جستجوی مقالات مرتبط با کلیدواژه « health technology assessment » در نشریات گروه « پزشکی »

Health technology assessment (HTA) plays a crucial role in enhancing equity within universal health coverage (UHC) by making sure that health technologies are accessible, effective, and affordable for all groups, including those historically underserved. HTA informs policy-making concerning the adoption and prioritization of health technologies to fulfill the needs of the populace, particularly those afflicted with rare ailments and those residing in low- and middle-income nations. Through assessing both the clinical and costeffectiveness of health technologies, HTA identifies the most appropriate options for the needs of the community, thereby facilitating a fairer allocation of resources. Furthermore, HTA ensures the development and evaluation of health technologies are conducted impartially, incorporating the viewpoints and necessities of at-risk groups such as women, children, and the elderly. HTA is instrumental in mitigating healthcare disparities by pinpointing and tackling the elements that hinder equal access to health technologies. For instance, it evaluates the availability and accessibility of health technologies across various regions and demographic groups, identifies obstacles to access, and formulates recommendations to overcome these challenges. HTA is vital in advancing equity in UHC, ensuring that health technologies meet the accessibility, effectiveness, and affordability needs of all, particularly marginalized groups. By addressing healthcare disparities and considering the perspectives of vulnerable populations, HTA promotes transparency and accountability in decision-making and suggests ways to rectify inequities in access to health technologies.

An evidence-informed deliberative process (EDP) is defined as “a practical and stepwise approach for health technology assessment (HTA) bodies to enhance legitimate health benefit package design based on deliberation between stakeholders to identify, reflect and learn about the meaning and importance of values, informed by evidence on these values.” In this commentary, I discuss some considerations for EDPs that arise from acknowledging the difference between social and moral values. First, the best practices for implementing EDPs may differ depending on whether the approach is grounded in moral versus social values. Second, the goals of deliberation may differ when focused on moral versus social values. I conclude by offering some considerations for future research to support the use of EDPs in practice, including the need to assess how different approaches to appraisal (eg, more quantitative versus qualitative) impact perceptions of the value of deliberation itself.

As countries around the world seek to deliver universal health coverage, they must prioritize which services to pay for with public funds, to whom, and at what cost. Countries are increasingly using health technology assessment (HTA) to identify which interventions provide the best value for money and merit inclusion in their health benefit packages (HBPs)—the explicit lists of health services provided using public funds. Oortwijn et al understand the importance of providing practical guidance on the foundation of HBP design, and their article, “Evidence-Informed Deliberative Processes for Health Benefit Package Design – Part II: A Practical Guide,” provides recommendations for HTA bodies to improve the legitimacy of their decision-making by incorporating four elements in their HBP procedures: stakeholder involvement, evidence-informed evaluation, transparency, and appeal. This article proposes three approaches to enhance the value of the guide: moving from structure to compliance and performance, prioritizing key issues of legitimacy within HBP processes, and acknowledging potential the costs and risks associated with the use of this framework.

The second edition of the practical guide for evidence-informed deliberative processes (EDPs) is an important addition to the growing guidance on deliberative processes supporting priority setting in healthcare. While the practical guide draws on an extensive amount of information collected on established and developing processes within a range of countries, EDPs present health technology assessment (HTA) bodies with several challenges. (1) Basing recommendations on current processes that have not been well-evaluated and that have changed over time may lead to weaker legitimacy than desired. (2) The requirement for social learning among stakeholders may require increased resourcing and blur the boundary between moral deliberation and political negotiation. (3) Robust evaluation should be based on an explicit theory of change, and some process outcomes may be poor guides to overall improvement of EDPs. This comment clarifies and reinforces the recommendations provided in the practical guide.

In their recent article on evidence-informed deliberative processes (EDPs) for health benefit package decisions, Oortwijn et al examine how the different steps of EDP play out in eight countries with relatively mature institutions for using health technology assessment (HTA). This commentary examines how EDP addresses stakeholder involvement in decision-making for equitable progress towards universal health coverage (UHC). It focuses on the value of inclusiveness, the need to pay attention to trade-offs between desirable features of EDP and the need to broaden the scope of processes examined beyond those specifically tied to producing and using HTAs . It concludes that EDPs have contributed to significant progress for health benefit design decisions worldwide and holds much potential in further application. At the same time, this commentary calls for prudence: investments in EDPs should be efficiently deployed to enhance the pre-existing legislative, institutional and political framework that exist to promote fair and legitimate healthcare decisions.

