By John D. Perry, PhD
In
the first month following HCFA's Medical-Surgical Panel Public Hearings on
April 12-13, 2000, attention was focused on the various procedural
irregularities that surrounded the formal process. Everyone was stunned by the outcome, and we waited to see the
promised protest of the Consumer Representative, Ms. Greenberger. Eventually a large number of individuals and
professional organizations submitted additional protest letters as well,
including the American Medical Association, which had not entered the process
in April.
On
May 1st I attended a poster presentation by Dr. Bary Berghmans at
the AUA meeting in Atlanta, and for the first time got a grasp on the conceptual
confusion ("biofeedback is a form of physical therapy") that
underlies the BC/BS TEC report (#1). Soon
thereafter HCFA published the Executive Committee's March 1st transcripts
and reports, and the basis for the Med-Surg Panel's activities finally became
clear. Also clear was that the EC
recommendations were honored more in the breach than the promise. (See #2-5). In #6 we point out that Burton et al (1988) didn't qualify, since
he didn't do any PME! (a TEC oversight.)
In #7 we discuss levels of evidence and the controversy with the EC. #8 concerns the claim that there were
"no relevant outcomes" in two studies. In #9 we take issue with TEC's claims of bias, and also point out
that Franke (2000) also did not have a PME-alone control group - another TEC
error. Finally, in #10 we introduce
three new forms of bias that apply to behavioral interventions such as
biofeedback, and fault the TEC heros on all three forms of bias.
1. Berghmans' EGG and Conceptual Confusion (5/11/00)
2. What the EC recommended to Panels (5/26/00)
3. Dr. Landy's "report" (5/26/00)
4. Dr. Zendle's "report" (5/26/00)
5. The slide they asked to see (5/27/00)
6. Another BC/BS error (Burton & Burgio) (5/30/00)
Burton's Urge patients didn't get PME Alone!
7. What happened to the AHCPR Guidelines? (5/31/00)
8. No relevant outcomes? (5/31/00)
9. TEC's three forms of bias (6/1/00)
Franke didn't have a PME alone control group
10.
Three additional forms of bias (6/4/00)
Bary
Berghmans presented a poster at the AUA convention in Atlanta last week that
was essentially a re-hash of his February 2000 paper on Biofeedback and Urge
Urinary Incontinence.
But
there was one important difference -- as a poster presentation he included a
graphic that was not part of that BJU paper.
The graphic showed his concept of "biofeedback", and explains
the conceptual confusion that was included in the Monaco Report, and
subsequently became the cornerstone of the BC/BS TEC report on Biofeedback.
The
key is Berghmans' drawing of the relationship between "physical
therapy" and "biofeedback".
Picture,
if you will, an egg, with a yoke. The
entire egg is labeled "physical therapy", while the yoke is labeled
"biofeedback".
In
Berghmans' view, everything that is called "biofeedback" is a sub-set
of "physical therapy". There
is no part of biofeedback that isn't a "physical therapy"
activity. Thus Berghmans set out to
"assess the efficacy of *physical therapies* for first-line use in the treatment
of urge urinary incontinence..." (Feb.
2000 abstract, emphasis added).
And,
as you know, he concludes that there are "too few studies to evaluate the
effects of PFM exercise with or without biofeedback...". That's notwithstanding that the very best
study, in terms of methodological criteria defined by Berghmans, is Burgio's
1998 JAMA study, which found that biofeedback was vastly superior to drugs or
to placebo.
Burgio's
problem is that, in spite of her study being the largest study ever done of
Urge Incontinence, it is only ONE good study, and in Berghmans' so-call
evidence-based model you have to have three high-quality studies to
"prove"
a
point.
[In
Berghmans' model, you need at least an n of 50; Burgio had nearly 200. In other words, if the Burgio authors had
published their results in three groups of over 65 subjects each, we would have
"three high quality studies" and biofeedback would be acknowledged as
superior to PME alone. If that isn't
arbitrary, I don't know what is.] Interestingly enough, in the Berghmans
graphic the relationship between "physical therapies" and
"electrical stimulation" are shown as two only partially overlapping
circles. In other words, there are activities
that are uniquely electrical stimulation, there are activities that are
uniquely physical therapy, and there are activities that are part of both
electrical stimulation and part of physical therapy. I don't have any problem with that.
But
what I don't understand is Berghman's instance that the entire world of
biofeedback can be described as a circle WITHIN the sphere of Physical
Therapy.
It
is this very assumption that leads Monaco and the BC/BS TEC report to assume
that biofeedback can be considered an "additive" to physical therapy,
and one can legitimately investigate the value of this additive by comparison
to physical therapy (PME) that does NOT include the additive, biofeedback.
But
if biofeedback is not merely a branch of physical therapy, the entire process
unravels. Suppose that biofeedback
includes elements or activities that are not properly or commonly considered
aspects of "physical exercise", and are not provided by physical
therapists? The entire PME with
Biofeedback vs. PME Alone comparison collapses.
And
there is evidence that this is so.
Ironically, it comes from one of Berghmans' own frequent collaborators,
Norwegian physiotherapist Prof. Kari Bo.
Bo argues that biofeedback therapy for incontinence cannot work by
"strengthening pelvic muscles" because biofeedback produces results
in too quick a time to be explained by changes in muscle physiology as a result
of exercise. And, since EMG readings go
up at a much faster rate than can be explained by what is known about exercise
in general sports medicine, Bo concludes, quite mistakenly, that EMG scores are
NOT a reliable indicator of pelvic muscle strength. She considers them "invalid".
There
is, of course, another explanation, which is already widely understood within
the field of biofeedback, if not in physical therapy. That is that what the EMG device is measuring is the
"effective" strength of the muscles; that is, the combination of
basic muscle physiology and vastly improved central nervous system function
resulting from biofeedback training.
[This
point is drawn from my essay "Are we really 'strengthening muscles' down
there?" in the March, 2000 issue of California Biofeedback, Jeff Cram,
editor.] It is the combination of improved CNS functioning and slight
improvements in muscle physiology that gives "biofeedback" the
competitive edge over plain pelvic muscle exercise (physical therapy)
alone.
Improvement
in CNS functioning can be readily shown, based on Bo's argument, by increases
in measured EMG Pelvic Muscle Strength that are TOO rapid to be accounted for
by exercise physiology alone. If the
EMG goes up by 50% in seven days, and exercise can only account for (say) a 5%
increase in seven days, then the other 45% clearly comes from improved CNS functioning.
Improvements
of 30-100% in the first few weeks of biofeedback training are not uncommon,
especially after the first or second week of home biofeedback training.
Publications
promoting PMEs alone, such as those of the National Association For Continence,
are quite consistent in stating that patients must do daily PMEs for
"several months" before they will notice significant
improvement. But with biofeedback
results are obtained in a matter of a few weeks. Why?
Even
Berghmans noted "the positive trend in speed of improvement with the
addition of biofeedback (1998, p.
188)".
Ceresoli
1993, for example, compared six weeks of biofeedback with 13 weeks of plain
PMEs. The biofeedback group was
insignificantly a tad better than the plain group. (And Ceresoli used an inferior form of biofeedback -- perineal
measurements rather than vaginal feedback, further depressing the biofeedback
results.)
Further
support for the notion that biofeedback adds CNS improvements that are not part
of plain PME alone come from comparison with the results of electrical
stimulation studies.
When
the muscle is only *passively* exercised, as in electrical stimulation (whether
magnetically coupled or directly coupled), the results (1) take longer, more
like plain PMEs, and (2) are not as dramatic, as biofeedback results.
The
latest Neotonus results, for instance, show only a 25% reduction in pad weights
(20 -> 15 grm.) In another such study, leaks per day declined only 48%. (1999 AUA paper). Sand et al (1995) reported a 29% reduction in leakage reports
after 14 weeks of stim therapy. In
other stim studies passive treatment required 3.5 months (Bergman and Eriksen,
1986) to "4 to 19 months" (Fall et al, 1977) to obtain good
improvements.
The
average training time in our biofeedback program was 4.3 visits over 8 weeks;
since patients were required to train until they had been "dry"
(without any leaks) for 30 days, the average time to dry was 4 weeks. [See http://www.incontinet.com/effective.htm
for details.] The role of CNS enhancement in the treatment of incontinence is
already the topic of anecdotal reports on the internet, where several
researchers have reported success using EEG biofeedback alone for incontinence.
In these reports, improvement in CNS
function alone, not muscle exercise, was used to treat incontinence.
In
a panel discussion at the AAPB Convention in Denver last month, two clinicians
(Linda Kirk and Louise Marks) reported on difficult cases treated with a
combination of EMG pelvic muscle biofeedback AND EEG biofeedback (now called
"neurofeedback").
There
is an interesting parallel tradition that supports the role of CNS enhancement
in the treatment of incontinence. The
work of Moshe Feldenchrist involves a "mental rehearsal" method that
is claimed to be as effective as physical exercise at certain tasks. It provides an interesting parallel
development to biofeedback.
So
we return to the question; is biofeedback a sub-category of physical therapy? It is true, to be sure, that biofeedback is
sometimes a "modality" that is used by physical therapists, just like
hot packs and ultrasound.
Consider
an analogy: If physical therapists pray with and for their patients, does that
make "prayer" a form of physical therapy? Of course not.
In
other words, just because physical therapists sometimes do it doesn't make
biofeedback a form of PT. Like
religion, biofeedback exists outside the realm of PT. Berghmans' egg model for the relationship is simply wrong. Biofeedback should be described, like
electrical stimulation, as a partly overlapping but distinct separate circle of
activity.
The
HCFA-TEC presentation focused on the issue of whether ADDING biofeedback to PME
resulted in increased benefit. They
repeated the common mistake of thinking of biofeedback as a technique ADDED TO
"plain pelvic muscle exercises".
