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Designing GTP3 prompts to screen articles for systematic reviews of RCTs 设计 GTP3 提示,筛选 RCT 系统性综述文章
IF 3.4 3区 医学
Health Policy and Technology Pub Date : 2024-11-12 DOI: 10.1016/j.hlpt.2024.100943
James A Strachan
{"title":"Designing GTP3 prompts to screen articles for systematic reviews of RCTs","authors":"James A Strachan","doi":"10.1016/j.hlpt.2024.100943","DOIUrl":"10.1016/j.hlpt.2024.100943","url":null,"abstract":"<div><h3>Introduction</h3><div>Satisfactory sensitivity in screening articles for appropriate inclusion in systematic reviews has not yet been achieved using the group of GPT artificial intelligence (AI) systems. One issue in designing prompts for article screening is that while most of the prompt can be validated before use, i.e. on previously published systematic reviews, the part containing the inclusion criteria cannot. This study aimed to advance work in this area by trying to identify a prompt that is robust to variations in the precise wording of inclusion criteria. Prompts with this property should be able to achieve more consistent performance when applied to similar systematic reviews of health topics.</div></div><div><h3>Methods</h3><div>A prompt, into which alternative wordings (variants) of inclusion criteria could be inserted, was tested on a training dataset of articles identified during the re-run of electronic searches for a single published review. Modification and re-testing of the prompt was undertaken until satisfactory screening sensitivity across six different inclusion criteria variants was achieved. This prompt was then validated by assessing its performance on three “test” datasets, derived from re-run electronic searches from three different reviews.</div></div><div><h3>Results</h3><div>A prompt was successfully developed using the training dataset that achieved sensitivities of 95.8 %, 100.0 % &amp; 100.0 % respectively in the three test datasets derived from the three different reviews.</div></div><div><h3>Discussion</h3><div>Iterative design and testing on inclusion criteria variants produced a prompt that consistently achieved satisfactory screening sensitivity. The classification process was fast, cheap and had high specificity.</div></div><div><h3>Public Interest Summary</h3><div>Systematic reviews summarise all articles that have tried to answer scientific questions. They are usually the gold standard of evidence in medical science and widely inform healthcare policy. However, they are very expensive and time consuming to write. The initial stage of writing systematic reviews consists of reviewing potentially tens of thousands of scientific abstracts. This process may be able to be automated by artificial intelligence (AI) including GPT3 an AI system operated by OpenAI. Previous attempts to use closely related AI models have not worked likely in part because GPT3´s performance is strongly dependant on the exact instructions or “prompts” given to GPT3. This study investigated a new method of designing these prompts which consistently achieved satisfactory screening performance when tested on articles collected for three previously published systematic reviews.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 1","pages":"Article 100943"},"PeriodicalIF":3.4,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142707062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
When blood is not an option. The awareness of bloodless medicine among Polish nurses 当血液不再是一种选择时波兰护士对无血医学的认识
IF 3.4 3区 医学
Health Policy and Technology Pub Date : 2024-11-10 DOI: 10.1016/j.hlpt.2024.100941
Jan Domaradzki , Katarzyna Głodowska , Piotr Jabkowski
{"title":"When blood is not an option. The awareness of bloodless medicine among Polish nurses","authors":"Jan Domaradzki ,&nbsp;Katarzyna Głodowska ,&nbsp;Piotr Jabkowski","doi":"10.1016/j.hlpt.2024.100941","DOIUrl":"10.1016/j.hlpt.2024.100941","url":null,"abstract":"<div><h3>Objectives</h3><div>Blood transfusions (BTs) are generally safe and potentially life-saving but come with risks. The World Health Organization advocates reducing unnecessary transfusions and using patient blood management strategies and techniques. However, providing bloodless medical care to patients who prefer to avoid blood-related treatments is a challenge. This is because healthcare professionals’ beliefs about blood transfusion may not align with those of their patients. This study delves into Polish nursing personnel's attitudes toward bloodless medicine (BM), highlighting the potential gap between their knowledge and patient needs.