Value-based payment for high-cost treatments in Singapore: a qualitative study of stakeholders' perspectives.

OBJECTIVES: The rising costs of drugs have necessitated the exploration of innovative payment methods in healthcare systems. Risk-sharing agreements (RSAs) have been implemented in many countries as a value-based payment mechanism to manage the uncertainty associated with expensive technologies. This study aimed to investigate stakeholder perspectives on value-based payment in the Singaporean context, providing insights for future directions in health technology assessment and financing. METHODS: This descriptive qualitative inquiry involved participant interviews conducted between October 2021 and April 2022. Thematic analysis was conducted in two phases to analyze the interview transcripts. RESULTS: Seventeen respondents participated in the study, and five key themes emerged from the analysis. Stakeholders viewed RSAs as moderately positive, despite limited experience with them. They emphasized the importance of clearly defining objectives and establishing transparent criteria for implementing these schemes. The current data infrastructure was identified as both a barrier and facilitator, as RSAs impose administrative burdens. To successfully implement these payment mechanisms, capacity building, and effective stakeholder engagement that fosters mutual trust and cocreation are crucial. CONCLUSION: This study confirms previously identified barriers and facilitators to successful RSA implementation while contextualizing them within the Singaporean setting. The findings suggest that value-based payment has the potential to address uncertainty and improve access to healthcare technologies, but these barriers must be addressed for the schemes to be effective.

Cancer screening programs in South-east Asia and Western Pacific.

BACKGROUND: The burden of cancer can be altered by screening. The field of cancer screening is constantly evolving; from the initiation of program for new cancer types as well as exploring innovative screening strategies (e.g. new screening tests). The aim of this study was to perform a landscape analysis of existing cancer screening programs in South-East Asia and the Western Pacific. METHODS: We conducted an overview of cancer screening in the region with the goal of summarizing current designs of cancer screening programs. First, a selective narrative literature review was used as an exploration to identify countries with organized screening programs. Second, representatives of each country with an organized program were approached and asked to provide relevant information on the organizations of their national or regional cancer screening program. RESULTS: There was wide variation in the screening strategies offered in the considered region with only eight programs identified as having an organized design. The majority of these programs did not meet all the essential criteria for being organized screening. The greatest variation was observed in the starting and stopping ages. CONCLUSIONS: Essential criteria of organized screening are missed. Improving organization is crucial to ensure that the beneficial effects of screening are achieved in the long-term. It is strongly recommended to consider a regional cancer screening network.

Acceptance of silver diamine fluoride use in community dwelling older adults, nursing home residents, and caregivers.

OBJECTIVES: To compare the level of acceptance of silver diamine fluoride (SDF) treatment between different functional groups of older adults aged 65-years-old and above. METHODS: Three groups were recruited representing functionally-independent ("Community dwelling"), frail ("Nursing home"), and functionally-dependent older adults ("Caregiver": proxy respondent involved in caring for an older adult of all functional levels). Participants viewed a video on SDF and an interviewer-led questionnaire collected demographics, dental experience and perception on SDF use. RESULTS: The study recruited 201 participants (100 "Community dwelling", 51 "Nursing home", 50 "Caregiver"). Overall, 73 % of participants were accepting of SDF treatment. Those in the "Community dwelling" group were most accepting (85 %), followed by the "Nursing home" group (61 %) and "Caregiver" group (60 %) (p<0.001). Participants were more accepting of SDF use on posterior (73 %) compared to anterior teeth (46 %). They were more accepting when SDF was presented as a treatment to avoid infection and pain (87 %), and general anesthesia (78 %). In a regression analysis, "Nursing home" and "Caregiver" participants were three times less likely to accept SDF (OR 0.27 [95 % CI: 0.13 to 0.60], and OR 0.27 [95 % CI: 0.12 to 0.58] respectively) compared to "Community dwelling" participants. After adjusting for other factors, only the "Caregiver" group remained significant (Adjusted OR 0.32 [95 % CI: 0.13 to 0.78]). CONCLUSIONS: Older adults were accepting of SDF and this treatment modality has the potential to be a routine treatment option in dental caries management in this population. However, this was less certain among frail and functionally dependent older adults. CLINICAL SIGNIFICANCE: An SDF program to manage caries is likely to be well-received by functionally-independent older adults. However, the acceptance among frail and functionally-dependent older adults were lower even though SDF is mostly likely to benefit these populations. There is a need to investigate this relatively lower levels of acceptance.

