Download - Valerie d acremont
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Epidemiology and Public Health
Diagnostic parasitologique des accès
palustres: acquis et défis
Valérie D‘Acremont, MD, PhD
Atelier paludisme Madagascar, 22 Mars 2011
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How to deal with malaria in patients?
Prompt treatment
Suspected malaria
Early and accurate diagnosis
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What is ‘malaria’?
Different definitions depending on the purpose:
1) For epidemiological analysis (malaria infection)
� quantify burden of malaria, modelling...
2) For clinical management (malaria disease)
� to decide who should be treated for an
episode of malaria
Definitions of malaria
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What is a true malaria episode (= illness) ?
CoughDiarrhea
ArthralgiaHeadache
General
population
Sick population
Febrile patients
‘Clinical malaria’
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What is a true malaria episode (= illness) ?
General
population
Sick population
Febrile patients
Parasites in blood
‘Clinical malaria’
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What is a true malaria episode (= illness) ?
‘Clinical malaria’
‘Malaria episode’
General
population
Febrile patients
Sick population
Parasites in blood
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What is a true malaria episode (= illness) ?
CoughDiarrhea
ArthralgiaHeadache
Sick population
General
population
Parasites in blood
Sick people withincidental parasitemia
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What is a true malaria episode (= illness) ?
‘Clinical malaria’
‘Malaria episode’
General
population
Febrile patients
Sick population
Sick people withincidental parasitemia
OVERDIAGNOSIS
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What is a true malaria episode (= illness) ?
‘Malaria episode’
General
population
Febrile patients
Sick population
HEALTH FACILITIES:
Only patients that
should be treated !
Parasites in blood
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In the context of elimination ?
General
population
Parasitemia in healthy people
Sick population
Febrile patients
Parasites in blood
POPULATION SURVEYS:
Treatment of the
hidden reservoir
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Magnitude of overdiagnosis
Systematic review of 39 studies performed between 1986 and 2007
in 16 African countries including 42,979 patients
Proportion of feversassociated with Pf (%)
0
10
20
30
40
50
60
70
80
90
100
<2000 >2000
44%
22%
D’Acremont, CID 2010
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Systematic review
Proportion of malaria among fevers in children < 5 years
81%1986Tanzania (rural)
5%2003Dar es Salaam
57%1995
38%1997
21%2005
4%2004Highlands
urbanruralYearCountry
Rooth, Font, Nsimba, Reyburn, Wang
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Systematic review
Studies providing stratified values of PFPf
by age groups, including older children:
<5 years MEDIAN PR = 27% (IQR 20-50%)
5-14 years MEDIAN PR = 40% (IQR 22-48%)
>15 years MEDIAN PR = 24% (IQR 11-27%)
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Consequences of over-treatment
Drugs wastage
Left untreatedfor real cause
Reattendances
Costs for patient
Parasite resistanceMistrust
in ACT
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Predictors for malaria:
Clinical diagnosis: impossible to rely on it
0
Proportion of malaria
among fevers
Drug wastage (overdiagnosis)
20% 40% 60% 80% 100%
20%
40%
60%
80%
100%
Failure to treat (missed cases)
Reviewed by
Chandramohan et al
in 2002
high temperature of short duration
, absence of abdominal pain, absence of rash
, absence of cough
splenomegaly
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How to deal with malaria in patients?
Prompt treatment
Suspected malaria
Early and accurate diagnosisLAB TEST
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How to get universal access to
parasitological diagnosis?
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Available malaria tests: microscopy
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REGIONAL COURSE ON TRAINING OF TRAINERS ON USE OF
MALARIA RAPID DIAGNOSTIC TESTS (RDTS)
Components of good microscopy performance
Competency
Selection
Training
Assessment
Equipment/
reagents
Support networkSlide /results delivery
Work
environment
Performance
Supervisione.g. cross-checking??
