Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
Objective To develop a preliminary "pulmonary nodule symptom scale" based on the Delphi method, providing a tailored, standardized, normalized, and promotable symptomatic evaluation tool for the efficacy assessment of pulmonary nodule patients treated with traditional Chinese medicine or integrated traditional Chinese and Western medicine interventions. Methods A preliminary pool of scale items was formed through literature review, interviews with doctors and patients, and reference to guidelines and consensus on pulmonary nodules and patient-reported outcome (PRO) scales related to lung cancer. Two rounds of expert consultation were conducted using the Delphi method. Based on the concentration and variation indicators of expert evaluations, and considering experts’ suggestions for specific item deletions and modifications, a core group meeting was held to screen and refine the scale items. Results Invitations were sent to 54 experts, with 51 accepting the consultation. The active coefficient for the first round of consultation was 94.4%, and for the second round, it was 100%. The average authority coefficient for the 51 experts was 0.896. The Kendall’s coefficient of concordance and the average coefficient of variation for the first and second rounds of consultation were 0.215 (P<0.001) and (0.34±0.07), 0.162 (P<0.001) and (0.24±0.05), respectively. Through two rounds of Delphi expert consultation, a preliminary "pulmonary nodule symptom scale" covering 17 items across four dimensions - respiratory symptoms, systemic manifestations, psychological state, and overall assessment - was formed. Conclusion The experts participating in this Delphi consultation had high authority and enthusiasm, and they have a good level of acceptance and consistency for the preliminary "pulmonary nodule symptom scale". Subsequent empirical research will be conducted on a large sample cohort of pulmonary nodule patients to verify the scale’s stability and effectiveness.
There are many problems in the selection of outcomes in clinical trials of traditional Chinese medicine (TCM), such as insufficient research on the applicability of outcomes, insufficient research of individualized outcomes for syndrome differentiation and treatment, incomplete selection methods for overall/comprehensive evaluation outcomes, lack of evidence in the importance of outcomes for researchers, and insufficient reflection of the humanistic value of outcomes. Although the core outcome sets (COS) may help clinical trialists to select outcomes to a certain extent, the COS has not been widely used at present, and the judgment of the importance of the outcomes in the COS is mainly based on the personal experience of the participants. The lack of methodology will also lead to multiple COS in the same disease area. The authors believe that it is necessary to improve the methodology of outcomes research, especially in the development of COS. Developing evidence and humanistic values framework may be a potential way to help researchers select core outcomes in clinical efficacy evaluation of TCM.
ObjectiveTo evaluate the clinical efficacy of medical absorbent pads in the treatment of wouds.
MethodsA total of 200 patients treated in the Wound Treating Center of a first-class hospital between November 2014 and August 2015 were randomly divided into trial group and control group with 100 patients in each. Patients in the trial group received medical absorbent pads, while patients in the control group received the treatment of Zetuvitò E. All patients received four times of treatment. Then we used self-made observation record form to evaluate such indexes as water absorption and compliance of the dressing, patients' pain and secondary trauma scores and the score of skins around the wounds.
ResultsThere was no significant difference in water absorption property and compliance between the two groups (P>0.05). But the score of visual analogue scale was lower in the trial group than that in the control group at the fourth dressing changing (P<0.05), and the score of secondary trauma was also lower in the trial group than that in the control group at the third and fourth dressing changing (P<0.05).
ConclusionThe medical absorbent pads used in the trial group can relieve pain and promote wound healing. It can be used for the treatment of wounds, and also has better effectiveness and safety.
Objective To investigate the advances and clinical efficacy evaluation method on neoadjuvant chemotherapy in patients with gastric cancer. Methods Literatures on the advances and clinical efficacy evaluation method on neoadjuvant chemotherapy in patients with gastric cancer were reviewed and analyzed. The agreement between computed tomography (CT), endoscopic ultrasound (EUS), magnetic resonance imaging (MRI) and positron emission tomography (PET) and the results of histopathology and survival was analyzed.Results CT and EUS were the method of efficacy evaluation commonly used at present, but the evaluation indexes and criteria were controversial, and the criteria for solid tumors seemed to be not feasible for gastric cancer. Diffusionweighted imaging (DWI) method needed more investigation, while PET held advantage in early selection of patients without response accurately.Conclusion There is no uniform standard for clinical efficacy evaluation yet, so an integration of diverse imaging methods may be the best choice to improve the accuracy of neoadjuvant chemotherapy in patients with gastric cancer.
