The WHO 10-Step Treatment Modality for Severe Malnutrition in the Context of HIV/AIDS Co-morbidity: An Operational Resea

1. The WHO 10-Step Treatment Modality for Severe Malnutrition in the Context of HIV/AIDS Co-morbidity: An Operational Research in the Eastern Cape Province MoïseMuzigaba Supervisors: Prof T. Puoane Prof D. Sanders School of Public Health University of the Western Cape SACEMA Research Days – March 2013 Stellenbosch University

2. 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

3. 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

4. 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 %

5. 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

6. 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

7. 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

8. 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

9. Study setting St Patrick’s Hospital MBIZANA Holy Cross Hospital FLAGSTAFF

10. Study started with an intervention • To introduce and promote the implementation of the WHO treatment guidelines in both hospitals • Encompasses various inputs and processes

11. The intervention

12. 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

13. 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

14. Design Cont..... • Component 1&2 • Quasi-experimental study design using multiple cohorts of SM children • The quasi experiment Removed Treatment Design • 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)

15. The intervention

16. Variables Outcome variables (dependant variables) • Case Fatality Rates, • Duration of Stay in the Hospital and • Rate of Weight Gain • Time of death • Quality of care Independent variables • HIV status • HIV diseases stage (I – IV) • Time • Quality of care • Hospital • Severity of Severe Malnutrition and status • Etc.

17. Research questions component 1 For each hospital the following questions are to be answered • 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) • 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 deathor time from admission to discharge – expressed as duration of stay in the Hospital • 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) • What are the odds of dying for children who are HIV positive and Malnourished compare to those who are HIV negative and Malnourished?

18. Research questions component 1 HIV disease stage • 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)? • 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)? • Does the time from admission to death or admission to discharge differ across all four HIV disease stages for patients who are HIV positive?

19. Research questions component 1 Malnutrition status • How do marasmic HIV negative patients differ from kwashiorkor HIV negative patients in terms of the rate of weight gain (g/kg/day)? • How do marasmic HIV positive patients differ from kwashiorkor HIV positive patients in terms of the rate of weight gain (g/kg/day)? • How do marasmic HIV negative patients differ from kwashiorkor HIV negative patients in terms of the duration of stay in the hospital • 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)

20. Research questions component 1 Trends over time • 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)

21. 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?

22. 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)?

23. 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

24. Design Cont... Study Number------------------------- Date of data collection---------------- • The tool (76-item questionnaire)

25. 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

26. Research questions component 3 Modeled on the IDRC’s Performance Evaluation Matrix • To what extent does strategic leadership affect the hospitals’ performance in terms of MSM? • Is the organizational structure in the hospital facilitating or hindering movement towards the better health care outcomes for SM • To what extent does governance affect the hospitals’ performance? • To what extent do the hospitals have adequate staffing procedures to ensure its performance? • To what extent do the hospitals have appropriate human resources development systems and approaches to ensure their performance? • To what extent does the organization have effective human resources relations? • In the hospitals, is there adequate financial planning being undertaken to support performance?

27. Research questions component 3 Cont … • Is the facilities infrastructure adequate to support performance? • To what extent do technology resources affect the hospitals’ performance? • Are the problem-solving and decision-making processes supporting the hospitals’ capacity to carry out its functions vis a vis MSM? • Is the communication system effective in supporting performance? • Is adequate organizational monitoring and evaluation occurring to improve performance? • Are external linkages adequately established or pursued to support performance? • How is the organization affected by the administrative/legal environment? • How is the organization affected by the political environment? • is the organization affected by the social/cultural environment?

28. 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

29. 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

30. 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

31. THANK YOU