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: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Heart failure ( HF ) is the leading cause of rehospitalization in older adults . The purpose of this pilot study was to examine whether telemonitoring by an advanced practice nurse reduced subsequent hospital readmissions , emergency department visits , costs , and risk of hospital readmission for patients with HF . One hundred two patient/caregiver dyads were r and omized into 2 groups postdischarge ; 84 dyads completed the study . Hospital readmissions , emergency department visits , costs , and days to readmission were abstract ed from medical records . Participants were interviewed soon after discharge and 3 months later about effects of telemonitoring on depressive symptoms , quality of life , and caregiver mastery . There were no significant differences due to telemonitoring for any outcomes . Caregiver mastery , informal social support , and electronic home monitoring were not significant predictors for risk of hospital readmission . Further studies should address the interaction between the advanced practice nurse and follow-up intervention with telemonitoring of patients with HF to better target those who are most likely to benefit IMPORTANCE It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure ( HF ) after hospitalization . OBJECTIVE To evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF . DESIGN , SETTING , AND PARTICIPANTS We r and omized 1437 patients hospitalized for HF between October 12 , 2011 , and September 30 , 2013 , to the intervention arm ( 715 patients ) or to the usual care arm ( 722 patients ) of the Better Effectiveness After Transition-Heart Failure ( BEAT-HF ) study and observed them for 180 days . The date s of our study analysis were March 30 , 2014 , to October 1 , 2015 . The setting was 6 academic medical centers in California . Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF . INTERVENTIONS The intervention combined health coaching telephone calls and telemonitoring . Telemonitoring used electronic equipment that collected daily information about blood pressure , heart rate , symptoms , and weight . Central ized registered nurses conducted telemonitoring review s , protocol ized actions , and telephone calls . MAIN OUTCOMES AND MEASURES The primary outcome was readmission for any cause within 180 days after discharge . Secondary outcomes were all-cause readmission within 30 days , all-cause mortality at 30 and 180 days , and quality of life at 30 and 180 days . RESULTS Among 1437 participants , the median age was 73 years . Overall , 46.2 % ( 664 of 1437 ) were female , and 22.0 % ( 316 of 1437 ) were African American . The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge , which occurred in 50.8 % ( 363 of 715 ) and 49.2 % ( 355 of 722 ) of patients , respectively ( adjusted hazard ratio , 1.03 ; 95 % CI , 0.88 - 1.20 ; P = .74 ) . In secondary analyses , there were no significant differences in 30-day readmission or 180-day mortality , but there was a significant difference in 180-day quality of life between the intervention and usual care groups . No adverse events were reported . CONCLUSIONS AND RELEVANCE Among patients hospitalized for HF , combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01360203 BACKGROUND Lowering dietary sodium and adhering to medication regimens are difficult for persons with heart failure ( HF ) . Because these behaviors often occur within the family context , this study evaluated the effects of family education and partnership interventions on  dietary sodium ( Na ) intake and medication adherence ( MA ) . METHODS AND RESULTS HF patient and family member ( FM ) dyads ( n = 117 ) were r and omized to : usual care ( UC ) , patient-FM education ( PFE ) , or family partnership intervention ( FPI ) . Dietary Na ( 3-day food record ) , urinary Na ( 24-hour urine ) , and MA ( Medication Events Monitoring System ) were measured at baseline ( BL ) before r and omization , and at 4 and 8 months . FPI and PFE reduced urinary Na at 4 months , and FPI differed from UC at 8 months ( P = .016 ) . Dietary Na decreased from BL to 4 months , with both PFE ( P = .04 ) and FPI ( P = .018 ) lower than UC . The proportion of subjects adherent to Na intake ( ≤2,500 mg/d ) was higher at 8 months in PFE and FPI than in UC ( χ(2)(2 ) = 7.076 ; P = .029 ) . MA did not differ among groups across time . Both FPI and PFE groups increased HF knowledge immediately after intervention . CONCLUSIONS Dietary Na intake , but not MA , was improved by PFE and FPI compared with UC . The UC group was less likely to be adherent with dietary Na . Greater efforts to study and incorporate family-focused education and support interventions into HF care are warranted Background : Mobile health services may improve chronic illness care , but interventions rarely support informal caregivers ’ efforts . Objectives : To determine whether automated feedback to caregivers of chronic heart failure patients impacts caregiving burden and assistance with self-management . Research Design : R and omized comparative effectiveness trial . Subjects : A total of 369 heart failure patients were recruited from a Veterans Health Administration health care system . All patients participated with a “ CarePartner ” or informal caregiver outside their household . Intervention : Patients r and omized to “ st and ard mHealth ”  received weekly automated self-care support calls for 12 months with notifications about problems sent to clinicians . “ mobile health+CarePartner ” ( mHealth+CP ) patients received identical services , plus email summaries and suggestions for self-care assistance automatically sent to their CarePartners . Measures : At baseline , 6 , and 12 months , CarePartners completed assessment s of caregiving strain , depressive symptoms , and participation in self-care support . Results : mHealth+CP CarePartners reported less caregiving strain than controls at both 6 and 12 months ( both P⩽0.03 ) . That effect as well as improvements in depressive symptoms were seen primarily among CarePartners reporting greater burden at baseline ( P⩽0.03 for interactions between arm and baseline strain/depression at both endpoints ) . Although most mHealth+CP CarePartners increased the amount of time spent in self-care support , those with the highest time commitment at baseline reported decreases at both follow-ups ( all P<0.05 ) . mHealth+CP CarePartners reported more frequently attending patients ’ medical visits at 6 months ( P=0.049 ) and greater involvement in medication adherence at both endpoints ( both P⩽0.032 ) . Conclusions : When CarePartners experienced significant caregiving strain and depression , systematic feedback about their patient-partner decreased those symptoms . Feedback also increased most CarePartners ’ engagement in self-care Introduction The Rehabilitation EnAblement in CHronic Heart Failure ( REACH-HF ) trial is part of a research programme design ed to develop and evaluate a health professional facilitated , home-based , self-help rehabilitation intervention to improve self-care and health-related quality of life in people with heart failure and their caregivers . The trial will assess the clinical effectiveness and cost-effectiveness of the REACH-HF intervention in patients with systolic heart failure and impact on the outcomes of their caregivers . Methods and analysis A parallel two group r and omised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care ( intervention group ) or usual care alone ( control group ) in 216 patients with systolic heart failure ( ejection fraction < 45 % ) and their caregivers . The intervention comprises a self-help manual delivered by specially trained facilitators over a 12-week period . The primary outcome measure is patients ’ disease-specific health-related quality of life measured using the Minnesota Living with Heart Failure question naire at 12 months ’ follow-up . Secondary outcomes include survival and heart failure related hospitalisation , blood biomarkers , psychological well-being , exercise capacity , physical activity , other measures of quality of life , patient safety and the quality of life , psychological well-being and perceived burden of caregivers at 4 , 6 and 12 months ’ follow-up . A process evaluation will assess fidelity of intervention delivery and explore potential mediators and moderators of changes in health-related quality of life in intervention and control group patients . Qualitative studies will describe patient and caregiver experiences of the intervention . An economic evaluation will estimate the cost-effectiveness of the REACH-HF intervention plus usual care versus usual care alone in patients with systolic heart failure . Ethics and dissemination The study is approved by the North West — Lancaster Research Ethics Committee ( ref 14/NW/1351 ) . Findings will be disseminated via journals and presentations to publicise the research to clinicians , commissioners and service users . Trial registration number IS RCT N86234930 ; Pre- results Background . Everything known about the roles , relationships , and repercussions of comorbidity in cardiovascular disease is shaped by how comorbidity is currently measured . Objectives . To critically examine how comorbidity is measured in r and omized controlled trials or clinical trials and prospect i ve observational studies in acute myocardial infa rct ion ( AMI ) , heart failure ( HF ) , or stroke . Design . Systematic review of studies of hospitalized adults from MEDLINE CINAHL , PsychINFO , and ISI Web of Science Social Science data bases . At least two review ers screened and extracted all data . Results . From 1432 review ed abstract s , 26 studies were included ( AMI n = 8 , HF n = 11 , stroke n = 7 ) . Five studies used an  