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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.
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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.
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Objective:To evaluate the efficacy of ultrasound-guided adductor canal approach to nerve block using one-puncture four-point technique for analgesia after total knee arthroplasty (TKA).Methods:Sixty patients of both sexes, aged 65-80 yr, with body mass index of 18-27 kg/m 2, of American Society of Anesthesiologists physical status Ⅱor Ⅲ, scheduled for elective unilateral TKA under general anesthesia, were enrolled in this study.Peripheral nerve block was performed for postoperative analgesia under ultrasound guidance.All the patients were allocated into 2 groups ( n=30 each) using a random number table method: adductor canal block combined with posterior approach to sciatic nerve block group (group ASB) and adductor canal approach to nerve block using one-puncture four-point technique including sciatic nerve, medial vastus muscle nerve, saphenous nerve, anterior femoral cutaneous nerve at adductor canal level group (group ANSB). When visual analogue scale score ≥4 during postoperative movement, ketorolac tromethamine 0.6 mg/kg was intravenously injected as rescue analgesic. The muscle strength of quadriceps on the affected side, range of knee joint motion and rate of the ability to walk for 10 m using the walker were recorded at 2, 8, 24 and 48 h after surgery.The consumption of analgesics for rescue analgesia, manipulation completion time, length of hospital stay and patients′ satisfaction score were recorded within 48 h after surgery. Results:Compared with group ASB, the consumption of ketorolac tromethamine was significantly reduced, manipulation completion time and length of hospital stay were shortened, patients′ satisfaction scores were increased, and the range of knee joint motion and rate of the ability to walk for 10 m using the walker were increased at 2, 8, 24 and 48 h after surgery in group ANSB ( P<0.05). There was no significant difference in muscle strength of quadriceps between two groups ( P>0.05). Conclusion:Ultrasound-guided adductor canal approach to nerve block using one-puncture four-point technique provides better efficacy than adductor canal block combined with posterior approach to sciatic nerve block when used for analgesia after TKA.
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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.
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A comprehensive assessment tool for home care can help to determine the service needs.This article summarizes some of the advanced assessment scales that have been internationally applied for the home health care and to discuss the direction for development of the assessment tools in China.
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Objective To compare of the application of tracheal intubation guided by Lightwand,Shikani optical stylet,or Macintosh. Methods Ninety ASA Ⅰ~Ⅱ patients undergoing elective general anesthesia were randomly divided into three groups(n = 30):Macintosh group(group M),Lightwand group(group L)and Shi-kani optical stylet group(group S). MAP and HR were recorded at the time of entering the operating room(T1), before intubation(T2),at the immediate time of intubation(T3),3 mins(T4)and 5 mins after intubation(T5). The intubation duration,the first intubation success rate,the number of intubation,and the incidence of complications including sore throat were observed. Results As compared with T1,MAP and HR decreased significantly at T2in the three groups(P<0.05). As compared with T2,HR increased in group L and MAP and HR increased in group S at T3(P<0.05). As compared with group M,MAP and HR at T4and T5were lower in groups L and S(P<0.05). The first intubation time was obviously shorter in group L than in other groups(P<0.05). The incidence of compli-cations was lower in group S(P < 0.05). The first success rate of intubation,the intubation times and the inci-dence of airway complications did not differ significantly among the three groups.(P > 0.05). Conclusions As compared with Macintosh,Lightwand and Shikani optical stylet have less influence on hemodynamic parameters. Lightwand needs shorter intubation time,Shikani optical stylet has the lowest rate of sore throat.
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Given the increasing exploitation of antibodies in different contexts such as molecular diagnostics and therapeutics, it would be beneficial to unravel properties of antigen-antibody interaction with modeling of computational protein-protein docking, especially, in the absence of a cocrystal structure. However, obtaining a native-like antigen-antibody structure remains challenging due in part to failing to reliably discriminate accurate from inaccurate structures among tens of thousands of decoys after computational docking with existing scoring function. We hypothesized that some important physicochemical and energetic features could be used to describe antigen-antibody interfaces and identify native-like antigen-antibody structure. We prepared a dataset, a subset of Protein-Protein Docking Benchmark Version 4.0, comprising 37 nonredundant 3D structures of antigen-antibody complexes, and used it to train and test multivariate logistic regression equation which took several important physicochemical and energetic features of decoys as dependent variables. Our results indicate that the ability to identify native-like structures of our method is superior to ZRANK and ZDOCK score for the subset of antigen-antibody complexes. And then, we use our method in workflow of predicting epitope of anti-Ebola glycoprotein monoclonal antibody-4G7 and identify three accurate residues in its epitope.
