David Peiris

Task Shifting for Non-Communicable Disease Management in Low and Middle Income Countries - A Systematic Review

Background One potential solution to limited healthcare access in low and middle income countries (LMIC) is task-shifting- the training of non-physician healthcare workers (NPHWs) to perform tasks traditionally undertaken by physicians. The aim of this paper is to conduct a systematic review of studies involving task-shifting for the management of non-communicable disease (NCD) in LMIC. Methods A search strategy with the following terms “task-shifting”, “non-physician healthcare workers”, “community healthcare worker”, “hypertension”, “diabetes”, “cardiovascular disease”, “mental health”, “depression”, “chronic obstructive pulmonary disease”, “respiratory disease”, “cancer” was conducted using Medline via Pubmed and the Cochrane library. Two reviewers independently reviewed the databases and extracted the data. Findings Our search generated 7176 articles of which 22 were included in the review. Seven studies were randomised controlled trials and 15 were observational studies. Tasks performed by NPHWs included screening for NCDs and providing primary health care. The majority of studies showed improved health outcomes when compared with usual healthcare, including reductions in blood pressure, increased uptake of medications and lower depression scores. Factors such as training of NPHWs, provision of algorithms and protocols for screening, treatment and drug titration were the main enablers of the task-shifting intervention. The main barriers identified were restrictions on prescribing medications and availability of medicines. Only two studies described cost-effective analyses, both of which demonstrated that task-shifting was cost-effective. Conclusions Task-shifting from physicians to NPHWs, if accompanied by health system re-structuring is a potentially effective and affordable strategy for improving access to healthcare for NCDs. Since the majority of study designs reviewed were of inadequate quality, future research methods should include robust evaluations of such strategies.

A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk

Background Most individuals at high cardiovascular disease (CVD) risk worldwide do not receive any or optimal preventive drugs. We aimed to determine whether fixed dose combinations of generic drugs (‘polypills’) would promote use of such medications. Methods We conducted a randomized, open-label trial involving 623 participants from Australian general practices. Participants had established CVD or an estimated five-year CVD risk of ≥15%, with indications for antiplatelet, statin and ≥2 blood pressure lowering drugs (‘combination treatment’). Participants randomized to the ‘polypill-based strategy’ received a polypill containing aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg. Participants randomized to ‘usual care’ continued with separate medications and doses as prescribed by their doctor. Primary outcomes were self-reported combination treatment use, systolic blood pressure and total cholesterol. Results After a median of 18 months, the polypill-based strategy was associated with greater use of combination treatment (70% vs. 47%; relative risk 1.49, (95% confidence interval (CI) 1.30 to 1.72) p < 0.0001; number needed to treat = 4.4 (3.3 to 6.6)) without differences in systolic blood pressure (−1.5 mmHg (95% CI −4.0 to 1.0) p = 0.24) or total cholesterol (0.08 mmol/l (95% CI −0.06 to 0.22) p = 0.26). At study end, 17% and 67% of participants in polypill and usual care groups, respectively, were taking atorvastatin or rosuvastatin. Conclusion Provision of a polypill improved self-reported use of indicated preventive treatments. The lack of differences in blood pressure and cholesterol may reflect limited study power, although for cholesterol, improved statin use in the polypill group counter-balanced use of more potent statins with usual care.

Addressing inequities in access to quality health care for indigenous people

Many issues influence access to quality health care for indigenous people. In this issue of CMAJ , Gao and colleagues[1][1] describe inequities in access to health care and service utilization among Canadian Aboriginal people with chronic kidney disease. Similar findings have been reported in

Use of mHealth Systems and Tools for Non-Communicable Diseases in Low- and Middle-Income Countries: a Systematic Review

With the rapid adoption of mobile devices, mobile health (mHealth) offers the potential to transform health care delivery, especially in the world’s poorest regions. We systematically reviewed the literature to determine the impact of mHealth interventions on health care quality for non-communicable diseases in low- and middle-income countries and to identify knowledge gaps in this rapidly evolving field. Overall, we found few high-quality studies. Most studies narrowly focused on text messaging systems for patient behavior change, and few studies examined the health systems strengthening aspects of mHealth. There were limited literature reporting clinical effectiveness, costs, and patient acceptability, and none reporting equity and safety issues. Despite the bold promise of mHealth to improve health care, much remains unknown about whether and how this will be fulfilled. Encouragingly, we identified some registered clinical trial protocols of large-scale, multidimensional mHealth interventions, suggesting that the current limited evidence base will expand in coming years.

