Warung Bebas

Jumat, 27 Januari 2012

Insulin and Obesity: Another Nail in the Coffin

There are several versions of the insulin hypothesis of obesity, but the versions that are most visible to the public generally state that elevated circulating insulin (whether acute or chronic) increases body fatness.  Some versions invoke insulin's effects on fat tissue, others its effects in the brain.  This idea has been used to explain why low-carbohydrate and low-glycemic-index diets can lead to weight loss (although frankly, glycemic index per se doesn't seem to have much if any impact on body weight in controlled trials). 

I have explained in various posts why this idea does not appear to be correct (1, 2, 3), and why, after extensive research, the insulin hypothesis of obesity lost steam by the late 1980s.  However, I recently came across two experiments that tested the hypothesis as directly as it can be tested-- by chronically increasing circulating insulin in animals and measuring food intake and body weight and/or body fatness.  If the hypothesis is correct, these animals should gain fat, and perhaps eat more as well. 

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Elephants We Can Notice But Cannot Name

We have often discussed the anechoic effect, how cases involving or discussions of the topics we address on Health Care Renewal, the concentration and abuse of power in health care, fail to produce any responses, or echoes. 

Last month, an article with the provocative title, "Elephants in Academic Medicine," by Souba et al addressed the anechoic effect, but was unable to discuss what people in academic medicine cannot discuss.(1)

"Organizational Silence"

In summary, the authors surveyed chairs of departments of medicine and surgery at all accredited US medical schools to ask about the "elephants in their living rooms." By this they meant the problems which people are unwilling to discuss at their medical schools.  Their goal was to assess "organizational silence" in academic medicine, as they discussed in their introduction:
Morrison and Milliken popularized the term 'organizational silence,' which refers to the collective-level phenomenon of doing or saying very little about the problems facing an organization. Organizational silence derives both from people's fears of negative feedback and from a set of behavioral cues adopted by supervisors that lead to structures, procedures, and processes that discourage speaking up. Two common structural features of organizations that foster organizational silence are centralized decision making and a lack of formal feedback mechanisms.

Some organizations face an apparent dilemma in which employees know the truth about specific problems within the organization yet dare not speak that truth to their superiors. A key factor that fosters the creation of a climate of organizational silence is senior leaders' fears of receiving criticism, especially from subordinates. The unwritten message from the top is 'No bad or unpleasant news.' Fearing retaliation or the label 'not a team player' if they speak their minds, subordinates become silent; even if they do speak up, they may discover that their feedback is disregarded. A culture of silence becomes ingrained.

Methods

The investigators sought to learn from these academic leaders:
(1) What are the major elephants in your AHC [academic health center]? (2) What do you believe to be the most prevalent reasons people do not speak up? and (3) What are the consequences of remaining silent?

The survey response rate was 55%. The major elephants, in the order that they were ranked by the participants, were
- misalignment between goals and available resources
- ignoring information that clearly indicates a performance problem
- unwillingness to give up on a failed strategy
- unwillingness to speak up about inequities (e.g., pay, space, favoritism, special deals)
- failure to deal with disruptive behavior

The wording of these items were chosen by the investigators. The survey allowed for respondents to write in additional items, but the paper did not discuss any such responses. Its discussion of the results did not further define the nature of any elephants.

In addition, survey results suggested that more open discussion is unlikely to be in the offing.

- The majority of respondents thought that the elephants were someone else's problem:
Both chairs of surgery and of medicine believed that elephants are more commonly ignored by deans and hospital leaders than by other department chairs or themselves. Surgery chairs were more likely to say that hospital leaders ignore elephants, whereas medicine chairs were more likely to say that deans disregard elephants.

- The majority thought that other leaders did not encourage discussion of elephants:
Only 52 of the chairs (37%) said that elephants are usually discussed in an appropriate venue, whereas 87 (63%) said that elephants are discussed in less constructive venues or not discussed at all. Less than a quarter of the chairs (32; 23%) reported that the top leaders at their institutions actually encourage people to call out and deal with elephants. More commonly, the chairs (77; 55%) reported that the top leaders of their institutions say they want people to be frank about elephants, but their actions or nonverbal cues indicate otherwise. A higher percentage of medicine chairs than of surgery chairs (16 of 53 [30%] versus 16 of 86 [19%]), said that top leaders pretend that elephants do not exist.

- An important minority did not think the elephants were a problem at all:
nearly a fifth (26 of 139; 19%) agreed that, indeed, some issues are best left undiscussed.

- While the majority favored discussing elephants, they did not think it would be easy to do so:
two-thirds (92 of 137; 67%) felt that creating a culture in which elephants are openly discussed would be very or moderately difficult.

Their and Our Discussion

It was particularly striking that an article about elephants in the living room did not more fully describe what sorts of elephants they were. The descriptions of elephants above, taken verbatim from the survey instrument, were vague. They were not clarified in the discussion section of the article.