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Objective To compare the applicability of the Beijing Version of the Montreal Cognitive Assessment (MoCA) and the Mini Mental State Examination (MMSE) in screening for cognitive impairment in patients with acute ischemic stroke for 2-3 weeks.Methods MoCA and MMSE were conducted in 201 patients with acute ischemic stroke within 2 to 3 weeks after the onset of stroke.With MoCA＜23 and MMSE ＜26 as the cut off value,we assessed the clinic effect of the MoCA and MMSE and explored the correlation between two instruments.Results The average scores of MoCA and MMSE scale were (20.5±4.3) and (25.4±3.5) points.The prevalence of cognitive impairment evaluated with MoCA and MMSE were 57.2％and 43.3％,respectively.MoCA showed significant correlation with MMSE score (Pearson's correlation coefficient=0.833,P＜0.001),and an agreement with Kappa values of 0.532 (P＜0.01) in screening for cognitive impairment.Conclusions The prevalence of cognitive impairment assessed with MoCA is higher than that of with MMSE when using MoCA＜23 and MMSE＜26 as the cut off values.Both instruments show a good agreement for screening cognitive impairment in acute ischemic stroke within 2 to 3 weeks following the disease onset.
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Communication skills are the basic requirement for general practitioners,the continuous improvement of communication skills is the guarantee of the service quality.It is crucial to establish an effective evaluation system in the training of communication skills for general practitioners.This article reviews the current status of evaluation scales of doctor-patient communication skill commonly used in China and other countries to provide reference for the establishment of the communication skill evaluation system for general practitioners which is suitable for China's condition.
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Objective Through summarizing quality management practices of international cooperative academic clinical studies funded by Peking University Health Science Center,analyzing its present major challenges of implementation in China,this paper proposed related measurements and suggestions to improve the quality of clinical research.Methods To sort the project management archive data,as well as descriptive analysis of the common monitoring/auditing findings.Results From the year 2011 to 2016,there were 14 such studies funded by Peking University health science center,common findings during monitoring and or auditing were classified as following categories,study files problem (100.0％),ethics problem (71.4％),protocol noncompliance (64.3％),data quality issues (71.4％),communication problem in study teams (14.3％),export problems of bio-specimens (14.3 ％),recruiting delay (14.3 ％) and cooperation termination in advance (7.1 ％).Conclusions In order to obtain credible and reliable data,peer recognized research conclusion and accurate answered scientific questions,it is essential for investigators to comply with laws and regulations and being strongly supported.Furthermore,researchers also need to establish and strictly follow study protocols,standard operating procedures (SOPs),research quality management system and relevant national laws and regulations that are comply with actual requirements in China.
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Objective To evaluate analgesic effect of dexmedetomidine (DEX) combined with ropivacaine in single sciatic nerve block after total knee arthroplasty (TKA) with continuous femoral never block.Meth ods One hundred and twenty patients,ASA physical status Ⅰ ～ Ⅱ,who underwent unilateral TKA were randomly allocated into two groups:group D (DEX with ropivacaine);group R (ropivacaine only).Both groups experienced spinal-epidural anesthesia.Continuous femoral nerve block was performed after operation.Rest and movement visual analogue score (VAS),Ramsay sedation scores were recorded.In addition to the date of the analgesia drug dose,the pressed times of PCA,the mobility of knee joint and the force of quadriceps femoris were obtained at different points of time.Results Rest Pain scores (RVAS) of the group D were lower at time point 8,12,24,36,48 h and Ramsay sedation scores were higher at time point 4,8,12 h than that in the group R (P ＜ 0.05).The analgesia drug dose and the pressed times of PCA reduced in the group D.The range of motion (ROM) was better in the group D at 1 d,2 d after operation (P ＜ 0.05).There was no significant difference in the force of quadriceps femoris in both groups.Conclusion Dexmedetomidine combined with ropivacaine in single sciatic nerve block after TKA provided better analgesia when continuous femoral nerve block was performed.Meanwhile,analgesia lasted longer and did not increase the motor nerve blockade.
