Comparison of two data collection processes in clinical studies: electronic and paper case report forms

Abstract

BackgroundElectronic Case Report Forms (eCRFs) are increasingly chosen by investigators and sponsors of clinical research instead of the traditional pen-and-paper data collection (pCRFs). Previous studies suggested that eCRFs avoided mistakes, shortened the duration of clinical studies and reduced data collection costs.MethodsOur objectives were to describe and contrast both objective and subjective efficiency of pCRF and eCRF use in clinical studies. A total of 27 studies (11 eCRF, 16 pCRF) sponsored by the Paris hospital consortium, conducted and completed between 2001 and 2011 were included. Questionnaires were emailed to investigators of those studies, as well as clinical research associates and data managers working in Paris hospitals, soliciting their level of satisfaction and preferences for eCRFs and pCRFs. Mean costs and timeframes were compared using bootstrap methods, linear and logistic regression.ResultsThe total cost per patient was 374€ ±351 with eCRFs vs. 1,135€ ±1,234 with pCRFs. Time between the opening of the first center and the database lock was 31.7 months Q1 = 24.6; Q3 = 42.8 using eCRFs, vs. 39.8 months Q1 = 31.7; Q3 = 52.2 with pCRFs (p = 0.11). Electronic CRFs were globally preferred by all (31/72 vs. 15/72 for paper) for easier monitoring and improved data quality.ConclusionsThis study found that eCRFs and pCRFs are used in studies with different patient numbers, center numbers and risk. The first ones are more advantageous in large, low–risk studies and gain support from a majority of stakeholders.

Implementing electronic data capture at a well-established health and demographic surveillance site in rural northern Malawi

“…Using EDC reduced the time needed before and after data collection, as printing and data entry were largely eliminated; the latter reflected in the reduction in the average number of days from data collection to availability to scientists. Other evaluations have found that the overall time required was always shorter with EDC [3,6,7,13,19], despite additional time needed at the beginning for making tablet forms [5,15], which is consistent with our findings.…”

“…With a study size above a certain threshold (as start-up costs can be high), costs tend to be lower with EDC [6,7,10,13]. We were able to reduce costs in some areas, for example by buying devices in the UK, as they were expensive to buy locally.…”

“…Other commentators also reported that users tended to prefer EDC over paper [8–13] and that interviewers without prior computing experience readily adapted to tablet use [2,8,23]. The experience has been less positive for data processing staff who feared for employment security, especially those without the higher level of skills and experience required to work on EDC.…”

“…Inconsistent electricity also causes problems with keeping devices charged in rural locations [2,5]. Several data collection software programmes now exist. Technical expertise required : In rural low-resource settings, finding local staff with the higher level of technical skills required maybe challenging. Cost : While economic analyses have found that, assuming a study beyond a certain size, the costs tend to be lower with EDC [6,7], a long-running site with existing infrastructure may incur different costs and savings. Acceptance of staff : It has been found that lack of previous experience with computers has not been a hindrance to fieldworkers learning to use the devices [2,8], and users tend to prefer EDC over paper [8–13]. However, fieldworkers are not the only people affected by a change to established procedures.…”

“…Acceptance of staff : It has been found that lack of previous experience with computers has not been a hindrance to fieldworkers learning to use the devices [2,8], and users tend to prefer EDC over paper [8–13]. However, fieldworkers are not the only people affected by a change to established procedures.…”