</div></div><div><h3>Methods</h3><div>We conducted an online survey amongst 202 Polish nurses on non-blood management techniques, risks related to BT and BM, and nurses’ educational needs regarding BM.</div></div><div><h3>Results</h3><div>Although many nurses had some knowledge of BM, Polish nurses’ awareness of non-blood management techniques is relatively low: while less than half knew alternative treatment methods and drugs used in BM, many were unaware of the various risks or side effects related to BM. It also shows that more than three-quarters of nurses believed that patients should have the right to make an informed refusal of BT. While 87.1 % of nurses rated their knowledge about BM insufficient or very poor, 66.3 % did not feel prepared to care for patients who require non-blood management techniques.</div></div><div><h3>Conclusions</h3><div>This study underscores the urgent need to educate nurses on blood conservation methods, blood substitutes, and techniques of non-blood management. Incorporating these into the nursing curriculum is crucial for patients’ safety and well-being and our healthcare system's effectiveness. The potential, impact of these findings on the healthcare system is significant, underlining the urgency and importance of addressing the knowledge gap in non-blood management techniques.</div></div><div><h3>Public interest summary</h3><div>Although the World Health Organization recommends using non-blood management techniques, most nurses providing bloodless medical care to patients who wish to avoid blood transfusion do not feel prepared to care for such patients. This study describes the attitudes of Polish nursing personnel toward bloodless medicine. It demonstrates that Polish nurses do not possess knowledge of non-blood management techniques, and their awareness of patient blood management methods and drugs used in bloodless medicine is low. However, it also reveals a positive aspect: Most Polish nurses are interested in broadening their knowledge of bloodless medicine. This strong motivation to improve their skills and knowledge in this area is encouraging and should be harnessed to drive positive change in the field of bloodless medicine.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"13 6","pages":"Article 100941"},"PeriodicalIF":3.4,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142651677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluating sustainability awareness and practices in podiatry clinics in Spain: A path toward a healthy and sustainable future 评估西班牙足科诊所的可持续发展意识和实践:通往健康和可持续未来之路
IF 3.4 3区 医学
Health Policy and Technology Pub Date : 2024-11-07 DOI: 10.1016/j.hlpt.2024.100940
Esther Chicharro-Luna , Gabriel Gijón-Nogueron , Angela M.F. Evans , Alfonso Martínez-Nova
{"title":"Evaluating sustainability awareness and practices in podiatry clinics in Spain: A path toward a healthy and sustainable future","authors":"Esther Chicharro-Luna ,&nbsp;Gabriel Gijón-Nogueron ,&nbsp;Angela M.F. Evans ,&nbsp;Alfonso Martínez-Nova","doi":"10.1016/j.hlpt.2024.100940","DOIUrl":"10.1016/j.hlpt.2024.100940","url":null,"abstract":"<div><h3>Background</h3><div>Sustainability in healthcare is crucial due to the sector's significant contribution to global greenhouse gas emissions. Medical practices must address environmental impact while maintaining high-quality care and equitable access. In podiatry, sustainable practices can reduce the environmental footprint of clinics and improve long-term healthcare outcomes by promoting prevention and resource efficiency.</div></div><div><h3>Study design</h3><div>Cross sectional study.</div></div><div><h3>Method</h3><div>We conducted an online survey with 357 practicing podiatrists, all registered with the General Council of Podiatrists of Spain and with at least one year of professional experience. The survey contained 26 questions focused on sustainability in healthcare, podiatry practices, and environmental impact. The questionnaire included both closed-ended questions and Likert-scale items. Responses were scored and categorized into arbitrary sustainability categories: low (&lt;12), medium (12 to 25), and high (&gt;25).</div></div><div><h3>Results</h3><div>Most respondents (82.6 %) did not regularly use public transport, and 14 % did not engage in any form of physical exercise. More than half of the sample were unaware of the United Nations Sustainable Development Goals (SDGs). Almost all (98 %) had not measured the carbon footprint of their clinics, yet 34.7 % planned to optimise energy consumption in their clinics. Overall, 41.7 % were categorized as low sustainability, 56.9 % medium, and 1.4 % met high sustainability.</div></div><div><h3>Conclusions</h3><div>Podiatry clinics in Spain demonstrate low sustainability actions and knowledge. Sustainable practice aligns with global environment healthcare urgency, and ensures more responsible podiatric services. This study provides the first baseline data for this issue, availing comparisons across global podiatric healthcare sectors.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"13 6","pages":"Article 100940"},"PeriodicalIF":3.4,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142651574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A prospective cost analysis model for financial impact of Connected Care interventions on hospitals’ budget 前瞻性成本分析模型:"连接护理 "干预措施对医院预算的财务影响
