The Use of Electronic Diaries in Respiratory Studies
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Drug Information Journal. Val. 31, pp. 759-764. 1997 Rinted in h e USA. All rights reserved.
THE USE OF ELECTRONIC DIARIES IN RESPIRATORY STUDIES B. TIPLADY,BA, PHD Head of Technology Projects, Astra Clinical Research Unit, Edinburgh, United Kingdom
G. K. CROMPTON, MB CHB Consultant Physician
M. H. DEWAR,BSc Clinical Research Nurse
F. G . E. B~LLERT, MB, CHB Research Registrar
S. P. MATUSIEWICZ, MB, CHB Registrar Respiratory Unit, Western General Hospital, Edinburgh, United Kingdom
L. M. CAMPBELL, MB, CHB General Practitioner, Kirkintilloch, Glasgow, United Kingdom
D. BRACKENRIDGE, BSc Managing Consultant, PA Consulting Group, Edinburgh, United Kingdom
Background-Electronic diary cards have advantages over paper diaries for daily collection of data on lung function and symptoms in patients with respiratory disorders. The suitability of a pen-based electronic diary (Apple Messagepad) for this purpose was assessed in a clinical trial setting. Methods-Two studies were carried out in patients with chronic obstructive airways disease: I . An open randomized two-period crossover study comparing electronic and paper diaries in 22 clinic outpatients aged 18-70. Data were collected for four weeks on each type of diary, and 2. An open study in 37 patients in general practice aged 13-80. Data were collected for four weeks on electronic diaries only. Results-In Study I , 59% of patients preferred the electronic diary and 18% preferred paper: Both paper and electronic diaries were found to be easy to use. There were fewer problematic data from the electronic diaries (0.24% of data points) compared with paper (5.6%), resulting in improved data reliability. There were more missing data, howevec with electronic diaries (8.9% vs 0.2%; p = 0.0001) which probably relates to the fact that the electronic diary did not permit retrospective entry. Data handling procedures were greatly simplified for the electronic diaries. Problems occurred with battery life and power management. Study 2 confirmed the acceptability of electronic diaries in this
Reprint address: Dr. B. Tiplady, Astra Clinical Research Unit, 10, Logie Mill, Beaverbank Office Park, Logie Green Road, Edinburgh EH7 4HG, United Kingdom.
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B. Tiplady et. a1 patient group, and showed no battery problems using a later model of the hardware ( M P 110). Conclusions-Pen-based electronic diaries are acceptable to patients, and offer m j o r benefits in terms of data reliability and simplification of data handling. Key Words: Electronic diaries; Peak expiratory flow; Chronic obstructive airways disease
INTRODUCTION DAILY DIARY CARDS have advantages over clinic assessments for monitoring severity of disease in chronic conditions such as asthma. Measurements are obtained repeatedly and fluctuations in the course of the illness can be followed. Regular assessments at home may reflect the patient’s overall condition more accurately than intermittent outpatient review. The method, however, has dis
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