Welcome to I-TECH HIV/AIDS Clinical Seminar Series

29 July, 2010Adapting Standard Clinical Guidelines to the

Context of HIV-Related Patient Care in Resource-Constrained Settings

Ian Crozier, MD and Paula Brentlinger, MD

First, thanks to our collaborators and 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

Today’s plan

• Scope of project• Context: task-shifting• Justification for guideline development in

Mozambique • Process of guideline development in

Mozambique• Use of guidelines in health worker training and

evaluation in Mozambique• Adaptation of process for use in Uganda• Challenges, next steps

A 5-year initiative (so far...)

Mozambique:2005-6: Definition of problem2006-7: Consultations with Ministry of Health, development of draft guidelines and curricula

2007-8: Review and revision; scope of work conference; initial field test of new guideline-based curriculum2009-present: MOH approval; nationwide rollout

Uganda: 2009-10: Adaptation and expansion of guidelines. 2010: Rollout in setting of randomized controlled trial

Context: task-shifting in sub-Saharan Africa

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!

Simple (?) case 2

• Now, imagine that you are a mid-level clinician in sub-Saharan Africa seeing 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!

Quick review of your answers

What: Danger sign check

History

Physical examination

DDx

Lab

Diagnosis? Classification?

Treatment

Why: Evidence, resources, guidelines, habit...

Mozambique, 2005-6: Dueling Guidelines, Anemia

1. Check for “general danger signs”. 2. If a patient seems pale, give ferrous sulfate,

mebendazole, and 1st line antimalarials (no laboratory testing needed). If extremely pale, refer.

3. If the anemic patient is on zidovudine, grade the adverse drug reaction and treat accordingly.

4. If the patient with severe malaria has a hemoglobin <5 g/dL, transfuse.

Mozambique, 2005-6: Dueling Guidelines, Fever

1. Check for “general danger signs”.

2. Give antimalarials (no lab tests required); add antibiotics if very sick.

3. Lumbar puncture; send for gram stain, AFB, india ink, VDRL

4. Consider adverse drug reaction to antiretrovirals; grade and treat accordingly

5. If severe malaria, give quinine; if uncomplicated malaria, give 1st line

What to do?

Options:

1.Pick one of the many competing guidelines and stick to it?

2.Adopt existing guidelines from other countries/sources?

3.Write new guidelines?

ARV-related Abdominal Pain Management Flow Chart

Patient developsabdominal pain on

ARVs

ARV related

Pancreatitis (dueto ddI or d4T)

Hepatitis (due toNVP, EFZ, AZT,

KTA)

Hyperlactatemia(on d4T, ddI, or

AZT)Ingestion related

Usually withnausea, vomiting,

epigastric pain

Measure serumamylase

Refer to hospital &hold ARVs

May have yelloweyes, light stool,

nausea, RUQ pain

Measure ALT

ALT 1.1 -2 XULN

Repeat ALT in 1-2weeks

ALT>2XULN

Consult expertabout stopping

ARVs

Jaundiceregardless of ALT

level

Stop allnon-emergentmedications

Refer promptly tohospital

Amylase elevated

Nausea, vomiting,bloating, ordistention

Measure venous lactate(no tourniquet, place on ice

immediately)

Lactate 2-5 mm/L

Measureelectrolytes

Consult expert

Lactate>5 mm/L

Measureelectrolytes

Stop all ARVs

Refer to hospitalimmediately

Occurs within 1 h ofingestion, crampy, &

goes away

Try taking withfood (unless ddI)

Not ARV related

If no relief, consultexpert

Characteristics of new Mozambican guidelines

Topics: Common signs or symptoms (patient-based, not disease-based)

Patient evaluation: Directed, based on history, physical examination, and use of available tests (malaria, HIV, AFB, hemoglobin)

Differential diagnosis: Emphasize common illnesses that can be diagnosed and treated with available resources within approved scope of practice of target cadre (more complex problems to be referred upward)

Layout: 1 page, easy to read, parallel organization for different guidelines

General: evidence based, consistent with major local (TB, malaria, AIDS, antenatal care programs) and international guidelines (IMAI etc) whenever possible, harmonize disease-specific guidelines whenever possible

°

1. HIV+ patient with axillary T>=37.5° C or history of fever.

2. Check for danger signs (convulsions, meningismus, coma, lethargy, other changes in behavior or mental status, intense headache, unable to eat, drink or walk, severe abdominal pain, respiratory distress)

3. If danger signs present: stabilize, admit or refer

4. If no danger signs, look for causes of fever: complete history, physical exam, malaria testing.

5. Malaria test(s) negative. 6. Malaria test(s) positive. Treat for malaria. If an additional cause of fever is also present, treat it as well.

7. If cause of fever known (or strongly suspected), initiate appropriate treatment or request studies.

8. If no cause detected, start antibiotics. If no improvement in 48 hours and cause still uncertain, add antimalarials.

9. If worse, or if not better in 2 to 7 days, see chronic fever algorithm.

Técnico de medicina algorithm for acute fever.

°

1. HIV+ patient with signs or symptoms of anemia (fatigue, weakness, dyspnea, pallor, bleeding, or hemoglobin <10g/dL)

2. Check for danger signs (shock, cardiac failure, severe pallor, active bleeding, surgical abdomen, obstetrical emergency, and/or hemoglobin < 5.0 g/dL)

3. If danger signs present: stabilize, admit or refer

4,5. If no danger signs, confirm presence of anemia. Check hemoglobin; compare to previous results if available. If bleeding without danger signs, treat per Mozambican norms in addition to remainder of algorithm.

