human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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  
    Output:
    
agent
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 .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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  
    Output:
    