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Conceptualization of children-reported outcome measures for sinonasal disease, the pSN-5.
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Description: Importance: There are no patient-reported outcome measures for children with sinonasal disease, limiting their ability to participate in decision making and treatment impact. Objective: To evaluate the internal validity, test-retest reliability, and construct validity of the pSN-5 against SN-5. Design: Prospective study with convenience sampling. Setting: The Ear, Nose and Throat out-patient department, Royal Hospital for Children, Glasgow between 4/12/2020-21/4/2021. Participants: Children aged 7-15 years-old. Patients with obstructive sleep apnea, developmental delay, communication limitations, craniofacial and syndromic abnormalities were excluded. Main outcome measures: Cronbach’s α determined the internal consistency. Test-retest reliability at 4 weeks and construct validity with SN-5 were evaluated with the Bland-Altman analysis. The level of agreement was set at ±1. Sensitivity analysis was performed with the ‘overall item means’ and based on two age categories (7-11 vs 12-15 years-old). Results: Eighty six patients were recruited. The mean age of participants was 11.0 ± 2.47 years. 55.8% (n: 48) were aged 7-11, 57.0% (n:47) female and 86.0% (n:76) were asymptomatic. Overall internal consistency was at α: 0.57 (95% CI: 0.42; 0.67), α:0.69 (95% CI: 0.58;0.79) with overall item means, α:0.70 (95% CI: 0.57;0.84) aged 7-11 and α:0.65 (95% CI: 0.48;0.82) aged 12-15. The pSN-5 is reliable within the test-retest reliability period in all items. Statistically significant and clinically important degree of bias towards the child’s response (pSN-5) can be appreciated in the physical domain; Item 1 (Bias: 2 [1;3], p<0.01), Item 2 (Bias: 2 [0;3], p<0.01) and Item 3 (Bias: 2 [1;4], p<0.01). Meanwhile, Item 6 bias towards SN-5 (Bias: -4 [-5;2], p<0.01). No clinically relevant degree of bias seen with the overall item means (Bias: 0.43 ± 0.97, p<0.01). Conclusion and relevance: The pSN-5 has acceptable internal consistency with adequate test-retest reliability. The pSN-5 has highlighted the different experience of children and their parents and may represent their different priorities. It should be used in conjunction with the SN-5 to guide management of pediatric rhinosinusitis.
REC: West Midlands – South Birmingham Research Ethics Committee (20/WM/0093)
Sponsor: NHS Greater Glasgow and Clyde (GN19EN564P)
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