METHODS AND ANALYSIS: REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18-80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.
ETHICS AND DISSEMINATION: The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.
Objective: To examine the long-term effects of lipid-lowering therapy on all-cause mortality, cardiovascular morbidity, CKD progression, and socioeconomic well-being in Australian, New Zealand, and Malaysian SHARP (Study of Heart and Renal Protection) trial participants-a randomized controlled trial of a combination of simvastatin and ezetimibe, compared with placebo, for the reduction of cardiovascular events in moderate to severe CKD.
Design: Protocol for an extended prospective observational follow-up.
Setting: Australian, New Zealand, and Malaysian participating centers in patients with advanced CKD.
Patients: All SHARP trial participants alive at the final study visit.
Measurements: Primary outcomes were measured by participant self-report and verified by hospital administrative data. In addition, secondary outcomes were measured using a validated study questionnaire of health-related quality of life, a 56-item economic survey.
Methods: Participants were followed up with alternating face-to-face visits and telephone calls on a 6-monthly basis until 5 years following their final SHARP Study visit. In addition, there were 6-monthly follow-up telephone calls in between these visits. Data linkage to health registries in Australia, New Zealand, and Malaysia was also performed.
Results: The SHARP-Extended Review (SHARP-ER) cohort comprised 1136 SHARP participants with a median of 4.6 years of follow-up. Compared with all SHARP participants who originally participated in the Australian, New Zealand, and Malaysian regions, the SHARP-ER participants were younger (57.2 [48.3-66.4] vs 60.5 [50.3-70.7] years) with a lower proportion of men (61.5% vs 62.8%). There were a lower proportion of participants with hypertension (83.7% vs 85.0%) and diabetes (20.0% vs 23.5%).
Limitations: As a long-term follow-up study, the surviving cohort of SHARP-ER is a selected group of the original study participants, which may limit the generalizability of the findings.
Conclusion: The SHARP-ER study will contribute important evidence on the long-term outcomes of cholesterol-lowering therapy in patients with advanced CKD with a total of 10 years of follow-up. Novel analyses of the socioeconomic impact of CKD over time will guide resource allocation.
Trial Registration: The SHARP trial was registered at ClinicalTrials.gov NCT00125593 and ISRCTN 54137607.
Methods: This is a multinational, multicenter, longitudinal, and observational registry of PC patients presenting to participating tertiary-care hospitals in eight Asian countries (www.clinicaltrials.gov NCT02546908. Registry Identifier: NOPRODPCR4001). Approximately 3500-4000 eligible patients with existing or newly diagnosed high-risk localized PC (cohort 1), nonmetastatic biochemically recurrent PC (cohort 2), or metastatic PC (cohort 3) will be consecutively enrolled and followed-up for 5 years. An enrollment cap of 600 patients each will be applied to cohorts 1 and 2. Disease status is collected at enrollment, and outcome variables captured at 3-monthly intervals include diagnostic/staging, treatments including reason for change, laboratory results, comorbidities, and concomitant medications. Treatments and survival outcomes will be captured real time until study end. Patient-reported quality-of-life will be measured every 6 months, and medical resource utilization summarized at study end. Data analysis will include exploratory analyses of potential associations between multiple risk factors and socioeconomic variables with disease progression and evaluation of various treatments for PC including novel therapies on clinical outcome and health-related quality-of-life outcomes.
Results: 3636 men with PC were enrolled until July 2018; 416 in cohort 1, 399 in cohort 2 and 2821 in cohort 3.
Discussion: A total of 3636 patients were enrolled until July 2018. The prospective disease registry will provide comprehensive and wide-ranging real-world information on how PC is diagnosed and treated in Asia. Such information can be used to inform policy development for best practice and direct clinical study design evaluating new treatments.
BACKGROUND: Data regarding the performance of a DCB-only approach, especially in patients with previously untreated de-novo coronary artery disease (CAD), are still limited.
METHODS: This study was conducted as an international, multicenter registry primarily enrolling patients with de-novo CAD. However, it was also possible to include patients with in-stent restenosis (ISR). The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 9 months.
