Download Developing Clinical Questions

Developing Clinical Questions
Clinton Pong, MD
Randi Sokol, MD, MPH
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Introductory Case:
•
A 45-year-old male with hypertension presents to your clinic
for follow up. At a prior visit he was screened for diabetes.
•
•
•
His hemoglobin A1C has been 7.0% on two occasions, which is
a new diagnosis of diabetes.
His blood pressure is well controlled at 125/80.
He has no evidence of microalbuminuria or kidney disease.
•
You recall from medical school that ACEi are good for
preventing diabetic kidney disease, but you’re not sure if this
fact applies to this patient.
•
You want to find this answer.
•
This module will walk you through the process of developing a
clinical question!
By the end of this session,
you will be able to:
• Explain the difference between
•
Background and foreground questions
• Differentiate between
•
Patient-oriented evidence and disease-oriented
evidence
• Identify foreground questions and then apply
the PICO format to create searchable clinical
queries
•
Population, Intervention/Comparison, Outcome
So, how do I develop a clinical
question?
•
•
Two types of questions:
1- Background Questions
•
2- Foreground Questions
•
•
Background questions ask
“who, what, where, when, why, or
how” about a single disease ,
drug, intervention, or concept.
Think of these as basic questions
you might find from a textbook or
a general EBM resource
•
Eg, prevalence, ddx, pathophys,
sensitivity/specificity of a test,
med dosing/adverse reactions
Background
Questions
Basic Clinical
EBM
Background
Intro case:
Background Question Brainstorming
•
What are some
background questions that
you can think of related to
our gentleman with
diabetes and HTN, related
to the use of an ACE
inhibitor?
• Who
Background
Questions
• What
• Where
• When
EBM
Basic Clinical
Background
• Why
• How
•
•
Some possibilities/suggestions:
For diabetic kidney disease:
•
•
•
How does an ACEi work
•
•
•
•
to lower BP?
to reduce diabetic nephropathy?
What dose of an ACEi do I
prescribe?
What labs should I check for
someone on an ACEi?
•
•
•
What is the mechanism?
What is the pathology?
Potassium? Creatinine?
How often?
What are the side effects of
using an ACEi in patients with
high blood pressure?
So, how do I develop a clinical
question?
•
•
•
•
Two types of questions:
1- Background Questions
2- Foreground questions:
Foreground questions ask for
specific knowledge to inform a clinical
issue on a specific patient,
intervention,or therapy.
•
•
If based on expert opinion or best
practices, they are guidelines.
If based on EBM, they typically
compare two things (or against
placebo) in a research study:
•
•
•
Diagnostic tests
Drugs
Treatments
Foreground
Questions
General
Resources
eg, Guidelines
Research
Studies
Information Mastery Resources, by Type:
Background
Questions
Basic Clinical
Foreground
Questions
EBM
Background
“Medical Student
Questions”
eg, etiology, pathophys,
pharmacology
General
Resources
eg, Guidelines
“Resident Questions”
eg, appropriate steps in
workup and management
Research
Studies
To develop a
searchable
clinical query,
you need to formulate
a foreground question
in the PICO format
(Based on BU and Dartmouth models)
The PICO Question Components
•
•
•
P
•
I
Problem and Population
Intervention
•
•
•
C
•
O
What is the intervention I am looking for?
Is it realistic (availability, cost, convenience, etc)?
Is this different from how I currently practice?
Comparison
•
•
What is the disease or condition?
What are the important characteristics of my
patient?
What is the alternative to the intervention?
Outcome
•
•
Is it something patients care about?
Or is it something only physiologists/pharmacists
care about?
(Jackson, 2006; Flaherty, 2004)
So, how do I develop a clinical
question?
Focusing the PICO question
•
Population
•
•
•
Intervention/Comparison
•
•
•
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Starting with your patient, ask "How would I describe a group of
patients similar to mine?"
Be precise but brief.
Ask “What is the main intervention I am considering?”
and “What is the main comparison/control?”
Be specific, but consider feasible alternatives.
Outcomes
•
•
Ask "What can I hope to accomplish?" or "What could this
exposure really affect?“
Select patient-oriented outcomes instead of “the numbers.”
