A systematic review of outcome tools used to measure lower leg conditions. Reliability and Validity of 6 Measures of Pain, Function, and Disability for Ankle Arthroplasty and Arthrodesis Psychometric Comparison of the PROMIS Physical Function CAT With the FAAM and FFI for Measuring Patient-Reported Outcomes Impact of comorbidities on the measurement of health in patients with ankle osteoarthritis. Evaluation of the foot and ankle outcome score in patients with osteoarthritis of the ankle. Are current foot- and ankle outcome measures appropriate for the evaluation of treatment for osteoarthritis of the ankle?: Evaluation of ceiling effects in foot- and ankle outcome measures. Validation of the Turkish version of the foot and ankle outcome score Spinal anesthesia mediates improved early function and pain relief following surgical repair of ankle fractures. Responsiveness and Validity of the SF-36, Ankle Osteoarthritis Scale, AOFAS Ankle Hindfoot Score, and Foot Function Index in End Stage Ankle Arthritis Responsiveness and minimally important change for the Manchester-Oxford foot questionnaire (MOXFQ) compared with AOFAS and SF-36 assessments following surgery for hallux valgus.
BACKGROUND CONTEXT A variety of self-report and physical performance-based outcome measures are commonly used to assess progress and recovery in the lower leg , ankle , and foot . A requisite attribute of any outcome measure is its ability to detect change in a condition , a construct known as " responsiveness " . There is a lack of consistency in how responsiveness is defined in all outcome measures . PURPOSE The purpose of this study was to review the currently used recovery outcome measures for lower leg , ankle and foot conditions in order to determine and report recommended responsiveness values . METHODS A systematic literature search that included electronic search es of PubMed , CINAHL and SportD iscus as well extensive cross-referencing was performed in January , 2013 . Studies were included if each involved : 1 ) a prospect i ve , longitudinal study of any design ; 2 ) any condition associated with the lower leg , ankle or foot ; 3 ) a measure of responsiveness ; and 4 ) was an acceptable type of outcome measure ( eg . self-report , physical performance , or clinician report ) . The quality of the included articles was assessed by two independent authors using the responsiveness sub-component of the Consensus-based St and ards for the selection of health Measurement Instruments ( COSMIN ) . RESULTS Sixteen different studies met the inclusion criteria for this systematic review . The most commonly used outcome measures were the Foot and Ankle Ability Measure and the Lower Extremity Functional Scale . Responsiveness was calculated in a variety of methods including effect size , st and ardized response mean , minimal clinical ly important difference/ importance , minimal detectable change , and minimal important change . CONCLUSION Based on the findings of this systematic review there is a lack of consistency for reporting responsiveness among recovery measures used in the lower leg , ankle or foot studies . It is possible that the variability of conditions that involve the lower leg , ankle and foot contribute to the discrepancies found in reporting responsiveness values . Further research must be conducted in order to st and ardize reporting measures for responsiveness . LEVEL OF EVIDENCE 2a Background : Patient-reported outcome measures are increasingly used evaluating clinical care . Many measures used to assess operative hindfoot interventions vary in content , and some have not been psychometrically vali date d in this population . The purpose of this study was to compare measurement properties of  6 lower-extremity patient-reported outcome measures  , and to evaluate their reliability and validity in light of patients ’ preferences . Methods : Cross-sectional survey of 42 preoperative and 100 postoperative patients completed 6 lower-extremity outcome measures  on 2 occasions : Foot Function Index ( FFI ) , Ankle Osteoarthritis Scale ( AOS ) , patient-reported items of the  American  Orthopaedic Foot & Ankle Society Question naire ( AOFAS ) , Lower Extremity Functional Scale ( LEFS ) , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , and the Short Musculoskeletal Function Assessment ( SMFA ) , as well as measures of preference , and symptoms . Results : Internal consistency was good to excellent for all scales and subscales ( α = .84-.97 ; ICC [ 2,1 ] = .81-.96 ) . Correlations between scales ranged from .50 ( WOMACStiffness and FFIActivity Limitations ) to .92 ( LEFS and SMFAOverall , WOMACPain and AOSOverall , FFIOverall and AOFASOverall ) . Higher correlations occurred within instruments ( r = .97 AOSPain and AOSOverall ) and between similar subscales from different instruments ( r = .91 WOMACPain and AOSPain ) . Construct validity showed moderate