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: OBJECTIVE The primary goal was to determine whether a composite measure of pain and activity is a more responsive assessment of analgesic effect than pain alone or activity alone in patients with osteoarthritis ( OA ) of the knee . DESIGN We conducted a r and omized , double-blind , placebo-controlled , 2-period , crossover study of celecoxib vs. placebo in subjects with chronic pain due to knee OA . Patients with knee OA and baseline pain intensity score ≥4 on a 0 - 10 numerical rating scale ( NRS ) before each period were r and omized . Pain endpoints included in-clinic pain score ( 24-hour and 1-week recall ) , daily paper diary pain score , current pain on an electronic pain diary ( each on NRS ) , and WOMAC pain subscale . Activity measures included WOMAC function subscale and actigraphy using a device . Three composite pain-activity measures were prespecified . RESULTS Sixty-three patients were r and omized and 47 completed the study . The WOMAC pain subscale was the most responsive of all five pain measures . Pain-activity composites result ed in a statistically significant difference between celecoxib and placebo but were not more responsive than pain measures alone . However , a composite responder defined as having 20 % improvement in pain or 10 % improvement in activity yielded much larger differences between celecoxib and placebo than with pain scores alone . Actigraphy was more responsive than the WOMAC function scale , possibly due to lower placebo responsiveness . CONCLUSION We have identified composite pain-activity measures that are similarly or more responsive than pain-alone measures in patients with OA . Further research is warranted to determine the optimal method for computing these composites BACKGROUND Universal pain screening with a 0–10 pain intensity numeric rating scale ( NRS ) has been widely implemented in primary care . OBJECTIVE To evaluate the accuracy of the NRS as a screening test to identify primary care patients with clinical ly important pain . DESIGN Prospect i ve diagnostic accuracy study PARTICIPANTS 275 adult clinic patients were enrolled from September 2005 to March 2006 . MEASUREMENTS We operationalized clinical ly important pain using two alternate definitions : ( 1 ) pain that interferes with functioning ( Brief Pain Inventory interference scale ≥ 5 ) and ( 2 ) pain that motivates a physician visit ( patient-reported reason for the visit ) . RESULTS 22 % of patients reported a pain symptom as the main reason for the visit . The most common pain locations were lower extremity ( 21 % ) and back/neck ( 18 % ) . The area under the receiver operator characteristic curve for the NRS as a test for pain that interferes with functioning was 0.76 , indicating fair accuracy . A pain screening NRS score of 1 was 69 % sensitive ( 95 % CI 60–78 ) for pain that interferes with functioning . Multilevel likelihood ratios for scores of 0 , 1–3 , 4–6 , and 7–10 were 0.39 ( 0.29–0.53 ) , 0.99 ( 0.38–2.60 ) , 2.67 ( 1.56–4.57 ) , and 5.60 ( 3.06–10.26 ) , respectively . Results were similar when NRS scores were evaluated against the alternate definition of clinical ly important pain ( pain that motivates a physician visit ) . CONCLUSIONS The most commonly used measure for pain screening may have only modest accuracy for identifying patients with clinical ly important pain in primary care . Further research is needed to evaluate whether pain screening improves patient outcomes in primary care & NA ;  Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies Background The psychometric properties of Patient Reported Outcomes Measurement Information System ( PROMIS ) instruments have been explored in a number of general and clinical sample s. No study , however , has evaluated the psychometric function of these measures in individuals with symptomatic knee osteoarthritis ( KOA ) . The aim of this project was to evaluate the construct ( structural ) validity and floor/ceiling effects of four PROMIS measures in this population . Methods We conducted a secondary analysis of baseline data from a r and omized trial comparing Tai Chi and physical therapy . Participants completed four PROMIS static short-form instruments ( i.e. , Anxiety , Depression , Physical Function , and Pain Interference ) as well as six well-vali date d ( legacy ) measures that assess pain , function , and psychological health . We calculated descriptive statistics and percentages of participants scoring the minimum ( floor ) and maximum ( ceiling ) possible scores for PROMIS and legacy measures . We also estimated the association between PROMIS scores and scores on legacy measures using Spearman ’s rank correlations coefficients . Results Data from 204 participants were analyzed . Mean age of the sample was 60 years ; 70 % were female .  