Health technology assessment in traditional and complementary medicine: a scoping review of international activity and examples of acupuncture.

BACKGROUND: Traditional therapies are crucial in maintaining and improving human well-being. China's healthcare policymakers are attempting to use health technology assessment (HTA) as a decision-making supportive tool. The value assessment framework for Chinese patent medicine (CPM) has been developed and is being adopted and validated widely by research institutions. Subsequently, the healthcare decision-makers particularly hanker for the value framework of traditional non-pharmacological therapies. METHODS: To construct a practical value framework for traditional non-pharmacological therapies, a scoping review methodology was adopted to identify the evaluation domains and obstacles. A search, screening, and analysis process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Evidence was retrieved from scientific databases and HTA agencies' websites. RESULTS: The search strategy identified 5 guidelines records and 17 acupuncture HTA reports. By synthesizing the valuable reports of CPM and acupuncture evaluation in representative countries, this study found that Mainland China was promoting the comprehensive value assessment of CPM, whereas the United Kingdom, Singapore, Canada, the United States, and Malaysia had carried out the HTA evaluation of acupuncture for various conditions among which chronic pain was the most common. UK and Singapore applied the HTA results to support acupuncture reimbursement decisions. Three domains, including safety, effectiveness, and economy, were commonly adopted. The identified biggest challenge of evaluating traditional non-pharmacological therapies is the scarce high-quality clinical evidence. CONCLUSIONS: This study identified value domains and issues of traditional therapies, and pointed out future research implications, to promote the development value framework of traditional therapies.

Development and validation of Medical Device Key Evidence Tool ('MeDKET'): An evidence-based framework to explain success in selected European and US companies.

Innovating in Medical Device (MD) industry is challenging. This study aims to develop and validate an evidence-based framework that helps innovators of small and large enterprises (SEs and LEs) assess their readiness for successful MD development and deployment. We conducted a key-informant process (stage 1) where 25 international experts identified a list of emergent Health Technology Assessment (HTA) themes they believed were essential to company success. A sample of 22 European and US selected companies (13 SEs and 9 LEs) then reached a consensus on a list of key themes through a robust Delphi process (stage 2). Finally, we constructed (stage 3) and validated (stage 4) the checklist for SEs and LEs. The checklist for SEs and LEs included 21 and 15 items (i.e., fundamental Yes/No questions) with nine overlapping criteria for both SEs and LEs. In both groups, MD success was driven by three major item categories: (i) R&D assessment strategy; (ii) device-outcome measures; (iii) company profiling. Alongside the retrospective validation study, we collected 40 case studies on MDs (23 successes and 17 failures) across the selected enterprises. The retrospective validation provided the proportion of successful and failed case studies that met the 'MeDKET' criteria. We discovered that early HTA plays a pivotal role in MD industry success with different implications based on enterprise size. This study is the first of its kind to provide a holistic picture of the perceived role of early-stage HTA in MD industry success.

[Three oral Chinese patent medicines for children with tic disorder: a rapid health technology assessment].

This study aims to comprehensively evaluate the clinical value of Shaoma Zhijing Granules(SZG), Changma Xifeng Tablets(CXT), and Jiuwei Xifeng Granules(JXG) in the treatment of children with tic disorder with the method of rapid health technology assessment(RHTA), which is expected to serve as a reference for medical and health decision-making and clinical rational use of drugs in children. To be specific, relevant articles were retrieved from eight databases and three clinical trial registry platforms. After the quality evaluation, rapid assessment was carried out from the dimensions of disease burden and unmet needs, technical characteristics, safety, efficacy and economy, and the results were analyzed and presented descriptively. A total of 22 articles(1 in English, 21 in Chinese) were screened out: 18 randomized controlled trials(RCTs) and 4 clinical controlled trials(CCTs). Among them, 5 were about the SZG(all RCTs) and 9 were on CXT(6 RCTs and 3 CCTs). The rest 8 focused on JXG(7 RCTs and 1 CCT). Moreover, the overall risk of bias for 94.40% RCTs was evaluated as "some concerns" and only one(5.60%) had high risk of bias. In terms of quality, the 4 CCTs scored 5-6 points(<7 points), suggesting low quality. SZG alone or in combination with tiapride has obvious advantages in improving traditional Chinese medicine syndromes and tic symptoms compared with tiapride alone, with the average daily cost of CNY 79.44-119.16. Compared with conventional western medicine or placebo, CXT alone or in combination with conventional western medicine can improve the total effective rate and alleviate tic symptoms, and the average daily cost is CNY 22.50-67.50. JXG alone or in combination with conventional western medicine can effectively relieve tic symptoms compared with conventio-nal western medicine or placebo, with the average daily cost of CNY 82.42-164.85. The adverse events related to the three Chinese patent medicines mainly occurred in the digestive, respiratory, and nervous systems, all of which were mild. In general, SZG, CXT, and JXG are effective for children with tic disorder. They have been approved to be used in this field, of which SZG was approved in 2019, with the most up-to-date research evidence and high-quality RCT in Q1 journals. However, the comparative analysis of the three was affected by many factors, which should be further clarified. Based on the large sample data available in multiple dimensions, a comprehensive comparative evaluation of the three Chinese patent medicines should be carried out, thereby highlighting the advantages and disadvantages of them and serving a reference for rational clinical use and drug supervision.