IF 3.4 3区 医学
Health Policy and Technology Pub Date : 2024-11-06 DOI: 10.1016/j.hlpt.2024.100926
Jedidja Lok-Visser , Jobbe P.L. Leenen , Heleen M. den Hertog , Gina van Vemde , Jeroen Rekveldt , Jan W.K. van den Berg , Gijs A. Patijn , Judith R. Cornelisse-Vermaat , Gréanne Leeftink , Jan Gerard Maring
{"title":"A prospective cost analysis model for financial impact of Connected Care interventions on hospitals’ budget","authors":"Jedidja Lok-Visser ,&nbsp;Jobbe P.L. Leenen ,&nbsp;Heleen M. den Hertog ,&nbsp;Gina van Vemde ,&nbsp;Jeroen Rekveldt ,&nbsp;Jan W.K. van den Berg ,&nbsp;Gijs A. Patijn ,&nbsp;Judith R. Cornelisse-Vermaat ,&nbsp;Gréanne Leeftink ,&nbsp;Jan Gerard Maring","doi":"10.1016/j.hlpt.2024.100926","DOIUrl":"10.1016/j.hlpt.2024.100926","url":null,"abstract":"<div><h3>Objectives</h3><div>To present a prospective cost analysis (PCA) model for estimating the financial impact of Connected Care interventions in hospitals to support managerial decision-making, and describe its application to three different care pathways.</div></div><div><h3>Methods</h3><div>Input of the developed PCA model consisted of standard of care input and intervention-specific input. The output of the model included: capacity benefits, costs, and reimbursements. The model was applied to three types of interventions in a large Dutch teaching hospital: 1) home telemonitoring for chronic patients (case (COPD), 2) remote aftercare for patients with acute illnesses (case: stroke), and 3) parenteral medication administration at home (case: prosthetic hip or knee joint infections).</div></div><div><h3>Results</h3><div>Output of the PCA model showed that the cost savings can exceed the intervention costs if an intervention decreases the length of stay of patients. For COPD telemonitoring 10.1 % of the healthcare utilization should be reduced to reach break-even, and for antibiotic treatment at home break-even is reached if 4.6 % of the length of stay is reduced. The cost savings of remote aftercare for stroke patients is focused on reducing outpatient visits, and in the current Dutch reimbursement system this does not completely cover the costs.</div></div><div><h3>Conclusions</h3><div>The PCA model is an easy to implement and useful tool for assessing the financial impact of CC interventions from a hospital perspective. It supports decision makers to prospectively assess the cost and capacity benefits of interventions and to inform decisions on implementation. Further studies are needed to extend the model across the entire healthcare continuum.</div></div><div><h3>Public interest summary</h3><div>We present a prospective cost analysis (PCA) model for estimating the financial impact of Connected Care interventions in hospitals to support managerial decision-making. Connected Care interventions are based on an integrated care approach utilizing digital health technologies to enhance patient-centred, collaborative care, where patients receive care at home. Examples are telemonitoring of chronic obstructive pulmonary disease (COPD) patients, remote aftercare for stroke patients and infusion treatment at home for orthopaedic patients with an infection. These interventions have additional costs, but also save part of the costs of the conventional care, and have benefits in terms of a decrease in outpatient visits or hospitalizations. We provide a model where a hospital can calculate the impact in costs and benefits of Connected Care interventions and test this on these three examples. We show that the cost savings are able to exceed the intervention costs if an intervention has impact on the hospitalization.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"13 6","pages":"Article 100926"},"PeriodicalIF":3.4,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142651676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Value-based healthcare in oncology: Can it drive transformative shifts in the Middle East and North Africa region? 以价值为基础的肿瘤医疗:它能否推动中东和北非地区的变革性转变?
