What is Evidence Based Medicine?

Posted on May 16, 2012 by Ted

One definition would be: Delivery of Medical Care based on results of best available evidence. This usually means finding or relying upon data, some of which will be from outside one’s immediate memory to help answer a clinical question. EBM began to be championed by investigators, probably in the early 1990’s[1].

Studies that comprise the evidence are often in the form of Clinical trials. Clinical Trials are a relatively recent addition to the armamentarium of the tools available to clinicians – the first Randomized Clinical Trial (RCT) was done in 1952[2]. Trials should, but often don’t, look at how an innovation compares with prior knowledge, standards of care, or diagnostic accuracy. This is called comparative effectiveness (CE). In addition, trials often achieve “statistical significance”, which may, however, be of little pragmatic significance. The biological significance of much newer data is frequently incremental, not disruptive. Trials are almost never done to look at cost, although some report cost considerations in analyses that are done after the original publication. When cost does become a consideration, political or other influences challenge the focus or reduce funding of whoever is doing the research. For instance, the dissolution of the US OTA[3], which functioned from 1965 to 1995, is an example of outside influences resulting in the dissolution of a system that had worked to improve care in the 30 years the office was in existence.

When evaluating evidence one needs to be aware of at least three considerations/tests:

  1. What is the source of the evidence (can you identify prospective biases, are the data reliable – Have non confirming data been looked for?)?
  2. What is the Strength of any recommendations?
  3. What is the Strength of the data that underlie the recommendations?

The AHA/ACC construct on strength of recommendations and the data supporting them is as good as any. Most other writing groups use some variations of those:

The strength of Recommendation is categorized as:

Class 1   Benefits Markedly Outweigh Risk, so the procedure/treatment should be done
Class IIa Benefits Somewhat Outweigh Risk, and it is reasonable to do the procedure/treatment
Class IIb Benefits May Equal or Minimally Outweigh Risk and it MAY be considered
Class III There is No Benefit or Harm may ensue. The procedure/treatment should generally be avoided unless there is a good reason to use it.

The Strength of the data is categorized as:

Level A Data are from multiple Randomized Clinical Trials (RCTs) or Meta-analyses
Level B Data are from limited populations (single RCT or non randomized studies)
Level C Consensus expert opinion, “standard of current care”, case studies.

There are two additional ways to look at EBM:

EBID – Evidence Based Individual Decision
EBG – Evidence Based Clinical Guidelines

Each has its place in the practice of EBM. In neither case should the evidence be looked at in isolation. New evidence should always be evaluated in the context of prior information, even though prior concepts may not be as soundly evidence based as newer information. The concept of Bayesian analysis where new evidence is evaluated based on prior heuristics should be applied. If new evidence comes about which markedly contradicts common or personal practice, the reliability of the source should be closely examined.

Guidelines are not new. One of the early guidelines was developed to help standardize and improve the diagnosis of Rheumatic Fever in 1944  – the Jones Criteria which were developed because, “From a study of the medical literature it is obvious that each observer has his (sic) own diagnostic criteria and these may differ widely”[4]. Thus, physicians couldn’t evaluate how therapies worked in this illness, because they didn’t really have a common definition of the illness. The guideline gave a way to be more confident of homogeneity in the diagnosis. The paper also allowed “clinical judgment” to override the criteria if done for good reason. CardioPulmonary Resuscitation was codified in 1966 because, “…clinical results vary widely and depend on the exact technique taught, the effectiveness of training…”[5]

Guidelines most often work for the majority of patients. When a patient or group of patients don’t respond to guideline based treatments, then a physician needs to determine why. Should the physician document that he/she has tried “standard or guideline recommended care” and that it hasn’t worked? How much should the patient know about a physician embarking on non-EBM care for this specific clinical condition? How much should the patient participate in any such “experiment” that such deviations from prior EBM/Guidelines represent? How much responsibility should the physician then have in sharing his/her observations with others? Alvin Feinstein in Clinical Judgment[6] discusses this concept.

Some Guidelines have multiple sources. Cardiac guidelines are often prepared with input from multiple physicians and other involved stakeholders from the ACC/AHA and the European Society of Cardiology. Some confusion may arise because there are “too many” guidelines. For heart failure, for example, there are FIVE distinct sets of guidelines, which are not concordant. Clearly for use by an individual or in groups, guidelines should be reviewed. For use by an institution or system a workable set should be developed.  This exercise often helps bring physician groups and practices together and helps them work better within an institution.

