Torres‐Castro 2016.
Study characteristics | ||
Methods |
Study design: prospective randomised cross‐over study comparing air (breath) stacking and glossopharyngeal breathing Study grouping: cross‐over 'Rescue' vs maintenance therapy: maintenance Ethics: informed consent was obtained from participants. Ethical approval was obtained from the Ethics Committee for Research Involving Human Beings, Faculty of Medicine, University of Chile. Additional information: the author provided selected separate period data on email request. |
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Participants |
Baseline characteristics Overall sample data
First‐period baseline data, as provided by author on request Breathstacking
Glossopharyngeal breathing
Inclusion criteria
Exclusion criteria
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Interventions |
Intervention characteristics Air/ breathstacking
Glossopharyngeal breathing
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Outcomes | Primary and secondary outcomes were not explicitly identified. Baseline VC and postintervention MIC
PCF
Adverse events: not reported |
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Identification |
Sponsorship source: no sponsorship source declared. Conflict of interest: no conflict‐of‐interest statement presented. Country: Santiago, Chile Setting: domiciliary NIV programme recipients, in the participants' own homes Comments: authors declared no competing interests exist. Author names: Rodrigo Torres‐Castro, Jordi Vilaró, Roberto Vera‐Uribe, Luis Vasconcello, Homero Puppo Institution: Rodrigo Torres‐Castro and Homero Puppo: Department of Kinesiology, University of Chile, Chile Jordi Vilaró: Faculty of Health Sciences Blanquerna, Research Group of Physiotherapy (GReFis) Roberto Vera‐Uribe and Luis Vasconcello: National Program of Non‐Invasive Ventilation, Ministry of Health, Chile Email: klgorodrigotorres@gmail.com Address: not provided |
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Notes | Additional separate‐period baseline and outcome data were provided by author on request. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "To minimize the risk of bias, the order of execution of each cough assistance technique was performed randomly for each participant." Quote: "Randomization was performed by a free software (for www.randomization.com) specifically designed for generating random number lists." |
Allocation concealment (selection bias) | Unclear risk | Quote: "To minimize the risk of bias, the order of execution of each cough assistance technique was performed randomly for each participant. Comment: the article did not describe whether or how allocation concealment was achieved. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "A chest physiotherapist insufflated the patient during the inspiratory phase." Quote: "The protocol was implemented in the patients' homes by a trained chest physiotherapist." Comment: the chest physiotherapist was physically performing the insufflation interventions; therefore, it would be impossible to blind them. Similarly, the participants could not feasibly be blinded to allocation considering the nature of the interventions. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "A chest physiotherapist insufflated the patient during the inspiratory phase." Quote: "The protocol was implemented in the patients' homes by a trained chest physiotherapist." Quote: "Baseline PCF assessment was performed with the patient seated and with a respiratory physiotherapist monitoring the seal between the entire surface of the mask and the flowmeter to avoid any leakage." Comment: the baseline, intervention, and outcome assessments seem to have been performed by the same physiotherapist, who could not have been blinded to intervention allocation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 3 participants were excluded after screening, but clear reasons for exclusion were not provided. |
Selective reporting (reporting bias) | Low risk | Comment: all outcome measures listed in the protocol were reported. |
Other bias | Unclear risk | Comment: the following factors placed this study at unclear risk of other bias.
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