Steve Lohr's June 19, 2008 New York Times opinion piece, "Most Doctors Aren't Using Electronic Health Records" cites a government report published in The New England Journal of Medicine ". . . that doctors who use electronic health records say overwhelmingly that such records have helped improve the quality and timeliness of care" and sadly notes that ". . . yet fewer than one in five of the nation's doctors has started using such records."
I checked the June 12 and June 19, 2008 print version of the NEJM and, noting that the article did not appear in print, concluded that the NEJM print edition uses its costly print resources more carefully than its virtual edition.
In this era of "show us the evidence" the first question Lohr should have asked is "what evidence proves that electronic health records reduce illness, reduce complications of illness, extend life and have a positive effect on outcome? The second question, with respect to the doctors' opinions, is "so what?"
Doctors' opinions reflect personal, colleagues and employers' bias. Opinions are interesting, but they are not hard evidence. Before we waste additional billions on technology which may not affect outcome positively and may affect outcome negatively, we need hard evidence. (See my blog "Clinical Competence or Electronic Medical Records" dated Sunday, May 11, 2008.)
One physician, who is implementing electronic records for a large medical group, recently told me that his job guarantees lifetime employment. Interesting observation - but how does that help patients? Another told me that he has less time for eye contact, communication and examining patients because he spends at least four minutes per visit preparing the computer record. And all of this without proof of outcome benefit.
Before we spend additional billions, buying technology which has not been proved to improve health care outcome, and before we fill the coffers of hardware and software companies and a new healthcare bureauracracy which never deals directly with patients, let's stop and ask for hard evidence of value.
The electronic health record is a tool not salvation. Before we waste additional resources, let's ask whether this technology meets the requirements of Occam's razor.
Wednesday, June 25, 2008
Tuesday, June 10, 2008
Who Is Responsible for Patient Health Decisions?
Kevin Sack's New York Times article, p.A14, June 10, 2008, portrays and seems to endorse a philosophy of U.S. medical care which appropriately died in the late 1950s. Under that patriarchal philosophy, physicians assumed full responsibility for patients, including all treatment and connected lifestyle decisions. It was the "don't worry your little head about your diagnosis, disease or treatment, I'll take care of everything since I'm the doctor-expert on your your illness, your treatment and what's best for you" school of medical practice.
According to Sack, The Archives of Internal Medicine Article, authored by Dr. Thomas Sequest of Harvard Medical School, made the point that physicians "do not discriminate in the way they counsel patients." Sequest was quoted as saying "Our one-size-fits-all approach may leave minority patients with needs that aren't being met." Sack cited standardized dietary advice as not realistic for the cultures being advised, including black or Latino patients, apparently under the uncritical acceptance of Sequest's inference that doctors should be conversant with the dietary, lifestyle and health habits of every culture, subculture, ethnic group, religious denomination, race and individual in America.
By the mid-1960s, physicians had changed their traditional patriarchal behavior to recognize not only that patients needed to be told about their conditions, treatments available, and prognosis, but that patients had a right to make decisions about their care which could be inconsistent with advice given by physicians, nurses or health care system. Any adequate review of modern literature on medical ethics, including legal texts reviewing U.S. Supreme Court cases, recognizes the importance of patient autonomy. Patient autonomy, a common issue in biomedical ethics consultations, invokes respect for a patient's understanding of salient facts about an illness, diagnosis, treatment course, alternatives, side effects and downside risks and respect for his or her informed decisions even if those decisions may cause illness and death.
When a patient chooses to eat rice and beans notwithstanding physician advice to eat fruits and vegetables, that does not mean that the physician has not given proper advice. It may mean that the physician lacks time for discussion because he is overscheduled, or that the patient does not have sufficient income, or a safely accessed well-provisioned neighborhood store, to allow the purchase of fruit and vegetables. If a black person chooses foods, practices, activities or medications (or not to take medications), which are not optimal for health, it is the height of condescension to assume that the person did not understand the doctor's recommendation and has made a dumb uninformed choice. And if a Jewish matron (who has been clearly told by her physician about the effect of salt intake on her health)chooses to eat a bagel, salty lox and creamcheese and provokes congestive heart failure, she is expressing her autonomy.
A condescending physician, or one who evokes guilt in patient for failure to follow advice, will find that the that patient will not return.
The physician's job is to apply science to patient communication, care and advice. The patient's responsibility is to listen to and consider that information and advice, and to act consistent with his or her autonomous decision.
According to Sack, The Archives of Internal Medicine Article, authored by Dr. Thomas Sequest of Harvard Medical School, made the point that physicians "do not discriminate in the way they counsel patients." Sequest was quoted as saying "Our one-size-fits-all approach may leave minority patients with needs that aren't being met." Sack cited standardized dietary advice as not realistic for the cultures being advised, including black or Latino patients, apparently under the uncritical acceptance of Sequest's inference that doctors should be conversant with the dietary, lifestyle and health habits of every culture, subculture, ethnic group, religious denomination, race and individual in America.
