TY - JOUR
T1 - Improving biofeedback for the treatment of fecal incontinence in women
T2 - implementation of a standardized multi-site manometric biofeedback protocol
AU - the Pelvic Floor Disorders Network
AU - Markland, A. D.
AU - Jelovsek, J. E.
AU - Whitehead, W. E.
AU - Newman, D. K.
AU - Andy, U. U.
AU - Dyer, K.
AU - Harm-Ernandes, I.
AU - Cichowski, S.
AU - McCormick, J.
AU - Rardin, C.
AU - Sutkin, G.
AU - Shaffer, A.
AU - Meikle, S.
N1 - Funding Information:
Full listing per PFDN guidelines will be submitted upon final acceptance. On behalf of the Pelvic Floor Disorders Network, we would like to thank the interventionists who participated in the certification process and the clinical trial visits. We would also like to thank the standardized patient volunteers and all the women participants in the clinical trial.
Publisher Copyright:
© 2016 John Wiley & Sons Ltd
PY - 2017/1/1
Y1 - 2017/1/1
N2 - Background: Standardized training and clinical protocols using biofeedback for the treatment of fecal incontinence (FI) are important for clinical care. Our primary aims were to develop, implement, and evaluate adherence to a standardized protocol for manometric biofeedback to treat FI. Methods: In a Pelvic Floor Disorders Network (PFDN) trial, participants were enrolled from eight PFDN clinical centers across the United States. A team of clinical and equipment experts developed biofeedback software on a novel tablet computer platform for conducting standardized anorectal manometry with separate manometric biofeedback protocols for improving anorectal muscle strength, sensation, and urge resistance. The training protocol also included education on bowel function, anal sphincter exercises, and bowel diary monitoring. Study interventionists completed online training prior to attending a centralized, standardized certification course. For the certification, expert trainers assessed the ability of the interventionists to perform the protocol components for a paid volunteer who acted as a standardized patient. Postcertification, the trainers audited interventionists during trial implementation to improve protocol adherence. Key Results: Twenty-four interventionists attended the in-person training and certification, including 46% advanced practice registered nurses (11/24), 50% (12/24) physical therapists, and 4% physician assistants (1/24). Trainers performed audio audits for 88% (21/24), representing 84 audited visits. All certified interventionists met or exceeded the prespecified 80% pass rate for the audit process, with an average passing rate of 93%. Conclusions & Inferences: A biofeedback protocol can be successfully imparted to experienced pelvic floor health care providers from various disciplines. Our process promoted high adherence to a standard protocol and is applicable to many clinical settings.
AB - Background: Standardized training and clinical protocols using biofeedback for the treatment of fecal incontinence (FI) are important for clinical care. Our primary aims were to develop, implement, and evaluate adherence to a standardized protocol for manometric biofeedback to treat FI. Methods: In a Pelvic Floor Disorders Network (PFDN) trial, participants were enrolled from eight PFDN clinical centers across the United States. A team of clinical and equipment experts developed biofeedback software on a novel tablet computer platform for conducting standardized anorectal manometry with separate manometric biofeedback protocols for improving anorectal muscle strength, sensation, and urge resistance. The training protocol also included education on bowel function, anal sphincter exercises, and bowel diary monitoring. Study interventionists completed online training prior to attending a centralized, standardized certification course. For the certification, expert trainers assessed the ability of the interventionists to perform the protocol components for a paid volunteer who acted as a standardized patient. Postcertification, the trainers audited interventionists during trial implementation to improve protocol adherence. Key Results: Twenty-four interventionists attended the in-person training and certification, including 46% advanced practice registered nurses (11/24), 50% (12/24) physical therapists, and 4% physician assistants (1/24). Trainers performed audio audits for 88% (21/24), representing 84 audited visits. All certified interventionists met or exceeded the prespecified 80% pass rate for the audit process, with an average passing rate of 93%. Conclusions & Inferences: A biofeedback protocol can be successfully imparted to experienced pelvic floor health care providers from various disciplines. Our process promoted high adherence to a standard protocol and is applicable to many clinical settings.
KW - anal sphincter exercises
KW - anorectal manometry
KW - factorial design
KW - fecal incontinence
KW - manometry-assisted biofeedback
KW - pelvic floor disorders
KW - randomized placebo-controlled trial
KW - treatment fidelity
KW - urge resistance training
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U2 - 10.1111/nmo.12906
DO - 10.1111/nmo.12906
M3 - Article
C2 - 27453154
AN - SCOPUS:85007273959
SN - 1350-1925
VL - 29
JO - Neurogastroenterology and Motility
JF - Neurogastroenterology and Motility
IS - 1
M1 - e12906
ER -