Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants.Aims
Methods
COVID-19 has compounded a growing waiting list problem, with over 4.5 million patients now waiting for planned elective care in the UK. Views of patients on waiting lists are rarely considered in prioritization. Our primary aim was to understand how to support patients on waiting lists by hearing their experiences, concerns, and expectations. The secondary aim was to capture objective change in disability and coping mechanisms. A minimum representative sample of 824 patients was required for quantitative analysis to provide a 3% margin of error. Sampling was stratified by body region (upper/lower limb, spine) and duration on the waiting list. Questionnaires were sent to a random sample of elective orthopaedic waiting list patients with their planned intervention paused due to COVID-19. Analyzed parameters included baseline health, change in physical/mental health status, challenges and coping strategies, preferences/concerns regarding treatment, and objective quality of life (EuroQol five-dimension questionnaire (EQ-5D), Generalized Anxiety Disorder 2-item scale (GAD-2)). Qualitative analysis was performed via the Normalization Process Theory.Aims
Methods
Aims. The ongoing COVID-19 pandemic has disrupted and delayed medical and surgical examinations where attendance is required in person. Our article aims to outline the validity of online assessment, the range of benefits to both candidate and assessor, and the challenges to its implementation. In addition, we propose
The risk to patients and healthcare workers of resuming elective orthopaedic surgery following the peak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has been difficult to quantify. This has prompted governing bodies to adopt a cautious approach that may be impractical and financially unsustainable. The lack of evidence has made it impossible for surgeons to give patients an informed perspective of the consequences of elective surgery in the presence of SARS-CoV-2. This study aims to determine, for the UK population, the probability of a patient being admitted with an undetected SARS-CoV-2 infection and their resulting risk of death; taking into consideration the current disease prevalence, reverse transcription-polymerase chain reaction (RT-PCR) testing, and preassessment pathway. The probability of SARS-CoV-2 infection with a false negative test was calculated using a lower-end RT-PCR sensitivity of 71%, specificity of 95%, and the UK disease prevalence of 0.24% reported in May 2020. Subsequently, a case fatality rate of 20.5% was applied as a worst-case scenario.Aims
Methods
COVID-19 represents one of the greatest global healthcare challenges in a generation. Orthopaedic departments within the UK have shifted care to manage trauma in ways that minimize exposure to COVID-19. As the incidence of COVID-19 decreases, we explore the impact and risk factors of COVID-19 on patient outcomes within our department. We retrospectively included all patients who underwent a trauma or urgent orthopaedic procedure from 23 March to 23 April 2020. Electronic records were reviewed for COVID-19 swab results and mortality, and patients were screened by telephone a minimum 14 days postoperatively for symptoms of COVID-19.Aims
Methods
Elective surgery has been severely curtailed as a result of the COVID-19 pandemic. There is little evidence to guide surgeons in assessing what processes should be put in place to restart elective surgery safely in a time of endemic COVID-19 in the community. We used data from a stand-alone hospital admitting and operating on 91 trauma patients. All patients were screened on admission and 100% of patients have been followed-up after discharge to assess outcome.Aims
Methods
COVID-19 has changed the practice of orthopaedics across the globe. The medical workforce has dealt with this outbreak with varying strategies and adaptations, which are relevant to its field and to the region. As one of the ‘hotspots’ in the UK , the surgical branch of trauma and orthopaedics need strategies to adapt to the ever-changing landscape of COVID-19. Adapting to the crisis locally involved five operational elements: 1) triaging and workflow of orthopaedic patients; 2) operation theatre feasibility and functioning; 3) conservation of human resources and management of workforce in the department; 4) speciality training and progression; and 5) developing an exit strategy to resume elective work. Two hospitals under our trust were redesignated based on the treatment of COVID-19 patients. Registrar/consultant led telehealth reviews were carried out for early postoperative patients. Workflows for the management of outpatient care and inpatient care were created. We looked into the development of a dedicated operating space to perform the emergency orthopaedic surgeries without symptoms of COVID-19. Between March 23 and April 23, 2020, we have surgically treated 133 patients across both our hospitals in our trust. This mainly included hip fractures and fractures/infection affecting the hand.Aims
