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 Adjustment for prognostic covariates can lead to increased power in the analysis of r and omized trials . However , adjusted analyses are not often performed in practice . Methods We used simulation to examine the impact of covariate adjustment on 12 outcomes from 8 studies across a range of therapeutic areas . We assessed ( 1 ) how large an increase in power can be expected in practice ; and ( 2 ) the impact of adjustment for covariates that are not prognostic . Results Adjustment for known prognostic covariates led to large increases in power for most outcomes . When power was set to 80 % based on an unadjusted analysis , covariate adjustment led to a median increase in power to 92.6 % across the 12 outcomes ( range 80.6 to 99.4 % ) . Power was increased to over 85 % for 8 of 12 outcomes , and to over 95 % for 5 of 12 outcomes . Conversely , the largest decrease in power from adjustment for covariates that were not prognostic was from 80 % to 78.5 % . Conclusions Adjustment for known prognostic covariates can lead to substantial increases in power , and should be routinely incorporated into the analysis of r and omized trials . The potential benefits of adjusting for a small number of possibly prognostic covariates in trials with moderate or large sample sizes far outweigh the risks of doing so , and so should also be considered Abstract Psychological factors consistent with fear‐avoidance models are associated with the development of chronic low back pain ( LBP ) . As a result , grade d activity ( GA ) and grade d exposure ( GX ) have been suggested as behavioral treatment options . This clinical trial compared the effectiveness of treatment‐based classification ( TBC ) physical therapy alone to TBC augmented with GA or GX for patients with acute and sub‐acute LBP . Our primary hypothesis was that GX would be most effective for those with elevated pain‐related fear . In total , 108 patients enrolled in this clinical trial and were r and omly assigned to receive TBC , GA , or GX . Outcomes were assessed by a blinded evaluator at 4 weeks and by mail at 6 months . The primary outcomes for this trial were disability and pain intensity , and the secondary outcomes were fear‐avoidance beliefs , pain catastrophizing , and physical impairment . There were no differences in 4‐week and 6‐month outcomes for reduction of disability , pain intensity , pain catastrophizing , and physical impairment . GX and TBC were associated with larger reductions in fear‐avoidance beliefs at 6 months only . Six‐month reduction in disability was associated with reduction in pain intensity , while 6‐month reduction in pain intensity was associated with reductions in fear‐avoidance beliefs and pain catastrophizing . This trial suggests that supplementing TBC with GA or GX was not effective for improving important outcomes related to the development of chronic LBP Background Perioperative administration of pregabalin , which is effective for neuropathic pain , might reduce early postoperative and chronic pain . This r and omized , double-blinded , placebo-controlled trial ( Clinical Trials.gov ID NCT00905580 ) was design ed to investigate the efficacy and safety of pregabalin for reducing both acute postoperative pain and the development of chronic pain in patients after robot-assisted endoscopic thyroidectomy . Methods Ninety-nine patients were r and omly assigned to groups that received pregabalin 150 mg or placebo 1 h before surgery , with the dose repeated after 12 h. Assessment s of pain and side effects were performed 48 h postoperatively . The incidences of chronic pain and hypoesthesia in the anterior chest were recorded 3 months after surgery . Results Ninety-four patients completed the study .  Verbal numerical rating scale scores for pain and the need for additional analgesics were lower in the pregabalin group ( n = 47 ) than the placebo group ( n = 47 ) during 48 h postoperatively ( P < 0.05 ) . However , incidences of sedation and dizziness were higher in the pregabalin group ( P < 0.05 ) . There were no differences between the groups in the incidences of chronic pain and chest hypoesthesia at 3 months after surgery . Conclusions Perioperative administration of pregabalin ( 150 mg twice per day ) was effective in reducing early postoperative pain but not chronic pain in patients undergoing robot-assisted endoscopic thyroidectomy . Caution should be taken regarding dizziness and sedation Background and Objectives The transversus abdominis plane ( TAP ) block is an established technique to manage post – cesarean delivery pain .  