I plan to blog quite a bit more on childhood nutrition in general, but the We Are Hungry video on YouTube, made by students in response to the new school lunch guidelines, has been making the rounds. If you haven't seen it yet, I've embedded it below:
Rabu, 03 Oktober 2012
Kata Mutiara: Pendidikan dan Harapan
Kata bijak:
CAPTION Kata kata indah bergambar dan kata mutiara kehidupan : Pendidikan melahirkan harapan baru
Kata kata bijak kehidupan,Gambar Motivasi, Kata Mutiara kehidupan, Kata kata Indah
Kata Bijak: Pendidikan melahirkan harapan baru
Kata mutiara motivasi: Percaya diri,Sukses menanti
Kata bijak motivasi:
Kata kata indah bergambar dan kata mutiara kehidupan : Percaya diri adalah cara meraih sukses
Kata kata bijak kehidupan,Gambar Motivasi, Kata Mutiara kehidupan, Kata kata Indah
Kata mutiara motivasi: Percaya diri adalah cara meraih sukses
Kata Bijak Motivasi: Perubahan dan Kematangan
Kata bijak motivasi:
Perubahan dan Kematangan
Perubahan dan Kematangan
Kata kata indah bergambar dan kata mutiara kehidupan : Perubahan menghasilkan kematangan Kata kata bijak kehidupan,Gambar Motivasi, Kata Mutiara kehidupan, Kata kata Indah |
Kata mutiara motivasi: Perubahan menghasilkan kematangan
Health Care Academics' Unrest and Bad Health Care Leadership?
Last month we discussed a recent, large scale study of physician burnout, and wondered whether it would finally inspire some discourse about why physicians are really so upset. In particular, we hypothesized, based on some real, if limited data, that physician angst, dissatisfaction, burnout, etc may mainly be a response to the problems with leadership and governance of health care organization we post about on Health Care Renewal.
After that post, one of our scouts found a very interesting and relevant article from earlier this year which got little attention at the time, but deserves more. [Pololi LH, Krupat E, Civian JT, Ash AS, Brennan RT. Why are a quarter of faculty considering leaving academic medicine? A study of their perceptions of institutional culture and intentions to leave at 26 representative U.S. medical schools. Acad Med. 2012; 87: 859-69. Link here.]
Study Design
This was a cross-sectional survey of faculty at 26 medical schools in the US, selected to be similar to the general population of medical schools in the country. At each school, 150 faculty were randomly chosen stratified by sex and age, and then the sample was enriched to include additional minority faculty and women surgeons, for a total of 4578.
The faculty were sent a multi item survey to assess their perception of the organizational culture of their institutions, and asked about their intentions to continue in or leave their current positions and academic medicine. Responses to each survey item were allowed to be from 1 = strongly disagree, to 5 = strongly agree. The items on the survey were combined into various scales. A number of items on the survey seemed to be related to issues we frequently discuss on Health Care Renewal. These items ended up in three different scales, entitled Relatedness/Inclusion, Values Alignment, and Ethical/Moral Distress. The survey items are listed below, grouped by issue, with the scales into which they were combined noted.
Issue: Mission-Hostile Leadership
Administration only interested in me for revenue (Reverse coded) (Values Alignment)
Institution committed to serving the public (VA)
Institution's actions well-aligned with stated values and mission (VA)
Institution puts own needs ahead of educational/clinical missions (RC) (VA)
My values well-aligned with school's (VA)
Institution awards excellence in clinical care (VA)
Institution does not value teaching (RC) (VA)
Have to compromise values to work here (Ethical/Moral Distress)
Issue: Deceptive, Unethical Leadership
Felt pressure to behave unethically (Ethical/Moral Distress)
Need to be deceitful in order to succeed (EMD)
Others have taken credit for my work (EMD)
Issue: Generation of the Anechoic Effect by Suppression of Free Speech, Academic Freedom, Dissent, Whistle-Blowing,
Feel ignored/ invisible (RC) (Relatedness/Inclusion)
Hide what I think and feel (RC) (R/I)
Reluctant to express opinion/ fear negative consequences (RC) (R/I)
So in summary, the survey contained quite a few questions about mission-hostile management, comprising nearly all of the Values Alignment scale, some questions about deceptive or unethical leadership, all in the Ethical/Moral Distress scale, and some about generation of the anechoic effect by suppression of free speech, academic freedom, dissent, and whistle-blowing, all in the Relatedness/Inclusion scale.
