29 July, 2010 Adapting Standard Clinical Guidelines to the

1. 29 July, 2010 Adapting Standard Clinical Guidelines to the Context of HIV-Related Patient Care in Resource- Constrained Settings Ian Crozier, MD and Paula Brentlinger, MD

2. First, thanks to ourcollaboratorsand funders! Collaborators: Mozambique (I-TECH, Ministry of Health, CDC, others): Paul Thottingal, Mark Micek, Oliver Bacon, José Vallejo, Rui Bastos, Rolanda Manuel, Pilar Martínez, Florindo Mudender, Maria Ruano, Monica Negrete, and others! Uganda (IDCAP, IDI, Accordia, I-TECH, Uganda MOH): Ann Miceli, Marcia Weaver, Allan Ronald, Mike Scheld, Lydia Mpanga Sebuyira, Kelly Willis. Funders: Mozambique: President’s Emergency Plan for AIDS Relief Uganda: Accordia Global Health Foundation

3. Today’s plan • Scopeofproject • Context: task-shifting • Justification for guidelinedevelopmentinMozambique • ProcessofguidelinedevelopmentinMozambique • Use ofguidelinesinhealthworkertrainingandevaluationinMozambique • Adaptationofprocess for usein Uganda • Challenges, nextsteps

4. A 5-year initiative (so far...) Mozambique: 2005-6: Definitionofproblem 2006-7: ConsultationswithMinistryofHealth, developmentofdraftguidelinesand curricula 2007-8: Reviewandrevision; scopeofworkconference; initialfieldtestofnewguideline-based curriculum 2009-present: MOHapproval; nationwiderollout Uganda: 2009-10: Adaptationandexpansionofguidelines. 2010: Rolloutinsettingofrandomizedcontrolledtrial

5. Context: task-shiftinginsub-SaharanAfrica

6. A simple (?) case • Imagine that you are a mid-level clinician in sub-Saharan Africa,seeing an HIV+ adult patient whose hemoglobin level is 7.7 g/dL. • What should you do first to address this patient’s anemia? • Why? TYPE YOUR ANSWERS NOW!

7. Simple (?) case 2 • Now, imagine that you are a mid-level clinician in sub-Saharan Africaseeing an HIV+ adult patient whose axillary temperature is 38.5° C. • What should you do first to address this patient’s fever? • Why? TYPE YOUR ANSWERS NOW!

8. Quick review of your answers What: Danger sign check History Physical examination DDx Lab Diagnosis? Classification? Treatment Why: Evidence, resources, guidelines, habit...

10. Mozambique, 2005-6: DuelingGuidelines, Anemia • Check for “generaldangersigns”. • If a patientseemspale, giveferrous sulfate, mebendazole, and1stline antimalarials (nolaboratorytestingneeded). Ifextremelypale, refer. • Iftheanemicpatientison zidovudine, gradethe adverse drugreactionandtreataccordingly. • Ifthepatientwithseveremalariahas a hemoglobin <5 g/dL, transfuse.

11. Mozambique, 2005-6: DuelingGuidelines, Fever • Check for “general danger signs”. • Give antimalarials (no lab tests required); add antibiotics if very sick. • Lumbar puncture; send for gram stain, AFB, india ink, VDRL • Consider adverse drug reaction to antiretrovirals; grade and treat accordingly • If severe malaria, give quinine; if uncomplicated malaria, give 1st line

12. What to do? Options: • Pickoneofthemanycompetingguidelinesand stick toit? • Adoptexistingguidelinesfromothercountries/sources? • Writenewguidelines?

