Abstract
BackgroundThe clinical and scientific usage of patient-reported outcome measures is increasing in the health services. Often paper forms are used. Manual double entry of data is defined as the definitive gold standard for transferring data to an electronic format, but the process is laborious. Automated forms processing may be an alternative, but further validation is warranted.Methods200 patients were randomly selected from a cohort of 5777 patients who had previously answered two different questionnaires. The questionnaires were scanned using an automated forms processing technique, as well as processed by single and double manual data entry, using the EpiData Entry data entry program. The main outcome measure was the proportion of correctly entered numbers at question, form and study level.ResultsManual double-key data entry (error proportion per 1000 fields = 0.046 (95% CI: 0.001–0.258)) performed better than single-key data entry (error proportion per 1000 fields = 0.370 (95% CI: 0.160–0.729), (p = 0.020)). There was no statistical difference between Optical Mark Recognition (error proportion per 1000 fields = 0.046 (95% CI: 0.001–0.258)) and double-key data entry (p = 1.000). With the Intelligent Character Recognition method, there was no statistical difference compared to single-key data entry (error proportion per 1000 fields = 6.734 (95% CI: 0.817–24.113), (p = 0.656)), as well as double-key data entry (error proportion per 1000 fields = 3.367 (95% CI: 0.085–18.616)), (p = 0.319)).ConclusionsAutomated forms processing is a valid alternative to double manual data entry for highly structured forms containing only check boxes, numerical codes and no dates. Automated forms processing can be superior to single manual data entry through a data entry program, depending on the method chosen.
Highlights
Information in the medical services is almost exclusively based on electronic recording systems in Denmark, including communication between primary and secondary health care systems [1]
The US Food and Drug Administration has strongly recommended inclusion of patientrecorded outcomes in clinical trials assessing the effect of medical procedures or pharmaceuticals
This has led to a demand for recording larger volumes of information, which traditionally have been collected on paper forms
Summary
Information in the medical services is almost exclusively based on electronic recording systems in Denmark, including communication between primary and secondary health care systems [1]. Among other areas of the health services, there has been a growing focus from medical clinicians on the use of patient-reported outcomes in studies [2]. The US Food and Drug Administration has strongly recommended inclusion of patientrecorded outcomes in clinical trials assessing the effect of medical procedures or pharmaceuticals. This has led to a demand for recording larger volumes of information, which traditionally have been collected on paper forms. With an increased focus on measuring and validating measurement tools [3], it is imperative to assess the quality of automated forms processing and this was the motivation for the current study. Automated forms processing may be an alternative, but further validation is warranted
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