Thrombocytopenia and venous thromboembolic events after BNT162b2, CoronaVac, ChAdOx1 vaccines and SARS-CoV-2 infection: a self-controlled case series study.

This study assessed the association between COVID-19 vaccines, SARS-CoV-2 infection and the risk of thrombocytopenia and venous thromboembolism (VTE). This self-controlled case series study used hospital records between 1st February 2021 and 28th February 2022 linked to the national immunisation registry and COVID-19 surveillance data in Malaysia. Conditional Poisson regression was used to estimate incidence rate ratios (IRR) of events in the risk period (day 1-21 post-exposure) relative to control period with the corresponding 95% confidence interval (CI) adjusted for calendar period. We found no significant increased risk of thrombocytopenia in 1-21 days following BNT162b2, CoronaVac and ChAdOx1 vaccines while the risk was increased following SARS-CoV-2 infection (IRR 15.52, 95% CI 13.38-18.00). Similarly, vaccination with BNT162b2, CoronaVac, or ChAdOx1 was not associated with an increased risk of VTE during the 1-21 days risk period. SARS-CoV-2 infection was associated with increased risk of VTE (IRR 39.84, 95% CI 27.45-32.44). Our findings showed low event rates of thrombocytopenia and VTE following booster vaccination with comparable safety profiles between those who received homologous and heterologous booster combinations. Our findings showed the risk of thrombocytopenia and VTE was not increased after COVID-19 vaccination while the risks were substantially higher after SARS-CoV-2 infection.

Myocarditis/pericarditis following vaccination with BNT162b2, CoronaVac, and ChAdOx1 among adolescent and adult in Malaysia.

This study evaluates 21-day risk of myocarditis/pericarditis following COVID-19 vaccination among those aged 12 years and older in Malaysia. We used data from nationwide COVID-19 vaccine registry linked to hospital episode database to identify individuals vaccinated with BNT162b2, CoronaVac, or ChAdOx1 and hospitalised for myocarditis/pericarditis between 1 February 2021 and 28 February 2022. There were 87 myocarditis/pericarditis cases identified within 1-21 days after vaccination. Most cases were reported following BNT16262 vaccination (77.0%) with absolute risk of 0.33 cases/100,000 vaccinated persons or 1.73 per million doses administered. Highest risk was observed following second dose and in younger, male individuals. The risk of myocarditis/pericarditis following CoronaVac and ChAdOx1 were much lower compared to BNT162b2. The findings on higher risk observed among younger following mRNA vaccine were consistent with literature and important for targeted surveillance.

The Effectiveness of Enhanced Primary Healthcare (EnPHC) interventions on Type 2 diabetes management in Malaysia: Difference-in-differences (DID) analysis.

AIMS: To evaluate the effectiveness of the Enhanced Primary Healthcare (EnPHC) interventions on process of care and intermediate clinical outcomes among type 2 diabetes patients. METHODS: This was a quasi-experimental controlled study conducted in 20 intervention and 20 control public primary care clinics in Malaysia from November 2016 to June 2019. Type 2 diabetes patients aged 30 years and above were selected via systematic random sampling. Outcomes include process of care and intermediate clinical outcomes. Difference-in-differences analyses was conducted. RESULTS: We reviewed 12,017 medical records of patients with type 2 diabetes. Seven process of care measures improved: HbA1c tests (odds ratio (OR) 3.31, 95% CI 2.13, 5.13); lipid test (OR 4.59, 95% CI 2.64, 7.97), LDL (OR 4.33, 95% CI 2.16, 8.70), and urine albumin (OR 1.99, 95% CI 1.12, 3.55) tests; BMI measured (OR 15.80, 95% CI 4.78, 52.24); cardiovascular risk assessment (OR 174.65, 95% CI 16.84, 1810.80); and exercise counselling (OR 1.18, 95% CI 1.04, 1.33). We found no statistically significant changes in intermediate clinical outcomes (i.e. HbA1c, LDL, HDL and BP control). CONCLUSIONS: EnPHC interventions was successful in enhancing the quality of care, in terms of process of care, by changing healthcare providers behaviour.

