McIlwaine 1991.
Study characteristics | ||
Methods | RCT. Cross‐over design: participants randomised into 3 groups (PD&P, AD and PEP) and used this technique for the first "treatment period" of 2 months, they sequentially performed the other techniques. Each treatment technique was separated by an interval of 1 month "off period" when the pre‐study regimen of PD was reinstated. Single centre. Location: Canada. |
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Participants | 18 participants with CF diagnosed by sweat test > 60 mEq/L. Age: mean (range) 17.3 (11 to 27) years. FVC: range 38% predicted to 117% predicted. Shwachman score: range 50 ‐ 94. |
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Interventions | Technique 1: 2x daily PEP mask treatment in sitting using cycles of 15 tidal volume breaths against a resistor creating a PEP of between 10 ‐ 20 cms H₂0 followed by FET and cough. Sequence repeated 6 times or for a minimum of 20 minutes (whichever was longer). Technique 2: 2x PD&P (PD&P, vibrations, deep breathing and FET) performed in 11 different PD positions, draining 6 positions in the morning and the other 5 in the afternoon. Treatment time of 30 minutes each session. Technique 3: 2x AD performed in sitting until all mucus was evacuated (maximum treatment session length no more than 45 minutes). | |
Outcomes | FEV1, FVC, and FEF25−75% clinical assessment and Shwachman score were measured at the start and end of each 2‐month treatment period.
Sputum expectorated during the weekly physiotherapist‐supervised physiotherapy session was collected and weighed. Other measures included reported treatment duration, treatment comfort, requirement for assistance with treatment, flexibility of treatment times, control in performing own treatment, and how interruptive treatment was to daily living. Physical activity and compliance with treatment were monitored using a weekly questionnaire. |
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Notes | The authors were contacted and an unpublished paper was kindly provided by the study investigators. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated. "In order to avoid seasonal variations which may have affected the outcome of the study, the patients were randomized into three groups. Each group was assigned by a different physiotherapy regiment for the first treatment period, then sequentially performed the other techniques". |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Neither participants nor physiotherapy personnel were blinded to the self‐administered physiotherapy techniques under study. As it is not possible to blind by design, the risk of bias is deemed to be low overall. The extent to which the lack of blinding may have had an effect on the reporting of subjective outcomes such as patient preference and QoL measures is unclear. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Physician was not told what type of physiotherapy was being performed by the participant at the time of assessment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The results are reported from 14/18 participants who completed the study, 4 withdrawals discussed. 1 participant required hospitalisation during the first period of the study (treatment regimen was PD&P) due to exacerbation of her pulmonary disease and was found to have ABPA. She was then considered too unstable to continue in the study. A second participant was dropped at the end of the first period, after requiring Prednisone to control an allergic reaction to an antibiotic. 2 other participants (treatment regimen AD) refused to complete the cross‐over study, instead they insisted on continuing AD. These participants were excluded from the analysis of sputum production. |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Low risk | None identified. |