UHM 2018, Vol. 45, No.
1 – LETTERS: REGULATOR PERFORMANCE IN POLAR DIVING
The need for ongoing testing is clear, and an awareness
that manufacturing changes can have unexpected
consequences is important. There is a fundamental
conflict between engineers trying to build extremely
easy breathing regulators and an environment in which
too much ease of breathing can promote earlier entry
into a cold-water failure cascade. The issues are
complex, and assessment requires proper research
design, capture of critical information, objective inter-
pretation of findings, and a clear acknowledgment of
the limitations of any effort.
The current report has value in identifying four
regulators associated with less than one free-flow in
60 dives. Further attention should be directed at
regulators with similarly high performance to refine
what should be the next workhorse regulators for polar
diving. New work is required to allow meaningful
comment on the contribution of the user to regulator
performance. Efforts that effectively combine bench
with properly designed field evaluations are strongly
encouraged.
___________________________________________________________________________________________________________________________________________
Re: Evaluation of regulator performance in polar diving – authors’ response
LETTER to the EDITOR/LTE Para. 1. In his first
paragraph, the writer claims that we misrepresented his
1995 non-peer-reviewed article. We could not disagree
more. In truth, we have long recognized a discrepancy
between what the 1995 paper reports, in terms of its
data, and what the authors claim. The authors claim
a highly significant (P<0.0001) difference between
internal temperatures in one regulator model with heat
retention blocks internal to the second stage, compared
to the same regulator without internal heat retention
blocks.
We commend the 1995 authors for attempting
measurement of second stage temperatures in the field.
That measurement is so fraught with difficulty that
NEDU only attempts it in the laboratory. However, even
casual inspection of Pollock’s Figures 1 through 3 reveal
the problem with his conclusion. In fact, the
present authors (Lang/Clarke) have had other
professionals attempt to understand the source of the
112
Neal W. Pollock, PhD
Université Laval
Québec, QC, Canada G1V 0A6
and
Service de médecine hyperbare
Centre de médecine de plongée du Québec
Hôtel-Dieu de Lévis
Lévis, QC, G6B 3Z1
Neal.Pollock@kin.ulaval.ca
References
1. Lang MA, Clarke JR. Performance of life support
breathing apparatus for under-ice diving operations.
Undersea Hyperb Med. 2017; 44(4): 299-308.
2. Mastro JG, Pollock NW. Sherwood Maximus
regulator temperature and performance during
Antarctic diving. In: Harper DE Jr, ed. Proceedings
of the 15th annual scientific diving symposium:
Diving for Science...1995. Nahant, MA: American
Academy of Underwater Sciences, 1995: 51-62.
3. Pollock NW, Mastro JG. A five-year review of
regulator performance in the US Antarctic Program.
Antc J US. 1996; 31(1): 24-26. ✦
P-value of <0.0001 based on the presented data,
without success. It seems highly implausible, as
described below.
If we perform an unpaired T-test on the overall data
shown by Pollock in the bottom line of his Table 7,
given only the mean temperatures and standard
deviation from Table 7, and assuming a sample size of
18 based on a pool of six divers, there is no statistical
difference between the two regulator treatments
(P > 0.11). Our statistical exercise assumes the measured
data was normally distributed. It may not have been,
but the authors say nothing about normality, so we are
left to wonder: 1) why they used a non-parametric test;
and 2) how a non-parametric rank order test could have
delivered such a significant P-value (P<0.0001) when a
parametric test showed no significance (P>0.05).
Using Monte Carlo methods, NEDU generated with
SigmaPlot (Systat Software) eight randomly sampled
Pollock NW vs. Lang MA, Clarke JR
 UHM 2018, Vol. 45, No. 1 – LETTERS: REGULATOR PERFORMANCE IN POLAR DIVING
data sets with statistical descriptors matching those of
Pollock’s Table 7 [3.8 ± 1.2°C (mean ± SD) and
3.2 ± 1.0°C], each with a sample size of 18. The P-values
for four data set comparisons using the unpaired T-test
in SigmaPlot were 0.113, 0.114, 0.124, and 0.104.
When the same comparisons were run using the tests
used by Pollock, the Mann-Whitney Rank Sum test
(or U statistic), respective P-values were 0.133, 0.235,
0.097 and 0.090. As expected, there was no net gain
in statistical significance afforded by using a non-
parametric test. So, on closer inspection, the LTE
author’s reported data does not support his stated
conclusion. We reported on the author’s data, not his
conclusion.
Regardless of the correct conclusion about temperatures,
like us, Pollock concluded that the presence of the heat
retention blocks internal to second-stage regulators did
not improve regulator failure rates (his Table 4).
LTE Para. 2: On page 308, Lang and Clarke state
“[This] is the only study that finds a statistically
significant grouping of regulators, those that fare well
under extreme polar conditions, and those that do not.”
While we acknowledged the prior team’s work a few
paragraphs before the above quote, the LTE author
claims that our reported findings do not represent the
first study to identify separate classes of regulators.
Indeed, Pollock and Mastro reported differences
between regulators in their 1995 report and the two-
page 1996 summary. However, their interesting Table 2
in the 1995 report is less the result of a scientific “study”
than a logging of observations in an uncontrolled, non-
randomized, multiyear compilation.
