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: Health status measures are conceptually relevant to the assessment of clinical outcome in the rheumatic diseases , but their ability to detect meaningful changes in health has not been clearly demonstrated . This report describes the performance of a self-administered health status question naire in a r and omized , double-blind , 21-week comparison of placebo , oral gold , and injectable gold in rheumatoid arthritis patients . Outcome was assessed by st and ard clinical measures , including joint count , grip strength , and laboratory tests , and by the Arthritis Impact Measurement Scales , a reliable and valid health status measure that assesses physical disability , psychological status , and pain . Data from the clinical and health status measures produced highly similar conclusions : injectable and oral gold are more effective than placebo for rheumatoid arthritis , and injections are slightly more effective than oral gold . The health status measure was thus quite sensitive to clinical ly meaningful drug-induced improvements . These findings provide justification for the further application of health status measures to clinical trials of chronic disease OBJECTIVE To determine the discriminant validity of the core set of outcome measures proposed by the American College of Rheumatology ( ACR ) and the Outcome Measures in Clinical Trials ( OMERACT ) conference committee to be used in clinical trials of rheumatoid arthritis ( RA ) . METHODS Utilizing data from a multicenter r and omized double-blind clinical trial of low-dose cyclosporine and placebo in RA , we estimated the relative efficiency ( RE ) of measures to detect a treatment effect ( relative to tender joint count , which was assigned a value of 1 ) . Four pain measures ( 10-cm visual analog scale [ VAS ] , 5-point categorical scale , Health Assessment Question naire [ HAQ ] pain index , Arthritis Impact Measurement Scales [ AIMS ] pain score ) and 3 quality -of-life measures ( Problem Elicitation Technique [ PET ] , HAQ , AIMS )  were compared . RESULTS Physician and patient global measures were the most responsive instruments , although neither was statistically superior to tender joint count . Swollen joint count , grip strength , pain measured on a 10-cm VAS , and functional status as measured by the PET and HAQ were all of intermediate responsiveness . Morning stiffness , 5-point pain scale , and erythrocyte sedimentation rate were the least responsive instruments . CONCLUSION This study provides further evidence to support the core set of outcome measures proposed by the ACR and OMERACT In clinical measurement comparison of a new measurement technique with an established one is often needed to see whether they agree sufficiently for the new to replace the old . Such investigations are often analysed inappropriately , notably by using correlation coefficients . The use of correlation is misleading . An alternative approach , based on graphical techniques and simple calculations , is described , together with the relation between this analysis and the assessment of repeatability Observational and longitudinal observational studies ( LOS ) provide essential information about the course and outcome of rheumatic disorders that can not be provided by r and omized controlled trials , and they constitute the major clinical scientific communication in rheumatology . There has been no consensus as to the full and appropriate content of LOS . This report defines a core set of domains and reporting requirements for LOS . At the 1998 OMERACT IV Conference a consensus process evaluated the literature of rheumatology in light of the constructs , variables , and outcomes of rheumatology by using introductory lectures , nominal groups , and plenary sessions . The result of this process was to identify 5 " core " domains that should be included in every LOS : Health Status , Disease Process , Damage , Mortality , and Toxicity/Adverse Reactions . Two additional domains , Work Disability and Costs , were recognized as important , but need not be used in all LOS . Eleven subdomains were identified that divided the domains into convenient clinical and conceptual units . A set of reporting requirements was also determined . The core recommendations , which follow on the WHO ICIDH-2 outline , are not disease-specific ; the substitution of different " disease process " and " damage " measures make them suitable for many rheumatic disorders . The core set is intended to serve as a core for LOS in almost all rheumatic conditions OBJECTIVE Validation of responsiveness and discriminative power of the World Health Organisation/International League of Associations for Rheumatology ( WHO/ILAR ) core set , the American College of Rheumatology ( ACR ) , and European League for Rheumatology ( EULAR ) criteria for improvement/response , and other single and combined measures ( indices ) in a trial in patients with early rheumatoid arthritis ( RA ) . METHODS Ranking of measures by response ( st and ardised response means and effect sizes ) and between-group discrimination ( unpaired ttest and χ2 values ) at two time points in the COBRA study . This study included 155 patients with early RA r and omly allocated to two treatment groups with distinct levels of expected response : combined treatment , high response ; sulfasalazine treatment , moderate response . RESULTS At week 16 , st and ardised response means of core set measures ranged between 0.8 and 3.5 for combined treatment and between 0.4 and 1.2 for sulfasalazine treatment ( 95 % confidence interval ±0.25 ) . Performance of patient oriented measures ( for example , pain , global assessment ) was best when the questions were focused on the disease . The most responsive single measure was the patient 's assessment of change in disease activity , at 3.5 . Patient utility , a generic health status measure , was moderately ( rating scale ) to poorly ( st and ard gamble ) responsive . Response means of most indices ( combined measures ) exceeded 2.0 , the simple count of core set measures improved by 20 % was most responsive at 4.1 . Discrimination performance yielded similar but not identical results : best discrimination between treatment groups was achieved by the EULAR response and ACR improvement criteria ( at 20 % and other percentage levels ) , the pooled index , and the disease activity score ( DAS ) , but also by the Health Assessment Question naire ( HAQ ) and grip strength . CONCLUSIONS Responsiveness and discrimination between levels of response are not identical concepts , and need separate study . The WHO/ILAR core set comprises responsive measures that discriminate well between different levels of response in early RA . However , the performance of patient oriented measures is highly dependent on their format . The excellent performance of indices such as the ACR improvement and EULAR response criteria confirms that they are the preferred primary end point in RA clinical trials OBJECTIVE To assess the performance of the Barthel Index ( BI ) in patients with rheumatoid arthritis ( RA ) in the acute care hospital , as compared to the Stanford Health Assessment Question naire ( HAQ ) and the Hannover Functional Question naire ( Funktionsfragebogen Hannover , FFbH ) . METHODS A prospect i ve study of 97 patients with RA admitted to an acute rheumatology hospital with new onset or acute flare of RA . Patients were required to self-complete the BI , the HAQ , and the FFbH.  Disease activity was measured using the Disease Activity Score ( DAS28 ) . RESULTS Seventy-eight percent of patients were female , average age was 61.5 ( SD 12.5 ) years , and 72.2 % were rheumatoid factor-positive . The median HAQ was 1.29 ( range 0 - 3 ) , median FFbH was 50 % ( 6 - 100 % ) , and median BI was 95 ( 0 - 100 ) , and distribution was highly skewed . All measures of physical functioning were significantly correlated with each other and with the DAS28 ; however , the BI discriminated poorly between low and high disease activity . CONCLUSION The BI is not a useful instrument to assess physical functioning in patients with acute symptoms of RA , but may have a role in assessing patients with comorbidities and in assessing nursing care needs in the acute care hospital Objectives For the measurement of  patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields As an alternative to the calculation of change scores for health status question naires used in clinical trials or longitudinal studies , transitional questions have been developed for patients to assess changes directly themselves . Here the original Health Assessment Question naire ( HAQ ) is compared with a modified version of the HAQ ( MHAQ ) which contains transition questions used at follow up . These , together with a set of st and ard rheumatological tests , were all completed by 100 patients with rheumatoid arthritis on two occasions , three months apart . Change scores were calculated for the HAQ and for the clinical measures and compared with the MHAQ . The results were strikingly in favour of encouraging patients to assess their own degree of change through the use of transition questions in the MHAQ OBJECTIVE To define clinical ly meaningful changes in 2 widely used health-related quality of life ( HQL ) instruments in studies of patients with rheumatoid arthritis ( RA ) . METHODS Patients with RA ( n = 693 ) who were enrolled in 2 double-blind , placebo-controlled clinical trials completed the Short Form 36 ( SF-36 ) modified health survey and the Health Assessment Question naire ( HAQ ) disability index at baseline and 6-week followup assessment s. Data on 5 RA severity measures were also collected at baseline and at 6 weeks ( patient and physician global assessment s , joint swelling and tenderness counts , and global pain assessment ) . Comparison of changes in the SF-36 scales and HAQ scores was made between groups of patients known to differ in the level of change on each RA severity measure . RESULTS With few exceptions , changes in the SF-36 and HAQ scores were different between patients who differed in the level of change on each RA severity measure . Changes in the SF-36 and HAQ scores were more strongly related to changes in the patient and physician global assessment s and patient pain assessment than to changes in the joint swelling and tenderness counts . CONCLUSION Based on these results , minimally important changes in the SF-36 scales and HAQ disability scores were determined , which will be useful in interpreting HQL results in clinical trials We present data from two studies which clarify the relationship between the responsiveness and validity of instruments design ed to measure health status in clinical trials . In a controlled