bluuebunny/crossref_metadata_2025 huggingface dataset:
PD77 Review Of Multicriteria Decision Analysis-Like Processes For Prioritization Of Newborn Bloodspot Screening Conditions
Authors: Finnegan Eanan , Maher Arielle , Jordan Karen , O’Donnell Helen , Comber Laura , Spillane Susan , Harrington Patricia , Ryan Máirín
Published: January 2025

Introduction

Newborn bloodspot screening (NBS) is used to identify rare, serious health conditions. The choice of conditions to screen for can be contentious, with no internationally agreed panel. Multicriteria decision analysis (MCDA), involving a priori identification and weighting of criteria, has been proposed as an approach to assess and rank conditions for inclusion in newborn screening panels or for further assessment.

Methods

The aim of this review was to summarize existing MCDA-like processes used internationally in the context of NBS conditions. Publications were identified using a scoping methodology including electronic database and gray literature searches. Information on the methodology used to derive criteria and weightings, the criteria used, the scoring systems, and the weightings were extracted. The results were synthesized narratively.

Results

Five publications reporting on the use of MCDA or MCDA-like processes in the context of NBS were identified. In three publications, the aim of the MCDA processes was to select conditions for inclusion in an NBS panel. Two referred to the potential use of MCDA to inform prioritization of candidate conditions for future evaluation. While the criteria used were broadly consistent across studies, assigned weightings varied. Key challenges noted in the studies in relation to applying MCDA included the subjectivity associated with the choice and weighting of criteria, the absence of data to inform criteria, and its low discriminatory power.

Conclusions

Choosing criteria and weightings for MCDA processes regarding NBS can be a highly deliberative process that is intrinsically linked to the values and perspectives of those involved. Given the lack of international consensus on criteria and weightings, MCDA processes to aid decision-making would likely require a de novo tool or careful adaptation of an existing tool to reflect local contexts.
PD89 Guidance For Designing Pivotal Studies Of High-Risk Medical Devices By International Regulatory Authorities: A Systematic Review
Authors: Schnell-Inderst Petra , Rochau Ursula , Fraser Alan G. , Siebert Uwe
Published: January 2025

Introduction

Health technology assessment of medical devices often faces the challenge that approval studies have an insufficient study design. The European Medical Device Regulation (MDR), which has been in force since May 2021, places stricter requirements on clinical studies for high-risk medical devices. One important way of implementing the regulation is through guidance documents from the Medical Device Coordination Group (MDCG).

Methods

Our objective was to systematically identify and analyze recommendations for the design of pivotal studies of high-risk therapeutic medical devices from the MDCG and other regulatory authorities of high-income countries. We systematically searched the websites of regulatory authorities and included both cross-device and device-specific recommendations on clinical trial design for cardiovascular, orthopedic, and diabetes related high-risk medical devices. We extracted and compared the recommendations according to the following seven topics: definitions of study types and level of evidence; need for clinical investigations; appropriate choice of study methodology; general aspects; statistical methods; consideration of context and learning curve; and reporting.

Results

We included 30 documents from regulatory authorities. Eight documents from the European Union (EU) focused mainly on procedural issues and reporting. Guidance on appropriate levels of evidence and choice of study methodology for design and analysis of clinical investigations was missing. Eleven guidance documents were from the United States Food and Drug Administration, which provided detailed recommendations on almost all topics regarding study design as well as new methods. The remaining documents originated from four other countries and the International Medical Device Regulators Forum. A document from Australia included device-specific recommendations but hardly any general recommendations on clinical trials.

Conclusions

The recommendations published to date in the EU are insufficient to support stakeholders in choosing or assessing appropriate study designs to implement the evidence requirements of the European MDR. Detailed guidance from the MDCG is needed to create a common understanding between manufacturers, notified bodies, MDR expert panels, and competent authorities regarding what sufficiency of clinical data means.
PD91 Gaps And Challenges In The Health Technology Assessment Of Genetic And Genomic Applications: A Systematic Review
Authors: Siena Leonardo Maria , Sciurti Antonio , Migliara Giuseppe , Isonne Claudia , Di Lorenzo Giuseppe , De Blasiis Maria Roberta , Marzuillo Carolina , Villari Paolo , Baccolini Valentina
Published: January 2025

Introduction

Evaluating genetic and genomic applications is critical for their adoption in healthcare practice, but this has several challenges, including limited evidence on clinical and non-clinical benefits and rapid development processes. Since these challenges lack comprehensive discussion, this study aimed to identify and analyze all the barriers emerging in the health technology assessment (HTA) of genetic and genomic tests.

Methods

The protocol of this study was registered in the Open Science Framework database. A systematic search of the PubMed, Scopus, and Web of Science bibliographic databases was undertaken to identify all studies that specifically discussed any difficulty, gap, or barrier in the HTA evaluation of genetic or genomic technologies. No restrictions were imposed on HTA domain, study type, or publication date. Gaps and challenges were then grouped into domains outlined in the EUnetHTA HTA Core Model®. A narrative synthesis of the results was performed for each HTA domain.

