OBJECTIVES: The purpose of the study was to evaluate content coverage and data quality of the Clinical Data Dictionary (CiDD) developed by the Center for Interoperable EHR (CiEHR). METHODS: A total of 12,994 terms were collected from 98 clinical forms of a tertiary cancer center hospital with 500 beds. After data cleaning, 9,418 terms were mapped with the data items of the CiDD by the research team, and validated by 30 doctors and nurses at the research hospital. RESULTS: Mapping results were classified into five categories: lexically mapped; semantically mapped; mapped to either a broader term or a narrower term; mapped to more than one term and not mapped. In terms of coverage, out of 9,418 terms, 6,750 (71.7%) terms were mapped; 4,319 (45.9%) terms were lexically mapped; 2,431 (25.8%) were semantically mapped; 281 (3.0%) terms were mapped to a broader term; 43 (0.5%) were mapped to a narrower term; and 550 (5.8%) were mapped to more than one term. In terms of data quality, the CiDD has problems such as errors in concept namingand representation, redundancy in synonyms, inadequate synonyms, and ambiguity in meaning. CONCLUSIONS: Although the CiDD has terms covering 72% of local clinical terms, the CiDD can be improved by cleaning up errors and redundancies, adding textual definitions or use cases of the concept, and arranging the concepts in a hierarchy.
Data Accuracy

BACKGROUND: In dental intravenous sedation, continuous intravenous infusion of a low-dose drug requires an infusion pump such as a syringe pump. To develop a new syringe pump for clinical use, the functions of the pump must meet certain international standards. Various safety and efficacy tests must be performed on the syringe pump, as stipulated by these standards, and an approval must be received from the approving agency based on such test results. METHODS: The authors of the present study developed a novel syringe pump and performed efficacy evaluation by testing its infusion speed at 1 and 25 ml/h, and infusion performance testing at 2 and 24 h. Moreover, performance evaluation was conducted by comparing the novel pump to an existing pump with the infusion speed varied from 1 to 5 ml/h. RESULTS: In the efficacy testing on the newly developed syringe pump, infusion with the infusion speed initially set to 1 ml/h resulted in infusion speeds of 1.00 and 0.99 ml/h in the 2- and 24-h assessment, respectively. Changing the infusion speed setting to 25 ml/h resulted in an infusion speed of 25.09 and 23.92 ml/h in the 2- and 24-h assessment, respectively. These results show no significant differences when compared with other commercially available pumps. CONCLUSIONS: The efficacy testing of the newly developed syringe pump showed the accuracy to be within tolerance. Based on these findings, we believe that the newly developed syringe pump is suitable for clinical use.
Data Accuracy ; Infusion Pumps ; Infusions, Intravenous ; Syringes*

OBJECTIVE: Medical narratives entry is a major issue to be solved in developing an electronic medical record system operating in practice, as they are, in large part, described in a free-text format. The issue can be dealt with in three aspects: to improve the reusability by structuring medical narratives, to support clinical pragmatics in medical fields, and to reduce the burden of data entry. With the aspects having in mind, this paper purports to present an ontological method for better way of medical narratives entry. METHODS: We developed an ontology for which medical knowledge is structurally represented. Then we can enter medical narrative texts with commands of the controlled natural language operable on the ontology model. RESULTS: Many theoretical studies on free-text entry were reviewed, based on which an authoring and editing tool for natural language description operable on the ontology model has been developed and tested. The performance of the tool is satisfactory within the limit of the domain models we developed here. CONCLUSION: The results of this paper are contributive for clinicians to make an easy entry of medical narratives as far as the ontology model covers their knowledge domain. It is also expected that the cost in recording medical narratives might be considerably reduced and data quality can be improved.
Electronic Health Records ; Models, Theoretical ; Data Accuracy

Rheumatic diseases are diverse groups characterized by a variety of clinical manifestations and disease courses in each patient. The best way to understand the course and prognosis of these patients is through observational cohort studies. The cohort studies also provide an opportunity to describe diseases outcomes including therapeutic responses and evaluate the effectiveness and safety of new therapy. It helps to understand disease pathogenesis and provide insight into the mechanisms of disease progression. The strengths of a cohort study are that it has a large number of patients over a long period of time. The patients in cohorts should be representative of the patients with diseases. Thoughtful study design and planning before establishment of cohorts will lead successful follow-up and increase data quality. The observation process must be clearly defined and followed according to the standard protocols.We reviewed numerous cohorts in rheumatic diseases and suggested the points to be considered for cohorts establishments.
Cohort Studies* ; Disease Progression ; Humans ; Prognosis ; Data Accuracy ; Rheumatic Diseases*

