Transcript INESS - INDEPTH Network

INDEPTH Network Effectiveness and
Safety Studies Platform (INESS)
Introduction to Systems Effectiveness Modules
Don de Savigny
INDEPTH Scientific Advisory Committee
Swiss Tropical Institute, Basel
Pune, 28 October, 2009
INESS systems effectiveness objective
 To assess the effectiveness, and determinants of effectiveness,
of new malaria treatments in real world health systems.
Challenge
 For INDEPTH DSS Sites…
 To move beyond population health observatories to include a health
system observatory function
 To link population health and health behaviours to health services
and to health system behaviours
Driving with the brakes on:
How interventions lose traction in health systems
Example of ACT anti-malarial treatment in Rufiji DSS in 2006
Efficacy
X 40%
98%
X Access
X 90%
X 60%
X Diagnostics
X 75%
X 95%
X Provider compliance
Averages mask inequities
X 60%
X 95%
X Patient adherence
Poorest quintile = 16%
Effectiveness
Data source: IMPACT Tanzania. Effectiveness data are actual. Poorest quintile estimates are hypothetical
X 70%
= 37%
What does this mean?
 Presently more traction can be gained by removing health
system bottlenecks than by improving the efficacy of new drugs.
INESS Technical approach for
systems effectiveness

Seven linked study modules provide the ingredients
for the effectiveness estimation:
Module
Task team facilitator
Level
STI
HH
2 Diagnostic targeting
CDC
HF
3 Provider compliance
CDC
HF
STI
HH
CDC
Community & HF
6 Contexts and other effects
STI
District & HH
7 Costs and cost effectiveness
SPH
District, HF & HH
1 Access
4 Patient Adherence
5 Community acceptability
INESS: Understanding barriers to effectiveness
Costs
Therapeutic
efficacy
Access
HH
Targeting
HF
Compliance AdherenceActual
Effectiveness
Practice
HF
HH
Module 1. Access
Main purpose:
 determine proportion of cases needing to seek care
that actually gain physical access to a point of
provision
Quick overview:
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Household surveys of fevers in prior two weeks
Determines who was able to access authorized provider within 24h
Determines reasons for choices and failed access
Analyzes across time, space, socio-economic quintiles and provider
characteristics
Module 1. Access
More details:
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DSS Total Population Monitoring via three core questions for every DSS
household
 Any fever in prior two weeks
 If yes, who (name, permanent ID)
 Did he/she take an antimalarial
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Provides annual pattern of fever burden
DSS Household Access Sample Survey for in-depth assessment of care
seeking and access on sample of those with fever (on PDAs)
 Sample size ~ 21,000 per year
 2 hh per routine DSS enumerator per week requiring full interview
 Modified Malaria Indicator Survey instrument to identify:
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ACT provider
Delay and sequence of care seeking
Whether any diagnostic test done for the ACT
Whether and what treatment(s) obtained
Whether full ACT course continuing or completed
Costs of episode
 RDT conducted and referral if needed
 Sample size ~ 1,690 per year
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Powered to provide estimate +/-5% of proportion of RDT +ve febrile individuals having
access to a source of ACT within 24 and 48h in both rainy and dry seasons by equity
quintile.
Module 2 & 3.
Diagnostic targeting & Provider compliance
Main purpose:
 determine the proportion of cases having access that are
correctly diagnosed / classified
 determine the proportion of correctly diagnosed cases
that are provided with the correct treatment
Quick overview:
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Health facility / provider surveys
Sampled at peak and low seasons
Exit interviews with gold standard diagnostic
Determines the drug and instructions provided or prescribed
Assesses stock-outs and quality of drugs on hand
Identifies cohorts for adherence follow-up survey at home
Module 2 & 3.
Diagnostic targeting & Provider compliance
More details:
 Stratified sampling of ACT providers
 Sample size: 1,750 patients per year over two seasons
 All patients presenting as initial illness to sampled ACT provider on
day of survey
 Gold standard diagnostic
 Patient exit interview
 Pharmacy and supply inventory
 Health worker interview
Module 4. Patient adherence
Main purpose:
 Estimate proportion of patients who receive
treatment who use it as intended; and the
proportion who are satisfied with the treatment
Quick overview:
 Household survey
 Sample of exit subjects from Module 3 followed at home on day after
last scheduled dose (plus filter paper blood sample)
 Standard interviews for adherence and acceptability
 Further follow-up and filter paper blood at day 28 (and 42 depending
on ACT)
 Gold standard diagnostic available
Sample size: Adherence
Three levels of adherence:
 High (complete):65% of users with treatment failure of 5%
 Medium:
25% of users with treatment failure of 30%
 Low:
10% of users with treatment failure of 50%
Calculations
 Sample size required to detect a difference in treatment failure rate between the
two smallest groups, medium and low.
