Summary of Clinical Outcome Measures for Sports-Related Knee Injuries

Transcription

1 Summary of Clinical Outcome Measures for Sports-Related Knee Injuries Final Report June 5, 2012 AOSSM Outcomes Task Force James Irrgang, PT, PhD, ATC, FAPTA

2 Table of Contents AOSSM Outcomes Task Force....1 Summary Table for All Clinical Outcome Measures...2 International Knee Documentation Committee (IKDC) Subjective Knee Form....6 Lysholm Knee Score Tegner Activity Scale. 74 Cincinnati Knee Scale.. 87 Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Subscale Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Knee Injury and Osteoarthritis Outcome Score (KOOS) ADL Subscale Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport/Rec Subscale Knee Injury and Osteoarthritis Outcome Score (KOOS) QOL Subscale Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Pain Subscale. 264 Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Function Subscale..289 Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Overall Subscale Western Ontario Meniscus Evaluation Tool (WOMET) Mohtadi Quality of Life Outcome Measure for Chronic ACL Deficiency. 361 Marx Activity Scale Kujala Knee Score International Knee Documentation Committee (IKDC) Subjective Knee Form Pediatric Version.. 381

3 AOSSM Task Force on Clinical Outcome Measures AOSSM-Affiliated Members: James Irrgang PT PhD Allen Anderson MD Warren Dunn MD MPH Min Kocher MD MPH Robert Marx MD MSc Bart Mann PhD Bruce Miller MD Members External to AOSSM: Julie Agel MA ATC Mark Clatworthy MD Jeffrey Katz MD MSc RobRoy Martin PT PhD Lori McLeod PhD Marc Swiontkowski MD Matt Provencher MD Bruce Reider MD John Richmond MD 1

4 Clinical Outcome Measures Table for All Instruments Designed to assess How to obtain instrument IKDC PEDS IKDC Lysholm Cincinnati Variety of knee conditions: ACL, PCL, meniscus, cartilage patellafemoral problems edical- Professionals/Research/Gr ants/ikdc-forms/ Knee condition: ACL, PCL, meniscus, cartilage patellafemoral problems dical- Professionals/Research/Grant s/ikdc-forms/ Initially designed for ACL. Subsequently used for variety of other knee conditions Provided in reference: Lysholm, Am J Sports Med 10: , 1982 ACL, PCL, MCL, Lateral/postlateral knee ligaments, meniscal repairs and allografts, high tibial osteomy Provided in reference: Barber-Westin. Am J Sports Med Jul- Aug;27(4): Permission No No No No Cost and licensing fees No No No No Generation and Selection of Items Clinical expert, Statistical model Clinical Experts, Patient input Clinical expert Clinical expert Normative data available Yes Not reported Yes Yes Number of questions Symptoms (4), Patient Perception (1), Sports Activity (4), ADL function (3), Sports function (3), Occupational (7), Time to administer ~10 minutes Not reported ~5 minutes Not reported Time to score by hand Not reported Not reported Not reported Not reported Automated Scoring available Languages available Yes ( Medical- Professionals/Research/Gr ants/ikdc-forms/) Brazilianⱡ, Simplified Chineseⱡ, Traditional Chineseⱡ, Englishⱡ, French, German, Greek, Italianⱡ, Japanese, Korean, Swedish, Dutchⱡ Not available Not Available Not Available English English English Scale (scoring) (100 best) (Verifying) (100 best) (100 best) *Various calculations possible Recall period 4 weeks 4 weeks Present Present Validity Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Demonstrates hypothesized relationships to measures of general physical and emotional function Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Internal consistency α = α = 0.91 α = Not reported Test-retest reliability ICC = ICC =.91 ICC = ICC= Responsiveness - Effect Size ES = ES = 1.39 ES = ES = Responsiveness - Standardized Response Mean SRM = SRM = 1.35 SRM = SRM = Responsiveness - Minimal Detectable Change MCD = * MCD = 18.3* MCD = * MCD = 27.5* Responsiveness- Minimal Clinically Important Difference MCID = Not reported MCID = *Includes calculated statistics ⱡ Formal assessment of psychometric properties included in this report

