| ObjectiveThis study analyzed the diagnosis and treatment status of vascular mild cognitive impairment(VaMCI)through retrospective investigation,qualitative interview,questionnaire survey,etc.On this basis,based on the actual problem that VaMCI lacks TCM diagnosis and treatment guidelines,further studied the development of TCM diagnosis and treatment guidelines by using mixed methods.The aim of VaMCI is to provide guidance to clinicians for integrated management and early intervention,so as to improve the quality of life and prolong the survival time of patients.Mehtods1.This study was a cross-sectional investigation.Effective patients admitted to Dongfang Hospital of Beijing University of Chinese Medicine encephalopathy Department from January 2015 to October 2020 for cognitive screening were selected,and the patients were divided into normal cognitive function group(NC group),VaMCI group,and vascular dementia group(VaD group)according to cognitive function.SPSS 26.0 statistical software was used to conduct descriptive statistical analysis based on frequency and rate of statistical data(demographic characteristics,co-morbidity,diagnosis,treatment,etc.),and Chi-square test or single factor ANOVA test was used to compare the differences in cognitive impairment characteristics and risk factors among the three groups.2.Qualitative study:A semi-structured interview was conducted with 3 clinicians,focusing on their understanding of VaMCI,intervention measures and concerned clinical outcome indicators.Colaizzi content analysis is used to extract the topics related to this study.Quantitative research:Through literature pre-search,combined with the results of qualitative research,clinical questionnaire was constructed;A questionnaire survey was conducted among 120 clinicians with different professional titles and working years ≥1 year from 24 cities in China.3.Through literature pre-search and expert interview,questionnaire on clinical problems of TCM Diagnosis and Treatment Guide for Vasogenic mild Cognitive Impairment was designed to construct clinical problems to be solved by this guide.Randomized controlled trials(RCTs)on Chinese patent medicines,classic famous prescriptions,acupuncture and other therapies for VaMCI were systematically searched,and the Cochrane bias risk assessment tool was used to assess the risk of bias of the included literatures,and meta-analysis was performed using RevMan 5.4 software.The GRADE system was used to grade the evidence quality and comprehensively evaluate the evidence-based evidence of TCM therapy for VaMCI.Then,the quality of evidence formed by a clinical problem is combined with the strength of recommendation to form the recommendation opinion.The main steps of qualitative research are:expert interview,clinical investigation,etc.;The main steps of quantitative research are evidence synthesis and evaluation.Results1.A total of 298 patients were screened,including 44 in the NC group,188 in the VaMCI group and 66 in the VaD group.There were significant differences in mean age,education level and marital status among the three groups(P<0.05).In VaMCI patients,visual space and executive function,language function,abstract ability,delayed recall,and orientation were significantly impaired,while in VaD patients,the differences between the two groups and the normal group were statistically significant(P<0.01).The diagnostic rate of VaMCI was 16.0%and that of VaD was 54.5%.All patients were treated with antihypertensive,hypoglycemic and lipid-lowering treatments to control vascular risk factors.Only 8.0%of VaMCI patients received improved cognitive therapy,30.3%VaD received improved cognitive therapy,and 7.6%VaD received improved psychobehavioral symptoms.2.A total of three themes were extracted from the qualitative study,namely,VaMCI should be early intervention,VaMCI currently has no targeted drugs,and the outcome indicators that clinicians pay more attention to are cognitive function and dementia conversion rate.A total of 120 clinicians participated in the questionnaire survey,and the results showed that 77.5%of them believed that the TCM disease name of VaMCI was amnesia.There were many kinds of Chinese patent drugs and TCM decoction used in the clinic.Cognitive function,dementia conversion rate,ability and quality of daily life and TCM efficacy were the most concerned outcome indicators,which were basically consistent with the results of qualitative research.3.Qualitative research:The mixed methods of in-depth interview with experts and questionnaire survey were adopted to study and initially construct clinical problems.Finally,13 clinical problems to be answered in this guide were formed by nominal group method.Quantitative study:132 literatures were finally included,with a total of 9466 subjects,including 4763 subjects in the experimental group and 4703 subjects in the control group.According to meta-analysis,Chinese patent medicine,classic famous prescription,acupuncture,and other TCM therapies alone or combined with Western medicine could improve patients’ cognitive function,improve quality of life,and improve TCM symptoms,and no obvious adverse reactions were observed.The GRADE tool was used to assess the level of evidence,and it was found that the quality of evidence was low.According to the results of quantitative research,the clinical problems constructed by qualitative research were answered,and recommendations were formed through the nominal group method.Conclusions1.Retrospective investigation found that the current diagnosis and treatment rates of VCI patients,especially VaMCI patients,are low,which has not attracted enough attention from clinicians.2.The clinician’s understanding of VaMCI in traditional Chinese medicine is not unified yet,and they hold a positive attitude towards early intervention of VaMCI.However,the current TCM intervention plan has not been unified,and there are many kinds of TCM medicines and TCM decoction involved.It is urgent to formulate TCM diagnosis and treatment plan based on the existing evidence-based evidence to guide the clinical treatment of VaMCI.The study of outcome indicators provides data support for the formulation of TCM diagnosis and treatment guidelines of VaMCI in the next step.3.Classical prescriptions,proprietary Chinese medicines,acupuncture and other TCM therapies are effective in delaying the dementia process of VaMCI and improving cognitive function,TCM symptoms,ability and quality of daily living.The strength of recommendation not only depends on the level of evidence,but also considers the actual clinical situation.Therefore,this guideline still obtains strong recommendations under the condition of low evidence level,providing reference for early intervention of VaMCI.The application of mixed methods to the formulation of TCM clinical practice guidelines,especially the determination of clinical problems and interventions,can make up for the deficiencies of relying solely on quantitative or qualitative research results,and may become one of the main methods for the formulation of guidelines in the future. |
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