Comparative performance of public and private primary care service delivery in Malaysia: An analysis of findings from QUALICOPC.

INTRODUCTION: Primary care services are essential in achieving universal health coverage and Malaysia is looking into public-private partnership to overcome resource constraints. The study aims to compare the performance of primary care service delivery dimensions between public and private sector. METHODS: This cross-sectional study used the data from the Malaysian International Quality and Costs of Primary Care (QUALICOPC) study conducted in 2015-2016. The relative performance of each sector in four dimensions was compared using multi-level linear regression by incorporating a dummy variable indicating public sector in the model. RESULTS: The public sector was shown to have higher performance in comprehensiveness and coordination, while the private sector was better in continuity. There was no significant difference in accessibility. The public primary care services were better in serving primary care sensitive conditions, better informational continuity, and with better skill-mix and inter- and intra- professional relationship. Meanwhile, the private sector was stronger in referral decision making process, specialist feedback and greater out of hours facilities access. CONCLUSIONS: The public and private sectors differ in their strengths, which the government may tap into to strengthen primary care services. Other areas for improvement include seamless care strategies that promote good referral, feedback, and information continuity.

A Case-Based Monitoring Approach to Evaluate Safety of COVID-19 Vaccines in a Partially Integrated Health Information System: A Study Protocol.

In response to Coronavirus disease 2019 (COVID-19) global pandemic, various COVID-19 vaccines were rapidly administered under emergency use authorization. Rare outcomes associated with COVID-19 vaccines might be less likely to be captured in clinical trials, leading to a knowledge gap in real-world vaccine safety. In contrast with high-income countries, many low-to-middle income countries have limited capacity to conduct active surveillance, owing to the absence of large and fully-integrated health information databases. This paper describes the study protocol, which aims to investigate risk of prespecified adverse events of special interests following COVID-19 vaccination in a partially integrated health information system with non-shareable electronic health records. The SAFECOVAC study is a longitudinal, observational retrospective study of active safety surveillance using case-based monitoring approach. This involves linkage of several administrative databases and hospitalization data monitoring to identify adverse events of special interests following administration of COVID-19 vaccines in Malaysia. The source population comprises of all individuals who received at least one dose of COVID-19 vaccine. Self-controlled design and vaccinated case-coverage design will be employed to assess risk of adverse events of special interests and determine the association with vaccine exposure. Data on vaccination records will be obtained from the national COVID-19 vaccination register to identify the vaccination platforms, doses and the timing of vaccinations. The outcome of this study is hospitalization for the adverse events of special interests between March 2021 and June 2022. The outcomes will be obtained through linkage with hospital admission database and national pharmacovigilance database. Findings will provide analysis of real-world data which can inform deliberations by government and public health decision makers relative to the refinement of COVID-19 vaccination recommendations.

Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: A self-controlled case series study.

BACKGROUND: Rapid deployment of COVID-19 vaccines is challenging for safety surveillance, especially on adverse events of special interest (AESIs) that were not identified during the pre-licensure studies. This study evaluated the risk of hospitalisations for predefined diagnoses among the vaccinated population in Malaysia. METHODS: Hospital admissions for selected diagnoses between 1 February 2021 and 30 September 2021 were linked to the national COVID-19 immunisation register. We conducted self-controlled case-series study by identifying individuals who received COVID-19 vaccine and diagnosis of thrombocytopenia, venous thromboembolism, myocardial infarction, myocarditis/pericarditis, arrhythmia, stroke, Bell's Palsy, and convulsion/seizure. The incidence of events was assessed in risk period of 21 days postvaccination relative to the control period. We used conditional Poisson regression to calculate the incidence rate ratio (IRR) and 95% confidence interval (CI) with adjustment for calendar period. RESULTS: There was no increase in the risk for myocarditis/pericarditis, Bell's Palsy, stroke, and myocardial infarction in the 21 days following either dose of BNT162b2, CoronaVac, and ChAdOx1 vaccines. A small increased risk of venous thromboembolism (IRR 1.24; 95% CI 1.02, 1.49), arrhythmia (IRR 1.16, 95% CI 1.07, 1.26), and convulsion/seizure (IRR 1.26; 95% CI 1.07, 1.48) was observed among BNT162b2 recipients. No association between CoronaVac vaccine was found with all events except arrhythmia (IRR 1.15; 95% CI 1.01, 1.30). ChAdOx1 vaccine was associated with an increased risk of thrombocytopenia (IRR 2.67; 95% CI 1.21, 5.89) and venous thromboembolism (IRR 2.22; 95% CI 1.17, 4.21). CONCLUSION: This study shows acceptable safety profiles of COVID-19 vaccines among recipients of BNT162b2, CoronaVac, and ChAdOx1 vaccines. This information can be used together with effectiveness data for risk-benefit analysis of the vaccination program. Further surveillance with more data is required to assess AESIs following COVID-19 vaccination in short- and long-term.

