Concordance between programmatically- and laboratory-determined treatment outcomes for multidrug-resistant tuberculosis patients in Peru 公开

Abstract

Concordance between programmatically- and laboratory-determined treatment outcomes for multidrug-resistant tuberculosis patients in Peru

By Emily Alexy

Background: Confirmation of cure for an MDR TB patient is based on laboratory tests for Mycobacterium tuberculosis growth on culture media. Testing takes 4-6 weeks and laboratory capacity is often limited in resource-poor settings; these factors contribute to a convention of programmatically-determined treatment outcomes. Outcome decisions dictate patient management and inaccuracies place patients at an increased risk of morbidity and mortality, and may contribute to community transmission of MDR TB.

Objective: To examine concordance between programmatically-determined and laboratory-confirmed treatment outcomes among MDR TB patients, and to look at patient sociodemographic and clinical characteristics as potential predictors of concordance.

Methods: Data were abstracted from medical records of all MDR TB patients in Peru who initiated treatment between August 1996 and March 2002. Patients with both programmatic and laboratory outcomes were included in the present analysis (n=1658). Laboratory outcomes were based on international standards requiring at least five consecutive negative cultures in the last 12 months of treatment to confirm cure.

Results: Using laboratory outcomes as the gold standard, clinicians had 98.9% sensitivity but only 45.7% specificity in assigning successful (cured or completed) treatment outcomes (versus failed). Laboratory results showed that 123 of 1152 (10.7%) patients declared cured and 27 of 287 (9.4%) categorized as completed by a clinician were bacteriologic failures. Overall, 10.4% of patients with programmatically-determined successful treatment outcomes still had positive bacteriologic results for MDR TB. Only treatment strategy type (individualized or standardized) was a significant predictor of concordance between laboratory- and programmatically-determined outcomes.

Conclusion: Clinicians in Peru correctly identify most successful treatment outcomes, yet miss many treatment failures. Until rapid diagnostics are readily available, treatment decisions will continue to rely on clinical judgment. Due to the implications of premature discontinuation of treatment, accurate final treatment outcomes are critical. Studies are needed to identify means to improve the diagnostic accuracy of programmatically-determined MDR TB treatment outcomes.

Table of Contents

Table of Contents

BACKGROUND/LITERATURE REVIEW................................................................. 1

Overview of Tuberculosis................................................................................................ 1

Tuberculosis Treatment.................................................................................................. 2

Multidrug-Resistant Tuberculosis................................................................................... 3

TB and MDR TB in Peru................................................................................................. 5

Laboratory Services in Peru........................................................................................... 6

Consequences of Inappropriate or Incomplete MDR TB Treatment............................ 6

Difficulty in Changing a Physician's Diagnosing Behavior............................................ 8

Accuracy of Clinical Judgment....................................................................................... 9

MANUSCRIPT............................................................................................................... 11

TITLE............................................................................................................................ 11

AUTHORS..................................................................................................................... 11

AFFILIATIONS............................................................................................................. 11

ABSTRACT................................................................................................................... 11

INTRODUCTION......................................................................................................... 13

METHODS..................................................................................................................... 15

Study Population.......................................................................................................... 15

Study Design................................................................................................................ 15

MDR TB Treatment Outcome Definitions.................................................................... 16

Patient Sociodemographic and Clinical Characteristics................................................ 18

Statistical Analyses...................................................................................................... 18

RESULTS....................................................................................................................... 20

Concordance between Programmatically- and Laboratory-Determined Treatment Outcomes 20

Modeling for Predictors of Concordance..................................................................... 21

DISCUSSION................................................................................................................. 23

Study Limitations......................................................................................................... 26

Conclusions................................................................................................................. 27

REFERENCES............................................................................................................... 30

TABLES........................................................................................................................... 35

Table 1. Sociodemographic & clinical characteristics of MDR TB patients in Peru, 1996-2002 35

Table 2. Concordance of programmatically-based and laboratory-determined treatment outcomes (all categories) for MDR TB patients in Peru, 1996-2002.................................................. 37

Table 3. Concordance of programmatically-based and laboratory-determined treatment outcomes in binary categories for MDR TB patients in Peru, 1996-2002................................................... 38

Table 4. P-values for chisquare univariate associations with outcome match variable 39

FIGURES......................................................................................................................... 40

Figure 1. Flow chart for inclusion in analysis of outcome concordance for MDR TB patients in Peru, 1996-2002........................................................................................................................................ 40

APPENDICES................................................................................................................. 41

Appendix A: IRB letter of non-HSR status................................................................... 41

Appendix B: Patient Data Form.................................................................................... 42

Appendix C: SAS code and output................................................................................. 57

About this Master's Thesis

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• Permission granted by the author to include this thesis or dissertation in this repository. All rights reserved by the author. Please contact the author for information regarding the reproduction and use of this thesis or dissertation.

School	Rollins School of Public Health
Department	Epidemiology
Subfield / Discipline	Global Epidemiology - MPH & MSPH
Degree	MPH
Submission	Master's Thesis
Language	English
Research Field	Health Sciences, Public Health Health Sciences, Epidemiology
关键词	Peru multidrug-resistant tuberculosis tuberculosis treatment outcomes
Committee Chair / Thesis Advisor	Sullivan, Kevin, Emory
Committee Members	Podewils, Laura, CDC
Partnering Agencies	International Non-governmental organization (e.g., CARE, Inc.) University, college or educational institution (other than Emory) CDC

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