Table 2 Variables, measures, and methods of analysis
From: HELP — Heidelberg decision aid for lung cancer patients: a randomized controlled clinical trial
Variable/outcome | Hypothesis | Outcome measure | Methods of analysis |
|---|---|---|---|
1) Primary | Intervention improved outcome in comparison to the control group | ||
Clarity of personal attitude/values clarity | Values clarity subscore of Decisional Conflict Scale (DCS-D) | van-Elteren-test | |
2) Secondary | |||
Decisional certainty | Improvement in comparison to control | Uncertainty subscore of Decisional Conflict Scale (DCS-D) | Cochran-Mantel-Haenszel test/ van-Elteren-test |
Decisional support | Improvement in comparison to control | Support subscore of Decisional Conflict Scale (DCS-D) | Cochran-Mantel-Haenszel test/ van-Elteren-test |
Being informed | Improvement in comparison to control | Informed subscore of Decisional Conflict Scale (DCS-D) | Cochran-Mantel-Haenszel test/ van-Elteren-test |
Decision Effectiveness | Improvement in comparison to control | Effective decision subscore of Decisional Conflict Scale (DCS-D) | Cochran-Mantel-Haenszel test/ van-Elteren-test |
Decreased decisional conflict | Improvement in comparison to control | Decisional Conflict Scale (DCS-D) – total score | Cochran-Mantel-Haenszel test/ van-Elteren-test |
Self-efficacy | Improvement in comparison to control | Decisional Self-Efficacy Scale (DSES) | Cochran-Mantel-Haenszel test/ van-Elteren-test |
Patient involvement in decision | Improvement in comparison to control | PDM subscore of Perceived Involvement in Care Scale (PICS-D) | Cochran-Mantel-Haenszel test/ van-Elteren-test |
Information seeking | Improvement in comparison to control | PI subscore of Perceived Involvement in Care Scale (PICS-D) | Cochran-Mantel-Haenszel test/ van-Elteren-test |
Health care provider facilitation | Improvement in comparison to control | HCP-FAC subscore of Perceived Involvement in Care Scale (PICS-D) | Cochran-Mantel-Haenszel test/ van-Elteren-test |
Quality of life | Improvement in comparison to control | EQ5D-5L | Cochran-Mantel-Haenszel test/ van-Elteren-test |
Emotional well-being | Improvement in comparison to control | Hospital Anxiety and Depression Scale (HADS-D) | Cochran-Mantel-Haenszel test/ van-Elteren-test |
3) Subgroup analyses | |||
Additional analysis IG | |||
Preparation for decision | (Explorative approach) | Preparation for Decision Making Scale (PDMS-D) | Descriptive |
4) Sensitivity analyses | |||
Per protocol analysis | Improvement in comparison to control | All outcomes | |