IF 3.4 3区 医学
Health Policy and Technology Pub Date : 2024-11-04 DOI: 10.1016/j.hlpt.2024.100939
Radwa Ahmed Batran , Mohab Kamel , Ayman Bahr , Ahmed Khalil , Mohamed Elsokary
{"title":"Value-based healthcare in oncology: Can it drive transformative shifts in the Middle East and North Africa region?","authors":"Radwa Ahmed Batran ,&nbsp;Mohab Kamel ,&nbsp;Ayman Bahr ,&nbsp;Ahmed Khalil ,&nbsp;Mohamed Elsokary","doi":"10.1016/j.hlpt.2024.100939","DOIUrl":"10.1016/j.hlpt.2024.100939","url":null,"abstract":"<div><div>The shift from volume-driven healthcare to value-driven healthcare, or value-based healthcare (VBHC), emerged in the 1990s, prioritizing healthcare quality over quantity. VBHC enjoys support from various healthcare stakeholders, emphasizing patient-centric outcomes that resonate with individual health experiences. Cancer is a major global cause of death, with low- and middle-income countries (LMICs) bearing a significant burden, particularly in the Middle East and North Africa (MENA) region, which is expected to witness a surge in cancer cases due to conflicts, changing demographics, and environmental factors. The MENA oncology market is poised for growth, fueled by biomarkers and targeted therapies. However, the MENA region's diversity leads to disparities in cancer care access and outcomes. Countries throughout the MENA region are presently in the midst of a substantial transformation of their healthcare systems. A number of MENA nations have taken steps to transition towards value-based care, recognizing its potential to reduce healthcare costs, enhance the quality of healthcare services, and promote healthier lifestyles among the populace. This review aims to highlight the ongoing initiatives within the MENA region toward implementing value-based cancer care. It also underscores the challenges associated with this transition while presenting a pragmatic and viable plan for the widespread adoption of value-based cancer care in the MENA region.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"13 6","pages":"Article 100939"},"PeriodicalIF":3.4,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142703686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Health technology assessment of nailfold capillaroscopy and digital retina imaging in diabetes screening 甲襞毛细血管镜和数字视网膜成像在糖尿病筛查中的卫生技术评估
IF 3.4 3区 医学
Health Policy and Technology Pub Date : 2024-11-04 DOI: 10.1016/j.hlpt.2024.100938
Vinaytosh Mishra , Zahiruddin Quazi Syed
{"title":"Health technology assessment of nailfold capillaroscopy and digital retina imaging in diabetes screening","authors":"Vinaytosh Mishra ,&nbsp;Zahiruddin Quazi Syed","doi":"10.1016/j.hlpt.2024.100938","DOIUrl":"10.1016/j.hlpt.2024.100938","url":null,"abstract":"<div><h3>Aim</h3><div>This study aims to identify the criteria for the evaluation of medical technologies in diabetes screening and then perform health technology assessment (HTA) for two technologies: digital retina imaging (DRI) and Nailfold Capillaroscopy (NFC).</div></div><div><h3>Methods</h3><div>A multicriteria decision-making tool measuring attractiveness using a categorical-based evaluation technique (MACBETH) was used to calculate and compare alternatives. A focus group of ten decision-makers with more than ten years of experience in health technology was used for the decision-making. The Delphi Method was used to get a consensus about comparing criteria and alternatives to these criteria. The sampling method used in the study was the nonprobability purposive sampling method.</div></div><div><h3>Results</h3><div>The study concluded that clinical efficacy (0.42) is the most important criterion for evaluating medical technologies, followed by cost-effectiveness (0.27). At the same time, ethical considerations were found to be less important (0.03). The sensitivity analysis concluded that the decision is sensitive to clinical efficacy and cost-effectiveness changes. The study found that none of the alternatives dominates others as an option for early detection of diabetes through vascular changes.</div></div><div><h3>Limitations</h3><div>This study primarily uses systemic literature review methods to identify criteria for evaluating alternatives. There may be additional criteria for evaluation.</div></div><div><h3>Conclusion</h3><div>This study provides an approach for a multicriteria comparison of medical devices. The study findings are useful for public health professionals and health policymakers.</div></div><div><h3>Plain language summary</h3><div>This study assesses nailfold capillaroscopy (NFC) as a substitute for digital retina imaging (DRI) in diabetes screening using the MACBETH multicriteria decision-making tool. The research identifies five key evaluation criteria: clinical efficacy, cost-effectiveness, patient needs, user safety, and ethical considerations. A focus group of experienced health technology decision-makers was used to compare NFC and DRI. Results indicate that clinical efficacy and cost-effectiveness are the most critical factors, with NFC showing potential but not significantly outperforming DRI. Sensitivity analyses highlight the need for further research to validate NFC as an effective diabetes screening tool.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 1","pages":"Article 100938"},"PeriodicalIF":3.4,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142707061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluating mobile health interventions for HIV patients in Nigeria: Healthcare policy implications from a simulation study 评估针对尼日利亚艾滋病患者的移动医疗干预措施:模拟研究对医疗政策的影响
