What exactly is “quality of life”?
To match objective measurements of menstrual bleeding and pair them with a rather subjective quality of life ideal, Tazim Dowlut-McElroy, MD, MS and her team at Children’s Mercy Hospital in Kansas City are relying on a validated, age-appropriate quality of life survey. They're investigating whether or not the use of a levonorgestrel-releasing intrauterine device (IUD) will make life better for adolescents with bleeding disorders that result in heavy menstrual bleeding (HMB).
“The goal of the study is to Increase our knowledge about optimal treatment of HMB for adolescents with blood disorders,” Dr. Dowlut-McElroy explains. “Ultimately, we want to improve the quality of life of adolescent girls with other chronic diseases and gynecological disorders.”
Dowlut-McElroy is the recipient of the Foundation for Women & Girls with Blood Disorders 2018 research fellowship award, Promoting XXcellence in Women’s Health: Optimal Management of Women and Girls with Blood Disorders. The funding, in part, will afford the use of the Pediatric Quality of Life Inventory™ (PedsQL). PedsQL purports to measure “health-related quality of life in both healthy children and those with acute and chronic health conditions and is responsive to clinical change over time.” Developmentally appropriate modules provide (for the purposes of this study) quality of life indicators for two relevant age groups, 8 to 12 and 13 to 18.
But can a data sheet really tell you if a person is feeling better? Dowlut-McElroy explains that these are clinical benchmarks necessary to validate the project. “As a physician, it’s helpful if I approach this study objectively. Progesterone-containing IUDs are already used to treat adolescents for birth control and heavy menstrual bleeding,” she says, adding that their efficacy has not been studied prospectively. “I hope this data will facilitate use and decrease hesitance of providers to offer the IUD as a means to help patients feel better.
“I’ve had a chance to observe patients suffering,” she continues. “It’s hard for any child to have a chronic disease without a cure. It’s difficult for that child and her family.”
One of the challenges some doctors face is in convincing patients to try the IUD method when there are other less-invasive (but perhaps less effective) hormone treatments for HMB. The stigma that IUDs involve a painful latch is far and wide. Cosmopolitan magazine (and others) have perpetuated this fear. “It felt like someone was shocking my cervix with a taser,” one woman alleges in the Cosmo article.
Nevertheless, IUD is a method of contraception endorsed by the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP); and, as Dowlut-McElroy explains, some doctors do offer levonorgestrel-releasing intrauterine devices to help patients with heavy menstrual bleeding. “Placing an IUD is a procedure that must be completed by a trained health provider,” she says. “It can be uncomfortable; however, there are various ways to make this more comfortable for the patient, such as sedation and anesthesia.”
Once the IUD has been placed, study participants can track their perception of menstrual blood loss via a mobile phone app specially developed for the project by Sreamroller Studios in Eustis, Florida. Dowlut-McElroy will be tracking safety and side effects through this remotely-sourced data. As is the case with many IUDs, some females may experience a total halt in menstruation – perhaps a good thing if you have a bleeding disorder. In this way, the side effects of the IUD can be beneficial.
Adolescent girls across the globe often struggle with menstruation: the pain, the isolation, the unwillingness of people to speak openly about it, the stigma that it makes them dirty, etc., Dr. Dowlut-McElroy explains. “Adding a bleeding disorder to the embarrassing prospect of teenage menstruation is almost unthinkable.”
And here we are back to the question of quality of life: taking something painful, debilitating, embarrassing and even life-threatening and making it bearable? Even without a data module, the improvement is easy to see.
This levonorgestrel-releasing IUD study will be statistically sound with 20 enrolled participants and 15 completed participants pertaining to adolescents ranging in age from 12 to 18 years. With any luck, that’s 15 to 20 fewer females suffering heavy menstrual bleeding every month. And in the future, perhaps many more.