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 Patients with type 2 diabetes mellitus ( T2DM ) have an increased risk to develop severe diabetes related complications , especially cardiovascular disease ( CVD ) . The risk to develop CVD can be estimated by means of risk formulas . However , patients have difficulties to underst and the outcomes of these formulas . As a result , they may not recognize the importance of changing lifestyle and taking medication in time . Therefore , it is important to develop risk communication methods , that will improve the patients ' underst and ing of risks associated with having diabetes , which enables them to make informed choices about their diabetes care . The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception , attitude and intention to change lifestyle behaviour in patients with T2DM . The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory . Methods A r and omised controlled trial will be performed in the Diabetes Care System West-Friesl and ( DCS ) , a managed care system . Newly referred T2DM patients of the DCS , younger than 75 years will be eligible for the study . The intervention group will be exposed to risk communication on CVD , on top of st and ard managed care of the DCS . This intervention consists of a simple explanation on the causes and consequences of CVD , and possibilities for prevention . The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram . The control group will receive st and ard managed care . The primary outcome is appropriateness of risk perception . Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception . Differences between baseline and follow-up ( 2 and 12 weeks ) between groups will be analysed according to the intention-to-treat principle . The study was powered on 120 patients in each group . Discussion This innovative risk communication method based on two behavioural theories might improve patient 's appropriateness of risk perception and attitude concerning lifestyle change . With a better underst and ing of their CVD risk , patients will be able to make informed choices concerning diabetes care . Trail registration The trial is registered as NTR1556 in the Dutch Trial Register Background Many patients at high risk of cardiovascular diseases are managed and monitored in general practice . Recommendations for cardiovascular risk management , including lifestyle change , are clearly described in the Dutch national guideline . Although lifestyle interventions , such as advice on diet , physical exercise , smoking and alcohol , have moderate , but potentially relevant effects in these patients , adherence to lifestyle advice in general practice is not optimal . The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics . The aim of this paper is to describe the design and methods of a study to evaluate an intervention aim ed at involving patients in cardiovascular risk management . Methods A cluster-r and omised controlled trial in 20 general practice s , 10 practice s in the intervention arm and 10 in the control arm , starting on October 2005 . A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited . In both arms , the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management . Nurses in the intervention arm will receive an extended training in risk assessment , risk communication , the use of a decision aid and adapted motivational interviewing . This communication technique will be used to support the shared decision-making process about risk reduction . The intervention comprises 2 consultations and 1 follow-up telephone call . The nurses in the control arm will give usual care after the risk estimation , according to the national guideline . Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment . Secondary outcome measures are the patients ' perception of risk and their motivation to change their behaviour . The measurements will take place at baseline and after 12 and 52 weeks . Clinical endpoints will not be measured , but the absolute 10-year risk of cardiovascular events will be estimated for each patient from medical records at baseline and after 1 year . Discussion The combined use of risk communication , a decision aid and motivational interviewing to enhance patient involvement in decision making is an innovative aspect of the intervention . Trial registration Current Controlled Trials IS RCT Background — Despite effective treatments to reduce cardiovascular disease risk , their translation into practice is limited . Methods and Results — Using a parallel arm cluster-r and omized controlled trial in 60 Australian primary healthcare centers , we tested whether a multifaceted quality improvement intervention comprising computerized decision support , audit/feedback tools , and staff training improved ( 1 ) guideline -indicated risk factor measurements and ( 2 ) guideline -indicated medications for those at high cardiovascular disease risk . Centers had to use a compatible software system , and eligible patients were regular attendees ( Aboriginal and Torres Strait Isl and er people aged ≥35 years and others aged ≥45 years ) . Patient-level analyses were conducted using generalized estimating equations to account for clustering . Median follow-up for 38 725 patients ( mean age , 61.0 years ; 42 % men ) was 17.5 months . Mean monthly staff support was < 1 hour/site . For the co primary outcomes , the intervention was associated with improved overall risk factor measurements ( 62.8 % versus 53.4 % risk ratio ; 1.25 ; 95 % confidence