities of pressure pain detection thresholds, temporal summation and conditioned pain modulation will be indices of central sensitization, and blood markers, swollen joints and ultrasound scans will be indices of inflammation. Primary data collection will be at baseline and 12 weeks. The test-retest reliability of CAP-RA questionnaire will be determined 1 week after the baseline visit. Pain and fatigue data will be collected weekly via text messages for 12 weeks. CAP-RA psychometric properties, and predictive validity for outcomes at 3 months will be evaluated. Discussion This study will validate a simple self-report questionnaire against psychophysical indices of central sensitization and patient reported outcome measures of traits associated with CS in a population of individuals with active RA. The application of this instrument in the clinical environment could provide a mechanism-based stratification tool to facilitate the provision of targeted therapy to individuals with pain and fatigue in RA, alongside treatments that target joint inflammation. Trial registration Clinicaltrials.gov NCT04515589. Date of registration 17 August 2020.

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