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Performance of Microscopy for malaria in DSM
Sensitivity = how sensitive is the test to detect the true positive cases
Specificity = how specific is the test to detect the true negative cases
Total
Total
Negative
Positive
Routine microscopy
NegativePositive
Expert microscopy
Sensitivity
= 70%
Specificity
= 45%
328322
148
173
2
5
7
178
150
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0
20
40
60
80
100
120
140
0 -<
1010
-<10
010
0 -<
1000
1'00
0 -<
10'0
00
10'0
00 -<
100'
000
>100'
000
Reported parasitemia: routine versus expert
Real positives…
Routine microscopy
Expert microscopy
Parasitemia (parasites/µl)
Number of slides
hospitals 41%
health cent. 49%
dispensaries 65%
(range 13-90%)
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Performance of Microscopy for malaria in
other places
In some places, problem of sensitivity
� cases missed:
71% in Moshi Reyburn et al, 2007
But more often, bad specificity
� overdiagnosis:
62% in Kenya Zurovac et al, 2006
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Consequences of suboptimal
microscopy for malaria
1) Clinicians do not trust microscopy � overtreatment
Kenya, 2002:
- blood slide performed in 79% of febrile patients
and in 51% of afebrile patients
- 43% (routine) versus 13% (expert) positive slides
- 96% of positive and 79% of negative malaria patients
received treatmentZurovac et al, 2006
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High mortality among patients admitted to hospital and incorrectly treated for
malaria, 10 hospitals, NE Tanzania
Admissions for malaria n=17,313Admissions for malaria n=17,313
Severe disease n=4670 (27%)Severe disease n=4670 (27%)
Readable slide results n=4474 (95%)Readable slide results n=4474 (95%)
No criteria forsevere disease n=12,643 (73%)120 deaths (1%)
No criteria forsevere disease n=12,643 (73%)120 deaths (1%)
Expert microscopy negativen=2412 (54%)
Expert microscopy negativen=2412 (54%)
Deadn=142 (7%)
Deadn=142 (7%)
Aliven=1920 (93%)
Aliven=1920 (93%)
Deadn=292 (12%)
Deadn=292 (12%)
Aliven=2120 (88%)
Aliven=2120 (88%)
Expert microscopy positiven=2062 (46%)
Expert microscopy positiven=2062 (46%)
Reyburn H et al. BMJ 2006
2) Clinicians tend to ignore non-malarial fevers
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High mortality among patients admitted to hospital and incorrectly treated for
malaria, 10 hospitals, NE Tanzania
Admissions for malaria n=17,313Admissions for malaria n=17,313
Severe disease n=4670 (27%)Severe disease n=4670 (27%)
Readable slide results n=4474 (95%)Readable slide results n=4474 (95%)
No criteria forsevere disease n=12,643 (73%)120 deaths (1%)
No criteria forsevere disease n=12,643 (73%)120 deaths (1%)
Expert microscopy negativen=2412 (54%)
Expert microscopy negativen=2412 (54%)
Deadn=142 (7%)
Deadn=142 (7%)
Aliven=1920 (93%)
Aliven=1920 (93%)
Deadn=292 (12%)
Deadn=292 (12%)
Aliven=2120 (88%)
Aliven=2120 (88%)
Expert microscopy positiven=2062 (46%)
Expert microscopy positiven=2062 (46%)
Reyburn H et al. BMJ 2006
2) Clinicians tend to ignore non-malarial fevers
Dar es Salaam (Muhimbili hospital)
‘cerebral malaria’
22% in slide negative patients13% in slide positive patients
Makani et al 2003
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A reliable test available at time and place of need,
used for more than 15 years in Europe
and 7 years in South Africa...
