Effectiveness of COVID-19 vaccines among children 6-11 years against hospitalization during Omicron predominance in Malaysia.

There is currently limited data on the effectiveness of COVID-19 vaccines for children aged 6-11 years in Malaysia. This study aims to determine vaccine effectiveness (VE) against COVID-19-related hospitalization after receipt of one- and two-doses of BNT162b2 mRNA (Comirnaty-Pfizer/BioNTech) vaccine over a duration of almost 1 year in the predominantly Omicron period of BA.4/BA.5 and X.B.B sub lineages. This study linked administrative databases between May 2022 and March 2023 to evaluate real-world vaccine effectiveness (VE) for the BNT162b2 mRNA (Comirnaty-Pfizer/BioNTech) vaccine against COVID-19-related hospitalization in the Omicron pre-dominant period with BA.4/BA.5 and X.B.B sub lineages. During the Omicron-predominant period, the cumulative hospitalization rate was almost two times higher for unvaccinated children (9.6 per million population) compared to vaccinated children (6 per million population). The estimated VE against COVID-19 hospitalization for one dose of BNT162b2 was 27% (95% CI - 1%, 47%) and 38% (95% CI 27%, 48%) for two doses. The estimated VE against hospitalization remained stable when stratified by time. VE for the first 90 days was estimated to be 45% (95% CI 33, 55%), followed by 47% (95% CI 34, 56%) between 90 and 180 days, and 36% (95% CI 22, 45%) between 180 and 360 days. Recent infection within 6 months does not appear to modify the impact of vaccination on the risk of hospitalization, subject to the caveat of potential underestimation. In our pediatric population, BNT162b2 provided moderate-non-diminishing protection against COVID-19 hospitalization over almost 1 year of Omicron predominance.

Measuring population health and quality of life: Developing and testing of the significant quality of life measure (SigQOLM).

Quality of life (QOL) should ideally be determined by a broader spectrum of measurable parameters. This study aims to develop and validate a study instrument that is designed to determine a holistic measure of health and non-health aspects of QOL, and it is called the 'Significant Quality of Life Measure' (SigQOLM). This study involves five phases which aim to (i) explore and understand the subject matter content, (ii) develop a questionnaire, (iii) assess its content validity and face validity, (iv) conduct a pilot study, and lastly (v) perform a field-test by using the questionnaire. For the field-testing phase, a cross-sectional study was conducted which elicited responses from healthcare workers via a self-administered survey for all the SigQOLM items. Based on the results, the overall framework of the SigQOLM consists of four elements, 18 domains with 69 items. The element of "Health" is measured by nine domains, while "Relationships", "Functional activities, and "Survival" are measured by three domains respectively. The SigQOLM has been developed successfully and then validated with a high level of reliability, validity, and overall model fit. Therefore, the SigQOLM will provide researchers and policymakers another viable option to elicit a more comprehensive outcome measure of QOL which shall then enable them to implement specific interventions for improving the QOL of all the people, both healthy or otherwise.

Development of a Quality-of-Life Instrument to Measure Current Health Outcomes: Health-Related Quality of Life with Six Domains (HRQ-6D).

Health-related quality of life (HRQOL) is one of the most important outcome measures to be assessed by medical research. This study aims to develop and validate an instrument called the "health-related quality of life with six domains" (HRQ-6D), which aims to measure an individual's health-related quality of life within a 24 h period of time. This is a questionnaire development study involving five phases, which are (i) to explore the subject matter content for gaining a better understanding of the topic, (ii) to develop the questionnaire, (iii) to assess both its content validity and face validity, (iv) to conduct a pilot study, and finally, (v) to undertake a field testing of the questionnaire. For the field-testing phase, a cross-sectional study involving a self-administered survey for HRQ-6D items was conducted among healthcare workers with various health conditions. Exploratory factor analysis was initially applied to construct the major dimensions of the HRQ-6D. Confirmatory factor analysis was subsequently applied to evaluate the model fit of the overall framework of the HRQ-6D. The clinical utility of this HRQ-6D was also assessed via its association with actual clinical evidence. A total of 406 respondents participated in the survey. Six domains were identified from the analysis, namely "pain", "physical strength", "emotion", "self-care", "mobility", and "perception of future health" comprising two items in each domain. Each domain was reported to have a minimum value of Cronbach's alpha of 0.731, and the model fit for the overall framework of the HRQ-6D was also found to be excellent. Exploratory factor analysis was undertaken for the 12 items of the HRQ-6D. All the domains can be categorized into three major dimensions, namely "health", "body function", and "future perception", with a minimum value for their factor loadings of at least 0.507. A notable finding was that the HRQ-6D was significantly associated with an individual's existing comorbidities and current status of health (p < 0.05). This study successfully validated the HRQ-6D, and we found it to possess both excellent levels of reliability and validity and a satisfactory degree of model fit; it was also significantly associated with actual clinical evidence.