to high correlations to global ratings of Pain , Stiffness , and difficulty performing Daily Activities . The highest correlations ( r > .75 ) occurred between Pain and AOSOverall ( r = .84 ) , stiffness and WOMACStiffness ( r = .81 ) , and Daily Activities and AOSDisability ( r = .87 ) . Patients rated instruments by preference . FFI , WOMAC , LEFS , and SMFA rated favorably for length . FFI , WOMAC , LEFS , and AOFAS rated high for underst and ability . FFI was rated by postoperative patients as most likely to capture change due to surgery . SMFA rated the best overall . Conclusions : Direct comparison of instruments revealed similarity between scales in construct validity and reliability . Patient preferences supported the use of these scales . Foot-specific instruments offered no clear advantage over lower-extremity instruments . Level of Evidence : Level II , prospect i ve comparative study Background : Selecting optimal patient-reported outcome ( PRO ) instruments is critical to improving the quality of health care . The purpose of this study was to compare the reliability , responsiveness , and efficiency of three PRO measures : the Foot and Ankle Ability Measure – Activity of Daily Living subscale ( FAAM_ADL ) , the Foot Function Index 5-point verbal rating scale ( FFI-5pt ) , and the PROMIS Physical Function computerized adaptive test ( PF CAT ) . Methods : Data were aggregated from 10 clinical sites in the AOFAS ’s National Orthopaedic Foot and Ankle Research ( OFAR ) Network from 311 patients who underwent elective surgery for a disorder of the foot or ankle . Patients were administered the FAAM_ADL , FFI-5pt , and PF CAT at their preoperative visit and at 6 months after surgery . Reliabilities were evaluated using a Rasch model . Responsiveness was calculated using paired sample s t test and efficiency was recorded as number of seconds to complete the instrument . Results : Similar reliabilities were found for the three instruments . Item reliabilities for FAAM_ADL , FFI-5pt , and PF CAT were all .99 . Pearson reliabilities for FAAM_ADL , FFI-5pt , and PF CAT were .95 , .93 , and .96 , respectively . On average , patients completed the FAAM_ADL in 179 seconds , the FFI-5pt in 194 seconds , and the PF CAT in 44 seconds , ( P < .001 ) . The PF CAT and FAAM_ADL showed significant improvement ( P = .01 and P = .001 , respectively ) in patients ’ physical function after treatment ; the FFI-5pt did not show improvement . Conclusions : Overall , the PF CAT performed best in terms of reliability , responsiveness , and efficiency in this broad sample of foot and ankle patients . It can be a potential replacement for the conventional PRO measures , but further validation is needed in conjunction with the PROMIS Pain instruments . Level of Evidence : Level I , prospect i ve comparative outcome study BACKGROUND Investigators seeking to underst and the impact of musculoskeletal disorders commonly use vali date d outcome instruments to assess the effect of diseases on physical function and quality of life . However , the influence of concomitant systemic or musculoskeletal comorbidities on these scores has not been widely considered in orthopaedic research . The purpose of this study was to determine how morbidity unrelated to the ankle influences the perception of physical function and pain by patients with ankle osteoarthritis . METHODS  Short Form-36 ( SF-36 ) Physical Component Summary ( PCS ) and Mental Component Summary ( MCS ) scores , Ankle Osteoarthritis Scale ( AOS ) pain scale scores ,  demographic data  , and systemic and musculoskeletal comorbidities were determined prospect ively for 195 patients with ankle osteoarthritis and ninety-five age and gender-matched controls . The effect of systemic and musculoskeletal comorbidities on each of the scores was determined . RESULTS On the average , patients with ankle osteoarthritis had a relatively normal MCS score ( 47 + /- 13 points ) and a markedly diminished PCS score ( 32 + /- 8 points ) . Both of these scores averaged 50 + /- 9 points in the control group . The AOS pain score averaged 61 + /- 23 points in the group with ankle osteoarthritis , whereas it averaged 10 + /- 15 points in the control group . We found the perception of ankle pain by patients with ankle osteoarthritis to be significantly and linearly associated with the number of other musculoskeletal problems ( not related to the foot or ankle ) . CONCLUSIONS The degree of physical impairment associated with ankle osteoarthritis , as measured with the SF-36 , is equivalent to that reported to be associated with severely disabling medical problems including end-stage kidney disease and congestive heart failure . The perception of ankle health status as measured with a vali date d , patient-oriented , anatomically specific instrument is influenced by the patients ' perception of their overall musculoskeletal comorbidity