Parent-Reported Symptom Assessments in Children Taking Multiple Medications

2019-02-25 00:28:26 | BioPortfolio


This study plans to learn about how to measure symptoms (like tiredness or rash) in children with special healthcare needs who take 5 or more medications. Sometimes symptoms change in severity over time or new symptoms develop. This can happen after a new medication is started. This can also happen after the dose of an existing medication is changed. The Investigators believe that parents will be able to provide the best assessment of any symptoms that their child might be experiencing.

Part 1 of this study asks parents to report any symptoms their child is currently experiencing. A certain number of people will be asked to participate in Part 2 of this study. The investigators will select these people based on the types of medicines the child takes.

Part 2 of this study asks parents to report any symptoms their child experiences before and after the start of a new medication or before and after the dose of an existing medication is changed.


An increasing number of children with complex chronic conditions (CCCs) who have intractable illnesses or multi-organ dysfunction are exposed to daily polypharmacy. Parents of children with polypharmacy often administer 5 or more medications each day, sometimes for months, including high-risk medications prescribed by many different specialists in multiple settings of care. While medications can be life-saving, polypharmacy increases the risk of additive adverse effects, drug-drug interactions, and can lead to serious adverse drug events (ADEs). Pediatric ADEs result in over 4.3 million estimated ambulatory visits annually, including >150,000 pediatric emergency room visits. Despite the risks associated with polypharmacy, little is known about how polypharmacy escalates and how polypharmacy should be managed. To enable children to thrive at home using medications while minimizing unwanted symptoms, this proposal aims to implement a prospective, parent-reported symptom assessment system to guide and monitor pharmaceutical care for high-risk children. Strategies to improve recognition of problematic symptoms will have a substantial impact on the health of children. Thus, the investigator will carry out the following research studies, specifically focusing on the high-risk population of children with neurological impairment (NI) and polypharmacy:

Part 1: Conduct cross-sectional parent-reported symptom assessments (PRSA). In a clinic population of 300 children, the investigator will administer an electronic validated symptom inventory to parents to advance the understanding of signal-to-noise and signal detection challenges in this population.

Part 2: Conduct a prospective cohort study to quantify the detection of known ADEs using PRSA. The investigator will follow 50 children expected to have medication changes (empaneled in Aim 1) and assess whether using PRSA prior to and after specific medication changes detects known and expected side effects.

Study Design


Neurologic Disorder


Parent-Reported Symptom Assessment


Children's Hospital Colorado
United States


Not yet recruiting


University of Colorado, Denver

Results (where available)

View Results


Published on BioPortfolio: 2019-02-25T00:28:26-0500

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