Rheumatic diseases are diverse groups characterized by a variety of clinical manifestations and disease courses in each patient. The best way to understand the course and prognosis of these patients is through observational cohort studies. The cohort studies also provide an opportunity to describe diseases outcomes including therapeutic responses and evaluate the effectiveness and safety of new therapy. It helps to understand disease pathogenesis and provide insight into the mechanisms of disease progression. The strengths of a cohort study are that it has a large number of patients over a long period of time. The patients in cohorts should be representative of the patients with diseases. Thoughtful study design and planning before establishment of cohorts will lead successful follow-up and increase data quality. The observation process must be clearly defined and followed according to the standard protocols.We reviewed numerous cohorts in rheumatic diseases and suggested the points to be considered for cohorts establishments.
Cohort Studies* ; Disease Progression ; Humans ; Prognosis ; Data Accuracy ; Rheumatic Diseases*

Blind review is one of the most important milestones in clinical trials, which connects data management process to statistical analysis. During blind review, data quality should be reviewed and assessed on both data management and statistical aspects. The primary work of data managers in blind review is to ensure the accuracy of data before it is handed over to biostatistics group. Database auditing, listing data reviewing and reconciliation should become a good clinical data management practice. Statisticians, on the other hand, will focus on quality findings related to protocol deviations or protocol violations. To investigate the protocol deviations and/or violations and relevant impacts on data outcomes, it is important to provide the essential basis of data quality through the blind review, and to assess the reliability of study outcomes.
Biostatistics ; Clinical Trials as Topic ; Data Accuracy ; Databases, Factual ; Reproducibility of Results

The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.
Clinical Trials as Topic ; standards ; Data Accuracy ; Reproducibility of Results

OBJECTIVETo evaluate the completeness of the death registration system, so as to understand the death patterns in Xuanwei.

METHODSThe investigation on under-reported deaths was conducted in 30 villages selected with a multi-stage random sampling strategy. Participants were asked about changes of their family members (family members born or dead) during past 3 years with door to door visit. Then, death cases obtained in our investigation were matched with those from routine death registration system and under-reported rate of deaths during 2011-2013 was calculated employing capture-recapture method.

RESULTSTotal under-reported rate of deaths was 31.88%. For people aged between 0-14, 15-39, 40-69 and 60 above, under-reported rates of death were 33.35%, 34.93%, 29.10%, and 32.88%, respectively. And they were 31.72% and 32.02% for males and females, respectively. There was no significant difference shown in under-reported rates among deaths in different age groups (χ² = 7.24, P = 0.065) and genders (χ² = 0.06, P = 0.803). The under-reported rates in high-mortality, medium-mortality and low-mortality regions were 17.48%, 38.01%, and 36.22%, respectively with a significant difference (χ² = 213.25, P < 0.001). Death in local regions with mortality rate higher than 600.00/10(5), between 400.00/10⁵ and 600.00/10⁵ and lower than 400.00/10⁵ were adjusted with under-reported rates in three regions above respectively. The total adjusted morality rate in Xuanwei during 2011-2013 was 776.47/10⁵. For males and females, they were 918.73/10⁵ and 617.46/10⁵, respectively.

CONCLUSIONOverall under-reported rate of death was high in death registration system in Xuanwei. It was necessary to adjust mortality data reported with under-reported rate of death to estimate death patterns in this area.

Real-world evidence (RWE) and randomized control trial (RCT) data are considered mutually complementary. However, compared with RCT, the outcomes of RWE continue to be assigned lower credibility. It must be emphasized that RWE research is a real-world practice that does not need to be executed as RCT research for it to be reliable. The advantages and disadvantages of RWE must be discerned clearly, and then the proper protocol can be planned from the beginning of the research to secure as many samples as possible. Attention must be paid to privacy protection. Moreover, bias can be reduced meaningfully by reducing the number of dropouts through detailed and meticulous data quality management. RCT research, characterized as having the highest reliability, and RWE research, which reflects the actual clinical aspects, can have a mutually supplementary relationship. Indeed, once this is proven, the two could comprise the most powerful evidence-based research method in medicine.
Bias (Epidemiology) ; Data Accuracy ; Electronic Health Records* ; Methods ; Privacy

For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.
Clinical Trials as Topic ; standards ; Data Accuracy ; Data Collection ; standards ; Databases, Factual ; Quality Control ; Reproducibility of Results