Keeping accredited content valid and balanced
Accredited continuing medical education has to be valid and fair and balanced, and in commercially supported education much of that rests on the writer: on the evidence a recommendation stands on, the weight each treatment option is given, the sources cited, the use of brand names, the pressure a supporter brings to bear, and the disclosures and slides that pass across the writer's desk.
Why content decisions fall to the writer
CME writing assignments are often rigid and flexible at once: the writer may be asked to stay within preexisting learning objectives and content outlines, and the work is typically reviewed by faculty experts, peer reviewers and CME providers, yet writers often make high-level decisions about content direction entirely on their own or with a minimum of guidance. One day that can mean selecting citable peer-reviewed sources for a monograph on diabetes management, and the next describing therapeutic selection in relapsed or refractory multiple myeloma, where at the last count there were 30 reasonable multidrug regimens to choose from, depending on the number and type of previous treatments.
The potential for bias makes those decisions harder still. Many CME assignments are for supported activities, developed with a grant from companies likely to have a commercial interest in the therapeutic area, so direct industry support is a potential source of bias, though not the only one: faculty, for example, may have conflicts of interest of their own to resolve. The total sum of grant funding is large, and with that in mind writers have a considerable responsibility to help ensure that supported content is scientifically sound and free of industry manipulation or influence.
Writers often work closely with faculty to develop CME content. A common approach is for the faculty to send a set of slides that the writer organises, carefully fact-checks and frequently develops further; another is for the writer to craft content that the faculty then review. Either way the writer must provide the oversight that keeps the content accurate and free from marketing messages or other commercial influence. Perhaps the two most important, and interrelated, concepts for writers to uphold under the standards of the Accreditation Council for Continuing Medical Education (ACCME) are content validity and fair balance. At a minimum, accredited content has to be evidence-based and take a fair and balanced approach to describing and evaluating the relevant therapeutic interventions within a recognised standard of care for the condition or disease.
Content validity, the first standard
Content validity requirements had long been part of ACCME policy, but separately from the standards. In the standards released in December 2020, content validity is the very first standard, which the ACCME's president has said was done intentionally to emphasise its significance amid proliferating medical misinformation and disinformation and questions about the validity of science.
Under Standard 1, the accredited provider is responsible for ensuring that education is fair and balanced and that any clinical content presented supports safe, effective patient care. In a nutshell, its expectations for content validity are these: recommendations for patient care have to be based on current scientific evidence and clinical reasoning while giving a fair and balanced view of options for diagnosis and treatment; research used to support or justify a recommendation has to conform to generally accepted standards of study design, data collection, analysis and interpretation; discussion and debate are appropriate, but the education cannot advocate or promote practices not firmly based on current scientific evidence and clinical reasoning; and it cannot advocate unscientific approaches, or practices known to be ineffective or whose risks outweigh their benefits.
The ACCME toolkit for the standards gives general advice on best practices in five areas. Clearly describe the level of evidence a presentation rests on, and give enough about the data, such as study dates and design, for learners to judge the validity of the research; where there is a range of evidence, make sure the credible sources cited present a balanced view of it; where clinical recommendations will be made, include balanced information on all available therapeutic options; address any potential risks or adverse effects of any clinical recommendation; and where the evidence base for a topic or treatment is low or absent, consider other strategies, such as a debate or dialogue between several faculty representing a range of opinions and perspectives. Multiple perspectives can, for example, address a clinical question under considerable debate, such as whether routine colorectal cancer screening should begin at 45. The ACCME also offers a peer-review checklist for clinical content validity for download.
Questions the guidance leaves open
The standards as published are not prescriptive about how to achieve their goals, which leaves writers to ponder exactly what it means to be fair and balanced, and many questions are not necessarily covered in detail in formal guidance:
- If one treatment is discussed in detail, do others need equal coverage to be fair and balanced?
- What if there is only one relevant treatment for the disease the education covers?
- Is it strictly forbidden to use brand names for drugs, and if so, what should a writer do when generic descriptors are overly complicated or confusing?
- Can a company press release be cited, and if not, how should research be cited that has apparently not yet been published or presented?
It is generally not all on the writer's shoulders to parse out difficult situations regarding fair balance, potential conflicts of interest or other issues. The accredited provider is ultimately responsible for ensuring that the overall activity aligns with the ACCME standards, and its staff should be skilled and experienced in applying them and can be an excellent resource. Writers are accordingly strongly encouraged to reach out to the provider when unsure how to proceed, ideally early rather than late in content development, so that carefully crafted content is not unexpectedly sidelined by last-minute revisions.
Fair balance
By the ACCME definition, fair and balanced information, recommendations or emphases “fairly represent” and are “based on a reasonable and valid interpretation” of the information available on the topic.
Experienced CME writers offer tips for applying it, not as unassailable expert advice but as a path forward that may be acceptable. The first is to provide fair balance but not necessarily equal time: it is important to avoid focusing on a specific treatment and to discuss efficacy as well as safety data, but there is no need to discuss each treatment option with exactly the same emphasis, and the strength of the evidence and the FDA-approved indications should guide the weight of discussion. For example, two treatments for a dermatologic condition may appear to have similar rates of response and tolerability, yet on closer inspection the evidence for one comes from a randomised, placebo-controlled phase 3 trial and the other from a single-arm phase 2 trial, and the first may have a specific FDA indication for the condition while the second is used off-label. Off-label use is common and sometimes necessary, but the education should be upfront about it, and ideally refer to the evidence supporting the unapproved use. High-quality review articles and clinical practice guidelines may offer clues for cataloguing the evidence to date, although caution is advised in relying on stale information, particularly in fast-moving areas such as immuno-oncology, where new data are always a meeting away or less.
