Research On Methods And Key Technologies For Registration Of Acupuncture Cases

AimTo introduce the methodology of patient registry into acupuncture-moxibustion filed,explore the main elements of acupuncture-moxibustion patient registry methodology,solve the key technologies for the establishment of acupuncture-moxibustion patient registry platform,and then prove its scientificity and feasibility through the case research,to form acupuncture-moxibustion patient registry system and provide a new method for acupuncture-moxibustion clinical research.Methods1 Methodology exploration-basic elements of acupuncture-moxibustion patient registryThrough literature research,taking the patient registry conducted in the past as an example,based on real world study,comparative effectiveness research,randomized controlled clinical trials,and other methodologies,combined with the development needs of acupuncture-moxibustion,the characteristics of acupuncture-moxibustion diagnosis and treatment,and the work foundation of our team,we explored basic elements of research design,implementation,evaluation,and ethics of acupuncture-moxibustion patient registry.2 Technical support-key technologies for establishing acupuncture-moxibustion patient registry platformCombined with the needs of acupuncture-moxibustion patient registry,a browser/server architecture based on the cloud platform model and Oracle database were used to build acupuncture-moxibustion patient registry platform.We tried to explore the operational mechanisms and key technologies of this platform in accordance with the characteristics of acupuncture-moxibustion clinical practice and patient registry.3 Case study-Factors influencing the effectiveness of acupuncture for chronic low back pain:a patient registry studyBased on acupuncture-moxibustion patient registry platform,we conducted a patient registry to collect the clinical cases of acupuncture for chronic low back pain in real world clinical practice.Basic information of acupuncturists,basic demographic information of patients,basic conditions of back pain,diagnosis,treatment,effectiveness and safety of acupuncture were analyzed.And then we used Logistic regression to explore the key factors affecting the clinical effectiveness of acupuncture for chronic low back pain.Results1 Methodology exploration-basic elements of acupuncture-moxibustion patient registry(1)Design:The acupuncture-moxibustion patient registry is mainly based on the clinical effectiveness evaluation of acupuncture-moxibustion.Through the establishment of a registry team,the protocol of acupuncture-moxibustion patient registry should be clear from the clinical research questions,research design types,research objects,the selection of data elements,duration of registration,and transparent of patient registry.(2)Implementation:The implementation process of acupuncture-moxibustion patient registry is basically the same as previous research,including the pre-trials,the recruitment of research centers,acupuncturists and patients,data management,quality control,and data statistical analysis.But the implementation should consider the clinical practice and characteristics of acupuncture-moxibustion,which is the key to guarantee high quality of clinical research.(3)Evaluation:The evaluation method and content were discussed in terms of quality of research and evidence from the acupuncture-moxibustion patient registry.The assessment of details of acupuncture operation was the key factor.(4)Ethics:Ethical principles and the four basic elements of ethical review,which included the approval of the ethics committee,risk and benefit evaluation of the research,science of the protocol and informed consent,should be followed in the design and implementation of acupuncture-moxibustion patient registry.Multi-centered ethical review and safety of acupuncture-moxibustion were the main considerations.2 Technical support-key technologies for establishing acupuncture-moxibustion patient registry platform(1)Function realization:The acupuncture-moxibustion patient registry platform was designed based on the flexible and versatile study protocol of acupuncture-moxibustion patient registry,the multi-center and wide range of users,and the dynamic,complex,and individualized diagnosis and treatment characteristics of acupuncture-moxibustion,to achieve the basic function,such as research management and data quality control.Define and standardize the data elements,and established data dictionaries were involved in the platform.Through the Portal module,template management module,system management module,patient management module,content management module,and data query statistical analysis module,the data and users' management function were achieved to meet the needs of research from the basic information recording,the query and export of clinical data and basic statistical analysis.The standardization of data element and achievement of the research and data quality management was the key technology.(2)Data security,optimization and promotion:The security of the registry data is ensured through the setting of hardware and software,and the function is continuously optimized and improved through later operation and maintenance.Academic organizations and conferences were used to strengthen the promotion of this acupuncture-moxibustion patient registry platform.3 Case study-Factors influencing the effectiveness of acupuncture for chronic low back pain:a patient registry studyNine hospitals and 27 acupuncturists were recruited to conduct research across the country.A total of 372 patients with chronic low back pain were registered and 348 cases were finally included in this analysis.