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461 Assessing the content validity of the sf-36, the skindex-29+3 patient reported outcomes (pro) instruments, and pain, fatigue in patients with cutaneous lupus erythematosus (cle)
  1. M Vanya1,
  2. M Cho1,
  3. S Chen2,
  4. A Kao2,
  5. K Howard1 and
  6. VP Werth3
  1. 1ICON plc, Clinical Outcomes Assessments, San Francisco, USA
  2. 2Biogen, HEOR, Boston, USA
  3. 3Corporal Michael J. Crescenz Veterans Affairs, Medical Centre Philadelphia PA, Philadelphia, USA


Background and aims Patients with CLE may experience symptoms, which can negatively impact their quality of life. The objectives of this study were as follows: 1) to investigate patient experiences associated with CLE, 2) to investigate the impact of living with CLE on patients’ lives, 3) to evaluate the content validity of the 36-item Short Form Health Survey (SF-36) and the Skindex-29+3 PRO instruments in the CLE population, and 4) to evaluate the appropriateness of a shorter recall period of 1 week instead of 4 weeks for the Skindex-29+3.

Methods This cross-sectional qualitative study utilised a combined concept elicitation (CE) and cognitive interview (CI) method. Study participants were recruited across three US clinical sites and interviewed one-on-one during a 90 min in-person interview. Interviews followed a semi-structured interview guide that elicited patient experiences with CLE and its impact on patients’ lives, followed by CI that assessed patients’ understanding and interpretation of each instrument.

Results Patients found these instruments to be readily understandable, interpreting items correctly and with minimal difficulty. Patients reported a one-week recall period for the Skindex-29+3 to be meaningful and easy to use, although many stated that their symptoms and experiences were felt over a longer period of time.

Abstract 461 Table 1

Sociodemographic characteristics.

Abstract 461 Table 2

Most commomny reported symptoms.

Abstract 461 Table 3

Most commonly reported symptom impacts.

Conclusions The majority of instruments’ items were confirmed to be meaningful, interpretable, and appropriate for use in the CLE patient population. The results of the interviews support the content validity of the SF-36 and Skindex-29+3in the CLE patient population.

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