Patient' and social aspects related to complementary mistletoe therapy in patients with breast cancer: A systematic review commissioned by the German agency for Health Technology Assessment.

PURPOSE: To mitigate side effects of conventional cancer care and improve quality of life, many patients with breast cancer in German-speaking countries opt for mistletoe therapy in addition to standard treatment. To understand the value for users, we evaluated the domain "Patient and Social aspects" in a health technology assessment on complementary mistletoe therapy in patients with breast cancer. METHODS: A systematic review was conducted according to PRISMA guidelines. Fifteen electronic databases and the internet were searched. Qualitative studies were analyzed using qualitative content analysis; quantitative studies were systematically summarized in evidence tables. RESULTS: Seventeen studies out of 1203 screened publications with 4765 patients and 869 healthcare professionals were included in the review. The median proportion of patients using mistletoe therapy was 26.7% (range: 7.3-46.3%). Predictors for use were younger age and higher educational level. Main reasons for patients' use of mistletoe therapy were to leave nothing untried and to be actively involved in the treatment process. Reasons against use were related to a lack of knowledge or uncertainty regarding effectiveness and safety. Physicians mainly aimed to support the patient's physical condition as main reason for use and a lack of resources and knowledge as main reason against use. CONCLUSION: Mistletoe therapy was commonly used in the treatment of breast cancer despite a lack of scientific knowledge among patients and physicians. Transparent communication on motivation for use and its potential effect enables realistic expectations. Relatively small samples of mistletoe therapy users limit the representativeness and validity of our results.

[Rapid health technology assessment of four oral Chinese patent medicines in treatment of functional gastrointestinal disorders].

To provide proof of the evidence-based medicine and decision-making information for the clinical decision of functional gastrointestinal disorders(FGIDs), this study evaluated and compared the efficacy, safety, and economy of four oral Chinese patent medicines(CPMs) in the treatment of FGIDs using the method of rapid health technology assessment. The literature was systematically retrieved from CNKI, Wanfang, VIP, SinoMed, EMbase, PubMed, Cochrane Library and ClinicalTrials.gov from the establishment of the databases to May 1, 2022. Two evaluators screened out the literature, extracted data, evaluated the quality of the literature, and descriptively analyzed the results according to the prepared standard. Eventually, 16 studies were included, all of which was rando-mized controlled trial(RCT). The results showed that Renshen Jianpi Tablets, Renshen Jianpi Pills, Shenling Baizhu Granules, and Buzhong Yiqi Granules all had certain effects on the treatment of FGIDs. Renshen Jianpi Tablets treated FGIDs and persistent diarrhea. Shenling Baizhu Granules treated diarrhea with irritable bowel syndrome and FGIDs. Buzhong Yiqi Granules treated diarrhea with irritable bowel syndrome, FGIDs, and chronic diarrhea in children. Renshen Jianpi Pills treated chronic diarrhea. The four oral CPMs all have certain effects on the treatment of FGIDs and have specific advantages for specific patients. Compared with other CPMs, Renshen Jianpi Tablets have higher clinical universality. However, there are problems such as insufficient clinical research evidence, generally low quality of evidence, lack of comparative analysis among medicines, and lack of academic evaluation. More high-quality clinical research and the economic research should be carried out in the future, so as to provide more evidence for the evaluation of the four CPMs.

Health technology assessment 2025 and beyond: lifecycle approaches to promote engagement and efficiency in health technology assessment.

Lifecycle considerations have always been part of health technology assessment (HTA). However, the concept of taking a fuller, more holistic "lifecycle approach" is gaining interest in the HTA community. The 2022 HTAi Global Policy Forum (GPF) discussed how adopting a lifecycle approach could promote stakeholder engagement and robust evidence generation, and whether it could enhance information sharing and transparency across stakeholder groups. This article summarizes the discussions held at the 2022 HTAi GPF and subsequent HTAi Annual Meeting panel session that debated some of the key challenges and opportunities, with particular focus on the pre- and postmarket and disinvestment phase activities. Core themes and recommendations identified that collaboration and patient involvement are happening but still needs to be strengthened, and moving to disease-based approaches may help, although individual contexts still need to be considered. Appropriately developed and mandated core outcome sets may help with information sharing and efficiency in all lifecycle activities. Further, methods for the appropriate use of big data and digital data collection should be developed and driven by the HTA community. The value of lifecycle activities should be reviewed; in particular, scientific advice appears valuable, but the magnitude of effect is somewhat unknown due to the challenges around the confidential nature of these activities. Not all lifecycle activities can be conducted for every technology, and while there is a move away from disinvestment phase activities, more structured prioritization criteria are required. This article ends with suggested next steps to bring forward some of the priority recommendations.

