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Friday, January 18, 2013

Evidence-Based Medicine

Evidence-Based Medicine
 
After my 3 year family medicine residency, I signed on to do a year-long fellowship in what is now called "Evidence-Based Medicine."  Back then we gave it all kinds of names like "quantitative methods in clinical decision-making."  The site of my work was through the University of Oklahoma Health Sciences Center Department of Family Medicine, where I had done my residency.  It was somewhat of a self-designed fellowship under the tutelage of Stephen Spann, MD, for whom I carry the utmost respect as an early champion of Evidence-Based Medicine.  I also did work through the Harvard Schools of Public Health (though I was only actually there for an 8 day course--but it sounds impressive!). 
 
Basically, physicians who are interested in Evidence-Based Medicine (or EBM) are complete skeptics.  We are scientists to the CORE.  We are Mr. Spock-like in our adherence to logic. We don't believe any claims that are made in medicine unless they are backed by hard-core evidence--that is, solid, well-designed studies of the effectiveness of the claim that are not damaged by many types of bias or poor study design. 
 
If a pharmaceutical manufacturer claims its drug reduces heart attack risk, then it better have the properly-designed, double-blinded, placebo-controlled trials to prove it.  It has been estimated (though I am not sure how anyone actually came up with the statistic) that at least 50% of modern, allopathic (standard western) medicine is NOT evidence-based.  That is, it does NOT have well-designed studies behind its claims.  This actually does not surprise me. 
 
It is extremely hard to do properly-designed studies that don't bring some type of bias into their results.  All of the pieces of the puzzle have to be put together just right to have a study or trial "strong" enough to really make their claims hold water.  They need of sufficient sample size for the "power" of their statistics to hold.  They need the proper type of statistical analysis.  They need to control for as many variables as possible.  They need to minimize the myriad types of bias that might enter into the study and its interpretation. 
 
In fact, it is so hard to find high-quality studies, that in EBM most interventions that are proposed in modern medicine, when evaluated, are graded on a strict taxonomic "grading scale."  For example, some type of medical intervention may be given a grade of "A" if the volume of evidence--the number of well-designed studies--clearly shows the intervention to do what it claims to do.  If the volume of evidence is more shaky, it might be given a grade of "C." 
 
Needless to say, I am simplifying to an extreme degree--back when I was working on my fellowship this science was still sort of in its infancy.  It took until 2004 for the larger groups of physicians who worked in this arena to come to a consensus on a somewhat universal grading system. 
 
 
Perhaps one of the most relevant applications of Evidence-Based Medicine guidelines involves Preventive Medicine--recommendations for services that primary care physicians provide that are chosen because they help prevent illness and injury and improve quality and length of life.  For example, mammograms and Pap smears and colon cancer screening.  We have a lot of evidence that has accumulated over the years as to what preventive services really do save lives and which ones sound good but actually don't save lives. 
 
Rather than spout off about individual services in detail, I'll give you the URL to one of EBM's proudest achievements:  the United States Preventive Services Task Force Recommendations. 
 
 
 
We in Family Practice use these guidelines every day.  Insurance companies (generally) follow these guidelines.  For example, most insurance companies (I'm proud to say) don't charge copays for proven preventive services such as colonoscopies.  
 
Another link to one of the most widely-respected Evidence-Based reviews of medical interventions is the Cochrane Collaboration: 
 
 
Cochrane's name is synonymous with high quality reviews of studies on an extremely wide range of medical subjects.  I go there often to research questions of the evidence-based validity of some issue I have heard about or read about or was presented by a patient. 
 
 
Quantitative Decision-Making:
 
The other part of my work in EBM involved trying to find better, more accurate ways of making difficult medical decisions.  As a brand-new physician, I was still uncomfortable with the uncertainty of many of the decisions we had to make.  I (and my research cohort physicians) knew there were mathematical and statistical ways to quantify many medical decisions. Our DREAM scenario would unwind this way:

A seriously ill patient presents to a physician.  The physician gets an initial history and then consults a computerized data base of relevent tests or procedures.  The data base indicates how those tests actually and quantitatively change the probability of the diagnoses the physician is considering. For example, I'm in the ER, and in front of me is a 46 year old man with chest pain.  But it is not "typical" heart attack-type chest pain.  I would have a rough estimate in my mind that he had perhaps a 15% probability of actually having a heart attack.  By consulting my computerized data base, I could then choose which tests (lab tests, CT coronary arteriography, stress test or heart catherization) by quantifiable means I need to do to either prove he is NOT having a heart attack or prove he is.  Or in other words, drops his probability of heart attack below, for example, 3%; in which case I'd be ok not keeping him in the hospital for a heart attack; or pushes the probability over say, 75% in which case I'm calling the cardiologist to take over his care. 

