Dissemination and Adoption of Comparative Effectiveness Research Findings When Findings Challenge Current Practices. Conclusions


SPORT appears to have had little impact on clinical practice, and the seeds of its low impact were sown mostly in the generation phase. The study design, which was unblinded, allowed for a very large patient crossover. As a result, what was intended to be an RCT with an intention-to-treat analysis had to also be analyzed as an observational-cohort study using an as-treated analysis. Analogous studies have avoided these difficulties, suggesting that they are not inherent to this type of CER but can be forestalled by careful study design and execution.

In the interpretation phase, the RCT results suggesting limited benefits from surgery were discounted because of high rates of patient crossover. In contrast, the observational-cohort study, at least within the spinal surgery community, served to confirm the relative advantage of surgery, which was already the prevailing method of treatment. Interpretation was further complicated by the study’s lack of detail on subgroups, which made it hard to judge who would most benefit from surgery, as well as the (possibly erroneous) perception that the surgical techniques used in the study were already outdated. Presenting competing analyses may have opened the results to conflicting interpretation, but the observational results alone produced different interpretations regarding the magnitude of the benefit provided by surgery.

In its formalization phase, SPORT again highlighted the challenges in weighing the relative strengths and weaknesses of RCTs and observational-cohort studies and the selective use of evidence. Multiple specialty societies, possibly influenced by various levels of industry sponsorship, issued competing and conflicting guidelines, while relevant data from European studies was generally discounted or ignored. Registries might help to bolster guidelines or to generate appropriateness criteria, but since many outcomes from spine surgery are subjective, registries may be best suited to report on harms. Orthopedic surgery has few registries, and financial incentives are not aligned to promote participation by surgeons.

While dissemination of the SPORT results appeared to be far-reaching, messaging about them emphasized the benefits of surgery rather than the significant clinical improvement among patients in the nonsurgical group and the relatively small difference in benefit between groups. Referring providers appear to be the optimal point for dissemination of the results, since referral to a surgeon is usually followed by surgery. Intense marketing of spinal hardware by the device industry may override the results of clinical trials, and, as SPORT illustrates, messages may be vague and selective, omitting key evidence provided by the trials. Similarly, payers and purchasers, faced with both the “positive” results from the observational-cohort analysis and the “equivalence” results from the intention-to-treat analysis, appear to have initially embraced the observational-cohort analyses and did not enact policies regarding decompression surgery. However, there are now some early examples of more-nuanced and data-driven reimbursement policies focusing on related procedures (e.g., fusion surgery).

Nevertheless, in the implementation phase, strong financial incentives continue to favor surgical over nonsurgical treatment. The alignment of financial incentives among physicians, hospitals, and device manufacturers appears to have increased the use of complex procedures despite uncertainty about their effectiveness and considerable evidence of greater risks. Countering this is the increasing use of RBMs, which may reduce inappropriate upstream diagnostic procedures and may play a potential role in the use of patient decision aids. While the SPORT results can be viewed as both flawed and confirmatory of current practice, the trial was successful in providing quality data on the relative risks and benefits of surgery, and these data have been integrated into patient decision aids. Those tools might ultimately change clinical practice by incorporating fully informed patient preferences into decisions about surgery. Currently, few incentives encourage the use of such shared decisionmaking or more rigorous informed-consent processes. The use of these techniques early in the pathway leading to surgery will be critical to their overall effectiveness. Incentives to promote the spread of patient decision aids and efforts to improve the appropriate use of diagnostic imaging represent the most important current strategies for changing clinical practice in the future.

Key findings from the SPORT case study are presented in Table 4.2.

Table 4.2

Key Findings from the SPORT Case Study


Key Findings


• Blinding participants regarding their treatment assignment was impractical, but in other surgical studies, it has revealed large placebo effects and a more limited benefit from surgery.

• The study design enabled very large (over 40 percent) crossover from both treatment arms, whereas analogous studies have limited noncompliance.


• The intention-to-treat results was ignored and the as-treated results from the observational-cohort study were considered the primary results.

• Publication of both the intention-to-treat and as-treated results allowed different stakeholders to glean confirmation of their competing viewpoints.

• The study provided insufficient detail on subgroups to judge which patients were most likely to benefit from surgery.

• The perception that study treatments were already outdated affected interpretation.


• Multiple specialty societies generated competing and conflicting guidelines, possibly influenced by their level of industry sponsorship.

• Strong evidence from European trials (which concluded that structured nonsurgical treatment works well) appears to have been generally ignored.

• Registries might help refine appropriateness criteria and quantify risks and benefits, but they are best suited to measure harms, so physicians have limited incentive to support their development.


• Decisionmaking by referring physicians is a key factor, so dissemination of CER results should focus on them.

• Performance measures and appropriateness guidelines for spinal surgery could work, but they are not yet widely employed.

• The device industry attempted to preemptively discredit the study, then reversed course to promote it when the results proved favorable—this can be anticipated.


• Reimbursement significantly favors surgery, especially more-complex procedures.

• Workers’ compensation reimbursement for both surgeons and patients also favors more-complex procedures.

• Referral to a surgeon can be interpreted as endorsement of the procedure.

• Payers have begun to impose modest limits specifying the indications for which they will compensate spinal procedures; while controversial, they may limit inappropriate surgeries.

• Payers are also employing RBMs to rein in inappropriate upstream diagnostic imaging procedures.

• Using decision support tools covering treatments for back pain may improve outcomes, but physicians are skeptical and have little incentive to use them.

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