Results

Of the 457 publications identified, 23 were included. Article designs exhibited considerable diversity, ranging from systematic reviews to semi-structured interviews, and stakeholder involvement varied from universities to national research groups. The challenges we found referred to the general HTA framework or, in most cases, to specific domains. More than 25 percent of the challenges were associated with economic aspects, with cost-effectiveness analysis being the focal point of debate. In addition, clinical effectiveness, in terms of non-health outcomes, lack of evidence, and clinical utility, was also frequently discussed, accounting for 23 percent of the challenges identified.

Conclusions

Our study systematically summarized gaps and barriers in the HTA of genetic and genomic applications, providing a thorough analysis and categorization of these issues. Various challenges surfaced across different domains, notably related to costs, economic evaluation, and clinical effectiveness. There is a need for exhaustive discussions on potential solutions to facilitate and enhance the assessment process for these genetic and genomic applications.
PD94 Adapting Existing Evidence-Based Clinical Practice Guidelines: A Case Example with Sexually Transmitted Infections Guidelines In Catalonia, Spain
Authors: Estrada Sabadell Maria Dolors , Caro Mendivelso Johanna Milena , Pla Anna Godo , Vivanco-Hidalgo Rosa Maria , Sáez Caridad Almazán , Botey Paula Lletjós , Lou Rosa Mansilla , Sebastià Mercè Armelles , Iglesias Mireia Alberny
Published: January 2025

Introduction

In the field of sexually transmitted infections (STI), high quality clinical practice guidelines (CPGs) have already been developed using rigorous methodology. To avoid duplicating effort, make cost-effective use of available resources, and facilitate customization to reflect local contexts, we adapted a CPG for prevention, care, and control of STIs in Catalonia, Spain.

Methods

The Guideline Adaptation Group (GAG) used the ADAPTE framework to guide transcontextual adaptation. The ADAPTE model has three phases: set-up; adaptation, with five main criteria for determining the relevance of a CPG and the adaptability of its recommendations (quality, currency, content, consistency, and acceptability or applicability); and finalization. We used the Spanish version of the AGREE II instrument to rate and select appropriate CPGs and the RIGHT-AD@pt checklist to guide reporting of the adaptation process. Each recommendation was given a level of evidence and a grade using the GRADE framework.

Results

Once the feasibility of carrying out the adaptation was confirmed, the governance structure was defined, which comprised a steering committee (n=8 members) and an expert committee (n=93 members). Clinical questions were defined from 164 recommendations taken from a CPG published in 2009. The systematic search identified 759 records published from 2016 to 2023. Of these, 57 CPGs met the inclusion criteria. On average, items 10 and 12 of the AGREE II scored between five and seven points (moderate to high quality methodological rigor). Content and consistency are being analyzed and matrices are being prepared to assess acceptability and applicability.

Conclusions

The ADAPTE methodology provides structure, rigor, and efficiency to the transcontextual adaptation of CPG recommendations. We expect that its application will provide practical and timely recommendations on the prevention, care, and control of STIs in the Catalan context.
PD96 Are Continuous Noninvasive Blood Pressure Monitoring Devices Accurate Enough To Replace Invasive Monitoring? A Rapid Review
Authors: Tan Yin Zhien , Ho Pwee Keng
Published: January 2025

Introduction

The intra-arterial catheter (invasive method) is the clinical and reference standard for continuous blood pressure (BP) monitoring. Continuous noninvasive blood pressure (CNBP) monitoring methods, for example applanation tonometry, volume clamp, and cuffless BP monitoring devices are gaining popularity. This review clarified the evidence on the accuracy of CNBP monitoring devices, which could potentially replace invasive monitoring in clinical care.

Methods

A systematic search was carried out to look for systematic reviews with the following elements:

•

Population: patients needing continuous BP monitoring;

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Intervention: CNBP monitoring devices;

•

Comparator: intra-arterial BP monitoring; and

•

Outcomes: accuracy of BP monitoring.

The databases searched included PubMed (MEDLINE), Epistemonikos, and the Cochrane Database of Systematic Reviews. Two reviewers independently reviewed the search results and shortlisted relevant articles for retrieval of full texts. Included reviews were critically appraised with the AMSTAR 2 instrument and the findings were summarized in a narrative synthesis.

Results

Three systematic reviews with meta-analyses of fairly good quality were included. The included primary studies were conducted in perioperative or critical care settings. Subgroup analyses by CNBP monitoring method were included in each meta-analysis. The findings from the systematic reviews were consistent. On average, CNBP devices consistently measured lower systolic BPs than the invasive method (mean difference <0) and measured higher diastolic BPs and mean arterial pressures than the invasive method (mean difference >0), with wide ranging 95 percent limits of agreement. It was evident from subgroup analyses that the measurements obtained from different CNBP methods varied significantly.