Acute pharyngitis belongs to the category of "acute throat impediment" in traditional Chinese medicine (TCM), which has a high incidence and is easy to recur. In clinical practice of TCM, Chinese patent medicines with the effects of clearing heat and detoxifying, reducing swelling and relieving pain are widely used in the treatment of acute pharyngitis. These medicines have the advantages of definite efficacy, low side effects, and low risk of developing drug resistance. However, at present, there are no standardized clinical diagnostic and therapeutic evaluation norms for acute pharyngitis in TCM, which has hindered the application of TCM in the prevention and treatment of acute pharyngitis and the development of new TCM preparations. Therefore, the China Association of Chinese Medicine initiated this expert consensus, which was led the formulation by Xiyuan Hospital, China Academy of Chinese Medical Sciences. This expert consensus integrates the current best evidence and extensive clinical expert experience from the front line, covering seven aspects: applicable scope, diagnosis in both Chinese and Western medicine, syndrome classification and evaluation scales, basis for efficacy evaluation, and time for efficacy evaluation. It has formed 8 types of TCM syndromes for acute pharyngitis, as well as the diagnostic criteria, syndrome classification and evaluation scales, evaluation basis for efficacy, and scoring standards for syndromes and diseases. This expert consensus can be used to standardize the diagnosis of the TCM syndromes of acute pharyngitis, as well as the core indicators and evaluation methods for syndrome and disease efficacy, with the aim of providing references for clinical practice and scientific research on acute pharyngitis.
Object As part of the core outcome set (COS), the core traditional Chinese medicine (TCM) syndrome set can improve the consistency of syndrome efficacy evaluation outcomes in TCM clinical research. Previous studies proposed and empirically verified a method of developing core TCM syndrome sets based on complex syndromes under the disease-syndrome combination research model. However, this method is developed on the basis of syndrome types, which has the limitation that the finally included syndrome types are too single to adapt to the complexity of clinical syndromes. Therefore, it is urgent to optimize the existing development method to balance the complexity of clinical syndromes and methodological feasibility. Methods This study adopted qualitative research methods to obtain opinions from TCM clinicians and researchers on developing methods, efficacy evaluation criteria, and construction forms through expert steering committee meetings and semi-structured interviews. The sample size of semi-structured interviews was determined until data saturation was reached, and thematic analysis was used to analyze the transcription results. Results In the expert steering committee meeting, 60% (3/5) of the experts believed that developing in the form of syndrome elements was more operable; in the semi-structured interviews, 77.78% (7/9) of the experts supported developing in the form of syndrome elements, considering it convenient to use. Meanwhile, the research team added an expert semi-structured interview link in the development process, which complemented the cross-sectional survey used in previous studies to jointly improve the original list of TCM syndrome elements. Conclusion The method of developing core TCM syndrome sets based on syndrome elements formed in this study can consider clinical practice while improving the unity of TCM syndrome efficacy evaluation standards, which is helpful to promote the standardized development of TCM clinical research.
