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: BACKGROUND AND OBJECTIVE To develop a checklist of items measuring the quality of reports of r and omized clinical trials ( RCTs ) assessing nonpharmacological treatments ( NPTs ) . STUDY DESIGN AND SETTING The Delphi consensus method was used to select and reduce the number of items in the checklist . A total of 154 individuals were invited to participate : epidemiologists and statisticians involved in the field of methodology of RCTs ( n = 55 ) , members of the Cochrane Collaboration ( n = 41 ) , and clinicians involved in planning NPT clinical trials ( n = 58 ) . Participants ranked on a 10-point Likert scale whether an item should be included in the checklist . RESULTS Fifty-five experts ( 36 % ) participated in the survey . They were experienced in systematic review s ( 68 % were involved in the Cochrane Collaboration ) and in planning RCTs ( 76 % ) . Three rounds of the Delphi method were conducted to achieve consensus . The final checklist contains 10 items and 5 subitems , with items related to the st and ardization of the intervention , care provider influence , and additional measures to minimize the potential bias from lack of blinding of participants , care providers , and outcome assessors . CONCLUSIONS This tool can be used to critically appraise the medical literature , design NPT studies , and assess the quality of trial reports included in systematic review OBJECTIVE We performed a r and omised trial to evaluate if intensive supervised training of the back should be offered to all patients after a first lumbar diskectomy . METHODS Forty consecutive patients were , after a first lumbar diskectomy , r and omly allocated to 2 groups undergoing " supervised training " twice a week for 3 months in an outpatient clinic or " home training " after 2 hours of instruction . RESULTS The two rehabilitation models both showed a significant effect on spinal mobility , isokinetic trunk flexion strength , isokinetic trunk extension strength and daily function . These improvements were unchanged at follow up 3 months later . The pain score remained unchanged , however , throughout the trial in both groups . No differences in effect between the two rehabilitation models could be found for any of the assessed parameters . Thirteen patients did not complete the trial , including 9 from the supervised endurance trained group , mainly because of increased pain and reprolaps ( n = 4 ) . Four patients dropped out of the home trained group , only one because of increased pain . The differences in drop-out rate and training side effects were , however , not statistically significant . CONCLUSION We conclude that it is not worthwhile to implement 3 months of supervised intensive endurance training as opposed to home training in all cases of first lumbar diskectomy , although a beneficial effect and better compliance might be found for a selected group of such patients As the average life expectancy of the population increases , surgical decompression of the lumbar spine is being performed with increasing frequency . It now constitutes the most common type of lumbar spinal surgery in older patients . The present prospect i ve study examined the 5-year outcome of lumbar decompression surgery without fusion . The group comprised 159 patients undergoing decompression for degenerative spinal disorders who had been participants in a r and omised controlled trial of post-operative rehabilitation that had shown no between-group differences at 2 years . Leg pain and back pain intensity ( 0–10 graphic rating scale ) , self-rated disability ( Rol and Morris ) , global outcome of surgery ( 5-point Likert scale ) and re-operation rates were assessed 5 years post-operatively . Ten patients had died before the 5-year follow-up . Of the remaining 149 patients , 143 returned a 5-year follow-up ( FU ) question naire ( effective return rate excluding deaths , 96 % ) . Their mean age was 64 ( SD 11 ) years and 92/143 ( 64 % ) were men . In the 5-year follow-up period , 34/143 patients ( 24 % ) underwent re-operation ( 17 further decompressions , 17 fusions and 1 intradural drainage/debridement ) . In patients who were not re-operated , leg pain decreased significantly ( p < 0.05 ) from before surgery to 2 months FU , after which there was no significant change up to 5 years . Low back pain also decreased significantly by 2 months FU , but then showed a slight , but significant ( p < 0.05 ) , gradual increase of < 1 point by 5-year FU . Disability decreased significantly from pre-operative