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Readers Write 10/27/09

October 26, 2009 Readers Write 21 Comments

Submit your article of up to 500 words in length, subject to editing for clarity and brevity (please note: I run only original articles that have not appeared on any Web site or in any publication and I can’t use anything that looks like a commercial pitch). I’ll use a phony name for you unless you tell me otherwise. Thanks for sharing!

CPOE Is The Surest Route to Meaningful Use
By Linda Gleespen, RN, BSN

lindag Few hospitals have complete EHRs, so demonstrating Meaningful Use to get government financial incentives looks like a pretty steep hill to climb. But if your institution’s strategy first begins with implementation of computerized physician order entry (CPOE) you will be on the road to success.

The 2011 Meaningful Use criteria for hospitals require the use of CPOE for at least 10 percent of orders, and many of the other requirements can be achieved with CPOE alone. For example, CPOE enables hospitals to collect data for many of the requisite quality measures because they’re related to test or medication orders. Examples include the use of high-risk medications in the elderly, the percentage of eligible surgical patients who received VTE prophylaxis, and the percentage of patients at high risk for cardiac events on aspirin prophylaxis.

Meaningful Use will also require medication reconciliation, which is much easier to do at discharge or during transfers if you have CPOE. And, each hospital will have to show it has implemented a clinical decision rule related to a high-priority hospital condition. My hospital system, Summa Health System in Akron, has created dozens of such decision support rules since we started using the Eclipsys Sunrise Clinical Manager application in 2006. For instance, for stroke care, we programmed a “hard stop” to prevent physicians from prescribing the clot-buster medication tPA if more than three hours have passed from initial onset of stroke symptoms. However, research has now defined clinical scenarios in which this three-hour window can be exceeded.

The beauty of clinical decision support rules is that the application can be altered to adhere to the most current standards of care.

I’m not minimizing the difficulty of successful CPOE adoption. At the two hospitals in my health system that have implemented CPOE, a couple of years of planning were required to prepare for CPOE, and early on, getting physician buy-in was a challenge. However, I’m proud to say that our latest statistics indicate that doctors are entering over 80 percent of their orders directly into the system. Only 8.8 percent of our orders are telephoned in, 7.3 percent are verbal, 2.3 percent are written, and under 1 percent are faxed.

Equally important, electronic order sets are used for 94 percent of hospital orders. These order sets incorporate evidence-based protocols that improve quality and safety, which is the paramount goal of Meaningful Use.

To add decision support features to the order sets, Eclipsys SCM enables us to create customized “medical logic modules” that automate key portions of orders. For example, when doctors enter orders for a patient with pneumonia, they are prompted to enter information about the type of pneumonia and other significant clinical information. The system then auto-selects the correct antibiotics. It functions like an electronic decision tree.

To measure how our order sets are affecting patient care, we compared how closely physicians were following the American Stroke Association and Joint Commission guidelines for stroke care with and without the use of order sets. We found that compliance with best practices was 40 percent higher with the order sets than without them. More important, the use of order sets in CPOE improved outcomes. When the order sets were used, 9.4 percent more patients went home directly from the hospital, and 21 percent fewer patients were readmitted.

By these demonstrations of Meaningful Use, the exceptional quality care and patient outcomes is truly what is meaningful.

Linda Gleespen, RN, BSN, is lead quality and clinical analyst for the Summa Health System of Akron, OH.


EMRs and Interoperability: HIT’s Oxymoron?
By Lynn Vogel, PhD, FHIMSS, FCHIME

ox·y·mo·ron; \äk-sē-‘mor-än\, noun, a combination of contradictory or incongruous words (as cruel kindness); broadly : something (as a concept) that is made up of contradictory or incongruous elements[1]

lynnvogel How odd, you say, to propose as an oxymoron two terms that politicians, IT luminaries, healthcare experts, vendor product brochures, and academic journals typically assume simply and reasonably can and must go together. But do they really go together, or are we just trying to make them fit when maybe they don’t?

Consider the fact that every EMR product on the market today started with a single purpose: to automate the workflow of clinicians within a specific organizational setting, and in the process, seek to make it more efficient and more effective. Among other features, EMRs focus on making data from previous encounters or activities easier to access, assuring that orders for tests and x-rays have the right information, or that the next shift knows what went on previously. In general, in spite of visible successes and failures for all manner of products, EMR products do a pretty good job of automating a complex workflow — of automating intra-organizational clinical processes.

