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: Objectives To compare the Visual Analogue Scale ( VAS ) and the Verbal Numerical Rating Scale ( VNRS ) , in the assessment of acute pain in the emergency department ( ED ) . Furthermore , to determine the influence of demographics on this agreement and practical limitations of the scales . Setting St Vincent 's University Hospital , Dublin ; a 479-bed teaching hospital ; annual ED census 36 000 adult patients . Methods A prospect i ve observational study was conducted on ED patients with acute pain as a component of their presenting complaint . Eligible patients scored their pain on both VAS and VNRS within 1 hour of arrival . They rescored their pain every 30 minutes for 2 hours using both scales . The primary outcome measure was agreement between VAS and VNRS .  Secondary outcomes were ease of pain scale use and effect of patient demographics on pain scores . Agreement between scores was evaluated using the Bl and -Altman method . Results 123 patients were included ( median age 35 ; 43.9 % male ) . There was a strong correlation between VAS and VNRS  ( rs=0.93 ) . However , there was not perfect agreement between the two scales . Patient age ( older age , p<0.005 , t=−4.448 ) , gender ( female sex , p<0.005 , t=4.903 ) and educational level attained ( third level education , p<0.005 , t=5.575 ) had a statistically significant influence on the agreement between VAS and VNRS . There was a preference for VNRS in those patients who expressed a preference for one pain scale over the other . Conclusions VAS and VNRS are not interchangeable in assessing an individual patient 's pain over time in the ED setting . VNRS has practical advantages over VAS in this setting Background : Pain intensity is commonly reported using a 0–10 Numeric Rating Scale in pain clinical trials . Analysis of the change on the Pain Intensity Numerical Rating Scale as a proportion has most consistently correlated with clinical ly important differences reported on the patient 's global impression of change . The correlation of data from patients with breakthrough pain with a Pain Relief Scale and a different global outcome measures will extend our underst and ing of these measures . Methods : Data were obtained from the open titration phase of a multiple crossover , r and omized , double-blind clinical trial comparing oral transmucosal fentanyl citrate with immediate-release oral morphine sulfate for the treatment of cancer-related breakthrough pain . Raw and percentage changes in the pain intensity scores from 1,307 episodes of pain in 134 oral transmucosal fentanyl citrate-naïve patients were correlated with the clinical ly relevant secondary outcomes of Pain Relief Verbal Response Scale and the global medication performance scale . The changes in raw and percentage change were assessed over time and compared with the ordinal Pain Relief Verbal Response Scale and Global Medication Performance Scale . Results : The P value of the interaction between the raw pain intensity difference was significant ( P = 0.034 ) for four 15-min time periods but not for the percentage pain intensity difference score ( P = 0.26 ) . We found similar results in comparison with the ordinal Pain Relief Verbal Response Scale ( P = 0.0048 and P = 0.36 respectively ) and global medication performance categories ( P = 0.048 and P = 0.45 , respectively ) . Conclusion : The change in pain intensity in breakthrough pain was more consistent over time and when compared with both the Pain Relief Verbal Response Scale and the Global Medication Performance Scale when the percentage change is used rather than raw pain intensity difference STUDY OBJECTIVE To identify the minimum clinical ly significant difference in pain in elderly emergency department ( ED ) patients . METHODS This was an observational , prospect i ve study of a convenience sample of patients aged 65 years or older with acute pain . Patients rated their pain on an 11-point numeric rating scale ( NRS ) on entering the study and every 30 minutes for 2 hours . The arithmetic minimum clinical ly significant difference was defined as the mean difference between current and preceding NRS scores when the subject described his or her pain as " a little less pain " or " a little more pain . " The proportional minimum clinical ly significant difference was change in NRS in a 30-minute interval divided by the NRS at the beginning of the interval . We used generalized estimating equations to adjust for nonindependence of pain scores and to test trend over time . RESULTS One hundred ninety-five patients were enrolled ( mean age 74 years ; 73 % women ; 51 % Hispanic ; 33 % black ) . The arithmetic minimum clinical ly significant difference averaged over all periods was 1.5 ( 95 % confidence interval 1.3 to 1.6 ) , the proportional minimum clinical ly significant difference was 25 % ( 95 % confidence interval 20 % to 29 % ) . The arithmetic minimum clinical ly significant difference unexpectedly decreased over time : 2.1 from baseline to 30 minutes , 1.4 from 30 to 60 minutes , 1.3 from 60 to 90 minutes , and 1.0 from 90 to 120 minutes ( P<.001 ) . In contrast , the proportional differences were more stable : 27 % from