RESULTS: A total of 1,025 patients with a mean age of 64.0 ± 11.2 years were enrolled. The majority of treated lesions were de-novo (66.9%), followed by drug-eluting-stent ISR (DES-ISR; 22.6%) and bare-metal-stent ISR (BMS-ISR; 10.5%). The TLR rate was lower in the de-novo group (2.3%) when compared to BMS- (2.9%) and DES-ISR (5.8%) (P = 0.049). Regarding MACE, there was a trend toward fewer events in the de-novo group (5.6%) than in the BMS- (7.8%) and DES-ISR cohort (9.6%) (P = 0.131). Subgroup analyses revealed that lesion type (95% CI 1.127-6.587); P = 0.026) and additional stent implantation (95% CI 0.054-0.464; P = 0.001) were associated with higher TLR rates.
CONCLUSIONS: Our results show that DCB-only angioplasty of de-novo coronary lesions is associated with low MACE and TLR rates. Thus, DCBs appear to be an attractive alternative for the interventional, stentless treatment of suitable de-novo coronary lesions.
BACKGROUND: Recently published randomized trials comparing BMS to DES with a focus on shortened dual-antiplatelet therapy reported incidences of stent thrombosis (ST) and bleeding complications (LEADERS FREE) in favor of drug eluting stents (DES).
METHODS: Data of previously published large-sale, international, single-armed, multicenter, observational studies of ultra-thin PF-SES, and BMS were propensity score (PS) matched for selected lesion morphological and cardiovascular risk factors to compare target lesion revascularization (TLR), myocardial infarction, cardiac death, major adverse cardiac events (MACE), bleeding complications and ST rates. Primary endpoint in both studies was TLR at 9 months.
RESULTS: At 9 months the rates of TLR was significantly lower in the PF-SES group as compared with patients treated with the BMS analogue of identical stent design (1.4% vs. 4.6%, P = 0.005). Likewise the 9-month MACE rates were lower in the PF-SES group (3.2% vs. 8.7%, P = 0.001) whereas there were no differences in the accumulated ST rates (0.5% vs. 1.5%, P = 0.109). Overall accumulated bleeding incidences (BARC 1-5) were not significantly different between PF-SES and BMS patients (1.8% vs. 2.7%, p = 0.388).
CONCLUSIONS: PF-SES are superior over analogue BMS of identical stent architecture in daily clinical routine with lower rates of TLR and MACE in a PS-matched, unselected patient population without differences in accumulated ST rates and bleeding frequencies given the currently favored postprocedural comedication (ClinicalTrials.gov Identifier NCT02629575).
OBJECTIVE: To determine the prevalence and sociodemographic factors predicting high-risk HPV infection in Malaysia based on a public, community-based cervical cancer screening registry targeting women at risk of getting HPV infection.
METHODS: The study used data from the Malaysian cervical cancer screening registry established by the Family Health Development Division from 2019 to 2021. The registry recorded sociodemographic data, HPV test details and results of eligible women who underwent HPV screening at public primary healthcare facilities. A vaginal sample (via self-sampling or assisted by a healthcare provider) was used for DNA extraction for HPV detection and genotyping. Registry data were extracted and analysed to determine prevalence estimates of high-risk HPV infection. Multifactorial logistic regression analysis was conducted to determine predictors of high-risk HPV infection. All analyses were performed using Stata version 14.
RESULTS: The programme screened a total of 36,738 women during the study period. Women who attended the screening programme were mainly from urban areas, aged 30-39 years, and of Malay ethnicity. The prevalence of high-risk HPV infection was 4.53% among women screened, with the yearly prevalence ranging from 4.27 to 4.80%. A higher prevalence was observed among urban settling women, those aged 30-49 years, those of Indian ethnicity, and those without children. The results from logistic regression showed that women from urban areas, lower age groups, of Indian or Chinese ethnicity, and who are self-employed were more likely to be infected with high-risk HPV.
CONCLUSION: Targeted and robust strategies to reach identified high-risk groups are needed in Malaysia. In addition, the registry has the potential to be expanded for an improved cervical cancer elimination plan.
TRIAL REGISTRATION: Trial registration number: NMRR ID-22-00187-DJU.
DESIGN: Secondary cross-sectional analysis of the Malaysian National Eye Database (NED) data.
