***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 OBJECT Recurrent laryngeal nerve ( RLN ) palsy is a well-known complication of cervical spine surgery . Nearly all previous studies were performed without laryngoscopy in asymptomatic patients . This prospect i ve study was undertaken to discern the true incidence of RLN palsy . Because not every RLN palsy is associated with hoarseness , the authors conducted a prospect i ve study involving the use of pre- and postoperative laryngoscopy . METHODS Prior to anterior cervical spine surgery preoperative indirect laryngoscopy was performed in 123 patients to evaluate the status of the vocal cords as a sign of function of the RLN . To assess postoperative status in 120 patients  laryngoscopy was repeated , and in cases of vocal cord malfunction follow-up examination was conducted 3 months later . In the group of 120 patients who attended follow-up examination , two ( 1.6 % ) had experienced a preoperative RLN palsy without hoarseness . Postoperatively the rate of clinical ly symptomatic RLN palsy was 8.3 % , and the incidence of RLN palsy not associated with hoarseness ( that is , clinical ly unapparent without laryngoscopy ) was 15.9 % ( overall incidence 24.2 % ) . At 3-month follow-up evaluation the rate had decreased to 2.5 % in cases with hoarseness and 10.8 % without hoarseness . Thus , the overall rate of early persisting RLN palsy was 11.3 % . CONCLUSIONS Laryngoscopy revealed that the true incidence of initial and persisting RLN palsy after anterior cervical spine surgery was much higher than anticipated . Especially in cases without hoarseness this could be proven , but the initial incidence of hoarseness was higher than expected . Only one third of new RLN palsy cases could be detected without laryngoscopy .  Resolution of hoarseness was approximately 70 % in those with preoperative hoarseness . The true rate of RLN palsy underscores the necessity to reevaluate the surgery- and intubation-related techniques for anterior cervical spine surgery and to reassess the degree of presurgical patient counseling BACKGROUND CONTEXT Cervical total disc replacement ( TDR ) is intended to address radicular pain and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease ( SCDD ) . PURPOSE The purpose of this trial is to compare the safety and efficacy of cervical TDR , ProDisc-C ( Synthes Spine Company , L.P. , West Chester , PA ) , to anterior cervical discectomy and fusion ( ACDF ) surgery for the treatment of one-level SCDD between C3 and C7 . STUDY DESIGN / SETTING The study was conducted at 13 sites . A noninferiority design with a 1:1 r and omization was used . PATIENT SAMPLE Two hundred nine patients were r and omized and treated ( 106 ACDF ; 103 ProDisc-C ) . OUTCOME MEASURES Visual analog scale ( VAS ) pain and intensity ( neck and arm ) , VAS satisfaction , neck disability index ( NDI ) , neurological exam , device success , adverse event occurrence , and short form-36 ( SF-36 ) st and ardized question naires . METHODS A prospect i ve , r and omized , controlled clinical trial was performed . Patients were enrolled and treated in accordance with the US Food and Drug Administration ( FDA ) -approved protocol . Patients were assessed pre- and postoperatively at six weeks , 3 , 6 , 12 , 18 , and 24 months . RESULTS Demographics were similar between the two patient groups ( ProDisc-C : 42.1+/-8.4 years , 44.7 % males ; Fusion : 43.5 + /- 7.1 years , 46.2 % males ) . The most commonly treated level was C5-C6 ( ProDisc-C : 56.3 % ; Fusion=57.5 % ) . NDI and SF-36 scores were significantly less compared with presurgery scores at all follow-up visits for both the treatment groups ( p<.0001 ) . VAS neck pain intensity and frequency as well as VAS arm pain intensity and frequency were statistically lower at all follow-up timepoints compared with preoperative levels ( p<.0001 ) but were not different between treatments . Neurologic success ( improvement or maintenance ) was achieved at 24 months in 90.9 % of ProDisc-C and 88.0 % of Fusion patients ( p=.638 ) . Results show that at 24 months postoperatively , 84.4 % of ProDisc-C patients achieved a more than or equal to 4 degrees of motion or maintained motion relative to preoperative baseline at the operated level . There was a statistically significant difference in the number of secondary surgeries with 8.5 % of Fusion patients needing a re-operation , revision , or supplemental fixation within the 24 month postoperative period compared with 1.8 % of ProDisc-C patients ( p=.033 ) . At 24 months , there was a statistically significant difference in medication usage with 89.9 % of ProDisc-C patients not on strong narcotics or muscle relaxants , compared with 81.5 % of Fusion patients . CONCLUSIONS The results of this clinical trial demonstrate that ProDisc-C is a safe and effective surgical treatment for patients with disabling cervical radiculopathy because of single-level disease . By all primary and secondary measures evaluated , clinical outcomes after ProDisc-C implantation were either equivalent or superior to those same clinical outcomes after Fusion OBJECT The authors report the results of a prospect i ve r and omized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion ( ACDF ) in patients treated for symptomatic single-level cervical degenerative disc disease ( DDD ) . METHODS Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and r and omly assigned to one of two treatment groups : 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System ( Medtronic Sofamor Danek ) ;  265 patients in the control group underwent decompressive ACDF . Eighty percent of the arthroplasty-treated patients ( 223 of 276 ) and 75 % of the control patients ( 198 of 265 ) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery . Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group . The arthroplasty group also had a statistically significant higher rate of neurological success ( p = 0.005 ) as well as a lower rate of secondary revision surgeries ( p = 0.0277 ) and supplemental fixation ( p = 0.0031 ) . The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months , as was relief of neck pain . The patients in the investigational group returned to work 16 days sooner than those in the control group , and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well ( p = 0.0492 , log-rank test ) . The cervical disc implant maintained segmental sagittal angular motion averaging more than 7 degrees . In the investigational group , there were no cases of implant failure or migration . CONCLUSIONS The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success , improved clinical outcomes , and a reduced rate of secondary surgeries compared with ACDF STUDY DESIGN A prospect i ve assessment , performed using the Health Status Question naire , of the outcomes for 28 patients with cervical radiculopathy treated with one- or two-level anterior cervical discectomy and fusion . OBJECTIVE To assess patient outcome using the Health Status Question naire after one- or two-level anterior cervical discectomy and fusion . SUMMARY OF BACKGROUND DATA Although outcomes for many types of surgical procedures already have been evaluated , few have focused on the results of cervical surgery . METHODS Before and after  anterior cervical discectomy and fusion for cervical radiculopathy , 28 patients filled out the Health Status Question naire .  The average follow-up interval was 21.8 months . There were 10 men and 18 women , with an average age of 44 years . All outcome instruments were grade d for individual scores of general health , physical function , role limitation because of physical health problems , role limitation because of emotional problems , social function , mental health , bodily pain , and energy . Data were analyzed using the age ( < 55 vs. > 55 ) , worker 's compensation status , and education status of the patient . Preoperative and postoperative scores were compared for each subscale . RESULTS Statistically significant improvements were found in postoperative scores for bodily pain ( P < 0.001 ) , vitality ( P = 0.003 ) , physical function ( P = 0.01 ) , role function/physical ( P = 0.0003 ) , and social function ( P = 0.0004 ) . No significant differences were found before and after surgery for three health scales : general health , mental health , and role function associated with emotional limitations . Age , educational status , and history of compensation litigation did not appear to affect outcome measures . CONCLUSIONS Although this is a preliminary report involving 28 patients , it would appear , based on the results of the Health Status Question naire , that anterior cervical discectomy and fusion performed on appropriately selected patients is a highly reliable surgical procedure for the management of cervical radiculopathy . Additional disease-specific questions may provide more sensitivity in evaluating radiculopathy after surgical and nonsurgical intervention Background PROCON was design ed to assess the clinical outcome , development of adjacent disc disease and costs of cervical anterior discectomy without fusion , with fusion using a st and alone cage and implantation of a Bryan 's disc prosthesis . Description of rationale and design of PROCON trial and discussion of its strengths and limitations . Methods / Design Since proof justifying the use of implants or arthroplasty after cervical anterior discectomy is lacking , PROCON was design ed . PROCON is a multicenter , r and omized controlled trial comparing cervical anterior discectomy without fusion , with fusion with a st and alone cage or with implantation of a disc .  The study population will be enrolled from patients with a single level cervical disc disease without myelopathic signs . Each treatment arm will need 90 patients . The patients will be followed for a minimum of five years , with visits scheduled at 6 weeks , 3 months , 12 months , and then yearly . At one year postoperatively , clinical outcome and self reported outcomes will be evaluated . At five years , the development of adjacent disc disease will be investigated . Discussion The results of this study will contribute to the discussion whether additional fusion or arthroplasty is needed and cost effective . Trial registration Current Controlled Trials IS RCT OBJECT There are now 3 r and omized , multicenter , US FDA investigational device exemption , industry-sponsored studies comparing arthroplasty with anterior cervical discectomy and fusion ( ACDF ) for single-level cervical disease with 2 years of follow-up . These 3 studies evaluated the Prestige ST , Bryan , and ProDisc-C artificial discs . The authors analyzed the combined results of these trials . METHODS A total of 1213 patients with symptomatic , single-level cervical disc disease were r and omized into 2 treatment arms in the 3 r and omized trials . Six hundred twenty-one patients received an artificial cervical disc , and 592 patients were treated with ACDF .  In the three trials , 94 % of the arthroplasty group and 87 % of the ACDF group have completed 2 years of follow-up . The authors analyzed the 2-year data from these 3 trials including previously unpublished source data . Statistical analysis was performed with fixed and r and om effects models . RESULTS The authors ' analysis revealed that segmental sagittal motion was preserved with arthroplasty ( preoperatively 7. 
    Output:
    
This means that smaller studies ( or small published subsets of larger studies ) showed larger differences for this outcome , which may indicate publication bias .
There was a tendency for clinical results to be in favour of arthroplasty ; often these were statistically significant .
However , differences in effect size were invariably small and not clinical ly relevant for all primary outcomes .
Significance was often gained or lost in the varying sensitivity analyses , probably owing to the relatively small number of studies , in combination with the small differences that were found .
However , at this time both treatments can be seen as valid options with respect to results at a maximum of one to two years .
There was high- quality evidence that the goal of preservation of segmental mobility in arthroplasty was met .
A statistically significant effect on the incidence of secondary symptoms at adjacent levels , the primary goal of arthroplasty over fusion , was not found at one to two years .
If there was a protective effect , this should become clearer over time .