Skip to main content

Assessing Genomic Sequencing Information for Health Care Decision Making Workshop Summary (2014) / Chapter Skim
Currently Skimming:

4 The Development of Practice Guidelines
Pages 43-50

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 43...
... • The use of genomic information can be guided by estab lished medical ethics principles for clinical practice and re search, including autonomy, beneficence, non-maleficence, and justice. • Obtaining informed consent from and providing genetic counseling for patients undergoing large-scale genome se quencing is essential to patient-centered care; opportunities remain to ensure consistent counseling by qualified clini cians across the health care delivery spectrum.
Read the entire page →
From page 44...
... While rigorous processes exist for developing clinical guidelines, such as those in oncology, development can be time consuming and may not meet the demands of the field. GUIDELINE DEVELOPMENT: LESSONS FROM ONCOLOGY As is the case in many other fields of medicine, the oncology community is trying to come to grips with the rapidly emerging trove of genomicdriven data, said Gary Lyman, a full member in the Cancer Prevention Program, Public Health Sciences Division, at the Fred Hutchinson Cancer Research Center.
Read the entire page →
From page 45...
... The IOM standards call for a transparent guideline development process; management and disclosure of conflicts of interest; multidisciplinary expert panels; rigorous systematic reviews of existing evidence; grades for strength of evidence and strength of recommendations; standardized and clear recommendations; external review, including public comment; and a plan for revising and updating. The ASCO protocol starts with topic selection for clinical practice guideline development, followed by the appointment of a steering committee to define the relevant questions and facilitate a systematic review of published research with explicit criteria for inclusion and exclusion.
Read the entire page →
From page 46...
... , which is attempting to compile, analyze, and annotate clinical information on patients in real time, including their treatments, side effects, and, where available, tumor genomic or molecular profile information, with the goal of eventually including clinical decision support. With genomic and biomarker information integrated, the project offers the potential for mining this database to formulate hypotheses for improving cancer care that can be tested in randomized clinical trials, Lyman said.
Read the entire page →
From page 47...
... Preliminary data captured from parents before the BabySeq clinical trial started and within 24 hours of giving birth revealed that the majority of those asked were at least "somewhat interested" in exploring genome sequencing for their newborns.2 Saal participated in generating updated guidelines on ethical and policy issues in genetic testing of children which were jointly released by the American Academy of Pediatrics (AAP) and ACMG in 2013 (Committee on Bioethics et al., 2013; Ross et al., 2013)
Read the entire page →
From page 48...
... In addition, he said, the need to respect patient autonomy dictates that patients can approve or refuse any possible testing of their genomes. "Most patients probably would want that information," he said, "but on the other hand you need to document that they do or do not." The obligation to treat all people equally, fairly, and impartially -- that is, to assure justice in treatment -- raises additional considerations about the significant issue of the high cost of genetic testing, given that health care has been unaffordable for many Americans and that health insurers often do not cover these tests, Saal said.
Read the entire page →
From page 49...
... Neurologists, developmental pediatricians, and family physicians, for example, may have the credentials to order this testing, but then the issue is who should be responsible for genetic counseling and ensuring that this component is an integral part of the testing. Informed consent for such testing cannot be obtained without genetic counseling, Saal said, yet there may not be enough genetic counselors to meet future workforce needs.
Read the entire page →

Key Terms

  • clinical practice
  • genetic testing
  • genome sequencing
  • developing clinical
  • genetic counseling

  • guideline development
  • genomic data
  • iom standards
  • clinical guidelines
  • clinical trial

  • order genetic
  • care physicians
  • quality indicators
  • breast cancer
  • public comment

  • informed consent
  • time consuming
  • external review
  • trustworthy clinical
  • clinical trials

  • clinical decision
  • asco clinical
  • clinical oncology
  • babyseq clinical
  • practice guideline

  • clinical information
  • oncology practice
  • genetic mutations
  • validated clinical
  • randomized clinical


    • This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
    More information on Chapter Skim is available.