Cost-Effectiveness of the Diabetes Care Protocol, a Multifaceted Computerized Decision Support Diabetes Management Intervention That Reduces Cardiovascular Risk Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial. Digital health intervention during cardiac rehabilitation: A randomized controlled trial Cost-effectiveness of interventions to control cardiovascular diseases and type 2 diabetes mellitus in South Asia: protocol for a systematic review Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India HEART: heart exercise and remote technologies: A randomized controlled trial study protocol Effectiveness and cost-effectiveness of a telehealth intervention to support the management of long-term conditions: study protocol for two linked randomized controlled trials A multifaceted quality improvement intervention for CVD risk management in Australian primary healthcare: a protocol for a process evaluation Development of mWellcare: an mHealth intervention for integrated management of hypertension and diabetes in low-resource settings A cardiovascular disease policy model that predicts life expectancy taking into account socioeconomic deprivation "Yes", "No" or "Yes, but"? Multinomial modelling of NICE decision-making. Clinical trial of an Internet-based case management system for secondary prevention of heart disease. Global Risk Assessment to Guide Blood Pressure Management in Cardiovascular Disease Prevention A Markov model of the cost-effectiveness of pharmacist care for diabetes in prevention of cardiovascular diseases: evidence from Kaiser Permanente Northern California. Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS): study protocol for a randomized controlled trial Evaluating the use of mobile phone technology to enhance cardiovascular disease screening by community health workers Drotrecogin alfa (activated) in severe sepsis: a systematic review and new cost-effectiveness analysis Hand function assessment in patients receiving haemodialysis. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: Methods of a decision-maker-researcher partnership systematic review Focus on health information technology, electronic health records and their financial impact: Cost-effectiveness of a shared computerized decision support system for diabetes linked to electronic medical records The Effectiveness of Technology-Based Strategies to Promote Engagement With Digital Interventions: A Systematic Review Protocol The systematic coronary risk evaluation (SCORE) for the prevention of cardiovascular diseases. Does evidence exist for its effectiveness? A systematic review An integrated general practice and pharmacy-based intervention to promote the use of appropriate preventive medications among individuals at high cardiovascular disease risk: protocol for a cluster randomized controlled trial
OBJECTIVE The Diabetes Care Protocol ( DCP ) , a multifaceted computerized decision support diabetes management intervention , reduces cardiovascular risk of type 2 diabetic patients . We performed a cost-effectiveness analysis of DCP from a Dutch health care perspective . RESEARCH DESIGN AND METHODS A cluster r and omized trial provided data of DCP versus usual care . The 1-year follow-up patient data were extrapolated using a modified Dutch microsimulation diabetes model , computing individual lifetime health-related costs , and health effects . Incremental costs and effectiveness ( quality -adjusted life-years [ QALYs ] ) were estimated using multivariate generalized estimating equations to correct for practice -level clustering and confounding . Incremental cost-effectiveness ratios ( ICERs ) were calculated and cost-effectiveness acceptability curves were created . Stroke costs were calculated separately . Subgroup analyses examined patients with and without cardiovascular disease ( CVD+ or CVD− patients , respectively ) . RESULTS Excluding stroke  , DCP patients lived longer ( 0.14 life-years , P = NS ) , experienced more QALYs ( 0.037 , P = NS ) , and incurred higher total costs ( € 1,415 , P = NS ) , result ing in an ICER of € 38,243 per QALY gained . The likelihood of cost-effectiveness given a willingness-to-pay threshold of € 20,000 per QALY gained is 30 % . DCP had a more favorable effect on CVD+ patients ( ICER = € 14,814 ) than for CVD− patients ( ICER = € 121,285 ) . Coronary heart disease costs were reduced ( € −587 , P < 0.05 ) . CONCLUSIONS DCP  reduces cardiovascular risk , result ing in only a slight improvement in QALYs , lower CVD costs , but higher total costs , with a high cost-effectiveness ratio . Cost-effective care can be achieved by focusing on cardiovascular risk factors in type 2 diabetic patients with a history of CVD AIMS Cardiovascular disease ( CVD ) is the leading cause of morbidity and mortality in people with diabetes in South Asia . The CARRS Translation Trial tests the effectiveness , cost-effectiveness , and sustainability of a clinic-based multi-component CVD risk reduction intervention among people with diabetes in India and Pakistan . METHODS We r and omly assigned 1146 adults with diabetes recruited from 10 urban clinic sites , to receive usual care by physicians or to receive an integrated multi-component CVD risk reduction intervention . The intervention involves electronic health record management , decision-support prompts to the healthcare team , and the support of a care coordinator to actively facilitate patient and provider adherence to evidence -based guidelines . The primary outcome is a composite of multiple CVD risk factor control ( blood glucose and either blood pressure or cholesterol , or all three ) . Other outcomes include control of the individual CVD risk factors , process and patient-centered measures , cost-effectiveness , and acceptability/feasibility . CONCLUSION The CARRS Translation Trial tests a low-cost diabetes care delivery model in urban South Asia to achieve comprehensive cardio-metabolic disease case-management of high-risk patients ( clinical trials.gov number : NCT01212328 ) Background Digital health interventions ( DHI ) have been shown to improve intermediates of cardiovascular health , but their impact on cardiovascular ( CV ) outcomes has not been fully explored . The aim of this study was to determine whether DHI administered during cardiac rehabilitation ( CR ) would reduce CV‐related emergency department ( ED ) visits and rehospitalizations in patients after percutaneous coronary intervention ( PCI ) for acute coronary syndrome ( ACS ) . Methods We r and omized patients undergoing CR following ACS and PCI