Real-world utilization and healthcare costs for multiple myeloma: A retrospective analysis of patients in Singapore.

Multiple myeloma, a hematological malignancy, imposes a significant financial burden on healthcare systems. Health technology assessments (HTA) and economic evaluations play vital roles in reimbursement decisions and cost containment. This study aimed to explore healthcare utilization patterns and costs among myeloma patients in Singapore through a retrospective analysis of 605 patients treated at two cancer centers. Data encompassing demographics, treatment utilization, and billing were extracted from electronic records, and a cost analysis was performed from the perspective of the Singapore healthcare system. The results revealed common usage of immunomodulatory agents (52%) and proteasome inhibitors (37%), with bortezomib being the most frequently used targeted treatment. Treatment costs increased with disease progression, displaying variations depending on the therapeutic agent used. Notably, hospitalization costs due to adverse events were substantial, with pneumonia as the leading cause. This study highlights the high cost of myeloma therapy in Singapore, posing a financial burden for households. Findings may inform economic evaluations, evidence generation, reimbursement, and subsidy decisions. Leveraging real-world data from electronic records provides valuable insights into local healthcare utilization patterns. Future studies may explore integrating billing databases with clinical repositories for a more comprehensive analysis, and consider limitations such as incomplete clinical information and potential selection bias.

Cross-sectional and prospective associations between children's 24-h time use and their health-related quality of life: a compositional isotemporal substitution approach.

Background: Promoting active, balanced lifestyles among children may be an important approach to optimising their health-related quality of life (HRQoL). However, the relationships between children's movement behaviours and HRQoL remain unclear. Methods: We examined the associations between movement behaviours (sleep, inactivity, light and moderate-to-vigorous intensity physical activity) assessed using accelerometers at ages 8 and 10 years and self-reported HRQoL scores (overall, and physical and emotional well-being, self-esteem, relationship with family and friends, and school functioning domains) at age 10 years among 370 children in a local birth cohort using compositional isotemporal substitution techniques. Findings: Cross-sectionally, light and moderate-to-vigorous intensity physical activities were associated with better self-esteem (ß = 15.94 [2.71, 29.18]) and relationship with friends (ß = 10.28 [3.81, 16.74]) scores respectively. Prospectively, inactivity was associated with lower overall HRQoL (ß = -10.00 [-19.13, -0.87]), relationship with friends (ß = -16.41 [-31.60, -1.23]) and school functioning (ß = -15.30 [-29.16, -1.44]) scores, while sleep showed a positive trend with overall HRQoL (ß = 10.76 [-1.09, 22.61]) and school functioning (ß = 17.12 [-0.87, 35.10]) scores. Children's movement behaviours were not associated with their physical and emotional well-being, or relationship with family scores. The isotemporal substitution analyses suggest that increasing time spent in physical activity and/or sleep at the expense of inactivity may benefit children's HRQoL. Interpretation: Our findings suggest that sleep and physical activity may be associated with better HRQoL, with the inverse for inactivity. However, the relationship between children's movement behaviours and HRQoL is complex and warrants further research. Funding: Singapore National Research Foundation, Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research.

Correction: Chua et al. Cost-Effectiveness Analysis of HPV Extended versus Partial Genotyping for Cervical Cancer Screening in Singapore. Cancers 2023, 15, 1812.

The authors wish to revise two words in Table 1 row 3, and the first paragraph of Section 2 [...].

The Impact of COVID-19 Infection Control Measures on End-Stage Renal Disease Patients in a Community Hemodialysis Setting.

