Developing Clinical Questions

Clinton Pong, MD
Randi Sokol, MD, MPH
http://img.timeinc.net/time/daily/2007/0702/a_scevidence_0214.jpg
 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
• Background questions ask Questions
“who, what, where, when, why, or
how” about a single disease ,
drug, intervention, or concept.
EBM
Basic Clinical
• Think of these as basic questions Background
you might find from a textbook or
a general EBM resource
• Eg, prevalence, ddx, pathophys,
sensitivity/specificity of a test,
med dosing/adverse reactions
 Intro case:
Background Question Brainstorming
• What are some • Some possibilities/suggestions:
background questions that • For diabetic kidney disease:
you can think of related to • What is the mechanism?
• What is the pathology?
our gentleman with
diabetes and HTN, related • How does an ACEi work
• to lower BP?
to the use of an ACE • to reduce diabetic nephropathy?
inhibitor? • What dose of an ACEi do I
• Who prescribe?
• What
Background
Questions • What labs should I check for
someone on an ACEi?
• Where • Potassium? Creatinine?
• When Basic Clinical
EBM • How often?
• Why
Background
• What are the side effects of
using an ACEi in patients with
• How high blood pressure?
 So, how do I develop a clinical
question?
• Two types of questions:
• 1- Background Questions
• 2- Foreground questions:
Foreground
• Foreground questions ask for Questions
specific knowledge to inform a clinical
issue on a specific patient,
intervention,or therapy.
General
• If based on expert opinion or best Resources Research
practices, they are guidelines. Studies
eg, Guidelines
• If based on EBM, they typically
compare two things (or against
placebo) in a research study:
• Diagnostic tests
• Drugs
• Treatments
 Information Mastery Resources, by Type:

Background Foreground
Questions Questions

General
EBM Resources Research
Basic Clinical
Background Studies
eg, Guidelines

To develop a
“Medical Student “Resident Questions” searchable
Questions” eg, appropriate steps in clinical query,
eg, etiology, pathophys, workup and management you need to formulate
pharmacology a foreground question
in the PICO format
(Based on BU and Dartmouth models)
The PICO Question Components
• Problem and Population
• What is the disease or condition?
P • What are the important characteristics of my
patient?
• Intervention
• What is the intervention I am looking for?
• Is it realistic (availability, cost, convenience, etc)?
I C • Is this different from how I currently practice?
• Comparison
• What is the alternative to the intervention?
• Outcome
O • 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
• Starting with your patient, ask "How would I describe a group of
patients similar to mine?"
• Be precise but brief.
• Intervention/Comparison
• 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
• “In adult patients with diabetes mellitus II and
P hypertension”
• Intervention
• “Does an ACEi”
• Comparison
I C • “Compared to placebo” or “BB/CCB/diuretic/etc.”
• Outcome
• “Prevent development of microalbumuria?”
OR
• “Prevent worsening of eGFR?”
O
Are these outcomes
our patient cares about?
 The Patient Is What Matters
Disease-Oriented Patient-Oriented Evidence
Evidence (DOE) That Matters (POEMs)
• Measures outcomes • Measure outcomes
that are markers for that our patients care
disease about.
• “Silent • They have the
numbers” potential to change
the way we practice!

(Slawson , 1994)
Characteristics of DOEs and POEMs
Disease-Oriented Patient-Oriented Evidence
Evidence (DOE) That Matters (POEMs)
• Pathophysiology • Morbidity
• Lab values • Symptoms
• Biochemical markers • Daily function
• Pharmacology • Mortality
• Plaque size • Quality of Life
• Blood pressure • (as perceived by the
• Etiology patient)
(Slawson , 1994)
 Examples of DOEs and POEMs
Disease-Oriented Patient-Oriented Evidence
Evidence (DOE) That Matters (POEMs)
Intensive treatment can Intensive treatment in patients
lower blood glucose levels with type II diabetes does not
in patients with type II decrease mortality.
diabetes

Neither beta-carotene or
Beta-carotene and vitamin vitamin E prevent
E are good antioxidants cardiovascular disease or
cancer
(Tufts, 2013)
 Examples of DOEs and POEMs
Disease-Oriented Patient-Oriented Evidence
Evidence (DOE) 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)
• 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?
Patient-Oriented Evidence
that Matters (POEMs)
• Outcomes to focus on:
• 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
• “In adult patients with diabetes mellitus II and
P hypertension”
• Intervention
• “ACEi”
• Comparison
I C = DOE
• “Placebo”
• Outcome
• “Prevent worsening of eGFR?”

O 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 • These are a list of flexible alternative
questions since the answer to your precise
I C question may not match the current scientific
literature.
O
• 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
• 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 co-
worker 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 • P- population
• I- intervention
I C • 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”
• 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 = Relevance x Validity
Work needed
• Relevance Today’s module helped you
• applicable to one’s practice
focus your questions to be
• focused on patient-oriented evidence that matters
• Validity
FASTER and SMARTER when
• developing
This is where evidence-based medicine a question
techniques are helpful
• 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 Foreground
Questions Questions
• PubMed Clinical
Queries
• TRIP Database
General Research • Google Scholar
Clinical
Resources Studies
• Google “site:.gov”

Case-control Randomized Critically-

Basic EBM Case-series Systematic
Guidelines Cohort Controlled Appraised
Clinical Background Reviews
studies Trials Topics

• Medscape Evidence-
Structured
• eMedicine Based
Abstracts
Summaries
• Epocrates
• Lexicomp

• JAMA Rational Clinical • Guideline.gov • ACP Journal • DynaMed • Cochrane

Examination • USPSTF/AHRQ Club • Essential Evidence Plus Library
• Symptom to Diagnosis • Institute for Clinical • BMJ EBM • Bandolier
• EE+ Calculators Systems Improvement Online • BMJ Clinical Evidence
• NICE-UK • Journal Watch
(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/ebm-
toolkit/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/mk-
impacte/documents/Puns%20and%20Dens%2
0booklet%20v2.4.pdf
 References
• 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/Family-
Medicine/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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