Framework for Continuing Professional Development (CPD) Courses for Practicing Surgeons: The New SAGES Course Endorsement System

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This document was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Jun 2016.

I. PREAMBLE

The Society of American Gastrointestinal Endoscopic Surgeons (SAGES) recognizes that the discipline of surgery is dynamic and continues to evolve. Modifications of standard surgical procedures and completely new procedures are usually introduced gradually into clinical practice, a process that may require special training or privileges. Additional training will often be required to integrate techniques or procedures that are new to the individual surgeon. The same is also true for procedures that represent a substantial change in existing methods or practices or that require familiarity with new technology. The purpose of this document is to provide guidelines for course directors who plan to design educational activities for continuing professional development (CPD) of practicing surgeons. Additionally, it provides guidance regarding requirements for SAGES endorsement of such courses.

THE PRIMARY PURPOSE OF THIS FRAMEWORK IS TO ENSURE SAFE AND HIGH QUALITY PATIENT CARE.

II. OBJECTIVE

This document is a framework upon which coursework for CPD educational activities may be developed. It provides both educational policy and practical guidelines for designing such programs, including those in which residents and clinical fellows participate outside of their formal curriculum. Individual societies or institutions may wish to develop more detailed documents relating to specific techniques or procedures.

These guidelines seek to further define evidence-based avenues by which appropriate training for CPD purposes may be achieved. In addition, mechanisms are proposed to assist educators, trainees and privileging bodies in assessing competence. It delineates those components of a course required for course endorsement by SAGES at each one of the two levels of endorsement (See below under the SAGES Endorsement System) (denoted by the term must (mandatory). There are also components that are strongly recommended denoted by the term should as well as those that are desired but not required denoted by the term may (optional). (Appendix B)

This document is advisory, and directed at surgical educators, institutions that grant privileges to practicing surgeons, and surgeons who seek additional training after graduation from standard residency programs. As an advisory document, it does not intend to restrict or regulate practices, nor be used for the purposes of medical-legal actions.

III. COMPONENTS OF TRAINING COURSES FOR CONTINUING PROFESSIONAL DEVELOPMENT (CPD) ACTIVITIES

A. COURSES & SKILLS LABORATORY SESSIONS

A course is a limited period of instruction with defined objectives designed to educate participants in clinical skills, techniques and/or procedures. Every skills course must have a mission statement defining objectives, curriculum and eligibility for training. Course structure and duration may vary according to the specific course objectives. In addition, a skills lab session may teach one skill or the entire set of skills required to perform a procedure.

B. CURRICULUM:

A recognized curriculum development strategy must be used. There are several curricular models such as Kern’s or the ADDIE (Analysis, Design, Development, Implementation, and Evaluation) model. For the current framework, we have used David Kern’s curricular model (Fig 1). This well-established model, known as “Kern’s Six-Step Approach to Curriculum”, is widely used to design course curricula. It includes the following steps:

• Problem Identification and General Needs Assessment: Applicants must state their rationale for offering a course to address a current problem and general needs. This may include literature review or a survey of the target population
• Needs Assessment of Targeted Learners: Applicants must state their rationale for offering a course to address needs of targeted learners. This may include literature review or a survey of the target population to demonstrate the added value of their offered course.
• Goals and Objectives: The course must include clear educational goals and learning objectives.
• Educational Strategies: The course must provide clear educational strategies to achieve the above mentioned goals. (See below under Educational strategies)
• Implementation: The applicants must provide evidence that the curriculum can be implemented successfully in their institution.
• Evaluation and Feedback (see below): The applicants must use Moore’s conceptual framework to incorporate evaluation and feedback into their curriculum. This framework was developed to assist CPD organizers in developing their CPD curricula.

Educational strategies (Step 4):

A course must contain clearly stated educational strategies (content and method of training) in the following areas as they may apply to the stated objectives:

• Patient selection
• Indications and contraindications of the procedure
• Documentation
• Pre- and post-operative care
• Follow-up
• Outcome
• Complications and their avoidance and treatment

Instructional methods to address instrumentation and operative techniques for specific task or procedure: The course curriculum should include a list of tasks, definitions of skill levels and a defined method of progressing from one skill level to the next. The curriculum must also include the learning components and their requirements. The curriculum may also include use and maintenance of medical instruments and equipment. Written materials (syllabus, reprints, bibliography) and pre- and post-testing are strongly recommended and may be employed.

