Assessment of the structural validity of three foot and ankle specific patient-reported outcome measures

BackgroundThe structural validity of the Lower extremity functional scale (LEFS), the Visual analogue scale foot and ankle (VAS-FA), and the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) has not been compared earlier in patients after foot and ankle surgery.MethodsAltogether 165 previously operated patients completed the foot and ankle specific instruments, the 15D health-related quality of life (HRQoL) instrument, and general health (VAS).ResultsThe LEFS, the VAS-FA and the WOMAC had slight differences in their measurement properties. The VAS-FA had the best targeting and coverage. All three foot and ankle measures accounted for mobility and usual activities when compared to the different aspects of generic HRQoL.ConclusionsThe LEFS, the VAS-FA and the WOMAC have relatively similar psychometric properties among foot and ankle patients, yet the VAS-FA provides the best targeting and coverage.     

Comparison of the Manchester–Oxford Foot Questionnaire (MOXFQ) and the Self-Reported Foot and Ankle Outcome Score (SEFAS) in patients with foot or ankle surgery

BackgroundPatient-reported outcome measures are a critical tool in evaluating the efficacy of orthopedic procedures. The intention of this study was to compare the psychometric properties of the Manchester–Oxford Foot Questionnaire (MOXFQ) and the Self-Reported Foot and Ankle Outcome Score (SEFAS) in patients with foot or ankle surgery.Methods177 patients completed both scores and FAOS, Foot and Ankle Outcome Score (FAOS), Short Form 36 (SF-36) and numeric scales for pain and disability (NRS) before and after surgery. Test-Retest reliability, internal consistency, floor and ceiling effects, construct validity, responsiveness and minimal important change were analyzed.ResultsThe MOXFQ and SEFAS demonstrated excellent test-retest reliability with interclass correlation coefficient values >0.9 Cronbach’s alpha (α) values demonstrated strong internal consistency. No floor or ceiling effects were observed for both questionnaires. As hypothesized MOXFQ subscales correlated strongly with corresponding SEFAS, FAOS and SF-36 domains. MOXFQ subscales showed excellent responsiveness between preoperative assessment and postoperative follow-up, whereas SEFAS demonstrated moderate responsiveness.ConclusionsThe MOXFQ and SEFAS demonstrated good psychometric properties and proofed to be valid and reliable instruments for use in foot and ankle patients. MOXFQ showed better outcomes in responsiveness.     

Structural validity of the foot and ankle outcome score for orthopaedic pathologies with Rasch Measurement Theory

BackgroundThe Foot and Ankle Outcome Score (FAOS) is one of the most frequently used patient-reported outcome measures for foot and ankle conditions. The aim is to test the structural validity of the Finnish version of the FAOS using Rasch Measurement Theory.MethodsFAOS scores were obtained from 218 consecutive patients who received operative treatment for foot and ankle conditions. The FAOS data were fitted into the Rasch model and person separation index (PSI) calculated.ResultsAll the five subscales provided good coverage and targeting. Three subscales presented unidimensional structure. Thirty-eight of the 42 items had ordered response category thresholds. Three of the 42 items had differential item functioning towards gender. All subscales showed sufficient fit to the Rasch model. PSI ranged from 0.73 to 0.94 for the subscales.ConclusionsThe Finnish version of the FAOS shows acceptable structural validity for assessing complaints in orthopaedic foot and ankle patients.     

Reliability,validity and responsiveness of the German Manchester-Oxford Foot Questionnaire (MOXFQ) in patients with foot or ankle surgery

Background

Patient-reported outcome measures are a critical tool in evaluating the efficacy of orthopaedic procedures. The intention of this study was to develop and culturally adapt a German version of the Manchester-Oxford Foot Questionnaire (MOXFQ) and to evaluate reliability, validity and responsiveness.