Results
The response rate was 52% (N=2381.)
Unfortunately, the article did not include the distributions of the responses to individual survey items, and only included the mean and standard error of the scale scores. The values for the scales of most interest were:
Relatedness/Inclusion 3.56 SE= 0.022
Values Alignment 3.25 SE=0.028
Ethical/Moral Distress 2.36 SE=0.022
Note that the article did not address the degree individual items, especially those listed above, contributed to variation in the scale scores.
A small majority of faculty indicated their intentions to stay at their institutions (57%). Of the remainder, 14% were considering leaving their school due to dissatisfaction, and another 21% were considering leaving academic medicine due to dissatisfaction. The remainder were considering leaving due to personal/ family reasons or to retire.
The authors did complex multinomial logit modeling to assess the relationships among the various scales, demographic factors, and intention to leave. Most relevant to us, Relatedness/Inclusion was significantly related to intention to leave the institution due to dissatisfaction (Coefficient -0.69, p lt 0.001, OR =0.50), as was Values Alignment (-0.39, p=0.04, OR=0.68), but not Ethical/ Moral Distress. Furthermore, Relatedness/Inclusion was related to intention to leave academic medicine due to dissatisfaction (-0.48, p lt 0.001, 0.62), as was Ethical/Moral Distress (0.60, p lt 0.001, OR =1.82). The article did not address whether individual survey items, including those of most interest listed above, were related to intention to leave. The article also did not address whether responses to the survey or intention to leave varied across faculty characteristics, medical school characteristics, or individual medical schools.
Summary and Comments
This very large survey of faculty from multiple US medical schools showed that more than one-third were considering leaving their institutions or academic medicine due to dissatisfaction, indicating a striking prevalence of faculty distress. Their responses to questions about perceived organizational cultural and leadership problems, including those possibly related to leadership's perceived hostility to the mission, leadership's perceived dishonesty or unethical behavior, and leadership's suppression of dissent, free speech, academic freedom, and whistle-blowing were related to their intentions to leave due to dissatisfaction.
These results suggest the hypothesis that much of faculty angst may be due to the sorts of problems with leadership and hence organizational culture that we discuss on Health Care Renewal. Since this was a cross-sectional survey, it certainly does not offer scientific proof of this hypothesis. Note that there is other evidence from numerous cases discussed in Health Care Renewal, qualitative studies and our much smaller study published only in abstract form that also supports this hypothesis (look here).
One part of the author's discussion of their findings was particularly relevant:
After that post, one of our scouts found a very interesting and relevant article from earlier this year which got little attention at the time, but deserves more. [Pololi LH, Krupat E, Civian JT, Ash AS, Brennan RT. Why are a quarter of faculty considering leaving academic medicine? A study of their perceptions of institutional culture and intentions to leave at 26 representative U.S. medical schools. Acad Med. 2012; 87: 859-69. Link here.]
Study Design
This was a cross-sectional survey of faculty at 26 medical schools in the US, selected to be similar to the general population of medical schools in the country. At each school, 150 faculty were randomly chosen stratified by sex and age, and then the sample was enriched to include additional minority faculty and women surgeons, for a total of 4578.
The faculty were sent a multi item survey to assess their perception of the organizational culture of their institutions, and asked about their intentions to continue in or leave their current positions and academic medicine. Responses to each survey item were allowed to be from 1 = strongly disagree, to 5 = strongly agree. The items on the survey were combined into various scales. A number of items on the survey seemed to be related to issues we frequently discuss on Health Care Renewal. These items ended up in three different scales, entitled Relatedness/Inclusion, Values Alignment, and Ethical/Moral Distress. The survey items are listed below, grouped by issue, with the scales into which they were combined noted.
