Pub Date : 2025-05-13DOI: 10.1016/j.hlpt.2025.101031
Colene Bentley , Helen McTaggart-Cowan , Diana Kato , Stephen Sundquist , Janet E. Dancey , Stuart Peacock
Objectives
Clinical trials provide opportunities for patients to access novel diagnostic screening, treatment, and supportive care options. Trial access is limited for many Canadians due to distribution and distance from cancer centres with clinical trials. In 2021-23, the Canadian Remote Access Framework for Clinical Trials (CRAFT) was implemented as a proof of concept (PoC) pilot to reduce these inequities by bringing trial opportunities to patients living outside metropolitan areas. CRAFT involves a “primary” site that delegates specific trial responsibilities to regional “satellite” centres to form a “trial cluster.” Our objective was to evaluate the CRAFT pilot implemented in three Canadian provinces: British Columbia, Ontario, and Newfoundland.
Methods
We recruited healthcare professionals participating in the PoC at primary and satellites locations. Using a framework with deductive and inductive codes, two researchers independently analyzed the interview data applying principles of constant comparison. Disagreements were settled by consensus.
Results
Thirteen one-on-one interviews were conducted with participants from British Columbia (n=4), Ontario (n=6), and Newfoundland (n=3). Participants endorsed CRAFT as means to improve equitable access to experimental therapies for underserved populations; upskill regional healthcare teams; integrate satellites with primary sites; and re-envision future trial delivery. Challenges included responsibilities for contract review and approvals at smaller centres and coordinating research services and senior management support across sites.
Conclusions
Healthcare teams endorsed CRAFT to improve equitable access to trials and grow research capacity. A follow-up workshop of all relevant parties in March 2025 addressed needed improvements in research, technology, and governance infrastructure to scale CRAFT to new jurisdictions.
Public Interest Summary
Clinical trials create opportunities for patients to access new and innovative approaches to treatment, and clinical trial activity has been reported to improve health system performance. However, patients living in rural and remote regions face barriers to trial participation, including financial, time, and health costs to travel to trials in metropolitan centres. Decentralizing clinical trial delivery, where some trial-related activities take place in regional hospitals, can help mitigate these inequities. This study evaluated a pilot demonstration of the Canadian Remote Access Framework for Clinical Trials (CRAFT) in oncology in three Canadian provinces in 2021-2023, from the perspectives of healthcare professionals participating in the pilot. The framework was endorsed by healthcare professionals to help reduce inequities in trial access and grow research capacity. Study findings show better infrastructure support (e.g., co
{"title":"Evaluation of the Canadian Remote Access Framework for Clinical Trials (CRAFT) Pilot: a Qualitative Study","authors":"Colene Bentley , Helen McTaggart-Cowan , Diana Kato , Stephen Sundquist , Janet E. Dancey , Stuart Peacock","doi":"10.1016/j.hlpt.2025.101031","DOIUrl":"10.1016/j.hlpt.2025.101031","url":null,"abstract":"<div><h3>Objectives</h3><div>Clinical trials provide opportunities for patients to access novel diagnostic screening, treatment, and supportive care options. Trial access is limited for many Canadians due to distribution and distance from cancer centres with clinical trials. In 2021-23, the Canadian Remote Access Framework for Clinical Trials (CRAFT) was implemented as a proof of concept (PoC) pilot to reduce these inequities by bringing trial opportunities to patients living outside metropolitan areas. CRAFT involves a “primary” site that delegates specific trial responsibilities to regional “satellite” centres to form a “trial cluster.” Our objective was to evaluate the CRAFT pilot implemented in three Canadian provinces: British Columbia, Ontario, and Newfoundland.</div></div><div><h3>Methods</h3><div>We recruited healthcare professionals participating in the PoC at primary and satellites locations. Using a framework with deductive and inductive codes, two researchers independently analyzed the interview data applying principles of constant comparison. Disagreements were settled by consensus.</div></div><div><h3>Results</h3><div>Thirteen one-on-one interviews were conducted with participants from British Columbia (n=4), Ontario (n=6), and Newfoundland (n=3). Participants endorsed CRAFT as means to improve equitable access to experimental therapies for underserved populations; upskill regional healthcare teams; integrate satellites with primary sites; and re-envision future trial delivery. Challenges included responsibilities for contract review and approvals at smaller centres and coordinating research services and senior management support across sites.</div></div><div><h3>Conclusions</h3><div>Healthcare teams endorsed CRAFT to improve equitable access to trials and grow research capacity. A follow-up workshop of all relevant parties in March 2025 addressed needed improvements in research, technology, and governance infrastructure to scale CRAFT to new jurisdictions.</div></div><div><h3>Public Interest Summary</h3><div>Clinical trials create opportunities for patients to access new and innovative approaches to treatment, and clinical trial activity has been reported to improve health system performance. However, patients living in rural and remote regions face barriers to trial participation, including financial, time, and health costs to travel to trials in metropolitan centres. Decentralizing clinical trial delivery, where some trial-related activities take place in regional hospitals, can help mitigate these inequities. This study evaluated a pilot demonstration of the Canadian Remote Access Framework for Clinical Trials (CRAFT) in oncology in three Canadian provinces in 2021-2023, from the perspectives of healthcare professionals participating in the pilot. The framework was endorsed by healthcare professionals to help reduce inequities in trial access and grow research capacity. Study findings show better infrastructure support (e.g., co","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 5","pages":"Article 101031"},"PeriodicalIF":3.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144271891","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}
Pub Date : 2025-05-13DOI: 10.1016/j.hlpt.2025.101028
Vilas Sawrikar , Kyle Buchan , Karri Gillespie-Smith
Objectives
While new models of youth mental health care will be introduced in the United Kingdom (UK) as part of the NHS’s Long Term Plan, little is known about how to design and implement these models for depression. This study investigated young people’s perspective on the key attributes of technology-enabled personalised youth mental health care for depression to ensure the crucial components are implemented.