Movement disorders: is the Feldenkrais method effective? IQWiG Reports - Commission

The Feldenkrais method is presumably preferred by social groups who generally strive to use non-drug and non-surgical interventions for preventing and treating diseases. Since chronic pain is more common in advanced age, older people are likely to be more interested in this method. This health technology assessment (HTA) report investigates the use of the Feldenkrais method as a therapeutic intervention, i.e. only in people with movement disorders, rather than for preventive purposes or in persons with mobility impairments which are not defined in more detail. Demand is nurtured, in part, by the Feldenkrais method being expected to favourably affect private and social life due to greater self-perceived physical mobility. Since the Feldenkrais method's trademark protection is viewed positively, these groups may harbour erroneous assumptions with regard to the benefits to be expected. From an ethical perspective, this tends to be viewed critically because users who do not reap any benefit may have incurred costs to be paid out of pocket (the relevance of this aspect differs between social groups) and not utilized effective therapies. A total of 6 randomized controlled trials (RCTs), all with a high risk of bias, were identified for 5 therapeutic indications, and hints of (greater) benefit were determined for 2 therapeutic indications. For patients with Parkinson's disease, there is a hint of greater benefit of the Feldenkrais method in comparison with the passive strategy of an educational programme in the form of lectures. This benefit consists of improved mobility and health-related quality of life at the end of treatment. In the comparison with active strategies, the available evidence for patients with chronic low back pain is inconsistent. Compared with an educational programme involving trunk stabilization exercises, there is a hint of greater benefit of the Feldenkrais method with regard to improved mobility and health-related quality of life at the end of the 5-week treatment period. In comparison with back school, there is a hint of greater benefit of the Feldenkrais method with regard to pain reduction, but also a hint of lesser benefit of this method with regard to health-related quality of life after 3 months. However, no differences in effects were found directly at the end of therapy. There is no hint of either long-term benefit of the Feldenkrais method or for its benefit in other therapeutic indications. It was also impossible to derive any hint of harm from the Feldenkrais method, with the studies failing to provide data on deaths and adverse events. The question about the benefit of the Feldenkrais method in comparison with active strategies such as extensive physiotherapy generally remains open. The determined evidence is based on group interventions in the "Awareness Through Movement" (ATM) format rather than one-on-one interventions in the "Functional Integration" format (only 4 sessions investigated in 1 study). The intervention costs equal €10 to €20 per person and group session or €60 to €90 per one-on-one session. These costs are typically to be paid out of pocket by patients, a fact which is of differing relevance for different social groups. No studies on health economic aspects are available. If greater benefit were to be confirmed for certain therapeutic indications, some problematic issues might arise from an ethical or organizational perspective, particularly in view of limited access to the method. Since liability issues are conceivable in case of demonstrable physical injuries, the use of the Feldenkrais method as a therapeutic intervention would require corresponding basic medical qualifications of Feldenkrais teachers, possibly with state accreditation. From a social and organizational perspective, use of the Feldenkrais method requires some patient collaboration (to ensure continuity of the intervention) and potentially leads to lower utilization of medically trained healthcare providers. If the costs of the Feldenkrais method were to be covered by statutory health insurance for therapeutic indications with established benefit, the service would need to be offered nationwide by appropriately trained personnel. Additional resources would likely be needed. Overall, little evidence is available. From an ethical perspective, the absence of evidence from RCTs is problematic for informed decision making but does not constitute evidence of an absent benefit. Only 2 small, ongoing RCTs of questionable relevance were identified, and therefore, the availability of evidence is not expected to change in the short term. Due to the limited availability of data, further research is needed, particularly regarding long-term effects of the Feldenkrais method, its application in various therapeutic indications, and in comparison with further active comparator therapies typically used in practice, e.g. physiotherapy.

Access to novel drugs and therapeutics for children and youth: Eliciting citizens' values to inform public funding decisions.

INTRODUCTION: The unique evidentiary, economic and ethical challenges associated with health technology assessment (HTA) of precision therapies limit access to novel drugs and therapeutics for children and youth, for whom such challenges are amplified. We elicited citizens' perspectives about values-based criteria relevant to the assessment of paediatric precision therapies to inform the development of a child-tailored HTA framework. METHODS: We held four citizen panels virtually in May-June 2021, informed by a plain-language citizen brief summarizing global and local evidence about the challenges, policy and programmatic options and implementation strategies related to enhancing access to precision therapies for Canadian children and youth. Panellists were recruited through a nationally representative database, medical/patient networks and social media. We inductively coded and thematically analysed panel transcripts to generate themes and identify priority values. RESULTS: The perspectives of panellists (n = 45) coalesced into four overlapping themes, with attendant subthemes, relevant to a child-tailored HTA framework: (1) Childhood Distinctions: vulnerability, 'fair innings', future potential, family impacts; (2) Voice: agency of children and youth; lived versus no lived experience; (3) One versus Many: disease severity, rarity, equity, unmet need and (4) Health System Governance: funding, implementation inequities, effectiveness and safety. Participants broadly agreed that childhood distinctions, particularly family impacts, justify child-tailored HTA. Dissent arose over whose voice should inform HTA and how such perspectives are best incorporated. CONCLUSIONS: Citizens can offer unique insights into criteria relevant to the development or revision of HTA frameworks to capture holistic, societally responsive dimensions of value attached to unique contexts or populations, including children. Balancing the hopes and expectations of patients and caregivers for access to expensive but potential life-altering therapies against the opportunity costs borne by encompassing health systems is a fundamental challenge that will require rigorous methods to elicit, weigh and reconcile varied views. PATIENT OR PUBLIC CONTRIBUTION: A patient advocate served on the steering committee of this study and co-authored this article. Key informants for the Citizen Brief included patient advocates and caregivers; a separate patient advocate reviewed the Brief before dissemination. Qualitative and quantitative data were collected from the general public and caregivers of children, with written consent.

