April 30, 2024
Decoding Clinical Studies – When Headlines Don’t Always Mean What You Think
They're a common feature of popular medical news today – headlines raving about miracle medicines or groundbreaking treatments based on "the latest clinical study." But before getting too excited (or too worried, in many cases), the public must understand that clinical studies are incredibly complex and their findings require expert, careful, and experienced interpretation. A healthy dose of caution is critical when encountering "news" about clinical study headlines.
One of the best ways for me to illustrate the discernment required in interpreting clinical studies is by exploring a real-world example. I was recently asked to critically analyze the results of a newly published study on a treatment purported as an alternative option for adult men and women to prevent recurrent urinary tract infections. It is important to note that I am a clinically trained and licensed medical doctor specializing in urology – the field of medicine concerned with matters of the urological organs – including the urethra and bladder. I also have over 30 years of experience in my chosen medical field. I call out my qualifications not to brag but to help illuminate the importance of professional expertise in evaluating clinical research studies.
Now, let's return to the study results for the UTI treatment.
In the study abstract (a summary of completed research for a study – think of it as an overview), the authors asserted that the participants in the study were given the UTI treatment, and researchers measured their rate of UTIs over nine years. The abstract indicated that 54 percent of the women and 53 percent of the men remained UTI-free after treatment. It noted that the medication was safe and had no adverse reactions among the study participants. The study concluded that the therapy involved showed great promise as an alternative option for preventing recurrent UTIs. If I were a reporter or journalist with no medical background, I might conclude that this study is an absolute WIN for UTI sufferers and run a story hailing its benefits. But would such a story be the final truth? Let's explore further.
In my critical clinical evaluation of the study and its abstract, here are some key considerations I made:
1. It was not indicated for how long the researchers administered the treatment. The study authors claimed in the literature that this treatment was a "vaccine." Vaccine treatment implies that the treatment would be administered for a short period and possibly repeated periodically. However, the authors mentioned that the participants took the treatment daily. It is not indicated for how many days, weeks, months, or years the participants were on this treatment.
2. The abstract mentions 92 participants in the clinical trial. However, it is not clear that these were patients with a history of recurrent UTIs. Instead, the participants appeared to be a regular group of people with no known UTI infections. Yet, the study concludes that the treatment holds promise for patients with recurrent UTIs. This conclusion would be misleading if the research had not been conducted on patients with recurrent UTIs.
3. The abstract mentions that the incidence of UTIs in the female population studied is 50 percent. The results show that the female participants had a 54 percent chance of being UTI-free by taking the studied treatment. This means that despite taking this treatment, 46 percent of women still developed UTI, which indicates only a four percent improvement in the incidence of UTI by taking the treatment. A four percent improvement is not a strong result for a published study and falls within the "insignificant difference" range in such a small sample population. One may conclude from the results that this treatment, at best, will reduce the chance of UTI by four percent, indicating the treatment is not very effective in preventing single incidences of UTI and is not a promising treatment option for recurrent UTI cases.
4. The results show a 53 percent "UTI-free" rate in men. This means there is a 47 percent UTI rate in the men in this study. A 47 percent UTI rate in men is extremely high in the general population. This study may have had a design flaw that showed a high rate of UTIs in men.
5. The study concludes that the treatment is promising for patients with recurrent UTIs. However, the study never mentions any results of recurrent UTIs in the tested population. It only lists the occurrence rate of UTI. In addition, the study does not delineate between solitary cases versus recurrent cases of UTI. Therefore, there is no evidentiary basis for the conclusion in the abstract.
6. There is no mention of how the study ensured and accounted for compliance with the studied treatment. It is not known whether the participants complied with the daily treatment regimen.
7. The study appears to be based on a retrospective or non-patient participation method. The authors merely reviewed the patient's charts to determine if there was a documented UTI. It does not appear that the investigators followed the patients prospectively and interviewed them to determine occurrences of UTI more accurately. It is possible that some participants experienced UTI and received treatment without any documentation in their medical records.
Upon my analysis of the study and based on my findings above, it does not appear the study's design and results support its conclusions. In fact, the results seem to show no benefit in using this treatment to prevent recurrent UTIs.
It is crucial to remember that medical science is constantly evolving – it's a journey, not a destination. One study, even an incredibly convicting one, is rarely the final word on a medical condition or concern. Large bodies of research are often needed to confirm findings and establish the best courses of treatment; as always, individual results can vary. So, when reading flashy headlines about the latest medical research or study results, view single studies as you would a piece of a puzzle – not the whole picture.
Sources:
Dr. Ramin’s email answers provided on 4/6/24.
