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 develop a sham needle device and test its credibility as a control for acupuncture when used in a r and omised controlled trial of myofascial trigger point needling in patients with whiplash associated pain . Methods Sham needles were developed by blunting true acupuncture needles . Whiplash injured patients ( < 16 weeks duration ) were r and omly allocated to receive either true acupuncture or the “ placebo ” sham needle control . The true and sham needling interventions were delivered using the same st and ardised procedure . Patients were informed that they would receive either real or placebo needles , and asked ( i ) to state which treatment they believed they had received ( treatment belief ) ; ( ii ) to complete the four item Borkovec and Nau self- assessment credibility scale . Results were compared between groups and the analysis explored whether a patient 's previous experience of acupuncture was related to their treatment belief . Other outcomes of the study will be reported elsewhere . Results 20 patients received the true acupuncture and 21 received the sham . There was no significant difference between the treatment beliefs of the two groups ( χ 2 = 1.51 ; p>0.2 ) nor in the mean item scores on the Borkovec and Nau credibility scale ( t test , p values ranged from 0.38 to 0.87 ) . Of the patients in the sham acupuncture group who had previous experience of acupuncture , none recorded receiving the sham intervention . Conclusion Within the context of this pilot study , the sham acupuncture intervention was found to be a credible control for acupuncture . This supports its use in a planned , definitive , r and omised controlled trial on a similar whiplash injured population Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials BACKGROUND AND PURPOSE Systematic review s and meta-analyses often include an evaluation of the method ological quality of the individual studies that have been included , and are usually conducted by at least 2 individuals . The objective of this study was to assess the method ological quality and reliability of a series of r and omized controlled trials ( RCTs ) of both pharmacological and nonpharmacological interventions by use of the 10-item Physiotherapy Evidence -Based Data base ( PEDro ) Scale . METHODS Two abstract ors independently review ed 81 RCTs assessing a variety of interventions . The Cohen kappa statistic and the intraclass correlation coefficient ( ICC ) were used to assess agreement between abstract ors . RESULTS The average total PEDro scores were 5.94 ( SD=1.43 ) for all studies combined , 6.88 ( SD=1.2 ) for pharmacological studies , and 5.29 ( SD=1.26 ) for nonpharmacological studies . The median score for pharmacological studies was significantly higher than that for nonpharmacological studies ( 7 versus 5 ) . Pair-wise kappa scores ranged from a low of .452 for concealed allocation among drug trials to perfect agreement ( 1.00 ) for r and omization and reporting of results from between-group comparisons . The ICCs associated with the cumulative PEDro score were .91 ( 95 % confidence interval [CI]=.83-.94 ) for all studies , .89 ( 95 % CI=.78-.95 ) for pharmacological studies , and .91 ( 95 % CI=.84-.952 ) for nonpharmacological studies . DISCUSSION AND CONCLUSION The method ological quality for pharmacological interventions was significantly higher than that for nonpharmacological interventions . There was good agreement between raters at an individual item level and in total PEDro scores . A lack of reporting clarity , poor organization of the report , or the failure to include salient details contributed to less-than-perfect agreement between raters The existing review s of massage therapy ( MT ) research are either limited to infants , adults , or were conducted prior to the publication of the most recent studies using pediatric sample s. R and omized controlled trials ( RCTs ) of pediatric MT are review ed . A literature search yielded 24 RCTs of pediatric MT  , defined as the manual manipulation of soft tissue intended to promote health and well-being in recipients between 2 and 19 years of age . Because RCTs of pediatric MT varied considerably in the amount and types of data reported , quantitative and narrative review methods were both used . Singledose and multiple-dose effects were examined separately . Among single-dose effects , significant reductions of state anxiety were observed at the first session ( g 1⁄4 0.59 , P < 0.05 ) and the last session ( g 1⁄4 1.10 , P < 0.01 ) of a course of treatment . Effects for salivary cortisol ( g 1⁄4 0.28 ) , negative mood ( g 1⁄4 0.52 ) and behavior ( g 1⁄4 0.37 ) were non-significant . Three of eleven multiple-dose effects were statistically significant . These were trait anxiety ( g 1⁄4 0.94 , P < 0.05 ) , muscle tone ( g 1⁄4 0.90 , P < 0.01 ) and arthritis pain ( g1⁄4 1.33 , P < 0.01 ) . Results of studies not permitting effect size calculation were judged to be generally consistent with quantitative results . MT benefits pediatric recipients , though not as universally as sometimes reported . Numerous weaknesses endemic to MT research ( e.g. low statistical power , frequent failure to report basic descriptive statistics ) are identified , and recommendations for future pediatric MT research are discussed OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture  was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than  acupuncture  that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture  trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries The aim of this study is to assess the reported quality of r and omized controlled trials ( RCTs ) on the effectiveness of neglect rehabilitation using a st and ardized scale . A search of seven electronic data bases was carried out . Selected articles were scored using the PEDro scale and classified as high or low quality study both with the original cut off of 6 and a modified cut off of 5 . A linear regression analysis between year of publication and quality rate was used to test whether the quality of the studies improved with time . A total of 18 RCTs were selected . Six articles ( 33.3 % ) and 10 articles ( 55.56 % ) were classified as having high quality when the original cut off or the modified cut off of the PEDro scale were used , respectively . Analysis shows no time-related changes in PEDro scores . The results show that reported quality is moderate for RCTs in neglect rehabilitation OBJECTIVE To determine the efficacy of acupuncture in the treatment of chronic musculoskeletal shoulder pain in subjects with spinal cord injury ( SCI ) . DESIGN R and omized , double blind ( participants , evaluator ) , placebo ( invasive sham ) controlled trial . SETTING Clinical research center . PARTICIPANTS Seventeen manual wheelchair-using subjects with chronic SCI and chronic musculoskeletal shoulder pain . INTERVENTIONS Participants were r and omly assigned to receive 10 treatments of either acupuncture or invasive sham acupuncture ( light needling of nonacupuncture points ) . MAIN OUTCOME MEASURE Changes in shoulder pain intensity were measured using the Wheelchair User 's Shoulder Pain Index . RESULTS Shoulder pain decreased significantly over time in both the acupuncture and the sham acupuncture groups ( P=.005 ) , with decreases of 66 % and 43 % , respectively . There was no significant difference between the 2 groups ( P=.364 ) . There was , however , a medium effect size associated with the acupuncture treatment . CONCLUSIONS There appears to be an analgesic effect or a powerful placebo effect associated with both acupuncture and sham acupuncture . There was a medium treatment effect associated with the acupuncture , which suggests that it may be superior to sham acupuncture . This observation , along with the limited power , indicates that a larger , more definitive r and omized controlled trial using a similar design is warranted Eighty patients with spinal cord injury ( SCI ) and neurogenic bladder were studied . Among them , 28 ( 70 % ) cases in the control group and 32 ( 80 % ) cases in the electroacupuncture group achieved ultimately balanced voiding and were selected for further analysis . The acupuncture group received electroacupuncture at four acupoints : Chung Chi ( Conception Vessel CV3 ) , Kuan Yuan ( CV4 ) , and bilateral Tzu Liao ( Urinary Bladder UB32 ) , in addition to conventional intermittent catheterization program ( ICP ) . Whereas the control group underwent conventional bladder training program with ICP only . The results revealed that the time of achieving balanced voiding was statistically significantly shorter with electroacupuncture than in the control group : 57.1±22.5 vs 85.2±27.4 days ( P<0.005 ) for upper motor neuron lesions , and 55.4±22.6 vs 83.4±26.1 days ( P<0.01 ) for lower motor neuron lesions . However , there was almost no difference between upper motor neuron lesions and lower motor neuron lesions . When acupuncture commenced was also a factor to influence the results . Those who received acupuncture within 3 weeks after injury had significantly shortened the total days to achieve a balanced bladder , as compared to those who received acupuncture 3 weeks after injury ( 46.6±13.2 vs 65.8±15.4 days , P<0.005 ) . Our study implied that acupuncture might be beneficial in the management of neurogenic bladder of SCI , and the earlier the patient received electro-acupuncture therapy , the sooner the bladder balanced . On the other h and , we also found that complete spinal cord injury , either with pronounced detrusor-sphincter dyssynergia in upper motor nueron lesion or with persistent areflexic bladder in lower motor neuron lesion , was not affected by acupuncture BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies 
    Output:
    
agent