The PROMIS Anxiety and Depression had floor effects with 17 and 24 % of participants scoring the minimum , respectively . PROMIS Anxiety and Depression scores had strongest associations with general mental health , including stress ( Perceived Stress Scale , r ≥ 0.65 ) and depression ( Beck Depression Index-II , r = 0.70 ) . PROMIS Pain Interference scores correlated most strongly with measures of whole body pain ( Short-Form 36 Bodily Pain , r = −0.73 ) and physical health ( Short-Form 36 Physical-Component Summary , r = −0.73 ) ; their correlations were lower with other legacy measures , including with the WOMAC knee-specific pain ( r = 0.47 ) . PROMIS Physical Function scores had stronger associations with scores on the Short-Form 36 Physical Function ( r = 0.79 ) than with scores on other legacy measures . Conclusion The four PROMIS static-short forms performed well among individuals with symptomatic knee osteoarthritis as evidence d in correlations with legacy measures . PROMIS Anxiety and Depression target general mental health ( e.g. , stress , depression ) , and PROMIS Pain Interference and Physical Function static-short forms target whole-body outcomes among participants with symptomatic knee osteoarthritis . Floor effects in the PROMIS Anxiety and Depression scores should be considered if needing to distinguish among patients with very low levels of these outcomes .Trial registration Clinical trials.gov NCT01258985 . Registered 10 December UNLABELLED The design used in this study was a prospect i ve cohort . Pain intensity levels recorded by the digital version of the visual analog scale ( VAS-D ) are easy to both score and share with other health care professionals . The purpose of the study was to examine the test-retest reliability , concurrent validity , and responsiveness of the VAS-D.  Thirty-three people with upper extremity injuries reported pain intensity levels before and after performing four maximal grip contractions ( pre- and postgripping ) . Our version of the VAS-D had high test-retest reliability ( r=0.96 ) and good concurrent validity ( r=0.84 - 0.97 ) with both the paper version of the VAS ( VAS-P ) and the verbal numerical rating scale ( NRS-V ) . Responsiveness of the VAS-D was indicated by a significant increase in pain levels from pre- to postgripping . Similar responsiveness to that of the VAS-P and NRS-V was indicated by similar effect size coefficients and analysis of variance of pain change scores . In conclusion , the VAS-D is a reliable , valid , and responsive measure of pain intensity for people with upper extremity injuries . However , differences in accuracy ( resolution ) among the VAS-D , VAS-P , or NRS-V may render the three pain scales not fully compatible . LEVEL OF EVIDENCE Not applicable OBJECTIVE To assess reliability , validity , and responsiveness of a 29-item short-form version of the Patient Reported Outcomes Measurement Information System ( PROMIS ) and a novel “ impact score ” calculated from those measures . DESIGN Prospect i ve cohort study . SETTING Rural primary care practice s. SUBJECTS Adults aged ≥ 55 years with chronic musculoskeletal pain , not currently receiving prescription opioids . METHODS Subjects completed the PROMIS short form at baseline and after 3 months . Patient subsets were compared to assess reliability and responsiveness . Construct validity was tested by comparing baseline scores among patients who were or were not applying for Worker 's Compensation ; those with higher or lower catastrophizing scores ; and those with or without recent falls . Responsiveness was assessed with mean score changes , effect sizes , and st and ardized response means . RESULTS Internal consistency was good to excellent , with Cronbach 's alpha between 0.81 and 0.95 for all scales . Among patients who rated their pain as stable , test-retest scores at 3 months were around 0.70 for most scales . PROMIS scores were worse among patients seeking or receiving worker 's compensation , those with high catastrophizing scores , and those with recent falls . Among patients rating pain as “ much less ” at 3 months , absolute effect sizes for the various scales ranged from 0.24 ( Depression ) to 1.93 ( Pain Intensity ) . CONCLUSIONS Results indicate that the PROMIS short 29-item form may be useful for the study of patients with chronic musculoskeletal pain . Our findings also support use of the novel “ impact score ” recommended by the National Institutes of Health ( NIH ) Task Force on Research St and ards for Chronic Low Back Pain OBJECTIVE To determine how well early responses to physical therapy for chronic low back pain predict outcomes at discharge . METHODS A prospect i ve single cohort study of chronic low back pain patients seen at a university spine physical therapy clinic . Self-reported pain severity on a 100-mm visual