to st and ard CR ( n = 40 ) or CR + DHI ( n = 40 ) for 3 months with 3 patients withdrawing from CR prior to initiation in the treatment arm and 6 in the control group . The DHI incorporated an online and smartphone‐based CR platform asking the patients to report of dietary and exercise habits throughout CR as well as educational information toward patients ' healthy lifestyles . We obtained data regarding ED visits and rehospitalizations at 180 days , as well as other metrics of secondary CV prevention at baseline and 90 days . Results Baseline demographics were similar between the groups . The DHI + CR group had improved weight loss compared to the control group ( −5.1 ± 6.5 kg vs. −0.8 ± 3.8 kg , respectively , P = .02 ) . Those in the DHI + CR group also showed a non‐significant reduction in CV‐related rehospitalizations plus ED visits compared to the control group at 180 days ( 8.1 % vs 26.6 % ; RR 0.30 , 95 % CI 0.08‐1.10 , P = .054 ) . Conclusions The current study demonstrated that complementary DHI  significantly improves weight loss , and might offer a method to reduce CV‐related ED visits plus rehospitalizations in patients after ACS undergoing CR . The study suggests a role for DHI as an adjunct to CR to improve secondary prevention of CV disease . Trial registration This trial is registered at clinical trials.gov ( NCT01883050 ) Introduction While a number of strategies are being implemented to control cardiovascular diseases ( CVDs ) and type 2 diabetes mellitus ( T2DM ) , the cost-effectiveness of these in the South Asian context has not been systematic ally evaluated . We aim to systematic ally review the economic ( cost-effectiveness ) evidence available on the individual- , group- and population -level interventions for control of CVD and T2DM in South Asia . Methods and analysis This review will consider all relevant economic evaluations , either conducted alongside r and omised controlled trials or based on decision modelling estimates . These studies must include participants at risk of developing CVD/T2DM or with established disease in one or more of the South Asian countries ( India , Bangladesh , Pakistan , Sri Lanka , Nepal , Maldives , Bhutan and Afghanistan ) . We will identify relevant papers by systematic ally search ing all major data bases and registries . Selected articles will be screened by two independent research ers . Method ological quality of the studies will be assessed using a modified Drummond and a Phillips checklist . Cochrane guidelines will be followed for bias assessment in the effectiveness studies . Results Results will be presented in line with the PRISMA ( Preferred Reporting Items for Systematic review and Meta- analysis ) checklist , and overall quality of evidence will be presented as per the GRADE ( Grade s of Recommendation , Assessment , Development and Evaluation ) approach . Ethics and dissemination The study has received ethics approval from the All India Institute of Medical Sciences , New Delhi , India . The results of this review will provide policy-relevant recommendations for the uptake of cost-effectiveness evidence in prioritising decisions on essential chronic disease care packages for South Asia . Study registration number PROSPERO CRD42013006479 Introduction Rising burden of cardiovascular disease ( CVD ) and diabetes is a major challenge to the health system in India . Innovative approaches such as mobile phone technology ( mHealth ) for electronic decision support in delivering evidence -based and integrated care for hypertension , diabetes and comorbid depression have potential to transform the primary healthcare system . Methods and analysis mWellcare trial is a multicentre , cluster r and omised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India .  mWellcare system is an And roid-based mobile application design ed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records , sending alerts and reminders for follow-up and adherence to medication . We recruited a total of 3702 participants from 40 Community Health Centres ( CHCs ) , with ≥90 at each of the CHCs in the intervention and control ( enhanced care ) arms . The primary outcome is the difference in mean change ( from baseline to 1 year ) in systolic blood pressure and glycated haemoglobin ( HbA1c ) between the two treatment arms . The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose , total cholesterol , predicted 10-year risk of CVD , depression , smoking behaviour , body mass index and alcohol use between the two treatment arms and cost-effectiveness . Ethics and dissemination The study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine . Findings will be disseminated widely through peer- review ed publications , conference presentations and other mechanisms . Trial registration mWellcare trial is registered with Clinical trial.gov ( Registration number NCT02480062 ; Pre- results ) and Clinical Trial Registry of India ( Registration number CTRI/2016/02/006641 ) . The current version of the protocol is Version 2 date d 19 October 2015 and the study sponsor is Public Health Foundation of India , Gurgaon , India ( www.phfi.org ) Background Cardiovascular disease ( CVD ) is the leading cause of death worldwide . Cardiac rehabilitation ( CR ) is aim ed at improving health behaviors to slow or reverse the progression of CVD disease . Exercise is a central element of CR . Technologies such as mobile phones and the Internet ( mHealth ) offer potential to overcome many of the psychological , physical , and geographical barriers that have been associated with lack of participation in exercise-based CR . We aim to trial the effectiveness of a mobile phone delivered exercise-based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD . This paper outlines the rationale and methods of the trial . Methods A single-blinded parallel two-arm r and omized controlled trial is being conducted . A total of 170 people will be r and omized at 1:1 ratio either to receive a  mHealth CR program  or usual care .  