Postoperative complications are important outcome measurements for surgical quality and safety control. However, the complication registration has always been problematic due to the lack of definition consensus and the other practical difficulties. This narrative review summarizes the data registry system for single institutional registry, national data registry, international multi-center trial registries in the western world, aiming to share the experience of complication classification and data registration. We interviewed Dr. Koh from Royal Prince Alfred Hospital in Australia for single institutional experience, Dr. van der Wielen and Dr. Desideriofor, from two international multi-center trial(STOMACH) and registry (IMIGASTRIC) respectively, and Prof. Dr. Wijnhoven from the Dutch Upper GI Audit(DUCA). The major questions include which complications are obligated to report in the respective registry, what are the definitions of those complications, who perform the registration, and how are the complications evaluated or classified. Four telephone conferences were initiated to discuss the above-mentioned topics. The DUCA and IMGASTRIC provided the definition of the major complications. The consent definition provided by DUCA was based on the LOW classification which came out after a four-year discussion and consensus meeting among international experts in the according field. However, none of the four registries asked for an obligatory standardization of the diagnostic criteria among the participating centers or surgeons. Instead, all the registries required a detailed recording of the diagnostic strategy and classification of the complications with the Clavien-Dindo scoring system. Most data were registered by surgeons or data managers during or immediately after the hospitalization. The investigators or an independent third party conducted the auditing of the data quality. Standardization of complication diagnosis among different centers is a difficult task, consuming much effort and time. On top of that, standardization of the complication registration is of critical and practical importance. We encourage all centers to register complications with the diagnostic criteria and following intervention. Based on this, the Clavien-Dindo classification can be properly justified, which has been widely accepted by most centers and should be routinely used as the standard evaluation system for postoperative complications in gastric tumor surgery.
Australia ; epidemiology ; Data Collection ; standards ; statistics & numerical data ; Diagnostic Techniques and Procedures ; standards ; statistics & numerical data ; Digestive System Surgical Procedures ; adverse effects ; statistics & numerical data ; Health Care Surveys ; Humans ; Netherlands ; epidemiology ; Postoperative Complications ; classification ; diagnosis ; epidemiology ; Registries ; standards ; Risk Assessment ; methods ; standards ; Stomach Neoplasms ; complications ; surgery

Due to a great amount of data in clinical trials, the data cleansing needs to adopt a variety of measures, including the latest developed visual check approach. According to the different types of clinical data and the different stages in the course of clinical data management, this study reviews 8 types of visual graphics that show the relevance and trend among the data. The series of graphics can rapidly detect abnormal data, monitor clinical research in real-time, make the data management process much easier and improve the clinical trial efficiency and data quality.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Information Storage and Retrieval ; methods

Missing data is a common but unavoidable issue in clinical trials. It not only lowers the trial power, but brings the bias to the trial results. Therefore, on one hand, the missing data handling methods are employed in data analysis. On the other hand, it is vital to prevent the missing data in the trials. Prevention of missing data should take the first place. From the perspective of data, firstly, some measures should be taken at the stages of protocol design, data collection and data check to enhance the patients' compliance and reduce the unnecessary missing data. Secondly, the causes of confirmed missing data in the trials should be notified and recorded in detail, which are very important to determine the mechanism of missing data and choose the suitable missing data handling methods, e.g., last observation carried forward (LOCF); multiple imputation (MI); mixed-effect model repeated measure (MMRM), etc.
Clinical Trials as Topic ; Data Collection ; methods ; standards ; Humans ; Models, Theoretical ; Research Design

Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: (1) important concepts of source data (e.g., source data originator, source data elements, source data identifier for audit trail, etc.); (2) various modalities of source data collection in paper and electronic methods (e.g., paper CRF, EDC, Patient Report Outcomes/eCOA, etc.); (3) seven main principles recommended in the aspect of data collection, traceability, quality standards, access control, quality control, certified copy and security during source data management; (4) a life cycle from source data creation to obsolete is used as an example to illustrate consideration and implementation of source data management.
China ; Data Collection ; standards ; Documentation ; standards ; Information Storage and Retrieval ; methods ; standards

According to the process of the technical specification (TS) design for the fourth national survey of the Chinese materia medica resources (CMMR), we analyzed the assignment and objectives of the national survey and pointed out that the differences about CMMR management around China, the distribution of CMMR and their habitat, the economic and technological level, and even enthusiasm and initiative of the staff, etc. are the most difficult points for TS design. And we adopt the principle of combination of the mandatory and flexibility in TS design. We fixed the key points which would affect the quality of national survey first, then proposed the framework of TS which including 3 parts of organization and 11 parts of technique itself. The framework will serve and lead the TS preparation, which will not only provide an action standard to the national survey but will also have a profound influence to the popularization and application of the survey technology of CMMR. [Key words]
Chemistry, Pharmaceutical ; legislation & jurisprudence ; manpower ; methods ; standards ; China ; Conservation of Natural Resources ; Data Collection ; Drugs, Chinese Herbal ; chemistry ; standards ; Materia Medica ; chemistry ; standards ; Quality Control

