Standards for Substantive Equivalency between Continuing Professional Development/Continuing Medical Education (CPD/CME) Accreditation Systems.

The International Academy for Continuing Professional Development Accreditation (IACPDA) is dedicated to advocating for and enhancing the development, implementation and evolution of continuing medical education (CME)/continuing professional development (CPD) accreditation systems throughout the world by providing an opportunity for individuals in leadership positions to (a) learn about the values, principles and metrics of varying CME/CPD accreditation systems; (b) explore the accreditation standards for CME/CPD provider organisations and activities under differing systems; and (c) foster evaluations to measure the impact of CME/CPD accreditation systems on physician learning, competence, performance, and healthcare outcomes. IACPDA has developed a shared set of international standards to guide the accreditation of CME/CPD for medical doctors and healthcare teams globally, which have been adopted in the Cologne Consensus Conference on 10 September 2020. These standards will also be used to determine substantive equivalency between accrediting bodies.

Introduction

IACPDA has developed a shared set of international standards to guide the accreditation of CPD/CME for medical doctors (doctors) and health-care teams globally. These standards will also be used to determine substantive equivalency between accrediting bodies. Substantive equivalency between accrediting bodies allows stakeholders – national authorities, regulators, credentialing bodies, certifying bodies, and most importantly, doctors and their patients – to know that the accredited education in support of improved patient care and patient safety meets the same level of independence, rigour, content validity, quality of design, and outcome measures. An added benefit is the ability to form agreements related to reciprocity of “credit” in jurisdictions that have and/or value credit as a currency of CPD/CME.

Development of the standards

Version 1: Delphi Process

A working group from the Academy developed the first set of standards by reviewing the literature on effective CPD/CME accreditation [1] and an original set of substantive equivalency values developed by the Accreditation Council for Continuing Medical Education (ACCME) and the Royal College of Physicians and Surgeons of Canada (Royal College). These substantive equivalency values have been used for more than two decades as a mechanism of peer review between accrediting bodies and as the basis for agreements for reciprocity between both the accreditation and credit systems.

Using a modified Delphi Process [2], the first draft standards were released in an electronic survey to a large group of accrediting bodies and regulators – both members and non-members of the Academy. The survey asked survey participants to indicate their level of agreement with the proposed standards – made up of six domains and standards for each of the domains – as well as to identify any missing domains and/or standards.

The survey results were presented at a meeting in Berlin on 16 May 2019 and at the Cologne Consensus Conference, in Cologne, Germany, on 13/14 September 2019. Participants were asked to discuss, in detail, the domains and standards.

Version 2: Feedback from a Broader Community

Using the feedback provided from the Berlin Meeting and the Cologne Consensus Conference, the working group from the Academy developed a second version of the standards. Version 2 was presented to the Academy members and other stakeholders at the European CME Forum held in Manchester, England on 6–8 November 2019. The feedback collected from the Forum has been integrated into this final version of Standards for Substantive Equivalency between CPD/CME Accreditation Systems.

Version 3: Call-for-Comment on Final Draft Standards

The final draft Standards for Substantive Equivalency (the Standards) were distributed through a formal call-for-comment in early 2020. Following this comment period, the Standards were finalised, and presented for adoption by the Academy at the Cologne Consensus Conference which was held virtually on 10–11 September 2020. Academy members participating in the conference unanimously adopted the Standards as presented. The Academy is responsible for communicating the Standards to stakeholders, seeking endorsement by individual accreditation systems, and implementing a process of review for substantive equivalency.

Scope

These Standards and supporting interpretations are used to determine and recognise substantive equivalency between accrediting bodies.

Terminology

The Standards for Substantive Equivalency utilise terminology defined in the glossary published by the International Academy (for more information please visit the IACPDA website). The Academy is responsible for clarifying definitions and adding additional terms as necessary.

Domains

The Standards for Substantive Equivalency consist of six domains with supporting requirements that are used to determine and recognise the substantive equivalency of CPD/CME accrediting bodies.

Domain 1: Eligibility and Responsibilities of an Accrediting Body

This domain focuses on which organisations are eligible to develop and implement CPD/CME accreditation systems and the Standards that describe the administrative roles and responsibilities of an accrediting body.

Domain 2: Independence and Transparency in Accredited Education

This domain focuses on requirements that seek to ensure that educational activities are designed and implemented independent from the influence of commercial interests defined as any entity producing, marketing, re-selling, or distributing health-care goods or services consumed by, or used on, patients.

Domain 3: Needs Assessment used in Planning Accredited Education

This domain focuses on the types of data sources that are used to identify the educational needs of individual doctors or health teams.

Domain 4: Content Validity in Accredited Education

This domain focuses on the process of developing content for accredited education that reflects the latest advances in scientific evidence and technological advances to continuously enhance the quality and safety of care provided to patients.