Some Sources of “Evidence”

Cochrane Collaboration

http://www.cochrane.org/

POEMS (Patient Oriented Evidence that Matters – Primary Care Oriented)

http://www.essentialevidenceplus.com/

USPSTF (United States Preventive Services Task Force)

http://www.ahrq.gov/clinic/uspstfix.htm

CADTH (Canadian Agency for Drugs and Technology in Health)

http://cadth.ca/

NICE (National Institute for Clinical Excellence – Great Britain)

http://www.nice.org.uk/

SBU (Swedish Council on Health Technology Assessment)

http://www.sbu.se/en/

Footnotes:

[1] McMaster EBM working group; Evidence Based Medicine: A new Approach to Teaching the Practice of Medicine; JAMA 1992, 268, 2420-5

[2] IOM (Institute of Medicine). 2011. Engineering a learning healthcare system: A look at the future: Workshop summary. Washington, DC: The National Academies Press

[3] OTA – Office of Technology Assessment: referred to in O’Donnell, JC et al: Health Technology Assessment: Lessons Learned from Around the World-An Overview: Value in Health, 2009, 12, Suppl. 2, S1-S5

[4] Jones, TD; The Diagnosis of Rheumatic Fever; JAMA, 1944, 126, 481-4

[5] Ad Hoc Committee on Cardiopulmonary Resuscitation … National Research Council: Cardiopulmonary Resuscitation; JAMA, 1966, 198, 138-145

[6] Feinstein, A; Clinical Judgment, 1967, Williams & Wilkins, Baltimore

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Providers, Patient Care Delivery and Policy: Hospitalist story

Posted on August 24, 2011 by Ted

There are often perverse incentives in health care. These incentives can, at times, create competing drives where providers are encouraged to do things that directly increase the costs of care.  Consider the reaction to the mandate to cut down hours that physicians in training (PIT) work to allow them to be able to think more clearly. This gave rise to the hospitalist movement[1], which was also in response to the Diagnosis-Related Group (DRG) concept signed into law by Ronald Regan in1983[2]. In the mid 1990s, hospitals began contracting with groups of physicians to care for hospitalized patients. Hospitalists began with an incentive to improve efficiency in hospital care and the inevitable shortening of the duration of hospitalization. Under DRG based payment, hospitals that could provide care to Medicare beneficiaries at a cost lower than the DRG payment level could keep the difference to cover other expenses. This was to encourage hospitals to become operationally more efficient and to negotiate more vigorously with suppliers to decrease their costs.

There have been multiple examples of Hospitalists being more proactive in navigating a patient’s inpatient care, thus decreasing the duration and cost of a hospitalization. It quickly became evident to hospital executives and their boards of directors that hospitalists appeared to decrease the hospital’s costs of delivering care, thus improving their “bottom line”.

A recent study from the University of Texas, reported in the Annals of Internal Medicine[3], confirmed that hospitalist do, in fact, keep the cost of an individual hospitalization down. However, on average, the costs of the post hospital care are greater. Therefore, while the hospital spends less on an individual hospitalization, the payer ends up spending more on the same patient mix. This leads to competing incentives. The hospital is encouraged to use hospitalists for care, because of the reduction in cost of a single hospitalization. This increased the margin from the DRG payment and also added potential revenue from subsequent hospitalizations[4]. Payers, on the other hand, may look at these data and question whether paying hospitalists for care gets the patient and payer better overall quality. On a population level, this might lead to an incremental health care cost of $1.1 Billion dollars a year.

The study suggests that the reason for higher total costs relates to differences in behaviour of hospitalists from PCPs. Patients cared for by hospitalists were less likely to be discharged to their home. In addition these patients were less likely to see their PCP shortly after discharge and more likely to be readmitted or seek ER care than were patients cared for by their PCPs while in the hospital. These latter observations suggest that there may be a suboptimal hand-off of care from the hospitalist back to the PCP. There may be other undefined reasons for increasing post hospital care as well.

For hospitals to improve overall quality, a culture of cooperation and communication between hospital based physicians and those in outpatient care (Primary Care) must be encouraged and enforced. This may in the short run interfere with profits, but will in the longer term improve patient and payer satisfaction.

[1] Wachter, RM, Goldman, L: The Emerging Role of “Hospitalists” in the American Health Care System: NEJM, 1966; 355, 514-17

[2] Part of Public Law 92-21 (http://thomas.loc.gov/cgi-bin/bdquery/z?d098:HR01900:@@@L&summ2=m& )

[3] Kuo, Y-F; Goodwin, JS: Association of Hospitalist Care with Medical Utilization After Discharge: Evidence of Cost Shift from a Cohort Study: Ann Intern Med, 2011, 155, 152-9

[4] Recent CMS policies to be implemented in 2012 will impose a penalty for readmissions that are potentially preventable. The effect of these proposed penalties on discouraging readmissions is not clear.

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Why do Physicians Behave the Way They Do?

Posted on July 25, 2011 by Ted

I believe that the vast majority of physicians do “the right thing” for their patients. I don’t think I’m being a Pollyanna. On the other hand, the “The Tragedy of the Commons”, which describes behavior in many cultures, doesn’t bypass the rod of Aescapelus. The story of “The Tragedy” reveals how individuals frequently tend to behave in a manner that satisfies short term personal goals rather than taking into account longer term outcomes of behavior that will benefit groups larger than a person’s close circle. This relates to the way that physicians behave relating to patient care.

There are several reasons that physicians “do things” for/to patients. The most common is that the individual physician honestly believes, based on his/her interpretation of information that is in their construct[1], that a diagnostic test or therapy will help the patient get better. When an appropriate test/treatment is provided to a patient, an improvement in health is most often the outcome. If the test/treatment is not appropriate, frequently either no benefit or an adverse outcome will result. (See “Who is responsible”). In addition to providing the right therapy, it should be in the right dose/form. It is not uncommon to see the phenomenon of the “treatment-paradox” where physicians will apply an effective therapy or test to those patients at low risk, but then avoid using the same procedure in sicker patients, who stand a greater absolute chance of benefiting. No one has adequately explained this behavior. In some instances it is related to contraindications to drug therapies in sicker patients. However, in many other instances there are no clear explanations (Peterson, P, et al: Circ Cardiovasc Qual Outcomes. 2010;3:309-315.).

A second explanation for physician behavior relates to experience embedded in the concept of “to a man with a hammer, everything looks like a nail that needs to be pounded”, When a physician is trained to do something, she/he becomes familiar with that and tends to use it because he/she believes it is beneficial. Who hasn’t heard a surgeon say, “A chance to cut is a chance to cure”? Physicians or surgeons who may be suspected of doing unnecessary procedures most often actually believe, because of this familiarity bias, that they are/were doing “the right thing”. I believe that this is partly why many physicians are still doing angioplasty/stent in patients with chronic stable angina before maximal medical therapy. They simply “believe” that angioplasty makes so much sense that it must “work”.

A third reason for physician choice in therapies may be that they are afraid to not do something because of fear of “liability exposure”. This has given rise to the malpractice debate. However, there are suggestions that even in regions where there is “tort reform”, physicians continue to apply procedures to avoid “malpractice risk”. Gawande, in his essay “The Cost Conundrum”, points this out. This behavior may relate to how badly physicians want to avoid legal confrontations even if the likelihood that they will personally loose much money is remote.

The elephant in the room, however, is when physicians do procedures for personal gain. He/she may duplicate a diagnostic test or therapeutic procedure because they know that they will be paid for doing it and that no one is going to check (How many of us read an explanation of benefits and understand it, much less inform our payer that a billed procedure wasn’t performed?). I have seen instances in which a physician group has a culture of doing repeat diagnostic tests exactly when payers say that they will pay for it. There are also instances in which patients are kept in hospital until the day insurance benefits run out, when miraculously the patient is “cured” or has received “maximal hospital benefit”. Many believe, even when it is difficult to prove, that this behavior is frequently applied to patients in psychiatric facilities.

Can unnecessary procedures, tests, therapies be identified and stopped? This will be difficult in a system where the culture is one of individual profit maximization and one where patients are not responsible for approving a bill before payment. Our current system of Relative Value Units or Diagnosis Related Groups as the basis for payment of physicians has led to the concept of “productivity”, which is often narrowly defined as how much one can bill. This is akin to the legal profession’s “billable hours”. (Does anyone remember the story of St. Peter talking to a lawyer who died at 45 years. When asked why now, St Peter said that he thought, based on hours billed, that the man had lived to be 100)? If this is the way that we will continue to pay (also called incentivize) physicians (and other caregivers) we will probably have physicians work only on treating patients, and doing as much as they can deliver. Taken to its “reductio ad absurdum”, payers would essentially be telling the physicians in our systems to do hands on care up to 10 -12 hours a day, keeping patients to themselves, not “sharing”. This would discourage working with “physician extenders”. It would also actively discourage our physicians from keeping time for other activities, which should improve medicine in general. Some of these outside activities would include: working on their own continuing education, or the continuing education of support staffs, participating in committee activities (which should help improve the way the system is run), participating in registries, working on improving quality locally or in national committees, or participating in community outreach (“free” clinics or community education). There are, I’m sure other things that we hope that physicians would participate in. We can, unfortunately, be fairly confident that there is no incentive to participate in any of these activities.

