Many European countries independently conduct horizon scanning activities. However, the costs, time, and resources required can be prohibitive. To address this, the International Horizon Scanning Initiative (IHSI) was launched in 2019. IHSI aims to facilitate decision-makers and payers in negotiating fair prices and preparing for potentially disruptive pharmaceuticals. IHSI developed the Joint Horizon Scanning Database, a repository of pharmaceuticals expected to enter the European market, and initiated a series of High Impact Reports (HIRs) to highlight pharmaceuticals that have the potential to significantly impact healthcare systems. This paper outlines the development of key performance indicators (KPIs) that can be used to evaluate IHSI’s work.

In close collaboration with representatives from IHSI member countries and its Executive Committee, the following KPIs were developed: “Number of IHSI member countries”, “Embedding of IHSI in national health technology assessment procedures”, “Database coverage”, “Data completeness”, “Data timeliness”, “Accuracy of identifying disruptive pharmaceuticals”, “Accuracy of identifying non-disruptive pharmaceuticals”, “Use of HIRs in preparing for disruption to the healthcare system”, and “Use of HIRs in price negotiations and financial arrangements”. Among these, “Accuracy of identifying disruptive pharmaceuticals” was considered most important, followed by “Data timeliness” and “Data completeness”. Additionally, based on consultations with nonmember countries, strategies for improvement were identified should the KPIs reveal areas for improvement. These include involving patients in the selection of pharmaceuticals and conducting reputation surveys alongside measuring KPIs. While the KPIs and strategies for improvement are specific to IHSI, they can be tailored to support other (international) horizon scanning initiatives.

Health technology assessment (HTA) has become an integral part of Ukraine’s health system since its formal introduction into national legislation in 2017. By 2020, HTA was mandated for evaluating publicly funded medicines, laying the groundwork for more evidence-based healthcare decisions. Although the creation of an independent HTA agency was initially planned for 2022, implementation was delayed due to the COVID-19 pandemic and Russia’s ongoing invasion. The relevant Cabinet Resolution calls for the establishment of an autonomous agency by January 2026. This commentary outlines a strategic, evidence-informed framework to guide the agency’s formation.

Drawing on the 2018 State Strategy for Access to Medicines, the 2022 Law on Medicinal Products, and international best practices, we proposed to the Government of Ukraine a two-tier structure encompassing core business functions (HTA and appraisal, guideline development, pricing, and listing) and support business functions (data and analytics, finance and strategy, IT, human resources, legal, and communications). Each department is tasked with clear mandates and supported by performance indicators to promote transparency, accountability, and operational efficiency.

A phased roadmap for 2025–2027 details the legal, institutional, and financial steps required for successful implementation. Key opportunities – including international partnerships and system-wide reform – are weighed alongside risks such as funding uncertainty, workforce limitations, and geopolitical instability.

By embedding HTA into national policy processes and ensuring institutional independence, Ukraine can enhance the value of healthcare investments and build long-term resilience into its health system.

As the variety of specific treatments in a disease area increases, there may be a growing interest in employing treatment sequencing within health economic models. The aim of this review was to identify and thematically analyze patterns regarding the approaches to modeling treatment sequencing in National Institute for Health and Care Excellence (NICE) appraisals.

A review of NICE technology appraisals (TAs) published between 1 January 2020 and 13 March 2023 was conducted.

A total of twenty-four TAs incorporating treatment sequencing were included, most commonly in autoimmune and oncology indications. Primary justifications for companies employing treatment sequencing were precedence and alignment with clinical practice, whilst lack of appropriate clinical data was cited to justify its exclusion. Relatedly, External Assessment Groups commonly criticized treatment sequences for oversimplifying clinical practice. Notably, almost half of identified TAs assumed that the relative efficacy of an intervention was maintained regardless of disease severity or position within the treatment sequence.

A substantial proportion of TAs employed treatment sequencing, but it is challenging to determine the impact of current approaches on the overall uncertainty associated with any health economic model. The challenges identified in this review could be used to inform future formal guidance and associated methodology for the implementation of treatment sequencing modeling, which could improve the comparability and reliability of models and their results.