INTRODUCTION: Several non-pharmaceutical infection control measures have been implemented at community-based hemodialysis centers to reduce the risk of Coronavirus Disease of 2019 (COVID-19) transmission, caused by the SARS-CoV-2 virus. However, there have been concerns that such measures may disrupt the routine and timely care required by patients, with adverse effects on their health outcomes. This cross-sectional study aims to determine the unintended consequences of COVID-19 infection control measures on hemodialysis patients. METHODS:  Electronic medical records were extracted from patients enrolled in community-based hemodialysis centers in Singapore. A baseline group prior of patients consisted of those enrolled in 2017, which was three years prior to the SARS-CoV-2-related pandemic (n = 548). This was compared with the study group of patients enrolled in 2019 (n = 426), just before the COVID-19 pandemic started. Medical records for these two groups were extracted from January to July 2018 for the baseline group and from January to July 2020, respectively. Three regression models were built to study dialysis adherence, kidney disease biomarkers, and hospitalization episodes. RESULTS:  There was no statistically significant difference in hospitalization and mortality outcomes, adherence to dialysis management, laboratory results for dialysis-related clearance, and anemia outcomes. There was a higher proportion of patients hospitalized for vascular access-related reasons in the study group as compared to the baseline group (OR 1.6, 95% CI: 1.10 to 2.29, P = 0.014). Patients in the study group had albumin levels 2.13% higher (95% CI: 0.88 to 3.39, P < 0.001) and alkaline phosphatase levels 7.3% lower (95% CI: 1.17 to 13.02, P = 0.020) than those in the baseline group. CONCLUSIONS:  From this community-based hemodialysis study in Singapore, it was shown that the COVID-19 pandemic did not disrupt regular healthcare services for these patients. With strategies instituted for a coordinated health delivery workflow, ensuring sufficient capacity in the various healthcare delivery sites and overall pandemic preparedness, the patient clinical outcomes measures continued to be met with no adverse consequences noted. Some improvements in dialysis-related laboratory values and quality of care targets may be due to more stringent measures instituted to protect these vulnerable patients in the community.

What, Where, and How to Collect Real-World Data and Generate Real-World Evidence to Support Drug Reimbursement Decision-Making in Asia: A reflection Into the Past and A Way Forward.

BACKGROUND: Globally, there is increasing interest in the use of real-world data (RWD) and real-world evidence (RWE) to inform health technology assessment (HTA) and reimbursement decision-making. Using current practices and case studies shared by eleven health systems in Asia, a non-binding guidance that seeks to align practices for generating and using RWD/RWE for decision-making in Asia was developed by the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) Working Group, addressing a current gap and needs among HTA users and generators. METHODS: The guidance document was developed over two face-to-face workshops, in addition to an online survey, a face-to-face interview and pragmatic search of literature. The specific focus was on what, where and how to collect RWD/ RWE. RESULTS: All 11 REALISE member jurisdictions participated in the online survey and the first in-person workshop, 10 participated in the second in-person workshop, and 8 participated in the in-depth face-to-face interviews. The guidance document was iteratively reviewed by all working group members and the International Advisory Panel. There was substantial variation in: (a) sources and types of RWD being used in HTA, and (b) the relative importance and prioritization of RWE being used for policy-making. A list of national-level databases and other sources of RWD available in each country was compiled. A list of useful guidance on data collection, quality assurance and study design were also compiled. CONCLUSION: The REALISE guidance document serves to align the collection of better quality RWD and generation of reliable RWE to ultimately inform HTA in Asia.

Implementing outcomes-based risk-sharing agreements: an integrative review of applications in blood cancer in the UK and beyond.

