The concept of clinical trial transparency has been promoted for more than 40 years. The act of clinical trial registration, report guidelines development, and data sharing has has been strongly pushed forward and become a common practice. The clinical trial process being the key procedure of trial operation and quality control, determines the accuracy of the results. However, the process report of clinical trials is insufficient. In this article, we summarize the importance of clinical trial process report and provide corresponding suggestions. We propose that medical journals, reporting guidelines developers and clinical trial registration platforms should work together to strengthen the process report of clinical trials and promote full transparency of clinical trials.
Sharing clinical trial data can increase the transparency of clinical trials and improve the its authenticity. The current requirements of clinical research data transparency is not fully adequate, and it is still difficult to create an environment in which the sharing of the clinical trial data becomes the norm. The article analyzed various concerns on data sharing and proposed solutions in data ownership, technology, implementation, and legal issues systematically, calling for clinical trial data sharing in order to promote transparency of clinical trials, and looking forward to minimize the risks and maximize the benefits of data sharing.
Evidence produced by clinical trial is the main basis for health care decision-making at all levels. In recent years, some problems been revealed in the national data audit of new drug clinical trials have sounded the alarm for the quality of clinical research in China. In addition to strengthening the implementation of clinical trial process management and supervision, we call attention to the coherence and consistency of trial design and implementation, including the promotion of clinical trial design in the agenda of improving the quality of the trials and putting forward reasonable suggestions. We hope that our work could make research ideas clear from the source of a clinical trial, with a view to avoid violating protocol behavior and provide standardized recommendations for improving the quality of clinical trials in China.
Objective To compare the effectiveness of three surgical methods in the treatment of Pauwels type Ⅲ femoral neck fracture in young and middle-aged patients, in order to provide reference for clinical selection of appropriate surgical methods. Methods The clinical data of 103 patients with Pauwels type Ⅲ femoral neck fracture who met the selection criteria between June 2018 and December 2021 were retrospectively analyzed. The fractures were fixed with hollow screws in an inverted triangular shape (37 cases, hollow screw group), hollow screws in an inverted triangular shape combined with eccentric shaft screw (34 cases, eccentric shaft screw group), and hollow screws in an inverted triangular shape combined with medial support plate (32 cases, support plate group). There was no significant difference in age, gender, cause of injury, body mass index, time from injury to operation, side of the fracture, and Garden classification, whether they were in traction preoperatively, and other baseline data between groups (P>0.05). The operation time, intraoperative blood loss, the number of fluoroscopy, the length of hospital stay, early postoperative complication and postoperative weight-bearing time of the three groups were recorded. Harris score was used to evaluate joint function at 6 and 12 months after operation, and the difference between the two time points (change value) was calculated for comparison between groups. X-ray films were reviewed to evaluate the quality of fracture reduction (Garden index) and healing, as well as the occurrence of internal fixation failure and femoral head necrosis. Results The patients of the three groups were successfully completed. Compared with the hollow screw group and the eccentric shaft screw group, the operation time and intraoperative blood loss of the support plate group significantly increased, the number of fluoroscopy reduced, and the quality of fracture reduction was better, the differences were significant (P<0.05). The operation time, intraoperative blood loss, and the number of fluoroscopy of the hollow screw group were less than those of the eccentric shaft screw group, the differences were significant (P<0.05). There was no significant difference in the length of hospital stay between groups (P>0.05). All patients in the three groups were followed up 21-52 months, with an average follow-up time of 36.0 months, and there was no significant difference between groups (P>0.05). The incisions of all patients healed by first intention. Imaging reexamination showed that there was no significant difference in the incidence of fracture nonunion between groups (P>0.05). The fracture healing, partial weight-bearing, and full weight-bearing were significantly earlier in the eccentric shaft screw group and the support plate group than in the hollow screw group (P<0.05). There was no significant difference in change value of Harris score, the incidence of postoperative deep venous thrombosis and femoral head necrosis between groups (P>0.05); however, the incidence of internal fixation failure in the support plate group and the eccentric shaft screw group was significantly lower than that in the hollow screw group (P<0.05). The incidence of postoperative lateral thigh irritation in the support plate group was significantly lower than that in the hollow screw group (P<0.05); there was no significant difference between the eccentric shaft screw group and the other two groups (P>0.05). The overall incidences of postoperative complications in the eccentric shaft screw group and the support plate group were significantly lower than that in the hollow screw group (P<0.05). Conclusion For young and middle-aged patients with Pauwels type Ⅲ femoral neck fracture, compared with simple hollow screw fixation in an inverted triangular shape, combined with medial support plate or eccentric shaft screw internal fixation can shorten the fracture healing time, reduce the incidences of postoperative complication, more conducive to early functional exercise of the affected limb; at the same time, the operation time and blood loss of combined eccentric shaft screw internal fixation are less than those of combined medial support plate internal fixation, so the hollow screw in an inverted triangular shape combined with eccentric shaft screw fixation may be a better choice.
Clinical research reports are the main form of clinical evidence. Based on the requirements of clinical research reports and the characteristics of clinical research on traditional Chinese medicine, it is an important basic systematic project to construct a standardized system of clinical curative effects study report on Chinese medicine. This article elaborates existing problems, focus of attention and construction process in order to help promote the improvement of clinical curative effects research report on Chinese medicine, provide more high-quality evidences for clinical decision-making and promote the development of Chinese medicine.
Reporting standard system of clinical research of traditional Chinese medicine (TCM) is composed of ten reporting standards in the areas of the design and preparation of TCM clinical researches, researches of different types, randomized controlled trials of various interventions, systematic reviews of the trials and the translation of research evidence, which were developed by different research groups. This article systematically analyzed the current reporting standards of clinical research of TCM. Achievements and problems were found in the review so as to provide insights for the ongoing reporting standards and to assist the construction of the reporting standard system so as to improve the reporting quality of clinical researches of TCM.