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.
AIM: To systematically review all available evidence to describe the incidence, clinical course with management and propose a definition.
METHODS: The databases PubMed, EMBASE and Cochrane databases were searched using with the keywords up to June 2020. Additional manual search was performed and cross-checked for additional references. Data collected included demographics, reason for colonoscopy, time to diagnosis, method of diagnosis (clinical vs imaging) and management outcomes.
RESULTS: A total of nine studies were included in the final systematic review with a total of 339 cases. The time to diagnosis post-colonoscopy ranged from 2 h to 30 d. Clinical presentation for these patients were non-specific including abdominal pain, nausea/vomiting, per rectal bleeding and chills/fever. Majority of the cases were diagnosed based on computed tomography scan. The management for these patients were similar to the usual patients presenting with diverticulitis where most resolve with non-operative intervention (i.e., antibiotics and bowel rest).
CONCLUSION: The entity of post-colonoscopy diverticulitis remains contentious where there is a wide duration post-procedure included. Regardless of whether this is a true complication post-colonoscopy or a de novo event, early diagnosis is vital to guide appropriate treatment. Further prospective studies especially registries should include this as a complication to try to capture the true incidence.
STUDY DESIGN: Prospective observational cohort study.
SETTING & PARTICIPANTS: 552 children and adolescents from 27 countries on maintenance HD followed up prospectively by the International Pediatric HD Network (IPHN) Registry between 2012 and 2017.
PREDICTOR: Type of vascular access: AVF, central venous catheter (CVC), or arteriovenous graft.
OUTCOME: Infectious and noninfectious vascular access complication rates, dialysis performance, biochemical and hematologic parameters, and clinical outcomes.
ANALYTICAL APPROACH: Univariate and multivariable linear mixed models, generalized linear mixed models, and proportional hazards models; cumulative incidence functions.
RESULTS: During 314 cumulative patient-years, 628 CVCs, 225 AVFs, and 17 arteriovenous grafts were placed. One-third of the children with an AVF required a temporary CVC until fistula maturation. Vascular access choice was associated with age and expectations for early transplantation. There was a 3-fold higher living related transplantation rate and lower median time to transplantation of 14 (IQR, 6-23) versus 20 (IQR, 14-36) months with CVCs compared with AVFs. Higher blood flow rates and Kt/Vurea were achieved with AVFs than with CVCs. Infectious complications were reported only with CVCs (1.3/1,000 catheter-days) and required vascular access replacement in 47%. CVC dysfunction rates were 2.5/1,000 catheter-days compared to 1.2/1,000 fistula-days. CVCs required 82% more revisions and almost 3-fold more vascular access replacements to a different site than AVFs (P<0.001).
LIMITATIONS: Clinical rather than population-based data.
CONCLUSIONS: CVCs are the predominant vascular access choice in children receiving HD within the IPHN. Age-related anatomical limitations and expected early living related transplantation were associated with CVC use. CVCs were associated with poorer dialysis efficacy, higher complication rates, and more frequent need for vascular access replacement. Such findings call for a re-evaluation of pediatric CVC use and practices.
METHODS: This is a population-based secondary data analysis using the national mortality registry from 2004 to 2014. Past trend estimation was conducted using Murtagh's minimum and maximum methods and Gómez-Batiste's method. The estimated palliative care needs were stratified by age groups, gender and administrative states in Malaysia. With this, the projection of palliative care needs up to 2030 was conducted under the assumption that annual change remains constant.
RESULTS: The palliative care needs in Malaysia followed an apparent upward trend over the years regardless of the estimation methods. Murtagh's minimum estimation method showed that palliative care needs grew 40% from 71 675 cases in 2004 to 100 034 cases in 2014. The proportion of palliative care needs in relation to deaths hovered at 71% in the observed years. In 2030, Malaysia should anticipate the population needs to be at least 239 713 cases (240% growth from 2014), with the highest needs among age group ≥80-year-old in both genders. Sarawak, Perak, Johor, Selangor and Kedah will become the top five Malaysian states with the highest number of needs in 2030.
CONCLUSION: The need for palliative care in Malaysia will continue to rise and surpass its service provision. This trend demands a stepped-up provision from the national health system with advanced integration of palliative care services to narrow the gap between needs and supply.
METHODS AND RESULTS: Data were pooled from two prospective, real-world Watchman LAAC registries running in parallel in Europe/Middle-East/Russia (EWOLUTION) and Asia/Australia (WASP) between 2013 and 2015. Of the 1140 patients, 142 subjects at 11 centres underwent a concomitant AF ablation and LAAC procedure. The mean CHA2DS2-VASc score was 3.4 ± 1.4 and HAS-BLED score 1.5 ± 0.9. Successful LAAC was achieved in 99.3% of patients. The 30-day device and/or procedure-related serious adverse event rate was 2.1%. After a mean follow-up time of 726 ± 91 days, 92% of patients remained off oral anticoagulation. The rates of the composite endpoint of ischaemic stroke/transient ischaemic attack/systemic thromboembolism were 1.09 per 100 patient-years (100-PY); and for non-procedural major bleeding were 1.09 per 100-PY. These represent relative reductions of 84% and 70% vs. expected rates per risk scores.
CONCLUSION: The long-term outcomes from these international, multicentre registries show efficacy for all-cause stroke prevention and a significant reduction in late bleeding events in a population of high stroke risk post-ablation patients who have been withdrawn from oral anticoagulation.
