The TCM-based syndrome treatment effectiveness assessment scale could provide a basis for objectively evaluating the effectiveness of syndrome-based treatment and enrich the evaluation system of TCM treatment results. There are no unified and standardized methods for developing this kind of scale. In accordance with the international standards for developing a scale and ideas for developing a scale for assessing TCM treatment results as well as features of the TCM syndrome, and the experience of developing Syndrome Therapeutic Evaluation Scale of Chronic Obstructive Pulmonary Disease, we proposed the general process 〔including seven main parts (forming a research group, pre-designing the basic characteristics of the scale, constructing a framework and item pool, screening the items, forming a draft form of the scale, determining the weight of the items, and test of the scale) , and three key techniques (data mining technology based on association rules and latent structure analysis, item screening based on classical test theory and item response theory, and item weighting based on random forest, factor analysis, and percent weight) 〕 for developing a TCM-based syndrome treatment effectiveness assessment scale, hoping to offer guidance for other relevant studies.
Traditional Chinese Drugs has proven to have unique merits in treating chronic atrophic gastritis (CAG) , but needs to be verified further by high-quality large-sample clinical studies. We detailed the technique essentials of clinical trial protocol design and assessment for CAG treated with Traditional Chinese Drugs, which may be used as a methodological reference for clinical trial protocol design for CAG treated using Traditional Chinese Drugs, promoting the quality improvement of relevant studies. Then we discussed the essentials of relevant clinical trial protocol design, especially the selection of outcome indicators, in accordance with the attributes of Traditional Chinese Drugs, and features and actual needs of such trials, providing ideas for comprehensive evaluation of efficacy of Traditional Chinese Drugs in treating CAG.
Massage is an important treatment for cervical spondylotic radiculopathy (CSR) . As massage-related research advances, numerous randomized controlled trials (RCT) concerning massage therapy in CSR have been published, but high-quality evidence is still limited due to some problems in the choice of outcomes.
To evaluate the outcomes used in RCTs in recent 10 years regarding CSR treated using massage, providing a basis for the choice of core outcomes used in studies about massage in CSR.
RCTs regarding CSR treated using massage were searched in databases of CNKI, Wanfang Data, CQVIP, SinoMed, PubMed, EMBase and Cochrane Library from January 2011 to May 2021. Literature screening, data extraction, and risk of bias assessment were performed by two researchers separately. A qualitative analysis was conducted to analyze the outcomes used in the RCTs.
In all, 66 RCTs were included, in which the outcomes were categorized into 7 categories based on functional attributes: quality of life (95 times, 41.48%) , symptoms and signs (64 times, 27.95%) , physical and chemical examinations (39 times, 17.03%) , safety events (12 times, 5.24%) , economic assessment (12 times, 5.24%) , long-term prognosis (5 times, 2.18%) , and TCM symptoms/syndromes (2 times, 0.87%) . The most frequently used five outcomes were overall response rate, Visual Analogue Scale (VAS) score, Neck Disability Index score, adverse reactions and adverse events, symptom and sign score, and the measurement time points for which were 17 in total in a period from one day after treatment to the sixth month of follow-up. The above-mentioned outcome indexes are mainly measured at 14 days (27.08%) , 14 days (26.67%) , 14 days (29.17%) , 28 days (28.57%) and 14 days (33.33%) after treatment. The number of RCTs using one, two, three, and at least four outcomes was 5, 20, 14, and 27, respectively. Forty-eight RCTs reported the overall response rate.
We found many problems existing in the choice of outcomes used in RCTs assessing massage for CSR. The problems are as follows: primary and secondary outcomes were not defined; alternative outcomes received more attention while endpoint outcomes were neglected; the blinding method was ignored in RCTs using subjective outcomes; there was tremendous heterogeneity between RCTs in the number or combination of outcomes used, composite outcomes were mostly used; there was non-uniformity in measurement times of outcomes. We suggest that further relevant studies should pay attention to sufficient top-level design and preliminary research, and actively take actions to establish a set of core outcomes.
The integrated traditional Chinese and Western medicine has proved to be significantly effective in low back pain. But the response rate, a key composite outcome index for assessing the efficacy, has not been unified and standardized in clinical research.
To perform a scoping review of the definition and contents of rate of chronic low back pain response to integrated traditional Chinese and Western medicine in clinical studies with response rate as a composite outcome indicator, offering a reference for appropriately selecting composite outcome indicators of this disease.
Databases including Web of Science, PubMed, EMBase, Cochrane Library, CNKI, CQVIP, Wanfang Data and SinoMed were searched for clinical studies of chronic low back pain treated by integrated traditional Chinese and Western medicine published from January 2015 to December 2019. Two researchers independently enrolled studies according to inclusion and exclusion criteria, extracted data according to the BPICOS principles, and reviewed and summarized the criteria for defining the response rate as a composite outcome indicator.
Among 830 included studies, lumbar muscle degeneration had been studied the most 〔178 (21.4%) 〕, followed by the third lumbar transverse process syndrome〔103 (12.4%) 〕, lumbar disc herniation〔91 (11 .0%) 〕, low back pain〔89 (10.7%) 〕, lumbodorsal myofasciitis〔72 (8.7%) 〕, lumbar spinal stenosis〔69 (8.3%) 〕, and lumbar spondylolisthesis〔61 (7.3%) 〕. 808 studies (97.3%) described the reference for the definition of response rate or explained the definition of response rate developed by the author. Specifically, different versions of Criteria for the Diagnosis, Syndrome Differentiation, and Response Assessment of Diseases by Chinese Medicine was referred the most〔271 (32.7%) 〕. Clinical symptoms, level of daily life activities, pain, signs and work & living ability, these five indictors were used most frequently as composite outcome indicators, and 2-5 of them were often randomly used in combination as the third or fourth level of response criteria. In addition, common low back pain measurement tools were also used.
Due to the lack of unified standard, composite outcome indicators used for response assessment in clinical studies about chronic low back pain treated by traditional Chinese and Western medicine might have many problems, such as various definitions, division criteria, and assessment items. In view of this, it is suggested to standardize the composite outcome indicators for response assessment in accordance with the CORE Outcome Measurement and Evaluation Tool, and to improve their validity to be used in clinical studies regarding integrated traditional Chinese and Western medicine as unified indicators, thereby improving the quality and value of such studies.
