Orthopedic Stem Cell Outcomes Are Being Fabricated Left and Right
POSTED ON 9/14/2017 IN Research BY Christopher Centeno
We have always prided ourselves in actually measuring outcomes with validated functional and pain questionnaires and then either making that data available online or publishing it in a medical journal. It's an arduous task that takes a significant amount of coordination and resources. However, this past few years, I've seen more and more that stem cell clinics who learned their trade at a weekend course are beginning to fabricate artificially optimistic results. if you're a patient, you need to be very concerned. Let me explain.
My First Brush with Made-Up Outcomes
Regenexx is the place where orthopedic stem cell injections were invented. So when we first started using stem cells in 2005, there was no one else on earth injecting stem cells into knee and hip joints. However, around 2008/9 we saw a few clinics pop up. At that time we had placed the results of our first knee arthritis patients online showing a 78% improvement overall for what's now called a SANE (Single Assessment Numeric Evaluation) score. Those results were good and were focused on the use of culture-expanded bone marrow mesenchymal stem cells injected into moderately to severely arthritic knees. I soon noticed that one of the other doctors who had just started using a completely different procedure had copied/pasted our outcome information onto his website. Given that this data didn't apply to what he was doing, I called him on it and he took it down. The next day when I checked his site, gone was our data, but it had been replaced with the number 80%. Huh? I knew he hadn't collected any formal data at all, so I called him to ask where he got this number. It was basically made up from what he thought his patients reported.
This made-up outcome information also happened with the same provider several years later. Once he finally did present some data he said he had collected, the preinjection pain score for his patients looked way off. I knew from collecting data on thousands of knee-arthritis patients that the preinjection pain score should be about a 3–4/10. In his approximately 100 patients, it was a very high 8/10. It didn't take long to find out from consultants involved in the data collection that he could never consistently collect the preinjection information. Hence, it was more likely than not that the preinjection-pain data had been fabricated as a high number to show a bigger drop in pain!
Patient- vs. Physician-Reported Data
Recently I blogged on a fat-stem-cell research paper where the outcomes were inflated by having the physicians report what they estimated as an outcome. I've also blogged on a xiphoidalgia surgical paper where the preoperative pain scores were ridiculously high. This is a common problem, as doctors frequently overestimate the extent to which they help patients compared to what patients report. That's not to say that physicians are trying to be unethical, but they're just being human.
The Made-Up Outcomes We See Today
The made-up outcome metrics of today pale in comparison to what I noticed eight years ago. We now have clinics who are randomly reporting success rates of 90%. There is no data behind any of these numbers. Some will extend this out to comments that suggest that a patient with severe arthritis can expect to be regrown a new knee. Just this week, our staff called a clinic that also claimed a 90% success rate with knee arthritis that didn't even know any medical history or other facts about the patient calling. Clearly, the regenerative space has gotten into a made-up-outcomes arms race, where one clinic tries to outdo the other for patient attention by fabricating a better outcome.
Fabricated Outcomes and the Law
With the recent FDA crackdown on fat-based, cure-all, stem cell clinics, one recent court case about patients suing a California clinic stands out. A California stem cell clinic who claimed to patients that its outcomes were perfect! In this case, they told new patients that 100% of past patients were satisfied with their treatment. Given that there is no medical procedure, drug, or surgery ever invented with a 100% satisfaction rate, a California judge has allowed a patient-driven class-action lawsuit to move forward.
The Right Way to Collect and Report Outcomes
At Regenexx, our real patient-reported outcomes are transparent. Anyone can go on our outcomes page and get live data from our registry that's updated monthly. This data is not culled, cleaned, or spit polished—it's what our patient's report. It's also not physician reported as that usually means that the numbers are inflated over what patients actually report. When we have enough data that merits it, we publish that data in the peer-reviewed literature.
How to Spot Made-Up Outcomes
- It all seems too good to be true. Your mother was right!
- Round numbers are reported. While there's a one in ten chance that any reported outcome might end in a zero (i.e., 70%, 80%, etc.), if you ask about outcomes for multiple areas and they all end in a zero, run...
- Staff is fuzzy on how the data was collected. Who collected the data? How many patients didn't respond? What questionnaires were used? What process is used if the patient didn't respond at any given time? Was the physician allowed any input into the outcome, or is it all patient reported? Is it scrubbed in any way?
- How long is a follow-up period reported? Meaning a patient may do well at three months and have lost all gains by six months. There's also no substitute for time, meaning that if you just began a new stem cell procedure last month or last year and it takes a few years before you can report durable outcomes, you have nothing to report.
The upshot? It's crazy out there. Most of the outcomes I see reported are clearly fabricated from thin air. It's tough and resource intensive to collect real outcome data. So look for the real thing; you'll be glad you did!
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