1.Three oral Chinese patent medicines for children with tic disorder: a rapid health technology assessment.
Xue WU ; Zhong WANG ; Xing LIAO ; Yong-Yan WANG
China Journal of Chinese Materia Medica 2023;48(14):3965-3976
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.
Humans
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Child
;
Drugs, Chinese Herbal/therapeutic use*
;
Nonprescription Drugs/therapeutic use*
;
Technology Assessment, Biomedical
;
Tiapride Hydrochloride/therapeutic use*
;
Tics/drug therapy*
;
Tic Disorders/drug therapy*
;
Medicine, Chinese Traditional
2.Rapid health technology assessment of four oral Chinese patent medicines in treatment of functional gastrointestinal disorders.
Ya-Qi ZU ; Jing-Hua LI ; Xing LIAO ; Qi YU ; Guo-Xiang LI ; Wen-Yan SHI ; Xu-Dong TANG
China Journal of Chinese Materia Medica 2023;48(4):1116-1123
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.
Child
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Humans
;
Irritable Bowel Syndrome
;
Technology Assessment, Biomedical
;
Gastrointestinal Diseases
;
Diarrhea
3.Four Chinese patent medicines for regulating stomach for functional dyspepsia: a rapid health technology assessment.
Si-Min XU ; Ze-Qi DAI ; Xue WU ; Miao-Miao LI ; Xing LIAO
China Journal of Chinese Materia Medica 2022;47(17):4778-4788
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.
Capsules
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China
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Chlorobenzenes
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Domperidone/therapeutic use*
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Drugs, Chinese Herbal/therapeutic use*
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Dyspepsia/drug therapy*
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Humans
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Nonprescription Drugs/therapeutic use*
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Stomach
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Sulfides
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Tablets
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Technology Assessment, Biomedical
4.Evaluating the usability of the expanded telerehabilitation program implemented by Philippine General Hospital during the COVID-19 pandemic: A cross-sectional study
Miguel Julio S. Valera ; Carl Froilan D. Leochico ; Sharon D. Ignacio ; Jose Alvin P. Mojica
Acta Medica Philippina 2022;56(4):41-50
Background:
The Department of Rehabilitation Medicine of the University of the Philippines-Philippine General Hospital (UP-PGH) established its telerehabilitation service program in 2017. The program previously catered to patients in a partner rural community by providing teleconsultation and teletherapy over a distance. With the unprecedented coronavirus disease 2019 (COVID-19) pandemic, the program has expanded its service to outpatients previously managed face-to-face by the department, regardless of location.
Objectives:
This study aimed to evaluate the usability of the telerehabilitation service program at UP-PGH when it was expanded during the pandemic and to associate telerehabilitation usability ratings with the participant groups, demographic characteristics, and prior telemedicine knowledge and experience.
Methods:
This cross-sectional study involved the doctors, physical therapists, occupational therapists, psychologists, patients, and patients’ carers, who participated in at least one telerehabilitation session and consented to respond to a digital survey thereafter. Total enumeration sampling of all telerehabilitation participants was employed. The study outcome was the usability of the expanded telerehabilitation program based on the System Usability Scale (SUS) benchmarked at 68. Descriptive and inferential statistics were done at a 95% confidence interval. The participants’ responses to open-ended questions regarding telerehabilitation experience and recommendations were also presented.
Results:
The participants consisted of 19 doctors, 11 therapists, 37 patients, and 74 caregivers. The majority of the participants were female and lived in urban areas. The primary online telerehabilitation platforms used were Viber™ and Zoom™. The mean of overall SUS scores was below average for health providers [doctors (mean = 61.71), therapists (mean = 67.73)]; and above average for end-users [patients (mean 74.56), and carers (mean = 71.89)]. There was a significant difference in the overall SUS scores between doctors (mean: 61.7) and patients (mean: 74.6), p<0.05. In terms of videoconferencing platform, participants reported significantly higher system usability for those who used either Zoom™ (mean: 75.0) or Viber™ (mean: 69.3), as compared to Google Meet™ (mean: 53.1), p<0.05. There was no significant difference in the overall SUS scores across sexes, places of residence, primary telerehabilitation techniques used, prior telemedicine knowledge, and experience. The majority viewed telerehabilitation as a valuable method to provide service during the pandemic, but they were mostly concerned with technical problems, particularly an unstable Internet connection.
