Diversity, Equity, and Inclusion in Patient and Family Advisory Councils: Advancing Best Practice in Children's Hospitals.

INTRODUCTION: This qualitative research study explored practices that support and advance diverse membership in Patient and Family Advisory Councils (PFACs) in children's hospitals and the involvement of PFACs in organization-level diversity, equity, and inclusion work. METHOD: This study consisted of a focused literature review and 17 key informant interviews. The study sought to identify important learnings about (1) recruiting and supporting patient and family advisors (PFAs) from historically marginalized populations and (2) ways to develop and sustain meaningful partnerships with PFAs and PFACs in diversity, equity, and inclusion work. RESULTS: The study findings highlighted a number of best practices for hospitals to adopt, including more actively reaching out to communities served, addressing barriers to participation through approaches and structures such as specialty PFACs and "tiered" options for participation by PFAs, and co-creation of inclusive environments. DISCUSSION: To move forward with this work, additional research, true commitment from health care organizations, and shared guidance and tools for the field are needed.

Development of a Health Equity Framework for the US Preventive Services Task Force.

Importance: Clinical practice guidelines can play an important role in mitigating health inequities. The US Preventive Services Task Force (USPSTF) has prioritized addressing health equity and racism in its recommendations. Objective: To develop a framework that would allow the USPSTF to incorporate a health equity lens that spans the entirety of its recommendation-making process. Evidence Review: Key guidance, policy, and explanatory frameworks related to health equity were identified, and their recommendations and findings were mapped to current USPSTF methods. USPSTF members as well as staff from multiple entities supporting the USPSTF portfolio were consulted. Based on all the gathered information, a draft health equity framework and checklist were developed; they were then circulated to the USPSTF's key partners for input and review. Findings: An equity framework was developed that could be applied to all phases of the recommendation process: (1) topic nomination, selection, and prioritization; (2) development of the work plan; (3) evidence review; (4) evidence deliberation; (5) development of the recommendation statement; and (6) dissemination of recommendations. For each phase, several considerations and checklist items to address are presented. These items include using health equity as a prioritization criterion and engaging a diverse group of stakeholders at the earliest phases in identifying topics for recommendations; developing necessary equity-relevant questions (eg, beyond effectiveness and harms) to address during the protocol phase; using methods in synthesizing the evidence and contextual issues in the evidence review related to specific populations experiencing a disproportionate burden of disease; and examining the magnitude and certainty of net benefit, implementation considerations, risk assessment, and evidence gaps through an equity lens when developing evidence-based recommendations. Conclusions and Relevance: Executing this entire framework and checklist as described will be challenging and will take additional time and resources. Nonetheless, whether adopted in its entirety or in parts, this framework offers guidance to the USPSTF, as well as other evidence-based guideline entities, in its mission to develop a more transparent, consistent, and intentional approach to addressing health equity in its recommendations.

The validation of Chinese version of workplace PERMA-profiler and the association between workplace well-being and fatigue.

BACKGROUND: Well-being is an important issue in workplace. One of these assessment tools of well-being, Workplace PERMA Profiler, is based on Seligman's five dimensions well-being. Prolonged fatigue may last for a long time, leading a great impact on both employees and enterprises. However, rare studies about the association between well-being and fatigue had been investigated. Our aim is to establish the Chinese version Profiler, and to discovery the association between workplace well-being and fatigue. METHODS: The Chinese version was established according to International Society of Pharmacoeconomics and Outcomes Research (ISPOR) task force guidelines. In the study, researchers employed simple random sampling by approaching individuals undergoing health checkups or receiving workplace health services, inviting them to participate in a questionnaire-based interview. Prolonged Fatigue was evaluated by Checklist Individual Strength (CIS). The reliability was evaluated by Cronbach's alphas, Intra-class Correlation Coefficients (ICCs), and measurement errors. Moreover, confirmatory factor analysis and correlational analyses were assessed for the validity. RESULTS: The analyses included 312 Chinese workers. Cronbach's alphas of the Chinese version ranged from 0.69 to 0.93, while the ICC ranged from 0.70 to 0.92. The 5-factor model of confirmatory factor analysis revealed a nearly appropriate fit (χ2 (82) = 346.560, Comparative Fit Index [CFI] = 0.887, Tucker-Lewis Index [TLI] = 0.855, Root Mean Square Error of Approximation [RMSEA] = 0.114, Standardized Root Mean Square Residual [SRMR] = 0.060). Moreover, the CIS and its four dimensions were significantly and negatively associated with the Positive Emotion, while they are positively associated with Engagement dimension except CIS-Motivation dimension. CONCLUSION: The Chinese version Workplace PERMA-Profiler indicate nice reliability and validity. Furthermore, all CIS dimensions were negatively influenced by Positive Emotion, while commonly positively associated with Engagement.