analog scale was measured before each physical therapy visit . The predictive variables were the change in pain score at the second , third , and fourth visits . The first outcome variable was discharge change in pain severity for a correlation analysis . The second outcome variable was a dichotomous variable of whether the subjects had achieved at least a 30 % reduction in pain severity at discharge for a discriminant analysis . RESULTS Spearman 's rank order correlation coefficient showed that early responses at the second ( r = 0.324 , P = 0.02 ) third ( r = 0.342 , P = 0.01 ) , and fourth visits ( r = 0.615 , P < 0.001 ) were all significantly correlated with discharge change in pain . The discriminant analysis showed that early responses from the second to fourth visits were able to correctly predict 80.4 % of the discharge outcomes ( P < 0.001 ) . CONCLUSIONS Early responses with physical therapy help predict discharge outcomes for chronic low back pain Several versions of the 24-item Rol and Morris Disability Question naire ( RMDQ ) have been proposed ; however , their responsiveness has not been extensively explored . The objective of this study was to compare the responsiveness of four versions of the RMDQ .  Perceived disability was measured using the 24-item , two 18-item and an 11-item RMDQ on 1,069 low back pain patients from six r and omised controlled trials .  Responsiveness was calculated using effect size , Guyatt ’s responsiveness index ( GRI ) and receiver operating characteristics ( ROC ) curves . Effect size analyses showed that both 18-item versions of the RMDQ were superior to the 24- and 11-item versions of the RMDQ . GRI showed that the 24- and 18-item versions of the RMDQ were similar but more responsive than the 11-item . ROC curves revealed that the 11-item was less responsive than the other three versions , which had similar responsiveness . The results of this study demonstrate that the 24-item and both 18-item versions of the RMDQ have similar responsiveness with all having superior responsiveness to the 11-item BACKGROUND The Army Surgeon General released the Pain Management Task Force final report in May 2010 . Among military providers , concerns were raised that the st and ard numeric rating scale ( N 
    Output:
    
agent
Our primary outcome was the measure ’s minimal important difference ( MID ) .
Conclusions In this focused evidence review , the most evidence on key psychometric properties in chronic musculoskeletal pain population s was found for the ODI , RMDQ , SF-36 BPS , NRS , and VAS .
***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: OBJECTIVE The primary goal was to determine whether a composite measure of pain and activity is a more responsive assessment of analgesic effect than pain alone or activity alone in patients with osteoarthritis ( OA ) of the knee . DESIGN We conducted a r and omized , double-blind , placebo-controlled , 2-period , crossover study of celecoxib vs. placebo in subjects with chronic pain due to knee OA . Patients with knee OA and baseline pain intensity score ≥4 on a 0 - 10 numerical rating scale ( NRS ) before each period were r and omized . Pain endpoints included in-clinic pain score ( 24-hour and 1-week recall ) , daily paper diary pain score , current pain on an electronic pain diary ( each on NRS ) , and WOMAC pain subscale . Activity measures included WOMAC function subscale and actigraphy using a device . Three composite pain-activity measures were prespecified . RESULTS Sixty-three patients were r and omized and 47 completed the study . The WOMAC pain subscale was the most responsive of all five pain measures . Pain-activity composites result ed in a statistically significant difference between celecoxib and placebo but were not more responsive than pain measures alone . However , a composite responder defined as having 20 % improvement in pain or 10 % improvement in activity yielded much larger differences between celecoxib and placebo than with pain scores alone . Actigraphy was more responsive than the WOMAC function scale , possibly due to lower placebo responsiveness . CONCLUSION We have identified composite pain-activity measures that are similarly or more responsive than pain-alone measures in patients with OA . Further research is warranted to determine the optimal method for computing these composites BACKGROUND Universal pain screening with a 0–10 pain intensity numeric rating scale ( NRS ) has been widely implemented in primary care . OBJECTIVE To evaluate the accuracy of the NRS as a screening test to identify primary care patients with clinical ly important pain . DESIGN Prospect i ve diagnostic accuracy study PARTICIPANTS 275 adult clinic patients were enrolled from September 2005 to March 2006 . MEASUREMENTS We operationalized clinical ly important pain using two alternate