title: Measurement of health status. Ascertaining the minimal clinically important difference. Clinical Interpretation of a Lower-Extremity Functional Scale–Derived Computerized Adaptive Test Responsiveness and minimally important change for the Manchester-Oxford foot questionnaire (MOXFQ) compared with AOFAS and SF-36 assessments following surgery for hallux valgus. Evaluation of the PROMIS physical function item bank in orthopaedic patients. The PROMIS of Better Outcome Assessment: Responsiveness, Floor and Ceiling Effects, and Internet Administration Responsiveness and Validity of the SF-36, Ankle Osteoarthritis Scale, AOFAS Ankle Hindfoot Score, and Foot Function Index in End Stage Ankle Arthritis Clinically important change in the visual analog scale after adequate pain control. The Foot Function Index: a measure of foot pain and disability. Introducing levels of evidence to the journal. Clinical interpretation of computerized adaptive test outcome measures in patients with foot/ankle impairments.
abstract: In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Background : The increasing use of computerized adaptive tests ( CATs ) to generate outcome measures during rehabilitation has prompted questions concerning score interpretation . Objective : The purpose of this study was to describe meaningful interpretations of functional status ( FS ) outcome measures estimated with a body part – specific CAT developed from the Lower-Extremity Functional Scale ( LEFS ) . Design : This investigation was a prospect i ve cohort study of 8,714 people who had hip impairments and were receiving physical therapy in 257 outpatient clinics in 31 states ( United States ) between January 2005 and June 2007 . Methods : Four approaches were used to clinical ly interpret outcome data . First , the st and ard error of the estimate was used to construct the 90 % confidence interval for each CAT-generated score estimate . Second , percentile ranks were applied to FS scores . Third , 2 threshold approaches were used to define individual subject – level change : statistically reliable change and clinical ly important change . The fourth approach was a functional staging method . Results : The precision of a single score was estimated from the FS score ±4 . On the basis of the score distribution , 25th , 50th , and 75th percentile ranks corresponded to intake FS scores of 40 , 48 , and 59 and discharge FS scores of 50 , 61 , and 75 , respectively . The reliable change index supported the conclusion that changes in FS scores of 7 or more units represented statistically reliable change , and receiver operating characteristic analyses supported the conclusion that changes in FS scores of 6 or more units represented minimal clinical ly important improvement . Participants were classified into 5 hierarchical levels of FS using a functional staging method . Limitations : Because this study was a secondary analysis of prospect ively collected data via a proprietary data base management company , generalizability of results may be limited to participating clinics . Conclusions : The results demonstrated how outcome measures generated from the hip LEFS CAT can be interpreted to improve clinical meaning . This finding might facilitate the use of patient-reported outcomes by clinicians during rehabilitation services 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 The patient-reported outcomes measurement information system ( PROMIS ) physical function item bank v1 ( PPFIB ) contains 124 item response theory ( IRT ) calibrated items ( Rose et al. 2008 . J Clin Epidemiol 61:17–33).We report the psychometric properties of these items within an outpatient , orthopaedic patient population . In particular , we investigated whether a single unidimensional IRT scale can adequately define physical function of patients presenting with primarily upper or lower extremity orthopaedic complaints . We conducted a prospect i ve study at an orthopaedic outpatient clinic to collect data from 865 adult patients with all 124 PROMIS physical function items and seven demographic items . Items were evaluated by a Rasch model . Total variance ( 60.6 % ) across the 124 items was explained by a single Rasch dimension . The variance explained by the second dimension was 7.7 % , reflecting differential item functioning in the upper and lower extremity patients . The upper extremity physical function items had a pronounced ceiling effect . A single physical function dimension accounts for most of the item variance in the PPFIB , suggesting that the items are measuring predominantly one single construct . Separate subscales for lower versus upper extremities , especially with additional items at the upper trait level of the upper extremity subscale , may further enhance evaluation of physical function in orthopaedic patients Objective . Use of item response theory ( IRT ) and , subsequently , computerized adaptive testing ( CAT ) , under the umbrella of the NIH-PROMIS initiative ( National Institutes of Health – Patient-Reported Outcomes Measurement Information System ) , to bring strong new assets to the development of more sensitive , more widely applicable , and more efficiently administered patient-reported outcome ( PRO ) instruments . We present data on current progress in 3 crucial areas : floor and ceiling effects , responsiveness to change , and interactive computer-based administration over the Internet . Methods . We examined nearly 1000 patients with rheumatoid arthritis and related diseases in a series of studies including a one-year longitudinal examination of detection of change ; compared responsiveness of the Legacy SF-36 and HAQ-DI instruments with IRT-based instruments ; performed a r and omized head-to-head trial of 4 modes of item administration ; and simulated the effect of lack of floor and ceiling items upon statistical power and sample sizes . Results . IRT-based PROMIS instruments are more sensitive to