trial of  long vs short duration adjuvant chemotherapy for women with Stage II breast cancer , the Breast Cancer Chemotherapy Question naire ( BCQ ) proved valid as a measure of subjective health status and was able to distinguish long vs short arms . Well vali date d measures of physical and emotional function developed by the R and Corporation were unable to distinguish between the two groups . The Eastern Co-operative Oncology Group Criteria ( ECOG ) distinguished the two groups , but failed criteria of clinical sensibility as a measure of subjective health status . In a study of patients with Crohn 's disease and ulcerative colitis , the Inflammatory Bowel Disease Question naire ( IBDQ ) showed small intrasubject variability over time . Gobal ratings of change showed moderate to high correlations with changes in IBDQ score , and patients who reported overall improvement or deterioration showed large changes in IBDQ score . Each of these findings support , in different ways , the reproducibility , validity , and responsiveness of the question naire . While the same data can at times bear on both validity and responsiveness , when assessing evaluative instruments it is useful to make a conceptual distinction between the two OBJECTIVE To examine correlations between clinical improvement as defined by the American College of Rheumatology ( ACR ) responder analysis and clinical improvement as determined by 4 function and /or health-related quality of life measures , and to estimate the sensitivity and relative efficiency of these measures compared with changes in the tender joint count in patients with rheumatoid arthritis ( RA ) . METHODS A 52-week , multicenter , double-blind controlled trial was conducted to compare treatment with leflunomide ( n = 182 ) , methotrexate ( n = 180 ) , or placebo ( n = 118 ) in patients with active RA .  ACR response rates and improvement in scores on the  Health Assessment Question naire ( HAQ ) , Problem Elicitation Technique ( PET ) , and Medical Outcomes Survey Short Form 36 ( SF-36 ) were compared in 438 of the patients . RESULTS In comparing leflunomide with placebo , the patient global assessment , HAQ disability index , and SF-36 bodily pain scale were most responsive to treatment group differences . The modified HAQ ( M-HAQ ) , PET Top 5 , SF-36 physical component score , physician global assessment , pain intensity scale , and SF-36 physical functioning scale were more responsive to treatment group differences than was the tender joint count 
    Output:
    
agent
Conclusion Based on this literature review , the disease-specificHAQ and the generic SF-36 can currently be most confidently recommended to measure PF in RA for most research purpose s. The HAQ , however , was frequently associated with considerable ceiling effects while the SF-36 has limited content coverage .
***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: Health status measures are conceptually relevant to the assessment of clinical outcome in the rheumatic diseases , but their ability to detect meaningful changes in health has not been clearly demonstrated . This report describes the performance of a self-administered health status question naire in a r and omized , double-blind , 21-week comparison of placebo , oral gold , and injectable gold in rheumatoid arthritis patients . Outcome was assessed by st and ard clinical measures , including joint count , grip strength , and laboratory tests , and by the Arthritis Impact Measurement Scales , a reliable and valid health status measure that assesses physical disability , psychological status , and pain . Data from the clinical and health status measures produced highly similar conclusions : injectable and oral gold are more effective than placebo for rheumatoid arthritis , and injections are slightly more effective than oral gold . The health status measure was thus quite sensitive to clinical ly meaningful drug-induced improvements . These findings provide justification for the further application of health status measures to clinical trials of chronic disease OBJECTIVE To determine the discriminant validity of the core set of outcome measures proposed by the American College of Rheumatology ( ACR ) and the Outcome Measures in Clinical Trials ( OMERACT ) conference committee to be used in clinical trials of rheumatoid arthritis ( RA ) . METHODS Utilizing data from a multicenter r and omized double-blind clinical trial of low-dose cyclosporine and placebo in RA , we estimated the relative efficiency ( RE ) of measures to detect a treatment effect ( relative to tender joint count , which was assigned a value of 1 ) . Four pain measures ( 10-cm visual analog scale [ VAS ] , 5-point categorical scale , Health Assessment Question naire [ HAQ ] pain index , Arthritis Impact Measurement Scales [ AIMS ] pain score ) and 3 quality -of-life measures ( Problem Elicitation Technique [ PET ] , HAQ , AIMS )  were compared . RESULTS Physician and patient global measures were the most responsive instruments , although neither was statistically superior to tender joint count . Swollen joint count , grip strength , pain measured on a 10-cm VAS , and functional status as measured by the PET and HAQ were all of intermediate responsiveness . Morning stiffness , 5-point pain scale , and erythrocyte sedimentation rate were the least responsive instruments . CONCLUSION This