Objective To compare the therapeutic effect of cannulated screws fixation at different time points through different reduction methods on the heal ing of displaced femoral neck fractures. Methods From January 1997 to September 2007, 240 patients with displaced femoral neck fracture were treated, including 121 males and 119 females aged 22-79 years old (average 56 years old). All cases were fresh and close fractures. According to the fractured part, there were 133cases of subcapital fracture, 64 of transcervical fracture and 43 of basal fracture. According to Garden classification, there were 105 cases of type III and 135 of type IV. Cannulated screws fixation was performed on all the patients, and the time from injury to operation was 6 hours to 7 days. Fifty-five cases received closed reduction and 59 cases received l imited open reduction as emergency treatment, while 65 cases received closed reduction and 61 cases received l imited open reduction as selective operation. Different groups were compared in terms of the heal ing rate of fracture, the excellent and good rate of reduction as well as the excellent and good rate of fixation. Results There was no significant difference between the closed reduction and the l imited open reduction in terms of operation time and bleeding volume (P gt; 0.05). Postoperatively, all wounds healed by first intention, no infection was observed, avascular necrosis of femoral head occurred in 44 cases, and the rate of avascular necrosis of femoral head in the l imited open reduction at emergency group was less than that of other 3 groups (P lt; 0.01). All the patients were followed up for 12-72 months (average 38 months), 193 cases got fracture heal ing at 10-23 months after operation (average 14 months). For the closed reduction as emergency operation group, the l imited open reduction as emergency operation group, the closed reduction as selective operation group, and the l imited open reduction as selective operation group, the heal ing rate of fracture was 74.55%, 91.53%, 69.23% and 86.89%, respectively; the excellent and good rate of reduction was 73.73%, 94.92%,70.77% and 91.80%, respectively; the excellent and good rate of fixation was 76.36%, 93.22%, 73.85% and 88.52%, respectively. The heal ing rate of fracture, the excellent and good rate of reduction as well as the excellent and good rate of fixation in the l imited open groups were higher than that of the closed reduction groups (Plt; 0.01), and there was no significant difference between the emergency operation groups and the selective operational groups (Pgt; 0.05). Conclusion The reduction methods have significant influences on the heal ing of fractures after cannulated screws fixation of the displaced femoral neck fracture, and the operation time has no obvious effect on fracture heal ing.
Objective
To explore the efficacy of multidisciplinary nutritional support model in the perioperative management of elderly patients with nutritional risks undergoing joint replacement.
Methods
Between March 1, 2014 and May 31, 2015, 342 elderly patients who underwent joint replacement due to osteoarthritis were screened with nutritional risk screening 2002 (NRS2002). For patients who got a NRS2002 score of equal to 3 points or higher, nutritional treatment and intervention was carried out by doctor-nurse-rehabilitation therapist-dietitian collaboration and hospital departments related to patients’ complications.
Results
Among all the 342 patients, 225 (65.79%) had a NRS2002 score of equal to 3 points or higher on the admission day, in which 117 (52.00%) were male and 108 (48.00%) were female, 168 (74.67%) were at the age between 60 and 70 years old and 57 (25.33%) were at the age between 71 and 87. One day before surgery, the number of patients with a NRS2002 score equal to 3 points or higher decreased to 10 (2.92%), and the number became 68 (19.88%) after surgery. The difference was statistically significant (P<0.05). In those 68 elderly patients, 10 had a preoperative NRS2002 score equal to 3 points or higher, and 58 had newly developed nutritional risks after surgery; there were 23 patients with an age over 75, and 7 over 80. The NRS2002 score of all the 342 patients was below 3 points before discharge. For patients with nutritional risks at different periods before and after surgery, their serum albumin and hemoglobin levels were both improved after the treatment of nutritional support (P<0.05).
Conclusion
Multidis- ciplinary nutritional support for elderly perioperative patients undergoing joint replacement can reduce the incidence of postoperative complications, providing favorable conditions for the patients to undergo joint replacement surgery.
With the advancement of modern research in traditional Chinese medicine (TCM), evidence regarding the clinical efficacy and mechanisms of action of TCM has rapidly accumulated. However, due to a lack of methodological safeguards, the disconnection between clinical and basic research in TCM has become increasingly prominent, making it difficult to form an evidence chain that supports the scientific value of TCM in a manner that is "clear and understandable". Therefore, it is necessary to develop methods for the translation and integration of clinical and basic research evidence oriented towards clinical value, to form a reliable evidence chain that can further discover patterns, confirm efficacy, and highlight advantages. This article discusses the construction and evaluation methods of the evidence chain for the efficacy of TCM, aiming to provide theoretical and methodological references for related work.
