Is It Time to Replace the HAQ?

Dr. Khanna and colleagues have assessed use of 11 CAT-administered PROMIS item banks among patients with scleroderma at a single center. They found that the average time to reliably complete the 11-item bank domains was about 11.9 minutes, or about one minute per domain. In comparison, Dr. Khanna says, a patient would spend about 18 to 30 minutes completing the 91 items in the five legacy instruments that assess six domains in patients with scleroderma (physical functioning, mental health, bodily pain, social functioning, sleep, and fatigue; manuscript in review).

Dr. Morgan DeWitt is principal investigator on another PROMIS research initiative, called Enhancing PROMIS in Pediatric Pain, Rheumatology, and Rehabilitation Research. The research is validating the pediatric measures that were developed in the first phase of PROMIS. “We’re taking the PROMIS 1 measures that were developed in pediatrics among a large cohort of both healthy kids and kids with chronic conditions and doing longitudinal validation in children with juvenile idiopathic arthritis [JIA] or chronic musculoskeletal pain,” she says.

The items developed in phase 1 are now being administered along with legacy scales at three different time points to children with JIA or chronic pain; this is coupled with clinical measures of disease activity, such as joint counts or global assessments. “This enables us to study the responsiveness of the PROMIS measures to changes in a patient’s clinical status. The results will facilitate the use of PROMIS measures for assessment of health outcomes over time. By determining how large of a change is clinically important, this will increase interpretability of change scores and the usefulness of the measure in these particular populations,” she says.³

“With PROMIS, we have a wide range of domains of health-related quality-of-life measures—such as fatigue and pain interference—that we haven’t previously had for children with JIA. Another goal of the research is to develop new measures to assess the multiple dimensions of pain in children with new pain behavior and pain quality items to test in patients with JIA, fibromyalgia, and sickle cell disease. “Currently there is a pain interference measure, but we don’t have other ways of measuring pain,” says Dr. Morgan DeWitt.

The next generation of outcomes measures is being developed by PROMIS.

18 Steps in Question Development

The science of IRT requires 18 steps for item development, according to Dr. Fries. His PROMIS research, called Improving Assessment of Physical Function and Drug Safety in Health and Disease, first required looking at all of the last 30 years of published articles written in English about instruments related to quality of life. That yielded 165 questionnaire instruments with 1,860 items that related to disability or physical function health outcomes. Through the process of “binning and winnowing,” items were grouped that were similar and redundant items were tossed out, leaving about 154 items.