Update Clinical Care Guidelines

Benefits of Guidelines

Clinical care guidelines serve as a framework for clinical decisions and support best practices. Guidelines are developed through a critical review of the medical literature, outcomes research, and clinical practice standards of care for diagnosing and treating the symptoms of disease. Benefits include:

• Provides evidence-based clinical guidance.
  • The level of evidence for each recommendation is included.
• Assesses the likely benefits and harms of a particular treatment
  • Strength of a specific recommendation is also rated and includes overall assessment of the treatment and impact of treatment.
• Enables clinicians to select the best care for a unique patient based on the patient’s preferences, the medical evidence, and the available options. In other words, the goal is patient-centered treatment. 
• Integrates newly approved medical interventions so that patients and their doctors can make informed decisions.
• Ensures current standard of care is provided to patients with rare diseases or diseases that are challenging to treat especially when access to specialists familiar with the disease is limited.

Guideline Development Process

The development of clinical care guidelines has been established to ensure the guidelines present recommendations based on current evidence and are feasible, measurable, and achievable. In many cases, guideline development involves a collaborative effort.

• Collaborators on clinical guidelines may include: 
  • Patient groups and associated medical advisors.
  • Specialists for a specific disease.
  • Medical professional societies. Societies most often provide a website with information on the guidelines development process. A few examples include: 
    • American Academy of Pediatrics (AAP) Clinical Practice Guideline Manual
    • American Academy of Family Physicians (AAFP) Clinical Practice Guideline Manual
    • Endocrine Society Practice Guidelines Methodology
    • American Academy of Neurology (AAN) Systematic Review and Guideline Development Process
• General process: Clinical Practice Guidelines We Can Trust: Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs) (2011) is a compilation of standards that can be used to determine how to successfully create clinical practice guidelines. 
  • The 8 standards are:
    • Establishing transparency.
    • Managing conflict of interest.
    • Guideline development group composition.
    • Clinical practice guideline/systematic review intersection.
    • Establishing evidence foundations for and rating strength of recommendations. 
    • Articulation of recommendations.
    • External review.
    • Updating.
  • The document provides recommendations for composing a group to create the guidelines and how to review and update the guidelines.
  • Medical professional societies base their own process on the standards set forth in this document.
  • These guidelines were developed by the Institute of Medicine (IOM), a division of the National Academies of Sciences, Engineering, and Medicine (the National Academies)
    • The document is only 2 pages in length. 
    • The IOM was renamed the Health and Medicine Division (HMD) in 2016.
    • The National Academies are a series of private, non-profit institutions that have been in operation since 1863, when President Lincoln signed a congressional charter to the National Academy of Science. The National Academies conduct independent, objective activities to solve complex problems and inform public policy decisions related to science, technology, and medicine. 

Supporting Guideline Development

Depending on who is leading the development of the guidelines, your involvement may differ. However the voice of the disease communities is increasingly essential to the development of clinical care guidelines, especially for rare or complex, challenging-to-treat diseases. Your group can:

• Organize an executive committee to oversee the development of clinical guidelines.
• Collaborate with a medical professional society or a group of specialists already in the process of developing guidelines to ensure your disease community’s concerns, preferences, and unmet medical needs are considered. You can provide data from:
  • Patient registry
  • Natural history study
  • Patient preference studies
  • Patient benefit risk studies

Disseminating the Guidelines

After publication of new or updated clinical care guidelines, your group can play a role in making sure clinicians treating your disease are aware of and have access to the guidelines. Your group can:

• Post the guidelines on your website.
• Use strategies listed in NCATS Toolkit module Develop Programs to Speed Diagnosis: Raising Awareness.
• Encourage patients who are not being seen by specialists familiar with your disease to share the guidelines with their doctors. 
  • Primary care doctors who may be coordinating a patient’s care may also benefit from the guidelines.
• Develop a Users Guide to provide additional information about how the guidelines were developed and how they can be used.
  • Friedrich’s Ataxia Research Alliance (FARA) provides information about their involvement in the development of clinical management guidelines for Friedrich’s ataxia (FA) and User Guide in: Consensus Clinical Management Guidelines For Friedreich’s Ataxia (FA).
• Consider offering alternative ways for patients to keep a copy of the guidelines with them at all times. For example:
  • FARA, in collaboration with a major pediatric hospital, offers patients with FA a USB bracelet to store the FA clinical care guidelines as well as a patient’s personal medical records. The bracelet provides a physician easy access to all of the patient’s medical information. 
    • Information about the bracelet is towards the bottom of their Consensus Clinical Management Guidelines For Friedreich’s Ataxia (FA)  webpage.
  • Some patient groups are also developing applications for smartphones to provide similar information. 

Resources