Appendix 2: Taxonomy of outcomes based on literature reviews, focus groups and formal requirements.
Hierarchy of outcomes
- Avoid burden of disease
- Avoid burden of mania
- Avoid burden of acute manic episodes
- Avoid burden of acute depressive episodes
- Avoid burden of depression
- Avoid burden of mania between episodes
- Avoid burden of depression between episodes
- Avoid burden of treatment
- Avoid burden of side effects
- Avoid bother
Attributes of outcomes
Burden of acute depressive episodes and burden of depression between episodes
•Depressive symptoms
•Social functioning reduced because of depressive symptoms
•Functioning at school/work reduced because of depressive symptoms
•Hospitalizations
•Substance abuse
•Economic loss
•Burden to society
•Burden to close people
•Risk to others
•Fear of relapses
•Suicide risk
•Risk of shorter life expectancy
•Reduced quality of lifeexperience because of depressive symptoms
•Self-harm
•Loss of autonomy
•Shame and stigma
Burden of acute manic episodes and burden of mania between episodes
•Manic symptoms
•Positive aspects of mania
•Social functioning reduced because of manic symptoms
•Functioning at school/work reduced because of manic symptoms
•Hospitalizations
•Substance abuse
•Economic loss
•Burden to society
•Burden to close people
•Risk to others
•Fear of relapses
•Suicide risk
•Risk of shorter life expectancy
•Self-harm
•Loss of autonomy
•Shame and stigma
Burden of side effects
•Weight gain
•Trouble sleeping
•Muscle stiffness
•Drowsiness
•Headache
•Trembling
•Stomach problems
•Dry mouth
•Rash
•Risk of developing diabetes
•Reduced kidney function
•Other short- and long-term side effects
•Dependency of medication
•Social functioning reduced because of side effects
•Functioning at school/work reduced because of side effects
•Shame and stigma
Bother
•Inconvenient time of the day to take the medication
•Number of blood tests
•Medication must be taken at specific times
•Having to switch to a different, generic medication
•Medication being difficult to acquire
•Alcohol restrictions while taking medication
•Food and drink restrictions while taking medication
•Medication cannot be taken outside of meals
•Having to take the medication at specific times of the day
•Having to learn about the medication
•Number of visits to the pharmacy
•Fear of forgetting to take medication
•Having to bring papers when travelling abroad and/or fear of being stopped in customs
•Practical inconvenience during travel
•Number of visits to the doctor
•Risk of drug interactions and having to talk with a clinician before using other medications
•Uncertain effect of medication
•Slowness of effect
•Having to be aware of side effects
•Social functioning reduced because of bother
•Functioning at school/work reduced because of bother
•Shame and stigma
The complete list of outcomes suggested in the focus groups is available on request.