Participants are identified by CR nurses from two metropolitan hospitals in Auckl and , New Zeal and through outpatient clinics and existing data bases . Consenting participants are contacted to attend a baseline assessment . The intervention consists of a theory-based , personalized , automated package of text and video message components via participants ' mobile phones and the Internet to increase exercise behavior , delivered over six months . The control group will continue with usual CR . Data collection occurs at baseline and 24 weeks ( post-intervention ) . The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks . Secondary outcomes include post-intervention measures on self-reported physical activity ( IPAQ ) , cardiovascular risk factors ( systolic blood pressure , weight , and waist to hip ratio ) , health related quality of life ( SF-36 ) , and cost-effectiveness . Discussion This manuscript presents the protocol for a r and omized controlled trial of a mHealth exercise-based CR program . Results of this trial will provide much needed information about physical and psychological well-being , and cost-effectiveness of an automated telecommunication intervention . If effective , this intervention has enormous potential to improve the delivery of CR and could easily be scaled up to be delivered nationally ( and internationally ) in a very short time , enhancing the translational aspect of this research . It also has potential to extend to comprehensive CR ( nutrition advice , smoking cessation , medication adherence).Trial Registration Background As the population ages , more people are suffering from long-term health conditions ( LTCs ) . Health services around the world are exploring new ways of supporting people with LTCs and there is great interest in the use of telehealth : technologies such as the Internet , telephone and home self-monitoring . Methods / Design This study aims to evaluate the effectiveness and cost-effectiveness of a telehealth intervention delivered by NHS Direct to support patients with LTCs . Two r and omized controlled trials will be conducted in parallel , recruiting patients with two exemplar LTCs : depression or raised cardiovascular disease ( CVD ) risk . A total of 1,200 patients will be recruited from approximately 42 general practice s near Bristol , Sheffield and Southampton , UK . Participants will be r and omly allocated to either usual care ( control group ) or usual care plus the NHS Direct Healthlines Service ( intervention group ) . The intervention is based on a conceptual model incorporating promotion of self-management , optimisation of treatment , coordination of care and engagement of patients and general practitioners . Participants will be provided with tailored help , combining telephone advice from health information advisors with support to use a range of online re sources . Participants will access the service for 12 months . Outcomes will be collected at baseline , four , eight and 12 months for the depression trial and baseline , six and 12 months for the CVD risk trial . The primary outcome will be the proportion of patients responding to treatment , defined in the depression trial as a PHQ-9 score < 10 and an absolute reduction in PHQ-9 ≥5 after 4 months , and in the CVD risk trial as maintenance or reduction of 10-year CVD risk after 12 months . The study will also assess whether the intervention is cost-effective from the perspective of the NHS and personal social services . An embedded qualitative interview study will explore healthcare professionals ’ and patients ’ views of the intervention . Discussion This study evaluates a complex telehealth intervention which combines evidence -based components and is delivered by an established healthcare organisation . The study will also analyse health economic information . In doing so , the study hopes to address some of the limitations of previous research by demonstrating the effectiveness and cost-effectiveness of a real world telehealth intervention . Trial registration Current Controlled Trials : Depression trial IS RCT N14172341 and cardiovascular disease risk trial IS RCT N27508731 Background Cardiovascular disease ( CVD ) is the leading cause of death and disability worldwide . Despite the widespread availability of evidence -based clinical guidelines and vali date d risk predication equations for prevention and management of CVD , their translation into routine practice is limited . We developed a multifaceted quality improvement intervention for CVD risk management which incorporates electronic decision support , patient risk communication tools , computerised audit and feedback tools , and monthly , peer-ranked performance feedback via a web portal . The intervention was implemented in a cluster r and omised controlled trial in 60 primary healthcare services in Australia . Overall , there were improvements in risk factor recording and in prescribing of recommended treatments among under-treated individuals , but it is unclear how this intervention was used in practice and what factors promoted or hindered its use . This information is necessary to optimise intervention impact and maximally implement it in a post-trial context . In this study protocol , we outline our methods to conduct a theory-based , process evaluation of the intervention . Our aims are to underst and how , why , and for whom the intervention produced the observed outcomes and to develop effective strategies for translation and dissemination . Methods / Design We will conduct four discrete but inter-related studies taking a mixed methods approach . Our quantitative studies will examine ( 1 ) the longer term effectiveness of the intervention post-trial , ( 2 ) patient and health service level correlates with trial outcomes , and ( 3 ) the health economic impact of implementing the intervention at scale . The qualitative studies will ( 1 ) identify healthcare provider perspectives on implementation barriers and enablers and ( 2 ) use video ethnography and patient semi-structured interviews to underst and how cardiovascular risk is communicated in the doctor/patient interaction both with and without the use of intervention . We will also assess the costs of implementing the intervention in Australian primary healthcare setting s which will inform scale-up considerations . Discussion This mixed methods evaluation will provide a detailed underst and ing of the process of implementing a  quality improvement intervention and identify the factors that might influence scalability and sustainability . Trials registration 12611000478910 ABSTRACT Background : Cardiovascular diseases and diabetes are among the leading causes of premature adult deaths in India . Innovative approaches such as clinical decision support ( CDS ) software could play a major role in improving the quality of hypertension/diabetes care in primary care setting s. Objective : To describe the steps and processes in the development of mWellcare , a complex intervention based on mobile health ( mHealth ) technology . Methods : The Medical Research Council framework