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Objective:To analyze the time cost in the start-up stages of clinical trials and to investigate the influencing factors of the initiation efficiency.Methods:We retrospectively analyzed time-cost of the review and approval of drug clinical trials initiated in Beijing Hospital from January 2020 to June 2021.The contract signing time and trial starting time of drug clinical trials in different situations were compared.Results:The mean time to sign the contract in our hospital was 19(11~26) days, and the mean time to start experiment was 235(175~317) days. There was no significant difference in the contract signature time between clinical trials with different stages, different sponsors, different types of drugs and whether to be the leading site ( P>0.05). Compared with other phases, phase Ⅲ drug trials took the longest time to start, and the mean initiation time of clinical trials initiated by foreign pharmaceutical companies was 136 days longer than that initiated by domestic pharmaceutical companies ( P<0.05). Conclusions:Clinical trial institutions should optimize the project management process, better organize the contract review and ethics review, encourage the sponsor to use our template document. Every department may set up a GCP contact to be responsible for clinical trials; The sponsor should improve the efficiency of internal circulation and communication, submit the review materials as soon as possible according to the requirements of the institution, and establish a good communication and feedback mechanism between both sides, may shorten the start-up time of clinical trials and improve the initiation efficiency.
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Objective: To decrease the preoperative area waiting-time forchildren posted for eye surgery.Methods: A pilot quality improvement project was conducted in asingle paediatric eye operation theatre in our tertiary-carehospital. Operation theatre process flow was analyzed, baselinedata was collected, and two Plan-Do-Study-Act cycles wereperformed on consecutive days. Average and maximal waiting-time were recorded across six operation theatre days.Results: The average and maximal waiting time at baseline were221 and 390 minutes, respectively. After two rapid Plan-Do-Study-Act cycles, these were reduced to 29 (87% reduction) and 52minutes (87% reduction) from baseline, respectively, and couldsubsequently be sustained.Conclusion: Preoperative waiting time in ophthalmic operationtheatre was significantly reduced by simple process flowoptimization, thereby improving quality of care.
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Objective To investigate the influence of start time of continuous renal replacement therapy (CRRT) on the survivay and renal function recovery of patients with severe acute kidney injury (AKI)Methods Two hundred cases of severe AKI patients in the Traffic Hospital of Shandong Province from January 2011 to January 2014 were selected and divide into groups A of 1 phase,group B of 2 phase and group C of 3phase based on the CRRT starting time.The survivary and renal function recovery of 3 groups patients were compared.Results After treatment,the recovery rate of renal function,survival rate and mortality of patients in group A were 91.04％,92.5％ and 36.2％,significantly higher than that of group B(52.11％,73.6％ and 7.5％) and group C (29.03％,36.2％ and 63.8％),the differences were statistically significant (x2 =6.266,16.143,16.143;P＜0.05);and the recovery rate of renal function and survival rate of group A was higher than of group B and C (P＜0.05);and renal function index of groupA,B,C all significantly improved than before treatment,there were statistically significant differences (P＜ O.05).Conclusion Early CRRT treatment can significantly improve the survival rate of patients with SCKI,which would be good for patients to recover renal function.
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A statistical study was done on the feeding trends of 2,965 children who had visited both the out-patient clinic and the well-baby clinic of Padiatric Department, St. Benedict Hosp., from Sept., 1979 to Aud., 1980. 1) Among the total 2,965 children, the distribution according to age was about the same. The percentage of male and female was 58.5% respectively. As for geographical area of the cases, the majority were from Busan City Kyung Nam Province and the percentage was 96% and 3% respectively. 2) As for the methods of feeding, breast-feeding was 65%, artificial-feeding 18% and mixed-feeding 15%. 81% among the total cases had been on breast-feeding at one time or another. 3) As for feeding trends according to age, the younger the chile was, the more frequent the chance of artificial feeding. 4) Breast-feeding was less common in the children of premature delivery than children of full-term delivery. 5) Breast-feeding was less common among children with difficult delivery than children with easy delivery. 6) Breast-feeding was less common among children of hospital delivery than children of home delivery. 7) The higher the education level of the mother, the less common breast-feeding was. 8) Breast-feeding was less common among children from Busan City than children from Kyung Nam Province. 9) As for the beginning of feeding, in case of breast-feeding 56% were from 3rd day after bitrh and also in case of mixed-feeding 56% were from 3rd day after birth. 10) As for the duration of breas-feeding children with more than 12months of breast-feeding were most common(48%) and children with less than 6months of breast-feeding least common(8%). 11) The reasons for breast-feeding or mixed-feeding were not enough breast-milk 59%), mother's job 8%), baby's illness 8%), mother's illness 6%) and mother's breast problem 4%) by its frequency.