Three oral Chinese patent medicines for children with tic disorder: a rapid health technology assessment / 中国中药杂志

This study aims to comprehensively evaluate the clinical value of Shaoma Zhijing Granules(SZG), Changma Xifeng Tablets(CXT), and Jiuwei Xifeng Granules(JXG) in the treatment of children with tic disorder with the method of rapid health technology assessment(RHTA), which is expected to serve as a reference for medical and health decision-making and clinical rational use of drugs in children. To be specific, relevant articles were retrieved from eight databases and three clinical trial registry platforms. After the quality evaluation, rapid assessment was carried out from the dimensions of disease burden and unmet needs, technical characteristics, safety, efficacy and economy, and the results were analyzed and presented descriptively. A total of 22 articles(1 in English, 21 in Chinese) were screened out: 18 randomized controlled trials(RCTs) and 4 clinical controlled trials(CCTs). Among them, 5 were about the SZG(all RCTs) and 9 were on CXT(6 RCTs and 3 CCTs). The rest 8 focused on JXG(7 RCTs and 1 CCT). Moreover, the overall risk of bias for 94.40% RCTs was evaluated as "some concerns" and only one(5.60%) had high risk of bias. In terms of quality, the 4 CCTs scored 5-6 points(<7 points), suggesting low quality. SZG alone or in combination with tiapride has obvious advantages in improving traditional Chinese medicine syndromes and tic symptoms compared with tiapride alone, with the average daily cost of CNY 79.44-119.16. Compared with conventional western medicine or placebo, CXT alone or in combination with conventional western medicine can improve the total effective rate and alleviate tic symptoms, and the average daily cost is CNY 22.50-67.50. JXG alone or in combination with conventional western medicine can effectively relieve tic symptoms compared with conventio-nal western medicine or placebo, with the average daily cost of CNY 82.42-164.85. The adverse events related to the three Chinese patent medicines mainly occurred in the digestive, respiratory, and nervous systems, all of which were mild. In general, SZG, CXT, and JXG are effective for children with tic disorder. They have been approved to be used in this field, of which SZG was approved in 2019, with the most up-to-date research evidence and high-quality RCT in Q1 journals. However, the comparative analysis of the three was affected by many factors, which should be further clarified. Based on the large sample data available in multiple dimensions, a comprehensive comparative evaluation of the three Chinese patent medicines should be carried out, thereby highlighting the advantages and disadvantages of them and serving a reference for rational clinical use and drug supervision.

Abordagem de narrativas como método de pesquisa em saúde pública: aproximações conceituais e contribuições da psicanálise / Narrative research in public health: conceptual approximations and contributions from psychoanalysis / Enfoque en narrativas como método de investigación en salud pública: aproximaciones conceptuales y aportaciones del psicoanálisis

Este artigo refere-se à parte de uma pesquisa de doutorado, realizada em hospital de alta complexidade do Sistema Único de Saúde, cujos participantes são os profissionais de saúde. O objetivo deste artigo é analisar o potencial da abordagem das narrativas como método de pesquisa e intervenção nos serviços de saúde, traçando aproximações com a teoria psicanalítica. Sua relevância no campo da Saúde Pública está calcada no reconhecimento do papel do sujeito como agente de mudanças. O texto divide-se em duas partes: na primeira, explora as especificidades do trabalho na área da saúde, o paradigma da saúde pública no que concerne à gestão e possíveis contribuições da clínica ampliada para esse modelo. Na segunda parte, analisa o uso das narrativas como método de pesquisa nesse campo e as aproximações conceituais entre a narrativa em Walter Benjamin e a psicanálise em Freud. Busca na literatura referências sobre experiências análogas que fundamentem a proposta ora realizada e conclui pela importância de, no momento atual, apostar na força germinativa das narrativas como fonte criativa de novas formas de cuidar.(AU)

This article derives from a PhD research conducted with health professionals at a high-complexity public hospital from the Brazilian Unified Health System (SUS). It analyzes the potential of the narrative as a research and intervention method in health services, outlining approximations with psychoanalysis. In the field of Public Health, the narrative approach acknowledges the individual as an agent of change. The text is divided into two parts. The first presents an overview of the peculiarities involved in healthcare, the Public Health paradigm regarding service management and possible contributions from the expanded clinic to this model. The second analyzes the use of narratives as a research method in this field and the conceptual approximations between Benjamin's narrative and Freud's psychoanalysis. It searches the literature for references on similar experiences to support the present proposal and concludes by highlighting the importance of betting on the creative power of narratives as a source for new ways to care.(AU)

