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:

Erythrocyte Sedimentation Rate: ESR

Erythrocyte Sedimentation Rate: ESR

ESR stands for erythrocyte sedimentation rate. It is commonly called a "sed rate."

It is a non-specific test for internal inflammation.


Below is one of the best sites explaining briefly what causes a high ESR.




http://www.nlm.nih.gov/medlineplus/ency/article/003638.htm

ESR

    

ESR stands for erythrocyte sedimentation rate. It is commonly called a "sed rate."

It is a test that indirectly measures how much inflammation is in the body.

How the Test is Performed
How to Prepare for the Test
How the Test will Feel
Why the Test is Performed

• Unexplained fevers

• Certain types of arthritis

• Muscle symptoms

• Other vague symptoms that cannot be explained

• Autoimmune disorders

• Bone infections

• Certain forms of arthritis

• Inflammatory diseases that cause vague symptoms

• Tissue death

Normal Results

• Men under 50 years old: less than 15 mm/hr

• Men over 50 years old: less than 20 mm/hr

• Women under 50 years old: less than 20 mm/hr

• Women over 50 years old: less than 30 mm/hr

• Newborn: 0 to 2 mm/hr

• Newborn to puberty: 3 to 13 mm/hr

What Abnormal Results Mean

• Anemia

• Cancers such as lymphoma or multiple myeloma

• Kidney disease

• Pregnancy

• Thyroid disease

• Lupus

• Rheumatoid arthritis in adults or children

• Allergic vasculitis

• Giant cell arteritis

• Hyperfibrinogenemia (increased fibrinogen levels in the blood)  

• Macroglobulinemia - primary

• Necrotizing vasculitis

• Polymyalgia rheumatica

• Body-wide (systemic) infection

• Bone infections

• Infection of the heart or heart valves

• Rheumatic fever

• Severe skin infections, such as erysipelas

• Tuberculosis

• Congestive heart failure

• Hyperviscosity

• Hypofibrinogenemia (decreased fibrinogen levels)

• Leukemia 

• Low plasma protein (due to liver or kidney disease)

• Polycythemia

• Sickle cell anemia

Alternative Names
References
Update Date 5/11/2013

A blood sample is needed. Most of the time blood is drawn from a vein located on the inside of the elbow or the back of the hand. The blood sample is sent to a lab.

The test measures how fast red blood cells (called erythrocytes) fall to the bottom of a tall, thin tube.

There are no special steps needed to prepare.

You may feel slight pain or a sting when the needle is inserted. You may also feel some throbbing at the site after the blood is drawn.

Reasons why a "sed rate" may be done include:

This test may also be used to monitor whether an illness is responding to treatment.

This test can be used to monitor inflammatory diseases or cancer. It is a screening test. This means it cannot be used to diagnose a specific disorder.

However, the test is useful for detecting and monitoring:

For adults (Westergren method):

For children (Westergren method):

Note: mm/hr = millimeters per hour

Normal value ranges may vary slightly among different laboratories. Talk to your doctor about the meaning of your specific test results.

An abnormal ESR may help with a diagnosis, but it does not prove that you have a certain condition. Other tests are almost always needed.

An increased ESR rate may be due to:

The immune system helps protect the body against harmful substances. An autoimmune disorder is when the immune system mistakenly attacks and destroys healthy body tissue. ESR is often higher than normal in people with an autoimmune disorder.

Common autoimmune disorders include:

Very high ESR levels occur with less common autoimmune disorders, including:

An increased ESR rate may be due to some infections, including:

Lower-than-normal levels occur with:

Erythrocyte sedimentation rate; Sed rate; Sedimentation rate

Pisetsky DS. Laboratory testing in the rheumatic diseases. In: Goldman L, Schafer AI, eds.Goldman's Cecil Medicine

Updated by: David C. Dugdale, III, MD, Professor of Medicine, Division of General Medicine, Department of Medicine, University of Washington School of Medicine. Also reviewed by David Zieve, MD, MHA, Bethanne Black, and the A.D.A.M. Editorial team.