INTRODUCTION: Outcomes-based risk-sharing agreements (OBRSA) have been increasingly used worldwide to manage uncertainty in value assessments. This review aimed to summarize motivations, barriers, and facilitators to implementing OBRSAs with a specific focus on therapies for hematological cancer. AREAS COVERED: An integrative review was conducted based on a scoping of existing reviews on the topic and reports published by UK NICE. Findings from 16 articles and 10 reports were summarized and categorized into three themes: applications in blood cancer drugs, motivations for adoption, and barriers and facilitators to implementation. EXPERT OPINION: There was a dissociation between the theoretical basis for opting for OBRSAs, and reasons stated or inferred from practice. The administrative burden was considered a notable barrier to implementation, which affects not only payers and manufacturers but also healthcare providers. Effective stakeholder engagement and building mutual trust among key groups were identified as factors enabling successful implementation. The review raises essential considerations in implementing OBRSAs and implications for their future role, particularly for blood cancer drugs where uncertainty is rife. Carefully designed and managed schemes may remain an option for health systems to manage risks involved when funding high-cost treatments.

Cost benefit analysis of alternative testing and quarantine policies for travelers for infection control: A case study of Singapore during the COVID-19 pandemic.

Background: Border control mitigates local infections but bears a heavy economic cost, especially for tourism-reliant countries. While studies have supported the efficacy of border control in suppressing cross-border transmission, the trade-off between costs from imported and secondary cases and from lost economic activities has not been studied. This case study of Singapore during the COVID-19 pandemic aims to understand the impacts of varying quarantine length and testing strategies on the economy and health system. Additionally, we explored the impact of permitting unvaccinated travelers to address emerging equity concerns. We assumed that community transmission is stable and vaccination rates are high enough that inbound travelers are not dissuaded from traveling. Methods: The number of travelers was predicted considering that longer quarantine reduces willingness to travel. A micro-simulation model predicted the number of COVID-19 cases among travelers, the resultant secondary cases, and the probability of being symptomatic in each group. The incremental net monetary benefit (INB) of Singapore was quantified under each border-opening policy compared to pre-opening status, based on tourism receipts, cost/profit from testing and quarantine, and cost and health loss due to COVID-19 cases. Results: Compared to polymerase chain reaction (PCR), rapid antigen test (ART) detects fewer imported cases but results in fewer secondary cases. Longer quarantine results in fewer cases but lower INB due to reduced tourism receipts. Assuming the proportion of unvaccinated travelers is small (8% locally and 24% globally), allowing unvaccinated travelers will accrue higher INB without exceeding the intensive care unit (ICU) capacity. The highest monthly INB from all travelers is $2,236.24 m, with 46.69 ICU cases per month, achieved with ARTs at pre-departure and on arrival without quarantine. The optimal policy in terms of highest INB is robust under changes to various model assumptions. Among all cost-benefit components, the top driver for INB is tourism receipts. Conclusions: With high vaccination rates locally and globally alongside stable community transmission, opening borders to travelers regardless of vaccination status will increase economic growth in the destination country. The caseloads remain manageable without exceeding ICU capacity, and costs of cases are offset by the economic value generated from travelers.

Economic Analysis of Border Control Policies during COVID-19 Pandemic: A Modelling Study to Inform Cross-Border Travel Policy between Singapore and Thailand.

With countries progressing towards high COVID-19 vaccination rates, strategies for border reopening are required. This study focuses on Thailand and Singapore, two countries that share significant tourism visitation, to illustrate a framework for optimizing COVID-19 testing and quarantine policies for bilateral travel with a focus on economic recovery. The timeframe is the month of October 2021, when Thailand and Singapore were preparing to reopen borders for bilateral travel. This study was conducted to provide evidence for the border reopening policy decisions. Incremental net benefit (INB) compared to the pre-opening period was quantified through a willingness-to-travel model, a micro-simulation COVID-19 transmission model and an economic model accounting for medical and non-medical costs/benefits. Multiple testing and quarantine policies were examined, and Pareto optimal (PO) policies and the most influential components were identified. The highest possible INB for Thailand is US $125.94 million, under a PO policy with no quarantine but with antigen rapid tests (ARTs) pre-departure and upon arrival to enter both countries. The highest possible INB for Singapore is US $29.78 million, under another PO policy with no quarantine on both sides, no testing to enter Thailand, and ARTs pre-departure and upon arrival to enter Singapore. Tourism receipts and costs/profits of testing and quarantine have greater economic impacts than that from COVID-19 transmission. Provided healthcare systems have sufficient capacity, great economic benefits can be gained for both countries by relaxing border control measures.

