Abstract
Any time something does that well, you gotta follow up.
Shawn Wayans
Dear EBSJ Readers,
First off, some housekeeping notes. Welcome to the new EBSJ, now combined with Global Spine Journal, and our expanded Editor-in-Chief team with Drs. Jeff Wang and Karsten Wiechert. Please welcome on board our new Managing Editor Danielle Lieberman, who has taken on her new role with much appreciated energy. We would like to thank Thea Swanson for her years of faithful service, and we wish her all the best in her new role as novelist. By combining our resources and outstanding global multispecialty reviewers, we will be able to further expand our readership and offer an ever-increasing variety of peer-reviewed scientific articles from around the world. For EBSJ, we will be able to concentrate even more on our popular in-depth formal systematic reviews as a special service to our AOSpine community. As always, we look forward to your topic suggestions and author inquiries.
As an introductory topic to this issue, I would like to recommend to you an article by Lurie et al recently published in Spine, titled “Long-Term Outcomes of Lumbar Spinal Stenosis: Eight-Year Results of the Spine Patient Outcomes Research Trial (SPORT).” 1 I encourage you to read this article for several reasons:
As you may remember, the initial results of this prospectively randomized surgical versus nonsurgical trial (SPORT trial for stenosis) were widely interpreted as supporting the role of some form of “traditional” decompression surgery, mostly without fusion surgery, over nonoperative treatments. An important side note of this landmark project was the realization of “self-determinism” of patients, who in a clear majority had refused to participate in the highest form of research—the prospective randomized clinical trial (PRCT). Of the original 1,091 eligible patients, 40% (n = 437) had declined to participate in the study. Of the remaining 654 patients, a majority of 365 patients had refused randomization but were agreeable to follow-up (these patients were referred to as “observational group”), leaving only 44% (289) of patients willing to submit to randomization (hitherto known as the “randomization group,” constituting 26.5% of the originally eligible population). This well-designed study with its robust budget, sophisticated project planning, and seasoned investigators was confronted with the unexpected—the unwillingness of patients to accept chance to determine their spine treatment. This was by all means an unanticipated reality check for all those demanding PRCTs to be used as the pinnacle of scientific evidence in surgical research.
A second insight gained from this article is that long-term follow-up is hard to come by—even in a study as well planned as SPORT. Which of the two groups would you as reader anticipate having a higher return rate at the 96-month mark, the randomized study “volunteers” or the observational “refusniks”? If you chose the randomized group, you would be wrong: only 59% (171/289) showed up for their 8-year follow-up compared with 67% (246/365) of the patients who had wanted to determine their treatment and were put into the observational group. Although the margin of follow-up may not appear to be dramatic to the casual reader, the fact that patients volunteering for an observational trial returned in higher numbers than those enlisted in a traditional study format clearly contradicts conventional clinical research wisdom.
Another interesting side note is the “known” conversion rates to surgery. Of the patients randomized to nonoperative care, 52% (78/151) of the patients at the 8-year mark had converted to surgery compared with only 27% of the patients (40/146) of the observational group, where patients had chosen their treatment. Again, one can make the argument that the substantial rate of patients lost to follow-up in the two nonoperative groups deserves more scrutiny than the surgically treated groups. But perhaps more importantly, one cannot help but note the apparent difference in “staying the course” in the group that had willfully chosen its treatment compared with the randomization group.
The sentinel finding of the original SPORT trial for lumbar stenosis was that, in general, surgically treated patient fared better than nonoperatively treated patients in virtually all outcomes scores. 2 This perhaps sounded too good to be true, thus further investigations, as suggested in the opening quote by the popular U.S. actor Mr. Wayans, almost inevitably followed. The compelling question was, how would the surgical stenosis results of the SPORT trial hold up in the longer run? After all, most results tend to fade away over time, and factors such as general aging, recurrent disease, or stenosis progression in other regions as well as rising effects of comorbidities may cloud results reporting. Indeed, in the randomized group, the patient-reported outcomes scores showed an approximation of results of the nonsurgically and surgically treated groups at the 8-year mark, reflecting a steady decline of outcomes over time. Would the skeptics after all be proven right?
Alas, the results of the 8-year follow-up study remain complex to say the least, as the observational group maintained a clear positive difference compared with the nonoperative outcomes in almost all categories, which is very much consistent with their original scores. In summary, patients who chose their surgical stenosis decompression remained happier over time than patients who chose not to have surgery, and also remained happier with their outcomes than patients who were randomized to have surgery. Confused? You are not alone.
The authors offered several possible interpretations such as differences in baseline demographics but interestingly did not discuss another plausible factor: the power of choice. As for myself, I could not help but see treatment effects being influenced by patient engagement in their treatment decision. I hope that the EBSJ/GSJ global readership takes this brief and somewhat cursory interpretation of mine as occasion to personally review this article by Lurie et al, and hopefully you will feel compelled to share your own observations with us. The recommended article certainly is most compelling as it perhaps raises more important new questions than it answers old ones.