The origins of Novo Nordisk and Novartis products: piloting a framework to identify the public contributions.

Background: The objective of this case study is to pilot a framework of public contributions examining the origins of products from two major European pharmaceutical companies, Novartis and Novo Nordisk, that received approval from the European Medicines Agency (EMA) between January 2014 and May 2024. Our primary focus was to investigate the extent of public contributions, including government grants, public-private partnerships, and other forms of public funding, that supported the development of these products. Additionally, we explored whether these companies primarily relied on in-house research and development (R&D) capabilities or acquired these products at various stages of their development.

International best-practice models for perinatal and infant mental health care - a scoping review.

Background: Perinatal mental illnesses (PMI) affect up to 20% of women and 10% of men during pregnancy and in the first year after the birth of the child. Perinatal mental illness contributes significantly to maternal mortality and adverse neonatal, infant, and child outcomes. Because of the high prevalence and the impact of PMI on both the parents and the infant, there is an urgent need for rapid and effective care.

Strategies to improve recruitment to multicomponent group programs for overweight and obesity: a systematic review.

Objective: Multicomponent programs are recommended for the treatment of children, adolescents, and adults with overweight or obesity. However, program providers often face difficulties reaching their target groups. This systematic review aimed at identifying recruitment strategies for multicomponent overweight and obesity programs in group settings and at summarizing barriers and facilitators for participation.

Implementation of the EU's Health Technology Assessment regulation: where does existing methods guidance require concretization and what are the relevant methodological options?

Objectives: The EUnetHTA Core Model is well-established in the HTA community. Some recommendations of corresponding guidance documents leave room for alternative methodological choices. Considering the new HTA regulation (HTAR), we aimed to identify needs for concretization (NCs) in EUnetHTA guidance and provide indicative methodological options.

'Piloting a framework for analysing the public contributions to R&D: new antibiotics in focus'.

Background: Within the context of increasing transparency around public contributions, a framework for reporting and analysing public contributions to research and development (R&D) was previously developed and is piloted here using the example of antibiotics. The aim of this work is to check whether the category system is feasible, to revise and adjust the granularity of the category system where necessary, and to expand the range of sources for detailed analyses.

Methods: All antimicrobial medicinal products in development, discontinued and approved in the last 10 years were identified in the literature.

The Prognostic Quality of Risk Prediction Models to Assess the Individual Breast Cancer Risk in Women: An Overview of Reviews.

Purpose: Breast cancer is the most common cancer among women globally, with an incidence of approximately two million cases in 2018. Organised age-based breast cancer screening programs were established worldwide to detect breast cancer earlier and to reduce mortality. Currently, there is substantial anticipation regarding risk-adjusted screening programs, considering various risk factors in addition to age.

Perinatal and infant mental health care in Austria : Mapping of existing prevention, screening, and care services.

Purpose: Perinatal mental illness (PMI) is one of the major health problems during pregnancy and one year after birth (the perinatal period), with robust evidence of its potentially detrimental effects on the parent's and child's health. Many countries have prioritised perinatal and infant mental health care (PIMHC). In Austria, it is currently unknown how many services are available in which region.

Public contributions to R&D of medical innovations: A framework for analysis.

Background And Objective: Article 57 of the proposed European Union (EU) Pharmaceutical Legislation (PL, Directive) will require market authorization applicants to publicly declare any direct financial support for R&D received from public authorities. Our research aims to identify the categories needed to capture direct or indirect public contributions to R&D, provide a framework for standardized reporting of public contributions, and reduce ambiguity in the interpretation of "direct" and "indirect" public contributions.

Methods: An iterative mixed-methods approach is applied: a targeted literature review was conducted, complemented by interviews with representatives of different stakeholder groups to identify categories of public contributions to R&D, followed by searches for relevant data sources.

The role of health economics within health technology assessment: past, present, and future - an Austrian perspective.

In many countries, the economics domain forms a routine part of health technology assessments (HTA) next to analyzing the comparative effectiveness and safety of a technology. The method applied most often is economic evaluation, such as cost-effectiveness analysis, which is supposed to support the efficient use of resources. In Austria, economic evaluation has played a negligible role in HTA and reimbursement decisions, even though the country faces the same public healthcare sustainability challenges as others.

Association of psychosocial factors at work with fertility and menstrual disorders: A systematic review.

Objectives: This systematic review aimed to assess the association between psychosocial factors in the workplace and menstrual abnormalities or fertility, focusing on literature implementing a prospective cohort design.

Methods: We searched MEDLINE, EMBASE, PsycINFO, PsycARTICLES, and Japan Medical Abstracts Society electronic databases for studies published from inception to February 26, 2020, and updated the search in PubMed on May 29, 2024. Inclusion criteria were (P) adult female workers (over 18 years old), (E) presence of adverse psychosocial factors at work, (C) absence of adverse psychosocial factors at work, and (O) any menstrual cycle disorders, menstrual-related symptoms, or fertility issues.

Costs, challenges and opportunities of decentralised chimeric antigen receptor T-cell production: a literature review and clinical experts' interviews.

The objectives were to summarise the evidence and clinical experts' views comparing the use of decentralised produced chimeric antigen receptor (CAR) T-cell therapies versus commercially available products, regarding drug costs, time to finalised product and other reported advantages, disadvantages, challenges and facilitators. A literature review according to the PRISMA guidelines was conducted in Medline, Embase and Trip databases. Publications were included if they reported information on cost estimates, time to finalised products and other outcomes of interest of a decentralised CAR T-cell production strategy.

An updated systematic review on spinal muscular atrophy patients treated with nusinersen, onasemnogene abeparvovec (at least 24 months), risdiplam (at least 12 months) or combination therapies.