Cost-Effectiveness Analysis of HPV Extended versus Partial Genotyping for Cervical Cancer Screening in Singapore.

Human papillomavirus (HPV) partial genotyping (PGT) identifies HPV16 and HPV18 individually, alongside 12 other high-risk HPV genotypes (hrHPV) collectively. HPV extended genotyping (XGT) identifies four additional hrHPV individually (HPV31, 45, 51, and 52), and reports the remaining eight in three groups (HPV33|58; 56|59|66; 35|39|68). Quality-adjusted life years (QALY), health care resource use, and costs of XGT were compared to PGT for cervical cancer screening in Singapore using DICE simulation. Women with one of the three hrHPV identified by XGT (HPV35|39|68; 56|59|66; 51), and atypical squamous cells of undetermined significance (ASCUS) on cytology, are recalled for a repeat screening in one year, instead of undergoing an immediate colposcopy with PGT. At the repeat screening, the colposcopy is performed only for persistent same-genotype infections in XGT, while with PGT, all the women with persistent HPV have a colposcopy. Screening 500,122 women, aged 30-69, with XGT, provided an incremental cost-effectiveness ratio (ICER) versus PGT of SGD 16,370/QALY, with 7130 (19.4%) fewer colposcopies, 6027 (7.0%) fewer cytology tests, 9787 (1.6%) fewer clinic consultations, yet 2446 (0.5%) more HPV tests. The XGT ICER remains well below SGD 100,000 in sensitivity analyses, (-SGD 17,736/QALY to SGD 50,474/QALY). XGT is cost-effective compared to PGT, utilizes fewer resources, and provides a risk-based approach as the primary cervical cancer screening method.

What are the impacts of increasing cost-effectiveness Threshold? a protocol on an empirical study based on economic evaluations conducted in Thailand.

BACKGROUND: Economic evaluations have been widely used to inform and guide policy-making process in healthcare resources allocation as a part of an evidence package. An intervention is considered cost-effective if an ICER is less than a cost-effectiveness threshold (CET), where a CET represents the acceptable price for a unit of additional health gain which a decision-maker is willing to pay. There has been discussion to increase a CET in many settings such as the United Kingdom and Thailand. To the best of our knowledge, Thailand is the only country that has an explicit CET and has revised their CET, not once but twice. Hence, the situation in Thailand provides a unique opportunity for evaluating the impact of changing CET on healthcare expenditure and manufacturers' behaviours in the real-world setting. Before we decide whether a CET should be increased, information on what happened after the CET was increased in the past could be informative and helpful. OBJECTIVES: This study protocol describes a proposed plan to investigate the impact of increased cost-effectiveness threshold using Thailand as a case study. Specifically, we will examine the impact of increasing CET on the drug prices submitted by pharmaceutical companies to the National List of Essential Medicine (NLEM), the decision to include or exclude medications in the NLEM, and the overall budget impact. MATERIALS AND DESIGNS: Retrospective data analysis of the impact of increased CET on national drug committee decisions in Thailand (an upper middle-income country) will be conducted and included data from various sources such as literature, local organizations (e.g. Thai Food and Drug Administration), and inputs from stakeholder consultation meetings. The outcomes include: (1) drug price submitted by the manufacturers and final drug price included in the NLEM if available; (2) decisions about whether the drug was included in the NLEM for reimbursement; and (3) budget impact. The independent variables include a CET, the variable of interest, which can take values of THB100,000, THB120,000, or THB160,000, and potential confounders such as whether this drug was for a chronic disease, market size, and primary endpoint. We will conduct separate multivariable regression analysis for each outcome specified above. DISCUSSION: Understanding the impact of increasing the CET would be helpful in assisting the decision to use and develop an appropriate threshold for one's own setting. Due to the nature of the study design, the findings will be prone to confounding effect and biases; therefore, the analyses will be adjusted for potential confounders and statistical methods will be explored to minimize biases. Knowledge gained from the study will be conveyed to the public through various disseminations such as reports, policy briefs, academic journals, and presentations.