Development and validation of the Sports Athlete Foot and Ankle Score: An instrument for sports-related ankle injuries

BackgroundMany existing scoring systems assess ankle function, but there is no evidence that any of them has been validated in a group of patients with a higher demand on their ankle function. Problems include ceiling effects, not being able to detect change or they do not contain a sports-subscale. The aim of this study was to create a validated self-administered scoring system for ankle injuries in the higher performing athlete.MethodsFirst, 26 patients were interviewed to solicit opinions needed to create the final score, which is modified from the Foot and Ankle Outcome Score (FAOS). Second, SAFAS was validated in a group of 25 athletes with and 14 athletes without ankle injury. It is a self-administered region specific sports foot and ankle score that contains four subscales assessing the levels of symptoms, pain, daily living and sports.ResultsThe Spearman correlation coefficients between SAFAS and the Foot and Ankle Ability Measure (FAAM) ranged from 0.78 to 0.88. Content validity is established by key informant interviews, expert opinions and a high satisfaction rate of 75%. Cronbach's alpha indicated good internal consistency of each subscale ranging from 0.77 to 0.92.ConclusionSAFAS has shown good evidence for being a valid instrudent for assessing sports-related ankle injuries in high-performing athletes.     

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.     

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

BackgroundPatient 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.MethodsRelevant PROMs were identified from PubMed and SCOPUS. The development and validation quality of the PROMs was assessed according to established scientific standards.ResultsSeventeen 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).ConclusionNo existing PROM is completely adequate to evaluate AI. However, FAAM is the best choice.     

Validation of the Turkish version of the Revised Foot Function Index for patients with foot and ankle disorders

BackgroundThe revised Foot Function Index (FFI-R) is a multidimensional instrument that was developed to assess a patient’s self-reported health-related foot function. The FFI-R is clinically useful and easy to apply, and it has comprehensive subscales assessing the pain, stiffness, psychosocial stress, disability, and activity limitations related to foot and ankle problems. The present study was conducted to validate the Turkish version of the FFI-R, and to demonstrate its use in a Turkish population with various foot and ankle problems.MethodsThe English version of the FFI-R was translated into Turkish, and then, it was administered to 124 patients (mean age of 39.9 years old) with foot and ankle problems and a mean symptom duration of 7.9 months. These patients completed two well-established foot and ankle-specific patient-reported outcome measures, the Foot and Ankle Outcome Score (FAOS) and the Manchester-Oxford Foot Questionnaire (MOX-FQ), and a general instrument, the 36-item Short Form Health Survey (SF-36). The test-retest reliability was evaluated using the intraclass correlation coefficient, and the internal consistency was measured using Cronbach’s alpha. The construct validity of the FFI-R was assessed by correlating its subscales with the FAOS, MOX-FQ, and SF-36 subscales.ResultsThe test-retest reliability of the FFI-R ranged between 0.84 and 0.97. The internal consistency was 0.97 for the overall FFI-R, and it ranged between 0.85 and 0.97 for the subscales. Significant correlations were obtained between the FFI-R subscales and the FAOS, MOX-FQ, and SF-36 subscales.ConclusionsThe Turkish version of the FFI-R was found to be a reliable and valid instrument for measuring the foot and ankle-related functional disability and health status of Turkish patients with foot and ankle problems.     

Validity and Reliability of Visual Analog Scale Foot and Ankle: The Turkish Version

The present study tested the reliability and validity of the Turkish version of the visual analog scale foot and ankle (VAS-FA) among healthy subjects and patients with foot problems. A total of 128 participants, 65 healthy subjects and 63 patients with foot problems, were evaluated. The VAS-FA was translated into Turkish and administered to the 128 subjects on 2 separate occasions with a 5-day interval. The test–retest reliability and internal consistency were assessed with the intraclass correlation coefficient and Cronbach's α. The validity was assessed using the correlations with Turkish versions of the Foot Function Index, the Foot and Ankle Outcome Score, and the Short-Form 36-item Health Survey. A statistically significant difference was found between the healthy group and the patient group in the overall score and subscale scores of the VAS-FA (p < .001). The internal consistency of the VAS-FA was very good, and the test–retest reliability was excellent. Adequate to good correlations were found between the overall VAS-FA score and the Foot Function Index, Foot and Ankle Outcome Score, and Short-Form 36-item Health Survey scores in the healthy and patient groups both. The Turkish version of the VAS-FA is sensitive enough to distinguish foot and ankle-specific pathologic conditions from asymptomatic conditions. The Turkish version of the VAS-FA is a reliable and valid method and can be used for foot-related problems.     