Transversus abdominis plane blocks with a local anesthetic only offer no analgesic benefits compared with intrathecal morphine . Adjuvants to extend TAP block duration and possibly reduce wound hyperalgesia , known to be a risk factor for chronic pain , have not been studied . We hypothesized that a TAP block with clonidine will affect postsurgical wound hyperalgesia and improve pain outcomes . Methods Ninety women were r and omly assigned to receive 1 of 3 TAP blocks after cesarean delivery  : saline ( placebo ) , bupivacaine ( BupTAP ) , or bupivacaine + clonidine ( CloTAP ) . The primary outcome was wound hyperalgesia index at 48 hours . Secondary outcomes included pain scores , analgesic consumption , and pain descriptors up to 12 months . Results Wound hyperalgesia index at 48 hours ( median [ 25th–75th percentiles ] ) was 1.07 ( 0.48–3.26 ) in the placebo group , 1.27 ( 0.59–2.95 ) in the BupTAP group , and 0.74 ( 0.09–2.25 ) in the CloTAP group ( P = 0.48 ) . Morphine request in the postanesthesia care unit was significantly higher in the placebo group compared with the other TAP groups ( P = 0.01 ) . Postoperative pain scores and requests for breakthrough medication at 48 hours ( 30 % in the placebo group , 24 % in the BupTAP group , and 12 % in the CloTAP group , P = 0.25 ) or chronic pain descriptors reported up to 12 months did not differ significantly among groups . Conclusions Adding clonidine to a TAP block with bupivacaine did not affect wound hyperalgesia index and it did not improve short-term or long-term pain scores in women undergoing elective cesarean delivery . Further studies are warranted to determine the benefits of antihyperalgesic adjuvants in TAP solutions for specific individuals at risk for chronic pain Background and objective To find out whether preoperative gabapentin use had a favourable effect on long-term postoperative pain in patients undergoing inguinal herniorrhaphy . Methods Sixty male patients – aged 20–40 years – who were scheduled for unilateral inguinal herniorrhaphy under spinal anaesthesia  were included in this prospect i ve , r and omized , double-blind study . The patients were r and omly allocated to two groups : the gabapentin group ( n = 30 ) received single-dose 1.2 g oral gabapentin 1 h before surgery , and the placebo group received a placebo capsule instead . Spinal anaesthesia was performed with heavy bupivacaine , and all operations were performed by the same surgeon with the same technique . Postoperative analgesia was evaluated during sitting and lying with a visual analogue scale . Assessment of postoperative pain at 1 , 3 and 6 months was carried out with an 11-point numerical rating scale ; 0 indicating ‘ no pain ’ and 10 indicating ‘ worst pain imaginable ’ . Patients who had numerical rating scale scores of more than 0 were further evaluated with regard to the impact of pain on their daily activities . Results When compared with the placebo group , the gabapentin group displayed significantly lower visual analogue scale scores ( lying and sitting ) and total tramadol consumption at 8 , 12 , 16 , 20 and 24 h after surgery ( P < 0.05 ) and higher postoperative patient satisfaction scores ( P < 0.05 ) . Numerical rating scale scores at 1 , 3 and 6 months after surgery were lower in the gabapentin group than in the placebo group ( P < 0.05 ) . The number of patients whose daily activities were adversely affected by pain was smaller in the gabapentin group at the first month ; however , the two groups were found to be similar at 3 and 6 months . Conclusion We conclude that preoperative single-dose gabapentin decreases the intensity of acute postoperative pain , tramadol consumption and the incidence and intensity of pain in the first 6 months after inguinal herniorrhaphy BACKGROUND : The issue of postoperative pain after neurosurgery is controversial . It has been reported as mild to moderate and its treatment may be inadequate . Infiltration of the surgical site with local anesthetics has provided transient benefit after craniotomy , but its effect on chronic pain has not been evaluated . Accordingly , we design ed the present study to test the hypothesis that ropivacaine infiltration of the scalp reduces acute and