Controversies in terminology associated with management of BCG-unresponsive NMIBC in Asia-Pacific.

OBJECTIVES: Examine the understanding of terminologies and management patterns of bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC) in six territories in Asia-Pacific. METHODS: This study involved two phases: (1) a survey with 32 urologists and 7 medical oncologists (MOs) and (2) a factorial experiment and in-depth interviews with 23 urologists and 2 MOs. All clinicians had ≥8 years' experience managing NMIBC patients in Australia, Hong Kong, Japan, South Korea, Singapore, and Taiwan. Data from Phase 1 were summarized using descriptive statistics; content and thematic analyses applied in Phase 2. RESULTS: In phase 1, 35% of clinicians defined BCG-unresponsive as BCG-refractory, -relapse and -resistant, 6% defined it as BCG-refractory and -relapse; 22% classified BCG-failure as BCG-refractory, -relapse, -resistant, and when muscle-invasive bladder cancer is detected. If eligible and willing, 50% (interquartile range [IQR], 50%-80%) of BCG-unresponsive patients would undergo radical cystectomy (RC), and 50% (IQR 20%-50%) of RC-eligible patients would receive bladder-sparing treatment or surveillance. In phase 2, we found that 32%, 88%, and 48% of clinicians, respectively, used "BCG-unresponsive," "BCG-refractory," and "BCG-relapse" in clinical practice but with no consistent interpretation of the terms. Compared with EAU definitions, 8%-60% of clinicians appropriately classified 9 tumor types that are persistent or recurrent after adequate BCG. Fifty percent of clinicians mentioned a lack of bladder-preserving treatment that outperforms RC in quality of life as a reason to retreat BCG-unresponsive patients with BCG. CONCLUSIONS: Our study revealed varied understanding and application of BCG-unresponsive terminologies in practice. There is a need for a uniform and simple definition of BCG-unresponsive disease in Asia-Pacific.

Risk stratification and management of non-muscle-invasive bladder cancer: A physician survey in six Asia-Pacific territories.

OBJECTIVES: Multiple clinical practice guidelines, conflicting evidence, and physician perceptions result in variations in risk stratification among patients with non-muscle-invasive bladder cancer (NMIBC). This study aims to describe the extent of this variation and its impact on management approaches in the Asia-Pacific region. METHODS: We conducted a cross-sectional survey involving 32 urologists and seven medical oncologists with ≥8 years of experience managing early-stage bladder cancer patients across Australia, Hong Kong, Japan, South Korea, Singapore, and Taiwan. The physicians completed an anonymous questionnaire that assessed their risk stratification and respective management approaches, based on 19 NMIBC characteristics. For each NMIBC characteristic, they were required to select one risk group, and their most preferred management approach. RESULTS: Our results demonstrated a higher consensus on risk classification versus management approaches. More than 50% of the respondents agreed on the risk classification of all NMIBC characteristics, but 42% or fewer chose the same treatment option as their preferred choice for all but two characteristics-existence of variant histology (55%) and persistent high-grade T1 disease on repeat resection (52%). Across territories, there was the greatest variation in preferred treatment options (i.e., no treatment, intravesical chemotherapy, or Bacillus Calmette-Guérin [BCG] treatment) for intermediate-risk patients and the highest consensus on the treatment of very high-risk patients, namely radical cystectomy. CONCLUSIONS: Our study revealed considerable variation in risk stratification and management of NMIBC in the region. It is critical to develop practical algorithms to facilitate the recognition of NMIBC and standardize the treatment of NMIBC patients.

Clinical decision pathway and management of locally advanced head and neck squamous cell carcinoma: A multidisciplinary consensus in Asia-Pacific.

