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.
In the process of guideline development and construction of clinical questions, it is necessary to guide clinicians to propose clinical problems into PICO (population, intervention, control, outcome) structured clinical questions. However, there are still unclear criteria to define and judge the appropriateness of the width of the PICO elements of a clinical question. Either too wide or too narrow can make the PICO question unsuitable to be a question for clinical practice guidelines to answer. We graded the clinical questions to be eight grades (3, 2, 1, 0, −1, −2, −3, mixed) according to the number of the PIC elements, which obviously needed to be adjusted to evaluate applicability of the appropriateness of the width of the clinical questions. Our work can provide methodological references for clinicians and guideline developers.
Objective To observe and describe anatomical types of the pulmonary arteries to keep safety of lung resection. Methods Between November 25, 2005 and January 22, 2013, 194 patients who underwent right upper lobectomy/sleeve lobectomy or combined lung resection including right upper lobectomy were included in Peking University Cancer Hospital. There were 128 males with a median age of 59 (37-86) years and 66 females with a median age of 60 (42-77) years. We separated the pulmonary arteries and recorded the number and positions of them. Some patients were recorded photographically. Results There were 10 types of right upper lobe pulmonary artery branches in this study. Type 1: 1 apicoanterior segmental artery, 1 ascending segmental artery, 96 patients (49.5%); Type 2: 1 apicoanterior segmental artery, 2 ascending segmental arteries, 48 patients (24.7%); Type 3: 2 apicoanterior segmental arteries, 1 ascending segmental artery, 28 patients (14.4%); Type 4: 2 apicoanterior segmental arteries, 2 ascending segmental arteries, 9 patients (4.6%); Type 5: 1 apicoanterior segmental artery only, 6 patients (3.1%); Type 6: 1 apicoanterior segmental artery, 3 ascending segmental arteries, 3 patients (1.5%); Type 7: 4 apicoanterior segmental arteries, 1 ascending segmental artery, 1 patient (0.5%); Type 8: 3 apicoanterior segmental arteries, 1 ascending segmental artery, 1 patient (0.5%); Type 9: 2 apicoanterior segmental arteries, 1 patient (0.5%); Type 10: 3 apicoanterior segmental arteries, 2 ascending segmental arteries, 1 patient (0.5%). Conclusion The types of pulmonary artery branches are predictable in some way. It would be helpful to reduce the risk of pulmonary artery injury and improve the operation safety by following the rules. Variations of pulmonary artery should be noticed to avoid the major bleeding due to the pulmonary artery injury.
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.
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.
ObjectiveThe application of the coefficient of variation (CV) in the development of clinical practice guidelines is limited to evaluating the consistency of the consensus panel in clinical questions rating, and the application of variability was limited. This study presents the application and results of variability evaluation in the development of guidelines. MethodsWe conducted a large-scale clinical survey through questionnaire survey, and conducted two rounds of questionnaire survey and face-to-face consensus meeting for the consensus group. Means and CV were calculated for clinical questions and outcome importance ratings. We performed the summary and analysis by SPSS and Microsoft Excel. ResultsA total of 356 clinical survey questionnaires and two rounds survey in consensus panel were collected. We found that in the clinical survey and the first-round of the consensus panel, the CV was greater than 25% for all clinical questions regardless of the overall importance score. In the consensus panel, the results of the second-round were greatly changed. On the one hand, compared with the first-round, the CV of almost all clinical questions was smaller in the second-round, and the CV of high-priority clinical questions was less than 25%, while the clinical questions with a CV greater than 25% were of low-priority. In view of the CV of outcome importance, the clinical survey was similar to the results of the first-round of consensus panel. The CV of very important outcomes was less than 30%. In the second-round of consensus panel, the variability of very important outcomes was less than 20%. The higher the importance level of the outcome was, the smaller the CV was. ConclusionThe study of variability evaluation has practical methodological value, which can assist clinical questions and outcomes priority selection, and help to fully consider the influence of different factors and values, and develop high-quality guidelines.
By employing the nominal group technique, as per the process standard of the EQUATOR Collaboration Network, experts were selected through purposeful sampling. Two rounds of nominal group discussions were conducted, and the essential information of the utilization of the consensus method was extracted from the literature. After comparison, discussion, evaluation, and optimization, a list of 3 fields, 11 themes, 63 necessary items, and 28 supplementary items was eventually constructed to upgrade the standardization and rigor of the application of the consensus method in the future, assisting guideline developers to plan the consensus process.
After the completion of a clinical trial, its conclusion generally depends on the results of statistical analysis of the main outcome, that is, whether the P-value in the hypothesis test is less than the α level of the hypothesis test, usually α=0.05. The size of the P-value indicates the sufficient degree of reason for making the hypothesis judgment, and can be interpreted as to determine whether a conclusion is statistically significant but does not involve the difference in the degree of drug effects or other effects. Fragility index, which is, the minimum number of patients required to change the occurrence of a target outcome event to a non-target outcome event from a statistically significant outcome to a non-significant outcome, can be used to assist in understanding of clinical trial statistical inference results and assisting in clinical decision making This paper discusses the concept, calculation method and clinical application of the fragility index, and recommends that the fragility index be routinely reported in all future randomized controlled trials to help patient clinicians and policymakers make appropriate and optimal decisions.