ABSTRACT: Data management has significant impact on the quality control of clinical studies. Every clinical study should have a data management plan to provide overall work instructions and ensure that all of these tasks are completed according to the Good Clinical Data Management Practice (GCDMP). Meanwhile, the data management plan (DMP) is an auditable document requested by regulatory inspectors and must be written in a manner that is realistic and of high quality. The significance of DMP, the minimum standards and the best practices provided by GCDMP, the main contents of DMP based on electronic data capture (EDC) and some key factors of DMP influencing the quality of clinical study were elaborated in this paper. Specifically, DMP generally consists of 15 parts, namely, the approval page, the protocol summary, role and training, timelines, database design, creation, maintenance and security, data entry, data validation, quality control and quality assurance, the management of external data, serious adverse event data reconciliation, coding, database lock, data management reports, the communication plan and the abbreviated terms. Among them, the following three parts are regarded as the key factors: designing a standardized database of the clinical study, entering data in time and cleansing data efficiently. In the last part of this article, the authors also analyzed the problems in clinical research of traditional Chinese medicine using the EDC system and put forward some suggestions for improvement.

Crush syndrome in patients rescued from earthquake is a complex clinical syndrome with many medical conditions.The most complications are hyperkalemia,acute kidney injury,shock,infection,ARDS,malnutrition and multiorgan dysfunction.Managing these critical issues appropriately is essential for effective treatment of the crush syndrome.

Objective To observe the effects of chemotherapy on nutritional status and quality of life in elderly patients aged 60 years and over with stage Ⅲ or Ⅳ non-small-cell lung cancer,who were unable to undergo molecular-targeted drug therapy according to genetic testing.Methods A total of 100 elderly patients with stage Ⅲ or Ⅳ non-small cell lung cancer were randomized into an observation group(n=50)and a control group(n=50).Patients in the observation group were treated with GP regimen(gemcitabine+ cisplatin),while patients in the control group were treated with TP regimen(paclitaxel+cisplatin).The scores of nutritionally relevant indicators and quality of life were compared between the two groups.Results After chemotherapy,the body weight,body mass index,plasma total protein,plasma albumin,and triglyceride concentrations were significantly lower in the GP regimen group than in the TP regimen group(P＜0.0001,P =0.0027,P =0.0305,P＜0.0001,P＜ 0.0001,respectively).The overall health status score,physical function,role function,and emotional function scores were higher in the GP group than in the TP group(P =0.0017,0.0044,0.0064,0.006,respectively) after chemotherapy.The scores of shortness of breath,insomnia,loss of appetite,constipation,and diarrhea were significantly lower in the GP group than in the TP group(P =0.0067,P ＜0.0001,P =0.0026,P =0.0066,P =0.0023).The clinical effective rate was significantly higher in GP regimen than in TP regimen(56.0％ vs 30.0％,x2 =6.90,P=0.009).The incidence of grade Ⅰ adverse reactions was higher in the observation group (54.0％,27/50 cases),and the incidences of grade Ⅱ,Ⅲ and Ⅳ adverse reactions were higher in the control group(36.0％,18/50 cases;24.0％,12/50 cases;and 24.0％,12/50 cases,respectively) (x2 =16.40,P =0.001).Conclusions The TP chemotherapy is more beneficial to patients' nutrition,while the GP chemotherapy can achieve both higher clinical efficacy and better quality of life.

Objective To investigate the efficacy,adverse reactions and immune function of time-adjusted chemotherapy combined with intensity-modulated radiation therapy (IMRT) and conventional chemotherapy combined with IMRT for locally advanced nasopharyngeal carcinoma.Methods Random number grouping method was used to divide 66 cases of locally advanced nasopharyngeal carcinoma into 2 groups,of which 36 cases in the time-adjusted chemotherapy group and 30 cases in the conventional group.Both of them received docetaxel + cisplatin + fluorouracil regimen to induce chemotherapy for 2 cycles.The time-adjusted chemotherapy group was treated with intravenous injection of electronic automatic injection pump,the conventional group was treated with conventional intravenous infusion,and both groups were treated with synchronous cisplatin combined with IMRT.Calculated survival rate was generated by Kaplan-Meier method and long-term adverse reactions was evaluated according to CTC 3.0 criteria.Results The 3-year overall survival (OS) rate was 86.1％ and 93.3％ in the time-adjusted chemotherapy group and the regular group,the 3-year progress-free survival (PFS) was 83.3％ and 93.3％,the 3-year RFS was 88.5％ and 93.3％,and the 3-year recurrence-free survival was 94.1％ and 100％ respectively with no statistically significant difference (P ＞ 0.05).The dryness and hearing loss of the time-adjusted chemotherapy group had a decreasing trend compared with the conventional group.However,CD3 +,CD3 + CD4 +,CD3 + CD4 + CD8 +,and CD4 +/CD8 + of the time-adjusted chemotherapy group had an increasing trend compared with the conventional group.Conclusions Both time-adjusted chemotherapy and conventional chemotherapy combined with IMRT had comparable mid-term efficacy,but the former had lower adverse reactions,improved quality of life and immune function.Trial registration Chinese clinical trial registry,ChiCTR1800016809

