Optimizing cardiovascular disease risk screening in a low-resource setting: cost-effectiveness of program modifications in Sri Lanka modelled with nationally representative survey data.

BACKGROUND: While screening for cardiovascular disease (CVD) risk can help low-resource health systems deliver low-cost, effective prevention, evidence is needed to adapt international screening guidelines for maximal impact in local settings. We aimed to establish how the cost-effectiveness of CVD risk screening in Sri Lanka varies with who is screened, how risk is assessed, and what thresholds are used for prescription of medicines. METHODS: We used data for people aged 35 years and over from a 2018/19 nationally representative survey in Sri Lanka. We modelled the costs and quality adjusted life years (QALYs) for 128 screening program scenarios distinguished by a) age group screened, b) risk tool used, c) definition of high CVD risk, d) blood pressure threshold for treatment of high-risks, and e) prescription of statins to all diabetics. We used the current program as the base case. We used a Markov model of a one-year screening program with a lifetime horizon and a public health system perspective. RESULTS: Scenarios that included the WHO-2019 office-based risk tool dominated most others. Switching to this tool and raising the age threshold for screening from 35 to 40 years gave an incremental cost-effectiveness ratio (ICER) of $113/QALY. Lowering the CVD high-risk threshold from 20 to 10% and prescribing antihypertensives at a lower threshold to diabetics and people at high risk of CVD gave an ICER of $1,159/QALY. The findings were sensitive to allowing for disutility of daily medication. CONCLUSIONS: In Sri Lanka, CVD risk screening scenarios that used the WHO-2019 office-based risk tool, screened people above the age of 40, and lowered risk and blood pressure thresholds would likely be cost-effective, generating an additional QALY at less than half a GDP per capita.

The Prevalence and Epidemiological Features of Ischaemic Heart Disease in Sri Lanka.

Background: There is limited evidence on the prevalence of ischaemic heart disease (IHD) and its association with risk factors and socioeconomic status (SES) in low- and middle-income countries (LMICs). Given the relatively high levels of access to healthcare in Sri Lanka, the association of IHD with SES may be different from that observed in other LMICs. Objectives: To estimate the prevalence of IHD in Sri Lanka, determine its associated risk factors and its association with SES. Methods: We analysed data from 6,513 adults aged ≥18 years examined in the 2018/19 Sri Lanka Health and Ageing Study. We used the Rose angina questionnaire to classify participants as having angina (Angina+) and used self-report or medical records to identify participants with a history of IHD (History+). The association of Angina+ and History+ with age, ethnicity, sector of residence, education level, household SES wealth quintile, area SES wealth quintile, hypertension, diabetes, smoking, total cholesterol, cholesterol-to-HDL ratio, waist-to-hip ratio and body mass index were analysed in unadjusted and adjusted models. Additional analyses were performed to investigate sensitivity to correction for missing data and to benchmark estimates against evidence from other studies. Conclusions: We estimated prevalence of History+ of 3.9% (95% CI 3.3%-4.4%) and Angina+ of 3.0% (95% CI 2.4%-3.5%) in adults aged 18 years and over. The prevalence of Angina+ was higher in women than men (3.9% vs. 1.9%, p < 0.001) whilst prevalence of History+ was lower (3.8% vs. 4.0%, p = 0.8), which may suggest a higher rate of undiagnosed IHD in women. A history of IHD was strongly associated with age, hypertension and diabetes status even after adjusting for sociodemographic factors. Though the prevalence of History+ was higher in the most developed area SES tertile and urban areas, History+ was also associated with less education but not household SES, consistent with patterns emerging from other LMICs.

Factors impacting sustained coverage in the context of donor transitions: experience from Sri Lanka.

