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. 2014 Dec 13;2014(12):CD001941. doi: 10.1002/14651858.CD001941.pub3

Jackson 2001.

Methods Single‐centre, single‐blind study, randomisation stratified according to bulbar versus limb onset
Participants 13 adults with ALS of less than 3 years duration, with an FVC ≥ 70% and nocturnal oxygen desaturation for ≥ 1 minute or at least 2 clinical symptoms of chronic hypoventilation
Interventions Control: no respiratory support until FVC fell below 50%
Experimental: nocturnal positive pressure ventilation
Outcomes No clear primary outcome
  • ALS functional rating scale‐respiratory version (ALSFRS‐R)

  • Short Form 36

  • Modified Calgary Sleep Apnea Quality of Life Index (SAQLI)

  • FVC% (sitting and supine, maximal inspiratory force (MIP), maximal expiratory force (MEP))

  • Daytime and nocturnal oximetry, and peak cough expiratory flow (PCEF)

  • Symptoms of hypoventilation, assessed using a pulmonary symptom scale consisting of 14 questions, which were answered on a scale from 1 to 7

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated list
Allocation concealment (selection bias) Unclear risk No information was provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and personnel were not blinded to the intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The outcomes were assessed by a blinded clinical evaluator
Incomplete outcome data (attrition bias) 
 All outcomes High risk One participant out of 7 in the experimental arm was lost to follow‐up at 3 months
Selective reporting (reporting bias) High risk Only preliminary data were published