5 Clinical Outcome Measures Table for All Instruments KOOS (Symptoms) KOOS (Pain) KOOS (ADL) KOOS (Sports/Rec) KOOS (QOL) Designed to assess How to obtain instrument Permission Cost and licensing fees Generation and Selection of Items Normative data available Number of questions Time to administer Time to score by hand Automated Scoring available Languages available Post traumatic osteoarthritis (OA); i.e. ACL, meniscus, chondral injuries No No Clinical expert, Patient input Yes ~10 minutes for all 5 scales Not reported Yes ( Austrian-German, Czech, Chineseⱡ, Croatian, Danish, Dutchⱡ, Estonian, English, Frenchⱡ, German, Italian, Japanese, Latvian, Lithuanian, Norwegian, Persianⱡ, Portuguese, Polish, Russian, Singapore English, Slovakian, Slovenian, Spanish, Swedishⱡ, Thai, Turkish, Ukranian Scale (scoring) Recall period Validity Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Total: (100 best) Last Week Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Internal consistency α = α = α = α = α = Test-retest reliability ICC= ICC= ICC= ICC= ICC= Responsiveness - Effect Size ES = ES = ES = ES = ES = Responsiveness - Standardized Response SRM = SRM = SRM = SRM = SRM = Mean Responsiveness - Minimal Detectable * * * * * Change Responsiveness- Minimal Clinically Important Not reported Not reported Not reported Not reported Not reported Difference *Includes calculated statistics ⱡ Formal assessment of psychometric properties included in this report 3

6 Clinical Outcome Measures Table for All Instruments WOMAC (Pain) WOMAC (Function) WOMAC (Stiffness) WOMAC (overall) Designed to assess Rheumatoid arthritis, hip/knee OA Rheumatoid arthritis, hip/knee OA Rheumatoid arthritis, hip/knee OA Rheumatoid arthritis, hip/knee OA How to obtain instrument Permission Cost and licensing fees Generation and Selection of Items Normative data available Yes Yes Clinical experts, Patient input Yes Number of questions Time to administer Time to score by hand Automated Scoring available Languages available Scale (scoring) Recall period Validity ~12 minutes for all 3 scales ~5-10 minutes Not Available (Permission required) Over 65 including: English, Arabic, Chinese, Dutch, French-Canadian, German, Hebrew, Italian, Thai, Turkishⱡ, Spanishⱡ 5 Point Likert scale: Pain (0-20 pts), Stiffness (0-8 pts), Function (0-68 pts) VAS scale: Pain (0-500 pts), Stiffness (0-200 pts), Function ( pts) Composite scores can be converted to scale (0 best) Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Current Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Internal consistency α = α = α = α = Test-retest reliability ICC= ICC= ICC= ICC= Responsiveness - Effect Size ES = ES = ES = ES = Responsiveness - Standardized Response Mean Responsiveness - Minimal Detectable Change SRM = SRM = SRM = SRM = MCD = * MCD = * MCD = * MCD = * Responsiveness- Minimal Clinically Important Difference MCID = MCID = MCID = MCID = 11.5 * Minimal detectable change ranges reported in article based on 5 point Likert version of the WOMAC ⱡ Formal assessment of psychometric properties included in this report 4

