Developing Clinical Questions

1. Developing Clinical Questions Clinton Pong, MD Randi Sokol, MD, MPH http://img.timeinc.net/time/daily/2007/0702/a_scevidence_0214.jpg

2. 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!

3. 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

4. So, how do I develop a clinical question? • Two types of questions: • Background Questions • Foreground Questions • Background questions asks“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 • e.g., prevalence, ddx, pathophys, sensitivity/specificity of a test, med dosing/adverse reactions

5. Intro case:Background Question Brainstorming 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? 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

6. So, how do I develop a clinical question? • Two types of questions: • Background Questions • Foreground questions: • Foreground questions ask forspecific knowledge to inform aclinical 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

7. Information Mastery Resources, by Type: To Develop a Searchable Clinical Query, You need to formulate a foreground question in the PICO Format “Medical Student Questions” e.g., etiology, pathophys, pharmacology “Resident Questions” e.g., appropriate steps in workup and management (Based on BU and Dartmouth models)

8. 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? P I C O (Jackson, 2006; Flaherty, 2004)

9. 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)

10. 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?” P I C O Are these outcomesour patient cares about?

11. The Patient is What Matters • Measure outcomes that our patients care about • They have the potential to change the way we practice! • Measures outcomes that are markers for disease • “Silent numbers” • Disease-Oriented Evidence (DOE) (Slawson, 1994) Patient-Oriented Evidence That Matters (POEMs)

12. Characteristics of DOEs and POEMs • Morbidity • Symptoms • Daily function • Mortality • Quality of Life • (as perceived by the patient) • Pathophysiology • Lab values • Biochemical markers • Pharmacology • Plaque size • Blood pressure • Etiology • Disease-Oriented Evidence (DOE) (Slawson, 1994) Patient-Oriented Evidence That Matters (POEMs)

13. Examples of DOEs and POEMs • Disease-Oriented Evidence (DOE) (Tufts, 2013) Patient-Oriented Evidence That Matters (POEMs)

14. Examples of DOEs and POEMs • Disease-Oriented Evidence (DOE) (Tufts, 2013) Patient-Oriented Evidence That Matters (POEMs)

15. Develop a DOE and a POEM for:Acute Otitis Media • Disease-Oriented Evidence (DOE) (Hoberman 2011; Takata 2001; Thompson 2009) 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)

16. Introductory PICO Question • Patient • “In adult patients with diabetes mellitus II and hypertension” • Intervention • “ACEi” • Comparison • “Placebo” • Outcome • “Prevent worsening of eGFR?” P I C = DOE O Is eGFR an outcomeour patient cares about?

17. Possible POEM Alternatives: “In patients with diabetes, are ACEi associated with lower mortality rates?” Or “In patients with diabetes, do ACEi delay progression towards end-stage kidney disease requiring dialysis?” Or “In patients with diabetes, do ACEidelay progression towards end-stage kidney disease requiring a kidney transplant?” (Cochrane, Lv 2012)

18. 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 P I C O (Cochrane, Lv 2012)

19. 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?

20. 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)

21. 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 2 pack/day smoker for the past 30+ years and his father died of a heart attack at age 49. • His blood pressure is 120/80 • He brings in a lab report of his cholesterol: • Total cholesterol: 200, HDL: 40, LDL 160 • You use the ASCVD Risk Estimator+ equation • http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/ • His 10-year risk to first ASCVD event is 7.7%. • He asks you: do I need a cholesterol medication (statin)? (Lancet, Ridker, 2013)

22. 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)

23. 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”

24. 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.

25. PICO Question—Case • P- population • I- intervention • C- comparison group • O- outcome (make it patient oriented) Answer? P I C O

26. 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]

27. 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!

28. “The Usefulness Equation” Usefulness of info source = Relevance x ValidityWork 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 Today’s module helped you focus your questions to be FASTER and SMARTER when developing a question (Slawson, 1994)

29. Information Mastery Resources • PubMed Clinical Queries • TRIP Database • Google Scholar • Google “site:.gov” • JAMA Rational Clinical Examination • Symptom to Diagnosis • EE+ Calculators • Medscape • eMedicine • Epocrates • Lexicomp • Cochrane Library • DynaMed • Essential Evidence Plus • Bandolier • BMJ Clinical Evidence • ACP Journal Club • BMJ EBM Online • Journal Watch • Guideline.gov • USPSTF/AHRQ • Institute for Clinical Systems Improvement • NICE-UK (Based on BU and Dartmouth models)

30. Shared Decision-Making Clinical Jazz = Traditional EBM + Shared Decision-Making (Structure) + (Improvisation) Medical Literature Appraise Read Apply Question Decide Patient (Shaughnessy, 1998)

31. 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

32. 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%20booklet%20v2.4.pdf

33. References • Boston University School of Medicine. (2013) Curricular Innovations: Finding Information Framework. [Online] Available from: http://medlib.bu.edu/busm/fif/ and http://www.bumc.bu.edu/oaa/files/2013/10/BUSM-FIF.pdf [Accessed 11th November 2013]. • Dartmouth College Biomedical Libraries. (2012) Evidence-Based Medicine Resources:Finding Evidence-Based Answers to Clinical Questions Quickly and Effectively. [Online] 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 11th November 2013]. • Tufts University School of Medicine: Department of Family Medicine: Center for Information Mastery: Concepts of Information Mastery. (2013). [Online] Available from http://medicine.tufts.edu/Education/Academic-Departments/Clinical-Departments/Family-Medicine/Center-for-Information-Mastery/Concepts-of-Information-Mastery [Accessed 11th November 2013]. • University of Oxford. (2013) Centre for Evidence Based Medicine: EBM tools. [Online] Available from http://www.cebm.net/index.aspx?o=1023 [Accessed 11th November 2013]. • Jackson R, et al. The GATE frame: critical appraisal with pictures. ACP Journal Club 2006 Mar/Apr: 144

34. References • Atroshi I, Flondell M, Hofer M, Ranstam J. Methylprednisolone injections for the carpal tunnel syndrome: a randomized, placebo-controlled trial. Ann Intern Med 2013;159(5):309-17. • Chan LS, Takata GS, Shekelle P, et al. Evidence assessment of management of acute otitis media: II. Research gaps and priorities for future research. Pediatrics2001;108:248-54. • Flaherty RJ. A simple method for evaluating the clinical literature. Fam PractManag 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. Lancet2013;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. JFam Pract1998;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.