Conclusions

This rapid review found the accuracy of CNBP monitoring devices to be suboptimal in comparison with invasive monitoring. CNBP devices should not be routinely used but may be considered when there is difficult arterial access, or in patients who do not require arterial puncture for other purposes.
PD99 Effectiveness And Safety Of Bioelectrical Stimulation Techniques In Fibromyalgia: A Systematic Review
Authors: Álvarez-Pérez Yolanda , Duarte-Díaz Andrea , Rivero-Santana Amado , García Vanesa Ramos , Cazaña-Pérez Violeta , Llamas-Ramos Inés , Trujillo Elisa , Téllez-Santana Teresa , Brocalero Ángela , Perestelo-Pérez Lilisbeth
Published: January 2025

Introduction

Fibromyalgia, a musculoskeletal ailment of unknown origin, profoundly affects quality of life. Emerging bioelectrical stimulation techniques, including transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and pulsed low-frequency magnetic field stimulation (PEMF), show promise in short-term pain alleviation. This study aimed to rigorously evaluate the effectiveness and safety of these techniques in treating fibromyalgia.

Methods

A systematic review (SR) of available literature on the effectiveness and safety of bioelectrical stimulation techniques was carried out according to the Cochrane Collaboration methodology and PRISMA reporting guideline. Evaluated studies included SRs (with or without meta-analyses) and randomized controlled trials (RCTs) published after the SRs. SRs were appraised with the AMSTAR-2 tool and RCTs were assessed with version two of the Cochrane Collaboration risk-of-bias tool for randomized trials. The findings were synthesized narratively. In the absence of SRs with meta-analyses for specific techniques, we conducted a meta-analysis for each available outcome measure, including pain, fatigue, symptom severity, quality of life, anxiety, and depression.

Results

Seven SRs incorporating 35 RCTs were included. Two SRs evaluated TMS effectiveness, while five focused on tDCS. Additionally, 17 RCTs were included: two on repetitive TMS, six on tDCS, and eight on PEMF (three assessing targeted PEMF). General confidence in the SR results varied, with most having critically low confidence. Three additional RCTs were rated as low risk of bias, seven were rated as unclear risk of bias, and the remaining seven were rated as high risk of bias. A meta-analysis covered additional RCTs on PEMF and assessed pain intensity, symptom severity, general health-related quality of life, and fibromyalgia-related quality of life.

Conclusions

Overall, the results suggest that repetitive TMS, tDCS, and PEMF could improve pain and quality of life in patients with fibromyalgia. It is, however, necessary to conduct high quality studies to demonstrate the clinical relevance of these effects. While the techniques evaluated appear to be safe, mild adverse effects involving the area of stimulation may occur.
PD119 Interventions To Improve Long COVID Symptoms: A Systematic Review Of Randomized Controlled Trials
Authors: McDowell Cillian , Tyner Barrie , Shrestha Shibu , McManus Leah , Comaskey Fearghal , Harrington Patricia , Walsh Kieran A. , Neill Michelle O’ , Ryan Máirín
Published: January 2025

Introduction

Long COVID, which encompasses a range of prolonged and persistent symptoms that occur after the acute SARS-CoV-2 infection period, can have substantial negative physical, mental, social, and economic effects. This systematic review aimed to assess the effectiveness and safety of interventions to improve long COVID symptoms to inform updates to the interim long COVID model of care in Ireland.

Methods

Studies were identified in the MEDLINE, Embase, and CENTRAL databases through February 2023. Inclusion criteria were: (i) participants with long COVID, as defined by the study authors; (ii) random assignment to either an intervention or a comparison group; and (iii) quantitative assessment of the severity or frequency of long COVID symptoms. Exclusion criteria were: (i) signs or symptoms not reasonably attributable to prior SARS-CoV-2 infection; (ii) interventions not intended to treat long COVID; and (iii) not a randomized controlled trial. Two reviewers independently screened studies, extracted data, and assessed study quality using the Cochrane risk-of-bias tool for randomized trials. The results were synthesized narratively.

Results

Fifty-seven studies were included, and 283 potentially relevant ongoing trials were identified. Twenty-four trials investigated pharmaceutical and other medical interventions, most of which were examined in single studies. Thirty-three trials investigated non-pharmaceutical interventions. Risk of bias was high in 41 of the 57 (72%) studies. Interventions targeted a diverse range of long COVID symptoms. Studies generally had small sample sizes and short follow-up periods and did not adequately examine intervention safety. Evidence for the effectiveness of pharmaceutical and other medical interventions was limited. Potential short-term improvements were seen for some people following personalized exercise and physiotherapy and rehabilitation programs. However, long-term outcomes were not assessed.

