Standards have been the key to freeing up time for innovation and creativity since the ancient Egyptians developed the royal cubit standard of measurement for use in building the pyramids nearly 5,000 years ago. The continuing medical education community’s monumental task—providing high-quality, cost-effective education that changes behavior—may not involve construction, but it has challenges of its own that cry out for standardization.

One is the budget process. Every grantor has its own budget and reconciliation templates, and its own “language” or set of definitions a medical educator has to interpret. Grantors reviewing educational requests also need to translate educational providers’ budget classifications to match their organizations’ templates. It’s nearly impossible to benchmark across the industry because each organization classifies components of an educational intervention quite differently.

This lack of consistency and standardization leads to confusion and inaccuracies, and it forces medical educators to expend resources to interpret multiple grantor budget templates and processes.

Could the development of standardized budget and reconciliation templates and a dictionary of standardized definitions help free up time and effort to spend on improving the quality of medical education interventions, rather than mundane tasks such as interpreting terminology and classifications?

We were part of a working group that believed it would. So we made it happen.

Brainstorming Best Practices
In 2009 a working group of medical education providers and grantors convened to brainstorm ways to standardize the inconsistent terminology, budget, and reconciliation templates and processes across the CME/CE community. We also wanted to find ways to negate the need for education providers to dedicate non-value-added resources to align internal processes with varying external requirements among the commercial supporters.

The science of standardization improves the exchange of information by providing a common method of communicating. The group—including pharmaceutical companies, medical education companies, a medical association, and a cancer center—believed standardization would reduce the confusion caused by having to navigate multiple formats, as well as the overhead associated with interpretation and translation.

The primary objectives of the collaborative working group of education providers and grantors were:

• to help education providers and grantors consistently classify facets of an educational intervention, from activity planning to continuous assessment,

• to share best practices that the CME/CE community could adopt as industry standards, and

• to develop a set of standard definitions that the broader community can use in developing educational activities.

Seven Steps to Standardization
The life cycle of standards development and implementation generally comprises seven major phases. Once the working group identified a need within the CME/CE community for standardization in this area, the remaining principles were used to guide the initiative.

Identification of need: Identify the need and determine whether a standard would be of benefit to the target community. Will a standard provide a technical and economic advantage to the sector? The need to improve the budget process, and the benefits standardization could bring, were easily identified within the CME/CE community. (See Thanks, We Needed That!)

Collective programming: Reflect upon needs identified and the priorities defined by partners involved. We reviewed several budget templates used by education providers and grantors and incorporated the most common and useful elements from each into a working draft.

Creation of standards: Prepare a draft of standards that represents a variety of partner perspectives. The draft was further refined based on working group input and consensus to develop standard templates and a corresponding data dictionary, which included a comprehensive collection of descriptions, meanings, and examples of elements that constitute an educational intervention.

Consensus: Take into account the views of all interests. Focus groups of both education providers and grantors were asked to provide feedback on components within the templates and dictionary. The group also got feedback from the Pharmaceutical Alliance for CME (PACME) member section leadership and the PACME/Medical Specialty Society (MSS) Workgroup, whose goal is to develop standardized definitions and processes and provide best practice recommendations for the CME/CE community.

Validation: Evaluate the draft standard through a public inquiry to ensure it conforms with the interests of all. Examine the results and comments received before finalizing the draft standard. The group also sent a survey to an industry distribution list to ascertain the likelihood industry supporters would adopt it. The working group reviewed the survey results and incorporated them into the standard tools. A total of 52 individuals responded, the majority of whom were with the pharmaceutical/medical device/biotech industry (65 percent; 34 colleagues). Twenty-three percent of respondents were the heads of their respective departments. Ninety-five percent endorsed the concept of a standardized budget template; a majority said they would likely adopt the standardized tool.

Approval: Approve the draft standard for publication as a standard. The templates and corresponding data dictionary have since been reviewed and endorsed by the PACME/MSS Workgroup, and the concept of using these tools has also been approved by the Alliance for CME, which has posted these resources on its Web site. Non-members can download the Excel file here.

