1 UC San Diego/ACCME Requirements & Guidelines for ENDURING & INTERNET MATERIALS Revised 04/17/11 **All content must be reviewed by the CME office prior to delivery to learners. Please allow a minimum of 5 business days for review.** The definition of Enduring Materials is as follows: An enduring material is a non-live CME activity that "endures" over time. The learning experience by the physician can take place at any time in any place, rather than only at one time, and one place, like a live CME activity. Examples of such materials for independent physician learning include: Programmed texts, audio-tapes, videotapes and computer assisted instructional materials (CD-ROMS, DVDs & programs) which are used alone or in combination with written materials. An enduring material is most typically a DVD, monograph, CD-Rom or podcast. Enduring materials can also be delivered via the Internet. Books, journals (unless specifically designated) and manuals are not classified as enduring materials. The following applies to any enduring material requesting CME: There are specific communication requirements for enduring materials because of the nature of the activities. For CME activities including those in which the learner participates electronically (e.g. via Internet, CD-ROM, satellite broadcasts), there is no direct interaction between the faculty and the learner, hence all required UCSD/ACCME information must be transmitted/communicated to the learner prior to the learner beginning the CME activity. Checklist DONE REQUIREMENT Activity Title (required) Logo (required) Sponsor Listed (required) Course Description (required) Target Audience (required) Objectives (required) COMMENTS Please list prominently. The UC San Diego School of Medicine Logo is required on the front of all materials and must be displayed prominently. If needed, request from CME office. The University of California, San Diego School of Medicine must be listed as the accrediting sponsor. Please seek assistance from CME if joint sponsor. List a description which tells the potential participants what you would like them to know about your program, e.g. highlight topic areas. List the identified types of health professionals specifically targeted (i.e., primary care physicians, cardiologists, neurologists, etc.) for this activity. Learning objectives should be clearly stated , must be measureable and written from the perspective of what you expect the learner to do in the practice setting with the information you are teaching. It is helpful to formulate the objectives by starting with: At the conclusion of this activity, the participants should be able to: Needs Assessment with practice gap (required) List the needs assessment for the activity including a paragraph summarizing the practice gaps. A Needs Assessment defines the need for the activity and assesses the 2 gap in terms of knowledge, skills and behavior between “What is” (actual patient care) and “What should be” (optimal patient care). Or in other words, it is the difference between what is occurring in practice and what is expected (the desired outcome), or, the difference between what is and what should be. The identified needs are the basis for content, format and evaluation. The needs identification process sets the stage for the development of the learning objectives (what the participants can expect to get out of the activity) which is then followed by format selection (the best method to deliver content and teach those objectives). There are 2 types of ACCME accreditation statements, direct or joint. Direct is used if UC San Diego directly sponsors the activity. The jointly sponsored statement is used if UC San Diego and another organization are jointly sponsoring the activity. Accreditation Statement (required) Credit Designation Statement (required) Direct: The University of California, San Diego School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Joint: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the University of California, San Diego School of Medicine and (Joint Sponsor). The University of California, San Diego School of Medicine is accredited by the ACCME to provide continuing medical education for physicians. AMA credit designation statement: The University of California, San Diego School of Medicine designates this enduring material for a maximum of [number of credits] AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Notes: AMA PRA Category 1 Credit™ must be italicized. The number of credits will be included in your approval letter. Other specialty credit designation statements may also be listed. This is a California state requirement regardless of location of activity. The subject of Cultural and Linguistic competency should be incorporated in to your activity. The statement below is required: Cultural and Linguistic Competency Statement (required) Principal faculty and their credentials (required) Disclosure Statement (required) This activity is in compliance with California Assembly Bill 1195 which requires continuing medical education activities with patient care components to include curriculum in the subjects of cultural and linguistic competency. Cultural competency is defined as a set of integrated attitudes, knowledge, and skills that enables health care professionals or organizations to care effectively for patients from diverse cultures, groups, and communities. Linguistic competency is defined as the ability of a physician or surgeon to provide patients who do not speak English or who have limited ability to speak English, direct communication in the patient’s primary language. Cultural and linguistic competency was incorporated into the planning of this activity. Additional resources on cultural and linguistic competency and information about AB1195 can be found on the UCSD CME website at http://cme.ucsd.edu. List full name, degree, and organizational affiliation for all faculty (speakers, panel members, authors, etc) and denote course director. The statement below is required: It is the policy of the University of California, San Diego School of 3 Disclosure summary (required) Medium or combination of media used (required) Method of physician participation in the learning process (required) Estimated time to complete the educational activity (required) Dates of original release, most recent review or update, and termination date (required) Commercial Support Acknowledgement Registration Information Institutional Acknowledgement Advertising Medicine to ensure balance, independence, objectivity and scientific rigor. All persons involved in the selection, development and presentation of content are required to disclose any real or apparent conflicts of interest. All conflicts of interest will be resolved prior to an educational activity being delivered to learners through one of the following mechanisms 1) altering the financial relationship with the commercial interest, 2) altering the individual’s control over CME content about the products or services of the commercial interest, and/or 3) validating the activity content through independent peer review. All persons are also required to disclose any discussions of off label/unapproved uses of drugs or devices. Persons who refuse or fail to disclose are disqualified from participating in the CME activity. This is a summary of all disclosures that were collected and should be placed after faculty list. Please see example. Hardware/Software requirements. At the start of an Internet CME activity, the hardware and software required must be indicated for the learner to participate. Instructions will vary depending on activity format, but should stipulate that participants: Review the materials on accreditation information, target audience, learning objectives, and disclosure information Complete the entire self-study activity Complete the self-assessment and evaluation/claim form The number of hours it should take to complete will be the same as number of designated credits. The Release Date is the date you plan to release the activity, the first day it will be available to participants. Termination Date or End Date is the date after which the enduring material is no longer certified for credit enduring materials are required to be reviewed at least once annually for up to 3 years, or more frequently if indicated by new scientific developments. List all commercial supporter(s) for the activity. Commercial support must be acknowledged in order to comply with the ACCME Standards for Commercial Support and references to a company or institution are allowed. This acknowledgement must be placed only at the beginning of the enduring material. Note: Fully executed LOAs on file with UCSD CME are required in order to acknowledge the commercial supporters. Instructions for registration. Add a form or link for potential participants to register for the activity. The institutional acknowledgement may state the name, mission, and areas of clinical involvement of the company or institution and may include corporate logos and slogans, if they are not product promotional in nature. Product specific advertising of any type is prohibited in enduring materials. No specific products may be referenced, even if they are not related to the topic of the enduring material. **Examples listed on pages 5-10** ADDITIONAL INTERNET CME GUIDELINES Live or enduring material activities that are provided via the Internet are considered to be “Internet CME.”. There are specific requirements for Internet CME because of the nature of the activities: 4 1. CME activities delivered via the Internet are expected to be in compliance with ACCME Essential Areas, Elements, and Policies. 2. Activity Location: There shall be no CME activities on a pharmaceutical or device manufacturers’ product website. 3. Links to Product Websites: With clear notification that the learner is leaving the Educational website, links from the website of a CME accredited activity to pharmaceutical and device manufacturers’ product website are permitted before or after the educational content of a CME activity, but shall not be embedded in the educational content of a CME activity. 4. Advertising: Advertising of any type is prohibited within the educational Content of CME activities on the Internet including, but not limited to, banner ads, subliminal ads, and pop-up window ads. For computer based CME activities, advertisements and promotional materials may not be visible on the screen at the same time as the CME content and not interleafed between computer ‘windows’ or screens of the CME content. 5. Hardware/Software Requirements: The hardware and software required must be indicated at the start of an Internet CME activity for the learner to participate. 6. Provider Contact Information: A mechanism must be in place for the learner to be able to contact the accredited provider if there are Questions about the Internet CME activity. 7. Policy on Privacy and Confidentiality: The accredited provider must have, adhere to and inform the learner about its policy on privacy and confidentiality that relates to the CME activities it provides on the internet. 8. Copyright: The accredited provider must be able to document that it owns the copyright for, or has received permission for use of, or is other wise permitted to use copyrighted materials within a CME activity on the Internet. 5 EXAMPLES Logo (required) Course Description (required) Example… Patients with obstructive sleep apnea may present significant problems in the perioperative period, including difficult airways, sensitivity to anesthetic agents, and postoperative adverse events. This eight page monograph is an assimilation of material presented at the Challenges in the Perioperative Management of OSA Patients symposium, held in October of 2010, and is designed to provide practical solutions and strategies for the perioperative care of patients with OSA. Additional contributions have been made by course faculty, and references to recent publications regarding OSA practice guidelines have been included. Target Audience (required) Example… This activity is designed for anesthesiologists, surgeons, physicians, nurse practitioners, certified nurse anesthetists, anesthesia assistants, respiratory therapists, and other healthcare providers interested in the perioperative care of patients with obstructive sleep apnea. Objectives (required) Example… Following completion of this educational activity, learners should be able to: Review the pathophysiology of OSA in the context of recent clinical research regarding perioperative care, sleep, and anesthesia. Determine the challenging link between comorbidities, including obesity, and their effects on airway management and ventilation. Formulate how to implement screening and treatment procedures for obstructive sleep apnea. Discuss the preoperative, intraoperative, and postoperative risks to patients with OSA, and apply strategies to mitigate these risks in support of positive patient outcomes. 6 Needs Assessment with Practice Gap (required) Example… Upper airway patency is essential for normal respiratory function. The maintenance of a patent airway is dependent primarily on the pharyngeal structures. However in some individuals, there is a loss of this airway patency and obstruction occurs during sleep. This interruption of airflow is due to the collapse of pharyngeal soft tissue. Obstructive sleep apnea (OSA) is caused by repetitive partial or complete obstruction of the upper airway, characterized by episodes of breathing cessation during sleep, which lasts 10 or more seconds. This airway obstruction in turn causes increase in sympathetic output and tone, repetitive arousals from sleep to restore airway patency, which may result in daytime hypersomnolence, memory loss, other psychological disturbances, and an increase in inflammatory mediators. OSA has known associations with several comorbidities. These consist of cardiovascular disease including acute myocardial infarction, heart failure, arrhythmias, hypertension, cerebrovascular disease, metabolic syndrome, obesity, and the attendant risk of gastro-oesophageal reflux and pulmonary aspiration. Untreated OSA is associated with an increase in morbidity and mortality. OSA is the most prevalent breathing disturbance during sleep. From estimations in the general population, a high proportion (24% men, 9% women) have an apnea hypopnea index of 5 or greater, and moderately severe OSA was present in 11.4% of men and 4.7% of women. It has been estimated that 90% of the patients with OSA in the general population are undiagnosed. Similarly, a significant proportion of these patients are undiagnosed prior to surgery. Severe OSA is a syndrome associated with hypoxaemia, hypercarbia, polycythaemia, cor pulmonale, and hypertension. From the standpoint of the anesthesiologist, there are concerns with difficult airways, and patient sensitivity to sedatives and analgesic medications. OSA has also been associated with an increase in postoperative complications. Therefore, OSA is increasingly being recognized as a significant perioperative concern. It is important for anesthesiologists, surgeons and physicians to have up-to-date knowledge about the perioperative management of the patients with obstructive sleep apnea in order to improve their performance and care of this patient population. This educational program will attempt to provide clinicians with “best practice” advice and practical solutions and is designed for anesthesiologists, surgeons, and physicians interested in the perioperative care of patients with obstructive sleep apnea. Other healthcare professionals who may benefit from this activity are nurses, certified nurse anesthetists and nurse practitioners, anesthesia assistants, respiratory therapists, hospital administrators, and anesthesia fellows or residents. Accreditation Statement and Credit Designation Statement (required) For all jointly sponsored activities, please use the following statement. The appropriate accreditation statement will also be included in your approval letter. This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the University of California, San Diego School of Medicine and (Joint Sponsor). The University of California, San Diego School of Medicine is accredited by the ACCME to provide continuing medical education for physicians. The University of California, San Diego School of Medicine designates this enduring material for a maximum of [number of credits] AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Faculty List (required) Co-Directors Frances Chung, MBBS Professor, Department of Anesthesia Medical Director, Combined Surgical Unit and Ambulatory Surgical Unit University Health Network University of Toronto Toronto, Ontario, Canada 7 Terence M. Davidson, MD Professor of Surgery, Head and Neck Surgery University of California, San Diego School of Medicine San Diego, California, USA Faculty Jonathan L. Benumof, MD Professor Department of Anesthesiology University of California, San Diego San Diego, California, USA Daniel Davis, MD Professor of Clinical Medicine Department of Emergency Medicine University of California, San Diego San Diego, California, USA Thomas Ebert, MD Professor and Program Director Department of Anesthesiology Medical College of Wisconsin Staff Anesthesiologist VA Medical Center Milwaukee, Wisconsin, USA David Hillman, MBBS, FANZCA, FRCP(Edin), FRACP(Hon) Head, Department of Pulmonary Physiology Director, West Australian Sleep Disorders Research Institute Sir Charles Gairdner Hospital Perth, Australia Shiroh Isono, MD Associate Professor, Department of Anesthesiology Graduate School of Medicine Chiba University Chiba, Japan Disclosure (required) It is the policy of the University of California, San Diego School of Medicine to ensure balance, independence, objectivity and scientific rigor. All persons involved in the selection, development and presentation of content are required to disclose any real or apparent conflicts of interest. All conflicts of interest will be resolved prior to an educational activity being delivered to learners through one of the following mechanisms 1) altering the financial relationship with the commercial interest, 2) altering the individual’s control over CME content about the products or services of the commercial interest, and/or 3) validating the activity content through independent peer review. All persons are also required to disclose any discussions of off label/unapproved uses of drugs or devices. Persons who refuse or fail to disclose are disqualified from participating in the CME activity. This information is used to plan future activities. The faculty have reported the following relevant financial relationships: Frances Chung, MBBS: Research grants from the ResMed Foundation and the Respironic Foundation Terence Davidson, MD: Member of the ResMed Foundation Board. David Hillman, MBBS: Consultant for ResMed 8 The following faculty have no financial relationships other than listed above with commercial interests relevant to the content of this activity. Jonathan Benumof, MD Daniel Davis, MD Thomas Ebert, MD Shiroh Isono, MD The CME staff, meeting planners, editorial staff, planning committee, and CME committee reviewers other than listed above do not have any relevant financial relationships to disclose. Off-label Disclosure: This educational activity may contain discussion of unlabeled and/or investigational uses of agents that are not approved by the FDA. Please consult the prescribing information for each product. The views and opinions expressed in this activity are those of the faculty and do not necessarily reflect the views of the University of California, San Diego. Medium or combination of media used (required) Example… ● Monograph - This activity is a monograph based on an original clinical paper written by Dr. Weber, Glass and Brouett. ● CD-ROM - Interactive CD-ROM ● DVD – DVD ● Internet - I. Overview Follow these steps to determine if your computer has the system requirements to view the presentations. A. Review Hardware Requirements - Please read Hardware Requirements, section II below, to be sure your computer has the proper hardware to view the presentations. If your computer does not meet the minimum system requirements, your system will perform slowly and will have a difficult time loading presentations and navigating within them. B. Review Software Requirements - This webcast is supported on computers running the Windows Operating System and Macintosh operating system. C. Mobile Device Users - mobile device users, view support information below. II. Hardware Requirements You must have the following hardware components in order to view presentations. A. COMPUTER: Minimum processor and memory as recommended by operating system manufacturer. B. INTERNET CONNECTION: A broadband Internet connection is required. Dial-up modem users can download event audio in mp3 format from event page or the podcast feed. C. SOUND: 16-bit sound card and speakers D. DISPLAY: A VGA display set to a screen area of 1024 x 768 pixels or higher and 16 bits of color or higher. 9 III. Software Requirements Windows OS System Requirements A. Versions supported: Windows XP, Vista, 7 B. Adobe Flash Player: The webcast requires version 10 or higher of Adobe Flash Player. Consult the table provided at the URL below to determine the minimum web browser supported on each operating system version. Check Operating System and Browser Version Support from Adobe C. Web Browser support: Microsoft Internet Explorer, or Firefox 3.x, Safari 4.x Your web browser should have JavaScript enabled. Macintosh System Requirements The webcast requires version 10 or higher of Adobe Flash Player. Consult the table provided at the URL below to determine the minimum web browser supported on each operating system version. Check Operating System and Browser Version Support from Adobe Your browser should have JavaScript enabled. IV. Mobile Device Support Users with the Apple iPad, iPhone, and iPod Touch with an enabled Internet connection can stream sessions to their mobile device directly from the event page. Users of non-streaming enabled mobile devices may use the podcast feed to download the session audio to their mobile device. Method of physician participation in the learning process (required) Example… ● Monograph The estimated time to complete this activity is 1 hour. To obtain credit, participants should register for the activity (link to registration/activity page), take the online pretest, read the monograph, answer the multiplechoice posttest questions, and complete the evaluation form online to receive a certificate online immediately upon completion. Adobe Reader is required to view this monograph, and can be downloaded at http://get.adobe.com/reader/. ● CD-ROM This CME activity incorporates instructional design to enhance your retention of the didactic information and pharmacological concepts that are presented. You are advised to go through this program from beginning to end. You will first study the figures and listen to the accompanying narrations for each figure. After completing, you will then go over the figures again. This will allow interaction with the materials and also provide repeated exposure to the data and concepts presented both visually and orally. After you have gone through the entire program, complete the Post Test. You must also complete the evaluation form and mail it along with your Post Test. 10 ● DVD Participants must score at least 70% on the post test to receive credit. Certificates will be mailed within 6 weeks of receipt to those who submit the Registration and Evaluation forms and successfully complete the post test. 1. Fill out the Evaluation Form 2. Fill out the post test answer sheet and the Registration form. 3. Detach and mail the Evaluation form, Post Test answer sheet, and Registration from to the following address. Dates of original release, most recent review or update, and termination date (required) Example… ● Release Date: July 1, 2009 Expiration Date: June 30, 2011 -ORDate of Release/Date of Expiration July 1, 2009 – June 30, 2011 Commercial Support Acknowledgement Example… This activity is supported by educational grants provided by Phillips Respironics and ResMed. Medium or combination of media used (required) Example… ● Monograph - This activity is a monograph based on an original clinical paper written by Dr. Weber, Glass and Brouett. ● CD-ROM - Interactive CD-ROM ● DVD – DVD ● Internet - See example below I. Overview Follow these steps to determine if your computer has the system requirements to view the presentations. A. Review Hardware Requirements - Please read Hardware Requirements, section II below, to be sure your computer has the proper hardware to view the presentations. If your computer does not meet the minimum system requirements, your system will perform slowly and will have a difficult time loading presentations and navigating within them. B. Review Software Requirements - This webcast is supported on computers running the Windows Operating System and Macintosh operating system. C. Mobile Device Users - mobile device users, view support information below. 11 II. Hardware Requirements You must have the following hardware components in order to view presentations. A. COMPUTER: Minimum processor and memory as recommended by operating system manufacturer. B. INTERNET CONNECTION: A broadband Internet connection is required. Dial-up modem users can download event audio in mp3 format from event page or the podcast feed. C. SOUND: 16-bit sound card and speakers D. DISPLAY: A VGA display set to a screen area of 1024 x 768 pixels or higher and 16 bits of color or higher. III. Software Requirements Windows OS System Requirements A. Versions supported: Windows XP, Vista, 7 B. Adobe Flash Player: The webcast requires version 10 or higher of Adobe Flash Player. Consult the table provided at the URL below to determine the minimum web browser supported on each operating system version. Check Operating System and Browser Version Support from Adobe C. Web Browser support: Microsoft Internet Explorer, or Firefox 3.x, Safari 4.x Your web browser should have JavaScript enabled. Macintosh System Requirements The webcast requires version 10 or higher of Adobe Flash Player. Consult the table provided at the URL below to determine the minimum web browser supported on each operating system version. Check Operating System and Browser Version Support from Adobe Your browser should have JavaScript enabled. IV. Mobile Device Support Users with the Apple iPad, iPhone, and iPod Touch with an enabled Internet connection can stream sessions to their mobile device directly from the event page. Users of non-streaming enabled mobile devices may use the podcast feed to download the session audio to their mobile device. Method of physician participation in the learning process (required) Example… ● Monograph - The estimated time to complete this activity is 1 hour. To obtain credit, participants should register for the activity (link to registration/activity page), take the online pretest, read the monograph, answer the multiple-choice posttest questions, and complete the evaluation form online to receive a 12 certificate online immediately upon completion. Adobe Reader is required to view this monograph, and can be downloaded at http://get.adobe.com/reader/. ● CD-ROM - This CME activity incorporates instructional design to enhance your retention of the didactic information and pharmacological concepts that are presented. You are advised to go through this program from beginning to end. You will first study the figures and listen to the accompanying narrations for each figure. After completing, you will then go over the figures again. This will allow interaction with the materials and also provide repeated exposure to the data and concepts presented both visually and orally. After you have gone through the entire program, complete the Post Test. You must also complete the evaluation form and mail it along with your Post Test. ● DVD - Participants must score at least 70% on the post test to receive credit. Certificates will be mailed within 6 weeks of receipt to those who submit the Registration and Evaluation forms and successfully complete the post test. 1. Fill out the Evaluation Form 2. Fill out the post test answer sheet and the Registration form. 3. Detach and mail the Evaluation form, Post Test answer sheet, and Registration from to the following address. Dates of original release, most recent review or update, and termination date (required) Example… ● Release Date: July 1, 2009 Expiration Date: June 30, 2011 -ORDate of Release/Date of Expiration July 1, 2009 – June 30, 2011 Commercial Support Acknowledgement Example… This activity is supported by educational grants provided by Phillips Respironics and ResMed.