Although not reliant on donor funding for health, the external assistance that Sri Lanka receives contributes to the improvement of the health system and health outcomes. In this study, we evaluated transition experiences of the expanded programme on immunization (EPI) that received Gavi funding to expand the vaccine portfolio and the Anti-Malaria Campaign (AMC) that received funding from the Global Fund for AIDS, Tuberculosis and Malaria to scale-up interventions to target and achieve malaria elimination. We assessed if EPI and AMC programmes were able to sustain coverage of previously donor-funded interventions post-transition and explain the facilitators and barriers that contribute to this. We used a mixed methods approach using quantitative data to assess coverage indicators and the financing mix of the health programmes and qualitative analysis guided by a framework informed by the Walt and Gilson policy triangle that brought together document review and in-depth interviews to identify facilitators and barriers to transition success. The EPI programme showed sustained coverage of Gavi-funded vaccines post-transition and the funding gap was bridged by mobilizing domestic financing facilitated by the Gavi co-financing mechanism, full integration within existing service delivery structures, well-established and favourable pharmaceutical procurement processes for the public sector and stewardship and financial advocacy by technically competent managers. Although the absence of indigenous cases of malaria since 2012 suggests overall programme success, the AMC showed mixed transition success in relation to its different programme components. Donor-supported programme components requiring mobilization of operational expenses, facilitated by early financial planning, were successfully transitioned (e.g. entomological and parasitological surveillance) given COVID-19-related constraints. Other key programme components, such as research, training, education and awareness that are dependent on non-operational expenses are lagging behind. Additionally, concerns of AMC's future financial sustainability within the current structure remain in the context of low malaria burden.

Financing malaria.

The faltering of progress towards malaria elimination follows a plateauing in international financing since 2010. Despite calls for increased international financing, this will be hard to achieve. Both developed country donors and developing countries with malaria face severe fiscal constraints in expanding malaria funding in the next few years. Simply exhorting countries to spend more is unlikely to be successful, just as the Abuja declaration was not, and the developing countries with most malaria burden suffer from weaker economic growth and less capacity to increase domestic financing. One major prospect for substantial new financing is China, but this may depend on established funders yielding influence in the global financing architecture to China and other emerging economies. This argues for greater emphasis on spending available financing better, but improving the impact of international funding is not straightforward. It is associated with significant transaction costs for recipients, impairs the ability of the WHO to coordinate global efforts, and may pressure recipient countries to focus more on commodities and easy wins instead of investing in health systems and management capacity. While more should be done to mitigate these perverse effects, much of this is the unavoidable price of such generosity and the inevitable need for accountability to funders. Ultimately, countries must do more with their own spending, which is often under-counted, but usually far exceeds the international contribution. The experience of Sri Lanka, El Salvador, and China-three countries that eliminated malaria-provides two pointers. First, achieving early and widespread treatment of most malaria cases, which is not the case in much of high burden Africa, may be critical to sustain accelerated elimination. Second, such coverage requires health systems that prioritize access for all services and conditions. Public opinion surveys indicate that this is consistent with what much of the affected population wants, prioritizes, and is willing to finance through higher taxes, which points to weaknesses in accountability of policy to people. International funders could do better to heed what affected populations want and let local partners be responsive to their own public's preferences.

Cost-Effectiveness and Distributional Impact of Opportunistic Screening for People at High-Risk of Cardiovascular Disease in Sri Lanka: A Modelling Study.

Background: While hypertension, diabetes, hypercholesterolemia and high-risk of cardiovascular disease can be easily diagnosed and treated with cost-effective medicines, a large proportion of people remain undiagnosed. We assessed the potential effectiveness, cost, and distributional impact of opportunistically screening for these chronic conditions at outpatient patient departments in Sri Lanka. Methods: We used nationally representative data on biomarkers and healthcare utilization in 2019 to model the screening of people aged 40+ without preexisting CVD and without a reported diagnosis of hypertension, diabetes, or hypercholesterolemia. We modelled an intensive one month program that would screen a proportion of those making an outpatient visit to a public or private clinic and follow-up a proportion of those screened to confirm diagnoses. We also modelled a less intensive one year program. The main outcomes were the new diagnoses of any of the chronic conditions. Program costs were calculated and the socioeconomic distributions of individuals screened, new cases diagnosed, and treatments delivered were estimated. Sensitivity analyses varied the probability of screening and follow-up. Results: Using data on 2,380 survey participants who met the inclusion criteria, we estimated that the one month program would diagnose 8.2% (95% CI: 6.8, 9.6) of those with a chronic condition who would remain undiagnosed without the program. The one year program would diagnose 26.9% (95% CI: 26.5, 27.4) of the otherwise undiagnosed and would have a cost per person newly diagnosed of USD 6.82 (95% CI: 6.61, 7.03) in the public sector and USD 16.92 (95% CI: 16.37, 17.47) in the private sector. New diagnoses would be evenly distributed over the socioeconomic distribution, with public (private) clinics diagnosing a higher proportion of poorer (richer) individuals. Both programs would reduce underdiagnosis among males relative to females. Conclusions: Opportunistic screening for cardiovascular diseases at outpatient clinics in Sri Lanka could be cost-effective and equitable.

Prevalence and Associations of Hypertension in Sri Lankan Adults: Estimates from the SLHAS 2018-19 Survey Using JNC7 and ACC/AHA 2017 Guidelines.

Background: Sri Lanka lacks robust estimates of hypertension (HTN) prevalence owing to few national studies, hindering optimization of control strategies. Evidence on how the revised 2017 American College of Cardiology/American Heart Association (ACC/AHA) HTN definition affects prevalence in low- and middle-income countries (LMICs) is also limited. Objectives: To make robust estimates of HTN prevalence in the Sri Lankan adult population, and to assess impact of the ACC/AHA 2017 definitions. Methods: Data were sourced from the 2018-2019 first wave of the Sri Lanka Health and Ageing Study (SLHAS), a nationally representative longitudinal study of the noninstitutionalized adult population. After excluding those with missing data and aged <18 years, 6,342 participants (95.1%) were included in the analysis. HTN was defined using either the traditional threshold of systolic BP (SBP) ≥140 mmHg or a diastolic BP (DBP) ≥90 mmHg, or the ACC/AHA 2017 threshold of SBP ≥130 mmHg or DBP ≥80 mmHg, or if taking antihypertensive medication. Results: Estimated prevalence of HTN in all Sri Lankan adults was 28.2% using the traditional definition, and it doubled to 51.3% when applying the ACC/AHA 2017 definition. Of those classified as hypertensive according to the older and ACC/AHA 2017 definitions, 53.4% and 31.2%, respectively, were previously diagnosed. Of the 23.2% of adults reclassified as hypertensive by the ACC/AHA 2017 definition, 16.6% had a history of CVD or diabetes. Increased prevalence was associated with urban residence, socioeconomic status, obesity, and Muslim ethnicity. Prevalence increased with age, but the increase was steeper in women from their 30s. Conclusions: Nearly one in three adult Sri Lankans are hypertensive, requiring antihypertensive treatment. Applying the ACC/AHA 2017 definitions almost doubles numbers, but many of those reclassified would require treatment under recent WHO guidelines. Study findings also suggest that design effects in HTN surveys may be higher than usually assumed.

The iHealth-T2D study: a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes-a statistical analysis plan.

BACKGROUND: South Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for the prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care. METHODS: The iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 sites across India, Pakistan, Sri Lanka and the UK. A total of 3682 South Asian men and women with age between 40 and 70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥ 95 cm in Sri Lanka or ≥ 100 cm in India, Pakistan and the UK) and/or prediabetes (HbA1c ≥ 6.0%)] were included in the trial. Here, we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after 3 years of follow-up after enrolment to the study and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after 1 and 3 years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance. DISCUSSION: The iHealth-T2D trial will provide evidence of whether an intensive family-based lifestyle modification programme for South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP. ETHICS AND DISSEMINATION: The trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations. TRIAL REGISTRATION: EudraCT 2016-001,350-18 . Registered on 14 April 2016. CLINICALTRIALS: gov NCT02949739 . Registered on 31 October 2016.

The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial.

