Developing Clinical Questions - PowerPoint Presentation

1. Developing Clinical QuestionsClinton Pong, MDhttp://img.timeinc.net/time/daily/2007/0702/a_scevidence_0214.jpg

2. Introductory Case:A 45-year-old pansexual transgender man (with female body parts) with PMH of CIN I presents to your clinic for follow up. At last year’s visit he was screened with a cervical pap smear and found to have the following result:Pap smear: ASCUS/HPV(+) Colposcopy with CIN IYou recall from medical school that cervical pap smears are good for preventing cervical cancer, but you’re not sure about the evidence about anal cancer surveillance and timing as it 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 questionsDifferentiate between:Patient-oriented evidence and disease-oriented evidenceIdentify foreground questions and then apply the PICO format to create searchable clinical queriesPopulation, Intervention/Comparison, Outcome

4. So, How Do I Develop a Clinical Question?Two types of questions:Background QuestionsForeground QuestionsBackground questions asks“who, what, where, when, why,or how” about a single disease,drug, intervention, or conceptThink of these as basic questions you might find from a textbook or a general EBM resourcee.g., prevalence, ddx, pathophys, sensitivity/specificity of a test, med dosing/adverse reactions

5. Intro Case:Background Question BrainstormingWhat are some background questions that you can think of related to our patient with CIN I, as it relates to pap smears?WhoWhatWhereWhenWhyHowSome possibilities/suggestions:Where can I quickly find the most up to date guidelines for cervical cancer screening?For patients with high risk for anal cancerIs there any guidance on timing for surveillance?For patients with a cervix with hx of ASCUSWhat is the appropriate follow up based on X guideline with X level of evidence?What is the threshold for the callback for a Colposcopy or not based upon?

6. So, How Do I Develop a Clinical Question?Two types of questions:Background QuestionsForeground questions:Foreground questions ask forspecific knowledge to inform aclinical issue on a specific patient,intervention or therapyIf based on expert opinion or best practices, they are guidelinesIf based on EBM, they typically compare two things (or against placebo) in a research study:Diagnostic testsDrugsTreatments

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

8. The PICO Question ComponentsProblem and PopulationWhat is the disease or condition?What are the important characteristics of my patient?InterventionWhat is the intervention I am looking for?Is it realistic (availability, cost, convenience, etc)? Is this different from how I currently practice?ComparisonWhat is the alternative to the intervention?OutcomeIs it something patients care about?Or is it something only physiologists/pharmacists care about?(Jackson, 2006; Flaherty, 2004)OI CP

9. How Do I Develop a Clinical Question?Focusing the PICO questionPopulationStarting with your patient, ask "How would I describe a group of patients similar to mine?" Be precise but brief.Intervention/ComparisonAsk “What is the main intervention I am considering?”and “What is the main comparison/control?”Be specific, but consider feasible alternatives.OutcomesAsk "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 BrainstormingProblem/Population“In adult patients with high risk sexual contact”Intervention“Does performing an anal cytological test and/or HPV test”Comparison“Compared to placebo”Outcome“Prevent development of anal precursor lesions” OR“Prevent development of anal cancer?”I COPAre these outcomes our patient cares about?

11. The Patient is What MattersMeasure 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)Patient-Oriented Evidence That Matters (POEMs)Disease-Oriented Evidence (DOE)

12. Characteristics of DOEs and POEMsPathophysiologyLab valuesBiochemical markersPharmacologyPlaque sizeBlood pressureEtiologyMorbidity Symptoms Daily functionMortalityQuality of Life(as perceived by the patient)(Slawson, 1994)Patient-Oriented Evidence That Matters (POEMs)Disease-Oriented Evidence (DOE)

13. Examples of DOEs and POEMs(Tufts, 2013)Patient-Oriented Evidence That Matters (POEMs)Disease-Oriented Evidence (DOE)Intensive treatment can lower blood glucose levels in patients with type II diabetesIntensive treatment in patients with type II diabetes does not decrease mortality.Beta-carotene and vitamin E are good antioxidantsNeither beat-carotene nor vitamin E prevent cardiovascular disease or cancer

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

15. Develop a DOE and a POEM for:Acute Otitis Media(Hoberman 2011; Takata 2001; Thompson 2009)Patient-Oriented Evidence That Matters (POEMs)Disease-Oriented Evidence (DOE)Treating children with antibiotics can sterilize the middle ear and treat bacterial acute otitis mediaThis pathological/pharmological mechanism helps doctors determine treatmentBut it does NOT focus on morbidity, mortality, or quality of lifeIn AOM, what do patients and parents really care about?Outcomes to focus on: time course, pain, complications and side effects of treatmentTime course: Untreated AOM resolves by 1 week for 4 of 5 childrenPain: 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 mastoiditisSide effects: Abx cause rash, diarrhea and nausea with an equal likelihood as treatment success (quality of life)

16. Introductory PICO QuestionPatient “In adult patients with high risk sexual contact”Intervention“anal HPV test”Comparison“Placebo”Outcome“Prevent development of anal precursor lesions?”I COPIs AIN an outcomeour patient cares about?= DOE

17. Possible POEM Alternatives: “In high-risk patients, are anal HPV tests associated with lower mortality rates from anal cancer?”Or “In high-risk patients, do anal HPV tests provide early detection and prevention of anal cancer?”Or “In high-risk patients, do early anal HPV tests prevent complications of treatment for late stages of anal cancer?”

