What the November, 2009, Breast Cancer Screening Argument Obscured

In November, 2009, a rancorous argument about screening mammography for women aged 40-49 was touched off by the publication of updated guidelines(1), supported by a systematic literature review(2) by the US Preventive Services Task Force (USPSTF).  The guidelines suggested that yearly mammographic screening for women in that age group should not be automatic, but a decision made for individual patients after discussion between the patients and their doctors.  This was based on a critical review of the best available data which suggested that the benefits of screening acrue to only a few patients.  1904 women would have to start screening and continue for multiple rounds to prevent one cancer death over 11-20 years of follow-up.  These benefits had to be balanced against a number of potential risks, including the risks of treatment of cancers that might never behave malignantly, and the at least theoretical risk of generating new cancers through radiation exposure from mammography. 

These seemingly reasonable recommendations generated heated responses.  The debate, to be charitable, seemed to be at its core about how one should weigh benefits and harms in making individual and health policy decisions.  Since different people value different outcomes differently, I was not sure at the time how to make a meaningful contribution to this debate, or whether the debate had to do with the issues we usually discuss on Health Care Renewal.

I should note that the USPSTF guidelines never said "do not screen" women under age 50, or that the government should not pay for such screening.  They did say "the decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take pateint context into account, including the patient's values regarding specific benefits and harms."  It is hard to see how anyone could argue with that as an expression empowering patients' choices and values.  (For further discussion about how the recommendations were actually modest and reasonable, see Partridge and Winer.)(3)

Now that the dust has settled, it may be useful to reflect further on this.  Doing so suggests that the rancorous US debate mainly obscured rather than illuminated the major issues regarding mammography screening, particularly about our lack of clear evidence from clinical research needed to make the best individual and  policy decisions about mammography. 

It seems to me that the main questions one must answer to make an individual or policy decision about screening mammography are:

Does it improve longevity?

This is not the same as asking whether mammography reduces mortality from breast cancer.  It is theoretically possible that while decreasing mortality due to breast cancer, screening and its downstream consequences increases mortality from other causes.  At least in theory, screening may detect small tumors that would never grow or metastasize.  Treating such tumors could sometimes lead to premature death due to complications of surgery, radiation, or chemotherapy.  Furthermore, screening also involves periodically exposing large numbers of women to radiation, which may sometimes cause new tumors.  So reducing breast cancer mortality does not automatically mean that overall longevity would be improved.

There have been eight major trials of breast cancer screening which included women younger than 50. (See reference 2.)  None demonstrated a statistically significant increase in overall survival (that is, an increase unlikely to have been due to chance alone) due to screening.

Does it reduce suffering, improve functioning or generally improve quality of life?

To my knowledge, no major trial attempted to answer this question.  No such data is mentioned in the USPSTF systematic review.

Do the above benefits outweigh all its potential harms and risks?

So we cannot answer this question, because the benefits that might be most meaningful to patients (overall survival, symptom reduction, functional improvement, overall quality of life improvement) have not been clearly measured.

A Lack of Relevant Evidence

So the USPSTF guidelines, like other relevant guidelines, were based on the evidence that is available.  Since the evidence did not directly answer the most important questions, the guideline writers were left doing the best they could with evidence that only indirectly addressed the main issues.  No wonder they ended up unable to make a clear recommendation, and leaving the decisions to individual discussions, and individual discussions that would necessarily hinge on guesses about the unknown. 

One would think that a big point of discussion about breast cancer screening would be why after eight trials enrolling a total of about 350,000 patients reported over 20 years we still cannot answer the big clinical questions.  A related point for discussion in the US is why only one, and the earliest trial was conducted here.  If we here in the US think breast cancer screening is such a major concern (and we should think so), why have we been unable to mount a single important trial of it since the HIP trial conducted more than 30 years ago?

Instead, the rancorous debate in the US included...

Anecdotes, Some Irrelevant

The press found a number of women who said they would not be alive were it not for screening mammography before age 50.  With all due respect, one cannot tell whether an individual whose tumor was found on screening mammography would still have been diagnosed early enough for succesful treatment in the absence of screening mammography.  (And also with all due respect, we have no idea whether there also are cases of women who died as a result of treatments of tumors that never would have progressed, or cases of women who died of tumors caused by radiation from multiple mammograms.)  Reasoning from single cases when people, diseases, and treatment results vary so much is likely to mislead. 

It is somewhat ironic that some of the cases cited were of women who had breast cancer diagnosed before age 40, even though the debate was supposedly about screening from ages 40-49.  For example, in an inflammatory article that suggested that some "oncologists" might want the USPSTF sent to the prison at Guantanamo Bay, Washington Post editorialist Dana Milbank cited cancer activist Nancy Brinker, who mentioned her sister "whose breast cancer was found with a mammogram at age 37," (and apparently who tragically is no longer alive).(4) 

Going Well Beyond the Evidence

As noted above, no trial has shown that screening mammography for women under 50 increases overall longevity.  We all hope it does, but so far, there is no clear evidence that it does. 

Yet multiple media reports included assertions that screening mammography saves lives.   For example, the breast cancer activist mentioned above said, "mammography saves lives," apparently including mammography under age 50.(4)  An op-ed column by Dr Alan Kaye, chairman of radiology at Bridgeport Hospital, asserted "large, multinational research studies have shown that mammography saves lives in all age groups covered by the current guidelines."(5)  I would challenge him to show me a single such study that found a statistically significant increase in overall survival for patients under 50.  A Texas radiologist stated, "I diagnosed a 40-year old woman with breast cancer last week.  If she had waited 10 years, with pre-menopause breast cancer she would have been dead."(6)  Unfortunately, since she was just diagnosed, how can he be certain that she will survive any given amount of time?  How could he know that the cancer might not have become manifest, absent that single mammogram, later while still treatable? 

I do not want to be too hard on patients who do not appreciate that the outcomes of testing and treatment for breast cancer are not certain.  However, one would hope that physicians would be able to deal with this uncertainty.

Conflicted Opinions

Some of the more strident discourse came from those who may have had financial vested interests in promoting screening mammography.  Fugh-Berman and Bell pointed out numerous "fact-free emotionally charged statements" made by people who appeared to "reading from the same script-book."(7)  They identified that many of the loudest critics of the USPSTF guidelines were affiliated with not-for-profit organizations with impressive names, but also with substantial financial support from corporations that make products used in mammography.  Also, some had personal financial relationships with such corporations. 

An op-ed article by former US Food and Drug Agency (FDA) commissioner Dr Andrew von Eschenbach and Ms Nancy Desmond distorted the USPSTF guidelines to mean "most women should delay screening until they are 50," and claimed that was based on cost concerns, not clinical evidence.(8).  Desmond is the CEO of and von Eschenbach is now a senior advisor to the Center for Health Transformation.  The Center's members include numerous pharmaceutical and device manufacturing corporations, including several that make mammography equipment (e.g., GE Healthcare and Siemens).

Summary

Cancer, especially breast cancer, has major emotional connotations, and can be a difficult issue to deal with from many people.  The conflicting emotions cancer brings out in many patients may understandably affect their physicians, as well as friends and family.  Nonetheless, physicians, other health policy professionals, and health policy experts can serve patients better if they do not allow the patients' understandable affective responses cloud their understanding of the clinical and scientific issues. 

Yet the late 2009 debate in the US about screening mammography included many responses in which emotion seemed to overwhelm reason.  It may also be that some such responses came from people who had vested interests, or whose employers had vested interests that supported the emotional, rather than the reasoned approach.  Meanwhile, no one seemed to acknowledge that a big reason we are still debating this topic is that we have not made the effort or expended the resources to do good trials of sufficient size to answer the questions that need answering.  Of course, such trials might provide answers that would upset some people, or threaten others' incomes.  (As one news article pointed out, mammography is now a $5 billion a year industry in the US.)(6)

So my end of annus horribilis 2009 message on Health Care Renewal is to better serve our patients, from 2010 onward we health care professionals need  to try harder to put evidence and logic ahead of our own emotions, and certainly ahead of our financial self-interest.  