OBJECTIVES: To develop consensus on patient characteristics and disease-related factors considered in deciding treatment approaches for locally advanced head and neck squamous cell carcinoma (LA-HNSCC) based on real-world treatment patterns in 4 territories in Asia-Pacific. METHODS: A three-round modified Delphi involving a multidisciplinary panel of HN surgeons, medical oncologists, and radiation oncologists was used. Of 41 panelists recruited, responses of 26 from Australia, Japan, Singapore, and Taiwan were analyzed. All panelists had ≥five years' experience managing LA-HNSCC patients and treated ≥15 patients with LA-HNSCC annually. RESULTS: All statements on definitions of LA-HNSCC, treatment intolerance and cisplatin dosing reached consensus. 4 of 7 statements on unresectability, 2 of 4 on adjuvant chemoradiotherapy, 7 of 13 on induction chemotherapy, 1 of 8 on absolute contraindications and 7 of 11 on relative contraindications to high-dose cisplatin did not reach consensus. In all territories except Taiwan, high-dose cisplatin was preferred in definitive and adjuvant settings for patients with no contraindications to cisplatin; weekly cisplatin (40 mg/m2) preferred for patients with relative contraindications to high-dose cisplatin. For Taiwan, the main treatment option was weekly cisplatin. For patients with absolute contraindications to cisplatin, carboplatin ± 5-fluorouracil or radiotherapy alone were preferred alternatives in both definitive and adjuvant settings. CONCLUSION: This multidisciplinary consensus provides insights into management of LA-HNSCC in Asia-Pacific based on patient- and disease-related factors that guide selection of treatment modality and systemic treatment. Despite strong consensus on use of cisplatin-based regimens, areas of non-consensus showed that variability in practice exists where there is limited evidence.

Direct medical costs of type 2 diabetes mellitus in the Philippines: findings from two hospital databases and physician surveys.

OBJECTIVE: To estimate the annual direct medical cost of type 2 diabetes mellitus (T2DM) in hospitals and outpatient care clinics from a healthcare payer perspective in the Philippines. DESIGN AND PARTICIPANTS: (1) A review of electronic hospital records of people with T2DM in two tertiary hospitals-Ospital ng Makati (OsMak) and National Kidney and Transplant Institute (NKTI) and (2) a cross-sectional survey with 50 physicians providing outpatient care for people with T2DM. SETTING: Primary, secondary and tertiary healthcare facilities in Metro Manila. OUTCOME MEASURES: Cost of managing T2DM and its related complications in US dollars (USD) in 2016. RESULTS: A total of 1023 and 1378 people were identified in OsMak and NKTI, with a complication rate of 66% and 74%, respectively. In both institutions, the average annual cost per person was higher if individuals were diagnosed with any complication (NKTI: US$3226 vs US$2242 and OsMak: US$621 vs US$127). Poor diabetes control was estimated to incur higher per person cost than good control in both public outpatient care (poor control, range: US$727 to US$2463 vs good control, range: US$614 to US$1520) and private outpatient care (poor control, range: US$848 to US$2507 vs good control, range: US$807 to US$1603). CONCLUSION: The results highlight the high direct medical cost resulting from poor diabetes control and the opportunity for cost reduction by improving control and preventing its complications.

Direct non-medical and indirect costs of diabetes and its associated complications in Vietnam: an estimation using national health insurance claims from a cross-sectional survey.

OBJECTIVE: The prevalence of diabetes in Vietnam has increased from 2.5% in 2007 to 5.5% in 2017, but the burden of direct non-medical and indirect costs is unknown. The objective of this study was to estimate the direct non-medical costs and indirect costs due to type 2 diabetes mellitus (T2DM) and its associated complications among Vietnam Health Insurance System (VHIS) enrollees in Vietnam. DESIGN: The first phase was a cross-sectional survey of patients with T2DM. In the second phase, data from the previous phase were used to predict direct non-medical costs and presenteeism costs of VHIS enrollees diagnosed with T2DM based on demographic and clinical characteristics in 2017. The human-capital approach was used for the calculation of indirect costs. SETTING AND PARTICIPANTS: This study recruited 315 patients from a national hospital, a provincial hospital and a district hospital aged 18 or above, diagnosed with T2DM, enrolled in VHIS, and having at least one visit to hospitals between 1 June and 30 July 2018. The VHIS dataset contained 1,395,204 patients with T2DM. OUTCOME MEASURES: The direct non-medical costs and presenteeism were collected from the survey. Absenteeism costs were estimated from the VHIS database. Costs of premature mortality were calculated based on the estimates from secondary sources. RESULTS: The total direct non-medical and indirect costs were US$239 million in 2017. Direct non-medical costs were US$78 million, whereas indirect costs were US$161 million. Costs of absenteeism, presenteeism and premature mortality corresponded to 17%, 73% and 10% of the indirect costs. Patients incurred annual mean direct non-medical costs of US$56. Annual mean absenteeism and presenteeism costs for patients in working age were US$61 and US$267, respectively. CONCLUSIONS: The impact of T2DM on direct non-medical and indirect costs on diabetes is substantial. Direct non-medical and absenteeism costs were higher in patients with complications.

Estimating direct medical costs of type 2 diabetes mellitus in the Philippines: a protocol.