[1] An individuals construct will be influenced by prior teaching, “personal experience” or exposure to expert opinion

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Registry Participation will help Develop Alignment and Improve Quality

Posted on May 23, 2011 by Ted

Many hospitals and hospital systems are trying to ensure that they are satisfying quality metrics to help with accreditation, and to confirm that they are satisfying their mission and providing community benefit. Superior performance in achieving clinical quality may allow an institution or system to acquire a competitive advantage. However, the definition and measurement of excellence is clearly more credible if from an independent source. In many ways participation in a disease based clinical registry will be the optimal way for institutions to know what they are really doing with respect to clinical quality. The most recent definition of what constitutes a credible registry is in the 2010 AHRQ publication on registries. AHRQ defines a registry as “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure,” Usually registry participation is across several systems (as in the New York State, Northern New England, or national medical association registries). In some very large health care delivery systems, the registry may be developed and maintained within the system (as in the Intermountain, Kaiser, or Geisinger systems). Registries can be used to develop rankings in quality measures. In addition, they can help institutions or groups understand rare diseases/conditions, or the outcomes of various therapies or results of implants. In almost all instances, registries reflect the real world rather than the somewhat artificial constraints of experiments (clinical trials). The size of effects will usually be less marked than those seen in the initial clinical trials. Thus, participation in registries will help improve the real scientific basis of medicine (“Evidence Based Medicine”).

Most other reporting methods of institutional performance have major shortcomings.

Measures of the process of care for conditions such as Acute Myocardial Infarction, Heart Failure and Pneumonia, often called “Core measures”, actually encourage a rush to mediocrity. They generally are summaries of what one of my colleagues is fond of calling “Checking the box”. There is a place on a report form to say, “I probably thought of this”. However, checking the box does not really ensure the robustness of the intervention that allowed the box to be checked. For example, everyone knows that smoking cessation in smokers is a valuable health outcome. The box on a discharge form can be checked if the patient is given a preprinted form that says, “stop smoking”. A more difficult, but probably more effective, intervention is to sit down with the patient who is a smoker, assess the smoking habit, assess willingness to quit and then help the physician institute a comprehensive behavior modification program, either with or without some pharmacologic adjuncts. Both allow the box to be checked.

CMS, in its hospital compare website, does report outcome data, which are more rigorous than process measures. However, providers frequently complain that these data, which are often approximately a year old, are dated. Everyone that I have talked to has said to me, “Those are old numbers, we are now doing better than that.” Often on review of updated numbers they didn’t really improve.

Many other data sources do give “benchmarks” and allow one to rank oneself. One complaint is that to provide data to these is expensive and may not have a real ROI (that is, drive more paying patients to the hospital). On the other hand, participation in most registries facilitates providing CMS and other payers many of the requirements for public reporting. This physician and system benefit works for both employed physicians and your independent physicians who will feel a greater sense of affiliation (alignment) to a system or institution, because it helped them do a better job.

Rankings such as Thompson, Health Grades, USNWR and others are often fraught with difficulties. In the early 1990s, one Chicago hospital system had a high grading from a national ranking organization, and the next year was investigated by HCFA (the predecessor to CMS) for financial and clinical irregularities. Most hospitals appear on someone’s top 100 hospitals of some kind or other.

On the other hand, registry participation, with groups such as the national cardiovascular and oncology systems has been a way to ensure that hospitals or systems are working toward optimal care. While the initial Cancer Cooperative groups were and still are means of collecting large amounts of data on cancer participation they also helped move participants toward practicing to a national standard.

Participants registries have almost uniformly improved performance and have seen provider and patient satisfaction increase, which makes for a marketing (Public Relations) bonanza. Helping with registry participation is a low cost way for institutions/systems to improve alignment with physicians, and to demonstrate superior performance to payers.

For a listing of some of the premier registries and their web address, send us an e-mail. We will send our version to you.

September 4, 2011

Recent reports from the European Society of Cardiology meeting held in August 2011 have confirmed the proposition that registries are going to be more and more important as we continue trying to improve medicine

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We should work to Identify Problems rather than try to Fix Blame in Medical Service delivery.

Posted on March 17, 2011 by Ted

Recently there have been stories of inappropriate cardiac procedures being. There are at least four glaring examples of instances in which cardiologists have acted in a way that was not consistent with what others would have considered optimal patient care. This behavior diminishes a hospital’s reputation in relation to mission, community need and quality. The cardiologists were found to be doing inappropriate angioplasties or recommending inappropriate surgeries. In some cases the inappropriate care was deemed so egregious that the hospitals where it was performed either closed or had to change management. Why did these occur?