A therapeutic area may be so underserved that there is only one relevant emerging or novel treatment option, as in a rare disease whose previous standard of care was supportive care, and fair balance may then be a discussion of emerging therapeutic options in earlier stages of clinical investigation. Failing that, balance can be provided by ensuring adequate discussion of the potential risks of therapy alongside its potential benefits, which is good practice in CME writing in any case.
A checklist for developing fair and balanced CE/CME content gives five steps:
- Use the best available source materials.
- Avoid focus on any one treatment.
- Give equal time to the benefits and risks of treatment.
- Avoid brand names for agents, devices or procedures; if a brand name is necessary for one intervention, provide brand names for all interventions.
- Be transparent about emerging therapies, including what clinical trial phase they are in.
The hierarchy of sources
For content validity, the use of appropriate source material is key. Experienced CME writers generally recognise a hierarchy of evidence and sources, although caveats apply at each level. Peer-reviewed, PubMed-indexed journal articles are usually considered highly citable, but some judgement is required, as not all peer-reviewed research is of high quality and not all journals are as impactful as others. Sources should include peer-reviewed clinical and scientific articles, published preferably in high-impact-factor journals.
Clinical practice guidelines also rank high, particularly from well-known medical societies or organisations such as the American Heart Association, although not all guidelines are rigorously developed. Look for methodologies such as GRADE, which can be used to evaluate the quality of evidence and quantify the strength of healthcare recommendations. Guidelines and special reports published by government sources or medical societies are valid resources, and so are textbooks, although textbooks may not have the most current information. Many writers like UpToDate as a comprehensive resource for clinical care, but it is not suitable as an original source.
Medical meeting presentations are generally considered fair game. However, the information in a meeting abstract may not be peer reviewed, and the conclusions of the research may change substantially between submission of the abstract and the meeting presentation, and sometimes again by publication in a peer-reviewed journal. Published abstracts of research to be presented at medical meetings are often peer reviewed and can serve as acceptable references. Posters based on those abstracts are generally not peer reviewed but often present the most current information available, so they may require a judgement call.
Sources to avoid include blogs, Wikipedia and other nonscholarly websites, other CE/CME programmes, ineligible companies’ websites and press releases, and outdated or obsolete references. Many agree that company press releases are not appropriate to cite, and as a result it can be tricky to develop a state-of-the-art CME presentation when a potentially practice-changing clinical trial result is available only as a press release. There are no easy solutions, but one approach may be to reference publicly available details of the trial design, from the ClinicalTrials.gov database for example, and state in the activity that published or presented results are awaited.
Logos and brand names
Omitting corporate logos is a no-brainer. Eschewing brand names is considered best practice, but it is not always straightforward or without challenges. Medical devices, biosimilars and proprietary formulations of common drugs are among the products that are sometimes difficult to discuss without brand names. The COVID-19 vaccines are widely referred to by their manufacturers' names, so many learners will not immediately know whether the Pfizer mRNA vaccine is BNT162b2, mRNA-1273 or Ad26.COV2.S (it is BNT162b2). Some audiences may know a drug only by its brand name, which makes education based on generic names an uphill battle.
Pressure from the supporter
In one writer's CME project, a supporter complained that the faculty had not given its therapy sufficient attention in a live preconference session, and the education provider then asked the writer to add material about the supporter’s product to the downloadable slide deck “to keep the supporter happy”. In that writer's view, such behaviour flouts a fair and balanced approach to content, threatens content integrity and damages the regulatory firewall.
The same writer holds that the mechanisms that protect content integrity and prevent commercial influence, financial and conflict-of-interest disclosures and independent, thorough content review, are for the most part sufficient to maintain the firewall. However, a pharmaceutical manufacturer issuing a request for proposals for education has internal objectives it expects the education to meet, and the business and sales managers in education provider organisations know this. Securing funding through grant development involves a delicate dance of keeping content firmly within the 2020 ACCME standards while also implicitly appealing to the supporter's interests, and at times these managers might zealously communicate those interests to writers, which is a form of tacit pressure. Writing extensively about clinical trial data for one particular therapy is a common way that content gets skewed.
Writers are bricks in the firewall between industry and education, charged with maintaining content independence and integrity, so they need to be meticulous about the sources they review and use. They can maintain that independence by raising their awareness of where tacit pressure can creep into content development and by pushing back on any potential to breach the firewall.
The other standards at the writer's desk
Content validity is one important piece of the ACCME standards, and others intersect with the writer's work too. Under the standard on identifying, mitigating and disclosing relevant financial relationships, writers should make sure disclosure information, their own included, is provided in the activity they are developing, and may need to solicit it if it is not already available. Under the standard on preventing commercial bias and marketing, a writer whose faculty member tries to add a slide that the local drug representative said would be "just perfect" for the activity should decline it and remind the faculty that decisions about the education must be made without influence or involvement from pharmaceutical company employees.
Writers are often on the front lines of developing accredited continuing education, so they should have a thorough working knowledge of the latest ACCME standards. Reviewing the available ACCME resources, including the guidance and checklist for clinical content validity, will help writers apply the standards to their current projects, and better prepare them to develop clinical content that is fair and balanced, unbiased and supportive of safe and effective patient care.