Chen 2005.
| Methods | STUDY DESIGN: parallel group LOCATION/NUMBER OF CENTRES: inpatients in China, unknown number of centres DURATION OF STUDY: 14 days |
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| Participants | N SCREENED = not stated N RANDOMISED = SCS ≤ 7 days n = 44, SCS > 7 days n = 43 N COMPLETED = SCS ≤ 7 days n = 41, SCS > 7 days n = 40 M = 98 F = 32 AGE INT = 70.3, CONTROL = 71.7 (NS diff) SMOKERS: INT = 18/44 (41%), CONTROL = 20/43 (47%) (NS diff) BASELINE DETAILS: Baseline comparison of groups showed no significant differences in age, gender, course of disease, proportion of current smokers or the prestudy course of exacerbation INCLUSION CRITERIA: exacerbation of COPD: type 2 AEs (i.e. at least 2/3 increased dyspnoea, increased sputum, purulent sputum); use of diagnostic criteria for COPD: 2 years of continuous productive cough, FEV1/FVC post bronchodilator < 0.7, FEV1 < 80% predicted EXCLUSION CRITERIA: respiratory failure, diabetes, bronchial asthma |
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| Interventions | SCS ≤ 7 days: prednisolone 30 mg/d 7 days + placebo 7 days SCS > 7 days: prednisolone 30 mg/d 10 days + 15 mg/d 5 days Delivery: oral Co‐interventions permitted: not stated Co‐interventions not permitted: not stated Follow‐up period: not stated |
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| Outcomes | Outcomes measured: lung function, arterial blood gas measurement, days of hospitalisation Composite symptom score: highest 18 (worse) to lowest 0 (no symptoms) for breathlessness, sputum volume, cough, amount of sleep, exercise capacity, wheezing Treatment failure: no definition stated Rate of relapse: no definition stated Side effects: corticosteroids |
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| Notes | INVESTIGATOR‐SUPPLIED DATA: outcomes reported: absolute values and change in FEV1, FEV1/FVC ratio, PEF, PaO2 # relapse, # failed treatment, # side effect | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Stochastic function used to create 150 numbers 0 to 1 Randomisation code prepared by an assistant not involved in other parts of the study Sealed envelopes prepared before study initiation by assistant |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes used and allocated by third party |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Participants: use of identical boxes and medications Researchers: blinded to medications |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Numbers of failed treatment given, numbers with side effects given and information included in publication Publication details, reasons for withdrawals as worsening disease, poor compliance, treatment failure |
| Selective reporting (reporting bias) | Unclear risk | Results given by study author for FEV1, PaO2, symptom scores, rate of relapse, number of side effects, number with failed treatment No information on hospital duration Unclear what symptom score scale was used |