To validate the use of the Index of Complexity, Outcome and Need (ICON) in assessing orthodontic treatment need among 12-13 year-olds in southern China, we determined the threshold value of ICON based on Chinese orthodontists' judgments. The samples consisted of 335 students in grade 7 from 16 randomly selected middle schools in Chengdu, China. Three associate professors provided ICON scores for each participant and the results were compared with the gold standard judgments from 25 experts on treatment needs. Based on the gold standard, 195 casts belonged to the treatment category, while the rest 140 belonged to the no-treatment category. With the international cutoff point of 43, the sensitivity and specificity of the ICON score were 0.29 and 0.98.The best compromise between sensitivity and specificity in Chengdu, compared with the gold standard, was found at a cutoff point of 29, and the sensitivity and specificity were 0.88 and 0.83. When used to evaluate the treatment need of 12-13 year-olds in southern China, the international ICON cutoff value did not correspond well with Chinese orthodontists' judgments; a lower cutoff value of 29 offered a greater sensitivity and specificity with respect to expert orthodontists' perception of treatment need.
Adolescent ; Child ; China ; epidemiology ; Cross-Cultural Comparison ; Data Collection ; Dental Health Surveys ; methods ; standards ; Female ; Health Services Needs and Demand ; statistics & numerical data ; Humans ; Male ; Malocclusion ; diagnosis ; epidemiology ; Needs Assessment ; statistics & numerical data ; Observer Variation ; Orthodontics, Corrective ; standards ; statistics & numerical data ; Reference Values ; Reproducibility of Results ; Sensitivity and Specificity

Content validity is the degree to which an instrument has an appropriate sample of items for the construct being measured and is an important procedure in scale development. Content validity index (CVI) is the most widely used index in quantitative evaluation. There are 2 kinds of CVI: I-CVI and S-CVI. A method to compute a modified kappa statistic (K*) can be used to adjust I-CVI for chance agreement. S-CVI/UA and S-CVI/Ave are both scale level CVI with different formulas. Researchers recommend that a scale with excellent content validity should be composed of I-CVIs of 0.78 or higher and S-CVI/UA and S-CVI/Ave of 0.8 and 0.9 or higher, respectively. The characteristics and qualifications of the experts, process and main results of content validity evaluation should be reported in scale-related manuscript.
Data Collection ; Humans ; Psychometrics ; methods ; Reproducibility of Results ; Surveys and Questionnaires ; standards

The digital operating-room, with highly integrated clinical information, is very important for rescuing lives of patients and improving quality of operations. Since equipments in domestic operating-rooms have diversified interface and nonstandard communication protocols, designing and implementing an integrated data sharing program for different kinds of diagnosing, monitoring, and treatment equipments become a key point in construction of digital operating room. This paper addresses interface interconnection and data integration for commonly used clinical equipments from aspects of hardware interface, interface connection and communication protocol, and offers a solution for interconnection and integration of clinical equipments in heterogeneous environment. Based on the solution, a case of an optimal digital operating-room is presented in this paper. Comparing with the international solution for digital operating-room, the solution proposed in this paper is more economical and effective. And finally, this paper provides a proposal for the platform construction of digital perating-room as well as a viewpoint for standardization of domestic clinical equipments.
Data Collection ; Humans ; Monitoring, Intraoperative ; economics ; instrumentation ; methods ; Operating Room Information Systems ; economics ; standards ; Operating Rooms ; organization & administration ; Systems Integration ; Video Recording ; economics ; instrumentation ; methods

To establish guidelines to diagnosis and treatment for distending pain in breasts during menstruation in traditional Chinese medicine (TCM). With Delphimethod, sent to the second survey questionnaires to 40 gynecology experts in TCM and integrated traditional and western medicine and recovery 35 experts, and the questionnaires were analyzed with SPSS11. 5. The experts' activity and professional level is high. The experts are from all over China and express the typical opinions of all experts in this field. The items in the frame of the guidelines to diagnosis and treatment for distending pain in breasts during menstruation in traditional Chinese medicine are generally recognized. First draft of the guidelines has basically been formed.
Breast ; physiology ; China ; epidemiology ; Data Collection ; methods ; Female ; Guidelines as Topic ; standards ; Humans ; Medicine, Chinese Traditional ; methods ; Menstruation ; physiology ; Pain ; diagnosis ; Pain Management ; Surveys and Questionnaires

INTRODUCTIONThis study evaluated the data completeness in the registration of prostate cancer after robotic radical prostatectomy (RRP) in the Urological Cancer Registry at the Singapore General Hospital (SGH), and its compliance to the international standards of US Commission on Cancer (CoC).

MATERIALS AND METHODSA certified cancer registrar reviewed all RRP cases between June 2003 and July 2008 in the Urological Cancer Registry at SGH.

RESULTSA total of 365 cases were reviewed. The results showed that 351 (96.2%) of RRP patients' demographic data were captured and 321 (87.9%) of RRP patients were staged. According to the international standards of CoC for an academic institution, the requirement is to capture 100% of all cancer cases and stage at least 90% of them. As for data completeness, 317 (86.7%) of RRP details were captured as compared to the CoC standard requirement of 90%.

CONCLUSIONSThe existing manual cancer registry does not fully meet the CoC standards. Hence, the registry increased sources of case-finding and used active case-finding. With improvements made to the data collection methodology, the number of prostate cancer cases identified has been increased by 52.1% from 215 in 2007 to 327 in 2009. The registry is expected to be fully compliant with the CoC standard with the recruitment of more full time cancer registrars when a new web-based cancer registry is in full operation.

Algorithms ; Data Collection ; methods ; Demography ; Humans ; Male ; Prostatectomy ; instrumentation ; methods ; statistics & numerical data ; Prostatic Neoplasms ; surgery ; Registries ; Research Design ; standards ; Robotics ; Singapore