Note that numerous bloggers have taken on this topic, so see posts on Respectful Insolence, GoozNews,  Health Care Organizational Ethics, and the Evidence in Medicine blog.
References

1. US Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement.  Ann Intern Med 2009; 151: 716-726. [link here]
2. Nelson HD, Tyne K, Naik A et al. Screening for breast cancer: an update for the U.S. Preventive Services Task Force.   Ann Intern Med 2009; 151: 727-737.  [link here]
3. Partridge AH, Winer EP. On mammography - more agreement than disagreement.  N Engl J Med 2009; 361: 2499-2501. [link here]
4. Milbank D. Feeling farther from the finish.  Washington Post, Nov 24, 2009.  [link here] 
5. Kaye A. An alarming retreat on early detection.  Hartford Courant, Nov 25, 2009 [link here]
6.  Jacobson SJ. Dallas-area clinics ignore proposed rules, still push for mammograms. Dallas News, Nov 27, 2009.  [link here]
7. Fugh-Berman A, Bell A. Mammography and the corporate breast.  Bioethics Forum, Nov 24, 2009.  [link here]
8. von Eschenbach A, Desmond N. Government panels can't put price on human life. Associated Press, Nov 24, 2009.  [link here]

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The Interim Final Rule on Standards

Yesterday at 4:15pm, HHS/ONC released the Interim Final Rule (IFR) - Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology.

Pages 79-81 contain the content and vocabulary standards

Page 85 contains the privacy standards.

Let's examine the major recommendations.

The standards selected leverage the hard work done by HITSP, Consolidated Health Informatics, Federal Health Architecture, NCVHS, and government agency efforts . The IFR notes that unless marked with the following superscripts, all of the adopted standards are from the ONC process that took place prior to the enactment of the HITECH Act or are required by other HHS regulations.

A number sign �#� indicates that the HIT Standards Committee recommended this standard to the National Coordinator but it was not part of the prior ONC process.

An asterisk �*� indicates that the standard was neither recommended by the HIT Standards Committee nor part of the prior ONC process.

A plus sign �+� as mentioned above indicates a standard that is not a voluntary consensus standard.

The content and vocabulary standards selected includes Adopted Standard(s) to Support Meaningful Use Stage 1 (2011) and Candidate Standard(s) to Support Meaningful Use Stage 2 (2013).

1. Patient Summary Record

The adopted content standard is HL7 CDA R2 CCD Level 2 or ASTM CCR. The candidate content standard is the hope that this will be converged to a single standard based on HIT Standards Committee recommendations. As I said in my Genius of the AND blog, I truly believe that CCD and CCR is the most parsimonious set of content standards for the summary record in 2009. I'm hopeful that HL7 and ASTM will continue their work together, simplifying the XML of CCD so that CCD and CCR can converge into a single approach which makes implementation easier for all.

Of interest, page 66 of the IFR notes that CCR must be parsed by all EHRs even if CCD is used. Per the IFR - "A final example would be, if an eligible professional uses Certified EHR Technology that has implemented the continuity of care document (CCD) standard for the exchange of a patient summary record and receives a patient summary record formatted in the continuity of care record (CCR) standard, their Certified EHR Technology must be capable of interpreting the information within the CCR message and displaying it in human readable format. We do not expressly state how this should be accomplished or in what format human readable information should be displayed (e.g., information in a CCR message could be converted to a text file or PDF). We only require that Certified EHR Technology must be capable of performing this function. We believe this requirement is critical and have included it to allow flexibility in the marketplace during meaningful use Stage 1 and to prevent good faith efforts to exchange information from going to waste (i.e., information is exchanged, but is unreadable to both Certified EHR Technology (machine readable) and humans)."

The adopted vocabulary standards for problem lists are the applicable HIPAA code set required by law (i.e.,ICD-9-CM) or SNOMED CT. The candidate standards are the applicable HIPAA code set required by law (e.g.,ICD-10-CM) or SNOMED CT. My hope is that SNOMED CT adoption is accelerated and that ICD-10's role will be limited to a back office function. Widespread implementation of ICD-10 will be costly and brings little added value to clinicians, while SNOMED CT captures clinical observations very well, enabling decision support and better quality measurement.

The adopted vocabulary standards for medications are any code set from an RxNorm drug data source provider that is identified by the United States National Library of Medicine as being a complete data set integrated within RxNorm+ (note the + indicating RxNorm is not a consensus standard from an SDO, it's a product of the National Library of Medicine). For a complete list of the allowable vocabularies, see the NLM list which includes:

GS - 10/01/2009 (Gold Standard Alchemy); MDDB - 10/07/2009 (Master Drug Data Base. Medi-Span, a division of Wolters Kluwer Health); MMSL - 10/01/2009 (Multum MediSource Lexicon); MMX - 09/28/2009 (Micromedex DRUGDEX); MSH - 08/17/2009 (Medical Subject Headings (MeSH)); MTHFDA - 8/28/2009 (FDA National Drug Code Directory); MTHSPL - 10/28/2009 (FDA Structured Product Labels); NDDF - 10/02/2009 (First DataBank NDDF Plus Source Vocabulary); SNOMED CT - 07/31/2009 (SNOMED Clinical Terms (drug information) SNOMED International); VANDF - 10/07/2009 (Veterans Health Administration National Drug File). Also, FDA Unique Ingredient Identifiers (UNII) are a component of RxNorm.

The candidate vocabulary standard is RxNorm. I believe that the EHRs will continue to use proprietary standards internally for many years to come, but will need to map to RxNorm for all data exchanged.

The adopted vocabulary standard for allergies is not specified at this time i.e. free text or local vocabularies are fine. The candidate vocabulary standard is the Unique Ingredient Identifier (UNII). This makes great sense, since it will take vendors and self built system operators several years to implement controlled allergy vocabularies throughout their products.

The adopted vocabulary standards for procedures are the applicable HIPAA code set required by law (i.e.,ICD-9-CM) or CPT-4. The candidate standards are the applicable HIPAA code set required by law (e.g.,ICD-10-CM) or CPT-4. Of all the vocabulary standards mentioned in the Interim Final Rule, only one, CPT-4, requires payment for its use. I hope that HHS licenses CPT-4 for general use just as it has licensed SNOMED-CT. This will significantly reduce the implementation burden.

The adopted vocabulary standard for Vital signs is not specified at this time i.e. free text or local vocabularies are fine. The candidate vocabulary is a CDA template. This makes sense. I'm a fan of CDA templates to make CDA easier to implement.

The adopted vocabulary standard for units of measure is not specified at this time i.e. free text or local vocabularies are fine. The candidate vocabulary is UCUM. This is a very reasonable approach, giving commercial and hospital labs the time they need to implement a controlled unit of measure vocabulary standard.

2. Drug Formulary Check

The adopted content standard for Drug Formulary Check is the Applicable Part D standard required by law (i.e., NCPDP Formulary & Benefits Standard 1.0). The candidate vocabulary standard will also be whatever is required by Part D. This standard is widely deployed and there are no credible alternatives.

3. e-Prescribing

The adopted content standard for e-Prescribing is NCPDP script 8.1 or NCPDP script 10.6. The candidate standard is NCPDP Script 10.6. We debated this at the HIT Standards Committee, hoping that NCPDP 10.6 could be accelerated, but it is a reasonable compromise to offer some transition time.

The adopted vocabulary standards are the same as for the Patient Summary Record above.

4. Administrative Transactions

The adopted and candidate standards for Administrative Transactions are those required by HIPAA i.e. 4010 now and 5010 in 2013. This is expected.

5. Quality Reporting

The adopted content standard for quality reporting is the CMS PQRI 2008 Registry XML Specification#,+ (note that this means it was suggested by the HIT Standards Committee and not by HITSP, it's not an SDO product but was produced by CMS). The candidate standards are those to be suggested by the HIT Standards Committee. We debated this at the HIT Standards Committee because QRDA is an emerging standard for quality reporting but not a widely implemented one. This glide path is reasonable, but does require implementers to change course - implementing PQRI XML now and possibly QRDA or other standards later. It will be interesting to follow the comments on this one - maybe PQRI and QRDA should be allowed now to prevent this rework.

6. Submission of Lab Results to Public Health Agencies

The adopted content standard for lab reporting is HL7 2.5.1. The candidate standards are potential newer versions to be recommended by the HIT Standards Committee such as CDA documents. This is very reasonable given that all lab transactions in the country currently use HL7 2.x approaches.