Globally, there is increasing interest in the use of real-world data (RWD) and real-world evidence (RWE) to inform health technology assessment (HTA) and reimbursement decision-making. Using current practices and case studies shared by eleven health systems in Asia, a non-binding guidance that seeks to align practices for generating and using RWD/RWE for decision-making in Asia was developed by the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) Working Group, addressing a current gap and needs among HTA users and generators.

  The guidance document was developed over two face-to-face workshops, in addition to an online survey, a face-to-face interview and pragmatic search of literature. The specific focus was on what, where and how to collect RWD/RWE.

  All 11 REALISE member jurisdictions participated in the online survey and the first in-person workshop, 10 participated in the second in-person workshop, and 8 participated in the in-depth face-to-face interviews. The guidance document was iteratively reviewed by all working group members and the International Advisory Panel. There was substantial variation in: (a) sources and types of RWD being used in HTA, and (b) the relative importance and prioritization of RWE being used for policy-making. A list of national-level databases and other sources of RWD available in each country was compiled. A list of useful guidance on data collection, quality assurance and study design were also compiled.

  The REALISE guidance document serves to align the collection of better quality RWD and generation of reliable RWE to ultimately inform HTA in Asia.

The second edition of the practical guide for evidence-informed deliberative processes (EDPs) is an important addition to the growing guidance on deliberative processes supporting priority setting in healthcare. While the practical guide draws on an extensive amount of information collected on established and developing processes within a range of countries, EDPs present health technology assessment (HTA) bodies with several challenges. (1) Basing recommendations on current processes that have not been well-evaluated and that have changed over time may lead to weaker legitimacy than desired. (2) The requirement for social learning among stakeholders may require increased resourcing and blur the boundary between moral deliberation and political negotiation. (3) Robust evaluation should be based on an explicit theory of change, and some process outcomes may be poor guides to overall improvement of EDPs. This comment clarifies and reinforces the recommendations provided in the practical guide.

Context: 

In the first stage of viral replication, COVID-19 may cause a remarkable inflammatory response in patients. Paxlovid is an oral antivirus medicine that functions through the inhibition of one of the essential enzymes to viral replication, called protease. The present study intends to help policymakers decide on using Paxlovid in COVID-19 treatment.

Evidence Acquisition:

 This rapid review searched databases including Cochrane, PubMed, and Google Scholar by the end of July 2022. The inclusion criteria were randomized clinical trials investigating the safety and effectiveness of Paxlovid oral medicine at different doses in COVID-19 patients, compared with placebo or other routine care methods.

Based on the results (from three studies meeting the inclusion criteria), Paxlovid has no serious side effects, but when used, the patients must be checked for renal and hepatic failure, as well as drug interactions. Patients treated with this medicine within five days after the symptom onset were hospitalized, with 1% (6/607) in the Paxlovid group and 6.7% (41/612) in the placebo group. Also, no fatalities were reported in the Paxlovid group until day 28, while 10 (1.6%) patients died in the placebo group.

Paxlovid is very effective in outpatient treatment and comes in a combination pack containing nirmatrelvir 150 mg and ritonavir 100 mg film-coated tablets, to be taken twice daily for five days after the symptom onset in adults and children (over 12 years old and a minimum weight of 40 kg) who have mild to moderate symptoms of COVID-19 in order to prevent severe disease, which may lead to hospitalization and death. However, there is high uncertainty about the possibility of drug interactions.

Countries around the world are using health technology assessment (HTA) for health benefit package design. Evidence-informed deliberative processes (EDPs) are a practical and stepwise approach to enhance legitimate health benefit package design based on deliberation between stakeholders to identify, reflect and learn about the meaning and importance of values, informed by evidence on these values. This paper reports on the development of practical guidance on EDPs, while the conceptual framework of EDPs is described in a companion paper.

The first guide on EDPs (2019) is further developed based on academic knowledge exchange, surveying 27 HTA bodies and 66 experts around the globe, and the implementation of EDPs in several countries. We present the revised steps of EDPs and how selected HTA bodies (in Australia, Brazil, Canada, France, Germany, Scotland, Thailand and the United Kingdom) organize key issues of legitimacy in their processes. This is based on a review of literature via PubMed and HTA bodies’ websites.

HTA bodies around the globe vary considerable in how they address legitimacy (stakeholder involvement ideally through participation with deliberation; evidence-informed evaluation; transparency; and appeal) in their processes. While there is increased attention for improving legitimacy in decision-making processes, we found that the selected HTA bodies are still lacking or just starting to develop activities in this area. We provide recommendations on how HTA bodies can improve on this.

The design and implementation of EDPs is in its infancy. We call for a systematic analysis of experiences of a variety of countries, from which general principles on EDPs might subsequently be inferred.