Methods
Qualitative data of young people’s perspectives was collected over two phases. In phase 1, 37 young people participated in interviews where they were presented with two depression vignettes differentiated by clinical stage and asked to outline the key attributes of care. In phase 2, 8 young people participated in a group workshop co-designing digital care pathways. Recordings were analysed thematically to identify key service, model, and digitised care attributes.
Results
Key service attributes emphasised youth-friendly, welcoming environments allowing for timely access to care. Key model attributes included needs-led care, supported by youth and family engagement, personalised care planning, care coordination, monitoring, and peer support. Key attributes of digitised care included facilitating access to care, centralised assessments, patient decision aid, monitoring, and design principles of flexibility and human assistance.
Conclusions
The results suggest that evidence-informed methods of delivering care based on individual needs is critical to personalised care and that the implementation of this model entails specific configuration of highly personalised and measurement-based capabilities within youth mental health services. In line with this, a digitised care pathway for delivering personalised care for depression is presented.
Public interest summary
Personalised care reforms in the United Kingdom (UK) will see the implementation of technology-enabled, youth specific models of care supported by emerging health technologies. An analysis of young people’s perspective of these models indicated that delivery of technology-enabled personalised youth mental health care can be defined in terms of service characteristics, service model, and digitised care pathways. Young people propose that services should be youth friendly and easy to access, while care should be tailored to individual needs and preferences. Treatments should also be organised on as needed bases with youth having greater choice. Digitised care pathways were proposed to help reduce barriers to care and streamline pathways from screening to referrals, assessments and transfers between services. The results are used to prototype a digitised care pathway for delivering personalised care for depression within youth mental health services in the UK.
{"title":"Young people’s perspective on technology-enabled personalised youth mental health care for depression in the UK","authors":"Vilas Sawrikar , Kyle Buchan , Karri Gillespie-Smith","doi":"10.1016/j.hlpt.2025.101028","DOIUrl":"10.1016/j.hlpt.2025.101028","url":null,"abstract":"<div><h3>Objectives</h3><div>While new models of youth mental health care will be introduced in the United Kingdom (UK) as part of the NHS’s Long Term Plan, little is known about how to design and implement these models for depression. This study investigated young people’s perspective on the key attributes of technology-enabled personalised youth mental health care for depression to ensure the crucial components are implemented.</div></div><div><h3>Methods</h3><div>Qualitative data of young people’s perspectives was collected over two phases. In phase 1, 37 young people participated in interviews where they were presented with two depression vignettes differentiated by clinical stage and asked to outline the key attributes of care. In phase 2, 8 young people participated in a group workshop co-designing digital care pathways. Recordings were analysed thematically to identify key service, model, and digitised care attributes.</div></div><div><h3>Results</h3><div>Key service attributes emphasised youth-friendly, welcoming environments allowing for timely access to care. Key model attributes included needs-led care, supported by youth and family engagement, personalised care planning, care coordination, monitoring, and peer support. Key attributes of digitised care included facilitating access to care, centralised assessments, patient decision aid, monitoring, and design principles of flexibility and human assistance.</div></div><div><h3>Conclusions</h3><div>The results suggest that evidence-informed methods of delivering care based on individual needs is critical to personalised care and that the implementation of this model entails specific configuration of highly personalised and measurement-based capabilities within youth mental health services. In line with this, a digitised care pathway for delivering personalised care for depression is presented.</div></div><div><h3>Public interest summary</h3><div>Personalised care reforms in the United Kingdom (UK) will see the implementation of technology-enabled, youth specific models of care supported by emerging health technologies. An analysis of young people’s perspective of these models indicated that delivery of technology-enabled personalised youth mental health care can be defined in terms of service characteristics, service model, and digitised care pathways. Young people propose that services should be youth friendly and easy to access, while care should be tailored to individual needs and preferences. Treatments should also be organised on as needed bases with youth having greater choice. Digitised care pathways were proposed to help reduce barriers to care and streamline pathways from screening to referrals, assessments and transfers between services. The results are used to prototype a digitised care pathway for delivering personalised care for depression within youth mental health services in the UK.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 3","pages":"Article 101028"},"PeriodicalIF":3.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144124373","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}
Cancer is the leading cause of death in Japan, and various cancer control policies have been implemented since the 1960s. The Cancer Control Act, enacted in 2006, states that the promotion of equity in cancer care is a fundamental principle. However, there has been no evaluation of whether the government's cancer-related policies have promoted equity. In this study, we evaluated whether equity in cancer care has progressed using the cost of illness (COI) method.
Methods
We estimated the COI from 2008 to 2020 by summing the direct, morbidity and mortality costs for each secondary medical area set to complete general hospitalization care. By measuring the coefficient of variation for each cost, we observed variation trends by categorizing secondary medical areas into urban or rural areas.