Issue: Mission-Hostile Leadership
Administration only interested in me for revenue (Reverse coded) (Values Alignment)
Institution committed to serving the public (VA)
Institution's actions well-aligned with stated values and mission (VA)
Institution puts own needs ahead of educational/clinical missions (RC) (VA)
My values well-aligned with school's (VA)
Institution awards excellence in clinical care (VA)
Institution does not value teaching (RC) (VA)
Have to compromise values to work here (Ethical/Moral Distress)
Issue: Deceptive, Unethical Leadership
Felt pressure to behave unethically (Ethical/Moral Distress)
Need to be deceitful in order to succeed (EMD)
Others have taken credit for my work (EMD)
Issue: Generation of the Anechoic Effect by Suppression of Free Speech, Academic Freedom, Dissent, Whistle-Blowing,
Feel ignored/ invisible (RC) (Relatedness/Inclusion)
Hide what I think and feel (RC) (R/I)
Reluctant to express opinion/ fear negative consequences (RC) (R/I)
So in summary, the survey contained quite a few questions about mission-hostile management, comprising nearly all of the Values Alignment scale, some questions about deceptive or unethical leadership, all in the Ethical/Moral Distress scale, and some about generation of the anechoic effect by suppression of free speech, academic freedom, dissent, and whistle-blowing, all in the Relatedness/Inclusion scale.
Results
The response rate was 52% (N=2381.)
Unfortunately, the article did not include the distributions of the responses to individual survey items, and only included the mean and standard error of the scale scores. The values for the scales of most interest were:
Relatedness/Inclusion 3.56 SE= 0.022
Values Alignment 3.25 SE=0.028
Ethical/Moral Distress 2.36 SE=0.022
Note that the article did not address the degree individual items, especially those listed above, contributed to variation in the scale scores.
A small majority of faculty indicated their intentions to stay at their institutions (57%). Of the remainder, 14% were considering leaving their school due to dissatisfaction, and another 21% were considering leaving academic medicine due to dissatisfaction. The remainder were considering leaving due to personal/ family reasons or to retire.
The authors did complex multinomial logit modeling to assess the relationships among the various scales, demographic factors, and intention to leave. Most relevant to us, Relatedness/Inclusion was significantly related to intention to leave the institution due to dissatisfaction (Coefficient -0.69, p lt 0.001, OR =0.50), as was Values Alignment (-0.39, p=0.04, OR=0.68), but not Ethical/ Moral Distress. Furthermore, Relatedness/Inclusion was related to intention to leave academic medicine due to dissatisfaction (-0.48, p lt 0.001, 0.62), as was Ethical/Moral Distress (0.60, p lt 0.001, OR =1.82). The article did not address whether individual survey items, including those of most interest listed above, were related to intention to leave. The article also did not address whether responses to the survey or intention to leave varied across faculty characteristics, medical school characteristics, or individual medical schools.
Summary and Comments
This very large survey of faculty from multiple US medical schools showed that more than one-third were considering leaving their institutions or academic medicine due to dissatisfaction, indicating a striking prevalence of faculty distress. Their responses to questions about perceived organizational cultural and leadership problems, including those possibly related to leadership's perceived hostility to the mission, leadership's perceived dishonesty or unethical behavior, and leadership's suppression of dissent, free speech, academic freedom, and whistle-blowing were related to their intentions to leave due to dissatisfaction.
These results suggest the hypothesis that much of faculty angst may be due to the sorts of problems with leadership and hence organizational culture that we discuss on Health Care Renewal. Since this was a cross-sectional survey, it certainly does not offer scientific proof of this hypothesis. Note that there is other evidence from numerous cases discussed in Health Care Renewal, qualitative studies and our much smaller study published only in abstract form that also supports this hypothesis (look here).
One part of the author's discussion of their findings was particularly relevant:
Our findings are congruent with metaanalyses of 25 years of organizational justice research outside medicine. These studies suggest that employee perceptions of organizational justice and an ethical climate are related to increased job satisfaction, trust in leadership, enhanced performance, commitment to one’s employer, and reduced turnover.I believe that the study by Pololi et al adds to the evidence that physician distress is a symptom of a dysfunctional system in which major health care organizations have been taken over by leaders more devoted to self-interest and short-term revenue than the values prized by health care professionals and academics. This applies obviously to academic medical institutions, but also to other organizations that might have been expected to defend such professional and academic values, such as professional associations, accrediting organizations, and health care foundations. As we said before, if physicians really want to address what is making them burned out and dissatisfied, they will have to regain control of their own societies, organizations, and academic institutions, and ensure that these organizations put core values, not revenue generation and providing cushy compensation to their executives, first.
