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    How to Do Operational

    Research

    George Schmid, M.D., M.Sc.

    World Health Organization/Centers for

    Disease Control and Prevention

    [email protected]

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    Format Informal

    Practicalif you want to hear about modeling (alegitimate, important part of OR), run out the door now

    The session is for you, and us

    You will forget 90% of what you hear today. So, we've

    given you materials on four CD-ROMs: Designing HIV/AIDS Intervention Studies (and other materials)

    (Pop Council);

    Training course materials in operations research (Pop Council)

    Framework for Operations and Implementation Research in Health

    and Disease Control Programmes (and other materials) (GlobalFund and WHO)

    Other materials (note the FHI guide to qualitative research)

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    Doing Operations andImplementation Research

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    Research Techniques

    Systematic data collection

    Qualitative techniques

    Quantitative techniques Surveys, experiments, focus groups.

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    The OR Process

    Problem identification

    Solution generation

    Solution testing Results dissemination

    Results utilization

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    OR Requires Collaboration

    Managers:

    responsible for decision parameters anddesired outcome

    Researchers:

    responsible for recommending andimplementing research techniques

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    Taking My Problem Into

    Operational Research

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    Q1.What Proportion of Individuals

    Potentially Helped by Bed Nets are

    Using Them?1. 2%

    2. 7%

    3. 14%

    4. 24%

    Morel CM et al. BMJ 2005

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    Taking My Problem Into

    Operational Research

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    First, You Must Recognize a Problem

    Wanting to know

    Wanting to act

    Having the ability to act

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    Q2. Who Typically Identifies Problems

    for OR? (more than one answer

    possible)1. The patient

    2. The programme staff

    3. The programme manager

    4. The District manager

    5. National staff

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    Zambia Example

    Problem: TB patients are not being

    tested for HIV

    Observation: "TB Corners" where TBpatients are seen are in open hallways

    Intervention: Provide counselling with

    privacySome issues simply need some common

    sense, and initiative

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    Identifying Problems

    The role of anyone who works in the

    programme!

    But, primarily, the role of the manager Identifying problems requires a team

    approach

    Managers must be present in their programmes Managers must have good relationships with

    their staff

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    You've Identified a Potential Problem

    Patients may not be taking their ART

    People may not be using condoms

    Patients may not be returning forfollow-up visits

    Your health care workers seem to

    have high rates of absenteeism .

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    The OR Process

    1. Problem identification

    2. Solution generation

    3. Solution testing4. Results dissemination

    5. Results utilization

    Diagnostic step

    Intervention step

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    There are Lots of Ways to Approach

    OR

    Some are simple, others more formal

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    Simple? Complex?

    Attendance at the ART clinic is low

    Patients do not have transport

    Injection drug users are not usingclean needles

    Clean needles are not available

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    There are Lots of Ways to Approach

    OR

    Some are simple, others more formal

    Flexibility needed and desired, to

    meet the objectives of what you needto do

    But, let's talk about more formal

    approaches now.

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    The Menu of the WHO/GF OR Book

    1. Research team

    2. Determine Issues

    3. Develop proposal

    4. Ethical clearance

    5. Funding

    6. Budget

    7. Capacity building

    8. Monitor project

    9. Pre-test

    10. Quality control

    11. Stakeholder

    discussions12. Dissemination plan

    13. Disseminate results

    14. Document changes

    15. Monitor changes

    16. Consider furtherimprovement

    WHO (TDR)/GF (Jane Kengeya-Kayondo, George Shakarishvili, Serge Xueref)

    and Bill Brieger and Amy Ellis of Johns Hopkins School of Public Health

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    Three Phases to OR

    1. Planning

    2. Implementation

    3. Follow Through

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    Planning

    1. Organize the Research Group

    What disciplines do you need? Epidemiology, behavioural science?

    Statistics?

    Economics (It is difficult to retroactively do the economicspart of a study)?