(University of Oxford EBM Tools, 2013)
Intro Case:
Foreground PICO Question Brainstorming
•
Problem/Population
•
P
•
Intervention
•
•
I
C
“Compared to placebo” or “BB/CCB/diuretic/etc.”
Outcome
•
O
“Does an ACEi”
Comparison
•
•
“In adult patients with diabetes mellitus II and
hypertension”
•
“Prevent development of microalbumuria?”
OR
“Prevent worsening of eGFR?”
Are these outcomes
our patient cares about?
The Patient Is What Matters
Disease-Oriented
Evidence (DOE)
• Measures outcomes
that are markers for
disease
• “Silent
numbers”
Patient-Oriented Evidence
That Matters (POEMs)
• Measure outcomes
that our patients care
about.
• They have the
potential to change
the way we practice!
(Slawson , 1994)
Characteristics of DOEs and POEMs
Disease-Oriented
Evidence (DOE)
• Pathophysiology
•
•
Lab values
Biochemical markers
• Pharmacology
•
•
Plaque size
Blood pressure
• Etiology
Patient-Oriented Evidence
That Matters (POEMs)
• Morbidity
•
•
Symptoms
Daily function
• Mortality
• Quality of Life
•
(as perceived by the
patient)
(Slawson , 1994)
Examples of DOEs and POEMs
Disease-Oriented
Evidence (DOE)
Intensive treatment can
lower blood glucose levels
in patients with type II
diabetes
Beta-carotene and vitamin
E are good antioxidants
Patient-Oriented Evidence
That Matters (POEMs)
Intensive treatment in patients
with type II diabetes does not
decrease mortality.
Neither beta-carotene or
vitamin E prevent
cardiovascular disease or
cancer
(Tufts, 2013)
Examples of DOEs and POEMs
Disease-Oriented
Evidence (DOE)
Patient-Oriented Evidence
that Matters (POEMs)
The drug varenicline can help
Varenicline increases the risk
smokers stop smoking
of cardiovascular events.
(which should lead to a decrease
in cardiovascular events).
Older antiarrhythmic medications Medical treatment of
can decrease irregular
asymptomatic arrhythmias
heartbeats in patients with
increases mortality by 10%.
asymptomatic arrhythmias.
(Tufts, 2013)
Develop a DOE and a POEM for:
Acute Otitis Media
Disease-Oriented
Evidence (DOE)
Patient-Oriented Evidence
that Matters (POEMs)
•
•
•
•
Treating children with antibiotics
can sterilize the middle ear and
treat bacterial acute otitis media
This pathological/pharmological
mechanism helps doctors
determine treatment
But it does NOT focus on
morbidity, mortality, or quality of
life
•
In AOM, what do patients and
parents really care about?
Outcomes to focus on:
•
•
•
•
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Time course, pain, complications and side effects
of treatment
Time course: Untreated AOM resolves
by 1 week for 4 of 5 children
Pain: Abx do not reduce pain at 1 day,
but may reduce it at 2 and 7 days follow
up (quality of life)
Complications: Abx do NOT decrease
incidence of mastoiditis (morbidity)
Side effects: Abx cause rash, diarrhea
and nausea with an equal likelihood as
treatment success (quality of life)
(Hoberman, 2011; Takata, 2001; Thompson, 2009)
Introductory PICO Question
•
Patient
•
P
•
Intervention
•
I
C
•
“Placebo”
= DOE
Outcome
•
O
“ACEi”
Comparison
•
•
“In adult patients with diabetes mellitus II and
hypertension”
“Prevent worsening of eGFR?”
Is eGFR an outcome
our patient cares about?
Possible POEM Alternatives:
“In patients with diabetes, are ACEi associated with
lower mortality rates?”
Or
“In patients with diabetes, do ACEi delay
progression toward end-stage kidney disease
requiring dialysis?”
Or
“In patients with diabetes, do ACEi delay
progression toward end-stage kidney disease
requiring a kidney transplant?”
(Cochrane, Lv 2012)
Alternate Clinical Queries
• After developing a “best” case-based
PICO question, the next step is exploring
other searchable clinical queries.