interval , 1.04–1.50 ; P=0.02 ) , but there was no significant differences in recommended prescriptions for the high-risk cohort ( n=10 308 ; 56.8 % versus 51.2 % ; P=0.12 ) . There were significant treatment escalations ( new prescriptions or increased numbers of medicines ) for antiplatelet ( 4.3 % versus 2.7 % ; P=0.01 ) , and BP lowering ( 18.2 % versus 11.0 % ; P=0.02 ) but not lipid-lowering medications . Conclusions — In Australian primary healthcare setting s , a computer-guided quality improvement intervention , requiring minimal support , improved cardiovascular disease risk measurement but did not increase prescription rates in the high-risk group . Computerized quality improvement tools offer an important , albeit partial , solution to improving primary healthcare system capacity for cardiovascular disease risk management . Clinical Trial Registration — URL : https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=336630 . Australian New Zeal and Clinical Trials Registry No. 12611000478910 Background Patient-centered diabetes care requires shared decision making ( SDM ) . Decision aids promote SDM , but their efficacy in nonacademic and rural primary care clinics is unclear . Methods We cluster-r and omized 10 practice s in a concealed fashion to implement either a decision aid ( DA ) about starting statins or one about choosing antihyperglycemic agents . Each practice served as a control group for another practice implementing the other type of DA .  From April 2011 to July 2012 , 103 ( DA=53 ) patients with type 2 diabetes participated in the trial . We used patient and clinician surveys administered after the clinical encounter to collect decisional outcomes ( patient knowledge and comfort with decision making , patient and clinician satisfaction ) . Medical records provided data on metabolic control . Pharmacy fill profiles provided data for estimating adherence to therapy . Results Compared to usual care , patients receiving the DA were more likely to report discussing medications ( 77 % vs. 45 % , p<.001 ) , were more likely to answer knowledge questions correctly ( risk reduction with statins 61 % vs. 33 % , p=.07 ; knowledge about options 57 % vs. 33 % , p=.002 ) and were more engaged by their clinicians in decision making ( 50 . vs. 28 , difference 21.4 ( 95 % CI 6.4 , 36.3 ) , p=.01 ) . We found no significant impact on patient satisfaction , medication starts , adherence or clinical outcomes , in part due to limited statistical power . Conclusion DAs improved decisional outcomes without significant effect on clinical outcomes . DAs design ed for point-of-care use with type 2 diabetes patients promoted shared decision making in nonacademic and rural primary care practice s . Trial Registration Background There is currently much interest in encouraging individuals to increase physical activity in order to reduce CVD risk . This study has been design ed to determine if personalised CVD risk appreciation can increase physical activity in adults at high risk of CVD . Methods / Design In a 2 × 2 factorial design participants are allocated at r and om to a personalised 10-year CVD risk estimate or numerical CVD risk factor values ( systolic blood pressure , LDL cholesterol and fasting glucose ) and , simultaneously , to receive a brief lifestyle advice intervention targeting physical activity , diet and smoking cessation or not . We aim to recruit 200 participants from Oxfordshire primary care practice s. Eligibility criteria include adults age 40–70 years , estimated 10-year CVD risk ≥20 % , ability to read and write English , no known CVD and no physical disability or other condition reducing the ability to walk . Primary outcome is physical activity measured by ActiGraph accelerometer with biochemical , anthropometrical and psychological measures as additional outcomes . Primary analysis is between group physical activity differences at one month powered to detect a difference of 30,000 total counts per day of physical activity between the groups . Additional analyses will seek to further eluci date the relationship between the provision of risk information , and intention to change behaviour and to determine the impact of both interventions on clinical and anthropometrical measures including fasting and 2 hour plasma glucose , fructosamine , serum cotinine , plasma vitamin C , body fat percentage and blood pressure . Discussion This is a pilot trial seeking to demonstrate in a real world setting , proof of principal that provision of personalised risk information can contribute to behaviour changes aim ed at reducing CVD risk . This study will increase our underst and ing of the links between the provision of risk information and behaviour change and if successful , could be used in clinical practice with little or no modification Background A healthy diet , low in saturated fat and high in fiber , is a popular medical recommendation in preventing cardiovascular disease ( CVD ) . One approach to motivating healthier eating is to raise individuals ’ awareness of their CVD risk and then help them form specific plans to change . Objectives The aim was to explore the combined impact of a Web-based CVD risk message and a fully automated planning tool on risk perceptions , intentions , and saturated fat intake changes over 4 weeks . Methods Of the 1187 men and women recruited online , 781 were r and omly allocated to one of four conditions : a CVD risk message , the same CVD risk message paired with planning , planning on its own , and a control group . All outcome measures were assessed by online self-reports . Generalized linear modeling was used to analyze the data . Results Self-perceived consumption of low saturated fat foods ( odds ratio 11.40 , 95 % CI 1.86–69.68 ) and intentions to change diet ( odds ratio 21.20 , 95 % CI 2.6–172.4 ) increased more in participants allocated to the planning than the control group . No difference was observed between the four conditions with regard to percentage saturated fat intake changes . Contrary to our expectations , there was no difference in perceived and percentage saturated fat intake change between the CVD risk message plus planning group and the control group . Risk perceptions among those receiving the CVD risk message changed to be more in line with their age ( change in slopeindividual = 0.075 , P = .01 ; change in slopecomparative = 0.100 , P = .001 ) , whereas there was no change among those who did not receive the CVD risk message . Conclusion There was no evidence that combining a CVD risk message with a planning tool reduces saturated fat intake more than either alone . Further research is required to identify ways in which matching motivational and volitional strategies can lead to greater behavior changes . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 91154001 ; http://www.controlled-trials.com/IS RCT N91154001 ( Archived by WebCite at http://www.webcitation.org/62sBoGeOO Background Countries in sub-Saharan Africa ( SSA ) are experiencing an epidemic of cardiovascular disease ( CVD ) propelled by rapidly increasing rates of hypertension . Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs . Although SSA bears 24 % of the global disease burden , it has only 3 % of the global health workforce . Given such limited re sources , cost-effective strategies , such as task shifting , are needed to mitigate the rising CVD epidemic in SSA . Ghana , a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization ( WHO ) task-shifting strategy . This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage , on blood pressure ( BP ) reduction . Methods Using a cluster r and omized design , 32 community health centers ( CHCs ) and district hospitals in Ghana will be r and omized to either the  intervention  group ( 16 CHCs ) or the control group ( 16 CHCs ) . A total of 640 patients with uncomplicated hypertension ( BP 140–179/90–99 mm Hg and absence of target organ damage ) will be enrolled in this study ( 20 patients per CHC ) . The intervention consists of WHO Package of CV risk assessment , patient education , initiation and titration of antihypertensive medications , 
    Output:
    
agent
There is uncertainty whether current strategies for providing CVD risk scores  affect CVD events .
Providing CVD risk scores may slightly reduce CVD risk factor levels and may increase preventive medication prescribing in higher-risk people without evidence of harm .
***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 Patients with type 2 diabetes mellitus ( T2DM ) have an increased risk to develop severe diabetes related complications , especially cardiovascular disease ( CVD ) . The risk to develop CVD can be estimated by means of risk formulas . However , patients have difficulties to underst and the outcomes of these formulas . As a result , they may not recognize the importance of changing lifestyle and taking medication in time . Therefore , it is important to develop risk communication methods , that will improve the patients ' underst and ing of risks associated with having diabetes , which enables them to make informed choices about their diabetes care . The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception , attitude and intention to change lifestyle behaviour in patients with T2DM . The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory . Methods A r and omised controlled trial will be performed in the Diabetes Care System West-Friesl and ( DCS ) , a managed care system . Newly referred T2DM patients of the DCS , younger than 75 years will be eligible for the study . The intervention group will be exposed to risk communication on CVD , on top of st and ard managed care of the DCS . This intervention consists of a simple explanation on the causes and consequences of CVD , and possibilities for prevention . The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram . The control group will receive st and ard managed care . The primary outcome is appropriateness of risk perception . Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception . Differences between baseline and follow-up ( 2 and 12 weeks ) between groups will be analysed according to the intention-to-treat principle . The study was powered on 120 patients in each group . Discussion This innovative risk communication method based on two behavioural theories might improve patient 's appropriateness of risk perception and attitude concerning lifestyle change . With a better underst and ing of their CVD risk , patients will be able to make informed choices concerning diabetes care . Trail registration The trial is registered as NTR1556 in the Dutch Trial Register Background Many patients at high risk of cardiovascular diseases are managed and monitored in general practice . Recommendations for cardiovascular risk management , including lifestyle change , are clearly described in the Dutch national guideline . Although lifestyle interventions , such as advice on diet , physical exercise , smoking and alcohol , have moderate , but potentially relevant effects in these patients , adherence to lifestyle advice in general practice is not optimal . The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics . The aim of this paper is to describe the design and methods of a study to evaluate an intervention aim ed at involving patients in cardiovascular risk management . Methods A cluster-r and omised controlled trial in 20 general practice s , 10 practice s in the intervention arm and 10 in the control arm , starting on October 2005 . A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited . In both arms , the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management . Nurses in the intervention arm will receive an extended training in risk assessment , risk communication , the use of a decision aid and adapted motivational interviewing . This communication technique will be used to support the shared decision-making process about risk reduction . The intervention comprises 2 consultations and 1 follow-up telephone call . The nurses in the control arm will give usual care after the risk estimation , according to the national guideline . Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment . Secondary outcome measures are the patients ' perception of risk and their motivation to change their behaviour . The measurements will take place at baseline and after 12 and 52 weeks . Clinical endpoints will not be measured , but the absolute 10-year risk of cardiovascular events will be estimated for each patient from medical records at baseline and after 1 year . Discussion The combined use of risk communication , a decision aid and motivational interviewing to enhance patient involvement in decision making is an innovative aspect of the intervention . Trial registration Current Controlled Trials IS RCT Background — Despite effective treatments to reduce cardiovascular disease risk , their translation into practice is limited . Methods and Results — Using a parallel arm cluster-r and omized controlled trial in 60 Australian primary healthcare centers , we tested whether a multifaceted quality improvement intervention comprising computerized decision support , audit/feedback tools , and staff training improved ( 1 ) guideline -indicated risk factor measurements and ( 2 ) guideline -indicated medications for those at high cardiovascular disease risk . Centers had to use a compatible software system , and eligible patients were regular attendees ( Aboriginal and Torres Strait Isl and er people aged ≥35 years and others aged ≥45 years ) . Patient-level analyses were conducted using generalized estimating equations to account for clustering . Median follow-up for 38 725 patients ( mean age , 61.0 years ; 42 % men ) was 17.5 months . Mean monthly staff support was < 1 hour/site . For the co primary outcomes , the intervention was associated with improved overall risk factor measurements ( 62.8 % versus 53.4 % risk ratio ; 1.25 ; 95 % confidence interval , 1.04–1.50 ; P=0.02 ) , but there was no significant differences in recommended prescriptions for the high-risk cohort ( n=10 308 ; 56.8 % versus 51.2 % ; P=0.12 ) . There were significant treatment escalations ( new prescriptions or increased numbers of medicines ) for antiplatelet ( 4.3 % versus 2.7 % ; P=0.01 ) , and BP lowering ( 18.2 % versus 11.0 % ; P=0.02 ) but not lipid-lowering medications . Conclusions — In Australian primary healthcare setting s , a computer-guided quality improvement intervention , requiring minimal support , improved cardiovascular disease risk measurement but did not increase prescription rates in the high-risk group . Computerized quality improvement tools offer an important , albeit partial , solution to improving primary healthcare system capacity for cardiovascular disease risk management . Clinical Trial Registration — URL : https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=336630 . Australian New Zeal and Clinical Trials Registry No. 12611000478910 Background Patient-centered diabetes care requires shared decision making ( SDM ) . Decision aids promote SDM , but their efficacy in nonacademic and rural primary care clinics is unclear . Methods We cluster-r and omized 10 practice s in a concealed fashion to implement either a decision aid ( DA ) about starting statins or one about choosing antihyperglycemic agents . Each practice served as a control group for another practice implementing the other type of DA .  From April 2011 to July 2012 , 103 ( DA=53 ) patients with type 2 diabetes participated in the trial . We used patient and clinician surveys administered after the clinical encounter to collect decisional outcomes ( patient knowledge and comfort with decision making , patient and clinician satisfaction ) . Medical records provided data on metabolic control . Pharmacy fill profiles provided data for estimating adherence to therapy . Results Compared to usual care , patients receiving the DA were more likely to report discussing medications ( 77 % vs. 45 % , p<.001 ) , were more likely to answer knowledge questions correctly ( risk reduction with statins 61 % vs. 33 % , p=.07 ; knowledge about options 57 % vs. 33 % , p=.002 ) and were more engaged by their clinicians in decision making ( 50 . vs. 28 , difference 21.4 ( 95 % CI 6.4 , 36.3 ) , p=.01 ) . We found no significant impact on patient satisfaction , medication starts , adherence or clinical outcomes , in part due to limited statistical power . Conclusion DAs improved decisional outcomes without significant effect on clinical outcomes . DAs design ed for point-of-care use with type 2 