Document Detail

Symptom recording in a randomised clinical trial: paper diaries vs. electronic or telephone data capture.
MedLine Citation:
PMID:  15588745     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Patients may be asked to register a symptom daily in clinical trials. A problem associated with this kind of registration is that patients do not always fill in the diary at the appropriate time. As there is evidence showing that memory is unreliable, this undermines the entire purpose of collecting daily data on paper diaries. We aimed to compare accuracy, autocorrelations of consecutive entries, and responsiveness in paper diaries (P-Diaries) with electronic diaries (E-Diaries) and telephone diaries (T-Diaries). METHODS: In a multi-centre, open, and parallel trial, 177 patients were allocated at random to P-Diaries, E-Diaries, or T-Diaries for the registration of symptoms through 4 weeks of treatment of gastro-oesophageal reflux disease (GORD). The primary outcome measure was the diaries. FINDINGS: The proportion of patients completing all morning and all evening entries on time was low for both E-Diary and T-Diary groups. By accepting entries that were done half a day late, the proportion was increased to 19/57 (33%) for the E-Diary group, and to 9/61 (15%) for the T-Diary group. For P-Diary, where no control for time registration and entries was adapted, 37/59 (63%) of the patients completed all morning and all evening entries. A significant higher autocorrelation in P-Diaries was also found. Responsiveness was similar regardless of method of data capture. INTERPRETATION: The results are consistent with the suggestion that data in the P-Diaries are not filled in at the appropriate time. Use of E-Diaries or T-Diaries improves quality and is recommended in future clinical trials.
Karsten Lauritsen; Alessio Degl' Innocenti; Lene Hendel; Jørgen Praest; Mogens F Lytje; Kjeld Clemmensen-Rotne; Ingela Wiklund
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Controlled clinical trials     Volume:  25     ISSN:  0197-2456     ISO Abbreviation:  Control Clin Trials     Publication Date:  2004 Dec 
Date Detail:
Created Date:  2004-12-13     Completed Date:  2005-04-26     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8006242     Medline TA:  Control Clin Trials     Country:  United States    
Other Details:
Languages:  eng     Pagination:  585-97     Citation Subset:  IM    
Department of Gastroenterology, Odense University Hospital, Odense, Denmark.
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MeSH Terms
Circadian Rhythm
Gastroesophageal Reflux / physiopathology,  therapy
Health Status Indicators*
Medical Records*
Middle Aged
Outcome Assessment (Health Care) / methods
Rural Population
Urban Population

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