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OP-062 Patient-reported outcome measures for children with acute rhinosinusitis and acute bronchitis
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  1. Katharina Piontek1,
  2. Ann-Kristin Baalmann1,
  3. Sophie Nestler1,
  4. Theresa Donhauser1,
  5. Claudia Bittner2,
  6. Christoph Abels2,
  7. Christian Apfelbacher1
  1. 1Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto von Guericke University Magdeburg, Magdeburg, Germany
  2. 2Research and Development, Bionorica SE, Neumarkt i. d. OPf., Germany

Abstract

Aim Patient-reported outcome measures (PROMs) are standardized questionnaires to evaluate the efficacy of medicinal products directly from the patient without interpretation of the patient’s response by a clinician. Using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, we performed a systematic review of the quality of available PROMs for use in children with Acute Rhinosinusitis (ARS), Acute Bronchitis (AB) and common cold, or their parents.

Material and Method EMBASE, PubMed and Web of Science were searched for studies reporting on the development and/or validation of any PROMs for ARS, AB and common cold. We assessed the methodological quality of each included study, evaluated the quality of measurement properties per PROM and study, and graded the evidence. Based on the overall evidence, we derived recommendations for use of the instruments.

Results We identified two studies on two PROMs for children measuring symptoms of ARS (Pediatric Rhinosinusitis Symptom Scale, PRSS; Sinus Symptom Questionnaire, S5). For AB in children, we included two studies on two PROMs assessing quality of life (Parent-proxy Children’s Acute Cough-specific QoL Questionnaire, PAC-QoL16; and its short form PAC-QoL6), and one study on a PROM assessing cold symptoms (Child Cold Symptom Questionnaire, CCSQ). All instruments are promising for use in future research (COSMIN category B), but require further validation. Particularly, content validity is a shortcoming, but also data on other important measurement properties, e.g., structural validity, are lacking.

Conclusions For ARS, the PRSS appears the most suitable tool for further validation. Given the intensive work on scale development and testing for PROM design, the CCSQ has the potential to be used in future clinical trials in AB. Intensive content validity assessments involving patients and experts are highly recommended for all identified PROMs.

  • patient-reported outcome measures
  • acute rhinosinusitis
  • acute bronchitis
  • systematic review
  • measurement properties

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