Este artículo es parte de una investigación doctoral, realizada con los profesionales de la salud de un hospital de alta complejidad del Sistema Único de Salud de Brasil. Su propósito es analizar el potencial del enfoque en narrativas como método de investigación e intervención en los servicios de salud, esbozando aproximaciones entre las narrativas y la teoría del psicoanálisis. Su relevancia en el campo de la salud pública se basa en el reconocimiento del rol del sujeto como agente de cambio. El texto se divide en dos partes: La primera investiga las especificidades del trabajo en el área de la salud, el paradigma de la salud pública en la gestión de los servicios y las posibles contribuciones de la clínica ampliada a este modelo. En la segunda parte, analiza el uso de narrativas como método de investigación en este campo y las aproximaciones conceptuales entre la narrativa de Walter Benjamin y el psicoanálisis de Freud. Este estudio busca en la literatura referencias sobre experiencias similares que apoyen la propuesta ahora realizada y concluye con la importancia de, en el momento actual, apostar por el poder de las narrativas como fuente creadora de nuevas formas de cuidar.(AU)

[Four Chinese patent medicines for regulating stomach for functional dyspepsia: a rapid health technology assessment].

This study evaluated and compared the efficacy, safety and economy of four Chinese patent medicines(CPMs) in the treatment of functional dyspepsia(FD) using the method of rapid health technology assessment. It aims to provide decision-makers with rapid decision-making information. The eight Chinese and English databases were comprehensively and systematically searched for the relevant clinical research. Studies were screened and evaluated. A total of 110 studies were identified, including 95 randomized controlled trials(RCTs), 7 controlled clinical trials(CCTs), 7 systematic review/Meta-analysis and 1 economic evaluation, among which 28 were Dalitong Granules, 49 were Zhizhu Kuanzhong Capsules, 3 were Biling Weitong Granules and 30 were Qizhi Weitong Granules(Tablets/Capsules). The quality of the included literature was generally low. The efficacy of four CPMs alone or combined with western medicine in the treatment of FD is different. Dalitong Granules was used to treat motility disorder in FD. Zhizhu Kuanzhong Capsules and Qizhi Weitong Granules(Tablets/Capsules) can treat FD patients with anxiety and depression. Qizhi Weitong Granules(Tablets/Capsules) were mainly used in FD for perimenopausal patients. There were no serious adverse reactions in the clinical study of four CPMs in the treatment of FD. Dalitong Granules has better effects than mosapride in the treatment of FD, but the cost is slightly higher. The cost-effectiveness ratio of Zhizhu Kuanzhong Capsules in the treatment of FD patients with anxiety and depression was lower than that of Domperidone. In terms of average daily price, Qizhi Weitong Tablets has the highest price(27.00 yuan per day), Qizhi Weitong Granules has the lowest price(5.04 yuan per day), Biling Weitong Granules has a relatively high price(15.53 yuan per day), followed by Dalitong Granules(13.03 yuan per day). The evidence of Dalitong Granules covered the efficacy, safety and economy, which is relatively complete compared with the other three drugs. It has effective potential in the treatment of motility disorder in FD. Further research in this field in the future is needed.

[Scoping review of domestic and overseas hospital-based health technology assessment].

This paper systematically sorted out the related research on hospital-based health technology assessment(HB-HTA) and clarified the research status of this field to provide a basis for the future research direction and focus of HTA in traditional Chinese medicine(TCM) hospitals. Based on the scoping review, relevant research papers were retrieved from Chinese databases(including CNKI, Wanfang, VIP, and SinoMed) and PubMed and analyzed. Among the included 99 papers, the earliest one was published in 2005 in China, and the number of papers has been increasing since 2016. In terms of journals, the included papers were published in 39 journals, including 24 core ones and 2 SCI ones. In terms of the number of publications, the Chinese Journal of Evidence-Based Medicine accounted for the majority(n=6). Among the 175 authors involved, three of them published 15 papers, respectively, accounting for 20.83% and ranking the top, and they came from Renmin University of China and the National Health Commission of China. There were 38 first units dominated by hospitals. Hebei General Hospital published the most papers(n=10), followed by Renmin University of China(n=9) and the National Health Commission of China(n=7). In terms of research type, the research papers were dominated by evaluation and practice ones(n=29), followed by reviews(n=20). In terms of research topic, the research was mainly carried out from devices(n=26) and macro-perspective scope(n=24). Half of the research in China was funded. For 27 research papers published abroad, the number of publications in the past five years was small, with 16 countries involved. Developed countries paid more attention to this field than developing countries. Especially in Europe and the US, the publishing institutions were mainly universities, and the types of research were mainly interviews and evaluation or practice. In recent years, the attention of HB-HTA in China has been increasing year by year, and the development of related projects has provided a scientific decision-making basis for the admission and management of new technologies in hospitals in China. However, there are few researchers and institutions in this field, and the research scope is small. In the future, more investment is needed to encourage more hospitals, especially TCM hospitals, to carry out HB-HTA, explore the HB-HTA system suitable for Chinese conditions, and improve the scientific decision-making of hospitals.

[Scoping review of rapid health technology assessment].

