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Table 2 Health-related quality of life assessment with the sf-36: baseline data and changes during study phases

From: Treatment of dysferlinopathy with deflazacort: a double-blind, placebo-controlled clinical trial

SF-36 scale Baseline Natural history Deflazacort (pooled) Placebo (pooled) p-value
End of year 1 – begin* End – begin of crossover* End – begin of crossover* Deflazacort vs. placebo
Subscales      
Physical functioning 38.3 ± 19.8 (5–85) −0.1 ± 13.4 −6.8 ± 9.3 +1.5 ± 11.1 0.118
Role Physical 70.6 ± 36.7 (0–100) +11.8 ± 46.9 −22.4 ± 32.2 +6.6 ± 38.0 0.114
Role Emotional 91.7 ± 22.8 (33–100) +6.3 ± 25.0 −14.8 ± 46.1 +13.0 ± 34.6 0.037
Social functioning 86.8 ± 12.5 (62–100) 0 ± 12.9 −5.9 ± 23.0 −3.3 ± 14.3 0.963
Mental health 79.8 ± 12.7 (44–96) −0.2 ± 5.6 −9.1 ± 9.4 +2.9 ± 14.3 0.009
Bodily pain 73.2 ± 16.2 (12–100) +7.1 ± 21.5 −1.9 ± 25.4 +3.2 ± 18.8 0.394
Vitality 60.0 ± 16.3 (40–95) +0.3 ± 11.3 −7.4 ± 16.1 +1.8 ± 11.2 0.096
General health perception 45.5 ± 14.4 (25–82) +6.0 ± 10.9 −4.3 ± 11.6 −1.7 ± 11.0 0.965
Standardized component Scales      
Physical 36.4 ± 8.0 (19–50.4) +1.5 ± 5.5 −2.5 ± 6.6 +0.4 ± 5.3 0.3123
Mental 56.2 ± 5.8 (40–65) +0.6 ± 4.6 −4.2 ± 10.7 +1.6 ± 8.7 0.0922
  1. †: The column shows arithmetic mean ± standard deviations (minimum and maximum) values. The scoring of the SF-36 scales ranges from 0 = very bad to 100 = very good quality of life in the different domains of the scale.
  2. *: The column shows arithmetic mean ± standard deviations for changes between end and begin of each study period. Deflazacort and placebo values are pooled across both crossover periods.
  3. ‡: p-values associated with the treatment effect in Lehmacher’s (1991) proposal for the non-parametric analysis of crossover-data (deflazacort vs. placebo). With the exception of “role emotional”, there were no carry-over effects detected. No period effects were identified.