Large variation in use of patient-reported outcome measures: A survey of 188 foot and ankle surgeons

Background

There is an increasing interest in the use of patient reported outcome measures (PROMs). However, there is a large variety of PROMs and a lack of consensus regarding preference for their use. Aim of this study is to determine how often PROMS are used for foot and ankle disorders, for what purpose PROMs are used, and what the preferences of the foot and ankle surgeons are, when choosing a PROM to use.

Validation of the Western Ontario and McMaster Universities Osteoarthritis Index in Patients Having Undergone Ankle Fracture Surgery

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a patient-reported outcome measure (PROM) that is widely used to evaluate the pain, stiffness, and physical function of patients with osteoarthritis of the hip and knee. Although the WOMAC has also been used for patients after foot and ankle surgery, it has not been validated for this purpose. A total of 130 patients with surgically treated ankle fractures completed the WOMAC, Visual Analogue Scale Foot and Ankle (VAS FA), Lower Extremity Functional Scale (LEFS), 15D Health-Related Quality-of-Life Questionnaire (15D), and Visual Analog Scale for General Health (VAS general health) after foot and ankle surgery. The structural validity of the WOMAC was assessed by using Cronbach's α, and convergent validity was tested between the WOMAC and reference outcome measures. Cronbach's α for the index score was 0.98 and 0.95, 0.86, and 0.98 for the Pain, Stiffness, and Physical Function subscales, respectively. The Spearman correlation coefficients were ‒0.84, ‒0.74, ‒0.58, and 0.55 for the VAS-FA, LEFS, 15D, and VAS general health, respectively. The relationships with the VAS-FA, LEFS, 15D, and VAS general health were strong. All relationships were statistically significant (p < .001). The WOMAC provides valid scores for assessing pain, stiffness, and physical function in patients having undergone ankle fracture surgery.     

Responsiveness of the Manchester-Oxford Foot Questionnaire (MOXFQ) compared with AOFAS, SF-36 and EQ-5D assessments following foot or ankle surgery

The responsiveness of the Manchester-Oxford Foot Questionnaire (MOXFQ) was compared with foot/ankle-specific and generic outcome measures used to assess all surgery of the foot and ankle. We recruited 671 consecutive adult patients awaiting foot or ankle surgery, of whom 427 (63.6%) were female, with a mean age of 52.8 years (18 to 89). They independently completed the MOXFQ, Short-Form 36 (SF-36) and EuroQol (EQ-5D) questionnaires pre-operatively and at a mean of nine months (3.8 to 14.4) post-operatively. Foot/ankle surgeons assessed American Orthopaedic Foot and Ankle Society (AOFAS) scores corresponding to four foot/ankle regions. A transition item measured perceived changes in foot/ankle problems post-surgery. Of 628 eligible patients proceeding to surgery, 491 (78%) completed questionnaires and 262 (42%) received clinical assessments both pre- and post-operatively. The regions receiving surgery were: multiple/whole foot in eight (1.3%), ankle/hindfoot in 292 (46.5%), mid-foot in 21 (3.3%), hallux in 196 (31.2%), and lesser toes in 111 (17.7%). Foot/ankle-specific MOXFQ, AOFAS and EQ-5D domains produced larger effect sizes (> 0.8) than any SF-36 domains, suggesting superior responsiveness. In analyses that anchored change in scores and effect sizes to patients' responses to a transition item about their foot/ankle problems, the MOXFQ performed well. The SF-36 and EQ-5D performed poorly. Similar analyses, conducted within foot-region based sub-groups of patients, found that the responsiveness of the MOXFQ was good compared with the AOFAS. This evidence supports the MOXFQ's suitability for assessing all foot and ankle surgery.     

Is the EQ-5D-5L a responsive test to evaluate results in elective foot and ankle surgery?