Conclusions

Effective interventions to improve the symptoms of long COVID remain elusive and those included in this review do not yet have sufficient evidence to support them. In the absence of strong evidence for specific interventions, a holistic approach should be used to support people with long COVID.
PD127 A Systematic Review Of The Clinical Effectiveness Of Recombinant Zoster Vaccine For Preventing Herpes Zoster In Adults
Authors: Byrne David , Reece Emma , Jenkins Orla , Bergin Aoife , McLoughlin Carol , Quigley Joan , Teljeur Conor , Harrington Patricia , Ryan Máirín
Published: January 2025

Introduction

The herpes zoster (HZ) virus is associated with significant morbidity. Its incidence and severity are higher among older adults and immunocompromised individuals. This systematic review assessed the clinical efficacy and effectiveness of recombinant zoster vaccine (RZV) for the prevention of HZ and associated complications in adults at least 50 years of age and in adults (≥18 years) at increased risk of HZ.

Methods

Electronic searches restricted to between 2008 and July 2023 were conducted in Embase, MEDLINE, the Cochrane Library, and clinical trial registries. Two reviewers independently screened articles and extracted data. The review adhered to the PRISMA reporting guidelines. Quality appraisal was assessed using version two of the Cochrane risk-of-bias tool for randomized trials tool and the Risk of Bias in Non-Randomized Studies - of Interventions tool. Meta-analysis was undertaken using Cochrane methodology, with preference given to random effects meta-analysis because of study heterogeneity.

Results

Twelve RCTs and five cohort studies were identified. Vaccine efficacy was defined as one minus the incidence rate ratio, multiplied by 100. For the general population, vaccine efficacy was 92 percent (n=29,311 individuals) and vaccine effectiveness was 70 percent (n=43,990,671 individuals). Based on one trial, vaccine efficacy in the general population (aged ≥50 years) waned from an initial 97.7 percent to 73.2 percent by year 10. Two RCTs reported vaccine efficacy for those at increased risk: 68.2 percent in hematopoietic stem cell transplant recipients and 87.2 percent in those with hematological malignancies. Secondary analyses were limited by sample size.

Conclusions

There is clear, consistent evidence that RZV is effective in reducing HZ incidence. Although the vaccine is effective in those who are least 18 years of age and are at increased risk of HZ, efficacy may be lower compared with a general population aged at least 50 years. Secondary analyses (age subgroups, HZ complications, and HZ-related hospitalizations) were limited by small sample size, leading to inconclusive results.
PD131 Literature Analysis And Hot Topics In Congenital Heart Disease Screening In China: A Bibliometrics Study Using CiteSpace
Authors: Liu Liu , Yang Yi , Liu Shimeng , Wei Yan , Chen Yingyao
Published: January 2025

Introduction

Congenital heart disease (CHD), the most common congenital malformation affecting fetuses and infants, poses a significant and rapidly emerging global challenge in children’s health. Prenatal and newborn screening are very important for preventing CHD. Therefore, this study aimed to analyze the status and corresponding foci of articles on CHD screening in the Chinese or English language using bibliometric methods.

Methods

Publications on prenatal or newborn screening for CHD were included. The Web of Science Core Collection (WoS) and China National Knowledge Infrastructure (CNKI) databases were searched to identify literature published from inception to 31 March 2023. CiteSpace was used to perform bibliometric analysis on the number of publications, institutions, authors, and keywords to generate corresponding knowledge maps.

Results

A total of 582 publications were retrieved from the WoS and 233 from the CNKI databases. There was an increasing trend in the number of English and Chinese articles published, with the trend beginning in 2010 for Chinese language articles and in 2007 for English language articles. In English language publications, GR Martin was the most influential author, and the top five institutions were from high-income countries. Among the Chinese language publications, Wenhong Ding was the most influential author and the Hunan Province Maternal and Child Health Care Hospital was the most commonly reported institution. Keyword analysis revealed that the most frequently occurring terms in both language publications were as follows: antenatal diagnosis, cardiac auscultation, and fetal echocardiography in English language articles and screening, prenatal screening, and fetal in Chinese language publications.

Conclusions

Increasingly, articles on CHD screening have been listed in the WoS and CNKI databases. This bibliometric study provides the status and trends in the research on screening for CHD and may help researchers identify hot topics and explore new research directions in this field.
PD158 Optimizing The Management Of Patients With Mitral Regurgitation Beyond Technological Innovations: A Proposed Set Of Actions
Authors: Campelos Paula , Díaz José Francisco , López-Haldón José , Nombela-Franco Luis , Pinar Eduardo , González-Pinto Ángel , Reina Margarita , Tarrío Rubén , Vidal Laura , Lorenzo-Herrero Seila , Cuervo Jesús , Mengual Marta , González Paloma
Published: January 2025

Introduction

Mitral regurgitation (MR) is the most prevalent valvular heart disease worldwide and is frequently underdiagnosed and undertreated, resulting in a substantial healthcare burden. This project aimed to define an optimized patient journey, identifying specific unmet needs and pain points in the management of MR in Spain, and to propose a set of recommendations that can be implemented at a clinical level.