14. CharacteristicsofnewMozambicanguidelines Topics: Commonsignsorsymptoms (patient-based, notdisease-based) Patientevaluation: Directed, basedonhistory, physicalexamination, and use ofavailabletests (malaria, HIV, AFB, hemoglobin) Differentialdiagnosis: Emphasizecommonillnessesthatcanbediagnosedandtreatedwithavailableresourceswithinapprovedscopeofpracticeoftargetcadre (more complexproblems to bereferredupward) Layout: 1 page, easy to read, parallelorganization for differentguidelines General: evidencebased, consistentwith major local (TB, malaria, AIDS, antenatalcareprograms) andinternationalguidelines (IMAIetc) wheneverpossible, harmonize disease-specificguidelineswheneverpossible

17. Integrationofnewguidelinesand curricula Modules/sessionsinbothin-serviceandpre-service curricula corresponded to guidelinetopics (e.g. “diarrhea”, “weightloss”, “coughor dyspnea”). Evidencesupportingguidelinedevelopment (epidemiologic, health-outcomes) summarizedin curricula. Stepwisepresentationofguidelines. In-class case studies to besolvedusingguidelines; generally, >=1 casepresentation per guidelinearm. Writing cases helpedus spot guidelineflaws, anddroverevisions!

18. Sample case-study questions • Whichguidelineorguidelinesshouldyou use toaddressthis case, andwhy? • Does thispatienthavedangersigns, orcanyouproceed to thenextstepsoftheguideline? • Whichpathwayshouldyoutakenext (e.g. Box xor Box y), andwhy? • Canyoumanagethispatientwiththeguideline, or do youneed to refer?

19. Use ofguidelinesinpracticumsessions Similarly, in practicum sessions (or post-course mentoring/supervision): Trainees practice using guidelines to manage real patients. Faculty/supervisors use guidelines as standard for evaluation of trainee performance

20. (Digression into textbook publishing)

21. Shift context  Uganda IDCAP RCT studying the most cost-effective way to build capacity for the care and prevention of infectious diseases among mid-level providers in Uganda

22. Context: the training design Classroom On-site

23. Context: the curriculum goal Develop training materials that: • INTEGRATE infectious diseases training (with emphasis on HIV/TB/malaria and common others) • use a CASE-BASED approach to frame key content • TARGET mid-level providers at the health center IV level in Uganda

24. A 35 yo woman with fever: After triaging (no danger signs), a careful history and physical examination reveals no localizing signs or symptoms to suggest an obvious cause of fever. The malaria smear is negative. What should you do?

25. Should you: • Give an antimalarial? • Give an antibiotic? • Give symptomatic treatment with f/up only? • Stop or start any other medicines? • Refer for further testing or care? What criteria impact these decisions? Does it make a difference if the patient is HIV-infected or not? Using cotrimoxazole? Pregnant? On TB treatment?

26. An HIV-infected mother gives birth to a healthy child in Uganda… • What routine important evaluation, prevention, and care should occur immediately? • What routine important evaluation, prevention, and care should occur over the next 12-18 months?

27. The hunter in pursuit of an elephant does not stop to throw stones at birds…….

28. Similar issues in Uganda: • “Dueling” clinical guidelines (HIV/TB/Malaria), • Guidelines often either • Impractical for MLPs at the HC IV level (i.e. incorporate unavailable laboratory testing, etc), or • Leave no “room” for MLP skill in clinical evaluation, reasoning, and decision-making • In some clinical scenarios, no clear guidelines

29. Focus on the important clinical decisions… • Prescriptive (when possible) • Practical tool for day-to day clinical use and consultation • Effective for classroom and on-site clinical mentoring

30. Clinical Decision-Making Guide(s) Anatomy • Introduction: rationale and how-to-use • Clinical decision-making guides (CDG): clinical algorithmsplus explanatory notes • Appendix tools: useful existing clinical reference material(s)

31. Types of decision-making • Evaluation and management of new signs/symptoms (“unknowns”) • Routine case management in HIV, TB, malaria

32. Section: common clinical problems

33. Section: HIV and ART

34. Section: routine case mgt Emphasizing: • Correct case-definitions and classification • Correct pre-treatment evaluation/preparation • Correct identification of those who require consultation/referral prior to initiation of Rx • Correct selection/dosing of specific and supportive Rx • Correct monitoring for AE and treatment effectiveness

35. Development of the CDGs Guides constructed around important clinical decision-making  • Identifying the important clinical decisions that may need to be made in a patient with _________. • Identifying the information needed to make these decisions? (this informs and focuses the clinical evaluation). • Identifying and outlining the criteria by which key decisions are made? • Representing this process in a graphical format (with explanatory notes AND referencing appendix tables)