In all occurrences, a single physician or pair of physicians were doing both procedures and the associated “peer review”. Institutional oversight of laboratories was deemed inadequate. The physicians were all high volume users of the hospital facilities and at times were encouraged by the hospital to continue, presumably because of the revenue that these doctors generated. In one instance, a hospital CEO listened to staff concerns regarding inappropriate procedures and asked outside consultants for a review of cases. In other occasions outside review was initiated by the legal system (OIG, or state regulators) and sanctions were brought on the hospitals.

Errors in medical judgment may be related to several factors:

1.     Proximity/Availability Bias (this is a procedure that is familiar to me and I do it – it must be good);
2.     Financial Bias (this procedure is highly valued because payers pay a lot for it – it must be good for many patients, thus I should do more);
3.     Representative Bias/Confirmation Trap (I believe the data that support “my procedure” – the people doing studies that don’t support my procedure aren’t as good as I and they just don’t understand new advances in the procedure);
4.     Finally there may be frank dishonesty (I can get paid for this, and I believe that no one is going to argue with my judgment).

Continuous quality review helps expose and overcome these biases.

One might ask why hospital systems didn’t recognize these biases in their physicians and why they didn’t correct them and the associated misuse of hospital facilities. The answers are complex, but often reflect similar biases and some “blinders”. I have been in many hospitals where a service line director says something like, “Dr. xxx is one of our best doctors, he/she does a lot of procedures”. Follow up of this doctor’s long-term patient outcomes and data on appropriateness are usually lacking. While this doctor generates revenue, hospital/system staff members are often afraid of alienating him/her by questioning his practices. If there is review of quality, the review committee is often chaired or run in isolation by this physician/surgeon. Another source of review, especially of adverse outcomes, is the Morbidity and Mortality review. The weakness of M&M review is that it often focuses on one or two cases and frequently ends up with censure, embarrassment or punishment of an operator. Instead these meetings should work to find system errors that can be corrected to prevent future undesirable events. If education and definition of system errors were to be done, then the hospital/system would be fulfilling the Institute of Medicine’s first mandate for quality health care making it SAFE. A third source of review is asking an outside reviewer to go over a sampling of cases. Guidelines for voluntary peer review for cardiac catheterization laboratories have been available since at least 1997

Recently the SCAI and ACC have asked the state of Maryland to mandate better cardiac catheterization lab oversight and review, including an outside body similar to the Accreditation for Cardiovascular Excellence (ACE) program.

Annual or quarterly reviews should be done by several physicians, some of who would not have a direct interest in doing the procedures (at least 1 or 2 non invasive cardiologists). Review should always be done with input from more than one clinical group. Sometimes this may necessitate bringing in an “outsider” who is still in practice, or recently out of practice.

If reviews are undertaken with these objectives in mind, we are likely to “Fix the problem, not the blame”.

This way our systems will provide measurably better care to all.

Citations for data in this post are available. Please e-mail us at ebjw@winslowmedical.com and we will send them to you.

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Who worries about physician behavior? Who is ultimately responsible?

Posted on January 15, 2011 by Ted

There is a true story of a 30 yo woman who has a history of rheumatoid arthritis, and who developed unusual eye symptoms. She went to a physician who referred her to a neurologist (both were “independent medical practitioners”). The neurologist diagnosed Myasthenia Gravis and ordered a CT scan of the thymus. When there was a report of an unusual density in the thymus, a thymectomy was recommended. The patient was told that the alternative therapy was potentially long term corticosteroids. She sought, and received, a second opinion from a nearby Academic Medical Center by a neurologist, specializing in neuromuscular diseases and especially in Myasthenia Gravis. The specialist at the AMC could not confirm the diagnosis of MG. The young woman then went to Mayo clinic, where again the diagnosis of MG was not confirmed and the diagnosis of thymus tumor was also unable to be verified. To date there is no clear diagnosis of this woman’s problem, but neither the diagnosis of Myasthenia Gravis, or of Thymus tumor was confirmed.

Questions:

  1. The AMA has long had a prohibition on disagreements with prior diagnoses by other physicians dating to a 1903 code of ethics. When is it ethical to discuss a disagreement in a diagnosis with a patient?
  2. What is the obligation of a hospital/system, if the surgery was done?
    1. The OR is clean, anesthetic gasses and drugs are appropriately labeled and dispensed.
    2. The Surgeon removes Thymus and there are no complications from the surgery.
    3. The Pathologist (a hospital employee in most instances) reports a non-diseased thymus.
    4. The Patient’s symptoms remain stable.
  3. If we assume A – D then does the hospital have an obligation to question the appropriateness of the therapy in a case like this?
  4. The referring physician and the neurologist believe that they have performed a valuable service to the patient. Did they?
    Is there a mandatory case review of a specific number of cases and what is
    the censure if reviews are not attended?
  5. What is the responsibility of the payer?
    1. The treatment was not for a diagnosis that was confirmed.
    2. There will be follow up visits.
    3. How can we incentivize doctors to make time to “go to the literature” when they don’t know the answer to a patient problem from their experience base?
    4. How can we incentivize doctors to find the person who may be best able to help this patient, without destroying the physician patient relationship?
  6. What is the responsibility of the Medical Society/State Licensing Board?

