How to Do Outcomes Research? How to Do Outcomes Research in Ophthalmology?

How to Do Outcomes Research? 

How to Do Outcomes Research in Ophthalmology?

The focus of my research has always been deeply connected with my desire to teach and improve our understanding of how to improve the surgical outcomes of residents and surgeons. Mostly I focused on outcomes research to improve how we teach surgical residents. Thus starting in 2000, my teaching and research contributions at Harvard Medical School focused on the establishment of a database of resident cataract surgery called OASIS (Objective Assessment of Skills in Intraocular Surgery) as part of the Harvard Medical School Residents in Ophthalmology Cataract Surgery outcomes study (HMS ROCS) at the Massachusetts Eye and Ear Infirmary. I started this study in order to improve our surgical outcomes and to identify factors increasing patients’ surgical risk in resident cases. In contrast to other surgical specialties, ophthalmology is severely lacking in published studies on medical education as well as risk analysis in resident cases. Knowledge about how a resident surgeon learns to become competent in their surgical skills and rely less on the surgical preceptor will improve surgical training programs. By mapping out when a surgical preceptor intervenes and when this intervention is no longer needed, we can begin to better understand the learning curve with surgical procedures. This can also apply to seasoned surgeons, if other surgeons are obtaining better results, we need to study why, and see if everyone can get such results. Benchmarks are important to help us all achieve better results for our patients. If I ever need a surgery, I would love to know if my surgeon is above the Benchmark. Currently, the way surgeons do this is by asking the scrub nurses in the OR: "how is he as a surgeon?""does he have a lot of complications." But this option is not available to everyone, so benchmarks, if done correctly, can protect everyone in the medical and surgical arena. 

At Harvard, we created a well organized database, that allowed us to identify some basic factors involved with preoperative surgical evaluation, surgical events, and surgical care that increase a patient’s surgical risk. This database was the first of its kind in any residency program in the United States and since then Harvard Medical School's Department of Ophthalmology has taken off in doing outcomes research in all aspects of surgery. 

Now the rest of the country is starting to see (or be forced) into doing outcomes research. 

“Comparative Effectiveness Research” and “Patient Centered Outcomes Research” (PCOR) are the relatively new interchangeable terms that came from legislation leading to the:

 Medicare Prescription Drug, Improvement and Modernization Act of 2003, which established the Effective Health Care Program at the Agency for Health Research and Quality (AHRQ); the American Recovery and Reinvestment Act of 2009 (ARRA) which allocated $1.1 billion for PCOR; and the Affordable Care Act of 2010 which created the Patient-Centered Outcomes Research Institute (PCORI). 

What is PCOR? 

PCOR is “The generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of comparative effectiveness research is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health."

[defined by the Institute of Medicine]

Basically this is 360 degrees of evaluation and outcomes research that could be open to insurance, the public and everyone to see. 

So it is in every surgeon's best interest to get moving with their own outcomes research asap before you and your practice are booted from an insurance plan because you fall below the benchmark.

Here is a short cut to doing outcomes research for your busy practice. I have used this to set up outcomes protocols at Harvard and now in private practice at Visionary Eye Doctors, where the owner, Dr. Alberto Martinez, saw immediately the importance of this in 2012 and signed on to hire a full time research assistant.

Here are the steps to launch an effective Outcomes Research Team and Outcomes Research Program

Short Version:

1. Find someone on your staff, an MD, OD, RN, or administrator who is passionate about helping patients get the best care in the world at your office. Put this person in charge of the Outcomes Research Program.

You should name the program.

At Harvard, I named our HMS ROCS: Harvard Medical School Residents in Ophthalmology Cataract Surgery outcomes study (HMS ROCS)

At Visionary Eye Doctors, a good title might be: Visionary Eye Doctors Patient-Centered Outcomes Research Institute (VEDPCORI). 

or Visionary Eye Doctors Outcomes Research Program (VEDORP)

2. Find a research fellow. At Harvard, my first research fellow made almost no money initially until I got a grant. He helped make the database in to a large source of information that allowed us to publish multiple studies. He is not an Assistant Professor at Harvard. 

There are many students out there that would love to have a chance to publish or even do some research. When my fellow and I started, we did not know exactly how we should do things, but all it took was an interest in helping patients and finding the truth in outcomes research.

3. Set up a database: There are many ways to do this. At Harvard we started with a simple Excel file and years later moved to SPSS. An example of our initial excel database is below in the Expanded Section. 

a. Decide what is important to you and your patients

b. Collect the data

c. Analyze the data

4. Find a statistician who can help you. At Harvard, our now world famous statistician initially wanted to be paid by the hour or to be listed on the paper. Towards the end of my time there, she wanted both: that was painful. But she was great. 

Currently, our fellow is excellent at statistics but is able to access help from the Statistics Department at Georgetown. 

5. Write it up. Don't be scared if you have never written a paper in your life. Just write down your results, analyze your results and write them down, write the conclusion, and write the introduction and title at the end. Add references. Have a couple of respected colleagues read it over. Submit it.

After a few times writing up your outcomes work, it becomes a process like putting a puzzle together, which can actually be enjoyable. Likely the reason it is most enjoyable is because you are revealing truths about yourself and your practice and striving to be the best for your patients who you love and adore. 

Expanded Version: