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: The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care CONTEXT R and omized controlled trials have been developed essentially in the context of pharmacological treatments ( ie , oral drugs ; intra-articular injection ; and topical , intramuscular , and intravenous treatments ) , but assessment of the effectiveness of nonpharmacological treatments ( ie , surgery , arthroscopy , joint lavage , rehabilitation , acupuncture , and education ) presents specific issues . OBJECTIVES To compare the quality of articles of  nonpharmacological and pharmacological treatments of hip and knee osteoarthritis and to identify specific method ological issues related to assessment of nonpharmacological treatments . DESIGN AND SETTING We search ed MEDLINE and the Cochrane Central Register of Controlled Trials for articles of r and omized controlled trials published between January 1 , 1992 , and February 28 , 2002 , in 28 general medical and specialty journals with high impact factors and assessing nonpharmacological and pharmacological treatments in patients with hip or knee osteoarthritis . MAIN OUTCOME MEASURES The quality of the methods reported in the selected articles was assessed by 2 independent review ers using the Jadad scale , the Delphi list , and guidelines found in the Users ' Guides to the Medical Literature . Investigators also used a checklist of items developed by the authors to analyze study characteristics . RESULTS A total of 110 articles were included in the analysis ; 50 ( 45.5 % ) assessed nonpharmacological treatments and 60 ( 54.5 % ) assessed pharmacological treatments . Reports of nonpharmacological treatments had a lower global quality score than did reports of pharmacological treatments as measured by the Jadad scale ( mean [ SD ] score , 1.4 [ 1.3 ] vs 3.0 [ 1.3 ] ) and the Delphi list ( mean [ SD ] score , 5.2 [ 1.5 ] vs 7.5 [ 1.1 ] ) . Lack of reporting adequate r and om sequence generation and intention-to-treat analyses were found in both nonpharmacological and pharmacological articles . Nonpharmacological treatments were less often compared with a placebo than were pharmacological treatments ( 28.0 % of articles vs 71.7 % ) . Compared with pharmacological articles , nonpharmacological articles less often described blinding of patients ( 26.0 % vs 96.7 % ) , care providers ( 6.0 % vs 81.7 % ) , and outcome assessors ( 68.0 % vs 98.3 % ) . Care providers ' skill levels could influence treatment effect in 84.0 % of nonpharmacological articles vs 23.3 % of pharmacological articles . CONCLUSIONS In this analysis of reports of hip and knee osteoarthritis therapy , nonpharmacological articles scored lower than pharmacological articles in terms of quality . Assessment s of nonpharmacological treatments must take into consideration additional method ological issues BACKGROUND The conduct of r and omized , controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports . OBJECTIVE To develop an extension of the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement for trials of nonpharmacologic treatments . DESIGN A consensus meeting was organized to develop an extension of the CONSORT Statement that addresses r and omized trials of nonpharmacologic treatments . To prepare for the meeting , a survey was conducted to identify the specific issues for discussion . SETTING Consensus meeting in Paris , France . PARTICIPANTS A total of 33 experts attended the meeting . The experts were method ologists ( n = 17 ) ; surgeons ( n = 6 ) ; editors ( n = 5 ) ; and clinicians involved in rehabilitation ( n = 1 ) , psychotherapy ( n = 2 ) , education ( n = 1 ) , and implantable devices ( n = 1 ) . MEASUREMENTS Experts indicated which of the 22 items on the CONSORT checklist should be modified or which additional items should be added specifically for nonpharmacologic treatments . During a 3-day consensus meeting , all items were discussed and additional method ological issues related to nonpharmacologic research were identified . RESULTS The consensus was that 11 items on the CONSORT checklist needed some modifications for nonpharmacologic trials : item 1 ( title and abstract ) , item 3 ( participants ) , item 4 ( interventions ) , item 7 ( sample size ) , item 8 ( r and omization ) , item 11 ( blinding ) , item 12 ( statistical methods ) , item 13 ( participant flow ) , item 15 ( baseline data ) , item 20 ( discussion : interpretation ) , and item 21 ( generalizability ) . In addition , the meeting participants added 1 item related to implementation of the intervention . LIMITATION Evidence was not always available to support the inclusion of each checklist item . CONCLUSION The methods and processes used to develop this extension could be used for other reporting guidelines . The use of this extension to the CONSORT Statement should improve the quality of reporting r and omized , controlled trials assessing nonpharmacologic treatments Background Hip replacement ( arthroplasty ) surgery is a highly successful treatment for patients with severe symptomatic arthritis of the hip joint . For older patients , several design s of Total Hip Arthroplasty have shown excellent results in terms of both function and value for money . However , in younger more active patients , there is approximately a 50 % failure rate at 25 years for traditional implants . Hip resurfacing is a relatively new arthroplasty technique . In a recent review of the literature on resurfacing arthroplasty it was concluded that the short-term functional results appear promising but some potential early disadvantages were identified , including the risk of femoral neck fracture and collapse of the head of the femur . The aim of the current study is to assess whether there is a difference in functional hip scores at one year post-operation between Total Hip Arthroplasty and Resurfacing Arthroplasty . Secondary aims include assessment of complication rates for both procedures as well cost effectiveness . Methods / design All patients medically fit for surgery and deemed suitable for a resurfacing arthroplasty are eligible to take part in this study . A r and omisation sequence will be produced and administered independently . After consenting , all patients will be clinical ly review ed and hip function , quality of life and physical activity level will be assessed through question naires . The allocated surgery will then be performed with the preferred technique of the surgeon . Six weeks post-operation hip function will be assessed and complications recorded . Three , six and 12 months post-operation hip function , quality of life and physical activity level will be assessed . Additional information about patients ' out-of-pocket expenses will also be collected . Trial registration Current Controlled Trials IS RCT N33354155UKCLRN portfolio ID BACKGROUND The use of larger femoral heads has been proposed to reduce the risk of dislocation after total hip arthroplasty , but there is a lack of evidence to support this proposal . The aim of this multicenter r and omized controlled trial was to determine whether the incidence of dislocation one year after total hip arthroplasty is significantly lower in association with the use of a 36-mm femoral head articulation as compared with a 28-mm articulation . METHODS Six hundred and forty-four middle-aged and elderly patients undergoing primary or revision arthroplasty were r and omized intraoperatively to receive either a 36 or 28-mm metal femoral head on highly cross-linked polyethylene .  Patients who were at high risk of dislocation ( including those with dementia and neuromuscular disease ) and those undergoing revision for the treatment of recurrent hip dislocation or infection were excluded . Patients were stratified according to other potential risk factors for dislocation , including diagnosis and age . Diagnosis of hip dislocation required confirmation by a physician and radiographic evidence of a dislocation . RESULTS Overall , at one year of follow-up , hips with a 36-mm femoral head articulation had a significantly lower incidence of dislocation than did those with a 28-mm articulation ( 1.3 % [ four of 299 ] compared with 5.4 % [ seventeen of 316 ] ; difference , 4.1 % [ 95 % confidence interval , 1.2 % to 7.2 % ] ) when controlling for the type of procedure ( primary or revision ) ( p = 0.012 ) . The incidence of dislocation following primary arthroplasty was also significantly lower for hips with a 36-mm femoral head articulation than for those with a 28-mm articulation ( 0.8 % [ two of 258 ] compared with 4.4 % [ twelve of 275 ] ; difference , 3.6 % [ 95 % confidence interval , 0.9 % to 6.8 % ] ) ( p = 0.024 ) . The incidence of dislocation following revision arthroplasty was 4.9 % ( two of forty-one ) for hips with a 36-mm articulation and 12.2 % ( five of forty-one ) for hips with a 28-mm articulation ; this difference was not significant with the relatively small sample size of the revision group ( difference , 7.3 % [ 95 % confidence interval , -5.9 % to 21.1 % ] ) ( p = 0.273 ) . CONCLUSIONS Compared with a 28-mm femoral head articulation , a larger 36-mm articulation result ed in a significantly decreased incidence of dislocation in the first year following primary total hip arthroplasty . However , before a 36-mm metal-on-highly cross-linked polyethylene articulation is widely recommended , the incidence of late dislocation , wear , periprosthetic osteolysis , and liner fracture should be established This prospect i ve , r and omized , multicenter study of alumina ceramic-on-alumina ceramic bearing couples includes 452 patients ( 475 hips ) . Their average age was 53 years with approximately two thirds men and 82 % with osteoarthritis . At an average 8-year follow-up , clinical results were