baseline to 30 minutes , 22 % from 30 to 60 minutes , 22 % from 60 to 90 minutes , and 28 % from 90 to 120 minutes ( P=.89 ) . CONCLUSION The arithmetic minimum clinical ly significant difference in older ED patients was 1.5 NRS units and decreased over time , whereas the proportional change was 25 % and more stable 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 Study Design . Prospect i ve study of two sample s of patients with acute and chronic low back pain , respectively . Objectives . To compare the responsiveness of four functional status question naires , Rol and Morris Disability Question naire ( RMDQ ) ,  Oswestry Disability Index ( ODI ) ,  Disability Rating Index ( DRI ) , and  Physical Functioning scale of the SF-36 ( PFSF-36 ) , and two  pain scales , a  Numerical Pain Rating Scale ( NRS ) and  Visual Analogue Scale ( VAS ) .  Summary of Background Data . Concurrent comparisons of different outcome measurements in back patients have been requested . Methods .  Norwegian versions of the scales and question naires  were completed by 54 patients with acute ( < 3weeks ) and 50 patients with chronic low back pain ( > 3 months ) . Clinical change was estimated on a global change index . An alternative external criterion was the expected clinical course in the two cohorts . Mean changes , st and ardized response mean ( SRM ) , and area under the receiver operating characteristic ( ROC ) curves with cutoff point for highest sensitivity and specificity were calculated . Results . At the follow-up , 63 % of the acute and 41 % of the chronic sample reported improvement on the global change index . Large SRMs ( 1.3–2.0 ) and areas under the ROC curves ( 0.84–0.93 ) were found for the measurements in the acute sample . In the chronic sample , the SRMs ( 0.4–1.1 ) and areas under the ROC curves ( 0.65–0.83 ) were lower , in particular for the PFSF-36 and the VAS . There was no statistically significant difference between the responsiveness in the measurements , except for higher responsiveness in the NRS compared with the VAS when using expected clinical course as the external criterion for change . Conclusion . The results suggest that all the outcome measures were appropriate for measuring changes in functional status and pain in patients with acute low back pain , whereas among chronic patients the RMDQ , ODI , DRI , and NRS were most appropriate BACKGROUND : Self-reported pain scores are used widely in clinical and research setting s , yet little is known about their interpretability in children . In this prospect i ve , observational study we evaluated the relationship between 0 to 10 numerical rating scale ( NRS ) pain scores and other self-reported , clinical ly meaningful outcomes , including perceived need for medicine ( PNM ) , pain relief ( PR ) , and perceived satisfaction ( PS ) with treatment in children postoperatively . METHODS : This study included children ages 7 to 16 years undergoing surgery associated with postoperative pain . One to 4 observations were recorded in each child within the first 24 hours postoperatively . At each assessment , children rated their pain with the NRS , stated their PNM , and rated their satisfaction with  pain management .  Assessment s were repeated within 1 to 2 hours , and children additionally rated their PR as the same , better , or worse in comparison with the earlier assessment . Receiver operator characteristic curves were developed to examine potential NRS cut-points for PNM and PS , and the minimum clinical ly significant difference ( MCSD ) in pain score associated with PR was calculated . RESULTS : Three hundred ninety-seven observations ( including 189 pairs ) were recorded in 113 children .  NRS scores associated with PNM were significantly higher than “ no need ” ( median 6 vs. 3 ; P < 0.001 ) . NRS scores > 4 had good sensitivity ( 0.81 ) and specificity ( 0.70 ) to discriminate PNM , but with a large number of false positives and negatives ( e.g. , 42 % of children with scores > 4 did not need analgesia ) . The MCSD in NRS scores was −1 ( 95 % confidence interval [ CI ] −0.5 to 1 ) or + 1 ( CI 0.5 to 2.7 ) in relation to feel “ a little better ” or “ worse , ” respectively ( P < 0.001 vs. the same ) . NRS scores > 6 had a sensitivity of 0.82 and specificity of 0.76 in discriminating dissatisfaction with treatment , yet 46 % and 24 % of children with scores > 6 , respectively , were somewhat to very satisfied with their analgesia . CONCLUSIONS : This study provides important information regarding the clinical interpretation of NRS pain scores in children . Data further support the NRS as a valid measure of pain intensity in relation to the child 's PNM , PR , and PS in the acute postoperative setting . However , the variability in scores in relation to other clinical ly meaningful outcomes suggests that application of cut-points for individual treatment decisions is inappropriate OBJECTIVE The purpose of this study is to quantify , using the  Color Analog Scale ( CAS ) , the degree of change in pain severity required to achieve a clinical ly significant improvement in pain . METHODS A prospect i ve descriptive study , using convenience sampling of children aged 5 and 12 years presenting