Where do they come from?
What do they mean?
How can we trust them?
How should we use them?
US Preventive Services Task Force: member 2016-2020.
Advisory Committee for Immunization Practices Immunization Schedules Workgroup, Centers for Disease Control: Liaison for American Academy of Family Physicians 2012-present.
Scenario #1 from a day in the office:
An 18 month-old male is in the office for a well-child check.
He is well, his parents have no concerns, his growth is on track, his developmental milestones are appropriate for his age.
At his 12 month visit, he had a mild viral URI (not COVID...), and it was decided not to give his immunizations at that time.
He was due to return for his immunizations in one month, but life got busy, and they're just now returning.
How do we get him caught up on his immunizations?
An immunization guideline would be very useful:
too many immunizations to search primary evidence
timing and coordination are important.
Where could we find an immunization guideline?
Who makes guidelines?
Scenario #2 from a day in the office:
A 43 year old female presents for a "well woman" examination.
When I graduated from residency in 1995, I would have recommended:
Cervical cancer screening yearly from onset of sexual activity until an undefined time after menopause including complete pelvic examination.
Mammography from age 50 on, with yearly clinical breast examination and advice about regular breast self examination.
Discussed when to start hormone replacement therapy around menopause.
Considered a bone density scan
Now (2021), I recommend:
Cervical cancer screening (pap and HPV) every 5 years if negative without routine pelvic examination.
Mammography every 2 years from 50-75, possibly every 2 years from 40-50.
An evaluation of her osteoporosis risk factors and calculation of her fracture risk prior to age 65, or bone density screening at age 65.
No hormone replacement therapy if undergoing normal menopause.
How can I determine which guidelines are the most useful to help me design my clinical practice?
What makes guidelines useful? (put some thoughts in the chat)
Usefulness = (Relevance X Validity)/Work
Guideline Critical Appraisal
DOMAIN 1. SCOPE AND PURPOSE
The overall objective(s) of the guideline is (are) specifically described.
The health question(s) covered by the guideline is (are) specifically described.
The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described.
DOMAIN 2. STAKEHOLDER INVOLVEMENT
The guideline development group includes individuals from all relevant professional groups.
The views and preferences of the target population (patients, public, etc.) have been sought.
The target users of the guideline are clearly defined.
DOMAIN 3. RIGOR OF DEVELOPMENT
Systematic methods were used to search for evidence.
The criteria for selecting the evidence are clearly described.
The strengths and limitations of the body of evidence are clearly described.
The methods for formulating the recommendations are clearly described.
The health benefits, side effects, and risks have been considered in formulating the recommendations.
There is an explicit link between the recommendations and the supporting evidence.
The guideline has been externally reviewed by experts prior to its publication.
A procedure for updating the guideline is provided.
DOMAIN 4. CLARITY OF PRESENTATION
The recommendations are specific and unambiguous.
The different options for management of the condition or health issue are clearly presented.
Key recommendations are easily identifiable.
DOMAIN 5. APPLICABILITY
The guideline describes facilitators and barriers to its application.
The guideline provides advice and/or tools on how the recommendations can be put into practice.
The potential resource implications of applying the recommendations have been considered.
The guideline presents monitoring and/or auditing criteria
DOMAIN 6. EDITORIAL INDEPENDENCE
The views of the funding body have not influenced the content of the guideline.
Competing interests of guideline development group members have been recorded and addressed.
Scenario #3 from a day in the office:
A 54 year old male presents for his routine chronic disease management visit.
"I need more of my high blood pressure medicine and y'all said I had to come in."
He is taking lisinopril, 10 mg per day and tolerating it well.
He takes his blood pressure three times per week at home - they have been ranging from 142/80to 154/90, with most of the blood pressures below 150/90.
His blood pressure in the office is 145/88. He examination is otherwise unremarkable.
He had gotten blood work done last week. His potassium and creatinine are within normal limits.
So, what should I do about his blood pressure?
Which guidelines should I use in my practice?
When Guidelines Differ - What is high blood pressure?
JNC VII - 1997
(if DM, CAD, CKD, >=130/80)
JNC VIII - 2014
Age < 60, > =140/90
Age >= 60, >=150/90
2017 Pharmacologic Treatment of Hypertension in Adults Aged 60 Years or Older to Higher Versus Lower Blood Pressure Targets: A Clinical Practice Guideline From the American College of Physicians and the American Academy of Family Physicians
Age >= 60, >= 150/90
2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines
- Establishing Transparency
Processes - explicit and publicly accessible.
- Management of Conflict of Interest (COI)
Selection of members, Disclosure, Divestment, Exclusions
- Guideline Development Group Composition
Multidisciplinary and balanced
Patient and public involvement
- Clinical Practice Guideline–Systematic Review Intersection
IOM Standards for Systematic Reviews of Comparative Effectiveness Research.
GDG and systematic review team should interact regarding the scope, approach, and output
- Establishing Evidence for and Rating Strength of Recommendations
Reasoning underlying the recommendation:
a clear description of potential benefits and harms;
a summary of relevant available evidence (and evidentiary gaps),
description of the quality (including applicability), quantity (including completeness), and consistency of the aggregate available evidence;
an explanation of the part played by values, opinion, theory, and clinical experience in deriving the recommendation.
A rating of the level of confidence in (certainty regarding) the evidence underpinning the recommendation
A rating of the strength of the recommendation in light of the preceding bullets
A description and explanation of any differences of opinion regarding the recommendation
- Articulation of Recommendations
standardized form - what the recommended action is, and when it should be performed.
Strong recommendations should be worded so that compliance with the recommendation(s) can be evaluated.
- External Review
full spectrum of relevant stakeholders: scientific and clinical experts, organizations (e.g., health care, specialty societies), agencies (e.g., federal government), patients, and representatives of the public.
Confidential authorship of reviews
The GDG should formally consider all external reviewer comments
A draft of the CPG should be made available to the general public for comment.
The CPG publication date, date of pertinent systematic evidence review, and proposed date for future CPG review should be documented in the CPG.
Literature should be monitored regularly following CPG publication to identify the emergence of new, potentially relevant evidence and to evaluate the continued validity of the CPG.
CPGs should be updated when new evidence suggests the need for modification of clinically important recommendations.
Scenario #4 from a day in the office:
A 68 year old female presents for her chronic disease management visit for hypertension and cholesterol.
Blood pressure is controlled on HCTZ 25 mg per day, and she is on a moderate potency statin for a 10 year ASCVD risk of 12%.
I do NOT auscultate her carotid arteries for bruits.
How can I be sure she doesn't have a stroke in the next few years?
How much should guidelines dictate our decision-making?
Can I get sued for following a guideline? Or for not following one?
Guidelines and Malpractice
I'm not a lawyer, this is not legal advice.
Establishing Standard of Care is important - mainly through expert testimony
Experts have to say that guidelines establish the standard of care in a community.
Most guidelines state that they themselves are not prescriptive - that the individual patient's circumstances should be considered.
Physicians are always responsible for their decisions. Malpractice is not defined solely by a bad outcome, it's defined by failure to perform professional responsibility - taking history, appropriately evaluating, documenting thinking, organizing management plan and follow up.
Using Guidelines - Closing Thoughts
For Knowledge to Guide Practice:
Identify systematic reviews
Most identify gaps in evidence --> basis for further research
Quality improvement initiatives
Scope issues (impact of multimorbidity)
EBM ideals: research evidence, patient values, clinical expertise (not really a limitation...)
How did we do?
Where they come from?
What they mean?
How we can trust them?
How we should use them?