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Abstract：
BACKGROUND: Quality assessments of gonococcal surveillance data are critical to improve data validity and to enhance the value of surveillance findings. Detecting data errors by systematic audits identifies areas for quality improvement. We designed and implemented an internal audit process to evaluate the accuracy and completeness of surveillance data for the Thailand Enhanced Gonococcal Antimicrobial Surveillance Programme (EGASP).
METHODS: We conducted a data quality audit of source records by comparison with the data stored in the EGASP database for five audit cycles from 2015-2021. Ten percent of culture-confirmed cases of Neisseria gonorrhoeae were randomly sampled along with any cases identified with elevated antimicrobial susceptibility testing results and cases with repeat infections. Incorrect and incomplete data were investigated, and corrective action and preventive actions (CAPA) were implemented. Accuracy was defined as the percentage of identical data in both the source records and the database. Completeness was defined as the percentage of non-missing data from either the source document or the database. Statistical analyses were performed using the t-test and the Fisher\'s exact test.
RESULTS: We sampled and reviewed 70, 162, 85, 68, and 46 EGASP records during the five audit cycles. Overall accuracy and completeness in the five audit cycles ranged from 93.6% to 99.4% and 95.0% to 99.9%, respectively. Overall, completeness was significantly higher than accuracy (p = 0.017). For each laboratory and clinical data element, concordance was >85% in all audit cycles except for two laboratory data elements in two audit cycles. These elements significantly improved following identification and CAPA implementation.
CONCLUSIONS: We found a high level of data accuracy and completeness in the five audit cycles. The implementation of the audit process identified areas for improvement. Systematic quality assessments of laboratory and clinical data ensure high quality EGASP surveillance data to monitor for antimicrobial resistant Neisseria gonorrhoeae in Thailand.
METHODS: We conducted a data quality audit of source records by comparison with the data stored in the EGASP database for five audit cycles from 2015-2021. Ten percent of culture-confirmed cases of Neisseria gonorrhoeae were randomly sampled along with any cases identified with elevated antimicrobial susceptibility testing results and cases with repeat infections. Incorrect and incomplete data were investigated, and corrective action and preventive actions (CAPA) were implemented. Accuracy was defined as the percentage of identical data in both the source records and the database. Completeness was defined as the percentage of non-missing data from either the source document or the database. Statistical analyses were performed using the t-test and the Fisher\'s exact test.
RESULTS: We sampled and reviewed 70, 162, 85, 68, and 46 EGASP records during the five audit cycles. Overall accuracy and completeness in the five audit cycles ranged from 93.6% to 99.4% and 95.0% to 99.9%, respectively. Overall, completeness was significantly higher than accuracy (p = 0.017). For each laboratory and clinical data element, concordance was >85% in all audit cycles except for two laboratory data elements in two audit cycles. These elements significantly improved following identification and CAPA implementation.
CONCLUSIONS: We found a high level of data accuracy and completeness in the five audit cycles. The implementation of the audit process identified areas for improvement. Systematic quality assessments of laboratory and clinical data ensure high quality EGASP surveillance data to monitor for antimicrobial resistant Neisseria gonorrhoeae in Thailand.
摘要：
背景：淋球菌监测数据的质量评估对于提高数据有效性和提高监测结果的价值至关重要。通过系统审计检测数据错误，确定质量改进的领域。我们设计并实施了内部审核流程，以评估泰国强化淋球菌抗菌药物监测计划（EGASP）监测数据的准确性和完整性。
方法：我们通过与EGASP数据库中存储的数据进行比较，对2015-2021年的五个审计周期进行了源记录的数据质量审计。随机抽取了10％的淋病奈瑟氏球菌培养确诊病例，以及任何发现抗菌药物敏感性测试结果升高的病例和重复感染的病例。调查了不正确和不完整的数据，并实施了纠正措施和预防措施(CAPA)。准确性定义为源记录和数据库中相同数据的百分比。完整性定义为来自源文档或数据库的非缺失数据的百分比。使用t检验和Fisher精确检验进行统计分析。
结果：我们在五个审计周期中对70、162、85、68和46个EGASP记录进行了采样和审查。五个审计周期的总体准确性和完整性范围为93.6％至99.4％和95.0％至99.9％，分别。总的来说,完整性显著高于准确性(p=0.017).对于每个实验室和临床数据元素，在所有审计周期中,一致性均>85%,除了两个审计周期中的两个实验室数据元素.在识别和CAPA实施之后，这些元素得到了显着改善。
结论：我们在五个审计周期中发现了高水平的数据准确性和完整性。审计过程的实施确定了需要改进的领域。对实验室和临床数据的系统质量评估确保了高质量的EGASP监测数据，以监测泰国的耐抗生素淋病奈瑟菌。
方法：我们通过与EGASP数据库中存储的数据进行比较，对2015-2021年的五个审计周期进行了源记录的数据质量审计。随机抽取了10％的淋病奈瑟氏球菌培养确诊病例，以及任何发现抗菌药物敏感性测试结果升高的病例和重复感染的病例。调查了不正确和不完整的数据，并实施了纠正措施和预防措施(CAPA)。准确性定义为源记录和数据库中相同数据的百分比。完整性定义为来自源文档或数据库的非缺失数据的百分比。使用t检验和Fisher精确检验进行统计分析。
结果：我们在五个审计周期中对70、162、85、68和46个EGASP记录进行了采样和审查。五个审计周期的总体准确性和完整性范围为93.6％至99.4％和95.0％至99.9％，分别。总的来说,完整性显著高于准确性(p=0.017).对于每个实验室和临床数据元素，在所有审计周期中,一致性均>85%,除了两个审计周期中的两个实验室数据元素.在识别和CAPA实施之后，这些元素得到了显着改善。
结论：我们在五个审计周期中发现了高水平的数据准确性和完整性。审计过程的实施确定了需要改进的领域。对实验室和临床数据的系统质量评估确保了高质量的EGASP监测数据，以监测泰国的耐抗生素淋病奈瑟菌。