Review: Continuously assess to ensure the standard adapts to new needs. The working group members intend to pilot the draft template within their organizations, where possible. This testing will enable group members to continuously assess the template and make any necessary modifications.

Introducing the Tools
These tools are intended to provide a consistent framework for classifying the multiple components of an activity’s budget. The data dictionary establishes standardized expense-related terminology. Definitions and clearly defined examples are provided for each budget line item to alleviate confusion. (Here are a few examples from the Data Dictionary). There also is guidance on how to further customize them to accommodate multiple activities and formats.

The templates have been designed so that rows/columns can be collapsed or added and tailored to meet individual grantor/education provider needs and include three standard expense sections: management, direct activity, and continuous assessment and educational effectiveness measures. The templates were also designed to address questions such as:

Where do I include costs associated with gap analyses, clinical/program content development, research/opinion leader consultation, and/or chart audits?

How do I categorize/break down a multifaceted initiative that includes a roundtable advisory board, several live events, enduring activity, educational exhibit, and a Web portal?

The benefits of implementing and utilizing a standardized budget and reconciliation template and corresponding data dictionary extend to both education providers and grantors. Among them:

• Standardized budget categories and definitions allow educators and grantors to streamline the grant development, submission, review, and reconciliation processes

• A common language facilitates enhanced communication among stakeholders, thereby reducing errors caused by misinterpretation.

• Consistent budget categories create operational efficiencies in reviewing and reconciling budgets.

• The use of consistent terminology brings opportunities to benchmark key components/costs associated with educational activity expenses across the industry.

Collaborating across sectors to develop a standard tool was not simple or expeditious; however, it has paved the path for future partnerships aimed at improving processes, enhancing communications, and setting standards across the industry. This initiative was envisioned as the first step toward creating consistencies across the CME/CE community. These tools can also be leveraged by the broader community to develop activities beyond the scope of CME/CE, as they were designed with cross-industry applicability in mind. In the spirit of continuous improvement, these tools reflect the initial phase in creating standardized templates and terminology, but the intent is to continue to perfect them based upon evolving needs. The great pyramids took time to build, yet simple standard measurements allowed for a sustainable structure to be created and for the evolution of subsequent pyramids built throughout history. Think simple, create monumental.

Authors’ note: Grantors interested in implementing changes to their organization’s existing budget/reconciliation template should confer with their grant system vendor and/or internal information technology department to appropriately assess the time and process associated with adoption of the standardized tools.

Sarah Krüg was global education director, Medical Education Group, with Pfizer Inc. during the development of these standards. Prior to joining Pfizer in 2001, Sarah spearheaded the development of the pediatric disease management clinical pathways and conducted clinical research at Memorial Sloan Kettering Cancer Center.
Haleh Kadkhoda is director, Collaborative Grants, Oncology, with Medscape LLC, where she builds partnerships with academic centers and oncology professional and patient advocacy organizations to develop comprehensive educational plans for the cancer care team’s multidisciplinary members.


Acknowledgments
The budget templates, data dictionary, and this article were developed through the collaboration of the following working group of grantors and education providers:

Sarah Krüg
Global Education Director,
Medical Education Group,
Pfizer Inc.

Todd Jackson, PharmD
Manager, Medical Education and Therapeutic Alliances,
Center for Medical Education,
GlaxoSmithKline

Patti Merwin
Director, Scientific Education,
Celgene Corp.

Patricia Jassak,
MS, RN, CCMEP
Associate Director of Independent Medical Education,
Astellas Pharma Global Development Inc.

Haleh Kadkhoda
Director, Collaborative Grants
Educational Services,
Medscape LLC

Marc Eigner
Partner,
Polaris Management Partners

Dierdre McKee, MPH
Director, Continuing Medical Education and Grants,
National Comprehensive Cancer Network

Kathy Ann Smith,
CMP, CCMEP
Coordinator of CME,
Fox Chase Cancer Center

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