6. Anemia confirmed (Hb <10 g/dL and not increasing, or decreasing. Test for malaria.

7. Anemia not confirmed: Hb >=10g/dL, or <10 g/dL but rising. Look for other causes of the patient’s symptoms.

8. Malaria test(s) negative. Check CBC. Review medication history (CTX, AZT, other medications that could cause anemia?)

9. Malaria test positive. Treat for malaria.

12. Adverse drug reaction unlikely. Give ferrous sulfate and folic acid or B complex for 1 month, ITN, nutritional counseling, single dose albendazole if not treated recently. Follow up in 1 month.

Técnico de medicina algorithm for anemia.

14. Anemia improved (Hb increase >=1 g/dL. Continue FeS04 for 3 months.

11. CBC: Leukopenia and/or thrombocytopenia. Refer. 10. CBC: Isolated anemia.

13. Adverse drug reaction (ADR) possible. See ADR guidelines.

15. Anemia worse or not improved. Refer for consideration of ART initiation and for investigation of other causes.

Integration of new guidelines and curricula

Modules/sessions in both in-service and pre-service curricula corresponded to guideline topics (e.g. “diarrhea”, “weight loss”, “cough or dyspnea”).

Evidence supporting guideline development (epidemiologic, health-outcomes) summarized in curricula.

Stepwise presentation of guidelines.In-class case studies to be solved using guidelines;

generally, >=1 case presentation per guideline arm.Writing cases helped us spot guideline flaws, and

drove revisions!

Sample case-study questions

• Which guideline or guidelines should you use to address this case, and why?

• Does this patient have danger signs, or can you proceed to the next steps of the guideline?

• Which pathway should you take next (e.g. Box x or Box y), and why?

• Can you manage this patient with the guideline, or do you need to refer?

Use of guidelines in practicum sessions

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

(Digression into textbook publishing)

Shift context Uganda

IDCAPRCT studying the most cost-

effective way to build capacity for the care

and prevention of infectious diseases

among mid-level providers in Uganda

Context: the training design

Classroom On-site

Context: the curriculum goal

Develop training materials that:o INTEGRATE infectious diseases training

(with emphasis on HIV/TB/malaria and common others)

ouse a CASE-BASED approach to frame key content

oTARGET mid-level providers at the health center IV level in Uganda

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?

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?

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?

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

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

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

Clinical Decision-Making Guide(s)

Anatomy

• Introduction: rationale and how-to-use

• Clinical decision-making guides (CDG): clinical algorithms plus explanatory notes

• Appendix tools: useful existing clinical reference material(s)

Types of decision-making

• Evaluation and management of new signs/symptoms (“unknowns”)

• Routine case management in HIV, TB, malaria

Section: common clinical problems

Section: HIV and ART

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

Development of the CDGs

Guides constructed around important clinical decision-making 1. Identifying the important clinical decisions that may

need to be made in a patient with _________.2. Identifying the information needed to make these

decisions? (this informs and focuses the clinical evaluation).

3. Identifying and outlining the criteria by which key decisions are made?

4. Representing this process in a graphical format (with explanatory notes AND referencing appendix tables)

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

Classroom On-site

FOCUS

Classroom On-site

Characteristics of new Mozambican (IDCAP) guidelines

Topics: Common signs or symptoms (patient-based, not disease-based)

Patient evaluation: Directed, based on history, physical examination, and use of available tests (malaria, HIV, AFB, hemoglobin)

Differential diagnosis: Emphasize common illnesses that can be diagnosed and treated with available resources within approved scope of practice of target cadre (more complex problems to be referred upward)

Layout: 1 page, easy to read, parallel organization for different guidelines

General: evidence based, consistent with major local (TB, malaria, AIDS, antenatal care programs) and international guidelines (IMAI etc) whenever possible, harmonize disease-specific guidelines whenever possible

Mozambique Uganda: key differences

1. Context: designed for use in RCT of 2 different approaches to MLP training in UG.

2. Target pop’n: address HIV+ and HIV- adults and children

3. Layout: extensive footnoting and appendix references

4. (?) link to trainee performance evaluation....

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…

Gaps and challenges (1)

Related to national or international policy:

1. The dueling algorithm problem does not originate locally – some

guidelines originate in Geneva or the US or European headquarters of locally active aid agencies.

2. Constant evolution of scope of work of non-physician clinicians (can they do lumbar punctures? Can they prescribe 2nd line antiretrovirals or TB drugs?). Required national consensus conference in Mozambique.

Related to the scientific evidence base:

1. Constant evolution of published evidence base drives frequent revisions of international (WHO, PEPFAR, etc) standards.

2. Still, many lacunae in evidence base (Which antimalarials can be given safely and effectively to patient s on ART + TB treatment? Is visceral leishmaniasis an important contributor to anemia in province x? )

Gaps and challenges (2)

Related to the complexities of patient care in resource-constrained settings:

1. Some common problems have not been amenable to guideline development (e.g. abdominal pain, overlapping adverse drug reactions in patients on ART + multiple other agents)

2. Lack of resources (laboratory, imaging, surgeons, drugs) is a serious constraint to construction of an effective approach to some clinically important problems (e.g. altered level of consciousness)

3. Use of guidelines in patients with multiple active comorbidities.

Priorities for the future

1. Validation of new guidelines (studies about to commence in Mozambique [Vanderbilt University])

2. Workable plan for frequent revision as evidence base and local/international policies evolve

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)

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?

Questions???

Thank you!

Welcome to I-TECH HIV/AIDS Clinical Seminar Series

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

Email: DLinfo@u.washington.edu

Welcome to I-TECH HIV/AIDS Clinical Seminar Series

Next session: 5 August, 2010Zied Mhirsi, MD

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