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Patient reported outcome measurement system (PROMIS) valid in assessing patient experience

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A study at Hospital for Special Surgery (HSS) evaluating the Patient Reported Outcomes Measurement Information System (PROMIS) in patients with lupus finds that the questionnaire is valid in assessing subjective patient experience. Researchers also observed a disconnect between the patient perspective and objective signs and symptoms, underscoring the need to integrate patient-reported outcomes into clinical care to 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. The patient questionnaire 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 questions to measure pain, fatigue, physical function, depression, anxiety, social function and other quality of life indicators. The online questionnaire administered by Hospital for Special Surgery investigators uses computerized adaptive testing (CAT), an interactive method to streamline surveys by selecting questions based on patients' previous responses.

"In order 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 to 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, lupus disease activity and organ damage. They also assessed the retest reliability of the PROMIS questionnaire.

Adult patients with lupus were recruited from the Lupus Center of Excellence at Hospital for Special Surgery. They completed the SF-36 and LupusQoL-US, which are considered gold-standard quality of life questionnaires, and PROMIS CATs 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.

Patient answers in PROMIS domains were compared with similar domains in the gold-standard surveys, and also with disease activity and damage. Retest reliability was evaluated among subjects reporting stable lupus activity at two assessments one week apart.

Of 198 patients approached, 163 (82%) completed at least one assessment. One hundred thirty-eight patients completed a retest. "The data show that PROMIS CATs can be successfully administered to a diverse group of SLE patients at the point of care or remotely, and are valid, reliable and responsive for many lupus-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 correlations. "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," Dr. Kasturi said.

Another important finding was that PROMIS scores did not correlate well with physician- derived lupus disease activity or damage measures, 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.

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Meeting: 2015 ACR/AHRP Annual Meeting

Session Title: Systemic Lupus Erythematosus – Clinical Aspects and Treatment II: Patient-Reported Measures, Outcomes and Reporting

Session Type: ACR Concurrent Abstract Session

Date/Time: Sunday, November 8, 2015, 4:30 p.m. – 6 p.m.

Study Title: "Feasibility and Validity of Patient Reported Outcome Measurement Information System (PROMIS) in SLE"

Authors: Shanthini Kasturi1, Jayme C. Burket2, Jessica Berman1, Kyriakos A. Kirou1, Alana B. Levine1, Lisa R. Sammaritano1 and Lisa Mandl1,3, 1Rheumatology, Hospital for Special Surgery, New York, NY; 2Healthcare Research Institute, Hospital for Special Surgery, New York, NY; 3Department of Rheumatology, Hospital for Special Surgery, New York, NY.

Disclosures: S. Kasturi, None; J. C. Burket, None; J. Berman, None; K. A. Kirou, None; A. B. Levine, None; L. R. Sammaritano, None; L. Mandl, section writer, UpToDate.

About Hospital for Special Surgery

Founded in 1863, Hospital for Special Surgery (HSS) is a world leader in orthopedics, rheumatology and rehabilitation. HSS is nationally ranked No. 1 in orthopedics, No. 3 in rheumatology and No. 7 in geriatrics by U.S. News & World Report (2015-2016), and is the first hospital in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center three consecutive times. HSS has one of the lowest infection rates in the country. HSS is a member of the New York-Presbyterian Healthcare System and 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 http://www.hss.edu.

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