The adopted vocabulary standard is LOINC when LOINC codes have been received from a laboratory. The candidate vocabulary standards are LOINC, UCUM, and SNOMED CT or Applicable Public Health Agency Requirements.

What does this mean? Per the IFR "We do not require Certified EHR Technology to be capable of mapping all laboratory orders or tests to LOINC codes. Rather, we require that Certified EHR Technology be capable of using LOINC codes that are received and retained to populate a patient summary record. Moreover, having LOINC codes used internally for meaningful use Stage 1 will prepare Certified EHR Technology for any future potential meaningful use Stage 2 requirements. We believe the use of LOINC, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT), and other vocabulary standards will accelerate the adoption and use of clinical decision support. Requiring LOINC as a vocabulary standard that Certified EHR Technology must have the capability to support for meaningful use Stage 1 provides an incremental approach to achieving these future goals." This is a very reasonable glide path to accelerating adoption of LOINC.

7. Submission to Public Health Agencies for Surveillance

The adopted content standards are HL7 2.3.1 or HL7 2.5.1. The candidate content standards are potentially newer version(s) or standards based on HIT Standards Committee Input, such as CDA documents. Of interest, Geocoded Interoperable Population Summary Exchange (GIPSE), a summary format for surveillance data submission, is listed as a vocabulary standard. I believe it should be moved to the candidate content standards area, as it is a great way to report summary surveillance data content.

The adopted vocabulary standard is listed as According to Applicable Public Health Agency Requirements. The candidate vocabulary standard is listed as GIPSE or According to Applicable Public Health Agency Requirements.

8. Submission to Immunization Registries

The adopted content standards are HL7 2.3.1 or HL7 2.5.1. The candidate content standards are potentially newer version(s) of standards based on HIT Standards Committee Recommendations such as CDA documents. The HIT Standards Committee discussed this, since HL7 2.3.1 is the currently accepted standard for immunization exchange, but HL7 2.5.1 is now ready. Allowing both for now makes sense.

The adopted vocabulary standard is CVX*,+, the CDC's National Center of Immunization and Respiratory Diseases (NCIRD) maintained HL7 code set. Note that this recommendation is marked as not made by either HITSP or the HIT Standards Committee, but actually it was made by both via the HITSP Interoperability Specification for Public Health Case Reporting

The Privacy and Security adopted standards represent the simplest set of technologies and policies that protect confidentiality and ensure data integrity. They are:

1. General Encryption and Decryption of Electronic Health Information - A symmetric 128 bit fixed-block cipher algorithm capable of using a 128, 192, or 256 bit encryption key must be used (e.g., FIPS 197 Advanced Encryption Standard, (AES), Nov 2001).+. This was recommended by the HIT Standards Committee.

2. Encryption and Decryption of Electronic Health Information for Exchange - An encrypted and integrity protected link must be implemented (e.g., TLS, IPv6, IPv4 with IPsec).+ This is a very reasonable recommendation that represents the best thinking of the HIT Standards Committee, HITSP and industry experts. We all recognize that TLS is great for point to point connections, while IPv6 and IPv4 with IPSec are better for organization to organization secure connections. It's a very wise approach.

3. Record Actions Related to Electronic Health Information (i.e., audit log) - The date, time, patient identification (name or number), and user identification (name or number) must be recorded when electronic health information is created, modified, deleted, or printed. An indication of which action(s) occurred must also be recorded (e.g., modification).+ Rather than require ATNA or CT profiles, this recommendation leaves the audit trail to policy - what data to record. This is a reasonable compromise distilled from many hours of expert testimony.

4. Verification that Electronic Health Information has not been Altered in Transit - A secure hashing algorithm must be used to verify that electronic health information has not been altered in transit. The secure hash algorithm used must be SHA- 1 or higher (e.g., Federal Information Processing Standards (FIPS) Publication (PUB) Secure Hash Standard (SHS) FIPS PUB 180-3).+ This was recommended by the HIT Standards Committee.

5. Cross-Enterprise Authentication - Use of a cross-enterprise secure transaction that contains sufficient identity information such that the receiver can make access control decisions and produce detailed and accurate security audit trails (e.g., IHE Cross Enterprise User Assertion (XUA) with SAML identity assertions).+ Just as with auditing, this is left to policy and does not require a single specific standard/profile such as XUA. The use of SAML approaches does make great sense and will be widely adopted in healthcare, since it is already widely used in other industries.

6. Record Treatment, Payment, and Health Care Operations Disclosures - The date, time, patient identification (name or number), user identification (name or number), and a description of the disclosure must be recorded.+ This too is left to policy, which is a great choice, since the industry has yet to figure out how disclosures will be tracked operationally.

These recommendations are consistent with the work of thousands of experts over the past decade. They do not include all the detailed recommendations from HITSP or implementation profile writers such as IHE but they do include all the highly mature constructs that are deployable in 2011 without over burdening the industry. From what I know about standards harmonization, the state of standards adoption, and the unresolved controversies/debates, the rule is the right mixture of harmonization and compromise. Not every stakeholder will be happy with it, but it is good enough. It moves us all forward toward the goal of less optionality, more constraints, and vocabulary controlled semantic interoperability.

Well done!

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My New Year's Resolutions

I've taken a few days off to travel to Southern California for a holiday family get together filled with seasonal celebration, great meals, a few hikes, and helping my parents around the house.

Now that it's New Year's Eve, it's time to reflect on the experiences of the previous 12 months and evaluate changes I can make in my priorities to improve my work, home, and personal lives. 2009 has been a year that required incredible energy just to keep pace with the changes in healthcare IT. Despite my best efforts in 2009, there are areas that need even more energy and focus in 2010.

1. Use all my skills to support EHR change management - it's very clear to me that many clinicians do not want an EHR. Meaningful use is an incentive, but many clinicians remain unconvinced that EHRs will save time, improve safety, and enhance their practices lives. They want to be implemented last in any rollout. Implementing hundreds of clinicians "last" is not doable. My role is to ensure every clinician associated with BIDMC understands the current federal, state, and local EHR activities, aligning incentives and building enthusiasm for EHRs, health information exchange, and quality registries. This means that I'll attend a lot of clinician group meetings and need to ramp up all forms of communication to share updates and experiences with the community.

2. Achieve breakthroughs in web communication tools - 2010 will be the year that we replace the BIDMC intranet, retiring the portal I personally wrote in 1997. 2010 will also be the year that Harvard Medical School moves its external web content to a content management system with distributed authorship. Both these efforts require careful alignment of stakeholders, constant vigilance to ensure alignment of functional requirements with technical capabilities, and active governance committees to serve as a guiding coalition for change. I never want to be so dogmatic that I become an impediment to innovation, so I'll embrace all the Web 2.0 concepts that both BIDMC and Harvard need to make our web sites - intranet and extranet - a very cutting edge experience.

3. Drive community interoperability efforts - The Federal and State environments in 2010 includes many catalysts - meaningful use/standards/certification regulations, ARRA funding (HIE grants, RHITEC grants, Beacon Communities grants, SHARP grants for research, training/education grants), a BIDMC/Boston Public Health Commission/NEHEN pilot to streamline disparities and surveillance reporting, a BIDMC/MAeHC/NEHEN pilot to accelerate community quality metric reporting and several efforts to support bidirectional EHR data exchange through NEHEN, locally implemented RESTful web services (more about these pilots on Monday), and most importantly evolving multi-stakeholder governance through the Eastern Massachusetts Healthcare Initiative, Massachusetts eHealth Institute and our Beacon Communities effort - Greater Boston Aligning Forces for Quality. Clearly 2010 is the year to push interoperability into every practice and hospital.

4. Support my family - Despite all the change around me, I also need to foster stability for those I support - my wife, daughter, and parents. My wife will be evolving her career from teaching to creating more art in her renovated studio and new gallery. My daughter will be applying to college. My parents will be enjoying their new, simpler house which is ideal for a retirement lifestyle. All these folks will need my heavy lifting, encouragement, and emotional support.

5. Renew myself - it's important that I maintain my relevance by adopting new technologies, embracing change, and innovating. Renewal can be technological, philosophical, or personal. The human mind gravitates to new ideas and novel approaches. I want to be at the center of change, inventing it or leading it if possible. I should never be considered a champion of the status quo or an impediment to innovation. How will I renew this year? You can be sure I'll adopt emerging interoperability technologies that accelerate adoption. I'll continue to pilot personal refinements as I've done in 2009 with riding a folding bicycle to all my Boston meetings while wearing experimental Kevlar clothing. I cannot precisely predict the changes of the next year, but when I see transformational possibilities, I will pursue them aggressively.