PurposeTo analyze the responsiveness and the minimally clinical important change (MCIC) of the EuroQol (EQ) 5D-5 L score in patients that had undergone foot/ankle surgery.MethodsPatients that underwent elective foot/ankle surgery from January 2019 to December 2020 were included. They were assessed with the EQ-5D-5L, visual analogue pain scale and Manchester Oxford Foot Questionnaire (MOXFQ) preoperatively and 1 year postoperatively. The pre-post differences of all variables, Effect Size (ES) and MCIC were analyzed.Results167 patients. All variables showed a significant pre-post improvement. The ES for EQ-index and EQ-VAS were 0.61 and 0.33 respectively. MCIC for EQ-index was 0.17 and EQ-VAS was 8.54. MOXFQ index ES was 1.46 and the MCIC was 23.8. VAS decreased from 59.4 to 26.62.ConclusionThe EQ-5D-5L is a sensitive test to detect changes after elective foot and ankle surgery with good responsiveness relative to the ES values in the EQ-index.Level of evidenceII     

Evaluation of Validity,Reliability, and Feasibility of 3 Patient-Reported Foot and Ankle Outcome Measures

BackgroundA wide range of patient-reported outcome measures have been developed to assess the impact of foot and ankle pathology on patients’ function. In this study, Manchester-Oxford Foot Questionnaire (MOXFQ), Foot and Ankle Ability Measure (FAAM), and Revised-Foot Function Index (R-FFI) scores were assessed independently of their developers for validity, reliability, item bias, acceptability, and feasibility.MethodsWe prospectively recruited 100 consecutive patients with a range of foot and ankle disorders over a 6-month period. Patients completed a set of 3 questionnaires at initial consultation. Patients were subsequently sent questionnaires in a random order with a prepaid envelope and asked to complete them with 2 to 14 days. To assess feasibility in routine clinical practice, the time taken to complete questionnaires was evaluated in a cohort of 65 patients.ResultsThe mean age of patients was 51.7 years (range 20 to 85). The majority were females (64 of 96). The internal consistency of all 3 questionnaires was high, suggesting good intercorrelation among the items of each questionnaire. The questionnaires were reproducible and valid. There was strong correlation between the total scores of all 3 questionnaires. There was no item bias on the overall scores by the assumed independent variables such as age, sex, site, and pathology. Form completion rates were 98% for MOXFQ, 89% for FAAM, and 75% for FFI. MOXFQ was the easiest to understand and complete. No significant difference was found in the time taken to complete each questionnaire.ConclusionAll 3 scores correlate with the level of function and have very good reproducibility. For routine use, the MOXFQ has good practical properties of patient acceptability, high item response rate, and ease of completion.     

Translation and validation of the German version of the foot and ankle outcome score

Purpose

Outcome assessment is critical in evaluating the efficacy of orthopaedic procedures. The Foot and Ankle Outcome Score (FAOS) is a 42-item questionnaire divided into five subscales, which has been validated in several languages. Germany has no validated outcome score for general foot and ankle pathology. The aim of this study was to develop a German version of the FAOS and to investigate its psychometric properties.

Materials and methods

Forward and backward translation was executed according to official guidelines. The final version of the FAOS was investigated in 150 patients with various foot and ankle disorders. All patients completed the FAOS, Short Form-36, numeric rating scales for pain and disability, and the Hannover questionnaire. The FAOS was re-administered after 1 week. Test–retest reliability, internal consistency, minimal detectable change, construct validity, and floor and ceiling effects were analyzed.

Results

Test–retest reliability and internal consistency of each subscale were excellent (intraclass correlation coefficient, 0.88–0.95; Cronbach’s α, 0.94–0.98). The minimal detectable changes of each subscale were 17.1–20.8 at the individual level and 2.0–2.4 at group level. There were moderate to strong correlations between FAOS subscales and physical outcomes and low to moderate correlations between FAOS subscales and mental outcomes. Floor and ceiling effects were not present.

Conclusion

The German version of the FAOS is a reliable and valid instrument for use in foot and ankle patients.     

