Volume 26, Number 3—March 2020
Online Report
Improving Quality of Patient Data for Treatment of Multidrug- or Rifampin-Resistant Tuberculosis
Jonathon R. Campbell, Dennis Falzon, Fuad Mirzayev, Ernesto Jaramillo, Giovanni Battista Migliori, Carole D. Mitnick, Norbert Ndjeka, and Dick Menzies
Table 2
Suggested steps to improve the accuracy and completeness of observational IPD
| Suggested steps | Additional notes |
|---|---|
| Persons responsible for capture and entry of data into electronic databases should be appropriately trained. |
• This includes obtaining a certificate in good clinical practice and training around the importance of confidentiality.
• This also includes training on the basics of MDR/RR-TB, relevant national guidelines, what to collect, how to collect it, and the importance of accuracy in the capture of data.
• These principles can be reinforced with detailed guidance for data capture and the definitions of the variables collected at the point of capture (e.g., within the electronic system or within a document kept where data are captured). |
| Quality control measures (e.g., data safeguards) should be implemented to prevent implausible or “out-of-range” entries. |
• A warning can be implemented for continuous variables falling outside plausible ranges (e.g., age outside 0–99 y).
• Drop-down lists can be created to reduce/remove need for free form data entry (e.g., including the most common extrapulmonary TB sites within the dropdown or limiting responses for HIV-coinfection status to positive, negative, or not tested).
• Safeguards can be logical, which prevent certain data from being entered without a specific response in another section (e.g., CD4 and viral load cannot be filled in unless HIV-coinfection status is positive). |
| Supervisors should have a standard quality assurance routine (e.g., perform routine follow-up for data accuracy of collected information). |
• Supervisors should have simple algorithms developed to detect implausible information that defy inbuilt measures (e.g., patients reported to be receiving a medicine to which their DST shows resistance).
• Complete checks should be run on at least 10% of records independently via dual extraction. These checks should be performed regularly and assessed by a supervisor with the goal of 95% accuracy.
• Corrective steps should be taken (e.g., further training, more comprehensive or routine checks of variables) when accuracy of data collection is an issue. |
| Concurrent checks for data completeness should be performed with assessments of accuracy. | • Reminders can be developed that automatically signal that certain variables are not completed each time a patient record is updated. • In addition, preventing the “finalization” of a patient file until all variables are entered can be implemented—however, files should still be permitted to be saved, and other files opened and populated while patient files await finalization. • Completeness of data is of utmost importance—high frequency of absence of certain information may necessitate exclusion of entire datasets from particular analyses for which these data are required. |
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