Methods

Using the Population, Intervention, Comparator, and Outcomes search strategy, a pragmatic literature review was conducted to contextualize the comprehensive management of patients with MR in Spain. Subsequently, a Delphi panel consisting of two rounds of questionnaires was implemented. Unmet needs detected for MR management along the patient journey were validated by a panel of clinical experts incorporating different profiles. A battery of actions to improve the MR patient journey was also gathered (first round), which were then systematically reviewed and prioritized by the experts using hierarchical point allocation methods (second round) based on their relevance and feasibility within the National Health System.

Results

A set of actions was proposed for the following core phases: detection-diagnosis, treatment-decision, treatment, and follow up. Actions for detection-diagnosis should be prioritized since boosting patient referral to specialized centers was considered crucial. Within the treatment-decision stage, experts emphasized strengthening healthcare services communication and training on risk stratification. For treatment, early referral to specialized centers was prioritized. Optimizing follow up required educating patients and relatives on adherence and self-care. Finally, experts supported a common pathway for heart valve diseases such as MR, tricuspid regurgitation, and aortic stenosis. Specifically, they concluded that optimization of tricuspid regurgitation management aligned with the actions proposed for MR.

Conclusions

Altogether, unmet needs and critical aspects in each of the management steps of MR in Spain were detected and an array of potential actions was suggested by clinical experts. The evaluation of such actions resulted in a preliminary strategic plan that can help prioritize interventions and healthcare policies regarding the optimization of the healthcare journey for patients with MR (and other valvulopathies) in Spain.
PD167 Charting A Sustainable Way To Subsidize Implants In Singapore
Authors: Soon Swee Sung , Ding Wayne , Ee Wong Yen , Ho Yan Teck , Ooi Lydia , See-Toh Rachel , PM Batcagan-Abueg Ada , Yi Ho Jun , Low Foo Eng , Unni Bindhu , Gan Hua Pey , Ye Yeo Chong , Heng Jeshuan , Chew Sarah , Lim Qinyi , Lim Elysia , Ng Zhen Long , Ng Jaryl , Ju Hong , Ng Kwong
Published: January 2025

Introduction

The diverse implant landscape, the rising and disparate costs of implants in public healthcare institutions (PHIs), and the limited application of health technology assessment (HTA) impede fair and sustainable implant subsidies in Singapore. This study described the Agency for Care Effectiveness (ACE) Implant Subsidy List (ISL) methodology and the key enablers for supporting government subsidy of clinically effective and cost-effective implants in Singapore.

Methods

A multi-tiered implant grouping scheme on the ISL was established by adapting overseas implant classifications, consulting clinicians, and conducting HTA evaluations, with subsidy extensions at the product group tier. Implants within a product group share similar biomechanical actions and patient outcomes and are subject to the same clinical criteria and pricing requirement. Implants on the ISL must be approved by the regulatory authority. Patients who meet the clinical criteria for ISL implants are eligible for subsidy. ACE conducted value-based pricing (VBP) and partnered with the public healthcare supply chain agency to harmonize PHI implant prices. The ISL is updated three times per year.

Results

Implants listed on the ISL were deemed clinically and cost effective. Underpinned by HTA principles, the implant grouping scheme promoted parsimonious classification, while allowing the creation of new product groups for implants offering superior benefits for patients. Reasonable prices set for the product groups aided affordability and cost sustainability. The ISL clinical criteria and standardized implant identifiers encouraged the appropriate use of subsidized implants and facilitated implementation. By ISL implementation in December 2023, ACE assessed 42,165 implants and listed 22,689 ISL implants spanning 143 product groups. Industry can apply for ISL listing three times per year, which keeps the ISL updated and relevant.

Conclusions

The ISL adopts a fit-for-purpose methodology to standardize implant classifications, enable scalable application of HTA, drive appropriate use of subsidized implants, and bring cost sustainability to the government subsidy of implants in Singapore. A strategic partnership with the public healthcare supply chain agency to concurrently establish national procurement contracts reduced disparate implant prices in PHIs and provided greater leverage for better implant prices.
PD180 Strategies To Minimize The Impact Of The COVID-19 Pandemic On People With Disabilities: Systematic Review And Deliberative Dialogues
Authors: Elias Flávia Tavares , Rezende Débora , Ramos Maira
Published: January 2025

Introduction

The impact of the COVID-19 pandemic was unequal, leading to losses for specific population groups already exposed to social vulnerabilities in the pre-pandemic period—for example, the inequity in access to health care among people with disabilities. The study aimed to identify strategies for people with disabilities during a public health emergency, in particular the COVID-19 pandemic.

Methods

A systematic review was conducted following the PRISMA guidelines. The population was adults with disabilities. There were no restrictions regarding the type of disability, which could include visual, auditory, intellectual, physical, or multiple disabilities. The COVID-19 pandemic was the study exposure and the outcomes were strategies aimed at improving prevention and health care for the target population during the pandemic period. A literature search was conducted in June 2021 and updated in November 2022 in the following databases: PubMed, Web of Science, Scopus, the Virtual Health Library, CINAHL, PDQ-Evidence, Health System Evidence, PEDro, and PsycInfo. The protocol for the systematic review was registered on PROSPERO (CRD42021266341).

Results

The systematic review included 29 studies of 49 non-pharmacological strategies. The evidence was synthesized and structured into categories. The following eight categories were found: habitation and infrastructure; work; occupation and income; planning and management; social assistance; telehealth; communication; comprehensive health care; and education for people with disabilities. The deliberative dialogue allowed stakeholders—represented by people with disabilities, policymakers, decision-makers, health professionals, members of associations, and researchers—to actively engage in constructing the synthesis.

Conclusions

The stakeholder engagement concluded that the project promoted social inclusion and equal, universal, and comprehensive access to social rights by people with disabilities. The experiences of stakeholders in society were incorporated into public policy and guided decision-making in health and social care.
PD184 Health Technology Assessment (HTA) Topics That Respond To National Needs: Considerations Around The Topic Selection Process When Institutionalizing HTA
Authors: Peacocke Elizabeth , Heupink Lieke , Ananthakrishnan Aparna , Frønsdal Katrine
Published: January 2025

Introduction

Most HTA processes follow similar institutional mechanisms, starting with topic selection and prioritization, followed by analysis (appraisal, deliberation, and decision-making) and implementation. The process of conducting an HTA is financially and time intensive. Therefore, to sustain HTA decision-makers, especially in countries with limited capacity, selecting topics for HTA that most respond to national needs is crucial.

Methods

Information on topic identification, selection, and prioritization (TISP) processes was taken from a recent report published by the Norwegian Institute of Public Health (NIPH) on how to support capacity building for HTA in low- and middle-income countries. An unpublished survey of 29 national HTA organizations around the world was also performed by the NIPH asking about their TISP processes. Issues around the institutional and organizational aspects necessary for explicit and transparent TISP processes were identified and discussed through an iterative process.

Results

The comprehensiveness of TISP processes varied according to each country’s needs and the types of decisions supported by HTA. Accordingly, the resources available for allocation within the health system, the number of dedicated personnel available to complete HTAs, and the number stakeholders and institutions involved in the decision-making process may all be relevant considerations for TISP. In countries where HTA was well-established, the process for TISP was usually institutionalized or at least somewhat formalized. In settings where HTA was emerging or relatively new, or where there may not be the necessary supporting institutional mechanisms, there was limited normative guidance on how to implement TISP.

Conclusions

When institutionalizing HTA, we argue for including formal and explicit processes for the topic selection step that include: (i) a clear link to health system feasibility; (ii) process transparency to ensure legitimacy and impact; and (iii) patient and public engagement. Insights and experiences from countries with more formalized HTA systems can provide valuable lessons.
PD189 Strengthening Health Decision-Making: The Role Of Capacity Building In Health Technology Assessment In Latin America
Authors: Colaci Carla , Alfie Verónica Andrea , Marti Sebastian Garcia , Alcaraz Andrea , Augustovski Federico , Pichon-Riviere Andres
Published: January 2025

Introduction

Health technology assessment (HTA) applications in low- and middle-income countries face limited technical capacities. The Institute for Clinical Effectiveness and Health Policy (IECS) is a key player in strengthening HTA expertise in the region and offers a variety of courses. Over 200 students from across Latin America have undertaken our introductory course on HTA and economic evaluation in the last four years.

Methods

The IECS provides a nine-week introductory online course focused on the fundamentals of HTA and economic evaluation. The course is designed for healthcare professionals (doctors, administrators, auditors, nurses, pharmacists, lawyers, etc.). The materials are available in Spanish and Portuguese on a virtual campus with asynchronous activities. Students are guided by instructors through an exchange forum. This study aimed to showcase the outcomes of this HTA course. Our analysis encompassed quantitative and qualitative data from a survey administered to nine student cohorts over the last four years. The surveys featured eight question categories covering materials, activities, quizzes, course dynamics, forum usage, tutoring, and satisfaction.

Results

A total of 234 students from Latin America were enrolled in the course. More than half came from Argentina (68%). Of the initial enrollees, 212 (91%) started the course and 192 (91%) of them passed. The satisfaction survey was completed by 168 students. Ninety-six percent of students were satisfied or very satisfied with the course overall, and the same percentage would recommend it to a colleague. Eighty-six percent felt that they could adequately follow the course, and 40 percent of students dedicating an average of two to four hours per week to the course.