Domain 5: Quality of Educational Design in Accredited Education

This domain focuses on the effectiveness of the design of educational formats in addressing the identified needs of the intended target audience.

Domain 6: Outcomes from Accredited Education

This domain focuses on assessment of the effectiveness and educational impact of accredited education on learning, competence, or performance of doctors, and/or the health status of patients.

Standards for Substantive Equivalency between CPD/CME Accreditation Systems

Domain 1: Eligibility and Responsibilities of an Accrediting Body

Introduction

The purpose of continuing professional development/continuing medical education (CPD/CME) is to promote maintenance and continuous improvement of the competence and performance of individual medical doctors or health-care teams in providing exemplary healthcare for patients.

Accreditation systems are intended to serve doctors and health-care teams by establishing that accredited education has complied with established accreditation standards. Given the importance of accreditation in supporting improved healthcare for patients, the pharmaceutical or device industry or other commercial interests are not eligible to be accrediting bodies.

The eligibility for an organisation to function as an accrediting body and the Standards that outline their roles/responsibilities are listed below:

Standards

1.1 The accrediting body must be:

(I) a legal entity or a collaboration among two or more legal entities;

(II) led by, or include the perspective of, the profession of medicine; and

(III) accountable to the public through transparent reporting of governance, accreditation decisions, and finances on a regular basis.

1.2 The accrediting body must not be:

(I) a commercial interest, or any entity under the direct or indirect control of a commercial interest, defined as any entity producing, marketing, selling, re-selling, or distributing health-care goods or services consumed by, or used on, a patient;

(II) under direct or indirect control or influence of an accredited provider or an organiser of accredited education with respect to governance, finances, rules, and procedures of the accreditation process. This does not preclude, that under strictly defined conditions, accrediting bodies (e.g. legally authorised bodies, including those organised under the principle of self-governance, or bodies accredited by another accrediting body), might also act as an accredited provider or organiser of accredited education; and

(III) controlled solely by individuals as stakeholders for personal gain.

1.3 The accrediting body must:

(I) identify which organisations are eligible to apply for accreditation;

(II) define and communicate a fair and transparent accreditation process that includes peer review by the medical profession and due process safeguards including a complaint process and reconsideration/appeal processes;

(III) require the review of both descriptions of compliance and demonstration of compliance, that is performance-in-practice, from organisations seeking accreditation or reaccreditation;

(IV) facilitate routine audit or inspection of accredited CPD/CME providers and accredited educational activities;

(V) engage with accredited CPD/CME providers and organisers of accredited education to improve understanding of the accreditation requirements and development of high quality, independent education for doctors and health-care teams;

(VI) require accredited CPD/CME providers or organisers of accredited education to improve areas found to be in non-compliance with the accreditation requirements;

(VII) ensure that accreditation decisions, as well as supporting documentation, are maintained by the accrediting body according to applicable national law or professional licencing requirements; and

(VIII) ensure that accredited CPD/CME providers or organisers of accredited education retain records related to compliance with the accreditation requirements, as well as learner completion for a time period defined by the accrediting body.

Domain 2: Independence and Transparency in Accredited Education

Since there are many competing interests within and external to the medical profession that interfere with rational and evidence-based decision-making in healthcare, every effort must be made to safeguard independence and transparency in accredited education. The accrediting body plays a critical role in setting eligibility standards that prohibit commercial interests (entities that produce, market, re-sell, or distribute health-care goods or services consumed by, or used on, patients) from seeking accreditation and implementing policies that prohibit control, influence or involvement in the planning, delivery, and evaluation of accredited education by commercial interests. If funding (commercial support) is provided by commercial interests to offset the costs of accredited education, that funding must be handled in a transparent manner and disclosed to learners.

2.1 The accrediting body must require accredited CPD/CME providers or organisers of accredited education to ensure that:

(I) commercial interests have no influence, control, or involvement with the planning, content development, selection of educational methods, selection of who can deliver that content, selection of target audience, delivery of content, or any other aspect of the provision or evaluation of accredited education;

(II) all individuals involved in the planning and development, presentation (verbal or through creation of a manuscript), or evaluation of the accredited education disclose the presence or absence of relevant relationships (conflicts of interest) with commercial interests;

(III) the accredited CPD/CME provider or organiser of accredited education actively mitigates the risk that relevant relationships could bias the content of the accredited education; and

(IV) learners are informed of the presence or absence of relevant relationships (conflicts of interest) for those in control of content (planners and faculty) in a meaningful and timely way that must not include any corporate branding.