BACKGROUND: People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalable across settings. HYPOTHESIS: Compared to usual care, the risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12-month lifestyle modification programme delivered by community health workers. DESIGN: Cluster randomised clinical trial (1:1 allocation to intervention or usual care), carried out in India, Pakistan, Sri Lanka and the UK, with 30 sites per country (120 sites total). Target recruitment 3600 (30 participants per site) with annual follow-up for 3 years. ENTRY CRITERIA: South Asian, men or women, age 40-70 years with (i) central obesity (waist circumference ≥ 100 cm in India and Pakistan; ≥90 cm in Sri Lanka) and/or (ii) prediabetes (HbA1c 6.0-6.4% inclusive). EXCLUSION CRITERIA: known type 1 or 2 diabetes, normal or underweight (body mass index < 22 kg/m2); pregnant or planning pregnancy; unstable residence or planning to leave the area; and serious illness. ENDPOINTS: The primary endpoint is new-onset T2D at 3 years, defined as (i) HbA1c ≥ 6.5% or (ii) physician diagnosis and on treatment for T2D. Secondary endpoints at 1 and 3 years are the following: (i) physical measures: waist circumference, weight and blood pressure; (ii) lifestyle measures: smoking status, alcohol intake, physical activity and dietary intake; (iii) biochemical measures: fasting glucose, insulin and lipids (total and HDL cholesterol, triglycerides); and (iv) treatment compliance. INTERVENTION: Lifestyle intervention (60 sites) or usual care (60 sites). Lifestyle intervention was delivered by a trained community health worker over 12 months (5 one-one sessions, 4 group sessions, 13 telephone sessions) with the goal of the participants achieving a 7% reduction in body mass index and a 10-cm reduction in waist circumference through (i) improved diet and (ii) increased physical activity. Usual care comprised a single 30-min session of lifestyle modification advice from the community health worker. RESULTS: We screened 33,212 people for inclusion into the study. We identified 10,930 people who met study entry criteria, amongst whom 3682 agreed to take part in the intervention. Study participants are 49.2% female and aged 52.8 (SD 8.2) years. Clinical characteristics are well balanced between intervention and usual care sites. More than 90% of follow-up visits are scheduled to be complete in December 2020. Based on the follow-up to end 2019, the observed incidence of T2D in the study population is in line with expectations (6.1% per annum). CONCLUSION: The iHealth-T2D study will advance understanding of strategies for the prevention of diabetes amongst South Asians, use approaches for screening and intervention that are adapted for low-resource settings. Our study will thus inform the implementation of strategies for improving the health and well-being of this major global ethnic group. IRB APPROVAL: 16/WM/0171 TRIAL REGISTRATION: EudraCT 2016-001350-18 . Registered on 14 April 2016. ClinicalTrials.gov NCT02949739 . Registered on 31 October 2016, First posted on 31/10/2016.

The quality of care in outpatient primary care in public and private sectors in Malaysia.

In Malaysia, first-contact, primary care is provided by parallel public and private sectors, which are completely separate in organization, financing and governance. As the country considers new approaches to financing, including using public schemes to pay for private care, it is crucial to examine the quality of clinical care in the two sectors to make informed decisions on public policy. This study intends to measure and compare the quality of clinical care between public and private primary care services in Malaysia and, to the extent possible, assess quality with the developed economies that Malaysia aspires to join. We carried out a retrospective analysis of the National Medical Care Survey 2014, a nationally representative survey of doctor-patient encounters in Malaysia. We assessed clinical quality for 27 587 patient encounters using data on 66 internationally validated quality indicators. Aggregate scores were constructed, and comparisons made between the public and private sectors. Overall, patients received the recommended care just over half the time (56.5%). The public sector performed better than the private sector, especially in the treatment of acute conditions, chronic conditions and in prescribing practices. Both sectors performed poorly in the indicators that are most resource intensive, suggesting that resource constraints limit overall quality. A comparison with 2003 data from the USA, suggests that performance in Malaysia was similar to that a decade earlier in the USA for common indicators. The public sector showed better performance in clinical care than the private sector, contrary to common perceptions in Malaysia and despite providing worse consumer quality. The overall quality of outpatient clinical care in Malaysia appears comparable to other developed countries, yet there are gaps in quality, such as in the management of hypertension, which should be tackled to improve overall health outcomes.

Improving Health Care Coverage, Equity, And Financial Protection Through A Hybrid System: Malaysia's Experience.

Malaysia has made substantial progress in providing access to health care for its citizens and has been more successful than many other countries that are better known as models of universal health coverage. Malaysia's health care coverage and outcomes are now approaching levels achieved by member nations of the Organization for Economic Cooperation and Development. Malaysia's results are achieved through a mix of public services (funded by general revenues) and parallel private services (predominantly financed by out-of-pocket spending). We examined the distributional aspects of health financing and delivery and assessed financial protection in Malaysia's hybrid system. We found that this system has been effective for many decades in equalizing health care use and providing protection from financial risk, despite modest government spending. Our results also indicate that a high out-of-pocket share of total financing is not a consistent proxy for financial protection; greater attention is needed to the absolute level of out-of-pocket spending. Malaysia's hybrid health system presents continuing unresolved policy challenges, but the country's experience nonetheless provides lessons for other emerging economies that want to expand access to health care despite limited fiscal resources.