[Unfortunately,
the titles of important papers by both Burgio and Tries reinforce this
ahistorical conception of "PMEs 'enhanced' by biofeedback".] The TEC
report says:
"PMEs are the main component of treatment.
PMEs derive from the Kegel exercises developed in
the 1940s and 1950s."
But
that is simply FALSE. The "Kegel
exercises" were developed by nurses in the 1970s and 1980s when Arnold
Kegel's perineometer (the first biofeedback device) became commercially
unavailable. [See the historical essay
"The Bastardization of Kegel's Exercises" at http://www.incontinet.com/articles/art_urin/bastard.htm]
Originally, "biofeedback" was the main component of treatment
developed by Kegel in the late 1940s and 1950s. (The term "biofeedback" wasn't coined until the late
1960s, but the process Kegel used has long been recognized as the first example
of biofeedback). [See http://www.incontinet.com/articles/art_urin/20yearbf.htm]
Kegel NEVER advocated the use of the non-biofeedback exercises that were only
developed after his death.
Therefore,
an historically-correct formulation would address the question of whether
SUBTRACTING biofeedback (including daily home training with a biofeedback
device) from Kegel's Program DECREASED the effectiveness of it.
Unfortunately,
the highly-touted research projects of Berghmans and Burns DO NOT address that
question, since they did NOT use a biofeedback program like Kegel's. Kegel required the daily at-home use of a
biofeedback device. (Berghmans and
Burns did not). Kegel understood that
patients learn at different rates, and did not use of fixed number of training
sessions. (Berghmans and Burns
did.)
The
only study that did follow the Kegel model was Shepherd, Montgomery and
Anderson (1983) which found an 83% symptom reduction rate for biofeedback
compared with a 25% rate for plain PMEs.
But this study is dismissed by TEC on the grounds that they did not
perform a test of statistical significance!
[Sorry, but back in 1983 when you got clear-cut results like 83% vs. 25%
no one EVER thought it was necessary to run stats. The computer revolution didn't come until 1984, when the MAC was
introduced! Hello?] Is
"biofeedback" a sub-class of physical therapies"? The biofeedback society (AAPB) doesn't think
so.
While
there are many prominent PTs who use biofeedback (Susan Middaugh and Stephen
Wolfe come quickly to mind), physical therapists have always been a minority in
the biofeedback world.
The
most prominent group in biofeedback is psychologists -- the same people who
developed behavior modification and behavioral medicine. Three quarters of the experts in the classic
text "Biofeedback", edited by Mark Schwartz, are psychologists. Physical therapy is an important application
of biofeedback, but biofeedback is not a branch of physical therapy.
When
Berghmans et al, and BC/BS assume that biofeedback is a special form of
physical therapy, they make a conceptual mistake that produces faulty
questions, faulty comparisons, and misleading conclusions.
I
recently recommended that listmembers review the recently-published
"Discussion Paper" at http://www.hcfa.gov/quality/8b1-i6.htm
as well as the transcript of the 3/1/00
MCAC Executive Committee ("next" button) and the "Interim
Recommendations" ("next" again) that followed the meeting. Finally I took my own advice, and here is
the result of a more careful reading.
-----------------------------------------------------
The
Working Group Report of 2//21/00 states clearly that the effectiveness of a
treatment should be evaluated "relative to other items or services" (p. 3) but this was not done in the case of
biofeedback, which was only compared to physical therapy (leading to the
exclusion of the Burgio 1998 study).
The
report also states, with respect to known IDEAL levels of evidence: "This
level of evidence will likely be unavailable for many of the interventions that
the MCAC panels will evaluate." It
further states that "in some cases the panel will determine that
observational evidence is sufficient to draw conclusions about
effectiveness.(p. 4)"
In
the "Interim Recommendations", the same point is stated this way:
"However in many cases the panel will determine
that observational evidence is sufficient to draw conclusions about
effectiveness."
Yet
the April 12-13 panel was told that ONLY RCT trials could be considered, and in
the case of biofeedback, only trials within physical therapy models could be
evaluated. But there is no basis in the
discussion paper for the rigid stand that HCFA staff took in evaluating
incontinence evidence.
Likewise,
the Interim Report appears fully aware of the complexities of
non-pharmacological research when they say:
"For example, the outcomes of a complex
surgical procedure can depend heavily on the skills of the surgeons and other
staff caring for the patient. "
The
AAPB's testimony to HCFA in January discussed at some length the ways in which
surgery and behavioral treatments were similar, and both differ from drug
research. For instance, clinician skill
is critical in surgery and biofeedback, while relatively or completely
unimportant in electrical stimulation and pharmacology studies. (http://www.incontinet.com/isestimadrug.htm)
HCFA
and TEC apparently did not agree.
The
Interim Report makes specific recommendations for evidence review. It states:
"The panel chair should assign at least two
panel members to work closely with the authors of the evidence reports. The rationale for this recommendation is to
ensure that the evidence report covers a sufficient scope of studies, that it
considers relevant alternative interventions, and that it will be useful to the
panels in other respects. The panel should include some people who have
acquired expertise in the topic of a coverage recommendation"
There
is no indication that the first part was done.