This study aims to summarize the research on rapid health technology assessment(RHTA) based on scoping review, which is expected to serve as a reference for future research on RHTA. First, articles on RHTA were retrieved from both Chinese and English databases. After data screening and extraction by two personnel independently, descriptive analysis was conducted on the results, and evidence distribution was analyzed based on tables, bar charts, line charts, radar charts, and pie charts. Finally, a total of 82 eligible articles were included and the characteristics were as follows.(1) Articles on RHTA were mainly published from 2011 to 2022. The number of articles showed an obvious increase from 2014 and surged in 2019.(2) Among the journals with the above RHTA papers published, Chinese Journal of New Drugs(21.5%), Evaluation and Analysis of Drug-Use in Hospitals of China(16.9%), and Chinese Pharmacy(15.4%) topped the Chinese journals in the number of the papers, while International Journal of Technology Assessment in Health Care(23.5%), Reviews in Medical Virology(11.8%), and Value in Health(11.8%) came out on top in the English journals.(3)The RHTA of drugs(especially western medicine)(68.7%) dominated the eligible articles, followed by the RHTA of therapy technology(13.1%), detection technology(5.1%), and diagnosis technology(1.0%). There was a significant gap in the number of studies among different health technology categories and an imbalance in the types of health technologies involved in the overall RHTA studies.(4) RHTA of tumors has been the research focus in recent years. In summary, RHTA plays a positive role in rapid health decision-making, but there is a lack of primary data sources at present. Compared with the systematic review, Meta-analysis, and pharmacoeconomic studies, a few reports on health technology assessment(HTA) were included. In the future, research on the evaluation of the safety, efficacy, cost effectiveness and social applicability of health technologies should be further strengthened.

[Rapid health technology assessment of four oral Chinese patent medicines for constipation].

This study evaluated the safety, efficacy, and cost effectiveness of Biantong Capsules(Tablets), Maren Runchang Pills, Qirong Runchang Oral Liquid, and Qihuang Tongmi Soft Capsules in the treatment of constipation by the rapid health technology assessment(RHTA) to provide evidence for clinical decision and references for rapid evaluation of Chinese patent medicine(CPM). CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Web of Science, and Cochrane Library were searched for research articles from database inception to February 2022. Two reviewers conducted literature screening, data extraction, and quality evaluation according to the predetermined standards. Descriptive analysis of the results combined with visual charts was performed. Sixty research articles were included, involving 44 randomized controlled trials(RCTs), 7 clinical controlled trials(CCTs), 4 systematic reviews/Meta-analyses, and 5 economic analysis studies. As revealed by the results, Biantong Capsules(Tablets) could be used for postoperative and senile constipation, in which some studies reported Biantong Capsules(Tablets) were superior to Maren Runchang Pills and Qirong Runchang Oral Liquid. Maren Runchang Pills were mainly used for senile constipation, and the efficacy was similar to that of conventional wes-tern medicine, but the cost was low and the compliance of patients was good. Qirong Runchang Oral Liquid was indicated for disease-derived or drug-induced constipation, chronic constipation, and senile constipation with fewer adverse reactions. Qihuang Tongmi Soft Capsules had good efficacy and safety in the treatment of functional constipation. Overall, compared with western medicine glycerine enema and lactulose, the number of clinical studies of the four CMPs was small, but they targeted constipation patients with different subtypes. In conclusion, the four CMPs have their advantages and characteristics in the treatment of constipation, but they are restric-ted by sparse existing evidence, low quality of evidence, and insufficient economic research. In the future, more high-quality and long-term follow-up studies should be carried out to obtain reliable evidence. Meanwhile, it is called for strengthening the economic evaluation of CMPs to provide evidence for decision-making.

[Enlightenment of WHO guideline on institutionalizing health technology assessment mechanism for traditional Chinese medicine].

To promote the institutionalization of the health technology assessment(HTA) mechanism in various countries, World Health Organization(WHO) has published the Institutionalizing Health Technology Assessment Mechanisms: a How to Guide to introduce five steps of institutionalizing the HTA mechanism systematically, specifically, "establishing a mandate; establishing the legal framework; reviewing or establishing the legal framework; establishing institutional and governance arrangements; processes and evidence required for assessment and appraisal; and monitoring and evaluation". Traditional Chinese medicine(TCM) HTA can provide scientific information and decision-making evidence for decision-makers at all levels to select TCM health technology reasonably, and promote the high-quality development of the TCM healthcare system. However, TCM HTA is in its infancy, and it is imperative to carry out relevant work under the guidance of global standard documents to ensure standardization, transparency, and fairness. In light of the WHO guidance, this research group put forward the necessity and logical framework for the institutionalizing HTA mechanism of TCM, which is helpful to establish the institutionalizing HTA mechanism in line with national conditions and suitable for TCM, provide scientific guidance for the research of TCM HTA, and contribute to TCM healthcare decision-making.

Knowledge Mapping of Multicriteria Decision Analysis in Healthcare: A Bibliometric Analysis.

