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: & NA ; The objective of the study was to examine the 1‐year cumulative incidence of episodic neck pain and to explore its associations with individual risk factors , including a history of previous neck injury . A baseline cross‐sectional survey of an adult general population sample made up of all 7669 adults aged 18–75 years , registered with two family practice s in South Manchester , United Kingdom , identified the study population of adults with no current neck pain . This study population was surveyed again 12 months later to identify all those who had experienced neck pain during the follow‐up period . At follow‐up , cumulative 1‐year episode incidence of neck pain was estimated at 17.9 % ( 95 % confidence interval 16.0–19.7 % ) . Incidence was independent of age , but was more common in women . A history of previous neck injury at baseline was a significant risk factor for subsequent neck pain in the follow‐up year ( risk ratio 1.7 , 95 % confidence interval 1.2–2.5 ) , independent of gender and psychological status . Other independent baseline risk factors for subsequent neck pain included number of children , poor self‐assessed health , poor psychological status and a past history of low back pain . We have carried out a prospect i ve study in a general population sample and demonstrated that established risk factors for chronic pain predict future episodes of neck pain , and shown that in addition a history of neck injury is an independent and distinct risk factor . This finding may have major public health and medicolegal implication The r and omized controlled trial ( RCT ) is the gold st and ard for assessing the efficacy of medical treatments . Over the past 50 years , RCT methodology has proven to be quite successful in identifying effective treatments and weeding out ineffective ones , thus transforming medicine from an intuitive art into an empirical science . However , the enormous success of the RCT has inadvertently contributed to a common inferential error that is insufficiently appreciated by some clinicians and research ers . Although RCTs can effectively distinguish between placebo and active treatment effects at the level of the group , contrary to intuition , this same disentanglement is much more difficult to achieve at the level of the individual . For individual patients it is surprisingly difficult to determine who is a treatment responder and who is not . Using data from a recent RCT , we illustrate the problem and detail its negative effects for research and clinical practice . Finally , we suggest strategies for minimizing these negative effects STUDY OBJECTIVES Osteoarthritis pain affects more than half of all older adults , many of whom experience co-morbid sleep disturbance . Pain initiates and exacerbates sleep disturbance , whereas disturbed sleep maintains and exacerbates pain , which implies that improving the sleep of patients with osteoarthritis may also reduce their pain . We examined this possibility in a secondary analysis of a previously published r and omized controlled trial of cognitive behavioral therapy for insomnia ( CBT-I ) in patients with osteoarthritis and co-morbid insomnia . METHODS Twenty-three patients ( mean age 69.2 years ) were r and omly assigned to  CBT-I  and 28 patients ( mean age 66.5 years ) to an attention control . Neither directly addressed pain management . Twelve subjects crossed over to CBT-I after control treatment .  Sleep and pain were assessed by self-report at baseline , after treatment , and ( for CBT-I only ) at 1-year follow-up . RESULTS CBT-I subjects reported significantly improved sleep and significantly reduced pain after treatment . Control subjects reported no significant improvements . One-year follow-up found maintenance of improved sleep and reduced pain for both the CBT-I group alone and among subjects who crossed over from control to CBT-I. CONCLUSIONS CBT-I but not an attention control , without directly addressing pain control , improved both immediate and long-term self-reported sleep and pain  in older patients with osteoarthritis and comorbid insomnia . These results are unique in suggesting the long-term durability of CBT-I effects for co-morbid insomnia . They also indicate that improving sleep , per se , in patients with osteoarthritis may result in decreased pain . Techniques to improve sleep may be useful additions to pain management programs in osteoarthritis , and possibly other chronic pain conditions as well Evidence that placebo acupuncture is an effective treatment for  chronic pain  presents a puzzle : how do placebo needles appearing to patients to penetrate the body , but instead sitting on the skin 's surface in the manner of a tactile stimulus , evoke a healing response ? Previous accounts of ritual touch healing in which patients often described enhanced touch sensations ( including warmth , tingling or flowing sensations ) suggest an embodied healing mechanism . In this qualitative study , we asked a subset of patients in a singleblind r and omized trial in irritable bowel syndrome to describe their treatment experiences while undergoing placebo treament . Analysis focused on patients ' unprompted descriptions of any enhanced touch sensations ( e.g. , warmth , tingling ) and any significance patients assigned to the sensations . We found in 5/6 cases , patients associated sensations including " warmth " and " tingling " with treatment efficacy . The conclusion offers a " neurophenomenological " account of the placebo effect by considering dynamic effects of attentional filtering on early sensory cortices , possibly underlying the phenomenology of placebo acupuncture 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 : To evaluate the safety of acupuncture in a large number of patients receiving conventional health care and , based on these results , to develop a new medical consent form for acupuncture . Methods : The prospect i ve observational study included patients who received acupuncture treatment for chronic osteoarthritis pain of the knee or hip , low back pain , neck pain or headache , allergic rhinitis , asthma , or dysmenorrhoea . After treatment , all patients documented adverse events associated with acupuncture ( defined as adverse effects ) . Patients who reported a need for treatment due to an adverse effect completed an additional st and ardised question naire on the most important adverse effect . Based on this data and considering ethical and legal aspects a new consent form was developed . Results : A total of 229,230 patients received on average 10.2 ± 3.0 acupuncture treatments . Altogether , 19,726 patients ( 8.6 % ) reported experiencing at least one adverse effect and 4,963 ( 2.2 % ) reported one which required treatment . Common adverse effects were bleedings or haematoma ( 6.1 % of patients , 58 % of all adverse effects ) , pain ( 1.7 % ) and vegetative symptoms ( 0.7 % ) . Two patients experienced a pneumothorax ( one needed hospital treatment , the other observation only ) . The longest duration of a side effect was 180 days ( nerve lesion of the lower limb ) . The result ing medical consent form consists of five modules : Introduction to acupuncture and moxibustion , Risks of acupuncture treatment , Conditions which can increase the risk , Doctor ’s statement , and Consent . Conclusion : Acupuncture provided by physicians is a relatively safe treatment and the proposed consent form could support both patients and professionals in the process of obtaining informed consent The purpose of the study was to evaluate the potential efficacy and acceptability of acupuncture for  posttraumatic stress disorder ( PTSD ) . People diagnosed with PTSD were r and omized to either an empirically developed acupuncture treatment ( ACU ) , a group cognitive-behavioral therapy ( CBT ) , or a wait-list control ( WLC ) . The primary outcome measure was self-reported PTSD symptoms at baseline , end treatment , and 3-month follow-up . Repeated measures MANOVA was used to detect predicted Group X Time effects in both intent-to-treat ( ITT ) and treatment completion models . Compared with the WLC condition in the ITT model , acupuncture provided large treatment effects for PTSD ( F [ 1 , 46 ] = 12.60 ; p < 0.01 ; Cohen ’s d = 1.29 ) , similar in magnitude to group CBT ( F [ 1 , 47 ] = 12.45 ; p < 0.01 ; d = 1.42 ) ( ACU vs. CBT , d = 0.29 ) . Symptom reductions at end treatment were maintained at 3-month follow-up for both interventions . Acupuncture may be an efficacious and acceptable nonexposure treatment option for PTSD . Larger trials with additional controls and methods are warranted to replicate and extend these findings BACKGROUND Acupuncture is a popular complementary and alternative treatment for chronic back pain . Recent European trials suggest similar short-term benefits from real and sham acupuncture needling . This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain . METHODS A total of 638 adults with chronic mechanical low back pain were r and omized to individualized acupuncture , st and ardized acupuncture , simulated acupuncture , or usual care . Ten treatments were provided over 7 weeks by experienced acupuncturists . The primary outcomes were back-related dysfunction ( Rol and -Morris Disability Question naire score ; range , 0 - 23 ) and symptom bothersomeness ( 0 - 10 scale ) . Outcomes were assessed at baseline and after 8 , 26 , and 52 weeks . RESULTS At 8 weeks , mean dysfunction scores for the individualized , st and ardized , and simulated acupuncture groups improved by 4.4 , 4.5 , and 4.4 points , respectively , compared with 2.1 points for those receiving usual care ( P < .001 ) . Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinical ly meaningful improvements on the dysfunction scale ( 60 % vs 39 % ; P < .001 ) . Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group ( P < .001 ) . After 1 year , participants in the treatment groups were more likely than those receiving usual care to experience clinical ly meaningful improvements in dysfunction ( 59 % to 65 % vs 50 % , respectively ; P = .02 ) but not in symptoms ( P > .05 ) . CONCLUSIONS Although acupuncture was found effective for chronic low back pain , tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits . These findings raise questions about acupuncture 's purported mechanisms of action . It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects Patients in the placebo arms of r and omized controlled trials ( RCT ) often experience positive changes from baseline . While multiple theories concerning such “ placebo effects ” exist , peculiarly , none has been informed by actual interviews of patients undergoing placebo treatment . Here , we report on a qualitative study ( n = 27 ) embedded within a RCT ( n = 262 ) in patients with irritable bowel syndrome . Besides identical placebo acupuncture treatment in the RCT , the qualitative study patients also received an additional set of interviews at the beginning , midpoint , and end of the trial . Interviews of the 12 qualitative subjects who underwent and completed placebo treatment  were transcribed . We found that patients ( 1 ) were persistently concerned with whether they were receiving placebo or genuine treatment ; ( 2 ) almost never endorsed “ expectation ” of improvement but spoke of “ hope ” instead and frequently reported despair ; ( 3 ) almost all reported improvement ranging from dramatic psychosocial changes to unambiguous , progressive symptom improvement to tentative impressions of benefit ; and ( 4 ) often worried whether their improvement was due to normal fluctuations or placebo effects . The placebo treatment was a problematic perturbation that provided an opportunity to reconstruct the experiences of the fluctuations of their illness and how it disrupted their everyday life . Immersion in this RCT was a co-mingling 
    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: & NA ; The objective of the study was to examine the 1‐year cumulative incidence of episodic neck pain and to explore its associations with individual risk factors , including a history of previous neck injury . A baseline cross‐sectional survey of an adult general population sample made up of all 7669 adults aged 18–75 years , registered with two family practice s in South Manchester , United Kingdom , identified the study population of adults with no current neck pain . This study population was surveyed again 12 months later to identify all those who had experienced neck pain during the follow‐up period . At follow‐up , cumulative 1‐year episode incidence of neck pain was estimated at 17.9 % ( 95 % confidence interval 16.0–19.7 % ) . Incidence was independent of age , but was more common in women . A history of previous neck injury at baseline was a significant risk factor for subsequent neck pain in the follow‐up year ( risk ratio 1.7 , 95 % confidence interval 1.2–2.5 ) , independent of gender and psychological status . Other independent baseline risk factors for subsequent neck pain included number of children , poor self‐assessed health , poor psychological status and a past history of low back pain . We have carried out a prospect i ve study in a general population sample and demonstrated that established risk factors for chronic pain predict future episodes of neck pain , and shown that in addition a history of neck injury is an independent and distinct risk factor . This finding may have major public health and medicolegal implication The r and omized controlled trial ( RCT ) is the gold st and ard for assessing the efficacy of medical treatments . Over the past 50 years , RCT methodology has proven to be quite successful in identifying effective treatments and weeding out ineffective ones , thus transforming medicine from an intuitive art into an empirical science . However , the enormous success of the RCT has inadvertently contributed to a common inferential error that is insufficiently appreciated by some clinicians and research ers . Although RCTs can effectively distinguish between placebo and active treatment effects at the level of the group , contrary to intuition , this same disentanglement is much more difficult to achieve at the level of the individual . For individual patients it is