Objective A set of core index sets applicable to the treatment of ischemic stroke (IS) by traditional Chinese medicine (TCM) has been constructed to IS as a basis for final determination of core index sets. Methods The exploratory sequence design of mixed methods research (MMR) was used to conduct qualitative research first and quantitative research, and the research model of quantitative research was determined based on the qualitative research results. In the qualitative research stage, focus groups composed of TCM encephalopathy and neurology experts, core indicator set methodology experts, clinical pharmacists of encephalopathy and researchers with more than 10 years of experience were selected by purpose sampling method, and focus group meetings were held around the theme of "indicator domain, indicator hierarchy and indicator attribution". Based on the discussion results, the meeting further designed the quantitative research questionnaire. A questionnaire survey was conducted among medical professionals with TCM background nationwide from September 11 to October 11, 2023, using convenient sampling method. Results In the qualitative research stage, 11 categories of IS index domain were successfully divided, including functional impairment evaluation, imaging index, daily living ability evaluation, TCM therapeutic characteristic index and TCM intervention advantage index. In the quantitative research part, 50 valid questionnaires were collected from 23 hospitals in 13 provinces, with a recovery rate of 76.92%. The recovery rate of the second round was 100%. In the end, the initial list of IS indicators in different stages of disease course was developed. The acute stage included 43 second-level evaluation indexes, 8 third-level evaluation indexes and 87 fourth-level evaluation indexes under 8 index domains. The recovery period includes 45 second-level evaluation indexes, 8 third-level evaluation indexes and 72 fourth-level evaluation indexes under 10 index domains. The sequelae stage included 33 second-level evaluation indicators, 8 third-level evaluation indicators and 70 fourth-level evaluation indicators in 9 indicator domains. Conclusion Based on the exploratory sequence design of MMR, this study successfully divide the index domain that IS scientific, in line with the characteristics of the disease and can reflect the characteristics of the intervention effect of TCM, ensuring the scientific and applicability of the initial IS index list, and laying a solid foundation for the construction of a comprehensive, objective and practical core index set.
Objective The core indicator pool of ischemic stroke (IS) was constructed to provide a basis for the establishment of the core outcome set (COS), so as to improve the consistency of clinical research and evaluation results of traditional Chinese medicine (TCM) treatment for IS. Methods In this study, the mixed methods research (MMR) convergent parallel design was used to carry out qualitative research and quantitative research at the same time, and the two research results were integrated to reach a conclusion. Quantitative research comprehensively collected the multi-source efficacy evaluation indicators of TCM treatment of IS, and carried out descriptive statistical analysis based on frequency theory. Semi-structured interviews were used in the qualitative research, relevant interest groups were selected to understand the evaluation indicators of the IS efficacy of TCM treatment that they were concerned about, and NVivo software was used for in-depth analysis, coding, classification, and extraction of the efficacy indicators. Based on the principle of pillar integration, quantitative and qualitative research results were integrated to construct an element pool of evaluation indicators for the treatment of IS with traditional Chinese medicine. Results A total of 437 standard papers, 71 registered trial protocols, 100 real-world medical data cases and several guideline consensus policy documents were included in the quantitative study, and a total of 314 indicators in the acute phase of IS, 154 indicators in the recovery phase, and 104 indicators in the sequelae phase were extracted. In the qualitative research part, a total of 32 indicators in the acute stage of IS, 34 indicators in the recovery stage and 35 indicators in the sequelae stage were extracted through interviews. Through group discussion and the principle of pillar integration, an element pool of IS indicators was formed, including 279 IS indicators in the acute stage, 142 indicators in the recovery stage and 91 indicators in the sequelae stage. Conclusion Based on the MMR convergent parallel design, the element pool of the characteristic indicators of the therapeutic effect of IS in TCM is constructed to meet the needs, which provides the preliminary work basis for the construction of the core outcome set of IS in the next stage.
