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Drug Information Journal; Vol. 34, pp. 129-136,2000 Printed in the USA. All rights reserved.
Copyright 2000 Drug Information Association Inc.
USE OF PEN-BASED ELECTRONIC
DIARIES IN AN INTERNATIONAL
CLINICAL TRIAL OF ASTHMA
BRIAN TIPLADY AND AUDREY H. JAMIESON
AstraZeneca Clinical Research Edinburgh, Edinburgh, United Kingdom GRAHAM K. CROMPTON
Western General Hospital, Edinburgh, United Kingdom The use of pen-based electronic diaries was evaluated in an international clinical trial ofasthma. The study compared bambuterol with salmeterol in nocturnal asthma, and wascarried out in Italy, Norway and UK. Two hundred and sixty-five patients were enrolled,of whom 135 were randomised and 118 completed the eight week study period. Patientscompleted the electronic diary at home each morning and evening throughout the 8week study period. Data could be entered into the diary only within specified time“windows”. No retrospective entry was permitted. Data collection was very satisfactory. Ninety-four percent of patients enrolled completed their diaries during the run-in period to the required standard for inclusion inthe study (at least 5 out of the last 7 days of the run-in complete). After randomisation,entries were completed on 86% of scheduled occasions. At the randomisation 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 inclusioncriteria. This saved work for the investigators, and helped to reduce the rate of incorrectrandomisation by comparison with 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 seenwith this method in earlier evaluation studies have been realised in a full-scale clinicaltrial. Key Words: Pen-based electronic diaries; Asthma; Clinical trial; Electronic data capture.
INTRODUCTION
procedures through the elimination ofmanual data editing and entry (1-4).
are increasingly being used to collect diary data from patients in clinical trials. Such benefits of improved data reliability and devices using a pen for input (e.g. Apple quality by the time-stamping of entries and MessagePad®); and custom-built electronic the prevention of retrospective entries; and particularly interested in pen-based systemsbecause of the natural interface theyprovide, particularly for patients who may Reprint address: Dr Brian Tiplady, AstraZeneca Clinical Research Edinburgh, 10 Logie Mill, Edinburgh, EH7 4HG, UK. EMail: brian.tiplady@acru.gb.astra.com Brian Tiplady, Audrey H. Jamieson, and Graham K. Crompton clinical trials, which have shown that the method works, that patients like it, and that there can be a real improvement in dataquality (4). These evaluations were on a STUDY DESIGN
small scale, and designed only to assess the This was a parallel group design with a two methodology. The next step was clearly to week run-in period, and a six week active use the method in a full-scale clinical trial, treatment period. The patients visited the identified by these initial evaluations are 1. At the beginning of the run-in period, electronic diary in a comparative study of They filled in the diary at home every day Norway. The electronic diary was basically patients had to meet the following criteria evaluation studies in asthma (4), collecting symptoms of asthma, as well as peak flow, was measured on a Vitalograph® peak flow differences from the previous diaries. Since patient woke early due to asthma, and the peak flow values recorded in the diary were the primary outcome measure in the study.
THE DIARY APPLICATION
recorded in the diaries during the two week run-in period. In particular, the change in used to enter diary data are shown in Fig 1.
“dragging” the diamond with the pen along calculated for each night of the run-in.
the screen to the appropriate point on the scale. They could also tap on the grey scale presenting the relevant data from the run- in, for use at the randomisation visit. We expected that it would be possible to show highlight. The number of times the relief FIGURE 1. Data entry screens from the patient diary. Patients used the pen to select
the appropriate choice on the touch-sensitive screen of the diary. Entries could be
changed until “OK” was tapped after which the entry was fixed.
Brian Tiplady, Audrey H. Jamieson, and Graham K. Crompton the up and down arrows to the right of the number box. Definitions of the scale points data transfer, and the checking and setting with no default choice selection. Patients had to specifically enter a zero or “None” patient in any of the questions until 

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