Countries around the world are increasingly rethinking the design of their health benefit packages to achieve universal health coverage (UHC). Health technology assessment (HTA) bodies support governments in these decisions, but employ value frameworks that do not sufficiently account for the intrinsically complex and value-laden political reality of benefit package design.

Several years ago, evidence-informed deliberative processes (EDPs) were developed to address this issue. An EDP is a practical and stepwise approach for HTA bodies to enhance legitimate health benefit package design based on deliberation between stakeholders to identify, reflect and learn about the meaning and importance of values, and to interpret available evidence on these values. We further developed the conceptual framework and initial 2019 guidance based on academic knowledge exchange, analysing practices of HTA bodies, surveying HTA bodies and experts around the globe, and implementation of EDPs in several countries around the world.

EDPs stem from the general concept of legitimacy, which is translated into four elements – stakeholder involvement ideally operationalised through stakeholder participation with deliberation; evidence-informed evaluation; transparency; and appeal. The 2021 practical guidance distinguishes six practical steps of a HTA process and provides recommendations on how these elements can be implemented in each of these steps.

There is an increased attention for legitimacy, deliberative processes for HTA and health benefit package design, but the development of theories and methods for such processes remain behind. The added value of EDPs lies in the operationalisation of the general concept of legitimacy into practical guidance for HTA bodies.

The European Medicines Agency (EMA) aims to resolve uncertainties associated with conditionally approved drugs by imposing post-approval studies. Results from these studies may be relevant for health technology assessment (HTA) organizations. This study investigated the role of regulator-imposed post-approval studies within HTA.

For all conditionally approved drugs up to December 2018, regulator-imposed post-approval studies were identified from EMA’s public assessment reports. The availability for and inclusion of study results in relative effectiveness (re)assessments were analyzed for 4 European HTA organizations: NICE (National Institute for Health and Care Excellence, England/Wales), HAS (Haute Autorité de Santé, France), ZIN (Zorginstituut Nederland, the Netherlands) and the European Network for Health Technology Assessment (EUnetHTA, Europe). When study results became available between an HTA organization’s initial assessment and reassessment, it was evaluated whether and how they affected the assessment and its outcome.

For 36 conditionally approved drugs, 98 post-approval studies were imposed. In total, 81 initial relative effectiveness assessments (REAs) and 13 reassessments were available, with numbers of drugs (re)assessed varying greatly between jurisdictions. Study results were available for 16 initial REAs (20%) and included in 14 (88%), and available for 10 reassessments (77%) and included in all (100%). Five reassessments had an outcome different from the initial REA, with 4 (2 positive and 2 negative changes) relating directly to the new study results. Reassessments often cited the inability of post-approval studies to resolve the concerns reported in the initial REA.

Results from regulator-imposed post-approval studies for conditionally approved drugs were not often used in REAs by HTA organizations, because they were often not yet available at the time of initial assessment and because reassessments were scarce. When available, results from post-approval studies were almost always used within HTA, and they have led to changes in conclusions about drugs’ relative effectiveness. Post-approval studies can be relevant within HTA but the current lack of alignment between regulators and HTA organizations limits their potential.

Public policy approaches to funding paediatric medicines in advanced health systems remain understudied. In particular, the ethical and social values dimensions of health technology assessment (HTA) and drug coverage decisions for children have received almost no attention in research or policy.

To elicit and understand the social values that influence decision-making for public funding of paediatric drugs, we undertook a series of in-depth, semi-structured interviews with a stratified purposive sample (n = 22) of stakeholders involved with or affected by drug funding decisions for children at the provincial (Ontario) and national levels in Canada. Constructivist grounded theory methodology guided data collection and thematic analysis.

Our study provides empirical evidence about the unique ethical and social values dimensions of HTA for children, and describes a novel social values typology for paediatric drug policy decision-making. Three principal categories of values emerged from stakeholder reflections on HTA and drug policy-making for children: procedural values, structural values, and sociocultural values. Key findings include the importance of attention to the procedural legitimacy of HTA for children, with emphasis on the inclusion of child health voices in processes of technology appraisal and policy uptake; a role for HTA institutions to consider the equity impacts of technologies, both in setting review priorities and in assessing the value of technologies for public coverage; and the potential benefits of a distinct national framework to guide drug policy for children.

Current approaches to HTA are not well designed for the realities of child health and illness, nor the societal priorities regarding children that our study identified. This research generates new knowledge to inform decision-making on paediatric drugs by HTA institutions and government payers in Canada and other publicly-funded health systems, through insights into the relevant social values for child drug funding decisions from varied stakeholder groups.

