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: Background Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality . Self management interventions have been shown to be effective in improving compliance in other chronic population s. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to st and ard care . Methods / Design This is a multicentre parallel arm block r and omized controlled trial ( RCT ) of a four session group self management intervention for  hemodialysis patients delivered by health care professionals compared to st and ard care .  A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be r and omized to receive the self management intervention or st and ard care . Primary outcomes are biochemical markers of clinical status and adherence . Secondary outcomes include general health related quality of life , disease-specific quality of life , mood , self efficacy and self-reported adherence . Outcomes will be measured at baseline , immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points . A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change . Discussion The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management . The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinical ly significant changes in biochemical markers , recruitment of a sufficiently large representative sample , a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points . Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes . This program , if found to be effective , has the potential to be implemented within the existing renal services delivery model in Singapore , particularly as this is being delivered by health care professionals already working with hemodialysis patients in these setting s who are specifically trained in facilitating self management in renal patients .Trial registration Current Controlled Trials This study aims to determine the effect of a trained dedicated dietitian on clinical outcomes among Lebanese hemodialysis ( HD ) patients : and thus demonstrate a viable developing country model . This paper describes the study protocol and baseline data . The study was a multicenter r and omized controlled trial with parallel-group design involving 12 HD units : assigned to cluster A ( n = 6 ) or B ( n = 6 ) . A total of 570 patients met the inclusion criteria . Patients in cluster A were r and omly assigned as per dialysis shift to the following : Dedicated Dietitian ( DD ) ( n = 133 ) and Existing Practice ( EP ) ( n = 138 ) protocol s. Cluster B patients ( n = 299 ) received Trained Hospital Dietitian ( THD ) protocol . Dietitians of the DD and THD groups were trained by the research team on Kidney Disease Outcomes Quality Initiative nutrition guidelines . DD protocol included : individualized nutrition education for 2 hours/month/HD patient for 6 months focusing on renal osteodystrophy and using the Trans-theoretical theory for behavioral change . EP protocol included nutrition education given to patients by hospital dietitians who were blinded to the study . The THD protocol included nutrition education to patients given by hospital dietitian as per the training received but within hospital responsibilities , with no set educational protocol or tools . Baseline data revealed that 40 % of patients were hyperphosphatemics ( > 5.5 mg/dl ) with low dietary adherence and knowledge of dietary P restriction in addition to inadequate daily protein intake ( 58.86%± 33.87 % of needs ) yet adequate dietary P intake ( 795.52 ± 366.94 mg/day ) . Quality of life ( QOL ) ranged from 48 - 75 % of full health . Baseline differences between the 3 groups revealed significant differences in serum P , malnutrition status , adherence to diet and P chelators and in 2 factors of the QOL : physical and social functioning . The data show room for improvement in the nutritional status of the patients . The NEMO trial may be able to demonstrate a better nutritional management of HD patients OBJECTIVE To examine the effect of self-management dietary counselling ( SMDC ) on adherence to dietary management of hyperphosphatemia among haemodialysis patients . DESIGN An eight-week cluster based r and omised control trial . PARTICIPANTS 122 stable adult patients were recruited from an HD unit in Sidon , Lebanon . Study groups were : full intervention ( A ) ( n = 41 ) , partial intervention ( B ) ( n = 41 ) and control ( C ) ( n = 40 ) . INTERVENTION Group ( A ) received SMDC , Group ( B ) received educational games only and Group ( C ) did not receive any research intervention . MAIN OUTCOME MEASURES Serum phosphorus ( P ) , Calcium Phosphate product ( Ca × P ) and two question naires : patient knowledge ( PK ) and dietary non-adherence ( PDnA ) to P reduced diet . RESULTS Group A experienced a significant improvement in mean ( ± SD ) P ( 6.54 ± 2.05 - 5.4 ± 1.97 mg/dl ) , Ca × P ( 58 ± 17 - 49 ± 12 ) , PK scores ( 50 ± 17 - 69 ± 25 % ) and PDnA scores ( 21.4 ± 4.0 - 18.3 ± 2.0 ) . Group B experienced a significant improvement in Ca × P ( 52 ± 14 - 45 ± 16 ) . Group C did not experience