Results
The variation in morbidity costs, which is thought to directly reflect policy, decreased significantly from 2008 to 2020 (0.245→0.221). However, the variation in mortality costs increased (0.171→0.189), and there was no statistically significant trend in COI overall. The increase in COI was lower in urban secondary medical areas than in rural secondary medical areas. Due to differences in the age structure of the population between rural and urban secondary medical areas and the more pronounced effectiveness of cancer treatment in younger individuals, the analysis using COI revealed a reduction in disparities in access to cancer care; however, this did not lead to the verification of these disparities within the COI framework.
{"title":"The impact of the cancer control equity policy for cancer care on social burdens","authors":"Kunichika Matsumoto, Kanako Seto, Yosuke Hatakeyama, Ryo Onishi, Koki Hirata, Ryosuke Hayashi, Tomonori Hasegawa","doi":"10.1016/j.hlpt.2025.101027","DOIUrl":"10.1016/j.hlpt.2025.101027","url":null,"abstract":"<div><h3>Objectives</h3><div>Cancer is the leading cause of death in Japan, and various cancer control policies have been implemented since the 1960s. The Cancer Control Act, enacted in 2006, states that the promotion of equity in cancer care is a fundamental principle. However, there has been no evaluation of whether the government's cancer-related policies have promoted equity. In this study, we evaluated whether equity in cancer care has progressed using the cost of illness (COI) method.</div></div><div><h3>Methods</h3><div>We estimated the COI from 2008 to 2020 by summing the direct, morbidity and mortality costs for each secondary medical area set to complete general hospitalization care. By measuring the coefficient of variation for each cost, we observed variation trends by categorizing secondary medical areas into urban or rural areas.</div></div><div><h3>Results</h3><div>The variation in morbidity costs, which is thought to directly reflect policy, decreased significantly from 2008 to 2020 (0.245→0.221). However, the variation in mortality costs increased (0.171→0.189), and there was no statistically significant trend in COI overall. The increase in COI was lower in urban secondary medical areas than in rural secondary medical areas. Due to differences in the age structure of the population between rural and urban secondary medical areas and the more pronounced effectiveness of cancer treatment in younger individuals, the analysis using COI revealed a reduction in disparities in access to cancer care; however, this did not lead to the verification of these disparities within the COI framework.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 3","pages":"Article 101027"},"PeriodicalIF":3.4,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144169775","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}
Pub Date : 2025-05-11DOI: 10.1016/j.hlpt.2025.101030
Marco Alibone, Marion Ludwig, Christina Simantiri, Josephine Jacob, Dirk Enders
Background
The COVID-19 pandemic has significantly impacted global healthcare systems through the prioritisation of COVID-19 cases and the reallocation of resources, leading, for example, to a postponement of elective procedures. This study quantifies the impact of the COVID-19 pandemic on healthcare utilization in 2020 and 2021.
Methods
Forecasting models were trained using data from the pre-pandemic years 2013 to 2019. The most suitable model was used to predict a trend in healthcare utilization unaffected by the pandemic in the two pandemic years. Deviations between observed and predicted utilization were interpreted as the pandemic impact on healthcare.
Results
During the COVID-19 pandemic, all-cause hospitalizations declined across the first three waves. The first drop occurred in April 2020, with hospitalization rates falling to 1.7 times below expected pre-pandemic levels. A second drop began in November 2020, reaching 1.4 times below expected levels by January 2021. Hospitalizations returned to pre-pandemic levels after strict lockdown measures eased. These declines affected elective procedures but also life-threatening conditions, such as myocardial infarctions (MI). In March and April 2020, admissions for these events were 1.29 times below expected levels. By July 2020, however, MI hospitalization increased, reaching 0.87 times higher than typical pre-pandemic rates.
Discussion
We investigate for the first time the impact of the pandemic on healthcare in Germany using modern forecasting methods showing delayed hospitalizations for acute conditions like MI. Findings highlight the need to protect vulnerable groups and underscore the importance of further research on long-term health impacts and improved public health responses.
Lay summary
The COVID-19 pandemic has significantly disrupted healthcare provision by prioritising COVID-19 cases over other conditions, leading to postponement of interventions and reduced care for serious problems such as myocardial infarctions (MI). This study examined healthcare utilization in Germany in 2020–2021 by comparing observed hospitalisations with predicted values based on pre-pandemic trends from 2013–2019. The results showed a sharp decline in hospitalisations during the first three pandemic waves. In April 2020, hospital admissions fell to almost half the expected level, with a second decline at the end of 2020. Normalisation only set in when the lockdown measures were lifted. Crucially, admissions for life-threatening conditions such as MI also fell temporarily, showing a time lag in hospital admissions. This analysis emphasises the importance of ensuring access to healthcare for critical illnesses, even in times of pandemic, to reduce negative health impacts and improve the resilience of healthcare in future crises.
