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

Mowinckel, Petter; Hagen, Kåre Birger; Heiberg, Turid; Kvien, Tore K

doi:10.1016/j.jclinepi.2007.12.004

Cited by 17 publications

(16 citation statements)

References 13 publications

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“…However, because of the considerable day-to-day variation in self-reported health status in patients with inflammatory rheumatic joint diseases, a previous study in Norwegian patients with RA has shown that using up to five repeated measurements per patient can decrease the between-person SD and consequently the number of patients required in a trial by as much as 20% 41. We therefore conducted a pilot study in which we calculated the individual means for five repeated measures on the GHQ-20 at baseline and the follow-up visits.…”

Section: Methodsmentioning

confidence: 99%

A mindfulness-based group intervention to reduce psychological distress and fatigue in patients with inflammatory rheumatic joint diseases: a randomised controlled trial

et al. 2011

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Section: Methodsmentioning

confidence: 99%

A mindfulness-based group intervention to reduce psychological distress and fatigue in patients with inflammatory rheumatic joint diseases: a randomised controlled trial

et al. 2011

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“…Symptoms can vary both during the day and over time, even in patients with a stable disease [1]. In fact, the daily variation in pain, fatigue and global disease activity has been shown to be substantial [2]. …”

Section: Introductionmentioning

confidence: 99%

Collection of patient-reported outcomes; - text messages on mobile phones provide valid scores and high response rates

Christie

Dagfinrud

Dale

et al. 2014

BMC Med Res Methodol

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BackgroundPatients with inflammatory rheumatic diseases have expressed a need for more frequent measurement of relevant outcomes, due to the variations in their symptoms during the day and from day to day. At present, patient-reported outcomes are extensively collected with questionnaires completed with pen and paper. However, as a measurement tool in frequent data collection the questionnaires are impractical. In contrast, text messages on mobile phones are suitable for frequent data collection.The aim of this study was two-fold; to compare daily registrations of patient-reported outcomes assessed with text-messages on mobile phones (SMS) or with questionnaires completed with pen and paper (P&P), with regard to scores and variation of scores, and to examine feasibility of the SMS method in a multicentre clinical study.MethodsTo compare scores, 21 patients with an inflammatory, rheumatic disease performed daily assessments of pain, fatigue, stiffness and ability to carry out daily activities on a numeric rating scale (NRS). The patients were asked to assess the variables every other day with the SMS method and every other day with the P&P method for 28 consecutive days. In total each participant had to answer 14 P&P forms and 14 SMS messages. Mean scores and variation, expressed as the pooled standard deviation or as the average range between the maximum and minimum scores for the two methods, were compared using paired sample t-tests or Wilcoxon Signed Rank Test. To examine feasibility, 36 patients with an inflammatory, rheumatic disease assessed the same four variables with SMS twice a week for 35 weeks. Feasibility of the SMS method was expressed as mean response-rate (%) in the total group and per centre.ResultsMean scores, standard deviation of mean scores and mean range scores did not differ significantly between the two methods (p > 0.05). Response-rate with the SMS method was 97.9% for the whole group and for the three centres 97.1%, 98.3% and 98.4%, respectively.ConclusionOutcomes assessed on numeric rating scales and reported with text-messages on mobile phones or with questionnaires completed with pen and paper provide comparable scores. Further, the SMS method provided high response rates (> 97%) in a multicentre setting. Our results encourage the use of text messages on mobile phones in studies requiring frequent data collection and real-time assessment, as in fluctuating diseases such inflammatory, rheumatic diseases.

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“…During 1 week, fluctuations in hormones and cytokines can be observed that might be associated with small fluctuations in disease activity. We wanted to investigate the short-term variability observed in disease activity (18) and not a trend in disease progression over time. We further hypothesized that the relative changes in LH and FSH and the relative changes in cytokines are associated with relative changes in disease activity markers in RA.…”

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confidence: 99%

The association of luteinizing hormone and follicle-stimulating hormone with cytokines and markers of disease activity in rheumatoid arthritis: a case–control study

Kåss

Lea

Torjesen

et al. 2010

Scandinavian Journal of Rheumatology

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The significant associations between percentage changes in LH and FSH and percentage changes in key cytokines and several cross-sectional markers of disease activity may indicate that LH and FSH influence crucial points of the cytokine cascade in RA. This may help to explain, partially, why disease activity initiates or worsens during periods of increased LH and FSH, such as the postpartum period and the menopause.

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

Cited by 17 publications

References 13 publications

A mindfulness-based group intervention to reduce psychological distress and fatigue in patients with inflammatory rheumatic joint diseases: a randomised controlled trial

A mindfulness-based group intervention to reduce psychological distress and fatigue in patients with inflammatory rheumatic joint diseases: a randomised controlled trial

Collection of patient-reported outcomes; - text messages on mobile phones provide valid scores and high response rates

The association of luteinizing hormone and follicle-stimulating hormone with cytokines and markers of disease activity in rheumatoid arthritis: a case–control study

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