INTERVIEW

Comparative effectiveness research from the perspective of a surgeon–scientist David F Penson is Professor of Urologic Surgery at Vanderbilt University (TN, USA) and Director of the Center for Surgical Quality and Outcomes Research in the Vanderbilt Institute for Medicine and Public Health. He is the Principal Investigator of the Prostate Cancer Outcomes Study, a large populationbased study of prostate cancer survivors funded by the National Cancer Institute that includes the longest longitudinal patient-reported follow-up in the field. Dr Penson is also the Principal Investigator of the CEASAR study, a comparative effectiveness study of surgery versus radiation for localized prostate cancer. Over 3600 men have been enrolled in the study that will determine ‘what works, in which patients and in whose hands’. His work has been published in a variety of journals, including the New England Journal of Medicine, JAMA, Health Affairs and Journal of the National Cancer Institute. Dr Penson’s research and clinical efforts were recognized by the American Urological Association in 2006, when he received the prestigious Gold Cystoscope award, given annually to the urologist who has contributed the most to the specialty in the first 10 years after completing his/her residency. Dr Penson obtained his MD from Boston University (MA, USA) in 1991. He completed his urology residency at University of California, Los Angeles Medical Center (CA, USA) in 1997 and then completed the Robert Wood Johnson Clinical Scholar fellowship at Yale University (CT, USA) in 1999. He also obtained an MPH at Yale University in 2000. He currently maintains a clinical practice in urologic oncology at Vanderbilt University Medical Center. Could you tell our readers a little about your career to date and how you came to your current role?

I guess I’m a little bit of an ‘odd bird’. I am a board-certified urologist who completed training at the University of California, Los Angeles in the late 1990s. When I was there I was strongly influenced by Mark Litwin, who is also a urologist who performs health services research. This led me to undertake a Robert Wood Johnson Clinical Scholars Fellowship at Yale University (CT, USA) with Alvan Feinstein. Alvan spent a lot of time impressing upon me the importance of generating evidence to support clinical practice and also stressing the value of different study designs, including randomized trials, observational cohorts and simulation models, in assessing clinical effectiveness. This of course serves as the basis for my research focus on population-based observational studies for comparative effectiveness research (CER). After finishing my fellowship at Yale, I returned to the West Coast, first at the University of Washington (WA, USA) and then at the University of Southern California (CA, USA). In 2009, I was offered the opportunity to create a research center focused on comparative effectiveness outcomes research and quality improvement in surgery at Vanderbilt University (TN, USA). It was simply an offer I couldn’t refuse. The chance to build an intellectual nexus of academic surgeon–scientists

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David F Penson*

“...my work is really aimed at using population-based observational study designs to try to determine ‘what works, in which patients and in whose hands’...”

*Vanderbilt University Medical Center, 1161 21st Avenue South, Nashville, TN 37212, USA Tel.: +1 615 343 1529 [email protected]

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focused on improving care through comparative effectiveness and better quality was too much to pass up. Helping to train the next generation of academic surgeons was perhaps the greatest draw for me and is the part of my job I like the most. How is your time balanced between clinical and research work?

I spent 40% of my time on clinical pursuits – one day in the operating room and one day in clinic. I have always felt that the 80% research/20% clinical model that is commonly used in the ‘cognitive’ fields, like internal medicine and pediatrics, doesn’t fit procedure-based clinicians well. We need to see our patients in the clinic before we can proceed with surgery, right? However, the real challenge is to ensure that the 60% research time truly is research time. It’s feasible but it requires real dedication. What is your research focusing on at present?

My research focus is CER in cancer – specifically prostate cancer. While there are numerous pressing questions in this space, my work is really aimed at using population-based observational study designs to try to determine ‘what works, in which patients and in whose hands’ in prostate cancer. I am the Principal Investigator of the CEASAR study, which was funded through the Agency for Healthcare Research and Quality’s CHOICE award mechanism and has enrolled over 3800 participants from five state tumor registries and an existing observational disease registry. We have prospectively enrolled these men and collected patient-reported outcomes, including quality of life, in addition to clinical information and data on the quality of care. I am hopeful that, when completed, CEASAR will really help patients, providers and policymakers to better understand treatment issues around this common malignancy. How successfully do you think CER is currently being translated into policy and practice worldwide?

Clearly, not as well as it should be. There are a lot of reasons why that is and some are easier to change than others. One of the things I think we neglect as comparative effectiveness researchers is the dissemination piece of our work – and I’m as guilty of this as anyone. I think we publish our findings in a peer-reviewed journal and hope that people will read it and change what they are

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doing. This often doesn’t happen. We need to expand our efforts to include this. How do you think this can be improved?

I think it is starting to improve already. The increased focus on CER by funding agencies and insurers is an important first step. I am also seeing earlier engagement of stakeholders in the research process, including seeking their input in the formulation of the research questions and study procedures. This gets them invested from the beginning and increases the impact of the work when it is completed. That being said, we have a lot more room to improve. We need to train new researchers in the field of implementation sciences and existing researchers need to learn more about dissemination techniques. We also need to start using other avenues to get CER results to patients and providers – things like social media and other new technological tools that facilitate the sharing of information. What are you excited about working on over the next year?

The CEASAR study is a full-time job and it is probably what I’m most excited about, but a big part of my job is training fellows and junior faculty in CER and health services research. I think this is just as exciting because they are the future. Finally, what do you think will be the hot topics in CER in your field over the next few years?

Dissemination and implementation, as I mentioned before. I think the other hot topics will involve new methodologies to facilitate CER. Randomized clinical trials are clearly very important, but they’re costly and don’t always reflect real-world situations. I think we’re going to see more observational studies and more modeling studies, but in order for these analyses to have meaning, we’re going to need better methods for risk adjustment. I think this will be a hot topic going forward. Financial & competing interests disclosure DF Penson has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert ­testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.

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Comparative effectiveness research from the perspective of a surgeon-scientist.

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