Pinto 1995.
Methods | Single‐centre, open, parallel‐group study with a 3‐year follow‐up period | |
Participants | 20 participants having ALS with bulbar features (definite diagnostic criteria) and with chronic hypercapnic respiratory failure | |
Interventions | Control: oxygen, bronchodilators and other palliative measures Experimental group: non‐invasive nasal nocturnal ventilation with bilevel airway pressure | |
Outcomes | Mortality at 1 and 3 years Survival time Bulbar and spinal Norris scores Quality of life Modified Barthel score Arterial blood gases Respiratory function tests |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Participants were alternately assigned to experimental or control arms |
Allocation concealment (selection bias) | High risk | Participants were alternately assigned to experimental or control arms |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No party was blinded to the intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The outcome assessor was not blinded to the intervention |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | Low risk | Outcomes presented in the results section matched those reported in the methods |