38. Principles of the CDGs (Uganda) • RECOMMENDATIONS for decision-making in particular clinical scenarios • Sourced from national guidelines whenever possible (then relevant local/regional scientific literature, int’l GL, expert opinion) • Designed to integrate decision-making in multiple populations when possible • Supplement to the core training material but real “rollout” in distance learning and booster sessions

39. Classroom On-site FOCUS

40. Classroom On-site

41. CharacteristicsofnewMozambican(IDCAP) guidelines Topics: Commonsignsorsymptoms (patient-based, notdisease-based) Patientevaluation: Directed, basedonhistory, physicalexamination, and use ofavailabletests (malaria, HIV, AFB, hemoglobin) Differentialdiagnosis: Emphasizecommonillnessesthatcanbediagnosedandtreatedwithavailableresourceswithinapprovedscopeofpracticeoftargetcadre (more complexproblems to bereferredupward) Layout:1 page, easy to read, parallelorganization for differentguidelines General: evidencebased, consistentwith major local (TB, malaria, AIDS, antenatalcareprograms) andinternationalguidelines (IMAIetc) wheneverpossible, harmonize disease-specificguidelineswheneverpossible

42. Mozambique  Uganda: key differences • Context: designed for use in RCT of 2 different approaches to MLP training in UG. • Target pop’n: address HIV+ and HIV- adults and children • Layout: extensive footnoting and appendix references • (?) link to trainee performance evaluation....

43. Measuring trainee performance • As part of the study, PB was tasked with design and creation of a set of “case scenarios” to accurately assess and capture trainee performance in clinical evaluation, reasoning, and management. • Forced identification of the key “testable” skills LINKED to core training material • This process was one of the prime drivers of the development and adaptation of the IDCAP guides…

44. Gaps and challenges (1) Related to nationalorinternationalpolicy: 1. Theduelingalgorithmproblem does notoriginatelocally – some guidelinesoriginateinGenevaortheUSorEuropeanheadquartersoflocally active aid agencies. 2. Constantevolutionofscopeofworkofnon-physicianclinicians (canthey do lumbarpunctures? Cantheyprescribe2ndline antiretrovirals or TB drugs?). RequirednationalconsensusconferenceinMozambique. Related to thescientificevidence base: 1. Constantevolutionofpublishedevidence base drivesfrequentrevisionsofinternational (WHO, PEPFAR, etc) standards. 2. Still, manylacunaeinevidence base (Which antimalarials canbegivensafelyandeffectively to patientsonART + TBtreatment? Is visceral leishmaniasisanimportantcontributor to anemiainprovincex? )

45. Gaps and challenges (2) Related to thecomplexitiesofpatientcareinresource-constrainedsettings: 1. Some commonproblemshavenotbeenamenable to guidelinedevelopment (e.g. abdominal pain, overlapping adverse drugreactionsinpatientsonART + multipleotheragents) 2. Lackofresources (laboratory, imaging, surgeons, drugs) is a seriousconstraint to constructionofaneffectiveapproach to someclinicallyimportantproblems (e.g. alteredlevelofconsciousness) 3. Use ofguidelinesinpatientswithmultiple active comorbidities. Priorities for thefuture 1. Validationofnewguidelines (studiesabout to commenceinMozambique [VanderbiltUniversity]) 2. Workableplan for frequentrevision as evidence base and local/international policies evolve

46. More gaps/challenges (Uganda) • In an expanded target population, unique challenges in designing and integrating guides with current models that are variably implemented (especially under 5’s and IMCI) • Less “mature” in the development process: more adaptation/refining of guides required, preferably in growing partnerships (MOH, etc)

47. African proverb The hunter in pursuit of an elephant does not stop to throw stones at birds….. What is the elephant? Are we in pursuit?

48. Questions???

49. Thank you!

50. Next session: 5 August, 2010 Listserv: itechdistlearning@u.washington.edu Email: DLinfo@u.washington.edu