IF 3.4 3区 医学
Health Policy and Technology Pub Date : 2024-11-03 DOI: 10.1016/j.hlpt.2024.100937
Eren Demir , Usame Yakutcan , Adekunle Olatayo Adeoti , Christian Isichei , Shola Adeyemi
{"title":"Evaluating mobile health interventions for HIV patients in Nigeria: Healthcare policy implications from a simulation study","authors":"Eren Demir ,&nbsp;Usame Yakutcan ,&nbsp;Adekunle Olatayo Adeoti ,&nbsp;Christian Isichei ,&nbsp;Shola Adeyemi","doi":"10.1016/j.hlpt.2024.100937","DOIUrl":"10.1016/j.hlpt.2024.100937","url":null,"abstract":"<div><h3>Objectives</h3><div>People living with HIV/AIDS (PLWHA) benefit from mobile health (mHealth) technologies through self-managing and monitoring their disease with enhanced patient experience and health outcomes. However, the efficiency and cost-effectiveness of these interventions are yet to be studied. The study aims to assess the impact of mHealth on operational and cost metrics relevant to PLWHA and HIV service delivery.</div></div><div><h3>Data Sources</h3><div>Data were a mixture of primary and secondary data from the hospital setting, experts’ opinions, reports, and the literature.</div></div><div><h3>Method</h3><div>Using a web-based simulation platform, SmartHIV Manager™, for the management of HIV services, we tested scenarios based on four possible reductions in the number of clinic visits and four groups of PLWHA who can be offered a mobile device free of charge (16 scenarios in total). The study was conducted in collaboration with Faith Alive Foundation Hospital (Nigeria) using a mHealth app (BSmart Chart).</div></div><div><h3>Results</h3><div>In the worst-case scenario, the hospital anticipates a 14 % decrease in the number of visits from stable patients, nine fewer doctors to operate their service, and a 3 % savings in total cost after accounting for mHealth intervention expenses and mobile phone acquisition. With the service currently running at 161 % doctor capacity, this intervention alleviates staff pressure and ensures quality care.</div></div><div><h3>Conclusion</h3><div>The study shows significant system efficiency gains, fewer visits, better health outcomes, economic benefits for stable patients, and increased capacity. These findings apply to most HIV services worldwide, especially in times of limited resources.</div></div><div><h3>Public Interest Summary</h3><div>Mobile health (mHealth) technologies support people living with HIV/AIDS by helping them manage their health and receive remote monitoring. This study examines the impact of mHealth apps on the costs and operations of HIV services. Conducted in a rural HIV setting in Nigeria, where many patients face financial challenges, the research used a simulation-based decision support tool (known as SmartHIV Manager) to test the scenario of providing free mobile devices and reducing clinic visits for stable patients. Results indicated that this approach could reduce patient visits and healthcare costs while easing the workload of overburdened doctors. Globally, introducing mHealth apps could be impactful, given the constraints of limited healthcare staff and budgets.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"13 6","pages":"Article 100937"},"PeriodicalIF":3.4,"publicationDate":"2024-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142651675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Market access regulations for mHealth applications in Germany, Austria and Switzerland: A Review 德国、奥地利和瑞士的移动医疗应用市场准入法规:回顾
IF 3.4 3区 医学
Health Policy and Technology Pub Date : 2024-11-01 DOI: 10.1016/j.hlpt.2024.100934
Kira Jürgens , Agnieszka Raddatz , Frank Tausendfreund , Timo Clemens
{"title":"Market access regulations for mHealth applications in Germany, Austria and Switzerland: A Review","authors":"Kira Jürgens ,&nbsp;Agnieszka Raddatz ,&nbsp;Frank Tausendfreund ,&nbsp;Timo Clemens","doi":"10.1016/j.hlpt.2024.100934","DOIUrl":"10.1016/j.hlpt.2024.100934","url":null,"abstract":"<div><div>Market access regulations for mobile health applications are divergent across countries. A uniform legal framework for mobile health applications is currently lacking, therefore, this review compares the requirements and processes for mobile health applications in Germany, Austria, and Switzerland. The review used a combined search in domestic law databases, PubMed and institutional websites to synthesise the available information for market access. The investigated countries have similar ongoing digital health projects; therefore, mandatory enforcement procedures to encourage the use of