New York, NY—November 8, 2015
A study at Hospital for Special Surgery (HSS) evaluating the Patient Reported Outcomes Measurement System (PROMIS) for patients with lupus finds that the questionnaire is a valid way to assess subjective patient experience. The research also suggests that the use of questionnaires that assess patients' quality of life can help ensure optimal disease management.
The HSS study, "Feasibility and Validity of Patient Reported Outcome Measurement Information System (PROMIS) in SLE," will be presented at the American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting on November 8 in San Francisco.
The National Institutes of Health assessment tool known as PROMIS seeks to measure the impact of disease on quality of life. It is a patient questionnaire that evaluates physical, psychological and social well–being.
"Accurate measurement of patient-reported outcomes is particularly important in systemic lupus erythematosus (SLE), a heterogeneous disease in which similar symptoms can affect patients in different ways," explains Shanthini Kasturi, MD, a rheumatology fellow at Hospital for Special Surgery and lead investigator. "PROMIS offers dynamic computer adaptive tests (CATs) to assess the subjective patient experience in a variety of relevant domains."
PROMIS surveys ask patients a series of questions measuring pain, fatigue, physical function, depression, anxiety and social function. The questionnaire administered by Hospital for Special Surgery used computerized adaptive testing, an interactive online survey that delivers a series of questions based on previous patient responses.
"For us to provide patient-centered care, we need to have an idea of what the patient is really experiencing," Dr. Kasturi said. "Having additional information about patients' quality of life will help us see how well our treatments are working and whether we should be pursuing different treatments. To our knowledge, this is the first study to assess the feasibility and validity of administering PROMIS CATs to adult SLE outpatients."
Researchers aimed to correlate PROMIS CATs with traditional patient reported outcome measures, SLE disease activity and organ damage. They also assessed the retest reliability of the PROMIS questionnaire.
Adult patients with lupus were recruited from the SLE Center of Excellence at Hospital for Special Surgery. They completed two established lupus questionnaires (the SF-36 and LupusQoL-US), which are considered the gold-standard, to assess how lupus affected their health-related quality of life. Disease activity, flares, and damage were evaluated with the SELENA-SLEDAI and SLICC-ACR indices.
PROMIS domains were compared with disease activity, damage, and similar domains in the traditional patient-reporting surveys. Retest reliability was evaluated among subjects reporting stable SLE activity at two assessments one week apart.
Of 114 patients approached, 101 (89%) completed at least one assessment. Ninety-one patients completed a retest. "The data show that PROMIS CATs can be successfully administered to diverse SLE patients at the point of care or remotely, and are valid, reliable and responsive for many SLE relevant domains," Dr. Kasturi said.
Most PROMIS domains showed moderate to strong correlations with similar domains in the established questionnaires, although social function and fatigue CAT categories showed poor, non-significant correlations with similar SF-36 domains.
Another important finding was that PROMIS scores did not correlate well with the SLEDAI damage index, according to Dr. Kasturi. "This disconnect between the subjective patient experience and objective signs and symptoms underscores the need to integrate patient reported outcomes into clinical care to ensure optimal disease management," she noted. "The weak correlations of social function and fatigue CATs with corresponding SF-36 domains point to a knowledge gap and the need for further study."
About Hospital for Special Surgery
Hospital for Special Surgery (HSS) is the world’s largest academic medical center focused on musculoskeletal health. HSS is nationally ranked No. 1 in orthopedics and No. 2 in rheumatology by U.S. News & World Report (2016-2017), and is the first hospital in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. HSS has one of the lowest infection rates in the country. HSS is an affiliate of Weill Cornell Medical College and as such all Hospital for Special Surgery medical staff are faculty of Weill Cornell. The hospital's research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. Hospital for Special Surgery is located in New York City and online at www.hss.edu.