Question 2
In an attempt to explain the results of the ENHANCE study, the researchers suggested that the population being studied was mostly white women, highly-educated, employed, and insured. They suggested that this population may have been more motivated than other populations to commit to lifestyle changes upon signing up for the study. This may be why both the control group and intervention group experienced the same biophysical outcomes. How could a future study be modeled that would be representative of the population as a whole? How do you think these changes might affect the outcome of the study?
posted by Amy Sammis @ 10:04 AM
15 comments
15 Comments:
Participants were recruited multiple ways, including newspaper and mass transit advertisements, exhibits at health fairs, posters, direct mailings, etc. Although this is a wide range of advertisement, the exclusion criteria probably discouraged participation for a lot of people. Individuals were excluded if they were unwilling or unable to self-monitor their blood glucose, if they could not participate in group sessions, if they had history of alcohol or substance abuse, if they had lack of support from their primary health provider, etc. It is understandable that each study must have exclusion criteria, but the more there is, the more similar participants will be who do not fall under those categories. A diverse behavioral intervention group may show patterns in men and women, those who may be less motivated or more, uninsured or not, etc when self-monitoring diabetes.
I would say that you could pull in participants from several different hospitals, schools, clinics that would be willing to participate in different cities with different levels of income/education. I would also think that the people conducting the study could set better guidelines to ensure a more well rounded group as apposed to just having anyone participate. I am sure there are plenty of people that would be willing to participate in such a study but the researchers did not market to different segments of the populations.
I agree with Alana's comment that the exclusion criteria purposefully was intending to make the trial group highly educated and well off people. I believe that the inclusion criteria could be lowered to represent a more real world group of individuals. I also think that they could have a baseline class to teach anyone specific skills that they would need. That way anyone could participate and it would yield more accurate results most likely.
I think that if participants were recruited through the use of many media outlets, more populations would be reached and a greater variety could participate. I'm not sure how those changes might affect the outcome of the study because more low income and older populations tend to be less technology-savvy. If the participants don't understand the technology their using, the results could vary or not be correct at all.
I agree with Alana's comment that exclusion criteria would limit the number of participants that will be received. The exclusion criteria in this study was quite limiting especially the support from their health provider. I understand that the participants all were diagnosed with diabetes, but some may not have the money to go to their doctor very often and they may not have wanted to waste a trip just to get their doctor to sign off on this study.
Perhaps offering compensation may attract more people. However, I know not every study has the finances available. The exclusion criterion is extensive and this is eliminating a very large group. Making it friendlier to people of wide ranges of lifestyles and health histories would open up the pool of available participants. Isn’t that what getting a representative population is all about anyway? Although some of it was completely necessary, I am not sure what they were expecting with all of the exclusions they enforced.
Kelsey-I agree with opening the study up to a larger pool of participants--especially considering past medical history. Although it may be undesirable to have those with a history of drug/alcohol abuse, non-compliance with group setting, etc., this mix and variety of people will help to show the true results of the study.
I would suggest that they pull from those seeking help from the health department in metropolitan areas, Medicare providers, and advertising on the American diabetes association website. This would help to pull a cross cultural sample of diabetic patients. As we know diabetes risks are higher in racial and ethnic groups (e.g., Non-Hispanic Blacks, Hispanic/Latino Americans, Asian Americans and Pacific Islanders, and American Indians and Alaska Natives).
Alana, you make good points about the exclusion criteria. Those criteria are cutting out a substantial chunk of the diabetic population.
A monetary incentive will usually draw from far-reaching corners of the population that are usually absent in population studies.
Including populations from various areas in a city, different jobs, concentration studies of a college, as well as equal amounts of men and women, through media contact, could include a better-rounded conclusion. This type of adversity throughout the study’s population has the potential to be able to have a better measure the effectiveness of the control group versus the intervention.
I think that other than the exclusion criteria the researchers employed a variety of recruitment methods to try and reach a diverse population. And I think the exclusion criteria are fairly reasonable to ensure the safety of the participants as well as their ability to adhere to the program. If we think about using a smart phone app to further this research, offering a phone as incentive upon completion of the study could be beneficial in encouraging participation. What we can't control for is the willingness of people to commit to a lifestyle change.
Angela-
You make a wonderful point with the fact that you can't control a person's willingness to a lifestyle change or to participate and follow guidelines for the study. We may get the participants that are lacking in the study but the reason they didn't sign up in the first place may be due to the fact that they knew they couldn't follow the guidelines and commit to this study to begin with.
In the future, researchers could set guidelines of different population groups needed in order to conduct the study. Using rewards that are tailored to certain population groups is an example of something that they could do to be sure to meet those standards.
Emily, I like your idea of setting specific guidelines of different population groups needed for the study. With diabetes affecting different populations groups this sounds like a great idea. One more thing to note, while I understand that participating in a study is not easy I think people forget about the possible benefits they may gain from participating. That as well as what it can do for those in the future who suffer from their very same disease and its complications.
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