mobile health applications are implemented. Mobile health applications must meet different additional domestic requirements including increased data security and interoperability with existing telematic structures which are common in all countries. A formal process of certification for mobile health applications must be completed in Germany. In Austria, there are no formal processes, and in Switzerland, healthcare facilities must provide certification. However, in all three countries regulatory steps involve: the Ministry of Health, a Medical Device agency and telemedicine/digital health expert center. Manufacturers need to familiarise themselves with diverse regulatory and legal requirements early in the product development process. In the future, new cooperation approaches between industry, policymakers and MedTech associations can help to fulfil requirements on time and thus advance market entry for digitalised health products in the healthcare sector.</div></div><div><h3>Public interest summary</h3><div>Rules for placing mobile health applications on the market differ in Germany, Austria, and Switzerland. Hence, manufacturers of such products must understand the requirements in each of the country separately. The study has examined these rules and compared them. Mobile health applications in these countries must meet extra requirements like better data security to protect users privacy and the ability of those products to “communicate” and exchange information with existing IT systems. In Germany, there is a formal process for approval of these products. In Austria, there is not a formal process but mobile health applications need to be evaluated according to set criteria, and in Switzerland, healthcare facilities must provide approval themselves. In all three countries, the government's Ministry of Health, a Medical Device agency, and a center of experts in digital health play a role in the regulations. Manufacturers need to understand these different rules early on when they are developing their products.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"13 5","pages":"Article 100934"},"PeriodicalIF":3.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142663953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluating progress towards implementation of the European HTA Regulation: Insights generated from the European Access Academy's multi-stakeholder survey 评估欧洲 HTA 法规的实施进展:欧洲准入学院多方利益相关者调查的启示
IF 3.4 3区 医学
Health Policy and Technology Pub Date : 2024-11-01 DOI: 10.1016/j.hlpt.2024.100930
Francine Brinkhuis , Jörg Ruof , Hendrika van den Ham , Fabrizio Gianfrate , Valentina Strammiello , Michael Berntgen , Mira Pavlovic , Peter Mol , Jürgen Wasem , Walter Van Dyck , Antonella Cardone , Christian Dierks , Anja Schiel , Oriol Solà-Morales , Wim Goettsch , Elaine Julian
{"title":"Evaluating progress towards implementation of the European HTA Regulation: Insights generated from the European Access Academy's multi-stakeholder survey","authors":"Francine Brinkhuis ,&nbsp;Jörg Ruof ,&nbsp;Hendrika van den Ham ,&nbsp;Fabrizio Gianfrate ,&nbsp;Valentina Strammiello ,&nbsp;Michael Berntgen ,&nbsp;Mira Pavlovic ,&nbsp;Peter Mol ,&nbsp;Jürgen Wasem ,&nbsp;Walter Van Dyck ,&nbsp;Antonella Cardone ,&nbsp;Christian Dierks ,&nbsp;Anja Schiel ,&nbsp;Oriol Solà-Morales ,&nbsp;Wim Goettsch ,&nbsp;Elaine Julian","doi":"10.1016/j.hlpt.2024.100930","DOIUrl":"10.1016/j.hlpt.2024.100930","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;We conducted a multi-stakeholder survey to assess stakeholders' perceptions of the progress made towards the implementation of the European Regulation on Health Technology Assessment (EU HTA R) and to identify and prioritize the remaining challenges for implementation.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;Using two iterative Delphi cycles, an exploratory, semi-quantitative survey was developed to identify how stakeholders 1) experienced preparatory activities of the Regulation, and 2) prioritized remaining challenges for successful implementation. The survey was distributed among the network of the European Access Academy and via social media to ensure coverage of key stakeholders. Descriptive analyses were performed on quantitative response items, and relative importance was calculated for ranking items. Free-text responses supplemented participants' answers to quantitative questions.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;N = 61 responses were received from N = 15 countries including Global/ EU-wide institutions (Patients and Patients’ representatives: 7; Clinicians’ representatives: 5; Regulators: 3; Health Technology Developers (HTDs): 20; HTA bodies: 10; Payers: 7; Policy Makers: 2; Academic representatives: 7). The majority of respondents were aware of preparatory activities, with 74 % (N = 45) observing the drafting of Guidance Documents and 64 % (N = 39) noting the establishment of the Coordination Group. Respondents ranked the success of preparatory activities neutral with a slight tendency towards a positive ranking. Key challenges were Member States' readiness for Joint Clinical Assessments, HTA capacity/ capability constraints, and the applicability/ feasibility of the methodological framework.