any significant change post intervention . CONCLUSION Our findings demonstrate the importance of patient-tailored counselling on serum P management Background Despite the evidence that phosphate binder ( PB ) is associated with improved outcomes many hemodialysis patients do not adhere to prescribed PB regimen . Therefore , barriers to PB adherence should be identified and eliminated . The purpose of this study was to evaluate PB adherence  among hemodialysis patients and to explore potentially modifiable factors associated with low PB adherence . Methods A cross-sectional study ( 502 patients ) was performed in four dialysis units in Salvador , Brazil , using data from the second phase of the Prospect i ve Study of the Prognosis of Chronic Hemodialysis Patients ( PROHEMO ) . Patients were categorized as adherent or non-adherent to PB based on their responses to a semi-structured question naire . Results Non-adherence to PB  was observed for 65.7 % of the patients . After adjustments for numerous covariates , cerebrovascular disease ( odds ratio ( OR ) , 3.30 ; 95 % confidence interval ( CI ) , 1.03 - 10.61 ) , higher PTH ( OR per each 300 pg/mL , 1.14 ; 95 % CI , 1.01 - 1.28 ) , lack of comprehension of the appropriate time to use PB ( OR , 7.09 ; 95 % CI , 2.10 - 23.95 ) and stopping PB use after feeling better ( OR , 4.54 ; 95 % CI , 1.45 - 14.25 ) or feeling worse ( OR , 11.04 ; 95 % CI , 1.79- 68.03 ) were significantly associated with PB non-adherence . By contrast , the adjusted odds of PB non-adherence were lower for patients with more years on dialysis ( OR by each 2 years , 0.87 ; 95 % CI , 0.80 - 0.95 ) , with serum phosphorus above 5.5 mg/dL ( OR , 0.53 ; 95 % CI 0.34 - 0.82 ) , who referred that were encouraged by the dialysis staff to be independent ( OR , 0.52 ; 95 % CI 0.30 - 0.90 ) , and reported that the nephrologist explained how PB should be used ( OR , 0.20 ; 95 % CI 0.05 - 0.73 ) . Conclusion The results of the present study are encouraging by showing evidence that improvement in the care provided by the dialysis staff and the attending nephrologist may play an important role in reducing the high prevalence of non-adherence to PB in maintenance hemodialysis patients . A new question naire is presented and may help to evaluate systematic ally the patients regarding PB adherence in hemodialysis setting Prior small studies have shown multiple benefits of frequent nocturnal hemodialysis compared to conventional three times per week treatments . To study this further , we r and omized 87 patients to three times per week conventional hemodialysis or to nocturnal hemodialysis six times per week , all with single-use high-flux dialyzers . The 45 patients in the frequent nocturnal arm had a 1.82-fold higher mean weekly stdKt/V(urea ) , a 1.74-fold higher average number of treatments per week , and a 2.45-fold higher average weekly treatment time than the 42 patients in the conventional arm . We did not find a significant effect of nocturnal hemodialysis for either of the two co primary outcomes ( death or left ventricular mass ( measured by MRI ) with a hazard ratio of 0.68 , or of death or R AND Physical Health Composite with a hazard ratio of 0.91 ) . Possible explanations for the left ventricular mass result include limited sample size and patient characteristics . Secondary outcomes included cognitive performance , self-reported depression , laboratory markers of nutrition , mineral metabolism and anemia , blood pressure and rates of hospitalization , and vascular access interventions . Patients in the nocturnal arm had improved control of hyperphosphatemia and hypertension , but no significant benefit among the other main secondary outcomes . There was a trend for increased vascular access events in the nocturnal arm . Thus , we were unable to demonstrate a definitive benefit of more frequent nocturnal hemodialysis for either co primary outcome CONTEXT High dietary phosphorus intake has deleterious consequences for renal patients and is possibly harmful for the general public as well . To prevent hyperphosphatemia , patients with end-stage renal disease limit their intake of foods that are naturally high in phosphorus . However , phosphorus-containing additives are increasingly being added to processed and fast foods . The effect of such additives on serum phosphorus levels is unclear . OBJECTIVE To determine the effect of limiting the intake of phosphorus-containing food additives on serum phosphorus levels among patients with end-stage renal disease . DESIGN , SETTING , AND PARTICIPANTS Cluster r and omized controlled trial at 14 long-term hemodialysis facilities in northeast Ohio . Two hundred seventy-nine patients with elevated baseline serum phosphorus levels ( > 5.5 mg/dL ) were recruited between May and October 2007 . Two shifts at each of 12 large facilities and 1 shift at each of 2 small facilities were r and omly assigned to an intervention or control group . INTERVENTION  Intervention participants ( n=145 ) received education on avoiding foods with