Medication Regimen Complexity and Medication Burden Among Patients With Type 2 Diabetes Mellitus: A Retrospective Analysis.

Introduction: Most type 2 diabetes mellitus (T2DM) patients with chronic conditions require multiple medications to achieve and maintain good glycemic control. Objective: This study assessed medication burden, regimen complexity, and adherence among T2DM patients and evaluate its association with glycemic control. Method: We analyzed data of 2,696 T2DM patients at public health clinics in Malaysia from January 2018 until May 2019. Medication burden was based on medication count, regimen complexity was measured using the validated Medication Regimen Complexity Index (MRCI) tool, and adherence was measured using proportion of days covered (PDC) formula. Logistic regression models were used to compute unadjusted and adjusted odds ratio (aOR) with 95% confidence interval (CI) for association between the medication parameters and glycemic control (HbA1c ≤ 7.0%) over a 90-day period. Results: The cohort mean age was 60.4 years old (±10.8) and 62.9% were female. Overall, the average medication count was 4.8 with MRCI score of 15.1. Mean adherence score (PDC) was 90%. High medication count and MRCI scores were associated with lower odds of achieving good glycemic control (aOR 0.88; 95% CI 0.82, 0.94 and aOR 0.89; 95% CI 0.87, 0.92, respectively) while inverse association was observed between adherence and HbA1c level (aOR 2.7, 95% CI 1.66, 5.19). Similar findings were observed for diabetes-specific measures. Conclusions: High medication count, high regimen complexity, and low medication adherence were associated with poor glycemic control over the 3-month follow-up period. These parameters could be used to identify patients with complex pharmacotherapy regimens so that targets for intervention can be taken to achieve optimum outcomes and ease of self-care.

Comparison between primary care service delivery in Malaysia and other participating countries of the QUALICOPC project: a cross-sectional study.

OBJECTIVES: Most countries including Malaysia have set goals to incorporate a strong primary care into the healthcare system. The aim of this study was to evaluate the strength of service delivery process dimensions in Malaysia and compare it with England, the Netherlands, Spain, North Macedonia, Romania and Turkey which participated in the Quality and Costs of Primary Care (QUALICOPC) study. METHODS: This cross-sectional study utilised the QUALICOPC study data on primary care performance, which was conducted in 2011-2013 (QUALICOPC in Europe Australia, New Zealand and Canada) and 2015-2016 (Malaysia). A standardised questionnaire was completed by primary care practitioners from participating countries. Multilevel regression analysis and composite scores were constructed to compare the performance of primary care on four process dimensions: accessibility, comprehensiveness, continuity of care and coordination. RESULTS: The high-income countries with strong primary care performed better in comprehensiveness, continuity and coordination but poorer in accessibility to services compared with upper-middle-income countries. Among the upper-middle-income countries, Malaysia scored the best in comprehensiveness and coordination. None of the studied countries were having consistent performance over all indicators either in their respective best or worst primary care services delivery dimensions. CONCLUSIONS: There is a wide variation in primary care services delivery across and within the studied countries. The findings indicate room for quality improvement activities to strengthen primary healthcare services. This includes addressing current healthcare challenges in response to the population health needs which are essential for more integrated and efficient primary care services delivery.

Optimal cut-off points for adherence measure among patients with type 2 diabetes in primary care clinics: a retrospective analysis.

