Sontag 2010.

Study characteristics
Methods	Multicentre (20 centres, study based in Denver, Colorado, USA), prospective parallel design RCT 166 participants with CF were stratified by age and randomly assigned to CCPT, FD or HFCWO.
Participants	166 participants with established CF diagnosis (sweat chloride or genotype with 2 documented CFTR mutations), and FEV1 > 45% were randomly assigned to CCPT, FD or HFCWO, using electronic randomisation, stratified by age (children: 7–11 years, adolescents: 12–17 years, adults: ≥ 18 years). Age range of adults not reported. Children: n = 86, 61 completed study, 25 withdrew (14 from CCPT, 9 from FD and 2 from HFCWO). Adolescents: n = 44, 30 completed study, 14 withdrew (12 from CCPT, 1 from FD and 1 from HFCWO). Adults: n = 36, 19 completed study, 17 withdrew (9 from CCPT, 6 from FD and 2 from HFCWO). Excluded if hospitalised for a pulmonary exacerbation or had gross haemoptysis (> 249 mL) within 60 days prior to screening, or a pneumothorax in the 6 months preceding screening.
Interventions	Participants were trained to perform the treatment twice daily for 20–40 min/session. CCPT: administered by an available carer using a wedge provided to assist with appropriate positioning. Positioning, percussion (vibration) and FET with coughing between each of 6 positions. After each position, participants were instructed to perform 3 FET and cough. Flutter device: self‐administered utilising the Flutter device (Scandipharm, Birmingham, Alabama), incorporating Flutter device airway vibration, and FET with coughing. Flutter device treatment was divided into 3 stages: 1. loosening and mobilisation breaths, followed by 2. mucus mobilisation and 3. expectoration. HFCWO: self‐administered utilising the Vest (Hill‐Rom, Minneapolis, Minnesota) incorporating HFCWO, deep breathing and FET with coughing between each frequency. Each frequency was instructed to be performed for 5 min with deep breathing to TLC every 2 min, and each cycle was followed by 3 FET.
Outcomes	Clinical status (rate of (FEV1) decline, time to need for IV antibiotics to treat pulmonary exacerbations, use of other pulmonary therapies), anthropometrics, and spirometry (FEV1, FVC, FEF25–75) were assessed every 3 months for 3 years, following a screening visit within 7 days of randomisation. At 'select visits,' a validated Treatment Satisfaction Survey and CF‐specific HRQoL instrument, the Cystic Fibrosis Questionnaire were administered, and adherence was measured using the daily telephone diary.
Notes	Study reported in 3 abstracts (Accurso 2004; Modi 2006; Quittner 2004) and 2 full‐text manuscripts (Sontag 2010; Modi 2010). Sontag 2010 is the primary reference for this study, from Pediatric Pulmonology. Jadad score: 3/5.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were stratified by age (children: 7–11 years, adolescents: 12–17 years, adults: ≥ 18 years) and randomly assigned using electronic randomisation.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not feasible (participants), not reported (personnel).
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described.
Incomplete outcome data (attrition bias) All outcomes	High risk	Sample size of 180 participants not met (with power = 85%) and 3‐year RCT terminated early because of disproportionate dropouts in 3 groups. 56 (33.7%) of participants withdrew from the trial. 15 participants withdrew within 60 days of randomisation and were not included in analyses. 2 were children (1 CCPT, 1 Flutter device), 7 adolescents (6 CCPT, 1 Flutter device) and 6 adults (4 CCPT, 2 Flutter device). 11 of these 15 withdrew on day of randomisation. A further 41 (24 from CCPT group) withdrew after first 60 days and were included in ITT analysis. 23 were children (13 CCPT, 8 Flutter device, 2 HFCWO), 7 adolescents (6 CCPT, 1 HFCWO), 11 adults (5 CCPT, 4 Flutter device, 2 HFCWO). Reasons for dropouts after 60 days (n = 41) were moved or lost to follow‐up (n = 13); lack of time (n = 7); preferred another therapy (n = 4); decrease in health (n = 4); compliance (n = 4); wanted to participate in another study (n = 3); family stress (n = 2); and lack of interest (n = 2); no reasons given for 3 participants. Participants randomised to the HFCC group who withdrew from the study had significantly lower FEV1 % predicted and FVC % predicted (P < 0.03 and P < 0.01) at baseline than those who continued in the study, adjusted for age group. Subgroup analysis showed that within the adolescents, baseline FVC % predicted was significantly higher (P < 0.02) in the HFCC group (94.9%) compared to the CCPT group (84.9%). 110 participants completed the entire study: 61 children (17 CCPT, 20 Flutter device, 24 HFCWO), 30 adolescents (3 CCPT, 11 Flutter device, 16 HFCWO), 19 adults (3 CCPT, 4 Flutter device, 12 HFCWO).
Selective reporting (reporting bias)	Low risk	All outcomes reported on those who finished the study.
Other bias	High risk	ITT analysis (41/151) or 27% of group included in analysis had withdrawn before termination of study. Withdrawals were overwhelmingly biased toward CCPT (51%) compared to Flutter device (16%) and HFCWO (9%), and towards older participants, compromising the generalisability of the study. Duration of "active participation" was 1.3–2.8 years at termination of study intended to run for 3 years. Sponsored by Hill‐Rom Company, Inc (manufacturer of HFCWO vest) and the US Cystic Fibrosis Foundation.