Objective: Multicriteria decision analysis (MCDA) is a useful tool in complex decision-making situations, and has been used in medical fields to evaluate treatment options and drug selection. This study aims to provide valuable insights into MCDA in healthcare through examining the research focus of existing studies, major fields, major applications, most productive authors and countries, and most common journals in the domain. Methods: A bibliometric analysis was conducted on the publication related to MCDA in healthcare from the Web of Science Core Collection (WoSCC) database on 14 July 2021. Three bibliometric software (VOSviewer, R-bibliometrix, and CiteSpace) were used to conduct the analysis including years, countries, institutes, authors, journals, co-citation references, and keywords. Results: A total of 410 publications were identified with an average yearly growth rate of 32% (1999-2021), from 196 academic journals with 23,637 co-citation references by 871 institutions from 70 countries/regions. The United States was the most productive country (n = 80). Universiti Pendidikan Sultan Idris (n = 16), Université de Montréal (n = 13), and Syreon Research Institute (n = 12) were the top productive institutions. A A Zaidan, Mireille Goetghebeur and Zoltan Kalo were the biggest nodes in every cluster of authors' networks. The top journals in terms of the number of articles (n = 17) and citations (n = 1,673) were Value in Health and Journal of Medical Systems, respectively. The extant literature has focused on four aspects, including the analytic hierarchy process (AHP), decision-making, health technology assessment, and healthcare waste management. COVID-19 and fuzzy TOPSIS received careful attention from MCDA applications recently. MCDA in big data, telemedicine, TOPSIS, and fuzzy AHP is well-developed and an important theme, which may be the trend in future research. Conclusion: This study uncovers a holistic picture of the performance of MCDA-related literature published in healthcare. MCDA has a broad application on different topics and would be helpful for practitioners, researchers, and decision-makers working in healthcare to advance the wheel of medical complex decision-making. It can be argued that the door is still open for improving the role of MCDA in healthcare, whether in its methodology (e.g., fuzzy TOPSIS) or application (e.g., telemedicine).

[Clinical comprehensive evaluation of Chinese patent medicine based on EVIDEM].

The clinical comprehensive evaluation of Chinese patent medicine is an important direction in the evaluation of traditional Chinese medicine(TCM), which positively promotes the development of TCM industry. The evaluation system of Chinese patent medicine is helpful to comprehensively evaluate the clinical value of different Chinese patent medicine in the same category, different dosage forms, and specifications, from different manufacturers on the basis of evidence and value. The establishment of a scientific and reasonable comprehensive evaluation index system for Chinese patent medicine is an important prerequisite to ensure clinical value. However, there has been neither a recognized systematic review on the clinical comprehensive evaluation of Chinese patent medicine nor a methodological system used for reference. The evidence and value: impact on decision-making(EVIDEM), developed by the international research team, is used to evaluate the comprehensive value of medical interventions. EVIDEM provides a methodological tool for scientific decision-making to evaluate evidence and value for health technologies on the basis of the multi-criteria decision analysis(MCDA) model and health technology assessment(HTA). Based on the ongoing EVIDEM research, the present study put forward that EVIDEM-based clinical comprehensive evaluation of Chinese patent medicine consisted of four aspects, seven modules, and ten steps, which is expected to references and practical experience for the follow-up comprehensive evaluation of Chinese patent medicine in the TCM field.

Market access for medicines treating rare diseases: Association between specialised processes for orphan medicines and funding recommendations.

Access to medicines treating rare diseases ('orphan medicines') has proven challenging due to high prices and clinical uncertainty. To optimise market access to these medicines, some healthcare systems are implementing specialised pathways and/or processes during marketing authorisation (MA) and/or health technology assessment (HTA). Comparing one setting where these medicines are classed as "orphan" (Scotland) to another where they considered "non-orphan" (Canada), this study aims to explore whether the presence of specialised pathways and processes at MA and HTA levels is associated with more favourable funding recommendations and faster time to market access. A matched sample of 116 medicine-indication pairs with MA approval from 2001 to 2019 in Europe and Canada was identified, and publicly available sources were used for data extraction. Descriptive statistics were used for data analysis. All medicines were commercially marketed in both countries, except one instance in Scotland. In Scotland, more orphan medicines (68.1%) had a favourable HTA recommendation than in Canada (60.4%), while Canada issued more negative HTA recommendations (20.7%) than Scotland (15.5%). Low levels of agreement on HTA recommendations and the main reasons driving recommendations were found between settings. In both countries, medicines with specialised MA approval were less likely to receive negative HTA recommendations than medicines with standard MA. Time to market access was faster in Canada than Scotland, though medicines with specialised MA approval had slower timelines than medicines with standard MA approval in both countries. However, it is unclear whether the presence of orphan designation and HTA specialised processes alone could result in favourable funding recommendations without accounting for other healthcare system-related factors and differences in the decision-making processes across settings. Holistic approaches and better alignment of evidentiary requirements across regulators are needed to optimise access to orphan medicines.

Assessing the value of healthcare innovations: a proposal for an integrated health technology assessment-responsible innovation in health approach in the "new normal".

There has been tremendous technological innovation in the healthcare sector, but it has also raised serious ethical and social concerns. The COVID-19 pandemic has only magnified these existing challenges. Hence, addressing these challenges becomes imperative in the "new normal." In this context, this article uses a narrative synthesis approach to discuss the linkages of health technology, innovation, and policy to identify the challenges of this complex interaction by applying the principles of pragmatism and historicity to the existing literature. Moreover, the existing scientific mechanisms in the form of health technology assessment (HTA) and responsible innovation in health (RIH) are described to address these challenges. Using inductive epistemology, the linkages between HTA and RIH within a health innovation ecosystem framework are discussed for the future application of an integrated approach to address societal challenges. The proposed integrated approach of HTA and RIH is a work in progress and conceptualized as transdisciplinary, flexible, and adaptive, which is expected to facilitate future discussion, research, and policy action.