This was not quite “Malpractice”, but it wasn’t good medical practice. There are probably no “right” answers to most of these questions. They may, however, be a place to start.

I would encourage you, the reader, to comment as you see fit.

Posted in General Interest | 4 Comments

Who is responsible? Is there Enough Accountability in Medicine?

Posted on January 12, 2011 by Ted

The Alligator Allegory reads:

“ The objective of all dedicated employees should be:
To thoroughly analyze all situations,
Anticipate all problems prior to their occurrence,
Have answers for these problems,
And
Move swiftly to solve these problems when called upon.

However, when you are up to your ass in alligators, it is difficult to remind yourself that your initial objective was to drain the swamp.”

Steven Spears in “Chasing the Rabbit” makes the point that in high velocity organizations senior staff must exhibit an openness to acknowledging when a system isn’t working and when mistakes are made. We don’t do this at all well in medicine. Hospitals and professional staffs are discouraged from looking for and reporting errors. There are many reasons for these behaviors, which, in the long run, will hinder our attempts to improve quality, safety and efficiency of health care. One of the most quoted hindrances to transparency in looking at errors is the fear of legal reprisal, in the form of “Medical Malpractice” exposure. However, the culture in medicine where the physician and, increasingly, the nurse are expected to “analyze all situations and have solutions to all problems before they arise” makes finding an error an admission of incompetence. Reporting an error may bring a torrent of blame from supervisors or teachers.

“Fix the Problem, not the Blame”, read a plaque above the head of one of the most revered hospital administrators in Chicago. To date, we haven’t been able to internalize that sentiment. There are also time constraints. Almost uniformly when an error is reported, the reporter has to make time to follow up and help with investigation of the incident. What should systems do to try to help undo the “code of silence”? There is no “easy” solution. The legal climate isn’t likely to be changed. However, in many states there is a way around discovery, because minutes of quality improvement committees are not “discoverable”. The Federal Patient Safety and Quality Improvement Act of 2005 – PL 109-41 includes protections in this area. However, some state laws also apply to these activities. AHRQ has a website devoted to Patient Safety Organizations and associated federal regulations..  Institutions or systems can encourage an atmosphere of openness, acknowledge that the system is NOT perfect and reward the reporting of inefficiencies or errors in the system. The enterprise can also authorize people to bring solutions to problems to supervisors, experts, or committees. (What ever happened to the suggestion box? It could even be a virtual suggestion box in the employee portal for most enterprises). Institutions can hold blameless people who do commit an error and acknowledge the error promptly. Clearly this wouldn’t hold for repeated instances of similar errors by the same person.

If organizations don’t develop a culture of real process improvement, we will continue to do the same thing over and over again. Three levers for improvement are:

  1. Acknowledge that errors can and do occur
  2. Authorize staff to look for and report errors
  3. Hold staff blameless when occasional errors are found and reported.

A corollary to this last lever is that staff should be held accountable for repeated errors that are not addressed and corrected.

Solving problems by transparency and openness will only help align staff, physicians and institutions into a more effective system and improve patient outcomes These outcomes would include mortality, readmissions, cost and patient satisfaction.

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Medical Ethics should address more than the individual patient encounter

Posted on December 22, 2010 by Ted

George Lundberg, reviewed what he called the Principles of medical ethics in his blog on  MedPageToday.com on December 20, 2010. He’s done us a service by bringing this up as the season for reflection is upon us.

The AMA’s Code of Medical ethics as revised in June 2001 is separate from the Hippocratic Oath, which most medical students recite on graduation. The AMA’s Code, which is less widely known, also reads like much of what should be noble in the profession, as it relates to an individual physician-patient encounter.