Objective: This systematic review provides an update on outcomes for patients with spinal muscular atrophy (SMA) type 1 to 4 treated with approved therapeutics, including the most recent, risdiplam, for an observation period of up to 48 months.

Methods: A systematic literature search was conducted in July 2023 in four databases. Selected publications were assessed for internal validity and risk of bias by two authors and relevant data were extracted into standardised tables.

Robot-assisted surgery in thoracic and visceral indications: an updated systematic review.

Background: In surgical advancements, robot-assisted surgery (RAS) holds several promises like shorter hospital stays, reduced complications, and improved technical capabilities over standard care. Despite extensive evidence, the actual patient benefits of RAS remain unclear. Thus, our systematic review aimed to assess the effectiveness and safety of RAS in visceral and thoracic surgery compared to laparoscopic or open surgery.

Optimising child and adolescent mental health care - a scoping review of international best-practice strategies and service models.

Background: Psychiatric disorders are among the most common health problems in children and adolescents, with a recent prevalence rise due to the COVID-19 pandemic. The increasing demand for service provision in this patient population, together with infrastructural, financial and staff limitations in child and adolescent mental health services, calls for an adaptation/advancement of current models of service provision. This review offers an internationally informed overview of best-practice child and adolescent mental health (CAMH) strategies and care models, with the aim of assisting decision-makers in implementing topical CAMH care models.

Mapping horizon scanning systems for medical devices: similarities, differences, and lessons learned.

Objectives: This article presents the mapping of horizons scanning systems (HSS) for medical devices, conducted by the Medical Devices Working Group of the International Horizon Scanning Initiative (IHSI MDWG). It provides an overview of the identified HSS, highlights similarities and differences between the systems, and lessons learned.

Methods: Potentially relevant HSS were identified through literature searches, scan of an overview of EuroScan members, and input from the IHSI MDWG members.

Digital Health Applications (DiHA): Approaches to develop a reimbursement process for the statutory health insurance in Austria.

Purpose: To elaborate a concept for implementing digital health applications (DiHA), including prioritisation criteria (PC) for the Austrian context and an overview of available prioritised DiHAs.

Methods: Based on European DiHA-listings and input by Austrian experts, a categorised meta-directory of DiHAs was created. PC were developed to reflect, inter alia, the provisions of the Austrian General Insurance Act, and were applied to the meta-directory to identify DiHAs potentially relevant for the Austrian statutory health insurance.

Wearable cardioverter defibrillator for preventing sudden cardiac death in patients at risk: An updated systematic review of comparative effectiveness and safety.

Objectives: To synthesise the available evidence of wearable cardioverter defibrillator (WCD) therapy as an add-on measure to optimal medical therapy (OMT) or as a replacement of hospital stay.

Methods: An update systematic review (SR) of comparative effectiveness and safety of WCD therapy was conducted. We included randomised controlled trials (RCT), prospective comparative studies and prospective uncontrolled studies with at least 100 patients.

Economic Evaluation of Family-Focused Programs When Parents Have a Mental Health Problem: Methodological Considerations.

Objectives: The nature of adverse effects of parental mental health problems and of the interventions to address them may require specific designs of economic evaluation studies. Nevertheless, methodological guidance is lacking. We aim to understand the broad spectrum of adverse effects from parental mental health problems in children and the economic consequences on an individual and societal level to navigate the design of economic evaluations in this field.

Subcutaneous implantable cardioverter-defibrillator: a systematic review of comparative effectiveness and safety.

This systematic review evaluated the clinical effectiveness and safety of subcutaneous implantable cardioverter-defibrillator (S-ICD) in patients at an increased risk of sudden cardiac death and with an ICD indication for primary or secondary prevention. A systematic literature search was conducted in four databases (Medline via Ovid, Embase, the Cochrane Library, and HTA-INAHTA). Randomized controlled trials (RCTs) and controlled observational studies with ≥100 S-ICD patients and a low to moderate risk of bias were eligible for inclusion.

Practices to support co-design processes: A case-study of co-designing a program for children with parents with a mental health problem in the Austrian region of Tyrol.

Forms of collaborative knowledge production, such as community-academic partnerships (CAP), have been increasingly used in health care. However, instructions on how to deliver such processes are lacking. We aim to identify practice ingredients for one element within a CAP, a 6-month co-design process, during which 26 community- and 13 research-partners collaboratively designed an intervention programme for children whose parent have a mental illness.

The therapeutic effects of climbing: A systematic review and meta-analysis.

Objective: Several recent studies show a growing popularity of therapeutic climbing (TC) for patients with various conditions. This could be an attempt to fill the gap left by traditional exercises that do not always address physical, mental, and social well-being. This review provides an overview of the physical, mental, and social effects and safety aspects of climbing for different indications.

Possible long COVID healthcare pathways: a scoping review.

Background: Individuals of all ages and with all degrees of severity of the coronavirus disease (COVID) can suffer from persisting or reappearing symptoms called long COVID. Long COVID involves various symptoms, such as shortness of breath, fatigue, or organ damage. The growing number of long COVID cases places a burden on the patients and the broader economy and, hence, has gained more weight in political decisions.

Clinical effectiveness and safety of self-expandable implantable bulking agents for faecal incontinence: a systematic review.

Purpose: The purpose of this systematic review is to evaluate whether self-expandable implantable vs non-self-expandable injectable bulking agents (second-line therapies) are equal/superior in terms of effectiveness (severity, quality of life [QoL]) and safety (adverse events) for faecal incontinence (FI).

Methods: A systematic review was conducted, and five databases were searched (Medline via Ovid, Embase, Cochrane Library, University of York Centre for Reviews and Dissemination, and International Network of Agencies for Health Technology database). In-/exclusion criteria were predefined according to the PICOS scheme.