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.

Assessment of Heterologous and Homologous Boosting With Inactivated COVID-19 Vaccine at 3 Months Compared With Homologous Boosting of BNT162b2 at 6 Months.

Importance: Evidence for the timing of booster vaccination after completion of BNT162b2 and CoronaVac primary vaccination is crucial to guide policy recommendations. Objective: To compare the odds of symptomatic SARS-CoV-2 infection and COVID-19-related outcomes after heterologous and homologous boosting of CoronaVac at 3-month intervals and homologous boosting of BNT162b2 at 6-month intervals, with BNT162b2 primary series (2 doses) as the reference group. Design, Setting, and Participants: This population-based retrospective cohort study used national data for Malaysia. Participants included all individuals aged 18 years and older who received a complete primary series of CoronaVac or BNT162b2 vaccine and were eligible for a booster dose between November 21, 2021, and December 28, 2021. Data were analyzed from November 21, 2021, to January 7, 2022. Exposures: Receipt of a booster vs no booster and categorized into primary series BNT162b2 (2 doses of BNT162b2), primary series CoronaVac (2 doses of CoronaVac), 3 doses of BNT162b2, primary series CoronaVac plus a BNT162b2 booster, and 3 doses of CoronaVac. Main Outcomes and Measures: The primary outcome was symptomatic SARS-CoV-2 infection. The secondary outcomes were COVID-19-related intensive care unit admission and death. All outcomes were observed from the day an individual was considered fully boosted (≥14 days after booster dose). Results: Our cohort included 13 840 240 individuals (mean [SD] age, 39.9 [15.5] years; 7 040 298 [50.9%] men; 4 451 180 individuals [32.2%] with ≥1 comorbidities), of whom 5 081 641 individuals (36.7%) had received a booster dose. Using the primary series BNT162b2 recipients as reference, the adjusted odds against symptomatic SAR-CoV-2 infection were lower for individuals who received the primary series CoronaVac plus a BNT162b2 (adjusted odds ratio [aOR], 0.06 [95% CI, 0.05-0.06]), 3 doses of CoronaVac (aOR, 0.08 [95% CI, 0.06-0.10]), or 3 doses of BNT162b2 (aOR, 0.01 [95% CI, 0.00-0.01]). Receipt of heterologous booster (primary series of CoronaVac plus a BNT162b2 booster) was associated with lower odds of SARS-CoV-2 infection (aOR, 0.17 [95% CI, 0.17-0.18]) compared with homologous booster (3 doses of CoronaVac) for individuals aged 60 years and older (aOR, 0.19 [95% CI, 0.19-0.20]). Conclusions and Relevance: In this cohort study, for individuals who received the CoronaVac primary series and a booster dose of BNT162b2 or CoronaVac at 3 months, the observed odds of symptomatic SARS-CoV-2 infection were similar to individuals who received the BNT162b2 primary series plus a third dose of BNT162b2 at 6 months. Heterologous booster is recommended for individuals aged 60 years or older who received the CoronaVac primary series, given the lower observed odds against symptomatic SARS-CoV-2 infection among those who received a BNT1612b2 booster.

Expert review on global real-world vaccine effectiveness against SARS-CoV-2.

INTRODUCTION: COVID-19 vaccines have been highly effective in reducing morbidity and mortality during the pandemic. While primary series vaccination rates are generally high in Southeast Asian (SEA) countries, various factors have limited the rollout and impact of booster doses. AREAS COVERED: We reviewed 79 studies in the International Vaccine Access Center (IVAC) VIEW-hub platform on vaccine effectiveness (VE) after primary immunizations with two-dose schedules. VE data were reported for SARS-CoV-2 infection, COVID-19-related hospitalizations and deaths, and stratified across variants of concern, age, study design and prior SARS-CoV-2 infection for mRNA vaccines (BNT162b2, mRNA-1273, and combinations of both), vector vaccines (AstraZeneca, AZD1222 [ChAdOx1 nCoV-19] 'Vaxzevria'), and inactivated virus vaccines (CoronaVac). EXPERT OPINION: The most-studied COVID-19 vaccines provide consistently high (>90%) protection against serious clinical outcomes like hospitalizations and deaths, regardless of variant. Additionally, this protection appears equivalent for mRNA vaccines and vector vaccines like AZD1222, as supported by our analysis of Asian and relevant international data, and by insights from SEA experts. Given the continued impact of COVID-19 hospitalizations and deaths on health-care systems worldwide, encouraging vaccination strategies that reduce this burden is more relevant than attempting to prevent broader but milder infections with specific variants, including Omicron.