The Pollock report does have value in pointing out an
observation: the Sherwood Maximus has historically
been a good performer. However, once again his
statistics are an enigma. While we do not doubt his
overall claim about the Sherwood Maximus, we have
no understanding of how he obtained his reported
chi square value of 18.03 for Maximus versus non-Max-
imus regulator failure incidence. Our statistician has
computed the chi square by hand, and others of us have
calculated the same value based on the “total” data
report in Pollock’s Table 3. We used both SigmaPlot and
Pollock NW vs. Lang MA, Clarke JR
web-enabled chi-square calculators. In every case, upon
re-examination of Pollock’s data we find a much larger
chi square value.
This once again draws attention to the unexplained
statistical procedures used by the author. We strongly
suspect these calculations would have been either cor-
rected, or better explained, had the paper been peer-
reviewed.
On the other hand, in the Lang/Clarke study, we took
great pains to not only use defensible statistics, but to
control and record as many regulator parameters as
possible. Table 2 of the 1995 paper contained a summary
(sometimes partial) of dive results from 1989 to 1995. As
interesting as that table was, it was not accompanied
by descriptions of controls, or information about the
divers and dives, how the regulators were treated
before, during or after the dives, how the regulators
were setup for the dives (e.g., intermediate pressures,
cracking pressures, etc.) or how divers were selected for
each regulator model. Indeed, the authors admitted that
the second best regulator in their summary (Poseidon
Thor, Table 2) involved dives almost exclusively by
two divers. In other words, their Table 2 was based on
diver preference and unknown regulator conditions
or treatment, and therefore was more anecdotal than a
controlled study, as conventionally defined.
We will leave it to the readers of our paper to decide
whether or not the 1995 Table 2 compilation of multi-
year, logged regulator data represents a scientifically
controlled “study,” per se, as the LTE author claims.
LTE Para. 3: Regarding our body habitus measures,
we provided the references for the modest methods
used, suitable for field studies of regulators. We stand
by both the measurements and the references. They
merely show that our population of divers was in fact
homogeneous; there was no obvious inhomogeneity
to skew the results of regulator performance. Of note,
we make no claims of any effect of body habitus on
regulator performance. The informed reader can take
those measurements for what they are and draw their
own conclusions, but we would be remiss not to report
them.
➠
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 UHM 2018, Vol. 45, No. 1 – LETTERS: REGULATOR PERFORMANCE; DAMO2CLES STUDY
LTE Para. 4: As stated above, the current authors’ work
was a controlled study, as well as any field study can be
controlled. Pollock’s implication that some regulators
were subjected to more rigorous conditions than others,
thus somehow accounting for our observation of a bi-
modal response, is unsupported by the facts, which are
too numerous to enumerate here, other than to say all
dives were conducted from heated huts.
In unmanned regulator testing by the U.S. Navy, where
conditions are even better controlled than in the field,
the identification of “acceptable” versus “unacceptable”
regulators is common. The acceptable ones are pub-
lished on the NAVSEA “Approved for Navy Use” list,
which currently has three regulators listed for cold-
water diving. The Sherwood Maximus is not one of
them.
LTE Para. 5: Although paragraph 5 asserts that it
expounds upon a “critical problem” with the Lang/
_____________________________________________________________________________________________________________________________________________________________________
Hyperbaric oxygen therapy in the
treatment of ischemic lower extremity ulcers in patients with diabetes:
Results of the DAMO2CLES multicenter randomized clinical trial.
Commentary on article in Diabetes Care [1]
Santema, et al. compared hyperbaric oxygen (HBO2)
therapy plus standard care to standard care alone for
wound healing and limb salvage in patients with
diabetes and concluded that HBO2 offered no advantage
[1]. Several aspects of this work beg address.
Lesions in 52% of enrollees were modest enough
(Wagner Grade 2) to not commonly represent a
hyperbaric treatment indication. As a significant limb
salvage difference favored HBO2 in per-protocol
analysis A, it would have been valuable to analyze
intention to treat outcome in lesions representing
accepted referral indications (Grades 3/4).
When electing to recalculate power secondary to low
recruitment, the authors chose to essentially double
effect size. If power is recalculated for the initial 12%
effect with the reported sample size, it drops to about
114
Clarke paper, we’re not sure what his point is. The
present authors’ choice of descriptors is clearly
arbitrary, and meant simply to describe the bimodal
distribution of regulators. Regarding Pollock’s
comments about the “best” regulator, the governing
agency’s decision as to which regulators will be
approved for polar service are based on many factors,
not just the lowest incidence of freeze up in both
manned and unmanned testing. The assertion that only
one regulator is “the best,” is an over-simplification,
and is soundly rejected by the U.S. military.
Michael A. Lang, PhD
University of California San Diego, Department
of Emergency Medicine, San Diego, California
m4lang@ucsd.edu
John R. Clarke, PhD
Navy Experimental Diving Unit, Panama City, Florida
john.r.clarke@navy.mil
0.50. Further to this point, adjusting effect size so that
power “appears” to reach a desired level is misleading
at best, as one can choose an arbitrary effect size to
achieve any desired power. A recalculation of power
using the original 12% effect size should have been
reported.
The authors state that protocol analysis A “should
show the maximum attainable effect of HBOT.”
From an intent-to-treat perspective, perhaps this is true.
However, when protocol B and SC groups are com-
bined, distinction between groups becomes less clear,
more so when placing four subjects who received HBO2
of their choice into the SC group. To truly assess maxi-
mum attainable effect, one should compare protocol A
group with SC only, excluding the four noted subjects.
Despite all of this, protocol A group analysis reached
Pollock NW vs. Lang MA, Clarke JR; Clarke R, Hussey JR