Four of five frequently used orthopedic PROMs possess inadequate content validity: a COSMIN evaluation of the mHHS, HAGOS, IKDC-SKF, KOOS and KNEES-ACL.

PURPOSE: Content validity is the most important property of PROMs. The COSMIN initiative has published guidelines for evaluating the content validity of PROMs, but they have only sparsely been applied to relevant PROMs for musculoskeletal conditions. The aim of this study was to use the COSMIN Risk of Bias checklist to evaluate the content validity of five PROMs, that are highly relevant in musculoskeletal research and used by the arthroscopic surgery community: the modified Harris' Hip Score (mHHS), the Copenhagen Hip and Groin Outcome Score (HAGOS), the International Knee Documentation Committee Subjective Knee evaluation Form (IKDC-SKF), the Knee injury and Osteoarthritis Outcome Score (KOOS) and the Knee Numeric-Entity Evaluation Score ACL (KNEES-ACL). METHODS: The development articles for the five PROMs were identified through searches in PubMed and SCOPUS. A literature search was performed to identify additional studies assessing content validity of the PROMs. Additional information, necessary for the assessments, was obtained from the PROM developers after direct request. To evaluate the quality of the development studies and rate the content validity, the COSMIN Risk of Bias checklist was applied to all studies. RESULTS: All five development studies were identified. Three subsequent content validity studies were identified, all evaluating KOOS and one also IKDC. One content validity study was of inadequate quality and excluded from further analysis. The development of mHHS, IKDC-SKF, and KOOS was rated inadequate and possess insufficient content validity for their target populations. Due to the irrelevance of multiple items, KOOS was in particular inappropriate to evaluate patients with an ACL injury. The development of HAGOS was also rated inadequate, although the insufficiency aspects can be regarded as minor. KNEES-ACL possessed sufficient content validity. CONCLUSION: Out of five PROMs, only KNEES-ACL possessed sufficient content validity. Particularly, KOOS should not be used as an outcome for patients with an ACL injury. There is an urgent need for condition-specific PROMs for musculoskeletal conditions, developed with adequate methods. LEVEL OF EVIDENCE: III.

Patient reported outcome measures for ankle instability. An analysis of 17 existing questionnaires.

BACKGROUND: Patient reported outcome measures (PROMs) are essential for evaluating treatment of ankle instability (AI). The aim was to assess the content validity and the measurement properties of all relevant PROMs for AI. METHODS: Relevant PROMs were identified from PubMed and SCOPUS. The development and validation quality of the PROMs was assessed according to established scientific standards. RESULTS: Seventeen PROMs and 56 validation studies were analyzed. Content validity, which ensures the PROM measures what is relevant, is obtained by involving target patients in the development process. Only three PROMs identified had some degree of patient involvement (Cumberland Ankle Instability Tool (CAIT), Lower Extremity Function Scale (LEFS), and the Foot and Ankle Ability Measure (FAAM)). Of these, only FAAM was somewhat rigorously validated using modern psychometric validation methods, and exhibited superior measurement properties (construct validity). CONCLUSION: No existing PROM is completely adequate to evaluate AI. However, FAAM is the best choice.

Dual-panel translation to Danish and Rasch validation of the Foot and Ankle Ability Measure (FAAM-DK).

BACKGROUND: The Foot and Ankle Ability Measure (FAAM) was developed by involvement of patients with chronic ankle instability (CAI) and has acceptable measurement properties, but is not available in Danish. METHODS: FAAM was translated and culturally adapted into Danish, and its measurement properties were assessed using Rasch analyses. RESULTS: A Danish version was produced with small adaptations, and content relevance was confirmed by Danish patients. The 21-item ADL domain showed misfit to the Rasch model, but after removing six items, the resulting 15-item scale displayed adequate fit. The Sports domain also exhibited misfit, but after removing one item and adjusting due to differential item functioning related to age for another item, a 7-item scale showed good fit. This resulted in a 22-item 2-dimensional Danish version of FAAM. CONCLUSION: The 22-item Danish FAAM exhibits robust measurement properties for patients with various conditions of the lower leg, ankle, and foot, including CAI.

Responsiveness, minimal important difference, minimal relevant difference, and optimal number of patients for a study.