The common thread of all 5 resolutions is people - aligning incentives for clinicians, empowering staff with new web tools, gaining stakeholder support for interoperability, ensuring the success of my family, and refining my own approach to life. If I can successfully maintain a focus on the people and treat the bits and bytes as secondary, 2010 will be a great year.

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Food Allergy Issues One of Top Restaurant Trends in 2010

The National Restaurant Association lists gluten-free and food allergy-conscious meals within their top ten list of trends for 2010.

Wouldn't it be wonderful to walk into a restaurant and ask to see the dairy, egg and nut-free menu? Then wouldn't it be even more wonderful to know that whatever is ordered will be prepared by a specially trained staff to avoid cross-contamination and accidental allergens?

This is a trend that I hope sticks and spreads.

Here's the complete list of restaurant trends.

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Petersburg Health Clinic

The Petersburg Health Care Alliance Clinic provides a wide range of medical services. It accepts Medicare and Medicaid, along with most major private health insurance plans. It also provides services on a sliding scale (depending on your income).

The clinic is located at 541 S. Sycamore St., and is open Monday -Friday. 8:15am to 5:00pm.

Visit their website by clicking here, or call (804) 957-9601

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On Automobile, and Health Care Companies Run by Finance People

The New Republic published "Upper Mismanagement" about what happens when businesses are run by people who do not understand their companies' businesses.  Although the article was focused on the decline of manufacturing in the US, its applicability to health care is obvious:

Harvard business professor Rakesh Khurana, with whom I discussed these questions at length, observes that most of GM�s top executives in recent decades hailed from a finance rather than an operations background. (Outgoing GM CEO Fritz Henderson and his failed predecessor, Rick Wagoner, both worked their way up from the company�s vaunted Treasurer�s office.) But these executives were frequently numb to the sorts of innovations that enable high-quality production at low cost. As Khurana quips, �That�s how you end up with GM rather than Toyota.�

How did we get to this point? In some sense, it�s the result of broad historical and economic forces. Up until World War I, the archetypal manufacturing CEO was production oriented�usually an engineer or inventor of some kind. Even as late as the 1930s, business school curriculums focused mostly on production. Khurana notes that many schools during this era had mini-factories on campus to train future managers.

After World War II, large corporations went on acquisition binges and turned themselves into massive conglomerates. In their landmark Harvard Business Review article from 1980, 'Managing Our Way to Economic Decline,' Robert Hayes and William Abernathy pointed out that the conglomerate structure forced managers to think of their firms as a collection of financial assets, where the goal was to allocate capital efficiently, rather than as makers of specific products, where the goal was to maximize quality and long-term* market share.

By the 1980s, the conglomerate boom was reversing itself. Investors began seizing control of overgrown public companies and breaking them up. But this task was, if anything, even more dependent on fluency in financial abstractions. The leveraged-buyout boom produced a whole generation of finance tycoons�the Michael Milkens of the world�whose ability to value corporate assets was far more important than their ability to run them.

The new managerial class tended to neglect process innovation because it was hard to justify in a quarterly earnings report, where metrics like �return on investment� reigned supreme. 'In an era of management by the numbers, many American managers � are reluctant to invest heavily in the development of new manufacturing processes,' Hayes and Abernathy wrote. 'Many of them have effectively forsworn long-term technological superiority as a competitive weapon.' By contrast, European and Japanese manufacturers, who lived and died on the strength of their exports, innovated relentlessly

Furthermore,

The business schools had their own incentives to channel students into high-paying fields like finance, thanks to the rising importance of school rankings, which heavily weighted starting salaries. The career offices at places like Harvard, Stanford, and Chicago institutionalized the process�for example, by making it easier for Wall Street outfits and consulting firms to recruit on campus. A recent Harvard Business School case study about General Electric shows that the company had so much trouble competing for MBAs that it decided to woo top graduates from non-elite schools rather than settle for elite-school graduates in the bottom half or bottom quarter of their classes.

No surprise then that, over time, the faculty and curriculum at the Harvards and Stanfords of the world began to evolve. 'If you look at the distribution of faculty at leading business schools,' says Khurana, '�they�re mostly in finance. � Business schools are responsive to changes in the external environment.' Which meant that, even if a student aspired to become a top operations man (or woman) at a big industrial company, the infrastructure to teach him didn�t really exist.

If business schools did little to teach about manufacturing, they did almost nothing to teach about health care. But at the same time the finance people were taking over manufacturing, health care organizations were pushed to turn over their leadership to business people to improve efficiency and break the physician's "guild." Would there be any reason to expect that a finance background would be better preparation to run a health care corporation than to run an automobile company?

For the latest thought- and wince-provoking example of how leaders of health care corporations seem to know almost nothing about the actual health care their companies provide, see a DailyFinance interview with Mr Kent Thiry, CEO of DaVita, a for-profit corporate provider of dialysis services. According to the company web-site, "prior to working for Vivra, Mr. Thiry was a partner at Bain & Company, an International management consulting company. He earned his BA degree, with distinction and Phi Beta Kappa, in Political Science from Stanford University in 1978, and his MBA, with honors from Harvard Business School in 1983"  So he got his MBA from an elite US business school at the time in which finance was becoming dominant as described above. 

Asked to explain his business model, Mr Thiry responded:

Most of us have a couple of kidneys. These kidneys are amazing organs -- some of the most complex, sophisticated organs in the human body, which is why they've been so difficult to replicate compared to other organs like the heart and lung and others. And when the kidney fails, you need to go on dialysis, unless you're one of the fortunate few to get a transplant. And we operate the centers that people come to if their kidney fails and they can't get a transplant.

And what we do in our centers is take care of these people typically three times a week -- four hours each time -- where we take their blood out of their body, clean out all the toxins that they would normally clean out themselves through the act of urinating. But you don't do that anymore once you've lost your kidney function. And we take that part out, take the toxins out and then put the blood back in with some other nutrients.

To be charitable, I do not think that would merit a "C" on a high school biology test. [Medical science cannot "replicate" hearts or lungs. Kidney function is not the same thing as "urinating." The functions of the kidney are far more complex than "cleaning out toxins."]

Does it make any sense to put someone who obviously understands so little about kidneys in charge of a kidney dialysis company?  (On the other hand, see this post on accusations that DaVita's ruthless business practices treat patients like "dialysis dollars.")

So, if putting finance people in charge of automobile companies turned out to be a recipe for bankruptcy, why should we expect from putting finance people in charge of dialysis companies, or hospitals, or drug, biotechnology or medical device companies, or health care insurance companies, or health care information technology companies?

The CEOs of big health care organizations, most of whom have business, not health care backgrounds, have mainly been good at paying themselves and their cronies well. (For example, according to the 2009 DaVita proxy statement, in 2008, Mr Thiry owned over 2 million shares of stock, 1.9% of all shares outstanding, and received more than $11 million in total compensation.  Clearly, he was not paid according to his knowledge of kidney biology.)  Meanwhile, health care costs rise, access falls, and quality degrades.

If we really want to reform health care, maybe we should take a lesson from Toyota. Put the car guys and gals in charge of car companies. And put the health care guys and gals in charge of health care.

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The $20 Million Dollar Journal Editor

Last week, the Milwaukee Journal-Sentinel reported on a royally paid journal editor:

In 2002, Thomas Zdeblick, a University of Wisconsin orthopedic surgeon who has pocketed millions of dollars in royalties from the spinal device maker Medtronic, took over as editor-in-chief of a medical journal about spinal disorders.

It would be the beginning of a beautiful friendship.

In the years to come, Zdeblick would receive more than $20 million in patent royalties from Medtronic for spinal implants sold by the company. And the medical journal he edited would become a conduit for positive research articles involving Medtronic spinal products, a Journal Sentinel analysis found.

Zdeblick took over editorship of the Journal of Spinal Disorders & Techniques seven years ago. Since then, studies involving Medtronic spinal products or that were funded by Medtronic appeared in the journal at least once per issue, on average.

Dozens of studies that mentioned Medtronic products have been published while Zdeblick has been editor. But in issue after issue, readers of the journal were not told that he was receiving millions of dollars in royalty payments from Medtronic at the same time.

