Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial
| Autor: | Sein Schmidt, Knut Mai, Robert Fleischmann, Antje Kraft, Anne-Marie Decker |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Randomization 020205 medical informatics Electronic data capture Epidemiology Health Informatics 02 engineering and technology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Weight Loss 0202 electrical engineering electronic engineering information engineering medicine Electronic Health Records Humans REDCap 030212 general & internal medicine lcsh:R5-920 Data collection Descriptive statistics business.industry Middle Aged Data handling Quality Improvement Data Accuracy Clinical trial Clinical research Data quality Physical therapy Female Electronic case report form Time efficiency lcsh:Medicine (General) business Research Article |
| Zdroj: | BMC Medical Research Methodology BMC Medical Research Methodology, Vol 17, Iss 1, Pp 1-10 (2017) |
| ISSN: | 1471-2288 |
| Popis: | Background Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity. Methods This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics. Results All randomized patients were included in the study (eCRF group n = 13, pCRF group n = 14). eCRF, as compared to pCRF, data collection was associated with significant time savings across all conditions (8.29 ± 5.15 min vs. 10.54 ± 6.98 min, p = .047). This effect was not defined by participant type, i.e. patients or study nurses (F(1,112) = .15, p = .699), CRF length (F(2,112) = .49, p = .609) or patient age (Beta = .09, p = .534). Additional 5.16 ± 2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was superior in the eCRF condition (0 versus 3 data entry errors). Conclusions This is the first study to prove in direct comparison that using eCRFs instead of pCRFs increases time efficiency of data collection in clinical trials, irrespective of item quantity or patient age, and improves data quality. Trial registration Clinical Trials NCT02649907 . |
| Databáze: | OpenAIRE |
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