Components that may be included as part of a course include the following:

• Inanimate model practice
• Ex-vivo / animate tissue / organ practice
• Animate laboratory instruction/practice
• Video instruction/practice
• Procedure observation
• Simulator models
• Computer-based instruction and simulation
• Interactive video simulation and testing
• Standardized patients
• Team training
• Cadaveric training
• Robotic training

Clinical case observation or clinical videos may be used to reinforce principles learned. Skills may also be developed using simulation technology such as virtual reality scenarios and/or tele-surgery or tele-conferencing, porcine models or cadavers.

The duration of skills training sessions may vary between individuals and should be criterion-based. This implies that the time for training should be sufficient for an individual to acquire the desired level of performance, based on objective metrics.

The post-test should quantitatively and/or qualitatively evaluate the participant’s acquisition of skills as defined by the program’s objectives.

The curriculum may need to be modified based on the trainee performance during participation in the skills course curriculum. Such modifications may include a series of exercises, tasks, or maneuvers which can be learned and later practiced outside the laboratory.

Evaluation and Feedback (Step 6):

The applicants must use Moore’s conceptual framework, which was developed to assist CPD organizers in developing their CPD curricula. (Table1). It is based on Miller’s pyramid of clinical competence (Figure 2) and consists of 6 main categories:

• Participation
• Satisfaction
• Learning: including declarative knowledge, procedural knowledge and competence “Declarative and Procedural knowledge” (Level 3 (A & B) and 4 in Moore’s framework)
• Performance. (Level 5 in Moore’s framework)
• Patient Health (Level 6 in Moore’s framework)
• Community Health (Level 7 in Moore’s framework)

Skills Laboratory:

A Skills Lab is a facility in which a practicing physician acquires, refines or improves his/her ability to perform specific medical/surgical tasks or procedures. Skills are the building blocks upon which procedures are constructed. The facility must be physically adequate to meet the stated objectives and to accommodate the course’s enrollment. A course may be conducted at an industry-sponsored facility, provided that it is operated in affiliation with a hospital, medical institution, or university or medical association, which is qualified to grant continuing medical education (CME) credits.

Inanimate training models: Inanimate, ex vivo models, or simulators are often preferable to animate models. Animate models may be necessary to simulate clinical situations when teaching certain surgical skills or techniques.

Qualifications of faculty:

The director of a skills course must be a member of SAGES. S/he has the overall responsibility for setting objectives, curriculum development, faculty and staff appointment, and development of evaluation criteria. The course director and the faculty members must have appropriate clinical and/or laboratory expertise to educate the participants in the stated objectives. When clinical procedures are taught, instructors must have clinical experience in those procedures. Proof of teaching expertise may come from qualitative and quantitative assessment from prior courses and participants. It may also include a faculty member’s own status on an assessed learning curve.

There must be an appropriate ratio of faculty to trainees in order to assure that progress is made and to enable documentation of achievement of objectives. The rationale for the ratio of faculty to learners should be included. The faculty must also be present for an appropriate quantity of time during the course to provide the learners adequate feedback.

Qualifications of participants

The skills course must define eligibility for participation. The trainee must have appropriate background knowledge, basic skills, and clinical experience relevant to the tasks to be learned.

Endorsement, disclosure and CME credits:

Course directors should provide CME credits and/or obtain endorsement by appropriate medical organizations. The course must have a written policy on disclosure of faculty/industry relationships, according to ACGME/AMA guidelines for CPD.

Documentation: 

Documentation for courses consisting of didactic instruction must include verification of attendance and course evaluations. The instructor or laboratory director must document required skills level for defined objectives and provide both qualitative and quantitative descriptions of the trainee’s performance.

Educational grants: Educational grants provided by industry, or other organizations or sources, to support any educational program, course, skills course or preceptorship must be clearly noted in promotional and educational materials.