Primary Care Interventions to Prevent Child Maltreatment: Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Child maltreatment is associated with serious negative physical, psychological, and behavioral consequences. Objective: To review the evidence on primary care-feasible or referable interventions to prevent child maltreatment to inform the US Preventive Services Task Force. Data Sources: PubMed, Cochrane Library, and trial registries through February 2, 2023; references, experts, and surveillance through December 6, 2023. Study Selection: English-language, randomized clinical trials of youth through age 18 years (or their caregivers) with no known exposure or signs or symptoms of current or past maltreatment. Data Extraction and Synthesis: Two reviewers assessed titles/abstracts, full-text articles, and study quality, and extracted data; when at least 3 similar studies were available, meta-analyses were conducted. Main Outcomes and Measures: Directly measured reports of child abuse or neglect (reports to Child Protective Services or removal of the child from the home); proxy measures of abuse or neglect (injury, visits to the emergency department, hospitalization); behavioral, developmental, emotional, mental, or physical health and well-being; mortality; harms. Results: Twenty-five trials (N = 14 355 participants) were included; 23 included home visits. Evidence from 11 studies (5311 participants) indicated no differences in likelihood of reports to Child Protective Services within 1 year of intervention completion (pooled odds ratio, 1.03 [95% CI, 0.84-1.27]). Five studies (3336 participants) found no differences in removal of the child from the home within 1 to 3 years of follow-up (pooled risk ratio, 1.06 [95% CI, 0.37-2.99]). The evidence suggested no benefit for emergency department visits in the short term (<2 years) and hospitalizations. The evidence was inconclusive for all other outcomes because of the limited number of trials on each outcome and imprecise results. Among 2 trials reporting harms, neither reported statistically significant differences. Contextual evidence indicated (1) widely varying practices when screening, identifying, and reporting child maltreatment to Child Protective Services, including variations by race or ethnicity; (2) widely varying accuracy of screening instruments; and (3) evidence that child maltreatment interventions may be associated with improvements in some social determinants of health. Conclusion and Relevance: The evidence base on interventions feasible in or referable from primary care settings to prevent child maltreatment suggested no benefit or insufficient evidence for direct or proxy measures of child maltreatment. Little information was available about possible harms. Contextual evidence pointed to the potential for bias or inaccuracy in screening, identification, and reporting of child maltreatment but also highlighted the importance of addressing social determinants when intervening to prevent child maltreatment.

Region-wide assessment of National Immunization Technical Advisory Groups (NITAGs) using the NITAG Maturity Assessment Tool (NMAT) - Experience from the Eastern Mediterranean Region of the World Health Organization, 2023.

National Immunization Technical Advisory Groups (NITAGs) are independent bodies that help improve national immunization programmes in decision making on immunization policy. The new NITAG Maturity Assessment Tool (NMAT) provided an opportunity to conduct a region-wide assessment to improve NITAG capacity and foster institutional growth. We share experience of the Eastern Mediterranean Region (EMR) of the World Health Organization (WHO) in using NMAT and the use of findings to develop improvement plans. NITAG chairs and secretariats from 22 EMR countries attended a virtual NMAT training in 2023. They self-assessed their NITAGs using the tool and developed improvement plans. An algorithm used the data to determine maturity levels for seven indicators. We consolidated results for the region by income groups. Of 22 countries (or NITAGs), 20 (91%) submitted NITAG assessment findings and 19 an improvement plan. The proportion of criteria met per indicator varied from 36% for independence and non-bias to 74% for establishment and composition. Maturity level varied by indicator. Of 20 NITAGs, less than half had an intermediate or higher-level maturity for the indicators of independence and non-bias 1 (5%), operations 3 (15%), making recommendations 4 (20%), stakeholder recognition 6 (30%), and resources and secretariat support 7 (35%). Meanwhile 11 (55%) NITAGs had an intermediate or higher maturity level for the indicators of establishment and composition and for integration into policy making process. Participants described NMAT as a concise, useful, user-friendly tool. NMAT is a practical tool that can be used by NITAGs to provide insights and strategic direction for individual countries and regionally. Prevention and management of conflict of interest is the domain that requires the most improvement in EMR. Planned activities should be implemented, monitored and a follow up assessment conducted in 2025.

