Introduction
Patients and methods
Study design
Standardized IC talk, interventions, and questionnaires
Ethics
Statistics and software
Results
Comparison of disease knowledge and comprehension resulting from the IC talk between (extended) IC talk groups
Estimate | p-value | |
---|---|---|
First step (initial model) | ||
Intercept | −2.367 | <0.0001 |
Gender | 0.016 | 0.92 |
Duration of the informed consent talk | 0.003 | 0.48 |
Duration between informed consent talk and filling up the first questionnaire | −0.004 | 0.54 |
Age | −0.016 | 0.017* |
DSA | −0.291 | 0.12 |
TEA | −0.410 | 0.042* |
Fontaine classification | 0.023 | 0.69 |
Self-Information before IC talk | 0.273 | 0.056 |
Chance to ask questions before IC talk | 0.057 | 0.65 |
Estimated quality of life after intervention | −0.183 | 0.15 |
Concerned about the risks | −0.026 | 0.77 |
Questions were helpfully answered | 0.075 | 0.54 |
Smoking | −0.118 | 0.25 |
Diabetes mellitus | 0.226 | 0.082 |
Coronary heart disease | 0.153 | 0.24 |
Atrial fibrillation | −0.096 | 0.61 |
Extended IC talk (PP or WD) | −0.026 | 0.78 |
Last step (containing only significant terms) | ||
Intercept | 1.92 | <0.001* |
Age | −0.013 | 0.010* |
DSA | −0.248 | 0.047* |
TEA | −0432 | 0.007* |
Self-information before IC talk | 0.283 | 0.031* |
Satisfaction with staff and treatment
Long-term impact of disease knowledge and patient education on QoL
Coefficients of linear discriminants | LD1 |
---|---|
Physical functioning | 0.034390417 |
Role limit: emotional problems | 0.006932905 |
Role limit: physical health | 0.030501062 |
Fatigue | −0.009631083 |
Emotional wellbeing | −0.046042247 |
Social functioning | 0.001989986 |
Pain | −0.028146515 |
General health | 0.025963679 |
All | PF | RLEP | RLPH | Fat | EWB | SF | Pain | GH | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
VARIABLE | P | p-value | F | p-value | F | p-value | F | p-value | F | p-value | F | p-value | F | p-value | F | p-value | F | p-value |
IC talk | 0.75 | 0.9 | 5.4 | 0.048 | 1.9 | 0.2 | 2.8 | 0.1 | 4.2 | 0.08 | 5.0 | 0.06 | 5.7 | 0.04 | 2.0 | 0.2 | 3.7 | 0.1 |
Treatment | 1.6 | 0.5 | 2.4 | 0.15 | 0.02 | 0.98 | 1.5 | 0.3 | 0.3 | 0.7 | 0.7 | 0.5 | 1.0 | 0.4 | 5.4 | 0.03 | 0.6 | 0.6 |
Fontaine | 0.9 | 0.5 | 19.2 | 0.002 | 2.0 | 0.2 | 1.1 | 0.3 | 4.5 | 0.07 | 6.5 | 0.03 | 4.9 | 0.06 | 6.5 | 0.03 | 10 | 0.01 |