But interoperability, in the sense in which the term is used in today’s discussions about Health Information Exchanges (HIEs), is not about intra-organizational workflow, but about inter-organizational work flow. Recognizing that patients often receive care in a variety of organizational settings — hospitals, multiple physician offices, rehabilitation facilities, pharmacies, etc. — the challenge is to extend the internal workflow beyond the boundaries of individual organizations so that data is available across a continuum of care. Interoperability, then, is not so much about what happens within an organization, but about what happens across organizations.

A major assertion here is that the architectural requirements for automating intra-organizational clinical workflows are very different from the architectural requirements for facilitating inter-organizational interoperability. An intra-organizational architecture focuses on facilitating real-time communications among providers, optimizing the process of collecting data at the point of care, and ensuring that clinical tasks are carried out in an appropriate sequence.

An inter-organizational architecture needs to be designed to minimize the duplicate collection of data in different care settings, to facilitate quick searches of relevant data from a variety of organizational sources, and to rank data in terms of relevance to a particular clinical question.

If these assumptions are true, then one has to wonder whether we can ever achieve true inter-organizational operability using an architecture that has focused for more than a decade on optimizing intra-organizational processes.

An appropriate analogy might be taking a bunch of cars, which were designed to accommodate small numbers of people, and somehow string them together to make a bus in order to accommodate a large number of people with the same goal of moving them from one point to another. Yes, you could make a bus out of cars — no doubt with a lot of effort — but why would you? Requirements for tires, suspension, seats, luggage storage, and even bathrooms are very different for buses than for cars and require a different architecture if you want to build a bus that works. But isn’t that what we are trying to do with current proposals for using EMR architectures to build HIEs?

Maybe it’s time to rethink this approach. Interestingly we don’t have to look very far to find a set of experiences that would make more sense for an interoperability architecture than trying to extend our current EMRs. It’s  the Internet. With millions of different data repositories around the world, an architecture that seems to work most of the time, and increasingly sophisticated search engines for locating data, it would seem that we should be looking more closely at the services-oriented architecture of this ubiquitous example of interoperability rather than trying to string EMRs together and replicate their architectures in an attempt to achieve objectives which were never in their initial designs.

So that’s why EMRs and Interoperability may be HIT’s oxymoron: the architectures may simply be too contradictory and too incongruous to fit together no matter how hard we try. If so, this would add a significant constraint to HIEs that are already being challenged by the sustainability of their business model. Bus manufacturers learned long ago that simply making cars bigger using the same underlying components wouldn’t result in a workable bus. Perhaps there is a lesson here for how we should be thinking about interoperability.

[1] Adapted from http://www.merriam-webster.com/dictionary/oxymoron, accessed on 9/19/2009.

Lynn Vogel, PhD, FHIMSS, FCHIME is vice president and chief information officer and associate professor of bioinformatics and computational biology at The University of Texas M.D. Anderson Cancer Center in Houston, TX.

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Currently there are "21 comments" on this Article:

  1. “We found that compliance with best practices was 40 percent higher with the order sets than without them. More important, the use of order sets in CPOE improved outcomes. When the order sets were used, 9.4 percent more patients went home directly from the hospital, and 21 percent fewer patients were readmitted. ”

    Very interesting. The problem is that these devices have not undergone assessment for overall safety and efficacy.

    Please cite the peer reviewed journal in which that was published? What ere the adverse events that occurred in patients whose care was administered by CPOE order sets? What are your conflicts and what are the hospital’s conflicts? Does the CMIO have a conflcit?

  2. “With millions of different data repositories around the world, an architecture that seems to work most of the time, and increasingly sophisticated search engines for locating data, it would seem that we should be looking more closely at the services-oriented architecture of this ubiquitous example of interoperability…”

    I don’t mean to be a reductionist, but there are two big problems here:

    1) Internet search engines work because all of that data is public. Patient demographics and health data are very private and can’t be publicly accessible.

    2) A SOA would only provide access to existing data silos, not interoperability.