{"title":"Predicting the utilization of healthcare services during COVID-19 - forecasting models based on routine data","authors":"Marco Alibone, Marion Ludwig, Christina Simantiri, Josephine Jacob, Dirk Enders","doi":"10.1016/j.hlpt.2025.101030","DOIUrl":"10.1016/j.hlpt.2025.101030","url":null,"abstract":"<div><h3>Background</h3><div>The COVID-19 pandemic has significantly impacted global healthcare systems through the prioritisation of COVID-19 cases and the reallocation of resources, leading, for example, to a postponement of elective procedures. This study quantifies the impact of the COVID-19 pandemic on healthcare utilization in 2020 and 2021.</div></div><div><h3>Methods</h3><div>Forecasting models were trained using data from the pre-pandemic years 2013 to 2019. The most suitable model was used to predict a trend in healthcare utilization unaffected by the pandemic in the two pandemic years. Deviations between observed and predicted utilization were interpreted as the pandemic impact on healthcare.</div></div><div><h3>Results</h3><div>During the COVID-19 pandemic, all-cause hospitalizations declined across the first three waves. The first drop occurred in April 2020, with hospitalization rates falling to 1.7 times below expected pre-pandemic levels. A second drop began in November 2020, reaching 1.4 times below expected levels by January 2021. Hospitalizations returned to pre-pandemic levels after strict lockdown measures eased. These declines affected elective procedures but also life-threatening conditions, such as myocardial infarctions (MI). In March and April 2020, admissions for these events were 1.29 times below expected levels. By July 2020, however, MI hospitalization increased, reaching 0.87 times higher than typical pre-pandemic rates.</div></div><div><h3>Discussion</h3><div>We investigate for the first time the impact of the pandemic on healthcare in Germany using modern forecasting methods showing delayed hospitalizations for acute conditions like MI. Findings highlight the need to protect vulnerable groups and underscore the importance of further research on long-term health impacts and improved public health responses.</div></div><div><h3>Lay summary</h3><div>The COVID-19 pandemic has significantly disrupted healthcare provision by prioritising COVID-19 cases over other conditions, leading to postponement of interventions and reduced care for serious problems such as myocardial infarctions (MI). This study examined healthcare utilization in Germany in 2020–2021 by comparing observed hospitalisations with predicted values based on pre-pandemic trends from 2013–2019. The results showed a sharp decline in hospitalisations during the first three pandemic waves. In April 2020, hospital admissions fell to almost half the expected level, with a second decline at the end of 2020. Normalisation only set in when the lockdown measures were lifted. Crucially, admissions for life-threatening conditions such as MI also fell temporarily, showing a time lag in hospital admissions. This analysis emphasises the importance of ensuring access to healthcare for critical illnesses, even in times of pandemic, to reduce negative health impacts and improve the resilience of healthcare in future crises.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 3","pages":"Article 101030"},"PeriodicalIF":3.4,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144070962","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}
Sales of health foods are soaring globally as health awareness increases. In Japan, health foods fall into four categories, including those with functional claims backed by scientific evidence. However, in March 2024, concerns about dietary supplements, notably the "Beni-koji (Red Yeast Rice) choleste helpⓇ" produced by KOBAYASHI Pharmaceutical Co., Ltd., sparked a loss of consumer confidence, linked to serious health issues, including five deaths. To prevent future incidents, enhanced health communication on supplement regulation, efficacy, and safety is crucial. Both the Japanese government and citizens need to reassess regulations, stressing the importance of adequate oversight in product development and evidence-based information maintenance. Moreover, healthcare professionals, particularly pharmacists, play pivotal roles in safeguarding the public against dietary supplement harms by offering empathetic support based on reliable information.
{"title":"Red yeast rice supplement consumption and health hazards in Japan–what role is desired for community pharmacists?","authors":"Yosuke Nomura , Yoshitaka Nishikawa , Shota Suzuki , Chiho Kaneko , Hiroshi Okada","doi":"10.1016/j.hlpt.2025.101029","DOIUrl":"10.1016/j.hlpt.2025.101029","url":null,"abstract":"<div><div>Sales of health foods are soaring globally as health awareness increases. In Japan, health foods fall into four categories, including those with functional claims backed by scientific evidence. However, in March 2024, concerns about dietary supplements, notably the \"Beni-koji (Red Yeast Rice) choleste help<sup>Ⓡ</sup>\" produced by KOBAYASHI Pharmaceutical Co., Ltd., sparked a loss of consumer confidence, linked to serious health issues, including five deaths. To prevent future incidents, enhanced health communication on supplement regulation, efficacy, and safety is crucial. Both the Japanese government and citizens need to reassess regulations, stressing the importance of adequate oversight in product development and evidence-based information maintenance. Moreover, healthcare professionals, particularly pharmacists, play pivotal roles in safeguarding the public against dietary supplement harms by offering empathetic support based on reliable information.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 3","pages":"Article 101029"},"PeriodicalIF":3.4,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143948592","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}
Pub Date : 2025-05-08DOI: 10.1016/j.hlpt.2025.101025
Zhisan He , Xiaoyi Chen , Shunlong Ou , Qian Jiang , Xiaoli Qin
Objectives
Although generic drugs offer comparable patient benefits and cost advantages to original drugs and are widely utilized in emerging nations, concerns persist regarding their product quality, bioequivalence, and clinical outcomes. Additionally, there is a lack of consensus on the value assessment for generic drugs, particularly in determining whether lower prices correspond to equivalent value. Our objective is to systematically describe and contrast the prevailing tools, scales, frameworks and etc. for assessing generic drugs, while integrating their core dimensions and criteria as a reference for emerging nations. Methods: This study systematically reviewed evaluation tools, scales, and frameworks etc. for generic or off-patent drugs. Given that meta-analysis is limited to qualitative research, thematic analysis was employed to comprehensively synthesize the primary concepts of generic drug evaluation. The literature search was conducted using PubMed, EMbase, CNKI, and WanFang Data, with a cut-off date of July 25, 2024. Additionally, thematic analysis was conducted to identify themes and subthemes related to the evaluation of generics across the included records. Results: A total of nine evaluation tools, scales, and frameworks for generic drugs were included in this study. Variations were observed in their dimensions, criteria, application procedures, and methods of calculating criteria weights among participants. Ultimately, four core themes and 16 subthemes for the evaluation of generics were synthesized through thematic analysis. Conclusions: The four themes and sixteen subthemes can be regarded as primary dimensions and criteria for evaluating the value of generic drugs. They serve as a benchmark for value assessment frameworks, thereby promoting advancements in healthcare systems in regions where generic drugs are widely utilized.