Tests are not perfect.  There are almost always false positives or false negative results.  A rapid strep test, for example, if done on one hundred people who actually have strep, will say 5 of those people are negative for strep.  When tested on one hundred people who do not have strep, it will falsely say 2 of them do have strep. 

Using this kind of data, we can generate how any given test changes the probability that a patient actually has or does not have a disease.  Using these sorts of mathematical probabalistic analyses, we often find some completely non-intuitive results. 

An example:  A college student wants to be tested for HIV.  He is not a high risk patient.  His general population likelihood of having HIV is around 0.1% (the general prevalence of HIV in his population).  So he gets a screening test that is pretty accurate.  The screening test turns up positive. Does that mean he has HIV?  No, his probability has moved up from 0.1% to only about 9%.  There is still a 91% probability he does NOT have HIV.  (He would then actually undergo much more specific testing of a second-step nature to confirm or refute the first test results.)

There is a common assumption among the lay public that if you have a positive test, you have the disease.  But as can be seen, this is often a fallacy, and not always intuitive.  It really becomes a problem when testing large populations at low risk.  That is why the vast number of abnormal mammograms are false positives.  But we are willing to scare a lot of women with false positives just so we catch the very rare REAL cancers. 

This is why the US Preventive Services Task Force evidence-based recommendations are so valuable.  Things we think might make sense in terms of screening tests actually DON'T help, and may make things worse.  For example, I still occasionally have a female patient who will ask me, "Why don't you screen for ovarian cancer?"  The answer is, when we've done studies using the tests available (ultrasound of the ovaries, Ca-125 tumor marker blood tests), we get too many false positives.  So when we calculate how many women would then undergo exploratory surgery to see if they actually have ovarian cancer, and how many women would have complications or die from the surgery or anesthesia--more women would be harmed than would be saved.  So we do not recommend routine ultrasounds or Ca-125 blood tests as general population screening for ovarian cancer.  (Many physicians DO offer these tests to women with a first-degree family history of ovarian cancer, however--as their overall risk is significantly higher than the general population.)

Then there is the issue of the "cascade effect."  For awhile a few years back, I'd get an occasional patient who'd ask me if they could have a "whole body CT scan" just to check if anything might be wrong or early cancers might be growing.  I'd have to explain that no study has ever shown that whole-body CT scanning prevents any form of cancer or other disease.  It would carry too high a false positive rate.  (Not to mention a huge radiation exposure and cost.)  We might find some little "thing" or shadow showing up in the liver.  But we can't tell exactly what that odd CT shadow is in the liver, so we then do an ultrasound.  Well, the ultrasound is not clearly defining a harmless lesion, so the patient then gets sent to a GI specialist who is now obligated to do a liver biopsy with a big needle to make sure the lesion is not cancer.  So then, during the liver biopsy procedure, a blood vessel gets nicked (a very rare complication of liver biopsy), and the patient then has to go to emergency surgery to fix the nick.  By the way, the liver lesion turned out to be a benign and insignificant growth.  This is the Cascade Effect--doing one test, which then finds something else that is a "red herring" or of no clinical significance.  Then that "something" needs to be investigated with still more testing, etc, etc.  


Monday, January 14, 2013

Frustrations in Providing Good Patient Care:

During a moment of exasperation while desperately searching for a "covered" medication or service on the computer in the exam room with a patient, I have been known to mutter, "I sometimes wish I were practicing in Borneo."  Or something like that.  What I mean by that is that I wish I didn't have so many restrictions to just doing my job.  My job is taking care of patients.  My job is to provide the best service in the safest way to help my patients improve or maintain their health. 