P
I C
O
• These are a list of flexible alternative
questions since the answer to your precise
question may not match the current scientific
literature.
• Typically the alternatives involve reasonable
variations of your interventions/comparison
or alternative outcomes.
(Cochrane, Lv 2012)
YOUR TURN!
For the next three cases, you will be divided up to
formulate the following:
• What are some background questions?
• What are your foreground PICO questions?
•
Population
•
•
"How would I describe a group of patients similar to mine?"
Intervention/Comparison
•
•
•
Ask “What is the main intervention I am considering?”
and “What is the main comparison/control?”
Outcomes
•
•
•
Ask "What can I hope to accomplish?" or "What could this
exposure really affect?“
Which outcomes are POEMs?
Which outcomes are DOEs?
Case 1:
• A 35-year-old migrant farm worker presents
to your clinic for follow-up visit.
• A few weeks ago at a health fair, his blood
pressure was 170/98.
• Today on follow up, his vitals are
• T 98, P 88, R 16, BP 166/100, O2 99%
• You diagnose him with hypertension and look
at the 2014 JNC 8 guidelines to guide
medical treatment.
• He asks you: “Do I need medication, doctor?”
(JAMA; James, 2014)
Case 2:
• A 48-year-old Caucasian male construction worker
without any significant PMH sees you for a routine
physical exam.
• He reports that he is a two pack/day smoker for the
past 30+ years, and his father died of a heart attack
at age 49. He brings in a lab report of his cholesterol:
•
Total cholesterol: 200, HDL: 40
• You use the Pooled Risk Cohort equation from the
2013 ACC/AHA Cholesterol Guidelines
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His 10-year risk to first ASCVD event is 7.7%.
• He asks you: Do I need a cholesterol medication
(statin)?
(Lancet; Ridker, 2013)
Case 3:
• A 55-year-old right-handed female executive
assistant presents to your clinic with numbness and
pain in both hands, primarily in the thumb and
index finger for the past year.
•
•
She is worried now that she drops pens and paper more
easily.
She wears a wrist splint at night and takes Naproxen
twice a day.
• She asks you about steroid injections that a coworker told her about and wants to know if this
could help her.
(Atroshi , 2013; Marshall , 2007)
So, how do I develop a clinical
question?
• Think about a tough case.
•
•
Why was it difficult?
Did any new or alternative decision points arise that you
had not considered before?
• List the questions you had and still have.
• Focus on a foreground question.
• Rephrase it into a PICO format.
•
•
•
P: Be precise but brief
I/C: Be specific, but consider feasible alternatives
O: Select patient-oriented outcomes instead of “the
numbers.”
Recount a challenging case
from the past few weeks
What questions…
•
•
•
•
did your PATIENT ask?
did YOU have while writing the
SOAP note?
did you ask your ATTENDING?
still remain unresolved?
List and label your questions as:
background or foreground questions
and POEMs or DOEs and then
Brainstorm a PICO question with a partner.
PICO question—Case
P
I C
•
•
•
•
P- population
I- intervention
C- comparison group
O- outcome (make it patient oriented)
O
Answer?
Your challenge
• For the next week, at the end of every
day:
• Write down a foreground PICO question
based on your patients
• Focus on patient unmet needs (PUNs)
• To help you identify your (doctor’s)
educational needs (DENs)
Foreground Question Searches
• “Developing Clinical Questions” is just the
beginning of information mastery on how to answer
clinical questions.
• See the accompanying module on
“Finding Answers to Clinical Questions”
•
•
•
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To minimize your work in selecting sources
To locate valid and relevant information
To maximize your learning in navigating information
mastery search engines and resources
To help you answer the questions you’ve developed
today!
