Quantitative OR methodologies I
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1 Quantitative OR methodologies I Mark Micek, MD, MPH Operations Research Mini Course August 1, 2008
2 Broad methodologies of OR Modeling (classic) Develop mathematical model to mimic health care system Manipulate to find the best possible solution Optimize efficiency Maximize X given constraints Y Intervention-based (Population Council) Design/test best way to deliver services Similarities to quality improvement (IHI/WHO)
3 Intervention-based OR Population Council Linear IHI Collaborative Cyclical 1. Identify program problem 1. Planlan 2. Generate program solution 2. Do 3. Test program solution 3. Studytudy Act Study Plan Do 4. Use/disseminate results 4. Actct
4 Step 1: Identifying the program problem Problem usually determined in an ongoing program A discrepancy noted between the desired and observed situation Routine program/clinic data (continuous indicators) Program evaluation (point indicators) Feasible, effective, and sustainable solution is possible Problem can be solved by the program manager
5 Step 2: Generate a program solution Actions that a program manager can take Has potential to make a large improvement Effects can be measured Easy to implement Affordable/sustainable
6 Sources of solutions How to develop a solution? Understand the current health system policies and workflow Talk to Program staff, clients Review data from good programs in your system Review experiences of other similar programs, scientific literature An understanding of the system is critical to develop an appropriate solution
7 What if a potential solution is not obvious? Consider an exploratory study to better understand problem Review of program data and experiences Quantitative / Qualitative research on patients / staff / policy- makers Compare program to other programs with better indicators Review of previous research Get to a point where you can identify a solution Refining not always necessary
8 Step 3: Test program solution Common OR study designs Non-experimental Experimental Quasi-experimental
9 Non-experimental designs: No randomization or good control group Posttest-only Design Time Exp group X O2 Pretest-Posttest Design Time Exp group O1 X O2 Static-group Comparison Design Time Non-RA Exp group X O1 Comp group O2
10 Non-experimental designs Advantages = easy and can get some information Disadvantages = Subjected to many biases (threats to validity): History bias Selection bias Testing/maturation bias Instrumentation bias Differential mortality Typically used if little time and money, or want to know basic characteristics of an intervention (i.e. basic pre/post data, uptake, perceptions) Descriptive, small case studies
11 Experimental designs: Random assignment & control group Posttest-only Control Group Design Pretest-Posttest Control Group Design Time Time RA Exp group X O1 Control group O2 RA Exp group O1 X O2 Control group O3 O4 Stepped-Wedge Time-Series Design Time Exp group 1 O1 X O2 O3 O4 RA Exp group 2 O5 O6 X O7 O8 Exp group 3 O9 O10 O11 X O12
12 Experimental designs Advantages: Reduces many sources of bias: Control group: reduces testing/maturation bias, instrumentation bias, history bias (stepped-wedge) Randomization: reduces selection bias Allows best isolation of effect to intervention ( gold( standard ) Disadvantages: Higher costs May be difficult or impractical Still subjected to History bias Differential mortality
13 Quasi-experimental designs: Non-random assignment & control group Non-equivalent Control Group Design Time Non-RA Exp group O1 X O2 Control group O3 O4 Time-Series Design Time Exp group O1 O2 O3 X O4 O5 O6 Stepped-Wedge Time-Series Design Time Exp group 1 O1 X O2 O3 O4 Non-RA Exp group 2 O5 O6 X O7 O8 Exp group 3 O9 O10 O11 X O12
14 Quasi-experimental designs Advantages: Often times more practical than randomized studies Reduces many sources of bias: Control group: reduces testing/maturation bias, instrumentation bias, history bias (time-series/stepped series/stepped- wedge) Selection bias not reduced, but can be mitigated by matching Disadvantages: Still subjected to Selection bias History bias Differential mortality
15 Study issues to consider: Choosing study design Weigh advantages and disadvantages of complex designs Money & time Meaningful magnitude of effect Consequences of wrong answer on health and resources Reality of field conditions (sometimes randomization is impossible) Advantages of using facilities as unit of intervention (vs. individuals) Able to look at real-world application Easier to measure added programmatic costs (training, costs)
16 Study issues to consider: Choosing study outcomes Choice of program outputs, outcomes, and impacts What are you interested in programmatically? Will testing enrollment in clinic starting HAART? Will number on HAART adherence? Will number on HAART HIV mortality? Are proximal outputs good enough? Are distal impacts attributable to your intervention? Routine data vs. added data gathering Money & time Adequacy/accuracy of routine indicators
17 Study issues to consider: Measure progress of implementation Important to measure if intervention was implemented as intended Evaluates feasibility of intervention Staff/patient acceptance Problems encountered and overcome Learn from experience for wider implementation How intervention was implemented may effect your results
18 Example 1: Strategy to increase MCH service utilization in Senegal* Program problem: : Low utilization of available MCH services in health units Pre/post natal visits Child vaccinations STD testing & treatment Child growth monitoring Family planning * Sanogo D, et al, Using Systematic Screening to Increase Integration of Reproductive Health Services Delivery in Senegal, Frontiers in Reproductive Health Program,
19 Interventional study Potential solution: Integration of services via check-list Used during outpatient visits Serves as clinical reminder Improve documentation of services provided
20 Study design: Pre/post non-experimental Pre-intervention measurement (7 sites) Interview women after clinic visit Ask about number of services received Implementation of intervention Clinical training (1/2 day) Supervision of use of checklist (2 days) Post-intervention measurement (7 sites) Interview women after clinic visit Ask about number of services received 6 weeks preintervention O Time X 6 weeks postintervention O
21 Results
22 Example 2: Strategy to increase HIV care utilization in TB patients in Program problem: Mozambique Few TB patients tested for HIV at local VCT New TB patients enrolled ~ 250/mo TB patients tested for HIV ~20/mo ~8% of estimated TB-HIV patients enrolled into care at HIV clinic* Likely due to HIV testing/care system for TB patients * Micek, MA, Integrating TB and HIV Care in Mozambique: Lessons from an HIV Clinic in Beira. CORE TB/HIV Case Study, The CORE Group, Washington DC, September 2004.