INTRODUCTION: Diabetes and its complications are a major cause of morbidity and mortality in the Philippines. The prevalence of diabetes in the Philippines has increased from 3.4 million in 2010 to 3.7 million in 2017. The government has formulated strategies to control this increase, for example, through its non-communicable disease prevention and control plan. However, there is scarce research on the financial burden of diabetes. Filling this gap may further help policymakers to make informed decisions while developing and implementing resource planning for relevant interventions. The primary objective of the current study is to estimate the direct medical costs associated with type 2 diabetes mellitus (T2DM). METHODS AND ANALYSIS: This is a 1-year retrospective cohort study of patients with T2DM in 2016. Data will be collected from: (1) hospital databases from public institutions to estimate the cost of diabetes treatment and (2) physician interviews to estimate the cost of management of diabetes in outpatient care. We will perform descriptive and comparative analyses on direct medical costs and healthcare resource utilisation, stratified by the presence of diabetes-associated complications. ETHICS AND DISSEMINATION: Research ethics board approval has been obtained from the Department of Health Single Joint Research Ethics Board and Cardinal Santos Medical Center Research Ethics Review Committee. Findings from the study will be reported in peer-reviewed scientific journals and local researcher meetings.

National Health Insurance Databases in Indonesia, Vietnam and the Philippines.

BACKGROUND: Social health insurance administrative databases were established in Indonesia, Vietnam and the Philippines in 2014, 2017 and 2012, respectively; however, these databases have been scarcely used for research, if at all. This study explored the feasibility and accessibility of using these databases for scientific research, highlighting challenges and barriers in their use. METHODOLOGY: The databases included in this evaluation comprised the Jaminan Kesehatan Nasional (JKN) from Indonesia, Vietnam Health Insurance Scheme (VHIS) from Vietnam and PhilHealth from the Philippines. These databases were qualitatively assessed based on the data capture, potential linkage to other databases or registries, data access and extraction, privacy and security, and quality and validation procedures. RESULTS: All databases contain population-based cohort data on the medical costs of reimbursed medical conditions, identified using International Classification of Diseases, Tenth Revision (ICD-10) codes. Linkage to other national databases, ensuring protection of patient privacy data, would improve their usability. Duration to database access and data extraction varies from country to country. The main limitations of all databases include the short span of data records, and the unknown degree of internal validity. Both JKN and PhilHealth databases capture bundled claims, inherently excluding information on prescriptions and out-of-pocket expenditure. Due to the recent establishment of the VHIS database, it may not be suitable for studies that intend to explore trends. CONCLUSION: The JKN, VHIS and PhilHealth databases offer population-based, financial, utilization, and demographic data, which could provide valuable epidemiological and pharmacoeconomic insights if the findings are interpreted within the limitations of each database.

An Abstinence and Safer Sex Intervention for Adolescents Attending the Public Sexually Transmitted Infection Clinic in Singapore.

PURPOSE: The objective of this study was to evaluate the efficacy of a behavioral intervention in increasing secondary abstinence and safer sex among heterosexually active adolescents aged 16-19 years. METHODS: This was a randomized controlled trial conducted at the only national sexually transmitted infection clinic in Singapore. The intervention focused on information giving, motivation, and skills building to abstain or practice safer sex. The outcome measures were self-reported secondary abstinence, consistent condom use, and keeping to one partner in the past 6 months over a 12-month period. We recruited 688 adolescents, with 337 participants receiving intervention and 351 receiving standard care (control). RESULTS: At the 12-month follow-up, 187 (56%) intervention participants and 189 (54%) control participants were retained. Over the 12-month period, the intervention had a significant effect on secondary abstinence in adolescent boys (42% vs. 27%, adjusted risk ratio [aRR] 1.80, 95% confidence interval [CI] 1.29-2.34) but not in adolescent girls (21% vs. 24%, aRR 1.10, 95% CI .68-1.66). Consistent condom use was higher among intervention adolescent girls than control adolescent girls (40% vs. 20%, aRR 2.01, 95% CI 1.32-2.82), but this effect was not evident in adolescent boys (51% vs. 43%, aRR 1.27, 95% CI .78-1.88). Intervention effect on keeping to one partner was evident in both adolescent boys (76% vs. 45%, aRR 1.35, 95% CI 1.06-1.50) and adolescent girls (79% vs. 65%, aRR 1.20, 95% CI 1.02-1.23). CONCLUSIONS: An intervention targeting adolescents in a clinical care setting did achieve an increase in secondary abstinence in adolescent boys, consistent condom use in adolescent girls, and keeping to one partner in both genders at 1-year assessment.