The quality of outpatient primary care in public and private sectors in Sri Lanka--how well do patient perceptions match reality and what are the implications?

OBJECTIVE: To compare the quality of clinical care and patient satisfaction in public and private outpatient primary care services in Sri Lanka. METHODS: A prospective, cross-sectional comparison was done by direct observation of patient encounters and exit interviews of outpatients in 10 public hospital general outpatient clinics and 66 private practitioner clinics in three districts of Sri Lanka. A total of 1027 public sector patients and 944 private sector patients were surveyed. Data were collected for 39 quality indicators covering diarrhoea, cough, hypertension, diabetes, asthma, upper respiratory tract infections (URTI) and five other conditions, along with prescribing indicators. The exit interviews collected data for 10 patient satisfaction indicators. RESULTS: The public sector performed better for some conditions (diarrhoea, cough and asthma) and the private sector performed better for others (hypertension, diabetes, URTI and tonsillitis). Overall quality was similar between the sectors in the domains of history taking, examination and investigations and management, but the private sector performed much better on patient education (57 vs 12%). Overall patient satisfaction was high in both sectors (98%), although the private sector performed much better in interpersonal satisfaction (94 vs 84%) and system-related indicators (95 vs 84%). Comparisons with studies from other countries suggest that both sectors perform considerably better than India, and similarly in many indicators to high-income countries. CONCLUSIONS: Quality of outpatient primary care in Sri Lanka is generally high for a lower-middle income developing country. The public and private sectors perform similarly, except that private sector patients have longer consultations, are more likely to receive education and advice, and obtain better interpersonal satisfaction. The public system, with its limited funding, is able to deliver care in diagnosis and management that is similar to the private sector, while private sector patients, who spend more on their healthcare receive better quality care in non-clinical areas.

Quality of inpatient care in public and private hospitals in Sri Lanka.

OBJECTIVE: To compare the quality of inpatient clinical care in public and private hospitals in Sri Lanka. METHODS: A retrospective, cross-sectional comparison was done of inpatient quality, in a sample of 11 public and 10 private hospitals in three of 25 districts. Data were collected for 55 quality indicators from medical records of 2523 public and 1815 private inpatient admissions. These covered treatment of asthma, acute myocardial infarction (AMI), childbirth and five other conditions, along with outcome indicators, and medicine prescribing indicators. RESULTS: Overall quality scores were better in the public sector than the private sector (77 vs 69%). Performance was similar for management of AMI and childbirth and somewhat better in the private sector for management of asthma. The public sector performed better in those indicators that are not constrained by resources (94 vs 81%), but worse in indicators that are highly resource intensive (10 vs 31%). Quality was comparable in assessment and investigation, but the public sector performed better in treatment and management (70 vs 62%) and drug prescribing (68 vs 60%), and modestly worse in terms of outcomes (92 vs 97%). CONCLUSIONS: For a range of indicators where comparisons were possible, quality of inpatient clinical care in Sri Lanka was comparable to levels reported from upper-middle income Asian countries, and often approaches that in developed countries, although the findings cannot be generalized. Quality in the public sector is better than in the private sector in many areas, despite spending being substantially less. Quality in public hospitals is resource constrained, and needs greater government investment for improvement, but when resource limitations are not critical, the public sector appears able to deliver equal or better quality than the private sector. Overall similarities in quality between the two sectors suggest the importance of physician training and other factors.

Catastrophic payments for health care in Asia.

Out-of-pocket (OOP) payments are the principal means of financing health care throughout much of Asia. We estimate the magnitude and distribution of OOP payments for health care in fourteen countries and territories accounting for 81% of the Asian population. We focus on payments that are catastrophic, in the sense of severely disrupting household living standards, and approximate such payments by those absorbing a large fraction of household resources. Bangladesh, China, India, Nepal and Vietnam rely most heavily on OOP financing and have the highest incidence of catastrophic payments. Sri Lanka, Thailand and Malaysia stand out as low to middle income countries that have constrained both the OOP share of health financing and the catastrophic impact of direct payments. In most low/middle-income countries, the better-off are more likely to spend a large fraction of total household resources on health care. This may reflect the inability of the poorest of the poor to divert resources from other basic needs and possibly the protection of the poor from user charges offered in some countries. But in China, Kyrgyz and Vietnam, where there are no exemptions of the poor from charges, they are as, or even more, likely to incur catastrophic payments.