I may know exactly what medication the patient would do best on for a given problem.  However, when I have to dodge around insurance restrictions, cost issues, availability problems, and other restrictions, I may have to "settle" for something decidedly less appropriate.  Blame Big Pharma (for the high price of medications), or blame health insurance companies and their sometimes very odd restrictive formularies (approved medication lists).  Each would have their excuses:  Big Pharma: "We need to pay for all the years of research and development of our drug, because it will only be a protected Name Brand drug for a few years before it goes off patent."  Health insurance companies: "We need to keep costs down to keep premiums down."  Anyway, this is just one example of the restrictions to practice that physicians face. 

An even more staggering problem is the unfortunate patient on Medicaid (the state funded health insurance for persons of low income).  Medicaid drug formularies are the most restrictive of all.  Many specialist physicians won't see patients on Medicaid, so if I want to send a patient with Medicaid to a dermatologist, for example, I have to have my staff search high and low to find a specialist (hopefully within 150 miles) who will agree to see them.  Medicaid patients have to wait months on a long waiting list if they need specialized services of a psychiatrist. 

All I want to do is to help get my patients healthy and keep them that way.  Without jumping through numerous "hoops."  Probably 50-60% of my work effort is spent making my way through these mazes of restrictions and roadblocks to good patient care.  All of us as physicians accept this as reality, and it is the favorite point of contention during our "gripe and moan" sessions in meetings. 

Modern physicians I think feel as though they are the most important link between the patient and good health care, but they are being rolled over roughshod by a medico-legal-insurance system that is completely out of control and that ignores the wants and needs of the patient as well as the physician. 

The problem is, we are generally really good at what we do--taking care of patients--but we are NOT good at changing the system.  We don't have time enough in our work day to even think about trying to change the system. Throughout my four years in medical school, I never got ANY instruction in how to work with insurance, how to do coding and billing, or really any business instruction. 

A new emerging model of practice is what has been called "boutique medicine" or "concierge care."  In these models, a few physicians will get together and assemble a collection of several hundred patients.  Each patient in the group pays an annual fee to have the group of MDs be their team of personal physicians.  The annual fee is designed to cover the very dedicated services of the physicians, and in return the physicians are virtually "personal physicians" of the members.  The patients can meet with their physician during a long office visit (which can be billed to the member's insurance), but much of the interaction with the physician is on-line or by phone.  Each physician may have around 200 individual patients they are "assigned to," and if each patient pays $2000 a year to maintain that service, then the physician makes $400,000 for the year.  Office visits and hospital stays and lab and imaging are billed to existing insurance.  But the patient's physician is THEIR physician and sticks by them through thick and thin, during hospitalizations, basically for everything. Of course only relatively wealthy patients would be able to choose this option, as they would have to pay the annual fee AND insurance premiums. 

There are some variations on this model of "concierge care," but many overworked physicians hear about these models and say, "Gee, where can I sign up for that?"  Some newer models have employers hiring groups of physicians in a somewhat similar manner, and pay the physicians for their services--completely avoiding involving health care insurance.  They place the emphasis on wellness and preventive care, and reward physicians more for keeping the patients healthy. 

So there is some evolutionary movement to try to take insurance out of the loop between patient and physician.  It will be interesting to see how far this actually goes. 

It is a well-known fact that other countries in the world spend far less on health care and have much healthier populations that we in the United States.  This is a huge issue of embarassment to the U.S.  I have a few opinions on why this is so: 

--We have a tremendous bureaucracy tied up in health care:  Medicare, insurance companies, and some of the largest pharmaceutical manufacturing companies.  This, in my mind, tremendously reduces efficiencies and poses an incredible amount of mass--thus inertia--in trying change things toward more efficiency.

--We have an extremely diverse patient population as opposed to the northern European countries who have the best health-to-expenditure ratio.  Diverse in terms of income, race, culture, and belief systems.  Therefore we can't practice "one-size-fits-all" medicine.  Reducing efficiency. 

--We are an incredibly litigious society.  I don't care what anyone says, I know that the threat of being sued enters into my medical decision making all the time.  And, knock on wood, I've never been sued!

To be continued......

Sunday, January 13, 2013

A Day In The Life:

Four days a week my days are basically the same: 

Alarm goes off at 6 am.  I go into autopilot.  Grope my way into the shower.  Wake up.  Cerebrum moves up to 80% functioning.  Pad quietly back into dark bedroom where my wife is sleeping and try to get dressed in the half-light (boy it is hard to tell black socks from dark brown socks from blue socks!).  Quietly head downstairs and put together breakfast.  Let the Corgi out, then in.  Get the newspaper.  Have a quiet breakfast while reading the news.  Hopefully cerebral function is close to 100%. 

