View Single Post
Old 10-17-2023, 10:38 AM
MuonOne's Avatar
MuonOne MuonOne is offline
Grand Magnate
 
Join Date: Feb 2007
Posts: 3,272
15 yr Member
MuonOne MuonOne is offline
Grand Magnate
MuonOne's Avatar
 
Join Date: Feb 2007
Posts: 3,272
15 yr Member
Question An odd caveat

Another critical flaw in the DiPALS report . . . long the bane of Amyotrophic Lateral Sclerosis patients: being counted as dead because they went on the ventilator . . . arguably sensible when, absent their vent, the patient would die almost immediately. In cases of the pacer however, this issue was moot because there is evidence of therapeutic value due the pacer use. The DiPALS study appears similarly in the extreme . . . their patients were counted as dead simply because they left the study. There were eight such patients in the pacing group before six months were reached, five were not even implanted but they were none the less treated as dead (even though alive) thereby the pacing cohort was the subject of an extreme handicap. The DiPALS researchers questioned the validity of the US FDA approval on the grounds of the absence of Randomized Controlled Trial but RespiStimALS also did a Randomized Controlled Trial with their study abending as the patients nearly reached the level of the patients in the studies the US FDA based their pacer approval on. The DiPALS study and the RespiStimALS study themselves are not in agreement with each other, even though in principle, they should be. I don't know why this is not pointed out by others?
MuonOne is offline   Reply With QuoteReply With Quote