Justifying the source of external comparators in single-arm oncology health technology submissions: a review of NICE and PBAC assessments.

Background: The drive to expedite patient access for diseases with high unmet treatment needs has come with an increasing use of single-arm trials (SATs), especially in oncology. However, the lack of control arms in such trials creates challenges to assess and demonstrate comparative efficacy. External control (EC) arms can be used to bridge this gap, with various types of sources available to obtain relevant data. Objective: To examine the source of ECs in single-arm oncology health technology assessment (HTA) submissions to the National Institute for Health and Care Excellence (NICE) and the Pharmaceutical Benefits Advisory Committee (PBAC) and how this selection was justified by manufacturers and assessed by the respective HTA body. Methods: Single-arm oncology HTA submission reports published by NICE (England) and PBAC (Australia) from January 2011 to August 2021 were reviewed, with data qualitatively synthesized to identify themes. Results: Forty-eight oncology submissions using EC arms between 2011 and 2021 were identified, with most submissions encompassing blood and bone marrow cancers (52%). In HTA submissions to NICE and PBAC, the EC arm was typically constructed from a combination of data sources, with the company's justification in data source selection infrequently provided (PBAC [2 out of 19]; NICE [6 out of 29]), although this lack of justification was not heavily criticized by either HTA body. Conclusion: Although HTA bodies such as NICE and PBAC encourage that EC source justification should be provided in submissions, this review found that this is not typically implemented in practice. Guidance is needed to establish best practices as to how EC selection should be documented in HTA submissions.

Undisclosed financial conflicts of interest in DSM-5-TR: cross sectional analysis.

OBJECTIVE: To assess the extent and types of financial ties to industry of panel and task force members of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, fifth edition, text revision (DSM-5-TR), published in 2022. DESIGN: Cross sectional analysis. SETTING: Open Payments database, USA. PARTICIPANTS: 92 physicians based in the US who served as members of either a panel (n=86) or task force (n=6) on the DSM-5-TR with information recorded in the Centers for Medicare and Medicaid Services Open Payments database during 2016-19. This period was chosen to include the year that development of the DSM-5-TR began and the three years preceding, a time consistent with previous research on conflicts of interest and consistent with the American Psychiatric Association's disclosure requirements for the fifth revision (DSM-5) of the manual. MAIN OUTCOME MEASURES: Type and amount of compensation the panel and task force members of DSM-5-TR received during 2016-19. RESULTS: After duplicate names had been removed, 168 individuals were identified who served as either panel or task force members of the DSM-5-TR. 92 met the inclusion criteria of being a physician who was based in the US and therefore could be included in Open Payments. Of these 92 individuals, 55 (60%) received payments from industry. Collectively, these panel members received a total of $14.2m (£11.2m; €13m). One third (33.3%) of the task force members had payments reported in Open Payments. CONCLUSIONS: Conflicts of interest among panel members of DSM-5-TR were prevalent. Because of the enormous influence of diagnostic and treatment guidelines, the standards for participation on a guideline development panel should be high. A rebuttable presumption should exist for the Diagnostic and Statistical Manual of Mental Disorders to prohibit conflicts of interest among its panel and task force members. When no independent individuals with the requisite expertise are available, individuals with associations to industry could consult to the panels, but they should not have decision making authority on revisions or the inclusion of new disorders.

Recommendations for Emerging Good Practice and Future Research in Relation to Family and Caregiver Health Spillovers in Health Economic Evaluations: A Report of the SHEER Task Force.

BACKGROUND: Omission of family and caregiver health spillovers from the economic evaluation of healthcare interventions remains common practice. When reported, a high degree of methodological inconsistency in incorporating spillovers has been observed. AIM: To promote emerging good practice, this paper from the Spillovers in Health Economic Evaluation and Research (SHEER) task force aims to provide guidance on the incorporation of family and caregiver health spillovers in cost-effectiveness and cost-utility analysis. SHEER also seeks to inform the basis for a spillover research agenda and future practice. METHODS: A modified nominal group technique was used to reach consensus on a set of recommendations, representative of the views of participating subject-matter experts. Through the structured discussions of the group, as well as on the basis of evidence identified during a review process, recommendations were proposed and voted upon, with voting being held over two rounds. RESULTS: This report describes 11 consensus recommendations for emerging good practice. SHEER advocates for the incorporation of health spillovers into analyses conducted from a healthcare/health payer perspective, and more generally inclusive perspectives such as a societal perspective. Where possible, spillovers related to displaced/foregone activities should be considered, as should the distributional consequences of inclusion. Time horizons ought to be sufficient to capture all relevant impacts. Currently, the collection of primary spillover data is preferred and clear justification should be provided when using secondary data. Transparency and consistency when reporting on the incorporation of health spillovers are crucial. In addition, given that the evidence base relating to health spillovers remains limited and requires much development, 12 avenues for future research are proposed. CONCLUSIONS: Consideration of health spillovers in economic evaluations has been called for by researchers and policymakers alike. Accordingly, it is hoped that the consensus recommendations of SHEER will motivate more widespread incorporation of health spillovers into analyses. The developing nature of spillover research necessitates that this guidance be viewed as an initial roadmap, rather than a strict checklist. Moreover, there is a need for balance between consistency in approach, where valuable in a decision making context, and variation in application, to reflect differing decision maker perspectives and to support innovation.

Making recommendations to subsidize new health technologies in Australia: A qualitative study of decision-makers' perspectives on committee processes.

OBJECTIVES: To explore experiences of, and perspectives on, health technology assessment (HTA) processes used to produce recommendations about subsidizing new medicines, and medical technologies in Australia, from the perspectives of those experienced in these processes. METHODS: Semi-structured interviews with a diverse group of 18 informants currently or previously members of the Pharmaceutical Benefits Advisory Committee (PBAC) or the Medical Services Advisory Committee (MSAC). Participants were interviewed September 2021-February 2022. Transcripts were analyzed using reflexive thematic analysis. RESULTS: 3 major themes were identified: contrasting technical and decision-making stages, resisting reductionist approaches, and navigating decision-making trade-offs. Participants discussed the complexities of the evaluative HTA process, especially when considering uncertainty in the evidence. As part of the current process, a deliberative decision-making stage was considered essential, allowing a flexible approach to decision making to consider factors beyond strength and quality of quantifiable data in the technical evaluation. Participants acknowledged these less-quantifiable factors were sometimes considered implicitly or were difficult to describe and this, paired with commercial in confidence requirements, presented challenges with respect to the desire to increase transparency. CONCLUSION (S): As HTA processes for new medicines and medical technologies in Australia continue to be reviewed, the balance between retaining flexibility during deliberation, confidentiality for sponsors and the public's desire for greater transparency may be a fruitful area for continuing research.

A Guide to an Iterative Approach to Model-Based Decision Making in Health and Medicine: An Iterative Decision-Making Framework.

Decision makers frequently face decisions about optimal resource allocation. A model-based economic evaluation can be used to guide decision makers in their choices by systematically evaluating the magnitude of expected health effects and costs of decision options and by making trade-offs explicit. We provide a guide to an iterative approach to the medical decision-making process by following a coherent framework, and outline the overarching iterative steps of model-based decision making. We systematized the framework by performing three steps. First, we compiled the existing guidelines provided by the ISPOR-SMDM Modeling Good Research Practices Task Force, and the ISPOR Value of Information Task Force. Second, we identified other previous work related to frameworks and guidelines for model-based decision analyses through a literature search in PubMed. Third, we assessed the role of the evidence and iterative process in decision making and formalized key steps in a model-based decision-making framework. We provide guidance on an iterative approach to medical decision making by applying the compiled iterative model-based decision-making framework. The framework formally combines the decision problem conceptualization (Part I), the model conceptualization and development (Part II), and the process of model-based decision analysis (Part III). Following the overarching steps of the framework ensures compliance to the principles of evidence-based medicine and regular updates of the evidence, given that value of information analysis represents an essential component of model-based decision analysis in the framework. Following the provided guide and the steps outlined in the framework can help inform various health care decisions, and therefore it has the potential to improve decision making.

Ethical Considerations for Artificial Intelligence in Medical Imaging: Data Collection, Development, and Evaluation.

The development of artificial intelligence (AI) within nuclear imaging involves several ethically fraught components at different stages of the machine learning pipeline, including during data collection, model training and validation, and clinical use. Drawing on the traditional principles of medical and research ethics, and highlighting the need to ensure health justice, the AI task force of the Society of Nuclear Medicine and Molecular Imaging has identified 4 major ethical risks: privacy of data subjects, data quality and model efficacy, fairness toward marginalized populations, and transparency of clinical performance. We provide preliminary recommendations to developers of AI-driven medical devices for mitigating the impact of these risks on patients and populations.

