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An Examination of the
Blue Cross/Blue Shield
Biofeedback Technology
Assessment Report (TAR)
John D. Perry, PhDAAPB Representative
Required Financial Disclosure
• Inventor of EMG vaginal sensor (1975); Quarter-century of personal investment
• Senior Fellow – Biofeedback Certification Institute of America (BCIA)
• Since 1994, 100% of my income has come from EMG Sensor royalties
• AAPB received a grant from Thought Technology Ltd. to cover my expenses
Overview
• Based on selective literature review
• Cited papers contradict TAR conclusion
• TAR’s academic objective is of debatable value in the real world
TAR’s Objective:
“...to determine whether adding biofeedback as an aid to performing pelvic muscle exercise results in a greater improvement in urinary incontinence, as compared to pelvic muscle exercises alone.”
Is Narrow (PME vs. PME+BFB) Compared with Broad PFES Objective:
“…to determine whether PFES improves health outcomes of patients with urinary incontinence.”
Is the TAR Objective Relevant?
• Continence therapy is typically staged, starting with PME and progressing to biofeedback
• HCFA’s present (regional) policies for biofeedback call for the exclusion of patients who have not yet failed PME Alone
TAR Conclusion
“ … the evidence is not sufficient to demonstrate an additional benefit for biofeedback above that obtained by PME alone.”
Is “PME alone” effective?
TAR claims:
“… several controlled trials of PME exist; and collectively these trials establish the effectiveness of PME. (p.4)”
But they cited only two studies:
1. Wells et al 1991 (79% Sx )
2. Burns et al 1993 (54% Sx )
1. Wells et al 1991 (79% Sx )
The “PME Alone” group actually included: 7 monthly vaginal palpations (with verbal biofeedback) 7 monthly EMG evaluations
2. Burns et al 1993 (54% Sx )
“PME Alone” group actually included two EMG evaluations (pre- and post-treatment) using a biofeedback instrument with an EMG sensor (below)
In Contrast, “PME Alone” is far less effective
PME Alone defined as:Verbal instruction only, with no “hands on” biofeedback and no EMG testing
27% Sx
Sampselle et al (March 2000)
Stress Inc. = “No Sig. Dif.”
Study OutcomeBFB-PME
Blue CrossReview
Biofeedback Quality Review
Burns 1993
61 – 54% Least Prone to bias
Poor Quality: untrained; PME got 2 EMGs
Berghmans 1996
53 – 60% Least Prone to bias
Poor Quality; stim electrode; PMEs got vag palp. & verbal feedback
Ceresoli1993
62 – 60% PotentialBias
Poor Quality; 6 vs. 13 weeks
Stress Inc. = “Sig. Dif. but…”
Study OutcomeBFB–PME
Blue CrossReview
Biofeedback Quality
Burgio1986
80 – 51% Potential Bias
Excellent; but PMEs got vag. Palp. & verbal biofeedback
Glavind1986
91 – 22% Potential Bias
Excellent
Shepherd1983
83 – 25% PotentialBias, no sig. test
Excellent, used home trainers like Kegel
Urge Incontinence
• Burton et al, 1988, is cited as finding “no sig. dif.” between BFB and PME alone.
• But Burton called his control group “behavioral treatment”; 11 Urge patients got bladder training and 3 Stress patients got PME instruction. Outcomes are not shown by treatment.
• Burton does not qualify for inclusion in this PME+BFB vs. PME-Alone report.
• A study that should have qualified for inclusion, Burgio 1998, got 81% Symptom Improvement
Levels of Pelvic Muscle Exercise
Written instruction
27% Sampselle 2000
Add Vaginal Palpation and verbal feedback
51 - 60% Berghmans 1996; Burgio 1986
Add EMG testing
54 - 77% Burns 1993, Wells 1991
Add formal biofeedback training
80 - 94% Burgio 1998, 1986; Sussett, Kegel, etc.
In Historical Perspective
• TAR asks about the benefits of adding Biofeedback to “PME Alone” – but…
• Historically, “PME Alone” results from subtracting Biofeedback from Kegel’s original training program (1948)
Historical Origin of PME
Arnold Kegel, the gynecologist who invented PME, conceived and practiced his method as instrument-assisted exercises
1956
Kegel’s patients were required to keep records of their
biofeedback results:
Am. J. Obst. & Gynec. 36(2) 1948
Summary
• TAR is an evaluation NOT of technology, but of research design
• Examination of even the cited papers contradicts TAR conclusion
• Real-world decisions must be based on the best available evidence
• Biofeedback is “Breakthrough Technology”
What is Biofeedback’s Added Value?
• Results in 6 weeks, not 6 months
• Increases patient awareness of differences in muscle state
• Ensures that exercises are done correctly
• Provides structure for clinical exercise program
• Provides documentation