Psilocybin-assisted psychotherapy (PAP) has gained attention as a promising intervention for conditions including depression, anxiety and post-traumatic stress disorder, but understanding of its side-effects is limited. This review evaluates the quality of side-effects reporting in PAP trials, to guide treatment, policy and research.

To assess side-effects reporting quality in PAP trials for psychiatric conditions, comparing published articles and ClinicalTrials.gov records.

A PROSPERO-registered review (no. CRD42023458960) included English-language PAP trials (2005–2024) identified via Embase, CENTRAL, PubMed and reference searches. Reporting quality was assessed using the CONSORT Harms extension, categorised as either high (17–21), moderate (12–16), low (7–11) or very low (0–6). Randomised controlled trials underwent risk of bias analysis, and descriptive statistics compared side-effects across sources.

Twenty-four trials were included. Reporting quality was high in six studies, moderate in four, low in nine and very low in five. All randomised controlled trials (n = 9) showed high risk of bias for side-effects outcomes. Variability in reporting hindered comparisons between articles and ClinicalTrials.gov, underscoring the need for standardisation. Overall, there was no evidence of systematic underreporting of side-effects in published articles compared with trial registers.

Side-effects reporting in PAP trials is inconsistent but is improving over time. Existing evidence has a high risk of bias. Future trials should align with best-practice guidelines for side-effects reporting. Discussions with patients should prioritise findings from high-quality studies and emphasise the current uncertainty regarding PAP side-effects.

To understand patterns of cannabis use and self-management experiences in patients with chronic disease during the post-legalization period in Thailand and to quantify such experiences and perceptions.

Patients with chronic disease are a population in which disease self-management is potentially involved with the use of complementary and alternative medicines (CAMs). The recent changes in cannabis regulation in Thailand have allowed retail selling and home cultivation. Cannabis is a medicinal herb in many traditional Thai recipes and is often adopted as a CAM in the chronic disease population. The adoption of cannabis products as part of CAM could lead to changes in chronic disease outcomes.

Exploratory-sequential mixed methods were used in this study. A descriptive qualitative study was conducted to acquire a basic understanding of the patients’ experiences. Semi-structured in-depth interviews were conducted, and thematic analysis was applied. Subsequently, a cross-sectional study was conducted to quantify the patterns of cannabis use and self-management experience in patients with diabetes and/or hypertension.

Eleven patients were interviewed, and 124 patients participated in the cross-sectional study. Most of the participants were male, married, and identified as Buddhist. Many patients believed that cannabis could improve their health, while fewer considered it a threat to their health. In general, the patients viewed cannabis as a way to enhance their quality of life and treat chronic diseases. Some patients embraced the principles of CAM. They primarily used cannabis tea daily to manage diabetes or hypertension, with their approaches being more complementary than alternative. However, only one-third (34.7%) were aware of potential drug interactions with their concurrent medications.

Historically US-based academic organizations dedicated limited resources, including policies, personnel to ensuring compliance with clinical trials registration and results reporting requirements. A recent follow-up survey finds that 6-years after an initial survey, there is increased attention and dedication of resources to improve compliance rates for clinical trials registration and results reporting.

Internet-based online survey using Qualtrics between 20 April 2023 and 30 September 2023 distributed to Protocol Registration and Results Reporting (PRS) Administrators at US-based academic organizations with ClinicalTrials.gov organizational accounts. The survey focused on the 249 respondents of the original 2016–2017 survey published in 2018. The overall response rate was 162/249 (65.06%) with 100% participation from National Cancer Center (NCI) Designated Cancer Centers and hubs of the Clinical and Translational Science Awards (CTSA).

Results indicated a marked increase of academic organizations with policies in place for registration (43 to 74%) and results reporting (35 to 68%). The median number of Full-time Equivalent (FTE) staff at responding academic organizations increased (from 0.08 to 0.5) with statistically significant difference between the number of organizational records and FTEs supporting registration and results reporting. Larger gains are seen with NCI-Designated Cancer Centers and/or CTSA hubs.

It appears academic organizations are more equipped to comply with requirements, and demonstrate a trend towards appropriate staffing. In the 6 years since the original survey, US-based academic organizations have significantly increased attention to compliance with clinical trials registration and results reporting requirements, indicated by an increase in institutional policies and dedicated personnel.

