Clinical Standards for Women’s Health
Clinical standards are systematically developed statements that detail the essential steps in the care of patients with a particular clinical condition. Their development involves a thorough review of evidence using the GRADE methodology, incorporation of clinical expertise, and an assessment of potential benefits and harms. The aim is to improve the overall quality of care by improving patient outcomes and reducing cost.
At Texas Children’s Hospital, we develop three types of clinical standards: evidence-based guidelines, evidence summaries, and evidence-informed pathways. All follow a similar process for development but differ in their scope and breadth.
- Evidence-based guidelines provide comprehensive guidance for a particular disease throughout a continuum of care.
- Evidence summaries address a smaller number of clinical questions and may only address specific phases or components of care within the continuum.
- Evidence-informed pathways allow for standardization of care where evidence is sparse.
Clinical standards are reviewed periodically and either reaffirmed, revised, or updated. A clinical standard is reaffirmed if practice has not markedly changed warranting a revision or update. It is revised if some components were changed to reflect current practice. And it is updated if the entire literature search and practice recommendations were updated.
For questions/comments or for requests for literature appraisals, please contact the Evidence-Based Outcomes Center staff at firstname.lastname@example.org.
Clinical Standards for Pediatrics
In addition to our perinatal/women’s health clinical standards, we have developed a set of standards related to pediatrics.
Process for Development of Clinical Standards
Clinical standards (evidence-based guidelines, evidence summaries, and evidence-informed pathways) are prepared by the Evidence-Based Outcomes Center (EBOC) team in collaboration with multidisciplinary content experts at Texas Children’s Hospital (TCH). Once a topic (typically a specific disease) is selected, PICO questions (Patient Intervention Comparison Outcomes) are developed and an evidence search strategy is formed. Both internal and external guidelines are evaluated using the AGREE II (Appraisal of Guidelines for Research and Evaluation) criteria, which evaluate guideline scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, applicability, and editorial independence.
An extensive literature search is then carried out and all of the relevant evidence is appraised and summarized using the GRADE (Grade of Recommendations Assessment, Development and Evaluation) criteria. Recommendations with transparency of the strength of evidence are stated for each PICO question. The guideline presents the evidence as in support of or against specific diagnostic strategies or therapeutic interventions and identifies where evidence is lacking/inconclusive. Practice recommendations are formulated based on existing evidence and consensus among the content experts. Evidence may not exist for a small proportion of clinical questions, for which consensus recommendations are made. Patient and family values and preferences are included when possible.
These practice recommendations are the foundation of the clinical standard, algorithm(s), order sets, and any other accompanying documents. Once the documents are complete, they are reviewed and approved by the content expert team and are sent to all TCH Medical Staff for review and comment. All questions during the vetting phase are addressed and archived. After this review period, the clinical standard is approved by hospital committees as deemed appropriate for the guideline’s intended use.
Evidence-based guidelines, evidence summaries, and evidence-informed pathways, all of which constitute “shared baselines” for care delivery, are not intended to apply to all people at all times. They are created with a Pareto principle of intent for application – that they will be used in 80% of that population for which they are intended, as nuances in the other 20% represent a need to apply specific tailored clinical care. Clinicians must use clinical judgment to determine when a guideline is applicable to a patient. Similar judgment must be exercised to determine whether all components of a guideline are applicable to a particular patient.
Disclaimer: Practice recommendations are based upon the evidence available at the time the clinical standard was developed. Clinical standards (guidelines, summaries, or pathways) do not set out the standard of care and are not intended to be used to dictate a course of care. Each physician/practitioner must use his or her independent judgment in the management of any specific patient and is responsible, in consultation with the patient and/or the patient’s family, to make the ultimate judgment regarding care.