Update Clinical Care Guidelines

Overview

If clinical care guidelines have been previously developed and published for your disease, you will want to ensure an updated version is published when a therapy receives U.S. Food and Drug Administration (FDA) marketing approval. You can work with your medical advisors, specialists involved in the clinical trials, and the specialists involved in the previous version of the guidelines to make sure the updates are clear and continue to provide a treatment decision framework for patients and their doctors. Addition of a new therapy will require the guidelines go through an approval process similar to the original development. 

If clinical care guidelines have not previously been developed for your disease, the approval of a new therapy can be a great time for your patient group to promote and encourage the development of clinical guidelines. Patients and their caregivers can provide input about symptoms, side effects of different treatments, and the importance of therapies.

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.

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.
  • 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. 
    • Some patient groups are also developing applications for smartphones to provide similar information. 

Resources

Guideline Development Process
Disseminating the Guidelines

If clinical care guidelines have been previously developed and published for your disease, you will want to ensure an updated version is published when a therapy receives U.S. Food and Drug Administration (FDA) marketing approval. You can work with your medical advisors, specialists involved in the clinical trials, and the specialists involved in the previous version of the guidelines to make sure the updates are clear and continue to provide a treatment decision framework for patients and their doctors. Addition of a new therapy will require the guidelines go through an approval process similar to the original development. 

If clinical care guidelines have not previously been developed for your disease, the approval of a new therapy can be a great time for your patient group to promote and encourage the development of clinical guidelines. Patients and their caregivers can provide input about symptoms, side effects of different treatments, and the importance of therapies.

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.

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.

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

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.
  • 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. 
    • Some patient groups are also developing applications for smartphones to provide similar information. 

Resources

Guideline Development Process
Disseminating the Guidelines