LAparoscopic Versus Abdominal hysterectomy (LAVA): protocol of a randomised controlled trial.

INTRODUCTION: There is uncertainty about the advantages and disadvantages of laparoscopic hysterectomy compared with abdominal hysterectomy, particularly the relative rate of complications of the two procedures. While uptake of laparoscopic hysterectomy has been slow, the situation is changing with greater familiarity, better training, better equipment and increased proficiency in the technique. Thus, a large, robust, multicentre randomised controlled trial (RCT) is needed to compare contemporary laparoscopic hysterectomy with abdominal hysterectomy to determine the safest and most cost-effective technique. METHODS AND ANALYSIS: A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial with integrated health economic evaluation and an internal pilot with an embedded qualitative process evaluation. A within trial-based economic evaluation will explore the cost-effectiveness of laparoscopic hysterectomy compared with open abdominal hysterectomy. We will aim to recruit 3250 women requiring a hysterectomy for a benign gynaecological condition and who were suitable for either laparoscopic or open techniques. The primary outcome is major complications up to six completed weeks postsurgery and the key secondary outcome is time from surgery to resumption of usual activities using the personalised Patient-Reported Outcomes Measurement Information System Physical Function questionnaire. The principal outcome for the economic evaluation is to be cost per QALY at 12 months' postsurgery. A secondary analysis is to be undertaken to generate costs per major surgical complication avoided and costs per return to normal activities. ETHICS AND DISSEMINATION: The study was approved by the West Midlands-Edgbaston Research Ethics Committee, 18 February 2021 (Ethics ref: 21/WM/0019). REC approval for the protocol version 2.0 dated 2 February 2021 was issued on 18 February 2021.We will present the findings in national and international conferences. We will also aim to publish the findings in high impact peer-reviewed journals. We will disseminate the completed paper to the Department of Health, the Scientific Advisory Committees of the RCOG, the Royal College of Nurses (RCN) and the BSGE. TRIAL REGISTRATION NUMBER: ISRCTN14566195.

CTFPHC recommends risk assessment-first screening to prevent fragility fractures in women aged ≥65 y.

SOURCE CITATION: Thériault G, Limburg H, Klarenbach S, et al; Canadian Task Force on Preventive Health Care. Recommendations on screening for primary prevention of fragility fractures. CMAJ. 2023;195:E639-E649. 37156553.

Canada's National Advisory Committee on immunization: Adaptations and challenges during the COVID-19 pandemic.

The COVID-19 pandemic has challenged traditional vaccine guidance infrastructure and frameworks, and added urgency and complexity to the operation of National Immunization Technical Advisory Groups (NITAGs). Canada's National Advisory Committee on Immunization (NACI) provides immunization guidance to the Public Health Agency of Canada (PHAC) who publicly shares expert and evidence-informed guidance with Canadian provinces and territories. Throughout the pandemic, NACI and PHAC implemented many adaptations to meet urgent needs for pandemic vaccine guidance. In this paper, we describe: structural adaptations in response to the accelerated pace and amount of work required to issue recommendations that were timed around product authorizations and dynamic epidemiology; technical adaptations in response to rapidly evolving evidence of variable quality which required close monitoring, and which promoted reliance on basic vaccine principles due to incomplete direct evidence; the need to provide nimble advice (e.g., off-label recommendations, preferential recommendations); communications adaptations (e.g. identify sustainable spokespeople for the committee, receive stakeholder feedback, and ensure urgent nuanced advice was communicated to a diverse audience); and research adaptations focussing on solutions to constrained supply (e.g. prioritisation, extended intervals, and heterologous schedules). The early pandemic vaccine experience has created a roadmap of lessons and adaptations that should be leveraged in future pandemic vaccine programs, and has highlighted the essential role of NITAGs to complement regulatory structures during pandemics to ensure timely, impactful, and evidence-informed public health vaccine guidance.

Pneumococcal vaccine uptake among Medicare Beneficiaries aged ≥65 years following the shared clinical decision-making recommendation for 13-valent pneumococcal conjugate vaccine in 2019.