As
far as the record goes, only HCFA staff worked with the TEC report staff. (See below for the second part.)
The
Interim Recommendations also state:
"In addition, the Executive Committee
recommends that the panel chair assign two primary reviewers for each
topic. These reviewers will not be the
individuals who assist in the development of the evidence report; they should
be new to the topic. They will evaluate
the evidence independently of one another.
Each will write a 1-2-page report ..."
Dr. Garber, panel chair, explained that this was
a new process that was only "partially" implemented for the
incontinence panel:
10
There is an extensive review process
11
that the executive committee asked for, which we
12
have implemented partially for this panel meeting,
13
not entirely. The review process that
they
14
recommended includes both internal and external
15
review, and I believe that we have come very close
16
to meeting their requests for the internal review.
17
And we have two panel members, Dr. Lisa Landy and
18
Dr. Les Zendle, who are essentially the
internal
19
reviewers from the panel of the topic at hand.
Others
will be less enthusiastic about how well the panel followed the
recommendations. The main problem was
that no one in the public had heard of the "Interim Recommendations"
until the hearing was already underway, so they were not aware of what was happening. [The Interim Recommendations were not
published on the HCFA website until a week AFTER the hearings.] Dr. Zendle, far
from presenting a formal 1-2 page report, made a few almost casual remarks at
the conclusion of the BCBS presentation.
But it appears that he spoke out of turn, because the agenda had listed
"open committee deliberation" to follow the Simon and Lefevre
presentations.
He
assumed it was his turn next. But after
his remarks, which were generally in full support of the TEC report, Chairman
Garber said:
1
DR. GARBER: Thank you. Before we
2
proceed with other questions and comments from
3
panelists, I think Ken Simon had a few other things
4
to add to finish off the HCFA presentation.
The
program did not indicate that Simon would speak twice. Only after Simon finished the HCFA staff
presentation, Garber said that the open committee discussion would begin, and
said:
6
As I mentioned at the outset, two panel
7
members were designated as reviewers, Les Zendle is
8
one of them, Lisa Landy is the other.
Les, I
9
assume that was your opening statement.
And I
10
would like to ask Lisa to speak before we open up
11
to the entire panel to ask questions and make
12
comments.
It
is important to note that neither Zendle nor Landy were listed on the printed
program, so the audience was not aware of the formal nature of their
"reviews".
Dr.
Zendle is a "geriatric medicine specialist" currently working for
Kaiser Permanente. He did not claim to
have ever worked with biofeedback or electrical stimulation.
Dr.
Landy, on the other hand, did meet the Interim Recommendations criteria as
expert in the topic at hand. She is a
urogenecologist who uses these techniques in her work. She was not a member of the med-surg panel,
but was imported for this one hearing, apparently to have at least one panel
member who actually knew something about biofeedback.
Landy's
testimony is worth reading in its own right, but may be best summarized by
noting that (1) she was the only panel member with professional experience in
the subject, and (2) she was the only panel member to vote in the affirmative
(and against BCBS-TEC) on both biofeedback and electrical stimulation reports.
That
tells you something!
None
of the panel members who voted against these modalities claimed to have any
professional (or personal) knowledge of them.
(For
that matter, none of the "experts" at BlueCross/ BlueShield claimed
any such experience, either.)
[Note:
Diane Smith, RN, a well known expert on biofeedback and electrical stimulation,
was a "guest" on the panel, but she was not allowed to vote.] The
Interim Recommendations also contain a provision for expert opinion prior to
the public hearing; The panel...
"should ask independent experts to comment upon
the evidence report in advance of panel meetings. The opinion of experts is the best way to assure everyone, the
public and the panel, that the evidence report is complete and fair. ....The Executive Committee envisions that
the panel will choose a small number of expert reviewers (perhaps no more than
six)...A reviewer may ask the panel's industry representative to obtain
additional information from industry sources.
Clearly,
NONE of these recommendations were followed.
Experts
in the field of Biofeedback and Electrical Stimulation were never consulted
prior to the hearing.
In
fact, the BCBS-TEC report's existence was not even made public until some two
weeks before the hearing. There is no
systematic review by any independent professionals with any clinical experience
in either field, as recommended, and therefore, no expert opinion to be made
part of the public hearing PRIOR to the panel's deliberations.
In
spite of the short notice, many biofeedback and electrical stimulation experts
did in fact review the TEC reports, and they were universal in condemning them
as inadequate and misleading. In the
end, their hands-on testimony was disregarded in favor of the arm-chair
research of "literature reviewers" employed by BlueCross/BlueShield.
There
is only one established expert group concerned with biofeedback, the
Association for Applied Psychophysiology and Biofeedback, and in spite of
frequent communications, these experts were not informed of the existence of
the TEC reports until a few days before their content was made public, just
prior to the hearings. The AAPB experts
did submit eight separate documents pertaining to the subject of incontinence
research, but this expert opinion was NEVER distributed to the Panel members,
in clear violation of both the letter and the spirit of the Interim Report.