METHODS: The Malaysian Cataract Surgery Registry collected data on patients who had cataract surgery from 2002-2004 and 2007-2012. Data collected included demography, operative events, time interval between 2 surgeries, and postoperative visual outcomes. Descriptive analysis was performed.
RESULTS: Total surgeries increased from 11,954 in 2002 to 30,265 in 2012 with a proportionate increase in SECS (30.7% in 2002 to 34.3% in 2012). Poor vision (<6/12) was reduced from 81.1% to 14.2% after surgery. With improved data capturing, missing data reduced from 29.22% to 1.05%. The time interval between surgeries was 10.58 months in 2002 and 14.49 months in 2012. Malays (40.2%) and those aged 61-70 years (38.1%) had the highest number of SECS. Those aged 40-50 years (10.96 months) and with poorer vision (9.97 months) had the shortest time interval between the 2 surgeries. The commonest surgical method was phacoemulsification (72.3%). Negeri Sembilan State had the highest SECS rate (35.91%) and Melaka had the shortest interval between surgeries (10.15 months).
CONCLUSIONS: Despite an increase in the number of SECS, the time interval is still long. Poor presenting second eye vision and disparity among different states warrants the health authority's attention and intervention.
METHODS: From Malaysian National Stroke Registry, we included patients with non-fatal ischemic stroke. Prescriptions of antiplatelet, anticoagulants, antihypertensive drugs and lipid-lowering drugs were assessed. Multi-level logistic regressions were performed to determine the relation between potential factors and drug prescriptions.
RESULTS: Of 5292 patients, 48% received antihypertensive drugs, 88.9% antiplatelet and 88.7% lipid-lowering drugs upon discharge. Thirty-three percent of patients with an indication for anticoagulants (n = 391) received it. Compared to patients <=50 years, patients above 70 years were less likely to receive antiplatelet (OR: 0.72, 95% CI: 0.50-1.03), lipid-lowering drugs (OR: 0.66, 95% CI: 0.45-0.95) and anticoagulants (OR: 0.27, 95% CI: 0.09-0.83). Patients with moderate to severe disability upon discharge had less odds of receiving secondary preventive drugs; an odds ratio of 0.57 (95% CI: 0.45-0.71) for antiplatelet, 0.86 (95% CI: 0.75-0.98) for antihypertensive drugs and 0.78 (95% CI: 0.63-0.97) for lipid-lowering drugs in comparison to those with minor disability. Having prior specific comorbidities and drug prescriptions significantly increased the odds of receiving these drugs. No differences were found between sexes and ethnicities.
CONCLUSIONS: Prescription of antihypertensive drugs and anticoagulants among ischemic stroke patients in Malaysia were suboptimal. Efforts to initiate regular clinical audits to evaluate the uptake and effectiveness of secondary preventive strategies are timely in low and middle-income settings.
DESIGN: Retrospective study.
SETTING: Malaysian National Cardiovascular Disease Database-Acute Coronary Syndrome (NCVD-ACS) registry years 2006-2013, which consists of 18 hospitals across the country.
PARTICIPANTS: 7180 male patients diagnosed with STEMI from the NCVD-ACS registry.
PRIMARY AND SECONDARY OUTCOME MEASURES: A graphical model based on the Bayesian network (BN) approach has been considered. A bootstrap resampling approach was integrated into the structural learning algorithm to estimate probabilistic relations between the studied features that have the strongest influence and support.
RESULTS: The relationships between 16 features in the domain of CVD were visualised. From the bootstrap resampling approach, out of 250, only 25 arcs are significant (strength value ≥0.85 and the direction value ≥0.50). Age group, Killip class and renal disease were classified as the key predictors in the BN model for male patients as they were the most influential variables directly connected to the outcome, which is the patient status. Widespread probabilistic associations between the key predictors and the remaining variables were observed in the network structure. High likelihood values are observed for patient status variable stated alive (93.8%), Killip class I on presentation (66.8%), patient younger than 65 (81.1%), smoker patient (77.2%) and ethnic Malay (59.2%). The BN model has been shown to have good predictive performance.
CONCLUSIONS: The data visualisation analysis can be a powerful tool to understand the relationships between the CVD prognostic variables and can be useful to clinicians.