to 2 months FU and showed a further significant decrease at 5 months FU . Thereafter , it remained stable up to the 5-year FU . Pain and disability scores recorded after 5 years showed a significant correlation with those at earlier follow-ups ( r = 0.53–0.82 ; p < 0.05 ) . Patients who were re-operated at some stage over the 5-year period showed significantly worse final outcomes for leg pain and disability ( p < 0.05 ) . In conclusion , pain and disability showed minimal change in the 5-year period after surgery , but the re-operation rate was relatively high . Re-operation result ed in worse final outcomes in terms of leg pain and disability . At the 5-year follow-up , the “ average ” patient experienced frequent , but relatively low levels of , pain and moderate disability . This knowledge on the long-term outcome should be incorporated into the pre-operative patient information process CONTEXT Lumbar diskectomy is the most common surgical procedure performed for back and leg symptoms in US patients , but the efficacy of the procedure relative to nonoperative care remains controversial . OBJECTIVE To assess the efficacy of surgery for lumbar intervertebral disk herniation . DESIGN , SETTING , AND PATIENTS The Spine Patient Outcomes Research Trial , a r and omized clinical trial enrolling patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 US states . Patients were 501 surgical c and i date s ( mean age , 42 years ; 42 % women ) with imaging-confirmed lumbar intervertebral disk herniation and persistent signs and symptoms of radiculopathy for at least 6 weeks . INTERVENTIONS St and ard open diskectomy vs nonoperative treatment individualized to the patient . MAIN OUTCOME MEASURES Primary outcomes were changes from baseline for the Medical Outcomes Study 36-item Short-Form Health Survey bodily pain and physical function scales and the modified Oswestry Disability Index ( American Academy of Orthopaedic Surgeons MODEMS version ) at 6 weeks , 3 months , 6 months , and 1 and 2 years from enrollment . Secondary outcomes included sciatica severity as measured by the Sciatica Bothersomeness Index , satisfaction with symptoms , self-reported improvement , and employment status . RESULTS Adherence to assigned treatment was limited : 50 % of patients assigned to surgery received surgery within 3 months of enrollment , while 30 % of those assigned to nonoperative treatment received surgery in the same period . Intent-to-treat analyses demonstrated substantial improvements for all primary and secondary outcomes in both treatment groups . Between-group differences in improvements were consistently in favor of surgery for all periods but were small and not statistically significant for the primary outcomes . CONCLUSIONS Patients in both the surgery and the nonoperative treatment groups improved substantially over a 2-year period . Because of the large numbers of patients who crossed over in both directions , conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00000410 Study Design This was a study of a st and ardized functional restoration program that included 11 centers in saven states , involving 303 patients in the treatment group and 94 patients in the comparison group . Objective To illustrative the positive effect a functional restoration program has on return to work rates and work retention regardless of previous surgical intervention . Summary of Background Data Data were obtained from the initial and discharge evaluations as well as at 6− and 12-month follow-up . Methods Patients received a st and ardized work capacity assessment upon entrance and were recommended to the program if they adhered to specific entrance criteria . Treatment patients received the same evaluation at discharge . Results Significant improvement in functional abilities , actual return to work , and work retention were noted in the treatment group regardless of treatment intervention . Conclusions This study demonstrated improved return to work rates and work retention with surgical and nonsurgical patients after their participation in a functional restoration program BACKGROUND Lumbar-disk surgery often is performed in patients who have sciatica that does not resolve within 6 weeks , but the optimal timing of surgery is not known . METHODS We r and omly assigned 283 patients who had had severe sciatica for 6 to 12 weeks to early surgery  or to prolonged conservative treatment with surgery if needed . The primary outcomes were the score on the Rol and Disability Question naire , the score on the visual-analogue scale for leg pain , and the patient 's report of perceived recovery during the first year after r and omization . Repeated- measures analysis according to the intention-to-treat principle was used to estimate the outcome curves for both groups . RESULTS Of 141 patients assigned to undergo early surgery  , 125 ( 89 % ) underwent  microdiskectomy  after a mean of 2.2 weeks . Of 142 patients design ated for conservative treatment , 55 ( 39 % ) were treated surgically after a mean of 18.7 weeks . There was no significant overall difference in disability scores during the first year ( P=0.13 ) . Relief of leg pain was faster for patients assigned to early surgery ( P<0.001 ) . Patients assigned to early surgery also reported a faster rate of perceived recovery ( hazard ratio , 1.97 ; 95 % confidence interval , 1.72 to 2.22 ; P<0.001 ) . In both groups , however , the probability of perceived recovery after 1 year of follow-up was 95 % . CONCLUSIONS The 1-year outcomes were similar for patients assigned to early surgery and those assigned to conservative treatment with eventual surgery if needed , but the rates of pain relief and of perceived recovery were faster for those assigned to early surgery . ( Current Controlled Trials number , IS RCT N26872154 [ controlled-trials.com ] . ) Study Design . We r and omized 200 patients after lumbar discectomy to receive  epidural steroid or none with a 2-year follow-up . Objective . To evaluate the outcome , neurologic impairment and safety of epidural steroid following lumbar discectomy for herniated disc disease . Summary of Background Data . Convalescence after discectomy for herniated disc disease is dependent on pain and the inflammatory response . Previous studies in arthroscopic and abdominal surgery demonstrate steroids , which reduce the inflammatory response and enhance recovery . Here we report a 2-year follow-up of a r and omized trial of epidural steroid following lumbar discectomy . Methods . Through 2001 and 2003 200 patients undergoing discectomy for herniated disc disease were r and omly allocated to receive epidural methylprednisolone 40 mg or none . In the control group ( 62 males and 38 females , median age 41 years , 18–66 ) 48 L5 , 50 L4 , and 6 L3 discectomies were performed and in the intervention group ( 60 males and 40 females , median age 45 years , 15–53 ) 56 L5 , 46 L4 , and 3 L3 discectomies . Contemporary with r and omization to epidural steroid or none both groups received preoperative prophylactic antibiotics and the same multimodal pain treatment . Results . Hospital stay was reduced from 8 to 6 days ( P = 0.0001 ) and the number of patients with neurologic signs were reduced more ( 70 % vs. 44 % , P = 0.0004 ) by epidural steroid . Incidence of reoperation at 1 year was 6 % in both groups and 8 % in the control group and 7 % in the intervention group after 2 years . No infections were registered . Conclusion . Epidural methylprednisolone enhances recovery after discectomy for herniated disc disease without apparent side effects Study Design . Three-group , r and omized , single blinded , controlled trial . Objective . To test the effectiveness of physiotherapy-based rehabilitation starting 1 week after lumbar disc surgery . In addition , we tried to estimate the contribution of specific effects to the observed outcome ( efficacy ) . Summary of Background Data . Physiotherapy-based rehabilitation is usually recommended for patients following lumbar disc surgery . Few and conflicting data exist for the relative effectiveness of this intervention . Methods . A total of 120 patients following first-time , uncomplicated lumbar disc surgery were r and omly assigned to “ comprehensive ” physiotherapy , “ sham ” neck massage , or no therapy . Before enrollment , all subjects completed a minimal physiotherapeutic intervention . Physiotherapy was administered by experienced physiotherapists and consisted of 20 sessions per patient over 12 weeks . Masseurs administered “ sham massage ” to the neck . The amount of treatment time was equal to that of physiotherapy . The main outcome measure was the Low Back Pain Rating Score ( LBPRS ) at 6 and 12 weeks , and 1.5 years after r and omization . Secondary parameters were patients ' overall satisfaction with treatment outcome and socioeconomic and psychologic measures . Results . At the end of therapy ( 12 weeks ) , the LBPRS revealed a significantly better improvement in the physiotherapy group than in the untreated group . LBPRS outcome , however , did not significantly differ between physiotherapy and “ sham ” therapy 
