Objective:To summarize the experiences of clinical study project management in Peking University Clinical Research Institute, REDCap (Research Electronic Data Capture) data management system was proposed to improve the follow-up process management.Methods:Current clinical study follow-up process management situation were analyzed and methods for utilizing REDCap in follow-up management was proposed.Results:Using REDCap through " direct management" and " system management" data management can improve the follow-up quality and standard level of management in clinical study, at the same time, secured better protection of participants′ privacy and rights during the process.Conclusions:REDCap plays crucial roles in securing follow-up data quality from the source, timely tracking and standardization of follow-up management, it can be adopted more widely in assisting clinical study follow-up management.

Objective:Proposed suggestions to improve the quality of investigator-initiated trials follow-up management under the normalization of COVID-19.Methods:Analyzed current status and challenges of follow-up management in China investigator initiated trial through a combination of literature review and previous work reflection, in the context of normalization of COVID-19.Results:Follow-up management of investigator initiated trial had shown variations in follow-up contents, methods, personnel and auxiliary tools. The insufficient research funding and lacking of professional clinical research team support have led to the challenges of low follow-up visits, insufficient follow-up personnel, lack of electronic follow-up platforms, and unknown follow-up time windows for investigator-initiated trials, which became more prominent in the context of COVID-19.Conclusions:In order to improve the quality of follow-up management during the normalization of COVID-19, appropriate amendment of the investigator-initiated trials follow up should be carefully considered. For instance, taking into account of the characteristics of the research disease, the main research endpoints, the content of the key indicators of the research key follow-up, follow-up methods, follow-up frequency, and follow-up tools to make sure the scientific validity and feasibility, as well as the mandate of clinical research related laws, regulations and ethical requirement. The possible amendments may include follow content, method, mode, frequency, time window. At the same time, re-consent or sufficient disclosure of information should be carried out with compliance of the updated protocols to assure the quality of clinical research follow up.

Objective According to the study of academic clinical research managed by Peking University Clinical Research Institute,identified problems that existed during the follow up in clinical research.Strategies and methods were proposed after analyzed the related problems,to enhance the quality of follow-up in clinical research.Methods Analysis of common follow-up management problems found in project management and on-site monitoring.Results Strategies and suggestions were proposed,table tools and management software were recommended to investigators for strengthening follow-up management.Conclusions Investigators should follow the scientific validity,research strategy and methodologies during the implementation of clinical research,to make sure compliance to increase the follow-up rates and guarantee the data quality.

Objective To analyze the rate and distribution of positive provocative tests in patients with inducible urticaria,and to investigate the role of provocative tests in the etiological diagnosis of chronic urticaria.Methods Among patients who visited the special clinic for urticaria in the Department of Dermatology of the Third Affiliated Hospital,Sun Yat-sen University from January 2016 to December 2017,127 patients with suspected inducible urticaria were selected,and underwent 6 provocative tests for inducible urticaria,including delayed pressure urticaria provocative test (DPUPT),symptomatic dermographism provocative test (SDPT),vibratory angioedema provocative test (VAEPT),cold urticaria provocative test (CUPT),heat urticaria provocative test (HUPT),and aquagenic urticaria provocative test (AUPT).Statistical analysis was carried out by chi-square test for comparison of positive rates between male and female patients.Results Among the 127 patients with suspected inducible urticaria,106(83.46％) showed one or more positive provocative tests.The positive rate of SDPT was the highest (79.53％,101/127),followed by HUPT (22.05％,28/127) and CUPT (9.45％,12/127).The positive rate of HUPT was significantly higher in female patients (30.14％,22/73) than in male patients (11.11％,6/54;X2 =4.301,P ＜ 0.05).The patients with positive DPUPT,VAEPT and AUPT all showed positive SDPT responses.Among the 12 patients with positive CUPT reactions,11 showed positive SDPT responses.Among the 28 patients with positive HUPT reactions,26 showed positive SDPT responses.Of the 48 patients with one or more positive non-SDPT provocative tests,the patients with 2 positive non-SDPT provocative tests accounted for 18.75％ (9/48).Conclusion Provocation tests for inducible urticaria are of great clinical significance for the etiological diagnosis of chronic urticaria.

Objective To explore the correlation between nursing document marking system (NCR-11) and APACHE Ⅲ score, and evaluate the value of NCR-11 for the assessment of critical care patients. Methods From March 1st to September 30th, 2013, 97 inpatients in ICU were chosen as sampling prospectively and were collected their clinical medical information. NCR-11 was calculated from next day to the sixth day of hospitalization and all patients were divided into two groups according to APACHE Ⅲ score: <60 score ( A group ) , ≥60 score ( B group ) , then statistically analyzed the correlation between NCR-11 and APACHE Ⅲ score and compared the difference between A and B group. Results The A group obtained the score of NCR-11 (52. 63 ± 10. 66), which had positive correlation with APACHE Ⅲ score (r=0. 619,P<0. 01), while B group acquired (56. 88 ± 9. 34) and correlation coefficent with APACHE Ⅲ score was r =0. 283,P<0. 01. The score of NCR-11 in B group was higher than that of A group (F=4. 873,P<0. 01), but the change of A and B group had no statistical significance from 5 days assessment (F=0. 096,P>0. 05). Conclusions NCR-11 and APACHE Ⅲ score has a certain correlation and could reflect the severity of the disease indirectly. It has some value in evaluating the severity of critical care patients.

This article describes the concept, theoretical basis, commonly used evaluation indicators of the intimacy enhancement therapy, as well as the application status and effects of the therapy among different cancer patients and their spouses, so as to provide a reference for the development of intimacy enhancement therapy suitable for Chinese culture and improve the quality of family life of cancer patients.

This article summarizes the whole-person care needs of patients in Intensive Care Unit (ICU) from the physiological, psychosocial, and spiritual aspects. This article reviews the whole-person care model of ICU palliative care from three aspects, namely physiological care, psychosocial support and spiritual support, so as to provide a reference for the development of ICU palliative care in China.