change , result ing in the potential to reduce sample size requirements substantially by up to a factor of 4 . The modes of administration tested did not differ from each other in any instance by more than one-tenth of a st and ard deviation . Floor and ceiling effects greatly reduce the number of available subjects , particularly at the ceiling . Conclusion . Failure to adequately address floor and ceiling effects , which determine the range of an instrument , can result in suboptimal assessment of many patients . Improved items , improved instruments , and computer-based administration improve PRO assessment and represent a fundamental advance in clinical outcomes research 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 define the minimum clinical ly important difference ( MCID ) for the visual analog scale ( VAS ) of pain severity by measuring the change in VAS associated with adequate pain control . METHODS The authors conducted a prospect i ve , observational study . Adult emergency department ( ED ) patients with acute pain ( < 72 hours ) were eligible . Patients rated their pain severity on a 100-mm VAS on presentation and at discharge . Patients were asked if they would accept any analgesic , then if they would accept a parenteral analgesic before treatment . At discharge , they were asked whether they had received adequate pain control . RESULTS The authors enrolled 143 patients ( mean age , 36 years ; 54 % female ) . The mean decrease in VAS was -30.0 mm ( 95 % confidence interval [ CI ] = -36.4 to -23.6 ) for the 116 of 143 ( 81 % ) patients with adequate pain control at discharge vs. -5.7 ( 95 % CI = -11.2 to -0.3 ) for the 27 with inadequate pain control ( p < 0.001 ) . At discharge , the mean VAS was 31.3 mm for those with adequate pain control vs. 55.1 for those without . Mean VAS for the 114 of 143 patients who would accept any analgesics initially was 64.7 vs. 47.1 for the 29 reporting no analgesic need . Initially , 77 patients would accept parenteral analgesics ( mean VAS = 72.5 mm ) . CONCLUSIONS A mean reduction in VAS of 30.0 mm represents a clinical ly important difference in pain severity that corresponds to patients ' perception of adequate pain control . Defining MCID based on adequate analgesic control rather than minimal detectable change may be more appropriate for future analgesic trials , when effective treatments for acute pain exist A Foot Function Index ( FFI ) was developed to measure the impact of foot pathology on function in terms of pain , disability and activity restriction . The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales . Both total and sub-scale scores are produced . The FFI was examined for test-retest reliability , internal consistency , and construct and criterion validity . A total of 87 patients with rheumatoid arthritis were used in the study .  Test-retest reliability of the FFI total and sub-scale scores ranged from 0.87 to 0.69 . Internal consistency ranged from 0.96 to 0.73 . With the exception of two items , factor analysis supported the construct validity of the total index and the sub-scales . Strong correlation between the FFI total and sub-scale scores and clinical measures of foot pathology supported the criterion validity of the index . The FFI should prove useful for both clinical and research purpose Orthopaedic surgeons have always based their clinical care on evidence . Surgeons use evidence to make decisions tailored to an individual patient 's needs and circumstances . The primary sources of evidence for clinicians are studies published in the medical and surgical literature , such as The Journal of Bone and Joint Surgery . In June 2000 , The Journal introduced the quarterly Evidence -Based Orthopaedics section 1 . This section introduces orthopaedic surgeons to recent r and omized trials relevant to the practice of orthopaedic surgery published in forty-two journals other than The Journal of Bone and Joint Surgery . Structured abstract s of these studies are STUDY DESIGN Prospect i ve cohort study of 10 287 patients with foot/ankle impairments receiving outpatient physical therapy .  OBJECTIVES To describe meaningful interpretations of functional status ( FS ) outcomes measures , estimated using a body-part-specific computerized adaptive test ( CAT ) . BACKGROUND Increased use of CATs to generate outcome measures in rehabilitation has stimulated questions concerning score interpretation . Identifying meaningful intra-individual change and reporting clinical interpretation of those generated outcomes are essential to advance the quality of rehabilitation practice . METHODS We performed 4 approaches to clinical ly interpret outcomes data . First , we used the st and ard error of the estimate to construct a 90 % confidence interval for each CAT estimated score . Second , we presented the percentile rank of FS scores . Third , we used 2 threshold approaches to define individual-patient-level change : statistically reliable change and clinical ly important change . Last , we illustrated a functional staging method . RESULTS Precision of a single score was estimated by an FS score of + /-4 . Based on score distribution , percentile ranks at 25th , 50th , and 75th percentiles corresponded to intake FS scores of 38 , 47 , and 57 , and discharge FS scores of 52 , 64 , and 77 , respectively . Minimal detectable change supported 7 or more FS change units out of 100 represented statistically reliable change , and ROC analyses supported 8 or more FS change units represented minimal clinical ly important improvement . Using a functional staging system , we established 5 hierarchical functional status levels . CONCLUSION CAT-generated outcome measures can be interpreted to improve clinical interpretation and to assist clinicians in using patient-reported outcomes during therapy practice
target: 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: 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 .