Conclusions

Having accessible and feasible training opportunities in the region is important. The IECS HTA and economic course enhances HTA expertise in Latin America, as evidenced by its high rates of enrolment, completion, and satisfaction, with over 90 percent of participants recommending it. This underscores its effectiveness in reinforcing health decision-making knowledge in Latin America and contributing to the advancement of health policy.
PD191 Global Disparities In Bariatric Surgery Reimbursement: A Comparative Analysis Of 23 Countries
Authors: Tibet Birol , Sharaf Amir Mustapha , Kockaya Guvenc
Published: January 2025

Introduction

Bariatric surgery is a weight loss procedure that supports significant and long-term weight loss for individuals with severe obesity by altering the digestive system. It improves health conditions associated with obesity and can be life changing. The purpose of the study was to examine the reimbursement criteria for bariatric surgery in certain countries.

Methods

A detailed review was conducted on bariatric surgery reimbursement criteria across 23 countries, analyzing official policies and guidelines from databases and government websites. The study compared national data to highlight similarities and differences in these criteria, offering insights into the varying reimbursement approaches for bariatric surgery internationally.

Results

The research compared global reimbursement policies for bariatric surgery, revealing that Australia, Belgium, Canada, Denmark, Egypt, France, Germany, Italy, Morocco, Russia, Saudi Arabia, Spain, Sweden, the Netherlands, Türkiye, and the UK support reimbursement for those with a body mass index over 40 kg/m2. However, Hungary, Nigeria, Libya, and Romania do not offer such reimbursements. This discrepancy highlights the diverse healthcare approaches to severe obesity treatment across countries. The absence of financial support in some regions indicates varying health priorities and economic constraints. These findings emphasize the need for harmonized global health policies, especially for obesity, which is a significant public health issue.

Conclusions

The study highlights substantial disparities in bariatric surgery reimbursement criteria across countries. These differences, despite the proven benefits of treating severe obesity and related health issues, suggest a need for more standardized reimbursement approaches. Future research should explore the specific conditions and requirements for reimbursement and how these policies impact access to and outcomes of bariatric surgery.
PD192 Criteria For Decision-Making In Health Economic Evaluations: An Analysis Of Global Practices
Authors: Migliavaca Celina Borges , Colpani Verônica , Zago Marcolino Miriam Allein , Falavigna Maicon , Polanczyk Carisi Anne
Published: January 2025

Introduction

Economic criteria have become critical for health technology assessment (HTA) due to the rising costs of health technologies. The use of explicit, predefined criteria for economic evaluations enhances the transparency, objectivity, and predictability of the process. We aimed to identify which organizations worldwide integrate explicit and predefined criteria into their health economic analyses during HTA.

Methods

We conducted a scoping review to identify organizations responsible for HTA processes at the national level in any country. The identification of eligible organizations was carried out by reviewing members of the EUnetHTA, HTAsiaLink, INAHTA, and RedETSA networks as well as organizations evaluated in reviews with a similar scope. For each eligible organization, information was extracted on the inclusion of economic factors during decision-making and the existence of predefined criteria for judging the results of economic evaluations.

Results

Sixty-nine organizations from 56 countries were identified, of which 66 (96%) considered economic factors for HTA. Fifty-two (79%) organizations conducted cost-effectiveness analyses, 42 (64%) assessed budget impact, and one focused solely on total technology costs. Thirty-four organizations (51%) declare not having criteria for economic evaluation, whereas 14 (21%) from 12 countries had explicit criteria. There were no data found for 18 organizations (27%). Among the organizations with explicit criteria, 11 (17%) applied willingness-to-pay thresholds in cost-effectiveness evaluations and five (8%) applied criteria related to budget impact for decision-making, such as a maximum percentage of budget impact.

Conclusions

Although most organizations consider economic factors for HTA, many do not have explicit, predefined criteria for decision-making. Among those that presented such criteria, willingness-to-pay thresholds for cost-effectiveness analyses were the most common. The findings of this study also help to identify complementary factors that can be considered to promote greater systematization and transparency in the decision-making process.
PD193 Submission Processes And Requirements For Health Technology Assessment In Australia, Canada, England, France, And Germany
Authors: Gregg Emily , Graham Charlotte , Watts Karina , Mealing Stuart
Published: January 2025

Introduction

As health technology assessment (HTA) bodies introduce more rigorous requirements, the submission process is becoming increasingly diverse between countries. This study assessed the HTA submission processes and requirements in Australia, Canada, England, France, and Germany. This helps identify where efficiencies can be made in the global market access strategy, such as when to submit HTA dossiers.

Methods

A pragmatic review and desk-based research were conducted in November 2023. Published articles, HTA guidelines, process documents, conference abstracts, and white papers were reviewed to identify country-specific processes with implications for market access strategy. Where available, information was extracted about the general submission process and stakeholders involved (including regulatory, HTA, and pricing authorities), clinical evidence requirements, and pharmacoeconomic evidence requirements for HTA submission. Comparisons of the median time from marketing authorization to HTA decision within each country allowed the identification of efficiencies in individual HTA submission processes. The key findings and between-country differences were summarized narratively.