Value frameworks play a crucial role in bridging the gap between evidence and decision making in health care, particularly in settings with limited resources as low- and middle-income countries (LMIC). In this study, we present the development of a value framework (VF) targeted to provide coverage recommendations in rapid health technology assessment reports (rHTA) as well as its first 5 years of implementation.

We performed an exhaustive literature search with the aim to identify existing VFs and their dimensions followed by the generation of a VF proposal through a mixed methods, qualitative–quantitative approach including a Delphi panel to weigh the criteria and correlate them with the subsequent recommendations. To describe its implementation, we present the results of 264 rHTA reports from 2017 to 2022.

The value framework has three main domains (quality of evidence, net benefit, and economic impact). We adapted widely used methodologies for quality of evidence and net benefit domains. The economic impact domain was the most complex to assess, so an ad hoc method was developed. Analysis of 265 HTAs revealed the distribution of recommendations across different criteria and technology types. Most were for drugs (40.5 percent) or therapeutic procedures (36 percent). With a five-category final recommendation, 0.8 percent were favorable, 19.7 percent were uncertain, and 44 percent were unfavorable.

The VF demonstrated its versatility and practicality in meeting the needs of rHTA audience, and can facilitate evidence-informed decision making. This VF serves as a valuable tool for conducting adaptive rHTAs and supports decision-making processes in Argentina and similar LMIC contexts.

The influence of democracy and democratization on health is difficult to disentangle from a complex web of factors such as population characteristics and social determinants of health. The goal of this study was to begin to characterize the roles of the individual attributes of democracy on a key measure of health, mortality rates among female children under five years of age.

We conducted a retrospective observational cohort study utilizing data over a study period from 1975–2021 with data from 173 countries. We utilized publicly available data from the Global State of Democracy Indices (GSoD) and the United Nations Inter Agency Group for Child Mortality Estimation (UN-IGME) databases.

Our data support prior work showing that strength of democracy is associated with improved population health measures. Stronger democracies are associated with improvements in female child mortality, even controlling for within-country variation over time and for income level. This relationship is most pronounced when examining the relationship between protections of civil rights and child mortality.

Child mortality increases when democracy declines. With declines in democracy worldwide, it is critical that advocates are concerned with the global democratic experience, especially with policies that compromise fundamental rights.

We sought to describe perspectives among Black nursing professionals and community leaders regarding the return of genetic test results, and place perspectives into context with aggregated findings in the All of Us Research Program’s Data Browser.

Semi-structured, virtual interviews were held with adults (≥18 years of age) self-identifying as Black. A 2-step thematic analysis process was used to assess interviewee perspectives with (sub)themes identified in the literature across two topics: drug/medication response and hereditary disease risk. Themes were placed into context with Data Browser content, focusing on genes and their respective alleles with frequencies ≥0.10 in African ancestry populations in All of Us.

Interviewee perspectives aligned with previously identified major themes in the literature (motivations to engage or disengage; integrating research and care), with five (5) subthemes emerging across major themes. Seven (7) alleles were observed with frequencies ≥0.10 for three (3) pharmacogenomic (PGx) biomarkers in the Data Browser for African ancestry populations: CYP2C19 (SNV, 10-94761900-C-T; SNV,10-94775367-A-G; SNV 10-94781859-G-A), DPYD (SNV, 1-97883329-A-G; SNV, 1-97515839-T-C), UGT1A1 (insertion, 2-233760233-C-CAT; SNV, 2-233757136-G-A). Four (4) alleles were observed with frequencies ≥0.10 for three (3) genes implicated in hereditary disease risk, two of which contemporaneously hold PGx implications for African ancestry populations: CACNA1S (PGx, SNV, 1-201112815-C-T; SNV, 1-201110107-C-T), SCN5A (no PGx, SNV, 3-38603929-T-C), TP53 (PGx, SNV, 17-7676154-G-C).

Our findings convey important clinical and translational science considerations for individuals and community leaders of African ancestry and researchers seeking reputable, publicly available information to understand, communicate, and act on genomic findings.