phosphorus additives when purchasing groceries or visiting fast food restaurants . Control participants ( n=134 )  continued to receive usual care . MAIN OUTCOME MEASURE Change in serum phosphorus level after 3 months . RESULTS At baseline , there was no significant difference in serum phosphorus levels between the 2 groups . After 3 months , the decline in serum phosphorus levels was 0.6 mg/dL larger among intervention vs control participants ( 95 % confidence interval , -1.0 to -0.1 mg/dL ) . Intervention participants also had statistically significant increases in reading ingredient lists ( P<.001 ) and nutrition facts labels ( P = .04 ) but no significant increase in food knowledge scores ( P = .13 ) . CONCLUSION Educating end-stage renal disease patients to avoid phosphorus-containing food additives result ed in modest improvements in hyperphosphatemia . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00583570 Background / Aim : A r and omized controlled trial was conducted involving 67 stable adult haemodialysis patients with hyperphosphataemia . The objective was to determine the effect of monthly dietetic consultations on patients ’ serum phosphate concentrations and calcium × phosphate product . Methods : The intervention group received monthly dietetic consultations for 6 months using advanced counselling skills aim ed at limiting phosphate intake in the diet and improving compliance with phosphate binders , whereas st and ard care with dietetic consultations every 6 months was provided to the control group .  Results : Serum phosphate concentrations decreased in the intervention group from 2.05 ± 0.48 to 1.80 ± 0.48 mmol/l by month 3 ( p < 0.05 ) . However , this subsequently increased and by month 6 there was no significant difference from baseline . After controlling for confounding variables , the difference between the groups was approaching significance at month 3 , but there was no difference by month 6 , or following conclusion of the study . The calcium × phosphate product similarly decreased in both groups , achieving K/DOQI st and ards , but was not sustained either during the remainder of the study but decreased further by the 12-month follow-up and , although it was not significantly different , it did improve significantly from baseline in both the intervention and control groups . Conclusion : Increased frequency of dietetic consultations can result in improved phosphate control in the short term , and therefore more innovative strategies appear necessary to 
    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: Background Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality . Self management interventions have been shown to be effective in improving compliance in other chronic population s. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to st and ard care . Methods / Design This is a multicentre parallel arm block r and omized controlled trial ( RCT ) of a four session group self management intervention for  hemodialysis patients delivered by health care professionals compared to st and ard care .  A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be r and omized to receive the self management intervention or st and ard care . Primary outcomes are biochemical markers of clinical status and adherence . Secondary outcomes include general health related quality of life , disease-specific quality of life , mood , self efficacy and self-reported adherence . Outcomes will be measured at baseline , immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points . A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change . Discussion The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management . The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinical ly significant changes in biochemical markers , recruitment of a sufficiently large representative sample , a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points . Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes . This program , if found to be effective , has the potential to be implemented within the existing renal services delivery model in Singapore , particularly as this is being delivered by health care professionals already working with hemodialysis patients in these setting s who are specifically trained in facilitating self management in renal patients .Trial registration Current Controlled Trials This study aims to determine the effect of a trained dedicated dietitian on clinical outcomes among Lebanese hemodialysis ( HD ) patients : and thus demonstrate a viable developing country model . This paper describes the study protocol and baseline data . The study was a multicenter r and omized controlled trial with parallel-group design involving 12 HD units : assigned to cluster A ( n = 6 ) or B ( n = 6 ) . A total of 570 patients met the inclusion criteria . Patients in cluster A were r and omly assigned as per dialysis shift to the following : Dedicated Dietitian ( DD ) ( n = 133 ) and Existing Practice ( EP ) ( n = 138 ) protocol s. Cluster B patients ( n = 299 ) received Trained Hospital Dietitian ( THD ) protocol . Dietitians of the DD and THD groups were trained by the research team on Kidney Disease Outcomes Quality Initiative nutrition guidelines . DD protocol included : individualized nutrition education for 2 hours/month/HD patient for 6 months focusing on renal osteodystrophy and using the Trans-theoretical theory for behavioral change . EP protocol included nutrition education given to patients by hospital dietitians who were blinded to the study . The THD protocol included nutrition education to patients given by hospital dietitian as per the training received but within hospital responsibilities , with no set educational protocol or tools . Baseline data revealed that 40 % of patients were hyperphosphatemics ( > 5.5 mg/dl ) with low dietary adherence and knowledge of dietary P restriction in addition to inadequate daily protein intake ( 58.86%± 33.87 % of needs ) yet adequate dietary P intake ( 795.52 ± 366.94 mg/day ) . Quality of life ( QOL ) ranged from 48 - 75 % of full health . Baseline differences between the 3 groups revealed significant differences in serum P , malnutrition status , adherence to diet and P chelators and in 2 factors of the QOL : physical and social functioning . The data show room for improvement in the nutritional status of the patients . The NEMO trial may be able to demonstrate a better nutritional management of HD patients OBJECTIVE To examine the effect of self-management dietary counselling ( SMDC ) on adherence to dietary management of hyperphosphatemia among haemodialysis patients . DESIGN An eight-week cluster based r and omised control trial . PARTICIPANTS 122 stable adult patients were recruited from an HD unit in Sidon , Lebanon . Study groups were : full intervention ( A ) ( n = 41 ) , partial intervention ( B ) ( n = 41 ) and control ( C ) ( n = 40 ) . INTERVENTION Group ( A ) received SMDC , Group ( B ) received educational games only and Group ( C ) did not receive any research intervention . MAIN OUTCOME MEASURES Serum phosphorus ( P ) , Calcium Phosphate product ( Ca × P ) and two question naires : patient knowledge ( PK ) and dietary non-adherence ( PDnA ) to P reduced diet . RESULTS Group A experienced a significant improvement in mean ( ± SD ) P ( 6.54 ± 2.05 - 5.4 ± 1.97 mg/dl ) , Ca × P ( 58 ± 17 - 49 ± 12 ) , PK scores ( 50 ± 17 - 69 ± 25 % ) and PDnA scores ( 21.4 ± 4.0 - 18.3 ± 2.0 ) . Group B experienced a significant improvement in Ca × P ( 52 ± 14 - 45 ± 16 ) . Group C did not experience any significant change post intervention . CONCLUSION Our findings demonstrate the importance of patient-tailored counselling on serum P management Background Despite the evidence that phosphate binder ( PB ) is associated with improved outcomes many hemodialysis patients do not adhere to prescribed PB regimen . Therefore , barriers to PB adherence should be identified and eliminated . The purpose of this study was to evaluate PB adherence  among hemodialysis patients and to explore potentially modifiable factors associated with low PB adherence . Methods A cross-sectional study ( 502 patients ) was performed in four dialysis units in Salvador , Brazil , using data from the second phase of the Prospect i ve Study of the Prognosis of Chronic Hemodialysis Patients ( PROHEMO ) . Patients were categorized as adherent or non-adherent to PB based on their responses to a semi-structured question naire . Results Non-adherence to PB  was observed for 65.7 % of the patients . After adjustments for numerous covariates , cerebrovascular disease ( odds ratio ( OR ) , 3.30 ; 95 % confidence interval ( CI ) , 1.03 - 10.61 ) , higher PTH ( OR per each 300 pg/mL , 1.14 ; 95 % CI , 1.01 - 1.28 ) , lack of comprehension of the appropriate time to use PB ( OR , 7.09 ; 95 % CI , 2.10 - 23.95 ) and stopping PB use after feeling better ( OR , 4.54 ; 95 % CI , 1.45 - 14.25 ) or feeling worse ( OR , 11.04 ; 95 % CI , 1.79- 68.03 ) were significantly associated with PB non-adherence . By contrast , the adjusted odds of PB non-adherence were lower for patients with more years on dialysis ( OR by each 2 years , 0.87 ; 95 % CI , 0.80 - 0.95 ) , with serum phosphorus above 5.5 mg/dL ( OR , 0.53 ; 95 % CI 0.34 - 0.82 ) , who referred that were encouraged by the dialysis staff to be independent ( OR , 0.52 ; 95 % CI 0.30 - 0.90 ) , and reported that the nephrologist explained how PB should be used ( OR , 0.20 ; 95 % CI 0.05 - 0.73 ) . Conclusion The results of the present study are encouraging by showing evidence that improvement in the care provided by the dialysis staff and the attending nephrologist may play an important role in reducing the high prevalence of non-adherence to PB in maintenance hemodialysis patients . A new question naire is presented and may help to evaluate systematic ally the patients regarding PB adherence in hemodialysis setting Prior small studies have shown multiple benefits of frequent nocturnal hemodialysis compared to conventional three times per week treatments . To study this further , we r and