  3. Re: ‘order sets incorporate evidence-based protocols that improve quality and safety’
    Are you able to disclose the type of evidence based protocols or clinical decision support toos used??

    Thanks!

  4. Re : Peer review
    Below is a list of the most cited studies related to HIT, found in a quick review of the academic archives. I didn’t pick the positive studies, I selected the most cited studies.

    Informatics Systems to Promote Improved Care for Chronic Illness: A Literature Review
    “Sixty-seven percent of reviewed experiments had positive outcomes; 94% of uncontrolled, observational studies claimed positive results. Components closely correlated with positive experimental results were connection to an electronic medical record, computerized prompts, population management (including reports and feedback), specialized decision support, electronic scheduling, and personal health records. Barriers identified included costs, data privacy and security concerns, and failure to consider workflow.”
    http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B7CPS-4N3VB7B-5&_user=3742306&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_rerunOrigin=scholar.google&_acct=C000061256&_version=1&_urlVersion=0&_userid=3742306&md5=65cbadfa4f8dabe9988c11f1ff623a73

    Electronic Health Records in Ambulatory Care — A National Survey of Physicians (Cited by 113)
    “Conclusions Physicians who use electronic health records believe such systems improve the quality of care and are generally satisfied with the systems”
    http://nejm.highwire.org/cgi/content/abstract/359/1/50

    Systematic Review: Impact of Health Information Technology on Quality, Efficiency, and Costs of Medical Care (Cited by 356)
    “Conclusions: Four benchmark institutions have demonstrated the efficacy of health information technologies in improving quality and efficiency.
    The advantages of health information technology over paper records are readily discernible.

    http://works.bepress.com/cgi/viewcontent.cgi?article=1005&context=shinyi_wu

    Improving Safety with Information Technology (Cited by 549)
    “Providing reliable, efficient, individualized care requires a degree of mastery of data and coordination that will be achievable only with the increased use of information technology. Information technology can substantially improve the safety of medical care by structuring actions, catching errors, and bringing evidence-based, patient-centered decision support to the point of care to allow necessary customization. ”
    http://nejm.highwire.org/cgi/content/full/348/25/2526

    Information technology payoff in the health-care industry: a longitudinal study (Cited by 187)
    “Our results provide support for the IT-performance relationship that is observed after certain time lags. Such a relationship may not be evident in cross-sectional or snapshot data analyses. Also, results indicate support for the impact of technology contingent on BPR practiced by hospitals. ”
    http://portal.acm.org/citation.cfm?id=1189430

    Reducing the Frequency of Errors in Medicine Using Information Technology (Cited by 431)
    “Conclusions: Appropriate increases in the use of information technology in health care— especially the introduction of clinical decision support and better linkages in and among systems, resulting in process simplification—could result in substantial improvement in patient safety. ”
    http://www.jamia.org/cgi/content/abstract/8/4/299?hits=10&FIRSTINDEX=0&SEARCHID=1013962916801_95&FULLTEXT=nursing+&gca=6%2F4%2F313&gca=8%2F4%2F299&sendit=Get+All+Checked+Abstract%28s%29

    Performance impacts of information technology: is actual usage the missing link? (Cited by 241)
    ” Technology usage was positively and significantly associated with measures of hospital revenue and quality, and this effect occurred after time lags.”
    http://www.jstor.org/pss/4133926

    Now, let’s see these other studies so we can compare and contrast the quality. Anybody willing to compile a list?

  5. Appreciated Bob’s comments; some thoughts in response:
    1. There are numerous examples of “private” repositories on the Internet, and in fact managing/restricting access to both data bases and transactions that work on the Internet is fairly common. Certainly both GoogleHealth and Microsoft’s Health Vault are examples of “private” data repositories on the Internet. Locating data sources and accessing them are two separately manged processes.

    2. Historically, interoperability has been occurred at the data base level–this is the model used today by both vendors and HIEs. This is expensive, requires significant changes in current data bases, and contributes to the discussions about whether HIEs have a long run sustainable business model. Wiith SOA, interoperabilty occurs above the data base level, at the services level and at the presentation level. In the long run, this is both a more flexible and a more cost effective architecture for interoperability. Data remains where it is created, and neither patients nor providers need to take responsibility for moving it someplace else–a huge advantage for making interoperability work.