Most of the time the articles, including some co-authored by Zdeblick himself about devices for which he gets royalties, had good things to say about the Medtronic products. Only on a small number of occasions did the articles find major problems with Medtronic devices.

And often the articles did not disclose financial ties the authors had to Medtronic.

Here are some specifics:

From 2003 through 2007, Zdeblick got more than $19 million in royalty payments for spinal devices from Medtronic, according to a January 2009 letter by U.S. Sen. Charles Grassley (R-Iowa), who has been investigating payments to orthopedic surgeons by Medtronic. In 2008, Zdeblick got another $2 million from Medtronic from royalties and working as a consultant, according to UW records.

To assess the relationship, the Journal Sentinel reviewed every article published in the journal since Zdeblick became editor.

The journal is published seven or eight times a year and typically has a dozen or so articles. The articles were searched to see if Medtronic products were used as a part of the study or if the study was funded by Medtronic.

At least 70 such articles were found in 56 issues of the journal from 2002 through October 2009.

� A 2005 study by researchers in France found favorable preliminary results with Medtronic's Maverick artificial disc.

In 2007, Medtronic paid Zdeblick $144,000 in royalties for the Maverick disc, according to Grassley's letter.

� In August 2009, Zdeblick co-authored a study that involved Medtronic's Premier Anterior Cervical Plate as well as the plate of another company, Synthes. The study involved using two different kinds of bone grafts with the plates. Zdeblick got $654,000 in Premier royalties from Medtronic in 2007.

� Zdeblick also co-authored three articles, in 2002, 2003 and 2005, involving Medtronic's BMP-2 and the LT-Cage, a device that paid him $1.4 million in royalties in 2007. None of those studies disclosed that he received millions of dollars in royalties from Medtronic.

Often articles in the journal had good things to say about Medtronic products:

� In the 2002 study, Zdeblick and the co-authors concluded that BMP-2 and the LT-Cage led to a solid union and high fusion rates. In the 2003 study they found that BMP-2 may become 'the new gold standard.'

� In a 2006 study, a different group of authors concluded that BMP-2 when used with a hip bone graft significantly improved the success of the fusion surgery with minimal risk to the patient. The 2005 French study of Medtronic's Maverick artificial disc that did not involve Zdeblick concluded it was a 'promising therapeutic technique.'

Dr Zdelblick declined to comment for the Journal-Sentinel, but:

In a statement, a spokesman for the spinal journal said Zdeblick has disclosed his financial relationship with Medtronic to the company that publishes the journal, Wolters Kluwer Health/Lippincott Williams & Wilkins.

All manuscripts submitted to the journal go through a rigorous review process using reviewers who have an objective viewpoint, Robert Dekker, director of communications with Philadelphia-based Wolters Kluwer Health & Pharma Solutions, said in a statement. 'Thanks to our strict peer review policies and processes, we have no concerns about the existence of this relationship,' Dekker said in an e-mail.

Dekker declined to provide a list of the reviewers used by the journal or information about their financial relationships with device companies. He also declined to comment on how Zdeblick made decisions about manuscripts and reviewers.

Of course, as the Journal-Sentinel pointed out, editors can make publication decisions independent of the recommendations of peer-reviewers. They also are free to select peer-reviewers who might have a particular viewpoint about a manuscript, its topic or authors, and to make and enforce editorial suggestions for changes in manuscripts.  It is beyond me what good that disclosure of conflicts of interest to a for-profit publishing corporation does in the absence of further disclosure.  Keep in mind also that the division of Wolters Kluwer that publishes the journals, Wolters Kluwer Health & Pharma Solutions, not only publishes journals and textbooks, but "provides marketing and publications services, business intelligence products, and advanced analytical tools and services" to pharmaceutical corporations.

Furthermore,

'It's absolutely a conflict,' said Richard Smith, the former editor of the British Medical Journal.

At a minimum, Zdeblick's conflict should be fully disclosed by his journal whenever a study involving a Medtronic product is published, said Smith, the author of 'The Trouble with Medical Journals.'

However, because he makes so much money from Medtronic royalties, he really should not be editing the journal at all, Smith said.

Just to add icing to the cake, Prof Margaret Soltan pointed out on her University Diaries blog that Dr Zdeblick is not only a journal editor, but a Professor and Chairman of Orthopedics and Rehabilitation at the University of Wisconsin.  In addition, his web-page at the University notes that he is on the editorial board of another orthopedics journal, Spine, also published by Wolters Kluwer Health. 

So here we go again.  How should we assess the objectivity of an ostensibly scholarly medical journal whose editor was made rich by royalties from a company whose devices were often evaluated in the articles published in the journal?  How should we assess the honesty of a journal editor who received millions in royalties from Medtronic, but who only deigned to disclose as an author in his own journal, "One or more of the author(s) has/have received or will receive benefits, (e.g., royalties, stocks, stock options, decision making position) for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript." (as in Zdelblick TA, Phillips FM. Interbody cage devices.  Spine 2003; 28: S2-S7.)  (Note that this sort of disclosure seems to be standard operating procedure for orthopedic surgeons who make millions from royalties and consulting fees, e.g. see this post.)

Prof Zdelblick had numerous opportunities to influence his colleagues, trainees, and students in his roles as journal editor, journal editorial board member, author of scholarly articles, and professor and chair of orthopedics.  At the very least, the people who read his journal or his articles, listened to his lectures, or participated in his clinical teaching should have at least had the opportunity to judge for themselves whether being paid over $20 million might have just biased what he wrote and said a tiny bit.  But can anyone doubt that $20 million dollars would profoundly influence one's thinking?  Can anyone doubt that an inventor who got rich from royalties might not be more enthused about the use of the devicesthat generated the royalties than would an academic whose salary is unrelated to the use of any device?   It seems to be an abuse of entrusted power for a journal editor, professor, and department chairman not to clearly disclose such huge conflicts of interests to readers, learners and colleagues.

This is just the latest vivid example of the conflicts of interest that permeate health care.  When multi-million dollar men pretend to be unbiased editors and professors, is it any wonder that we regularly overuse and overvalue the devices and drugs that they are selling?

ADDENDUM (6 January, 2010) - See also comments on the Spine Blogger, and by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

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Finnish EHR's Clumsy, Mission Hostile, Consume Doctors' Precious Time

It seems common wisdom in the U.S. that the "Europeans are way ahead of us" in computerized medicine.

Perhaps the common wisdom is not so wise. This from Finland:

HELSINGIN SANOMAT
INTERNATIONAL EDITION - HOME

Clumsy computer systems consume doctors� time

When Arto Virtanen, a doctor at a public health clinic, wants to access the information of a young patient, 12 windows of different sizes open up on different parts of his computer screen. Virtanen has to deal with each of them every time a patient visits him for routine postnatal care.

�It used to be that a municipal doctor would see six or seven patients in an hour, when documentation was not at its present level�, Virtanen says. �Then there came more paperwork, and four patients were seen in an hour. Now if a doctor wants to read all the information about a patient in the information system, there would only be time for consultations with, say, two patients in an hour.�

Clumsy computer systems are already seen as a danger to patient security, says Tiina L��veri, a member of the board of the Finnish Medical Association, who has acquainted herself with the various systems.

Clumsy retrieval of data is one source of danger. Important information can disappear into the nooks and crannies of the software.

�There can be 100 pages of text without any summary, out of which a doctor should find information in a couple of minutes."

In hospitals, the systems do not separately tell nurses about changed dosages of medicines.

�The information is there, mixed in the mass of all of the rest of it, where it gets lost.�

In addition to causing outright dangers, computer systems waste precious working hours. In addition to actual medical data, the computer requires the recording of various items of statistical information.

Patients can see the problem as well. Up to 43 per cent of time reserved for a patient with an appointment to see a public health doctor can be spent dealing with a computer, according to a study published earlier this year in L��k�rilehti, the publication of the Finnish Medical Assotiation.

A national health archive now under development would not help things, as data would still be handled with existing software.

�Software companies have started to become interested in listening to users only in recent years�, L��veri says.

Virtanen in Rajam�ki would like to see more compatibility between systems. �There could be a common database, which should be easily accessible by a network browser�, Virtanen says.

�It might also be constructed according to what this working process really is.� [You don't say? - ed.]

