Bilton 1992.
| Study characteristics | ||
| Methods | RCT Cross‐over design Single centre: Regional Adult Cystic Fibrosis Unit, Manchester Duration: 4 days |
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| Participants |
Inclusion criteria: not specified Exclusion criteria: not specified 18 participants Baseline characteristics Age, mean (range): 21 (16 to 34) years Sex: 13 males, 5 females Disease status: clinically stable at time of study; all colonised with Pseudomonas aeruginosa Lung function, FEV1 L, mean (SD): 2.3 L (1.1) |
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| Interventions |
Intervention 1: chest physiotherapy (ACBT), 20 minutes 2 x daily Intervention 2: exercise (cycling at 60% VO2 max), 20 minutes 2 x daily Intervention 3: chest physiotherapy (ACBT), 10 minutes 2 x daily plus exercise (cycling at 60% VO2 max), 10 minutes 2 x daily |
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| Outcomes | Absolute FEV1 L, adverse events, FVC L, participant preference, sputum expectorated during treatment (wet weight (g)), sputum expectorated during non‐treatment times (wet weight (g)), perceived effectiveness by high and low sputum producers | |
| Identification |
Sponsorship source: supported by the Cystic Fibrosis Trust Country: UK Setting: Regional Adult Cystic Fibrosis Unit, Monsall Hospital, Newton Heath, Manchester Authors name: Diana Bilton Institution: Faculty of Medicine, National Heart & Lung Institute, Imperial College London Email: diana.bilton@imperial.ac.uk Address: Regional Adult Cystic Fibrosis Unit, Monsall Hospital, Newton Heath, Manchester, M10 8WR |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Random allocation process not described: "The order of these was randomly allocated to each patient." |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not discussed. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and personnel carrying out or supervising interventions was not feasible due to the nature of the study intervention. |
| Blinding of participants and personnel (performance bias ‐ subjective outcomes) Subjective outcomes | High risk | Blinding was not possible due to the type of intervention used. Participant awareness of the intervention may have led to some impact on reporting of subjective measures, such as QoL, due to pre‐existing perceptions or preferences on the benefits of exercise versus traditional airway clearance techniques. |
| Blinding of participants and personnel (performance bias ‐ objective outcomes) Objective outcomes | Unclear risk | Blinding was not possible due to the type of intervention used; however this was unlikely to confer any impact on objective outcome measures such as lung function and exercise testing. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated who the outcome assessors were and whether or not they were blinded to allocation during data analysis. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "All 18 patients completed the study." No re‐inclusions in analysis performed by review authors. No withdrawal of participants mentioned. Mean 24‐hour sputum weights for each of the 4 treatments and non‐treatment times fully reported. Full data presented for participant preference. Narrative data presented for pulmonary function only. No access to raw data. |
| Selective reporting (reporting bias) | Unclear risk | No protocol for comparison ‐ outcomes in methodology compared with available results, numerical data for spirometry not reported. |
| Other bias | Unclear risk | There were specific inclusion and exclusion criteria set for participants, but no evidence for how study participants were recruited which may be attributed to the limited abstract wordcount. There was no reported power calculation. There is an unclear risk associated with the potentially insufficient sample size. |