 With following parameters
 Confidence level: 95%
 Power 80%
 Ratio unexposed (medium adherence)/ Exposed (low adherence)
= 25% / 10% = 2.1
 Prevalence of disease (treatment failure rate) in Exposed group: 50%
 Rate ratio = 50% / 30% = 1.67
 We need 175 in medium adherence group and 70 in low adherence group.
 As the low group is expected to be 10% of all, we will need a total of 700 patients
to be followed through to the last day.
 This would have to be corrected upwards to account for the losses.
 Perhaps to 1000 patients per treatment for each drug.
Module 4. Patient adherence
More details:
 Sample size: 400 per season
 Visited one day after expected end of treatment course
 Asked about:
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Doses taken on each day, individually
Time specificity limited to morning, noon, afternoon, night
How drugs were taken (with food, drink, etc)
Vomiting and specifics
 Pills remaining and packaging examined
 Filter paper blood sample taken
 28 day interview and filter paper blood sampling visit scheduled
Module 5. Community acceptance
Main purpose:
 Examine the social, cultural and behavioural factors
that facilitate or impede uptake and adherence to
new ACTs when introduced
Quick overview:
 Community survey of three different populations
 Persons having a recent malaria fever episode (45-50 interviews)
 Adult men & women living in DSS area (15 FGDs per year)
 ACT providers (15-20 interviews)
 Two communities <5km and two communities >5km from ACT
Module 6. Contexts and additional effects
Main purpose:
 Estimate the contribution to reduced morbidity &
mortality.
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HMIS document reviews for trends and patterns in:
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Proportion of fevers recorded as malaria (OPD, IPD)
Severe anemia
Incidence of severe malaria
Proportion requiring transfusion
DSS database and VA review for trends in:
 All cause and malaria specific mortality
 Health seeking prior to malaria death from verbal autopsy
 ITNs and IRS coverage
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District plan and budget reviews for trends in:
 Health system changes
 Malaria expenditures as a share of all expenditure
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Other contextual data (rainfall, EIR, molecular markers for resistance)
Repeat therapeutic efficacy (100 patients)
Module 7. Overall effectiveness and costs
Main purpose:
 Determine the effectiveness, and the
determinants of effectiveness
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Putting it all together
Determine overall population effectiveness by equity quintile
Determine the efficacy losses, and where the greatest losses occur
Determine the costs of change, comparative financial costs, and
expected cost-effectiveness
Systems effectiveness: 20 Indicators
Element of effectiveness
Indicator
Access
•Proportion of people with fever who have sought contact with a provider who should
have the drug
•Proportion of people with fever who seek care from other providers
Availability
•Proportion of providers with the product in stock
•Proportion of time product is in stock
Targeting accuracy
•Proportion of malaria positive patients correctly diagnosed/classified by health
providers
Compliance (health system and
worker)
•Proportion of prescriptions which are correct (in accordance with manufacturer’s or
MOH guidelines)
Adherence (individual)
•Proportion of people who receive product and take as prescribed
Acceptability
•Proportion of people who are satisfied with the tested antimalarial (qualitative
assessment)
•Proportion of people actually opting for the tested antimalarial
Other measures of effectiveness
(including sensitivity of drug
overtime)
•Parasitological cure rate (clearance of the initial parasite infection by day 7,
persisting at D28, with PCR correction and/or in vitro and molecular markers as
proxies for these measures optional for sites with capacity to measure them)
•Parasite and anaemia prevalence
•Blood drug level
•Proportion of cases recorded as malaria in health facilities (outpatient + admissions)
•Incidence of severe malaria and malaria-related anemia
•Proportion of malaria cases requiring blood transfusions
•Mortality rate (all causes, malaria-specific)
Related malariologic parameters
that could influence findings
•Entomological Inoculation Rate (EIR)
•Coverage of other malaria-control interventions
Costs / cost-effectiveness (based
on a standardized cost tracking
system)
•Incremental financial costs of drugs policy (costs of drugs + costs of other activities
required to change policy)
•Costs per clinical outcome
Systems Effectiveness Task Teams
 Will assist with:
 Development of field protocols
 Piloting protocols in initial sites / countries
 Developing training and capacity strengthening approaches
 General oversight on module performance
 Data management & analysis
Thank you
District expenditure shares – all strategies
District absolute annual per capita expenditure –
communicable diseases
Rufiji District 2007
Estimating District ACT requirements