Application Of Real World Research Methods In Clinical Evaluation Of Fu's Subcutaneous Needling

ObjectiveBy the methodological exploration and application example to try How to use real world clinical data to establish a system for clinical efficacy evaluation of acupuncture and moxibustion;Secondly,by summarizing the problems and experiences in the application example to provide reliable suggestions for more real-world researches of acupuncture and moxibustion in the future.Methods1 Methodological framework for establishing acupuncture clinical efficacy evaluation system based on real-world dataThrough the review and summary of the previous literature,this paper is based on the guidance books of real world studies,such as ?The Guide to Real World Research?,?Registries for Evaluating Patient Outcome : A User's Guide ?,and combined with thecharacteristics of clinical research on acupuncture and moxibustion and the requirements of ? Management Standard of Clinical Research on Acupuncture and Moxibustion.Therefore,exploring a set of methodological framework for clinical evaluation of acupuncture based on real-world clinical data.2 An application example—Standardization and efficacy evaluation of Fu's Subcutaneous Needling(FSN)for Knee Osseous Arthrophlogosis(KOA)The methodological framework was practiced and validated by FSN treatment of degenerative Knee Osseous Arthrophlogosis.Systematic specification of a variety of information data during the collection of FSN by establishing a patient registry platform of FSN for Knee Osseous Arthrophlogosis,including basic information of patients,medical information of patients,treatment information of FSN,basic information of doctors,efficacy evaluation information,follow-up information and security information,and using the principle of statistics and data mining to achieve the following three research objectives:(1)To evaluate the clinical effect of FSN on Knee Osseous Arthrophlogosis,and provide a basis for further clinical research;(2)In the course of the study,the clinical operation and treatment plan of FSN werestandardized,which provided the basis for further multi-center validation studies;(3)To analyze the influencing factors affecting the treatment of Knee Osseous Arthrophlogosis by FSN,and provide reference for further designing a confirmatory study in line with FSN.Result1 Establishing a methodology framework for clinical evaluation of acupuncture based on real-world dataTo establishing a methodology framework for clinical evaluation of acupuncture based on real-world clinical data by designing of the four stages of research initiation,research preparation,research implementation and research summary.(1)Research initiation:To clarified the value of the research by the collating and analysing results of previous research;To summarize the shortcomings existing under current conditions by using the PRECIS model to evaluating the current situation of the research problem,so helping researchers to clarify research goals.(2)Research preparation:Establishing research teams and identifying their research tasks;Key elements such as design type,design elements,research scale and research time are defined according to research objectives,and the real world clinical study program is designed according to the characteristics of thetherapy;Establishing an electronic patient registry platform based on the research protocol;Clinical trial registers and ethical review.(3)Research implementation:Recruiting research centers and research physicians;Trainning research physician;Recruiting patients;Performing clinical treatment and recording data;Data management and quality control.(4)Research summary:According to research objectives,appropriate data processing method is used for analysis and processing;Specific suggestions for further clinical design are proposed based on the research conclusions;2 Standardization and efficacy evaluation of FSN for KOA in real worldA total of 25 physicians of FSN were enrolled in the study,and227 patients with Knee Osseous Arthrophlogosis treated with FSN therapy were eventually included.(1)Descriptive analysis:(1)Basic demographic information of patients:Among the 227 patients,37.4% were male and 62.6% were female,with an average age of 56.39±8.46 years,the proportion of Han nationality is 97.4%,the proportion of patients with bachelor degree or above is 40.8%,the proportion of manual workers is 37.0%,and the proportion of non-manual workers is 25.6%;(2)Patient symptominformation:The proportion of patients with unilateral knee joint was 74.9%,and the average disease duration was 44.53 ± 18.81 months,the mainly natures of pain were swelling pain and soreness.77.1% of patients were aggravated by rainy days,and 83.3% of patients were aggravated by cold days.74.4% and 79.7% of patients had difficulty with up and down stairs,and 25.6% had other joint pain.