Add another malaria diagnostic test
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Meta-analysis published in 2006:
HRP2 RDT at least as sensitiveas expert microscopy
REF: Ochola Lancet Infect Dis 2006
100%
90
80
70
60
50
40
30
20
10
0
Microscopy
HRP2 RDT
pLDH RDT
QBCAO
Sensitivity in the absence of a gold standard
Relative performance of each method
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Technologies evolve quickly :
REF: Bell AJTMH 2005 Dal-Bianco AJTMH 2007 Stauffer CID 2009
Stauffer 2009
Dal-Bianco2007
Bell 2005
Author, year
SensitivityProportion
RDT(+) / BS(-)
positives by PCR
88%100%60%Travelers USA
22%46%80%Gabon
70%?91%92%Philippines
MicroscopyRDT
Origin of the samples
Conclusion: between 60 and 90% of so-called false-positive RDT
are real positives, reflecting the high sensitivity of HRP2 RDT
Relative performance of each method
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Putative explanation for greater sensitivity of a RDT
relying on detection of a persistent antigen
REF: Bell AJTMH 2005
Relative performance of each method
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Objective
To evaluate in an uncontrolled setting the
safety (clinical outcome) of withholding antimalarials
in febrile children with a negative RDT
in a moderately endemic area (urban setting)
in a highly endemic area (rural setting)
Safety study of RDT in Tanzania
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1000
febrile children
603 (60%) RDTm -ve
396
followed up
591 followed up
387 (98%)
cured573 (97%)
cured
18 (3%)
still sick
15 RDTm -ve
2 RDTm still +ve
1 still no RDTm
1 LOF 12 LOF
2 LOF
2 RDT -ve
9 (2%)
still sick
BS negative
8 cured
1 LOF
1 admitted
2 deceased2 RDTm&BS -ve
14
cured
1 admitted1 RDTm&BS -ve
Day
0 D
ay
7 >
Da
y14
397 (40%) RDTm +ve
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Translation of research findings into policy
Translation of research findings into policy
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Improve laboratory diagnosis for malaria
in routine management of fever cases at
OPD
Implementation of RDT in Dar es Salaam
Intervention:
Pilot implementation
of RDT in Dar es Salaam
in the 3 district hospitals,
3 health centres
and 3 dispensaries
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Methodology
Consultation process:
Baseline survey9 Intervention HF
Consultation process:
Post-intervention survey9 Intervention HF
INTERVENTIONTraining, RDTm implementation, quaterly supervision
3. Routine statistics of Health Facilities
Consultation process:3 Control HF
Consultation process:
3 Control HF
2. Cluster randomizedstudy
1. Before and afterstudy
2007 20082006
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1. Before-after cluster randomized study
Patients with history of fever
Proportions of patients treated with antimalarials
9 intervention HF
BEFORE AFTER
3 control HF
81%
24%
65%
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0%
20%
40%
60%
80%
100%
Ja
n
Fe
b
Ma
r
Ap
r
Ma
y
Ju
n
Ju
l
Au
g
Se
p
Oc
t
No
v
De
c
Ja
n
Fe
b
Ma
r
Ap
r
Ma
y
Ju
n
Ju
l
Au
g
Se
p
Oc
t
No
v
De
c
Ja
n
Fe
b
Ma
r
Ap
r
Ma
y
Ju
n
Ju
l
Au
g
Se
p
Po
sit
ivit
y r
ate
1) Performance of routine mRDT much better than
routine microscopy
� better specificity � less overdiagnosis
mRDT implementation
2006 2007 2008
Routine microscopy48%
Routine RDT8%
Results 1: why did it work?
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2) Negative RDT patients are not treated for malaria
more trust in mRDT � better adherence to the guidelines
Negative patients treated
With microscopy With mRDT
53%
7%
Results 1: why did it work?
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0
5000
10000
15000
20000
25000Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
dispensary 3
dispensary 2
dispensary 1
health centre 3
health centre 2
health centre 1
hospital 3
hospital 2
hospital 1
mRDT
2007 2008
Results 2: longitudinal study
Artemether/lumefantrine (ALu)
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0
2000
4000
6000
8000
10000
12000
14000
16000
18000
Jan
Mar
May
Jul
Sep
Nov
Jan
Mar
May
Jul
Sep
Nov
Jan
Mar
May
Jul
Sep
dispensary 3
dispensary 2
dispensary 1
health centre 3
health centre 2
health centre 1
hospital 3
hospital 2
hospital 1
mRDT
2007 20082006
Quinine vials
Results 2: longitudinal study
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Severe malaria
Give i.v quinine
Severe illness (NOT malaria)
• STOP antimalarials
• Continue with appropriate antibiotic
• Investigate for other causes of fever
• Repeat RDT and BS after 12-24hrs
Admission
Give immediately antimalarial and antibiotic
DANGER SIGNS
Perform RDT or BS
Uncomplicated malaria
Give antimalarial
Febrile illness(NOT malaria)
• Do NOT give
antimalarial
• Invest. for other
causes of fever
Do NOT
perform a
malaria test
NO
YES
NO
YES
Perform BS
+/- RDT
BS and RDT both
negatives
RDT and/or
BS positive
positive negative
Follow-up
PRIMARY AND SECONDARY LEVELPRIMARY LEVEL SECONDARY LEVEL
Refer the
patient
immediately
High malaria risk area
FEVER ANEMIA
Low malaria risk area
FEVER without an
obvious cause of fever ?