excellent and cortical erosions significantly less than in the conventional polyethylene-on-metal bearing group . Nine hips have undergone revision of one or both components for any reason . Of the 380 ceramic liners , 2 ( 0.5 % ) have fractured requiring reoperation , and 3 ( 0.8 % ) ceramic patients reported a transient squeaking sound , one of which had a head and liner change due to groin pain secondary to psoas tendinitis at 5 years . With no revisions for aseptic loosening and minimal cortical erosions , alumina-ceramic bearing couples are performing in a manner superior to the polyethylene-on-metal bearing in this young , active patient population BACKGROUND Highly cross-linked polyethylene was introduced for clinical use in total hip arthroplasty with the expectation that it would exhibit less wear when compared with conventional polyethylene . The purpose of this study was to report the clinical and radiographic results , after a minimum of five years of follow-up , of a r and omized , blinded , controlled trial comparing a conventional polyethylene with a first-generation highly cross-linked polyethylene . METHODS One hundred patients were enrolled in a prospect i ve , r and omized controlled study comparing highly cross-linked and conventional polyethylene acetabular liners in total hip arthroplasty . Fifty patients were in each group . At the time of follow-up , clinical outcomes were assessed and steady-state femoral head penetration rates ( after bedding-in ) for each patient were calculated with use of a vali date d radiographic technique . In addition , a statistical comparison of polyethylene wear between groups was performed with use of generalized estimating equations . RESULTS At a mean of 6.8 years postoperatively , there were no differences between the two polyethylene groups with regard to the Harris hip score , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , or Short Form-12 ( SF-12 ) score . The mean femoral head penetration rate in the first through fifth years was found to be significantly lower in the group treated with the highly cross-linked polyethylene ( 0.003 mm/yr [ 95 % confidence interval , + /-0.027 ] ) than it was in the group treated 
    Output:
    
agent
Patients experienced significant post-THR improvements in Harris Hip scores , but this did not differ between impact types .
Recipients of cross-linked vs. conventional polyethylene cup liners experienced reduced femoral head penetration and revision .
There was no impact of femoral stem fixation and cup shell design on implant survival rates .
Evidence on mortality and complications ( aseptic loosening , femoral fracture ) was inconclusive .
***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: The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care CONTEXT R and omized controlled trials have been developed essentially in the context of pharmacological treatments ( ie , oral drugs ; intra-articular injection ; and topical , intramuscular , and intravenous treatments ) , but assessment of the effectiveness of nonpharmacological treatments ( ie , surgery , arthroscopy , joint lavage , rehabilitation , acupuncture , and education ) presents specific issues . OBJECTIVES To compare the quality of articles of  nonpharmacological and pharmacological treatments of hip and knee osteoarthritis and to identify specific method ological issues related to assessment of nonpharmacological treatments . DESIGN AND SETTING We search ed MEDLINE and the Cochrane Central Register of Controlled Trials for articles of r and omized controlled trials published between January 1 , 1992 , and February 28 , 2002 , in 28 general medical and specialty journals with high impact factors and assessing nonpharmacological and pharmacological treatments in patients with hip or knee osteoarthritis . MAIN OUTCOME MEASURES The quality of the methods reported in the selected articles was assessed by 2 independent review ers using the Jadad scale , the Delphi list , and guidelines found in the Users ' Guides to the Medical Literature . Investigators also used a checklist of items developed by the authors to analyze study characteristics . RESULTS A total of 110 articles were included in the analysis ; 50 ( 45.5 % ) assessed nonpharmacological treatments and 60 ( 54.5 % ) assessed pharmacological treatments . Reports of nonpharmacological treatments had a lower global quality score than did reports of pharmacological treatments as measured by the Jadad scale ( mean [ SD ] score , 1.4 [ 1.3 ] vs 3.0 [ 1.3 ] ) and the Delphi list ( mean [ SD ] score , 5.2 [ 1.5 ] vs 7.5 [ 1.1 ] ) . Lack of reporting adequate r and om sequence generation and intention-to-treat analyses were found in both nonpharmacological and pharmacological articles . Nonpharmacological treatments were less often compared with a placebo than were pharmacological treatments ( 28.0 % of articles vs 71.7 % ) . Compared with pharmacological articles , nonpharmacological articles less often described blinding of patients ( 26.0 % vs 96.7 % ) , care providers ( 6.0 % vs 81.7 % ) , and outcome assessors ( 68.0 % vs 98.3 % ) . Care providers ' skill levels could influence treatment effect in 84.0 % of nonpharmacological articles vs 23.3 % of pharmacological articles . CONCLUSIONS In this analysis of reports of hip and knee osteoarthritis therapy , nonpharmacological articles scored lower than pharmacological articles in terms of quality . Assessment s of nonpharmacological treatments must take into consideration additional method ological issues BACKGROUND The conduct of r and omized , controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports . OBJECTIVE To develop an extension of the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement for trials of nonpharmacologic treatments . DESIGN A consensus meeting was organized to develop an extension of the CONSORT Statement that addresses r and omized trials of nonpharmacologic treatments . To prepare for the meeting , a survey was conducted to identify the specific issues for discussion . SETTING Consensus meeting in Paris , France . PARTICIPANTS A total of 33 experts attended the meeting . The experts were method ologists ( n = 17 ) ; surgeons ( n = 6 ) ; editors ( n = 5 ) ; and clinicians involved in rehabilitation ( n = 1 ) , psychotherapy ( n = 2 ) , education ( n = 1 ) , and implantable devices ( n = 1 ) . MEASUREMENTS Experts indicated which of the 22 items on the CONSORT checklist should be modified or which additional items should be added specifically for nonpharmacologic treatments . During a 3-day consensus meeting , all items were discussed and additional method ological issues related to nonpharmacologic research were identified . RESULTS The consensus was that 11 items on the CONSORT checklist needed some modifications for nonpharmacologic trials : item 1 ( title and abstract ) , item 3 ( participants ) , item 4 ( interventions ) , item 7 ( sample size ) , item 8 ( r and omization ) , item 11 ( blinding ) , item 12 ( statistical methods ) , item 13 ( participant flow ) , item 15 ( baseline data ) , item 20 ( discussion : interpretation ) , and item 21 ( generalizability ) . In addition , the meeting participants added 1 item related to implementation of the intervention . LIMITATION Evidence was not always available to support the inclusion of each checklist item . CONCLUSION The methods and processes used to develop this extension could be used for other reporting guidelines . The use of this extension to the CONSORT Statement should improve the quality of reporting r and omized , controlled trials assessing nonpharmacologic treatments Background Hip replacement ( arthroplasty ) surgery is a highly successful treatment for patients with severe symptomatic arthritis of the hip joint . For older patients , several design s of Total Hip Arthroplasty have shown excellent results in terms of both function and value for money . However , in younger more active patients , there is approximately a 50 % failure rate at 25 years for traditional implants . Hip resurfacing is a relatively new arthroplasty technique . In a recent review of the literature on resurfacing arthroplasty it was concluded that the short-term functional results appear promising but some potential early disadvantages were identified , including the risk of femoral neck fracture and collapse of the head of the femur . The aim of the current study is to assess whether there is a difference in functional hip scores at one year post-operation between Total Hip Arthroplasty and Resurfacing Arthroplasty . Secondary aims include assessment of complication rates for both procedures as well cost effectiveness . Methods / design All patients medically fit for surgery and deemed suitable for a resurfacing arthroplasty are eligible to take part in this study . A r and omisation sequence will be produced and administered independently . After consenting , all patients will be clinical ly review ed and hip function , quality of life and physical activity level will be assessed through question naires . The allocated surgery will then be performed with the preferred technique of the surgeon . Six weeks post-operation hip function will be assessed and complications recorded . Three , six and 12 months post-operation hip function , quality of life and physical activity level will be assessed . Additional information about patients ' out-of-pocket expenses will also be collected . Trial registration Current Controlled Trials IS RCT N33354155UKCLRN portfolio ID BACKGROUND The use of larger femoral heads has been proposed to reduce the risk of dislocation after total hip arthroplasty , but there is a lack of evidence to support this proposal . The aim of this multicenter r and omized controlled trial was to determine whether the incidence of dislocation one year after total hip arthroplasty is significantly lower in association with the use of a 36-mm femoral head articulation as compared with a 28-mm articulation . METHODS Six hundred and forty-four middle-aged and elderly patients undergoing primary or revision arthroplasty were r and omized intraoperatively to receive either a 36 or 28-mm metal femoral head on highly cross-linked polyethylene .  