charlie gilks stagingsurveillance
TRANSCRIPT
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World Health Organization
Clinical Staging, AIDS surveillance and
Mortality in resource-poor settingsa clinicians view of strategic information needs
Charlie Gilks
Surveillance, Research Monitoring and Evaluation
Department of HIV/AIDS
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Some core concepts
HIV slowly destroys part of the immune system
Infected individuals pass through different stages
Advanced infection characterised by a few diseases Death is the ultimate outcome for most
ARVs successfully modify the course of disease
We are in the three by five era
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Mortality: resource-rich countries
Universal registration of deaths
Cause of death and predispositions included
AIDS-defining diseases (ADDs)
HIV often listed as predisposition electronic linkages with HIV databases
comprehensive data with clear time trends
counting deaths is a HUGEadvocacy tool
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Annual number of reported HIV-relateddeaths, USA, 1991-2001
0
10,000
20,000
30,000
40,000
50,000
60,000
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
Source: CDC Surveillance Reports, 1 991-2001
N
umberofHIV-relateddeaths
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Mortality: resource-poor countries
Very little vital registration of deaths HIV or AIDS rarely included
only data come form population-based studies
much extrapolation from demographic data huge advocacy value of these estimates
BUT how can we capture changes with ART?
An information gap - better sentinel surveillance ...
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AIDS Surveillance
The first Public Health response to the epidemic The aim is to capture extent of HIV-related disease:
- successful in high and some middle income counties
- powerful advocacy tool
- clear trends with time emerge
- enables impact of ART to be seen quickly and clearly
AIDS (Acquired Immune Deficiency Syndrome) is
nota single disease entity but a surveillance definition
The CDC case definition has changed 3 times
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CDC case definition, 1993
Laboratory evidence of HIV infection; and
CD4 cell count less than 200 cells/ mm orCD4 cells account forfewer than 14 percent of all lymphocytes or
Presence of one or more indicator diseases: Candidiasis of bronchi, trachea, or lungs;Candidiasis, esophagea;Cervical cancer,
invasive;Coccidioidomycosis, disseminated or extrapulmonary; Cryptococcosis,extrapulmonary; Cryptosporidiosis, chronic intestinal (greater than 1 month's duration);Cytomegalovirus disease (other than liver, spleen, or nodes); Cytomegalovirus retinitis
(with loss of vision); Encephalopathy, HIV-related;Herpes simplex: chronic ulcer(s)(greater than 1 month's duration); or bronchitis, pneumonitis, or esophagitis;Histoplasmosis, disseminated or extrapulmonary; Isosporiasis, chronic intestinal (greaterthan 1 month's duration); Kaposi's sarcoma; Lymphoma, Burkitt's (or equivalent term);Lymphoma, immunoblastic (or equivalent term); Lymphoma, primary, of brain;Mycobacterium avium complex or M. kansasii, disseminated or extrapulmonary;Mycobacterium tuberculosis, any site (pulmonary or extrapulmonary); Mycobacterium,other species or unidentified species, disseminated or extrapulmonary; Pneumocystis
carinii pneumonia; Pneumonia, recurrent; Progressive multifocal leukoencephalopathy;Salmonella septicemia, recurrent; Toxoplasmosis of brain; Wasting syndrome due to HIV
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AIDS cases in the USA
0
20,000
40,000
60,000
80,000
100,000
120,000
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001
Numberofrepor
tedAIDScases
0
5
10
15
20
25
30
35
40
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001
Source: CDC Surveillance Reports, 1991-2001
ReportedAID
Scasesper
100,000population
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European case definition, 1993
Same as CDC 1993 minus CD4 cell count
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WHO case definition for AIDSsurveillance (Bangui)
At least 2 major signsin combination with at least 1 minor sign Major signs:
Weight loss of at least 10% of body weight
Chronic diarrhoea for > 1 month
Prolonged fever for > 1 month
Minor signs: Persistent cough for > 1 month
Generalized pruritic dermatitis
History of herpes zoster
Oropharyngeal candidiasis
Chronic progressive or disseminated herpes virus infection
Generalized lymphadenopathy
Orgeneralized KS or cryptococcal meningitis
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Expanded WHO case definition for AIDSsurveillance (Abidjan)
Laboratory evidence of HIV infection and
One or more of following: 10% body weight loss or cachexia, with diarrhoea or fever, or
both, intermittent or constant, for > 1 month; Cryptoccocalmeningitis; pulmonary or extra-pulmonary TB; KS; Neurologicalimpairment sufficient to prevent independent daily activitiesnot known to be due to a condition unrelated to HIV infection;Candidiasis of the oesophagus; Clinically diagnosed life-threatening or recurrent episodes of pneumonia; invasive
cervical cancer
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Revised Caracas/PAHO AIDS definition
Laboratory evidence of HIV infection and Cumulative points assigned to following
conditions exceed 10 points: KS (10); Disseminated/extrapulmonary/non-cavity pulmonary TB
(10);Oral candidiasis/hairy leukoplasia (5); Pulmonary TB withcavitation or unspecified (5); Herpes zoster in person of 60 years orless (5); central nervous system dysfunction (5); diarrhoea > 1 month(2); fever at least 38 for at least a month (2); cachexia or weight lossof more than 10% (2); asthenia of at least a month (2); persistentdermatitis (2); anaemia, lymphopenia, and/or thrombocytopenia (2);persistent cough or any pneumonia, and/or thrombocytopenia (2);
lymphadenopathy of at least 1 cm at at least two non-inguinal sites (2)(number of points in parenthesis)
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Limitations with current AIDS surveillance inlow and middle income counties
Several different definitions of AIDS Not all are biologically consistent (e.g. pTB, bacteria)
Haphazard self reporting systems with (very)incomplete data collection
Assumes a western natural history of disease
- most morbidity is with an ADD- all transit through AIDS to death
Provide an incomplete picture of burden of disease None are congruent with WHO clinical staging
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Do we need AIDS surveillance?