Should I Be Checked For Nutritional or Micronutrient Deficiency?

Should I Be Checked For Micronutrient Deficiency

Checking for nutrient deficiency is a very controversial subject in medicine partly because there are no published (in well-respected journals),  double blinded, randomized controlled studies to prove that such deficiencies directly impact a particular patient's symptoms or disease processes (with some exceptions such as an iron deficiency anemia, low magnesium, low calcium, low Vit D).

However, checking for a deficiency is not a bad idea for patients who have unexplained symptoms.

Below is an example of a posting for Spectra Cell test.

Results of such tests should be discussed with your physician and nutritionist to determine its importance in your health.

http://wholehealthchicago.com/2012/04/02/can-i-be-tested-for-nutritional-deficiencies-2/

Can I Be Tested for Nutritional Deficiencies?

Posted on April 2, 2012 by — 15 Comments ↓

This is a fairly common question in our office and the short answer is yes. It’s easy to understand the curiosity. You’ve cleaned up your eating habits, buying all those fruits and veggies. Whole grains, even. And more fish (oh, those omegas!) than you ever dreamed of eating when you were a kid.

On your kitchen counter sits a row of supplements you dutifully swallow each morning, maybe twice a day if the bottle tells you to. Is all that nutrition’s really getting into you? Are your efforts worthwhile?

With these investments, your nutritional status is likely solid, all the effort paying off. But keeping in mind that each of us is metabolically unique, know that some of us absorb nutrients better than others, have individual nutritional needs, or burn through certain vitamins more quickly.

If you’d like to see some hard data, a comprehensive test is available that measures your levels of an impressive array of micronutrients. The bad news is that you’ll have to pay for this test out-of-pocket, though you can always submit an insurance claim yourself and try your luck at reimbursement. The same holds true if you have a Health Savings Account where you work. You should be paid back…but nothing is predictable in health care these days.

It’s worth noting that the price of this test has dropped dramatically since it was first developed. And while you personally may prefer to spend its $373 test price tag on a meal at Charlie Trotter’s, this is one case in which you’re getting a lot of test for your health care dollar.

Spectra Cell Laboratories has been performing micronutrient testing for years using a patented technique called Functional Intracellular Analysis, which measures how an individual nutrient is being processed inside a cell. The test is performed on your lymphocytes, one type of white blood cell. Some researchers believe cellular analysis is superior to measuring levels of nutrients inserum or plasma because testing these latter two doesn’t determine if the nutrient accomplishing anything.

Here’s a list of what’s measured in the Spectra Cell test (pour yourself another coffee–it’s lengthy):

Vitamin A

B complex vitamins
B-1 (thiamine)
B-2 (riboflavin)
B-3 (niacinamide)
B-6 (pyridoxine)
B-12 (cobalamin)
Folic acid
Pantothenate
Biotin

Vitamin C

Vitamin D

Vitamin E

Vitamin K

Amino acids and metabolites
Serine
Glutamine
Asparagine
Choline
Inositol
Carnitine

Fatty acids
Oleic acid

Minerals
Calcium
Magnesium
Zinc
Copper
Manganese

Antioxidants
Glutathione
Cysteine
Coenzyme Q-10
Selenium
Alpha lipoic acid

The test also measures these specific cellular functions:

Carbohydrate metabolism (abnormalities point to increased diabetes risks)
Glucose-insulin interaction
Fructose sensitivity
Chromium

Total antioxidant function  

Low levels of antioxidants are linked to increased susceptibility to chronic degenerative diseases.

Cellular immunity function 
This measures your cell-mediated immune system performance (T-cell proliferation), a systemic measure of your general health (higher = better).

When the results are returned (we send them by email with the test attached, followed by a hard copy), SpectraCell also provides a list of recommended supplements and dosing levels. If you have a lot of deficiencies, I generally encourage you to schedule a visit with one of our nutritionists,Marla Feingold or Seanna Tully. If you have just one or two low results, you can purchase the supplements in our apothecary or at your local health food store.