Can health IT be any more mission hostile than this? (Unfortunately, the answer to what started as a rhetorical question is probably "yes." See this post on the US military's EHR AHLTA, and see my eight part series "Are Health IT Designers, Testers and Purchasers Trying to Harm Patients?" on mission hostile commercial HIT starting here.)

Reports of difficulty in EHR Utopia have leaked out of other European countries such as the Netherlands and Germany, not to mention the UK.

The most startling observation is that �software companies have started to become interested in listening to users only in recent years."

What manner of cavalier simpletons and opportunists populate such health IT companies?

-- SS

Addendum:

It appears AHLTA may be a bad as it is due in part to "politics as usual" a.k.a. corruption. See "Company won earmarked funds for work on military health records." If such conduct has been commonplace during AHLTA'a tortured history, it could explain just how AHLTA became as terrible as the senior military officials describe it in the linked article above.

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Are Dissmissive Industry and Government Reactions to Physician Concerns about EHR's and other Clinical IT Simply Perverse?

Yes, they are.

At the Nov. 10, 2009 essay "Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development" and preceding essays linked to it, I wrote about an Australian informatics professor's travails in writing about ED EHR's.

He wrote a mixed-method essay about the mission hostile user experiences ED physicians in NSW reported about the EHR's they were being compelled to use, in addition to similar negative commentary from ED physician experts in other lands. The latest version of the paper "A Critical Essay on the Deployment of an ED Clinical Information System - Systemic Failure or Bad Luck" is here (PDF) or accessible from his department's webpage here.

The government attempted to censor the paper and likely censure the author, and I speculate the HIT industry was not far behind.

Below is an example from my own city on why I found the reactions to the evolving ED EHR paper - reactions that "blamed the doctors" or dismissed what appear to be frequently encountered ED physician concerns - perverse.

I use the term "perverse" in the most formal sense of the word:

Merriam-Webster dictionary:

Perverse (adj).
Etymology: Middle English, from Anglo-French purvers, pervers, from Latin perversus, from past participle of pervertere
Date: 14th century

1 a : turned away from what is right or good : corrupt b : improper, incorrect c : contrary to the evidence or the direction of the judge on a point of law
2 a : obstinate in opposing what is right, reasonable, or accepted : wrongheaded b : arising from or indicative of stubbornness or obstinacy
3 : marked by peevishness or petulance : cranky
4 : marked by perversion : perverted

The very, very last thing patients need is to have ED clinicians slowed down.

Concerns expressed by even a minority of ED physicians that EHR's slow them down or reduce their effectiveness ought to set off alarm bells and rigorous government investigations of the kind that would arise if airline pilots started to complain about lax security allowing passengers on board with bombs:

Dec 24, 2009
Philadelphia Inquirer

Philadelphia ERs seek solutions to crowding

By Marie McCullough

Inquirer Staff Writer

Two of the region's leading medical centers have racked up the city's highest number of "diversions" - periods when ambulances are advised to steer clear because the emergency room is so full.

The Hospital of the University of Pennsylvania and Thomas Jefferson University Hospital are working to reduce such diversions as the number of emergency rooms in the city has continued to fall. This year, Penn has reduced the disruptions by 22 percent and Jefferson by 28 percent.

As they seek solutions, the hospitals are examining their own practices, reflecting a national shift in efforts to address the perennial crisis of ER overcrowding.

Consider Jefferson. This year it reduced diversion hours even though the number of ER patients, the severity of their medical needs, and staffing stayed about the same. Jefferson relieved overcrowding by finding ways to move patients in and out of the ER - and the whole hospital - faster.

"That's where I'm focused, on improving efficiencies," said Rex Mathew, hired by Jefferson two years ago for the new job of vice president of emergency medicine clinical operations.

This is not to suggest that the nation's emergency medical-care system has been slacking. From 1992 to 2002, the number of annual emergency-room visits increased 23 percent, while the number of ERs decreased 15 percent, studies show.

In the Philadelphia region, the contraction has been more dramatic - from 62 ERs in 1993 to 38 now, a 39 percent decrease. The most recent loss was this year's closing of Northeastern Hospital, which had 45,000 emergency visits annually. The impact has been felt at Aria Health-Frankford Campus, where Joaquin Rivera died in the ER while waiting for care on Nov. 28.

While there is no evidence that overcrowding played a role in his death, Frankford had nearly as many diversions in November - 121 hours - as all of last year.

Emergency departments are beset by growing numbers of the uninsured, the chronically ill, and the aged.

Nonetheless, experts say it's time for hospitals to stop blaming ER overcrowding on economic, social, and demographic factors that are beyond their control, and start looking inward. A recent Government Accountability Office report found that even in life-and-death cases, large percentages of ER patients do not see doctors within recommended times.

"Many hospitals have done little to address the patient-flow obstacles that lead to overcrowded" emergency rooms, says a report by Urgent Matters, an ER improvement initiative funded by the Robert Wood Johnson Foundation.

Jefferson and Hahnemann University Hospital are among six U.S. hospitals using grants from Urgent Matters to develop practical strategies for reducing ER crowding. These will be shared nationally through newsletters, the Web, and conferences.

... Most fixes, however, are neither easy nor obvious. Sick patients may lie on gurneys for hours in ERs, uncomfortable and taking up precious space, while they wait for a hospital bed to become available.

... "The problem is not just physical space but effective space," said Robert McNamara, chair of emergency medicine at Temple University Hospital. "With hospital margins tight, there may be beds, but no staff to cover them. And hospitals try to keep staffing tight to keep costs down."

Temple has the city's busiest ER, with 74,000 adult and 20,000 pediatric patients this year - 24 percent of whom were admitted to the hospital, McNamara said. Anticipating a surge in demand following Northeastern's closure, Temple added ER staff and made a concerted effort to speed up testing and discharge procedures, he said.

This year, through November, Temple had 118 hours when ambulances were diverted.

The Hospital of the University of Pennsylvania, with about 60,000 ER patients and a 26 percent admission rate, was by far the city's leading diverter - more than 1,000 hours through November.

... the crowding conundrum continues to evolve. One question is whether health-care reform - which now seems imminent - may increase ER volume rather than reducing it, as millions more Americans become insured.

The situation is actually even worse.

A patient recently died of a heart attack, sitting in the waiting room of a hospital where I once rotated during my internship, Frankford Hospital. He was not found until others in the waiting room stole the dead patient-in-waiting's wristwatch. The man sat unresponsive for nearly an hour in the waiting area of Aria Health Frankford Hospital before a visitor notified security and a doctor arrived.

Dec. 1, 2009

Philadelphia Inquirer

Waiting to be seen at hospital, dying Joaquin Rivera was robbed, police say

... According to Philadelphia police, Rivera walked into Aria Health's Frankford Campus, on Frankford Avenue near Harrison Street, about 10:45 p.m. Saturday.

He was alone, and apparently had walked from his nearby home on Duffield Street near Foulkrod, his son said.

Rivera complained of feeling pain in his left arm and abdomen, and was told to sit in the waiting area, said police spokesman Lt. Frank Vanore. [A middle aged man with left arm and abdominal pain told to 'sit in the waiting room?' One wonders who would qualify for sitting under medical observation - ed.]

At some point during the next hour, Rivera, a longtime bilingual counselor at Olney High School, lost consciousness. He inadvertently became a target, Vanore said, to three other people in the waiting room...

[One of the other people] signed up to be seen by a doctor, while his two cohorts sat near Rivera. "At some point, [one of the people] is observed taking the victim's watch and passing it to the other man," Vanore said.

When a witness ran to notify a security guard of the crime and Rivera's condition, the limping man and his female partner fled, Vanore said. Hospital personnel rushed to Rivera's aid, but it was too late.

He was pronounced dead shortly after midnight Sunday. Vanore said police have not yet learned of Rivera's cause of death.

The family said he was believed to have died of a heart attack.

I reiterate, the very last thing in the world ER clinicians need are ill-conceived and ill-implemented electronic health records systems that slow them down.

Instead of attempted censorship and spin control, such concerns should be addressed throughly, impartially and promptly if not immediately.

What could one call the arrogance or devil-may-care mindset in the government and health IT industry that dismisses such concerns so cavalierly, other than "perverse?"

-- SS

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Food Allergy Reactions

Do you carry more than one dose of epinephrine in the event of an allergic reaction?

