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Objective:To compare the application effect of whole-process seamless nursing and conventional nursing in the perioperative period of ankylosing spondylitis (AS) with kyphosis complicated by cervical spine fracture.Methods:A retrospective cohort study was conducted to analyze the clinical data of 64 patients with AS with kyphosis complicated by cervical spine fracture admitted to Henan Provincial People′s Hospital from April 2017 to December 2022, including 37 males and 27 females, aged 27-73 years [(49.8±14.6)years]. There were 43 patients with vertebral fractures and 21 with intervertebral space fractures. All patients underwent reduction and fixation or correction and fixation. Thirty-two patients admitted from April 2017 to August 2019 received conventional care (conventional nursing group), and 32 patients admitted from September 2019 to December 2022 received whole-process seamless care (seamless nursing group). The two groups were compared concerning the visual analog scale (VAS) before, at 12 hours, 24 hours, 1 month, 3 months after surgery and at the last follow-up, the American Spinal Injury Association (ASIA) score before surgery, at 1 and 3 months after surgery and at the last follow-up, the health survey questionnaire (SF-36) score and patient satisfaction score before surgery and at the last follow-up, as well as the incidence of postoperative complications.Results:All patients were followed up for 6-12 months [(9.8±3.2)months]. There was no statistical difference in preoperative VAS between the two groups ( P>0.05). The values of VAS in the seamless nursing group were (3.9±1.9)points, (4.2±0.7)points, (2.7±0.9)points, (2.6±0.6)points, and (1.7±0.8)points at 12 hours, 24 hours, 1 month, 3 months after surgery and at the last follow-up, respectively, lower than those of the conventional nursing group [(5.7±1.2)points, (5.8±1.1)points, (3.6±1.2)points, (3.2±1.1)points, and (2.4±1.0)points] ( P<0.05 or 0.01). The VAS of the seamless nursing group at 12 hours, 24 hours, 1 month, 3 months after surgery and at the last follow-up was lower than that before surgery (all P<0.05). The VAS at 1 and 3 months after surgery and at the last follow-up was lower than those before and at 12, 24 hours after surgery and the VAS at the last follow-up was lower than those at 1, 3 months after surgery (all P<0.05). The differences among VAS of the conventional nursing group before and at 12, 24 hours after surgery were statistically insignificant (all P>0.05). The VAS of the conventional nursing group at 1 and 3 months after surgery and at the last follow-up was lower than those before surgery and at 12, 24 hours after surgery and the VAS at the last follow-up was lower than those at 1, 3 months after surgery (all P<0.05). There was no statistically significant difference in VAS of the two groups between 12 hours and 24 hours after surgery, and between 1 month and 3 months after surgery (all P>0.05). There was no significant difference in the ASIA scores before surgery between the two groups ( P>0.05). There were significant improvements in ASIA scores in the seamless nursing group at 1, 3 months after surgery and at the last follow-up compared with those of the conventional nursing group ( P<0.05). There were no statistically significant differences in preoperative SF-36 score and patient satisfaction score between the two groups (all P>0.05). At the last follow-up, the SF-36 score and patient satisfaction score of the seamless nursing group were (47.4±6.2)points and (99.5±1.2)points, respectively, which were higher than those of the conventional nursing group [(42.2±7.3)points and (98.1±1.6)points] (all P<0.05). At the last follow-up, the SF-36 score and patient satisfaction score of the seamless nursing group were higher than those before surgery (all P<0.01). The SF-36 score of the conventional nursing group was higher than that before surgery ( P<0.01), but there was no significant difference in patient satisfaction score ( P>0.05). The incidence of postoperative complications in the seamless nursing group was 6.3% (2/32), lower than that of the conventional nursing group [25.0% (8/32)] ( P<0.05). Conclusion:For AS with kyphosis complicated by cervical spine fracture, whole-process seamless nursing is associated with alleviated postoperative pain, improved spinal nervous function, quality of life and degree of satisfaction, and reduced incidence of complications compared with the conventional nursing.
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OBJECTIVE：To identify and evaluate the risk factors of innovative drug clinical trials ，and to provide references for the development of risk management and control strategies. METHODS ：Using the method of literature research ，the risk factors of innovative drug clinical trials were obtained ，classified and sorted out ，and the risk evaluation indicators were initially formed. On this basis ，the questionnaire was designed. By means of interview and questionnaire survey ，54 experts were invited from 4 tertiary hospitals and 1 contract research organization to score. SPSS 24.0 software was used to perform principal component analysis on risk event status data. RESULTS & CONCLUSIONS ：The risk evaluation system included 9 first-class indicators such as policy and legal risk ，clinical trial institution risk and trial scheme design risk ，and 31 second-class indicators such as industrial policy，law and regulation changes ，intellectual property risk . According to the analysis ，the risk factors of innovative drug clinical trials mainly included drug and biological sample management risk ，trial scheme design risk ，clinical trial institution risk ，safety report management risk ，ethical review risk ，policy and legal risk ，and subject management risk. Relevant parties in clinical trials need to focus on monitoring various risk factors ，establish dynamic monitoring and control mechanism and implementation guarantee mechanism ，and effectively prevent and control risk ，to promote the smooth implementation of clinical trials.