was used to develop mWellcare in four steps : ( 1 ) identify gaps in usual care through literature review and health facility assessment s ; ( 2 ) identify the components of the intervention through discussion s and consultations with experts ; ( 3 ) develop intervention ( clinical algorithms and mHealth system ) ; and ( 4 ) evaluate acceptability and feasibility through pilot testing in five community health centers . Results : Lack of evidence -based , integrated , and systematic management of chronic conditions were major gaps identified . Experts in information technology , clinical fields , and public health professionals identified intervention components to address these gaps . Thereafter , clinical algorithm context ualized to primary care setting s were prepared and the mWellcare intervention was developed . During the 2-month pilot , 631 patients diagnosed with hypertension and /or diabetes were registered , with a follow-up rate of 36.2 % . The major barrier was resistance to follow mWellcare recommended patient workflow , and to overcome it , we emphasized onsite training and orientation program to cover all health care team member in each CHC . Conclusion : A pilot-tested mWellcare intervention is an mHealth system with important components , i.e. integrated management of chronic conditions , evidence -based CDS , longitudinal health data and automated short-messaging service to reinforce compliance to drug intake and follow-up visit , which will be used by nurses at primary health care setting s in India . The effectiveness and cost-effectiveness of the intervention will be tested through a cluster r and omized trial ( trial registration number NCT02480062 ) Objectives A policy model is a model that can evaluate the effectiveness and cost-effectiveness of interventions and inform policy decisions . In this study , we introduce a cardiovascular disease ( CVD ) policy model which can be used to model remaining life expectancy including a measure of socioeconomic deprivation as an independent risk factor for CVD . Design A state transition model was developed using the Scottish Heart Health Extended Cohort ( SHHEC ) linked to Scottish morbidity and death records . Individuals start in a CVD-free state and can transit to three CVD event states plus a non-CVD death state . Individuals who have a non-fatal first event are then followed up until death . Taking a competing risk approach , the cause-specific hazards of a first event are modelled using parametric survival analysis . Survival following a first non-fatal event is also modelled parametrically . We assessed discrimination , validation and calibration of our model . Results Our model achieved a good level of discrimination in each component ( c-statistics for men (women)—non-fatal coronary heart disease ( CHD ) : 0.70 ( 0.74 ) , non-fatal cerebrovascular disease ( CBVD ) : 0.73 ( 0.76 ) , fatal CVD : 0.77 ( 0.80 ) , fatal non-CVD : 0.74 ( 0.72 ) , survival after non-fatal CHD : 0.68 ( 0.67 ) and survival after non-fatal CBVD : 0.65 ( 0.66 ) ) . In general , our model predictions were comparable with observed event rates for a Scottish r and omised statin trial population which has an overlapping follow-up period with SHHEC . After applying a calibration factor , our predictions of life expectancy closely match those published in recent national life tables . Conclusions Our model can be used to estimate the impact of primary prevention interventions on life expectancy and can assess the impact of interventions on inequalities The National Institute for Health and Clinical Excellence ( NICE ) issues m and atory guidance on health technologies to the UK NHS , based on clinical evidence , cost-effectiveness and other considerations . However , the exact factors considered , their relative importance and tradeoffs between them are not made explicit . Previous research modelled NICE decisions as a binary choice ( accept/reject ) dependent on cost-effectiveness , amongst other variables . This paper proposes and tests an alternative model of decision-making that may better represent the " yes , but ... " nature of many NICE decisions . Decisions were categorised as " recommended for routine use " , " recommended for restricted use " or " not recommended " . The NICE appraisal process was modelled as a single decision between the three categories .  Multinomial logistic regression techniques were used to evaluate the impact of : quantity/ quality of clinical evidence ; cost-effectiveness ; decision date ; existence of alternative treatments ; budget impact ; technology type . Results suggest that interventions supported by more r and omised trials are more likely to be recommended and endorsed for routine use . Higher cost-effectiveness ratios increased the likelihood of interventions being rejected rather than recommended for restricted use but did not significantly affect the decision between routine and restricted use . Pharmaceuticals , interventions appraised early in the NICE programme and those with more systematic review s were also less likely to be rejected , while patient group su bmi ssions made a recommendation for routine rather than restricted use more likely . The presence of factors affecting the decision between routine and restricted use but not that between routine use and rejection suggests that modelling these three outcomes reflects NICE decision-making more closely than binary-choice analyses PURPOSE Despite demonstrated benefits of cardiac rehabilitation and risk factor reduction , only 11 % to 38 % of eligible patients with cardiovascular disease ( CVD ) participate in cardiac rehabilitation programs .  Women and older adults are particularly less likely to participate in cardiac rehabilitation . In an effort to broaden access to cardiac rehabilitation , the authors developed an alternative Internet-based program that allows nurse case managers to provide risk factor management training , risk factor education , and monitoring services to patients with CVD . METHODS The evaluation consisted of a r and omized , clinical trial involving 104 patients with CVD , 53 of whom used the program as a special intervention ( SI ) for 6 months and 51 of whom received usual care ( UC ) .  