study provides further evidence to support the core set of outcome measures proposed by the ACR and OMERACT In clinical measurement comparison of a new measurement technique with an established one is often needed to see whether they agree sufficiently for the new to replace the old . Such investigations are often analysed inappropriately , notably by using correlation coefficients . The use of correlation is misleading . An alternative approach , based on graphical techniques and simple calculations , is described , together with the relation between this analysis and the assessment of repeatability Observational and longitudinal observational studies ( LOS ) provide essential information about the course and outcome of rheumatic disorders that can not be provided by r and omized controlled trials , and they constitute the major clinical scientific communication in rheumatology . There has been no consensus as to the full and appropriate content of LOS . This report defines a core set of domains and reporting requirements for LOS . At the 1998 OMERACT IV Conference a consensus process evaluated the literature of rheumatology in light of the constructs , variables , and outcomes of rheumatology by using introductory lectures , nominal groups , and plenary sessions . The result of this process was to identify 5 " core " domains that should be included in every LOS : Health Status , Disease Process , Damage , Mortality , and Toxicity/Adverse Reactions . Two additional domains , Work Disability and Costs , were recognized as important , but need not be used in all LOS . Eleven subdomains were identified that divided the domains into convenient clinical and conceptual units . A set of reporting requirements was also determined . The core recommendations , which follow on the WHO ICIDH-2 outline , are not disease-specific ; the substitution of different " disease process " and " damage " measures make them suitable for many rheumatic disorders . The core set is intended to serve as a core for LOS in almost all rheumatic conditions OBJECTIVE Validation of responsiveness and discriminative power of the World Health Organisation/International League of Associations for Rheumatology ( WHO/ILAR ) core set , the American College of Rheumatology ( ACR ) , and European League for Rheumatology ( EULAR ) criteria for improvement/response , and other single and combined measures ( indices ) in a trial in patients with early rheumatoid arthritis ( RA ) . METHODS Ranking of measures by response ( st and ardised response means and effect sizes ) and between-group discrimination ( unpaired ttest and χ2 values ) at two time points in the COBRA study . This study included 155 patients with early RA r and omly allocated to two treatment groups with distinct levels of expected response : combined treatment , high response ; sulfasalazine treatment , moderate response . RESULTS At week 16 , st and ardised response means of core set measures ranged between 0.8 and 3.5 for combined treatment and between 0.4 and 1.2 for sulfasalazine treatment ( 95 % confidence interval ±0.25 ) . Performance of patient oriented measures ( for example , pain , global assessment ) was best when the questions were focused on the disease . The most responsive single measure was the patient 's assessment of change in disease activity , at 3.5 . Patient utility , a generic health status measure , was moderately ( rating scale ) to poorly ( st and ard gamble ) responsive . Response means of most indices ( combined measures ) exceeded 2.0 , the simple count of core set measures improved by 20 % was most responsive at 4.1 . Discrimination performance yielded similar but not identical results : best discrimination between treatment groups was achieved by the EULAR response and ACR improvement criteria ( at 20 % and other percentage levels ) , the pooled index , and the disease activity score ( DAS ) , but also by the Health Assessment Question naire ( HAQ ) and grip strength . CONCLUSIONS Responsiveness and discrimination between levels of response are not identical concepts , and need separate study . The WHO/ILAR core set comprises responsive measures that discriminate well between different levels of response in early RA . However , the performance of patient oriented measures is highly dependent on their format . The excellent performance of indices such as the ACR improvement and EULAR response criteria confirms that they are the preferred primary end point in RA clinical trials OBJECTIVE To assess the performance of the Barthel Index ( BI ) in patients with rheumatoid arthritis ( RA ) in the acute care hospital , as compared to the Stanford Health Assessment Question naire ( HAQ ) and the Hannover Functional Question naire ( Funktionsfragebogen Hannover , FFbH ) . METHODS A prospect i ve study of 97 patients with RA admitted to an acute rheumatology hospital with new onset or acute flare of RA . Patients were required to self-complete the BI , the HAQ , and the FFbH.  