BACKGROUND: Medication adherence measures are often dichotomized to classify patients into those with good or poor adherence using a cut-off value ⩾80%, but this cut-off may not be universal across diseases or medication classes. This study aimed to examine the cut-off value that optimally distinguish good and poor adherence by using the medication possession ratio (MPR) and proportion of days covered (PDC) as adherence measures and glycated hemoglobin (HbA1c) as outcome measure among type 2 diabetes mellitus (T2DM) patients. METHOD: We used pharmacy dispensing data of 1461 eligible T2DM patients from public primary care clinics in Malaysia treated with oral antidiabetic drugs between January 2018 and May 2019. Adherence rates were calculated during the period preceding the HbA1c measurement. Adherence cut-off values for the following conditions were compared: adherence measure (MPR versus PDC), assessment period (90-day versus 180-day), and HbA1c target (⩽7.0% versus ⩽8.0%). RESULTS: The optimal adherence cut-offs for MPR and PDC in predicting HbA1c ⩽7.0% ranged between 86.1% and 98.3% across the two assessment periods. In predicting HbA1c ⩽8.0%, the optimal adherence cut-offs ranged from 86.1% to 92.8%. The cut-off value was notably higher with PDC as the adherence measure, shorter assessment period, and a stricter HbA1c target (⩽7.0%) as outcome. CONCLUSION: We found that optimal adherence cut-off appeared to be slightly higher than the conventional value of 80%. The adherence thresholds may vary depending on the length of assessment period and outcome definition but a reasonably wise cut-off to distinguish good versus poor medication adherence to be clinically meaningful should be at 90%.

Quality of hypertension management in public primary care clinics in Malaysia: An update.

INTRODUCTION: Adequate control of hypertension is a global challenge and is the key to reduce cardiovascular disease risk factors. This study evaluates management of hypertensive patients in primary care clinics in Malaysia. METHODS: A cross-sectional analysis of 13 784 medical records from 20 selected public primary care clinics in Malaysia was performed for patients aged ≥30 years old who were diagnosed with hypertension and had at least one visit between 1st November 2016 and 30th June 2019. Multivariable logistic regression adjusted for complex survey design was used to determine the association between process of care and blood pressure (BP) control among the hypertensive patients. RESULTS: Approximately 50% of hypertensive patients were obese, 38.4% of age ≥65 years old, 71.2% had at least one comorbidity and approximately one-third were on antihypertensive monotherapy. Approximately two-third of the hypertensive patients with diabetic proteinuria were prescribed with the appropriate choice of antihypertensive agents. Approximately half of the patients received at least 70% of the target indicated care and 42.8% had adequately controlled BP. After adjusting for covariates, patients who received counseling on exercise were positively associated with adequate BP control. Conversely, patients who were prescribed with two or more antihypertensive agents were negatively associated with good BP control. CONCLUSIONS: These findings indicated that BP control was suboptimal and deficient in the process of care with consequent gaps in guidelines and actual clinical practices. This warrants a re-evaluation of the current strategies and approaches to improve the quality of hypertension management and ultimately to improve outcome.

Age, sex and primary care setting differences in patients' perception of community healthcare seeking behaviour towards health services.