persistent postoperative pain after intracranial tumor resection . METHODS : This was a prospect i ve , single-blinded study . Inclusion criteria were intracranial tumor resection , age ≥18 or ≤80 yr , and ability to underst and and use a visual analog scale ( VAS ) . Exclusion criteria were history of craniotomy , chronic drug abuse , and neurologic disorders . All eligible patients were r and omly included in Group I ( infiltration ) or C ( control ) . Postoperative analgesia was IV acetaminophen combined with nalbuphine . At the end of the surgery , Group I received an infiltration of the surgical site with 20 mL of ropivacaine 0.75 % . Acute pain was evaluated hourly by VAS during the first 24 h. The analgesic effect of ropivacaine was evaluated based on total consumption of nalbuphine and VAS scores . The incidence of persistent pain and neuropathic pain was assessed at the 2-mo postoperative evaluation . We used the Student ’s t-test to compare total nalbuphine consumption , repeated measures analysis of variance with post hoc Bonferroni t-test for VAS score and the Fisher ’s exact test for chronic and neuropathic pain . RESULTS : Fifty-two patients were enrolled , 25 in Group I and 27 in Group C. Demographic and intraoperative data were similar between groups . Group I showed a nonsignificant trend toward reduced nalbuphine consumption during the first postoperative day , 11.2 ± 9.2 mg vs 16.6 ± 11.0 mg for Group C ( mean ± sd , P = 0.054 ) . VAS scores were significantly higher in Group C. Two months after surgery , persistent pain was significantly lower in Group I , 2/24 ( 8 % ) vs 14/25 ( 56 % ) , P = 0.0003 . One patient ( 4.1 % ) in Group I versus six ( 25 % ) patients in Group C ( P = 0.04 ) experienced neuropathic pain . CONCLUSIONS : Because pain is moderate after intracranial tumor resection , there is limited interest in scalp infiltrations with ropivacaine in the acute postoperative period . Nevertheless , these infiltrations may be relevant for the rehabilitation of neurosurgical patients and their quality of life by limiting the development of persistent pain and particularly neuropathic pain Background Fibromyalgia ( FM ) is a chronic disorder characterized by widespread , persistent pain . Prospect i ve and retrospective studies have demonstrated substantial health-care costs associated with FM in a number of countries . This study evaluated and compared health-re source use ( HRU ) and associated costs related to FM in routine clinical practice across the US , France , and Germany . Methods Two separate , cross-sectional , observational studies of subjects with FM were conducted : one in the US and one in France and Germany .  HRU related to prescription medication , physician office visits , diagnostic tests , and hospitalizations was abstract ed from chart review ; patient out-of-pocket costs and lost productivity were collected via subject self-report . Costs were assigned to HRU based on st and ard algorithms . Direct and indirect costs were evaluated and compared by simple linear regression . Results A total of 442 subjects ( 203 US , 70 France , 169 Germany ) with FM were analyzed . The mean ( st and ard deviation ) age in the US , France , and Germany was 47.9 ( 10.9 ) , 51.2 ( 9.5 ) , and 49.2 ( 9.8 ) , respectively ( P = 0.085 ) . Most subjects were female ( 95 % US , 83 % France , 80 % Germany ) ( P < 0.001 ) . Adjusted annual direct costs per subject for FM were significantly higher in the US ( $ 7087 ) than in France ( $ 481 , P < 0.001 ) or Germany ( $ 2417 , P < 0.001 ) . Adjusted mean annual indirect costs per subject for FM were lower in the US ( $ 6431 ) than in France ( $ 8718 ) or Germany ( $ 10,001 ) , but represented a significant proportion of total costs in all countries . Conclusion The significant HRU and costs associated with FM in the US , France , and Germany documented in this study highlight the substantial global economic burden of FM . Indirect costs represented a significant proportion of the total costs , particularly in Europe . Comparisons between the three countries show differences in HRU , with significantly higher direct costs in the US compared with France and Germany BACKGROUND :  Chronic postsurgical pain ( CPSP )  affects between 5 % and 70 % of surgical patients , depending 
    Output:
    
agent
Such interventions would have the potential to reduce the prevalence of chronic pain in the population .
