Quality of Life Assessment as an Endpoint. Are results in the eye of the beholder?
Quality of Life questionnaires are pretty standard fare in IBD clinical trails. The information gleaned from them is often used as a secondary endpoint in the trial. I spend all this time handing them and collecting the data without thinking about the actual meaning behind them.
So, what exactly is the definition of quality of life? It’s a pretty subjective endpoint don’t you think? As a clinical researcher I am looking for an improvement in scores after treatment. Decreased number in loose bowel movements per day, reduction in abdominal pain score, increased energy. The patient is most likely hoping for these items as well. However, and I am assuming a lot here since I do not suffered from IBD, I would bet that these items are just the measurable data researchers chose to define the desired outcome.
In order to better explain my thought process let me share a little experiment with you that I recently completed. After speaking with a patient who suffers from IBD and learning that she can have up to 20 bowel movements a day I decided to see what that many bathroom trips did to my daily routine. And, because these calls of nature probably do not present themselves at convenient times or on a preset schedule, I enlisted the help of my son.
So, here’s a little glimpse of my pretend day with IBD. Wake up, walk into kitchen for first cup of coffee, head to table to breathe in the energizing aroma and sip to my heart’s content. But wait- per my son who is my bathroom master it seems it time to make a dash to the toilet. I go, I sit, I think. Ok, so my morning cup of joe was interrupted and that’s annoying but so far not so bad.
Fast forward to 3 pm. I have made mad dashes to the bathroom 11 times so far. In the middle of doing dishes, at the grocery store with a cart full of product, on the drive home where finding a toilet took a bit of time, in the middle of making lunch, and even while trying to eat that lunch. Each time I sit, I don’t have to go but I am trying to stick as close to real life as possible. I make sure I am in the bathroom and away from the life going on around me for an adequate amount of time. I wipe even though I don’t need too. My bottom is getting sore. Honestly this sucks. I have left good conversations, had to eat cold vegetables, missed out on happenings that while not super important are part of the little things that make up life. Odd but I have to say I am starting feel left out and kind of alone.
By bedtime I am exhausted. Why? I wonder. It doesn’t take up much energy to sit in the bathroom. And the walk there isn’t really aerobic. Then it hits me. I am mentally tired. Tired of wondering when my son will announce it’s time to go. Tired of worrying about what I will miss or if my bathroom break will mess up the activity I am currently involved in. Bottom line- tired of worrying.
As I fall asleep I am thinking, “Can I really do this for another day?” By the time morning arrives I am pretty sure the answer to that question is going to be no. I was summons twice by my alarm to head to the bathroom during the night and woke up by yet another call of nature. This whole thing is really starting to make me cranky. Now my irritability is further pushing my friends and family away, resulting in even more loneliness and feelings of being left out. Before I can spend too much time feeling sorry for myself my loving son orders me back to what is beginning to feel like my prison- the bathroom.
Three days in and I have had enough. Yes, questions that measure the number of loose bowel movements in a day, severity of abdominal pain, and energy level are very crucial to assigning a degree to quality of life. However, for a true understanding of improvements I now believe that questions such as quality of relationships, levels of anxiety, and even feelings of insecurity should be included in these assessments. Why? It’s surprising but even on day 4 when I wasn’t being summoned to the bathroom or wasting time on the throne away from everyone, I was still worried. After three days of living a life based on bathroom trips it had started to take over my life and the anxiety lingered.
Now take the results of my measly three days of experimenting and multiply that by months, years, or even a lifetime of dealing with IBD. Quality of life is in the tank! So yes, we need to treat the condition and improve the symptoms. However, in order to really help improve our patient’s quality of life, I think we need to offer more. We need to other services or at least provide resources to these services since there is obviously so much more to dealing with this disease then just the medical symptoms. Counseling, coping mechanisms, family education, and even work place education for co-workers and supervisors need to be a standard part of any treatment plan for IBD.
