Research 101 Jim Krieger, MD, MPH February 19, 2008

What is research? Finding out what works The dictionary says:  “ investigation or experimentation aimed at …the practical application of new or revised theories or laws” (Webster's)  In our case: Investigating if our theory that home visits improve asthma and save money is true.

Why do research? Want to use the best, most effective approach to providing a service Just because it’s always been done that way, doesn’t mean it’s the best way New ideas can sound promising, but they need to be tested to see if they really work Personal, day-to-day experience can be misleading

Research and Services Research gains new knowledge Service helps people by giving them something already known to be helpful Research asks if services work and why they do Research can help programs provide the best services Services provided as part of a research project are different than usual program services.  They are carefully evaluated  They are provided in a standard way

Define the research project Define the research question  Do some laundry soaps clean better than others? Define the theory to be addressed  A new laundry soap is better than the one I use now Define the intervention the project will use  Using different soaps to clean dirty clothes

Select the study design Observational: describe and observe events  see what types of soap people use and how clean their clothes are Experimental: do something and see its impact compared to doing something else  CONTROLLED: Compare how good the new soap is relative to the one I use now. Have some people use the new soap and others use the old.  RANDOMIZE: People assigned by chance to use new or old soap.

Decide how to select participants Whom to select  People who use laundry soap in their washing machines at home and who don’t have unusually clean or dirty clothes. Inclusion criteria: use laundry soap, have a washing machine Exclusion criteria: don’t work as chimney cleaners or construction workers Where to find them  People buying soap at several supermarkets across several different neighborhoods

Decide what variables to measure and collect data Predictor variables: things that might influence the outcome in addition to the intervention  type of work, number of kids, type of washing machine Outcome variables  how clean clothes get  how soft clothes are (ask family to rate vs. trained observer)  how clothes smell Collect data  Observe clothes  Questionnaire (How many kids? What kind of work? How soft are clothes? How do they smell?)  Record type of washing machine

Get enough participants Need enough people so that we can be sure that we can find a difference between the soaps. The more people who are part of the study, the better chance we have of finding a difference if there really is one.

Define the research question  How can we help people with asthma control it better? Define the theory to be addressed  Home visits improve asthma control more than usual care for asthma Define the intervention the project will use  CHWs will provide education and support to people with asthma in their homes

Develop a Theory of Change

Select the study design Experimental  Randomized controlled trial  One group gets visits now (intervention group)  One group gets visits later (control group)

Study Design Outcomes Baseline CHW Group 2 Group 1 Randomize Clients

Why Randomize Makes the two groups the same If the groups are different, then the results could be due to these differences rather than because of the intervention Example:  Smoking makes asthma worse  Say there were more smokers in the home visit group  The home visit group might end up with more symptoms, not because home visits don’t work, but because smoking makes asthma worse

Decide how to select participants Whom to select (inclusion criteria)  Have doctor-diagnosed asthma  Live in King County  Low-income  Speak English or Spanish (or Vietnamese for Medicaid)  Uncontrolled asthma or have a hospitalization or emergency room visit in the past year  Exclusion criteria: No other chronic illnesses Where to find them  in clinics, hospitals, emergency rooms, ads, CBOs

Decide what variables to measure Predictor variables: things that influence the outcome  THE HOME VISITS  presence of asthma triggers in home  Use of asthma medications  Social support, etc. Outcome variables  Final: asthma control, use of hospital/clinic/emergency room for asthma, quality of life  Intermediate: Asthma behaviors like taking medicines, getting rid of triggers, etc.

Collect Data Home visit Questionnaire Breathing test Allergy test

Get enough participants Need enough people so that we can be sure that we can find a difference the high and low intensity groups. Meeting recruitment goals is IMPORTANT The more people who are part of the study, the better chance we have of finding a difference if there really is one. HomeBASE: 420 people Medicaid: people

Proper Treatment of Human Subjects Respect for persons Minimize harm Benefits should outweigh risks Informed Consent  Free choice to participate  Understand what the research is about  Understand risks and benefits Confidentiality The IRB

Confidentiality Never share information about participants beyond the study staff Keep research materials locked up and off your desk when not using them Don’t keep research materials in your home or car Keep identifiers separate from data Use password protected computer

Combining Research and Service Participatory Research Methods Partnership of community and researchers who jointly develop projects for mutual benefit Research focuses on a defined community and brings benefit to the community All partners have real influence on all project phases  project focus and objectives  implementation (including budget, hiring)  evaluation design, data collection and analysis  interpretation and dissemination of research findings The values, perspectives, and contributions of all partners are respected Research process builds trust and nurtures long-term relationships

KCAP Participatory Research Methods Study governance  Steering Committee  Advisory Group Get advice Recruitment Education materials  Dissemination of findings  Newsletter  Celebration

Phases of a Research Project The Idea Getting funding Developing the protocols Human Subjects Recruitment Enrollment and data collection Intervention Data analysis Sharing the results

Doing Research Well Standard protocols Making sure the intervention group gets the intervention Making sure the control group gets only regular services and NOT the intervention Consistent data collection Respecting Privacy Keeping participants in the project

CHW Responsibilities Respect the participants and their cultures Assure human subjects protections Follow protocols to ensure the study is done well Pay attention to all the details

Sampling error Random error: the results, by chance, differ from the true results  If you don’t have enough people in the study, the measures of outcomes won’t be very precise or accurate. You might, by chance, pick people who have hot water and good washing machines. But if we have a lot of people in the study, these chance factors will tend to cancel each other Systematic error: the results, because of research design, differ from the true results  If we only found participants from certain neighborhoods that had hard water, and one soap didn’t work well with hard water, then our findings would be misleading.

Community Health Workers Community members trained to provide culturally- competent health education and support services Share race/ethnicity and culture with clients Viewed as trusted source of information Address many determinants of health  Access  Health behaviors  Social Support  Education and self-management support  Healthy environments  Cross-cultural mediation

Measurement error Random error:  If the machine that measured “whiteness” didn’t always produce the same result when measuring the same sheet, this would add some error into the measurement of the soap’s effectiveness. Systematic error  if all the sheets were measured before they were dry, this would affect the measurement of “whiteness.”

Does the research answer the question? Internal validity:  Are the findings true for the study population: was the study done well? External validity  Are the findings generally true for other populations: how does the study population compare to other populations?

Type I error: saying there is an effect when there really isn’t one  The two soaps have the same cleaning power, but our study seemed to find a difference.  This might have happened because the two study groups were different, and one had better washing machines or cleaner clothes to start with.  Randomization should eliminate this type of error.

Type II error: saying there isn’t an effect when there really is one  One soap really is better than the other, but our study found no difference.  This could be because we didn’t have enough people in our study, so our measurement of the average effect in each group wasn’t precise enough to pick up the difference.  Recruiting enough participants prevents this error