instrument  to  measure comorbidity  while the remaining used the presence or absence of an unsubstantiated list of individual diseases . Comorbidity data were obtained from 1–4 different sources with 35 % of studies not reporting the source . A year-by-year analysis showed no changes in measurement . Conclusions . The measurement of comorbidity remains limited to a list of conditions without stated rationale or st and ards increasing the likelihood that the true impact is underestimated OBJECTIVE To evaluate the effects of a psycho-educational intervention on caregiver burden in partners of patients with postoperative heart failure . BACKGROUND Since partners of cardiac surgery patients play a significant role in the patient 's recovery , it is important to address their needs during hospitalization and after discharge . METHODS Forty-two patients with postoperative heart failure and their partners participated in a r and omized controlled pilot study . Dyads in the intervention group received psycho-educational support from a multidisciplinary team . Dyads in the control group received usual care . RESULTS No significant differences were found in the performance of caregiving tasks and perceived caregiver burden in the control versus the intervention group . CONCLUSION A pilot study exploring the effects of a psycho-educational intervention in patients and their partners did not reveal significant effects with regard to reduced feelings of burden in partners . Alleviating caregiver burden in partners may need a more intense or specific approach Background : Heart failure is a progressive condition characterized by frequent hospitalizations for exacerbated symptoms . Informal family caregivers may help patients improve self-care , which may in turn reduce hospitalizations . However , little is known about how mutuality , defined as the quality of the patient – caregiver relationship , and caregiver burden affect self-care . Objective : This study examines the associations among mutuality , patient self-care confidence ( beliefs in abilities to engage in self-care behaviors ) and maintenance ( behaviors such as medication adherence , activity , and low salt intake ) , caregiver confidence in and maintenance of patient care , and caregiver perceived burden . Methods : This study used cross-sectional baseline data from a multi-site r and omized clinical trial of a symptom and psychosocial care intervention . Patient – care 
    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: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Heart failure ( HF ) is the leading cause of rehospitalization in older adults . The purpose of this pilot study was to examine whether telemonitoring by an advanced practice nurse reduced subsequent hospital readmissions , emergency department visits , costs , and risk of hospital readmission for patients with HF . One hundred two patient/caregiver dyads were r and omized into 2 groups postdischarge ; 84 dyads completed the study . Hospital readmissions , emergency department visits , costs , and days to readmission were abstract ed from medical records . Participants were interviewed soon after discharge and 3 months later about effects of telemonitoring on depressive symptoms , quality of life , and caregiver mastery . There were no significant differences due to telemonitoring for any outcomes . Caregiver mastery , informal social support , and electronic home monitoring were not significant predictors for risk of hospital readmission . Further studies should address the interaction between the advanced practice nurse and follow-up intervention with telemonitoring of patients with HF to better target those who are most likely to benefit IMPORTANCE It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure ( HF ) after hospitalization . OBJECTIVE To evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF . DESIGN , SETTING , AND PARTICIPANTS We r and omized 1437 patients hospitalized for HF between October 12 , 2011 , and September 30 , 2013 , to the intervention arm ( 715 patients ) or to the usual care arm ( 722 patients ) of the Better Effectiveness After Transition-Heart Failure ( BEAT-HF ) study and observed them for 180 days . The date s of our study analysis were March 30 , 2014 , to October 1 , 2015 . The setting was 6 academic medical centers in California . Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF . INTERVENTIONS The intervention combined health coaching telephone calls and telemonitoring . Telemonitoring used electronic equipment that collected daily information about blood pressure , heart rate , symptoms , and weight . Central ized registered nurses conducted telemonitoring review s , protocol ized actions , and telephone calls . MAIN OUTCOMES AND MEASURES The primary outcome was readmission for any cause within 180 days after discharge . Secondary outcomes were all-cause readmission within 30 days , all-cause mortality at 30 and 180 days , and quality of life at 30 and 180 days . RESULTS Among 1437 participants , the median age was 73 years . Overall , 46.2 % ( 664 of 1437 ) were female , and 22.0 % ( 316 of 1437 ) were African American . The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge , which occurred in 50.8 % ( 363 of 715 ) and 49.2 % ( 355 of 722 ) of patients , respectively ( adjusted hazard ratio , 1.03 ; 95 % CI , 0.88 - 1.20 ; P = .74 ) . In secondary analyses , there were no significant differences in 30-day readmission or 180-day mortality , but there was a significant difference in 180-day quality of life between the intervention and usual care groups . No adverse events were reported . CONCLUSIONS AND RELEVANCE Among patients hospitalized for HF , combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01360203 BACKGROUND Lowering dietary sodium and adhering to medication regimens are difficult for persons with heart failure ( HF ) . Because these behaviors often occur within the family context , this study evaluated the effects of family education and partnership interventions on  dietary sodium ( Na ) intake and medication adherence ( MA ) . METHODS AND RESULTS HF patient and family member ( FM ) dyads ( n = 117 ) were r and omized to : usual care ( UC ) , patient-FM education ( PFE ) , or family partnership intervention ( FPI ) . Dietary Na ( 3-day food record ) , urinary Na ( 24-hour urine ) , and MA ( Medication Events Monitoring System ) were measured at baseline ( BL ) before r and omization , and at 4 and 8 months . FPI and PFE reduced urinary Na at 4 months , and FPI differed from UC at 8 months ( P = .016 ) . Dietary Na decreased from BL to 4 months , with both PFE ( P = .04 ) and FPI ( P = .018 ) lower than UC . The proportion of subjects adherent to Na intake ( ≤2,500 mg/d ) was higher at 8 months in PFE and FPI than in UC ( χ(2)(2 ) = 7.076 ; P = .029 ) . MA did not differ among groups across time . Both FPI and PFE groups increased HF knowledge immediately after intervention . CONCLUSIONS Dietary Na intake , but not MA , was improved by PFE and FPI compared with UC . The UC group was less likely to be adherent with dietary Na . Greater efforts to study and incorporate family-focused education and support interventions into HF care are warranted Background : Mobile health services may improve chronic illness care , but interventions rarely support informal caregivers ’ efforts . Objectives : To determine whether automated feedback to caregivers of chronic heart failure patients impacts caregiving burden and assistance with self-management . Research Design : R and omized comparative effectiveness trial . Subjects : A total of 369 heart failure patients were recruited from a Veterans Health Administration health care system . All patients participated with a “ CarePartner ” or informal caregiver outside their household . Intervention : Patients r and omized to “ st and ard mHealth ”  received weekly automated self-care support calls for 12 months with notifications about problems sent to clinicians . “ mobile health+CarePartner ” ( mHealth+CP ) patients received identical services , plus email summaries and suggestions for self-care assistance automatically sent to their CarePartners . Measures : At baseline , 6 , and 12 months , CarePartners completed assessment s of caregiving strain , depressive symptoms , and participation in self-care support . Results : mHealth+CP CarePartners reported less caregiving strain than controls at both 6 and 12 months ( both P⩽0.03 ) . That effect as well as improvements in depressive symptoms were seen primarily among CarePartners reporting greater burden at baseline ( P⩽0.03 for interactions between arm and baseline strain/depression at both endpoints ) . Although most mHealth+CP CarePartners increased the amount of time spent in self-care support , those with the highest time commitment at baseline reported decreases at both follow-ups ( all P<0.05 ) . mHealth+CP CarePartners reported more frequently attending patients ’ medical visits at 6 months ( P=0.049 ) and greater involvement in medication adherence at both endpoints ( both P⩽0.032 ) . Conclusions : When CarePartners experienced significant caregiving strain and depression , systematic feedback about their patient-partner decreased those symptoms . Feedback also increased most CarePartners ’ engagement in self-care Introduction The Rehabilitation EnAblement in CHronic Heart Failure ( REACH-HF ) trial is part of a research programme design ed to develop and evaluate a health professional facilitated , home-based , self-help rehabilitation intervention to improve self-care and health-related quality of life in people with heart failure and their caregivers . The trial will assess the clinical effectiveness and cost-effectiveness of the REACH-HF intervention in patients with systolic heart failure and impact on the outcomes