INTRODUCTION: Understanding the potential determinants of community healthcare seeking behaviour helps in improving healthcare utilisation and health outcomes within different populations. This in turn will aid the development of healthcare policies and planning for prevention, early diagnosis and management of health conditions. OBJECTIVE: To evaluate patients' perception of community healthcare seeking behaviour towards both acute and preventive physical and psychosocial health concerns by sex, age and type of primary care setting (as a proxy for affordability of healthcare). METHODS: A total of 3979 patients from 221 public and 239 private clinics in Malaysia were interviewed between June 2015 and February 2016 using a patient experience survey questionnaire from the Quality and Cost of Primary Care cross-sectional study. Multivariable logistic regression analysis adjusted for the complex survey design was used. RESULTS: After adjusting for covariates, more women than men perceived that most people would see their general practitioners for commonly consulted acute and preventive physical and some psychosocial health concerns such as stomach pain (adjusted odds ratio (AOR), 1.64; 95% confidence interval (CI), 1.22-2.21), sprained ankle (AOR, 1.29; 95% CI, 1.06-1.56), anxiety (AOR, 1.32; 95% CI, 1.12-1.55), domestic violence (AOR, 1.35; 95% CI, 1.13-1.62) and relationship problems (AOR, 1.24; 95% CI, 1.02-1.51). There were no significant differences in perceived healthcare seeking behaviour by age groups except for the removal of a wart (AOR, 1.41; 95% CI, 1.12-1.76). Patients who visited the public clinics had generally higher perception of community healthcare seeking behaviour for both acute and preventive physical and psychosocial health concerns compared to those who went to private clinics. CONCLUSIONS: Our findings showed that sex and healthcare affordability differences were present in perceived community healthcare seeking behaviour towards primary care services. Also perceived healthcare seeking behaviour were consistently lower for psychosocial health concerns compared to physical health concerns.

Patient experience on self-management support among primary care patients with diabetes and hypertension.

OBJECTIVE: To determine the extent of self-management support (SMS) provided to primary care patients with type 2 diabetes (T2D) and hypertension and its associated factors. DESIGN: Cross-sectional survey conducted between April and May 2017. SETTING: Forty public clinics in Malaysia. PARTICIPANTS: A total of 956 adult patients with T2D and/or hypertension were interviewed. MAIN OUTCOME MEASURES: Patient experience on SMS was evaluated using a structured questionnaire of the short version Patient Assessment of Chronic Illness Care instrument, PACIC-M11. Linear regression analysis adjusting for complex survey design was used to determine the association of patient and clinic factors with PACIC-M11 scores. RESULTS: The overall PACIC-M11 mean was 2.3(SD,0.8) out of maximum of 5. The subscales' mean scores were lowest for patient activation (2.1(SD,1.1)) and highest for delivery system design/decision support (2.9(SD,0.9)). Overall PACIC-M11 score was associated with age, educational level and ethnicity. Higher overall PACIC-M11 ratings was observed with increasing difference between actual and expected consultation duration [ß = 0.01; 95% CI (0.001, 0.03)]. Better scores were also observed among patients who would recommend the clinic to friends and family [ß = 0.19; 95% CI (0.03, 0.36)], when health providers were able to explain things in ways that were easy to understand [ß = 0.34; 95% CI (0.10, 0.59)] and knew about patients' living conditions [ß = 0.31; 95% CI (0.15, 0.47)]. CONCLUSIONS: Our findings indicated patients received low levels of SMS. PACIC-M11 ratings were associated with age, ethnicity, educational level, difference between actual and expected consultation length, willingness to recommend the clinic and provider communication skills.

Mortality in Children Under 5: Prevalence of Congenital Malformations and its Associated Demographic Variables

Congenital malformations (CM) comprise a wide range of abnormalities of body structure or function that are present at birth and are of prenatal origin. It has contributed to a significant proportion of infant morbidity and mortality. The aims of this study were to determine the extent and investigate the relationship between CM and its associated demographic variables. Data was extracted from Ministry of Health (MOH) database compiled from the reports on Stillbirth & Under 5 Mortality from year 2013 to 2014. Out of 9,827 child death, 2,840 (28.9%) were classified under CM as defined under ICD-10 classification. Majority of those with CMs died at neonatal stage (62.7%) and among mothers aged between 20 to 35 years old (67.3%). The mean age of mothers among CM children was 30.8±6.5 years old. Approximately 5.8%, 6.7% and 3.3 % of total CM were neural tube defects, heart defects and hydrops fetalis respectively. The prevalence of CM in males was 15% higher than females. The difference were evident between CM and age of death of children under 5 years old (p<0.001) as well as between CM and maternal age groups (p<0.001). CM is responsible for 28.9% of total causes of child death with higher occurrence of malformation in males. A significantly higher risk of CMs among mother aged between 20 to 35 years old was observed. This emphasises the importance of raising awareness and the need to strengthen appropriate response for surveillance and prevention program of common CM in Malaysia.