With the big ADA conference underway this weekend, now we’re being bombarded with headlines concerning diabetes clinical trials — and foremost all the news concerning the conflicting results of the ADVANCE and ACCORD studies. Should you browse the details, you’ll find a lot of stuff about randomized, controlled, double-blind, yada, yada, yada studies. That’s a lot of jargon to digest. And what does it all mean?
Considering that clinical trials are so crucial to advancements in diabetes therapy, it seemed like a good time to revisitthe “research primer” that Dr. Jackson and I hunted for our book. (Research for Dummies? I heard a lot) Know all the statements and your jargon will make sense:
Prospective means that the research were proposed prior to the occurrence of these events that they quantified, in comparison with retrospective studies, which are conducted to “look backward” and explore events which have already happened
Controlled means that there’s second set of subjects, very similar to people who have been treated, but who did not get the key therapy. So it is possible to compare the results of the 2 groups to better understand what the effects of the treatment were, you need them. As an example, in the event that you followed a bunch of individuals treated with a pill for ten years, you might discover that they gained an average of ten lbs. Can this weight gain an immediate effect of the pill that is pink? If you also followed a control group, that did not get the pink pill, you might discover that their average weight reduction was 20 lbs. Your decision might be very different; it appears that the pink pill might help people keep their weight down. Of course, for the control comparison to be useful, the groups have to be comparable in most risk factors which are important to the topic. For example, here you’d want to understand that amounts were active members of fitness facilities, or that the amount of men and women in each group live next to a store.
Randomizingresearch groups means that a computer program randomly assigns people to the treatment team, or the control group. This compensates for any risk factors that are unidentified which you might not have recognized. Perhaps people with blue eyes are more likely to gain weight compared to individuals with brown eyes, and since you’re attracted to individuals with blue eyes, you may assign more of these to the research group compared to control group. Randomizing eliminates this potential.
Blinding(or occasionally referred to as masking) adds another layer of protection from biased results. The idea is that research subjects do not really know if they are a part of the control group, or if they are currently getting the therapy. In our example above, the control group also requires a pink-colored pill, but one that is a placebo, i.e. includes no active ingredient. In what’s referred to as a double-blind study, the investigators don’t understand who’s receiving the real therapy, until the end of the trial, even when the “code” is broken, and the information is examined. Mystery could make the whole thing more fun!
Less approaches are used by a lot of research, because it is difficult to execute a long-duration, prospective, randomized, controlled , trial. This is one of the reasons why news reports of research look contradictory and perplexing; does your wellbeing hurt or help it? And what about alcohol? Many studies suggest that heart problems may decrease. But nobody actually knows, and it’s not likely that we will soon be able to identify large numbers of men and women in their ’40s or ’50s who don’t drink, and then randomly assign a few to moderate alcohol consumption for the next five to ten years, and others to total abstinence. Blinding the study would be even harder: how could some people today drink alcohol without understanding it? You have the idea; a few questions are difficult to answer with certainty through clinical research.
But regarding the effect of microalbumin, blood pressure, lipids, A1c, and eye exams, the answers are much more clear. There have been large-scale, long-duration, prospective, randomized, controlled double-blinded (with a few exceptions in which blinding was tough) trials which supported the strong effects of controlling those factors. Moreover, there weren’t just one or two or three studies in each area, but multiple research, all supporting the decision that keeping these five factors in a safe range will ensure that you have reduced or even eliminated your chance of developing diabetes complications.
Disclaimer: Content created by the Diabetes Mine team. For more details click here.
This content is created a consumer health blog concentrated on the diabetes community, for Diabetes Mine. The content is not medically reviewed and doesn’t stick to the editorial instructions of Healthline. To learn more about Healthline’s venture with Diabetes Mine, please click here.
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Written by on Dec 06, 2017