Barriers to breast cancer screening in Singapore: A literature review.

INTRODUCTION: Breast cancer is a leading cause of cancer death among women, and its age-standardised incidence rate is one of the highest in Asia. We aimed to review studies on barriers to breast cancer screening to inform future policies in Singapore. METHOD: This was a literature review of both quantitative and qualitative studies published between 2012 and 2020 using PubMed, Google Scholar and Cochrane databases, which analysed the perceptions and behaviours of women towards breast cancer screening in Singapore. RESULTS: Through a thematic analysis based on the Health Belief Model, significant themes associated with low breast cancer screening uptake in Singapore were identified. The themes are: (1) high perceived barriers versus benefits, including fear of the breast cancer screening procedure and its possible outcomes, (2) personal challenges that impede screening attendance and paying for screening and treatment, and (3) low perceived susceptibility to breast cancer. CONCLUSION: Perceived costs/barriers vs benefits of screening appear to be the most common barriers to breast cancer screening in Singapore. Based on the barriers identified, increasing convenience to get screened, reducing mammogram and treatment costs, and improving engagement with support groups are recommended to improve the screening uptake rate in Singapore.

The Relative Importance of Vulnerability and Efficiency in COVID-19 Contact Tracing Programmes: A Discrete Choice Experiment.

Objectives: This study aims to assess the trade-offs between vulnerability and efficiency attributes of contact tracing programmes based on preferences of COVID-19 contact tracing practitioners, researchers and other relevant stakeholders at the global level. Methods: We conducted an online discrete choice experiment (DCE). Respondents were recruited globally to explore preferences according to country income level and the prevailing epidemiology of COVID-19 in the local setting. The DCE attributes represented efficiency (timeliness, completeness, number of contacts), vulnerability (vulnerable population), cooperation and privacy. A mixed-logit model and latent class analysis were used. Results: The number of respondents was 181. Timeliness was the most important attribute regardless of country income level and COVID-19 epidemiological condition. Vulnerability of contacts was the second most important attribute for low-to-lower-middle-income countries and third for upper-middle-to-high income countries. When normalised against conditional relative importance of timeliness, conditional relative importance of vulnerability ranged from 0.38 to 0.42. Conclusion: Vulnerability and efficiency criteria were both considered to be important attributes of contact tracing programmes. However, the relative values placed on these criteria varied significantly between epidemiological and economic context.

Health care provider's experience and perspective of cervical cancer screening in Singapore: A qualitative study.

Background: In Singapore, the current cervical cancer screening (CCS) coverage rate of 48% falls below the national target of 70%. Health care providers (HCPs) play a critical role in promoting CCS uptake. However, there is limited understanding of the perspectives of HCPs regarding CCS. Hence, we aimed to understand the challenges encountered by HCPs delivering CCS in different care settings in the Singapore health system. We also aimed to explore perspectives on newer features of CCS such as self-sampling and HPV genotyping. Methods: Physicians, nurses, program administrators and laboratory technicians involved with CCS were invited for a one-on-one semi-structured interview conducted over Zoom between May to August 2021. The interviews were transcribed and analyzed using thematic analysis. Results: Eighteen HCPs from 12 institutions were interviewed. Most participants were women (61.1%) and worked in public health institutions (72.2%). For factors influencing CCS, nine key themes were identified and organized into four categories: (1) patient factors, (2) HCP factors, (3) health system factors and (4) health promotion factors. Key themes commonly highlighted by study participants were related to patients' preferences and acceptance for screening, the processes of delivering CCS, the national priority for cervical cancer and the effectiveness of existing health promotion efforts. Five key themes were identified for CCS innovations. Self-sampling was viewed favorably to increase CCS uptake, while primary HPV screening with HPV partial genotyping had higher sensitivities to detect pre-cancers and cancers compared to cytology. Extended HPV genotyping beyond HPV16/18 could play an important role in CCS with increasing HPV vaccination coverage, as well as in the management of persistent HPV infection. Conclusion: In Singapore, HCPs face multiple challenges for CCS in practice. Insights from this study are directly relevant to, and useful for developing policies around national CCS programs and treatment guidelines.

