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      Development and prospective external validation of a tool to predict poor recovery at 9 months after acute ankle sprain in UK emergency departments: the SPRAINED prognostic model

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          Abstract

          Objectives

          To develop and externally validate a prognostic model for poor recovery after ankle sprain.

          Setting and participants

          Model development used secondary data analysis of 584 participants from a UK multicentre randomised clinical trial. External validation used data from 682 participants recruited in 10 UK emergency departments for a prospective observational cohort.

          Outcome and analysis

          Poor recovery was defined as presence of pain, functional difficulty or lack of confidence in the ankle at 9 months after injury. Twenty-three baseline candidate predictors were included together in a multivariable logistic regression model to identify the best predictors of poor recovery. Relationships between continuous variables and the outcome were modelled using fractional polynomials. Regression parameters were combined over 50 imputed data sets using Rubin’s rule. To minimise overfitting, regression coefficients were multiplied by a heuristic shrinkage factor and the intercept re-estimated. Incremental value of candidate predictors assessed at 4 weeks after injury was explored using decision curve analysis and the baseline model updated. The final models included predictors selected based on the Akaike information criterion (p<0.157). Model performance was assessed by calibration and discrimination.

          Results

          Outcome rate was lower in the development (6.7%) than in the external validation data set (19.9%). Mean age (29.9 and 33.6 years), body mass index (BMI; 26.3 and 27.1 kg/m 2), pain when resting (37.8 and 38.5 points) or bearing weight on the ankle (75.4 and 71.3 points) were similar in both data sets. Age, BMI, pain when resting, pain bearing weight, ability to bear weight, days from injury until assessment and injury recurrence were the selected predictors. The baseline model had fair discriminatory ability (C-statistic 0.72; 95% CI 0.66 to 0.79) but poor calibration. The updated model presented better discrimination (C-statistic 0.78; 95% CI 0.72 to 0.84), but equivalent calibration.

          Conclusions

          The models include predictors easy to assess clinically and show benefit when compared with not using any model.

          Trial registration number

          ISRCTN12726986; Results.

          Related collections

          Most cited references20

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          Regression modelling strategies for improved prognostic prediction.

          Regression models such as the Cox proportional hazards model have had increasing use in modelling and estimating the prognosis of patients with a variety of diseases. Many applications involve a large number of variables to be modelled using a relatively small patient sample. Problems of overfitting and of identifying important covariates are exacerbated in analysing prognosis because the accuracy of a model is more a function of the number of events than of the sample size. We used a general index of predictive discrimination to measure the ability of a model developed on training samples of varying sizes to predict survival in an independent test sample of patients suspected of having coronary artery disease. We compared three methods of model fitting: (1) standard 'step-up' variable selection, (2) incomplete principal components regression, and (3) Cox model regression after developing clinical indices from variable clusters. We found regression using principal components to offer superior predictions in the test sample, whereas regression using indices offers easily interpretable models nearly as good as the principal components models. Standard variable selection has a number of deficiencies.
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            Validation of the foot and ankle outcome score for ankle ligament reconstruction.

            We studied the validity and reliability of the Foot and Ankle Outcome Score (FAOS) when used to evaluate the outcome of 213 patients (mean age 40 years, 85 females) who underwent anatomical reconstruction of the lateral ankle ligaments with an average postoperative follow-up of 12 years (range, three to 24 years). The FAOS is a 42-item questionnaire assessing patient-relevant outcomes in five separate subscales (Pain, Other Symptoms, Activities of Daily Living, Sport and Recreation Function, Foot- and Ankle-Related Quality of Life). The FAOS met set criteria of validity and reliability. The FAOS appears to be useful for the evaluation of patient-relevant outcomes related to ankle reconstruction.
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              What is the clinical course of acute ankle sprains? A systematic literature review.

              Ankle sprains are one of the most common musculoskeletal injuries. In order to evaluate the effectiveness of therapeutic interventions and to guide management decisions, it is important to have clear insight of the course of recovery after an acute lateral ankle injury and to evaluate potential factors for nonrecovery and re-sprains. A database search was conducted in MEDLINE, CINAHL, PEDro, EMBASE, and the Cochrane Controlled trial register. Included were observational studies and controlled trials with adult subjects who suffered from an acute lateral ankle sprain that was conventionally treated. One of the following outcomes had to be described: pain, re-sprains, instability, or recovery. Two reviewers independently assessed the methodological quality of each included study. One reviewer extracted relevant data. In total, 31 studies were included, from which 24 studies were of high quality. There was a rapid decrease in pain reporting within the first 2 weeks. Five percent to 33% of patients still experienced pain after 1 year, while 36% to 85% reported full recovery within a period of 3 years. The risk of re-sprains ranged from 3% to 34% of the patients, and re-sprain was registered in periods ranging from 2 weeks to 96 months postinjury. There was a wide variation in subjective instability, ranging from 0% to 33% in the high-quality studies and from 7% to 53% in the low-quality studies. One study described prognostic factors and indicated that training more than 3 times a week is a prognostic factor for residual symptoms. After 1 year of follow-up, a high percentage of patients still experienced pain and subjective instability, while within a period of 3 years, as much as 34% of the patients reported at least 1 re-sprain. From 36% up to 85% of the patients reported full recovery within a period of 3 years.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2018
                5 November 2018
                : 8
                : 11
                : e022802
                Affiliations
                [1 ] departmentCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences , University of Oxford , Oxford, UK
                [2 ] departmentCentre for Rehabilitation Research, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences , University of Oxford , Oxford, UK
                [3 ] departmentPatient and Public Involvement , Quality and Outcomes of Person-Centred Care Policy Research Unit , Canterbury, UK
                [4 ] departmentFaculty of Health and Human Sciences , University of Plymouth , Plymouth, UK
                [5 ] departmentSchool of Health and Related Research , University of Sheffield , Sheffield, UK
                [6 ] departmentOxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences , University of Oxford , Oxford, UK
                [7 ] departmentWarwick Research in Nursing, Division of Health Sciences , Warwick Medical School, University of Warwick , Coventry, UK
                [8 ] departmentDepartment of Sport, Health Sciences and Social Work , Oxford Brookes University , Oxford, UK
                Author notes
                [Correspondence to ] Dr Michael M Schlussel; michael.schlussel@ 123456csm.ox.ac.uk
                Author information
                http://orcid.org/0000-0002-3488-847X
                Article
                bmjopen-2018-022802
                10.1136/bmjopen-2018-022802
                6231561
                30397008
                b8816d7a-eae7-4fe2-b31a-55e955c1bc32
                © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

                History
                : 09 March 2018
                : 05 June 2018
                : 23 August 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000664, Health Technology Assessment Programme;
                Categories
                Rehabilitation Medicine
                Research
                1506
                1727
                Custom metadata
                unlocked

                Medicine
                prognosis,clinical prediction rule,logistic model,ankle injuries,sprains and strains
                Medicine
                prognosis, clinical prediction rule, logistic model, ankle injuries, sprains and strains

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