    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: BACKGROUND AND OBJECTIVE To develop a checklist of items measuring the quality of reports of r and omized clinical trials ( RCTs ) assessing nonpharmacological treatments ( NPTs ) . STUDY DESIGN AND SETTING The Delphi consensus method was used to select and reduce the number of items in the checklist . A total of 154 individuals were invited to participate : epidemiologists and statisticians involved in the field of methodology of RCTs ( n = 55 ) , members of the Cochrane Collaboration ( n = 41 ) , and clinicians involved in planning NPT clinical trials ( n = 58 ) . Participants ranked on a 10-point Likert scale whether an item should be included in the checklist . RESULTS Fifty-five experts ( 36 % ) participated in the survey . They were experienced in systematic review s ( 68 % were involved in the Cochrane Collaboration ) and in planning RCTs ( 76 % ) . Three rounds of the Delphi method were conducted to achieve consensus . The final checklist contains 10 items and 5 subitems , with items related to the st and ardization of the intervention , care provider influence , and additional measures to minimize the potential bias from lack of blinding of participants , care providers , and outcome assessors . CONCLUSIONS This tool can be used to critically appraise the medical literature , design NPT studies , and assess the quality of trial reports included in systematic review OBJECTIVE We performed a r and omised trial to evaluate if intensive supervised training of the back should be offered to all patients after a first lumbar diskectomy . METHODS Forty consecutive patients were , after a first lumbar diskectomy , r and omly allocated to 2 groups undergoing " supervised training " twice a week for 3 months in an outpatient clinic or " home training " after 2 hours of instruction . RESULTS The two rehabilitation models both showed a significant effect on spinal mobility , isokinetic trunk flexion strength , isokinetic trunk extension strength and daily function . These improvements were unchanged at follow up 3 months later . The pain score remained unchanged , however , throughout the trial in both groups . No differences in effect between the two rehabilitation models could be found for any of the assessed parameters . Thirteen patients did not complete the trial , including 9 from the supervised endurance trained group , mainly because of increased pain and reprolaps ( n = 4 ) . Four patients dropped out of the home trained group , only one because of increased pain . The differences in drop-out rate and training side effects were , however , not statistically significant . CONCLUSION We conclude that it is not worthwhile to implement 3 months of supervised intensive endurance training as opposed to home training in all cases of first lumbar diskectomy , although a beneficial effect and better compliance might be found for a selected group of such patients As the average life expectancy of the population increases , surgical decompression of the lumbar spine is being performed with increasing frequency . It now constitutes the most common type of lumbar spinal surgery in older patients . The present prospect i ve study examined the 5-year outcome of lumbar decompression surgery without fusion . The group comprised 159 patients undergoing decompression for degenerative spinal disorders who had been participants in a r and omised controlled trial of post-operative rehabilitation that had shown no between-group differences at 2 years . Leg pain and back pain intensity ( 0–10 graphic rating scale ) , self-rated disability ( Rol and Morris ) , global outcome of surgery ( 5-point Likert scale ) and re-operation rates were assessed 5 years post-operatively . Ten patients had died before the 5-year follow-up . Of the remaining 149 patients , 143 returned a 5-year follow-up ( FU ) question naire ( effective return rate excluding deaths , 96 % ) . Their mean age was 64 ( SD 11 ) years and 92/143 ( 64 % ) were men . In the 5-year follow-up period , 34/143 patients ( 24 % ) underwent re-operation ( 17 further decompressions , 17 fusions and 1 intradural drainage/debridement ) . In patients who were not re-operated , leg pain decreased significantly ( p < 0.05 ) from before surgery to 2 months FU , after which there was no significant change up to 5 years . Low back pain also decreased significantly by 2 months FU , but then showed a slight , but significant ( p < 0.05 ) , gradual increase of < 1 point by 5-year FU . Disability decreased significantly from pre-operative to 2 