    Structure

    Assign tasks, with deadlines

    Meet regularly

    Give credit!!!!!!

    Who had the research idea? Builds teamwork among departments/persons and avoids

    hard feelings

    Pays off in the future

    Pl i

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    Planning

    2. Determine the research questions

    (and objectives) Be clear, be specific

    Research questionWhat do you want to know?

    Observation

    "Our health care workers seem to have high rates of

    absenteeism"

    Research question

    "What is the rate of absenteeism among our nurses in the

    Kiev city hospital, and the reasons for it?"

    Objective

    Not: To study adherence

    But: To determine rates of adherence among attendees at the

    XX hospital and reasons for adherence and nonadherence

    Pl i

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    Planning

    3. Develop a research

    proposal/protocol

    A document that details:

    1. What the research is about and why it

    is important

    2. How the study will be conducted

    3. How the results will be used

    Planning

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    Planning

    3. Develop a research

    proposal/protocol"standard parts" Research objectives and questions

    Background Literature review

    Local context

    Research team

    Methods (study design, study population,sampling details, how data will be collected, datamanagement, quality assurance)

    Data collection instruments Plans for use of data

    Budget

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    Planning

    3. Develop a research protocol

    Does every "formal" OR project need

    a research protocol?

    Yes

    Makes you clearly state what you will do

    (and helps to improve your thinking)

    Gives you the plan that you will follow, so

    everyone knows what will be done, andshould be done

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    Q3. Does Every OR Proposal need

    to go through Ethical Review?

    1. Yes

    2. No

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    Planning

    4. Obtain ethical clearance

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    Q4. What is the most common thing

    wrong with consent forms?

    1. Do not contain the contact

    information for the local ethics board

    2. Cannot be understood by potentialparticipants

    3. Do not mention the word "research"

    4. All risks are not revealed5. Give the patient too much information

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    Planning

    5. Identify funding

    A variety of sources

    Requests for small amounts of money arealmost always preferred

    Follow closely the guidelines of fundingagencies

    Ensure projects are well-written

    Having money from one agency for aproject enhances the ability to get furtherfunds from any agency, i.e., "a proven trackrecord"

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    Planning

    6. Establish a budget

    Should be comprehensive, even if nota large budgetensure you havecosted everything, including

    dissemination costs A good budget is a sign of careful

    planning

    ? Include a financial officer

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    Planning

    7. Technical capability/capacity

    building

    Ensure that staff know their roles and

    responsibilities

    Ensure that staff have the training and

    capability to perform their jobs

    Short term training (courses, TA)

    Long term training (building capacity)

    Help staff gain skills to advance

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    Implementation

    8. Quality Assurance of the project

    There must be a protocol!

    There almost always is a work plan, that includes: All activities to be implemented, before and during the

    study

    Starting date, completion date, intermediate deadlines

    Persons who are responsible for each activity

    Milestones for each activity

    An advisory group that meets regularly may assistin maintaining quality and the work plan

    Monitoring should be part of regular team meetings

    A quality assurance plan should be part of theprotocol

    If you do not perform the study exactly as you

    said you would, you cannot trust the results

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    Implementation

    9. Pre-test all research materials

    Valid? (Do data collection instrumentscapture the desired information reliably?)

    Reliable? (Do data collection instrumentscapture the desired information

    consistently?)

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    Implementation

    9. Pre-test all research materials

    Questionnaires Is the wording clear? Do people understand what

    you want? Do the questions ask what they aresupposed to?

    Test in 5-20 persons

    Focus groups Are the guides clear?

    Hold one or two focus groups.

    Consent forms

    Do people understand them? Language level?(have your child read it) (sometimes, to checkunderstanding during study, develop a series of 5or so questionspatient must answer 4 or 5 toenter study)

    Dissemination

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    Dissemination

    10. Establish and maintain data

    management and QA

    Forms should be easy to use

    Observe data collectors regularly,supervisors review all data collection

    instruments daily for completeness andaccuracy, have regular meetings of the datacollectors (daily, likely)

    Data entry into computers preferably asstudy is ongoing so errors by datacollectors can be quickly caught and fixed

    Double-entry of data?