surprisingly difficult to determine who is a treatment responder and who is not . Using data from a recent RCT , we illustrate the problem and detail its negative effects for research and clinical practice . Finally , we suggest strategies for minimizing these negative effects STUDY OBJECTIVES Osteoarthritis pain affects more than half of all older adults , many of whom experience co-morbid sleep disturbance . Pain initiates and exacerbates sleep disturbance , whereas disturbed sleep maintains and exacerbates pain , which implies that improving the sleep of patients with osteoarthritis may also reduce their pain . We examined this possibility in a secondary analysis of a previously published r and omized controlled trial of cognitive behavioral therapy for insomnia ( CBT-I ) in patients with osteoarthritis and co-morbid insomnia . METHODS Twenty-three patients ( mean age 69.2 years ) were r and omly assigned to  CBT-I  and 28 patients ( mean age 66.5 years ) to an attention control . Neither directly addressed pain management . Twelve subjects crossed over to CBT-I after control treatment .  Sleep and pain were assessed by self-report at baseline , after treatment , and ( for CBT-I only ) at 1-year follow-up . RESULTS CBT-I subjects reported significantly improved sleep and significantly reduced pain after treatment . Control subjects reported no significant improvements . One-year follow-up found maintenance of improved sleep and reduced pain for both the CBT-I group alone and among subjects who crossed over from control to CBT-I. CONCLUSIONS CBT-I but not an attention control , without directly addressing pain control , improved both immediate and long-term self-reported sleep and pain  in older patients with osteoarthritis and comorbid insomnia . These results are unique in suggesting the long-term durability of CBT-I effects for co-morbid insomnia . They also indicate that improving sleep , per se , in patients with osteoarthritis may result in decreased pain . Techniques to improve sleep may be useful additions to pain management programs in osteoarthritis , and possibly other chronic pain conditions as well Evidence that placebo acupuncture is an effective treatment for  chronic pain  presents a puzzle : how do placebo needles appearing to patients to penetrate the body , but instead sitting on the skin 's surface in the manner of a tactile stimulus , evoke a healing response ? Previous accounts of ritual touch healing in which patients often described enhanced touch sensations ( including warmth , tingling or flowing sensations ) suggest an embodied healing mechanism . In this qualitative study , we asked a subset of patients in a singleblind r and omized trial in irritable bowel syndrome to describe their treatment experiences while undergoing placebo treament . Analysis focused on patients ' unprompted descriptions of any enhanced touch sensations ( e.g. , warmth , tingling ) and any significance patients assigned to the sensations . We found in 5/6 cases , patients associated sensations including " warmth " and " tingling " with treatment efficacy . The conclusion offers a " neurophenomenological " account of the placebo effect by considering dynamic effects of attentional filtering on early sensory cortices , possibly underlying the phenomenology of placebo acupuncture 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 : To evaluate the safety of acupuncture in a large number of patients receiving conventional health care and , based on these results , to develop a new medical consent form for acupuncture . Methods : The prospect i ve observational study included patients who received acupuncture treatment for chronic osteoarthritis pain of the knee or hip , low back pain , neck pain or headache , allergic rhinitis , asthma , or dysmenorrhoea . After treatment , all patients documented adverse events associated with acupuncture ( defined as adverse effects ) . Patients who reported a need for treatment due to an adverse effect completed an additional st and ardised question naire on the most important adverse effect . Based on this data and considering ethical and legal aspects a new consent form was developed . Results : A total of 229,230 patients received on average 10.2 ± 3.0 acupuncture treatments . Altogether , 19,726 patients ( 8.6 % ) reported experiencing at least one adverse effect and 4,963 ( 2.2 % ) reported one which required treatment . Common adverse effects were bleedings or haematoma ( 6.1 % of patients , 58 % of all adverse effects ) , pain ( 1.7 % ) and vegetative symptoms ( 0.7 % ) . Two patients experienced a pneumothorax ( one needed hospital treatment , the other observation only ) . The longest duration of a side effect was 180 days ( nerve lesion of the lower limb ) . The result