Public Interest Summary
Although generic drugs provide comparable patient benefits and cost advantages to original drugs and are widely used in emerging nations, concerns persist regarding their product quality, bioequivalence, and clinical outcomes. Our objective is to systematically describe and contrast the prevailing tools, scales, frameworks, and other relevant methodologies for assessing generic drugs, while integrating their core dimensions and criteria. This study incorporates a total of nine evaluation tools, scales, and frameworks for generic drugs, synthesizing them into four core themes and 16 subthemes for the evaluation of generics. These four themes and sixteen subthemes can be regarded as primary dimensions and criteria for assessing the value of generic drugs. They serve as a benchmark for value assessment frameworks, thereby promoting advancements in healthcare systems in regions where generic drugs are widely utilized.
{"title":"Dimensions and criteria of value assessment frameworks for generic drugs: A scoping review and thematic analysis","authors":"Zhisan He , Xiaoyi Chen , Shunlong Ou , Qian Jiang , Xiaoli Qin","doi":"10.1016/j.hlpt.2025.101025","DOIUrl":"10.1016/j.hlpt.2025.101025","url":null,"abstract":"<div><h3>Objectives</h3><div>Although generic drugs offer comparable patient benefits and cost advantages to original drugs and are widely utilized in emerging nations, concerns persist regarding their product quality, bioequivalence, and clinical outcomes. Additionally, there is a lack of consensus on the value assessment for generic drugs, particularly in determining whether lower prices correspond to equivalent value. Our objective is to systematically describe and contrast the prevailing tools, scales, frameworks and etc. for assessing generic drugs, while integrating their core dimensions and criteria as a reference for emerging nations. Methods: This study systematically reviewed evaluation tools, scales, and frameworks etc. for generic or off-patent drugs. Given that meta-analysis is limited to qualitative research, thematic analysis was employed to comprehensively synthesize the primary concepts of generic drug evaluation. The literature search was conducted using PubMed, EMbase, CNKI, and WanFang Data, with a cut-off date of July 25, 2024. Additionally, thematic analysis was conducted to identify themes and subthemes related to the evaluation of generics across the included records. Results: A total of nine evaluation tools, scales, and frameworks for generic drugs were included in this study. Variations were observed in their dimensions, criteria, application procedures, and methods of calculating criteria weights among participants. Ultimately, four core themes and 16 subthemes for the evaluation of generics were synthesized through thematic analysis. Conclusions: The four themes and sixteen subthemes can be regarded as primary dimensions and criteria for evaluating the value of generic drugs. They serve as a benchmark for value assessment frameworks, thereby promoting advancements in healthcare systems in regions where generic drugs are widely utilized.</div></div><div><h3>Public Interest Summary</h3><div>Although generic drugs provide comparable patient benefits and cost advantages to original drugs and are widely used in emerging nations, concerns persist regarding their product quality, bioequivalence, and clinical outcomes. Our objective is to systematically describe and contrast the prevailing tools, scales, frameworks, and other relevant methodologies for assessing generic drugs, while integrating their core dimensions and criteria. This study incorporates a total of nine evaluation tools, scales, and frameworks for generic drugs, synthesizing them into four core themes and 16 subthemes for the evaluation of generics. These four themes and sixteen subthemes can be regarded as primary dimensions and criteria for assessing the value of generic drugs. They serve as a benchmark for value assessment frameworks, thereby promoting advancements in healthcare systems in regions where generic drugs are widely utilized.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 3","pages":"Article 101025"},"PeriodicalIF":3.4,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143929475","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}
In Japan, reimbursements of technical fees for percutaneous coronary intervention (PCI) are not considered to reflect actual medical costs, since medical procedures frequently cost hospitals more than they make. This study evaluated the appropriateness of PCI technical fees in Japan as part of reimbursed medical fees.
Methods
We estimated the PCI technical fee’s validity from three approaches including 1) costing calculation, 2) survey-based cost estimation, and 3) lost profit methods.
Results
For the costing calculation method, we used the draft proposal that is evaluated by the Japanese Health Insurance Federation for Surgery (Gaihoren draft proposal). The proposal indicated PCI technical fees of ¥727,997 for acute myocardial infarction (AMI) and ¥596,397 for unstable angina (UA). For the survey-based cost estimation method, a survey of cardiologists showed the appropriateness of ¥814,600 and ¥554,825 for AMI-PCI and UA-PCI, respectively, while the lost profit method evaluated AMI-PCI at ¥812,210 and UA-PCI at ¥773,961. The average costs of technical fees calculated according to the three approaches were ¥772,186 for AMI-PCI and ¥566,688 for UA-PCI, which are higher than the existing reimbursements of ¥343,800 and ¥243,800, respectively.
Conclusion
The present study showed that technical fees for PCI did not reflect estimated costs in three approaches. The majority of hospitals in Japan are operating at a loss for medical profit, and these results call into question, the need for a review of the healthcare costs reimbursed by the government.
Lay summary
In Japan, reimbursement prices of percutaneous coronary intervention (PCI) technical fees are considered to be lower than the actual cost, which can translate to losses for hospitals, especially when complex PCI procedures are performed. We estimated the appropriateness of technical fees using three approaches including 1) costing calculation, 2) survey-based cost estimation, and 3) lost profit methods. The results confirmed that technical fees, which form the core of medical fees, do not reflect estimated costs. It was suggested that this discrepancy has led to a deficit in the structure of Japanese hospitals.