Real-world effectiveness of homologous and heterologous BNT162b2, CoronaVac, and AZD1222 booster vaccination against Delta and Omicron SARS-CoV-2 infection.

Given emerging evidence of immune escape in the SARS-CoV-2 Omicron viral variant, and its dominance, effectiveness of heterologous and homologous boosting schedules commonly used in low-to-middle income countries needs to be re-evaluated. We conducted a test-negative design using consolidated national administrative data in Malaysia to compare the effectiveness of homologous and heterologous BNT162b2, CoronaVac, and AZD1222 booster vaccination against SARS-CoV-2 infection in predominant-Delta and predominant-Omicron periods. Across both periods, homologous CoronaVac and AZD1222 boosting demonstrated lower effectiveness than heterologous boosting for CoronaVac and AZD1222 primary vaccination recipients and homologous BNT162b2 boosting. Broadly, marginal effectiveness was smaller by 40-50 percentage points in the Omicron period than the Delta period. Without effective and accessible second-generation vaccines, heterologous boosting using BNT162b2 for inactivated and vectored primary vaccination recipients is preferred.

Assessing the Availability of Teleconsultation and the Extent of Its Use in Malaysian Public Primary Care Clinics: Cross-sectional Study.

BACKGROUND: The integration of teleconsultation into health care systems as a complement to existing approaches to care is growing rapidly. There is, however, limited information on the extent of its implementation across low- and middle-income countries. OBJECTIVE: The aim of this study was to determine the availability and the extent of teleconsultation in Malaysian primary care clinics. METHODS: A cross-sectional study of public primary care clinics in Malaysia was conducted between November 2020 and December 2020. All clinics in Malaysia that see more than 300 daily patients were recruited. A web-based, self-administered questionnaire including questions on availability of the service, whether it uses video or telephone, and the types of services it provides was distributed to the medical officer in charge of each clinic. RESULTS: In total, 97.6% (249/255) of the clinics responded. Out of these clinics, 45.8% (114/249) provided teleconsultation. A majority of the clinics providing consultation (69/114, 60.5%) provided only telephone consultation, while 24.6% (28/114) of the clinics offered video and telephone consultation, and 14.9% (17/114) offered only video consultation. Eighty percent (92/114) of the clinics were located in urban areas. A breakdown by state showed that 17.5% (20/114) and 16.7% (19/114) of the clinics were from two larger states; other states comprised less than 10% each (range 7-9/114). For the clinics providing video consultation, funding for the service came mostly (42/45, 93%) from the Ministry of Health. Conversely, nearly 1 out of 4 (23/97) clinics that provided telephone consultation funded the service either from donations or through self-funding. Most of the clinics provided teleconsultation for diabetes and hypertension. Less than 50% of the clinics with teleconsultation used it for follow up with allied health care providers or pharmacists (video consultation, 20/45; telephone consultation, 36/97). CONCLUSIONS: Our findings show that telephone consultation is more widely used than video consultation, despite a quarter of its funding being self-subsidized or obtained through donations. Also, teleconsultation was less utilized by allied health care providers and pharmacists. Plans for the expansion of teleconsultation in Malaysian primary health care should take into consideration these findings to ensure a better and more cost-effective implementation of the service.

Real-world effectiveness of BNT162b2 vaccine against SARS-CoV-2 infection among adolescents (12 to 17-year-olds) in Malaysia.