7 ` Clinical Outcome Measures Table for All Instruments Designed to assess How to obtain instrument WOMET Mohtadi Kujala Tegner Marx Meniscus injury Sharon Griffin - s.griffin@uwo.ca Health related quality of life due to ACL injury Provided in reference: Mohtadi. Am J Sports Med.1998 May- Jun;26(3):350-9 Patellofemeral disorders Contact author: Kujala UM - urho.kujala@sport.jyu.fi Activity level competitive sports, recreational sports, work and activities of daily living Provided in reference: Tegner, Clin Orthop 198:43-49, ACL injury Provided in reference: Marx,Am J Sports Med Mar-Apr;29(2):213-8 Permission No No No No No Cost and licensing fees No No No No No Generation and Selection of Items Normative data available Patient input Clinical expert, Patient item generation Clinical Expert Clinical expert Clinical expert, Patient input Not reported Not reported Not reported Yes Not reported Number of questions (10 levels) 4 Time to administer ~5-10 minutes ~10-15 minutes ~10-15 minutes ~1-2 minutes ~1 minute Time to score by hand Not reported Not reported Not reported Not reported Not reported Automated Scoring available Not available Not available Not available Not Available Not available Languages available English English English, Turkishⱡ English English Scale (scoring) (0 best) (100 best) (100 best) 0-10 (10 best) 0 16 (16 best) Recall period 1 week Last 3 months Present Present Past year Validity Demonstrates hypothesized relationships to other similar measures and to measures of general physical function Not reported Demonstrates hypothesized relationships to other similar measures and to measures of general physical function Demonstrates hypothesized relationships to other similar measures and to measures of general physical and emotional function Demonstrates hypothesized relationships to similar scales Internal consistency α = Not reported α = Not reported Not reported Test-retest reliability ICC =.92 Not reported ICC= ICC = ICC =.97 Responsiveness - Effect Size Responsiveness - Standardized Response Mean Responsiveness - Minimal Detectable Change Responsiveness- Minimal Clinically Important Difference ES = 1.17 Not reported Not reported ES = Not reported SRM = Not reported Not reported SRM = Not reported Not reported Not reported Not reported MCD = Not reported Not reported Not reported Not reported Not reported *Includes calculated statistics ⱡ Formal assessment of psychometric properties included in this report

8 IKDC SUBJECTIVE KNEE FORM Irrgang (1) Padua (2) Anderson (3) Study Characteristics Purpose Reliability, validity Reliability, validity of Italian translation Normative Data Study Population/Sample (inclusion/exclusion) Patients with a variety of knee problems Patients undergoing ACL reconstruction Random sample representative of general population Number Age range (average ± SD, min-max) 37.5 years ±16.2 ( ) 24 (18-42) 39 years ±14 (18-65) Sex (% female) 47% (identified) 18% 51% Reliability Internal consistency α = 0.92 α = 0.91 Test-retest reliability ICC = 0.94 ICC = 0.90 Time interval 50 days 5 days Validity Correlation to similar scale Correlation to general measures of Physical function Fair (25%), Moderate (75%) correlation to general measures of physical function Little (33%), Moderate (66%) correlation to general measures of physical function Correlation to general measures of mental function Little (75%), Fair (25%) correlation to general measures of mental function Little (66%), Moderate (33%) correlation to general measures of mental function Responsiveness ES SRM MDC 12.83(calc) (calc) MCID Time Interval Other Floor/Ceiling Effect No No No Normal Distribution Yes No Normal Data Yes OA Osteoarthritis 6

9 IKDC SUBJECTIVE KNEE FORM Irrgang (4) Haverkamp (5) Crawford (6) Study Characteristics Purpose Reliability, validity Reliability, validity of Swedish translation Validity, Responsiveness Study Population/Sample (inclusion/exclusion) Patients with a variety of knee problems Patients with a variety of knee problems Patients with meniscus pathology Number Test re-test = 31, Construct/Content = 246, SF-12 group = 50, Responsiveness = 100 Age range (average ± SD, min-max) 40.5 years ± 16.7 ( ) 54.6 (21-84) Test re-test = 50.6 (19-73); Construct/Content = 45.4 (18-81); Responsiveness = 47.9 (18-81) Sex (% female) 53% 58% Test re-test = 32%, Construct/Content = 29%, Responsiveness = 29% Reliability Internal consistency α = 0.9 α = Test-retest reliability ICC = 0.96 ICC = 0.95 Time interval 1 week 4 weeks Validity Correlation to similar scale Little (66%), Excellent (33%) correlation to similar scales Correlation to general measures of Physical function Moderate (100%) correlation to general measures of physical function Moderate (100%) correlation to general measures of physical function Correlation to general measures of mental function Little(50%), Fair(50%) correlation to general measures of mental function Responsiveness ES SRM MDC 11.5 (sens =.82 spec =.64) 20.5 (sens =.84 spec =.64) 8.8 MCID Time Interval 19 months 12 months Other Floor/Ceiling Effect No No Normal Distribution Yes Yes Normal Data 7

