Launch of the TeMPO Trial

ECL: First, can you give us an overview of the TeMPO trial in your own words? Why are we conducting this study? What do we want to know?

JS: TeMPO is a randomized controlled trial of treatments for degenerative meniscal tear among adults who also have mild-to-moderate knee osteoarthritis. All the treatments are non-operative, including strengthening exercises and physical therapy (PT). The non-operative nature of the treatments is an important part of the rationale. Several studies in the past 10 years (including the MeTeOR trial conducted at OrACORe) have shown similar results from surgery and PT in this population. These studies were groundbreaking because they suggest that PT may be just as effective. But we don’t know what components of PT make it effective. Is it muscle strengthening, interacting with a therapist, manual therapy, or a combination of several factors? That’s what the TeMPO Trial aims to find out.

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ECL: Right now, we’re in the first days of enrollment at the Brigham after a busy phase of preparing to launch the trial. Could you reflect on that preparation phase and what’s to come in the next several months?

JS: The preparation phase was definitely fast-paced! Over the past 9 months, we’ve developed and refined study protocols. We’ve worked to creatively solve problems and create new materials that will help us recruit participants and keep the study running smoothly. We’ve poured time into perfecting all these elements—I’m excited to finally see them at work!

As a Research Assistant, I feel lucky to have been part of this trial in all its stages to date—from grant-writing through the beginning of enrollment this month.

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ECL: What is the most unexpected new skill you’ve gained through this?

JS: Creating protocol flowcharts. We found that flowcharts were an efficient, visual way for us to outline and discuss complicated trial protocols. We used them to guide discussions and find the best procedures for each situation that might come up.

When planning a complex trial like this, you have to think about all the contingencies and “what-ifs.” Our protocols have to account for so many possible scenarios.

Take the following scenario, for example. An RA is meeting a potential subject in clinic to recruit her for the trial. Maybe the patient misses her appointment, or the RA isn’t able to get the paperwork needed to recruit her. Then, even if all that goes right, the patient may or may not be interested in the study, or she might want some time to think it over. All those branching possibilities would be mapped out in a flowchart. It shows the logic of that process much more easily than a block of text could.

ECL: What does it do for us to understand all the contingencies in something like the recruitment process?

JS: The answer gets back to the nature of a controlled trial. We need to recruit all subjects in the same manner. Rigorous protocols for all situations will help us keep protocols consistent—both over time here at BWH, and across all four study sites. We have teams who will be enrolling subjects in Buffalo, Pittsburgh, and Cleveland as well.

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ECL: That leads us to my last question. What is it like working with teams at sites so far away? Have you met the staff at other sites?

JS: It’s been really cool working with distant sites and learning about their research contexts and organizations, which are quite different from OrACORe. For example, some of their research teams include physical therapists or experienced research coordinators who bring their own backgrounds to the table. The settings are different, too—we are recruiting at a major urban medical center, but that is not the case at all sites. And that makes it even more interesting to figure out protocols that will work for everyone.

ECL: Thanks, James! Break a leg.