RESULTS The results indicate that fewer cardiovascular events occurred among the SI subjects ( 15.7 % ) than among the UC subjects ( 4.1 % ) ( P = .053 ) , result ing in a gross cost savings of $ 1418 US dollars per patient . With a projected program cost of $ 453 USD per patient , the return on investment is estimated at 213 % . More weight loss occurred in the SI group ( -3.68 pounds ) than in the UC group ( + .47 pounds ) ( P = .003 ) . The differences between the two groups in terms of blood pressure , lipid levels , depression scores , minutes of exercise , and dietary habits were not statistically significant . CONCLUSION An Internet-based case management system could be used as a cost-effective intervention for patients with CVD , either independently or in conjunction with traditional cardiac rehabilitation Elevated blood pressure ( BP ) is a causal risk factor for cardiovascular disease ( CVD ) . Epidemiological analyses have established the grade d and continuous association between higher BP and CVD . Moreover , r and omized clinical trials among individuals with hypertension have demonstrated , in aggregate , a reduction in CVD events by 20 % , coronary heart disease ( CHD ) by 17 % , stroke by 27 % , and heart failure by 28 % for every 10 mm Hg systolic BP ( SBP ) lowering with medical therapy.1 Therefore , prevention , detection , treatment , and control of elevated BP , and its clinical correlate hypertension , is an important public health priority and a primary target for CVD prevention . Although national health surveys have demonstrated improvements in hypertension awareness and treatment , strategic opportunities to improve the efficiency and efficacy of applying BP-lowering therapy in patients most likely to benefit remain.2 Global CVD risk assessment , using multivariable prediction models that estimate absolute CVD risk from routinely measured clinical variables , has been promulgated in several CVD prevention guidelines for cholesterol management to target the most intensive preventive therapies to those at highest absolute CVD risk.3–5 Hypertension guidelines , however , have instead relied solely on isolated BP thresholds and BP goals to guide treatment initiation and intensity . In this review , we provide a rationale for incorporating global CVD risk assessment in BP treatment decision-making and propose a framework to guide its implementation in future CVD prevention guidelines . Epidemiological analyses have firmly established that CVD is a multifactorial condition and that modest increases of several CVD risk factors can often lead to greater overall risk than a severe elevation of a BACKGROUND It has been demonstrated in previous studies that pharmacist management of patients with type 2 diabetes mellitus ( T2DM ) in the outpatient setting not only improves diabetes-related clinical outcomes such as hemoglobin A1c but also blood pressure ( BP ) , total cholesterol ( TC ) , and quality of life . Improved control of BP and TC has been shown to reduce the risks of cardiovascular disease ( CVD ) , which has placed a heavy economic burden on the health care system . However , no study has evaluated the cost-effectiveness of pharmacist intervention programs with respect to the long-term preventive effects on CVD outcomes among T2DM patients . OBJECTIVES To ( a ) quantify the long-term preventive effects of pharmacist intervention on CVD outcomes among T2DM patients using evidence from a matched cohort study in the outpatient primary care setting and ( b ) assess the relative cost-effectiveness of adding a clinical pharmacist to the primary care team for the management of patients with T2DM based on improvement in CVD risks with the aid of an economic model . METHODS Clinical data between the periods of June 2007 to February 2010 were collected from electronic medical records at 2 separate clinics at Kaiser Permanente ( KP ) Northern California , 1 with primary care physicians only ( control group ) and the other with the addition of a pharmacist ( enhanced care group ) . Patients in the enhanced care group were matched 1:1 with patients in the control group according to baseline characteristics that included age , gender , A1c , and Charlson comorbidity score . The estimated 10-year CVD risk for both groups was calculated by the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) Risk Engine ( version 2 ) based on age , sex , race , smoking status , atrial fibrillation , duration of diabetes , levels of A1c , systolic BP ( SBP ) and TC , and high-density lipoprotein cholesterol ( HDL-C ) observed at 12 months . There was no statistical difference in the baseline clinical inputs to the Risk Engine ( A1c [ P=0.115 ] , SBP [ P=0.184 ] , TC [ P=0.055 ] , and HDL-C [ P=0.475 ] ) between the 2 groups . A Markov model was developed to simulate the estimated CVD outcomes over 10 years and to estimate cost-effectiveness . The final outcomes examined included incremental cost and effectiveness measured by life years and per quality -adjusted life year gained . Both deterministic sensitivity analysis ( SA ) and probabilistic SA were conducted to examine the robustness of the results . RESULTS The estimated risks for coronary heart disease ( CHD ) and stroke ( both nonfatal and fatal ) at the end of the follow-up were consistently lower in the enhanced care group compared with the control group , even though baseline risks in both groups were similar . The absolute risk reduction ( ARR ) between the enhanced care and control groups increased over time . For example , the ARR for nonfatal CHD risk in year 1 was 0.5 % ( 1.2 % vs. 0.7 % ) , whereas the ARR increased to 5.5 % in year 10 ( 14.8 % vs. 9.3 % ) . Similarly , the ARR between the enhanced care and the control groups was calculated as 0.3 % for fatal CHD in year 1 and increased to 4.6 % in year 10 . Results from the Markov model suggest that the enhanced care group was shown to be a dominant strategy ( less expensive and more effective ) compared with the control group in the 10-year evaluation period in the base-case ( average or mean results ) scenario . Sensitivity analysis that took into account the uncertainty in all important variables , such as wage of pharmacists , utility weight ( the degree of preference individuals have for a particular health state or condition ) , response rate to pharmacists ' care , and uncertainty associated with the estimated 10 years of CVD risk , revealed that the relative value of enhanced care was robust to most of the variations in these parameters . Notably , the level of cost-effectiveness measured by net monetary value depends on the time horizon adopted by the payers and the magnitude of CVD risk reduction . The enhanced care group has a higher chance of being considered as a cost-effective strategy when a longer time horizon such as a minimum of 4 to 5 years is adopted . CONCLUSIONS