Antipsychotic treatment experiences of people with bipolar I disorder: patient perspectives from an online survey.

BACKGROUND: Oral antipsychotic (AP) medications are frequently prescribed to people with bipolar I disorder (BD-I). A cross-sectional online survey examined the experiences of people living with BD-I with a history of recent AP use. METHODS: Adults with self-reported physician-diagnosed BD-I (N = 200) who received oral APs during the prior year completed a survey on AP-related experiences, including side effects and their perceived burden on social functioning, adherence, and work. Items also assessed preferences for trade-offs (balancing symptom management and side effects) when considering a hypothetical new AP. The perceived impact of specific, prevalent side effects on adherence, work, and preferences for a hypothetical AP were also examined. Analyses were descriptive. RESULTS: The survey sample had a mean age of 43.2 (SD = 12.4) years, was 60% female, and 31% nonwhite. Almost all participants (98%) had experienced AP side effects. Common self-reported side effects were feeling drowsy or tired (83%), lack of emotion (79%), anxiety (79%), dry mouth (76%), and weight gain (76%). Weight gain was cited as the most bothersome side effect, rated by most participants (68%) as "very" or "extremely bothersome." Nearly half of participants (49%) reported that AP side effects negatively impacted their job performance; almost all (92%) reported that side effects - most commonly anxiety and lack of emotion - negatively impacted social relationships (e.g., family or romantic partners). The most commonly-reported reason for stopping AP use was dislike of side effects (48%). Side effects most likely to lead to stopping or taking less of AP treatment included "feeling like a 'zombie'" (29%), feeling drowsy or tired (25%), and weight gain (24%). When considering a hypothetical new AP, the most common side effects participants wanted to avoid included AP-induced anxiety (50%), weight gain (48%), and "feeling like a 'zombie'" (47%). CONCLUSIONS: Side effects of APs were both common and bothersome, and impacted social functioning, adherence, and work. Findings highlight the prevailing unmet need for new APs with more favorable benefit-risk profiles.

Adapting traditional content validation methods to fit purpose: an example with a novel video assessment and training materials in Duchenne muscular dystrophy (DMD).

PURPOSE: The Duchenne muscular dystrophy (DMD) Video Assessment requires a caregiver to record six videos of their ambulatory child performing physical activities using a smartphone application (app). Innovative assessments that combine a performance measure, technology, and an observer require new approaches to content validation studies. This study presents a novel approach to establish the feasibility and content validity of the Video Assessment and usability of the app. METHODS: Interviews used concept elicitation and an adapted cognitive debriefing approach. Interviews were conducted with 8 clinicians who reviewed training materials prior to the interview and provided feedback on the appropriateness and usefulness of the DMD Video Assessment and the relevance of the physical activities. Four caregivers reviewed training materials and used the app to record their child performing the physical activities prior to the interview. Researchers reviewed the recordings against a checklist to identify discrepancies in caregivers' understanding of the training materials prior to an interview. During the interview, caregivers commented on comprehension of the materials, appropriateness of the activities, and feasibility of recording the videos. RESULTS: Clinicians found the DMD Video Assessment and materials appropriate and useful for assessing disease progression and treatment response. Caregivers found the activities appropriate and the training materials and app easy to understand and use. Feedback resulted in changes to the training materials, but not the activities or videotaping procedure. CONCLUSIONS: Researchers used an innovative methodological approach that adapted traditional methods of content validation for the purpose of evaluating a technology-based performance measure in its totality. While future studies should be conducted with a larger, more diverse sample, these study findings add to our understanding of the content validity of the DMD Video Assessment.