Put together something for lunch.  Head back upstairs.  Put the Corgi in bed with my wife (the terrier is already in bed). Kiss my wife goodbye (she'll be getting up in an hour to go to work).  Drive to work (3 minutes, 2 miles).  Hopefully at my office desk by 7:00 am as the first patient is being roomed by my most excellent Medical Office Assistant (MOA). 

My patients are scheduled every 20 minutes, with 40 minutes set up for physicals, or new patients, or patients that I know are more complicated/need more time.  However, one of the biggest challenges I and my MOA face is making sure patients arrive on time. 

I am obsessive with running ON TIME.

My MOA has a huge list of things she needs to enter into the electronic (computerized) medical record.  She has to get the patient's vitals (blood pressure, pulse, temperature, weight, sometimes height).  Then she has to go over the current issue we are dealing with that day ("chief complaint"), and then go over the patient's current medications, making sure our records accurately reflect what they are actually taking (obviously an issue of HUGE risk if wrong).   She has a whole long list of other questions, most of them in an effort to update the medical record so that everything is accurate when I walk in the door. 


The MOA's data-gathering can easily take 10 minutes.  So if my patient is told their appointment with me is at 10:00 a.m., and arrives at the front desk at 10:00 a.m., by the time my MOA is finished with her data-gathering, it is then 10:10 a.m, and I have only 10 minutes to spend with the patient before I am scheduled to be in the next room with my next patient.  I do not feel I can adequately LISTEN to the patient's issues, do an appropriate exam and then make recommendations in 10 minutes.  We have brainstormed all kinds of ways to address this issue. 

My MOA will call my patients a few days before their appointment and ask them to be there 10-15 minutes prior to their appointment time with me, just for this purpose.  However, MY proposal to our office system is to use the TEAM appointment philosophy.  I believe we should tell our patients that they have an appointment with their medical TEAM:  MOA, physician, and RN (at the end of the visit).  Patients should be given an appointment time to arrive at the clinic that REALISTICALLY reflects the time the MOA can begin her data-gathering, then my 20 minutes, then possibly another 5-20 minutes with the RN or in the lab or whatever else might be needed before the patient leaves the building.

So, back to the daily schedule:  I walk in the exam room with my first patient of the day, anticipating a 20 minute visit.  Generally on average this is no problem.  A significant percentage of my daily office visits are "re-checks" of stable, long-term medical problems such as hypertension, diabetes, depression, headaches, asthma or other problems that are under control and just need periodic office visits to update the status and make sure the medications are working, and that things remain under good control. 

If a patient's long-term chronic problem is not under good control, then we need to spend a little more time brainstorming what we (both the patient and I) can do to try to get things again under control.  If the patient has multiple problems (diabetes AND hypertension AND high cholesterol AND arthritis) and ALL of them are out of control, that can quickly move a 20 minute visit into a 30 minute visit as we attempt to address all the issues.  This is okay with me; it is more important to me that we get the patient's problems resolved.   Chances are good that the schedule will "average out" ok over the next hour or so anyway--often the next patient will only need 15 minutes and I can start to catch up. 

If it is clear that the patient is presenting with a long list of problems, or has several difficult problems that need a lot of attention and I am limited to a 20 minute visit, I will have to "divide and conquer."  That is, I will have to work with the patient to determine the highest-priority issues to address in our somewhat limited time.  We then set up a follow-up appointment in the near future to continue to work on the list. 

So my schedule moves through the morning like this.  I may have perhaps one "no-show," meaning a patient simply doesn't show up for their appointment.  This is very frustrating for me, but it has positives also.  The negatives:  I cannot update the missing patient's medical status, I cannot provide appropriate care for the missing patient, AND some other patient who has been waiting for an appointment now cannot be seen in that time slot because the missing patient did not cancel their appointment when they knew they wouldn't make it.  The small positive is that I get a chance to catch up with phone calls and messages from my nurses. 

