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Two to five repeated measurements per patient reduced the required sample size considerably in a randomized clinical trial for patients with inflammatory rheumatic diseases.

BMC research notes
January 1, 1970
Geir Smedslund et al. (4 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine how repeated measurements of patient-reported outcomes in a mindfulness-based group intervention could reduce required sample sizes in clinical trials for patients with inflammatory arthritis.

Results Summary

Measuring outcomes multiple times (up to five) reduced the necessary sample size by an average of 27%, with three to five measurements significantly lowering required group sizes for pain, fatigue, disease activity, self-care, and emotional wellbeing.

Population

Patients with inflammatory arthritis (n=71).

Effective Dosage

Not specified.

Duration

Not specified.

Interactions

None mentioned.

Extracted Claims (10)
InterventionDirectionEndpointPopulationDosageImpactClaim #
mindfulness-based group intervention
decrease
required sample size
patients with inflammatory arthritis
15%
reduced the required sample sizes
#1
mindfulness-based group intervention
decrease
required sample size
patients with inflammatory arthritis
21%
reduced the required sample sizes
#2
mindfulness-based group intervention
decrease
required sample size
patients with inflammatory arthritis
24%
reduced the required sample sizes
#3
mindfulness-based group intervention
decrease
required sample size for GHQ-20
patients with inflammatory arthritis
from 56 to 39
reduced the required sample size per group
#4
mindfulness-based group intervention
decrease
required sample size for pain
patients with inflammatory arthritis
from 71 to 60
reduced the required sample size per group
#5
mindfulness-based group intervention
decrease
required sample size for fatigue
patients with inflammatory arthritis
from 96 to 71
reduced the required sample size per group
#6
mindfulness-based group intervention
decrease
required sample size for disease activity
patients with inflammatory arthritis
from 57 to 51
reduced the required sample size per group
#7
mindfulness-based group intervention
decrease
required sample size for self-care
patients with inflammatory arthritis
from 59 to 44
reduced the required sample size per group
#8
mindfulness-based group intervention
decrease
required sample size for emotional wellbeing
patients with inflammatory arthritis
from 47 to 37
reduced the required sample size per group
#9
mindfulness-based group intervention
decrease
necessary sample size
patients with inflammatory arthritis
by an average of 27%
reduced the necessary sample size
#10
Abstract

BACKGROUND: Patient reported outcomes are accepted as important outcome measures in rheumatology. The fluctuating symptoms in patients with rheumatic diseases have serious implications for sample size in clinical trials. We estimated the effects of measuring the outcome 1-5 times on the sample size required in a two-armed trial. FINDINGS: In a randomized controlled trial that evaluated the effects of a mindfulness-based group intervention for patients with inflammatory arthritis (n=71), the outcome variables Numerical Rating Scales (NRS) (pain, fatigue, disease activity, self-care ability, and emotional wellbeing) and General Health Questionnaire (GHQ-20) were measured five times before and after the intervention. For each variable we calculated the necessary sample sizes for obtaining 80% power (α=.05) for one up to five measurements.Two, three, and four measures reduced the required sample sizes by 15%, 21%, and 24%, respectively. With three (and five) measures, the required sample size per group was reduced from 56 to 39 (32) for the GHQ-20, from 71 to 60 (55) for pain, 96 to 71 (73) for fatigue, 57 to 51 (48) for disease activity, 59 to 44 (45) for self-care, and 47 to 37 (33) for emotional wellbeing. CONCLUSIONS: Measuring the outcomes five times rather than once reduced the necessary sample size by an average of 27%. When planning a study, researchers should carefully compare the advantages and disadvantages of increasing sample size versus employing three to five repeated measurements in order to obtain the required statistical power.

Medical Subject Headings (MeSH)
HumansRheumatic FeverSample SizeSelf CareSurveys and Questionnaires
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations3
Citations/Year0.3
Relative Citation Ratio0.13
NIH Percentile6.4%
Research Impact Scores
APT Score0.05
Weight Score1.58
Normalized Score0.67
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