***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background In 2007 , the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM ) convened a special conference to discuss quality control for TCM clinical research . Control and assurance st and ards were established to guarantee the quality of clinical research . This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture r and omized controlled trials ( RCTs ) . Methods A st and ard quality control program ( QCP ) was established to monitor the quality of acupuncture trials . Case report forms were design ed ; qualified investigators , study personnel and data management personnel were trained . Monitors , who were directly appointed by the project leader , completed the quality control programs . They guaranteed data accuracy and prevented or detected protocol violations . Clinical centers and clinicians were audited , the r and omization system of the centers was inspected , and the treatment processes were audited as well . In addition , the case report forms were review ed for completeness and internal consistency , the eligibility and validity of the patients in the study was verified , and data was monitored for compliance and accuracy . Results and discussion The monitors complete their reports and su bmi t it to quality assurance and the sponsors . Recommendations and suggestions are made for improving performance . By holding regular meetings to discuss improvements in monitoring st and ards , the monitors can improve quality and efficiency . Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials . It will also develop academic excellence and further promote the international recognition of acupuncture The Multiple Risk Factor Intervention Trial ( MRFIT ) was a r and omized primary prevention trial design ed to test the effect of multifactor intervention on mortality from coronary heart disease . Before r and omization , men were seen at three screening visits to establish eligibility . A total of 361,662 men were screened , and 12,866 men were r and omized , 866 more than the goal of 12,000 . The total time required for planning and recruitment was 44 months . Eligibility rates and dropout or refusal rates between screening visits varied considerably among the 20 clinics that took part in MRFIT . The variation in eligibility rates result ed largely from subjective interpretation by the staff of the willingness of the men to participate in the study and to make risk factor changes . Cigarette smokers and blacks were more likely to discontinue their participation between screening exams . The ultimate success of the MRFIT recruitment is attributed to ( 1 ) the previous experience of investigators in screening large numbers of participants for clinical trials and similar epidemiologic investigations , ( 2 ) the identification at each clinic of one or more persons whose specific responsibility was recruitment , ( 3 ) the phased entry of clinics into the study , ( 4 ) routine monitoring and reporting of recruitment rates by the coordinating center , ( 5 ) regular discussion of recruitment successes and problems at the Steering Committee meetings , and ( 6 ) site visits to examine in detail recruitment problems The Prostate , Lung , Colorectal and Ovarian ( PLCO ) Cancer Screening Trial is enrolling 148,000 men and women ages 55 - 74 at ten screening centers nationwide with balanced r and omization to intervention and control arms . For prostate cancer , men receive a digital rectal examination and a blood test for prostate-specific antigen . For lung cancer , men and women receive a posteroanterior view chest X-ray . For colorectal cancer , men and women undergo a 60-cm flexible sigmoidoscopy . For ovarian cancer , women receive a blood test for the CA125 tumor marker and transvaginal ultrasound . Members of the control arm continue with their usual care . Follow-up in both groups will continue for at least 13 years from r and omization to assess health status and cause of death . The primary endpoint is mortality from the four PLCO cancers , which accounts for about 53 % of all cancer deaths in men and 41 % of cancer deaths in women in the United States each year . Blood specimens are collected from screened participants , buccal cell DNA from controls , and histology slides from cases ; these are maintained in a biorepository . Participants complete a baseline question naire ( covering health status and risk factors ) and a dietary question naire . More than 12,000 participants were enrolled in the pilot phase ( concluded in September 1994 ) . Changes in the eligibility criteria followed . As of April 2000 , enrollment exceeded 144,500 . Data are scanned into design ated on-site computers for uploading by participant identification number to the coordinating center for quality checks , archival storage , and preparation of analysis data sets for use by the National Cancer Institute ( NCI ) . Scientific direction is provided by NCI scientists , trial investigators , external consultants , and an independent data safety and monitoring board . Performance and data quality are monitored via data edits , site visits , r and om record audits , and teleconferences . The PLCO trial is formally endorsed by the American Cancer Society and has been ranked by the American Urological Association as one of the most important prostate cancer studies being conducted . Special efforts to enroll black participants are cosponsored by the U.S. Centers for Disease Control and Prevention The Optic Neuritis Treatment Trial ( ONTT ) was an investigator-initiated , multi-centered , r and omized , controlled clinical trial supported by cooperative agreements and grants . It was design ed to evaluate the efficacy and safety of oral prednisone or intravenous methylprednisolone followed by oral prednisone as compared with oral placebo . The primary outcome measures were contrast sensitivity and visual field ; secondary measures were visual acuity and color vision .  