Suspected malaria case
NO
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Antibiotic prescriptions in Dar es Salaam
Antibiotics
Antimalarials
� Proportion of febrile patients receiving:
D’Acremont et al, 2010, submitted
Before RDT implementation
After RDT implementation
49% 73%
81% 24%
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But what are the causes of all these fevers
that are not malaria ?
?
8%
Study on etiologies of fever in children
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To determine the etiology of fever
episodes in small children living in urban
and rural Tanzania
children 2 months - 10 yrs
temperature > 38°C
Methodology of the fever study
1005 patients
(507 in Dar es Salaam
and 498 in Ifakara)
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Methodology
• Prospective study including children attending two outpatient
clinics (one urban and one rural) in Tanzania
• Inclusion criteria:
- aged 2 months - 10 yrs
- temperature > 38°C
• Full clinical assessment and investigations
based on pre-defined algorithms
• Computer-based diagnosis with levels of probability
• Real-time (RT-)PCR of naso-pharyngeal swabs for 13 viruses
• PCR and serologies on blood ongoing
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All ARI50%
4%
12%
1%
5%
3%
20%
1%
3%
10%
31%
All gastroenteritis9%
Acute Resp. Infect.
URTI
Bronchiolitis
Non-doc. pneumonia
Doc. pneumonia
Gastroenteritis
amoeba
Rota/Adenovirus
Salmonella/Shigella
unknown etiology
Urine infection
Skin infection
Other
Sepsis due tobacteriemia
TyphoidMalaria
Unknown
Results 1: etiologies in all patients
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All ARI38%
All gastroenteritis8%
Acute Resp. Infect.
URTI
Bronchiolitis
Non-doc. pneumonia
Doc. pneumonia
Gastroenteritis
amoeba
Rota/Adenovirus
Salmonella/Shigella
unknown etiology
Urine infection
Skin infection
Other
Sepsis due tobacteriemia
TyphoidMalaria
Unknown
5%
20%
2% 4%
6%
10%
36%
2%
7%
Results 2: etiologies in severe patients
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Results 3: proportion of children infected with viruses
0%
20%
40%
60%
80%
100%
severe
pneumoniapneumonia URTI
unknown
fever
other
disease
any virus
any virus except PIC
Kenyan study (same
viruses)
Ref: Berkley JAMA 2010
86% 87%
82% 80%
64%
WHO definition
‘control
group’
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Results 6: seasonality of influenza
0%
10%
20%
30%
40%
50%
Apr May Jun Jul Aug
FLUAV
FLUBV
0%
10%
20%
30%
40%
50%
Jul Aug Sep Oct Nov
Dar es Salaam
Ifakara
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Development of improved practice guidelines for clinicians
Modified IMCI including
1. laboratory tools : malaria test, urine dipstick
2. additional clinical criteria: predictors for bacterial infections
(Acute Resp. Infect., typhoid)
Emphasis on rationale use of drugs (antimalarials and antibiotics)
Fever study: beyond the findings
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Development of improved practice guidelines for clinicians
Modified IMCI including
1. laboratory tools : malaria test, urine dipstick
2. additional clinical criteria: predictors for bacterial infections
(Acute Resp. Infect., typhoid)
Emphasis on rationale use of drugs (antimalarials and antibiotics)
Fever study: beyond the findings
The e-IMCI interface
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Remerciements
DSM City Medical Office of Health, Tanzania
Judith Kahama (co-researcher)
Ndeniria Swai (research assistant)
Gerumana Mpawa (logistics and data entry)
Ministry of health and Welfare, Tanzania
Deo Mtasiwa (Chief Medical Officer)
Ifakara Health Institute, Tanzania
Hassan Mshinda (ex-director)
Amana and St Francis hospital, Tanzania
Willy Sangu and P. Kibatala (directors)
Swiss Tropical and Public Health Institute
Christian Lengeler & Blaise Genton
Hôpitaux Universitaires de Genève
Laurent Kaiser & Pascal Cherpillod
Support financier de la part du Fonds National de la Recherche Suisse
TDR fournis en grande partie par USAID/Tanzania sous President Malaria Initiative