In between patients throughout the day, I stop at my main desk computer and check for phone messages from patients sent to me by my nurses, prescription refill requests from the nurses, patient lab and x-ray results, and e-mail requests from patients.   I also sift through the mountain of faxes regarding my patients from the 2 local hospitals and other specialist physicians who have seen my patients.  I also have to fill out forms or sign nursing home orders.  If I am on call that day, I have to do many of these same things for not only my own patients but for the patients of any of my partners who might be out of the office that day. 

Generally I finish the morning pretty close to noon.  My noontime routine:  Call my wife and check on how things are going with her--new developments in her life/work, things going on at home, who is doing what that evening.   Then I grab whatever lunch I threw together, and get on my computer to work on more phone messages or prescriptions refills:  things I can do while eating lunch. 

Occasionally there is a lunch-time meeting, during which I eat lunch at a meeting table discussing something of administrative importance.  But in doing so, I am getting behind on the constantly-piling up phone call messages from patients routed through my nurses. 

Once I finish actually eating lunch, generally I have about 40 minutes or so to catch up on my charting of my interactions with patients of the morning.  Try as I might, I generally do NOT finish all my charting on a patient during my 20 minutes of assigned time for that visit.  So then I go back through my schedule of the morning, identifying visits that are not "closed;" that is, still have to be finished with regard to documenting their problems, exam findings, and my "assessment and plan," which outlines what I think is going on and what we are going to do about it.  I then type in my notes and findings and plans, or else (if more complicated), dictate my notes through the computer.  With any luck, I'll have finished (closed) all the morning's office visits by the end of my "lunch hour." 

NOTES ABOUT THE ELECTRONIC RECORD OF AN OFFICE VISIT:

In the computerized medical record, when a patient comes in for a visit (termed an "encounter") a complete documentation of that episode is required.  Basically, this is what is involved:

Demographic information:  the front office staff enters the patient's insurance information, updated address, etc.

MOA's information:  as described above:  vital signs, medications, updated medical history.

MD's information:  This takes on a time-honored format called a "SOAP note:"  S:  subjective information--information coming from the patient regarding their problems, complaints, symptoms, and anything they want us to know.  O:  objective information--information coming from direct observation, such as lab work, imaging/radiology, physical examination findings, vital signs, measurements. (Terming this data as "objective" is of course something of a misnomer--physical examination findings and imaging results are often very subjective.)  A:  Assessment--what I  as the physician (with the input of the patient) think is going on.  Diagnosis, hypotheses, ideas.  This is, in my mind, the most important section of the entire record.  P:  Plan--what I and the patient have determined is the most appropriate course of action based on our assessment.  For example, changes in lifestyle, changes in medication, further diagnostic options (lab work, testing, imaging), and how we are going to follow up on these changes.

The end of the "encounter" document will include medications ordered, immunizations given, referral orders if the patient is being sent to a specialist for consultation, and any printed instructions for the patient to follow. 

The last thing I do prior to "closing" a patient visit entry in the electronic medical record is determine the billing "code" for the office visit.  The details and idiosyncrasies of billing is the subject of another entry on this blog.  Basically, I have to determine--based on the time, effort, difficulty, complexity, or urgency of the issues addressed--how much should I charge for the visit.  This is arguably one of the most difficult parts of the job.

Back to the day-in-the-office: 

I start my afternoon schedule at 1:00 p.m.  It is exactly like the morning.  Running from 1:00 to 6:00 p.m. with patients every 20-40 minutes, trying to stay caught up with the phone calls, paperwork, prescription refill requests, and charting on patient encounters.  I generally finish up seeing patients around 5:30 or 6:00, and then spend another 30-60 minutes "cleaning up."  That is, finishing my visit notes, "closing encounters," finishing up phone call questions and prescription refill requests, and making sure the nurses are all set to go. 

If I am on call, then I might get a couple of phone calls in the evening from the nurses that staff the after-hours phone center.  I have to say, that the evolution of after-hours call has improved dramatically over the past 20 years.  Many years ago, if I was on call, I could expect 10-20 calls a night directly from patients, mostly very minor questions of typically a triage nature--should the patient go to the ER, PromptCare, or is it something that can wait at home and be seen in the office in a few days--that sort of thing.  Since plugging the after-hours phone calls through a Nurse Call system employing skilled and experienced RNs who can make these decisions, the number of calls that get filtered out and never reach me is huge. 

