Establishing and improving the quality control system of drug clinical trial institutions is the key to ensure the quality of clinical trial. In recent years, the number of drug clinical trial has been continuously improved, and the quality control requirements have been continuously improved. However, in clinical work, the workload of medical staff is heavy, and the energy devoted to clinical trial is limited. Clinical research coordinator (CRC), as a participant and coordinator of clinical trial, has carried out transactional work related to non-medical judgment under the authorization and guidance of researchers, and has undertaken any specific work in clinical trial. Based on the quality control management experience of nosocomial CRC and hospital drug clinical trial institutions in West China Hospital of Sichuan University, this paper discusses the mode of nosocomial CRC participating in clinical trial quality control. By participating in the quality control of clinical trial, the nosocomial CRC has improved the quality control efficiency, enriched the quality control team and improved the overall level of CRC. This model enriches the quality control system of drug clinical trial.
ObjectiveTo summarize research progress of quality of life in patients after colorectal cancer surgery.MethodsThe literatures about quality of life of patients with colorectal cancer surgery in recent years are reviewed.ResultsQuality of life had became an important criterion for evaluating the therapeutic effect and prognosis of cancer. At present, the assessment tools for the quality of life of colorectal cancer patients mainly included the universal scale [such as Short Form Health Survey (SF-36)], the applicable scales for cancer patients [such as European Organization for Research and Treatment of Cancer: quality of life questionaire-C30 (EORTC QLQ-C30) and European Organization for Research and Treatment of Cancer: quality of life questionaire-CR38 (EORTC QLQ-CR38)], and the special scales for stoma patients represented by City of Hope Quality of Life-Ostomy Questionnaire (COH-QOL-OQ), Stoma Quality Of Life (Stoma-QOL), Stoma Quality Of Life Scale (SQOLS), and so on. The short-term quality of life of colorectal cancer patients was lower at 1 month after operation and recovered at 3 months after operation. Five years after surgery, attention should also be paid to the long-term quality of life. Besides, postoperative quality of life of colorectal cancer patients was affected by age, occupational status, economy, preoperative physical activity level, psychological and social factor, personality, surgical method, co-morbidity, complication, stoma, and so on.ConclusionsUnderstand the longitudinal changes and influencing factors of patients’ quality of life after operation, grasp the time point of effective intervention, and select appropriate assessment tools are necessary for medical staff. It is of great significance to further optimize the clinical management pathway and improve the quality of life of patients with colorectal cancer after operation.
Objective To explore the compliance improvement of rehabilitation exercise for patients after spine surgery. Methods Forty-nine in-patients who underwent spinal surgery between June 1st and July 14th 2016 were selected as the control group and 50 in-patients who underwent spinal surgery between July 15th and August 30th 2016 were selected as the trial group. The control group received conventional nursing for rehabilitation exercise, and the tiral group adopted a series of quality improvement measures for rehabilitation exercise. The compliance of functional exercise, the accuracy of patients’ exercise and the satisfaction with health education of the patients were compared between the two groups. Results The functional exercise compliance in the trial group (complete compliance in 45 cases, partial compliance in 4 cases, non-compliance in 1 case) was higher than that in the control group (complete compliance in 9 cases, partial compliance in 34 cases, non-compliance in 6 cases) with a statistical difference (Z=–6.910, P<0.001). The functional exercise accuracy rate of patients was higher in the trial group [84.00%(168/200)] than that in the control group [53.06% (104/196)] with a statistical difference (χ2=44.060, P<0.001). The patients’ satisfaction with health education in the trial group (4.64±0.49) was higher than that in the control group (4.20±0.89) with a statistical difference (t=3.084, P=0.003). Conclusion The implementation of nursing quality improvement intervention can improve the compliance and accuracy rate of rehabilitation functional exercise of patients undergoing spinal surgery, and improve the satisfaction of patients, which is worth promoting.
ObjectiveTo investigate the effects of health education pathway intervention on self-care agency and health lifestyle promotion in colostomy patients. MethodsEighty-eight rectal cancer patients who had undergone colostomy were randomly divided into control group and intervention group (with 44 patients in each) between March 2012 and September 2013. The control group received conventional nursing only, while the intervention group were given health education pathway intervention besides conventional nursing. The self-care agency and health lifestyle promotion in the two groups under pre-colostomy state, one week after colostomy and two weeks after colostomy were surveyed and compared based on the exercise of self-care agency scale and the health promotion lifestyle profile. ResultsAfter health education pathway intervention, the scores of self-care agency and health lifestyle promotion in the intervention group were significantly higher than those in the control group (P<0.05), and the hospitalization expenditure was also obviously lower. Furthermore, the satisfaction degree on nursing service was significantly higher than that of the control group (P<0.05). ConclusionThe health education pathway intervention can greatly improve self-care agency and quality of life in rectal cancer patients who have undergone colostomy.
objective To analyze the impact of body mass index (BMI) on medical and surgical complications of colorectal cancer patients served by West China Hospital, based on the current version of Database from Colorectal Cancer (DACCA). Methods The data of DACCA was updated on September 27, 2021. The data included BMI, surgical complications, liver nodules, liver function, renal nodules, renal function, operation history, medical complications, diabetes, hypertension, pneumonia, pulmonary nodules, pulmonary function, heart disease, thrombosis, and cardiac function. Results After scanning, 5 305 data rows were included. BMI was divided by Chinese four classification methods. The analysis results showed that in terms of surgical complications, obese patients were more likely to be complicated with surgical complications of digestive system (χ2= 43.883, P<0.001) and reproductive system (χ2=13.139, P=0.004). Lean patients were more likely to have surgical complications of urinary system (χ2=223.415, P<0.001), and obese patients had liver function (H=61.521, P<0.001) and renal function (H=9.994, P=0.019) might be even worse. In terms of operation history, BMI in colorectal cancer patients had nothing to do with the number of times of operation (H=6.262, P=0.100), and operation history of each system or department (P>0.05). Regarding to medical complications, with the increase of BMI, the risk of colorectal cancer patients with diabetes mellitus (χ2=118.597, P<0.001), or hypertension (χ2= 163.334, P< 0.001) increased. Patients with low BMI were more likely to have pneumonia (H=7.899, P= 0.048) and worse pulmonary function (H=40.673, P<0.001). Conclusions The analysis results of DACCA database show that BMI is not related to the occurrence of any special surgical history included in the research. Because the internal and external complications of patients are closely related to the treatment plan and prognosis, we should pay more attention to the obese patients in the process of clinical treatment, and they are more likely to have multisystemic abnormalities and various abnormal indicators than other patients. For thin patients, we should pay more attention to their lung function and inflammatory lesions, so as to improve the clinical therapeutic effect.