The post-marketing clinical safety re-evaluation studies of traditional Chinese medicine injections have obtained safety evidence of various research types such as active monitoring, passive monitoring and literature review. However, there is a lack of comprehensive evaluation methods that can effectively integrate the data of the above research types. So far, it is impossible to further produce more comprehensive and objective high-level evidence-based evidence, which seriously affects the supervision and management of traditional Chinese medicine injections and clinical rational use. The key to establishment of a comprehensive evaluation method is to first establish a comprehensive evaluation of the core indicators of the preferred method, the formation of weighted quantitative scoring model applied to the comprehensive evaluation method. Mixed methods research (MMR) can effectively and deeply integrate different types of research data and scientifically and normatively complete the screening of indicators in the evaluation model through repeated quantitative and qualitative research on data. Secondly, for the most critical index weighting and weight adjustment research in the model construction research, the author innovatively combines the analytic hierarchy process with the invariant weight sub-constraint method, and introduces the quantitative research part of the MMR design. It ensures the accurate weighting of indicators in the process of model construction. Therefore, based on the research on the core outcome set proposed for the core outcome outcomes of the effectiveness test, this paper proposes the use of MMR to carry out index screening and weight adjustment research based on multi-source complex data, and to construct a comprehensive evaluation model of post-marketing clinical safety of traditional Chinese medicine injections that integrates different research types of data. It provides measurement tools and new methods for the comprehensive evaluation of post-marketing clinical safety of traditional Chinese medicine injections.
Objective To establish a modeling method for an animal model simulating the decline of digestive function after a large amount of tissue necrosis of the pancreas due to acute injury after severe acute pancreatitis (SAP). Methods Twenty male SD rats were randomly divided into the model group and the sham operation group according to the random number table method, with 10 rats in each group. First, the SAP model was established by retrograde bile duct injection of sodium taurocholate in the model group, whereas the sham operation group received physiological saline injection. Fluid infusion began 2 hours later, twice a day, with an 8-hour interval, for 2 days. The traditional Chinese medicine Dachengqi Decoction without Decoction Granules was formulated into a suspension in proportion and administered by gavage once at 18 hours and once at 24 hours after the operation to ensure the blood volume of rats and reduce inflammatory damage. Normal drinking water was allowed 48 hours after modeling. After 72 hours, ordinary feed was given for feeding. The feeding lasted for 14 days (the total duration of the experiment was 17 days). The body weight, vitality status and stool characteristics of the rats were observed and recorded on the day of open feed feeding and 14 days later. Fourteen days after feeding, the animals were sacrificed and samples were collected for examination of blood glucose, fecal elastase and hematoxylin-eosin staining pathological scores. Results All 10 rats in the model group were successfully modeled with a 100% survival rate. The body weight of rats in the model group 14 days after ordinary feeding was lower than that on the day of open diet [(180.80±4.39) vs. (222.90±6.14) g, P<0.001], and lower than that of rats in the sham operation group 14 days later [(180.80±4.39) vs. (221.70±7.45) g, P<0.001]. Compared with the sham operation group, inflammatory cell infiltration injury still existed in the pancreatic tissue of the model group, and some pancreatic tissues showed pathologically related changes of chronic injury. The pathological score of the model group was higher than that of the sham operation group [7.5 (7, 9) vs. 0 (0, 0), P<0.001]; the blood glucose concentration increased [(13.000±1.531) vs. (8.070±0.851) mmol/L, P<0.001]. The secretion of fecal elastase, a metabolite of trypsin in vivo, was significantly decreased [(5.451±0.936) vs. (8.593±1.105) mg/mL, P<0.001]. Conclusion The use of short-term liquid supplementation, traditional Chinese medicine anti-inflammatory treatment, and early dietary stimulation can effectively combat early severe inflammatory damage in SAP, protect the life of model rats, and enable them to survive and experience digestive dysfunction, thus establishing an experimental animal model of digestive dysfunction in the late stage of SAP.