months FU and showed a further significant decrease at 5 months FU . Thereafter , it remained stable up to the 5-year FU . Pain and disability scores recorded after 5 years showed a significant correlation with those at earlier follow-ups ( r = 0.53–0.82 ; p < 0.05 ) . Patients who were re-operated at some stage over the 5-year period showed significantly worse final outcomes for leg pain and disability ( p < 0.05 ) . In conclusion , pain and disability showed minimal change in the 5-year period after surgery , but the re-operation rate was relatively high . Re-operation result ed in worse final outcomes in terms of leg pain and disability . At the 5-year follow-up , the “ average ” patient experienced frequent , but relatively low levels of , pain and moderate disability . This knowledge on the long-term outcome should be incorporated into the pre-operative patient information process CONTEXT Lumbar diskectomy is the most common surgical procedure performed for back and leg symptoms in US patients , but the efficacy of the procedure relative to nonoperative care remains controversial . OBJECTIVE To assess the efficacy of surgery for lumbar intervertebral disk herniation . DESIGN , SETTING , AND PATIENTS The Spine Patient Outcomes Research Trial , a r and omized clinical trial enrolling patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 US states . Patients were 501 surgical c and i date s ( mean age , 42 years ; 42 % women ) with imaging-confirmed lumbar intervertebral disk herniation and persistent signs and symptoms of radiculopathy for at least 6 weeks . INTERVENTIONS St and ard open diskectomy vs nonoperative treatment individualized to the patient . MAIN OUTCOME MEASURES Primary outcomes were changes from baseline for the Medical Outcomes Study 36-item Short-Form Health Survey bodily pain and physical function scales and the modified Oswestry Disability Index ( American Academy of Orthopaedic Surgeons MODEMS version ) at 6 weeks , 3 months , 6 months , and 1 and 2 years from enrollment . Secondary outcomes included sciatica severity as measured by the Sciatica Bothersomeness Index , satisfaction with symptoms , self-reported improvement , and employment status . RESULTS Adherence to assigned treatment was limited : 50 % of patients assigned to surgery received surgery within 3 months of enrollment , while 30 % of those assigned to nonoperative treatment received surgery in the same period . Intent-to-treat analyses demonstrated substantial improvements for all primary and secondary outcomes in both treatment groups . Between-group differences in improvements were consistently in favor of surgery for all periods but were small and not statistically significant for the primary outcomes . CONCLUSIONS Patients in both the surgery and the nonoperative treatment groups improved substantially over a 2-year period . Because of the large numbers of patients who crossed over in both directions , conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00000410 Study Design This was a study of a st and ardized functional restoration program that included 11 centers in saven states , involving 303 patients in the treatment group and 94 patients in the comparison group . Objective To illustrative the positive effect a functional restoration program has on return to work rates and work retention regardless of previous surgical intervention . Summary of Background Data Data were obtained from the initial and discharge evaluations as well as at 6− and 12-month follow-up . Methods Patients received a st and ardized work capacity assessment upon entrance and were recommended to the program if they adhered to specific entrance criteria . Treatment patients received the same evaluation at discharge . Results Significant improvement in functional abilities , actual return to work , and work retention were noted in the treatment group regardless of treatment intervention . Conclusions This study demonstrated improved return to work rates and work retention with surgical and nonsurgical patients after their participation in a functional restoration program BACKGROUND Lumbar-disk surgery often is performed in patients who have sciatica that does not resolve within 6 weeks , but the optimal timing of surgery is not known . METHODS We r and omly assigned 283 patients who had had severe sciatica for 6 to 12 weeks to early surgery  or to prolonged conservative treatment with surgery if needed . The primary outcomes were the score on the Rol and Disability Question naire , the score on the visual-analogue scale for leg pain , and