Use of Pen-Based Electronic Diaries in An International Clinical Trial of Asthma
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USE OF PEN-BASED ELECTRONIC DIARIES IN AN INTERNATIONAL CLINICAL TRIAL OF ASTHMA BRIANTIPLADY AND AUDREY H. JAMIESON AstraZeneca Clinical Research Unit Edinburgh, Edinburgh, United Kingdom
GRAHAM K. CROMFTON Western General Hospital. Edinburgh, United Kingdom
The use of pen-based electronic diaries was evaluated in an international clinical trial of asthma. The study compared bambuterol with salmeterol in nocturnal asthma, and was carried out in Italy, Norway, and the United Kingdom. Two hundred and sixty-jive patients were enrolled, of whom I35 were randomized and 118 completed the eight-week study period. Patients completed the electronic diary at home each morning and evening throughout the eight-week study period. Data could be entered into the diary only within specified time “windows. ” No retrospective entry was permitted. Data collection was very satigactory. Ninety-four percent of patients enrolled completed their diaries during the run-in period to the required standard for inclusion in the study (at least five out of the last seven days of the run-in complete). After randomization, entries were completed on 84% of scheduled occasions. At the randomization stage, a review facility was provided for the investigator which gave a summary of the run-in data to indicate whether the patient met the inclusion criteria. This saved work for the investigators, and helped to reduce the rate of incorrect randomization compared to a previous similar study. Data handling was substantially faster than in similar paper-based studies, contributing to locking the database well within schedule. Thus, the potential gains seen with this method in earlier evaluation studies have been realized in a full-scale clinical trial. Key Work: Pen-based electronic diaries; Asthma; Clinical trial; Electronic data capture
INTRODUCTION HANDHELD ELECTRONIC DEVICES are increasingly being used to collect diary data from patients in clinical trials. Such electronic data capture (EDC) offers the benefits of improved data reliability and quality by the time-stamping of entries and the prevention of retrospective entries; and can simplify and speed up data handling procedures
Reprint address: Dr. Brian Tiplady, Astrfineca Clinical Research Unit Edinburgh, 10, h g i e Mill, &burgh, EH7 4HG, UK. E-mail: [email protected].
through the elimination of manual data editing and entry (1-4). A number of different types of device have been used for this purpose, including handheld organizers with keyboards (eg, Psion@);touch screen devices using a pen for input (eg, Apple Messagepad@);and custombuilt electronic diaries (eg, MiniDoc’). We have been particularly interested in penbased systems because of the natural interface they provide, particularly for patients who may not be comfortable with computer keyboards. We have carried out several pilot studies
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Brian Tiplady, Audrey H. Jamieson, and Gr
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