23 Potential solution: : Change HIV care for TB patients Old system TB patient treated at TB center New system TB patient treated at TB center Referred to VCT center for HIV testing If HIV+ Opt-out HIV testing at TB center Rotating VCT counselors TB nurses If HIV+ Continue at TB clinic for: TB treatment Referred to HIV clinic for: HIV counseling Treatment of OIs CTX proph. HAART Continue at TB clinic for: HIV counseling TB treatment CTX proph. Referred to HIV clinic for: HIV counseling Treatment of OIs HAART
24 Study design: Time series (quasi-experimental) TB patients tested for HIV per month Intervention - 2 week training - vacations - Limited test supplies 300 Number of Patients Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Average 25/mo (7 mos prior) 184/mo (7 mos after), p=.002 Remained significant after adjustment for time (p=.003)
25 TB patients registered at the Beira HIV clinic per month, Feb Mar Intervention Number of patients Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Average 49/mo (7 mos prior) 96/mo (7 mos after), p=0.001 Remained significant after adjustment for time (p=.020)
26 TB program patients starting HAART, by month of registration at Beira HIV clinic, Feb Dec Intervention Number of patients Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2005 Average 18/mo (7mos prior) 25/mo (4mos after), p=0.23
27 Next steps TB treatment outcome analysis pending More work needed Overcome barriers to HIV testing (mostly logistical) Increase referral to HIV clinic better counseling? Improve flow at HIV clinic streamline TB patients? Decentralize more HIV services to TB sites? CD4 counts HAART, with appropriate personnel New OR cycle
28 Example 3: How to increase the number of patients who start HAART? National ARV Program 60 Beira Chimoio Q Q Q Q Q Q Q3 2005
29 Identify steps required to start ART STEP 1 HIV Testing STEP 2 Arrival to Day Hospital STEP 3 CD4 Testing STEP 4 Start HAART HIV testing centers Community Home-based Care VCT Day Hospital Clinical evaluation (CD4) Start HAART in eligible patients TB patients Ill/Hospitalized Hospital Adherence to Care Adherence to ARV Treatment Youth Youth VCT Pregnant pmtct
30 Using programmatic data: Where are patients lost? Step 1 Monthly flow through the HIV care system in Beira and Chimoio, Mozambique, Jun 04 - Sept HIV+ Step 2 Step 3 Average patients per month Enroll at HIV clinic (59%) Undergo CD4 testing (78%) Eligible for HAART (48%) Step Start HAART (46%) 0
31 Using programmatic data: What are priorities to address? By City Beira Chimoio Step 1: Tested for HIV Step 1: Tested for HIV HIV+ HIV % 25% Step 2: Enroll in clinic Extra if fixed Step 2: Enroll in clinic Extra if fixed 240 to 100% 150 to 100% 54% 30 65% 15 Adults Adults % 96% Step 3: Obtain CD4 Extra if fixed Step 3: Obtain CD4 Extra if fixed 191 to 100% 102 to 100% 83% 7 71% 12 Eligible Eligible % 54% Step 4: Start HAART Extra if fixed Step 4: Start HAART Extra if fixed 36 to 100% 29 to 100% 42% 50 52% 27
32 Why do HAART-eligible patients not start ARVs (step 4)? Follow-up of HAART eligible patients (CD4<200) that do and do not start HAART Proportion with follow-up beyond timepoint 100.0% 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% FU>0d FU>30d FU>60d FU>90d HAART No HAART Poor follow-up also reported as reason for not starting HAART in other studies Giordano TP et al, Factors Associated with the Use of Highly Active Antiretroviral Therapy in Patients Newly Entering Care in an Urban Clinic. JAIDS, 32:
33 Improving rates of starting ARVs in HAART-eligible patients Reasons for poor follow-up Pre-HAART procedure too cumbersome Dissatisfaction with services Trouble paying transportation costs Poor understanding of clinic procedures Stigma of going to HIV clinic Death Potential solutions Change workflow around HAART-eligible patients Improve counseling Improve relationship between patients and health care workers Decentralize ARV services
34 Number of HIV+ pregnant women enrolled at ART site <30 days after HIV testing Total HIV + Enrolled % 22% 76% 74% 0 Beira Chimoio Nhamatanda Catandica Off-site ART clinic On-site ART clinic 30% 75% On-site ART vs. Off-site ART clinic: OR 7.2 (CI , p<0.001)
35 100.0% ART-eligible starting ART (Total and <90 days), Sofala and Manica, % 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% ART Total ART <90days Total stated on ART: Vertical 50% vs. Integrated 65% (p<0.001) ART <90 days: Vertical 37% vs. Integrated 59% (p<0.001) 0.0% Beira Nhamatanda Caia Ponta Gea Marromeu Chimoio Catandica Manica Espungabera Gondola 1o de Maio Chitobe N=9,193 Vertical Integrated Vertical Integrated
36 Thank you
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