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August 1, 2018Lupus Science & MedicineOpen Access

Patient-reported outcome measures for use in clinical trials of SLE: a review

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Key result

SF36, PROMIS, LupusQoL and LIT had the strongest evidence for acceptable measurement properties in SLE, though sensitivity to longitudinal change was generally poor to moderate across measures.

Why the study?

What are the measurement properties and responsiveness of health-related quality of life (HRQoL) measures used in adult SLE clinical trials?

Population

English-speaking adult patients with SLE (25 validation papers and 26 SLE drug RCTs)

Design

Systematic_review

Authors

ZIZara IzadiUniversity of California, San FranciscoJGJulie GandrupUniversitetshospitalernes Center for Sundhedsfaglig ForskningPKPatricia KatzUniversity of California, San Francisco

Discussion

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Member takes

Implication

Favors SF36, PROMIS, LupusQoL, and LIT for SLE trials; extends validation evidence while highlighting moderate longitudinal responsiveness.

Study Design

Type

Systematic Review (n=51)

Structured PICO

What are the measurement properties and responsiveness of health-related quality of life (HRQoL) measures used in adult SLE clinical trials?

P
Population
Systematic review of 25 validation papers and 26 RCTs evaluating health-related quality of life measures in English-speaking adults with SLE.
E
Exposure
Health-related quality of life (HRQoL) measures (4 generic and 3 disease-specific instruments)
O
Outcome
Measurement properties (validity, reliability, responsiveness) of HRQoL measurespatient reported

This review identifies SF36, PROMIS, LupusQoL, and LIT as having the strongest evidence for acceptable measurement properties in SLE, advocating for broader use of SLE-specific HRQoL measures in RCTs.

Limitations

  • Data on PROMIS responsiveness have not been published
  • Few measures aside from the SF36 have been incorporated into clinical trials

Cite This Study

Izadi et al. (2018) conducted a systematic review in Systemic Lupus Erythematosus (SLE) (n=51). Health-related quality of life (HRQoL) measures was evaluated on Measurement properties and responsiveness to interventions. SF36, PROMIS, LupusQoL and LIT had the strongest evidence for acceptable measurement properties in SLE, though sensitivity to longitudinal change was generally poor to moderate across measures.

synapsesocial.com/papers/6a86c519bb0787ff27ca067fhttps://doi.org/10.1136/lupus-2018-000279
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