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Objective To investigate the utilization and satisfaction of family doctor service among contract-signing residents in Beijing urban area,and the related influencing factors.Methods Total 740 contract-signing residents visiting community health service centers of two urban districts in Beijing from June to September of 2015 were selected with purposive sampling as study subjects.All participants completed a questionnaire survey on the utilization and satisfaction of the service provided by family doctors.The influencing factors related to satisfaction were analyzed by chi-square test and multivariate Logistic regression.Results The survey showed that 73.9％ (547/740) of the participants would seek service in community health service centers first when their illness was mild;while 56.2％ (416/740) of the participants would seek service in secondary or tertiary hospitals directly.Four out of 8 contracted services were mostly utilized:personalized health counseling (732/740,98.9％),chronic disease management (721/740,97.4％),health promotion guidance (626/740,84.6％),and health education (614/740,83.0％).The satisfaction rates for service attitude of family doctor,the contents of contracted service,the competence of family doctor and the environment of clinical setting were 82.7％ (612/740),75.4％ (558/740),72.8％ (539/740) and 70.4％ (521/740),respectively.The satisfaction rates of service contents were 85.4％ (164/192) for home visit,81.3％ (248/305) for appointment of experts in tertiary hospital,76.8％ (562/732) for personalized health counseling,76.3％ (550/721) for chronic disease management,75.2％ (471/626) for health promotion guidance,74.4％ (457/614) for health education,72.8％ (302/415) for referral service,and 65.7％ (305/464) for appointment of next visit.Logistic regression showed that the quality of family doctor service in the community health service institutions (OR =2.693,P =0.000) and education levels of residents (OR =0.680,P =0.008) were the factors related to the satisfaction of the patients.Conclusion The contract-signing residents in Beijing urban area are willing to go to the community health service institutions,and generally satisfied with the service.But the service contents and service quality need to be further improved.
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Objective To compare the application of Shikani optical stylet(SOS)and Clarus Video Sty-let(Tracway)in patient with cervical spine immobilization in tracheal intubation. Method Sixty patients,ASAⅠ~Ⅱ,undergoing cervical internal fixation operation,were randomly divided into Shikani optical stylet group (Group S,n = 30)and Clarus Video Stylet group(Group T,n = 30). MAP,HR and RPP(The rate-pressure product)were recorded at the point before induction of anesthesia(T1),before intubation(T2),at the immediate time of intubation(T3)and 1 min(T4),3 mins(T5),and 5 mins after intubation(T6).The intubation time,one-time success rate of intubation,the number of intubation times and the incidence of sore throat and other complica-tions were observed. Results The one-time intubation time in group S was obviously shorter than that in group T (P<0.05).The incidence of mild sore throat and intubation throat injury rate were lower in group S than those in group T(P<0.05).Compared with those at T1,MAP and RPP decreased significantly at point of T2~T6in both of two groups(P<0.05).There was no significantly difference in MAP,HR and RPP at any points of time between the two groups. The one-time success rate of intubation,the number of intubation times and the incidence of air-way complications in two groups(P>0.05)were no significantly different. Conclusions Compared with Clarus Video Stylet(Tracway),Shikani optical stylet can shorten the intubation time in patients with cervical spine immo-bilization,but no difference was found in regard to the hemodynamic influence on intubation,success rate of intu-bation,the intubation times,the sore throat and the other related complications.
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Objective To solve the difficulty of intubation of nasojejunal feeding tube under digital subtraction angiography (DSA) system when conventional methods were failed.Methods Seventy-one patients who failed to place the nasojejunal feeding tube by single guide wire under DSA conventional methods.With the methods of decreasing the stomach volume,changing the body posi-tion,and using a catheter or gastrointestinal motility,the nasojejunal feeding tube was placed into the proper position (more than 30cm far away from Treitz or gastrointestinal anastomosis).Results All the procedures were successfully accomplished.No compli-cations,such as throat damage,abdominal pain,perforation and hemorrhage of digestive tract were found.The mean duration under DSA was four minutes (2-7min).Conclusion With the help of various methods above,we can improve the success rate of intuba-tion and reduce the duration of the nasojejunal feeding tube placement,when conventional methods were failed.