status . The authors of clinical studies using these instruments should adjust for concomitant musculoskeletal disease The foot and ankle outcome score ( FAOS ) has been evaluated for many conditions of the foot and ankle . We evaluated its construct validity in 136 patients with osteoarthritis of the ankle , its content validity in 37 patients and its responsiveness in 39 . Data were collected prospect ively from the registry of patients at our institution . All FAOS subscales were rated relevant by patients . The Pain , Activities of Daily Living , and Quality of Life subscales showed good correlation with the Physical Component score of the Short-Form-12v2 . All subscales except Symptoms were responsive to change after surgery . We concluded that the FAOS is a weak instrument for evaluating osteoarthritis of the ankle . However , some of the FAOS subscales have relative strengths that allow for its limited use while we continue to seek other satisfactory outcome instruments BACKGROUND Many PROMs used for evaluation of ankle  osteoarthritis  are not vali date d for this purpose . We hypothesize that frequently used PROMs have an early ceiling or floor effect . METHODS We prospect ively collected data from patients with ankle osteoarthritis between 2011 and 2013 . At baseline visit patients completed the Foot and Ankle Outcome Score , the Ankle Osteoarthritis Score , the American Orthopaedic Foot and Ankle Society scale , a visual analogue scale for pain and quality of life . Outcomes were analyzed for floor or ceiling effects . RESULTS 197 patients were included in the study . A floor effect was present for the AOFAS and VAS for pain in all groups . Floor and ceiling effect are absent for the FAOS outcome measure for all groups . CONCLUSIONS Physicians should be aware of floor or ceiling effects when evaluating treatment using patient reported outcome measures . The FAOS outcome measure lacks early ceiling or floor effects The objective is to develop a Turkish version of the foot and ankle outcome score ( FAOS ) and to investigate its validity and reliability . The Turkish version of FAOS was developed after the translation and back-translation . The translated version was pretested on 20 patients with rheumatoid arthritis . Then , the Turkish FAOS was administered to 55 patients having foot and ankle problems . They were also evaluated by using the four subscales of the Turkish version of AIMS 2 , and the Turkish version of SF-36 question naire to test validity . Fifty patients filled out the FAOS for second time to determine test – retest reliability . Construct validity was investigated with use of Spearman ’s rank correlation coefficient . Test – retest reliability was assessed with use of the intraclass correlation coefficient ( ICC ) and Cronbach ’s alpha score . The psychometric properties of the Turkish FAOS were generally similar to the original FAOS . The r and om ICC for the five subscales ranged from 0.70 to 0.96 . The Cronbach ’s alpha coefficient ranged from 0.79 to 0.97 . Construct validity of the FAOS was good . The Turkish FAOS correlated with the SF-36 and AIMS 2 scales . The Turkish version of FAOS was valid and reliable instrument to assess the foot and ankle related problems . However , to assess its responsiveness further studies are needed BACKGROUND To our knowledge , no study to date has compared the use of spinal and general anesthesia in patients undergoing operative fixation of an unstable ankle fracture . The purpose of this study was to assess the effects of anesthesia type on postoperative pain and function in a large cohort of patients . METHODS Between October 2000 and November 2006 , 501 patients who underwent surgical fixation of an unstable ankle fracture were followed prospect ively . Patients receiving spinal anesthesia were compared with a cohort who received general anesthesia .  All patients were evaluated at three , six , and twelve months postoperatively with use of st and ardized , vali date d general and limb-specific outcome instruments . St and ard and multivariable analyses comparing outcomes at these intervals were performed . RESULTS Four hundred and sixty-six patients ( 93 % ) who had been followed for a minimum of one year met the inclusion criteria . Compared with the general anesthesia group , the spinal anesthesia group had a greater mean age ( p = 0.005 ) , higher classification on the American Society of Anesthesiologists system ( p = 0.03 ) , and a greater number of patients with diabetes ( p = 0.02 ) . There was no difference in sex distribution between the groups . At three months , patients who received spinal anesthesia had significantly better pain scores ( p = 0.03 ) and total scores on the American Orthopaedic Foot and Ankle Society outcome instrument ( p = 0.02 ) . At six months , patients in the spinal anesthesia group continued to have better pain scores ( p = 0.04 ) , but there was no longer a difference in total scores ( p = 0.06 ) . At twelve months , no difference was detected between the groups in terms of functional or pain scores . There was no difference in complication rates between the groups . CONCLUSIONS Patients who undergo fixation of an ankle fracture under spinal anesthesia  seem to experience less pain and have better function in the early postoperative period . We recommend that , unless there is a specific contraindication , patients should be offered spinal anesthesia when undergoing operative fixation of an ankle fracture Background : We examined four commonly used scores , the SF-36 , the  Ankle Osteoarthritis Scale ( AOS )  , the  American Orthopaedic Foot and Ankle Society ( AOFAS ) Ankle Hindfoot Score  , and the  Foot Function Index ( FFI )  to determine their responsiveness and validity . Methods : Patients with end stage ankle arthritis were recruited into a prospect i ve multicenter cohort study and baseline and one year outcome scores were compared . The St and ardized Response Mean and Effect Size for the AOS , AOFAS , and FFI were calculated and the three region- or disease-specific scores were compared with the SF-36 to determine their criterion validity . Results : All four scores showed acceptable responsiveness , and when using the vali date d SF-36 as the st and ard the three region or disease specific scores all showed similar criterion validity . Conclusion : All four scores are responsive and can be considered for use in this population . The objective component of the AOFAS Ankle Hindfoot Score may make it harder to perform than the other three scores which have subjective components only , and as yet its objective component has not been shown to demonstrate reliability . We recommend use of a purely subjective score such as the Ankle Osteoarthritis Scale or Foot Function Index as the region- or disease-specific score of choice in this population . As the SF-36 shows acceptable responsiveness , using it alone could also be considered . Level of Evidence : II , Prospect i ve Comparative OBJECTIVES To assess responsiveness and minimally important change ( MIC ) for the Manchester-Oxford foot question naire ( MOXFQ ) using anchor and distribution-based approaches . Responsiveness and estimates of minimal clinical ly important difference ( MCID ) and minimal detectable change are compared with those from the Short-Form 36 ( SF-36 ) and American Orthopaedic Foot & Ankle Society ( AOFAS ) measures . METHODS A prospect i ve observational study of 91 consecutive patients ( 125 foot operations ) undergoing hallux valgus surgery at an orthopaedic hospital . Pre- and 12 month post-surgery , patients completed the MOXFQ and SF-36 , and foot surgeons assessed all four AOFAS scores corresponding to four regions of the foot . Transition items were asked about perceived changes compared with before surgery . RESULTS Mean changes in all domains of each instrument were statistically significant , but foot-specific MOXFQ and AOFAS domains produced much larger effect sizes ( > 1 ) than any SF-36 domains , indicating superior responsiveness . Clear associations occurred between transition items and all MOXFQ and AOFAS scores , but with only one ( physical function ) SF-36 domain . Anchor and distribution-based approaches identified generally comparable measures of MIC , which for the MOXFQ and AOFAS domains were between 1 and 2 st and ard error of measurement . In metric terms , the MCIDs were 16 , 12 , and 24 for the MOXFQ Walking/st and ing , Pain , and Social Interaction domains , respectively . CONCLUSIONS For hallux valgus surgery , the MOXFQ is highly responsive . Performance is comparable to the AOFAS and notably better than the generic SF-36 . Study estimates of MIC for the MOXFQ are useful to inform sample -size calculations for future clinical trials
A considerable variety of outcome measurement tools are used in the foot and ankle clinical literature , with a small proportion used consistently .
The AOFAS scales continue to be used at a high rate relative to other scales that have been vali date d. Data from the present study underscore the need for a paradigm shift toward the use of consistent , valid , and reliable outcome measures for studies of foot and ankle procedures and disorders .
It is not clear which existing vali date d outcome instruments will emerge as widely used and clinical ly meaningful .
BACKGROUND In the orthopaedic literature , there is a wide range of clinical outcome measurement tools that have been used in evaluating foot and ankle procedures , disorders , and outcomes , with no broadly accepted consensus as to which tools are preferred .
The purpose of this study was to determine the frequency and distribution of the various outcome instruments used in the foot and ankle literature , and to identify trends for use of these instruments over time .