of their caregivers . Methods and analysis A parallel two group r and omised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care ( intervention group ) or usual care alone ( control group ) in 216 patients with systolic heart failure ( ejection fraction < 45 % ) and their caregivers . The intervention comprises a self-help manual delivered by specially trained facilitators over a 12-week period . The primary outcome measure is patients ’ disease-specific health-related quality of life measured using the Minnesota Living with Heart Failure question naire at 12 months ’ follow-up . Secondary outcomes include survival and heart failure related hospitalisation , blood biomarkers , psychological well-being , exercise capacity , physical activity , other measures of quality of life , patient safety and the quality of life , psychological well-being and perceived burden of caregivers at 4 , 6 and 12 months ’ follow-up . A process evaluation will assess fidelity of intervention delivery and explore potential mediators and moderators of changes in health-related quality of life in intervention and control group patients . Qualitative studies will describe patient and caregiver experiences of the intervention . An economic evaluation will estimate the cost-effectiveness of the REACH-HF intervention plus usual care versus usual care alone in patients with systolic heart failure . Ethics and dissemination The study is approved by the North West — Lancaster Research Ethics Committee ( ref 14/NW/1351 ) . Findings will be disseminated via journals and presentations to publicise the research to clinicians , commissioners and service users . Trial registration number IS RCT N86234930 ; Pre- results Background . Everything known about the roles , relationships , and repercussions of comorbidity in cardiovascular disease is shaped by how comorbidity is currently measured . Objectives . To critically examine how comorbidity is measured in r and omized controlled trials or clinical trials and prospect i ve observational studies in acute myocardial infa rct ion ( AMI ) , heart failure ( HF ) , or stroke . Design . Systematic review of studies of hospitalized adults from MEDLINE CINAHL , PsychINFO , and ISI Web of Science Social Science data bases . At least two review ers screened and extracted all data . Results . From 1432 review ed abstract s , 26 studies were included ( AMI n = 8 , HF n = 11 , stroke n = 7 ) . Five studies used an  instrument  to  measure comorbidity  while the remaining used the presence or absence of an unsubstantiated list of individual diseases . Comorbidity data were obtained from 1–4 different sources with 35 % of studies not reporting the source . A year-by-year analysis showed no changes in measurement . Conclusions . The measurement of comorbidity remains limited to a list of conditions without stated rationale or st and ards increasing the likelihood that the true impact is underestimated OBJECTIVE To evaluate the effects of a psycho-educational intervention on caregiver burden in partners of patients with postoperative heart failure . BACKGROUND Since partners of cardiac surgery patients play a significant role in the patient 's recovery , it is important to address their needs during hospitalization and after discharge . METHODS Forty-two patients with postoperative heart failure and their partners participated in a r and omized controlled pilot study . Dyads in the intervention group received psycho-educational support from a multidisciplinary team . Dyads in the control group received usual care . RESULTS No significant differences were found in the performance of caregiving tasks and perceived caregiver burden in the control versus the intervention group . CONCLUSION A pilot study exploring the effects of a psycho-educational intervention in patients and their partners did not reveal significant effects with regard to reduced feelings of burden in partners . Alleviating caregiver burden in partners may need a more intense or specific approach Background : Heart failure is a progressive condition characterized by frequent hospitalizations for exacerbated symptoms . Informal family caregivers may help patients improve self-care , which may in turn reduce hospitalizations . However , little is known about how mutuality , defined as the quality of the patient – caregiver relationship , and caregiver burden affect self-care . Objective : This study examines the associations among mutuality , patient self-care confidence ( beliefs in abilities to engage in self-care behaviors ) and maintenance ( behaviors such as medication adherence , activity , and low salt intake ) , caregiver confidence in and maintenance of patient care , and caregiver perceived burden . Methods : This study used cross-sectional baseline data from a multi-site r and omized clinical trial of a symptom and psychosocial care intervention . Patient – care 
    Output:
    