Knowledge | 0.9 | 0.7 | 1.7 | 0.22 | 5.1 | 0.05 | <0.1 | 0.95 | 0.2 | 0.7 | 5.5 | 0.048 | 0.5 | 0.5 | 0.9 | 0.4 | 7.2 | 0.03 |
Marital st | 0.9 | 0.7 | 0.2 | 0.6 | 3.1 | 0.11 | 0.4 | 0.5 | 0.6 | 0.4 | 3.8 | 0.09 | 11.9 | 0.008 | 0.8 | 0.4 | <0.1 | 1.0 |
Education | 0.9 | 0.7 | 1.3 | 0.3 | 0.45 | 0.5 | 1.8 | 0.2 | 0.4 | 0.6 | 1.5 | 0.3 | 0.4 | 0.6 | 0.5 | 0.5 | 0.6 | 0.5 |
Care | 0.9 | 0.5 | 1 | 0.4 | 0.06 | 0.8 | <0.1 | 0.8 | 1 | 0.3 | 4.0 | 0.08 | 13.2 | 0.007 | 0.5 | 0.5 | 7.7 | 0.02 |
Income | 0.9 | 0.7 | 0.9 | 0.4 | 3.8 | 0.09 | 2.8 | 0.13 | 0.3 | 0.6 | 1.1 | 0.3 | 0.3 | 0.6 | 0.01 | 0.9 | 7.3 | 0.03 |
ICT:Treat | 0.9 | 0.6 | 0.2 | 0.7 | 0.2 | 0.7 | <0.1 | 0.8 | 1 | 0.3 | 0.9 | 0.4 | 0.3 | 0.6 | 0.03 | 0.9 | 3.4 | 0.1 |
ICT:Font | 1.0 | 0.4 | 0.2 | 0.9 | 0.02 | 0.9 | 0.3 | 0.6 | <0.1 | 0.9 | <0.1 | 0.8 | 0.08 | 0.8 | 2.0 | 0.2 | 5.1 | 0.05 |
Treat:Font | 0.6 | 0.9 | 0.02 | 0.9 | 3.6 | 0.09 | 0.2 | 0.7 | <0.1 | 0.8 | 1.2 | 0.3 | 0.2 | 0.7 | 0.07 | 0.8 | 0.02 | 0.9 |
ICT:Know | 0.9 | 0.7 | 1.4 | 0.3 | 0.8 | 0.4 | 1.7 | 0.2 | 4.5 | 0.07 | 4.3 | 0.07 | 0.7 | 0.4 | 0.03 | 0.9 | 1.1 | 0.3 |
Treat:Know | 1.8 | 0.2 | 3 | 0.1 | 0.07 | 0.9 | 0.6 | 0.6 | 0.9 | 0.4 | 0.9 | 0.5 | 2.5 | 0.1 | 0.12 | 0.9 | 0.4 | 0.7 |
Font:Know | 0.9 | 0.7 | <0.1 | 0.96 | <0.1 | 1 | <0.1 | 0.9 | 0.5 | 0.5 | <0.1 | 0.9 | 1.2 | 0.3 | 0.5 | 0.5 | 0.1 | 0.7 |
ICT:Marit | 0.9 | 0.6 | 7.6 | 0.03 | 3.3 | 0.1 | 1.6 | 0.2 | 3.2 | 0.1 | 5.8 | 0.04 | 5.4 | 0.047 | 2.6 | 0.2 | <0.1 | 1.0 |
Treat:Marit | 1.5 | 0.4 | 0.4 | 0.7 | 1.2 | 0.3 | 0.5 | 0.6 | 1.2 | 0.4 | 1.2 | 0.4 | 3.0 | 0.1 | 1.5 | 0.3 | 2.6 | 0.1 |
Know:Marit | 1.0 | 0.5 | 1.9 | 0.2 | 0.05 | 0.8 | 0.5 | 0.5 | 0.2 | 0.7 | 1.8 | 0.2 | 5.9 | 0.04 | 2.0 | 0.2 | 5.2 | 0.05 |
ICT:Edu | 0.3 | 1.0 | <0.1 | 0.95 | 0.03 | 0.9 | 0.6 | 0.4 | 0.3 | 0.6 | 0.2 | 0.7 | 0.04 | 0.8 | 0.05 | 0.8 | 0.5 | 0.5 |
Treat:Edu | 1.4 | 0.8 | 1.9 | 0.2 | 4.5 | 0.049 | 0.5 | 0.6 | 5.5 | 0.03 | 5.4 | 0.03 | 8.6 | 0.01 | 0.5 | 0.6 | 6.5 | 0.02 |
Font:Edu | 0.9 | 0.5 | 3.8 | 0.09 | 3 | 0.12 | <0.1 | 0.8 | 0.4 | 0.6 | 5.6 | 0.046 | 1.0 | 0.3 | 0.03 | 0.9 | 0.2 | 0.6 |
Know:Edu | 0.9 | 0.5 | 0.08 | 0.8 | 1.3 | 0.3 | <0.1 | 1 | 1.3 | 0.3 | 4.6 | 0.06 | 3.1 | 0.1 | 0.8 | 0.4 | 3.1 | 0.1 |
Marit:Edu | 0.8 | 0.7 | 0.2 | 0.6 | 1.5 | 0.3 | <0.1 | 0.8 | 0.5 | 0.5 | 2.8 | 0.1 | 10.0 | 0.01 | 0.5 | 0.5 | <0.1 | 1.0 |
ICT:Care | 0.7 | 0.9 | <0.1 | 1 | 0.6 | 0.5 | 0.1 | 0.7 | <0.1 | 0.9 | 0.2 | 0.7 | 3.1 | 0.1 | 0.03 | 0.9 | 0.3 | 0.6 |
Treat:Care | 0.8 | 0.8 | 5.8 | 0.04 | 0.5 | 0.5 | 0.6 | 0.5 | 0.7 | 0.4 | 0.3 | 0.6 | 0.3 | 0.6 | 0.8 | 0.4 | 3.5 | 0.1 |
Know:Care | 0.8 | 0.7 | 0.3 | 0.6 | 3.2 | 0.1 | <0.1 | 0.9 | 0.2 | 0.7 | 1.0 | 0.3 | 3.1 | 0.1 | 0.02 | 0.9 | 0.5 | 0.5 |
Treat:Income | 0.9 | 0.7 | 1.1 | 0.33 | 2.3 | 0.2 | 1.6 | 0.2 | 5.4 | 0.048 | 7.1 | 0.03 | 6.3 | 0.04 | 0.9 | 0.4 | 3.4 | 0.1 |
Know:Income | 0.9 | 0.7 | 4.4 | 0.06 | 0.01 | 0.9 | 2.2 | 0.2 | 0.8 | 0.4 | 1.5 | 0.3 | 0.03 | 0.9 | 1.4 | 0.3 | 0.5 | 0.5 |
Marit:Income | 0.9 | 0.6 | 1.7 | 0.22 | 1.2 | 0.3 | 0.5 | 0.5 | 3.9 | 0.08 | 8.7 | 0.02 | 0.1 | 0.7 | <0.1 | 1.0 | 1.2 | 0.3 |
Edu:Income | 0.9 | 0.7 | 0.13 | 0.7 | 5.5 | 0.047 | 0.3 | 0.6 | 2.7 | 0.1 | 12 | 0.008 | 3.5 | 0.1 | <0.1 | 1.0 | 0.6 | 0.5 |
Know:Edu:Income | 0.8 | 0.8 | 0.17 | 0.7 | <0.1 | 1 | 0.4 | 0.5 | 0.5 | 0.5 | <0.1 | 0.9 | 4.1 | 0.08 | 1.1 | 0.3 | 1.0 | 0.4 |
Discussion
Conclusion
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There are several factors that should have an impact on the verbal disease knowledge level of the patient after the informed consent (IC) talk; they might be improved by additional education.
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Remembrance and comprehension rates were in general low and did not improve significantly with additional PowerPoint presentations (PP) or walking diary (WD).
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Age was inversely associated with disease knowledge.
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Age was also inversely and WD/PP and knowledge level directly associated with mid-term quality of life (QoL).
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However, other factors, such as care provision and social status, were important as well.
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The fact that signing the IC form does not necessarily mean that the patients feel informed about the disease and all aspects of the planned treatment should lead to revisions of the legal requirements.
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Communication with and education of vascular surgery patients is one of the mainstays of treatment and should be continued beyond the legal and formal requirements during treatment and after discharge from hospital, in order to keep the QoL as high as possible.