Daily health status registration (patient diary) in patients with rheumatoid arthritis: A comparison between personal digital assistant and paper‐pencil format

Abstract

Objective. The patient perspective workshops at the Outcome Measures in Rheumatology Clinical Trials have included daily measures of health status (patient diary) and use of electronic tools for data collection in the research agenda. The objective of this study was to compare daily and weekly registrations of self-reported health status measures between personal digital assistant (PDA) and paper-pencil (PP) format regarding scores, variation, and feasibility. Methods. Thirty-eight patients with stable rheumatoid arthritis recorded their health status during 84 days in a repeated crossover design, using PDA or PP format during four 21-day periods. Visual analog scales (VAS) for pain, fatigue, and global disease and the Rheumatoid Arthritis Disease Activity Index were scored daily; the Short Form 36 and Modified Health Assessment Questionnaire were scored weekly. Results. The average scores and measures of variation of the 4 daily health status measures over 21 days did not differ significantly between PDA and PP formats in either of the 2 crossover periods. The values for the average range between the maximum and minimum values for daily measures were similar between the 2 formats, but showed considerable variation (e.g., range for pain VAS was 19 -28 mm over each 21-day period). The time to complete the instruments was similar between the 2 formats. Missing daily data entries were generally low for both periods and somewhat higher for PDA. The majority of patients (82.9%) preferred using PDA. Conclusion. Daily assessments with PDA may be efficiently used for frequent data collection because this format performs similarly to the traditional PP format.

Repeated measures in rheumatoid arthritis reduced the required sample size in a two-armed clinical trial

“…The selection of patients are described elsewhere [5]. Briefly, patients with stable disease between 25 and 79 years were recruited from the Oslo RA registry [6].…”

“…In a recently published article we demonstrated that the fluctuations in self-reported health status measures were considerable, even in patients with stable disease [5]. This observation is of methodological interest for controlled clinical trials since patient-reported outcomes often are among primary endpoints and because parts of the within-patient variation will be included in the betweensubject variation.…”

Revmatoid artritt

“…Spørreskjemaer har bred anvendelse for å vurdere helserelatert livskvalitet 59,60 , og har vist seg å vaere sensitive for endring 61,62 , og selvrapportert tap av fysisk funksjon predikerer mortalitet 63 . Selvrapportering av helse kan foregå ved hjelp av elektroniske hjelpemidler 64,65 og det er utviklet grenser for hva som er viktig bedring 66 og grenser for hva pasientene synes er et akseptabelt nivå på plagene 67 . Konvensjonelle røntgenbilder er fortsatt standardmetoden for å vurdere tilstedevaerelse og endring i skjelettskade, og van der Heijdes modifisering av Sharp 3 score synes i dag å vaere mer brukt enn skå-ringssystemet som ble utviklet av Arvi Larsen og Knut Dale 68 .…”

Surveying patients with smart devices

“…Many studies (e.g., [9,11]), demonstrated the reliability of computerized questionnaires running on desktop and touchscreen computers with respect to their paper-based equivalents. Some researches also focused on the reliability of PDAs [3,4], tablets [10], and web-based forms [7]. Other studies were concerned with the acceptability of computerized questionnaires.…”

“…Other studies were concerned with the acceptability of computerized questionnaires. A preference for computerized versions over paperbased forms is illustrated in [3,12], while the usefulness of computerized questionnaires was obserbed in [2,7,10].…”