We
can only hope that the Executive Committee will call HCFA staff on this blatant
violation of their recommendations.
On
the other hand, the EC had been warned that their role was only advisory; the
HCFA preamble to the Discussion Paper (2/21/00) stated:
"When the panels offer comments to HCFA about
medical evidence, both HCFA and the public should understand the panels’ basis
for making those judgments. Those
standards are the MCAC’s; we do not take them to be criteria or processes
binding to HCFA."
Obviously
they meant it.
Below
is the testimony of Dr. Lisa Landy, the
only voting member of the Med-Surg Panel who had ANY actual professional
experience with biofeedback and electrical stimulation. She was acting in the role of "official
reviewer" of the TEC report for the panel, although at the time the
meaning of this role wasn't clear.
Dr. Landy was not a 'regular' member of the med-
surg panel, but was brought in for this one hearing because NONE of the regular
panel members had ANY experience with biofeedback or stim.
Dr. Landy was the only panel member to vote in
favor of both biofeedback and electrical stimulation at the hearing. Being experienced, she felt that the
evidence was compelling enough.
Following
Dr. Landy's comments, at page 193, is
the only humorous event in the whole two days.
Triggered
by one of Landy's remarks, Dr. Epstein
asked me to elaborate on one of my slides in "two minutes". When he clarified his request, he changed it
to "five minutes", whereupon the Chairman interjected "Not five
minutes though.
Let's
keep this brief.", which brought a round of laughter from the panel. The stenographer did not record the
laughter.
As
I remember it, that was the ONLY laughter in two full days.
It is
noteworthy that although Dr. Epstein voted with the male majority against
biofeedback on the first day of the hearings (a few minutes after the excerpted
part), on the second day he abstained on the electrical stimulation vote.
====
from the official transcript ========
20
DR. LANDY: Yeah. I had some opening
21
remarks. Some of them are kind of
reiterating
22
what's been said already today, but I kind of want
23
to summarize things.
24
The first one is, the task set before us
25
is a very specific one, and it's to answer a series
00188
1
of efficacy and additional benefit. The
MCAC
2
committee has helped us and set forth guidelines
3
for us as panel members specifically to follow, and
4
these guidelines were set up to assess new
5
technologies and compare them to established
6
practices. And we're to use evidence
based
7
medicine as the foundation for our decisions.
8
And as we can see from today's
9
presentations, multiple presentations, that there
10
are several levels of evidence that we can consider
11
and weigh appropriately when we answer these
12
questions. We've heard today from
representatives
13
of multiple professional societies and specialty
14
organizations presenting their consensus statements
15
regarding efficacy of this behavioral
16
intervention.
17
The 1998 [sic: 1988] NIH consensus statement
18
recognized the efficacy of behavioral intervention
19
and specifically biofeedback. There are
guidelines
20
of practice that we all use when we practice in
21
this field based from the AHCPR guidelines which
22
recommend the use of behavioral interventions,
23
including biofeedback, as first line therapy.
We
24
also heard presentations of a technology assessment
25
which confirmed biofeedback efficacy, and then
00189
1
focused on answering the question of whether there
2
is additional benefit achieved from biofeedback
3
over PME alone.
4 I
would like to summarize some of these
5
key points that come out of today's presentations
6
before we go into our discussion, and use this as a
7
launching point for our deliberation.
One of the
8
points is that biofeedback is not a new technology
9
and that the guidelines that were set up to do is
10
to compare to established practice.
Biofeedback is
11
a very well established practice. And
that goes
12
back to the issue of why is PME alone chosen as the
13
standard for comparison? In the
original
14
presentation by the statistician, there was the
15
question of choosing appropriate standards.
And I
16
think we should keep that in the back of our head
17
when we look at all this information and data.
18
From 1948 on, when PME was introduced,
19
Kegel himself recognized the need of using a device
20
to assist and be adjuvant to the PME alone.
And
21
from the very beginning of therapy in this area, a
22
device or perineometer, or some kind of
23
intervention was utilized. So it has
always been a
24
part of established care and standard to use some
25
form of biofeedback method. It really
isn't a new
00190
1
technology.
2
And we have been given evidence from
3
multiple sources, the Bump study in 1991, Kerri [sic]
4
Bo's study in 1990, and most recently, the
5
Sampselle study, 2000, showing the drawbacks of
6
doing Kegel exercise with just verbal instruction,
7
and I think that was brought up very clearly.
8
In 1992 and 1996 updates, the AHCPR
9
guidelines for treatment was more developed, and
10
this was a panel of experts in the field, who came
11
up with these guidelines and recommendations, and
12
they came up with these guidelines based on strong
13
scientific evidence, rated their evidence, and this
14
is akin to our task set before us today.
Their job
15
as panel of experts back in 1996 was very similar
16
to what we are being charged with today.
