The DiPALS report may be a study incurred of a false negative sample; In ALS a treatment group may appear to fair less successfully than the control group when the patient count is small. I have seen cases where a patient lasts only six months from disease onset to cases where a patient remains alive after fifty years from disease onset. So the patients lived less long in the treatment group; did they live longer than they would have? Efficacy is about whether they lived longer with than without the treatment.

Given a group of 37 ALS patients, we might expect to see seven slow regressors and presumably seven fast regressors (yet I know of very little literature on fast regressors).

This note pertains to Figure 2 of the DiPALS report in Lancet Neurology. There are tic marks on both lines in the chart: the upper line has about twenty of them and the lower line about ten. The caption regards them as indicating censored patients. The term censored is sometimes used to indicate cases excluded from consideration because of missing criterion(s): the report suggests some datums were instead interpolated because they were not received. I have wondered whether the tic marks indicate a patient passed the point where their speech was no longer intelligible? Such an indication would be scientifically valuable. Surely they do not mean they told the patient to shut up.

Prognostic factors in ALS: A critical review
Chio, et alia (Torino-Italy, Harvard, Dublin-Ireland, Dundee-Scotland, Preston-UK, Milano-Italy, NIH-USA)
Published 2009, "Amyotrophic Lateral Sclerosis"
http://www.tandfonline.com/doi/abs/1...82960802566824

Respiratory effects of amyotrophic lateral sclerosis: problems and solutions.
Lechtzin, Noah (Johns Hopkins)
Published August 2006, "Respiratory Care" Vol 51 No 8
http://www.ncbi.nlm.nih.gov/pubmed/16867198

A new status is posted on the ClinicalTrials.gov database for the French study:

"This study has been terminated.

(in the absence of benefits and because of a statistically significant excess mortality in the group of patients receiving active stimulation.)"

Further to my review of The Lancet Neurology report . . . :

The report ". . . patient population in the present study is characteristic of the ALS population in terms of age, sex, site of onset, and proportion with a clear family history . . ." is erroneous insofar as gender is concerned . . . no publication I am aware of has males nearly four times more likely to acquire ALS than females. The idea of randomization in the context of these kind of trials is to produce what could be called 'fair teams' in the groups undergoing treatment in consideration of whether there is efficacy against the disease(s) processes . . . one of the problems of ALS research is the unpredictability of each particular patient's likely survival. Would equal unfairness improve the reliability of a result? Variances as high as those found in ALS are quite rare among diseases, if there are any existing at all. The easiest tactic to compensate for this problem is to make the 'teams' larger, probably much larger; in a group of thirty-seven patients one would expect about seven whose regression rate is slow. "The Lancet Neurology's" report indicates five plus one patients had effectively abandoned the DPS branch of the trial. Could all of these have been slow regressors? How vulnerable are these trials to disruption . . . "to death from any cause."

Why did they call it ALS rather than MND (in the UK they call it MND)?

I have no print copy of the report . . . although I am searching for one. To the best of my knowledge and belief the French have not yet published a full report.

These URLs the assessments included in the DiPALS report.

SAQLI (Sleep Apnoea Quality of Life)
http://www.thoracic.org/members/asse...ires/saqli.php

SF-36 (Short Form Health Survey)
http://www.sf-36.org/tools/sf36.shtml

EQ-5D
http://www.euroqol.org/about-eq-5d.html

EQ-5D-3L (Euroqol 5D questionaire 3-level format)
http://www.euroqol.org/eq-5d-products/eq-5d-3l.html
Patient
Health State
Thermometer scale
Carer
Health State
Thermometer scale

I thought I should suggest listening to the audio commentary associated with the DiPALS report . . . you might have overlooked the audio recording of Chris McDermott and Richard Lane discussing the DiPALS study. The interesting audio commentary is found adjacent to the report on The Lancet Neurology's web site and adds content not found in the report:

http://www.thelancet.com/journals/la...152-0/abstract

UK's MNDA comments on DiPALS results:

https://mndresearch.wordpress.com/20...mnd/#more-3701

I am nearing the completion of my review of the DiPALS Writing Committee report . . . sorry for the delay.

I would like to encourage SiTraN's DiPALS Writing Group to conduct a study on the " . . . web-based randomisation system. . . " using the remainder of their applicants . . . their report indicated there were 759 applicants, whereas they only needed 108 for their study. Such would result in about a dozen or so groups, wherefrom one can derive survival statistics . . . then consider whether the several groups developed similar or dissimilar survival profiles. Generally, PREDICTING the survival of patients is considered difficult to do, some researchers even say impossible and such is a primary issue in the development of sound treatment trials. Will the ". . . web-based randomisation system . . ." produce groups with similar or dissimilar survival profiles? Such study may produce a basis for a journal paper all by itself.