An Electronic Clinical Decision Support Tool to Assist Primary Care Providers in Cardiovascular Disease Risk Management: Development and Mixed Methods Evaluation

Background Challenges remain in translating the well-established evidence for management of cardiovascular disease (CVD) risk into clinical practice. Although electronic clinical decision support (CDS) systems are known to improve practitioner performance, their development in Australian primary health care settings is limited. Objectives Study aims were to (1) develop a valid CDS tool that assists Australian general practitioners (GPs) in global CVD risk management, and (2) preliminarily evaluate its acceptability to GPs as a point-of-care resource for both general and underserved populations. Methods CVD risk estimation (based on Framingham algorithms) and risk-based management advice (using recommendations from six Australian guidelines) were programmed into a software package. Tool validation: Data from 137 patients attending a physician’s clinic were analyzed to compare the tool’s risk scores with those obtained from an independently programmed algorithm in a separate statistics package. The tool’s management advice was compared with a physician’s recommendations based on a manual review of the guidelines. Field test: The tool was then tested with 21 GPs from eight general practices and three Aboriginal Medical Services. Customized CDS-based recommendations were generated for 200 routinely attending patients (33% Aboriginal) using information extracted from the health record by a research assistant. GPs reviewed these recommendations during each consultation. Changes in CVD risk factor measurement and management were recorded. In-depth interviews with GPs were conducted. Results Validation testing: The tool’s risk assessment algorithm correlated very highly with the independently programmed version in the separate statistics package (intraclass correlation coefficient 0.999). For management advice, there were only two cases of disagreement between the tool and the physician. Field test: GPs found 77% (153/200) of patient outputs easy to understand and agreed with screening and prescribing recommendations in 72% and 64% of outputs, respectively; 26% of patients had their CVD risk factor history updated; 73% had at least one CVD risk factor measured or tests ordered. For people assessed at high CVD risk (n = 82), 10% and 9%, respectively, had lipid-lowering and BP-lowering medications commenced or dose adjustments made, while 7% newly commenced anti-platelet medications. Three key qualitative findings emerged: (1) GPs found the tool enabled a systematic approach to care; (2) the tool greatly influenced CVD risk communication; (3) successful implementation into routine care would require integration with practice software, minimal data entry, regular revision with updated guidelines, and a self-auditing feature. There were no substantive differences in study findings for Aboriginal Medical Services GPs, and the tool was generally considered appropriate for use with Aboriginal patients. Conclusion A fully-integrated, self-populating, and potentially Internet-based CDS tool could contribute to improved global CVD risk management in Australian primary health care. The findings from this study will inform a large-scale trial intervention.

Effectiveness of fixed dose combination medication ('polypills') compared with usual care in patients with cardiovascular disease or at high risk : A prospective, individual patient data meta-analysis of 3140 patients in six countries

AIMS To conduct a prospective, individual participant data (IPD) meta-analysis of randomised controlled trials comparing a polypill-based approach with usual care in high risk individuals. METHODS AND RESULTS Three trials comparing polypill-based care with usual care in individuals with CVD or high calculated cardiovascular risk contributed IPD. Primary outcomes were self-reported adherence to combination therapy (anti-platelet, statin and ≥ two blood pressure (BP) lowering agents), and difference in mean systolic BP (SBP) and LDL-cholesterol at 12 months. Analyses used random effects models. Among 3140 patients from Australia, England, India, Ireland, New Zealand and The Netherlands (75% male, mean age 62 years), median follow-up was 15 months. At baseline, 84%, 87% and 61% respectively were taking a statin, anti-platelet agent and at least two BP lowering agents. At 12 months, compared to usual care, participants in the polypill arm had higher adherence to combination therapy (80% vs. 50%, RR 1.58; 95% CI, 1.32 to 1.90; p < 0.001), lower SBP (-2.5 mmHg; 95% CI, -4.5 to -0.4; p = 0.02) and lower LDL-cholesterol (-0.1 mmol/L; 95% CI, -0.2 to 0.0; p = 0.04). Baseline treatment levels were a major effect modifier for adherence and SBP (p-homog < 0.0001 and 0.02 respectively) with greatest improvements seen among those under-treated at baseline. CONCLUSIONS Polypill therapy significantly improved adherence, SBP and LDL-cholesterol in high risk patients compared with usual care, especially among those who were under-treated at baseline.

Effect of a computer-guided, quality improvement program for cardiovascular disease risk management in primary health care: the treatment of cardiovascular risk using electronic decision support cluster-randomized trial

Background— Despite effective treatments to reduce cardiovascular disease risk, their translation into practice is limited. Methods and Results— Using a parallel arm cluster-randomized 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 Islander 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 coprimary 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 settings, 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/TrialReview.aspx?id=336630. Australian New Zealand Clinical Trials Registry No. 12611000478910.

