| Objective:Under the guidance of the construction method of the medical research report specification,and based on literature research,questionnaire survey and expert consultation,the preliminary draft of the research report specification conforming to the characteristics of the acupuncture animal experiment literature was established,which laid the foundation for the later research.Methods:Through the literature review method,literature analysis,expert consulting method,questionnaire survey method and scale method,summarizes the existing animal experiment report specification guide or the list of entries,combined with acupuncture experimental animal structure characteristic,content,characteristics and existing problems,through expert consultation and two rounds of questionnaire survey,it is concluded that acupuncture animal experiment report specification list the specific items.According to the previous report standard,the final report standard list of needling animal experiment was developed.All statistics were analyzed online by SPSS.Use the mean to judge the degree of concentration of expert opinions;The coefficient of variation(CV)of indicators was used to judge the coordination degree of indicators,and the items whose CV<0.25 were retained.The consistency of the questionnaire results is judged by Kendall’s concordance coefficient which ranges from 0 to 1 and generally fluctuates in the range of 0-0.5.The closer it is to 1,the better the degree of coordination is.The reliability of the questionnaire results was judged by Cronbach’s alpha.The closer to 1,the higher the reliability of the questionnaire results.Results:In study 1 and study 2,a preliminary entry pool was obtained through literature analysis,questionnaire survey and expert consultation.The results of the questionnaire have high reliability and high consistency of expert opinions.The items with coefficient of variation ≥0.25 are removed and the items suggested by experts are added.The resulting specific item pool is:Research background,research purpose,the use of animals in the experiments and the total number of animals in each group,experimental animals,animal genetic or specific information of genetic information,animal production license,follow the principle of the care,animals,discharge standard,model selection basis,details,experimental apparatus and reagents,the control group set up reasonable,building details and building success criteria,method of randomization,blinding,experiment steps,acupuncture treatment way of reason,the types of therapy,acupuncture,acupoint names,meridian necessary value,including acupuncture technique,parameters,the body’s reaction,the types of needles,retaining needle time,frequency of treatment,control group intervention measures,the main monitoring indicators,all results measure,charts,since the Ming,statistical method and detail,result analysis,the basic principle of the experiment,fund investors to help,a total of 40.The results of the second round of questionnaires have high credibility,high consistency and high concentration of expert opinions.The items with coefficient of variation ≥0.25 were removed,and the same batch of acupuncture animal experimental reports were evaluated with the lists before and after elimination.The results showed that the evaluation result was better after elimination,and the excluded items were not applicable to the standard of acupuncture animal experimental report.The items excluded include: detailed description of observation indicators,detailed technical methods,essential value of acupoints,correlation between animal models and human biology,operation site,experimental accidents and treatment methods,and experimental principles.The remaining items were retained and sorted into the final specification list.Finally,the following items were included in the draft of the report standard for needling animal experiments: scientific and systematic research hypothesis;Clear research objectives;Models of main laboratory reagents and equipment;The number of the organization and permission scheme for ethical examination and approval;Principles of care followed;Details of experimental animals;The number of animal production license;Animal health/immune status,gene modification status,etc;Feeding environment(temperature,humidity,lighting,food,drinking water,etc.);Sample size;Recognized basis for modeling;Modeling steps(anesthesia method,animal position,operation method);Judgment criteria for mold success;Inclusion and exclusion criteria and circumstances of animals;Experimental grouping;Random method and specific operation;Blind method and specific operation;Acupoint name;Acupoint positioning or positioning basis;Needle type;Insertion depth,Angle and technique;Electroacupuncture parameters(intensity,frequency,waveform,etc);Control group intervention measures;Operation time(start time of intervention,retention time,frequency,etc);Main outcome measures;Outcome index detection method;Statistical software and statistical methods;Statistical data expression form(median,standard deviation,etc.);A statistically significant standard;Summary/descriptive statistics of data for each experimental group;Confidence interval;Self-clarity of charts and images;Interpretation of results;The value of experimental data to clinical and other studies;Limitations of the experiment,a total of 35.Conclusion:1.It is necessary and feasible to develop the report standard of needling animal experiment.2.There were 35 items included in the report specifications for needling animal experiments,which were verified by literature and showed good performance.3.This study put forward specific requirements for the experimental design,transparency of operation,data availability and repeatability of experiments on needling animals,and provided a basis for improving the quality of experimental research on needling animals. |