COA At-a-Glance
Evidence of cognitive interviewing of draft instrument in target patient population
Evidence of internal consistency
Evidence of test-retest or inter-rater reliability
Evidence of concurrent validity
Evidence of known-groups validity
Evidence of ability to detect change over time
Evidence of responder thresholds
Inclusion of the COA in product labelling
- Overview
- Content Validity
- Reliability
- Validity
- Ability to Detect Change
- Responder Thresholds
- Reference(s) of development / validation
- Other references
- Inclusion of the COA in product labelling
- Inclusion of the COA in product labelling (agency, drug, drug approval date, COA results) from PROLABELS search
- Existence of Scoring / Interpretation / User Manual
- Original language and translations
- References of translations
- Authors and contact information
- Condition of use: copyright
- Website
- Review copy
Overview
Instrument Name: Obstructive Sleep Apnea-18
Abbreviation: OSA-18
Points for Consideration:
None
Description of Tool:
The Obstructive Sleep Apnea-18 (OSA-18) is an 18-item ObsRO developed to determine the impact of OSA on children's health-related quality of life (HRQoL). Parents are asked to describe how often during the previous 4 weeks their child had exhibited specific symptoms. Items are rated on a 7-level scale ranging from 1="None of the time", 2="Hardly any of the time", 3="A little of the time", 4="Some of the time", 5="A good bit of the time", 6="Most of the time", to 7="All of the time". A higher score indicates a poorer disease-specific quality of life. Parents are also asked to respond to a global item about sleep-disordered breathing related HRQL, with a 10 point visual analogue scale graded from 1 (worst quality of life possible) to 10 (best quality of life possible).
Other Related Tools (if applicable):
The OSA-20 consists of 20 items to determine the impact of OSA on children's health-related quality of life. This version includes two additional items: Item 12 (Social problems) and Item 16 (School problems).
The OSA-5 consists of 5 items to help screen and triage children at risk of obstructive sleep apnea among large numbers of referrals for sleep-disordered breathing. The OSA-5 consists of 5 items to help screen and triage children at risk of obstructive sleep apnea among large numbers of referrals for sleep-disordered breathing. This revised version consists of Item 1 (Loud snoring), Item 2 (Breath holding spells or pauses in breathing at night), Item 3 (Choking or gasping sounds while asleep), Item 5 (Mouth breathing because of nasal obstruction) and Item 16 (Breathing problems during sleep that made you worried that they were not getting enough air) included in the OSA-18.
Minimum Qualification Required by COA Administrator: No degree requirement
Comment:
The OSA-18 was originally developed as a 20-item ObsRO (OSA-20) by Franco et al., 1999. This revised version does not include Item 12 (Social problems) and Item 16 (School problems) included in the OSA-20.
Year: 1999
Objective of Development:
To determine the impact of OSA on children's health-related quality of life
Population of Development: Age range (therapeutic indication):
Age range: 6 months-12 years old (Sleep-disordered breathing)
Pediatric Population(s) in which COA has been used:
None identified
COA type: ObsRO
Number of Items 18
Mode of Administration: Caregiver-rated
Data Collection Mode: Paper and pen administration
Time for Completion: No information
Response Scales: 7-point scale: ranging from 1="None of the time", 2="Hardly any of the time", 3="A little of the time", 4="Some of the time", 5="A good bit of the time", 6="Most of the time", and 7="All of the time". 10 point visual analogue scale graded from 1 (worst quality of life possible) to 10 (best quality of life possible).
Summary of Scoring:
Available scores: A total score is obtained by summing the scores of all 18 items. The total score can range from 18 to 126. Scores less than 60 suggest a small impact on health-related quality of life (HRQL), scores between 60 and 80 suggest a moderate impact, and scores above 80 suggest a large impact. The direct global rating of quality of life (visual analogue scale) provides additional information but is not included in calculating the survey score.
Weighting: No
Score interpretation: Higher scores=Poorer disease-specific quality of life.
Content Validity
Evidence of Literature Review: None identified
Evidence of Instrument Review: None identified
Evidence of Clinical or Expert Input: Yes
Evidence of concept elicitation in target patient population: Yes
Evidence of a Saturation Grid: None identified
Evidence for Selection of Data Collection Method: None identified
Recall/Observation Period: Past 4 weeks
Evidence for Selection of Reponse Options: Yes
Evidence of cognitive interviewing of draft instrument in target patient population: None identified
Evidence of Preliminary Scoring of Items and Domains: None identified
Evidence related to respondent and administrator burden: None identified
Evidence of a Conceptual Framework: None identified
Evidence of an item-tracking matrix: None identified
Evidence related to item selection: Yes
Evidence of re-testing the final version: None identified
Reliability
Internal consistency (Cronbach's alpha): None identified
Evidence of internal consistency: None identified
Test-retest Reliability (ICC):
Franco RA (1999)
Test-retest reliability
-Spearman rank correlation coeficient: Excellent test-retest reliability was obtained for the individual survey items (R > 0.74).