Disease activity was measured using the Disease Activity Score ( DAS28 ) . RESULTS Seventy-eight percent of patients were female , average age was 61.5 ( SD 12.5 ) years , and 72.2 % were rheumatoid factor-positive . The median HAQ was 1.29 ( range 0 - 3 ) , median FFbH was 50 % ( 6 - 100 % ) , and median BI was 95 ( 0 - 100 ) , and distribution was highly skewed . All measures of physical functioning were significantly correlated with each other and with the DAS28 ; however , the BI discriminated poorly between low and high disease activity . CONCLUSION The BI is not a useful instrument to assess physical functioning in patients with acute symptoms of RA , but may have a role in assessing patients with comorbidities and in assessing nursing care needs in the acute care hospital Objectives For the measurement of  patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields As an alternative to the calculation of change scores for health status question naires used in clinical trials or longitudinal studies , transitional questions have been developed for patients to assess changes directly themselves . Here the original Health Assessment Question naire ( HAQ ) is compared with a modified version of the HAQ ( MHAQ ) which contains transition questions used at follow up . These , together with a set of st and ard rheumatological tests , were all completed by 100 patients with rheumatoid arthritis on two occasions , three months apart . Change scores were calculated for the HAQ and for the clinical measures and compared with the MHAQ . The results were strikingly in favour of encouraging patients to assess their own degree of change through the use of transition questions in the MHAQ OBJECTIVE To define clinical ly meaningful changes in 2 widely used health-related quality of life ( HQL ) instruments in studies of patients with rheumatoid arthritis ( RA ) . METHODS Patients with RA ( n = 693 ) who were enrolled in 2 double-blind , placebo-controlled clinical trials completed the Short Form 36 ( SF-36 ) modified health survey and the Health Assessment Question naire ( HAQ ) disability index at baseline and 6-week followup assessment s. Data on 5 RA severity measures were also collected at baseline and at 6 weeks ( patient and physician global assessment s , joint swelling and tenderness counts , and global pain assessment ) . Comparison of changes in the SF-36 scales and HAQ scores was made between groups of patients known to differ in the level of change on each RA severity measure . RESULTS With few exceptions , changes in the SF-36 and HAQ scores were different between patients who differed in the level of change on each RA severity measure . Changes in the SF-36 and HAQ scores were more strongly related to changes in the patient and physician global assessment s and patient pain assessment than to changes in the joint swelling and tenderness counts . CONCLUSION Based on these results , minimally important changes in the SF-36 scales and HAQ disability scores were determined , which will be useful in interpreting HQL results in clinical trials We present data from two studies which clarify the relationship between the responsiveness and validity of instruments design ed to measure health status in clinical trials . In a controlled trial of  long vs short duration adjuvant chemotherapy for women with Stage II breast cancer , the Breast Cancer Chemotherapy Question naire ( BCQ ) proved valid as a measure of subjective health status and was able to distinguish long vs short arms . Well vali date d measures of physical and emotional function developed by the R and Corporation were unable to distinguish between the two groups . The Eastern Co-operative Oncology Group Criteria ( ECOG ) distinguished the two groups , but failed criteria of clinical sensibility as a measure of subjective health status . In a study of patients with Crohn 's disease and ulcerative colitis , the Inflammatory Bowel Disease Question naire ( IBDQ ) showed small intrasubject variability over time . Gobal ratings of change showed moderate to high correlations with changes in IBDQ score , and patients who reported overall improvement or deterioration showed large changes in IBDQ score . Each of these findings support , in different ways , the reproducibility , validity , and responsiveness of the question naire . While the same data can at times bear on both validity and responsiveness , when assessing evaluative instruments it is useful to make a conceptual distinction between the two OBJECTIVE To examine correlations between clinical improvement as defined by the American College of Rheumatology ( ACR ) responder analysis and clinical improvement as determined by 4 function and /or health-related quality of life measures , and to estimate the sensitivity and relative efficiency of these measures compared with changes in the tender joint count in patients with rheumatoid arthritis ( RA ) . METHODS A 52-week , multicenter , double-blind controlled trial was conducted to compare treatment with leflunomide ( n = 182 ) , methotrexate ( n = 180 ) , or placebo ( n = 118 ) in patients with active RA .  ACR response rates and improvement in scores on the  Health Assessment Question naire ( HAQ ) , Problem Elicitation Technique ( PET ) , and Medical Outcomes Survey Short Form 36 ( SF-36 ) were compared in 438 of the patients . RESULTS In comparing leflunomide with placebo , the patient global assessment , HAQ disability index , and SF-36 bodily pain scale were most responsive to treatment group differences . The modified HAQ ( M-HAQ ) , PET Top 5 , SF-36 physical component score , physician global assessment , pain intensity scale , and SF-36 physical functioning scale were more responsive to treatment group differences than was the tender joint count 
    Output:
    