  6. I have been an infomatics nurse and solution architect for several years and have seen the industry transform from CCOW to some SOA type solutions. Whatever solution is crafted (via interfaces) within any healthcare system today need to force interoperability between the disparate and proprietary systems. The view into the systems is then at the presentation layer or portal. The CIS of the past was a stand alone system and in todays world needs to be more open with the data viewable.

    A) Interoperability between systems can be achieved using the source systems data, using a clinical data repository, an identity matching hub and a portal creating the “view at the glass”. Security can be maintained based on roles and privileges. The view is portable (web based). The portal just allows decision making at the point of care by presenting (into context) the view of the data. Any documentation done today needs to be done into the source system or forced back into it.

    B) Clinical systems being created today need to match the workflow of the clinician. The practitioner – nurse, PA, NP, MD, etc. – need to create templates within the CIS that matches their workflow for a particular patient encounter. they should not be forced to comply with vendor created workflow screens (one size for all). Order entry, wellness monitoring and alerts, referrals, results reporting and radiology (PACS, RIS) then should be incorporated creating the clinical presentation. This can be a single CIS or part of an interoperability solution that combines the best of sevearal systems that suport both inpatient and outpatient settings.

  7. Re : SOA, clouds and web services.

    Redundancy : If the “cloud” goes down, multiple hospitals could be without data for some time. Gmail goes down, Google.com has outages, twitter (with millions of users) can be made unavailable with just a few hundred zombie PC’s. We could have two “clouds” with mirrored data at different locations. What if the hospitals data line goes out? We need redundancy there as well. What about down time plans? Would we still need data downloaded from the “cloud” periodically to a local machine, so downtime reports can be printed?

    Security : Security is an issue with any Web service or “cloud” solution. SSL has been broken with 200 PS3’s (http://blogs.zdnet.com/security/?p=2339). Any other solution short of quantum entanglement will also be broken, in time. Fine when it’s a credit card that’s insured and can be cancelled, not so fine for medical records.

    The cloud and web services have their place, but they are not THE model for healthcare. Cost should not be the primary motivator, security and availability should be.

  8. Lynn,

    what’s your take on the IHE XDS models for cross-enterprsie data sharing ? Would you say that SOA is the way to go instead of XDS ?

  9. Dr. Lynn,

    You are absolutely right on, when you highlighted the need for two different architectures for intra-organizational clinical workflows and inter-organization interoperability.

    Also I agree with you on your Internet example to get a sense what this architecture would look like. The inter-organization interoperability architecture should not duplicate data collection and should facilitate quick searches of relevant data variety of sources and link data to a unified patient index.

    To see this in example you don’t have to look far. IHE’s XDS architecture framework enables inter-organizational interoperability. At a high level there are three components, XDS Registry, Repository and Consumer. XDS registry is a search index of clinical data and XDS repository is a wrapper around existing clinical repository to update the search index(XDS registry). There is an XDS Consumer- essentially a portal that enables a clinical user to view unified EHR on a patient. Essentially its a federated architecture that leverages existing clinical data sources and investment and enables interoperability for a HIE.

    And IHE XDS is based on SOA framework( to answer RadioGuy) and uses web services for communication between the relevant systems. For some reason, IHE doesn’t seem to strike a chord with HIT folks in US where as, its not the same in rest of the world. Is this the reason for HIEs focus or reliant on EMR’s intra-organizational architecture ?

    If you want to see IHE XDS based inter-organization interoperability systems live and running, you just have to come to Canada (currently implemented in Diagnostic Imaging). Its being currently implemented in province of Alberta, Quebec and Ontario all using IHE XDS as a framework and funded by Canada Health Infoway ( a Canadian Federal Organization) that funds Canadian equivalent of US HIE’s.

    Great article to start the right discussion to enable interoperability in Healthcare in US.

    Cheers,
    Saravana Rajan

    http://essarr.wordpress.com/

  10. blah – what does “most cited” have to do with anything? Except perhaps show an echo chamber?

    I don’t think many doubt the benefits of good health IT. The problem is there seem to be too many examples of badly done health IT. The issue is addressing the reasons for that, not arguing over esoteric articles from the Ivory tower or how often they’ve been cited.

  11. “what does “most cited” have to do with anything? Except perhaps show an echo chamber?”

    Ask a scientist. It has nothing to do with echo chambers. This is peer review not the media.

    As for the rest i fully agree.

  12. One of the challenges with these discussions is that terms and concepts that are very different are presented as if they were related. SOA as an architecture really has nothing to do with cloud computing–you can access a cloud via SOA or not, and SOA can be used (and most often is) without regard to a cloud. So architecture and data source can be related, but need not be. Similarly, services do not have to be web based, so again blah is confusing terms that are quite distinct. Security is always a challenge, but no more so with SOA than other architectures. And I would argue that making data available through SOA is much more feasible than trying to move data around.

    XDS is in interesting challenge–and similar to all standards, the question is what do you do (in this case) with documents that don’t meet the standard? And will you still have to move XDS-based documents into a central depository in order to be accessed? XDS and SOA are of course highly compatible, but you don’t have to have all documents meeting the XDS standard in order for SOA to be useful. One of the strengths of SOA is that documents and data do not have to be moved, but can be accessed (or “exposed” in SOA terminology) at their source. The source retains the data, maintains responsibility for keeping data current and with a vested interest in the quality of data it keeps, does not have to rely on third parties for any of these.

  13. I will chime in on the literature topic:

    “Most cited” can be an indication of popularity of an article, which might reflect its scientific merit, or could also reflect its use in supporting others’ research and/or preconceived notions. Popularity is not, however, a measure of scientific validity, and low-cited papers can be equally relevant and valuable. That’s why when my staff did a world comprehensive literature search for drug discovery scientists, we did not consider article popularity, and sometimes had to retain a specialized world literature retrieval company to physically obtain obscure articles existing only in print in, say, a collection in some sleepy corner of the world.

    But citations can be used for other purposes as well, and one of those uses is citation analysis. Citation analysis can be used to trace the evolution of ideas in a field, which ideas and themes are most popular, and ore importantly, which are missing.

    In “Tracing persistent highly visible research themes in medical informatics”, a work by library professor Kate McCain and myself (2007), we examined trends in the informatics literature. We found a significant gap in study of unintended consequences and adverse events from health IT:

    http://en.scientificcommons.org/22790992
    The research presented in this poster examines trends in the field of Medical Informatics through its published literature. We focus on the twelve years since the debut of Journal of the American Medical Informatics Association (JAMIA)—1994-2005. The goal is to identify topics that have persisted in the MI literature and those that are underrepresented or missing, although called for in critical appraisals of the field. Two groups of topics predominate. Many of these topics are of high visibility in both the clinical and consumer literature—CPOE (Computerized Practitioner Order Entry), medical error prevention and cost issues are examples. Other topics such as clinical classifications and vocabularies and medical decision analysis are of significant interest to both MI professionals and clinicians. Some themes that, in our experience, are of growing interest to healthcare informaticians were not visible. These include ethics and legal issues in medical informatics, information technology & health professions education, and telemedicine and social informatics, most especially, sociotechnical issues related to clinical information technology (see http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm). The absence of these topics represents a gap in research and authorship in areas important to the success of health informatics initiatives, especially national EMR initiatives such as have been initiated in the US and the UK supporting culture change and more effective, evidencebased practice. This suggests that medical informatics research and training, while facilitating the improvement of healthcare, may itself benefit from an evaluation of these themes.

    The absence was an interesting observation, and I believe they are due in part to “industry capture” of research in HIT – loosely translated, that means that those who write on these themes may find themselves persona non grata in the industry or even in academia itself, which can see industry as a source of funding grants, consulting opportunities, etc. As an example, the professor in Australia who wrote the paper on ED’s in the EHR in NSW will likely not be getting a position working for a commercial health IT vendor anytime soon.

    The citation analysis findings are also consistent with recommendations by the National Research Council in its report about the inadequacies in current approaches to health IT ( http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572 ) that:

    “…in the long term, [HIT] success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering” [i.e., in order to improve health IT].

  14. On another issue, having a cross disciplinary background in both healthcare IT and pharmaceuticals, I would like to comment on the investigation of health IT by Sen. Grassley.

    He has done a great public service in the pharma industry. To wit:

    Outspoken critics on drug safety issues such as Dr. David Graham, a senior official in the FDA’s Office of Drug Safety often come under fire for their views.