Anticipating your next question: why doesn’t health insurance cover this? The quick answer is that everyone with health insurance would want to have this test and health insurance companies want to keep your money for themselves. The longer answer is that your health insurance has very specific guidelines on what they’ll allow for screening tests (generally covered are those that everyone should have, like cholesterol levels) and diagnostic tests, those needed in the diagnosis of a specific illness.

Your insurance would cover one or two of these nutrient tests if I were using them to diagnose a specific illness, but they draw the line at my ordering them all. They also add some interesting roadblocks. If, for example, I were to order the five antioxidant tests (separately, about $450), they’d likely request a letter from me with an explanation—what exactly was I trying to diagnose?

If you’re interested in having the micronutrient test, call WholeHealth Chicago and schedule a “lab only.” One of our assistants will call you to verify that we have a SpectraCell test kit in stock. Overnight fasting (no food after midnight) is recommended to improve accuracy. You’ll come in, we’ll draw some blood, and you’ll receive documentation for submission to your insurance carrier or Health Savings Account.

Be well,

David Edelberg, MD

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Tagged with: functional intracellular analysis, lab test, nutritional deficiencies, Spectra Cell Laboratories
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1. Michele Salustro-Doll says:

   April 3, 2012 at 6:25 am

   I paid for this test, my cardiologist read the results they sent me and said it was a hoax, that if my B12 were as low as this test claimed that I would be dead. I paid $400. for the test, bought all the supplements and none of it made any difference in how I feel.
2. Patricia Schulze says:

   April 3, 2012 at 7:24 am

   David,
   Thank you so much! Plain talk with specific information. That is so rare.
   I live in Connecticut but heard about your practice from my younger sister, so I signed up for your newsletter.

   Best Regards,
   Patricia
3. Mark Evans says:

   April 3, 2012 at 8:07 am

   So how often do you encounter a patient with a pathologically low level of something that you didn’t already suspect?
4. Dr E says:

   April 3, 2012 at 9:16 am

   Hi Michele
   I frequently encounter comments like your cardiologist’s when something is introduced that is beyond a doctors area of expertise. Similar comments occur when it comes to food sensitivity testing, salivary hormone testing, and urinary measurements of neurotransmitters. The attitude “if I didn’t learn it in medical school, it can’t be real” is really not a helpful stance for any physician to take. SpectraCell is a CLIA certified lab, meaning it meets very strict govenment standards about how a lab should operate and tests run. I strongly doubt if your cardiologist has actually sat down and read how the technique was developed, the standards they follow, etc., etc. Being an authority figure, you’re accepting his opinions as “facts” (as he does himself)
5. Judy Kayser says:

   April 3, 2012 at 4:38 pm

   This sounds like a very good test, especially for those like me who have serveral serious health conditions. I have seen so many doctors, before I became Doctor E’s patient, who simply dismiss that which is not evident through a test or taught in med school. Specialist are so focused on their specialty they never stop to realize thier area of expertise makes up only one part of a very complicated system. It is seldom that any of my different specialist, although very good in their areas, stop to consider my overall health and how everything in my body plays off each other. I am lucky to have Dr. E who understands this. This is a test I will gladly pay for and thanks for letting us know it’s out there.
6. Anne says:

   April 4, 2012 at 1:36 pm

   Hi Dr. E,

   This topic leads me to ask another question about testing for metabolic efficiency. Is this something that can be tested (either by blood, breath, etc.)? I think nutrient testing is probably very useful but I personally am also interested in getting a baseline to understand my metabolism and become more effective in weight loss (assuming good diet and exercise). I noticed that this nutrient testing looks at carb metabolism but is that the only piece of it?