A recent study shows certain risk factors associated with the need for more than one dose. One surprise...a history of asthma does not appear to be one of those risk factors.

People requiring more than one dose tend to be younger and tend to present with wheezing, cyanosis (bluish/purplish tinge to the skin), arrhythmias (abnormal heart rhythms), nausea, vomiting and shock. Those who present with hives are less likely to require a second dose.

Check out the full abstract and think about whether more than one dose of epinephrine is right for you or your child.

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Food Allergy Assistant Wishes Everyone a Merry Christmas!

Photo Credit

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Measuring Happiness

It's Christmas Eve and I've put the Blackberry to bed, stopped the strategic planning, and set aside the work of worry.

My daughter does not want to discuss upcoming college tours or the cube root of 127. Instead, we're discussing our personal definitions of happiness.

For my daughter, it's the little things that make her happy. The smiles from her friends, the smell of soy hot chocolate, and the idea of sleeping for 12 hours without homework to do.

For me, I measure happiness by looking at my reflection in the people around me. Have my parents had a good year because of something I've done? Has my wife been empowered to pursue her dreams? Has my daughter gained more self confidence? Do my staff feel good about our trajectory and the stability of their work environment? Do my colleagues feel that I'm a convener who can be trusted to bring people together seeking the greatest good for the greatest number?

Measuring happiness through the eyes of others is imperfect - you cannot make everyone happy. However, you can treat them fairly, positively, and with respect, even if they are naysayers. My metric is to simply ask if I've done my best.

As I sit with my family, a snow covered wreath hanging on my front door (the photo above), the smell of chestnuts drafting through the house, sipping a cup of Graham's 1985 Port and watching The Polar Express, I have a sense that my wife, daughter, parents, friends, staff, and colleagues are achieving their own happiness. I'm at peace with the world and thankful for the year that's passed, happy by all measure.

Happiness to you and to all a good night.

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Merry Christmas, ER & cocci reactivation scares

Merry Christmas! As you can see from this year's Christmas picture, Denise looks healthy and Jacob wins the prize for best expression. We're grateful for another year that Denise has been able to continue on the long road to recovery and I can't help but reflect on this picture from 2005 when she wasn't doing so well.
We had a couple points of anxiety since the last post.

During a summer vacation trip we had a scare that resulted in a trip to ER, but all turned out well. Denise was swimming and doing somersaults in the pool with the kids. After getting out, she suddenly complained of severe chest/ab pain, numbness in hands, shortness of breath, and she had a weak pulse & looked very pale. We went to the ER at Palomar hospital in Escondido where they said she had low blood pressure and was dehydrated. At the end of it all, they figured that she had been dehydrated (& hadn't noticed since the weather was so nice and we were in the pool), and perhaps her hernia had become aggravated by the swimming, causing her to hyperventilate while dealing with the pain (causing numbness).

Then more recently (November) we were greatly alarmed when Denise's regular testing for cocci showed that the disease had reactivated. Fortunately a second set of tests showed no cocci. This was corroborated by other test & scans (bone scan, MRI, CT, spinal tap, liver tests). We are encouraged because it seems that Denise's immune system is able to fight off a mild recurrence of the cocci without having to increase her medication. The infectious disease doctor said that much like a person that has had chicken pox will always have the antibodies in their system and could test positive for chicken pox without actually being ill, Denise may test positive for cocci from time to time since the test looks for cocci antibodies. As long as the titers are low, we probably don't have any reason to be alarmed. Nice to hear, but I admit I still get a little nervous thinking about it.

A bittersweet event for Denise came in the form of a job offer. Some parents from my school run a prosthetic business (Aesthetic Prosthetics in Pasadena CA) and needed an artist to paint the products. They picked Denise and started training her for the job. Ultimately she decided to quit. She just didn't have the energy and was getting very fatigued, and she didn't feel that her vision was up to what it should be. She was sad to leave, as she really loved the family that runs the business, the other employees, the work environment, the paychecks, and it seemed like a small miracle to be offered a job in this economy in the first place. At the end of it all, though, it made her feel good that they thought she was talented enough to get a shot at the job. She has expressed frustration with her lack of energy & abilities since her illness, and felt like a bad mom & wife for not being able to help as much as she'd like with the kids, or work to contribute more income to our family (as if that's been a concern after almost losing her). The opportunity to work made her realize just how nice it is for our family to have her alive, and even thriving enough to participate in running the home front.

As we celebrate Christmas and prepare for a new year we hope that you likewise take the time to be thankful for your own life and for the family and friends that make your life enjoyable.

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Boston Scientific (Again) Settles - This Time, Charges of Kickbacks Disguised as Clinical Studies

One would think that the stories about bad behavior by health care organizations would quiet down just before Christmas, but no...

As reported by the AP:

U.S. attorneys in Boston said Wednesday heart device maker Boston Scientific will pay $22 million to resolve allegations its Guidant division paid kickbacks to doctors to get them to use its heart devices.

The U.S. Department of Justice said Guidant paid physicians $1,000 to $1,500 each in 2003 and 2004 to participate in four studies, called RaCE, RaCE II, RaCE III, and MERITS. It said the studies were designed to increase sales of pacemakers and defibrillators.

Federal officials said the company targeted doctors who favored products made by other companies, hoping the payments would induce them to use Guidant devices more often. They said Guidant submitted claims for payment on the devices to Medicare.

Boston Scientific did not admit wrongdoing as part of the civil settlement. Under the agreement, its cardiac rhythm management division will have to publicly disclose payments to physicians on a Web site. Boston Scientific also entered into a corporate integrity agreement.

So here we have an example of a "seeding study," that is, a marketing effort to persuade physicians to prescribe a product disguised as a clinical research study, but for medical devices, not drugs.  Seeding studies seem to combine multiple kinds of unethical behavior, deceptive marketing and manipulated research.  There had been some question in the past whether seeding studies exist, but this is the second recent example to come to light, suggesting that not only do they exist, but that they are used by device as well as pharmaceutical companies.

Note that, as Bloomberg reports, this is the third major settlement of allegations of bad behavior made by Boston Scientific,

The company agreed last month to pay $296 million to settle a Justice Department probe into Guidant�s handling of heart devices and restated third-quarter results. [See post here.] In 2007, Boston Scientific agreed to pay $240 million to settle more than 8,000 lawsuits claiming Guidant hid defects in defibrillators, which are devices that shock the heart back into regular rhythm.

Cataloging legal settlements seems to be a useful way to assess the sorts of bad behavior manifested by large health care organizations (see some posts here). However, as we have said frequently, such settlements, including the "corporate integrity agreements" now frequently attached to them, seem to have done little to deter bad behavior.  Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts will suffer any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior.

I submit that would-be health care reformers who want to improve care, reduce costs and improve access should advocate for real negative consequences for people who implement, direct or approve the various versions of fraud, kickbacks, and miscellaneous corruption and malfeasance we have discussed on Health Care Renewal.

By the way, the board of directors of Boston Scientific includes two noted academics with leadership roles in academic health care.  Marye Anne Fox is the Chancellor of the University of California - San Diego, and hence the leader of a major medical school and academic medical center.  The university's mission statement, alongside which sits her picture, proclaims it "strives to maintain a climate of fairness, cooperation, and professionalism." Uwe Reinhardt, Professor at Princeton, is a noted health care economist, and blogger on the Economix blog for the New York Times.  Perhaps such august academic personages could tell  us how they are assuring that the company they are paid well to oversee upholds, rather than undermines professionalism and fairness.

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ONC Defines a Taxonomy of Robust Healthcare IT Leadership

As in my post "More On Healthcare Management By Domain Neutral Generalists", Roy Poses' post "Health Care Leaders: Don't Know Much About Health Care" and many others on the topic of ill informed healthcare management (query link) at Healthcare Renewal, a common theme is lack of appropriate education and background in many of today's healthcare leaders.

ONC, the Office of the National Coordinator of health IT at HHS, has apparently now defined a taxonomy of health IT leadership in their funding opportunity announcements (FOA's).