***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 develop a sham needle device and test its credibility as a control for acupuncture when used in a r and omised controlled trial of myofascial trigger point needling in patients with whiplash associated pain . Methods Sham needles were developed by blunting true acupuncture needles . Whiplash injured patients ( < 16 weeks duration ) were r and omly allocated to receive either true acupuncture or the “ placebo ” sham needle control . The true and sham needling interventions were delivered using the same st and ardised procedure . Patients were informed that they would receive either real or placebo needles , and asked ( i ) to state which treatment they believed they had received ( treatment belief ) ; ( ii ) to complete the four item Borkovec and Nau self- assessment credibility scale . Results were compared between groups and the analysis explored whether a patient 's previous experience of acupuncture was related to their treatment belief . Other outcomes of the study will be reported elsewhere . Results 20 patients received the true acupuncture and 21 received the sham . There was no significant difference between the treatment beliefs of the two groups ( χ 2 = 1.51 ; p>0.2 ) nor in the mean item scores on the Borkovec and Nau credibility scale ( t test , p values ranged from 0.38 to 0.87 ) . Of the patients in the sham acupuncture group who had previous experience of acupuncture , none recorded receiving the sham intervention . Conclusion Within the context of this pilot study , the sham acupuncture intervention was found to be a credible control for acupuncture . This supports its use in a planned , definitive , r and omised controlled trial on a similar whiplash injured population Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials BACKGROUND AND PURPOSE Systematic review s and meta-analyses often include an evaluation of the method ological quality of the individual studies that have been included , and are usually conducted by at least 2 individuals . The objective of this study was to assess the method ological quality and reliability of a series of r and omized controlled trials ( RCTs ) of both pharmacological and nonpharmacological interventions by use of the 10-item Physiotherapy Evidence -Based Data base ( PEDro ) Scale . METHODS Two abstract ors independently review ed 81 RCTs assessing a variety of interventions . The Cohen kappa statistic and the intraclass correlation coefficient ( ICC ) were used to assess agreement between abstract ors . RESULTS The average total PEDro scores were 5.94 ( SD=1.43 ) for all studies combined , 6.88 ( SD=1.2 ) for pharmacological studies , and 5.29 ( SD=1.26 ) for nonpharmacological studies . The median score for pharmacological studies was significantly higher than that for nonpharmacological studies ( 7 versus 5 ) . Pair-wise kappa scores ranged from a low of .452 for concealed allocation among drug trials to perfect agreement ( 1.00 ) for r and omization and reporting of results from between-group comparisons . The ICCs associated with the cumulative PEDro score were .91 ( 95 % confidence interval [CI]=.83-.94 ) for all studies , .89 ( 95 % CI=.78-.95 ) for pharmacological studies , and .91 ( 95 % CI=.84-.952 ) for nonpharmacological studies . DISCUSSION AND CONCLUSION The method ological quality for pharmacological interventions was significantly higher than that for nonpharmacological interventions . There was good agreement between raters at an individual item level and in total PEDro scores . A lack of reporting clarity , poor organization of the report , or the failure to include salient details contributed to less-than-perfect agreement between raters The existing review s of massage therapy ( MT ) research are either limited to infants , adults , or were conducted prior to the publication of the most recent studies using pediatric sample s. R and omized controlled trials ( RCTs ) of pediatric MT are review ed . A literature search yielded 24 RCTs of pediatric MT  , defined as the manual manipulation of soft tissue intended to promote health and well-being in recipients between 2 and 19 years of age . Because RCTs of pediatric MT varied considerably in the amount and types of data reported , quantitative and narrative review methods were both used . Singledose and multiple-dose effects were examined separately . Among single-dose effects , significant reductions of state anxiety were observed at the first session ( g 1⁄4 0.59 , P < 0.05 ) and the last session ( g 1⁄4 1.10 , P < 0.01 ) of a course of treatment . Effects for salivary cortisol ( g 1⁄4 0.28 ) , negative mood ( g 1⁄4 0.52 ) and behavior ( g 1⁄4 0.37 ) were non-significant . Three of eleven multiple-dose effects were statistically significant . These were trait anxiety ( g 1⁄4 0.94 , P < 0.05 ) , muscle tone ( g 1⁄4 0.90 , P < 0.01 ) and arthritis pain ( g1⁄4 1.33 , P < 0.01 ) . Results of studies not permitting effect size calculation were judged to be generally consistent with quantitative results . MT benefits pediatric recipients , though not as universally as sometimes reported . Numerous weaknesses endemic to MT research ( e.g. low statistical power , frequent failure to report basic descriptive statistics ) are identified , and recommendations for future pediatric MT research are discussed OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture  was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than  acupuncture  that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture  trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries The aim of this study is to assess the reported quality of r and omized controlled trials ( RCTs ) on the effectiveness of neglect rehabilitation using a st and ardized scale . A search of seven electronic data bases was carried out . Selected articles were scored using the PEDro scale and classified as high or low quality study both with the original cut off of 6 and a modified cut off of 5 . A linear regression analysis between year of publication and quality rate was used to test whether the quality of the studies improved with time . A total of 18 RCTs were selected . Six articles ( 33.3 % ) and 10 articles ( 55.56 % ) were classified as having high quality when the original cut off or the modified cut off of the PEDro scale were used , respectively . Analysis shows no time-related changes in PEDro scores . The results show that reported quality is moderate for RCTs in neglect rehabilitation OBJECTIVE To determine the efficacy of acupuncture in the treatment of chronic musculoskeletal shoulder pain in subjects with spinal cord injury ( SCI ) . DESIGN R and omized , double blind ( participants , evaluator ) , placebo ( invasive sham ) controlled trial . SETTING Clinical research center . PARTICIPANTS Seventeen manual wheelchair-using subjects with chronic SCI and chronic musculoskeletal shoulder pain . INTERVENTIONS Participants were r and omly assigned to receive 10 treatments of either acupuncture or invasive sham acupuncture ( light needling of nonacupuncture points ) . MAIN OUTCOME MEASURE Changes in shoulder pain intensity were measured using the Wheelchair User 's Shoulder Pain Index . RESULTS Shoulder pain decreased significantly over time in both the acupuncture and the sham acupuncture groups ( P=.005 ) , with decreases of 66 % and 43 % , respectively . There was no significant difference between the 2 groups ( P=.364 ) . There was , however , a medium effect size associated with the acupuncture treatment . CONCLUSIONS There appears to be an analgesic effect or a powerful placebo effect associated with both acupuncture and sham acupuncture . There was a medium treatment effect associated with the acupuncture , which suggests that it may be superior to sham acupuncture . This observation , along with the limited power , indicates that a larger , more definitive r and omized controlled trial using a similar design is warranted Eighty patients with spinal cord injury ( SCI ) and neurogenic bladder were studied . Among them , 28 ( 70 % ) cases in the control group and 32 ( 80 % ) cases in the electroacupuncture group achieved ultimately balanced voiding and were selected for further analysis . The acupuncture group received electroacupuncture at four acupoints : Chung Chi ( Conception Vessel CV3 ) , Kuan Yuan ( CV4 ) , and bilateral Tzu Liao ( Urinary Bladder UB32 ) , in addition to conventional intermittent catheterization program ( ICP ) . Whereas the control group underwent conventional bladder training program with ICP only . The results revealed that the time of achieving balanced voiding was statistically significantly shorter with electroacupuncture than in the control group : 57.1±22.5 vs 85.2±27.4 days ( P<0.005 ) for upper motor neuron lesions , and 55.4±22.6 vs 83.4±26.1 days ( P<0.01 ) for lower motor neuron lesions . However , there was almost no difference between upper motor neuron lesions and lower motor neuron lesions . When acupuncture commenced was also a factor to influence the results . Those who received acupuncture within 3 weeks after injury had significantly shortened the total days to achieve a balanced bladder , as compared to those who received acupuncture 3 weeks after injury ( 46.6±13.2 vs 65.8±15.4 days , P<0.005 ) . Our study implied that acupuncture might be beneficial in the management of neurogenic bladder of SCI , and the earlier the patient received electro-acupuncture therapy , the sooner the bladder balanced . On the other h and , we also found that complete spinal cord injury , either with pronounced detrusor-sphincter dyssynergia in upper motor nueron lesion or with persistent areflexic bladder in lower motor neuron lesion , was not affected by acupuncture BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies 
    Output:
    