    Dissemination

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    Dissemination

    11. Explore with stakeholders

    interpretation of results

    Review preliminary results with theteam early, e.g., within a week afterdata entry is complete, to identifyreasons for unusual findings

    Subsequently, review data with theteam and stakeholders, e.g.,

    community leaders or project advisorygroup, to identify key findings andinterpretations

    Follow-through

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    Follow-through

    12 & 13. Develop dissemination plan

    and disseminate the results

    Audience #1 ("internal"). Those who can benefitfrom, and act on, the information locally Local meetings

    Meetings with decision makers

    Audience #2 ("external"). Those who can adaptthe information for their own context, or use it forfurther research National or international meetings

    Journals Create the right documents/strategy/medium for

    the right audience

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    Q5. Who Need Not Be Part of the

    Pre-Test Evaluation of Materials?

    1. Potential participants

    2. Staff who use the materials, e.g.,interviewers, focus group leaders

    3. Data management staff4. The members of the research team

    developing the materials

    5. All must be

    Dissemination

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    Dissemination

    14. Document changes as a result of

    the research

    Were the results implemented? If not,

    why not?

    Dissemination

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    Dissemination

    15. Monitor changes in the revised

    program

    If the findings were valid, andappropriately implemented, thenprogram changes should occur whenthe results are implemented

    More of a monitoring (and evaluation)function than OR, but gets into the

    area of Translation Research.

    Dissemination

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    Dissemination

    16. Consider ways of further

    improving the program

    Q6 Which Format of Information

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    Q6. Which Format of Information

    Sharing Do Decision-makers Like

    Least (Industrialized Country)1. Internet/e-mail

    2. Meetings/conferences

    3. Colleagues

    4. Journal articles

    5. Short summaries

    Dobbins M et al. Implementation Sci 2007

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    Q7. Who Typically Acts on Identified

    Problems?

    1. The patient

    2. The programme staff

    3. The programme manager

    4. The District manager

    5. The National staff

    6. Too few people act

    Q1 What Proportion of Individuals

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    Q1.What Proportion of Individuals

    Potentially Helped by Bed Nets are

    Using Them?1. 2%

    2. 7%

    3. 14%

    4. 24%

    Morel CM et al. BMJ 2005

    Q2 Who Typically Identifies Problems

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    Q2. Who Typically Identifies Problems

    for OR? (more than one answer

    possible)1. The patient

    2. The programme staff

    3. The programme manager

    4. The District manager

    5. National staff

    Q3 D E OR P l d

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    Q3. Does Every OR Proposal need

    to go through Ethical Review?

    1. Yes

    2. No

    Q4 Wh t i th t thi

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    Q4. What is the most common thing

    wrong with consent forms?

    1. Do not contain the contact

    information for the local ethics board

    2. Cannot be understood by potentialparticipants

    3. Do not mention the word "research"

    4. All risks are not revealed5. Give the patient too much information

    Q5 Wh N d N t B P t f th

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    Q5. Who Need Not Be Part of the

    Pre-Test Evaluation of Materials?

    1. Potential participants

    2. Staff who use the materials, e.g.,interviewers, focus group leaders

    3. Data management staff4. The members of the research team

    developing the materials

    5. All must be

    Q6 Which Format of Information

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    Q6. Which Format of Information

    Sharing Do Decision-makers Like

    Least (Industrialized Country)1. Internet/e-mail

    2. Meetings/conferences

    3. Colleagues

    4. Journal articles

    5. Short summaries

    Dobbins M et al. Implementation Sci 2007

    Q7 Wh T i ll A t Id tifi d

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    Q7. Who Typically Acts on Identified

    Problems?

    1. The patient

    2. The programme staff

    3. The programme manager

    4. The District manager

    5. The National staff

    6. Too few people act