2.2 The accrediting body must require accredited CPD/CME providers or organisers of the accredited education to ensure that:

(I) the conditions and methods of payment of commercial support, defined as financial or in-kind support from entities that produce, market, sell, re-sell, or distribute health-care goods or services consumed by, or used on, patients, for the accredited education meets national legal requirements, in particular tax and anti-corruption law, as well as professional law;

(II) if professional law prohibits commercial support, then it cannot be accepted;

(III) the provision of commercial support never constitutes a relationship between individual learners and the commercial supporter;

(IV) if the accredited provider or organiser of accredited education responds to a request for grant proposal issued by a commercial interest for commercial support, the accredited CPD/CME provider or organiser of accredited education retains control over the identification of needs, selection of faculty, selection of target audience, and all other aspects of planning, presentation, and evaluation of the education;

(V) commercial support is not used to pay the personal expenses (such as travel, accommodation, honoraria, or registration fees) of individual learners;

(VI) learners are informed prior to the start of the accredited education if commercial support is received, including the source of the commercial support; and

(VII) if promotional or sales activities are allowed, such as exhibits at accredited education, those interactions must be kept separate from the accredited education and learners must never be required to engage in such activities.

2.3 The accrediting body must measure compliance by accredited CPD/CME providers or organisers of accredited education with the requirements stated in standards 2.1 and 2.2.

Domain 3: Needs Assessment Used in Planning Accredited Education

Needs assessment is an essential building block for the planning, implementation, and evaluation of accredited education. Accrediting bodies value educational planning that is nimble and flexible, allowing for immediate needs of learners to be identified and addressed.

The accrediting body must have requirements in place that ensure accredited education is developed in response to an analysis of the needs of doctors, patients, and communities. Educational needs may be identified from a variety of data sources including the expressed (perceived) needs of doctors and health-care teams, practice gaps of doctors and health-care teams, and/or the health status of patients and populations. The accredited education developed to address these needs may also address the range of competencies relevant to the professional practice of doctors.

3.1 The accrediting body must require the accredited CPD/CME providers or organisers of the accredited education to ensure that identified needs are:

(I)based on an analysis of one or more of the following data sources:

the expressed needs of the target audience

the health status of individual patients, communities or populations

gaps in the knowledge base of doctors and health-care teams

variations in the knowledge, competence, or performance of doctors and health-care teams

variations in systems of care

variation in the performance of teams;

(II)documented;

(III)used to inform the educational design of the accredited education;

(IV)used by those responsible for content development; and

(V)used to assess or evaluate the accredited education.

3.2 The accrediting body must measure compliance by accredited CPD/CME providers or organisers of accredited education with the requirements stated in standard 3.1.

Domain 4: Content Validity in Accredited Education

The content presented in accredited education must present the latest advances in scientific evidence and technological advances relevant to the practice of medicine and delivery of healthcare in order to continuously enhance the quality and safety of care provided to patients. In addition, faculty, authors, and others in control of content must ensure that the content is relevant, evidence-based, balanced, and free from commercial bias.

4.1 The accrediting body must require that the accredited CPD/CME providers or organisers of the accredited education ensure that the content presented:

(I)is relevant and responsive to the identified needs of the target audience;

(II)addresses the range of competencies relevant to the practice of medicine;

(III)provides recommendations that are based on the highest level of evidence available;

(IV)is balanced by informing learners about potential benefits and risks, especially if the content is based only on expert opinion; and

(V)is not influenced or controlled by commercial interests.

4.2 The accrediting body must measure compliance by accredited CPD/CME providers or organisers of accredited education with the requirements stated in standard 4.1.

Domain 5: Quality of Educational Design in Accredited Education

Educational design is critical to the provision of effective education. Based on the education literature, adults learn better when the education is multi-modal, episodic, and interactive. Adaptive education allows for learners with different or changing needs to participate and improve. The educational format of the accredited education should reflect the intended outcome. For example, enhancing procedural skills using only didactic lectures is less likely to be effective than hands-on, skills-based training. Workplace learning should be encouraged and supported by accrediting bodies.

5.1 The accrediting body must require that accredited CPD/CME providers or organisers of the accredited education ensure the design of the accredited education:

(I)addresses the identified needs;

(II)utilises educational formats appropriate to the intended goals and outcomes of the education;

(III)facilitates the translation of new knowledge, skills and competencies into practice; and

(IV)supports thoughtful reflection and the joy of learning within the educational setting.

5.2 The accrediting body must measure compliance by accredited CPD/CME providers or organisers of accredited education with the requirements stated in standard 5.1.

Domain 6: Outcomes from Accredited Education

The assessment of the impact of, or outcomes, from accredited education allows the accredited CPD/CME provider or organiser of the accredited education to determine if the education has been effective and to identify additional educational needs.

6.1 The accrediting body must require that accredited CPD/CME providers or organisers of the accredited education ensure the accredited education:

(I) includes one or more assessment methods (quantitative and/or qualitative) appropriate to the intended goals or outcomes of the accredited education;

(II) measures improvements in knowledge, skills, competencies, and/or intent-to-change during and/or after the accredited education;

(III) measures improvements in learner performance (where applicable); and

(IV) measures changes in patient health status (where practical).

6.2 The accrediting body must measure compliance by accredited CPD/CME providers or organisers of accredited education with the requirements stated in standard 6.1.