Minimal important change for the visual analogue scale foot and ankle (VAS-FA)

BackgroundVisual analogue scale foot and ankle (VAS-FA) is a patient-reported outcome measure for foot and ankle disorders. The VAS-FA is validated into several languages and well adopted into use. Nonetheless, minimal important change (MIC) for the VAS-FA has not been estimated thus far.MethodsThe VAS-FA score was obtained from 106 patients undergoing surgery for various foot and ankle complaints. MIC was estimated using an anchor-based predictive method.ResultsThe adjusted MIC was 6.8 for total VAS-FA score, and 9.3 for the Pain, 5.8 for the Function, and 5.7 for the Other complaints subscales. The VAS-FA score was found to separate improvement and deterioration in patients’ foot and ankle condition.ConclusionsMIC was successfully defined for the VAS-FA in the current study. The VAS-FA can be used to evaluate foot and ankle patients’ clinical foot and ankle status and its change. Further research on estimating disease-specific MICs is recommended.     

A scoring system for the foot and ankle that is acceptable,reliable, valid and responsive

We read with interest the recent paper by Groarke et al. (Quality of life in individuals with chronic foot conditions: a cross sectional observational study. The Foot (2012) doi:10.1016/i.foot.2011.11.007).The paper ended by stating that ‘there is no scoring system for the foot and ankle that is valid, repeatable and reliable’. This statement is misleading.The authors could have made reference to the patient-reported Manchester-Oxford Foot Questionnaire (MOXFQ). The MOXFQ has been subjected to more rigorous testing of its measurement properties than is the case for most instruments, and has been demonstrated to be acceptable, reliable, valid and responsive in the context of foot or ankle surgery.     

Translation,cross-cultural adaptation,and psychometric properties of the Thai version of the Identification of Functional Ankle Instability (IdFAI-THAI) questionnaire

BackgroundThis study developed a Thai version of the Identification of Functional Ankle Instability (IdFAI-THAI) questionnaire.MethodsTo determine construct validity, 200 participants with a history of lateral ankle sprain completed the IdFAI-THAI, the Modified Thai Lower Extremity Functional Scale (LEFS), the Visual Analog Scale of Instability (VAS-I), and the Thai Foot and Ankle Ability Measure (FAAM). Eight days later, 100 randomly selected participants refilled the IdFAI-THAI to assess test-retest reliability and internal consistency.ResultsThe IdFAI-THAI moderate correlated with the LEFS (r_s = ?0.62), the VAS-I (r_s = 0.62), and the FAAM (r_s = ?0.63 and ?0.69 for the activities of daily living and sports subscales, respectively). The IdFAI-THAI had good test-retest reliability (ICC_2,1 = 0.89) and excellent internal consistency (Cronbach’s alpha = 0.94). Ceiling and floor effects were absent.ConclusionThe valid and reliable IdFAI-THAI can identify chronic ankle instability among Thai speakers in clinical and research settings.     

Validity and internal consistency of the American Orthopaedic Foot and Ankle Society Midfoot Scale in patients with Lisfranc injury

BackgroundThe American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot Scale is an extensively used outcome measure instrument for evaluating outcomes after foot and ankle surgery or trauma.MethodsIn total, 117 patients with Lisfranc injury completed the AOFAS Midfoot Scale and the Visual Analogue Scale Foot and Ankle (VAS-FA) instruments. Internal consistency (correlation between different items), floor and ceiling values, convergent validity, item threshold distribution, and the coverage (item difficulty) of the AOFAS Midfoot scale were tested.ResultsAOFAS Midfoot Scale had high convergent validity and acceptable internal consistency (Cronbach’s alpha >0.70). The ceiling effect was confirmed. The person-item distribution indicated that the scale had a lack of coverage and targeting in our sample.ConclusionsOur data suggests that the AOFAS Midfoot Scale has acceptable validity and internal consistency. However, due to the lack of coverage and targeting, it should not be the primary outcome measure to be used to evaluate the outcomes after Lisfranc injury in the future studies.     

Evidence for validity and reliability of a french version of the FAAM

Background  

The Foot and Ankle Ability Measure (FAAM) is a self reported questionnaire for patients with foot and ankle disorders available in English, German, and Persian. This study plans to translate the FAAM from English to French (FAAM-F) and assess the validity and reliability of this new version.