Methods | Quasi‐RCT (alternate allocation). Cross‐over design. Location: single centre in USA. Duration: 8 days (treatments alternating daily for 4 days). |
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Participants | 29 participants (15 males, 14 females). Age range 7 ‐ 47 years. Diagnosis of CF and clinical evidence of chronic disease. | |
Interventions | 3x daily 30 min CPT/PD versus 3x daily 30 min HFCWO. Participants continued to receive their standard bronchodilators prior to therapies. | |
Outcomes | Sputum weight (wet and dry). Each participant provided 3 samples per day for 4 days and all 12 samples were used to calculate the means and standard deviations. | |
Notes | 1 individual not enrolled due to intolerance of HFCWO, although had met the inclusion criteria ‐ never really entered the study therefore not really a drop out. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Initially randomly assigned, but method not stated then treatment assignments alternating daily. |
Allocation concealment (selection bias) | High risk | Alternate. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not discussed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 individual not enrolled due to intolerance of HFCWO, although had met the inclusion criteria ‐ never really entered the trial therefore not really a drop out. |
Selective reporting (reporting bias) | Low risk | Potential adverse effects were identified but none occurred. |
Other bias | Unclear risk | Not discussed. |