A measles IgM rapid diagnostic test to address challenges with national measles surveillance and response in Malaysia.

INTRODUCTION: A lateral flow rapid diagnostic test (RDT) enables detection of measles specific immunoglobulin M (IgM) antibody in serum, capillary blood, and oral fluid with accuracy consistent with enzyme immunoassay (EIA). The objectives of the study were: 1) to assess measles RDT inter-reader agreement between two clinic staff; 2) to assess the sensitivity and specificity of the measles RDT relative to standard surveillance testing in a low transmission setting; 3) to evaluate the knowledge, attitudes, and practices of staff in clinics using the RDT; and 4) to assess the impact of RDT testing on the measles public health response in Malaysia. MATERIALS AND METHODS: The clinic-based prospective evaluation included all suspected measles cases captured by routine measles surveillance at 34 purposely selected clinics in 15 health districts in Malaysia between September 2019 and June 2020, following day-long regional trainings on RDT use. Following informed consent, four specimens were collected from each suspected case, including those routinely collected for standard surveillance [serum for EIA and throat swabs for quantitative reverse transcriptase polymerase chain reaction (RT-qPCR)] together with capillary blood and oral fluid tested with RDTs during the study. RDT impact was evaluated by comparing the rapidity of measles public health response between the pre-RDT implementation (December 2018 to August 2019) and RDT implementation periods (September 2019 to June 2020). To assess knowledge, attitudes, and practices of RDT use, staff involved in the public health management of measles at the selected sites were surveyed. RESULTS: Among the 436 suspect cases, agreement of direct visual readings of measles RDT devices between two health clinic staff was 99% for capillary blood (k = 0.94) and 97% for oral fluid (k = 0.90) specimens. Of the total, 45 (10%) were positive by measles IgM EIA (n = 44, including five also positive by RT-qPCR) or RT-qPCR only (n = 1), and 38 were positive by RDT (using either capillary blood or oral fluid). Using measles IgM EIA or RT-qPCR as reference, RDT sensitivity using capillary blood was 43% (95% CI: 30%-58%) and specificity was 98% (95% CI: 96%-99%); using oral fluid, sensitivity (26%, 95% CI: 15%-40%) and specificity (97%, 95% CI: 94%-98%) were lower. Nine months after training, RDT knowledge was high among staff involved with the public health management of measles (average quiz score of 80%) and was highest among those who received formal training (88%), followed by those trained during supervisory visits (83%). During the RDT implementation period, the number of days from case confirmation until initiation of public response decreased by about 5 days. CONCLUSION: The measles IgM RDT shows >95% inter-reader agreement, high retention of RDT knowledge, and a more rapid public health response. However, despite ≥95% RDT specificity using capillary blood or oral fluid, RDT sensitivity was <45%. Higher-powered studies using highly specific IgM assays and systematic RT-qPCR for case confirmation are needed to establish the role of RDT in measles elimination settings.

Assessing the impact of simplified HCV care on linkage to care amongst high-risk patients at primary healthcare clinics in Malaysia: a prospective observational study.