Patients who were at high risk of dislocation ( including those with dementia and neuromuscular disease ) and those undergoing revision for the treatment of recurrent hip dislocation or infection were excluded . Patients were stratified according to other potential risk factors for dislocation , including diagnosis and age . Diagnosis of hip dislocation required confirmation by a physician and radiographic evidence of a dislocation . RESULTS Overall , at one year of follow-up , hips with a 36-mm femoral head articulation had a significantly lower incidence of dislocation than did those with a 28-mm articulation ( 1.3 % [ four of 299 ] compared with 5.4 % [ seventeen of 316 ] ; difference , 4.1 % [ 95 % confidence interval , 1.2 % to 7.2 % ] ) when controlling for the type of procedure ( primary or revision ) ( p = 0.012 ) . The incidence of dislocation following primary arthroplasty was also significantly lower for hips with a 36-mm femoral head articulation than for those with a 28-mm articulation ( 0.8 % [ two of 258 ] compared with 4.4 % [ twelve of 275 ] ; difference , 3.6 % [ 95 % confidence interval , 0.9 % to 6.8 % ] ) ( p = 0.024 ) . The incidence of dislocation following revision arthroplasty was 4.9 % ( two of forty-one ) for hips with a 36-mm articulation and 12.2 % ( five of forty-one ) for hips with a 28-mm articulation ; this difference was not significant with the relatively small sample size of the revision group ( difference , 7.3 % [ 95 % confidence interval , -5.9 % to 21.1 % ] ) ( p = 0.273 ) . CONCLUSIONS Compared with a 28-mm femoral head articulation , a larger 36-mm articulation result ed in a significantly decreased incidence of dislocation in the first year following primary total hip arthroplasty . However , before a 36-mm metal-on-highly cross-linked polyethylene articulation is widely recommended , the incidence of late dislocation , wear , periprosthetic osteolysis , and liner fracture should be established This prospect i ve , r and omized , multicenter study of alumina ceramic-on-alumina ceramic bearing couples includes 452 patients ( 475 hips ) . Their average age was 53 years with approximately two thirds men and 82 % with osteoarthritis . At an average 8-year follow-up , clinical results were excellent and cortical erosions significantly less than in the conventional polyethylene-on-metal bearing group . Nine hips have undergone revision of one or both components for any reason . Of the 380 ceramic liners , 2 ( 0.5 % ) have fractured requiring reoperation , and 3 ( 0.8 % ) ceramic patients reported a transient squeaking sound , one of which had a head and liner change due to groin pain secondary to psoas tendinitis at 5 years . With no revisions for aseptic loosening and minimal cortical erosions , alumina-ceramic bearing couples are performing in a manner superior to the polyethylene-on-metal bearing in this young , active patient population BACKGROUND Highly cross-linked polyethylene was introduced for clinical use in total hip arthroplasty with the expectation that it would exhibit less wear when compared with conventional polyethylene . The purpose of this study was to report the clinical and radiographic results , after a minimum of five years of follow-up , of a r and omized , blinded , controlled trial comparing a conventional polyethylene with a first-generation highly cross-linked polyethylene . METHODS One hundred patients were enrolled in a prospect i ve , r and omized controlled study comparing highly cross-linked and conventional polyethylene acetabular liners in total hip arthroplasty . Fifty patients were in each group . At the time of follow-up , clinical outcomes were assessed and steady-state femoral head penetration rates ( after bedding-in ) for each patient were calculated with use of a vali date d radiographic technique . In addition , a statistical comparison of polyethylene wear between groups was performed with use of generalized estimating equations . RESULTS At a mean of 6.8 years postoperatively , there were no differences between the two polyethylene groups with regard to the Harris hip score , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , or Short Form-12 ( SF-12 ) score . The mean femoral head penetration rate in the first through fifth years was found to be significantly lower in the group treated with the highly cross-linked polyethylene ( 0.003 mm/yr [ 95 % confidence interval , + /-0.027 ] ) than it was in the group treated 
    Output:
    