Berkhof 2015.
| Study characteristics | ||
| Methods |
Study design: single‐centre, open‐label, parallel individual randomised controlled trial in the Netherlands Duration: 26 weeks Setting: Hospital Isala in Zwolle |
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| Participants |
Population: 101 adults recruited from 1 hospital, Isala, in Zwolle, Netherlands Baseline characteristics: % Male: 65 TM and 69 UC, Mean age: 68 TM in past 12 months: TM: 23 (44.2) and UC: 17 (34.7). Participants in TM group were more likely to have worse CCQ total and symptom scores, increased home oxygen and hospitalisations Inclusion criteria: smoking history > 10 pack‐years, diagnosis of severe COPD, post‐bronchodilator FEV₁ < 50%, FEV₁/FVC < 70%, written informed consent Exclusion criteria: history of asthma, unable to answer phone, life expectancy < 6 months |
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| Interventions | Measurements taken at baseline and 6 months Treatment arms
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| Outcomes |
Primary outcomes: COPD‐specific health status using clinical COPD questionnaire Secondary outcomes: SGRQ and SF‐36 questionnaires, resource use in primary and secondary care |
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| Notes |
Funding: Isala hospital Other identifier: none |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization was performed with a computer minimisation programme to achieve balanced groups for gender, age (< 65 years or ≥ 65 years), predicted forced expiratory volume in 1 second (FEV₁ < 35% or ≥ 35%), body mass index (< 21 or ≥ 21 kg/m²) |
| Allocation concealment (selection bias) | Unclear risk | No further information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind patients and personnel due to nature of treatment |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Although no further information was provided, it was probably not possible to blind due to nature of intervention |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Although attrition was slightly higher in control group, it was still below 10% |
| Selective reporting (reporting bias) | High risk | No protocol found on registry websites, so unclear whether outcomes were reported as planned. Hospitalisation outcomes reported as median and IQR, suggesting that data are not normally distributed. Contacted study authors, no response |
| Other bias | Low risk | None |