And they
17
felt that based on their review and the strength of
18
evidence, they've made recommendations regarding
19
pelvic muscle rehabilitation and bladder inhibition
20
using biofeedback therapy as recommendations for
21
treatment of these patient groups. They
22
specifically did not sort out biofeedback and
23
remove it from the formula. And I think
there is
24
something flawed with that whole question of taking
25
away a therapy that's always been part of the
00191
1
treatment from the very beginning.
2
The technology assessment has come to
3
certain conclusions. I think in our
discussions,
4
we can critically analyze the data.
Like they
5
said, the AHCPR guidelines specifically did not
6
address the issue of whether the addition of
7
biofeedback to PME is more effective than PME
8
alone, and I think it specifically was avoided as
9
to not take that out of therapeutic treatment
10
modalities. We have to treat people,
because we
11
treat people in this area with multimodality
12
treatment.
13
Since then though, the question has come
14
up and been the focus of several evidence based
15
reviews. In de Kruif and van Wegen, one
in 1996;
16
Berghmans in 1998; and the meta-analysis by
17
Weatherall in 1999, as well as the current
18
technology assessment, all of them with varying
19
conclusions.
20
I would like to make a point too. This
21
panel was initially charged with addressing the
22
issue of efficacy of biofeedback as an incontinence
23
intervention, and now we are being asked to compare
24
it as an adjunct therapy to PME versus PME alone.
25
Now the question is asking about efficacy as an
00192
1
adjunct to a therapy, and this is an important
2
distinction when looking at the literature.
And
3
when we reviewed this before we came here, we may
4
not have looked at the literature in quite the same
5
way as this nuance brings up. But for
the question
6
at hand, those studies comparing PME alone to
7
biofeedback and PME are the ones we really need to
8
critically review.
9
And we have to look at them for
10
comparison of groups, methodology, and outcome
11
measures. And while analyzing the data,
we need to
12
keep in mint that the PME alone groups show
13
variability between the studies as to what the
14
treatment intervention was in those groups, and
15
consist of interventions other than PMEs, and that
16
may influence the results of the data.
And that
17
brings me back to the issue of, did we select an
18
appropriate standard to compare it to?
19
So that -- in one of the presentations
20
by Dr. Perry, he gave us some slides and I think we
21
critically need to look at those, but he brought
22
out some of the potential information about
23
methodology, about the PME alone group.
24
So, I thought that was a good launching
25
point now for us to open up discussion.
00193
1
DR. GARBER: Thank you, Lisa. Arnie?
2
DR. EPSTEIN: Even without the prompting
3
by Lisa, I was thinking the same thing, that the
4
final slide you brought out, you actually brought
5
out two, but the final one was particularly
6
interesting to me, where you talked about the 25
7
percent, 50 to 60, and 55 to 70 percent, and he had
8
very little time when he did that, and I wonder if
9
we could give him two minutes to get him to expand
10
on where those numbers came from and the strength
11
of the studies behind them?
12
DR. PERRY: I didn't really get the
13
question.
14
DR. GARBER: I think Dr. Epstein is
15
asking if you can show us the last slide, is that
16
correct, or the second to the last?
17
MS. SMITH: He means this one, the
18
levels of PME where you compared the written
19
instruction from Sampselle, Berghmans in '96, and
20
Burgio, where you had 27 percent, then 51 to 60
21
percent.
22
DR. HILL: We have it in our handout.
23
MS. SMITH: We have it in our handout.
24
DR. EPSTEIN: Yeah, and I was really --
25
I have the handout and I have the visual memory,
00194
1
and I didn't have the Sampselle study that I can
2
recall beforehand. It's partly because
of that but
3
also partially because I think it makes potentially
4
an interesting case, and I wonder if you can take
5
the talking points that you would have used five
6
minutes for but were forced not to, and now take
7
them.
8
DR. GARBER: Not five minutes though.
9
Let's keep this brief.
10
DR. PERRY: The Sampselle study is
11
especially interesting because they avoid all the
12
problems with contamination and really did do PMEs
13
alone. They just had a handout, here it
is, a
14
one-pager and you know, this is your education.
15
And I'm amazed, you know, really the differences
16
between us all come down to one thing.
TEC wants
17
to use a rigid definition of biofeedback and a
18
catchall definition of PME alone. It's
interesting
19
because it was sort of the other way around back in
20
the guidelines where they used surgery, clear;
21
drugs, clear; everything else is behavioral,
22
including stim. Does that answer? So, you have a
23
really rigid category of biofeedback, and a
24
catchall category of everything else counts as PME
25
alone, and when you do that, you get nonsignificant
00195
1
results.
2
DR. LANDY: A comment I'd like to make.
3 I
think the importance of sorting out the PME alone
4
group is that if it truly is an intervention, then
5
what you're looking at is the result of an
6
intervention, as opposed to how we clinically use
7
the descriptive term of PME alone. And
when
8
clinically applied, most clinicians in this area
9
would do some form of verbal instruction, written
10
instruction sheet and send the patient home, and
11
that's truly what the studies are not comparing.