This study evaluated the use of Cochrane systematic reviews (CSRs) by Quebec’s local health technology assessment (HTA) units to promote efficiency in hospital decision-making. An online survey was conducted to examine: Characteristics of the HTA units; Knowledge about works and services from the Cochrane Collaboration; Level of satisfaction about the use of CSRs; Facilitating factors and barriers to the implementation of CSRs evidence in a local context; Suggestions to improve the use of CSRs. Data accuracy was checked by 2 independent evaluators. Ten HTA units participated. From their implementation a total of 321 HTA reports were published (49.8% included a SR). Works and services provided by the Cochrane collaboration were very well-known and HTA units were highly satisfied with CSRs (80%-100%). As regards to applicability in HTA and use of CSRs, major strengths were as follow: Useful as resource for search terms and background material; May reduce the workload (eg, brief review instead of full SR); Use to update a current review. Major weaknesses were: Limited use since no CSRs were available for many HTA projects; Difficulty to apply findings to local context; Focused only on efficacy and innocuity; Cannot be used as a substitute to a full HTA report. This study provided a unique context of assessment with a familiar group of producers, users and disseminators of CSRs in hospital setting. Since they generally used other articles from the literature or produce an original SR in complement with CSRs, this led to suggestions to improve their use of CSRs. However, the main limit for the use of CRS in local HTA will remain its lack of contextualisation. As such, this study reinforces the need to consider the notion of complementarity of experimental data informing us about causality and contextual data, allowing decision-making adapted to local issues.

The development of a medicine is not only underpinned by good science but also by Quality DecisionMaking Practices (QDMPs). Indeed, it is important to ensure that all organisations involved in the lifecycle of medicines are aligning their practices in decision-making to the QDMPs to ensure quality, transparent and consistent decisionmaking processes.

The aim of this study was to evaluate the practicality of QoDoS (Quality of Decision-Making Orientation Scheme) in assessing the incorporation of ten QDMPs during the development, review and reimbursement of medicines, illustrated by case studies with a pharmaceutical company, a regulatory authority and a health technology assessment (HTA) agency. Individuals from each organisation completed the 47-item QoDoS questionnaire.

The results demonstrate the applicability of QoDoS in identifying favourable and unfavourable practices and in assessing the consistency and transparency of the QDMPs within each organisation, as well as across the different stakeholders. Furthermore, the study established the value of the methodology in raising awareness of the biases and best practices in decision-making, as well as having a basis for discussion for differences within and across stakeholders to promote consistency and alignment in decision-making. Finally, the QoDoS demonstrated the need for improvement across a number of decision-making practices for the 3 organisations such as the evaluation of alternatives and of the decision impact.

The QoDoS can be used to benchmark organisations’ decision-making practices to provide a basis for discussion to ultimately encourage a level of trust across and within organisations and helping to identify areas for improvement.

Lung cancer is recognized as one of the most prevalent cancers and the most important cause of cancer mortality worldwide. Given the incidence and mortality of this disease, implementing preventive interventions is necessary. In this regard, the present study has investigated the effectiveness of one of the most important interventions of lung cancer screening (using low-dose computed tomography (CT) scan (LDCT)) in high-risk individuals.

The present study is an applied study performed as a comprehensive review. To assess safety, studies on the technical specifications of CT scans and issues related to the safety of applying this device for lung cancer screening were searched and surveyed using keywords in medical databases such as PubMed, Google Scholar, etc. To evaluate the clinical effectiveness, a comprehensive review of all studies regarding health technology assessment, systematic review and meta-analysis studies, and screening guidelines around the world was performed in this regard.

After searching and reviewing the safety issue, 1982 articles were extracted and finally the results of 15 studies were used. The diagnosis of harmless tumors, false positives and performing invasive complementary interventions for them, and the possible negative effects of radiation exposure are safety discussable issues. To measure clinical effectiveness, a total of 17827 studies were found through the surveyed medical databases, and finally 16 studies entered into the final phase of analysis. Based on the synthesis of studies, the effectiveness of lung cancer screening intervention using LDCT has been found to reduce lung cancer mortality by 15% to 20% and mortality from other causes by 0% to 6%. Also, as a result of this screening, the incidence of lung cancer and its diagnosis in the early stages of the disease increase and the incidence of this disease in its upper stages decreases significantly. The findings of the clinical effectiveness survey show that performing this intervention does not create any psychological consequences in individuals’ quality of life.

Lung cancer screening using LDCT in older people with a high smoking history is safer than not performing the intervention, and does not threat the health of individuals undergoing screening. The disadvantages of this screening are negligible compared to its advantages. Compared to non-intervention, this screening is more clinically effective and will lead to a statistically significant reduction in lung cancer mortality and the increase of timely diagnosis of this disease.