Several terms are used to describe changes in PROM scores in relation to treatments. Whether the change is small, large, or relevant is defined in different ways, yet these change scores are used to recommend or oppose treatments. They are also used to calculate the necessary number of patients for a study. This article offers a theoretical explanation behind the terms responsiveness, minimal important difference (MID), minimal important change (MIC), minimal relevant difference (MIREDIF), and threshold of clinical importance. It also gives instructions on how these and the optimal number of patients for a study are calculated. Responses to two domains of the Knee Injury and Osteoarthritis Outcome Score (KOOS), before and 1 year after reconstruction of the anterior cruciate ligament of 164 patients, are used to illustrate the calculations. This paper presents the most common methods used to calculate and interpret MID. Results vary substantially across domains, patient location on the scale, and health conditions. The optimal number of patients depends on the minimal relevant difference (MIREDIF), the standard error of the measure (SEM), the desired statistical power for the measurement, and the responsiveness of the measurement instrument (the PROM). There is often uncertainty surrounding the calculation and interpretation of responsiveness, MID, and MIREDIF, as these concepts are complex. When MID is used to evaluate research results, authors should specify how the MID was calculated, and its relevance for the study population. These measures should only be used after thorough consideration to justify healthcare decisions.

KNEES-ACL has superior responsiveness compared to the most commonly used patient-reported outcome measures for anterior cruciate ligament injury.

PURPOSE: For clinical trials, it is essential that measures are sensitive to change. The aim of this study was to conduct a head-to-head comparison of responsiveness of four PROMs used to measure outcome after anterior cruciate ligament (ACL) reconstruction. The PROMs compared were the knee injury osteoarthritis outcome score (KOOS), the international knee documentation committee subjective form (IKDC), the Lysholm score, and the knee numeric-entity evaluation score (KNEES-ACL). We hypothesized that KNEES-ACL would be more responsive than the other PROMs, as KNEES-ACL was created based on patient interviews and validated using Rasch analysis. METHODS: One-hundred and sixty-six consecutive adults completed the four PROMs before and 3, 6, and 12 months after ACL-reconstructive surgery. Responsiveness was calculated as Cohen's Effect Size and Standardized Response Means. Bootstrapping was used to generate 95% confidence intervals for comparisons of responsiveness across PROMs. Repeated-measures ANOVA was also computed for each PROM. RESULTS: The largest effect sizes at 12 months were seen for KNEES-ACLSports-Behaviour (1.35, p < 0.001) and KNEES-ACLSports-Physical (1.19, p < 0.001), the smallest for KOOSADL (0.35, p < 0.001) and KOOSSymptoms (0.39, p < 0.001). IKDC and Lysholm lay between these with IKDC slightly more responsive. Head-to-head comparisons of similar subscales of KOOS and KNEES-ACL showed substantial differences in effect size in the domains of symptoms (0.69, p < 0.001), daily activities (0.31, p = 0.005), and Sports activity (0.63, p = 0.013) all in favour of KNEES-ACL. CONCLUSION: These results demonstrate superior responsiveness for KNEES-ACL, which is the only PROM that has been constructed through exhaustive patient feedback and validated for patients with ACL deficiency using the most stringent psychometric methods (Rasch analysis). KNEES-ACL is the most precise and accurate PROM for patients with ACL injury and the most trustworthy instrument for clinicians and clinical researchers. LEVEL OF EVIDENCE: Prospective cohort study, Level II.

Validation of a health screening questionnaire for primary care using Rasch models.

BACKGROUND: Health inequality is on the rise due to various social and individual factors. While preventive health checks (PHC) aim to counteract health inequality, there is robust evidence against the use of PHC in general practice. It is unknown which factors can identify persons who will benefit from preventive interventions that are more beneficial than harmful. Hence, valid screening instruments are needed. METHODS: The aim of this study was to assess the psychometric properties of a screening questionnaire (SQ-33), which targets vulnerable persons in primary care practice who can benefit from preventive consultations. Survey data were acquired from 20 primary care clinical practices in the Northern Region of Jutland, Denmark. Respondents were 2056 persons between 20 and 44 years old who, for any reason, consulted their family doctor. The psychometric properties of the SQ-33 were assessed using Rasch item response modelling. Follow-up analysis was performed on a subsample of 364 persons one year subsequent to initial inclusion, in order to assess responsiveness and predictive validity using a general health anchor item. RESULTS: Twenty-three of the SQ-33 items in four subscales fit a Graphical loglinear Rasch model (GLLRM) at baseline and follow-up, thus confirming the scaling properties. The modified 23-item version (HSQ-23) revealed superior responsiveness and predictive validity compared with the SQ-33. CONCLUSIONS: The Health Screening Questionnaire (HSQ-23) was shown to possess adequate psychometric properties and responsiveness and can thus be used as an outcome measure in preventive intervention studies. Future study should address whether the HSQ-23 successfully identifies patients who will benefit from PHC consultations.