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Table 6 Responsiveness and association of change in possible primary outcomes with global change and EQ5D

From: Self-management advice, exercise and foot orthoses for plantar heel pain: the TREADON pilot and feasibility randomised trial

 

Baseline mean (SD)

12 weeks mean (SD)

Changea, mean (SD)

Responsivenessb

With global change

With EQ5D change

Spearman’s correlation

AUC (95% CI)c

Spearman’s correlation

NRS change

5.9 (1.9)

3.3 (2.4)

2.6 (2.5)

1.04

0.60

0.88 (0.79, 0.96)

0.87

FFI-pain change

50.6 (17.7)

32.8 (23.9)

21.6 (22.4)

0.96

0.74

0.84 (0.69, 0.99)

0.71

MFPDI-pain change

14.0 (2.8)

12.3 (3.5)

1.7 (3.0)

0.57

0.57

0.72 (0.58, 0.67)

0.75

  1. aChange from baseline to 12 week
  2. bResponsiveness statistic (standardised response mean = mean change in score / SD of change scores; usually interpreted against the benchmarks ≤ 0.2: small, 0.5: moderate, ≥ 0.8: large [35])
  3. cGlobal change dichotomised as (completely recovered or much better / somewhat better or no change or somewhat worse or much worse)