to a pediatric emergency department ( ED ) with acute pain , was done . Children were asked to mark their pain severity on a previously vali date d CAS . After a pain intervention , the child was again asked to mark their pain intensity on the CAS and asked to describe the relative change in their pain . The main outcome measure was to quantify the smallest change required for the child to state that their pain was improved . RESULTS One hundred twenty-six children with a mean age of 8.6 years ( SD , 2.8 years ) were enrolled . Males accounted for 56 % . Pain was traumatic in 47.6 % and nontraumatic in 52.4 % . Of the 126 pain comparisons made , 28 children described their pain as " the same " and had a mean change in score of -0.10 cm ( 95 % confidence interval [ CI ] , -2.27 to 2.07 cm ) . Pain was judged to be a " little less " in 58 children , and the CAS score changed by a mean of -2.4 cm ( 95 % CI , -3.15 to -1.72 cm ) . In the 29 children who judged their pain to be " much less , " the CAS score decreased by a mean of -5.4 cm ( 95 % CI , -6.50 to -4.40 ) . CONCLUSION A decrease on the CAS pain scale of 2.4 cm ( 95 % CI , 2.95 - 1.92 ) is a clinical ly significant change in pain for children aged 5 to 12 years with acute pain . The CAS is a valuable tool in assessing responses to pain interventions To test the relative merits of administering question naires with previous responses available ( the informed condition ) or unavailable ( the blind condition ) , we administered blind and informed versions of a quality of life question naire ( the Chronic Respiratory Disease Question naire , or CRQ ) in a r and omized , double-blind trial of bronchodilators in chronic airflow limitation . The responsiveness of the two methods , as reflected in the p-values associated with salbutamol and theophylline effects were comparable for three of the four dimensions of the CRQ . The data suggested possible increased responsiveness of the informed method for the emotional function dimension of the question naire . Changes in the informed CRQ dyspnea and fatigue dimensions showed stronger correlations with changes in spirometry , 6 minute walk distance , and rating of dyspnea after the walk test than did blind administration . Further , changes in all four CRQ dimensions showed stronger correlations with corresponding global ratings using the informed question naire . These 
    Output:
    
agent
From analyses of individual patient data ( seven studies , 918 patients ) , we found baseline pain strongly associated with absolute , but not relative , MCID as patients with higher baseline pain needed larger pain reduction to perceive relief .
Conclusions The MCID in acute pain varied greatly between studies and was influenced by baseline pain , definitions of improved patients and study design .
***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: Objectives To compare the Visual Analogue Scale ( VAS ) and the Verbal Numerical Rating Scale ( VNRS ) , in the assessment of acute pain in the emergency department ( ED ) . Furthermore , to determine the influence of demographics on this agreement and practical limitations of the scales . Setting St Vincent 's University Hospital , Dublin ; a 479-bed teaching hospital ; annual ED census 36 000 adult patients . Methods A prospect i ve observational study was conducted on ED patients with acute pain as a component of their presenting complaint . Eligible patients scored their pain on both VAS and VNRS within 1 hour of arrival . They rescored their pain every 30 minutes for 2 hours using both scales . The primary outcome measure was agreement between VAS and VNRS .  Secondary outcomes were ease of pain scale use and effect of patient demographics on pain scores . Agreement between scores was evaluated using the Bl and -Altman method . Results 123 patients were included ( median age 35 ; 43.9 % male ) . There was a strong correlation between VAS and VNRS  ( rs=0.93 ) . However , there was not perfect agreement between the two scales . Patient age ( older age , p<0.005 , t=−4.448 ) , gender ( female sex , p<0.005 , t=4.903 ) and educational level attained ( third level education , p<0.005 , t=5.575 ) had a statistically significant influence on the agreement between VAS and VNRS . There was a preference for VNRS in those patients who expressed a preference for one pain scale over the other . Conclusions VAS and VNRS are not interchangeable in assessing an individual patient 's pain over time in the ED setting . VNRS has practical advantages over VAS in this setting Background : Pain intensity is commonly reported using a 0–10 Numeric Rating Scale in pain clinical trials . Analysis of the change on the Pain Intensity Numerical Rating Scale as a proportion has most consistently correlated with clinical ly important differences reported on the patient 's global impression of change . The correlation of data from patients with breakthrough pain with a Pain Relief Scale and a different global outcome measures will extend our underst and ing of these measures . Methods : Data were obtained from the open titration phase of a multiple crossover , r and omized , double-blind clinical trial comparing oral transmucosal fentanyl citrate with