18. Alternate Clinical QueriesAfter 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.I COP

19. For the Next Three Cases, You Are 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/ComparisonAsk “What is the main intervention I am considering?” and “What is the main comparison/control?”OutcomesAsk "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 55-year-old migrant farm worker presents to your clinic for follow up visit. A few weeks ago, at a health fair, she received a form inviting her for a mammogram and a cervical cancer screening.Today on follow up, her results are:HPV18(+), Atypical Glandular CellsYou look at the ASCCP guidelines to guide management.She asks you: “What should I do, doctor?”(Perkins, RB. J Low Genit Tract Dis 2020)

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 120/80He brings in a lab report of his cholesterol:Total cholesterol: 200, HDL: 40, LDL 160You use the ASCVD Risk Estimator+ equationhttp://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. How Do I Develop a Clinical Question?Think about a tough caseWhy was it difficult?Did any new or alternative decision points arise that you had not considered before?List the questions you had and still haveFocus on a foreground questionRephrase it into a PICO formatP: Be precise but briefI/C: Be specific, but consider feasible alternativesO: Select patient-oriented outcomes instead of “the numbers”

24. Recount a Challenging Case From the Past Few WeeksWhat 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 thenBrainstorm a PICO question with a partner.

25. PICO Question—CaseP- populationI- interventionC- comparison groupO- outcome (make it patient oriented)Answer?I COP

26. Your ChallengeFor the next week, at the end of every dayWrite down a foreground PICO question based on your patientsFocus 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 informationTo maximize your learning in navigating information mastery search engines and resourcesTo help you answer the questions you’ve developed today!

28. “The Usefulness Equation”Usefulness of info source = Relevance x Validity                                                   Work neededRelevanceApplicable to one’s practice Focused on patient-oriented evidence that mattersValidityThis is where evidence-based medicine techniques are helpfulDifferences in study design and study conduct influence our comfort in the validity of the resultsWorkTime, energy, and money needed to find the informationIn 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

29. Information Mastery ResourcesJAMA Rational Clinical ExaminationSymptom to DiagnosisEE+ CalculatorsDynaMedEssential Evidence PlusBandolierBMJ Clinical EvidenceGuideline.govUSPSTF/AHRQInstitute for Clinical Systems ImprovementNICE-UKACP Journal ClubBMJ EBM OnlineJournal WatchCochrane LibraryMedscapeeMedicineEpocratesLexicompPubMed Clinical QueriesTRIP DatabaseGoogle ScholarGoogle “site:.gov”(Based on BU and Dartmouth models)

30. Shared Decision-MakingClinical Jazz = Traditional EBM + Shared Decision-Making (Structure) + (Improvisation)(Shaughnessy, 1998)Medical LiteraturePatientQuestionReadAppraiseApplyDecide

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. ResourcesAAFP. EBM Toolkithttp://www.aafp.org/journals/afp/authors/ebm-toolkit/resources.html University of Oxford. EBM toolkithttp://www.cebm.net/index.aspx?o=1023PUNs and DENs worksheethttp://www.networks.nhs.uk/nhs-networks/mk-impacte/documents/Puns%20and%20Dens%20booklet%20v2.4.pdf

33. ReferencesBoston 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. ReferencesAtroshi 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. Pediatrics 2001;108:248-54.Chen CC, Chou YY. Predictive value of the anal cytology for detecting anal intraepithelial neoplasia or worse: A systematic review and meta-analysis. Diagn Cytopathol. 2019 Apr;47(4):307-314. doi: 10.1002/dc.24078. Epub 2019 Jan 3. PMID: 30605263.Egemen D, Cheung LC, Chen X, et al. Risk estimates supporting the 2019 ASCCP Risk Based Management Consensus Guidelines. J Low Genit Tract Dis 2020; 24:132-43.Flaherty RJ. A simple method for evaluating the clinical literature. Fam Pract Manag 2004 May;11(5):47-52.Marshall SC, Tardif G, Ashworth NL. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev 2007;2: CD001554.Perkins RB, Guido RS, Castle PE, et al. 2019 ASCCP risk-based management consensus guidelines for abnormal cervical cancer screening tests and cancer precursors. J Low Genit Tract Dis 2020; 24:102-31Ridker 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.