***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 Adjustment for prognostic covariates can lead to increased power in the analysis of r and omized trials . However , adjusted analyses are not often performed in practice . Methods We used simulation to examine the impact of covariate adjustment on 12 outcomes from 8 studies across a range of therapeutic areas . We assessed ( 1 ) how large an increase in power can be expected in practice ; and ( 2 ) the impact of adjustment for covariates that are not prognostic . Results Adjustment for known prognostic covariates led to large increases in power for most outcomes . When power was set to 80 % based on an unadjusted analysis , covariate adjustment led to a median increase in power to 92.6 % across the 12 outcomes ( range 80.6 to 99.4 % ) . Power was increased to over 85 % for 8 of 12 outcomes , and to over 95 % for 5 of 12 outcomes . Conversely , the largest decrease in power from adjustment for covariates that were not prognostic was from 80 % to 78.5 % . Conclusions Adjustment for known prognostic covariates can lead to substantial increases in power , and should be routinely incorporated into the analysis of r and omized trials . The potential benefits of adjusting for a small number of possibly prognostic covariates in trials with moderate or large sample sizes far outweigh the risks of doing so , and so should also be considered Abstract Psychological factors consistent with fear‐avoidance models are associated with the development of chronic low back pain ( LBP ) . As a result , grade d activity ( GA ) and grade d exposure ( GX ) have been suggested as behavioral treatment options . This clinical trial compared the effectiveness of treatment‐based classification ( TBC ) physical therapy alone to TBC augmented with GA or GX for patients with acute and sub‐acute LBP . Our primary hypothesis was that GX would be most effective for those with elevated pain‐related fear . In total , 108 patients enrolled in this clinical trial and were r and omly assigned to receive TBC , GA , or GX . Outcomes were assessed by a blinded evaluator at 4 weeks and by mail at 6 months . The primary outcomes for this trial were disability and pain intensity , and the secondary outcomes were fear‐avoidance beliefs , pain catastrophizing , and physical impairment . There were no differences in 4‐week and 6‐month outcomes for reduction of disability , pain intensity , pain catastrophizing , and physical impairment . GX and TBC were associated with larger reductions in fear‐avoidance beliefs at 6 months only . Six‐month reduction in disability was associated with reduction in pain intensity , while 6‐month reduction in pain intensity was associated with reductions in fear‐avoidance beliefs and pain catastrophizing . This trial suggests that supplementing TBC with GA or GX was not effective for improving important outcomes related to the development of chronic LBP Background Perioperative administration of pregabalin , which is effective for neuropathic pain , might reduce early postoperative and chronic pain . This r and omized , double-blinded , placebo-controlled trial ( Clinical Trials.gov ID NCT00905580 ) was design ed to investigate the efficacy and safety of pregabalin for reducing both acute postoperative pain and the development of chronic pain in patients after robot-assisted endoscopic thyroidectomy . Methods Ninety-nine patients were r and omly assigned to groups that received pregabalin 150 mg or placebo 1 h before surgery , with the dose repeated after 12 h. Assessment s of pain and side effects were performed 48 h postoperatively . The incidences of chronic pain and hypoesthesia in the anterior chest were recorded 3 months after surgery . Results Ninety-four patients completed the study .  Verbal numerical rating scale scores for pain and the need for additional analgesics were lower in the pregabalin group ( n = 47 ) than the placebo group ( n = 47 ) during 48 h postoperatively ( P < 0.05 ) . However , incidences of sedation and dizziness were higher in the pregabalin group ( P < 0.05 ) . There were no differences between the groups in the incidences of chronic pain and chest hypoesthesia at 3 months after surgery . Conclusions Perioperative administration of pregabalin ( 150 mg twice per day ) was effective in reducing early postoperative pain but not chronic pain in patients undergoing robot-assisted endoscopic thyroidectomy . Caution should be taken regarding dizziness and sedation Background and Objectives The transversus abdominis plane ( TAP ) block is an established technique to manage post – cesarean delivery pain .  