Adding pharmacists to the health care management team for diabetic patients improves the long-term CVD risks . The longer-term CVD risk reductions were shown to be more dramatic than the short-term reduction . A longer time horizon adopted by health plans in managing T2DM patients has a higher probability of making the intervention cost-effective Background Medication regimens for asthma are particularly vulnerable to adherence problems because of the requirement for long-term use and periods of symptom remission experienced by patients . Pharmacists are suited to impact medication adherence given their training , skills , and frequent contact with patients . The Empowering pharmacists in asthma management through interactive SMS ( EmPhAsIS ) trial involves an intervention leveraging mobile health ( mHealth ) technology to support community pharmacy practice with the hypothesis of improved medication adherence in asthma . Methods / Design This study is a pragmatic pharmacy-based , cluster , r and omized controlled trial with 12 months of intervention delivery and follow-up . Pharmacies ( the clusters ) will be r and omized at a 1:1 ratio to provide intervention or usual care . The EmPhAsIS intervention consists of patient asthma education , short message service (SMS)-based monthly assessment of adherence , and follow-up of non-adherent individuals by community pharmacists . There are no inclusion or exclusion criteria for pharmacies . Patients are eligible if they : are 14 years of age or older , fill a prescription for inhaled corticosteroid ( either monotherapy or in a combination inhaler with long-acting beta-agonists ) , have been diagnosed with asthma , possess a mobile phone with SMS capabilities , and have no communication difficulties such as inability to communicate in English , or significant impairment in vision , hearing , or speech . The primary outcome is adherence to inhaled corticosteroids ascertained by the medication possession ratio , the ratio of the days of medication supplied to days in a given time interval . This study will also evaluate secondary outcomes including : asthma control , asthma-related quality of life , asthma-related hospital admissions , and use of reliever medications during the follow-up period . A nested economic evaluation using a probabilistic decision-analytic model will be used to perform a cost-effectiveness analysis from the societal perspective of the intervention compared with usual care over a 10-year time horizon . Discussion Considering the prevalence of asthma , the extent of the non-adherence problem in this disease , and the availability of effective treatments , there is a tremendous potential to reduce the burden of asthma through improving adherence . This is the first study of an intervention based on mobile communication technology involving community pharmacists in asthma management . Trial registration Clinical Trials.gov identifier : NCT02170883 ; date of registration : 19 June 2014 BACKGROUND Primary prevention of cardiovascular disease (CVD),by identifying individuals at risk is a well-established , but costly strategy when based on measurements that depend on laboratory analyses . A non-laboratory , paper-based CVD risk assessment chart tool has previously been developed to make screening more affordable in developing countries . Task shifting to community health workers ( CHWs ) is being investigated to further scale CVD risk screening . This study aim ed to develop a mobile phone CVD risk assessment application and to evaluate its impact on CHW training and the duration of screening for CVD in the community by CHWs . METHODS A feature phone application was developed using the open source online platform , CommCare ( © ) . CHWs ( n=24 ) were trained to use both paper-based and mobile phone CVD risk assessment tools . They were r and omly allocated to using one of the risk tools to screen 10 - 20 community members and then crossed over to screen the same number , using the alternate risk tool . The impact on CHW training time , screening time and margin of error in calculating risk scores was recorded . A focus group discussion evaluated experiences of CHWs using the two tools . RESULTS The training time was 12.3h for the paper-based chart tool and 3h for the mobile phone application . 537 people were screened . The mean screening time was 36 min ( SD=12.6 ) using the paper-base chart tool and 21 min ( SD=8.71 ) using the mobile phone application , p=<0.0001 . Incorrect calculations ( 4.3 % of average systolic BP measurements , 10.4 % of BMI and 3.8 % of CVD risk score ) were found when using the paper-based chart tool while all the mobile phone calculations were correct . Qualitative findings from the focus group discussion corresponded with the findings of the pilot study . CONCLUSION The reduction in CHW training time , CVD risk screening time , lack of errors in calculation of a CVD risk score and end user satisfaction when using a mobile phone application , has implication s in terms of adoption and sustainability of this primary prevention strategy to identify people with high CVD risk who can be referred for appropriate diagnoses and treatment Background Activated drotrecogin alfa ( human activated protein C , rhAPC ) , is produced by recombinant DNA technology , and purports to improve clinical outcomes by counteracting the inflammatory and thrombotic consequences of severe sepsis . Controversy exists around the clinical benefits of this drug and an up date d economic study that considers this variability is needed . Methods A systematic literature review was performed using Medline , Embase and the International Network of Agencies for Health Technology Assessment ( INAHTA ) data bases to determine efficacy , safety and previous economic studies . Our economic model was populated with systematic estimates of these parameters and with population life tables for longer term survival information . Monte Carlo simulations were used to estimate the incremental cost-effectiveness ratios ( ICERs ) and variance for the decision analytic models . Results Two r and omized clinical trials ( RCTS ) of drotrecogin alfa in adults with severe sepsis and 8 previous economic studies were identified . Although associated with statistical heterogeneity , a pooled analysis of the RCTs did not show a statistically significant 28-day mortality benefit  for drotrecogin alfa compared to placebo either for all patients ( RR : 0.93 , 95 % CI : 0.69 , 1.26 ) or those at highest risk as measured by APACHE II ≥ 25 ( RR : 