Feasibility of keying data from screen-displayed facsimile images in an ongoing trial: the collaborative ocular melanoma study.

As part of an ongoing clinical trial, we conducted an experiment to assess the feasibility and to determine the reliability of data entry from a computer screen display of images of data collection forms transmitted by facsimile (fax) machines directly into a computer for paper forms designed without consideration of fax or image display requirements. Feasibility was assessed on the basis of accuracy and reliability of data entry and on operator satisfaction. During a 2-week period, half of the forms received at the Collaborative Ocular Melanoma Study (COMS) coordinating center were key-entered twice, using the paper forms as the source (paper source entry). The remaining forms were entered once using paper source and were later reentered using the screen display of images of the faxed forms as the source (image source entry). The latter group of forms, or 50% of all forms received, were entered a third time, using the image source entry. Two data entry operators participated in the experiment. Discrepancy rates between and within data entry operators were calculated for both modes of entry. A total of 50,861 keystrokes (28,095 items) across 1122 records were checked for consistency. The overall discrepancy rate associated with double paper source entry was approximately 21 per 10,000 keystrokes (20 per 10,000 items). Discrepancy rates associated with paper source versus image source entry (53 per 10,000 keystrokes [57 per 10,000 items]) and double image source entry (57 per 10,000 keystrokes [47 per 10,000 items]) were similar in magnitude. Image source entry of forms received by facsimile may provide an acceptable alternative to paper entry in ongoing multicenter clinical trials where the costs of converting existing forms and systems to automated data capture may be unacceptable. This experiment confirmed the feasibility of such an alternative and suggested that improved screen displays and changes in equipment to facilitate entry of data from the screen display may enhance accuracy of entries.

[1]  D Gibson,et al.  Is double data entry necessary? The CHART trials. CHART Steering Committee. Continuous, Hyperfractionated, Accelerated Radiotherapy. , 1994, Controlled clinical trials.

[2]  J P Mullooly,et al.  The effects of data entry error: an analysis of partial verification. , 1990, Computers and biomedical research, an international journal.

[3]  A. G. Duchene,et al.  An examination of the efficiency of some quality assurance methods commonly employed in clinical trials. , 1990, Statistics in medicine.

[4]  Lloyd D. Fisher,et al.  Biostatistics: A Methodology for the Health Sciences , 1993 .

[5]  B. Hawkins,et al.  Data collection and transcription. , 1995, Controlled clinical trials.

[6]  D. Taylor,et al.  ·P-45 The datafax project , 1990 .

[7]  Conducting clinical trials in a pediatric population , 1985 .

[8]  J. Gassman,et al.  Data quality assurance, monitoring, and reporting. , 1995, Controlled clinical trials.

[9]  B A Blumenstein Verifying keyed medical research data. , 1993, Statistics in medicine.

[10]  R. Reynolds-Haertle,et al.  Single vs. double data entry in CAST. , 1992, Controlled clinical trials.

[11]  Lloyd D. Fisher,et al.  2. Biostatistics: A Methodology for the Health Sciences , 1994 .

[12]  J A Barwick,et al.  Addition of an error correction facility to a functioning data management system. , 1990, Controlled clinical trials.

[13]  Andrew Dillon,et al.  Reading From Paper Versus Reading From Screen , 1988, Comput. J..