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<p><b>OBJECTIVE</b>Psoriasis is an autoimmune-related chronic inflammatory skin disease strongly associated with the dysfunction of Th17 cells. Retinoic acid-related orphan nuclear receptor γt (RORγt) plays a critical role in the differentiation and maturation of Th17 cells and in cell-derived immunologic derangement. We conducted this study to investigate potential mechanism by which the derivative of digoxin selectively antagonizes RORγt transcriptional activity.</p><p><b>METHOD</b>Using molecular docking in combination with molecular electrostatic potential (MEP), we detected the interaction between the derivative of digoxin (Dhd) and ROR transcription factor (RORα,RORβ and RORγt), and the results were further confirmed by bioluminescent assay.</p><p><b>RESULT</b>Molecular docking demonstrated that Dhd could exclusively inhibit the conformation of RORγt; bioluminescent assay further indicated that RORγt was selectively antagonized by Dhd in a dose- and time-dependent manner.</p><p><b>CONCLUSION</b>Dhd can selectively suppress RORγt transcriptional activity.</p>
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Humans , Digoxin , Pharmacology , Models, Chemical , Molecular Docking Simulation , Nuclear Receptor Subfamily 1, Group F, Member 1 , Genetics , Transcription, GeneticABSTRACT
Objective To study the effect of health education on glycolipid metabolism of patients with diabetes mellitus.Methods 120 patients with type-2 diabetes mellitus were divided into the general-education group and the reinforcement-education group with 60 patients in each group,who received routine health education and reinforced health education.The index of glycolipid metabolism between two groups were compared.Results The TG,TC,HDL,LDL,HbA1C,GLU0 and GLU120 of the two groups were all higher than those before treatment.And the TG,TC,LDL,HbA1C,GLU0 and GLU120 of the reinforcement-education group were higher than those of the general-education group after six months.Conclusions The earlier health education,especially reinforced health education,has profound significance on maintaining good glycolipid metabolism for patients with diabetes mellitus.
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OBJECTIVE To explore the incidence of sharp instrument injuries among nurses from the various classes of medical institutions and to analyze the cause and investigate the preventive countermeasures.METHODS To survey the sharp instrument injuries in nursing among 1050 nurses from 50 medical institutions.From 1050 questionaires,1028 were performed.RESULTS Among 1028 nurses from 50 medical institutions,903 nurses suffered different degrees of sharp instrument injuries with 87.84%,of which 40.75% and 31.12% were caused respectively in working age of 6-10 years and 11-15 years.All injury cases added up to 7059,with average of 7.80 times per person and 287(31.78%) cases were with over 10 times.Injuries for ampule in dispensing and clearance of instruments accounted for 70.63% and 15.54%,with the times of 4986 and 1097.Degrees of injury:the light injury of skin accounted for 57.69% with 4076 cases.CONCLUSIONS It is suggested to reform the craft of ampules and safety of instruments continually.Instrument cleaner is recommended if necessary.The key point is to strengthen the education of awareness on occupational protection and do self-protection best,which is sharply important to reduce the incidence of injuries.
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Objective To study the effects of Grape Procyanidins(GPC)on hemorheology in long distance runner.Method In vitro study: 22 long distance runners were divided into two groups randomly,the experimental group and control group.With ten days period,the experimental group was given GPC 200 mg per day;while the control group were given the capsule of starch 200 mg per day.In vivo study: the vein blood samples were taken from 5 long distance runners and every example was divided into five parts,and then treated with different concentrations of GPC or H2O2.Items of the hemorheology such as Er,HCT,Eb,Ep,PFC and VAI were tested both in vivo and vitro before and after the study.Results in vitro study: all items of the experimental group showed significant decline at then end of the study than those before the study.The contents of Er,Eb and Ep before the study(6.830?0.164,4.145?0.177,1.647?0.020,respectively) were significantly higher than those after the study(6.759?0.158,4.088?0.173,1.621?0.013,respectively)(P