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. 2017 May 4;2017(5):CD006842. doi: 10.1002/14651858.CD006842.pub4
Methods RCT.
Cross‐over design (1‐day washout between treatments). Location: single centre in Italy. Duration: 2 days for each of 3 treatments with 1 rest day in between treatment 1 and 2. No follow up reported.
Participants 16 (8 males, 8 females) participants. Mean (SD) age 20.3 (4) years, range 15 ‐ 27 years. All participants had FEV₁ >40%, sputum volume >30 ml/day and were accustomed to ACTs. Mean (SD) Schwachmann score 65.1 (11). Mean (SD) Crispin Norman score 18.5 (4.3).
Interventions 3 interventions: PD (specific PD positions were not identified); PEP; HFCWO. 15 min saline nebulised prior to treatment. 2 treatments per day for 2 days, then rest 1 day; next intervention for 2 days, then 1 rest day; then the final intervention. Each session lasting 50 min (not clear if this included the 15 min of nebulisation).
Outcomes RFTs (FEV₁) 30 minutes pre‐ and post‐treatment, wet and dry sputum weight collected in 50 min of treatment and 30 min following. Only spontaneous coughs were allowed and the number of cough manoeuvres were counted and documented. Each treatment was scored for efficacy and tolerance by participant and for tolerance by therapist (method of efficacy or tolerance scoring was not defined).
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised according to Latin square design described by Williams.
Allocation concealment (selection bias) Unclear risk Not discussed.
Blinding (performance bias and detection bias) All outcomes High risk Blinding of participants or assessors not performed.
Incomplete outcome data (attrition bias) All outcomes High risk Withdrawals had not been discussed
Selective reporting (reporting bias) High risk Efficacy and tolerance for the treatments were scored by the participant, and tolerance was also scored by the physiotherapist. These were then referred to as good but with no further evaluation of this score made.
Other bias Unclear risk None identified.