SCAI Position Statement on Best Practices for Clinical Proctoring of New Technologies and Techniques

ErrataJournal of the Society for Cardiovascular Angiography & InterventionsVol. 1Issue 6100522PreviewConflict of interest statements for the following articles published in previous issues of the Journal of the Society for Cardiovascular Angiography and Interventions were originally provided in the supplementary material of each article. These statements are also provided in full below. Full-Text PDF Open AccessSee One, Do One, Teach One? Not So Fast, My FriendJournal of the Society for Cardiovascular Angiography & InterventionsVol. 1Issue 3100311PreviewThe field of interventional cardiology has become so subspecialized that it is impossible for anyone to be completely up to date and facile on all the technologies and techniques that are being utilized. Even highly subspecialized operators within the fields of coronary, structural, and peripheral intervention may benefit from instruction from others with more experience in a particular technique. In addition, less experienced operators such as recent graduates or operators branching out into a new space certainly stand to benefit from guidance from more experienced operators. Full-Text PDF Open Access The field of interventional cardiology continues to evolve with the introduction of new techniques and technologies. From the first angioplasty to transcatheter aortic valve replacement (TAVR), dissemination of new treatments has generally required a training program of didactics and observation, culminating in a hands-on experience with a patient. Trainees and facilities starting new programs often require support from outside experts, traditionally known as “medical proctors,” whose costs are typically borne by the medical device industry. While medical proctoring is a longstanding practice beneficial with respect to training, it may also be associated with some risks to the patient, operator, proctor and host institution. These risks include, but may not be limited to, lack of appropriate equipment at the host institution, scheduling of inappropriate patients for proctored cases, and unclear medico-legal indemnification of the proctor. These potential risks have not been previously documented or described in the medical literature. The aim of this position statement of SCAI is to educate all parties of the potential risks involved with medical proctoring and to recommend best practices to reduce the potential for adverse events, misunderstandings, conflicts of interest, and unexpected medico-legal liability. While this document focuses on industry-sponsored proctoring of approved uses of medical devices, some aspects may be applicable to investigational devices and off-label use. SCAI is not structured to provide legal advice and the recommendations outlined herein should not be considered definitive or the “last word” on untested legal matters. SCAI and the authors of this paper assume no responsibility for any actions taken under any legal theory against a proctor based on the considerations outlined. This statement has been developed according to SCAI Publications Committee policies for writing group composition, disclosure and management of relationships with industry (RWI), internal and external review, and organizational approval.1Szerlip M. Feldman D.N. Aronow H.D. et al.SCAI publications committee manual of standard operating procedures.Catheter Cardiovasc Interv. 2020; 96: 145-155https://doi.org/10.1002/ccd.28754Crossref PubMed Scopus (12) Google Scholar The writing group has been organized to ensure diversity of perspectives and demographics, multi-stakeholder representation, and appropriate balance of RWI. Relevant author disclosures are included in Supplement 1. Before appointment, members of the writing group were asked to disclose financial and intellectual relationships from the 12 ​months prior to their nomination. A majority of the writing group disclosed no relevant, significant financial relationships. Disclosures were periodically reviewed during document development and updated as needed. SCAI policy requires that writing group members with a current, relevant financial interest are recused from participating in related discussions or voting on recommendations. Conflicts were identified and resolved as noted in the supplemental material. The work of the writing committee was supported exclusively by SCAI, a nonprofit medical specialty society, without commercial support. Writing group members contributed to this effort on a volunteer basis and did not receive payment or any form of compensation from SCAI. Where applicable, literature searches were performed by group members designated to lead each section and initial section drafts were authored primarily by the section leads in collaboration with other members of the writing group. Recommendations were discussed by the full writing group until a majority of group members agreed on the text and qualifying remarks. All recommendations are supported by a short summary of the evidence or specific rationale. Due to the legal issues addressed in this position statement, the writing committee included a lawyer with malpractice expertise. The draft document was also reviewed by a SCAI staff member with a law degree and separately by SCAI organizational counsel. Industry feedback was specifically sought through the public comment process. The draft manuscript was peer reviewed in November 2021 and the document was revised to address pertinent comments. The writing group unanimously approved the final version of the document. The SCAI Publications Committee and Executive Committee endorsed the document as official society guidance in February 2022. A preceptor (from Latin praeceptor “teacher, instructor”) provides the trainee with experience and training in a new skill. This is conducted in an environment where the preceptor has the primary responsibility for the care of the patient whether delivered by the preceptor themselves or the trainee. Attending physicians in accredited graduate medical education programs serve as preceptors for their trainees, but other less formal preceptorships can be appropriate for new technologies. A proctor (from Middle English proctour “manager, steward”) as defined in American English is a person who monitors students during an examination of skills the students have already learned. The proctor differs from a preceptor in that the proctor functions as an independent observer to evaluate, not teach, the technical and cognitive skills of another physician, typically on behalf of the hospital or credentialing body. Proctors traditionally have no formal role for the patient’s care and outcome, these are solely the responsibility of the primary operator. Different inpatient or outpatient practice settings, procedural specifications, case complexity, specific needs of student/institution, and hospital privilege requirements will determine the role of proctor for the type of procedure(s) being supervised. To date, the use of proctors during interventional cardiology procedures has represented a combination of the traditional roles of preceptor (teacher) and proctor (evaluator), particularly for new devices and techniques, often without clear delineation of the proctor’s responsibilities. In order of increasing involvement and responsibility, the clinical proctor might be asked to:1.Retrospectively review case(s) already completed (i.e., procedural indications, procedural records, angiography, periprocedural imaging) in order to recognize operators with successful case completion. This activity frequently occurs for procedures (i.e., percutaneous coronary intervention, closure of a patent foramen ovale) that are not new, where a well-trained provider merely requires peer review of a specific number of cases required for initial hospital privileging.2.Observe case(s) on site without being scrubbed case(s) from within the cognitive advice to the into and in the hands-on of the the being proctored in this document as the operator, or host as as the may have or no experience with a new or new This initial experience is often described as being of the the for of as as of case In an of malpractice of in patient or lack of technical was identified as the in of M. et of in malpractice at PDF PubMed Scopus Google Scholar to the proctoring with the care of the and these potential conflicts of interest can some of the risks associated with the proctoring The being on the new device may be to experience and may the of the patient or clinical for the or the potential and treatments to In their is a that may not be completely with their patient their and the role of the may lead to with the care provided is an adverse the device has a financial to have and The on the other is by the not have a with the patient, may be for of the may not be involved in the of the not serve in a and may not be to ensure a successful the best of all the potential for inappropriate or use of new technologies is the position of this committee that patient is and that it is the patient’s to have the appropriate performed by who are proctored by and to be the and of involvement of a proctor during their in their increasing the clinical proctor increasing of for their in a The is not for all as it be inappropriate for a proctor to a or a during an examination in any other the use of to a of training and in will to use the this document. 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