Choices, choices: selecting, defining, and measuring outcomes for young people with depressive disorders

ABSTRACT

Talk 1 Presenter Dr Darren Courtney Title ''Response,'' ''Remission,'' and ''Recovery'' in randomized clinical trials for the Treatment of Adolescent Depression. ''Response,'' ''Remission,'' and ''Recovery'' are often used as dichotomized outcomes to define clinically important change in randomized clinical trials for mental disorders. These dichotomizations can guide clinical decisions to continue, intensify, switch, or stop treatment. Through a rigorous scoping review of randomized clinical trials for the treatment of adolescent major depressive disorder (N = 98), we found high variability in how these terms were operationally defined;with 53 unique outcome definitions of ''response'' across 45 trials that assessed response, 47 unique definitions of ''remission'' in 29 trials that assessed remission, and 19 unique definitions of ''recovery'' across 11 trials that assessed recovery. Moreover, there was a dearth of rationale based on empirical findings. Finally, reports of input from youth with lived experience in establishing these definitions were minimal. In studying and implementing interventions to address mental disorders arising from the COVID-19 pandemic, a new and standardized approach to define clinically important change is needed. Talk 2 Presenter Dr Nancy Butcher Title Measurement Matters Evaluating Methods of Assessing Depression in Adolescent Clinical Trials. Rates of major depressive disorder in youth are on the rise, creating urgency for well-designed trials using well-measured outcomes during the COVID-19 pandemic era. Timely conduct of psychiatric trials in youth, however, may require innovative and virtual methods for outcome measurement as an alternative design to in-person assessments. The Children's Depression Rating Scale-Revised is the most commonly used method of measuring depressive symptoms in clinical trials of adolescents with major depressive disorder. Originally developed for use in children, it is unknown whether the Children's Depression Rating Scale-Revised is fit-for-purpose for measuring depression in adolescents. This study aimed to identify all existing evidence of key measurement properties of the Children's Depression Rating Scale-Revised in adolescents with major depressive disorder through a systematic review, and to evaluate these properties using a well-established appraisal method developed by the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) Initiative. We found that it is unclear whether the Children's Depression Rating Scale-Revised can appropriately measure depression symptom severity of adolescents with major depressive disorder, either in person or via virtual assessment. No study assessed content validity, cross-cultural validity/measurement invariance, or measurement error of the Children's Depression Rating Scale-Revised in adolescents with major depressive disorder. Low-quality evidence was found for sufficient construct validity (n = 4 studies) and responsiveness (n = 2 studies). Very low-quality evidence was found for sufficient inter-rater reliability (n = 2 studies). The results for structural validity (n = 3 studies) and internal consistency (n = 5 studies) were inconclusive. No study evaluated the validity of the Children's Depression Rating Scale-Revised using a virtual mode of administration. Implications and future directions for depression outcome research will be discussed including tools to guide outcome measurement instrument selection and reporting using innovative and virtual methods. Talk 3 Presenter Dr. Karolin Krause Title Are Symptoms All That Matters? Contrasting Outcome Measurement in Youth Depression Trials with Youth Perceptions and Priorities Depression is a common mental health problem in adolescence worldwide. The COVID-19 pandemic is putting additional strain on youth wellbeing and may lead to a rising demand for effective treatment in the coming years. Within a person-centered healthcare framework, treatment effectiveness should be judged with reference to individual patient needs. A recent systematic review suggests that most clinical trials for adolescent depression assess outcomes in the domain of symptom change, and half assess functional impairment, while other outcomes are rarely considered. We conducted a mixed-methods investigation of youth outcome perceptions and priorities, to understand the extent to which this focus reflects what matters to youth. In semi-structured interviews conducted with 34 youth following participation in a psychotherapy trial for depression, symptomatic change was the most frequently discussed outcome (by 65%) but change in coping skills was discussed just as often, followed by improved family functioning (47%) and social functioning (35%). These outcomes were assessed by less than 5% of recently published quantitative treatment studies. Subsequently, Q-methodology was used in a purposive sample of 28 youth with lived experience of depression, to investigate which outcomes they considered most important. Four distinct profiles were identified ''symptom reduction and enhanced well-being'';''improved coping and self-management'';''better understanding past and present'';and ''less interference with daily life.'' Findings suggest that a narrow focus on symptom metrics fails to cover secondary outcomes that matter to youth. Trialist should draw on emerging guidance provided by Core Outcome Sets to consider a broader range of outcomes. Trialists should further consider including a personalized outcome measure to reflect varying individual priorities and understand whether treatments enable progress toward youth's individual treatment goals. Talk 4 Presenter Dr Suneeta Monga Title Engaging Youth in Defining What Outcomes Matter Development of a Core Outcome Set for Adolescent Depression with Active Youth Participation Reviews of the literature document the wide heterogeneity in what, how, and when outcomes are measured in adolescent major depressive disorder. Such heterogeneity significantly limits the ability to draw conclusions around the best or most effective treatment as individual trial results cannot be pooled together in systematic reviews when outcomes differ across trials. A Core Outcome Set, as defined by the Core Outcome Measures in Effectiveness Trials Initiative, is an agreed, minimum, standardized set of outcomes that should be measured and reported in all clinical trials and audits in a specific area of health or healthcare. In other areas of medicine, development of a Core Outcome Set has increased consistency across trials, maximized the potential for a trial to contribute to systematic reviews of key outcomes, increased measurement of appropriate outcomes, and reduced selective outcome reporting. The development of a Core Outcome Set for adolescent major depressive disorder with a strong emphasis on youth and caregiver involvement to ensure that outcomes that really matter to youth and caregivers are incorporated into the final Core Outcome Set is currently underway. The use of innovative approaches that support engagement and participation of youth with lived experience, and caregivers, in all steps of the development of this Core Outcome Set will be a focus of this presentation. Important adaptations to manage the current impact of COVID-19 on the Core Outcome Set development will also be discussed as part of this presentation.