Particularly lacking were the sort of nasty elephants described by Pololi et al in a qualitative study of barriers to the advancement of primary care faculty.(2) As we summarized in our letter,(3) these elephants included academic leaders who put revenues ahead of patient care, teaching, and research; and who allegedly used deception for personal gain. Also lacking were nasty elephants we have discussed on Health Care Renewal. We have discussed examples of self-interested, conflicted, and corrupt leadership of health care organizations, including academic medical institutions.

I am glad that Souba et al brought up the topic of elephants in academic medicine's living room. However, I am disappointed that these elephants were never clearly identified. It seems that while we are getting to the point of being able to say there are things we cannot say, we are not yet at the point of saying what those things are. The strength of the anechoic effect is demonstrated by cases in which we cannot talk about what we cannot talk about.

Souba et al concluded:
We believe that AHCs are designed, often subconsciously, to keep the range of conversation limited to a few voices, usually the voices of those in power. The powerful silence the voices of others because they consider others' views to be either contrary to the status quo or of limited value.

We would add that those in power often may value the status quo not merely because of philosophical conservatism, but because maintaining the status quo supports their self interest. In particular, it has become increasingly lucrative to be in a leadership position in a health care organization, even in a non-profit academic institution. Executive compensation at these institutions has been rising inexorably, driven by increasing institutional relationships with corporate health care. Individuals in leadership positions in academic medicine frequently have their own, increasingly lucrative financial relationships with the health care industry. (A study by Campbell et al showed that the majority of department chairs, like those who answered the survey above, have such relationships.[4]) Ever increasing hunger for institutional and personal revenue may lead to a variety of practices that are hostile to the academic and professional mission.  Discussing any of these aspects of the status quo may offend and threaten those who are profiting from it. 

However, as long as we cannot even talk about such problems, the problems will only get worse.

References


1. Souba W, Way D, Lucey C, Sedmak D, Notestine M. Acad Medicine 2011; 86: 1492-1499.  Link here.
2. Pololi L, Kern DE, Carr P, Conrad P, Knight S. The culture of academic medicine: faculty perceptions of the lack of alignment between individual and institutional values. J Gen Intern Med 2009; 24: 1289-95. Link here.
3. Poses RM, Smith WR. Faculty values. J Gen Intern Med 2010; 25: 646. Link here.
4.  Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786, link here.]

Wikipedia page on EHR's: ==Disadvantages== material seems to keep disappearing

It's interesting how most of the information below seems to have a hard time "staying put" on the Wikipedia page for "Electronic Health Record" at http://en.wikipedia.org/wiki/Electronic_health_record

The information is presented in a neutral fashion from impeccable sources. Yet several Wikipedia "editors" take issue with it and, rather then editing it or refuting it (and stating their rationale and sources!), they keep deleting it. (The most recent edit history comments follow this "disappearing" information, at the bottom of this post):


==Disadvantages==

===Software quality and usability deficiencies===
EHR software is unregulated, unlike computer systems used both in the development and production of, and as a part of pharmaceutical products, medical devices, food, blood establishments, tissue establishments, and clinical trials.http://en.wikipedia.org/wiki/Validation_%28drug_manufacture%29 Other life-critical industries also have strict software validation and testing standards, e.g., Federal Aviation Administration, NASA.http://www.faa.gov/regulations_policies/advisory_circulars/index.cfm/go/document.information/documentID/1019261http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf.

As a result, EHR software quality and usability is often suboptimal. For example, in "A study of an Enterprise Health information System", March 2011, a Medical Informatics researcher at [[University of Sydney]] in Australia found that a major EHR system for Emergency Departments slated for deployment in the public hospitals of [[New South Wales]] has serious deficiencies in software architecture and fit with clinician workflow. These deficiencies make it difficult to use and unreliable in terms of data integrity and loss, in one of the most demanding of clinical environments .http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146

The [[Healthcare Information and Management Systems Society]] (HIMSS), a very large U.S. healthcare IT industry trade group, observed that EHR adoption rates "have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available."http://www.himss.org/content/files/HIMSS_DefiningandTestingEMRUsability.pdf

Serious reliability and usability problems with the U.S. Department of Defense’s [[AHLTA]] EHR system have been reported to the Congress.http://www.usmedicine.com/articles/electronic-records-system-unreliable-difficult-to-use-service-officials-tell-congress.html

The U.S. [[National Institute of Standards and Technology]] (NIST) issued a Sept. 2011 report on deficient usability of current EHR systems, with recommendations for usability evaluation, testing and validation.http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf

===Unintended adverse consequences===
EHRs can introduce new unintended consequences, compared to paper records, and adverse outcomes, including patient injury and death, according to regualtory and governmental agencies, researchers, and others; for example, in an internal 2009 FDA memorandumhttp://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf of Feb. 23, 2010 obtained and released by the Huffington Post Investigative Fundhttp://web.archive.org/web/20110425002322/http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight, EHR-related medical errors are categorized as: errors of commission (EOC), errors of omission or transmission (EOT), errors in data analysis (EDA), and incompatibility between multi-vendor software applications or systems (ISMA).