12
The studies are comparing one intervention to
13
another, so that PME alone is not really a good
14
standard. The best standard we have are
looking at
15
the studies with, comparing a waiting list control
16
group, because that most represents what we see
17
clinically, because those are people who on their
18
own, at some point in their association with a
19
physician were taught or told to do Kegel
20
exercises, or they read it in a magazine article,
21
and that's what they're doing on their own.
And
22
that best represents the result we get with PME
23
alone clinically.
==============end
of excerpt===============
The
full transcripts are available on the hcfa.gov/quality website, or
incontinet.com.
Following
are the comments of Dr. Zendle at the
Incontinence hearings in Baltimore. As
mentioned in a previous post, Dr. Zendle was one of two panel members asked to
"review" the TEC report and prepare a recommendation to the full
panel.
Due
to a lack of clarity in the printed program, Dr. Zendle made these remarks in
the middle of the HCFA/BCBS presentation.
Taken by themselves, his remarks do not constitute much of a
"review" of the TEC report.
He first praises the AHCPR Guidelines (which TEC rejected), and then
agrees with TEC that "there isn't enough evidence". Then he complains about the lack of research
in this area. Apparently he isn't aware
that there isn't a lot of money to be made in behavioral treatment of
incontinence, and that the potential for profit -- big profit -- is what drives
research.
8
DR. ZENDLE: Well, this has been a very
9
interesting day. It's hard to believe
we have
10
already been here for six hours; it's gone pretty
11
quickly. I want to thank and congratulate
the
12
presenters and the organizers of this.
I've
13
learned a lot.
14
After today -- you know, I went over the
15
questions myself beforehand and I have listened
16
very carefully to what people had to say.
And I
17
have no problem accepting the AHCPR '96 guidelines,
18
and I have no problem agreeing with the clinicians
19
who feel that some patients do better with feedback
20
and PMEs than with the exercises alone.
And I
21
actually think it should be made available to those
22
patients who are so identified, especially if a
23
guideline is being followed that tells you which
24
patients it works best on and which form of
25
biofeedback and what the regimen should be.
00182
1
But I have to agree with the TEC
2
assessment that there isn't sufficient evidence,
3
scientific evidence of sufficient quality really,
4
to conclude that adding biofeedback to the
5
exercises is better or not better than doing the
6
exercises alone. And I guess the only
other point
7 I
would make is that the statistical definition of
8
what's enough evidence isn't really a matter of
9
opinion, it's a scientific matter, that science has
10
already made agreements as to what is
11
scientifically relevant, and I don't think this
12
meets the magnitude of that.
13
It does leave me with one important
14
question, though, and that's why hasn't there been
15
more research in this area? It's not
like this is
16
a rare problem, and it's not like these are mild
17
symptoms. This is a common problem that
is a major
18
life disruption not only for the patient, but for
19
families and for society. And it's
shocking to me
20
actually that there are so few patients that have
21
been looked at in a rigorous way and therefore, we
22
can't reach conclusions with statistical validity.
23
And I'm not sure who's to blame for that, but it's
24
just a question that I'm left with and frustrated
25
with.
======
end of remarks =========
See
the full transcript on the hcfa.gov or incontinet.com websites for proper
context.
Previous
comments in this series mentioned a request by Dr. Epstein for elaboration of a
slide I had presented showing the increasing levels of effectiveness of adding
various interventions to "PME Alone".
Although
my handout containing the content of the slides was actually given to the
stenographer, the transcript as published gives only the verbal presentation,
omitting the visual presentation that was the basis for that verbal
presentation.
Since
each of us had only eight minutes to present our testimony, most people made
the same assumption that I did, namely, that we should use our limited verbal
opportunity to elaborate, rather than repeat, our visual presentations.
But
the result is that the very precise and legal official transcript is of limited
value, because it does not include the words that were presented visually at
the hearing. The reader can only guess
as to what the audience was reading while the speaker was speaking.
(IncontiNet.com
has already published, as a public service, all the testimony of expert
witnesses that was submitted for publication.
See the opening paragraphs at: http://www.incontinet.com/home.htm
for details and links.)
The
following is the text of the slide that Drs. Epstein and Landy asked me to
elaborate.
Levels
of Pelvic Muscle Exercise
|
Written
instruction alone |
27% |
Sampselle
2000 |
|
ADD
vaginal palpation |
51%
to 60% |
Berghmans
1996 |
|
ADD
EMG testing |
54%
to 77% |
Burns
1993 |
|
ADD
formal biofeedback training |
80%
94% |
Burgio
1998 1986; Sussett,
Kegel, etc. |
Commentary:
The numbers represent the percentage reduction in symptoms reported by the
noted researchers for the intervention added beyond "mere verbal instruction
alone", which is best exemplified in Sampselle (March, 2000).
Sampselle
et al reported on the success of a genuine "PME alone" intervention
-- they gave subjects a written handout describing how to do PMEs. They had no confounding interventions, such
as therapist's manual palpation of the pelvic muscles and verbal feedback of
success. It was a case of PURE
"PME Alone", and the results were dismal -- 27% symptom change --
barely above the expected placebo effect for therapeutic attention.