10 IKDC SUBJECTIVE KNEE FORM Lertwanich (8) Greco (10) Metsavahl (11) Fu (12) Study Characteristics Purpose Study Population/Sample (inclusion/exclusion) Number 55 Age range (average ± SD, minmax) Sex (% female) 1.8% Validity, Responsiveness of Thai Translation Various knee related complaints 27.6 (18-50) Reliability, validity Patients following articular cartilage surgery Reliability = 17, Responsiveness = 50 Reliability = 43.8 years ± 10.4 (21-60), Responsiveness = 36.6 years±9.7 (15-56) Reliability = 39%, Responsiveness = 39.2% Reliability, validity of Brazilian translation Patients with general knee complaints Reliability, validity of Chinese translation 46.7 (15-84) 52.6 (16-85) 50.4% 36% Patients with various knee injuries Reliability Internal consistency α = 0.92 Test-retest reliability ICC = 0.92 ICC 6mo. = 0.91 ICC 12mo. = 0.93 α =.928 ;.935 (test ; retest) α = 0.97 ICC = ICC =.87 Time interval 7 days 6 mo. 12 mo. 1 week 10 days Validity Correlation to similar scale Excellent (100%) correlation to similar scale Correlation to general measures of Physical function Fair (25%), Moderate (75%) correlation to general measures of physical function Moderate (75%), Excellent (25%) correlation to general measures of physical function Moderate (100%) correlation to general measures of physical function Correlation to general measures of mental function Fair (100%) correlation to mental function Fair (100%) correlation to mental function Little (50%), Fair (50%) correlation to mental function Responsiveness ES 6mo =.76 12mo = 1.06 SRM 6mo = mo = 1.0 MDC (calc) 6.7 MCID 6mo = mo = 16.7 Time Interval 6 and 12 months Equation Other Floor/Ceiling Effect No Yes No Normal Distribution Normal Data 8

11 IKDC SUBJECTIVE KNEE FORM Study Characteristics Schmitt (13) Purpose Study Population/Sample (inclusion/exclusion) Number Validity, Reliability Variety of knee injuries 673 Age range (average ± SD, minmax) 6-18 Sex (% female) 54% Reliability Internal consistency Test-retest reliability Time interval α = 0.91 Validity Correlation to similar scale Correlation to general measures of Physical function Correlation to general measures of mental function Excellent (100%) correlation to physical function Responsiveness ES SRM MDC MCID Time Interval Other Floor/Ceiling Effect Normal Distribution Normal Data 9

12 IKDC STUDY CONSOLIDATION REFERENCES 1) Irrgang JJ, Anderson AF, Boland AL, Harner CD, Kurosaka M, Neyret P, Richmond JC, Shelborne KD. Development and validation of the international knee documentation committee subjective knee form. Am J Sports Med Sep- Oct; 29(5): ) Padua R, Bondi R, Ceccarelli E, Bondi L, Romanini E, Zanoli G, Campi S. Italian version of the International Knee Documentation Committee Subjective Knee Form: cross- cultural adaptation and validation. Arthroscopy Oct; 20(8): ) Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. Am J Sports Med Jan; 34(1): ) Irrgang JJ, Anderson AF, Boland AL, Harner CD, Neyret P, Richmond JC, Shelbourne KD; International Knee Documation Committee. Responsiveness of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med Oct; 34(10): ) Haverkamp D, Sierevelt IN, Breugem SJ, Lohuis K, Blankevoort L, van Dijk CN. Translation and Validation of the Dutch Version of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med Oct; 34(10): ) Crawford K, Briggs KK, Rodkey WG, Steadman JR. Reliability, Validity, and Responsiveness of the IKDC score for meniscus injuries of the Knee. Arthroscopy Aug: 23(8): ) Lertwanich P, Praphruetkit T, Keyurapan E,Lamsam C, Kulthanan T. Validity and reliability of Thai version of the International Knee Documentation Committee Subjective Knee Form. J.Med Assoc Thai.2008 Aug; 91(8): ) Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med May;38(5): Epub 2009 Dec ) Metsavaht L, Leporace G, Riberto M, Sposito MM, Batista LA.Translation and Cross-Cultural Adaptation of the Brazilian Version of the International Knee Documentation Committee Subjective Knee Form: Validity and Reproducibility. Am J Sports Med May ) Fu SN, Chan YH. Translation and validation of Chinese version of International Knee Documentation Committee Subjective Knee Form. Disabil Rehab. 2011; 33(13-14): Epub 2010 Oct 22 13) Schmitt LC, Paterno MV, Huang S. Validity and internal consistency of the international knee documentation committee subjective knee evaluation form in children and adolescents. Am J Sports Med Dec;38(12): Epub 2010 Aug 30. PubMed PMID:

13 IKDC SUBJECTIVE KNEE FORM Ratings 1 Yes 2 No 3 Not evaluated or not reported Not applicable Outcome Measure IKDC SUBJECTIVE KNEE FORM Author s Last Name Irrgang Title of the Article Development and Validation of the International Knee Documentation Committee Subjective Knee Form Year 2001 PubMed ID: Reviewer s Name Travis Hamilton Date of Review June 16, 2011 Content Validity Reported that items were generated by team of experts 1 Reported that items were developed from patient input Reported that content was developed from statistical modeling 1 Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 2; positively skewed/platykurtic distribution Construct Validity Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: Pearson coefficients PF=.63, RP=.47, BP=.64, PCS=.66 Correlated with theoretically similar scale If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: RE=.26, MH=.25, MCS=.16 Tested specific hypothesis to demonstrate construct validity? If yes. What is found? Criterion Validity Correlated with gold standard Predictive of a future outcome If yes to either of above, report how this was demonstrated Internal Consistency Evidence for acceptable internal consistency 1 (eg.. Cronbach s α >.60).92 Indicate value: Test-Retest Reliability Evidence for test-retest reliability (eg.. ICC>.70) 1 11

14 Indicate value:.94 Testing interval (time between repeated measures) 49.7 days ± 24.4 (4-92) Interrater Reliability Evidence for interrater reliability (eg..kappa >.60) Indicate Value: Responsiveness Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt s responsiveness index. Regression model) Report statistics: ES. SRM. Guyatt s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change) Report statistics: Change in measure related to change in external standard Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) Time interval between baseline and follow-up assessments Descriptive Features Age range of sample 37.5 years ±16.2 ( ) Number: 533 Sex Male 252/479 (patients sex not recorded in 54 cases) Female Diagnosis Table 2 ACL injury/surgery PCL injury/surgery Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL OA PF General knee pain Combined injury Sport related Cartilage degeneration or surgery Provide normative data Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. in the last month ) 4 weeks Language(s) of instrument used in this report 1 Is this the first or primary report about this instrument? 1 Notes: 12

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16 IKDC SUBJECTIVE KNEE FORM Ratings 1 Yes 2 No 3 Not evaluated or not reported Not applicable Outcome Measure IKDC SUBJECTIVE KNEE FORM Author s Last Name Padua Title of the Article Italian Version of the International Knee Documentation Committee Subjective Knee Form: Cross-Cultural Adaptation and Validation Year 2004 PubMed ID: Reviewer s Name Travis Hamilton Date of Review Content Validity Reported that items were generated by team of experts Reported that items were developed from patient input Reported that content was developed from statistical modeling Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 1 Was the document translated using standard procedure? 1 If yes. How? Standard forward and backward translation (English to Italian) Construct Validity Correlated with a generic instrument/scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-36: PF =.67, BP =.56, PCS = -.60 Correlated with theoretically similar scale If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale 1 If yes. Indicate instrument/scale and correlation coefficient SF-35: MH = -.65, MCS = -.40 RE =.44 Tested specific hypothesis to demonstrate construct validity? If yes. What is found? Criterion Validity Correlated with gold standard Predictive of a future outcome If yes to either of above, report how this was demonstrated Internal Consistency Evidence for acceptable internal consistency 1 (eg.. Cronbach s α >.60) α = 0.91 Indicate value: 14

17 Test-Retest Reliability Evidence for test-retest reliability (eg.. ICC>.70) 1 Indicate value:.90 Testing interval (time between repeated measures) 5 days Interrater Reliability Evidence for interrater reliability (eg..kappa >.60) Indicate Value: Responsiveness Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt s responsiveness index. Regression model) Report statistics: ES. SRM. Guyatt s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change) Report statistics: Change in measure related to change in external standard Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) Time interval between baseline and follow-up assessments Descriptive Features Age range of sample 24 (18-42) Number: 50 (20 Pts. Randomly for reproducibility) Sex Male 41 Female 9 Diagnosis ACL injury/surgery 100% PCL injury/surgery Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL OA PF General knee pain Combined injury Sport related Cartilage degeneration or surgery Provide normative data Provide information about scoring and weighting of items: Provided information about calculating with missing values: Recall period (eg. in the last month ) 4 WEEKS Language(s) of instrument used in this report Italian Is this the first or primary report about this instrument? 2 Notes: Correlation between the Italian IKDC and the SF-36 was calculated using the Spearman correlation (R). 15