However, the code is fuzzy when it talks about the patient as paramount. There is nothing in these principles that relates to stewardship of health resources that are not limitless. There are multiple examples where physicians have done what they may have thought were in the patient’s best interest, but actually hurt them. One of the most egregious examples of this was in the 1990s when there was benefit presumed from bone marrow transplant based therapies for women with stage IV breast cancer. Physicians sent women for this therapy believing that it would help prolong their lives. Most often this was based on thinking of the patient as paramount, even if the therapy actually didn’t help most patients who had been studied. Where does the physician’s responsibility for evaluating the mountain of medical literature and for reaching a valid independent conclusion about an individual patient’s likelihood of benefiting from a therapy begin or end. In 2010 there were approximately 4600 journals catalogued in the Medline Database at the National Center for Biotechnology Information (NCBI). What a physician does for an individual patient must clearly be in the best interest of that patient. However, an individual physician’s “clinical judgment” may often be colored by his heuristics and individual biases. We need to work on ways of allowing us to be better informed and generally work in the patient’s as well as society’s best interests. We simply cannot do everything possible for an individual patient without taking into account the incremental benefit of individual diagnostic tests or therapeutic adventures.  There multiple examples of where a “it can’t hurt” to do a diagnostic or therapeutic procedure has led to catastrophic outcomes.

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What is “CE Research/Analysis”? Who should be responsible for it’s implementation?

Posted on December 7, 2010 by Ted

“CE” in medical parlance stands for either Comparative Effectiveness or Cost Effectiveness analysis. Both types of analyses are intended to allow health care providers (physicians, health systems, physician extenders) and patients reach rational decisions about choices in the treatment of specific clinical conditions. Most of the discussion today is on Comparative Effectiveness analysis, without a specific cost component. Comparative effectiveness analysis is critically important in today’s environment when there are often multiple therapeutic options. In the current practice, a practitioner who is familiar with a single modality is more likely to believe in that technique and will frequently, in good faith, recommend his/her most familiar therapy to most of her/his patients. Two examples come immediately to mind:

  • Treatment of a patient with coronary disease and mild stable angina: -
    a.  An interventional cardiologist is likely to believe that angioplasty, usually with a stent, is optimal
    b.  A cardiac surgeon is likely to recommend CABG, especially if the patient has multi vessel disease
    c.  Finally, the medical cardiologist will recommend pharmacotherapy in conjunction with exercise training in cardiac rehabilitation.

The results of the COURAGE trial, released in 2007, suggest that from the vantage of trying to prevent myocardial infarction or death, the three therapies are equivalent.

  • Treatment of a middle aged man with localized low risk prostate cancer:
    a.  A urologic surgeon has two potential procedures to offer: open or robotically assisted prostatectomy
    b.  A radiation oncologist has external beam radiation (IMRT, proton beam, or others) or implantation of “seeds” in the gland.
    c.  A third option would be watchful waiting.

Again from the vantage point of survival it appears that none of these have a clear advantage (see Watchful Waiting Wins Better Life).

One study identified five hundred potential screening measures for a general population of patients. A busy generalist cannot/should not be expected to be familiar with all potential therapies and come up with his/her reasoned preferences to all clinical conditions that might be seen in any month of practice.

Recognizing that there were few data sets to help with decision-making when competing therapies are present, a Democratic Congress authorized, and Ronald Regan signed, legislation creating and funding the Agency for Health Care Policy & Research. The charge to this agency was to encourage “Health Services Research”. In 1999, a Republican Congress and President Bill Clinton, extended the charge to the agency, but changed the name to the Agency for Healthcare Research and Quality (AHRQ). In 2003, the 108th Congress, with Republican majorities in both houses, and President G. W. Bush, passed the “Medicare Prescription Drug Improvement and Modernization Act” (MMA 11/25/03 PL 108-73), which authorized $50MM on outcomes and clinical effectiveness research (sect 1013). At this time there was a shift in terminology, calling CE research “Patient Centred Outcomes Research” (PCOR). In 2009, as part of the American Recovery & Reinvestment Act, Congress authorized $1.1BB for PCOR, $600MM of which went to directly fund or be administered by AHRQ. Finally, in 2010, as part of the Patient Protection and Affordable Care Act (PPACA, PL 111-148), further funding to PCOR was made into law. Clearly, the history of Comparative Effectiveness research has been non-partisan and supported by Congresses and presidents of both parties.

As currently configured, the goal of PCOR is to encourage thoughtful analysis of various ways of delivering care so that a patient in one part of the country should receive care that is not dissimilar to that from another. It is also intended to help with informed discussion between providers and patients. The PPACA has clear language that the results of CE analysis are not to be used to make guidelines or to limit payment. PCOR results are to be “descriptive not proscriptive”. The results of these analyses are to identify what is known and what is not (shades of Rumsfeld’s – known unknowns and unknown unknowns). There are gaps in what we know about effectiveness as opposed to efficacy, and we need to look at therapies in the light of potential benefits and harms. Many of these data will come from registries (a few of which are already active). While registries don’t have the scientific rigor of a randomized clinical trial, if done well, they can give useful information. Some data should always be better than none. As we get more registry data, our ability to do a better job of data collection will improve.