THE SAGES ENDORSEMENT SYSTEM

The Society of American Gastrointestinal Endoscopic Surgeons (SAGES) has implemented a two tier (2 level) endorsement system based on Moore’s conceptual framework. This ranges from “Learning” and, “Competence”, to “Performance” and “Patient Health”. All courses must demonstrate active “Participation” and “Satisfaction” of attendees. We believe that achieving the above levels may not be adequate to change participants’ clinical practice but they are essential components of any course to engage participants in an educational activity. The Community Health (Level 7) is beyond the scope of most offered courses and has therefore been excluded.

The SAGES two- tier endorsement system consists of Level 1(Silver), Level 2 (Gold) characterized by the following components

TIER or LEVEL 1 (Sliver):

• Attendees will be tested on new knowledge via pre & post-test of knowledge or another method (Learning)
• Attendees will show how to do what the educational activity intended them to be able to do in a controlled educational environment (e.g. simulation laboratory) (Competence)

TIER or LEVEL 2 (Gold):

• Attendees will do what the educational activity intended them to be able to do in their practices (e.g., clinical environment) (Performance)
• Attendees will be able to change the health status of their patients after participation in the course. (Patient Health)

The endorsement of courses is based on provided objective data obtained using a structured assessment system rather than subjective self-reports from participants. Ideally, assessment tools with established evidence of validity should be used. See table 1, for suggested methods of assessments.

Summary:

This document outlines a framework for design and implementation of Continuing Professional Development (CPD) courses for practicing surgeons. It provides definitions of key terms and roles, and suggests educational programs appropriate to Joint Commission guidelines. The course directors are required to submit an application in order to be considered for endorsement from the SAGES Continuing Medical Education Committee. The requirements for course endorsement are included in this document (checklists). The eligibility for endorsement will be determined based on whether the course directors provide adequate evidence to support their applications and their course meets the criteria for any of the above-mentioned levels: Level 1 (Sliver) or Level 2 (Gold).

APPENDIX A:

DEFINITIONS

Some of the terms used in this document were carefully selected to indicate the specific meaning and relative weight attached to each statement. These terms are used in an educational context, not used for strict legal interpretation.

Continuing Professional Development (CPD) is the process by which health professionals keep updated to meet the needs of patients, the health service, and their own professional development. It includes the continuous acquisition of new knowledge, skills, and attitudes to enable competent practice.

Continuing Medical Education (CME) consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession. The content of CME is that body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of health care to the public. We preferably use the term CPD since these types of activities promote positive changes in practice.

Residency Surgical Education assumes completion of a formal, recognized training program, such as an Accreditation Council for Graduate Medical Education (ACGME) or Royal College of Physicians and Surgeons of Canada Accredited surgical residency training program in surgery.

Post-Residency Education: Coursework which is separate from formal residency or fellowship programs. While directed at the board certified surgeon, residents or fellows in training will often participate in such coursework.

Must or shall: Indicates a mandatory or indispensable recommendation.

Should: Indicates a highly desirable recommendation.

May or Could: Indicates an optional recommendation; alternatives may be appropriate.

Declarative knowledge (Knows):  The degree to which participants state what the Continuing Medical Education (CME) activity intended them to know.

Procedural knowledge (Knows how): The degree to which participants state what the CME activity intended them to know.

Competence (Shows how):  The degree to which participants state how to do what the CME activity intended them to know how to do (Observation in educational setting).

Performance (Does): The degree to which participants do what the CME activity intended them to be able to do in their practices (Observation in clinical setting).

Patient Health: The degree to which the health status of patients improves due to changes in the practice behavior of participants after the CPD activity (Outcomes in clinical setting).

Credentials: Documents provided following successful completion of a period of education or training.

Clinical Privileges: Authorization by a local institution (usually an accredited hospital) to perform a particular procedure.

Pre-test: A quantifiable examination of a trainee level of clinical knowledge and/or operative skills prior to commencing a training course.

Post-test: A quantifiable examination of a trainee level of clinical knowledge and / or operative skills upon completion of a training course.

