***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 : The Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events ( EVOLVE ) clinical trial evaluated the effects of cinacalcet on clinical events in patients with secondary hyperparathyroidism ( sHPT ) who were on hemodialysis .  Health-related quality of life ( HRQoL ) was assessed by a generic , preference-based health outcome measure ( EQ-5D ) at scheduled visits and after a study event . Here , we report the HRQoL analysis from EVOLVE . Methods : We assessed changes in HRQoL from baseline to scheduled visits , and estimated the acute ( 3 mo ) and chronic ( beyond 3 mo ) effects of sHPT-related events on HRQoL using generalized estimating equation analysis controlling for baseline HRQoL and r and omized assignment . Results : Data on  HRQoL were available for 3547 of 3883 subjects , with 1650 events in the placebo and 1502 in the cinacalcet arm . At the study end , no difference in change from baseline HRQoL was observed in the direct comparison of EQ-5D by treatment arms . The regression analysis showed significant effects of events on HRQoL and a modest positive effect of cinacalcet . Estimated quality -adjusted life-year gains were of similar magnitude based on the observed data or the predictions from the model , with only a small gain in precision from the predicted analysis . Conclusions : By contrast with a conventional comparison , a regression analysis demonstrated large decrements in HRQoL after events and a modest improvement in HRQoL with cinacalcet . As r and omized controlled trials are rarely powered to detect differences in HRQoL , a prespecified regression analysis may be acceptable to improve precision of the effects and underst and their origin 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 The parathyroidectomy assessment of symptoms ( PAS ) score was design ed initially for primary hyperparathyroidism to provide a specific symptom assessment and was vali date d later in secondary and tertiary hyperparathyroidism . The aim of our study was to evaluate changes in the PAS scores and quality of life before and after parathyroidectomy for secondary hyperparathyroidism . METHODS This prospect i ve study included 49 consecutive patients who underwent parathyroidectomy for secondary hyperparathyroidism . The  PAS and Short Form (SF)-36 question naires were completed before parathyroidectomy and at 12 months postoperatively . RESULTS All 13 symptoms included in the PAS score improved significantly . The mean ± st and ard deviation PAS score decreased from 545 ± 263 to 284 ± 201 ( P < .0001 ) after parathyroidectomy . Quality of life was enhanced in both physical ( 40.3 ± 17.1 to 59.0 ± 14.9 ; P < .0001 ) and mental ( 47.6 ± 17.1 to 63.7 ± 13.0 ; P < .0001 ) components . The PAS score was inversely correlated with the SF-36 global score preoperatively and postoperatively ( r(2 ) = 0.48 and 0.25 ; P < .001 ) . The change in PAS score also correlated with the change in SF-36 global score ( r(2 ) = 0.29 ; P < .001 ) . Multiple linear regression analysis showed that preoperative PAS score and bone mineral density T-score were predictors of the decrease in PAS score . Preoperative SF-36 global score and intact parathyroid hormone levels were predictors of the increment in SF-36 score . CONCLUSION The symptom burden of secondary hyperparathyroidism has a negative impact on a patient 's quality of life . Parathyroidectomy is associated with a marked improvement in symptoms and quality of life BACKGROUND Patients with secondary hyperparathyroidism often require therapy that provides long-term control of parathyroid hormone concentrations without increasing calcium and phosphorus concentrations . Cinacalcet modulates the calcium-sensing receptor on the parathyroid gl and to reduce secretion of parathyroid hormone and lower serum calcium , phosphorus and calcium-phosphorus product in haemodialysis patients . METHODS Dialysis patients with secondary hyperparathyroidism [ parathyroid hormone ( PTH ) level > or = 300 pg/ml ] who were enrolled in one of four phase 2 placebo-controlled studies were eligible to enroll in an open-label extension study in which all patients received cinacalcet . For this extension study , cinacalcet was initiated at 30 mg in all patients and the dose was escalated to a maximum of 180 mg once daily if PTH concentrations were > 250 pg/ml . Use of concomitant vitamin D sterols and phosphate binders was not restricted . RESULTS The analysis of all patients ( n = 59 ) completing 100 weeks of cinacalcet treatment showed long-term control of PTH and calcium-phosphorus product . Approximately 55 % achieved a PTH concentration < or = 300 pg/ml at the week-100 study visit , and approximately 60 % had at least a 30 % reduction in PTH from baseline . Serum calcium , phosphorus and the calcium-phosphorus product did not increase during the study . Concomitant vitamin D sterol and phosphate binder therapy remained stable . Cinacalcet was safe and generally well tolerated at doses up to 180 mg/day . CONCLUSIONS In this long-term study , cinacalcet effectively sustained reductions in PTH for up to 3 years without increasing concentrations of serum calcium , phosphorus or calcium-phosphorus product Patients with secondary hyperparathyroidism experience a variety of clinical symptoms which may adversely affect