(1)Basic descriptive analysis:?Basic information of acupuncturists:27 acupuncturists were mainly distributed in Beijing,with an average age of 38.83±10.66 years,and an average career period of 12.38±8.40 years.Among them,there were 13 doctors with senior professional titles.?Basic demographic information of patients with low back pain:The average age of the patients included in the study was 48.71±15.30 years old.64.1%were female patients.The Han population accounted for 96.8%.62.6%were distributed in Beijing.87.4%were married.Among occupational distribution,the middle staff and students,retirees,and others distributed approximately one-third each,and 67.8%of the patients received higher education.?Basic conditions of low back pain:The average duration of disease included in the patients was 4.7±6.84 years.The pain sites were mainly concentrated in the middle of the lumbar spine and within 3 inches of the midline of the spine.Pain was mainly due to soreness and pain,and the reason for increased pain was sedentary.Long-term standing,heavy physical labor,and cold and damp were the main environmental factors.Most patients experienced pain relief after rest,warming,and rubbing,and many suffered low back pain due to strain or work environment.44.0%of patients were associated with lower limb paresthesia,1/3 of patients had received acupuncture treatment before this visit.?Diagnosis:According to the anatomical location of the lesions diagnosed by the first disease,the lesion types were mainly disc lesions and soft tissue lesions,mainly lumbar disc herniation(55.5%),lumbar muscle strain(20.1%),Lumbar degenerative changes(11.2%),et al.Etiological diagnosis of traditional Chinese medicine were mainly kidney deficiency(39.1%),cold-dampness(38.8%),and blood stasis(35.1%).The main meridian differentiations were Taiyang meridian(88.8%).12.4%of patients had comorbidities.?Acupuncture intervention:The treatment was mainly guided by the traditional Chinese medicine acupuncture theory.88.5%of patients were applied local acupuncture points.The number of acupuncture points involved was usually within 10 acupuncture points,and the most-used points were Shenshu(72.7%),Dachangshu(69.0%),Veizhong(62.1%),etc.97.4%of patients had deqi,67.2%were supplemented with TDP during acupuncture operation,and 14.1%had some special acupuncture procedures during the operation.The needle retention time was concentrated in 20-30 min.The number of acupuncture included in the observation patients was mostly concentrated in 3 times,and the frequency of acupuncture of 43.1%patients was once a week.64.9%of the patients had other therapies during acupuncture treatment,such as cupping,moxibustion,proprietary Chinese medicines,analgesics,physiotherapy,and massage.?Effectiveness and safety evaluation:The NRS scale and ODI scale scores were reduced by 2.00± 1.94 and 11.76±15.23,respectively,compared to baseline.The total effective rate was 62.4%.There were 13 cases of acupuncture adverse events during the acupuncture treatment,accounting for 3.7%,and no serious adverse events were recorded.(2)Factors analysis:?The probability of acupuncture was greater when the muscle twitch induced by acupuncture,the higher the frequency of acupuncture,combining with other therapies,the greater the baseline value of NRS and ODI scale,the OR and P values were(OR 1.884,95%CI 1.102 to 3.220;P=0.021),(OR 1.350,95%CI 1.031 to 1.768;P=0.029),(OR 1.897,95%CI 1.088 to 3.306;P=0.024),(OR 1.297,95%CI 1.085 to 1.551;P=0.004),(OR 1.039,95%CI 1.020 to 1.059;P=0.000),respectively.?Patients with older age,accompanying dyskinesia,TCM syndrome differentiation for blood stasis,the possibility of worse acupuncture effectiveness would be greater,the OR value and P value were(OR 0.956,95%CI 0.929 to 0.985;P=0.003),(OR 0.981,95%CI 0.963 to 1.000;P=0.046),(OR 0.362,95%CI 0.184 to 0.715;P=0.003),(OR 0.459,95%CI 0.261 to 0.808;P=0.007),respectively.Conclusion1 Through domestic and foreign literatures review,there is still no research report on acupuncture-moxibustion patient registry.We preliminary demonstrate that acupuncture-moxibustion patient registry is a scientific and feasible clinical research model.2 The acupuncture-moxibustion patient registry is guided by the evaluation of acupuncture and moxibustion clinical effectiveness.The basic elements of methodology focus on the design,implementation,evaluation and ethics based on the complex and individualized features of acupuncture and moxibustion.Research and data quality is the key to the formation of high quality evidence-based evidence.And the definition of data elements and the achievement of acupuncture data management functions are the key technologies for the establishment of acupuncture-moxibustion patient registry platform.3 Through the case study,we find that the age,concomitant symptom associated with dyskinesia,traditional Chinese medicine syndrome associated with blood stasis,muscle twitch during the acupuncture intervention,combining with other therapies,acupuncture frequency,the baseline values of NRS and ODI scale may be the key factors affecting the acupuncture clinical effectiveness for chronic low back pain.4 Innovations of this study:?The methodology of patient registry is introduced into acupuncture-moxibustion filed,combining the features of acupuncture and moxibustion to explore the basic elements of design,implementation,evaluation,and ethics of acupuncture-moxibustion patient registry.?The acupuncture-moxibustion patient registry platform is established to solve the key technologies in the construction of the platform database and data management of acupuncture and moxibustion.?Through the patient registry study of acupuncture for chronic low back pain,the basic characteristics of acupuncturists,TCM syndrome differentiation,meridian differentiation and acupuncture intervention are included in the regression analysis to discuss the factors influencing the effectiveness of acupuncture for chronic low back pain.