The first thing you need to do when reading a trial is to decide whether the results are valid. In other words, can you trust the results? Here are a few questions to ask yourself to see if the study results are valid:
- Was the study done in humans, in animals, or in a test tube or laboratory setting ("in vitro")? Test tube, laboratory, and animal studies mean that the research is still at an early stage. Studies in humans will give the best idea of how well the treatment will work for people with MS.
- Was the new treatment compared with a current, well-established treatment, or with a placebo ("sugar pill" with no active ingredients)? The best studies will test the treatment against a placebo or another well-established treatment to see how it compares. Testing against a placebo allows us to see whether the benefits are due to the new treatment or to other factors. Testing against an established treatment gives information on whether the new treatment is better than, the same as, or worse than the established treatment.
- Were the study participants assigned randomly to a treatment group? This "randomization" helps eliminate bias that may occur if study personnel were allowed to choose which patients went into which groups.
- Were the treatment groups similar to each other in all ways except for which treatment they were receiving? During the study, were they treated equally except for the experimental treatment received? The more similar the groups and the more similarly they are treated during the study (for all factors except the treatment being studied), the more likely it will be that any differences seen between them are due to the treatment and not to other external factors.
- How many people were in the study? The investigators of clinical trials use the letter "n" to mean "number of people in the study." In general, the more people (the greater the n), the better.
- How long were the study participants monitored? If the participants were monitored for only a short time, there is less chance of understanding the long-term benefits and side effects of the new treatment.
- At the end of the study, were all study participants accounted for? Did a large number of study volunteers "drop out" of the study? If so, this may affect the results. The authors should explain how many people dropped out and what effect, if any, this may have on the results.
- Were the study participants, their doctors, and other "study personnel" "blind" to treatment? In other words, did anyone know which treatment the study participants were getting? The best studies will use a "double-blind" design where neither the study participants nor the doctors and other study personnel know which treatment the participants are receiving. This helps eliminate bias due to pre-determined expectations that people may have from a certain treatment.
If the study meets these criteria, your next step is to check what the study results were. When reading the study results, it's important to understand how the treatment effects were measured. This is called an "outcome measure." MS trials often use a disability rating scale (which rates a person's level of disability on a numbered scale) as an outcome measure. Look at the difference between the study treatment and the treatment it was compared to (a placebo or standard treatment). Did the treatment have better results than what it was compared to? The study should say whether this difference in results was "statistically significant." This means that the result is more likely to be due to a real effect caused by the treatment. A "p-value" is often used to measure statistical significance, and a p-value of less than 0.05 is usually considered to be statistically significant.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/healthfeature/gethealthfeature/MS-Doing-Your-Own-Research