Data quality assessment of the Enhanced Gonococcal Antimicrobial Surveillance Programme (EGASP), Thailand, 2015-2021

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.

Discussion: 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.

Fig 1. Overall data flow, EGASP Thailand, 2015–2021.

Diagram showing the pathway for clinical and laboratory data in this surveillance pilot program, including the data audit approach for Bangrak Hospital (BH) and Silom Community Clinic (SCC).

Fig 2. Accuracy of laboratory and clinical data by data audit cycle, EGASP Thailand, 2015–2021.

Comparison of source document and database accuracy over the course of the pilot surveillance project from 2015–2020 (Cycle 1: 11/2015–6/2016, Cycle 2: 7/2016–11/2017, Cycle 3: 12/2017–10/2018, Cycle 4: 11/2018–10/2019, and Cycle 5: 11/2019–12/2020). Accuracy was calculated as the proportion of data elements from both source documents and surveillance database that were identical (n) compared to all elements reviewed during the audit (N), for data from the clinical encounter (clinical data), laboratory workup (laboratory data), and clinical/laboratory combined (overall). The trend in accuracy of clinical (dashed line) and laboratory (solid line) data are shown over the surveillance period (cycles 1–5) with 95% confidence intervals (vertical bars).

Fig 3. Completeness of laboratory and clinical data by data audit cycle, EGASP Thailand, 2015–2021.

Comparison of source document and database completeness over the course of the pilot surveillance project from 2015–2020 (Cycle 1: 11/2015–6/2016, Cycle 2: 7/2016–11/2017, Cycle 3: 12/2017–10/2018, Cycle 4: 11/2018–10/2019, and Cycle 5: 11/2019–12/2020). Completeness was calculated as the proportion of data elements from source documents and surveillance database that were complete (no missing data in either source documents or database, n) compared to all elements reviewed during the audit (N), for data from the clinical encounter (clinical data), laboratory workup (laboratory data), and clinical/laboratory combined (overall). The trend in completeness of clinical (dashed line) and laboratory (solid line) data are shown over the surveillance period (cycles 1–5) with 95% confidence intervals (vertical bars).