Coenzyme Q10 to manage chronic heart failure with a reduced ejection fraction: a systematic review and economic evaluation.

BACKGROUND: Chronic heart failure is a debilitating condition that accounts for an annual NHS spend of £2.3B. Low levels of endogenous coenzyme Q10 may exacerbate chronic heart failure. Coenzyme Q10 supplements might improve symptoms and slow progression. As statins are thought to block the production of coenzyme Q10, supplementation might be particularly beneficial for patients taking statins. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of coenzyme Q10 in managing chronic heart failure with a reduced ejection fraction. METHODS: A systematic review that included randomised trials comparing coenzyme Q10 plus standard care with standard care alone in chronic heart failure. Trials restricted to chronic heart failure with a preserved ejection fraction were excluded. Databases including MEDLINE, EMBASE and CENTRAL were searched up to March 2020. Risk of bias was assessed using the Cochrane Risk of Bias tool (version 5.2). A planned individual participant data meta-analysis was not possible and meta-analyses were mostly based on aggregate data from publications. Potential effect modification was examined using meta-regression. A Markov model used treatment effects from the meta-analysis and baseline mortality and hospitalisation from an observational UK cohort. Costs were evaluated from an NHS and Personal Social Services perspective and expressed in Great British pounds at a 2019/20 price base. Outcomes were expressed in quality-adjusted life-years. Both costs and outcomes were discounted at a 3.5% annual rate. RESULTS: A total of 26 trials, comprising 2250 participants, were included in the systematic review. Many trials were reported poorly and were rated as having a high or unclear risk of bias in at least one domain. Meta-analysis suggested a possible benefit of coenzyme Q10 on all-cause mortality (seven trials, 1371 participants; relative risk 0.68, 95% confidence interval 0.45 to 1.03). The results for short-term functional outcomes were more modest or unclear. There was no indication of increased adverse events with coenzyme Q10. Meta-regression found no evidence of treatment interaction with statins. The base-case cost-effectiveness analysis produced incremental costs of £4878, incremental quality-adjusted life-years of 1.34 and an incremental cost-effectiveness ratio of £3650. Probabilistic sensitivity analyses showed that at thresholds of £20,000 and £30,000 per quality-adjusted life-year coenzyme Q10 had a high probability (95.2% and 95.8%, respectively) of being more cost-effective than standard care alone. Scenario analyses in which the population and other model assumptions were varied all found coenzyme Q10 to be cost-effective. The expected value of perfect information suggested that a new trial could be valuable. LIMITATIONS: For most outcomes, data were available from few trials and different trials contributed to different outcomes. There were concerns about risk of bias and whether or not the results from included trials were applicable to a typical UK population. A lack of individual participant data meant that planned detailed analyses of effect modifiers were not possible. CONCLUSIONS: Available evidence suggested that, if prescribed, coenzyme Q10 has the potential to be clinically effective and cost-effective for heart failure with a reduced ejection fraction. However, given important concerns about risk of bias, plausibility of effect sizes and applicability of the evidence base, establishing whether or not coenzyme Q10 is genuinely effective in a typical UK population is important, particularly as coenzyme Q10 has not been subject to the scrutiny of drug-licensing processes. Stronger evidence is needed before considering its prescription in the NHS. FUTURE WORK: A new independent, well-designed clinical trial of coenzyme Q10 in a typical UK heart failure with a reduced ejection fraction population may be warranted. STUDY REGISTRATION: This study is registered as PROSPERO CRD42018106189. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 4. See the NIHR Journals Library website for further project information.

People living with chronic heart failure suffer from shortness of breath, ankle swelling, tiredness, frequent stays in hospital and reduced quality of life and have shorter lives. The NHS spends over £2 billion each year managing chronic heart failure. Coenzyme Q10 is a vitamin-like substance made by the body that helps cells produce energy. Low levels of coenzyme Q10 in heart muscle may lead to, or exacerbate, chronic heart failure. Taking coenzyme Q10 supplements might improve symptoms or slow deterioration. To the best of our knowledge, we found all randomised clinical trials of coenzyme Q10 in patients with the type of chronic heart failure caused by muscle weakness (i.e. heart failure with reduced ejection fraction, where the heart's pumping function is weaker than normal). We asked the research groups responsible for these trials to provide the patient data that they had collected in their trials. Most research groups did not share their data and so we mainly used information from published trial reports. This limited our planned analyses. We found that taking coenzyme Q10 alongside usual treatment for heart failure with reduced ejection fraction potentially reduced deaths by approximately one-third and reduced readmission to hospital by around 40%. However, these results were uncertain. Side effects were not increased. We had some concerns about how reliable the data were, and it is not clear how well the results apply to UK patients. We also worked out what the benefits and costs to the NHS would be if coenzyme Q10 became available on prescription for patients with heart failure with reduced ejection fraction. Our model found that prescription could be worthwhile; however, a new trial is needed first to make sure that coenzyme Q10 improves outcomes for patients. A new trial would be particularly important because coenzyme Q10 has not been assessed in the same way as prescribed medicines. A new trial could make sure that there is better evidence about whether or not prescribing would be a good use of NHS resources.