Transversus abdominis plane blocks with a local anesthetic only offer no analgesic benefits compared with intrathecal morphine . Adjuvants to extend TAP block duration and possibly reduce wound hyperalgesia , known to be a risk factor for chronic pain , have not been studied . We hypothesized that a TAP block with clonidine will affect postsurgical wound hyperalgesia and improve pain outcomes . Methods Ninety women were r and omly assigned to receive 1 of 3 TAP blocks after cesarean delivery  : saline ( placebo ) , bupivacaine ( BupTAP ) , or bupivacaine + clonidine ( CloTAP ) . The primary outcome was wound hyperalgesia index at 48 hours . Secondary outcomes included pain scores , analgesic consumption , and pain descriptors up to 12 months . Results Wound hyperalgesia index at 48 hours ( median [ 25th–75th percentiles ] ) was 1.07 ( 0.48–3.26 ) in the placebo group , 1.27 ( 0.59–2.95 ) in the BupTAP group , and 0.74 ( 0.09–2.25 ) in the CloTAP group ( P = 0.48 ) . Morphine request in the postanesthesia care unit was significantly higher in the placebo group compared with the other TAP groups ( P = 0.01 ) . Postoperative pain scores and requests for breakthrough medication at 48 hours ( 30 % in the placebo group , 24 % in the BupTAP group , and 12 % in the CloTAP group , P = 0.25 ) or chronic pain descriptors reported up to 12 months did not differ significantly among groups . Conclusions Adding clonidine to a TAP block with bupivacaine did not affect wound hyperalgesia index and it did not improve short-term or long-term pain scores in women undergoing elective cesarean delivery . Further studies are warranted to determine the benefits of antihyperalgesic adjuvants in TAP solutions for specific individuals at risk for chronic pain Background and objective To find out whether preoperative gabapentin use had a favourable effect on long-term postoperative pain in patients undergoing inguinal herniorrhaphy . Methods Sixty male patients – aged 20–40 years – who were scheduled for unilateral inguinal herniorrhaphy under spinal anaesthesia  were included in this prospect i ve , r and omized , double-blind study . The patients were r and omly allocated to two groups : the gabapentin group ( n = 30 ) received single-dose 1.2 g oral gabapentin 1 h before surgery , and the placebo group received a placebo capsule instead . Spinal anaesthesia was performed with heavy bupivacaine , and all operations were performed by the same surgeon with the same technique . Postoperative analgesia was evaluated during sitting and lying with a visual analogue scale . Assessment of postoperative pain at 1 , 3 and 6 months was carried out with an 11-point numerical rating scale ; 0 indicating ‘ no pain ’ and 10 indicating ‘ worst pain imaginable ’ . Patients who had numerical rating scale scores of more than 0 were further evaluated with regard to the impact of pain on their daily activities . Results When compared with the placebo group , the gabapentin group displayed significantly lower visual analogue scale scores ( lying and sitting ) and total tramadol consumption at 8 , 12 , 16 , 20 and 24 h after surgery ( P < 0.05 ) and higher postoperative patient satisfaction scores ( P < 0.05 ) . Numerical rating scale scores at 1 , 3 and 6 months after surgery were lower in the gabapentin group than in the placebo group ( P < 0.05 ) . The number of patients whose daily activities were adversely affected by pain was smaller in the gabapentin group at the first month ; however , the two groups were found to be similar at 3 and 6 months . Conclusion We conclude that preoperative single-dose gabapentin decreases the intensity of acute postoperative pain , tramadol consumption and the incidence and intensity of pain in the first 6 months after inguinal herniorrhaphy BACKGROUND : The issue of postoperative pain after neurosurgery is controversial . It has been reported as mild to moderate and its treatment may be inadequate . Infiltration of the surgical site with local anesthetics has provided transient benefit after craniotomy , but its effect on chronic pain has not been evaluated . Accordingly , we design ed the present study to test