The WHO 10-Step Treatment
Modality for Severe Malnutrition in
the Context of HIV/AIDS Comorbidity: An Operational Research
in the Eastern Cape Province
Moïse Muzigaba
Supervisors: Prof T. Puoane
Prof D. Sanders
School of Public Health
University of the Western Cape
SACEMA Research Days – March 2013
Stellenbosch University
Presentation outline
Recap of last SRD presentation –
Background
Theoretical framework
Aims
Methodology
More emphasis on:
Specific evaluation questions (quantitative and
qualitative)
The interventional aspect and the evaluation design
Progress to date and challenges
Plan moving forward
Background
Major cause of
morbidity and
mortality among
young children in
Africa
25-50% mortality rate in some
SA hospitals –
54% of deaths in
children <5 year
Background cont...
Treatment of SM
World Health Organization (WHO) “Ten steps”
guidelines for managing severe malnutrition
Recognized and promoted worldwide as the
standard by which severely malnourished children
should be treated
Correct implementation can improve case fatality
rates from around 40% to less than 10 %
Background cont...
10 Steps summarised
Management of hypoglycemia and
hypothermia
Treatment of hidden infections
Correcting electrolyte and micronutrient
deficiencies
Provision of energy and nutrients for rapid
catch up growth
Why the research – The problem
Available evidence has mostly focused on
effectiveness of the WHO guidelines in low HIV
prevalent settings
Potential role of HIV infection on treatment
outcomes not adequately documented
Little literature available reports inconsistent
findings
Only ONE SA-based study which used a
small sample size
Implications of the evidence gap
↓Quality of and confidence in
patient care using the WHO
guidelines
Anecdotal reports – high CFR and poor
recovery for SM in two district hospitals in
the EC are being attributed to HIV infection
rather than to mismanagement by nurses
Perception that effectiveness of the
guidelines depends on the HIV disease stage
The research AIM
To evaluate the implementation of
the WHO treatment guidelines for
management of SM in the era of
high HIV infection and provide a
context for effectiveness of these
guidelines in terms of the quality of
care and related factors
Study setting
St Patrick’s
Hospital
MBIZANA
Holy Cross
Hospital
FLAGSTAFF
Study started with an intervention
To introduce and promote the implementation
of the WHO treatment guidelines in both
hospitals
Encompasses various inputs and processes
The intervention
Intervention
Inputs/structure
Outcomes
Process
Short term
Medium term
Training of health care and medical professionals
Patient diagnosis, documentation of
clinical/medical history, disease classification, HIV
testing and disease staging
Amenities/facilities
Medical equipment,
therapeutic resources,
number and
qualification of medical
and health care
personnel,
Hospital support
services,
Organizational
structure,
Communication
structures,
Financial resources and
incentives,
Therapeutic guidelines
(WHO management
protocol), etc…
Documentation of disease condition and
treatment protocol and admission of the patient
Children recover well - in terms
weight gain
Patient treatment according to the WHO 10-step
guidelines by doctors and nurses
Regular hospital visits to reinforce implementation
of the guidelines
Regular face-to-face feedback with hospital staff
to report on performance and discuss areas
needing improvement
Externally initiated onsite didactic training of
health care professionals and supervision of
health care givers
Induction training with new doctors and student
nurses on the principles of using the WHO
guidelines to treat SM children
Provision of job aids such as drug dose charts,
fluid and feed prescription charts, performance
monitoring tool, anthropometric charts, and
standardized admission charts,
Children spend less time in the
hospital while on treatment
Children do not die on
admission
Children do not develop further
medical complications
Discharge after full
or moderate
recovery
Study design
Mixed methods design using quantitative and
qualitative methods
Design based on two theories:
Guild’s theory of operational research (Health outcomes
research)
Donabedian theory of quality care assessment
Study entails 3 components
Design Cont.....
Component 1
Epidemiological evaluation of the WHO treatment modality for
management of severely malnourished children with and without
HIV co-morbidity
Component 2
Quality care assessment in relation to management of SM in the
context of HIV infection:
Component 3
Assessment of the organizational structure of the two hospitals
and how it impacts the implementation of the WHO guidelines
Design Cont.....