The scale of ethical/moral distress (see Table 1) reflects reactions to the prevailing norms and possible erosion of professionalism and increased organizational self-interest. There is a growing belief that organizations influence and are responsible for the ethical or unethical behaviors of their employees.To our knowledge, faculty perceptions of 'moral atmosphere' and 'just community' embedded in our survey have not been previously investigated in academic medicine, even though the ethical concepts of professionalism and justice can be used to guide the pursuit of excellence in the missions of medical schools. Several scholars have called for academic medicine to attend to its social justice and moral mission. Faculty perceptions
of organizational justice are pivotal to the critical issue of professionalism in medicine. The ethical/moral distress scale in the survey reported here included items such as 'the culture of my institution discourages altruism' and 'I find working here to be dehumanizing.' (See Table 1 for other items in this scale.) In that ethical/moral distress was more strongly related to intent to leave academic medicine entirely than intent to leave one’s own institution, these negative feelings among faculty must be particularly disheartening to them and may color major career decisions.
Allegheny Health System Computer Crash (Again) and Paper Backups
I reported on a health IT crash in my May 2011 post "Twelve Hour Health IT Glitch at Allegheny General Hospital - But Patients Unaffected, Of Course..."
Now, there's this at the same healthcare system:
Some systems were up eight hours later and others were expected to come online overnight, according to a report at HisTalk.
Assuming the statement about "doctors keep paper copies of almost all their records" was not spin control regarding skeletal paper records, a question arises.
Why, exactly, spend hundreds of millions of dollars on computing if paper records are kept, and are perfectly sufficient to accomplish the following, the usual refrain in health IT crash scenarios?
As a physician/ham radio enthusiast who did an elective in Biomedical Engineering in medical school, I also want to know:
1) What caused the “power surge?”
2) Why were the systems not protected against a “power surge?”
3) Exactly how did the “power surge” affect the IT?
Note: I've created a new, searchable indexing term for HIT outage stories with the usual refrain along the lines that "patient care has not been compromised."
See this query link using the new indexing term.
-- SS
Addendum Oct. 3:
Australian EHR reseacher and professor Dr. Jon Patrick opines:
-- SS
Now, there's this at the same healthcare system:
Computer system at West Penn Allegheny restored after crash
Liz Navratil
Pittsburgh Post-Gazette
October 2, 2012
The computer system at West Penn Allegheny Health System crashed about noon today, temporarily leaving doctors and nurses to work off of paper records instead.
Kelly Sorice, vice president of public relations for the health system, said all systems have since been restored. She said the servers crashed about noon today when the system experienced a power surge.
Doctors in the health system keep paper copies of almost all of their records so they can reference them during power outages or scheduled maintenance times, Ms. Sorice said.
Some systems were up eight hours later and others were expected to come online overnight, according to a report at HisTalk.
Assuming the statement about "doctors keep paper copies of almost all their records" was not spin control regarding skeletal paper records, a question arises.
Why, exactly, spend hundreds of millions of dollars on computing if paper records are kept, and are perfectly sufficient to accomplish the following, the usual refrain in health IT crash scenarios?
Ms. Sorice said she did not know of any procedures that had been rescheduled and added that, "Patient care has not been compromised."
As a physician/ham radio enthusiast who did an elective in Biomedical Engineering in medical school, I also want to know:
1) What caused the “power surge?”
2) Why were the systems not protected against a “power surge?”
3) Exactly how did the “power surge” affect the IT?
Note: I've created a new, searchable indexing term for HIT outage stories with the usual refrain along the lines that "patient care has not been compromised."
See this query link using the new indexing term.
-- SS
Addendum Oct. 3:
Australian EHR reseacher and professor Dr. Jon Patrick opines:
Even if [the paper records are] skeletal they suggest an endemic lack of confidence. I think the hospital spokesperson hasn't seen the implication of their statement.
-- SS
Honesty and Good Sense on Electronic Medical Records From Down Under
Australians seem to not be as seduced by the Siren Song of cybernetic miracles as health IT leaders in the United States.
It took an Australian computer scientist at U. Sydney to dissect and perform a detailed analysis of the internals of an American EHR system, the results of which were disturbing to say the least. This was a task the American members of the American Medical Informatics Association (AMIA) should have taken on. It's not as if they're unaware of clinical IT problems.
It also seems to take a group of Australian researchers at the Univ. of New South Wales, the Australian Patient Safety Foundation, and the University of South Australia to perform a forensic analysis on U.S. data in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database, instead of Americans themselves.
