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 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• What• Where• When• Why• How

• Some possibilities/suggestions:• For diabetic kidney disease:

• What is the mechanism?• What is the pathology?

• 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?• Potassium? Creatinine?• How often?

• What are the side effects of using an ACEi in patients with high blood pressure?

Background Questions

Basic Clinical EBM Background

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

ForegroundQuestions

General Resources

eg, Guidelines

Research Studies

Background Questions

Basic Clinical EBM Background

ForegroundQuestions

General Resources

eg, Guidelines

Research Studies

Information Mastery Resources, by Type:

(Based on BU and Dartmouth models)

To develop a searchable clinical query,

you need to formulate a foreground question

in the PICO format

“Resident Questions”eg, appropriate steps in

workup and management

“Medical Student Questions”

eg, etiology, pathophys, pharmacology

The PICO Question Components• Problem and Population

• What is the disease or condition?• What are the important characteristics of my

patient?

• Intervention• 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 alternative to the intervention?

• Outcome• Is it something patients care about?• Or is it something only physiologists/pharmacists

care about?

O

I C

P

(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

hypertension”

• Intervention• “Does an ACEi”

• Comparison• “Compared to placebo” or “BB/CCB/diuretic/etc.”

• Outcome• “Prevent development of microalbumuria?”

OR• “Prevent worsening of eGFR?”

I C

O

P

Are these outcomesour patient cares about?

The Patient Is What MattersDisease-Oriented Evidence (DOE)

Patient-Oriented Evidence That Matters (POEMs)

• Measures outcomes that are markers for disease

• “Silent numbers”

• Measure outcomes that our patients care about.

• They have the potential to change the way we practice!

(Slawson , 1994)

Characteristics of DOEs and POEMsDisease-Oriented Evidence (DOE)

Patient-Oriented Evidence That Matters (POEMs)

• Pathophysiology• Lab values• Biochemical markers

• Pharmacology• Plaque size• Blood pressure

• Etiology

• Morbidity • Symptoms • Daily function

• Mortality• Quality of Life

• (as perceived by the patient)

(Slawson , 1994)

Examples of DOEs and POEMsDisease-Oriented Evidence (DOE)

Patient-Oriented Evidence That Matters (POEMs)

(Tufts, 2013)

Intensive treatment can lower blood glucose levels in patients with type II diabetes

Intensive treatment in patients with type II diabetes does not decrease mortality.

Beta-carotene and vitamin E are good antioxidants

Neither beta-carotene or vitamin E prevent cardiovascular disease or cancer

Examples of DOEs and POEMsDisease-Oriented Evidence (DOE)

Patient-Oriented Evidence that Matters (POEMs)

(Tufts, 2013)

The drug varenicline can help smokers stop smoking (which should lead to a decrease in cardiovascular events).

Varenicline increases the risk of cardiovascular events.

Older antiarrhythmic medications can decrease irregular heartbeats in patients with asymptomatic arrhythmias.

Medical treatment of asymptomatic arrhythmias increases mortality by 10%.

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:• 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 hypertension”

• Intervention• “ACEi”

• Comparison• “Placebo”

• Outcome• “Prevent worsening of eGFR?”

I C

O

P

Is eGFR an outcomeour patient cares about?

= DOE

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.• 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)

I C

O

P

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 questionsand POEMs or DOEs and then

Brainstorm a PICO question with a partner.

PICO question—Case

• P- population• I- intervention• C- comparison group• O- outcome (make it patient oriented)

Answer?

I C

O

P

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• applicable to one’s practice • focused on patient-oriented evidence that matters

• Validity• This is where evidence-based medicine 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)

Today’s module helped you focus your questions to be

FASTER and SMARTER when developing a question

Background

Questions

Clinical

Basic Clinical

EBM Background

Foreground

Questions

General Resources

Guidelines

Research Studies

Case-controlCase-series

Cohort studies

Randomized Controlled

Trials

Critically-Appraised

Topics

Structured Abstracts

Evidence-Based

Summaries

Systematic Reviews

Information Mastery Resources

• JAMA Rational Clinical Examination

• Symptom to Diagnosis• EE+ Calculators

• DynaMed• Essential Evidence Plus• Bandolier• BMJ Clinical Evidence

• Guideline.gov• USPSTF/AHRQ• Institute for Clinical

Systems Improvement

• NICE-UK

• ACP Journal Club

• BMJ EBM Online

• Journal Watch

• Cochrane Library

• Medscape• eMedicine• Epocrates• Lexicomp

• PubMed Clinical Queries

• TRIP Database• Google Scholar• Google “site:.gov”

(Based on BU and Dartmouth models)

Shared Decision Making

Clinical Jazz = Traditional EBM + Shared Decision Making (Structure) + (Improvisation)

Medical Literature

Patient

Question

Read

Appraise

Apply

Decide

(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-t

oolkit/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-i

mpacte/documents/Puns%20and%20Dens%20booklet%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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priorities for future research. Pediatrics 2001;108:248-54.• Flaherty RJ. A simple method for evaluating the clinical literature. Fam Pract Manag 2004 May;11(5):47-52.• James PA, Oparil S, Carter BL, et al. Evidence-based guideline for the management of high blood pressure in adults:

report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA 2014. doi:10.1001/jama.2013.284427.

• Lv J, Perkovic V, Foote CV, Craig ME, Craig JC, Strippoli GF. (). Antihypertensive agents for preventing diabetic kidney disease. Cochrane Database Syst Rev 2012 Dec 12;23:CD004136.

• Marshall SC, Tardif G, Ashworth NL. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev 2007;2: CD001554.

• Ridker PM, Cook NR. Statins: new American guidelines for prevention of cardiovascular disease. Lancet 2013;13: 62388-0.

• Slawson D, Shaughnessy A, Bennett J. Becoming a medical information master: feeling good about not knowing everything. J Fam Pract 1994;38(5):505-13.

• Slawson D, Shaughnessy A, Bennett J. Becoming an information master: a guidebook to the medical information jungle. J Fam Pract 2004;39(5):489-99.

• Shaughnessy AF, Slawson DC, Becker L. Clinical jazz: harmonizing clinical experience and evidence-based medicine . J Fam Pract 1998;47:425-8.

• Thompson PL, Gilbert RE, Long PF, Saxena S, Sharland M, Wong IC. Effects of antibiotics for otitis media on mastoiditis in children: a retrospective cohort study using the United Kingdom General Practice Research Database. Pediatrics 2009; 123(2):424-30.