{"title":"Appropriateness of the percutaneous coronary intervention technical fee in Japan","authors":"Satoru Hashimoto , Yoshihiro Motozawa , Burt Cohen , Toshiki Mano","doi":"10.1016/j.hlpt.2025.101026","DOIUrl":"10.1016/j.hlpt.2025.101026","url":null,"abstract":"<div><h3>Objectives</h3><div>In Japan, reimbursements of technical fees for percutaneous coronary intervention (PCI) are not considered to reflect actual medical costs, since medical procedures frequently cost hospitals more than they make. This study evaluated the appropriateness of PCI technical fees in Japan as part of reimbursed medical fees.</div></div><div><h3>Methods</h3><div>We estimated the PCI technical fee’s validity from three approaches including 1) costing calculation, 2) survey-based cost estimation, and 3) lost profit methods.</div></div><div><h3>Results</h3><div>For the costing calculation method, we used the draft proposal that is evaluated by the Japanese Health Insurance Federation for Surgery (Gaihoren draft proposal). The proposal indicated PCI technical fees of ¥727,997 for acute myocardial infarction (AMI) and ¥596,397 for unstable angina (UA). For the survey-based cost estimation method, a survey of cardiologists showed the appropriateness of ¥814,600 and ¥554,825 for AMI-PCI and UA-PCI, respectively, while the lost profit method evaluated AMI-PCI at ¥812,210 and UA-PCI at ¥773,961. The average costs of technical fees calculated according to the three approaches were ¥772,186 for AMI-PCI and ¥566,688 for UA-PCI, which are higher than the existing reimbursements of ¥343,800 and ¥243,800, respectively.</div></div><div><h3>Conclusion</h3><div>The present study showed that technical fees for PCI did not reflect estimated costs in three approaches. The majority of hospitals in Japan are operating at a loss for medical profit, and these results call into question, the need for a review of the healthcare costs reimbursed by the government.</div></div><div><h3>Lay summary</h3><div>In Japan, reimbursement prices of percutaneous coronary intervention (PCI) technical fees are considered to be lower than the actual cost, which can translate to losses for hospitals, especially when complex PCI procedures are performed. We estimated the appropriateness of technical fees using three approaches including 1) costing calculation, 2) survey-based cost estimation, and 3) lost profit methods. The results confirmed that technical fees, which form the core of medical fees, do not reflect estimated costs. It was suggested that this discrepancy has led to a deficit in the structure of Japanese hospitals.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 3","pages":"Article 101026"},"PeriodicalIF":3.4,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143929474","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}
Pub Date : 2025-05-02DOI: 10.1016/j.hlpt.2025.101023
Ofir Ben-Assuli
Background
According to leading health organizations such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), telehealth applications have the potential to improve patients' health, particularly for the billions of patients suffering from chronic diseases such as Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD). While telehealth solutions hold promise, there is currently inadequate clinical evidence supporting their use in public health surveillance and home-based care, making it difficult to draw decisive conclusions.
Objective
The objective of this work was to evaluate the cost-effectiveness, use, and implementation of telehealth solutions for patients with chronic diseases, specifically CHF and COPD, through a review of the current literature. This narrative review examined studies presenting cost-effectiveness analyses, use, and implementation of telehealth for these patients.
Methods
This work implemented the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. In order to receive recency and to examine recent and innovative telehealth solutions, articles published in English from 2010 to 2023 were included in the search. The inclusion criteria were papers on telehealth tools employed for CHF and COPD patients that assessed their cost-effectiveness.
Results
The majority of the studies were conducted in Europe. Approximately half had an adequate sample size and tracked patients prospectively for a sufficient duration. The most frequently used telehealth method was distance monitoring, with only a few studies incorporating home visits or phone calls. The parameters monitored included blood pressure, oxygen saturation, heart rate, and spirometry, among others. General statistical analyses and regression models were the most frequently used methods, although several studies incorporated Markov models and simulations.
Discussion
The majority of the papers (20 out of 26) concluded that the tools implemented led to either cost-effectiveness, cost-savings or strongly dominance. This promising result shows that telehealth is an important topic that deserves further research on its effectiveness as well as cost-effectiveness for chronic disease management.
Limitations
One key limitation of this PRISMA review is that the literature search was restricted to two major diseases, and the language of the publications was exclusively English. Thus, the generalizability of the findings to other chronic diseases is subject to caution.
