| Objective:Interpretation of "Acupuncture And Clomiphene Citrate On Live Birth In Infertile Women With Polycystic Overy Syndrome:Randomized Controlled Trail"(PCOSAct),based on Internet-based platform,It’s mainly about the project management and quality control measures,analyzing methods as well as results,based on Internet-based platform,for PCOSAct project management and quality control results,sharing experiences,in order for the Internet platform applications on large RCT management functionality and the need to provide an objective basis for the promotion of Chinese medicine to contribute to the international clinical trials.Method:Research starting from July 2012 to March 2015,which covers the whole course of PCOSAct project,including the daily work reports DCC,9 times DSMB meeting reports real-time database monitoring information,and statistical analysis for the PCOSAct project management and quality control results.1.PCOSAct recruitment project progress:analyzing the recruitment of 1000 cases of subjects from July,2012 to October 2014,studying the whole course of recruitment,and evaluating PCOSAct recruitment project progress.2.Deviation from the program event:collecting the reports for the "deviation from the program event" conducted by DCC,analyzing 23 different reasons classification,the occurrence of "deviation from the program event" in 21 branch centers,"deviation from the program event" caused by the mistake of researchers,as well as assessing the understanding and implementation of the researchers,with regard to the project scheme.3.eCRF entry conditions:analyzing the overall inspecting results of eCRF in October,2013,counting up the type of entries errors,entries locations and the process of entries of each branch center,as well as evaluating the quality of entries of eCRF.4.Adverse event cases:analyzing the adverse event cases,which includes adverse events during subject’s medication,adverse events of subject’s husband,as well as the adverse events of subject’s pregnancy and newborns.Evaluating the security for subjects conducted by PCOSAct.5.Subjects credibility analysis:analyzing the credibility of the subjects during the early period of the treatment(after the third time of acupuncture)and the period when the treatment has just finished(after the last time of acupuncture),so as to evaluate the subjects’ credibility for PCOSAct.6.Investigation for pathogenic factors among subjects:analyzing the distribution of BMI,WHR and LH/FSH among subjects of PCOSAct project in 13 provinces and municipalities,and giving statistics concerning clinical characteristics among subjects and the related pathogenic factors.7.Analysis of ovulation and pregnancy:(1)subjects of ovulation and pregnancy situation in north and south branch-center(2)subjects of ovulation and pregnancy situation in Traditional Chinese and Western hospital(3)subjects of ovulation and pregnancy situation in the capital of hospitals and local hospitals(4)subjects of ovulation and pregnancy situation in all the administrative regions(5)subjects of ovulation and pregnancy situation in different BMI(6)subjects of ovulation and pregnancy situation in different WHR(7)subjects of ovulation and pregnancy situation in different LH/FSH.Evaluating of the possibilities of promotions for PCOSAct project.Results:1.PCOSAct recruitment project progress:The actual recruitment took 28 months to complete,with an average enrollment of about 38 cases a month.The original recruitment is expected to take 18 months to complete,with an average enrollment of about 56 cases a month.It’s about 32%slower than the original enrollment.It’s inconsistent among different branch-centers with regard to recruitment progress.The recruitment progress is also inconsistent in three management teams,including the South branch-center recruiting 442 subjects,the north branch-center recruiting 558 subjects,new branch-center recruiting 364 subjects,old branch-centers recruiting 636 people,branch-centers of Traditional Chinese recruiting 535 subjects,and sub-centers of West hospital recruiting 465 subjects.However,due to other factors mixed,the described data above is not statistically compared.2.Deviation from the program event:according to the classification of 23 various kinds of reasons resulting from deviation from the program event,five reasons are as follows:subjects didn’t have the inspection for weekly progesterone and HCG;the subjects undertook the treatment without having all the inspections;the subjects were given other drugs for treatment,not based on original plan;test drugs were lost or missing;subjects did not follow the program of acupuncture twice one week.There are all together 210 cases of deviation from the program event based on the five reasons mentioned above,accounting for 63 percent,mainly caused by subjects themselves.Deviation caused by the researchers scattered among 23 kinds of reasons,not sharing a common characteristic.