Brito 2009.
Study characteristics | ||
Methods |
Study design: prospective randomised cross‐over trial comparing MAC, breathstacking, and MAC + breathstacking Study grouping: cross‐over 'Rescue' vs maintenance therapy: maintenance Ethics: ethical clearance provided by Federal University of São Paulo (UNIFESP) Research Ethics Committee (CEP 0775/06) |
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Participants |
Baseline characteristics Separate data were not documented for group allocations in the first period of cross‐over. Data were presented for all participants, who received all interventions.
Inclusion criteria
Exclusion criteria
Pretreatment
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Interventions |
Intervention characteristics Baseline spontaneous MEE
Manual chest compression (MAC)
Breathstacking using a manual resuscitation bag
Chest compressions (MAC) + breathstacking
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Outcomes | Separate first‐period data were not presented, precluding analysis. PCF
Adverse events: not reported |
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Identification |
Funding source: financial support was provided by the Associação Fundo de Incentivo à Psicofarmacologia (AFIP, Association for the Incentive Funding of Psychopharmacology). Conflict of interest statement: funding source declared and unlikely to constitute a conflict of interest. Country: Brazil Setting: outpatient clinic: Pediatric Sector of the Noninvasive Mechanical Ventilation Outpatient Clinic of the Psychobiology Department of the Sleep Institute at UNIFESP, Federal University of São Paulo Author name: Magneide Fernandes Brito (corresponding author) Institution: Sleep Medicine and Biology Division of the Psychobiology Department; Federal University of São Paulo Email: magneide@gmail.com Address: Rua Marselhesa, 500, 14° andar, Vila Clementino, CEP 04020‐060, São Paulo, SP, Brazil |
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Notes | Attempts to contact the corresponding author for additional data were unsuccessful. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "To avoid the influence of the order of the maneuvers and minimize patient fatigue, the sequence of the time points (other than, obviously, baseline) was random." Comment: there was no intervention and control group, each participant acted as their own control in a cross‐over design. All participants had baseline measurements, which were compared to various cough augmentation interventions. Although there was random allocation of intervention order, there was no indication of how randomisation was done. Separate group/period data were not provided so baseline imbalances could not be determined. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. Unclear whether or how allocation concealment was maintained. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: although not stated in the study, this was likely not achieved, as both participants and personnel performing the interventions would have been aware of allocation. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "the PCF measurements were taken during a spontaneous MEE accompanied by chest compression…" Quote: "For the air stacking‐only time point, the PCF measurements were made after air stacking…" Quote: "…after the third insufflation, the patient made a forced exhalation, and the PCF with MEE was measured." Quote: "For the combined technique time point, the PCF was measured after the use of air stacking with a manual resuscitation bag followed by chest compression with MEE." Comment: PCF values were measured while performing the cough assist techniques and, therefore, assessment could not have been performed blinded. This leads to potential detection bias. The same examiner performed all measurements. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "We excluded 2 patients for not having the intellectual capacity to understand and perform the maneuvers involved in the spirometry and PCF measurements." Comment: 2 participants were excluded with reasons provided; there were no other missing data or dropouts reported. All 28 participants' data were presented in Figure 2 of the publication. |
Selective reporting (reporting bias) | High risk | Comment: not all the prespecified outcome measures were reported in the results, e.g. SpO2, expired CO2, and all spirometric measures. Of the last‐mentioned, only FVC was reported (mean FVC% predicted 29% (SD 12%)); no other spirometry or bio‐demographic values were provided. Data for the primary outcome measure, PCF, were presented; however, separate period data were not provided, precluding the possibility of meta‐analysis. |
Other bias | High risk | Comment: the following factors placed the study at high risk of other bias.
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