Investigational procedure: A procedure is considered investigational if 1) it has not been substantially accepted into general clinical practice, 2) it has not been critically assessed in peer reviewed medical literature, and/or 3) it has not been presented and discussed at suitable scientific meetings. Alternatively, a procedure is not investigational if sufficient studies are available to prove its efficacy and safety, or, if it has already been accepted into general clinical practice without existing rigorous scientific study.

Surgical progress would be impeded if every logical surgical innovation were required to be tested by randomized trials prior to clinical use. Furthermore, it is impossible to rigorously test every aspect of clinical practice. The surgeon should use his/her judgment to determine when such directed coursework and study is appropriate. Introduction of an investigational procedure may require the approval of the appropriate institutional review board (IRB). Self-training in new procedures must take place on a background of basic surgical skills. The surgeon should recognize when and how much additional training in each new procedure is necessary.

Certification: Certification is a symbol of successful completion of a program of study. Successful completion of any one or more training components or objectives does not necessarily signify an individual’s clinical competence in a specific procedure or technique.

Appendix B:

SAGES CPD Course Evaluation Checklist

REFERENCES

1. Cheifetz RE, Phang, PT: Evaluating Learning and Knowledge Retention after a Continuing Medical Education Course on Total Mesorectal Excision for Surgeons. Am J Surg 2006;191:687-90.
2. Chekan EG, Muryama K, Provost D, et al. Society of American Gastrointestinal Endoscopic Surgeons (SAGES) Guidelines on Continuing Medical Education and Financial Relationships. Surg Endosc 2006;20:1168-1170.
3. Kern DE. Curriculum development for medical education: a six-step approach. JHU Press; 1998.
4. Kurt ER, Bell RL, Duffy AJ. Evolution of Surgical Skills Training. World J Surg 2006:12: 3219-32.
5. Miller GE. The assessment of clinical skills/competence/performance. Academic medicine. 1990 Sep 1;65(9):S63-7.
6. Moore DE, Green JS, Gallis HA. Achieving desired results and improved outcomes: integrating planning and assessment throughout learning activities. Journal of Continuing Education in the Health Professions. 2009 Dec 1;29(1):1-5.
7. Pearl J, Fellinger E, Dunkin B, Pauli E, Trus T, Marks J, Fanelli R, Meara M, Stefanidis D, Richardson W. Guidelines for privileging and credentialing physicians in gastrointestinal endoscopy. Surgical endoscopy. 2016 Aug 1;30(8):3184-90.
8. Peck C, McCall M, McLaren B, Rotem T. Continuing medical evaluation and continuing professional development: International comparisons. British Medical Journal. 2000 Feb 12;320(7232):432.
9. Piskurich, G. M. (2006). Rapid instructional design: learning ID fast and right. 2nd ed. San Francisco, CA: Pfeiffer.
10. Rogers DA, Elstein AS, Bordage G. Improving Continuing Medical Education for Surgical Techniques: Applying the Lessons Learned in the First Decade of Minimal Access Surgery. Ann Surg 2001; 233:159-166, 2001.
11. Rosser JC, et. al. Telementoring and Teleproctoring. World J Surg 2001;25: 1438-1448.
12. Sachdeva AK, Russell TR. Safe Introduction of New Procedures and Emerging Technologies in Surgery: Education, Credentialing, and Privileging. Surg Clin N Am 2007; 87: 853-866.
13. Sachdeva AK. Acquiring Skills in New Procedures and Technology: The Challenge and the Opportunity. Arch Surg 2005;140: 387-389.

In regards to Reference #7, this statement was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in June 2016.

This is a revision of SAGES publication #18 printed Jan 1994, revised Apr 1998, Jun 2003, Jul 2010, and June 2016.

For more information please contact:

SOCIETY OF AMERICAN GASTROINTESTINAL ENDOSCOPIC SURGEONS (SAGES)
11300 West Olympic Blvd., Suite 600
Los Angeles, CA 90064
Tel: (310) 437-0544
Fax: (310) 437-0585
Email: publications@sages.org

Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.

Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.

Table 1: Comparison of an Expanded Outcomes Framework with the Original Framework for Planning and Assessing CME Activities

Figure 1: Kern’s Six-Step Approach to Curriculum:

Figure 2: Miller’s Pyramid of Clinical Competence: