Individual Memberships

NIHSS CLINICAL TRIALS DISCLOSURE / DISCLAIMER for CRO, Sponsors and Regulatory Agencies

Sponsors and institutions using this program to document rater competency, inter-rater reliability and educational compliance for studies, programs and clinical trials: You may need additional documentation beyond a completion certificate (WHICH HAVE BEEN KNOWN TO BE USED IN FRAUD AND ABUSE CASES IN HEALTHCARE AND CLINICAL RESEARCH) to fulfill requirements of regulatory agencies. Certificate records should be checked against centralized repositories / databases in order to verify their authenticity. Neither HealthCarePoint.com nor any BlueCloud network member is responsible for any liabilities resulting from the improper use or improper documentation required to properly document competency, inter-rater reliability or evidence based education for clinical trial programs. Please call our program administrator if you require additional information.

© 1999-Present - Copyright Notice - All legal rights reserved

HealthCarePoint, in collaboration with global organizations, have developed this world-wide standardized certification methodology and it is now accepted across healthcare organizations, clinical trial sponsors, CROs and regulatory agencies as the industry standard. This 8 year long globally harmonized, standardized and accredited program was originally developed to eliminate training and education redundancies, document compliance, improve inter-rater reliability in clinical trials, minimize and ultimately eliminate fraud and abuse across the global healthcare and clinical research ecosystem. Violators of copyright infringement will be prosecuted to the full extent of the law.

Method of participation

THIS PROGRAM IS FREE OF CHARGE TO ALL HEALTHCARE PROFESSIONALS!

My Activities Page

This page is where you will find your program for your to 'Enroll' according to your hospital requirements. Once enrolled, the system will dynamically place the chosen activity under your 'Assigned' activities where you can begin the chosen program.

Program Guidelines and Timelines

The program consists of a self-paced Instruction-Demonstration module and the certification modules. The NIH Stroke Scale International (NIHSSI) Test contains 6 sections, each containing a single patient interview. You must score all 6 patients at >84 out of 90 items correct to achieve certification.As of June 19, 2018 – certification is VALID FOR UP TO ONE -1- YEAR FROM THE DATE OF COMPLETION when used in clinical research or, more than one year, time line controlled by the local SOP requirements of your organization - recommended 2 years when used for healthcare purposes only.

NIHSS - Program Orientation and Training

Use the self paced training activity as many times as you need until you feel comfortable with the scale and feel confident enough to properly score / rate patients. The system will then automatically release your certification module so that you may then continue onto the certification component of the program.You must complete the training prior to the system releasing your certification module.

NIHSS - Certification Test Groups A, B, C, D, E, F and others

Use additional test groups to recertify per guidelines detailed below on this page. Consult your supervisor to determine the requirements of your organization. You may only apply for CME/CE credit for completing the program orientation and one test group per 12 month period. You may apply for credit for future test groups based on the certification periods specified.

If this is your first time and you have never been certified, you should begin the program by successfully completing Test Group A. You may come back to update your certification by choosing your next test group. You may apply for additional corresponding credits at that point in time.You may apply for a maximum of one completed test group.

To Obtain a Certificate of Completion

Use additional test groups to recertify per guidelines detailed below on this page. Consult your supervisor to determine the requirements of your organization. You may only apply for CME/CE credit for completing the program orientation and one test group per 12 month period. You may apply for credit for future test groups based on the certification periods specified.

CME or CNE Credits are awarded for one certification and only according to guidelines herein!

The system will remember your answers. Once you begin a course you will have 3 weeks to complete it before the system removes all answers and you will need to start the course once more.

To Claim CME/CNE Credit (FREE)

See detailed instructions located on the accreditation link to the right.

001A- Certification TEST GROUP A

– The suggested certification period for this group is 12 months. After passing Group A, you must wait at least 12 months before taking Group B.

001B- Certification TEST GROUP B

- The suggested certification period for this group is 12 months. After passing Group B, you must wait at least 12 months before taking Group C.

001C- Certification TEST GROUP C

– The suggested certification period for this group is 12 months. After passing Group C, you must wait at least 12 months before taking Group D.

Additional test groups such as D, E, F, G, H, I J, K, etc.

These test groups will be distributed and released to your personal account based on the expert panel’s suggested time guidelines.

NIHSS -Advisory Working Group and their affiliations at the time this online training was developed.

Patrick Lyden, M.D.

Neurologist, Chief of Stroke Clinic • Veteran's Affairs Medical Center • Chairman, Department of Neurology • Sinai Hospital • Professor of Neuroscience • UCSD School of Medicine • San Diego, CA

Walter J. Koroshetz, M.D.

Vice Chair, Neurology Service • Medical Director, Neurointensive Care Unit • Massachusetts General Hospital • Boston, MA

John R. Marler, M.D.

Medical Officer (former) • National Institute of Neurological Disorders and Stroke • National Institutes of Health • Bethesda, MD

Marian Emr

Director, Office of Communications and Public Liaison • National Institute of Neurological Disorders and Stroke • National Institutes of Health • Bethesda, MD

Margo Warren

Chief Public Liaison Section, Office of Communications and Public Liaison • National Institute of Neurological Disorders and Stroke • National Institutes of Health • Bethesda, MD

NIHSS Disclosures

According to the disclosure policy of the Academy, planning committee members, editors, managers, and other individuals who are in a position to control content are required to disclose any relevant relationships with any commercial interests related to this activity. The existence of these interests or relationships is not viewed as implying bias or decreasing the value of the presentation. All educational materials are reviewed for fair balance, scientific objectivity, and levels of evidence.

This educational activity does not include discussion of drugs or devices or uses of drugs and devices that have not been approved by the FDA. The opinions expressed in this educational activity are those of the faculty, and do not represent those of the Academy. This activity is intended as a supplement to existing knowledge, published information, and practice guidelines. Learners should appraise the information presented critically, and draw conclusions only after careful consideration of all available scientific information. All relevant financial relationships listed for these individuals have been mitigated.

Advisory Working Group Members:

Marian Emr, Walter J.Koroshetz, Patrick Lyden, John Marler, Margo Warren – reported no relevant financial relationships to disclose at the time this online training was developed.

Examiners:

Yu D.Cheng, MD, PhD (University of California at San Diego Stroke Center), Kama Z.Goluma, MD (University of California at San Diego); Judith A.Hinchey, MD (New England Medical Center); Mary A.Kalafut, MD (Scripps Clinic); Brett C.Meyer, MD (University of California at San Diego); Karen S.Rapp, RN, BSN, CCRC (University of California at San Diego Stroke Center); Sandi G.Shaw, RN, BSN (University of Texas Medical School at Houston); Sidney Starkman (University of California at Los Angeles) reported they had no relevant financial relationships at the time the training was developed.

Expert Commentators:

Thomas G.Brott, MD (Mayo Medical School—Jacksonville); Larry B.Goldstein, MD (Duke University Medical Center): James C.Grotta, MD (University of Texas Medical School at Houston); Christopher A.Lewandowski, MD (Henry Ford Hospital); Judith A.Spilker, RN (University of Cincinnati)-reported they had no relevant financial relationships to disclose at the time the training was developed.

Harold P. Adams, Jr, MD (University of Iowa) reported the following relationships at the time the training was developed. Consultant: Merck (adjudicate end points) and Medtronic (safety board)

Joseph P. Broderick, MD (University of Cincinnati): Consultant: Ono Pharmaceuticals (chair, Data Safety Monitoring Committee), Novo Nordisk (steering committee); Grant support: AstraZeneca, EKOS Corporation (PI), Genentech; Honoraria for speaking: Boehringer Ingelheim; Scientific Advisor: Genentech;

K. Michael Welch, MD (Finch University of Health Sciences--The Chicago Medical School) reported the following relationships at the time the training was developed. Advisor and grant support: Pfizer; Lecture grant (migraine and stroke): GlaxoSmithKline

Academy Planners:

American Academy of CME: John JD Juchniewicz, MCIS, CHCP, Natalie Kirkwood, RN, BS, JD, Sondra Moylan, MS, RN, Tina Posey - have no relevant financial relationships to disclose.

Accreditation

In support of improving patient care, American Academy of CME, Inc. is Jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

FREE NIHSS TRAINING AND EDUCATION PROGRAM:

There are no fees for participating in this activity. After reviewing the Program Orientation, please proceed with completing ONLY ONE (1) of the program test Group A, B, C, D and so on... If this is your first time using this program, please begin with test Group A -- Additional modules, B, C, D, E,.... are used to re-certify on an annual basis.

To Obtain a Completion and CME/CE Certificate (FREE)

The successful completion of the Program Orientation and one test group is sufficient to receive a certificate of completion. To receive CME/CE Credit you must also complete the activity evaluation. A CME/CE certificate is issued by the system immediately upon your successful completion of the Test Group and completion of the activity evaluation. You must achieve a passing score of at least 84 out of 90. You are able to retake the Test Group if this score is not achieved. Your completion certificate history can be viewed and/or printed from “My Activities” at any time. Each certificate of completion is valid for a maximum of 1 year from the date of successful completion.

IMPORTANT:

The successful completion of one test group is sufficient to receive a certificate of completion. You may apply for a maximum of one completed test group. You may complete additional Test Groups to recertify per guidelines. Consult your supervisor to determine the requirements of your organization. You may only apply for CME/CE credit for completing the program orientation and one test group per 12 month period. You may apply for credit for future test groups based on the certification periods specified.

Physicians

American Academy of CME designates this enduring material for a maximum of 3.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses

American Academy of CME, Inc. designates this educational activity for 3.0 contact hours.

California

Provider approved by the California Board of Registered Nursing, Provider Number CEP16993 for 3.0 contact hours.

Release date: July 1, 2011

Reviewed: May 5, 2014

Reviewed: May 5, 2017

Reviewed: May 5, 2020

Reviewed: May 5, 2023

Expiration date: May 4, 2026

For technical questions or support, contact: CampusHelp@TrainingCampus.com or call our support desk at 512-302-3113. For questions about this activity, contact CEServices@academycme.org.

How does this program work?

If you have registered at any other TrainingCampus™ website as an International Electronic Education Network™ member, such as hospitals, pharmaceutical companies, sponsors or investigative sites participating in clinical trials, please log into the system to automatically set up your account. If this is your first time visiting our network, please take a moment to register and create your own unique single sign on personal account. During the registration process you must provide a valid email address. This will allow you to receive reminders concerning your course progress and also allow you to retrieve lost passwords. If you do not have a valid email account we suggest obtaining one from any of the many free email providers e.g. Yahoo, gmail or Hotmail.

NOTE: Never register more than once as this will delay your program status and can eventually delete your duplicate account from the system. To avoid the aforementioned delays, simply log in with your previously registered e-mail and password information. If you forgot the e-mail you registered with, contact our help desk # 512-302-3113 (M-F) during regular business hours 8am-5pm CST.

Training - Test Groups and Timelines

The program consists of a series of digital video recordings and accompanying written material which includes a self paced Instruction-Demonstration module and the certification modules.

Self Paced Training

The training modules comprises an introductory description of the modified Rankin Scale mRS.

There are 4 brief patient interviews to be scored anonymously for practice purposes before optional group discussion. Correct scores and their justification follow each case (20 minutes). A transcript of the interviews is available. You will be able to obtain a completion certificate for documentation of training only and not for certification purposes.

Use the self paced training curriculum as many times as you need until you feel comfortable with the scale and futhermore, properly score patients if you decide to move onto the certification and receive program certification.

Testing and Certification Test Groups

Certification of successful training will depend on correct completion of all 9 further scenarios under ‘test’ conditions (60 minutes). You will have 3 attempts to score all patients correct before additional proctoring may be required. Certification and accreditations is now good for up to 12 months, after which re-certification is recommended using different scenarios which directly apply to clinical settings. Additional material may be available for future re-certification purposes. Translations of the material are available at related sites and can be customized for international projects.

You must score all case patients correctly in order to receive certification!

You will have 3 attempts to score all patients correct before addtional proctoring may be required.

CME/CE and Completion Certificates

After achieving a passing score, learners must complete and submit the activity evaluation, which will result in a certificate of credit/certification being issued. Your certificate can be printed immediately, and will also be stored in your personal account on the system. Your completion certificate history can be viewed and/or printed from your Personal Experience and Training (PET) account at any time 24/7.

Future Certifications

Your account will be supplied with future certification opportunities and are normally provided on an annual basis and will have the same passing certification criteria as the original certification.

About Dr John Rankin

Dr John Rankin (1923-1981) is one of the many distinguished alumni of the former University Department of Materia Medica and Therapeutics, Stobhill Hospital Glasgow. While his varied international career encompassed pulmonary physiology, occupational medicine and public health, he remains best remembered in the UK for his early stroke publications. In a series of articles published 50 years ago in the Scottish Medical Journal he described early rehabilitative stroke medicine using a novel grading system. Half a century on and Rankin’s eponymous stroke scale has become the endpoint of choice in acute stroke trials. This paper describes Rankin’s remarkable career and the legacy of his work, with a particular focus on his stroke research and grading system. Dr John Rankin; His Life, Legacy and the 50th Anniversary of the Rankin Stroke Scale. TJ Quinn, J Dawson, M Walters Scot Med Journal 2008 53(1)44-7.

General Information

When assessing outcome after stroke, the main issue that concerns patients or the regulatory authorities that license drugs, is the degree of disability that the patient is left with. The degree of disability is usually assessed by an independent observer and can be scored according to a standardised scale.

The modified Rankin scale is a 6 point disability scale with possible scores ranging from 0 up to 5. A separate category (of 6) is sometimes added for patients who die. The modified Rankin scale has been used widely in both secondary prevention and acute stroke trials, including most of the thrombolysis trials. In order to detect a treatment effect or to demonstrate clinical improvement, it is important that patients are rated in a consistent manner, minimising variability.

mRS Activity Faculty

Kennedy R Lees, MD, FRCP, FESO, FRSE (UK)

Professor of Cerebrovascular Medicine - Honorary Consultant Physician - Director, Acute Stroke Project - University of Glasgow

Clinical Trials - Global Standarization Methodology

Investigators required to certify in use of the modified Rankin Scale often participate in several trials, running across institutions and countries. These trials may each have a different sponsor. It is important that the arrangements for certification remain consistent between trials and among investigators within trials. Investigators who hold a certificate from a source other than this site cannot recertify here or transfer their certificate to a new trial without undertaking full training and certification de novo. This ensures that certificates in existence were based on a common, validated and harmonized approach in order to have consistent inter-rater-reliability during clinical trials. The training and certification material on this site is monitored and updated as necessary to ensure maintain validity.

Subsidized Programs

In some cases, your training and certification programs may be subsidized by either a university, CRO, Not for profit organization, or other organization. Participation in this CE training cannot be subsidized by an ineligible company, defined as: an entity whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

If your mRS program is being subsidized, e-mail us with the following information, after you have successfully registered to create your own personal account:

• Name of subsidizing organization

• If applicable, name of clinical trial

• Contact name from subsidizing organization

• Your name and contact information

SEND E-MAIL TO: Support@BlueCloud.net

You will be contacted by e-mail within 24-48 hours once your information has been verified and your program curriculum has been assigned to your personal account.

About the Barthel Index

As rehabilitation became established as a medical discipline, many scales offering objective measures of recovery were described by physicians or therapists. In the “chronic disease” hospitals of Baltimore, a “Maryland disability index” was developed. Dr Florence I Mahoney and Dorothea W Barthel modified this Disability Index; their aim was to produce a tool that allowed “simple index of independence, useful in scoring improvement in rehabilitation”. The resulting ten item assessment instrument was named after one of its creators – the Barthel index.