0.90 , 95 % CI : 0.54 , 1.49 ) . Our economic analysis based on the totality of the available clinical evidence suggests that the cost-effectiveness  of drotrecogin alfa is uncertain ( < 59 % probability that incremental cost-effectiveness ratio ( ICER ) life year gained ( LYG ) ≤ $ 50,000/LYG ) when applied to all patients with severe sepsis . The economic attractiveness of this therapy improves when administered to those at highest risk as assessed by APACHE II ≥ 25 ( 93 % probability ICER ≤ $ 50,000/LYG ) but these results are not robust to different measures of disease severity . Conclusion The evidence supporting the clinical and economic attractiveness of drotrecogin alfa is not conclusive and further research appears to be indicated OBJECTIVE To assess the usefulness of Duruöz 's H and Index ( DHI ) in patients undergoing haemodialysis . METHODS Patients receiving haemodialysis for more than 2 months were recruited r and omly . Demographic , clinical and functional characteristics of patients were evaluated . Functional assessment was performed with  DHI , H and Functional Index ( HFI ) ,  Health Assessment Question naire ( HAQ ) ,  Purdue Pegboard  , grip strength and 3 kinds of pinch strengths . DHI was correlated ( Spearman 's ) with the other functional parameters in assessing the convergent validity and with non-functional parameters in assessing the divergent validity . RESULTS Sixty patients with a mean age of 50.05 were recruited . The average duration of haemodialysis was 55.02 months . DHI is significantly correlated with HAQ , HFI , Purdue Pegboard scores , grip strength and 3 types of pinch strengths while no significant correlation was found with non-functional parameters . CONCLUSIONS DHI is a practical scale which is efficient in assessing accurately the functional disability of the h and in patients receiving haemodialysis Background Computerized clinical decision support systems are information technology-based systems design ed to improve clinical decision-making . As with any healthcare intervention with cl aims to improve process of care or patient outcomes , decision support systems should be rigorously evaluated before widespread dissemination into clinical practice . Engaging healthcare providers and managers in the review process may facilitate knowledge translation and uptake . The objective of this research was to form a partnership of healthcare providers , managers , and research ers to review r and omized controlled trials assessing the effects of computerized decision support for six clinical application areas : primary preventive care , therapeutic drug monitoring and dosing , drug prescribing , chronic disease management , diagnostic test ordering and interpretation , and acute care management ; and to identify study characteristics that predict benefit . Methods The review was undertaken by the Health Information Research Unit , McMaster University , in partnership with Hamilton Health Sciences , the Hamilton , Niagara , Haldim and , and Brant Local Health Integration Network , and pertinent healthcare service teams . Following agreement on information needs and interests with decision-makers , our earlier systematic review was up date d by search ing Medline , EMBASE , EBM Review data bases , and Inspec , and review ing reference lists through 6 January 2010 . Data extraction items were exp and ed according to input from decision-makers . Authors of primary studies were contacted to confirm data and to provide additional information . Eligible trials were organized according to clinical area of application . We included r and omized controlled trials that evaluated the effect on practitioner performance or patient outcomes of patient care provided with a  computerized clinical decision support system compared with patient care without such a system . Results Data will be summarized using descriptive summary measures , including proportions for categorical variables and means for continuous variables . Univariable and multivariable logistic regression models will be used to investigate associations between outcomes of interest and study specific covariates . When reporting results from individual studies , we will cite the measures of association and p-values reported in the studies . If appropriate for groups of studies with similar features , we will conduct meta-analyses . Conclusion A decision-maker- research er partnership provides a model for systematic review s that may foster knowledge translation and uptake BACKGROUND Computerized decision support systems ( CDSSs ) are believed to enhance patient care and reduce healthcare costs ; however the current evidence is limited and the cost-effectiveness remains unknown . OBJECTIVE To estimate the long-term cost-effectiveness of a CDSS linked to evidence -based treatment recommendations for type 2 diabetes . METHODS Using the Ontario Diabetes Economic Model , changes in factors ( eg , HbA1c ) from a r and omized controlled trial were used to estimate cost-effectiveness . The cost of implementation , development , and maintenance of the core data set , and projected diabetes-related complications were included . The base case assumed a 1-year treatment effect , 5 % discount rate , and 40-year time horizon . Univariate , one-way sensitivity analyses were carried out by altering different parameter values . The perspective was the Ontario Ministry of Health and costs were in 2010 Canadian dollars . RESULTS The cost of implementing the intervention was $ 483,699 . The one-year intervention reduced HbA1c by 0.2 and systolic blood pressure by 3.95 mm Hg , but increased body mass index by 0.02 kg/m² , result ing in a relative risk reduction of 14 % in the occurrence of amputation . The model estimated that the intervention result ed in an additional 0.0117 quality -adjusted life year ; the incremental cost-effectiveness ratio was $ 160,845 per quality -adjusted life-year . CONCLUSION The web-based prototype decision support system slightly improved short-term risk factors . The model predicted moderate improvements in long-term health outcomes . This disease management program will need to develop considerable efficiencies in terms of costs and processes or improved effectiveness to be considered a cost-effective intervention for treating patients with type 2 diabetes Background Digital interventions provide effective and potentially cost-effective models for improving health outcomes as they deliver health information and services that are widely disseminated , confidential , and can be