METHODS: An Excel-based budget impact model was constructed to assess dialysis-associated costs when changing dialysis modalities between PD and ICHD. The model incorporates the current modality distribution and accounts for Malaysian government dialysis payments and erythropoiesis-stimulating agent costs. Epidemiological data including dialysis prevalence, incidence, mortality, and transplant rates from the Malaysian renal registry reports were used to estimate the dialysis patient population for the next 5 years. The baseline scenario assumed a stable distribution of PD (8%) and ICHD (92%) over 5 years. Alternative scenarios included the prevalence of PD increasing by 2.5%, 5.0%, and 7.5% or decreasing 1% yearly over 5 years. All four scenarios were accompanied with commensurate changes in ICHD.
RESULTS: Under the current best available cost information, an increase in the prevalent PD population from 8% in 2014 to 18%, 28%, or 38% in 2018 is predicted to result in 5-year cumulative savings of Ringgit Malaysia (RM) 7.98 million, RM15.96 million, and RM23.93 million, respectively, for the Malaysian government. If the prevalent PD population were to decrease from 8% in 2014 to 4.0% by 2018, the total expenditure for dialysis treatments would increase by RM3.19 million over the next 5 years.
CONCLUSIONS: Under the current cost information associated with PD and HD paid by the Malaysian government, increasing the proportion of patients on PD could potentially reduce dialysis-associated costs in Malaysia.
MATERIALS AND METHODS: The evaluation was conducted among key informants in the National Cancer Registry (NCR) and reporting facilities from FebMay 2012 and was based on US CDC guidelines. Representativeness was assessed by matching cancer case in the Health Information System (HIS) and state pathology records with those in NCR. Data quality was measured through case finding and reabstracting of medical records by independent auditors. The reabstracting portion comprised 15 data items. Selfadministered questionnaires were used to assess simplicity and acceptability. Timeliness was measured from date of diagnosis to date of notification received and data dissemination.
RESULTS: Of 4613 cancer cases reported in HIS, 83.3% were matched with cancer registry. In the state pathology centre, 99.8% was notified to registry. Duplication of notification was 3%. Data completeness calculated for 104 samples was 63.4%. Registrars perceived simplicity in coding diagnosis as moderate. Notification process was moderately acceptable. Median duration of interval 1 was 5.7 months.
CONCLUSIONS: The performances of registry's attributes are fairly positive in terms of simplicity, case reporting sensitivity, and predictive value positive. It is moderately acceptable, data completeness and inflexible. The usefulness of registry is the area of concern to achieve registry objectives. Timeliness of reporting is within international standard, whereas timeliness to data dissemination was longer up to 4 years. Integration between existing HIS and national registration department will improve data quality.
Aim: This study sought to investigate whether glucose and lipid profiles could prognosticate stroke recurrence in Malaysia.
Methods: We conducted a retrospective hospital-based study where we analyzed the first-ever stroke cases regarding about which the Malaysia National Stroke Registry was informed between 2009 and 2017, that fulfilled this study's criteria, and that were followed for stroke recurrence. Using the Cox proportional hazard regression analysis, we estimated the adjusted hazard ratios (HRs), which reflected the prognostic effect of the primary variables (i.e., glucose and lipid profiles on the first-stroke admission) on stroke recurrence.
Results: Among the 8,576 first-ever stroke patients, 394 (4.6%) experienced a subsequent first stroke recurrence event. The prognostic effect measured by univariable Cox regression showed that, when unadjusted, ten variables have prognostic value with regards to stroke recurrence. A multivariable regression analysis revealed that glucose was not a significant prognostic factor (adjusted HR 1.28; 95% CI [1.00-1.65]), while triglyceride level was the only parameter in the lipid profile found to have an independent prognostication concerning stroke recurrence (adjusted HR: 1.28 to 1.36).
Conclusions: Triglyceride could independently prognosticate stroke recurrence, which suggests the role of physicians in intervening hypertriglyceridemia. In line with previous recommendations, we call for further investigations in first-ever stroke patients with impaired glucose and lipid profiles and suggest a need for interventions in these patients.
METHODS: Clinical, laboratory, and PRO data (Chronic Liver Disease Questionnaire-nonalcoholic steatohepatitis [NASH], Functional Assessment of Chronic Illness Therapy-Fatigue, and the Work Productivity and Activity Index) were collected from NAFLD patients seen in real-world practices and enrolled in the Global NAFLD/NASH Registry encompassing 18 countries in 6 global burden of disease super-regions.
RESULTS: Across the global burden of disease super-regions, NAFLD patients (n = 5691) were oldest in Latin America and Eastern Europe and youngest in South Asia. Most men were enrolled at the Southeast and South Asia sites. Latin America and South Asia had the highest employment rates (>60%). Rates of cirrhosis varied (12%-21%), and were highest in North Africa/Middle East and Eastern Europe. Rates of metabolic syndrome components varied: 20% to 25% in South Asia and 60% to 80% in Eastern Europe. Chronic Liver Disease Questionnaire-NASH and Functional Assessment of Chronic Illness Therapy-Fatigue PRO scores were lower in NAFLD patients than general population norms (all P < .001). Across the super-regions, the lowest PRO scores were seen in Eastern Europe and North Africa/Middle East. In multivariate analysis adjusted for enrollment region, independent predictors of lower PRO scores included younger age, women, and nonhepatic comorbidities including fatigue (P < .01). Patients whose fatigue scores improved over time experienced a substantial PRO improvement. Nearly 8% of Global NAFLD/NASH Registry patients had a lean body mass index, with fewer metabolic syndrome components, fewer comorbidities, less cirrhosis, and significantly better PRO scores (P < .01).
CONCLUSIONS: NAFLD patients seen in real-world practices in different countries experience a high comorbidity burden and impaired quality of life. Future research using global data will enable more precise management and treatment strategies for these patients.