At least AMIA allowed the Australians the opportunuty to present their findings.
In "Patient Safety Problems Associated with Heathcare Information Technology: an Analysis of Adverse Events Reported to the US Food and Drug Administration" (free fulltext at this link), AMIA Annual Symposium Proceedings 2011;2011:853-7 the Australian researchers including Medical Informaticist and critical thinker Dr. Enrico Coiera (see here) analyzed healthcare information technology (HIT) events associated with patient harm submitted to the MAUDE database:
These submissions are voluntary, and due to systematic, severe impediments to submissions as below, this data likely represents a very small fraction ("tip of the iceberg" per FDA itself, link) of the true incidence of these events. See the addendum to this post "Systematic impediments to voluntary reporting of health IT risks."
Summarizing the Australian researchers' findings (read the entire paper at the link above):
The authors recommended that "strategies to improve the safety of HIT should focus on designing safe user interfaces, integrated checks of key identifiers and decision support, and engineering safer clinical processes."
Unfortunately, that does not appear to be occurring in the U.S. to any significant degree. "Certification" of health IT to meet government criteria for financial incentives is unrelated to such measures and is in my view symptomatic of industry regulatory capture (see here and here). The IOM itself has instituted a "watch and wait" policy, a likely unique special accommodation in current regulation of medical devices (see here).
I reiterate this MAUDE data is voluntary and the impediments to its reporting systematic and severe. See addendum to this post.
In the category of good sense on electronic medical records, I note the following articles:
What this means is abandoning the approach of large, single-source (monolithic), proprietary clinical information systems from large health IT vendors that try to cover everything, in favor of smaller, open standards-based "best-of-breed" applications (from vendors of all sizes) that can be woven together to meet users' needs:
I note that another article in eHealth Insider mentions the same strategy in the UK, "Winchester switches off Cerner in ED":
The U.S. has yet to learn these lessons, and will likely repeat the same mistakes at the cost of hundreds of billions of dollars.
Unfortunately, I have no answers. I see no way to avoid it, considering the HITECH momentum that favors the large-vendor monolithic product model.
-- SS
--------------------------------------
Addendum. Systematic impediments to voluntary reporting of health IT risks:
From the 2010 FDA internal memo on health IT risks:
From the 2012 IOM report on health IT safety:
Not knowing the magnitude of the risks is an effect of the impediments, and does not represent a good environment for national implementation in my view.
I also add "fear of medical malpractice litigation" to the lists above.
-- SS
It took an Australian computer scientist at U. Sydney to dissect and perform a detailed analysis of the internals of an American EHR system, the results of which were disturbing to say the least. This was a task the American members of the American Medical Informatics Association (AMIA) should have taken on. It's not as if they're unaware of clinical IT problems.
It also seems to take a group of Australian researchers at the Univ. of New South Wales, the Australian Patient Safety Foundation, and the University of South Australia to perform a forensic analysis on U.S. data in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database, instead of Americans themselves.
At least AMIA allowed the Australians the opportunuty to present their findings.
In "Patient Safety Problems Associated with Heathcare Information Technology: an Analysis of Adverse Events Reported to the US Food and Drug Administration" (free fulltext at this link), AMIA Annual Symposium Proceedings 2011;2011:853-7 the Australian researchers including Medical Informaticist and critical thinker Dr. Enrico Coiera (see here) analyzed healthcare information technology (HIT) events associated with patient harm submitted to the MAUDE database:
We downloaded all 899,768 reports that were submitted to MAUDE from January 2008 to July 2010 and searched for events using a broad definition of HIT as “hardware or software that is used to electronically create, maintain, analyse, store, receive, or otherwise aid in the diagnosis, cure, mitigation, treatment, or prevention of disease, and that is not an integral part of (1) an implantable device or (2) medical equipment.” We retrieved and classified 678 reports describing 436 unique events using a previously published methodology. Of the 436 HIT-related events that we examined, 11% (n=46) were associated with patient harm [this excludes the "near misses" - ed.] ... In this paper we specifically focus on examining the 46 events where HIT problems were associated with patient harm.
These submissions are voluntary, and due to systematic, severe impediments to submissions as below, this data likely represents a very small fraction ("tip of the iceberg" per FDA itself, link) of the true incidence of these events. See the addendum to this post "Systematic impediments to voluntary reporting of health IT risks."