The [[National Health Service]] (NHS) in the UK reports specific examples of EHR-caused patient harms in a 2009 document on guidance on the management of clinical risk relating to the deployment and use of health software, Annex A "Examples of potential harm presented by health software."http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf.

Also, in "Research in Ambulatory Patient Safety 2000–2010: A 10-year review", Dec. 2011http://www.ama-assn.org/resources/doc/ethics/research-ambulatory-patient-safety.pdf, the American Medical Association reports:

:While health IT may confer benefits, some research has also suggested that health IT systems can create new issues or exacerbate existing problems. Wachter noted that, “[i]n both professional and lay publications, concerns have been raised that today’s electronic health records promote the copying and pasting of clinical information, instead of its thoughtful analysis; foster a focus on completing computerized checklists and templates rather than detailed probing of the patient’s history, and support less thoughtful diagnostic reasoning and more automatic behavior on the part of caregivers." Research indicates that a great deal depends on the design of the health information technology system, with poorly designed systems contributing to instances of errors (Ash et al). Where user interface designs are cumbersome to use and do not fit into the clinician’s natural work context, some have noted the potential for “cognitive overload,” among other reactions, and ultimately the possibility of increasing errors in data entry and retrieval as well as errors in the process of communication and coordination (Ash et al, Singh et al).


In the U.S., FDA's MAUDE (Manufacturer and User Facility Device Experience) databasehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFMreveals many reported EHR problems, some of which could result in patient injury or death http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html. Both FDA (in the 2010 memo referenced above) and the [[Institute of Medicine]] of the National Academies in a 2011 study http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF reveal that EHR-related injuries and deaths are real, but the true extent is likely understated, they report, due to numerous factors impeding diffusion of knowledge such as contractual gag and hold harmless clauseshttp://jama.ama-assn.org/content/301/12/1276.extract and lack of familiarity by users of where to report EHR-related adverse events (per aforementioned 2009 FDA internal memo). A Medical Informatics researcher in the U.S. has compiled a well-referenced teaching site that covers unintended consequences of EHRs, health IT project difficulties and failure and related issues{{cite web | last=Silverstein| first=Scot| year=2012 | url=http://www.ischool.drexel.edu/faculty/ssilverstein/cases/ | title=Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties| publisher=Drexel University |accessdate=2012-01-26}}.

The literature is conflicting on benefits and harms of EHRs http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html, and as in the Jan. 2009 U.S. National Academies study "COMPUTATIONAL TECHNOLOGY FOR EFFECTIVE HEALTH CARE: IMMEDIATE STEPS AND STRATEGIC DIRECTIONS", EHR's ultimate success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572

===Regulatory controversy===
FDA's Jeffrey Shuren, MD JD, Director of the [[Center for Devices and Radiological Health]] (CDRH), has explicitly declared EHRs are a medical device.http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910717_0_0_18/3Shuren_Testimony022510.pdf So has the [[Medical Products Agency (Sweden)]]; Swedish law for medical devices is based on EU Directives.http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf. In medicine, legal and ethical standards such as the NIH Guidelines for Conduct of Research Involving Human Subjectshttp://ohsr.od.nih.gov/guidelines/index.html and the World Medical Association Declaration Of Helsinkihttp://ohsr.od.nih.gov/guidelines/helsinki.html restrict introduction of new drugs and medical devices without informed consent, and without extensive preclinical and clinical testing and post-marketing surveillance, especially when risks of the technology are unknown. As in the 2011 U.S. [[Institute of Medicine]] study "Health IT and Patient Safety: Building Safer Systems for Better Care"http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, there are calls for formal governmental regulation of the technology.


The edit-history comments are quite interesting, where a poster who uses the ID "Barek" keeps deleting all or most of the information on EHR disadvantages, despite indications the material is impeccably sourced and does not draw its own conclusions. Read from bottom to top:


17:29, 27 January 2012‎ Ohnoitsjamie (talk | contribs)‎ (67,826 bytes) (please discuss on talk page, as you are approaching WP:3RR)

17:28, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,232 bytes) (clarifying that information comes from the cited sources.)

17:26, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,137 bytes) (→Unintended adverse consequences)

17:24, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,151 bytes) (If you have factual disageements, let them be known and document the source of your information.)

17:23, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,137 bytes) (If you have factual disageements, let them be known and document the source of your information.)

17:18, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,122 bytes) (Undid revision 473542684 by Barek (talk). Barek may have a conflict of interest regarding exposure of health IT difficulties.)