BACKGROUND: In November 2019, the US Advisory Committee on Immunization Practices recommended shared clinical decision-making (SCDM) for use of 13-valent pneumococcal conjugate vaccine (PCV13) among immunocompetent elderly adults. The impact of SCDM on PCV13 use in this population, immunocompromised persons, and vulnerable subgroups has not been well documented. METHODS: Using Medicare Research Identifiable Files (01/2018 - 09/2020), monthly uptake of pneumococcal vaccine (PCV13, 23-valent pneumococcal polysaccharide vaccine [PPSV23]) was identified among fee-for-service beneficiaries aged ≥ 65 years with Part B coverage and no evidence of prior PCV13. Uptake was stratified by vaccine, risk profile, and demographics. RESULTS: Among the > 12 M beneficiaries included each month, PCV13 uptake declined from > 70% of pneumococcal vaccinations before SCDM to < 60% after SCDM (02/2020). Reductions in PCV13 uptake were consistent across vulnerable subgroups as well as immunocompromised persons. CONCLUSIONS: PCV13 use decreased among immunocompetent and immunocompromised persons alike, despite continued routine PCV13 recommendation for the latter group.

Understanding the resilience of children living on an American Indian reservation: A mixed methods participatory study.

AIM: To explore the resilience of children, six to thirteen years old, living on a Northern Plains American Indian Reservation using a situation specific nursing theory. BACKGROUND: American Indian and Alaska Native children experience mental health inequities compared to their white peers, including substance use, suicide, depression, and anxiety. Resilience is a strength of children that can be leveraged to improve their mental health. DESIGN: A parallel convergent mixed methods design. METHODS: A community advisory board culturally adapted resilience instruments. During two weeks in summer 2022, forty-seven children/caregiver dyads completed surveys about the child's resilience. Descriptive statistics gave the scores of each child's personal, relational, and total resilience. A subset of 20 children participated in a semi-structured interview. RESULTS: Children scored high on overall resilience, and higher on the relational subscale than the personal subscale. Caregiver survey scores were not significantly correlated with their child's scores and were higher than the children's scores. Qualitative coding revealed six themes of resilience. Integration of data showed a concordance and expansion of the quantitative data across themes. CONCLUSION: The children reported high resilience supported by a strong ecosystem of relationships. Resilience, as explained through children's voices, corroborated with findings from the surveys. IMPLICATIONS FOR NURSING: Findings will help nurses across sectors of primary, secondary, and tertiary care create resilience-enhancing interventions and prevent mental health crises in this community. IMPACT STATEMENT: This findings from this study will inform local mental health interventions on the Reservation. The study provides a reproducible design to adapt to other Indigenous communities. PUBLIC CONTRIBUTION: A community advisory board was a partner in every stage of the study. Children and caregivers participated in data collection. CONTRIBUTION TO THE WIDER CLINICAL COMMUNITY: This research provides knowledge that will further social justice efforts within nursing to promote health equity across diverse populations.

Is the quality of evidence in health technology assessment deteriorating over time? A case study on cancer drugs in Australia.

OBJECTIVE: This study aimed to assess whether there have been changes in the quality of clinical evidence submitted for government subsidy decisions on cancer medicines over the past 15 years. METHODS: We reviewed public summary documents (PSDs) reporting on subsidy decisions made by the Pharmaceutical Benefits Advisory Committee (PBAC) from July 2005 to July 2020. Information was extracted on the study design, directness of comparison, sample size, and risk of bias (RoB). Changes in the quality of evidence were assessed using regression analysis. RESULTS: Overall, 214 PSDs were included in the analysis. Thirty-seven percent lacked direct comparative evidence. Thirteen percent presented observational or single-arm studies as the basis for decisions. Among PSDs presenting indirect comparisons, 78 percent reported transitivity issues. Nearly half (41 percent) of PSDs reporting on medicines supported by head-to-head studies noted there was a moderate/high/unclear RoB. PSDs reporting concerns with RoB increased by a third over the past 7 years, even after adjusting for disease rarity and trial data maturity (OR 1.30, 95% CI: 0.99, 1.70). No time trends were observed regarding the directness of clinical evidence, study design, transitivity issues, or sample size during any of the analyzed periods. CONCLUSION: Our findings indicate that the clinical evidence supplied to inform funding decisions for cancer medicines is often of poor quality and has been deteriorating over time. This is concerning as it introduces greater uncertainty in decision making. This is particularly important as the evidence supplied to the PBAC is often the same as that supplied to other global decision-making bodies.

It's time for the NIH to formally designate people with disabilities as a US health disparity population.

This commentary discusses the implications of the report and recommendations of the Working Group on Diversity's Subgroup on Individuals with Disabilities, recently endorsed by the full Advisory Committee to the Director (ACD) of the National Institutes of Health (NIH). We suggest that one of these recommendations, the formal designation of people with disabilities as a US health disparity population, can be enacted immediately, which would spur new federal investment in disability-based disparities research.