Development and Application of Patient-Reported Outcome Measures (PROMs) in Patients on Chronic Home Oxygen Therapy

Background/Objectives: Chronic home oxygen therapy—long-term oxygen therapy (LTOT)—improves survival and quality of life in chronic respiratory failure when used ≥15 h/day, but adherence is frequently suboptimal and specific patient-reported outcome measures (PROMs) are scarce. To develop, validate and apply a specific PROM for patients on LTOT. Methods: A prospective observational cohort study was conducted at San Juan de Alicante University Hospital (April 2024–December 2025) following a four-stage process: conceptual framework definition and expert workshop, content validation and item reduction, cognitive interviews with pilot reliability testing (n = 25), and field application to 120 consecutive chronic LTOT users. The LTOT-PROM was designed to capture the patient-perceived impact attributable to LTOT during the previous 4 weeks. Internal consistency was assessed with Cronbach’s α and test–retest reproducibility with the intraclass correlation coefficient (ICC). Results: The final instrument comprises 15 scored items in two dimensions—Daily Activity (9 items) and Adverse Effects (6 items)—plus one ambulatory-only mobility item excluded from the total score. Cronbach’s α was 0.814 (95% CI 0.681–0.906) for Daily Activity, 0.743 (95% CI 0.548–0.872) for Adverse Effects and 0.808 (95% CI 0.677–0.902) for the total scale; total ICC(A,1) was 0.890 (95% CI 0.767–0.950). Among the 120 patients (62 men, 58 women; mean age 78 ± 13 years; mean therapy duration 40 ± 32 months), 68% reported reduced effort for daily activities, 66% reported a reduction in dyspnoea and 67% reported improved self-confidence; 49% reported morning airway dryness and 7% abandoned the equipment due to nasal dryness or rhinitis. Conclusions: The LTOT-PROM is a brief, reliable and reproducible oxygen-specific instrument for assessing the recent patient-perceived impact of LTOT in routine clinical practice. Further studies should evaluate structural validity, external validity and the relationship between LTOT-PROM scores and objective adherence measures. The construct was predefined as the patient-perceived impact attributable to LTOT during a standardised 4-week recall window, and cognitive interviews confirmed that respondents interpreted the items as experienced benefit/burden during that period rather than as week-to-week symptom change.

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Journal
Journal of Clinical Medicine
Published
2026-06-25
DOI
https://doi.org/10.3390/jcm15134948
Primary Topic
Delphi Technique in Research
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article
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article

Development and Application of Patient-Reported Outcome Measures (PROMs) in Patients on Chronic Home Oxygen Therapy

Eusebi Chiner, Sandra Vañes, Ignacio Boira, Sergio García Ferrer et al.
Journal of Clinical Medicine
Delphi Technique in Research
article

Development and Application of Patient-Reported Outcome Measures (PROMs) in Patients on Chronic Home Oxygen Therapy

Eusebi Chiner, Sandra Vañes, Ignacio Boira, Sergio García Ferrer, Mónica Llombart, Violeta Esteban, Paula Fernández Martínez, Marian Fernández, Francesco Gigliarano, Joaquín Fernández-Serrano, Sandra Navarro
article en

Abstract

Background/Objectives: Chronic home oxygen therapy—long-term oxygen therapy (LTOT)—improves survival and quality of life in chronic respiratory failure when used ≥15 h/day, but adherence is frequently suboptimal and specific patient-reported outcome measures (PROMs) are scarce. To develop, validate and apply a specific PROM for patients on LTOT. Methods: A prospective observational cohort study was conducted at San Juan de Alicante University Hospital (April 2024–December 2025) following a four-stage process: conceptual framework definition and expert workshop, content validation and item reduction, cognitive interviews with pilot reliability testing (n = 25), and field application to 120 consecutive chronic LTOT users. The LTOT-PROM was designed to capture the patient-perceived impact attributable to LTOT during the previous 4 weeks. Internal consistency was assessed with Cronbach’s α and test–retest reproducibility with the intraclass correlation coefficient (ICC). Results: The final instrument comprises 15 scored items in two dimensions—Daily Activity (9 items) and Adverse Effects (6 items)—plus one ambulatory-only mobility item excluded from the total score. Cronbach’s α was 0.814 (95% CI 0.681–0.906) for Daily Activity, 0.743 (95% CI 0.548–0.872) for Adverse Effects and 0.808 (95% CI 0.677–0.902) for the total scale; total ICC(A,1) was 0.890 (95% CI 0.767–0.950). Among the 120 patients (62 men, 58 women; mean age 78 ± 13 years; mean therapy duration 40 ± 32 months), 68% reported reduced effort for daily activities, 66% reported a reduction in dyspnoea and 67% reported improved self-confidence; 49% reported morning airway dryness and 7% abandoned the equipment due to nasal dryness or rhinitis. Conclusions: The LTOT-PROM is a brief, reliable and reproducible oxygen-specific instrument for assessing the recent patient-perceived impact of LTOT in routine clinical practice. Further studies should evaluate structural validity, external validity and the relationship between LTOT-PROM scores and objective adherence measures. The construct was predefined as the patient-perceived impact attributable to LTOT during a standardised 4-week recall window, and cognitive interviews confirmed that respondents interpreted the items as experienced benefit/burden during that period rather than as week-to-week symptom change.

Journal of Clinical MedicineVol. 15(13)
Universitat de Miguel Hernández d'Elx (ES), Hospital Universitari Sant Joan D'Alacant (ES), Red Electrica de Espana (Spain) (ES)
Openalex Percentile: Top 4%
Delphi Technique in Research
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