***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: A disease-specific question naire was developed for patients receiving chronic hemodialysis by interviewing patients to determine which aspects of their quality of life were adversely affected by their disease . The final question naire contained 26 questions in five dimensions ( physical symptoms , fatigue , depression , relationships with others , frustration ) . The question naire demonstrated construct validity when compared with the Sickness Impact Profile , time trade-off technique and an exercise stress test . It was reproducible in stable , placebo-treated patients ( correlation coefficient 0.85 - 0.98 for the 5 dimensions ) . It was more responsive than other measures in detecting an improvement with erythropoietin therapy  in a r and omized , placebo-controlled trial . This question naire should be useful for the assessment of the effect of various interventions upon the quality of life of hemodialysis patients In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials The Normal Hematocrit Trial ( NHT ) was the largest trial of epoetin r and omizing 1265 hemodialysis patients with cardiac disease to lower ( 9–11 g/dl ) or higher ( 13–15 g/dl ) hemoglobin ( Hgb ) , hypothesizing that higher Hgb would reduce mortality , and improve survival and quality of life . The trial was terminated early , and a 1998 publication reported that targeting higher hematocrit levels led to an insignificant increase in the primary end points ( death or myocardial infa rct ) , or risk ratio 1.3 , 95 % confidence interval ( CI ) , 0.9–1.90 , but the P-value was not given , and all-cause death risk was not reported . A higher target reportedly did not increase hospitalization rates , but did significantly improve the ‘ physical function ' domain of quality of life . Comparing the 1996 Food and Drug Administration ( FDA ) -filed clinical trial report to the 1998 publication , however , found several discrepancies . Among these , the 1998 article reported interim trial results with only the adjusted CI but did not state that the unadjusted CIs were 99.912th percentile , and despite being a secondary end point , reported only the association of achieved Hgb with higher quality of life score . R and omization to the higher target had actually increased the risk for the primary end point ( risk ratio 1.28 , 95 % CI=1.06–1.56 ; P=0.0112 ; 99.92 % CI=0.92–1.78 ) , the risk of death ( risk ratio 1.27 , 95 % CI=1.04–1.54 ) , non-access thrombotic events ( P=0.041 ) , and hospitalization rate ( P=0.04 ) , while ‘ physical function ' did not improve ( P=0.88 ) . Hence , disclosure of these results in the 1998 publication or access to the FDA -filed report on the NHT in the late 1990s would likely have led to earlier concerns about epoetin safety and greater doubts about its benefits BACKGROUND The Dialysis Outcomes and Practice Patterns Study ( DOPPS ) is a prospect i ve , observational study based on data collected from nationally representative sample s of haemodialysis facilities . The burden of anaemia in haemodialysis patients is substantial , leading to considerable morbidity , mortality and reduced quality of life . This study examines anaemia management and outcomes based on data from five European countries participating in the DOPPS : France , Germany , Italy , Spain and the UK . METHODS Baseline data on demographics , co-morbidities and anaemia management in 4591 haemodialysis patients from 101 nephrology facilities were collected in 1998 - 2000 . Using multivariate Cox survival analyses to adjust for patient characteristics , relationships between haemoglobin concentration at study entry and rates of mortality and hospitalization were evaluated . RESULTS For a year 2000 sample of prevalent patients on haemodialysis > 180 days , mean haemoglobin concentration was 11.0 g/dl ; 53 % had a haemoglobin concentration > or = 11 g/dl [ 1998 - 1999 = 44 % ( P < 0.05 ) ] . In 2000 , 84 % of prevalent patients were prescribed recombinant human erythropoietin ( rHuEpo ) . Higher haemoglobin concentrations were associated with decreased relative risk ( RR ) for mortality ( RR = 0.95 for every 1 g/dl higher haemoglobin , P = 0.03 ) and hospitalization ( RR = 0.96 , P = 0.02 ) . Patients with haemoglobin < 10 g/dl were 29 % more likely to be hospitalized than patients with haemoglobin 11 - 12 g/dl ( P < 0.001 ) . CONCLUSION Even after adjustment , lower haemoglobin concentrations were associated with higher morbidity and mortality in European haemodialysis patients . A trend to increased haemoglobin concentrations was observed following publication of the European Best Practice Guidelines ( EBPG ) on anaemia management for chronic kidney disease patients , but efforts must continue to achieve EBPG goals BACKGROUND AND OBJECTIVES The effects of different hemoglobin targets when using erythropoiesis-stimulating agents on quality of life are somewhat controversial , and predictors of change in quality of life in endstage renal disease have not been well characterized . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Five hundred ninety-six incident hemodialysis patients without symptomatic cardiac disease were r and omly assigned to hemoglobin targets of 9.5 to 11.5 g/dl or 13.5 to 14.5 g/dl for 96 weeks , using epoetin_alfa as primary therapy . Patients and attending physicians were masked to treatment assignment . Quality of life , a secondary outcome , was prospect ively recorded using the Kidney Disease Quality of Life ( KDQoL ) question naire at weeks 0 , 24 , 36 , 48 , 60 , 72 , 84 , and 96 , with prespecified outcomes being fatigue and quality of social interaction . RESULTS The mean age and prior duration of dialysis therapy of the study population were 50.8 and 0.8 yr . Mortality was low , reflecting the relatively healthy group enrolled . Of 20 domains within the KDQoL only the prespecified domain of fatigue showed significant change over time between the two groups . Improvement in fatigue scores in the high-target group ranged from 3.2 to 7.9 over time ( P = 0.007 ) compared with change in the low-target group . Higher body mass index and lower erythropoietin dose at baseline were independent predictors of improvement in multiple KDQoL domains . CONCLUSIONS In relatively healthy hemodialysis patients , normal hemoglobin targets may have beneficial effects on fatigue . Improvement in multiple domains of quality of life is associated with higher body mass index and lower erythropoietin requirements BACKGROUND Patients with diabetes and anemia are at high risk of cardiovascular disease . The Anemia CORrection in Diabetes ( ACORD ) Study aim ed to investigate the effect of anemia correction on cardiac structure , function , and outcomes in patients with diabetes with anemia and early diabetic nephropathy . METHODS One hundred seventy-two patients with type 1 or 2 diabetes mellitus , mild to moderate anemia , and stage 1 to 3 chronic kidney disease were r and omly assigned to attain a target hemoglobin ( Hb ) level of either 13 to 15 g/dL ( 130 to 150 g/L ; group 1 ) or 10.5 to 11.5 g/dL ( 105 to 115 g/L ; group 2 ) . The primary end point was change in left ventricular mass index ( LVMI ) . Secondary end points included echocardiographic variables , renal function , quality of life , and safety . RESULTS Median Hb level and LVMI were similar in groups 1 and 2 ( Hb , 11.9 and 11.7 g/dL [ 119 and 117 g/L ] ; LVMI , 113.5 and 112.3 g/m(2 ) , respectively ) . At study end , Hb levels were 13.5 g/dL ( 135 g/L ) in group 1 and 12.1 g/dL ( 121 g/L ) in group 2 ( P < 0.001 ) . No significant differences were observed in median LVMI at month 15 between study groups ( group 1 , 112.3 g/m(2 ) ; group 2 , 116.5 g/m(2 ) ) . Multivariate analysis showed a nonsignificant decrease in LVMI ( P = 0.15 ) in group 1 versus group 2 . Anemia correction had no effect on the rate of decrease in creatinine clearance , but result ed in significantly improved quality of life in group 1 ( P = 0.04 ) . There were no clinical ly relevant differences in adverse events between study groups . CONCLUSION In patients with diabetes with mild to moderate anemia and moderate left ventricular hypertrophy , correction to an Hb target level of 13 to 15 g/dL ( 130 to 150 g/L ) does not decrease LVMI . However , normalization of Hb level prevented an additional increase in left ventricular hypertrophy , was safe , and improved quality of life BACKGROUND This r and omized clinical trial is design ed to assess whether the prevention and /or correction of anemia , by immediate versus delayed treatment with erythropoietin alfa in patients with chronic kidney disease , would delay left ventricular ( LV ) growth . Study design and sample size calculations were based on previously published Canadian data . METHODS One hundred seventy-two patients were r and omly assigned . The treatment group received therapy with erythropoietin alfa subcutaneously to maintain or achieve hemoglobin ( Hgb ) level targets of 12.0 to 14.0 g/dL ( 120 to 140 g/L ) . The control/delayed treatment group had Hgb levels of 9.0 + /- 0.5 g/dL ( 90 + /- 5 g/L ) before therapy was started : target level was 9.0 to 10.5 g/dL ( 90 to 105 g/L ) . Optimal blood pressure and parathyroid hormone , calcium , and phosphate level targets were prescribed ; all patients were iron replete . The primary end point is LV growth at 24 months .  RESULTS One hundred fifty-two patients were eligible for the intention-to-treat analysis : mean age was 57 years , 30 % were women , 38 % had diabetes , and median glomerular filtration rate was 29 mL/min ( 0.48 mL/s ; range , 12 to 55 mL/min [ 0.20 to 0.92 mL/s ] ) . Blood pressure and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use were similar in the control/delayed treatment and treatment groups at baseline . Erythropoietin therapy was administered to 77 of 78 patients in the treatment group , with a median final dose of 2,000 IU/wk . Sixteen patients in the control/delayed treatment group were administered erythropoietin at a median final dose of 3,000 IU/wk . There was no statistically significant difference between groups for the primary outcome of mean change in LV mass index ( LVMI ) from baseline to 24 months , which was 5.21 + /- 30.3 g/m2 in the control/delayed treatment group versus 0.37 + /- 25.0 g/m2 in the treatment group . Absolute mean difference between groups was 4.85 g/m2 ( 95 % confidence interval , -4.0 to 13.7 ; P = 0.28 ) . Mean Hgb level was greater in the treatment group throughout the study and at study end was 12.75 g/dL ( 127.5 g/L in treatment group versus 11.46 g/dL [ 114.6 g/L ] in control/delayed treatment group ; P = 0.0001 ) . LV growth occurred in 20.1 % in the treatment group versus 31 % in the control/delayed treatment group ( P = 0.136 ) . In patients with a stable Hgb level , mean LVMI did not change ( -0.25 + /- 26.7 g/m2 ) , but it increased in those with decreasing Hgb levels ( 1 
    Output:
    
In particular , younger , healthier patients may benefit from higher hemoglobin targets , and the harm may be concentrated in older individuals with preexisting cardiovascular risk factors .