INTRODUCTION: To achieve the elimination of hepatitis C virus (HCV), substantial scale-up in access to testing and treatment is needed. This will require innovation and simplification of the care pathway, through decentralisation of testing and treatment to primary care settings and task-shifting to non-specialists. The objective of this study was to evaluate the feasibility and effectiveness of decentralisation of HCV testing and treatment using rapid diagnostic tests (RDTs) in primary healthcare clinics (PHCs) among high-risk populations, with referral of seropositive patients for confirmatory viral load testing and treatment. METHODS: This observational study was conducted between December 2018 and October 2019 at 25 PHCs in three regions in Malaysia. Each PHC was linked to one or more hospitals, for referral of seropositive participants for confirmatory testing and pretreatment evaluation. Treatment was provided in PHCs for non-cirrhotic patients and at hospitals for cirrhotic patients. RESULTS: During the study period, a total of 15 366 adults were screened at the 25 PHCs, using RDTs for HCV antibodies. Of the 2020 (13.2%) HCV antibody-positive participants, 1481/2020 (73.3%) had a confirmatory viral load test, 1241/1481 (83.8%) were HCV RNA-positive, 991/1241 (79.9%) completed pretreatment assessment, 632/991 (63.8%) initiated treatment, 518/632 (82.0%) completed treatment, 352/518 (68.0%) were eligible for a sustained virological response (SVR) cure assessment, 209/352 (59.4%) had an SVR cure assessment, and SVR was achieved in 202/209 (96.7%) patients. A significantly higher proportion of patients referred to PHCs initiated treatment compared with those who had treatment initiated at hospitals (71.0% vs 48.8%, p<0.001). CONCLUSIONS: This study demonstrated the effectiveness and feasibility of a simplified decentralised HCV testing and treatment model in primary healthcare settings, targeting high-risk groups in Malaysia. There were good outcomes across most steps of the cascade of care when treatment was provided at PHCs compared with hospitals.

Clinic and patient variation in intermediate clinical outcomes for type 2 diabetes: a multilevel analysis.

BACKGROUND: Variation at different levels of diabetes care has not yet been quantified for low- and middle-income countries. Understanding this variation and its magnitude is important to guide policy makers in designing effective interventions. This study aims to quantify the variation in the control of glycated haemoglobin (HbA1c), systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-C) for type 2 diabetes (T2D) patients at the clinic and patient level and determine patient and clinic factors associated with control of these outcomes in T2D. METHODS: This is a cross-sectional study within the baseline data from the impact evaluation of the Enhanced Primary Health Care (EnPHC) intervention on 40 public clinics in Malaysia. Patients aged 30 and above, diagnosed with T2D, had a clinic visit for T2D between 01 Nov 2016 and 30 April 2017 and had at least one HbA1c, SBP and LDL-C measurement within 1 year from the date of visit were included for analysis. Multilevel linear regression adjusting for patient and clinic characteristics was used to quantify variation at the clinic and patient levels for each outcome. RESULTS: Variation in intermediate clinical outcomes in T2D lies predominantly (93% and above) at the patient level. The strongest predictors for poor disease control in T2D were the proxy measures for disease severity including duration of diabetes, presence of microvascular complications, being on insulin therapy and number of antihypertensives. Among the three outcomes, HbA1c and LDL-C results provide greatest opportunity for improvement. CONCLUSION: Clinic variation in HbA1c, SBP and LDL-C accounts for a small percentage from total variation. Findings from this study suggest that standardised interventions need to be applied across all clinics, with a focus on customizing therapy based on individual patient characteristics.

Empanelment: A foundational component of primary health care.

Empanelment is a foundational strategy for building or improving primary health care systems and a critical pathway for achieving effective universal health coverage. However, there is little international guidance for defining empanelment or understanding how to implement empanelment systems in low- and middle-income countries. To fill this gap, a multi-country collaborative within the Joint Learning Network for Universal Health Coverage developed this empanelment overview, proposing a people-centered definition of empanelment that reflects the responsibility to proactively deliver primary care services to all individuals in a target population. This document, building on existing literature on empanelment and representing input from 10 countries, establishes standard concepts of empanelment and describes why and how empanelment is used. Finally, it identifies key domains that may influence effective empanelment and that must be considered in deciding how empanelment can be implemented. This document is designed to be a useful resource for health policymakers, planners and decision-makers in ministries of health, as well as front line providers of primary care service delivery who are working to ensure quality people-centered primary care to everyone everywhere.

Postnatal depression and intimate partner violence: a nationwide clinic-based cross-sectional study in Malaysia.