   Thanks — Anne
7. Kathleen says:

   May 19, 2012 at 6:52 pm

   Is there a way to get this test done when you don’t live in the Chicago area?
   I would be willing to get the test done and then go to Chicago for nutritional evaluation once the results are complete. I’m located 80 minutes from New York City.
8. Dr. R says:

   May 20, 2012 at 8:04 pm

   You might check with SpectraCell laboratory for a referral of a doctor in your area that runs this test. http://www.spectracell.com/
9. Teddy bear says:

   February 22, 2015 at 8:51 pm

   I have MS. I have dramatically improved my eating habits, and have started a vitamin regimen( on my own). Still feel tired and wore out 3/4 of the time. Would this be a helpful test? Or do I chalk the tiredness to the disease?
10. Dr E says:

    February 24, 2015 at 11:06 am

    Hi
    I think either this or the Individual Optimal Nutritional test (by Genova) would be worthwhile. You should also be tested for borderline hypothyroidism and adrenal fatigue, two frequently overlooked causes of tiredness in MS patients
11. Sarah says:

    March 10, 2015 at 4:43 pm

    I came across this website when I decided to research how to get tested for nutritional deficiency and that’s how I found you – praise GOD!

    I live in Scotland and wondered if there is similar tests I could do here? I suffer from lack of motivation which is mainly due to a diagnosed BPD (borderline Personality Disorder, not because I’m lazy), anxiety which is brought on by stress and lower back pain which has a knock on effect on my whole body by causing my nervous muscles to contract which makes my entire body tense. It’s a never-ending battle and trying to get my psychiatrists to understand that I’d prefer supplements rather than what they are prescribing which is ‘Sertraline’, and instead treat my condition naturally through an organic supplement yet can’t find anyone that would support nutritional supplements to aid the deficiency instead of treating the deficiency with chemicals which could infect and make things worse especially with it not being monitired given that I attend an outpatient clinic. Can you point me in the right direction? I’m willing to travel?

    Thank you for reading!
    Sarah
12. Dr E says:

    March 11, 2015 at 8:30 am

    Hi Sarah
    When patients tell me of back pain and ‘entire body is tense’ sort of phrasing, I think of fibromyalgia with chronic fatigue. Psychiatrists virtually never check for this and treat patients for years with antidepressants. Ask your GP about fibromyalgia (which may go by a different name in Scotland, myalgic encepahlomyelitis
    Dr E
13. Nikki says:

    June 21, 2015 at 10:33 am

    Hi Dr E,

    I have been really physically sick for 9 weeks because of what seems to be Thyroid related.

    The diagnosis is likely to be Hyperthyroidism or Hashimoto’s Thyroiditis.

    I’m on a Vegan diet, however, I’m very malnourished and I haven’t eaten properly for a long time. I’m losing weight rapidly and very worried. I’m probably deficient in everything.

    This is mostly because of money problems and staying as an In-patient in several Hospitals over the past weeks where I was fed very inadequately.

    I’m very Anemic, and on 80 mg Iron supplements as well as 1000 mcg B12 both daily.

    Very worried if I will be OK? Is an omnivore diet necessary?

    I will do whatever it takes to survive. I hope that there’s help for me.

    I feel that I need to have a test such as what is offered by Whole Health Chicago for the above reasons. I’m doubt that my declining physical health allows any more blood to be taken, and this is the same reason why I don’t have a confirmed diagnosis on my Thyroid, however I seriously need it because this is possibly contributing to my Anemia.

    What do I do?

    I’m living in Australia.

    Please help me. I don’t want to die. Please help me.
14. Dr E says:

    June 23, 2015 at 5:15 pm

    Hi Nikki
    Sorry to hear abut your health challenges. Thyroid disorders (overactive or underactive) can be diagnosed with a simple blood test that requires very little blood. Likewise, key vitamin levels can be tested and you don’t need the SpectraCell test for these. Since you are already in the hospital, your doctors can order these tests for you. Good luck!
15. lee wilson says:

    June 28, 2015 at 8:23 pm

    I had to beg my Doctors to test me for Magnesium and finally they did, i was below minimum requirements. my heart skips disappeared after a few weeks of mag supplement, i had to deal with heart skips for 6 months and going to doctors and the ER. i later discovered that the ER and docs just use a basic blood testing that overlooks dozens of other blood test that can or should be performed.