Patient-important outcomes in long-term treatment of bipolar disorder: a mixed-methods approach investigating relative preferences and a proposed taxonomy Øystein Eiring, MD specialist in psykiatri, PhDc University of Oslo

Introduction Former studies Our study Use

Ann-Toril Hytten 47 y.o. Bipolar disorder Photo licence: iStockphoto

What´s the best long- term medication for me?

What have you used before? Did you take is as it was prescribed? How did it work? Were the effects monitored? What have you used before? Did you take is as it was prescribed? How did it work? Were the effects monitored?

Network meta-analysis, The Lancet, sep options, 5 outcomes 1.All relapses and recurrences 2.Manic/mixed relapses and recurrences 3.Depressive relapses and recurrences 4.Tolerability (side effects) 5.Acceptability 1.All relapses and recurrences 2.Manic/mixed relapses and recurrences 3.Depressive relapses and recurrences 4.Tolerability (side effects) 5.Acceptability

Most patients prefer shared decision-making Chewning, Betty, et al. "Patient preferences for shared decisions: A systematic review." Patient education and counseling 86(1) 2012: Patients preferring shared decision-making: 50 percent before percent after 2000 Patients preferring shared decision-making: 50 percent before percent after 2000

What is important to you?

Introduction Former studies Our study Use

1: Cognitive status Cognitive effect and severity of depression were equally important in one study.

2: Weight gain Weight gain within 3 months was found to be equally important to cognitive impairment and severity of depression, and three times more important than serious side effects. A weight gain of more than 2.3 kg reduced the utility with 0.07.

3: Patients had not selected the outcomes Most authors had not involved patients when they selected and developed the outcomes in their studies. Only a limited selection of potentially important outcomes were presented to patients.

4: Not predictable The patients’ preferences did not vary consistently with age, gender, disease severity or other demographic or disease variables.

5: Patients are not psychiatrists Patients valued disease states higher than did other groups …and perceived side effects more negatively than clinicians did.

What outcomes are meaningful and important to patients? Which risks and benefits should I bring into the conversation? What outcomes are meaningful and important to patients? Which risks and benefits should I bring into the conversation?

Introduction Former studies Our study Use

The objectives 1.To investigate the relative importance of treatment outcomes to patients with bipolar disorder

The objectives 1.To investigate the relative importance of treatment outcomes to patients with bipolar disorder 2.To assess the discriminative value and feasibility of the method

The objectives 1.To investigate the relative importance of treatment outcomes to patients with bipolar disorder 2.To assess the discriminative value and feasibility of the method 3.To construct a holistic taxonomy of patient- important outcomes.

The methods 1.Literature review

The methods 1.Literature review 2.Four focus groups with 23 patients in total

The methods 1.Literature review 2.Four focus groups with 23 patients in total 3.The ”self-explicated” method

The methods 1.Literature review 2.Four focus groups with 22 patients in total 3.The ”self-explicated” method 4.Construction of the taxonomy

The participants Between 18 and 65 years, mean age 42 The majority had bipolar I Nearly 2/3 women In a stable phase and regularly seeing a clinician Patients with comorbid conditions and substance dependency included

Main results 1 Outcomes suggested in clinical guidelines and textbooks vary widely. All patients were able to complete the exercises, with consistent results

Main results 2 Severe symptoms, experienced quality of life and functioning was most important Avoiding burden to society was significantly more less important than all other outcomes Patients´ preferences varied considerably

Results: Focus groups 141 medication-associated outcomes suggested. All of these outcomes could be categorised within the first 23 outcomes Largest number of outcomes suggested for depression, mania, side effects, practical burden of treatment, social functioning and fear of relapse.

Results: self-explicated method

Findings consistent with other studies Severe depression and mania among the least desired outcomes to patients with bipolar disorder Weight gain has prominence among side effects

Proposed taxonomy Avoid burden of disease – Avoid burden of mania Avoid burden of acute manic episodes Avoid burden of mania between acute episodes – Avoid burden of depression Avoid burden of acute depressive episodes Avoid burden of depression between acute episodes Avoid burden of treatment – Avoid burden of side effects – Avoid bother

Proposed taxonomy Avoid burden of disease – Avoid burden of mania Avoid burden of acute manic episodes Avoid burden of mania between acute episodes – Avoid burden of depression Avoid burden of acute depressive episodes Avoid burden of depression between acute episodes Avoid burden of treatment – Avoid burden of side effects – Avoid bother

Burden of mania in/between episodes Manic symptoms Positive aspects of mania Social functioning reduced because of manic symptoms Functioning at school/work reduced because of mania Hospitalisations Substance abuse Economic loss Burden to society Burden to close people Risk to others Fear of relapses later Suicide risk Risk of shorter life expectancy Self-harm Loss of autonomy Shame and stigma

Meaning of study Patients have heterogeneous outcome preferences When evaluating symptoms and side effects, the impact of these outcomes on functioning and quality of life should be included The self-explicated method is feasible and warrants exploration in clinical practice

Take home message “In patient-centered medicine and shared decision-making… …medications should be assessed and selected based on outcomes important to the individual… …and the patient´s trading off of the likely benefits and harms of the options”

Introduction Former studies Our study Use

Compare options head-to-head

Monitor the current treatment based on her priorities.

Look at how the treatment works - together

Two screens to make decisions - together Two screens to make decisions - together