Determining key clinical predictors for chronic ankle instability and return to sports with cost of illness analysis: protocol of a prospective cohort study

Introduction: Ankle sprains are common in sports and the general population. Although considered innocuous, a large proportion has residual complaints such as recurrent ankle sprains and develop chronic ankle instability. Although some predicting factors are identified, there is no unequivocality regarding the development of chronic ankle instability, nor about the optimal rehabilitation for an acute ankle sprain. Alongside the biomechanical impairments, ankle sprains are a burden on society due to substantial economic costs. Therefore, we aim to identify key clinical predictors of chronic ankle instability or recovery after acute lateral ankle sprain. Additionally, we aim to determine cost-of-illness of patients who developed chronic ankle instability. Methods and analysis: This prospective cohort study (Clinicaltrials.gov: NCT05637008 - pre-results) aims to recruit adult (18-55 years) patients with an acute lateral ankle sprain who are active in sports. Clinical assessments and patient-reported outcome measures will be used to collect data at 7-14 days, 6 weeks, 12 weeks and 12 months after enrolment in the study. The primary outcome will be chronic ankle instability at 12-month follow-up. Salient outcomes will be analysed by logistic regression to determine association with the development of chronic ankle instability. Participants will fill in a cost diary containing direct and indirect costs related to their injury. Ethics and disseminations: The ethical committee of the Antwerp University Hospital (B3002022000138) has given approval of the protocol and consent forms on 10 October 2022. We perform this study according to the Helsinki Declaration. We will present results at conferences or webinars and publish in peer-reviewed articles.NCT05637008

Impairment-based assessments for patients with lateral ankle sprain: A systematic review of measurement properties

Study design Systematic review. Background and objective The International Ankle Consortium developed a core outcome set for the assessment of impairments in patients with lateral ankle sprain (LAS) without consideration of measurement properties (MP). Therefore, the aim of this study is to investigate MPs of assessments for the evaluation of individuals with a history of LAS. Methods This systematic review of measurement properties follows PRISMA and COSMIN guidelines. Databases Pubmed, CINAHL, Embase, Web of Science, Cochrane Library and SPORTDiscus were searched for eligible studies (last search: July 2022). Studies on MP of specific tests and patient-reported outcome measurements (PROMs) in patients with acute and history of LAS (>4 weeks post injury) were deemed eligible. Results Ten studies of acute LAS and 39 studies of history of LAS patients with a total of 3313 participants met the inclusion criteria. Anterior Drawer Test (ADT) in supine position five days post injury and Reverse Anterolateral Drawer Test are recommended in acute settings in single studies. In the history of LAS patients, Cumberland Ankle Instability Tool (CAIT) (4 studies) as a PROM, Multiple Hop (3 studies) and Star Excursion Balance Tests (SEBT) (3 studies) for dynamic postural balance testing showed good MPs. No studies investigated pain, physical activity level and gait. Only single studies reported on swelling, range of motion, strength, arthrokinematics, and static postural balance. Limited data existed on responsiveness of the tests in both subgroups. Conclusion There was good evidence to support the use of CAIT as PROM, Multiple Hop, and SEBT for dynamic postural balance testing. Insufficient evidence exists in relation to test responsiveness, especially in the acute situation. Future research should assess MPs of assessments of other impairments associated with LAS

How robust are clinical trials in primary and secondary ankle sprain prevention?

Abstract: Objectives: Determine the statistical stability of RCTs examining primary and secondary prevention of ankle sprains.Methods: Databases were searched to August 2023. We included parallel design RCTs, using conservative interventions for preventing ankle sprain, reporting dichotomous injury event outcomes. Statistical stability was quantified using Fragility Index (FI) and Fragility Quotient (FQ). Subgroup analyses were undertaken to test if FI varied based on by study objective, original approach to analysis (frequency vs time to event), follow-up duration, and pre-registration.Results: 3559 studies were screened with 45 RCTs included. The median number of events required to change the statistical significance (FI) was 4 (IQR 1-6). FI was similar regardless of study objective, original analysis, followup duration, and pre-registration status. Median (IQR) FQ was 0.015 (0.005-0.046), therefore reversing events <2 patients/100 would alter significance. In 80% of studies the number of patients lost to follow-up was greater than the FI.Conclusion: RCTs informing primary and secondary prevention of ankle sprain are fragile. Only a small percentage of outcome event reversals would reverse study significance, and this is often exceeded by the number of drop outs. Robust reporting of dichotomous outcomes requires the use P values and key metrics such as FI or FQ

How robust are clinical trials in primary and secondary ankle sprain prevention?

Objectives: Determine the statistical stability of RCTs examining primary and secondary prevention of ankle sprains. Methods: Databases were searched to August 2023. We included parallel design RCTs, using conservative interventions for preventing ankle sprain, reporting dichotomous injury event outcomes. Statistical stability was quantified using Fragility Index (FI) and Fragility Quotient (FQ). Subgroup analyses were undertaken to test if FI varied based on by study objective, original approach to analysis (frequency vs time to event), follow-up duration, and pre-registration. Results: 3559 studies were screened with 45 RCTs included. The median number of events required to change the statistical significance (FI) was 4 (IQR 1-6). FI was similar regardless of study objective, original analysis, follow-up duration, and pre-registration status. Median (IQR) FQ was 0.015 (0.005-0.046), therefore reversing events <2 patients/100 would alter significance. In 80% of studies the number of patients lost to follow-up was greater than the FI. Conclusion: RCTs informing primary and secondary prevention of ankle sprain are fragile. Only a small percentage of outcome event reversals would reverse study significance, and this is often exceeded by the number of drop outs. Robust reporting of dichotomous outcomes requires the use P values and key metrics such as FI or FQ