immediate-release oral morphine sulfate for the treatment of cancer-related breakthrough pain . Raw and percentage changes in the pain intensity scores from 1,307 episodes of pain in 134 oral transmucosal fentanyl citrate-naïve patients were correlated with the clinical ly relevant secondary outcomes of Pain Relief Verbal Response Scale and the global medication performance scale . The changes in raw and percentage change were assessed over time and compared with the ordinal Pain Relief Verbal Response Scale and Global Medication Performance Scale . Results : The P value of the interaction between the raw pain intensity difference was significant ( P = 0.034 ) for four 15-min time periods but not for the percentage pain intensity difference score ( P = 0.26 ) . We found similar results in comparison with the ordinal Pain Relief Verbal Response Scale ( P = 0.0048 and P = 0.36 respectively ) and global medication performance categories ( P = 0.048 and P = 0.45 , respectively ) . Conclusion : The change in pain intensity in breakthrough pain was more consistent over time and when compared with both the Pain Relief Verbal Response Scale and the Global Medication Performance Scale when the percentage change is used rather than raw pain intensity difference STUDY OBJECTIVE To identify the minimum clinical ly significant difference in pain in elderly emergency department ( ED ) patients . METHODS This was an observational , prospect i ve study of a convenience sample of patients aged 65 years or older with acute pain . Patients rated their pain on an 11-point numeric rating scale ( NRS ) on entering the study and every 30 minutes for 2 hours . The arithmetic minimum clinical ly significant difference was defined as the mean difference between current and preceding NRS scores when the subject described his or her pain as " a little less pain " or " a little more pain . " The proportional minimum clinical ly significant difference was change in NRS in a 30-minute interval divided by the NRS at the beginning of the interval . We used generalized estimating equations to adjust for nonindependence of pain scores and to test trend over time . RESULTS One hundred ninety-five patients were enrolled ( mean age 74 years ; 73 % women ; 51 % Hispanic ; 33 % black ) . The arithmetic minimum clinical ly significant difference averaged over all periods was 1.5 ( 95 % confidence interval 1.3 to 1.6 ) , the proportional minimum clinical ly significant difference was 25 % ( 95 % confidence interval 20 % to 29 % ) . The arithmetic minimum clinical ly significant difference unexpectedly decreased over time : 2.1 from baseline to 30 minutes , 1.4 from 30 to 60 minutes , 1.3 from 60 to 90 minutes , and 1.0 from 90 to 120 minutes ( P<.001 ) . In contrast , the proportional differences were more stable : 27 % from baseline to 30 minutes , 22 % from 30 to 60 minutes , 22 % from 60 to 90 minutes , and 28 % from 90 to 120 minutes ( P=.89 ) . CONCLUSION The arithmetic minimum clinical ly significant difference in older ED patients was 1.5 NRS units and decreased over time , whereas the proportional change was 25 % and more stable 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 Study Design . Prospect i ve study of two sample s of patients with acute and chronic low back pain , respectively . Objectives . To compare the responsiveness of four functional status question naires , Rol and Morris Disability Question naire ( RMDQ ) ,  Oswestry Disability Index ( ODI ) ,  Disability Rating Index ( DRI ) , and  Physical Functioning scale of the SF-36 ( PFSF-36 ) , and two  pain scales , a  Numerical Pain Rating Scale ( NRS ) and  Visual Analogue Scale ( VAS ) .  Summary of Background Data . Concurrent comparisons of different outcome measurements in back patients have been requested . Methods .  Norwegian versions of the scales and question naires  were completed by 54 patients with acute ( < 3weeks ) and 50 patients with chronic low back pain ( > 3 months ) . Clinical change was estimated on a global change index . An alternative external criterion was the expected clinical course in the two cohorts . Mean changes , st and ardized response mean ( SRM ) , and area under the receiver operating characteristic ( ROC ) curves with cutoff point for highest sensitivity and specificity were calculated . Results . At the follow-up , 63 % of the acute and 41 % of the chronic sample reported improvement on the global change index . Large SRMs ( 1.3–2.0 ) and areas under the ROC curves ( 0.84–0.93 ) were found for the measurements in the acute sample . In the chronic sample , the SRMs ( 0.4–1.1 ) and areas under the ROC curves ( 0.65–0.83 ) were lower , in particular for the PFSF-36 and the VAS . There was no statistically significant difference between the responsiveness in the measurements , except for higher responsiveness in the NRS compared with the VAS when using expected clinical course as the external criterion for change . Conclusion . The results suggest that all the outcome measures were appropriate for measuring changes in functional status and pain in patients with acute low back pain , whereas among chronic patients the RMDQ , ODI , DRI , and NRS were most appropriate BACKGROUND : Self-reported