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