Abstract
Background: COPD exacerbations (AECOPD) are characterized by increased sputum volume, purulence and breathlessness. Patients are encouraged to recognize and treat AECOPD as part of a self-management (SM) plan. Only half of AECOPD are caused by bacterial infection, but SM plans generally advocate use of antibiotics and steroids for all events, hence antibiotics may be over-used. Sputum colour relates closely to bacterial load thus could determine whether antibiotics are appropriate. This pragmatic RCT tested whether use of a sputum colour chart is safe and effective in UK primary care.
Methods: Colour COPD was a multicentre, RCT in adults with COPD who had ≥2 AECOPD or ≥1 hospital admission for AECOPD in the preceding year. The primary objective was to demonstrate that the Bronkotest sputum colour chart is non-inferior to usual care (safe). The primary outcome was rate of hospital admission for AECOPD at 12 months; secondary outcomes included requirement for second courses of treatment and quality of life (QOL; CAT score). Nested sub-studies examining daily symptoms via an e-diary and sputum culture assessed untreated AECOPD rate and antibiotic resistance respectively. A process evaluation examined trial fidelity and acceptability of the intervention, employing qualitative research methods incorporating patients as co-researchers.
Limitations: The study was terminated early due to low recruitment (115/2954 planned sample size).
Results: 115 patients were recruited and randomised 1:1 to colour chart use or usual care; they generally had severe GOLD D COPD, with significant breathlessness (54% MRC 4 or 5) and poor quality of life (QOL; CAT score at baseline 24). Co-morbid respiratory and systemic disease was common. Self-management was delivered well in both arms, and the colour chart acceptable to patients and staff; no specific issues for patients with multiple long-term conditions were identified. Hospital admissions for AECOPD tended to occur more in colour chart users (32 v 16%, Relative risk 1.95 (0.92-4.18)), and antibiotic courses within 14 days of initial AECOPD treatment were also more common (34 v 18%, adjusted relative risk 1.80 (0.85 to 3.79)). Despite this, QOL was better in colour chart users at 12 months (CAT 19.9 v -24.5, adjusted mean difference -2.95 (-5.93 to -0.04)). 38 patients consented to the sputum sub-study and 57 samples were received (42 stable state, 15 during AECOPD), of which 30% contained a potentially pathogenic bacterium (PPB). Sputum was more likely to be purulent in subjects with bronchiectasis, independent of disease state (stable vs exacerbation) or whether the sample was positive for a PPB, suggesting that colour alone cannot be used to guide antibiotic use. 11 patients completed the e-diary study and 42 symptom defined AECOPD events were captured, many of which were untreated, exhibiting lower EXACT scores than those which were treated. Untreated events were slower to settle. Differences between study arms were not meaningful to compute due to low numbers.
Conclusion and future work: Our results imply the Bronkotest sputum colour chart is unlikely to be a useful addition to self-management for COPD patients in primary care but further work is require to confirm this.
Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme.
Trial registration: The parent trial was prospectively registered - ISRCTN 14955629
Methods: Colour COPD was a multicentre, RCT in adults with COPD who had ≥2 AECOPD or ≥1 hospital admission for AECOPD in the preceding year. The primary objective was to demonstrate that the Bronkotest sputum colour chart is non-inferior to usual care (safe). The primary outcome was rate of hospital admission for AECOPD at 12 months; secondary outcomes included requirement for second courses of treatment and quality of life (QOL; CAT score). Nested sub-studies examining daily symptoms via an e-diary and sputum culture assessed untreated AECOPD rate and antibiotic resistance respectively. A process evaluation examined trial fidelity and acceptability of the intervention, employing qualitative research methods incorporating patients as co-researchers.
Limitations: The study was terminated early due to low recruitment (115/2954 planned sample size).
Results: 115 patients were recruited and randomised 1:1 to colour chart use or usual care; they generally had severe GOLD D COPD, with significant breathlessness (54% MRC 4 or 5) and poor quality of life (QOL; CAT score at baseline 24). Co-morbid respiratory and systemic disease was common. Self-management was delivered well in both arms, and the colour chart acceptable to patients and staff; no specific issues for patients with multiple long-term conditions were identified. Hospital admissions for AECOPD tended to occur more in colour chart users (32 v 16%, Relative risk 1.95 (0.92-4.18)), and antibiotic courses within 14 days of initial AECOPD treatment were also more common (34 v 18%, adjusted relative risk 1.80 (0.85 to 3.79)). Despite this, QOL was better in colour chart users at 12 months (CAT 19.9 v -24.5, adjusted mean difference -2.95 (-5.93 to -0.04)). 38 patients consented to the sputum sub-study and 57 samples were received (42 stable state, 15 during AECOPD), of which 30% contained a potentially pathogenic bacterium (PPB). Sputum was more likely to be purulent in subjects with bronchiectasis, independent of disease state (stable vs exacerbation) or whether the sample was positive for a PPB, suggesting that colour alone cannot be used to guide antibiotic use. 11 patients completed the e-diary study and 42 symptom defined AECOPD events were captured, many of which were untreated, exhibiting lower EXACT scores than those which were treated. Untreated events were slower to settle. Differences between study arms were not meaningful to compute due to low numbers.
Conclusion and future work: Our results imply the Bronkotest sputum colour chart is unlikely to be a useful addition to self-management for COPD patients in primary care but further work is require to confirm this.
Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme.
Trial registration: The parent trial was prospectively registered - ISRCTN 14955629
| Original language | English |
|---|---|
| Journal | NIHR Journals Library |
| Publication status | Accepted/In press - 7 Nov 2024 |
Keywords
- chronic obstructive pulmonary disease
- exacerbations
- sputum
- self-management