OBJECTIVES: In this study, we aimed to investigate vaccine effectiveness (VE) against SARS-CoV-2 infections among adolescents aged 12 to 17 years in Malaysia and examine potential VE differences after full vaccination. METHODS: We consolidated data on COVID-19 testing, vaccination, and outcomes for all public school-going adolescents in Malaysia from September 1, 2021, to December 31, 2021, and estimated the VE against SARS-CoV-2 infections during this period. Cases were defined as positive tests, either by reverse transcriptase- PCR (RT-PCR) or rapid antigen (RTK-Ag) testing, while controls were negative tests. Secondarily, we restricted the analysis to all tests performed in December 2021 and compared VE by month of full vaccination. RESULTS: A total of 175,880 eligible tests (53.4% or 93,995 RT-PCR tests) were included. After full vaccination with BNT162b2, VE against SARS-CoV-2 infections was 65.7% (95% confidence interval [CI] 64.4, 66.9) over the study period. When restricted to tests in December 2021, VEs for those fully vaccinated in September 2021, October 2021, and November 2021 were comparable (60.6% [95% CI 23.7, 81.5], 56.9% [95% CI 51.1, 62.0], and 65.7% [95% CI 59.8, 70.7] respectively). CONCLUSIONS: Among adolescents, full vaccination with BNT162b2 offered considerable protection against SARS-CoV-2 infections over at least three months without substantial evidence of waning.

Translation and Validation of the Questionnaire on Acceptance to Telemedicine from the Technology Acceptance Model (TAM) for Use in Malaysia.

The COVID-19 pandemic has accelerated implementation of telemedicine in healthcare facilities for delivery of care. Healthcare providers' acceptance of the telemedicine services is important for successful implementation of this new system. A questionnaire based on the Technology Acceptance Model (TAM) has been used to measure user acceptance of telemedicine service. The aim of this study was to translate and validate the English version of the questionnaire into Malay, to extend the availability and utilization of this questionnaire in Malaysia. A forward and backward translation of the questionnaire was conducted to produce the TAM in the Malay version (Malay-TAM). Panel experts assessed content validity. Internal consistency reliability was determined using Cronbach's alpha. Confirmatory factor analysis based on structural equation modelling was performed to validate the factor structure. The questionnaire was then tested on and completed by 149 healthcare workers from several public health clinics across Malaysia. The Malay-TAM demonstrated good reliability with Cronbach's alphas ranging from 0.823 to 0.912. Factor analysis showed good convergent validity but relatively poor discriminant validity. All five constructs were retained to preserve content validity. The findings suggest that the Malay-TAM can serve as a reliable and valid instrument to measure acceptance to telemedicine.

Waning COVID-19 Vaccine Effectiveness for BNT162b2 and CoronaVac in Malaysia: An Observational Study.

OBJECTIVES: We aimed to investigate and compare waning vaccine effectiveness (VE) against COVID-19 infection, COVID-19 related ICU admission, and COVID-19-related death for BNT162b2 and CoronaVac vaccines. METHODS: We consolidated national data on COVID-19 vaccination and outcomes, and used cases from September 1st-30th, 2021 to compare VE between the 'early' (fully vaccinated in April-June 2021) and 'late' (July-August 2021) groups. We estimated VE against COVID-19 infection with a negative binomial regression and VE against ICU admission and death among confirmed COVID-19 cases with a logistic regression. RESULTS: For BNT162b2, VE against COVID-19 infections declined from 90.8% (95% CI 89.4, 92.1) in the 'late' group to 79.3% (95% CI 76.1, 82.1) in the 'early' group. VE for BNT162b2 against ICU admission and death were stable. For CoronaVac, VE waned against COVID-19 infections from 74.5% (95% CI 70.6, 78.0) to 30.4% (95% CI 18.8, 40.3). Effectiveness against ICU admission waned from 56.0% (95% CI 51.2, 60.2) to 28.7% (95% CI 12.2, 42.1). CoronaVac's effectiveness against death remained stable. CONCLUSION: VE against COVID-19 infection waned after 3-5 months of full vaccination for both BNT162b2 and CoronaVac vaccines in Malaysia. For CoronaVac, protection against ICU admission also declined.

PICK-ing Malaysia's Epidemic Apart: Effectiveness of a Diverse COVID-19 Vaccine Portfolio.

