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Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder
Jessica T Markowitz1, Dorothee Oberdhan2, Anna Ciesluk1
1Research Department, Modus Outcomes, Cambridge, MA 02142, USA.
Insights
Most clinical outcome assessments for pediatric ADHD trials miss key patient and caregiver concerns. Future research should include these broader impacts for comprehensive assessment.
Area of Science:
- Pediatric Psychology
- Clinical Research Methodology
- Neurodevelopmental Disorders
Background:
- Clinical outcome assessments (COAs) are vital for evaluating treatment efficacy in pediatric attention-deficit/hyperactivity disorder (ADHD).
- Existing COAs may not capture the full spectrum of concerns important to patients and caregivers.
- A gap exists in comparing the concepts measured by commonly used pediatric ADHD COAs.
Purpose of the Study:
- To identify concepts important to pediatric patients and caregivers regarding ADHD.
- To evaluate the alignment of existing COAs with these identified concepts.
- To compare the scope of concepts measured by COAs used in pediatric ADHD clinical research.
Main Methods:
- Conducted qualitative literature reviews to extract patient, parent, and teacher-reported ADHD concepts.
- Developed a conceptual framework for pediatric ADHD incorporating DSM criteria and literature-identified impacts.
- Mapped items of identified COAs against this conceptual framework.
Main Results:
- Four of 27 reviewed COAs exclusively assessed DSM symptoms.
- The Swanson, Nolan, and Pelham Rating Scale-DSM-IV (SNAP-IV) demonstrated the most comprehensive coverage of the conceptual framework.
- ADHD-Rating Scale-IV (ADHD-RS-IV) was the most frequently used COA in clinical trials (n=77).
Conclusions:
- Qualitative studies reveal ADHD symptoms and impacts beyond DSM criteria that are crucial for patients and caregivers.
- Current COAs in pediatric ADHD trials primarily focus on DSM symptoms, potentially overlooking broader patient/caregiver concerns.
- Further research is necessary to develop and implement COAs that encompass all concepts vital to pediatric ADHD patients and their caregivers.
Purpose:
Various clinical outcome assessments (COAs) are used in clinical research to assess and monitor treatment efficacy in pediatric attention-deficit/hyperactivity disorder (ADHD) trials. It is unclear whether the concepts assessed are those that are important to patients and their caregivers. The concepts measured by commonly used COAs in this population have not been explicitly compared.
Methods:
We conducted reviews of the qualitative literature to extract information on pediatric ADHD-related concepts reported by pediatric patients, parents, and teachers. Using these concepts, we developed a conceptual framework of pediatric ADHD using both the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria and the additional symptoms and behavioral impacts identified in the literature. We searched for COAs that have been used in pediatric ADHD research and mapped their items based on their conceptual underpinning.
Results:
Of the 27 COAs found in the empirical literature, 4 COAs assessed only DSM symptoms. The most comprehensive coverage of our conceptual framework was seen in the Swanson, Nolan, and Pelham Rating Scale-DSM-IV (SNAP-IV). Eighteen COAs were used in at least 1 clinical trial: ADHD-Rating Scale-IV (ADHD-RS-IV) was used most often (n=77), followed by SNAP-IV (n=50), Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP; n=31), Weiss Functional Impairment Rating Scale (WFIRS; n=24), and Vanderbilt ADHD Diagnostic Rating Scale (VADRS; n=15).
Conclusion:
We identified symptoms and behavioral impacts from qualitative studies in pediatric ADHD that are not included in DSM-based criteria. Most COAs used in pediatric ADHD clinical trials measure only those symptoms listed in the DSM. While these COAs can measure symptom severity, they may not assess the full range of symptoms and impacts important to patients and their caregivers. Future research is needed to measure all concepts important to patients and caregivers within ADHD clinical trials.
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