There are several main obstacles to structure clinical questions in the process of developing evidence-based clinical practice guidelines, such as clinicians have misconceptions about clinical question structure, and clinical questions do not fit clinical practice. These obstacles results in the incomplete structure and not standardized expression of the clinical questions, and reduce the quality and applicability of guidelines. To overcome these obstacles, this article introduced the application and specific details of clinical question framing and expression with practical examples, to assist clinicians in understanding clinical questions and to provide methodological references for clinical question formulation in the guidelines.
ObjectiveTo explore the parameter selection of different sample size estimation methods and the differences in estimation results in single-group target value clinical trials with rate as the outcome evaluation index. MethodsWe conducted a literature review to assess the method of target value selection for single-group target value clinical trials. Then, different values of target value (P0), clinical expected value (P1), and class II error level (β) were set through numerical simulation. Sample size results estimated using different sample size estimation methods were obtained using PASS software. The coefficient of variation, range/mean, analysis of variance and other methods were used to compare the differences between different methods. ResultsAnalysis of the data simulation results showed: when the expected value P1 was fixed, the sample size first decreased rapidly and then decreased slowly along with the increase or decrease of the targeted value P0 on both sides of the sample size limit value. When the difference between P0 and P1 was within 0.15, the ratio before and after correction could be controlled within 0.9. When the difference between P0 and P1 was more than 0.6, the ratio before and after correction approached 0.5. When P0+P1≈1, the ratio of different standard error choices (Sp0 or Sp1) to the estimated sample size was close to 1. When 0.65<P0+P1<1.35, the ratio of different standard error choices (Sp0 or Sp1) to the estimated sample size was about 3:1. When the confidence was 0.8, P0 and P1 were between 0.25 and 0.75 and between 0.20 and 0.80, respectively. We found little difference among the sample sizes estimated using these five methods (CV<0.10, range/mean<0.2). ConclusionThere are some differences among different sample size estimation methods, however, when P0 and P1 values are around 0.5, the differences between different methods are small, suggesting that appropriate methods should be selected for sample size estimation.
Objective To systematically review the requirements of patient participation in clinical practice guidelines (CPGs) in Chinese and foreign guideline development manuals. Methods Thirty-six authoritative society websites and guideline databases and 5 commonly used databases were searched online. Relevant information on patients’ participation in the guideline manuals was collected, summarized, and analyzed. Results A total of 37 manuals (33 foreign and 4 Chinese) were included. The requirements for the number of patients, the right to speak, status equality, and the right to vote in the guideline development manual accounted for 35.1%, 13.5%, 8.1%, and 5.4%, respectively. The requirements for participants’ mode of participation were not mentioned in the guideline development manuals from 2000 to 2010. There were 6 (16.2%) in 2011–2015 and 12 (32.4%) in 2016–2022. The comprehensive guidelines for multiple disease types accounted for 35.7%, 28.6%, and 57.1%, respectively, in terms of requirements for participants’ knowledge or experience, management of specialized personnel, and training support. The specific guidelines for a certain type of disease or drug accounted for 21.7%, 4.3%, and 17.4%, respectively; fifteen (40.5%) guideline development manuals mentioned the specific collection forms of patients’ values and preferences in guideline development. Conclusion Given changes to medical models and the emphasis on patients’ rights and interests, an increasing number of manuals have proposed requirements that consider the expression of patients’ values and preferences in manual development, and the dimensions of manual development are constantly enriched. However, manuals outlining the requirements of patient participation are still not comprehensive and can continue to improve.
In the formulation of the clinical question of traditional Chinese medicine clinical practice guidelines, even if the intervention elements (intervention or control) have an appropriate scope, guideline developers are still faced with a variety of interventions. By analyzing the difficulty and necessity of priority selection of intervention interventions, we propose the approach of extending expert evidence to the process of priority selection of intervention interventions, and further provide the methodology of expert evidence data collection table design, application, data presentation and expert decision-making method to provide references and guidance for guideline developers.
Clinical practice guidelines will be incorporated in different evidence sources and evidence types, the research and exploration of multiple sources of evidence at China and foreign, this paper advocates the construction of both characteristics of multi-source evidence of traditional Chinese medicine, by combing 70 guide manuals, analyze the necessity and advantages of multi-source evidence construction, and further from the multi-source evidence source and evidence logic theory interpretation and application, in order to provide methodological references for the formulation of evidence-based clinical practice guidelines of traditional Chinese medicine.
Currently, the recommendations of the clinical practice guidelines related to acupuncture in China and abroad are opaque to the source of the acupuncture prescription, there is a lack of comprehensive evaluation of the rationality of the acupuncture prescription, and the standards for the selection of the acupuncture prescription are opaque and nonstandard, and the writing and reporting details are insufficient, thus affecting the clinical applicability of the guidelines. To a certain extent, the utilization rate of the recommendations of the guidelines is low. This paper discusses the origin, rationality comprehensive evaluation, priority selection, writing and reporting of acupuncture prescriptions, and puts forward detailed methodological suggestions, to provide guidance makers of methodological optimization thoughts and suggestions for the evaluation, selection and writing of acupuncture prescriptions in the recommendations.
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.
In the process of formulation, traditional Chinese medicine clinical practice guidelines are often faced with the dilemma of lack of evidence. Guidelines development groups tend to make final decisions based on expert experience or expert opinion, but the limitations of cognitive bias reduce the credibility and transparency of the guidelines. By clarifying the difference between the expert experience and expert opinion and expert evidence, the expert evidence of traditional Chinese medicine discipline advantages and necessity, providing the recommendation form link using expert evidence methodology design and implementation details, retaining the empirical characteristics of traditional Chinese medicine and improving the lack of evidence, has certain practical application value.