omized 87 patients to three times per week conventional hemodialysis or to nocturnal hemodialysis six times per week , all with single-use high-flux dialyzers . The 45 patients in the frequent nocturnal arm had a 1.82-fold higher mean weekly stdKt/V(urea ) , a 1.74-fold higher average number of treatments per week , and a 2.45-fold higher average weekly treatment time than the 42 patients in the conventional arm . We did not find a significant effect of nocturnal hemodialysis for either of the two co primary outcomes ( death or left ventricular mass ( measured by MRI ) with a hazard ratio of 0.68 , or of death or R AND Physical Health Composite with a hazard ratio of 0.91 ) . Possible explanations for the left ventricular mass result include limited sample size and patient characteristics . Secondary outcomes included cognitive performance , self-reported depression , laboratory markers of nutrition , mineral metabolism and anemia , blood pressure and rates of hospitalization , and vascular access interventions . Patients in the nocturnal arm had improved control of hyperphosphatemia and hypertension , but no significant benefit among the other main secondary outcomes . There was a trend for increased vascular access events in the nocturnal arm . Thus , we were unable to demonstrate a definitive benefit of more frequent nocturnal hemodialysis for either co primary outcome CONTEXT High dietary phosphorus intake has deleterious consequences for renal patients and is possibly harmful for the general public as well . To prevent hyperphosphatemia , patients with end-stage renal disease limit their intake of foods that are naturally high in phosphorus . However , phosphorus-containing additives are increasingly being added to processed and fast foods . The effect of such additives on serum phosphorus levels is unclear . OBJECTIVE To determine the effect of limiting the intake of phosphorus-containing food additives on serum phosphorus levels among patients with end-stage renal disease . DESIGN , SETTING , AND PARTICIPANTS Cluster r and omized controlled trial at 14 long-term hemodialysis facilities in northeast Ohio . Two hundred seventy-nine patients with elevated baseline serum phosphorus levels ( > 5.5 mg/dL ) were recruited between May and October 2007 . Two shifts at each of 12 large facilities and 1 shift at each of 2 small facilities were r and omly assigned to an intervention or control group . INTERVENTION  Intervention participants ( n=145 ) received education on avoiding foods with phosphorus additives when purchasing groceries or visiting fast food restaurants . Control participants ( n=134 )  continued to receive usual care . MAIN OUTCOME MEASURE Change in serum phosphorus level after 3 months . RESULTS At baseline , there was no significant difference in serum phosphorus levels between the 2 groups . After 3 months , the decline in serum phosphorus levels was 0.6 mg/dL larger among intervention vs control participants ( 95 % confidence interval , -1.0 to -0.1 mg/dL ) . Intervention participants also had statistically significant increases in reading ingredient lists ( P<.001 ) and nutrition facts labels ( P = .04 ) but no significant increase in food knowledge scores ( P = .13 ) . CONCLUSION Educating end-stage renal disease patients to avoid phosphorus-containing food additives result ed in modest improvements in hyperphosphatemia . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00583570 Background / Aim : A r and omized controlled trial was conducted involving 67 stable adult haemodialysis patients with hyperphosphataemia . The objective was to determine the effect of monthly dietetic consultations on patients ’ serum phosphate concentrations and calcium × phosphate product . Methods : The intervention group received monthly dietetic consultations for 6 months using advanced counselling skills aim ed at limiting phosphate intake in the diet and improving compliance with phosphate binders , whereas st and ard care with dietetic consultations every 6 months was provided to the control group .  Results : Serum phosphate concentrations decreased in the intervention group from 2.05 ± 0.48 to 1.80 ± 0.48 mmol/l by month 3 ( p < 0.05 ) . However , this subsequently increased and by month 6 there was no significant difference from baseline . After controlling for confounding variables , the difference between the groups was approaching significance at month 3 , but there was no difference by month 6 , or following conclusion of the study . The calcium × phosphate product similarly decreased in both groups , achieving K/DOQI st and ards , but was not sustained either during the remainder of the study but decreased further by the 12-month follow-up and , although it was not significantly different , it did improve significantly from baseline in both the intervention and control groups . Conclusion : Increased frequency of dietetic consultations can result in improved phosphate control in the short term , and therefore more innovative strategies appear necessary to 
    Output:
    