By the mid-1960s, physicians had changed their traditional patriarchal behavior to recognize not only that patients needed to be told about their conditions, treatments available, and prognosis, but that patients had a right to make decisions about their care which could be inconsistent with advice given by physicians, nurses or health care system. Any adequate review of modern literature on medical ethics, including legal texts reviewing U.S. Supreme Court cases, recognizes the importance of patient autonomy. Patient autonomy, a common issue in biomedical ethics consultations, invokes respect for a patient's understanding of salient facts about an illness, diagnosis, treatment course, alternatives, side effects and downside risks and respect for his or her informed decisions even if those decisions may cause illness and death.
When a patient chooses to eat rice and beans notwithstanding physician advice to eat fruits and vegetables, that does not mean that the physician has not given proper advice. It may mean that the physician lacks time for discussion because he is overscheduled, or that the patient does not have sufficient income, or a safely accessed well-provisioned neighborhood store, to allow the purchase of fruit and vegetables. If a black person chooses foods, practices, activities or medications (or not to take medications), which are not optimal for health, it is the height of condescension to assume that the person did not understand the doctor's recommendation and has made a dumb uninformed choice. And if a Jewish matron (who has been clearly told by her physician about the effect of salt intake on her health)chooses to eat a bagel, salty lox and creamcheese and provokes congestive heart failure, she is expressing her autonomy.
A condescending physician, or one who evokes guilt in patient for failure to follow advice, will find that the that patient will not return.
The physician's job is to apply science to patient communication, care and advice. The patient's responsibility is to listen to and consider that information and advice, and to act consistent with his or her autonomous decision.
Saturday, June 7, 2008
European Health Inequalities: Socioeconomic or Cultural?
The New England Journal of Medicine article by Mackbach, Stirbu et al, "Socioeconomic Inequalities in Health in 22 European Countries," (N Engl J Med 358:23, June 5, 2008) states, as a summary conclusion, "We observed variation across Europe in the magnitude of inequalities in health associated with socioeconomic status. These inequalities might be reduced by improving educational opportunities, income distribution, health-related behavior or access to health care." (p. 2468). This appears to more of a political statement or agenda than public health policy. It also focuses on issues which are easier to analyze and deal with than the hard one: "culture."
In the editorial section of the same issue of the New England Journal of Medicine, Berkman and Epstein (p. 2509), look at Mackbach's article and note that: (i) the results in the 16 country mortality data show higher death rates for socioeconomically disadvantage people; (ii) the size of the risks varies across countries, and that " . . .the proportion of excess deaths related to diseases that are potentially amenable to medical intervention was strikingly low . . ." for the socioeconomically disadvantaged.
Berkman and Epstein (p. 2510) comment that, " . . . . although national health coverage is important for many reasons, we should not count on it to reduce more than a small part of the socioeconomic, racial and ethnic disparities and improve the health of the population."
A politically sensitive, and potentially more rewarding study, would focus on the health characteristics of identifiable cultures and subcultures. What are the cultural characteristics of socioeconomically disadvantaged persons who place a high value on the practice of a healthy life style (diet, alcohol, tobacco, societal value of females, maternal and child health, health education, physical activity) and how do their cultures vary from others which experience higher member illness and mortality? While it may be relatively comforting to identify socioeconomic disadvantage, and write a check to remedy this issue, without identifying and modifying cultural characteristics, no health benefit will accrue. (Those who have treated alcoholism know that alcoholism has cultural attributes which may help to predict treatment success.) While it may be politically easier and less threatening to talk about matters of economics, those who conduct health research should move to study scientific issues and not be constrained by political considerations.
In the editorial section of the same issue of the New England Journal of Medicine, Berkman and Epstein (p. 2509), look at Mackbach's article and note that: (i) the results in the 16 country mortality data show higher death rates for socioeconomically disadvantage people; (ii) the size of the risks varies across countries, and that " . . .the proportion of excess deaths related to diseases that are potentially amenable to medical intervention was strikingly low . . ." for the socioeconomically disadvantaged.
Berkman and Epstein (p. 2510) comment that, " . . . . although national health coverage is important for many reasons, we should not count on it to reduce more than a small part of the socioeconomic, racial and ethnic disparities and improve the health of the population."
A politically sensitive, and potentially more rewarding study, would focus on the health characteristics of identifiable cultures and subcultures. What are the cultural characteristics of socioeconomically disadvantaged persons who place a high value on the practice of a healthy life style (diet, alcohol, tobacco, societal value of females, maternal and child health, health education, physical activity) and how do their cultures vary from others which experience higher member illness and mortality? While it may be relatively comforting to identify socioeconomic disadvantage, and write a check to remedy this issue, without identifying and modifying cultural characteristics, no health benefit will accrue. (Those who have treated alcoholism know that alcoholism has cultural attributes which may help to predict treatment success.) While it may be politically easier and less threatening to talk about matters of economics, those who conduct health research should move to study scientific issues and not be constrained by political considerations.