“The Usefulness Equation”
Usefulness of info source =
•
•
Today’s module helped you
•
applicable to one’s practice
focus your questions to be
•
focused on patient-oriented evidence that matters
FASTER and SMARTER when
Validity
developing
a question
•
This is where evidence-based medicine
techniques
are helpful
Relevance
•
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Relevance x Validity
Work needed
Differences in study design and study conduct influence our comfort in
the validity of the results
Work
•
•
time, energy, and money needed to find the information
In the clinic, aim for less than 1 minute
(Slawson, 1994)
Information Mastery Resources
Background
Questions
Clinical
Basic
Clinical
•
•
•
•
EBM
Background
Foreground
Questions
General
Resources
Guidelines
Research
Studies
Case-control
Case-series
Cohort
studies
Randomized
Controlled
Trials
Medscape
eMedicine
Epocrates
Lexicomp
• JAMA Rational Clinical • Guideline.gov
Examination
• USPSTF/AHRQ
• Symptom to Diagnosis • Institute for Clinical
Systems Improvement
• EE+ Calculators
• NICE-UK
CriticallyAppraised
Topics
Structured
Abstracts
• ACP Journal
Club
• BMJ EBM
Online
• Journal Watch
•
•
•
•
• PubMed Clinical
Queries
• TRIP Database
• Google Scholar
• Google “site:.gov”
Systematic
Reviews
EvidenceBased
Summaries
DynaMed
• Cochrane
Essential Evidence Plus Library
Bandolier
BMJ Clinical Evidence
(Based on BU and Dartmouth models)
Shared Decision Making
Medical Literature
Appraise
Read
Apply
Question
Decide
Patient
Clinical Jazz = Traditional EBM + Shared Decision Making
(Structure) + (Improvisation)
(Shaughnessy, 1998)
Congratulations!
You are now able to:
• Explain the difference between foreground
and background questions
• Differentiate between patient-oriented
evidence and disease-oriented evidence
• Identify a foreground question and apply the
PICO format to create a searchable clinical
query
Resources
• AAFP. EBM Toolkit
• http://www.aafp.org/journals/afp/authors/ebmtoolkit/resources.html
• University of Oxford. EBM toolkit
• http://www.cebm.net/index.aspx?o=1023
• PUNs and DENs worksheet
• http://www.networks.nhs.uk/nhs-networks/mkimpacte/documents/Puns%20and%20Dens%2
0booklet%20v2.4.pdf
References
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•
•
•
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Boston University School of Medicine. Curricular innovations: finding information
framework. 2013. Available from: http://medlib.bu.edu/busm/fif/ and
http://www.bumc.bu.edu/oaa/files/2013/10/BUSM-FIF.pdf Accessed November 11, 2013].
Dartmouth College Biomedical Libraries. Evidence-based medicine resources: finding
evidence-based answers to clinical questions quickly and effectively. 2012. Available from
http://www.dartmouth.edu/~biomed/resources.htmld/guides/ebm_resources.shtml and
http://www.dartmouth.edu/~biomed/resources.htmld/guides/FindingGoodAnswers.pdf
Accessed November 11, 2013.
Tufts University School of Medicine, Department of Family Medicine, Center for
Information Mastery. Concepts of information mastery. 2013. Available from
http://medicine.tufts.edu/Education/Academic-Departments/Clinical-Departments/FamilyMedicine/Center-for-Information-Mastery/Concepts-of-Information-Mastery Accessed
November 11, 2013.
University of Oxford. Centre for Evidence Based Medicine: EBM tools. 2013. Available
from http://www.cebm.net/index.aspx?o=1023 Accessed November 11, 2013.
Jackson R, et al. The GATE frame: critical appraisal with pictures. ACP Journal Club 2006
Mar/Apr: 144
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Atroshi I, Flondell M, Hofer M, Ranstam J. Methylprednisolone injections for the carpal tunnel syndrome: a randomized,
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Chan LS, Takata GS, Shekelle P, et al. Evidence assessment of management of acute otitis media: II. Research gaps and
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Lv J, Perkovic V, Foote CV, Craig ME, Craig JC, Strippoli GF. (). Antihypertensive agents for preventing diabetic kidney
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Shaughnessy AF, Slawson DC, Becker L. Clinical jazz: harmonizing clinical experience and evidence-based medicine. J
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Thompson PL, Gilbert RE, Long PF, Saxena S, Sharland M, Wong IC. Effects of antibiotics for otitis media on mastoiditis in
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