Why then, is there so much anxiety over government sponsored health systems research while there is almost none over NIH funding for “basic biomedical research”? Many stakeholders may find the reasons in a feeling, that further research is simply not needed. Some people, especially physicians, are afraid that the data will be imperfect and may be misleading. Others are anxious that once the data are available, they will be used to limit payment for some forms of therapies that have been found to be less effective. They believe that even though the current legislation prohibits this, future congresses or executive departments (CMS) may “misuse” the results of the analyses. There is certainly precedent for this feeling. On the other hand, in the absence of CE analysis, some therapies with a large potential for real harm and little return may be used with the best of intentions. Finally, individual providers (health systems and physicians at least) may feel anxiety that something they have invested dollars or training in may be found to be no more effective than another treatment. The more effective treatment may be either less costly or provided by another specialist or institution. Thus, there may be a need for an institution to reconsider use of a facility that has already been built. A physician may need to re-train in another medical field.

It would appear that with both the knowns and the unknowns that exist in medicine in the early 21st century, we should do as much as possible to understand the relative merits of differing therapies. CE research/analysis is clearly one technique to help gain such insight. If the private sector (industry, professional organizations) won’t do it in an unbiased manner, then perhaps an agency such as AHRQ should have our support, counsel and thought.

Posted in Policy, effectiveness/efficacy, treatment options | Tagged , , | 2 Comments

What does the Patient Protection and Affordable Care Act (PP ACA; PL 111-148) say about Alignment?

Posted on October 26, 2010 by Ted

The PP ACA, stored as HR 3590 and signed into law on March 23, 2010, is 906 pages long. Most of the bill consists of amendments to other portions of the Laws of the United States as enumerated in the United States Code (USC). The first 12 pages of the law are the table of contents and the last 141 pages are amendments. This leaves 753 pages of the initial law as proposed. Believe me, the act is not riveting reading. (If you are interested, send me an e-mail or comment and I will forward a copy of the table of contents with page references to the bill referred to above.)  Part III of Title III (from page 271 -297 or 3% of the bill) refers to “Encouraging Development of New Patient Care Models”. One of these models is the Shared Savings Program, which refers to the beginning of the definition of Accountable Care Organizations. Contracts for ACOs are to be initiated by January 2012. ACOs must be responsible for costs of both Part A (Hospital Care) and Part B (Supplementary Medical Insurance Benefits….) which include: Physician Fees, services of Nurse-Midwives, Psychologists, and Nurse Anesthetists as well as Nurse Practitioners or Clinical Nurse Specialists and provision of prosthetics. (There is nothing in this version of the bill on Physician Assistants) The bill also precludes participation in an ACO if the group is also participating in other programs that may include shared savings programs. Such programs may be proposed by the Center for Medicare and Medicaid Innovation, which will also be established under this legislation. These programs leave a great deal of uncertainty as to which model one wants to initially explore.

In the ACO portion of the law there are sets of requirements that ACOs should meet:

(1)  There are 5 groups of requirements for providers who may participate

(2)  There are 8 groups of requirements for financial arrangements including:

a.      A three-year commitment for the ACO to remain in the program.

b.     Minimum provider and patient (beneficiary) numbers

c.     Leadership structure including both administrative and clinical representation

(3)  There is a group of 4 reporting requirements including quality measures

(4)  There is a specific provision that forbids duplication of participation with other SSPs (see above)

The amendment section of the bill also allows the secretary to explore other payment models, including not being responsible for ALL of the components of Part B. In addition the amendments allow ACOs to work with “other third party arrangements”.  In fact, the Secretary may give preference to ACOs that work with both CMS and other payers.

One must also keep in mind that the Secretary of Health and Human Services (currently Mrs. Sebelius) is obligated to explore other models. These include programs to reduce hospital readmissions, an extension of gainsharing initiatives, as well as pilot programs on payment bundling. The latter is also to begin in 2013.

Bundling projects have been around since at least 1996 when the CABG Program involving 7 hospitals resulted in savings to Medicare of approximately $42,000,000 (Almost $73MM in today’s dollars).  At the same time these hospitals had an approximately 20% risk adjusted reduction in mortality while maintaining higher patient satisfaction. The Acute Care Episode Project that is currently underway is also demonstrating savings in some of the hospitals that have contracted with CMS.

Are there opportunities for systems that are better aligned with their medical providers to excel in the era of PP ACA? The above summary of some of the provisions of Title III would suggest that there are many. Those systems that have closely aligned with their physicians or who are now attempting to working with their physicians will have a leg up on others in their geography when it comes to providing services within the parameters of the new law.

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