(2)extracting deviation caused by the researchers,the matter south,north,hospitals,Western Hospital,in the new center,the old center and three management teams in each group were prompted deviation caused by the investigator program compared with fewer incidents caused by the subjects;in North and South sub-centers,sub-centers and Western hospital,deviation between the old and new sub-program events center between two groups of researchers caused no significant difference in the three management groups there are differences between the comparison.3.eCRF entry conditions:(1)the general condition:429 entries problems are found,of which 361 are baseline problem,accounting for 84.15%;26 entries belong to the problems of the treatment,accounting for 6.06%;42 entries are the ones after treatment,accounting for 9.79%.(2)the conditions in branch-centers:17,21and 20 branch-centers are the ones having relatively high typographical errors while 11,12 and 10 branch-center have lower typographical errors.(3)Type of errors:Unit typographical errors,time entry errors,numerical entry errors and errors in filling were:92,296,20,21.accounting for 21.45%,69.00%,4.66%,and 4.90%,respectively.4.Adverse event cases:(1)adverse events during the PCOSAct project medication were 1080,wherein 152 are the subject needling adverse events,902 are the subject non-acupuncture adverse events,52 are adverse events caused by subjects’ husbands.(2)657 adverse events of pregnant mother giving birth to newborns exist in PCOSAct projects,including 600 adverse events during pregnancy,6 maternal events,and 51 neonatal adverse events.5.Subjects credibility analysis:(1)analyzing the credibility of the subjects during the early period of the treatment(after the third time of acupuncture):compared with south branch-centers,subjects in north branch-centers have higher credibility for this project;compared with hospitals of traditional Chinese medicine,the subjects in western hospitals have higher credibility for this project;there are no significant difference between the old and new sub-centers.(2)the period when the treatment has just finished(after the last time of acupuncture):compared with hospitals of traditional Chinese medicine,the subjects in western hospitals have higher credibility for this project;there are no significant difference between the old and new sub-centers.6.Investigation for pathogenic factors among subjects:(1)the average of BMI is the 24.24±3.38.The first three among 13 provinces and municipalities are the highest Tianjin 26.23±3.95,Heilongjiang 26.20 ±3.70,and Shandong 25.55 ±3.54;(2)the average WHR of the subjects is 0.87 ±0.06.The first three among 13 provinces and municipalities are Shanxi 0.91 ±0.06,Heilongjiang 0.89 ±0.06,and Hunan 0.89 ±0.05.(3)the average LH/FSH of the subjects is 1.78 ± 0,80.The first three among 13 provinces and municipalities are Anhui 2.23± 1.09,Jiangsu 1.99±0.88,and Jiangxi,1.90±0.80.7.Analysis of ovulation and pregnancy:(1)there is no significant statistical difference in the number of cases PCOSAct project ovulation between north and south center,Western and traditional Chinese Medicine hospitals,as well as capital hospitals and local hospitals;(2)as for pregnancy rate,there is no significant statistical difference between north and south centers,between capital hospitals and local hospitals.However,compared with hospitals of Traditional Chinese Medicine,pregnancy in western hospitals are higher;(3)ovulation rate and pregnancy rate differ among different provinces;(4)subjects of BMI>28 have lower ovulation cases than those below BMI<28 subjects while subjects of BMI>28 have lower pregnancy rate than those of BMI<18.5.(5)the number of cases of subjects ovulation and pregnancy rate has nothing to do with the WHR distribution;(6)subjects of LH/FSH<1 subject have higher number of cases of ovulation than LH/FSH>1;but there are no connections between LH/FSH distribution and pregnancy rates.conclusion:1,The management and quality control of PCOSAct project,based on Internet platform,are effective.2,It is inconsistent in the recruitment progress in each team.Therefore,it’s better to adjust branch-centers recruiting standards which is based on the real recruitment of subjects.3,According to factors that deviate from the program of events,it is good to strengthen the explanation of subjects,minimizing deviation from the program event of non-objective factors.4,The researchers grasp and implement the project in a stable way.5,The quality of database entry needs to be improved,and it should focus on baseline data entry time and units.6,There are less adverse events in PCOSAct project,which has a good basis for promotion.7,The recruited subjects from the western hospital do not exclude acupuncture treatment,which indicates that there is higher trust in the project.8,China BMI PCOS patients with WHR,LH/FSH are lower than in other countries.9,Ovulation condition among subjects in PCOSAct is closely connected with BMI and LH/FSH;pregnancy situation is closely connected with BMI and WHR. |