    “A Food and Drug Administration official [Graham] who sought to estimate the harm done to patients by side effects of the painkiller Vioxx said yesterday that his supervisors tried to suppress his conclusions, according to Sen. Charles Grassley (R-Iowa).” Since 1988, Graham has called for the removal of 12 drugs from pharmacy shelves, leading to 10 actual recalls of harmful drugs. Graham told Congress that FDA’s problems with ensuring drug safety were “immense in scope” and left the nation “virtually defenseless” against the chance that unsafe drugs will reach consumers ( International Biopharmaceutical Association. Drug Recall: Effects on consumer confidence, http://www.ibpassociation.org/IBPA_articles/Drug_Recal_%20Effects_on_consumer_confidence.htm ).

    Grassley defends the iconoclast and/or those who fight bad science and industry capture of regulatory agencies, so before condemning him, remember that the drugs pulled by those he’s defended might have otherwise harmed or killed you or your family members.

    — SS

  15. My apologies if I misunderstood the model you were proposing.

    I understand SOA is independent of the web services and cloud services. However, as you said in your article, that’s where its strength lies. As previously mentioned by Bob, it’s strength when discussing the internet is its open and public. Two concepts not suited to our medical records.

    If you are talking about SOA, behind the hospitals firewall, to aid interoperability? I would be really interested in seeing a follow-up article going in to more detail about how you see that working.

  16. S Silverstein: good summation on the citation. It’s certainly not a measure of quality or accuracy. The citation could be used as backup for a certain concept or argument, it could also be a critical citation. I think popularity is a bad word to use though. I think a citation just shows activity. In order to cite, the report must have been read and digested. At that stage you either decide to use the study as background or you may be writing an article to correct or criticism the cited article. Either way that represents an extension of the review process. While it’s true that there may be fantastic studies out there with few citations its equally as true that a study with over 300 citations (in the HIT field) is either controversial or well respected. I quickly checked before posting the list, that the citations were not mainly negative (anybody can do the same by clicking the links and clicking the citation link). I could have picked random studies, but that would have been meaningless. Citation indexes are widely used, with caution, in most fields of research. They are certainly no substitute for editorial peer review, but they can be useful.

    I posted the list as a challenge to the people deriding HIT to bring the none anecdotal evidence. However I think it also shows something else; that there is plenty of activity in academic studies covering HIT. Another charge, frequently made in the comments, there are few studies. I was suppressed how many studies have been carried out.

  17. XDS is a framework that uses existing standards like HL7 and DICOM and on top of that uses ebXML and SOA concepts to make it truly service oriented. So practically any clinical document that’s defined in HL7/DICOM can be shared inter-organizationally using XDS framework. So you don’t have to have all the documents to be defined by IHE for achieving interoperability goals using XDS.

    And you don’t need to move XDS based documents to a central repository for accessing them. Leave the documents / clinical data where it is and access it using an adaptor or wrapper componet that takes the legacy data(hl7 2.x) and wraps it with XDS to enable XDS and SOA. And any strength of SOA can be directly transferred to XDS as well, as SOA is a building block that’s used by XDS.

    SOA is a generic architectural framework and XDS is a manifestation of SOA for healthcare that also encompasses the existing healthcare standards like HL7 and DICOM.

    Cheers,
    Saravana Rajan,
    http://essarr.wordpress.com

  18. Blah,

    your points are wll taken. As I hope most know, I have long written that health IT can achieve the benefits claimed for it, with the caveat that only when done well.

    I can also add that absence of evidence in not evidence of absence regarding unintended consequences (UC’s) of health IT, events none of us ever want to see. UC’s need to be eliminated.

    A relatively smaller number of UC studies and articles compared to the positive findings studies and articles could have many possible causes. We need to know which of those causes is/are operative, ranging from, on one extreme, the possibility that unintended consequences never occur, to the opposite possibility that they occur in hair raising numbers but are not reported on, due to what really are social reasons, or somewhere in between. I do not believe we know the true rates of UC’s with any certainty in 2009.