Malaysia rolled out a diverse portfolio of predominantly three COVID-19 vaccines (AZD1222, BNT162b2, and CoronaVac) beginning 24 February 2021. We evaluated vaccine effectiveness with two methods, covering 1 April to 15 September 2021: (1) the screening method for COVID-19 (SARS-CoV-2) infection and symptomatic COVID-19; and (2) a retrospective cohort of confirmed COVID-19 cases for COVID-19 related ICU admission and death using logistic regression. The screening method estimated partial vaccination to be 48.8% effective (95% CI: 46.8, 50.7) against COVID-19 infection and 33.5% effective (95% CI: 31.6, 35.5) against symptomatic COVID-19. Full vaccination is estimated at 87.8% effective (95% CI: 85.8, 89.7) against COVID-19 infection and 85.4% effective (95% CI: 83.4, 87.3) against symptomatic COVID-19. Among the cohort of confirmed COVID-19 cases, partial vaccination with any of the three vaccines is estimated at 31.3% effective (95% CI: 28.5, 34.1) in preventing ICU admission, and 45.1% effective (95% CI: 42.6, 47.5) in preventing death. Full vaccination with any of the three vaccines is estimated at 79.1% effective (95% CI: 77.7, 80.4) in preventing ICU admission and 86.7% effective (95% CI: 85.7, 87.6) in preventing deaths. Our findings suggest that full vaccination with any of the three predominant vaccines (AZD1222, BNT162b2, and CoronaVac) in Malaysia has been highly effective in preventing COVID-19 infection, symptomatic COVID-19, COVID-19-related ICU admission, and death.

Recruitment and participation of a survey in a public-private primary care setting: experience from the QUALICOPC Malaysia.

AIM: The purpose of this paper is to describe the recruitment strategies, the response rates and the reasons for non-response of Malaysian public and private primary care doctors in an international survey on the quality, cost and equity in primary care. BACKGROUND: Low research participation by primary care doctors, especially those working in the private sector, is a challenge to quality benchmarking. METHODS: Primary care doctors were sampled through multi-stage sampling. The first stage-sampling unit was the primary care clinics, which were randomly sampled from five states in Malaysia to reflect their proportions in two strata - sector (public/private) and location (urban/rural). Strategies through endorsement, personalised invitation, face-to-face interview and non-monetary incentives were used to recruit public and private doctors. Data collection was carried out by fieldworkers through structured questionnaires. FINDINGS: A total of 221 public and 239 private doctors participated in the study. Among the public doctors, 99.5% response rates were obtained. Among the private doctors, a 32.8% response rate was obtained. Totally, 30% of private clinics were uncontactable by telephone, and when these were excluded, the overall response rate is 46.8%. The response rate of the private clinics across the states ranges from 31.5% to 34.0%. A total of 167 answered the non-respondent questionnaire. Among the non-respondents, 77.4 % were male and 22.6% female (P = 0.011). There were 33.6% of doctors older than 65 years (P = 0.003) and 15.9% were from the state of Sarawak (P = 0.016) when compared to non-respondents. Reason for non-participation included being too busy (51.8%), not interested (32.9%), not having enough patients (9.1%) and did not find it beneficial (7.9%). Our study demonstrated the feasibility of obtaining favourable response rate in a survey involving doctors from public and private primary care settings.

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.

Study protocol on Enhanced Primary Healthcare (EnPHC) interventions: a quasi-experimental controlled study on diabetes and hypertension management in primary healthcare clinics.

AIM: This paper describes the study protocol, which aims to evaluate the effectiveness of a multifaceted intervention package called 'Enhanced Primary Healthcare' (EnPHC) on the process of care and intermediate clinical outcomes among patients with Type 2 diabetes mellitus (T2DM) and hypertension. Other outcome measures include patients' experience and healthcare providers' job satisfaction. BACKGROUND: In 2014, almost two-thirds of Malaysia's adult population aged 18 years or older had T2DM, hypertension or hypercholesterolaemia. An analysis of health system performance from 2016 to 2018 revealed that the control and management of diabetes and hypertension in Malaysia was suboptimal with almost half of the patients not diagnosed and just one-quarter of patients with diabetes appropriately treated. EnPHC framework aims to improve diagnosis and effective management of T2DM, hypertension or hypercholesterolaemia and their risk factors by increasing prevention, optimising management and improving surveillance of diagnosed patients. METHODS: This is a quasi-experimental controlled study which involves 20 intervention and 20 control clinics in two different states in Malaysia, namely Johor and Selangor. The clinics in the two states were matched and randomly allocated to 'intervention' and 'control' arms. The EnPHC framework targets different levels from community to primary healthcare clinics and integrated referral networks.Data are collected via a retrospective chart review (RCR), patient exit survey, healthcare provider survey and an intervention checklist. The data collected are entered into tablet computers which have installed in them an offline survey application. Interrupted time series and difference-in-differences (DiD) analyses will be conducted to report outcomes.