physical and mental function . As part of a multicenter , open-label clinical trial , subjects completed a question naire that included the Medical Outcomes Study Short Form-36 and 14 kidney disease-related symptoms at multiple time points during the study . Out of the 567 subjects who received at least one dose of cinacalcet  , 528 to 535 ( 93.8 - 94.4 % ) completed all or portions of the question naire at baseline . The median bioactive parathyroid hormone ( PTH ) was 294 pg/mL ( 10 % , 90 % range , 172 - 655 pg/mL ) . Following treatment with cinacalcet and low-dose vitamin D sterols , subjects reported significant improvement in the frequency of pain in muscles , joints and bones , stiff joints , dry skin , itchy skin , excessive thirst , and trouble with memory . At end of the efficacy assessment phase ( Weeks 16 to 22 ) , the magnitude of improvement was the greatest in joint pain , bone pain , dry skin , and excessive thirst ( > 5 on a 0 - 100 scale ; P < 0.001 ) . There were no clinical ly or statistically significant changes in any of the Short Form-36 subscales or in the physical or mental health composite scores . Among patients on hemodialysis with moderate to severe secondary hyperparathyroidism , treatment with cinacalcet and low-dose vitamin D sterols results in significant improvement in pain in the muscles , joints and bones , joint stiffness , dry and itchy skin , excessive thirst , and trouble with memory BACKGROUND We prospect ively studied changes in the perception of health-related quality of life , pruritus , and degree of left ventricular hypertrophy in end-stage renal disease patients with tertiary hyperparathyroid disorder , before and 6 months after  total parathyroidectomy treatment .  METHODS A series of 12 consecutive patients were enrolled . Throughout the follow-up period , all subjects completed the Kidney Disease Quality of Life Short Form-36 ( KDQOL SF-36 ) question naire at inclusion and after 6 months . Serial clinical and physiological parameters including uremic pruritus , blood pressure control and left ventricular hypertrophy measured by echocardiography were recorded . RESULTS Mean scores of the KDQOL SF-36 question naires were substantially higher 6 months after parathyroidectomy , with reference to physical functioning , bodily pain , role-physical , role-emotional , symptom list and burden of kidney disease .  Parathyroidectomy result ed in a 22 % reduction in left ventricular mass index , with significant improvement from the baseline value of 246 + /- 131 to 192 + /- 131 g/m2 ( p = 0.03 ) . CONCLUSION Our findings highlight the potential importance of parathyroidectomy in improving health-related quality of life and left ventricular hypertrophy among dialysis patients with tertiary hyperparathyroidism Background Parathyroidectomy for primary hyperparathyroidism ( PHPT ) is expected to trigger an improvement in the quality of life . This has been demonstrated previously by using the SF-36 question naire , whose interpretation is difficult in routine clinical practice . As an alternative , the 13-item question naire developed by Pasieka et al. can be used to assess the severity of symptoms on a visual analogue from which a parathyroid assessment of symptoms score ( PAS ) can be calculated . The purpose of this study was to correlate results of these two assessment tools . Methods Prospect i ve case-series study recruiting consecutive unselected patients who underwent successful parathyroidectomy for PHPT . SF-36(v2 ) and Pasieka ’s question naires were collected before parathyroidectomy and at 3 , 6 , and 12 months postoperatively . Results Between November 2005 and December 2006 , 101 patients were diagnosed with PHPT ( 30 men ; aged 18–89 years ) . Preoperative PAS ranged 0–1040 and did not correlate with the severity of hypercalcemia ( 2.91 ± 0.25 ; range , 2.56–3.4 mmol/l ) . Scores from the SF-36 question naire were under the 50th percentile for the normal population in three domains ( vitality , emotional role , and physical role ) . Minimally invasive parathyroidectomy was performed in 69 patients and bilateral cervical exploration in 32 patients . All were found to have a single parathyroid adenoma and were normocalcemic at 3–12 months after parathyroidectomy . At follow-up , there was a significant reduction of PAS from 460 ± 257 preoperatively to 254 ± 234 at 3 months postoperatively ( n = 72 ) , to 245 ± 215 at 6 months ( n = 50 ) , and 249 ± 212 at 12 months ( n = 63 ) ( p < 0.05 , Student ’s t-test ) . There was a significant and persistent improvement in five domains of SF-36 question naire : bodily pain , general health , vitality , social functioning and mental health . Overall analysis of 244 assessment s using both question naires demonstrated a negative correlation between increasing PAS and decreasing mental component scores and physical component scores of the SF-36 assessment ( r2 = 0.372 and 0.301 , respectively ) . Conclusions Pasieka ’s parathyroid assessment of symptom scores ( PAS ) correlate with SF-36 question naire scores . Because PAS allows easier and faster analysis , we advocate that Pasieka ’s question naire should be integrated into the assessment of patients with PHPT as a reliable tool 
    Output:
    
Conclusions PTx improved QoL in patients treated for ESRD-related HPT , whereas cinacalcet did not .