Incorporation of New Treatments into Clinical Practice




INTRODUCTION



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Female pelvic medicine and reconstructive surgery (FPMRS), or urogynecology, as a field has undergone a unique evolution with recent recognition as a subspecialty of obstetrics and gynecology and urology. It has never suffered from a shortage of innovation or of innovators, and thus new treatments and therapeutic options are regularly being introduced. Who is best to perform or prescribe new, therapeutic options and their implementation in a responsible manner is controversial. In this chapter, we will review accreditation, credentialing, and the relevant training involved in the United States (Table 26-1). In addition, new product implementation will be discussed within an ethical framework. As part of the larger medical profession, FPMRS shares a commitment to professionalism that demands certain standards of safety and aims to achieve exemplary levels of care. The challenge lies in where safety and exemplary cross, and in implementing the two, we make practical our commitment to the profession and its embodiment.




Table 26-1

Summary of Approval Processes





Incorporation of new treatments into clinical practice in FPMRS is evolving as the field evolves. Surgical practice is dictated on the personal, hospital, and national regulatory levels. Ultimately the choice of surgical treatment and incorporation of new surgical techniques and devices is driven by the desire to provide better care for patients. Surgeons are required by ethical mandates to critically self-assess skills and their individual experience in providing care for pelvic floor dysfunction. In this chapter we review the evolution of FPMRS as an accredited subspecialty in the United States, and discuss how this process has highlighted the incorporation of new therapies to treat pelvic floor dysfunction.




ACCREDITATION



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Key Point




  • In 2011, the American Board of Medical Specialties (ABMS) officially recognized the field of FPMRS as a subspecialty.




Accreditation is the term used to designate the approval or official recognition of a field of medicine or specific program. In 2011, American Board of Medical Specialties (ABMS) officially recognized the field of FPMRS as a subspecialty. According to the ABMS bylaws, a new subspecialty meets the following criteria: the differentiation of a new specialty must be based on major new concepts in medical science and represent a distinct and well-defined field of medical practice. A single standard of preparation for and evaluation of expertise in each specialty must be recognized and the training needed to meet certification requirements by the applicant must be distinct from that required for certification by other ABMS Member Boards so that it is not included in established training programs leading to certification by another ABMS Board. In addition, the medical subspecialty board must demonstrate that candidates for certification will acquire, and its diplomates will maintain, capability in a defined area of medicine and demonstrate special knowledge and competencies in that field. Evidence must be presented that the new board will establish defined standards for training and that there is a system for evaluation of educational program quality. The applicant medical subspecialty board must demonstrate support from the relevant field of medical practice and broad professional support, in this case the American Board of Obstetrics and Gynecology (ABOG) and the American Board of Urology (ABU). FPMRS has met all of these requirements to the satisfaction of ABMS. With this approval, the parent boards were given permission to set requirements and to develop the process for individual physicians to be certified as female pelvic medicine and reconstructive surgeons. ABOG and ABU will henceforth certify individuals. Certification will include an initial test that is followed by Maintenance of Certification over a career as designated by ABMS.



In granting the recognition of FPMRS as a subspecialty, the ABMS designated that the accreditation of the training programs (fellowships) would be under the supervision of the Accreditation Council for Graduate Education (ACGME). Standards, program requirements, and periodic reviews of the fellowship training programs will be prescribed and maintained by the ACGME. These new guidelines, official in 2013, will be based on the ABOG- and ABU-published requirements for the subspecialty of FPMRS from 2011.1 Within that training, guidelines regarding what is the standard of knowledge and skill in urogynecology have been put forth by ABOG as well as the Educational Committee of the International Urogynecological Association (IUGA).2 While it is recognized there are basic levels of knowledge and skills that every physician taking care of women should have, subspecialists in FPMRS should have an advanced level of skill and training.




CREDENTIALING



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While a subspecialty is accredited, individuals are credentialed. In medicine, we typically use the term “credentialed” in two instances. First, as discussed above, medical specialty boards credential individuals who complete standardized training, meet stated criteria, and pass examinations. In the second instance, credentialing is typically a locally driven process, subject to the constraints of institutions and the requirements of licensing bodies. Its goal is to ensure that the provider possesses the relevant knowledge, skills, and attitude to perform his or her duties within the set parameters of a chosen specialty or subspecialty. In other words, can a provider provide safe and high-quality patient care and work effectively in a team environment? This is a key component of medical professionalism and, as such, is usually peer driven. Behind it is the implicit trust of the public in an institution. In short, it lets the public know what they can expect. While the process appears daunting, it is necessary to protect all parties involved including the applicant, the department, the hospital, and most importantly the patient.



Predetermined standards and core skills established through common legal, professional, and administrative practices, endorsed by a formal consensus process, that are publicly available ensure the continued provision of optimal health care and hopefully produce an applicant who not only possesses all the attributes required to provide good medical practice but also shows a fitness to practice including clinical and educational competency, and establishment and maintenance of effective relationships with patients, acts with probity, and makes the care of the patient his or her first concern.3,4



Typically, the dynamic and fluid credentialing process comprises four steps involving regular reappraisal thus ensuring continued patient protection, maintenance of hospital care standards, and avoidance of medical malfeasance.5 The final decision determining the acceptance of a candidate typically rests with the Departmental Chair, Executive Committee, and finally the Governing Board of the hospital. The process begins with transparency in the appointment or reappointment process. There, with clear and standard departmental policies and procedures that the applicant must meet, there is typically a collection and authentication of all documentation supplied by the applicant. Within that, there is an assumption of responsibility of the applicant to submit all required data and the hospital and medical staff to confirm and verify the data that have been supplied. Typically, such material includes proof of education and training, license, certification, experience, medical malpractice or negative clinical outcomes, and character references. Many of the organizations that assist in this authentication step have been crucial in the formation of FPMRS as a subspecialty, including the American Board of Medical Specialties (ABMS).



Once credentialing has taken place, an applicant may be appointed on a probationary period ranging from 3 to 12 months enabling employers to observe the practical skills, clinical judgment, bedside manner, and collegial interaction of the applicant. Self-critique and review is crucial to the process, just as it is to the review of the applicant. During the reappraisal period, the applicant may request additional training or experience in new technology for privileges beyond the basic predetermined criteria such as what has occurred with the introduction of robotic surgery. Typically, each request is evaluated on an individual basis.



If an applicant has dropped all or a portion of his or her practice and would like to reenter full-time practice, the credentialing division of a medical affairs department or a departmental chair needs to consider which pathway would best serve the applicant and the department; reentry may require formal reeducation, retraining, supervised experience, or simulation center training.5

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Dec 27, 2018 | Posted by in OBSTETRICS | Comments Off on Incorporation of New Treatments into Clinical Practice

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