Conclusion
The expanded telerehabilitation service program of the PGH was perceived as useful by patients and caregivers but not by the health providers. While the program succeeded in providing continued outpatient rehabilitation services during the pandemic, the challenges experienced by its telehealth providers must be investigated and addressed.
Telemedicine
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Telerehabilitation
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Physical and Rehabilitation Medicine
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Technology Assessment, Biomedical
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Delivery of Health Care
5.Study on establishing a methodology of comprehensive clinical evaluation for Chinese patent medicine based on health technology assessment.
Xing LIAO ; Wu-Dong GUO ; Zhuang CAO ; Hai-Yu XU ; Yun-Ling ZHANG ; Hui ZHAO ; Yong-Yan WANG
China Journal of Chinese Materia Medica 2020;45(16):3749-3758
At present, most of Chinese patent medicines have problems, such as weak scientific basis, unclear clinical value evaluation, etc., which lead to the lack of sufficient evidence for the entry into the essential medicine list, medical insurance catalog and other important health resource allocation tools. This has a negative impact on the development of traditional Chinese medicine. It is urgent to establish a comprehensive evaluation methodology system of Chinese patent medicine in China. There are at least three reasons including producing evidence for clinical rational use scientifically, developing an objective and transparent selecting strategy, eventuating and highlighting its clinical value. The process and method of health technology assessment(HTA) can provide reference for the establishment of comprehensive evaluation method of Chinese patent medicine. However, HTA is rarely carried out in the field of traditional Chinese medicine. The latest domestic and international research showed that HTA combined with multi-criteria decision analysis(MCDA) can increase the transparency of decision-making and improve the quality of decision-making. The combined two formed the EVIDEM framework, which is conducive to drug selection and its clinical use. In this paper, the EVIDEM framework was introduced to establish the methodology framework of the comprehensive clinical evaluation system of Chinese patent medicine. A preliminary research idea has been put forward. In the future, we can establish a set of comprehensive clinical evaluation methods for Chinese patent medicine in cooperation with relevant national drug decision-making departments and management departments. It is believed that such cooperation could promote the full implementation of the re-evaluation for Chinese patent medicine.
China
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Drugs, Essential
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Medicine, Chinese Traditional
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Nonprescription Drugs
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Technology Assessment, Biomedical
6.The role of evidence-based algorithms for rotational thromboelastometry-guided bleeding management
Klaus GÖRLINGER ; Antonio PÉREZ-FERRER ; Daniel DIRKMANN ; Fuat SANER ; Marc MAEGELE ; Ángel Augusto Pérez CALATAYUD ; Tae Yop KIM
Korean Journal of Anesthesiology 2019;72(4):297-322
Rotational thromboelastometry (ROTEM) is a point-of-care viscoelastic method and enables to assess viscoelastic profiles of whole blood in various clinical settings. ROTEM-guided bleeding management has become an essential part of patient blood management (PBM) which is an important concept in improving patient safety. Here, ROTEM testing and hemostatic interventions should be linked by evidence-based, setting-specific algorithms adapted to the specific patient population of the hospitals and the local availability of hemostatic interventions. Accordingly, ROTEM-guided algorithms implement the concept of personalized or precision medicine in perioperative bleeding management (‘theranostic’ approach). ROTEM-guided PBM has been shown to be effective in reducing bleeding, transfusion requirements, complication rates, and health care costs. Accordingly, several randomized-controlled trials, meta-analyses, and health technology assessments provided evidence that using ROTEM-guided algorithms in bleeding patients resulted in improved patient's safety and outcomes including perioperative morbidity and mortality. However, the implementation of ROTEM in the PBM concept requires adequate technical and interpretation training, education and logistics, as well as interdisciplinary communication and collaboration.