definitions : ( 1 ) pain that interferes with functioning ( Brief Pain Inventory interference scale ≥ 5 ) and ( 2 ) pain that motivates a physician visit ( patient-reported reason for the visit ) . RESULTS 22 % of patients reported a pain symptom as the main reason for the visit . The most common pain locations were lower extremity ( 21 % ) and back/neck ( 18 % ) . The area under the receiver operator characteristic curve for the NRS as a test for pain that interferes with functioning was 0.76 , indicating fair accuracy . A pain screening NRS score of 1 was 69 % sensitive ( 95 % CI 60–78 ) for pain that interferes with functioning . Multilevel likelihood ratios for scores of 0 , 1–3 , 4–6 , and 7–10 were 0.39 ( 0.29–0.53 ) , 0.99 ( 0.38–2.60 ) , 2.67 ( 1.56–4.57 ) , and 5.60 ( 3.06–10.26 ) , respectively . Results were similar when NRS scores were evaluated against the alternate definition of clinical ly important pain ( pain that motivates a physician visit ) . CONCLUSIONS The most commonly used measure for pain screening may have only modest accuracy for identifying patients with clinical ly important pain in primary care . Further research is needed to evaluate whether pain screening improves patient outcomes in primary care & NA ;  Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies Background The psychometric properties of Patient Reported Outcomes Measurement Information System ( PROMIS ) instruments have been explored in a number of general and clinical sample s. No study , however , has evaluated the psychometric function of these measures in individuals with symptomatic knee osteoarthritis ( KOA ) . The aim of this project was to evaluate the construct ( structural ) validity and floor/ceiling effects of four PROMIS measures in this population . Methods We conducted a secondary analysis of baseline data from a r and omized trial comparing Tai Chi and physical therapy . Participants completed four PROMIS static short-form instruments ( i.e. , Anxiety , Depression , Physical Function , and Pain Interference ) as well as six well-vali date d ( legacy ) measures that assess pain , function , and psychological health . We calculated descriptive statistics and percentages of participants scoring the minimum ( floor ) and maximum ( ceiling ) possible scores for PROMIS and legacy measures . We also estimated the association between PROMIS scores and scores on legacy measures using Spearman ’s rank correlations coefficients . Results Data from 204 participants were analyzed . Mean age of the sample was 60 years ; 70 % were female .  The PROMIS Anxiety and Depression had floor effects with 17 and 24 % of participants scoring the minimum , respectively . PROMIS Anxiety and Depression scores had strongest associations with general mental health , including stress ( Perceived Stress Scale , r ≥ 0.65 ) and depression ( Beck Depression Index-II , r = 0.70 ) . PROMIS Pain Interference scores correlated most strongly with measures of whole body pain ( Short-Form 36 Bodily Pain , r = −0.73 ) and physical health ( Short-Form 36 Physical-Component Summary , r = −0.73 ) ; their correlations were lower with other legacy measures , including with the WOMAC knee-specific pain ( r = 0.47 ) . PROMIS Physical Function scores had stronger associations with scores on the Short-Form 36 Physical Function ( r = 0.79 ) than with scores on other legacy measures . Conclusion The four PROMIS static-short forms performed well among individuals with symptomatic knee osteoarthritis as evidence d in correlations with legacy measures . PROMIS Anxiety and Depression target general mental health ( e.g. , stress , depression ) , and PROMIS Pain Interference and Physical Function static-short forms target whole-body outcomes among participants with symptomatic knee osteoarthritis . Floor effects in the PROMIS Anxiety and Depression scores should be considered if needing to distinguish among patients with very low levels of these outcomes .Trial registration Clinical trials.gov NCT01258985 . Registered 10 December UNLABELLED The design used in this study was a prospect i ve cohort . Pain intensity levels recorded by the digital version of the visual analog scale ( VAS-D ) are easy to both score and share with other health care professionals . The purpose of the study was to examine the test-retest reliability , concurrent validity , and responsiveness of the VAS-D.  