Summarizing the Australian researchers' findings (read the entire paper at the link above):
Medication problems represented 41% of the events of these types:
- Wrong patient
- Wrong dose or overdose
- Missed and delayed doses
Clinical process problems represented 33% of the events:
- Use errors in entering information ("use error" is an error due to poor and confusing design, as opposed to "user errors")
- Poor functionality of CPOE and PACS
Exposure to radiation occurred in 15% of the events
Surgery problems occurred in 11% of the events.
The authors recommended that "strategies to improve the safety of HIT should focus on designing safe user interfaces, integrated checks of key identifiers and decision support, and engineering safer clinical processes."
Unfortunately, that does not appear to be occurring in the U.S. to any significant degree. "Certification" of health IT to meet government criteria for financial incentives is unrelated to such measures and is in my view symptomatic of industry regulatory capture (see here and here). The IOM itself has instituted a "watch and wait" policy, a likely unique special accommodation in current regulation of medical devices (see here).
I reiterate this MAUDE data is voluntary and the impediments to its reporting systematic and severe. See addendum to this post.
In the category of good sense on electronic medical records, I note the following articles:
Victoria aims for more open ICT strategy
Pulse+IT Magazine
Kate McDonald
02 October 2012
The newly formed Victorian Information and Communications Technology Advisory Committee (VITAC) has released a draft strategy (PDF) describing how the state government should manage and use ICT to better provide government services.
The strategy recommends that the government engage more closely with the ICT sector and move away from customised products in favour of existing market offerings.
... It recommends that the government engage with the ICT market early in the procurement lifecycle. “We will avoid being locked into single suppliers by favouring open standards and will be open to any qualified ICT provider regardless of size. Procurement of ICT services will be made more efficient.”
The strategy should also provide guidance to agencies to move away from customised major ICT developments and use existing market offerings with little or no customisation instead.
What this means is abandoning the approach of large, single-source (monolithic), proprietary clinical information systems from large health IT vendors that try to cover everything, in favor of smaller, open standards-based "best-of-breed" applications (from vendors of all sizes) that can be woven together to meet users' needs:
The subsequent fallout from the Ombudsman's report led to the Victorian government cancelling several programs, including the $323 million HealthSMART program, an ambitious project to roll out common eHealth infrastructure throughout Victoria's public health services.
This included implementing iSOFT's (now CSC) i.PM patient administration system and Cerner's clinical information system in its hospitals, as well as InterSystems' TrakCare platform for community health agencies.
I note that another article in eHealth Insider mentions the same strategy in the UK, "Winchester switches off Cerner in ED":
The Royal Hampshire County Hospital in Winchester has switched off Cerner Millennium in A&E and moved to Patient First. The electronic patient record system will also be switched off for theatres and order communications at the old Winchester and Eastleigh Healthcare NHS Trust ... Basingstoke and North Hampshire was pursuing an alternative IT strategy, built around a 'best of breed' approach to building on its existing systems.
The U.S. has yet to learn these lessons, and will likely repeat the same mistakes at the cost of hundreds of billions of dollars.
Unfortunately, I have no answers. I see no way to avoid it, considering the HITECH momentum that favors the large-vendor monolithic product model.
-- SS
--------------------------------------
Addendum. Systematic impediments to voluntary reporting of health IT risks:
From the 2010 FDA internal memo on health IT risks:
Limitations of the MAUDE search and final subset of MDRs include the following:
1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including:
... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;
... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;
... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.
2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.
3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.
4. Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.
5. The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.
From the 2012 IOM report on health IT safety:
... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.
Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.
… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.
More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”
Not knowing the magnitude of the risks is an effect of the impediments, and does not represent a good environment for national implementation in my view.
I also add "fear of medical malpractice litigation" to the lists above.
-- SS
Abnormal OGTT Results - The many causes
direct image link |
As often happens, when looking for something a bit more specific, I came across this image at right, which led me to this webpage: Laboratory Testing for Diabetes Mellitus.
Curve 1 is a normal OGTT, Curve 6 is a diabetic. The other causes are listed:
- Hypercorticism - curve 5.
- Acromegaly - between curves 4 and 5
- Hyperthyroidism - curve 4.
- Pheochromacytoma (or "emotional hyperglycemia") - between curves 4 and 5
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