pain scores are used widely in clinical and research setting s , yet little is known about their interpretability in children . In this prospect i ve , observational study we evaluated the relationship between 0 to 10 numerical rating scale ( NRS ) pain scores and other self-reported , clinical ly meaningful outcomes , including perceived need for medicine ( PNM ) , pain relief ( PR ) , and perceived satisfaction ( PS ) with treatment in children postoperatively . METHODS : This study included children ages 7 to 16 years undergoing surgery associated with postoperative pain . One to 4 observations were recorded in each child within the first 24 hours postoperatively . At each assessment , children rated their pain with the NRS , stated their PNM , and rated their satisfaction with  pain management .  Assessment s were repeated within 1 to 2 hours , and children additionally rated their PR as the same , better , or worse in comparison with the earlier assessment . Receiver operator characteristic curves were developed to examine potential NRS cut-points for PNM and PS , and the minimum clinical ly significant difference ( MCSD ) in pain score associated with PR was calculated . RESULTS : Three hundred ninety-seven observations ( including 189 pairs ) were recorded in 113 children .  NRS scores associated with PNM were significantly higher than “ no need ” ( median 6 vs. 3 ; P < 0.001 ) . NRS scores > 4 had good sensitivity ( 0.81 ) and specificity ( 0.70 ) to discriminate PNM , but with a large number of false positives and negatives ( e.g. , 42 % of children with scores > 4 did not need analgesia ) . The MCSD in NRS scores was −1 ( 95 % confidence interval [ CI ] −0.5 to 1 ) or + 1 ( CI 0.5 to 2.7 ) in relation to feel “ a little better ” or “ worse , ” respectively ( P < 0.001 vs. the same ) . NRS scores > 6 had a sensitivity of 0.82 and specificity of 0.76 in discriminating dissatisfaction with treatment , yet 46 % and 24 % of children with scores > 6 , respectively , were somewhat to very satisfied with their analgesia . CONCLUSIONS : This study provides important information regarding the clinical interpretation of NRS pain scores in children . Data further support the NRS as a valid measure of pain intensity in relation to the child 's PNM , PR , and PS in the acute postoperative setting . However , the variability in scores in relation to other clinical ly meaningful outcomes suggests that application of cut-points for individual treatment decisions is inappropriate OBJECTIVE The purpose of this study is to quantify , using the  Color Analog Scale ( CAS ) , the degree of change in pain severity required to achieve a clinical ly significant improvement in pain . METHODS A prospect i ve descriptive study , using convenience sampling of children aged 5 and 12 years presenting to a pediatric emergency department ( ED ) with acute pain , was done . Children were asked to mark their pain severity on a previously vali date d CAS . After a pain intervention , the child was again asked to mark their pain intensity on the CAS and asked to describe the relative change in their pain . The main outcome measure was to quantify the smallest change required for the child to state that their pain was improved . RESULTS One hundred twenty-six children with a mean age of 8.6 years ( SD , 2.8 years ) were enrolled . Males accounted for 56 % . Pain was traumatic in 47.6 % and nontraumatic in 52.4 % . Of the 126 pain comparisons made , 28 children described their pain as " the same " and had a mean change in score of -0.10 cm ( 95 % confidence interval [ CI ] , -2.27 to 2.07 cm ) . Pain was judged to be a " little less " in 58 children , and the CAS score changed by a mean of -2.4 cm ( 95 % CI , -3.15 to -1.72 cm ) . In the 29 children who judged their pain to be " much less , " the CAS score decreased by a mean of -5.4 cm ( 95 % CI , -6.50 to -4.40 ) . CONCLUSION A decrease on the CAS pain scale of 2.4 cm ( 95 % CI , 2.95 - 1.92 ) is a clinical ly significant change in pain for children aged 5 to 12 years with acute pain . The CAS is a valuable tool in assessing responses to pain interventions To test the relative merits of administering question naires with previous responses available ( the informed condition ) or unavailable ( the blind condition ) , we administered blind and informed versions of a quality of life question naire ( the Chronic Respiratory Disease Question naire , or CRQ ) in a r and omized , double-blind trial of bronchodilators in chronic airflow limitation . The responsiveness of the two methods , as reflected in the p-values associated with salbutamol and theophylline effects were comparable for three of the four dimensions of the CRQ . The data suggested possible increased responsiveness of the informed method for the emotional function dimension of the question naire . Changes in the informed CRQ dyspnea and fatigue dimensions showed stronger correlations with changes in spirometry , 6 minute walk distance , and rating of dyspnea after the walk test than did blind administration . Further , changes in all four CRQ dimensions showed stronger correlations with corresponding global ratings using the informed question naire . These 
    Output:
    