Monday, June 2, 2008
California Senator Defends Pilaging of Patient Confidentiality
In a June 2, 2008 interview on a local San Francisco area news program, California's Don Perata, Senator and Senate President Pro Tem, defended his vote in favor of S.B. 1096 which would grant vaguely defined parties, including pharmaceutical, research and marketing companies, access to confidential patient records in the guise of providing information to patients, saying that he voted for the bill because mental health groups wanted it. He didn't say which mental health groups. He didn't say whether they were organized independent patient/family groups, or whether they were fake non-profits organized, subsidized and controlled by pharmaceutical companies. He sidestepped the issue of the loss of confidentiality by all patients (the bill has a laundry list of medical conditions), not just patients with mental disorders, although he did mention that there was some consideration of requiring an "opt-in" rather than proceeding with the "opt-out" now contained in the bill. The vague terms of the bill would permit pharmacies to provide (for payment) confidential individual patient medical information to pharmaceutical companies through intermediaries, giving them access not only to confidential medical information, but more importantly from a pharmaceutical manufacturer's perspective, to the prescribing practices of physicians so that they can be targeted for intensive marketing efforts.
Note that the medical conditions described are those for which many prescriptions are written. The drugs prescribed provide enormous revenue to pharmacies, marketing companies, pharmaceutical companies, and communications media. This is a big money bill.
I suggest reading S.B. 1096 in full. In part the bill reads (emphasis supplied):
(20) The information may be disclosed as described in Section
56.103.
(d) Except to the extent expressly authorized by the patient or
enrollee or subscriber or as provided by subdivisions (b) and (c), no
provider of health care, health care service plan, contractor, or
corporation and its subsidiaries and affiliates shall intentionally
share, sell, use for marketing, or otherwise use any medical
information for any purpose not necessary to provide health care
services to the patient. For purposes of this section, a written
communication mailed to a patient by a pharmacy shall be deemed to be
necessary to provide health care services to the patient and shall
not require prior authorization, if all of the following conditions
are met:
(1) The written communication encourages the patient to adhere to
the prescribed course of medical treatment as prescribed by a
licensed health care professional and may include information about
that particular pharmaceutical drug as authorized in this section.
(2) The communication is written in the same language as the
prescription label produced by the pharmacy when the medication was
dispensed.
(3) The written communication instructs the patient to contact the
prescribing or dispensing health care professional if:
(A) The patient has questions about the medication.
(B) The patient is having difficulty adhering to the medication
due to adverse effects, dosing requirements, or other causes.
(4) The written communication pertains only to the prescribed
course of medical treatment, and does not describe or mention any
other pharmaceutical products. The written communication shall be
limited to the following diseases:
(A) Diabetes.
(B) Osteoporosis.
(C) Asthma.
(D) Chronic obstructive pulmonary disease.
(E) Cancer.
(F) Gastric disorder.
(G) Hypertension.
(H) Cardiovascular disease.
(I) Thyroid disorder.
(J) Organ transplantation.
(K) Chronic eye disorder.
(L) Rheumatoid arthritis and osteoarthritis.
(M) Renal disorders.
(N) Parkinson's disease.
(O) Seizures.
(P) Multiple sclerosis.
(Q) Depression.
(R) Schizophrenia.
(S) Bipolar disorder.
(T) Anxiety disorders.
(U) Attention deficit disorder.
(5) Further written communication shall not be provided if there
are no refills remaining on the prescribed course of therapy and
there are no doses remaining on the final prescribed refill, or the
pharmacy has been notified by a health care provider that a
prescribed course of therapy has been discontinued or substituted
with a different drug.
(6) All product-related information in the written communication
shall be consistent with the current federal Food and Drug
Administration (FDA) approved product package insert, and provide
fair and balanced information regarding the product's benefits and
risks in accordance with the FDA requirements and policies.
(7) A copy of each written communication version shall be
submitted to the FDA Center for Drug Evaluation and Research,
Division of Drug Marketing, Advertising and Communications, prior to
program implementation.
(8) Evidence-based or consensus-based practice guidelines shall be
the basis of any information that is provided to patients in order
to improve their overall health, prevent clinical exacerbations or
complications, or promote patient self-management strategies.
(9) All personally identifiable medical information collected,
used, and disclosed pursuant to this subdivision shall be
confidential and shall be used solely to deliver the written
communication to the patient. Access to the information shall be
limited to authorized persons. Any entity that receives the
information pursuant to this subdivision shall comply with existing
requirements, including Sections 56.101 and 1798.84, concerning
confidentiality and security of information. The pharmacy must have a
written agreement with any entity that receives the information. The
written agreement shall require the entity to maintain the
confidentiality of the information it receives from the pharmacy and
prohibit the entity from disclosing or using the information for any
purpose other than to deliver to the patient the written
communication that is the subject of the written agreement.