17:14, 27 January 2012‎ Barek (talk | contribs)‎ m (67,826 bytes) (Reverted edits by InformaticsMD (talk) to last version by Barek)

17:14, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,122 bytes) (→Regulatory controversy)

17:12, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,217 bytes) (The added information is factual, well-referenced from impeccable sources, and does not draw conclusions.)

17:08, 27 January 2012‎ Barek (talk | contribs)‎ (67,826 bytes) (→Disadvantages: restore some content after purging WP:SYNTH material)

17:06, 27 January 2012‎ Ohnoitsjamie (talk | contribs)‎ (65,826 bytes) (rv per WP:SYNTH)

17:01, 27 January 2012‎ 108.16.62.235 (talk)‎ (76,341 bytes) (Undid revision 473539844 by Barek (talk))

16:57, 27 January 2012‎ Barek (talk | contribs)‎ (65,826 bytes) (rv - some of that content is usable - but most is pure WP:SYNTH, attempting to draw conclusions rather than simply stating what's in the sources - requires a total re-write to be encyclopedic)

...
20:22, 26 January 2012‎ SarekOfVulcan (talk | contribs)‎ (65,058 bytes) (→Unintended Adverse Consequences: actually, remove whole section - BAD HANDWRITING can result in patient injury and death)

20:21, 26 January 2012‎ SarekOfVulcan (talk | contribs)‎ (65,860 bytes) (→Unintended Adverse Consequences: If it's unknown, we don't need to report it. If it's not a RS, we don't need to report its conclusions. And "a researcher says" isn't notable enough to mention without establishing authority in the subject) (undo)



I note that the logically fallacious "Bad handwriting can cause patient injury and death, so remove whole EHR Unintended Adverse Consequences section" and "if it's unknown, we don't need to report it" [regarding the referenced FDA and IOM observations that the true extent of EHR adverse consequences is unknown -- which is on its face a matter critical to public health and policy - ed.], coming from an editor who ironically calls him/herself "Sarek of Vulcan", offers a prime example of how the utopian concept of tapping "community wisdom" can fall flat on its face.

WP:SYNTH is Wikipedia-talk for "Synthesis of published material that advances a position", i.e., "drawing conclusions." Apparently, when it comes to EHR, citing the work of governmental regulatory and healthcare agencies, expert researchers, etc. is "drawing conclusions."

Wikipedia is essentially open to all, including the HIT industry and its pundits.

It is possible that the Wikipedia editors who keep deleting the material could have some sort of conflict of interest. COI could cause them to find easily-verifiable information from impeccable sources on the Wikipedia EHR page (viewed 22924 times in the last 30 days as of this morning) that refutes common cybernetic legends to be "inconvenient." We've certainly seen that type of person before (link).

This affair may also be another example of the "anechoic effect", the notion we discuss often on this blog that certain topics in medicine and health care 'just aren't talked about', in action.

The 'disadvantages' material, revised, will be re-posted again soon, after my being blocked (for 'reverting', i.e., restoring the material three times in 24 hrs.) expires tomorrow. It will be revised to have as neutral a tone as possible, with exact page numbers where possible, in accordance with written Wikipedia examples. If the additions still disappear, that will be revelatory.

-- SS




well hello there friday....you snuck up on me but i'm SO glad to see ya!!

*images courtesy of meg biram, is it love or just paris, jan showers

A perfect example of why I post what I do about LC personalities

I frequently read folks wondering out loud why I spend (waste?) the time that I do to post on various low carb gurus and personalities.  It doesn't seem like a worthwhile endeavor at times ... and I must admit I occasionally wonder if it's worth the flack and time either.  And then along comes another LC'er "helping others" with their wisdom.  Some of the people I've written about don't "get me" ... after all they are just every day folks sharing their experiences trying to (selflessly) help others.   That "selflessly" is often silent, sometimes strongly implied in their repeated reminders that this is their goal, and sometimes shouted straight out, lest you not notice the generous benevolence in their actions.  They may even go so far as to remind you of the expense they've endured to bring you the free service you're using .....

For all the touting of how any day now the Insurgency will persevere, of how the low carb message is spreading, etc., the LC community remains a small niche in the wide wide world of dietary lifestyles and weight loss strategies.  It seems to me that, because there are so relatively few, the internet presence is all the more inflated compared to other approaches.  In real life, many who follow more traditional or popular approaches have buddies or support groups they can attend.  Or there are TV shows they can tune into, etc.  Low carbers don't have nearly the options, and in many ways these have dwindled rather than increased in the past five years or so.  Yes, despite the best efforts of Gary Taubes, the drop-off of the Atkins boom was mostly staved a bit but not halted.   It is because the community is so relatively small and intertwined, that the onus is all the more powerful to put out a truthful and realistic welcome mat.
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