Post on 18-Jan-2016
Operational research to Policy and Practice: examples
Anthony D Harries,
The Union, Paris, France
London School Hygiene & Tropical medicine
MALAWI
16 Million people
GNP $380
1 Million PLHIV
20,000 TB cases per yr
Life expectancy 59 years
World Health Statistics 2014
Malawi TB Control Programme
• Nationwide coverage of “DOTS” by 1984
• Initially very good progress
• Good case finding
• Good treatment outcomes
• THEN – along came HIV
0.00
0.02
0.04
0.06
0.08
0.10
0.12
0.14
0.16
1985 1990 1995 2000 2005
Adult HIV prevalence
Adult HIV-prevalence in Malawi
Increased case numbersIncreased case fatality
Notified TB cases in Malawi: 1985 - 2005
0
5000
10000
15000
20000
25000
30000
1985 1989 1993 1997 2001 2005
Sm-TBSm+PTB
26% 52% 67% 75% 75%
HIV-prevalence rate in TB patients
0
5
10
15
20
25
% deaths
86 88 90 92 94 96 98
Year
Deaths in New Sm+ve PTB patients in Malawi
Can HIV testing and cotrimoxazole preventive therapy (CPT) reduce
TB treatment mortality?
Background and problem
• Cote d’Ivoire RCT: CPT associated with significant mortality reduction in HIV-infected TB patients (Wiktor et al, Lancet 1999)
• UNAIDS 2000 Provisional Recommendations
• Malawi Ministry of Health: CPT may not have the same efficacy in Malawi as Cote d’Ivoire because different resistance patterns and different spectrum of HIV-related illness
• Malawi not prepared to adopt UNAIDS Recommendations on CPT because no evidence of effectiveness and may be dangerous
• Strong endorsement for district operational research
Aim of district studies:Thyolo and Karonga
To determine the feasibility and effectiveness of “HIV testing and CPT” in reducing case fatality in a cohort of TB
patients registered under routine program conditions
Methods
Patients:• TB patients registered in DTO office• TB treatment started - standardized regimens• All patients offered HIV testing /counselling• HIV-positive patients offered CPT
End of Treatment Outcomes:• Mortality
Analysis
• HIV test +CPT group: the cohort of all TB patients offered HIV testing and CPT and registered during a full 1 year period
• Control group: the cohort of all TB patients not offered HIV testing and CPT and registered the previous year during a full 1 year period
Comparison of mortality at the end of treatment between the two groups
Results [1]: Registered cases
Thyolo
HIV test+CPT1061
Control 925
Karonga
HIV test+CPT 362
Control 355
Results [2]: Interventions in HIV+CPT group
Thyolo Karonga
Number enrolled 1061 362
HIV tested 91% 73%
HIV-positive 69% 51%
Started CPT 94% 96%
Results [3]: case fatality in all TB types
Thyolo:
HIV test+CPT 28%
Control 36%
p < 0.001
Karonga:
HIV test+CPT 29%
Control 37%
p < 0.001
CPT safe in both districts with non-severe skin reactions at 2% and 5%
Number of TB patients that needed treatment with “HIV testing and CPT”
to prevent one death = 12in both Thyolo and Karonga
“estimated cost to prevent one death = USD$100”
Conclusion and Policy
• In the two districts, the package of “HIV testing and CPT” given to TB patients at or shortly after registration was associated with a significant reduction in case fatality
• October 2002: Ministry of Health Meeting with national stakeholders – policy adopted to roll out the intervention
Zachariah et al, AIDS 2003; Mwaungulu et al, Bulletin WHO 2004
HIV Testing and care in TB patients in Malawi: progress every 2 years
MALAWI 2004 2006 2008 2010 2012
TB patients 26136 26659 25688 22536 20463
HIV tested 26% 66% 84% 88% 93%
HIV positive 72% 66% 63% 64% 59%
Start CPT 97% 98% 96% 94% 88%
Start ART <10% 38% 38% 54% 81%
Source: Malawi NTP
TB treatment outcomes in patients with new smear-positive PTB at national level
Year Treatment Success Death Other
2002 71% 19% 10%
2004 71% 16% 13%
2006 79% 13% 8%
2008 85% 8% 7%
2010 88% 8% 4%
Source: Malawi NTP
India
Screening TB patients for diabetes in India
Diabetes Mellitus increases the risk of TB by a factor of 2 - 3
Dooley and Chaisson, Lancet Infectious Diseases, 2009
Ruslami et al, Tropical Medicine & International Health, 2010
Goldhaber-Fiebert et al, International Journal Epidemiology 2011
Some evidence that poor DM control increases TB risk (HbA1c >7% = RR 2.56) [USA,UK, Canada, Mexico, Russia, India, Taiwan, South Korea, Indonesia]
Stevenson et al, Chronic Illness 2007
Jeon and Murray, PLoS Medicine 2008
Framework for a public health approach to bi-
directional screening and care for TB and diabetes
Launched in August 2011
The recommendations
http://www.who.int/tb/publications/2011/en/index.html Document available at:
Bi-Directional Screening and Care of TB and Diabetes Mellitus
India
World Diabetes Foundation Support
• National Stakeholders Meeting
• Training for implementers
• Implementation of screening
• Review of activities and data
• National Stakeholders Meeting
Screen TB patients for DM
Is there is a known diagnosis of DM?
No known diagnosis - screen first with RBG
If RBG ≥ 6.1 mmol/l, screen with FBG
If FBG ≥ 7.0 mmol/l, then diagnose DM and refer to DM care
Screening TB patients for DM in India
Indicator TOTAL
Number of patients with TB registered and enrolled 8269
Number (%) with known diagnosis of DM 682 (8)
Number needing to be screened with RBG 7587
Number (%) actually screened with RBG 7467 (98)
Number with RBG >110 mg/dl and needing to be screened with FBG 2838
Number (%) screened with FBG 2703 (95)
Number (%) with FBG ≥ 126 mg/dl (newly diagnosed with DM) 402 (5)
Number (%) with known and newly diagnosed DM 1084 (13)
Number (%) with known / newly diagnosed DM referred to DM care 1033 (95)
India TB-DM study group TMIH 2013: 18: 636-45
Screening TB patients for DM in
India
Policy decision from India RNTCP and NCD that all TB patients in India be routinely screened for DM
India TB-Diabetes Study Group
Back of the TB Treatment card used in India
Simple parameters added for routine recording in quarterly TB reports
• Number of TB patients registered
• Number of TB patients screened for DM
• Number of TB patients diagnosed with DM
Conclusion
• With the research think ahead to what you want to achieve
• Ensure that the research is done in close collaboration with the programme and with the decision makers
• Involve the decision makers at the beginning and at the end