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Care path emphasizes informed consent and learner participation on surgical team
Cleveland Clinic formalized its informed consent care path for pelvic exams that may be performed while a patient is under anesthesia for surgery. The purpose of the care path is to disseminate Cleveland Clinic’s current best practices throughout the enterprise, as well as to educate future caregivers.
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“We assembled a taskforce to formalize a care path regarding genital, pelvic and anorectal examinations under anesthesia. Our taskforce included a bioethicist as well as colleagues in colorectal surgery, general surgery, urology and gynecology,” states Kenneth Edelman, MD, MBA, Cleveland Clinic Enterprise Medical Director for Patient Safety and Clinical Risk Management & Quality Improvement Officer in Cleveland Clinic’s Ob/Gyn & Women’s Health Institute.
A national study conducted in 2010 found that while just over half of gynecologic surgery patients expect a medical student to be present during their procedures at an academic institution, only 19% were aware that a student might perform a pelvic examination on them while they were under anesthesia.1 Among gynecologic surgery patients, 75% had had a pelvic examination under anesthesia performed by a medical student without prior discussion or approval, another national study indicates.2,3 While there isn’t a lot in the literature regarding male genital or rectal examinations under anesthesia, reports demonstrate a comparable issue with informed consent.4
“We take this issue very seriously,” Dr. Edelman continues. “At Cleveland Clinic, the formalization of this care path demonstrates our collaborative efforts to support our patient’s autonomy over their bodies while having procedures performed under anesthesia. Properly obtained informed consent not only explains the procedures to be performed, but also informs the patient that members of the surgical team — including a medical student — may also perform an exam under anesthesia when medically necessary as part of the planned surgery. We do not perform procedures for the sole sake of education.”
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Several medical organizations have outlined their recommendations for teaching in clinical settings, including operating rooms. Nearly 20 years ago, the American Medical Association (AMA) reviewed the available literature, concluding that patients should give informed consent when medical students may be involved in their care – including when patients may be anesthetized.5 In 2003, the Association of American Medical Colleges (AAMC) released a statement emphasizing the importance of treating patients with dignity and respect. In this statement, the AAMC condemns performing pelvic examinations on women who are under anesthesia without informed consent as “unethical and unacceptable.”6 Additionally, a handful of states have enacted laws requiring surgeons to obtain consent for pelvic examinations under anesthesia before surgery; however, at the present time there is no legislation in Ohio regarding this matter.
In March 2019, the Association of Professors of Gynecology and Obstetrics (APGO) released a statement about teaching pelvic exams to medical students. Their recommendation, which is supported by the AAMC and endorsed by the American College of Obstetricians and Gynecologists, the American College of Osteopathic Obstetricians & Gynecologists and the American Urogynecologic Society, states that learners only perform pelvic examinations for teaching purposes under the following conditions:
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In keeping with the APGO recommendation, Cleveland Clinic believes patient informed consent to a genital or pelvic exam under anesthesia is essential to maintain patients’ autonomy over their bodies – and their trust in their medical providers and the medical profession as a whole. The Cleveland Clinic care path states that genital, pelvic and anorectal examinations under anesthesia should only be performed as medically indicated and in conjunction with the primary surgical procedure or for surgical planning, and not solely for educational purposes. All members of the Cleveland Clinic taskforce were provided a copy to distribute and discuss with their respective clinical departments on an ongoing basis. The care path was emailed to every clinical provider in the Ob/Gyn & Women’s Health Institute, including the medical student clerkship director. This care path ensures that Cleveland Clinic’s current best practices are followed throughout the health system, and may be a model for other systems.
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