A Data-Driven Analysis of the Economic Cost of Non-Pharmaceutical Interventions: A Cross-Country Comparison of Kenya, Singapore, and Thailand.

Objective: To estimate the economic impact of border closure and social distancing by estimating the decline of gross domestic product (GDP) in Kenya, Singapore and Thailand. Methods: We analysed secondary data retrospectively. To calculate impact of NPIs on GDP, the relationship between GDP and stock market index was examined using ordinary least squares (OLS). Then, autoregressive and moving averages (ARMA) model was used to examine the impact of NPI on stock market index. The change in GDP due to NPIs was derived by multiplying coefficients of OLS and ARMA models. Results: An increase in stock market index correlated with an increase in GDP, while both social distancing and border closure negatively correlated with stock market index. Implementation of NPIs correlated with the decline in GDP. Thai border closure had a greater decline in GDP than social distancing; Kenya exhibited the same trends; Singapore had the opposite trend. Conclusion: We quantified the magnitude of economic impact of NPIs in terms of GDP decline by linking stock market index and GDP. This approach may be applicable in other settings.

Professional Oversight of Emergency-Use Interventions and Monitoring Systems: Ethical Guidance From the Singapore Experience of COVID-19.

High degrees of uncertainty and a lack of effective therapeutic treatments have characterized the COVID-19 pandemic and the provision of drug products outside research settings has been controversial. International guidelines for providing patients with experimental interventions to treat infectious diseases outside of clinical trials exist but it is unclear if or how they should apply in settings where clinical trials and research are strongly regulated. We propose the Professional Oversight of Emergency-Use Interventions and Monitoring System (POEIMS) as an alternative pathway based on guidance developed for the ethical provision of experimental interventions to treat COVID-19 in Singapore. We support our proposal with justifications that establish moral duties for physicians to record outcomes data and for institutions to establish monitoring systems for reporting information on safety and effectiveness to the relevant authorities. Institutions also have a duty to support generation of evidence for what constitutes good clinical practice and so should ensure the unproven intervention is made the subject of research studies that can contribute to generalizable knowledge as soon as practical and that physicians remain committed to supporting learning health systems. We outline key differences between POEIMS and other pathways for the provision of experimental interventions in public health emergencies.

BREAst screening Tailored for HEr (BREATHE)-A study protocol on personalised risk-based breast cancer screening programme.

Routine mammography screening is currently the standard tool for finding cancers at an early stage, when treatment is most successful. Current breast screening programmes are one-size-fits-all which all women above a certain age threshold are encouraged to participate. However, breast cancer risk varies by individual. The BREAst screening Tailored for HEr (BREATHE) study aims to assess acceptability of a comprehensive risk-based personalised breast screening in Singapore. Advancing beyond the current age-based screening paradigm, BREATHE integrates both genetic and non-genetic breast cancer risk prediction tools to personalise screening recommendations. BREATHE is a cohort study targeting to recruit ~3,500 women. The first recruitment visit will include questionnaires and a buccal cheek swab. After receiving a tailored breast cancer risk report, participants will attend an in-person risk review, followed by a final session assessing the acceptability of our risk stratification programme. Risk prediction is based on: a) Gail model (non-genetic), b) mammographic density and recall, c) BOADICEA predictions (breast cancer predisposition genes), and d) breast cancer polygenic risk score. For national implementation of personalised risk-based breast screening, exploration of the acceptability within the target populace is critical, in addition to validated predication tools. To our knowledge, this is the first study to implement a comprehensive risk-based mammography screening programme in Asia. The BREATHE study will provide essential data for policy implementation which will transform the health system to deliver a better health and healthcare outcomes.