diabetes patients promoted shared decision making in nonacademic and rural primary care practice s . Trial Registration Background There is currently much interest in encouraging individuals to increase physical activity in order to reduce CVD risk . This study has been design ed to determine if personalised CVD risk appreciation can increase physical activity in adults at high risk of CVD . Methods / Design In a 2 × 2 factorial design participants are allocated at r and om to a personalised 10-year CVD risk estimate or numerical CVD risk factor values ( systolic blood pressure , LDL cholesterol and fasting glucose ) and , simultaneously , to receive a brief lifestyle advice intervention targeting physical activity , diet and smoking cessation or not . We aim to recruit 200 participants from Oxfordshire primary care practice s. Eligibility criteria include adults age 40–70 years , estimated 10-year CVD risk ≥20 % , ability to read and write English , no known CVD and no physical disability or other condition reducing the ability to walk . Primary outcome is physical activity measured by ActiGraph accelerometer with biochemical , anthropometrical and psychological measures as additional outcomes . Primary analysis is between group physical activity differences at one month powered to detect a difference of 30,000 total counts per day of physical activity between the groups . Additional analyses will seek to further eluci date the relationship between the provision of risk information , and intention to change behaviour and to determine the impact of both interventions on clinical and anthropometrical measures including fasting and 2 hour plasma glucose , fructosamine , serum cotinine , plasma vitamin C , body fat percentage and blood pressure . Discussion This is a pilot trial seeking to demonstrate in a real world setting , proof of principal that provision of personalised risk information can contribute to behaviour changes aim ed at reducing CVD risk . This study will increase our underst and ing of the links between the provision of risk information and behaviour change and if successful , could be used in clinical practice with little or no modification Background A healthy diet , low in saturated fat and high in fiber , is a popular medical recommendation in preventing cardiovascular disease ( CVD ) . One approach to motivating healthier eating is to raise individuals ’ awareness of their CVD risk and then help them form specific plans to change . Objectives The aim was to explore the combined impact of a Web-based CVD risk message and a fully automated planning tool on risk perceptions , intentions , and saturated fat intake changes over 4 weeks . Methods Of the 1187 men and women recruited online , 781 were r and omly allocated to one of four conditions : a CVD risk message , the same CVD risk message paired with planning , planning on its own , and a control group . All outcome measures were assessed by online self-reports . Generalized linear modeling was used to analyze the data . Results Self-perceived consumption of low saturated fat foods ( odds ratio 11.40 , 95 % CI 1.86–69.68 ) and intentions to change diet ( odds ratio 21.20 , 95 % CI 2.6–172.4 ) increased more in participants allocated to the planning than the control group . No difference was observed between the four conditions with regard to percentage saturated fat intake changes . Contrary to our expectations , there was no difference in perceived and percentage saturated fat intake change between the CVD risk message plus planning group and the control group . Risk perceptions among those receiving the CVD risk message changed to be more in line with their age ( change in slopeindividual = 0.075 , P = .01 ; change in slopecomparative = 0.100 , P = .001 ) , whereas there was no change among those who did not receive the CVD risk message . Conclusion There was no evidence that combining a CVD risk message with a planning tool reduces saturated fat intake more than either alone . Further research is required to identify ways in which matching motivational and volitional strategies can lead to greater behavior changes . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 91154001 ; http://www.controlled-trials.com/IS RCT N91154001 ( Archived by WebCite at http://www.webcitation.org/62sBoGeOO Background Countries in sub-Saharan Africa ( SSA ) are experiencing an epidemic of cardiovascular disease ( CVD ) propelled by rapidly increasing rates of hypertension . Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs . Although SSA bears 24 % of the global disease burden , it has only 3 % of the global health workforce . Given such limited re sources , cost-effective strategies , such as task shifting , are needed to mitigate the rising CVD epidemic in SSA . Ghana , a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization ( WHO ) task-shifting strategy . This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage , on blood pressure ( BP ) reduction . Methods Using a cluster r and omized design , 32 community health centers ( CHCs ) and district hospitals in Ghana will be r and omized to either the  intervention  group ( 16 CHCs ) or the control group ( 16 CHCs ) . A total of 640 patients with uncomplicated hypertension ( BP 140–179/90–99 mm Hg and absence of target organ damage ) will be enrolled in this study ( 20 patients per CHC ) . The intervention consists of WHO Package of CV risk assessment , patient education , initiation and titration of antihypertensive medications , 
    Output:
    