SMARTHealth India: Development and Field Evaluation of a Mobile Clinical Decision Support System for Cardiovascular Diseases in Rural India

Background Cardiovascular disease (CVD) is the major cause of premature death and disability in India and yet few people at risk of CVD are able to access best practice health care. Mobile health (mHealth) is a promising solution, but very few mHealth interventions have been subjected to robust evaluation in India. Objective The objectives were to develop a multifaceted, mobile clinical decision support system (CDSS) for CVD management and evaluate it for use by public nonphysician health care workers (NPHWs) and physicians in a rural Indian setting. Methods Plain language clinical rules were developed based on standard guidelines and programmed into a computer tablet app. The algorithm was validated and field-tested in 11 villages in Andhra Pradesh, involving 11 NPHWs and 3 primary health center (PHC) physicians. A mixed method evaluation was conducted comprising clinical and survey data and in-depth patient and staff interviews to understand barriers and enablers to the use of the system. Then this was thematically analyzed using NVivo 10. Results During validation of the algorithm, there was an initial agreement for 70% of the 42 calculated variables between the CDSS and SPSS software outputs. Discrepancies were identified and amendments were made until perfect agreement was achieved. During field testing, NPHWs and PHC physicians used the CDSS to screen 227 and 65 adults, respectively. The NPHWs identified 39% (88/227) of patients for referral with 78% (69/88) of these having a definite indication for blood pressure (BP)-lowering medication. However, only 35% (24/69) attended a clinic within 1 month of referral, with 42% (10/24) of these reporting continuing medications at 3-month follow-up. Physicians identified and recommended 17% (11/65) of patients for BP-lowering medications. Qualitative interviews identified 3 interrelated interview themes: (1) the CDSS had potential to change prevailing health care models, (2) task-shifting to NPHWs was the central driver of change, and (3) despite high acceptability by end users, actual transformation was substantially limited by system-level barriers such as patient access to doctors and medicines. Conclusions A tablet-based CDSS implemented within primary health care systems has the potential to help improve CVD outcomes in India. However, system-level barriers to accessing medical care limit its full impact. These barriers need to be actively addressed for clinical innovations to be successful. Trial Registration Clinical Trials Registry of India: CTRI/2013/06/003753; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=6259&EncHid=51761.70513&userName=CTRI/2013/06/003753 (Archived by WebCite at http://www.webcitation.org/6UBDlrEuq).

Rationale and design of the Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP) study: a randomised controlled trial of a polypill-based strategy amongst indigenous and non indigenous people at high cardiovascular risk.

BackgroundThe Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP) Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents) amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels.Methods/DesignThe study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations.DiscussionThe Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated.Trial RegistrationThis trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.

Quarter-dose quadruple combination therapy for initial treatment of hypertension: placebo-controlled, crossover, randomised trial and systematic review.

BACKGROUND Globally, most patients with hypertension are treated with monotherapy, and control rates are poor because monotherapy only reduces blood pressure by around 9/5 mm Hg on average. There is a pressing need for blood pressure-control strategies with improved efficacy and tolerability. We aimed to assess whether ultra-low-dose combination therapy could meet these needs. METHODS We did a randomised, placebo-controlled, double-blind, crossover trial of a quadpill-a single capsule containing four blood pressure-lowering drugs each at quarter-dose (irbesartan 37·5 mg, amlodipine 1·25 mg, hydrochlorothiazide 6·25 mg, and atenolol 12·5 mg). Participants with untreated hypertension were enrolled from four centres in the community of western Sydney, NSW, Australia, mainly by general practitioners. Participants were randomly allocated by computer to either the quadpill or matching placebo for 4 weeks; this treatment was followed by a 2-week washout, then the other study treatment was administered for 4 weeks. Study staff and participants were unaware of treatment allocations, and masking was achieved by use of identical opaque capsules. The primary outcome was placebo-corrected 24-h systolic ambulatory blood pressure reduction after 4 weeks and analysis was by intention to treat. We also did a systematic review of trials evaluating the efficacy and safety of quarter-standard-dose blood pressure-lowering therapy against placebo. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12614001057673. The trial ended after 1 year and this report presents the final analysis. FINDINGS Between November, 2014, and December, 2015, 55 patients were screened for our randomised trial, of whom 21 underwent randomisation. Mean age of participants was 58 years (SD 11) and mean baseline office and 24-h systolic and diastolic blood pressure levels were 154 (14)/90 (11) mm Hg and 140 (9)/87 (8) mm Hg, respectively. One individual declined participation after randomisation and two patients dropped out for administrative reasons. The placebo-corrected reduction in systolic 24-h blood pressure with the quadpill was 19 mm Hg (95% CI 14-23), and office blood pressure was reduced by 22/13 mm Hg (p<0·0001). During quadpill treatment, 18 (100%) of 18 participants achieved office blood pressure less than 140/90 mm Hg, compared with six (33%) of 18 during placebo treatment (p=0·0013). There were no serious adverse events and all patients reported that the quadpill was easy to swallow. Our systematic review identified 36 trials (n=4721 participants) of one drug at quarter-dose and six trials (n=312) of two drugs at quarter-dose, against placebo. The pooled placebo-corrected blood pressure-lowering effects were 5/2 mm Hg and 7/5 mm Hg, respectively (both p<0·0001), and there were no side-effects from either regimen. INTERPRETATION The findings of our small trial in the context of previous randomised evidence suggest that the benefits of quarter-dose therapy could be additive across classes and might confer a clinically important reduction in blood pressure. Further examination of the quadpill concept is needed to investigate effectiveness against usual treatment options and longer term tolerability. FUNDING National Heart Foundation, Australia; University of Sydney; and National Health and Medical Research Council of Australia.