- Was a definition of stability applied to identify stable patients: Not stated
- Time frame between the two administrations: 3 days
- Population/disease: Children aged 6 months-12 years; n=61
Inter-rater/ inter-interviewer reliability (kappa):
None identified
Evidence of test-retest or inter-rater reliability: Yes
Validity
Concurrent validity (convergent, divergent):
Franco RA (1999)
Convergent validity
- Correlation coefficient used: Spearman rank correlation coefficient
- Measures: Respiratory distress index (RDI), tonsil size and adenoid size
- Results: All of the domains had significant correlation with at least 1 of the external measures, except for daytime function which showed poor correlation with the external measures. Sleep disturbance and caregiver concerns had the strongest associations with the RDI. A significant association was noted between emotional distress and adenoid size (R = 0.36). Validity of the survey was suggested by significant correlation with the RDI, tonsil size, and adenoid size.
- Population/Disease: Children aged 6 months-12 years; n=61
Known-group validity:
Franco RA (1999)
- Measure/Groups of patients: Severe obstructive sleep apnea syndrome (OSAS), moderate OSAS, None or Mild OSAS based on Respiratory distress index (RDI).
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Kruskal-Wallis analysis of variance and Newman-Keuls multiple comparison test. When the RDI was categorized into 3 distinct groups, the OSA-18 survey score remained significantly associated (Kruskal-Wallis analysis of variance, H =9.25, P = 0.01). The first 2 groups (none or mild OSAS and moderate OSAS) were statistically equivalent, the third (severe OSAS) was distinct (Newman-Keuls multiple comparison test, P < 0.05).
- Population/disease: Children aged 6 months-12 years; n=61
Evidence of Translatability Assessment: None identified
Evidence related to missing data: None identified
Evidence for Selection of Recall Period: None identified
Evidence of Administration Instructions and Training Provided: None identified
Evidence of concurrent validity: Yes
Evidence of known-groups validity: Yes
Evidence of ability to detect change over time: Yes
Ability to Detect Change
Ability to detect change (Responsiveness):
Soh HJ (2003) -
- Method:
Validity of the OSA-18 as a measure of longitudinal change was determined using the change score, calculated by subtracting the mean survey score at visit 2 from the mean score at visit 1. The OSA-18 change score was correlated with 3 external construct measures: direct caregiver estimate of change, OSD-6 change score, and global change score from the OSA-18 visual analogue scale. Responsiveness to longitudinal change was also assessed using the Standardized Response Mean (SRM), defined as the change score divided by its standard deviation, for patients undergoing surgery for a primary indication of sleep-disordered breathing. SRMs were determined for the OSA-18 overall score, domain score, and individual items. The OSA-18 overall score SRM was correlated with the SRM for the OSD-6 as a further validity assessment.
- Results:
The OSA-18 survey score had very good correlation with the OSD-6 survey score (r=0.73, P=0.0001) and with the Brouilette score (r=0.69, P 0.0001). Similarly, the OSA-18 change score had very good correlation with the OSD-6 change score (r=0.71, P=0.0001). The OSA-18 change score did not correlate with change in the direct global QOL rating (r=0.21, P=0.082). There was fair correlation between the direct change estimate and the OSA-18 change score
(r=0.34, P=0.005). Results indicate that 0.5 to 1.0 suggest a small clinical change and ≥ 1.0 suggesting a moderate or large change. The OSA-18 change score showed fair correlation with baseline tonsil size (r=0.40, P=0.001) and adenoid size (r=0.31, P=0.009). Effect sizes for change in QOL after surgery suggest large responsiveness to change for the OSA-18 survey. The lower limit of the 95% CI for the SRM also indicated large responsiveness for the domains of sleep disturbance, physical suffering, and caregiver concerns; daytime problems had moderate to large responsiveness, and emotional distress had small responsiveness (which was statistically significant). The level of clinical change detected by the OSA-18 and OSD-6 can be categorized as trivial, small, moderate, and large using change score cut points of 0.50, 1.00, and 1.50. Thirty-six children (52%) had concordant change levels on both surveys, and 59 (86%) had scores on one survey within ±1 level of the other survey. More children had large change as judged by the OSD-6 (42%) than by the OSA-18 (22%); responses for trivial change were more consistent (17% versus 20%).
- Population/Disease: Children aged 6-13 years; n=69; n=54 for children with a primary indication of sleep-disordered breathing.