the hypothesis that ropivacaine infiltration of the scalp reduces acute and persistent postoperative pain after intracranial tumor resection . METHODS : This was a prospect i ve , single-blinded study . Inclusion criteria were intracranial tumor resection , age ≥18 or ≤80 yr , and ability to underst and and use a visual analog scale ( VAS ) . Exclusion criteria were history of craniotomy , chronic drug abuse , and neurologic disorders . All eligible patients were r and omly included in Group I ( infiltration ) or C ( control ) . Postoperative analgesia was IV acetaminophen combined with nalbuphine . At the end of the surgery , Group I received an infiltration of the surgical site with 20 mL of ropivacaine 0.75 % . Acute pain was evaluated hourly by VAS during the first 24 h. The analgesic effect of ropivacaine was evaluated based on total consumption of nalbuphine and VAS scores . The incidence of persistent pain and neuropathic pain was assessed at the 2-mo postoperative evaluation . We used the Student ’s t-test to compare total nalbuphine consumption , repeated measures analysis of variance with post hoc Bonferroni t-test for VAS score and the Fisher ’s exact test for chronic and neuropathic pain . RESULTS : Fifty-two patients were enrolled , 25 in Group I and 27 in Group C. Demographic and intraoperative data were similar between groups . Group I showed a nonsignificant trend toward reduced nalbuphine consumption during the first postoperative day , 11.2 ± 9.2 mg vs 16.6 ± 11.0 mg for Group C ( mean ± sd , P = 0.054 ) . VAS scores were significantly higher in Group C. Two months after surgery , persistent pain was significantly lower in Group I , 2/24 ( 8 % ) vs 14/25 ( 56 % ) , P = 0.0003 . One patient ( 4.1 % ) in Group I versus six ( 25 % ) patients in Group C ( P = 0.04 ) experienced neuropathic pain . CONCLUSIONS : Because pain is moderate after intracranial tumor resection , there is limited interest in scalp infiltrations with ropivacaine in the acute postoperative period . Nevertheless , these infiltrations may be relevant for the rehabilitation of neurosurgical patients and their quality of life by limiting the development of persistent pain and particularly neuropathic pain Background Fibromyalgia ( FM ) is a chronic disorder characterized by widespread , persistent pain . Prospect i ve and retrospective studies have demonstrated substantial health-care costs associated with FM in a number of countries . This study evaluated and compared health-re source use ( HRU ) and associated costs related to FM in routine clinical practice across the US , France , and Germany . Methods Two separate , cross-sectional , observational studies of subjects with FM were conducted : one in the US and one in France and Germany .  HRU related to prescription medication , physician office visits , diagnostic tests , and hospitalizations was abstract ed from chart review ; patient out-of-pocket costs and lost productivity were collected via subject self-report . Costs were assigned to HRU based on st and ard algorithms . Direct and indirect costs were evaluated and compared by simple linear regression . Results A total of 442 subjects ( 203 US , 70 France , 169 Germany ) with FM were analyzed . The mean ( st and ard deviation ) age in the US , France , and Germany was 47.9 ( 10.9 ) , 51.2 ( 9.5 ) , and 49.2 ( 9.8 ) , respectively ( P = 0.085 ) . Most subjects were female ( 95 % US , 83 % France , 80 % Germany ) ( P < 0.001 ) . Adjusted annual direct costs per subject for FM were significantly higher in the US ( $ 7087 ) than in France ( $ 481 , P < 0.001 ) or Germany ( $ 2417 , P < 0.001 ) . Adjusted mean annual indirect costs per subject for FM were lower in the US ( $ 6431 ) than in France ( $ 8718 ) or Germany ( $ 10,001 ) , but represented a significant proportion of total costs in all countries . Conclusion The significant HRU and costs associated with FM in the US , France , and Germany documented in this study highlight the substantial global economic burden of FM . Indirect costs represented a significant proportion of the total costs , particularly in Europe . Comparisons between the three countries show differences in HRU , with significantly higher direct costs in the US compared with France and Germany BACKGROUND :  Chronic postsurgical pain ( CPSP )  affects between 5 % and 70 % of surgical patients , depending 
    Output:
    