Hospital Coverage: 

When I started out in practice in McFarland, Wisconsin, I had a hospital-based practice also.  That is, I would care for my patients if they landed in the hospital.  That of course meant that every morning, I'd  stop at the hospital(s) and see the few patients I might have there, go over their progress, write orders on them, and make sure things were progressing.  I'd then get to my office around 9:00 a.m., and start my clinic practice for the day.  If I needed to, I'd stop at the hospital on my way home and check again on the inpatients under my care. 

As I got busier, my call partners (who worked at a different clinic) and I rotated hospital responsibilities.  That is, on our "call day" we would make hospital rounds on all of our group patients.  So one in four days a week, I'd see my other three partners' patients in the hospital, and I could start in my office a little earlier on the days my partners made rounds on our patients. 

I went through various permutations of call groups and call schedules over the first 15 years of my practice in Wisconsin.  The perpetual problem:  do we maintain a large call group of many physicians so that we can be "off-call" for long periods and just accept that we'll be ridiculously busy on the few nights a month we are on call, since we'll be covering for many doctors?  Or do we just stay with a small call group of 3-4 docs so that we are on call much more frequently, but hopefully much less busy when we are on call.  Some of my partners, when I was a member of a large call group, would have anxiety attacks on their days on call anticipating getting deluged with calls and 5-6 hospital admissions.

Call responsibilities also meant that if one of the patients I was responsible for came in to the hospital ER and needed to be admitted, I would be called in to do the admission processing and get the patient situated into the hospital.  An average night time hospital admission from the ER would take approximately 2 hours, not counting commute time.  For the majority of my practice years in Wisconsin I lived about 30 minutes from the hospital (I know, I know, my own choice!--but isn't it odd how in many cities the hospitals are located in the seediest areas of town), so that getting called to a middle-of-the-night hospital ER admission would take 3 hours from getting out of bed to getting back in bed (if I was lucky enough to get back in bed). 

On my arrival in Bloomington in 2005, all that changed.  The hospitals in Bloomington were going through a major change that almost all hospitals around the country have made:  they were employing "hospitalists" to manage the inpatients.   Studies were showing that physicians who were basically dedicated to managing the in-house hospital patients and were available 24 hours a day, 7 days a week dramatically improved efficiency, care, and safety of the hospitalized patients.  The system also seemed to significantly shorten hospital stays.  So it was seen as a major improvement for the good of the patient and the hospital.  Of course, it was a major boon to the lifestyle of primary care doctors, who no longer needed to divide their time and attention between the clinc and the hospital. 

I can clearly attest to the frustration of working in a busy outpatient clinic with patients waiting in the waiting room, then being called to go to the hospital because of an emergency with one of my hospitalized patients.  So I'd have to cancel a couple of hours of patients' visits right then and there, making apologies as I was flying out the door to race to the hospital. 

The advent of hospitalists has proved a positive impact on almost every aspect of care, except I think patients, as a general rule, don't like it.  They don't know these hospital physicians, and of course would rather be dealing with their primary care physician during their most needful time. Unfortunately, I don't have an answer to this.  It is how things are now.  I don't have enough time in my work day to make rounds in the hospital and maintain my current clinic hours and maintain any semblance of sanity. 

So I pack up things around 6:30 or 7:00 p.m. each evening, and make my way home.  On reflecting how the day went, I realize that when I am in the room with the patient, isolated from the hubbub of the clinic, just fixated on the issues at hand and how the patient's problems are affecting him/her, I am completely at home and content.  Admittedly, some problems are very thorny and difficult, but still, while it is just me and the patient problem-solving, I feel like I am in my element.  I enjoy that facet of medicine immensely.  Trying to solve a challenging issue.  Using my 26 years of experience to draw upon to figure out how I and the patient, together, can work toward a solution. 

If the day has been heavily loaded with very complex problems with very few workable solutions, then I can feel that stress by the end of the day.  Usually, however, things even out pretty well.  Some days, it feels like everyone is doing great, and there have been relatively few major challenges, and those days really keep me going.  Probably the factor that makes me feel the most tired by the end of the day is NOT the problems the patients and I have been working on, but the amount of extra work--the phone calls, the forms needing filled out, the lab results that need addressing--those "extra" issues (which of course are a normal part of any practice) really just can sap my time and energy.  But thinking about "shooting the breeze" with some of my well-established patients or families, I feel like I really am making a difference in their lives, and that gets me going for the next day.