Responder Thresholds
Responder Thresholds:
None identified
Evidence of responder thresholds: None identified
Reference(s) of development / validation
Franco RA Jr, Rosenfeld RM, Rao M. First place--resident clinical science award 1999. Quality of life for children with obstructive sleep apnea. Otolaryngol Head Neck Surg. 2000 Jul;123(1 Pt 1):9-16. doi: 10.1067/mhn.2000.105254. PMID: 10889473. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/10889473/
Sohn, H., & Rosenfeld, R. M. (2003). Evaluation of sleep-disordered breathing in children. Otolaryngology–Head and Neck Surgery, 128(3), 344-352. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/12646836/
Other references
Soh HJ, Rowe K, Davey MJ, Horne RSC, Nixon GM. The OSA-5: Development and validation of a brief questionnaire screening tool for obstructive sleep apnea in children. Int J Pediatr Otorhinolaryngol. 2018 Oct;113:62-66. doi: 10.1016/j.ijporl.2018.07.029. Epub 2018 Jul 19. PMID: 30174012. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/30174012/
Inclusion of the COA in product labelling
None identified
Inclusion of the COA in product labelling (agency, drug, drug approval date, COA results) from PROLABELS search
None identified
Existence of Scoring / Interpretation / User Manual
Yes
Original language and translations
Original language: English for the USA
Translations and adaptations found in Google Scholar:
Arabic
Chinese
Greek
Italian
Spanish
Thai
Turkish
References of translations
Arabic:
Al-Iede M, Alshrouf MA, Al-Ani A, Alkurdi A, Jaber AH, Husain O, Abusabra B, Almasri NA. Validation of the Arabic version of the Obstructive Sleep Apnea-18 quality of life questionnaire for evaluating children with sleep apnea-hypopnea syndrome. Ann Thorac Med. 2024 Oct-Dec;19(4):266-274. doi: 10.4103/atm.atm_94_24. Epub 2024 Oct 3. PMID: 39544343; PMCID: PMC11559703.
Chinese:
Huang, Y. S., Hwang, F. M., Lin, C. H., Lee, L. A., Huang, P. Y., & Chiu, S. T. (2015). Clinical manifestations of pediatric obstructive sleep apnea syndrome: Clinical utility of the C hinese‐version O bstructive S leep A pnea Q uestionaire‐18. Psychiatry and Clinical Neurosciences, 69(12), 752-762.
Kang, K. T., Weng, W. C., Yeh, T. H., Lee, P. L., & Hsu, W. C. (2014). Validation of the Chinese version OSA-18 quality of life questionnaire in Taiwanese children with obstructive sleep apnea. Journal of the Formosan Medical Association, 113(7), 454-462.
Greek:
Mousailidis, G. K., Lachanas, V. A., Skoulakis, C. E., Sakellariou, A., Exarchos, S. T., Kaditis, A. G., & Bizakis, J. G. (2014). Cross-cultural adaptation and validation of the Greek OSA-18 questionnaire in children undergoing polysomnography. International journal of pediatric otorhinolaryngology, 78(12), 2097-2102.
Italian:
Arezzo E, Festa P, D'Antò V, Michelotti A, De Vincentiis GC, Sitzia E, Giuliani M, Piga S, Galeotti A. Linguistic adaptation and validation of Italian version of OSA-18, a quality of life questionnaire for evaluation of children with obstructive sleep apnea-hypopnea syndrome (OSAS). Int J Pediatr Otorhinolaryngol. 2020 Feb;129:109727. doi: 10.1016/j.ijporl.2019.109727. Epub 2019 Oct 17. PMID: 31734562.
Spanish:
Chiner, E., Landete, P., Sancho-Chust, J. N., Martínez-García, M. Á., Pérez-Ferrer, P., Pastor, E., ... & Selma, M. J. (2016). Adaptation and validation of the Spanish version of OSA-18, a quality of life questionnaire for evaluation of children with sleep apnea-hypopnea syndrome. Archivos de Bronconeumología (English Edition), 52(11), 553-559.
Thai:
Kuptanon, T., Chukumnerd, J., Leejakpai, A., & Preutthipan, A. (2015). Reliability and validity of Thai version Quality of Life Questionnaire (OSA-18) for pediatric obstructive sleep apnea. J Med Assoc Thai, 98(5), 464-71.
Turkish:
Yazıcı ZM, Bilgin FB, İnan BK, Abakay MA, Sayın İ. Optimizing Early Detection: Validating Obstructive Sleep Apnea-18 (OSA-18) in Turkish-Speaking Pediatric Patients. Turk Arch Otorhinolaryngol. 2023 Dec;61(4):151-159. doi: 10.4274/tao.2023.2023-10-1. Epub 2024 May 21. PMID: 38784954; PMCID: PMC11110084.
Condition of use: copyright
None identified
Website
None identified
Review copy
https://choc.org/wp-content/uploads/2020/07/ENT-Patient-Form-OSA-18-ENG.pdf