Thirty-three people with upper extremity injuries reported pain intensity levels before and after performing four maximal grip contractions ( pre- and postgripping ) . Our version of the VAS-D had high test-retest reliability ( r=0.96 ) and good concurrent validity ( r=0.84 - 0.97 ) with both the paper version of the VAS ( VAS-P ) and the verbal numerical rating scale ( NRS-V ) . Responsiveness of the VAS-D was indicated by a significant increase in pain levels from pre- to postgripping . Similar responsiveness to that of the VAS-P and NRS-V was indicated by similar effect size coefficients and analysis of variance of pain change scores . In conclusion , the VAS-D is a reliable , valid , and responsive measure of pain intensity for people with upper extremity injuries . However , differences in accuracy ( resolution ) among the VAS-D , VAS-P , or NRS-V may render the three pain scales not fully compatible . LEVEL OF EVIDENCE Not applicable OBJECTIVE To assess reliability , validity , and responsiveness of a 29-item short-form version of the Patient Reported Outcomes Measurement Information System ( PROMIS ) and a novel “ impact score ” calculated from those measures . DESIGN Prospect i ve cohort study . SETTING Rural primary care practice s. SUBJECTS Adults aged ≥ 55 years with chronic musculoskeletal pain , not currently receiving prescription opioids . METHODS Subjects completed the PROMIS short form at baseline and after 3 months . Patient subsets were compared to assess reliability and responsiveness . Construct validity was tested by comparing baseline scores among patients who were or were not applying for Worker 's Compensation ; those with higher or lower catastrophizing scores ; and those with or without recent falls . Responsiveness was assessed with mean score changes , effect sizes , and st and ardized response means . RESULTS Internal consistency was good to excellent , with Cronbach 's alpha between 0.81 and 0.95 for all scales . Among patients who rated their pain as stable , test-retest scores at 3 months were around 0.70 for most scales . PROMIS scores were worse among patients seeking or receiving worker 's compensation , those with high catastrophizing scores , and those with recent falls . Among patients rating pain as “ much less ” at 3 months , absolute effect sizes for the various scales ranged from 0.24 ( Depression ) to 1.93 ( Pain Intensity ) . CONCLUSIONS Results indicate that the PROMIS short 29-item form may be useful for the study of patients with chronic musculoskeletal pain . Our findings also support use of the novel “ impact score ” recommended by the National Institutes of Health ( NIH ) Task Force on Research St and ards for Chronic Low Back Pain OBJECTIVE To determine how well early responses to physical therapy for chronic low back pain predict outcomes at discharge . METHODS A prospect i ve single cohort study of chronic low back pain patients seen at a university spine physical therapy clinic . Self-reported pain severity on a 100-mm visual analog scale was measured before each physical therapy visit . The predictive variables were the change in pain score at the second , third , and fourth visits . The first outcome variable was discharge change in pain severity for a correlation analysis . The second outcome variable was a dichotomous variable of whether the subjects had achieved at least a 30 % reduction in pain severity at discharge for a discriminant analysis . RESULTS Spearman 's rank order correlation coefficient showed that early responses at the second ( r = 0.324 , P = 0.02 ) third ( r = 0.342 , P = 0.01 ) , and fourth visits ( r = 0.615 , P < 0.001 ) were all significantly correlated with discharge change in pain . The discriminant analysis showed that early responses from the second to fourth visits were able to correctly predict 80.4 % of the discharge outcomes ( P < 0.001 ) . CONCLUSIONS Early responses with physical therapy help predict discharge outcomes for chronic low back pain Several versions of the 24-item Rol and Morris Disability Question naire ( RMDQ ) have been proposed ; however , their responsiveness has not been extensively explored . The objective of this study was to compare the responsiveness of four versions of the RMDQ .  Perceived disability was measured using the 24-item , two 18-item and an 11-item RMDQ on 1,069 low back pain patients from six r and omised controlled trials .  Responsiveness was calculated using effect size , Guyatt ’s responsiveness index ( GRI ) and receiver operating characteristics ( ROC ) curves . Effect size analyses showed that both 18-item versions of the RMDQ were superior to the 24- and 11-item versions of the RMDQ . GRI showed that the 24- and 18-item versions of the RMDQ were similar but more responsive than the 11-item . ROC curves revealed that the 11-item was less responsive than the other three versions , which had similar responsiveness . The results of this study demonstrate that the 24-item and both 18-item versions of the RMDQ have similar responsiveness with all having superior responsiveness to the 11-item BACKGROUND The Army Surgeon General released the Pain Management Task Force final report in May 2010 . Among military providers , concerns were raised that the st and ard numeric rating scale ( N 
    Output:
    