Component 1&2
Quasi-experimental study design using multiple cohorts
of SM children
The quasi experiment  Removed Treatment Design
O1
X
O2 .....On1
X .....On2
The aim is to demonstrate that the outcomes improve and
worsen with the presence or absence of Intervention - result
that could be otherwise explained only by a threat to
validity that similarly rose and fell over the same time
(Kussek et al 1999)
The intervention
Intervention
Inputs/structure
Outcomes
Process
Short term
Medium term
Training of health care and medical professionals
Patient diagnosis, documentation of
clinical/medical history, disease classification, HIV
testing and disease staging
Amenities/facilities
Medical equipment,
therapeutic resources,
number and
qualification of medical
and health care
personnel,
Hospital support
services,
Organizational
structure,
Communication
structures,
Financial resources and
incentives,
Therapeutic guidelines
(WHO management
protocol), etc…
Documentation of disease condition and
treatment protocol and admission of the patient
Children recover well - in terms
weight gain
Patient treatment according to the WHO 10-step
guidelines by doctors and nurses
Regular hospital visits to reinforce implementation
of the guidelines
Regular face-to-face feedback with hospital staff
to report on performance and discuss areas
needing improvement
Externally initiated onsite didactic training of
health care professionals and supervision of
health care givers
Induction training with new doctors and student
nurses on the principles of using the WHO
guidelines to treat SM children
Provision of job aids such as drug dose charts,
fluid and feed prescription charts, performance
monitoring tool, anthropometric charts, and
standardized admission charts,
Children spend less time in the
hospital while on treatment
Children do not die on
admission
Children do not develop further
medical complications
Discharge after full
or moderate
recovery
Variables
Outcome variables (dependant variables)
1. Case Fatality Rates,
2.
Duration of Stay in the Hospital and
3. Rate of Weight Gain
4. Time of death
5. Quality of care
Independent variables
1. HIV status
2. HIV diseases stage (I – IV)
3. Time
4. Quality of care
5. Hospital
6. Severity of Severe Malnutrition and status
7. Etc.
Research questions component 1
For each hospital the following questions are to be answered
1. What is the profile of patients from 2009 to 2013 by HIV status,
malnutrition status, HIV disease stage, Disease severity etc
General (Case Fatality Rates, Duration of Stay in the
Hospital and Rate of Weight Gain)
2. How does the survival time for HIV positive SM patients differ from
the survival time for HIV negative SM patients? (I.e. Time from
admission to death or time from admission to discharge – expressed
as duration of stay in the Hospital
3. How does the rate of weight gain for HIV positive patients differ from
the rate of weight gain of HIV negative patients (this is expressed in
g/kg/day)
4. What are the odds of dying for children who are HIV positive and
Malnourished compare to those who are HIV negative and
Malnourished?
Research questions component 1
HIV disease stage
5.
How does mortality (Case fatality rates) differ for SM patients
who are HIV positive across all four HIV disease stages (stage
I, II, III, and IV)?
6.
How does the rate of weight gain (g/kg/day) differ for patients
who are HIV positive across all four HIV disease stages (stage
I, II, III, and IV)?
7.
Does the time from admission to death or admission to
discharge differ across all four HIV disease stages for patients
who are HIV positive?
Research questions component 1
Malnutrition status
8.
How do marasmic HIV negative patients differ from
kwashiorkor HIV negative patients in terms of the rate of
weight gain (g/kg/day)?
9. How do marasmic HIV positive patients differ from
kwashiorkor HIV positive patients in terms of the rate of
weight gain (g/kg/day)?
10. How do marasmic HIV negative patients differ from
kwashiorkor HIV negative patients in terms of the duration of
stay in the hospital
11. How do marasmic HIV positive patients differ from
kwashiorkor HIV positive patients in terms of the duration of
stay in the hospital (time from admission to death or
discharge)
Research questions component 1
Trends over time
12.How have the following outcomes manifested from month to
month between 2009 and 2013 for HIV positive cases and HIV
negative cases
 Case fatality rates
 Rates of weight gain differed from month to month over the period
of 2009 to 2013for HIV positive cases and HIV negative cases?
 Duration of stay in the hospital
13. Was there any notable worsening of outcomes following the
withdrawal of some interventional components (were outcomes
sustainable)
Research questions component 1
Time of death analysis
14. What time of the day do most deaths occur?
15. Does the time of death for HIV positive and HIV negative cases
differ between the two hospitals?
Research questions component 2
Modeling Quality of care
16. How does the quality of care (what happens during care)
compare between HIV infected and HIV uninfected severely
malnourished children, over time? (Is there some form of
longitudinal variation/pattern?)
17. Did the quality of care remain the same even after withdrawing
a component of the intervention
18. If there were variations in the quality of care, how do they
compare between the two hospitals under study?