First used in clinical practice around 1955, Barthel’s eponymous scale became popular in rehabilitation and was well established by 1965. Although not designed for clinical trials, BI has been used as trial endpoint, either singly or as part of a “global” measure, in several landmark international studies. Use of the Barthel Index spread quickly, such that it is now arguably one of the most popular activities of daily living scales used in clinical practice. Examples of BI assessment in studies of: spinal injury; burns; cardiac disease; rheumatoid arthritis; amputations and frail elderly are available.

Outcome assessment

When assessing outcome in a clinical trial, the main issue that concerns patients or the regulatory authorities that license drugs, is the patient’s degree of residual disability – i.e. functional ability. Functional ability is usually assessed by an independent observer and scored according to a standardised scale.

Many functional assessment scales are available for research and practice. The Barthel Index can be used to describe activity limitation. Various versions of the Barthel Index have been described. For consistency use of a 10 item, 100 point scale has been recommended.

Barthel Index has been used widely in stroke and rehabilitation research. In order to detect a treatment effect or to demonstrate clinical improvement, it is important that patients are rated in a consistent manner, minimising variability.

References

1- Mahoney F. Barthel D (1965). Functional evaluation: the Barthel Index. Md Med J 14: 61–65.

2- Wade DT, Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Dis Studies. 1988;10:64–67.

3- Quinn TJ, McArthur KS, Ellis G, Stott DJ.Functional assessment in older people. BMJ.2011;343:d4681

4- Quinn TJ, Langhorne P, Stott DJ. Barthel index for stroke trials: development, properties, and application. Stroke.2011;42:1146-1151.

5- Quinn TJ, Dawson J, Walters MR, Lees KR. Functional outcome measures in contemporary stroke trials. International Journal of Stroke. 2009;3:200-5.

Terence J Quinn MD, MRCP (UK)

Lecturer in Geriatric Medicine • Institute of Cardiovascular and Medical Sciences, School of Medicine • University of Glasgow

Kennedy R Lees MD, FRCP, FESO, FRSE (UK)

Professor of Cerebrovascular Medicine and Honorary Consultant Physician • Institute of Cardiovascular and Medical Sciences, School of Medicine • University of Glasgow

THE ADVISORY WORKING GROUPS, THE UNITED STATES GOVERNMENT, THE NATIONAL INSTITUTES OF HEALTH (NIH), NATIONAL INSTITUTES OF NEUROLOGICAL DISORDERS AND STROKE (NINDS), UNIVERSITIES NOR ANY OTHER INDIVIDUAL OR ENTITY INVOLVED IN DEVELOPING THIS OF THESE GLOBALLY STANDARIZED PROGRAMS, ARE NOT RESPONSIBLE FOR ANY REGULATORY, PRIVACY, GDPR OR LEGAL LIABILITIES AND ISSUES AND LITIGATIONS THAT MAY ARISE FROM THE IMPROPER USE OF THIS PROGRAM. ANYONE USING THESE PROGRAMS, INCLUDING BUT NOT LIMITED TO HEALTHCARE PROFESSIONALS, PHARMACEUTICAL COMPANIES, MEDICAL DEVICE COMPANIES, SPONSORS, HOSPITALS, RESEARCH SITES OR ANY OTHER HEALTHARE OR CLINICAL RESEARCH ENTITIES USING THESE PROGRAMS SHOULD FOLLOW PROGRAM STANDARDS ACCORDINGLY. USERS OF THESE GLOBALLY STANDARDIZED TRAINING AND CERTIFICATION PROGRAMS, THE EXECUTION, IMPLEMENTATION, TRACKING OF INTER-RATER-RELIABILITY TO MINIMIZE DATA VARIANCE, OR THE DOCUMENTATION OF COMPETENCIES, ARE ADVICED TO PROPERLY FOLLOW STANDARDS BY WHICH THESE PROGRAMS WERE ORIGINALLY INTENDED FOR (THE IMPROVEMENT OF PATIENT, SUBJECT AND PUBLIC SAFETY).

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