Treatment Preferences and Risk Tolerance Study
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1 Treatment Preferences and Risk Tolerance Study Pat Furlong, BSN, MS Holly Peay, MS CGC Vice President, Education and Outreach
2 Study Goals Objective: explore how parents/guardians of individuals with DMD prioritize risk and benefit in the context of new therapies Specific Aims: Describe risk tolerance, health-related QoL, and numeracy Explore treatment preferences, risk tolerance and benefit priorities Evaluate the effect of child s disorder progression on treatment preferences Explore Duchenne-related worries
3 Methodology Developed in consultation with health economist Best/worst scaling type 2 BWS is a theory about how people make best and worst (most and least, smallest and largest, two extremes, etc.) choices from choice sets consisting of three or more things. (Louviere and Flynn 2010) Based on random utility theory- value respondent derives from an object compared with a comparator is proportional to how often he/she chooses it in preference to comparator
4 Attribute Development: Worries 5 parents contributed a broad list of DMDrelated worry items Researchers refined the items and grouped under domains Final worry domains child-focused (health, QoL, and social support) external to the child (parent/guardian QoL, social support, family effects)
5 Attribute Development: Treatments Large pool of hypothetical attributes and levels identified in consultation with parents, providers, and biotech/pharma Items reduced and refined during the stakeholder consultation Identified plausible attributes that are sufficiently balanced to allow a successful experiment
6 Refinement and Piloting Draft instruments refined in consultation with social scientists with expertise in clinical research and rare disorder populations Survey instrument piloted by 7 parents who provided extensive feedback on the items and instrument as a whole Final survey developed and implemented online
7 Worry List: In the past 7 days, most/least worried A My child missing out on new treatments B My child getting weaker C Getting the right care for my child over time D My child feeling happy E My child having good friends F My child feeling like a burden on the family G My child becoming independent from me over time H My child not being able to express deep worries J Being a good enough parent for my child K Me handling the emotional demands of Duchenne L Managing my uncertainty about my child s future M Having time for myself N Feeling isolated from other families P Affording care my child needs within the family budget Q Effects of Duchenne on my closest relationships R The wellbeing of my other children
8 Treatment Attributes LABEL A1 Muscle function A2 Muscle function A3 Muscle function B1 Lifespan B2 Lifespan B3 Lifespan C1 Drug knowledge C2 Drug knowledge C3 Drug knowledge EXPERIMENT DESCRIPTION Stops the progression of weakness Slows the progression of weakness Does not change progression of weakness 5 year gain in expected lifespan 2 year gain to expected lifespan No extra gain to expected lifespan 2 years of post-approval drug information available 1 year of post-approval drug information available No post-approval drug information available
9 Treatment Attributes Con t Label D1 Nausea D2 Nausea D3 Nausea E1 Bleeds E2 Bleeds E3 Bleeds F1 Arrhythmia F2 Arrhythmia F3 Arrhythmia Experiment description No increased chance of nausea Causes loss of appetite Causes loss of appetite with occasional vomiting No increased risk of bleeds Increased risk of bleeding gums and increased bruising Increased risk of hemorrhagic stroke and lifelong disability No increased risk of heart arrhythmia Increased risk of harmless heart arrhythmia Increased risk of dangerous heart arrhythmia and sudden death
10 Inclusion Criteria & Recruitment Recruited from PPMD, DuchenneConnect Registry, and snowball recruiting Parents or guardians of at least one living child with Duchenne muscular dystrophy, living in the United States, over 18 years of age, and able to complete an online survey in English Study determined to be exempt by the Western Institutional Review Board
11 Survey Components Treatment experiment: 18 treatment scenarios Worries experiment: 16 worries lists Risk Taking Measure (Pearson et al.,1995): 6 items from the Jackson Personality Index Numeracy (Fagerlin et al., 2007) 3 items adapted from Subjective Numeracy Scale SF-12 Health-Related QoL Child DMD status (mobility and self-care PROM) Care/support items Demographics
12 Design Detailed description of attributes and levels; example task 18 treatment choice tasks generated from Youden design assessing the best and worst attribute Each treatment scenario followed by acceptability question ( If this treatment were real, would you use it for your child? ) 16 worry choice tasks assessing the most and least significant worries over the past 7 days
13 Experiment Example Choose the best thing by clicking the circle under best and choose the worst thing by clicking the circle under worst. You have to choose a best thing and a worst thing to move on. Remember that a computer chose combinations to make the experiment work, and some of them seem bad. Even so, please pick the best and worst thing.
14 Preliminary Analysis Level utility scores (across all choice sets and respondents) # of times attribute level chosen worst - # of times chosen best/# times attribute appears in experiment*# participants Attribute importance scores Max level mean - min level mean/total of all attribute max-min means Multinomial analysis ongoing
15 Preliminary Results 119 parents completed entire survey Mean participant age 43.7 (SD 7.7) Mean affected child age 12.1 (SD 6.4) 80 (67%) biological mothers, 34 (29%) biological fathers, 5 (4%) adoptive parents 109 (92%) Caucasian 107 (90%) married, 11 (9%) divorced/separated, and 1 (1%) widowed
16 6. What is your annual household income? Frequency % Valid % Less than $25, $25,000-$50, $50,000-$75, $75,000-$100, More than $100, Total System Total
17 5. What is the highest level of education you have completed? Freq % Valid % High school or GED Some college but no degree Technical school Associate s degree (2-year college degree) year college degree (e.g., BA, BS) Some graduate school but no degree Graduate or professional degree (e.g., MBA, MS, MD, PhD) Total System 1.8 Total
18 Affected Children 110 (92%) have one affected child; 9 (8%) have two or more affected children 101 (85%) have private insurance; 40 (34%) have a state/government program 68 (58%) participated in clinical research and 40 (34%) participated in a clinical trial 22 (19%) child has experienced a lifethreatening emergency that caused parent to worry that the child would die
19 4. Chose the option that best describes your child s physical abilities today. Frequency % Is a baby, a toddler, or a very young child who is too young to walk far yet Walks independently for long distances outdoors (more than ½ mile) Walks less than ½ mile, but more than short distances Walks independently outdoors for short distances (such as to the car) Walks outdoors with help from a person 1.8 Walks independently indoors but needs a wheelchair for outdoors Walks indoors with help from a person and requires wheelchair outdoors Uses wheelchair and can go indoors and outdoors Uses wheelchair but unable to go outdoors in some situations (such as cold weather) Unable to control wheelchair without help Total
20 Preliminary Conclusions Within the context our experiment: Worries related to child s illness progression and care accounted for the largest proportion of the variance in the worries attributes. Stopping or slowing the progression of muscle weakness accounted for the largest proportion of the variation in treatment attributes. Our evidence suggests that the presence of side effects/risks could be compensated for by a treatment that stops progression to muscle function.
21 Next Steps Further analysis ongoing Seeking input from FDA about acceptability and interest Possible refinement and second survey Focus groups/community input Tell Your Story open-ended data collection and analysis ongoing
22 Collaborators John Bridges, PhD, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health Ilene Hollin, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health Sharon Hesterlee, PhD, PPMD Hadar Sheffer, MPH, PPMD
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