Results

The review identified several areas with implications for market access strategy. The median HTA review time was shortest in Australia (125 days) and longest in England (266 days). Australia and Canada have both sequential and parallel regulatory and HTA processes. The median time taken from regulatory approval to HTA recommendation was faster with the parallel process than with the sequential process in both countries. All countries required comparative clinical evidence within the indication. The weight placed on pharmacoeconomic evidence varied between countries. In Germany, economic evaluation has yet to play a real role. Requirements for additional information after HTA submission occurred within all HTA bodies.

Conclusions

HTA processes in Australia, Canada, England, France, and Germany differ from one another. This will likely affect the market access strategy for health technology developers. Similar requirements allow efficiencies in the preparation of submission documentation. Future research should investigate the impact of the European Union HTA regulation on market access and how this could affect strategic decision-making.
PD195 Variation In Decision-Making And Market Access Routes For Vaccines: Insights From Seven Countries
Authors: Gregg Emily , Watts Karina , Graham Charlotte , Mealing Stuart
Published: January 2025

Introduction

Quick and equitable market access to vaccines is a global priority. However, market access routes for vaccines are complex and differ from those for pharmaceuticals. Furthermore, there is variation in decision-making between countries due to local requirements. This work aimed to increase awareness of the key elements of these pathways and the stakeholders involved in European Union (EU) and non-EU countries.

Methods

Pragmatic desk-based research was undertaken in November 2023 to explore key elements of the market access pathways for vaccines and how these differ between countries. Specifically, the countries of interest were Canada, England, France, Germany, Italy, Spain, and the USA. Where available, information was extracted about the key stages and stakeholders involved in the decision-making pathway as well as details about any post-licensing monitoring, the value assessment framework used, vaccine pricing, and the procurement process. In addition, examples of barriers to vaccine access were extracted. The key findings and between-country differences were summarized narratively.

Results

National Immunization Technical Advisory Groups (NITAGs) were key stakeholders in all countries explored and had varying roles. The evidence requirements differed among countries, such as Germany’s requirement for economic and epidemiological modeling. The Vaccine Monitoring Platform coordinates studies for post-authorization monitoring of vaccines across EU countries. However, England is not part of this network and uses a national agency instead. Vaccine procurement and pricing also differed (e.g., France uses individual reimbursement, England uses national tendering, and Canada uses regional tendering). There was variation in vaccine pricing within the USA, depending on the healthcare provider. Barriers to vaccine access were well reported.

Conclusions

These results can influence the market access strategy of vaccine developers to ensure rapid and equitable vaccine access across countries. Several between-country differences in vaccine market access routes were identified; for example, the role of NITAGs, evidence requirements, and post-licensing monitoring processes. Barriers to vaccine access have been reported in the literature, with some organizations providing recommendations to overcome these.
PD228 Standardized Open Access Reporting Of Health Technology Assessment And Stakeholder Involvement
Authors: Nunn Jack , Mason Gillian , John Denny
Published: January 2025

Introduction

There is currently no standardized way to share information about health technology assessment (HTA). Standardised Data on Initiatives (STARDIT) can be used to overcome current limitations in sharing data about HTA processes by providing a way to report these data. This includes which stakeholders have been involved and how, the data sources used, and any impacts or outcomes observed.

Methods

STARDIT development began in 2019, guided by participatory action research paradigms. A multidisciplinary international team of over 100 citizens, experts, and data users was involved in cocreating STARDIT. These cocreators included patients with cancer, people living with rare diseases, Indigenous Peoples from multiple countries, representatives involved in HTA processes, health researchers, environmental researchers, economists, librarians, and academic publishers. Methods used to involve people included public events, online discussions, and a public consultation process. STARDIT is free to use, and data can be submitted by anyone. Report authors can be verified to improve trust and transparency, and data can be checked for quality.

Results

STARDIT has been used to create open access information about HTA processes that can be verified or edited by anyone at all stages of the HTA process, in multiple languages. This allows stakeholders involved in or affected by HTA processes (including patients, the public, Indigenous Peoples, and people from industry) to appraise and edit information and to self-identify the labels and terminology used to describe them. Organizations, including Australian Genomics, have recommended the use of STARDIT. Wikimedia Australia is a formal supporter and hosts data on their servers. The working beta version of STARDIT is available at ScienceForAll.World/STARDIT.

Conclusions

STARDIT improves access to standardized, verified information about HTA processes, enabling well-founded comparisons of the effectiveness of different HTA methods, including the most effective methods for involving stakeholders. Since STARDIT is open access and editable by anyone, it can support participatory ways of working and help improve the equity and quality of HTA processes worldwide.