Methods
The adequate provision of personal protective equipment (PPE) for healthcare workers has come under considerable scrutiny during the COVID-19 pandemic. This study aimed to evaluate staff awareness of PPE guidance, perceptions of PPE measures, and concerns regarding PPE use while caring for COVID-19 patients. In addition, responses of doctors, nurses, and other healthcare professionals (OHCPs) were compared. The inclusion criteria were all staff working in clinical areas of the hospital. Staff were invited to take part using a link to an online questionnaire advertised by email, posters displayed in clinical areas, and social media. Questions grouped into the three key themes - staff awareness, perceptions, and concerns - were answered using a five-point Likert scale. The Kruskal-Wallis test was used to compare results across all three groups of staff.Aims
Methods
There is widespread variation in the management of rare orthopaedic disease, in a large part owing to uncertainty. No individual surgeon or hospital is typically equipped to amass sufficient numbers of cases to draw robust conclusions from the information available to them. The programme of research will establish the British Orthopaedic Surgery Surveillance (BOSS) Study; a nationwide reporting structure for rare disease in orthopaedic surgery. The BOSS Study is a series of nationwide observational cohort studies of pre-specified orthopaedic disease. All relevant hospitals treating the disease are invited to contribute anonymised case details. Data will be collected digitally through REDCap, with an additional bespoke software solution used to regularly confirm case ascertainment, prompt follow-up reminders and identify potential missing cases from external sources of information (i.e. national administrative data). With their consent, patients will be invited to enrich the data collected by supplementing anonymised case data with patient reported outcomes. The study will primarily seek to calculate the incidence of the rare diseases under investigation, with 95% confidence intervals. Descriptive statistics will be used to describe the case mix, treatment variations and outcomes. Inferential statistical analysis may be used to analyze associations between presentation factors and outcomes. Types of analyses will be contingent on the disease under investigation.Introduction
Methods
The contemporary practice of orthopaedic surgery
requires an evidence-based approach to support all medical and surgical
interventions. In this essay, the author expresses a forthright,
personal and somewhat prejudiced appeal to retain the legitimacy
of clinical decision making in conditions that are rare, contain
multiple variables, have a solution that generally works or has
an unpredictable course. Cite this article:
High-quality randomised controlled trials (RCTs)
evaluating surgical therapies are fundamental to the delivery of
evidence-based orthopaedics. Orthopaedic clinical trials have unique
challenges; however, when these challenges are overcome, evidence
from trials can be definitive in its impact on surgical practice.
In this review, we highlight several issues that pose potential
challenges to orthopaedic investigators aiming to perform surgical randomised
controlled trials. We begin with a discussion on trial design issues,
including the ethics of sham surgery, the importance of sample size,
the need for patient-important outcomes, and overcoming expertise
bias. We then explore features surrounding the execution of surgical
randomised trials, including ethics review boards, the importance
of organisational frameworks, and obtaining adequate funding. Cite this article:
The poor reporting and use of statistical methods in orthopaedic papers has been widely discussed by both clinicians and statisticians. A detailed review of research published in general orthopaedic journals was undertaken to assess the quality of experimental design, statistical analysis and reporting. A representative sample of 100 papers was assessed for compliance to CONSORT and STROBE guidelines and the quality of the statistical reporting was assessed using a validated questionnaire. Overall compliance with CONSORT and STROBE guidelines in our study was 59% and 58% respectively, with very few papers fulfilling all criteria. In 37% of papers patient numbers were inadequately reported; 20% of papers introduced new statistical methods in the ‘results’ section not previously reported in the ‘methods’ section, and 23% of papers reported no measurement of error with the main outcome measure. Taken together, these issues indicate a general lack of statistical rigour and are consistent with similar reviews undertaken in a number of other scientific and clinical research disciplines. It is imperative that the orthopaedic research community strives to improve the quality of reporting; a failure to do so could seriously limit the development of future research.