    I think the HIT industry can learn from the pharma industry. Per observations of my blog colleague:

    —————————————————–

    … A new study in the Archives of Internal Medicine focused on how articles report adverse effects found by clinical trials. [Pitrou I, Boutron I, Ahmad N et al. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med 2009; 169: 1756-1761] The results were not encouraging.

    The investigators assessed 133 articles reporting the results of randomized controlled trials published in 2006 in six English language journals with high impact factors, that is, the most prestigious journals, including the New England Journal of Medicine, Lancet, JAMA, British Medical Journal, and Annals of Internal Medicine. They excluded trials with less common designs, such as randomized cross-over trials. The majority of trials (54.9%) had private, or private mixed with public funding.

    The major results were:
    15/133 (11.3%) did not report anything about adverse events
    36/133 (27.1%) did not report information about the severity of adverse events
    63/133 (47.4%) did not report how many patients had to withdraw from the trial due to adverse events
    43/133 (32.3%) had major limitations in how they reported adverse events, e.g., reporting only the most common events (even though most trials do not enroll enough patients to detect important but uncommon events).

    The authors concluded, “the reporting of harm remains inadequate.”

    An accompanying editorial [Ioannidis JP. Adverse events in randomized controlled trials: neglected, distorted, and silenced. Arch Intern Med 2009; 169: 1737-1739] raised concerns about why the reporting of adverse events is so shoddy:

    …”Perhaps conflicts of interest and marketing rather than science have shaped even the often accepted standard that randomized trials study primarily effectiveness, whereas information on harms from medical interventions can wait for case reports and nonrandomized studies. Nonrandomized data are very helpful, but they have limitations, and many harms will remain long undetected if we just wait for spontaneous reporting and other nonrandomized research to reveal them. In an environment where effectiveness benefits are small and shrinking, the randomized trials agenda may need to reprogram its whole mission, including its reporting, toward better understanding of harms.”

    I think there are lessons to be learned from this regarding IT.

    — SS

  19. I want to comment on the very good Vogel article posted on October 27. I agree with 99% of the information in the article as well as many of the article’s comments (SOA, XDS, etc.).

    However, I believe that too many provider organizations suffer from an inability to exchange information within their own boundaries — i.e., intra-organizational interoperability, architectures, and workflow. No wonder it’s difficult to try to exchange information externally when organizations cannot even exchange the information internally. (Maybe MD Anderson is different!)

    Yes, today’s discussions about HIEs are about inter-organizational interoperability, architectures, and workflow. And this might be HIT’s oxymoron.

    But too many individual organizations suffer from duplicate collection of data in their different care settings, can’t facilitate quick search of relevant data from a variety of their intra-organizational sources, and cannot rank data in terms of relevance to a particular clinical question — all design specs of inter-organizational architecture, as proposed by Vogel.

  20. Appreciate Saravana’s further clarification of the contribution of XDS. One of the challenges here would be for documents/data that do not meet XDS/HL7/DICOM standards and still need to be accessed inter-organizationally.

    Deborah’s comments are right on target–although I will say that MD Anderson has made significant strides using SOA to facilitate intra-organizational data availability. Single vendor solutions try to solve this problem by expecting customers to purchase all their products from a single vendor–works well with some, less so with others, and of course makes inter-organizational interoperability even more challenging and our oxymoron claim a little more legitimate!

  21. last week I commented on an article, here, http://histalk2.com/2011/09/14/readers-write-91411/, which was about interoperability. I stumbled across it and I am NOT a health IT expert, so please forgive me if I don’t know all of your jargon.

    I looked to see if I had a response to my questions, this was about Epic systems, and I see no answer. Forgetting about the particular company, Epic, what really concerns me is that there doesn’t seem to be any agreement in your field about whether interoperability is even possible.

    I researched Epic and there is some talk about the CEO of that firm (forget name) being on a government board that is supposed to implement interoperability, although some say this person’s company doesn’t believe in it.

    What I want to know is, will my doctor be able to share records with my surgeon if the two don’t use the same system of platform from the same provider? Is Epic actually the norm, in other words, that none of these systems can communicate with one another, and if so, then why is a government board trying to make this happen?

    I don’t care about all the politics, which the article I referenced seems to be all about, but I DO care about whether or not my records would be safe and whether or not they can be shared with the people I WANT sharing them.

    Can anyone help me?

    Lance







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