ClearlyYES to have any handle on the epidemic of disease
to capture changes in the burden of disease
if we want to be able to show impact of ARTBUT it needs to be a better tool, more relevant
to HIV disease process in resource-poor settings
It MUST BEconsistent so trends can be compared
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Disease Staging
Hierarchical description of disease progression Has prognostic significance for the patient
In clinical guidelines, help specify when to use
antiretroviral therapy Allows comparability in clinical trials
entry criteria
outcome
especially where immunological markers not available
WHO Cli i l St i S t
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WHO Clinical Staging SystemClinical Stage 1:
Asymptomatic
Persistent generalised lymphadenopathy (PGL)
Performance scale 1: asymptomatic, normal activity
Clinical Stage 2:
Weight loss, 10% of body weight
Unexplained chronic diarrhoea, >1 month
Unexplained prolonged fever (intermittent or constant), > 1 month
Oral candidiasis (thrush)
Oral hairy leukoplakia
Pulmonary tuberculosis, within the past year.
Severe bacterial infections (e.g. pneumonia, pyomyositis)
And/or Performance scale 3: bed-ridden, >50% of the day during the last monthClinical stage 4:HIV wasting syndrome, as defined by CDC1
Pneumocystis carinii pneumonia
Toxoplasmosis of the brain
Cryptosporidiosis with diarrhoea, >1 month
Cryptococcosis, extra pulmonary
Cytomegalovirus (CMV) disease of an organ other than liver, spleen or lymph nodes
Herpes Simplex Virus (HSV) infection, mucocutaneous >1 month, or visceral any duration
Progressive multifocal leukoencephalopathy (PML)
Any disseminated endemic mycosis (e.g. histoplasmosis, coccidioidomycosis)
Candidiasis of the oesophagus, trachea, bronchi or lungsAtypical mycobacteriosis, disseminated
Non-typhoid Salmonella septicaemia
Extra Pulmonary tuberculosis
Lymphoma
Kaposi's sarcoma (KS)
HIV encephalopathy, as defined by CDC2
And/or Performance scale 4: bed-ridden, >50% of the day during the last month
Survival by clinical staging at enrolment in a cohort of 1371 HIV-infected
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Kaplan-Meier survival estimates, by stage
analysis time0 1 2 3 4
0.00
0.25
0.50
0.75
1.00stage 1
stage 2
stage 3
stage 4
Survival by clinical staging at enrolment in a cohort of 1371 HIV infected
adults from TASO, Entebbe in a trial of pneumococcal vaccine
Time in years
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Limitations with current clinical staging
Staging needs revising - interim proposal from 1990(several inconsistencies and inaccuracies)
Stage 4 does not correspond with AIDS
(no correspondence between staging & surveillance) No clinical criteria proposed for how to establish
presumptive or definitive staging diagnosis
Different trial centres using different approachesso results may not be easily comparable
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Conclusions
HIV/AIDS disease and deathhas been largelyignored by epidemiologists
AIDS surveillance inconsistent and incomplete
AIDS relates badly to clinical staging (confusing)
Impact of HIV/AIDS on death rarely measured Approaches used have been non-standardised
Projections and data cannot easily be compared
All this untenable as we enter the 3x5 ART era
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Strategic Information Needs
Revised and standardised AIDS case definitions Updated clinical staging with definitions
- must ensure staging and AIDS more compatible
- do this for both adults and children Agree practical approach to count HIV-related
deaths in sentinel sites
Move fast to establish baselines and standardsas interventions rapidly scaled up