{"title":"Cost-effectiveness, use and implementation of telehealth solutions for CHF and COPD: A systematic review using the PRISMA method","authors":"Ofir Ben-Assuli","doi":"10.1016/j.hlpt.2025.101023","DOIUrl":"10.1016/j.hlpt.2025.101023","url":null,"abstract":"<div><h3>Background</h3><div>According to leading health organizations such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), telehealth applications have the potential to improve patients' health, particularly for the billions of patients suffering from chronic diseases such as Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD). While telehealth solutions hold promise, there is currently inadequate clinical evidence supporting their use in public health surveillance and home-based care, making it difficult to draw decisive conclusions.</div></div><div><h3>Objective</h3><div>The objective of this work was to evaluate the cost-effectiveness, use, and implementation of telehealth solutions for patients with chronic diseases, specifically CHF and COPD, through a review of the current literature. This narrative review examined studies presenting cost-effectiveness analyses, use, and implementation of telehealth for these patients.</div></div><div><h3>Methods</h3><div>This work implemented the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. In order to receive recency and to examine recent and innovative telehealth solutions, articles published in English from 2010 to 2023 were included in the search. The inclusion criteria were papers on telehealth tools employed for CHF and COPD patients that assessed their cost-effectiveness.</div></div><div><h3>Results</h3><div>The majority of the studies were conducted in Europe. Approximately half had an adequate sample size and tracked patients prospectively for a sufficient duration. The most frequently used telehealth method was distance monitoring, with only a few studies incorporating home visits or phone calls. The parameters monitored included blood pressure, oxygen saturation, heart rate, and spirometry, among others. General statistical analyses and regression models were the most frequently used methods, although several studies incorporated Markov models and simulations.</div></div><div><h3>Discussion</h3><div>The majority of the papers (20 out of 26) concluded that the tools implemented led to either cost-effectiveness, cost-savings or strongly dominance. This promising result shows that telehealth is an important topic that deserves further research on its effectiveness as well as cost-effectiveness for chronic disease management.</div></div><div><h3>Limitations</h3><div>One key limitation of this PRISMA review is that the literature search was restricted to two major diseases, and the language of the publications was exclusively English. Thus, the generalizability of the findings to other chronic diseases is subject to caution.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 3","pages":"Article 101023"},"PeriodicalIF":3.4,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143936687","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}
Pub Date : 2025-05-02DOI: 10.1016/j.hlpt.2025.101022
Yigal Chechik , Michal Bitan , Orna Tal
Objective
Telemedicine can enhance efficiency and accessibility to high-quality care. Moreover, it can improve satisfaction by increasing the responsiveness of medical professionals, expert consultation and multidisciplinary meetings, especially in an era of a pandemic. During 2020, ambulatory care was dramatically reduced, and while telemedicine emerged as the only method of delivering care, we witnessed variability among physicians in the implementation of telemedicine. In order to identify leading themes to assess the successful implementation of telemedicine, we used SWOT (strengths, weaknesses, opportunities and threats) methodology that enables management of positions on the assimilation of technology.
Materials and Methods
A structured questionnaire was distributed in a controlled manner to all the teams that were involved in hospital ambulatory clinics (HAC).
Results
Out of 306 workers directly involved in HAC telemedicine, 146 replied (48 % response rate). The professional distribution of the responders was: 75 physicians (56 % specialists, 40 % medical directors), 51 nurses (51 % of them in managerial positions) and 20 administrators. Using SWOT analysis, we identified that the most positive influential factor to telemedicine implementation was improving accessibility, and the main barrier was the lack of sufficient physical examination. Nurses and administrators scored higher on telemedicine opportunities (P = 0.048), threats (P < 0.001) and technological added value (P = 0.001). The multivariable model showed that when the participant was more experienced, telemedicine was less perceived as a weakness and considered less threatening.
Conclusions
We found significant differences in perceptions toward telemedicine regarding threats and opportunities. Improving access to care, bridging the digital technology gap and preventing infections were all scored as the most important factors to accelerate implementation. SWOT analysis offers a wise methodology to assess the impact of change while many factors and stakeholders are involved. Additional analysis by value-based assessment elements (VBAE) revealed that >40 % of the users declared that improving "professionalism" was a major principle that added value and incentive to favor telemedicine.
{"title":"The challenge of telemedicine – using SWOT methodology and value-based assessment to analyze barriers, incentives and opportunities: Opening the digital doors to expand access and health equity","authors":"Yigal Chechik , Michal Bitan , Orna Tal","doi":"10.1016/j.hlpt.2025.101022","DOIUrl":"10.1016/j.hlpt.2025.101022","url":null,"abstract":"<div><h3>Objective</h3><div>Telemedicine can enhance efficiency and accessibility to high-quality care. Moreover, it can improve satisfaction by increasing the responsiveness of medical professionals, expert consultation and multidisciplinary meetings, especially in an era of a pandemic. During 2020, ambulatory care was dramatically reduced, and while telemedicine emerged as the only method of delivering care, we witnessed variability among physicians in the implementation of telemedicine. In order to identify leading themes to assess the successful implementation of telemedicine, we used SWOT (strengths, weaknesses, opportunities and threats) methodology that enables management of positions on the assimilation of technology.</div></div><div><h3>Materials and Methods</h3><div>A structured questionnaire was distributed in a controlled manner to all the teams that were involved in hospital ambulatory clinics (HAC).</div></div><div><h3>Results</h3><div>Out of 306 workers directly involved in HAC telemedicine, 146 replied (48 % response rate). The professional distribution of the responders was: 75 physicians (56 % specialists, 40 % medical directors), 51 nurses (51 % of them in managerial positions) and 20 administrators. Using SWOT analysis, we identified that the most positive influential factor to telemedicine implementation was improving accessibility, and the main barrier was the lack of sufficient physical examination. Nurses and administrators scored higher on telemedicine opportunities (<em>P</em> = 0.048), threats (<em>P</em> < 0.001) and technological added value (<em>P</em> = 0.001). The multivariable model showed that when the participant was more experienced, telemedicine was less perceived as a weakness and considered less threatening.</div></div><div><h3>Conclusions</h3><div>We found significant differences in perceptions toward telemedicine regarding threats and opportunities. Improving access to care, bridging the digital technology gap and preventing infections were all scored as the most important factors to accelerate implementation. SWOT analysis offers a wise methodology to assess the impact of change while many factors and stakeholders are involved. Additional analysis by value-based assessment elements (VBAE) revealed that >40 % of the users declared that improving \"professionalism\" was a major principle that added value and incentive to favor telemedicine.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 3","pages":"Article 101022"},"PeriodicalIF":3.4,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143936686","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}
Pub Date : 2025-04-29DOI: 10.1016/j.hlpt.2025.101020
Nashmil Ghadimi , Alireza Olyaeemanesh , Ali Akbar Fazaeli , Rajabali Daroudi , Sara Kaveh
Objectives
To synthesize evidence on the volume-cost relationship (VCR) in pancreatic surgery, focusing on the impact of hospital and surgeon volumes on economic indicators.