tailored to needs of the individual user . Digital interventions have been used successfully for health promotion , mental health , and for enabling self-management of long-term conditions . However , their effectiveness is limited by low usage rates , with non-engagement a major challenge . Hence , it is crucial to find effective strategies to increase user engagement with digital interventions . Objective This systematic review will aim to evaluate the effectiveness of technology-based strategies  to promote engagement with digital interventions . Methods We will follow Cochrane Collaboration guidelines on systematic review methodology . The search strategy will be executed across seven e- data bases ( including MEDLINE , EMBASE , PsycINFO , CINAHL ) using the concepts “ digital intervention ” and “ engagement ” , limited by study type ( r and omized controlled trial ) . Grey literature and reference lists of included studies will be search ed . Titles and abstract s will be independently screened by 2 authors . Then the full text of potentially eligible papers will be obtained and double screened . Data from eligible papers will be extracted by 1 author and checked for accuracy by another author . Bias will be assessed using the Cochrane bias assessment tool . Narrative synthesis will report on all included studies , and where appropriate , data will be pooled using meta- analysis . All findings will be reported according to the Preferred Reporting Items for Systematic Review s and Meta-Analyses guidelines . Sources of heterogeneity will be further investigated if required . Results Our research is in progress . The final draft of the systematic review is being written and will be su bmi tted before the end of 2015 . Conclusions The review findings will inform research ers and digital intervention providers about optimal use of technology-based strategies to promote engagement with digital interventions . Trial Registration PROSPERO International Prospect i ve Register of Systematic Review s : CRD42014010164 ; http://www.crd.york.ac.uk/ PROSPERO /display_record.asp?ID = CRD42014010164#.VTZmmiFViko ( Archived by WebCite at http://www.webcitation.org/6XxQC8fT8 ) Objectives : The SCORE model predicts the ten-year risk of cardiovascular mortality but it is still unknown whether applying the SCORE in clinical practice subsequently improves cardiovascular disease ( CVD ) outcomes . The objective of this study is to assess the effect of total cardiovascular risk estimation using the SCORE in preventing serious cardiovascular events in European adults without prior CVD . Methods and results : Data sources : eight bibliographical data bases ( 2003 – August 2015 ) , other internet sources and reference lists of articles were checked . This was supplemented by contact with the board members of the European Society of Cardiology ( ESC ) and the authors of the SCORE model . Study eligibility criteria : all prospect i ve studies in any language investigating the effect of using the SCORE on the clinical outcome ( CVD death , major events and adverse outcomes ) in an adult population were examined . Two review ers assessed the studies independently ( titles , abstract s , full texts ) . After removal of duplicates , 5,256 records were screened and 14 full text papers considered . No eligible studies were identified . An extensive literature search revealed no r and omized control trial or other prospect i ve study comparing significant clinical outcomes between groups that used the SCORE and those who did not . Conclusions : The effect of using the SCORE ( with or without subsequent intervention ) on CVD death , all-cause mortality , major CVD events like myocardial infa rct ion and stroke , as well as adverse outcomes , is still unknown . A cluster r and omised controlled trial is warranted to evaluate the use of the SCORE on important outcomes Background Cardiovascular diseases ( CVD ) are responsible for significant morbidity , premature mortality , and economic burden . Despite established evidence that supports the use of preventive medications among patients at high CVD risk , treatment gaps remain . Building on prior evidence and a theoretical framework , a complex intervention has been design ed to address these gaps among high-risk , under-treated patients in the Australian primary care setting . This intervention comprises a general practice quality improvement tool incorporating clinical decision support and audit/feedback capabilities ; availability of a range of CVD polypills ( fixed-dose combinations of two blood pressure lowering agents , a statin ± aspirin ) for prescription when appropriate ; and access to a pharmacy-based program to support long-term medication adherence and lifestyle modification . Methods Following a systematic development process , the intervention will be evaluated in a pragmatic cluster r and omized controlled trial including 70 general practice s for a median period of 18 months . The 35 general practice s in the intervention group  will work with a nominated partner pharmacy , whereas those in the control group will provide usual care without access to the intervention tools . The primary outcome is the proportion of patients at high CVD risk who were inadequately treated at baseline who achieve target blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) levels at the study end . The outcomes will be analyzed using data from electronic medical records , utilizing a vali date d extraction tool . Detailed process and economic evaluations will also be performed . Discussion The study intends to establish evidence about an intervention that combines technological innovation with team collaboration between patients , pharmacists , and general practitioners ( GPs ) for CVD prevention . Trial registration Australian New Zeal and Clinical Trials Registry
This study is the first systematic review of decision analytic model-based cost-effectiveness analyses of DHIs in the management of CVDs .
All the included studies found the DHIs to be cost-effective
BACKGROUND With the advancement in information technology and mobile internet , digital health interventions ( DHIs ) are improving the care of cardiovascular diseases ( CVDs ) .
The impact of DHIs on cost-effective management of CVDs has been examined using the decision analytic model-based health technology assessment approach .
OBJECTIVE The aim of this study was to perform a systematic review of the decision analytic model-based studies evaluating the cost-effectiveness of DHIs on the management of CVDs .