Primary economic evaluations are needed in the case that the systematic review of existing economic evidence is not capable of informing economic profiles of marketed medicines. Following the first section of this programs, we presented the principles of designing a study, measuring costs and outcomes, and performing sensitivity analyses. Generally, four designs of economic evaluations are available to perform economic evaluations, each of which has specific strengths and weaknesses. Valuation of outcomes and costs may differ in methods, mainly based on the requirements and applicability of study. The possible factors leading to variation of results should be analyzed using analytic methods with different techniques.
When prioritizing clinical questions in the development of the clinical practice guidelines, clinical questions with high recognition and low variability, or high score and less disagreement among experts were often prioritized, while questions with high recognition but high variability were excluded. By this approach, clinical questions with practical value but also showed high variability due to different causes were not accepted as priorities. There were some methodological and clinical limitations by doing so. By summarizing the causes and connotations of expert opinion variability in terms of clinical experience, expertise and values, this paper analyzed the advantages of the variability quantification application, and proposed corresponding methodological recommendations, so as to provide references for guideline developers in the priority selection of clinical questions.
In the process of formation of recommendations of clinical practice guidelines, experts have many difficult problems of lack of transparency and high subjectivity in making final decisions, such as incomplete comprehensive consideration of dimensions and great heterogeneity in the evaluation of importance between dimensions, etc. As a decision-making tool, multi-criterion decision analysis improves the decision-making level of recommendation by adding the combination of qualitative and quantitative methods. By analyzing the challenges facing the formation of recommendations, this paper introduces the decision assistance of multi-criterion decision, and analyzes and summarizes the advantages and methods of the application of multi-criterion decision, so as to provide reference and guidance for guide makers to solve the difficulties in the formation of recommendations.
Since the concept of core outcome set (COS) was introduced into clinical trials of traditional Chinese medicine (TCM), researchers have paid much more attention to develop COS for specific diseases. Although researchers believe that the characteristics of TCM, such as syndromes, should be considered in the COS of TCM, it was insufficiently addressed. In addition, the naming of TCM syndromes has not been standardized, and the classification and diagnostic criteria for specific diseases have been inconsistent. Thus, it is difficult to include TCM syndromes in the COS. Different diseases may show similar TCM syndromes which makes research difficult. Based on previous studies, this paper provided methods of developing core TCM syndromes set according to the model of combination of disease and syndrome and the model of syndrome dominating disease to provide references for future researches.
ObjectiveTo evaluate the methodological quality of cross-sectional surveys about Chinese medicine syndrome in a population at potential risk of cerebrovascular diseases. Methods The CNKI, WanFang Data, CBM and PubMed databases were electronically searched to collect cross-sectional surveys about Chinese medicine syndromes in a population at potential risk of cerebrovascular diseases from inception to December, 2022. The methodological quality was assessed using the JBI scale. Results A total of 105 studies were included. The average reporting rate of JBI was 52.06%, and the items with the highest scores included "sufficient coverage of the identified sample in data analysis" (100%), "description of study subjects and setting" (92.38%), and "using valid methods for the identification of the condition" (86.67%). Items with the lowest scores included "adequate sample size" (13.33%), "adequate response rate or low response rate managed appropriately" (14.29%), and "study participants recruited in an appropriate way" (20.95%). Subgroup analysis suggested that type of publication and number of implementation centers were potential factors influencing methodology quality (P<0.05). Conclusion The methods essential to a cross-sectional survey such as sampling, sample size calculation and handling with the response rate, and the syndrome diagnosis scales specific to Chinese medicine require further improvement.
World Federation of Acupuncture-Moxibustion Societies (WFAS) standard Norms for Formulation and Evaluation of the Clinical Practice Guidelines of Acupuncture and Moxibustion (Hereinafter referred to as Norms) is the first methodological specification for the development of guidelines of acupuncture and moxibustion (Acup-Mox) issued by an international academic organization. The Norms stipulates the principles, procedures, review process and requirements of the development of WFAS guidelines of Acup-Mox. It also proposes the development method, evaluation method, and reporting standards of WFAS guidelines of Acup-Mox. This article introduces the development process of the Norms and provides an interpretation of the methodological supplementary requirements for key links such as "formulation of clinical questions", "evidence retrieval, evaluation and synthesis", and "consensus decision-making", as well as the "framework and contents of recommendation" to provide relevant references for users in learning and using the Guidelines.
Health technological innovation has helped to improve health care delivery and patient outcomes. However, the proliferation of health care technology has accompanied burgeoning health care costs and evoked social, ethical, legal, and political concerns. Health technology assessment (HTA) is the systematic evaluation of properties, effects and/or other impacts of health care technology. The main purpose of HTA is to inform persons of technology-related policy making in health care. There is great variation in the scope, selection of methods and level of detail in the practice of HTA. This paper will introduce the basic concepts and methods of HTA in order to help those who are interested in conducting HTA.
Rapid, living evidence-based points, as a new model promoting the rapid translation of evidence, aim to integrate the current best evidence, clinical status, public/patient preferences and values, and provide concise and practical guidance rapidly to important questions concerned in clinical medicine and public health. This paper introduces the methodological framework for the development of "Rapid, Living Evidence-Based Points" from 4 aspects: initiation and planning, evidence search and review, development, update, publication and dissemination of evidence-based points, in order to provide a reference for domestic scholars in developing rapid, living evidence-based points.
This article introduces development methods and notices about evidence-based clinical practice guidelines of ventilator-associated pneumonia (VAP) and discuss the similarities and differences between GRADE system and the methodological studies of other clinical guidelines, focusing on the analysis of literature retrieval, quality of evidence, formation of recommendation strength, and detailed measures on how to ensure correct understanding and rationally using the GRADE system. Applying the GRADE system to develop evidence-based clinical practice guidelines of VAP could clearly present the quality of evidence and make recommendations.
ObjectiveTo evaluate the developing methodologies of Essential Medicines Lists for Children (EMLcs) in global, in order to provide reference in developing EMLc of China. MethodsWe searched ProQuest, ScienceDirect, SpringerLink and MEDLINE databases, World Health Organization (WHO) official website, and 67 websites of National Ministry of Health and Drug Administration Section, to collect literature about selection methodology of children and/or adult essential medicines list (EML). A descriptive analysis was conducted. ResultsA total of fourteen literatures were included. Of which, 6 were about the essential medicines selection methodology in children, and the other 8 were about the essential medicines selection methodology in adult. The WHO had established independent EMLc selection committee. Paediatricians were involved in the selection of EMLc in the WHO and India. There was no selection criteria and process for EMLc globally. The WHO, India, and South Africa selected their EMLcs referring to the WHO EML selection criteria. The WHO and South Africa had their own updating time, period and process for EMLc. The WHO EMLc was updated per 2 years, which in high frequency and conducts in rigorous process. However, the EMLc of India had not been updated yet. ConclusionIt is suggested that China could build a national EMLc selection committee involving paediatricians and evidence-based medicine experts etc. in referring to the framework of the WHO Child Health Working Group. The EMLc selection criteria and process of China could be established referring to the one of the WHO, based on the disease burden, drug accessibility and medical insurance of children of China. The EMLc of China should be simultaneously updated with the adult EML of China.