Cooperative Behavior
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Education
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Health Care Costs
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Hemorrhage
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Humans
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Interdisciplinary Communication
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Methods
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Mortality
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Organization and Administration
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Patient Safety
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Point-of-Care Systems
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Precision Medicine
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Technology Assessment, Biomedical
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Thrombelastography
7.Improvement Status and Development Direction of New Health Technology Assessment
Health Policy and Management 2018;28(3):272-279
Since the introduction of new health technology assessment in 2007, benefit coverage process of health insurance related to new health technology has become an upgraded system through the evidence-based decisions. As a result of enforcing this system for 10 years, however, there have been several rising concerns. It needs to support the insufficient evidence of medical technologies, introduce reassessment system for post management of market entry technologies, and improve evaluation methods and process. In addition, there is the possibility of emerging an unheard-of medical technology, fused various categories like artificial intelligence, robot, information technology, physics and life science in the fourth industrial revolution. Now, new updated system introduced to improve new technology assessment, such as ‘limited health technology assessment system,’ ‘system for postponement of new health technology assessment,’ ‘one-stop service system,’ and ‘integrated operation of approval for medical devices and new health technology assessment.’ Therefore it needs to prepare the improvement plan for new health technology assessment to be established more advanced system, and we have to resolve concerns by communication with various healthcare experts and patients now and for ever.
Artificial Intelligence
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Biological Science Disciplines
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Biomedical Technology
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Delivery of Health Care
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Humans
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Insurance, Health
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Social Planning
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Technology Assessment, Biomedical
8.Roles of Health Technology Assessment for Better Health and Universal Health Coverage in Korea
Health Policy and Management 2018;28(3):263-271
Health technology assessment (HTA) is defined as multidisciplinary policy analysis to look into the medical, economic, social, and ethical implications of the development, distribution, and use of health technology. Following the recent changes in the social environment, there are increasing needs to improve Korea's healthcare environment by, inter alia, assessing health technologies in an organized, timely manner in accordance with the government's strategies to ensure that citizens' medical expenses are kept at a stable level. Dedicated to HTA and research, the National Evidence-based Healthcare Collaborating Agency (NECA) analyzes and provides grounds on the clinical safety, efficacy, and economic feasibility of health technologies. HTA offers the most suitable grounds for decision making not only by healthcare professionals but also by policy makers and citizens as seen in a case in 2009 where research revealed that glucosamine lacked preventive and treatment effects for osteoarthritis and glucosamine was subsequently excluded from the National Health Insurance's benefit list to stop the insurance scheme from suffering financial losses and citizens from paying unnecessary medical expenses. For the development of HTA in Korea, the NECA will continue exerting itself to accomplish its mission of providing policy support by health technology reassessment, promoting the establishment and use of big data and HTA platforms for public interest, and developing a new value-based HTA system.
Adenosine-5'-(N-ethylcarboxamide)
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Administrative Personnel
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Biomedical Technology
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Decision Making
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Delivery of Health Care
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Evidence-Based Practice
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Glucosamine
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Humans
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Insurance
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Korea
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Osteoarthritis
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Policy Making
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Social Environment
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Technology Assessment, Biomedical
9.Advanced medical devices and regulatory innovations in new health technology assessments
Journal of the Korean Medical Association 2018;61(12):702-705
Advances in technology lead to advances in medical devices, and these advances have the positive effect of creating opportunities for beneficial developments in healthcare, such as innovating traditional healthcare processes or expanding opportunities for diagnosing and treating diseases. Nonetheless, device developers, suppliers, users, insurers, and patients all face the challenge of balancing patient safety and health effectiveness with a reasonable profit. In Korea, the New Health Technology Assessment system aims to introduce safe and effective health technology, but this is only effective for the entry of devices onto the healthcare market. This system is not enough for creating a healthy ecosystem in which high-quality technologies and devices survive in the market and naturally exit from the market if not successful. The nation must not lag in the rapid development of medical devices, but the concomitant requirement for patient safety is like two rabbits moving in different directions. There is not enough time to resolve each source of uncertainty for both developers and users. The early adoption of health technologies, including medical devices, offers new opportunities for treatment and diagnosis, but also poses unexpected health risks. Thus, we need to design a plan to generate scientific evidence related to medical devices after they introduced into practice. Additionally, regarding the use of individual medical devices, we believe that the creation of a healthy ecosystem for medical devices by implementing medical device surveillance culture is a way to manage the opportunities and risks of the early introduction of innovative medical devices.
Biomedical Technology
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Delivery of Health Care
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Diagnosis
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Ecosystem
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Health Care Sector
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Humans
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Insurance Carriers
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Korea
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Patient Safety
;
Rabbits
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Technology Assessment, Biomedical
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Uncertainty
10.Value-Based Health Technology Assessment and Health Informatics.
Healthcare Informatics Research 2017;23(3):139-140
No abstract available.
Biomedical Technology*
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Informatics*
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Technology Assessment, Biomedical*


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