Creating Sound Clinical Consensus Statements

    Creating-Sound-Clinical-Consensus-StatementsClinical consensus statements and clinical practice guidelines are among the documents used to ensure that patients are receiving the best care possible and that clinical decisions reflect the opinions of the experts who are invested in excellent clinical outcomes.

    In other words, consensus statements are created when experts provide guidance for medical issues, even when the evidence is still being gathered, whereas clinical practice guidelines are developed based on high-level evidence. Medical writers, including freelancers, are sometimes tasked with helping to craft consensus statements. 

    What is a clinical consensus statement, and how does it differ from clinical practice guidelines? What are the practical and ethical considerations in creating a clinical consensus statement?

    Clinical Consensus Statements

    An emerging body of literature examines consensus statements and outlines best practices for creating them. An article published by the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) defines clinical consensus statements as “statements based on expert opinion and the best available research evidence for which consensus is sought using an explicit a priori methodology to identify areas of agreement and disagreement.”

    Consensus statements are often issued while clinical evidence is still being collected with the aim of creating clinical practice guidelines, which are more detailed, systematic recommendations for practice. A clinical consensus statement “is most applicable to situations where the evidence base is insufficient for a clinical practice guideline (CPG) but for which significant practice variations and quality improvement opportunities exist,” the AAO-HNSF states. 

    Clinical Practice Guidelines vs Clinical Consensus Statements

    There are some key differences between clinical practice guidelines and consensus statements, both in the content and in the process used to develop them. 

    Clinical practice guidelines are recommendations developed by multidisciplinary teams that may include consumers. The group uses systematic reviews and the results of randomized clinical trials to arrive at their recommendations. The process can take as long as 12 to 18 months.

    Consensus statements reflect agreement among a group of experts about a clinical situation or treatment based on observational studies and other currently available evidence. They are usually developed by content experts over a period of 6 to 8 months. 

    The process used to arrive at the consensus is called the modified Delphi method—a way of arriving at consensus without being in the same room.  

    Assessing the Quality and Transparency of Consensus Statements

    Several studies have examined the rigor of published consensus statements and have found that these documents do not always meet ethical standards. For example, a study of cancer-specific journals in PLoS ONE found that the “rigor of development” score of consensus statements was 32% lower than that of the clinical practice guidelines the authors evaluated. “No journals adhered to all the items related to transparency of document development,” the article reads. “One journal’s consensus statements endorsed a product made by the sponsoring pharmaceutical company in 64% of cases.”

    A number of resources and guidelines exist that can increase the transparency and rigor of consensus statements. 

    Creating Ethical Consensus Statements

    Several organizations have created criteria to address potential issues of ethics and transparency in the development of consensus statements. 

    The Process

    The Clinical Consensus Statement Development Manual published by the American Academy of Otolaryngology-Head and Neck Surgery includes a table that outlines the major steps in creating a clinical consensus statement. 

    The sample timeline includes the following steps, which take place over an 8-month period.

    1. Planning: Find and recruit the personnel/stakeholders that will develop the statement.

    2. Stage 1 literature search: Search for guidelines, systematic reviews, and narrative reviews.

    3. Conference call 1: Define statement scope, outline topics and questions.

    4. Stage 2 literature search: Search for randomized controlled trials and observational studies.

    5. Conference call 2: Review ranked questions and statements.

    6. Delphi survey 1: Develop and distribute first Delphi survey.

    7. Conference call 3: Discuss first Delphi survey results, determine topics to include in second survey.

    8. Delphi survey 2: Develop and distribute second Delphi survey.

    9. Conference call 4: Discuss second Delphi survey results, determine writing assignments.

    10. Manuscript development: Consolidate writing assignments, submit for review and editing.

    11. Journal peer review: Submit manuscript for publication.

    The Flow of Consensus

    Professional medical writers can play key roles in facilitating the consensus process, conducting literature searches, and collating and synthesizing materials from various stakeholders. They may also provide editorial assistance to authors as they develop and prepare manuscripts for submission. 

    When everyone involved has a full understanding of the ethics and processes involved, clinical consensus statements can help to educate clinicians and advance patient care.

    AMWA acknowledges the contributions of Kathleen Labonge, MBA for peer review in the development of this AMWA resource.


    May 20, 2024 at 9:00 AM

    American Medical Writers Association

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