the patient 's report of perceived recovery during the first year after r and omization . Repeated- measures analysis according to the intention-to-treat principle was used to estimate the outcome curves for both groups . RESULTS Of 141 patients assigned to undergo early surgery  , 125 ( 89 % ) underwent  microdiskectomy  after a mean of 2.2 weeks . Of 142 patients design ated for conservative treatment , 55 ( 39 % ) were treated surgically after a mean of 18.7 weeks . There was no significant overall difference in disability scores during the first year ( P=0.13 ) . Relief of leg pain was faster for patients assigned to early surgery ( P<0.001 ) . Patients assigned to early surgery also reported a faster rate of perceived recovery ( hazard ratio , 1.97 ; 95 % confidence interval , 1.72 to 2.22 ; P<0.001 ) . In both groups , however , the probability of perceived recovery after 1 year of follow-up was 95 % . CONCLUSIONS The 1-year outcomes were similar for patients assigned to early surgery and those assigned to conservative treatment with eventual surgery if needed , but the rates of pain relief and of perceived recovery were faster for those assigned to early surgery . ( Current Controlled Trials number , IS RCT N26872154 [ controlled-trials.com ] . ) Study Design . We r and omized 200 patients after lumbar discectomy to receive  epidural steroid or none with a 2-year follow-up . Objective . To evaluate the outcome , neurologic impairment and safety of epidural steroid following lumbar discectomy for herniated disc disease . Summary of Background Data . Convalescence after discectomy for herniated disc disease is dependent on pain and the inflammatory response . Previous studies in arthroscopic and abdominal surgery demonstrate steroids , which reduce the inflammatory response and enhance recovery . Here we report a 2-year follow-up of a r and omized trial of epidural steroid following lumbar discectomy . Methods . Through 2001 and 2003 200 patients undergoing discectomy for herniated disc disease were r and omly allocated to receive epidural methylprednisolone 40 mg or none . In the control group ( 62 males and 38 females , median age 41 years , 18–66 ) 48 L5 , 50 L4 , and 6 L3 discectomies were performed and in the intervention group ( 60 males and 40 females , median age 45 years , 15–53 ) 56 L5 , 46 L4 , and 3 L3 discectomies . Contemporary with r and omization to epidural steroid or none both groups received preoperative prophylactic antibiotics and the same multimodal pain treatment . Results . Hospital stay was reduced from 8 to 6 days ( P = 0.0001 ) and the number of patients with neurologic signs were reduced more ( 70 % vs. 44 % , P = 0.0004 ) by epidural steroid . Incidence of reoperation at 1 year was 6 % in both groups and 8 % in the control group and 7 % in the intervention group after 2 years . No infections were registered . Conclusion . Epidural methylprednisolone enhances recovery after discectomy for herniated disc disease without apparent side effects Study Design . Three-group , r and omized , single blinded , controlled trial . Objective . To test the effectiveness of physiotherapy-based rehabilitation starting 1 week after lumbar disc surgery . In addition , we tried to estimate the contribution of specific effects to the observed outcome ( efficacy ) . Summary of Background Data . Physiotherapy-based rehabilitation is usually recommended for patients following lumbar disc surgery . Few and conflicting data exist for the relative effectiveness of this intervention . Methods . A total of 120 patients following first-time , uncomplicated lumbar disc surgery were r and omly assigned to “ comprehensive ” physiotherapy , “ sham ” neck massage , or no therapy . Before enrollment , all subjects completed a minimal physiotherapeutic intervention . Physiotherapy was administered by experienced physiotherapists and consisted of 20 sessions per patient over 12 weeks . Masseurs administered “ sham massage ” to the neck . The amount of treatment time was equal to that of physiotherapy . The main outcome measure was the Low Back Pain Rating Score ( LBPRS ) at 6 and 12 weeks , and 1.5 years after r and omization . Secondary parameters were patients ' overall satisfaction with treatment outcome and socioeconomic and psychologic measures . Results . At the end of therapy ( 12 weeks ) , the LBPRS revealed a significantly better improvement in the physiotherapy group than in the untreated group . LBPRS outcome , however , did not significantly differ between physiotherapy and “ sham ” therapy 
    Output:
    