Methods
A scoping review was conducted using PubMed, Web of Science, and Scopus to identify studies published from inception to November 30, 2024, to ensure a comprehensive and unbiased review of all relevant studies. The PRISMA-ScR framework guided data extraction, focusing on hospital and surgeon volumes in relation to costs, length of stay (LOS), resource utilization, and readmissions. The metrics included cost definitions, volume thresholds, and economic indicators. Studies that analyzed the economic impact of centralization in pancreatic surgery were included.
Results
Twenty-two studies (1996–2024), primarily from the United States, were included. Pancreaticoduodenectomy was the most studied procedure. High-volume Hospitals (HVHs) consistently demonstrated reduced costs, shorter LOS, lower resource utilization, and higher discharge-to-home rates compared to low-volume hospitals (LVHs). Cost reductions were attributed to enhanced efficiency and fewer complications. However, there was significant variability in volume thresholds and limited use of cost-effectiveness analyses (CEAs). Few studies addressed broader societal costs, such as productivity losses or caregiver burden.
Conclusions
Centralizing pancreatic surgeries in HVHs offers clear economic impact through improved efficiency and outcomes. Addressing gaps in standardized volume definitions, incorporating socioeconomic factors, and expanding CEAs are critical for optimizing resource allocation and ensuring equitable and cost-effective care. Future research should focus on these areas to inform better health policies.
目的综合胰腺手术中数量-成本关系（VCR）的证据，重点研究医院和外科医生数量对经济指标的影响。方法使用PubMed、Web of Science和Scopus进行范围审查，以确定从成立到2024年11月30日发表的研究，以确保对所有相关研究进行全面和公正的审查。PRISMA-ScR框架指导数据提取，重点关注与成本、住院时间（LOS）、资源利用和再入院相关的医院和外科医生数量。度量标准包括成本定义、容量阈值和经济指标。研究分析了胰腺手术中心化的经济影响。结果纳入主要来自美国的22项研究（1996-2024）。胰十二指肠切除术是研究最多的手术。与小容量医院（LVHs）相比，大容量医院（HVHs）一贯表现出更低的成本、更短的LOS、更低的资源利用率和更高的出院回家率。成本的降低归功于效率的提高和并发症的减少。然而，在容量阈值方面存在显著的可变性，成本效益分析（cea）的使用有限。很少有研究涉及更广泛的社会成本，如生产力损失或照顾者负担。结论集中式胰腺手术在HVHs中通过提高效率和预后具有明显的经济效益。解决标准化数量定义中的差距、纳入社会经济因素和扩大cea对于优化资源分配和确保公平和具有成本效益的护理至关重要。未来的研究应侧重于这些领域，以便为更好的卫生政策提供信息。
{"title":"Volume-cost relationship in Pancreatic Surgery: A scoping review","authors":"Nashmil Ghadimi , Alireza Olyaeemanesh , Ali Akbar Fazaeli , Rajabali Daroudi , Sara Kaveh","doi":"10.1016/j.hlpt.2025.101020","DOIUrl":"10.1016/j.hlpt.2025.101020","url":null,"abstract":"<div><h3>Objectives</h3><div>To synthesize evidence on the volume-cost relationship (VCR) in pancreatic surgery, focusing on the impact of hospital and surgeon volumes on economic indicators.</div></div><div><h3>Methods</h3><div>A scoping review was conducted using PubMed, Web of Science, and Scopus to identify studies published from inception to November 30, 2024, to ensure a comprehensive and unbiased review of all relevant studies. The PRISMA-ScR framework guided data extraction, focusing on hospital and surgeon volumes in relation to costs, length of stay (LOS), resource utilization, and readmissions. The metrics included cost definitions, volume thresholds, and economic indicators. Studies that analyzed the economic impact of centralization in pancreatic surgery were included.</div></div><div><h3>Results</h3><div>Twenty-two studies (1996–2024), primarily from the United States, were included. Pancreaticoduodenectomy was the most studied procedure. High-volume Hospitals (HVHs) consistently demonstrated reduced costs, shorter LOS, lower resource utilization, and higher discharge-to-home rates compared to low-volume hospitals (LVHs). Cost reductions were attributed to enhanced efficiency and fewer complications. However, there was significant variability in volume thresholds and limited use of cost-effectiveness analyses (CEAs). Few studies addressed broader societal costs, such as productivity losses or caregiver burden.</div></div><div><h3>Conclusions</h3><div>Centralizing pancreatic surgeries in HVHs offers clear economic impact through improved efficiency and outcomes. Addressing gaps in standardized volume definitions, incorporating socioeconomic factors, and expanding CEAs are critical for optimizing resource allocation and ensuring equitable and cost-effective care. Future research should focus on these areas to inform better health policies.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 3","pages":"Article 101020"},"PeriodicalIF":3.4,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143943148","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}
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