(10) If the written communication is paid for, in whole or in
part, by a manufacturer, distributer, or provider of a health care
product or service, the written communication shall disclose whether
the pharmacy receives direct or indirect remuneration, including, but
not limited to, gifts, fees, payments, subsidies, or other economic
benefits from a third party for making the written communication and
shall disclose, in a clear and conspicuous location, the source of
any sponsorship in a typeface no smaller than 14-point type.
Note that the medical conditions described are those for which many prescriptions are written. The drugs prescribed provide enormous revenue to pharmacies, marketing companies, pharmaceutical companies, and communications media. This is a big money bill.
I suggest reading S.B. 1096 in full. In part the bill reads (emphasis supplied):
(20) The information may be disclosed as described in Section
56.103.
(d) Except to the extent expressly authorized by the patient or
enrollee or subscriber or as provided by subdivisions (b) and (c), no
provider of health care, health care service plan, contractor, or
corporation and its subsidiaries and affiliates shall intentionally
share, sell, use for marketing, or otherwise use any medical
information for any purpose not necessary to provide health care
services to the patient. For purposes of this section, a written
communication mailed to a patient by a pharmacy shall be deemed to be
necessary to provide health care services to the patient and shall
not require prior authorization, if all of the following conditions
are met:
(1) The written communication encourages the patient to adhere to
the prescribed course of medical treatment as prescribed by a
licensed health care professional and may include information about
that particular pharmaceutical drug as authorized in this section.
(2) The communication is written in the same language as the
prescription label produced by the pharmacy when the medication was
dispensed.
(3) The written communication instructs the patient to contact the
prescribing or dispensing health care professional if:
(A) The patient has questions about the medication.
(B) The patient is having difficulty adhering to the medication
due to adverse effects, dosing requirements, or other causes.
(4) The written communication pertains only to the prescribed
course of medical treatment, and does not describe or mention any
other pharmaceutical products. The written communication shall be
limited to the following diseases:
(A) Diabetes.
(B) Osteoporosis.
(C) Asthma.
(D) Chronic obstructive pulmonary disease.
(E) Cancer.
(F) Gastric disorder.
(G) Hypertension.
(H) Cardiovascular disease.
(I) Thyroid disorder.
(J) Organ transplantation.
(K) Chronic eye disorder.
(L) Rheumatoid arthritis and osteoarthritis.
(M) Renal disorders.
(N) Parkinson's disease.
(O) Seizures.
(P) Multiple sclerosis.
(Q) Depression.
(R) Schizophrenia.
(S) Bipolar disorder.
(T) Anxiety disorders.
(U) Attention deficit disorder.
(5) Further written communication shall not be provided if there
are no refills remaining on the prescribed course of therapy and
there are no doses remaining on the final prescribed refill, or the
pharmacy has been notified by a health care provider that a
prescribed course of therapy has been discontinued or substituted
with a different drug.
(6) All product-related information in the written communication
shall be consistent with the current federal Food and Drug
Administration (FDA) approved product package insert, and provide
fair and balanced information regarding the product's benefits and
risks in accordance with the FDA requirements and policies.
(7) A copy of each written communication version shall be
submitted to the FDA Center for Drug Evaluation and Research,
Division of Drug Marketing, Advertising and Communications, prior to
program implementation.
(8) Evidence-based or consensus-based practice guidelines shall be
the basis of any information that is provided to patients in order
to improve their overall health, prevent clinical exacerbations or
complications, or promote patient self-management strategies.
(9) All personally identifiable medical information collected,
used, and disclosed pursuant to this subdivision shall be
confidential and shall be used solely to deliver the written
communication to the patient. Access to the information shall be
limited to authorized persons. Any entity that receives the
information pursuant to this subdivision shall comply with existing
requirements, including Sections 56.101 and 1798.84, concerning
confidentiality and security of information. The pharmacy must have a
written agreement with any entity that receives the information. The
written agreement shall require the entity to maintain the
confidentiality of the information it receives from the pharmacy and
prohibit the entity from disclosing or using the information for any
purpose other than to deliver to the patient the written
communication that is the subject of the written agreement.
(10) If the written communication is paid for, in whole or in
part, by a manufacturer, distributer, or provider of a health care
product or service, the written communication shall disclose whether
the pharmacy receives direct or indirect remuneration, including, but
not limited to, gifts, fees, payments, subsidies, or other economic
benefits from a third party for making the written communication and
shall disclose, in a clear and conspicuous location, the source of
any sponsorship in a typeface no smaller than 14-point type.
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