To establish the experts consensus on the management of delirium in critically ill patients.A special committee was set up by 15 experts from the Chinese Critical Hypothermia-Sedation Therapy Study Group.Each statement was assessed based on the GRADE (Grading of Recommendations Assessment,Development,and Evaluation) principle.Then the Delphi method was adopted by 36 experts to reassess all the statements.(1) Delirium is not only a mental change,but also a clinical syndrome with multiple pathophysiological changes.(2) Delirium is a form of disturbance of consciousness and a manifestation of abnormal brain function.(3) Pain is a common cause of delirium in critically ill patients.Analgesia can reduce the occurrence and development of delirium.(4) Anxiety or depression are important factors for delirium in critically ill patients.(5) The correlation between sedative and analgesic drugs and delirium is uncertain.(6) Pay attention to the relationship between delirium and withdrawal reactions.(7) Pay attention to the relationship between delirium and drug dependence/ withdrawal reactions.(8) Sleep disruption can induce delirium.(9) We should be vigilant against potential risk factors for persistent or recurrent delirium.(10) Critically illness related delirium can affect the diagnosis and treatment of primary diseases,and can also be alleviated with the improvement of primary diseases.(11) Acute change of consciousness and attention deficit are necessary for delirium diagnosis.(12) The combined assessment of confusion assessment method for the intensive care unit and intensive care delirium screening checklist can improve the sensitivity of delirium,especially subclinical delirium.(13) Early identification and intervention of subclinical delirium can reduce its risk of clinical delirium.(14) Daily assessment is helpful for early detection of delirium.(15) Hopoactive delirium and mixed delirium are common and should be emphasized.(16) Delirium may be accompanied by changes in electroencephalogram.Bedside electroencephalogram monitoring should be used in the ICU if conditions warrant.(17) Pay attention to differential diagnosis of delirium and dementia/depression.(18) Pay attention to the role of rapid delirium screening method in delirium management.(19) Assessment of the severity of delirium is an essential part of the diagnosis of delirium.(20) The key to the management of delirium is etiological treatment.(21) Improving environmental factors and making patient comfort can help reduce delirium.(22) Early exercise can reduce the incidence of delirium and shorten the duration of delirium.(23) Communication with patients should be emphasized and strengthened.Family members participation can help reduce the incidence of delirium and promote the recovery of delirium.(24) Pay attention to the role of sleep management in the prevention and treatment of delirium.(25) Dexmedetomidine can shorten the duration of hyperactive delirium or prevent delirium.(26) When using antipsychotics to treat delirium,we should be alert to its effect on the heart rhythm.(27) Delirium management should pay attention to brain functional exercise.(28) Compared with non-critically illness related delirium,the relief of critically illness related delirium will not accomplished at one stroke.(29) Multiple management strategies such as ABCDEF,eCASH and ESCAPE are helpful to prevent and treat delirium and improve the prognosis of critically ill patients.(30) Shortening the duration of delirium can reduce the occurrence of long-term cognitive impairment.(31) Multidisciplinary cooperation and continuous quality improvement can improve delirium management.Consensus can promote delirium management in critically ill patients,optimize analgesia and sedation therapy,and even affect prognosis.

Objective: To analyze the epidemiological history, clinical manifestations, treatment and the short-term prognosis of 31 cases of 2019 novel coronavirus(2019-nCoV) infection in children from six provinces (autonomous region) in northern China. Methods: A retrospective analysis of the epidemiological history, clinical symptoms, signs, laboratory examinations, chest imaging, treatment and the short-term prognosis of 31 cases of 2019-nCoV was conducted. The patients were diagnosed between January 25th, 2020 and February 21st, 2020 in 21 hospitals in 17 cities of six provinces(autonomous region) of Shaanxi, Gansu, Ningxia, Hebei, Henan and Shandong. Results: The age of the 31 children with 2019-nCoV infection was 7 years and 1 month (6 months -17 years). Nine cases (29%) were imported cases. Other 21 cases (68%) had contact with confirmed infected adults. One case (3%) had contact with asymptomatic returnees from Wuhan. Among the 31 children, 28 patients (90%) were family cluster cases. The clinical types were asymptomatic type in 4 cases (13%), mild type in 13 cases (42%), and common type in 14 cases (45%). No severe or critical type existed. The most common symptom was fever (n=20, 65%), including 1 case of high fever, 9 cases of moderate fever, 10 cases of low fever. Fever lasted from 1 day to 9 days. The fever of fifteen cases lasted for ≤3 d, while in other 5 cases lasted > 3 d. Other symptoms included cough (n=14, 45%), fatigue (n=3, 10%) and diarrhea (n=3, 9%). Pharyngalgia, runny nose, dizziness, headache and vomiting were rare. In the early stage, the total leukocytes count in peripheral blood decreased in 2 cases (6%), the lymphocytes count decreased in 2 cases (6%), and the platelet count increased in 2 cases (6%).Elevation of C-reactive protein (10%, 3/30), erythrocyte sedimentation rate(19%,4/21), procalcitonin(4%,1/28), liver enzyme(22%, 6/27) and muscle enzyme (15%, 4/27) occurred in different proportions. Renal function and blood glucose were normal. There were abnormal chest CT changes in 14 cases, including 9 cases with patchy ground glass opacities and nodules, mostly located in the lower lobe of both lungs near the pleural area. After receiving supportive treatment, the viral nucleic acid turned negative in 25 cases within 7-23 days. Among them, 24 children (77%) recovered and were discharged from hospital. No death occurred. Conclusions In this case series, 2019-nCoV infections in children from six provinces (autonomous region) in northern China are mainly caused by close family contact. Clinical types are asymptomatic, mild and common types. Clinical manifestations and laboratory examination results are nonspecific. Close contact history of epidemiology, nucleic acid detection and chest imaging are important bases for diagnosis. After general treatment, the short-term prognosis is good.