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Table 4 Trial outcomes: Intent to treat and adjusted intent to treat

From: Effects of a support group leader education program jointly developed by health professionals and patients on peer leader self-efficacy among leaders of scleroderma support groups: a two-arm parallel partially nested randomised controlled trial

 

Intent to treata

Adjusted intention to treatb

 

Difference (95% CI)

Hedges’ g SMD (95% CI)

Difference (95% CI)

Hedges’ g SMD (95% CI)

Primary outcome (post-intervention)

Leader self-efficacy (SSGLSS) scorec

16.68 (11.04, 22.32)

0.84 (0.58, 1.09)

17.05 (11.81, 22.29)

0.85 (0.59, 1.11)

Secondary outcomes (post-intervention)

Emotional distress (PHQ-8) score

− 0.93 (− 1.84, − 0.03)

− 0.26 (− 0.50, − 0.02)

− 1.15 (− 2.03, − 0.26)

− 0.32 (− 0.56, − 0.08)

Burnout (OLBI) score (among experienced leaders)

− 0.53 (− 1.66, 0.59)

− 0.13 (− 0.38, 0.11)

− 0.64 (− 1.81, 0.54)

− 0.16 (− 0.41, 0.09)

Volunteer satisfaction (VSI) score (among experienced leaders)

5.08 (3.25, 6.91)

0.70 (0.46, 0.94)

4.94 (3.05, 6.82)

0.68 (0.45, 0.92)

Secondary outcomes (3 months post-intervention)

Leader self-efficacy (SSGLSS) score

15.61 (10.24, 20.97)d

0.73 (0.49, 0.98)d

16.20 (10.63, 21.78)d

0.76 (0.51, 1.01)d

Emotional distress (PHQ-8) score

− 0.81 (− 1.86, 0.25)

− 0.19 (− 0.41, 0.02)

− 1.01 (− 2.03, 0.00)

− 0.24 (− 0.46, − 0.03)e

Burnout (OLBI) score (among experienced leaders)

− 0.91 (− 1.94, 0.13)

− 0.25 (− 0.51, 0.00)

− 0.98 (− 2.05, 0.08)

− 0.28 (− 0.53, − 0.02)e

Volunteer satisfaction (VSI) score (among experienced leaders)

3.91 (2.10, 5.72)

0.53 (0.31, 0.75)

3.91 (2.09, 5.72)

0.53 (0.32, 0.75)

  1. All models are presented with multiply imputed data. For the Scleroderma Support Group Leader Self-Efficacy Scale and Volunteer Satisfaction Index, positive numbers favour the intervention. For the Patient Health Questionnaire-8 and Oldenburg Burnout Inventory, negative numbers favour the intervention. Analyses of SSGLSS and PHQ-8 include all 148 participants, whereas analyses of OLBI and VSI include only the 114 experienced participants, since these are not relevant to candidate leaders
  2. CI confidence interval, PHQ-8 Patient Health Questionnaire-8, OLBI Oldenburg Burnout Inventory, SMD standardized mean difference, SSGLSS Scleroderma Support Group Leader Self-efficacy Scale, VSI Volunteer Satisfaction Index
  3. aAdjusted for baseline outcome score only
  4. bAdjusted for baseline score plus age (continuous); sex (male vs. female); whether the leader has scleroderma (no vs. yes); and, for outcomes that included both experienced and new leaders, whether the leader was a prospective vs. experienced leader
  5. cModels were simplified to remove random slopes and to only include a single random intercept for each separate intervention group and for all waitlist participants combined to facilitate convergence
  6. dOne intervention arm participant scored 118 on the Scleroderma Support Group Leader Self-Efficacy Scale (possible scores 32–192) at baseline, 187 post-intervention, and 32 (all items “strongly disagree”) at 3 months post-intervention. We inquired with the participant about the unusual variability in scores, and she indicated that she had intended to score all items as “strongly agree” at 3 months post-intervention (score = 192) but had mistakenly responded backwards. Thus, her score was counted as missing at 3 months post-intervention
  7. eThe Borenstein and Hedges’ formula for converting regression coefficients to standardized mean differences was adapted for use with the PN-RCT design and, thus, closely approximates the SMD and 95% CI. In two cases, there were discrepancies between statistical significance based on raw scale scores and Hedges’ g; the raw score results should be interpreted for statistical significance. See Additional file 6: S6
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Orphanet Journal of Rare Diseases

ISSN: 1750-1172