Note the formal educational recommendations I've highlighted. Seems they�ve heard the message about the importance of cross-disciplinary -- and formal -- education for health IT leaders and even lower level workers:

From the Founding Opportunity Announcement "Program of Assistance for University-Based Training" at http://healthit.hhs.gov/portal/server.pt?open=512&objID=1428&mode=2

... Targeted Information Technology Professionals in Healthcare Roles

The six types of roles targeted by this FOA are:

(i) Clinician/Public Health Leader: By combining formal clinical or public health training with training in health IT, individuals in this role will be able to lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States. In the health care provider settings, this role may be currently expressed through job titles such as Chief Medical Information Officer (CMIO), Chief Nursing Informatics Officer (CNIO). In public health agencies, this role may be currently expressed through job titles such as Chief Information or Chief Informatics Officer. Training appropriate to this role will require at least one year of study leading to a university-issued certificate or master�s degree in health informatics or health IT, as a complement to the individual�s prior clinical or public health academic training. For this role, the entering trainees may be physicians or other clinical professionals (e.g. advanced-practice nurses, physician assistants) or hold a master�s or doctoral degree(s) in public health or related health field. Individuals could also enter this training while enrolled in programs leading directly to degrees qualifying them to practice as physicians or other clinical professionals, or to master�s or doctoral degrees in public health or related fields (such as epidemiology). Thus, individuals could be supported for training if they already hold or if they are currently enrolled in courses of study leading to physician, other clinical professional, or public-health professional degrees.

(ii) Health Information Management and Exchange Specialist: Individuals in these roles support the collection, management, retrieval, exchange, and/or analysis of information in electronic form, in health care and public health organizations. We anticipate that graduates of this training would typically not enter directly into leadership or management roles. We would expect that training appropriate to this role would require specialization within baccalaureate-level studies or a certificate of advanced studies or post-baccalaureate-level training in Health Information Management, health informatics, or related fields, leading to a university-issued certificate or master�s degree.

(iii) Health Information Privacy and Security Specialist: Maintaining trust by ensuring the privacy and security of health information is an essential component of any successful health IT deployment. Individuals in this role would be qualified to serve as institutional/organizational information privacy or security officers. We anticipate that training appropriate to this role would require specialization within baccalaureate-level studies or a certificate of advanced studies or post-baccalaureate-level training in health information management, health informatics, or related fields, leading to a university-issued certificate or master�s degree.

(iv) Research and Development Scientist: These individuals will support efforts to create innovative models and solutions that advance the capabilities of health IT, and conduct studies on the effectiveness of health IT and its effect on health care quality. Individuals trained for these positions would also be expected to take positions as teachers in institutions of higher education including community colleges, building health IT training capacity across the nation. We anticipate that training appropriate to this role will require a doctoral degree in informatics or related fields for individuals not holding an advanced degree in one of the health professions, or a master�s degree for physicians or other individuals holding a doctoral degree in any health professions for which a doctoral degree is the minimum degree required to enter professional practice.

(v) Programmers and Software Engineer: We anticipate that these individuals will be the architects and developers of advanced health IT solutions. These individuals will be cross-trained in IT and health domains, thereby possessing a high level of familiarity with health domains to complement their technical skills in computer and information science. As such, the solutions they develop would be expected to reflect a sophisticated understanding of the problems being addressed and the special problems created by the culture, organizational context, and workflow of health care. We would expect that training appropriate to this role would generally require specialization within baccalaureate-level studies or a certificate of advanced studies or post-baccalaureate-level training in health informatics or related field, but a university-issued certificate of advanced training in a health-related topic area would as also seem appropriate for individuals with IT backgrounds.

(vi) Health IT Sub-specialist: The ultimate success of health IT will require, as part of the workforce, a relatively small number of individuals whose training combines health care or public health generalist knowledge, knowledge of IT, and deep knowledge drawn from disciplines that inform health IT policy or technology. Such disciplines include ethics, economics, business, policy and planning, cognitive psychology, and industrial/systems engineering. The deep understanding of an external discipline, as it applies to health IT, will enable these individuals to complement the work of the research and development scientists described above. These individuals would be expected to find employment in research and development settings, and could serve important roles as teachers. We would expect that training appropriate to this type of role would require successful completion of at least a master�s degree in an appropriate discipline other than health informatics, but with a course of study that closely aligns with health IT. We would further expect that such individuals� original research (e.g. master�s thesis) work would be on a topic directly related to health IT.

They've also called on Community Colleges to take the lead in producing worker bees:

http://healthit.hhs.gov/portal/server.pt?open=512&objID=1414&mode=2

It is also recommended that the teachers of these worker bees have a formal cross disciplinary background.

These are encouraging signs, as they lend significant formalism to the current marketplace where, completely alien to the culture of medicine itself, anyone of any educational background (or no educational background) can be a healthcare IT / informatics "expert" and leader.

Even with these definitions, doing health IT "right" is still far, far harder than it looks, but at least the rigor of medicine is starting to be applied to the "anything goes" world of healthcare IT and IT workers in healthcare-related roles.

That domain has long suffered striking inattention to education and qualifications requirements, and a healthcare-dyscompetent leadership that I believe has significantly fueled healthcare IT difficulty and failure.

This is a helpful stance against devil-may-care attitudes such as those of major health IT leadership recruiters. From an article a number of years ago in the journal �Healthcare Informatics�:

I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman.

Now, if only ONC's thinking can percolate to the highest levels of healthcare and pharmaceutical leadership, including the "C" level and the boards of directors.

-- SS

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How to Give a Course on Corruption in the Health Sector

Just out from the U4 Anti-Corruption Resource Center is a brief paper on "Approaches to teaching and learning about corruption in the health sector."  (Note that U4 has a very useful web-page on corruption health care, also now appearing in the links in our side-bar.)

The paper begins by describing the overall goals of such a course:

The overall goals for training in anti-corruption in health are to help people develop the knowledge, skills, and attitudes they will need to identify and understand problems of corruption in health, design anti-corruption strategies, strengthen health systems for good governance,
transparency, and accountability, and advocate for integrity in governance. An additional goal is to prepare people to respond to individual experiences they may have with corruption, such as how to react when they suspect someone has engaged in corruption, when they are asked
to pay or accept a bribe, or other situations.

Then it lists a set of learning objectives:

- Define corruption.
- Identify the types of corrupt activities that occur in the health sector, and their scope and seriousness.
- Explain why corruption occurs, applying principles of economics, governance, and crime prevention to understand the issues involved.
- Assess risks and vulnerabilities which make corruption more likely in certain settings.
- Identify the consequences which can result from corruption.
- Discuss cultural differences in defining morality and corruption, including the blurred line between corruption and trading favours, giving gifts, using contacts, etc.
- Describe the core elements of corruption prevention and control programmes.
- Given a particular country situation or programme, explain how corruption can be reduced in drug supply, financial systems, and delivery of health services.
- Become an effective advocate for anti-corruption strategies and reforms to promote accountability and transparency in health programmes.

The rest of the paper was devoted to specific content that might be included in such courses, and various activities that could facilitate learning.

Although the paper seems to be aimed at people in developing countries, I would submit that its content, and the sort of courses it proposes, would be equally useful in developed countries, including the US.  After all, Transparency International has pointed out that health care corruption seems to plague most countries regardless of income, level of economic development, or type of organization of health care systems.  The details of how corruption occurs just vary from country to country according to these factors.  On Health Care Renewal, we certainly have documented some striking instances of corruption in developed countries, mainly in the US, as well as corruption's little siblings, conflicts of interest and self-interested mismanagement.

However, I suspect that courses about health care corruption are rare, if not completely non-existent, in US medical schools, as are courses about corruption occuring "within country" at US public health schools.  In fact, the only "politically correct" way to talk about health care corruption in most developed countries is to talk about how it affects other, usually less developed countries. 

At least the author of the paper, Taryn Vian, has the courage to teach her course in the US, at the Boston University School of Public Health.  (She also drew on experience giving professional workshops in several countries.)  However, while the course does include examples from the US and developed countries, it is aimed at students interested in international public health.  I would guess that no one has invited Ms Vian to each the course for US medical students at BU or elsewhere.  (And if anyone knows about similar courses taught at US medical schools, US public health schools directed at in-country problems, or at medical or public health schools in other developed countries, please let us know.) 

It is a striking example of the anechoic effect that corruption in health care is not considered an important topic for US medical schools.  Of course, as long as we do not talk about the problem, we can pretend it does not exist.  Is it any wonder that our health care continues to get more expensive and less accessible?

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