(3)Patient physical examination information:The average height of the patient was 1.61±0.46 m,the weight was 55.17±22.66 kg,the BMI was 23.01±5.74 kg/m2,51.1% of patients with knee joint next crouching amplitude is less than 30°,68.3% of patients were accompanied by joint bouncing,all patients had tight muscles around the knee joint.(4)Patient past history information:71.4% of the patients had previous treatment,of which 26.9% had consciously relieved symptoms,31.7% had a previous medical history,7.0% had a history of trauma,and no patients had a history of surgery.(5)Basic demographic information of physicians:The proportion of male clinicians participating in the study was 76%,the proportion of females was 24%,the average age was 36.45±11.28 years,the average duration of practice was 15.33±7.28 years,the proportion of physicians with senior professional was 40%,and the average learning time of FSN was 9.35± 5.37 years.(2)Efficacy and safety evaluation of FSN for KOA:The VAS scoreof the patient before treatment was 5.81±2.27,and decreased to2.13 ± 1.57 after the third treatment.The difference was statistically significant before and after treatment.The Lysholm score of the patient before treatment was 62.77±10.31,and the functional score after treatment for 3 times was 83.12±12.33 points.The difference was statistically significant before and after treatment.According to the curative effect evaluation criteria set by the study,there were 155 effective patients after3 treatments,and the effective rate was 68.3%.During the whole treatment process,31 possible needle-related adverse events occurred,among which bleeding and subcutaneous hematoma were the most common.The average Lysholm knee function score of 65 patients at 1 month after treatment was 69.47± 12.79.(3)Standardized study of treatment regimens of FSN for KOA:The commonly used position of floating needle are supine position and prone position,the angle of the knee joint is usually placed horizontally,the average number of affected muscles at each treatment was 5.35 ± 2.33,more than 10 kinds of muscles involved,commonly used muscles include the rectus femoris,the lateral femoral muscles,the medial femoral muscles,the tibialis anterior muscle,the soleus muscle and the gastrocnemius,the sweep frequency of FSN is usually 40-60 times/min,the average sweep timeof each muscle is 2.57±1.55 min,the retention time is mainly concentrated in 4-6 hours.(4)Analysis of factors influencing therapeutic effect of FSN:Through a comprehensive analysis of clinical data,the length of time for physicians to FSN(OR=1.092,95%CI 1.043 to 1.165;P=0.003),BMI index(OR=0.912,95% CI 0.823 to 1.00;P=0.039),stinging(OR=0.533,95% CI 0.325 to 0.813;P=0.01),baseline Lysholm score(OR=1.311,95% CI 1.086)To 1.581;P=0.004),whether the patient has been traumatized in the past(OR=0.362,95% CI 0.224 to 0.737;P=0.000)may be factors that influence the treatment of Knee Osseous Arthrophlogosis by FSN in real world.Research conclusion1 Based on real-world clinical data to establish a clinical evaluation system for acupuncture,it is feasible to use real-world research evidence as a basis for further verification of the clinical efficacy of acupuncture.2 The real world research of acupuncture needs to be standardized design from the four stages of research preparation,research design,research implementation,and research summary.The design principles must conform to the clinical characteristics of acupuncture and the general pattern of case registration research.3 The results of the study on the registration of patients withKOA treated with FSN:(1)The clinical practice of FSN for the treatment of KOA is better,the treatment of pain and knee joint function can be improved by 3 times or more,and the safety is high.The follow-up results of some patients suggest that the effect may last for about 1 month after the end of treatment;(2)According to the summary of the clinical practice of FSN in the real world,researchers can refer to the following contents when formulating FSN treatment plan:During FSN treatment,the patient's position is supine and prone,and the knee joint is placed horizontally.The rectus femoris,lateral femoral muscle,medial femoral muscle,tibialis anterior muscle,soleus muscle and gastrocnemius muscle can be selected as the target of treatment,the sweep time of each muscle is 2-3 minutes,the sweep frequency is 40-60 beats / min,and the tube can be left for 4-6 hours after the FSN treatment is over.(4)According to the result of factor analysis,when the researchers further design randomized controlled study should choose clinical application of FSN for a long time,and be attention to the balance of the patient's BMI index,the proportion of stinging patients,and the baseline Lysholm score between the groups.Patients with previous definite knee trauma should be excluded from the study.4 The design of real-world clinical research on acupuncture andmoxibustion needs to be combined with the characteristics of each therapy,so it is necessary to make appropriate improvements and supplements under the current methodological framework.