The
Wells 1991 report got the best results for "PME Alone" (77%) --
because she did much more than PME Alone. She actually "tested" subjects' pelvic muscles with an
EMG biofeedback device, before "PME Alone" and every month thereafter
for six months -- a total of *7 EMG sessions*.
TEC
2000 failed to notice this important fact, and as a result, erroneously ascribed
to "PME Alone" greater success than it deserved.
The
original slide is visible in a PowerPoint presentation referenced on the
IncontiNet home page.
We
have previously called attention to the BC/BS-TEC error in considering Burton
et al as an instance of "PME Alone vs.
PME plus biofeedback" in the treatment of Urge Incontinence. The vast majority (11 of 14, or 79%) of
Burton's control group was given "education"; but only 3 of the 14
(21%), those who had stress incontinence, were given instruction in pelvic
muscle exercise.
The
"education" resembles modern bladder retraining:
"Patients...(were) taught to respond to an urge
sensation by: relaxing; tightening their urethral sphincter; relaxing their
abdominal musculature, and, when the urge passes, walking slowly to a lavatory
to void." (p. 695)
There
is no way that can be construed as a form of "pelvic muscle exercise
alone".
(One
has to read the text carefully and compare the text with the tables to discern
precisely who got what. The issue is not spelled out clearly because the
purpose of the 1988 research was not address the issue TEC tried to study 12
years later.)
In
any case, Burton was invoked as an example (the only example) of a controlled
study of PME on Urge Incontinence, and NONE of Burton's Urge patients got ANY
PME at all!
In
reviewing the TEC report yet one more time, we note that a similar mistake was
made by TEC in the classification of Burgio et al, 1986 ("The role of
biofeedback...").
TEC
says:
"The nonrandomized trial by Burgio et al. (1986) assigned 24 patients to PME alone or
PME plus biofeedback after stratifying by age and frequency of
incontinence. The authors reported a
significantly greater percent improvement in incontinent episodes for patients
treated with PME plus biofeedback (76% improvement versus 51%, p <
0.05)."
But
Burgio et al, 1986 says:
"This study examined the effectiveness of
teaching pelvic floor exercises with the use of bladder-sphincter biofeedback
compared with training with VERBAL FEEDBACK BASED ON VAGINAL PALPATION in 24
women..." (Abstract, emphasis added).
Since
the point is made in the abstract, TEC didn't even have to read the article
itself to realize that this study did NOT qualify for inclusion in a field that
was supposed to be limited (albeit arbitrarily) to "PME Alone vs.
PME+BFB".
Burgio
clearly states:
"Verbal feedback training consists of
instructing the patient to squeeze the vaginal muscles around the examiner's
fingers and providing her with verbal performance feedback." (Abstract)
The
Biofeedback technique of Burgio is well known, being the subject a documentary
film by NIA in 1984. Burgio herself
provides substantial verbal feedback when helping the patient to interpret and
understand the tracings of the polygraph.
The
study showed that patients did much better when they were given instantaneous
biofeedback with verbal interpretation instead of delayed, relayed feedback
from a human being alone.
In
addition, it seems plausible that many of the women in this study were slightly
uncomfortable performing exercises with another woman's hand inside their
vaginas, thus reducing the effectiveness of the technique.
In
any case, it is worth noting that this kind of "verbal feedback" is
more labor intensive than "PME with biofeedback", since it requires a
much higher level of clinician experience.
In other words, biofeedback costs about the same as manual-verbal
feedback therapy, but delivers 50% more results.
1. What happened to the AHCPR Guidelines?
Many
people have noted that the famous AHCPR Guidelines on Incontinence (1992 &
1996) were not distributed to the April 12-13 Panel discussing
Incontinence. Both Diane Smith and Lisa
Landy, guest members of the panel, remarked about this omission explicitly, and
several of the speakers mentioned the Guidelines as having shaped and
established the accepted standards of treatment in this country.
The
omission is complex. None of the people
involved in the 2/21/00 committee report, nor the 3/1/00 Executive Committee
meeting, nor the 4/17/00 "Interim Recommendations" had any direct
awareness of incontinence treatments or research and practice in
incontinence. They were reaching for
broad principles that could be applied to ALL areas of medicine.
These
people, mostly physicians, attempted to bring the latest standards and values
in medical research into a broad guide for Medicare-related research in the new
Millennium. The latest trends emphasize
"evidence-based-medicine", which had not been invented when the AHCPR
guidelines were prepared and published.
So
the AHCPR guidelines are considered "primitive" by today's new
standards. Indeed, they are no longer
"politically correct". They
have become an embarrassment to the medical establishment.
This
is clear in item 4 in the "Discussion Report" of 2/21/00, which states:
(Note the omission of AHCPR, [now "AHRQ"])
"The standard of excellence for the evidence
report should be the best work in the private sector (e.g., Blue Cross-Blue
Shield), by professional organizations (e.g., ACP-ASIM), and for other
Federally sponsored panels (e.g., the Evidence-based Practice Centers technical
support for the U.S. Preventive
Services Task Force)."