Two to five repeated measurements per patient reduced the required sample size considerably in a randomized clinical trial for patients with inflammatory rheumatic diseases.
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.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
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 |
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.