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European Pharmaceutical Contractor

Technology Solutions for the Collection of Patient Reported Outcomes Data

Many research articles have exposed the limitations of paper diaries and questionnaires in the collection of patient reported outcomes data. In a study comparing paper diary records to those secretly stored with an electronic peak flow metre, significant limitations were illustrated in paper diary data (1). It was found that 46 per cent of data recorded on paper were missing, but also that a surprising 22 per cent of paper data were invented by the subject, being entered onto the paper diary but not recorded electronically. Sometimes referred to as the 'car park effect', it would seem that individuals feel uncomfortable returning a blank diary and hence retrospectively complete a number of entries just before a clinic visit. More recently, a study using a paper diary with an embedded light sensor to record when the diary was opened and closed found that few subjects recorded data when scheduled, and in fact some subjects recorded data prospectively (2)!

These studies do not stand alone, the literature contains many other examples that criticise the integrity of paper diaries because they cannot assure the timeliness of data entry and guard against retrospective and prospective completion. The magnitude of missing and invented data can have a significant impact on the overall findings of the study. Empirical estimates suggest that four times as many subjects may be required in a study with 50 per cent missing data to achieve the same power as a trial with 100 per cent diary data (3). With the high rates of missing and invented data observed in studies using paper diaries, these studies may either be underpowered or may accommodate this additional noise by being designed with much larger sample sizes than necessary to detect relevant treatment-related differences.


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By Dr Bill Byrom, Product Development Director at ClinPhone Group Ltd

Dr Bill Byrom joined the pharmaceutical industry in 1991 after completing a PhD in disease modelling related to animal health at Strathclyde University. He has worked for a number of pharmaceutical companies in a variety of roles including Statistician, Clinical Study Director, Medical Marketing Representative and Health Economist. His experience in therapeutic areas includes diabetes, asthma, heart failure and schizophrenia. Bill joined ClinPhone in July 2000 where he is Product Development Director with responsibility for product development and management of a number of accounts. Bill's background in clinical trials from both a clinical and statistics/data management perspective means that he plays an important role in the development of new ClinPhone services and areas of technology application.

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Dr Bill Byrom
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