Investing in the R&D sector of new medical technologies is associated with the risk of being rejected by paying organizations because of the lack of value-for-money. The purpose of this study is to investigate the different methods of evaluating the impacts of emerging medical technologies.

Using scoping review method, we analyzed studies that investigated methods for assessing the impacts of emerging medical technologies on development. To find these studies, the Cochran Library, ISI Web of Knowledge, Embase, Ebsco and Pubmed databases from 2000 to 2018 were searched. The methodological quality of the studies was assessed using the STROBE Checklist. Two reviewers independently selected the qualified studies. Charting and collating the data were used based on the method proposed by Arksey and Ochr('39')Malley.

Overall, 38 studies met the inclusion criteria. Sixteen methods were identified and put in five distinct categories: forecasting, Pro-HTA, Early-HTA, priority setting, and HHS were found to measure the impact of emerging technologies. The quality of these studies was acceptable. Few studies were conducted on emerging pharmaceutical technologies, and they were mostly on emerging medical devices. The Early HTA methods were often used to measure the effects of pharmaceutical technologies and medical devices technologies. The Pro-HTA method used dynamic modeling to examine the impact of medical technologies on a broad range of dimensions, while the HTA and Early-HTA methods used cost-effectiveness techniques throughout the development process. The HHS method used a multivariate decision-making technique.

Different methods were used to investigate the impacts of emerging medical technologies. Chronologically Pro-HTA methods are new ways for investigating emerging medical technologies beyond clinical and economic impacts. Assessing the feasibility of implementing Pro-HTA in real environments deserves further research.

Various studies have used multiple attribute decision making (MADM) techniques to assess and rank health technologies.  The goal of the present study was to prioritize health technologies using various techniques of MADMs in combination with decision rules.

The study is an applied research using multi-attribute decision making (MADM) methods. This study extracted the attributes related to health technology assessment from global literature and experts’ opinions. In this study, two different types of experts were consulted: the first type, including three experts in the field of the decision-making techniques, on the subject of setting priority on health focusing on MADM; and the second one consists of seven experts in the field of HTA, asked about the selection of attributes and determination their importance. Candidate health technologies were individually weighted and ranked using TOPSIS, SAW and VIKOR by the weight and decision matrix. The results obtained from various techniques were combined and ranked using Copeland’s technique to obtain the final ranking of health technologies. To determine HTA type reports, decision rules were defined. All models were designed via MS Excel.

This study chose eight technologies according to six tradeoff attributes. These attributes included health benefits at the population level, vulnerable population size, availability of alternative technologies, budget impact, financial protection, and quality of evidence. Their exact weights were 0.25, 0.121, 0.146, 0.132, 0.167 and 0.181, respectively. Also, safety and uncertainty about the cost-effectiveness were considered as the veto and decision rules respectively. Copeland’s method was therefore used to combine the methods Whereas HT2 (The technology for treating patients suffering from varicose) was ranked the highest priority and HT3 (The palliative method for patients who suffer from various cancers) was ranked the lowest (for preventing from any ethical issue, the exact name of each technology wasn’t mentioned).

Finally, in accordance with decision rules which are based on various conditions of “uncertainty about the cost-effectiveness”, it is recommended that full health technology assessment report be performed on three technologies, rapid health technology assessment report be performed on four others, and, finally no prioritizing for health technology assessment be made on one of them.

It is essential to improve the educational curriculum over time. This study aims to evaluate the quality of the health technology assessment (HTA) curriculum in Iran.

This cross-sectional study was conducted in three groups of professors, students, and graduates of HTA by the census. The data needed for this purpose were collected using a specific questionnaire. Finally, descriptive and analytical statistics were used for data analysis.

Of 127 individuals, 114 ones responded to the study (response rate = 89%). The quality of the curriculum in terms of design elements in the core courses and the elements of the executive courses in the curriculum are in the range of medium to medium-to-optimal (1.66< mean> 2.32 to mean> 2.32, respectively). Also, the majority of the elements of the core courses and design elements are from compensatory courses in an unfavorable to moderate (1.66> mean to 1.66< mean> 2.32, respectively).

The results of this study showed that there was no significant problem in most design elements of the curriculum sections. However, there are some challenges in some elements of the operation. Therefore, it is suggested madding some changes to correct inappropriate elements. To achieve this objective, it is necessary to investigate the interests of other stakeholders involved in this field and thus enhance the quality of the curriculum. Implementing the proposed proposals and reviewing the curriculum studied can be considered as an important step to improve the HTA curriculum in Iran.