Healthy sleep is essential for children’s happiness, attentiveness, and energy, yet estimates suggest that up to 30 percent of children are affected by sleep problems. While parents usually have no difficulty describing their poor sleepers’ crankiness and fussiness, physicians have not had a standard, reliable way to measure these patient reports of children’s sleep.
Patient reported outcome measures are ways of obtaining information about your health or your well-being from your own perspective, without any translation from a clinician or an interviewer. The National Institutes of Health offers assessment tools called the Patient Reported Outcomes Measurement Information System (PROMIS) to help physicians precisely measure what patients are able to do and how they feel by asking a set of questions that have undergone rigorous scientific testing.
The PROMIS Pediatric Profile has core measures covering domains such as anxiety, depression, fatigue, pain, physical function, and social participation, but the big missing piece of the portfolio is sleep health. Christopher B. Forrest, MD, PhD, a CHOP pediatrician and professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania, recently received a two-year grant from the Patient-Centered Outcomes Research Institute (PCORI) to develop PROMIS pediatric sleep health measures that will fill this gap and enable patients and their families to express exactly how health conditions and treatments affect their sleep.
“These questions address the dimensions of life that I like to call feelings, doings, and beings,” said Dr. Forrest, who has been involved with the PROMIS initiative since 2009. “It’s how you feel about yourself and your life, what you can do in life, and then your ‘beings’ is what you become — your personal growth and development. You cannot get that information unless you ask somebody, and what we’ve done through the National Institutes of Health PROMIS program is standardize the methodology.”
For example, “In the past seven days, I fell asleep during school,” is one of the PROMIS items being considered to measure wakefulness and sleep-related impairment. A section of questions on sleep practices includes, “In the past seven days, what time did you go to bed on school nights?”
Once the set of PROMIS pediatric sleep health measures are developed, the idea is for the questionnaires to be offered on tablets, computer kiosks, or paper forms in physicians’ waiting rooms. Two versions will be available for child self-report (ages 8 and up) and parent-proxy (children ages 5 and up).
At CHOP, efforts are underway to eventually incorporate answers to the sleep bank items and other patient-reported outcomes measures as part of the electronic health record. In addition to giving clinicians a standardized way to assess sleep quality and address pediatric sleep concerns as they change over time, the sleep health measures could be used as clinical trial endpoints.
“A medical treatment ought to make kids feel better, but they are not fully recovered until they are able to do things better, like go to school, interact with friends, have sleepovers,” Dr. Forrest said. “Those tend to be the kinds of concerns that families have, but often they don’t get brought up at conventional medical encounters.”
An innovative facet of how the pediatric sleep health item banks are being created is the project’s engagement model. Twenty individuals from five stakeholder groups — parents, youth, advocates, clinicians, and researchers — help to design and oversee the research. One leader from each group plus the project staff make operational decisions.
The team already has accomplished a substantial part of the groundwork. They have interviewed sleep experts, parents, and children, as well as conducted a literature search to identify pediatric sleep measures that were developed previously. Based on the information that they gathered, they generated a preliminary list of 180 pediatric sleep measures. Their next step is to test and validate the questions by surveying about 4,000 children and parents from across the country. They will be recruiting children from CHOP’s Sleep Center, and another group of children with autism being treated at CHOP have agreed to participate in the research.
Dr. Forrest expects the PROMIS pediatric sleep measures will be narrowed down to about 100 items that will be ready for the engagement team to disseminate within the next two years. The final set of measures will be posted on the PROMIS website for free access.
“In addition to publishing papers, we will want to make known across the country through advocacy groups, through scientific communities, and clinical societies that these measures are available,” Dr. Forrest said. “Our hope is that they get used by thousands of researchers and tens of thousands of clinicians and patients.”
Dr. Forrest also serves as the principal investigator of PEDSnet, which is part of the PCORnet national patient-centered research network established by PCORI to reduce the time and effort needed to launch new studies and focus research on questions and outcomes especially useful to patients and those who care for them.