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;This study identified the key remaining challenges for the successful establishment of the EU HTA process. Key findings emphasize the readiness of national systems and procedures as pivotal factors. Balancing operational efficiency with strategic objectives, including the development of a European Value Framework, is imperative for harnessing the full potential of the joint HTA process and enhancing patient access to innovative technologies on a pan-European scale.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Public interest summary&lt;/h3&gt;&lt;div&gt;In January 2022, the European Union (EU) adopted the European Regulation on Health Technology Assessment (HTA). By harmonizing HTA practices and promoting collaboration across Member States, the joint procedure as set out in the regulation aims to improve efficient use of resources and ensure long-term sustainability of EU-wide HTA cooperation. Close to reaching the half-way mark of the preparation phase in mid-2023, we conducted a multi-stakeholder survey to assess perceptions of the progress made towards implementation of a joint procedure and to prioritize remaining challenges. The responses indicated a neutral to positive perception of the preparatory activitie","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"13 5","pages":"Article 100930"},"PeriodicalIF":3.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142587308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Practices and systems employed by health professionals toward protection and confidentiality of patient health records in Ghana 加纳卫生专业人员保护和保密病人健康记录的做法和系统
IF 3.4 3区 医学
Health Policy and Technology Pub Date : 2024-11-01 DOI: 10.1016/j.hlpt.2024.100933
Eric Gotah, Emmanuel Adjei, Philip Kwaku Kankam, Monica Mensah Danquah
{"title":"Practices and systems employed by health professionals toward protection and confidentiality of patient health records in Ghana","authors":"Eric Gotah,&nbsp;Emmanuel Adjei,&nbsp;Philip Kwaku Kankam,&nbsp;Monica Mensah Danquah","doi":"10.1016/j.hlpt.2024.100933","DOIUrl":"10.1016/j.hlpt.2024.100933","url":null,"abstract":"<div><h3>Objectives</h3><div>Health information relies on a patient's sensory perceptions as well as objective assessments, diagnoses, and test findings. Ghana's current laws governing the confidentiality of patient health data seems a little pertinent in spite of ongoing conversations on the significance of patient health information and the necessity to protect patient information from improper disclosure. The study therefore investigated the extent of patient confidentiality in Ghana by looking into the guidelines, regulations, and rules that govern patient records.</div></div><div><h3>Methods</h3><div>The interpretive, phenomenological, and narrative methodologies used in qualitative research were employed to study the phenomenon. Twenty (20) participants were interviewed in a semi-structured manner to gather the data needed for the analysis comprising of Doctors, Nurses, Administrative staff, Record Officers, and Information Communication Technology (ICT0 Technicians of five Departments in La General Hospital. The Activity Theory was used as a theoretical foundation for the study</div></div><div><h3>Conclusions</h3><div>The study revealed that healthcare professionals uphold the moral standards relating to patient confidentiality and trust. Again, the findings of the study showed that medical records are safely stored through the use of Electronic Health Record system in the hospital in a manner that wouldn't compromise patient confidentiality. However, the results establishes that health care workers can potentially serve as a conduit for the leak or breach of patient information through negligence and unprofessional practices.</div></div><div><h3>Public interest statement</h3><div>The study investigated systems and practices that are employed by health workers in Ghana to ensure that patient health records are safeguarded in order to build patients confidence in how their health records are protected. Health workers were interviewed in this study and the findings of the study show that there are practices and systems put in place to safeguard patient health records in the hospitals. Although, it was established that EHR systems help in safeguarding patient health records, the study recommends the need for users of the Health Electronic Records to be fully involved in the implementation process and strict enforcement of policies regarding the use of the EHR system to help prevent negligence and unprofessional application of the system.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"13 5","pages":"Article 100933"},"PeriodicalIF":3.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142561387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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