Am I a Guinea Pig If I Participate in a Research Study?

Absolutely not! Research studies are a very important component of many surgeons’ practices and your participation is the most important part. Being in the study isn’t going to benefit you or your surgery, but it could help improve care for future spine patients. Those that participated in research studies in the past helped to improve the surgery YOU are having. Did you know that in the past patients had to stay in bed for a month or more after surgery and wear a brace or cast for several months? Thanks to the improvement in instrumentation systems AND to patients that were willing to be in research studies, surgeons have found that prolonged bed rest and bracing/casting are not necessary anymore. Aren’t you glad those patients before you took part in studies when they had surgery?! By filling out the questionnaires to show how they were doing and reporting complications or any other issues, they were able to develop the care you are receiving now.

There are different kinds of research studies that you may be asked to participate in. They are based on the time you are enrolled relative to your surgery date:

• Retrospective Study: This is a review of past surgeries, usually looking at a certain type of procedure for a certain diagnosis and comparing different treatments or looking at outcomes/complications.

• Example: Look up all the patients in the past 10 years that had surgery for Scheuermann’s Kyphosis who are now 5 years postoperative to see how many have had reoperations, negative changes in their spinal alignment, or problems with function/pain/satisfaction. Outcomes of studies like this have resulted in, for example, changing the recommended upper and lower vertebrae to include in the surgery to prevent extra stress on the spine at the ends of the instrumentation. It has also led to a change in the surgical approach, which was traditionally performed with an anterior and posterior fusion to now most surgeons just doing an all-posterior surgery.

• Prospective Study: Your enrollment would be prior to your surgery. This type of study is preferred to make sure that inclusion in a study by all that meet the criteria is accomplished. (The concern with some retrospective studies is that patients with complications may not be included for one reason or another which skews the results.)

• Example: Patients with thoracic idiopathic scoliosis traditionally had posterior surgery. There was a shift in that trend to treating those types of curves with an anterior surgery to be able to do a shorter fusion with a less visible scar. A study was done on patients that met strict criteria to be in the study where the surgeon would present both approaches to them and they could pick which type they preferred. If the surgeon felt strongly that one surgery was better for that patient than the other, they would be placed in that arm of the study. That study resulted in a shift back to more surgeons treating those types of curves with a posterior surgery. With the introduction of more modern, very secure instrumentation for posterior fusions, the difference in the number of levels fused wasn’t significantly different for either approach. Additionally, by reviewing pulmonary function tests (aka the breathing tests) they found that patients having the anterior surgery, where they cut thru the muscles/ligaments/tissue along the rib cage to gain access to the front of the spine, took longer for the patients’ lung function to return to normal. Now, surgeons are able to perform posterior fusions for thoracic scoliosis with fewer vertebrae fused and a much faster return to normal activities.

• Prospective Randomized Study: This type of study sets up different arms by ‘chance’.

• If the surgeon feels that, in the previous example, both treatments are perfectly acceptable, the patient can let the computer pick which ‘arm’ they are in, thus what surgery they are having.

• Prospective, Randomized, Blinded study: This type of study automatically uses the computer to decide which treatment arm a patient is in.

• Example: Spine surgery can be very bloody. There was a study done comparing 2 different drugs to decrease the blood loss during surgery. The only person that knew who was in what study was the study coordinator. Even the surgeon didn’t know if the patient received one of the study drugs or the placebo, which in this case was an IV bag with normal saline in it but no medicine. At the end of the study, all patients and their charts were reviewed to assess the amount of blood loss and if there were any complications related to the study drugs. One of the drugs is now commonly used to decrease blood loss during complicated spine surgery as it made a significant difference over the placebo. The 2^nd drug worked even better but unfortunately was found to have a higher risk of complications in cardiac patients who received it during their heart surgery so its use was discontinued.

Those are just a few examples of how patient participation in studies has helped to change treatment. All studies that are done have to be reviewed by an Institutional Review Board (IRB) at the hospital or university that is involved in the study. The job of the IRB is to make sure that the study is ethical and not likely to cause harm to a patient. There must be a consent written for each study and a research coordinator or other staff will review that with you and explain the study. Participation in a study is completely voluntary and will not affect your care whether you choose to be in the study or not. You can also withdraw at any time if you are uncomfortable with the study. There generally aren’t extra visits to the doctor for most studies and yes, you still will be asked to fill out the questionnaires whether you are in the study or not!

So to answer the initial question, no, you are not being used as a guinea pig if you participate in a study. You are, on the other hand, helping surgeons improve the quality and safety of spine surgery for future patients so your involvement is very much appreciated!!