ing medical consent form consists of five modules : Introduction to acupuncture and moxibustion , Risks of acupuncture treatment , Conditions which can increase the risk , Doctor ’s statement , and Consent . Conclusion : Acupuncture provided by physicians is a relatively safe treatment and the proposed consent form could support both patients and professionals in the process of obtaining informed consent The purpose of the study was to evaluate the potential efficacy and acceptability of acupuncture for  posttraumatic stress disorder ( PTSD ) . People diagnosed with PTSD were r and omized to either an empirically developed acupuncture treatment ( ACU ) , a group cognitive-behavioral therapy ( CBT ) , or a wait-list control ( WLC ) . The primary outcome measure was self-reported PTSD symptoms at baseline , end treatment , and 3-month follow-up . Repeated measures MANOVA was used to detect predicted Group X Time effects in both intent-to-treat ( ITT ) and treatment completion models . Compared with the WLC condition in the ITT model , acupuncture provided large treatment effects for PTSD ( F [ 1 , 46 ] = 12.60 ; p < 0.01 ; Cohen ’s d = 1.29 ) , similar in magnitude to group CBT ( F [ 1 , 47 ] = 12.45 ; p < 0.01 ; d = 1.42 ) ( ACU vs. CBT , d = 0.29 ) . Symptom reductions at end treatment were maintained at 3-month follow-up for both interventions . Acupuncture may be an efficacious and acceptable nonexposure treatment option for PTSD . Larger trials with additional controls and methods are warranted to replicate and extend these findings BACKGROUND Acupuncture is a popular complementary and alternative treatment for chronic back pain . Recent European trials suggest similar short-term benefits from real and sham acupuncture needling . This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain . METHODS A total of 638 adults with chronic mechanical low back pain were r and omized to individualized acupuncture , st and ardized acupuncture , simulated acupuncture , or usual care . Ten treatments were provided over 7 weeks by experienced acupuncturists . The primary outcomes were back-related dysfunction ( Rol and -Morris Disability Question naire score ; range , 0 - 23 ) and symptom bothersomeness ( 0 - 10 scale ) . Outcomes were assessed at baseline and after 8 , 26 , and 52 weeks . RESULTS At 8 weeks , mean dysfunction scores for the individualized , st and ardized , and simulated acupuncture groups improved by 4.4 , 4.5 , and 4.4 points , respectively , compared with 2.1 points for those receiving usual care ( P < .001 ) . Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinical ly meaningful improvements on the dysfunction scale ( 60 % vs 39 % ; P < .001 ) . Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group ( P < .001 ) . After 1 year , participants in the treatment groups were more likely than those receiving usual care to experience clinical ly meaningful improvements in dysfunction ( 59 % to 65 % vs 50 % , respectively ; P = .02 ) but not in symptoms ( P > .05 ) . CONCLUSIONS Although acupuncture was found effective for chronic low back pain , tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits . These findings raise questions about acupuncture 's purported mechanisms of action . It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects Patients in the placebo arms of r and omized controlled trials ( RCT ) often experience positive changes from baseline . While multiple theories concerning such “ placebo effects ” exist , peculiarly , none has been informed by actual interviews of patients undergoing placebo treatment . Here , we report on a qualitative study ( n = 27 ) embedded within a RCT ( n = 262 ) in patients with irritable bowel syndrome . Besides identical placebo acupuncture treatment in the RCT , the qualitative study patients also received an additional set of interviews at the beginning , midpoint , and end of the trial . Interviews of the 12 qualitative subjects who underwent and completed placebo treatment  were transcribed . We found that patients ( 1 ) were persistently concerned with whether they were receiving placebo or genuine treatment ; ( 2 ) almost never endorsed “ expectation ” of improvement but spoke of “ hope ” instead and frequently reported despair ; ( 3 ) almost all reported improvement ranging from dramatic psychosocial changes to unambiguous , progressive symptom improvement to tentative impressions of benefit ; and ( 4 ) often worried whether their improvement was due to normal fluctuations or placebo effects . The placebo treatment was a problematic perturbation that provided an opportunity to reconstruct the experiences of the fluctuations of their illness and how it disrupted their everyday life . Immersion in this RCT was a co-mingling 
    Output:
    