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19 IKDC SUBJECTIVE KNEE FORM Ratings 1 Yes 2 No 3 Not evaluated or not reported Not applicable Outcome Measure IKDC SUBJECTIVE KNEE FORM Author s Last Name Anderson Title of the Article The International Knee Documentation Committee Subjective Knee Evaluation Form: Normative Data Year 2006 PubMed ID: Reviewer s Name Travis Hamilton Date of Review June 16, 2011 Content Validity Reported that items were generated by team of experts Reported that items were developed from patient input Reported that content was developed from statistical modeling Evaluated floor and ceiling effect 1 If yes. <30% of sample scored at endpoint 1 Data normally distributed 3 (was not established for age group <18 years) Construct Validity Correlated with a generic instrument/scale If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? 1 If yes. What is found? 1. People experiencing knee problems would score lower than those without knee problems. Criterion Validity Correlated with gold standard Predictive of a future outcome If yes to either of above, report how this was demonstrated Internal Consistency Evidence for acceptable internal consistency (eg.. Cronbach s α >.60) Indicate value: Test-Retest Reliability Evidence for test-retest reliability (eg.. ICC>.70) Indicate value: Testing interval (time between repeated measures) 17

20 Interrater Reliability Evidence for interrater reliability (eg..kappa >.60) Indicate Value: Responsiveness Group level statistics reported (eg. Effect size. Standardized response mean. Guyatt s responsiveness index. Regression model) Report statistics: ES. SRM. Guyatt s Individual level statistics reported (eg. Minimal detectable change. Minimum clinically important change) Report statistics: Change in measure related to change in external standard Measure demonstrated change for patients who received known efficacious treatment (indicate statistic) Time interval between baseline and follow-up assessments Descriptive Features Age range of sample 39 years ±14 (18-65) Number: 2670 returned, used: 2625 right knee 2621 left knee (5246 Knees) Sex Male 1285 Female 1385 Diagnosis ACL injury/surgery PCL injury/surgery Other ligament injury/surgery + ACL Meniscus. Articuler artroscopy +ACL OA PF General knee pain Combined injury Sport related Cartilage degeneration or surgery Provide normative data 1 Provide information about scoring and weighting of items: 1 Provided information about calculating with missing values: 1 Recall period (eg. in the last month ) 4 weeks Language(s) of instrument used in this report English Is this the first or primary report about this instrument? 2 18

21 IKDC SUBJECTIVE KNEE FORM Ratings 1 Yes 2 No 3 Not evaluated or not reported Not applicable Outcome Measure IKDC Subjective Knee Form Author s Last Name Irrgang Title of the Article Responsiveness of International Knee Documentation Committee Subjective Knee Form Year 2006 PubMed ID: Reviewer s Name Travis H Date of Review June 16, 2011 Content Validity Reported that items were generated by team of experts Reported that items were developed from patient input Reported that content was developed from statistical modeling Evaluated floor and ceiling effect If yes. <30% of sample scored at endpoint Data normally distributed Construct Validity Correlated with a generic instrument/scale If yes. Indicate instrument/scale and correlation coefficient Correlated with theoretically similar scale If yes. Indicate instrument/scale and correlation coefficient Uncorrelated with theoretically distinct scale If yes. Indicate instrument/scale and correlation coefficient Tested specific hypothesis to demonstrate construct validity? If yes. What is found? Criterion Validity Correlated with gold standard 1 Predictive of a future outcome If yes to either of above, report how this was demonstrated Group level analysis of between-groups differences used 7- level global rating of change scale in comparison to IKDC. ANOVA = 37.1% of change in IKDC was accounted for by global scale. Internal Consistency Evidence for acceptable internal consistency (eg.. Cronbach s α >.60) Indicate value: 19