Four hundred fifty-seven patients were followed for a minimum of 6 months and a maximum of 3 years . This article describes the design and the methods used to implement the ONTT Background Surgery is of increasing importance in the treatment and outcome of diseases of the pancreas worldwide . The incidence of pancreatic cancer ( 7—11/ 100,000 per year ) has risen over the last years and surgical resection remains the only option for definite cure . Twenty-five percent of all resections are left of the superior mesenteric vein ( distal pancreatectomy ) and the appropriate closure technique for the pancreatic remnant remains unclear . Pancreatic fistulas are the most common ( 0—40 % ) and relevant postoperative complication . The optimal surgical strategy for pancreatic resection needs to be identified from the large number of surgical procedures available today . Purpose To evaluate the effectiveness of the two most common surgical techniques for distal pancreatectomy : stapler versus h and -sewn closure of the pancreatic remnant . Methods In order to account for the uncertainty and clinical heterogeneity in the management of the pancreatic remnant following distal pancreatectomy , a study protocol is developed on the basis of a retrospective survey of patients in a center of excellence for pancreatic surgery and a systematic review with meta- analysis . Results The DISPACT trial is a multicentered , r and omized , controlled and patient- and observer-blinded trial using a two-group parallel group-sequential superiority design to compare the two techniques mentioned above . It will include approximately 336 r and omized patients at up to 20 centers of excellence in pancreatic surgery , who are undergoing elective distal pancreatectomy for resectable benign , malign , and neuroendocrine tumors , chronic pancreatitis and pseudocysts of the pancreatic body and tail . The combination of the rate of postoperative pancreatic fistula and mortality will be evaluated as the primary endpoint . In addition , a set of general and surgical parameters will be analyzed . Pre-specified treatment manuals and continuous intra-operative ( photo-documentation of surgical procedures and blinded evaluation thereafter ) and on-site monitoring will assure that the treatment of the study patients conforms to protocol and will minimize clinical heterogeneity . Due to uncertainties about the effect sizes of the primary endpoint , an a priori planned interim analysis of the primary endpoint will be conducted after 224 evaluable patients are selected in order to reassess the initially planned sample size . Limitations Since pre-existing evidence was limited our initial sample size calculation is based on uncertain assumptions and may need to be modified in a planned interim analysis . Moreover , since surgical experience remains a potential confounder in surgical trials , learning curve bias has to be taken into account when analyzing the results . Given the participating trial sites , st and ardization of peri- and postoperative treatment represents a major issue of trial conduct . Conclusions A group-sequential study design accounts for the uncertainty of pre-existing evidence . Also , st and ardization of surgical and postoperative care and blinded outcome assessment as well as adjustment for varying surgical expertise will contribute to a high validity and generalizability of the results . Clinical Trials 2008 ; 5 : 534—545 . Objective : To provide an overview of the National Institute of Mental Health ( NIMH ) Collaborative HIV/STD Prevention Trial taking place in five population s at risk of HIV and sexually transmitted diseases in China , India , Peru , Russia , and Zimbabwe , including the rationale , study management , methods , and proposed data analyses . Design : The Trial will scientifically evaluate the effectiveness of the community popular opinion leader ( C-POL ) community-level HIV prevention intervention that was adapted for use in the various cultures within the re source limitations faced by service providers in world regions threatened by high rates of HIV infection . Methods : The study phases consist of an ethnographic study , pilot studies , an epidemiological study , and a community-r and omized trial . The Trial uses the C-POL intervention , which research ers selected on the basis of research that shows the intervention 's success in population s vulnerable to HIV risk behavior in the United States , and has the potential to be applied in a variety of international setting s. Results : Trial results will be tabulated by and across country by r and omization assignment . Results will include a careful review of data to substantiate original assumptions used in the study design . Data collection will not conclude until August 2007 . Conclusion : Although data collection is incomplete , research ers have learned lessons throughout the development of the study . These include the importance of preliminary epidemiological studies ; the close monitoring of biological testing , follow-up rates and process measures at international sites ; the tailoring of assessment s and interventions to various cultures ; regular communication ; and a review of the timeline to accommo date Institutional Review Board clearances The World Health Organisation , in collaboration with four developing countries , is conducting a r and omised controlled clinical trial to evaluate a new programme of antenatal care .  In a city or region in Argentina , Cuba , Saudi Arabia and Thail and , 53 clinical units were r and omly allocated to provide either the new programme or the programme currently in use . This paper describes the organisation of the data management system used to collect the data . Each woman participating in the trial is uniquely identified , and information such as her name , address and expected delivery date is recorded in the trial ' subject number list ' . If the clinic belongs to the intervention group , information about the woman 's eligibility is recorded on the classification form . Details of the outcome of the pregnancy are indicated on two additional case report forms : the antenatal  hospital  admission form and the summary form . When forms are completed by the investigators , they are su bmi tted to the country data coordinating centre ( CDCC ) . The CDCCs are responsible for the processing of the country study forms . This includes verification of the batch of forms , data capture into computer files , data verification , data validation , production of query sheets for data problems , maintenance and updating of study master files . All operations on data such as additions or modifications are performed using transaction processing . At monthly intervals , recruitment reports and transaction files are sent to the trial coordinating centre in Geneva . All transaction files are processed to accumulate data on the trial 's consoli date d master files . A monthly report including number of women recruited in the trial , adverse events reported by the countries , recruitment charts by clinic and analyses on eligible women in the intervention group is prepared and su bmi tted to the data safety and monitoring committee . A workshop was organised in 1995 , before the start of the trial , to introduce the data management system to the four participating countries . Annual site visits were made to each CDCC to monitor progress . Additional visits were made when major or critical problems could not be solved by the CDCC . At the closure of data collection , a visit is made to review and assess all data management procedures including form filling , maintenance of registers , computer files , query sheets , data modifications . In addition , final cleaning of the data is performed , and an analysis file is produced for inclusion in the central ised trial analyses and in the country-specific analyses . Based on the experience gained in this trial , the de central ised data management model can be advocated only if CDCCs that will be involved in the trial are already in place with competent and experienced staff . Uniformity of the data management system and of st and ard operating procedures across countries is also a crucial issue for the effective management of the data collection phase Pediatric asthma remains an important public health concern as its prevalence and cost to the health care system is rising . In order to promote innovative research in asthma therapies , the National Heart , Lung and Blood Institute created the Childhood Asthma Research and Education Network in 1999 . As its first study , the steering committee of the Childhood Asthma Research and Education Network design ed a r and omized clinical trial to determine if persistent asthma could be prevented in children at a high risk to develop the disease . This communication presents the design of its first clinical trial , the Prevention of Asthma in Kids ( PEAK ) trial and the organization of the Childhood Asthma Research and Education Network that developed and implemented this trial . Studies of the natural history of asthma have shown that , in persistent asthma , the initial asthma-like symptoms and loss of lung function occur predominately during the first years of life . Therefore , in the Prevention of Asthma in Kids study , children 2 and 3 years old with a positive asthma predictive index were r and omized to twice daily treatment with fluticasone 88 microg or placebo via metered-dose inhaler and Aerochamber for 
    Output:
    
Conclusions This review demonstrated that on-site monitoring is utilised in trials worldwide but systems vary considerably with little evidence to support practice .