19. Is there any association between the quality of care (expressed
as a composite score derived from multiple care quality
indicators) and the treatment outcome (case fatality rate, rate of
weight gain, duration of stay in the hospital)?
Design Cont...
Sample size
650 SM cases are required - roughly half HIV +ve and
the other half HIV-ve
Children admitted and treated for SM between 2009 and
2013.
Data collection
Collected at baseline in 2009 and then at two-monthly
intervals till 2013
Standardised tool comprising of patient information and
diagnosis, process and outcome indicators related to
individual treatment will be used
Design Cont...
The tool (76-item questionnaire)
Study Number------------------------Date of data collection---------------B
HOSPITAL:
C
Folder Number:
Yes
Q1
Status of child when admitted to current ward
Q2
Age (months)
Q6
Standard deviation of weight for height below median
Q7
Oedema grade (0 + ++ +++)
Q8
Dermatosis grade (0 + ++ +++)
Q9
HIV status
Q10
Was the child terminally ill?( write presenting signs and symptoms)
Started treatment in casualty or other ward (state where, if applicable)
Key dates
Date admitted to current ward
Q11
Date discharged or died
Time of death (if applicable)
Q12
Date of transition onto F100
Q13
Date Orsol prescribed (if applicable)
Feeding
Q14
Given 10% sucrose/ glucose within 10 minutes of arrival on ward
Q15
Fed F75 as first feed
Q16
Fed F75 within 30 minutes of arrival on ward
Q17
Correct volume of F75 prescribed 3 hourly on day 1 -130/kg/day
Q18
If child has gross oedema, reduce volume to 100 ml/kg//day
Antibiotics
Q26
Antibiotics prescribed on day 1
Q27
Appropriate course of antibiotics prescribed
Q28
Cotrimoxazole prescribed if HIV +/ suspected
Q29
Antibiotics administered as prescribed
Q30
If HIV positive, is ARV prescribed
Electrolytes/Micronutrients
Q31
K administered (e.g. as mineral solution mixture)
Q32
Mg administered (e.g. as mineral solution mixture)
Q33
Zn administered (e.g. as mineral solution mixture)
No
Notes
Design Cont...
Component 3
Ethnographic design
Data collection Runs concurrently with Component 1&2
– two monthly) and uses:
34-item observational checklist
Field diary –
FGDs with clinical personnel and KIIs with selected
hospital staff
Research questions component 3
Modeled on the IDRC’s Performance Evaluation Matrix
1. To what extent does strategic leadership affect the hospitals’
performance in terms of MSM?
2. Is the organizational structure in the hospital facilitating or hindering
movement towards the better health care outcomes for SM
3. To what extent does governance affect the hospitals’ performance?
4. To what extent do the hospitals have adequate staffing procedures to
ensure its performance?
5. To what extent do the hospitals have appropriate human resources
development systems and approaches to ensure their performance?
6. To what extent does the organization have effective human resources
relations?
7. In the hospitals, is there adequate financial planning being undertaken
to support performance?
Research questions component 3
Cont …
8. Is the facilities infrastructure adequate to support performance?
9. To what extent do technology resources affect the hospitals’
performance?
10. Are the problem-solving and decision-making processes supporting the
hospitals’ capacity to carry out its functions vis a vis MSM?
11. Is the communication system effective in supporting performance?
12. Is adequate organizational monitoring and evaluation occurring to
improve performance?
13. Are external linkages adequately established or pursued to support
performance?
14. How is the organization affected by the administrative/legal
environment?
15. How is the organization affected by the political environment?
16. is the organization affected by the social/cultural environment?
Progress to date
 Collected data for 380 +cases admitted
between 2009 and 2011
 All this data captured already
 Have discussed the analysis plan with a
SACEMA-based biostatistics mentor and
have set targets
 Write-up underway
Way forward
Collect the rest of the data (280 cases admitted in 2012 and 1/5
of 2013) by Mid May 2013
Capture the rest of it by 10 June 2013
Collect qualitative data by 30 June 2013
Complete the analysis by the 10 July 2013
Continue with dissertation write-up
Complete and submit two manuscripts by December 2013
Challenges
Withdrawal of part of the intervention may
have led to inadequate documentation of:
Key process indicators (missing HIV test results,
diseases staging, treatment charts, key etc) and
Outcome indicators
Filing system generally poor and locating
patient charts takes long
Hospitals are far apart from each other so
logistics for data collection may be
problematic
THANK YOU