INTRODUCTION: An estimated 13% of women in the postnatal period suffer from postnatal depression (PND) worldwide. In addition to underprivileged women, women who are exposed to violence are at higher risk of PND. This study aimed to investigate the relationship between intimate partner violence (IPV) and PND in Malaysia. METHODS: This survey was conducted as a nationwide cross-sectional study using a cluster sampling design. Probable PND was assessed using a self-administered Edinburgh Postnatal Depression Scale (EPDS). Demographic profiles and IPV were assessed using a locally validated WHO Multicountry Study on Women's Health and Life Events Questionnaire that was administered in a face-to-face interview. An EPDS total score of 12 or more and/or a positive tendency to self-harm were used to define PND. RESULTS: Out of 6669 women, 5727 respondents were successfully interviewed with a response rate of 85.9%. The prevalence of probable PND was 4.4% (95% CI 2.9 to 6.7). The overall prevalence of IPV was 4.9% (95% CI 3.8 to 6.4). Among the women in this group, 3.7% (95% CI 2.7 to 5.0), 2.6% (95% CI 1.9 to 3.5) and 1.2% (95% CI 0.9 to 1.7) experienced emotional, physical and sexual violence, respectively. Logistic regression analysis revealed that women who were exposed to IPV were at 2.3 times the risk for probable PND, with an adjusted OR (aOR) of 2.34 (95% CI 1.12 to 4.87). Other factors for PND were reported emotional violence (aOR 3.79, 95% CI 1.93 to 7.45), unplanned pregnancy (aOR 3.32, 95% CI 2.35 to 4.69), lack of family support during confinement (aOR 1.79, 95% CI 1.12 to 2.87), partner's use of alcohol (aOR 1.59, 95% CI 1.07 to 2.35) or being from a household with a low income (aOR 2.99; 95% CI 1.63 to 5.49). CONCLUSIONS: Exposure to IPV was significantly associated with probable PND. Healthcare personnel should be trained to detect and manage both problems. An appropriate referral system and support should be made available.

Evaluation of awareness & utilisation of clinical practise guideline for management of adult Dengue infection among Malaysia doctors.

Clinical Practice Guideline (CPG) provides evidence-based guidance for the management of Dengue Infection in adult patients. A cross sectional study was conducted to evaluate awareness and utilization of CPG among doctors in public or private hospitals and clinics in Malaysia. Doctors practicing only at hospital Medical and Emergency Departments were included, while private specialist clinics were excluded in this study. A multistage proportionate random sampling according to region (Central, Northern, Southern, Eastern, Sabah and Sarawak) was performed to select study participants. The overall response rate was 74% (84% for public hospitals, 82% for private hospitals, 70% for public clinics, and 64% for private clinics). The CPG Awareness and Utilization Feedback Form were used to determine the percentage in the study. The total numbers of respondent were 634 with response rate of 74%. The mean lengths of service of the respondent were 13.98 (11.55).A higher percentages of doctors from public facilities (99%) were aware of the CPG compared to those in private facilities (84%). The percentage of doctors utilising the CPG were also higher (98%) in public facilities compared to private facilities (86%). The percentage of Medical Officer in private facilities that utilizing the CPG were 84% compares to Medical Officer in public facilities 98%. The high percentage of doctors using the CPG in both public (97%) and private (94%) hospitals were also observed. However, only 69% of doctors in private clinics utilised the CPG compared to doctors in public clinics (98%). Doctors in both public and private facilities were aware of the dengue CPG. However, most doctors in private clinic were less likely to utilise the CPG. Therefore, there is a need to increase the level of CPG utilisation especially in private clinics.

Addressing non-communicable diseases in Malaysia: an integrative process of systems and community.

The prevalence of non-communicable diseases (NCDs) and NCD risk factors in Malaysia have risen substantially in the last two decades. The Malaysian Ministry of Health responded by implementing, "The National Strategic Plan for Non-Communicable Diseases (NSP-NCD) 2010-2014", and the "NCD Prevention 1Malaysia" (NCDP-1M) programme. This paper outlines the primary health system context in which the NCDP-1M is framed. We also discuss the role of community in facilitating the integration of this programme, and outline some of the key challenges in addressing the sustainability of the plan over the next few years. The paper thus provides an analysis of an integration of a programme that involved a multi-sectoral approach with the view to contributing to a broader discourse on the development of responsive health systems.