Uwe Reinhardt said it perfectly in a Tuesday plenary but I can only paraphrase his point: “health information is a public good that brings more wealth the more people use it.” Or, as Doc Searls puts it: personal data is worth more the more it is used. Datapalooza is certainly the largest meeting of the year focused on health data, and our Health and Human Services data liberation army was in full regalia. My assessment is: so far, so good but, as always, each data liberation maneuver also reveals the next fortified position just ahead. This post will highlight reciprocity as a new challenge to the data economy.
The economic value of health data is immense. Without our data it’s simply impossible to independently measure quality, get independent second opinions or control family health expenses. The US is wasting $ 750 Billion per year on health care which boils down to $ 3,000 per year that each man, woman and child is flushing down the drain.
Data liberation is a battle in the cloud and on the ground. In the cloud, we have waves of data releases from massive federal data arsenals. These are the essential roadmap or graph to guide our health policy decisions. I will say no more about this because I expect Fred Trotter (who is doing an amazing job of leading in this space) will cover the anonymous and statistical aspects of the data economy. Data in the cloud provides the basis for clinical decision support.
On the ground, where $ 2.7 Trillion of clinical decisions are made one patient and doctor at a time, the data liberation weapon of choice is Blue Button and Blue Button+. Blue Button is the patient’s ability to download and to transmit a useful health record to Anywhere. The economic impact of Blue Button follows from the power of Anywhere to liberate data for independent analysis and even competition. Meaningful Use Stage 2 mandates this foundation for data liberation but stops well short of actually making it timely, complete or scalable to the extent required for it to have economically meaningful impact on our $ 3,000 per year.
Blue Button + adds automation and scalability on top of the MU2 mandate and shows us, for the first time, a path to patient-directed health reform. Blue Button + enables the cost-effective delivery of second opinions. This technolgy will allow every patient to access independent information about risks and costs. Think Consumer Reports for your costliest and most life-changing decisions.
Unfortunately for us and for the federal regulators, Blue Button + is not part of Meaninful Use Stage 2. Adoption of BB+ to the extent needed to have a real impact on health reform therefore has to be driven by public relations extravaganzas like Datapalooza, by the power of the purse in federal EHR and state health information exchange procurement and, most important, by the leadership of corporations that stand to gain from data liberation. This private-sector leadership leads to the issue of reciprocity.
Reciprocity is the commitment by every data holder that benefits from Blue Button data liberation to implement Blue Button +. Reciprocity is essential for a network effect that enables the explosion in the economic value of our personal data.
Datapalooza brings together all of the hopeful beneficiaries of data liberation: Personal health records in the cloud, personal health records on your smartphone, health records in your state health information exchange, in the state all payer claims database, in a research project or clinical trial and in all of the other private and public-sector systems that are not your health care provider or insurance company.
Data liberation reciprocity is simply the call for everyone that has data about me to give me convenient and standardized access to my data via Blue Button +. The beneficiaries of data liberation are not subject to Meaningful Use and some are not even subject to HIPAA. Their voluntary adoption of Blue Button + is absolutely essential to the network and economic effect. This is the reason for reciprocity.
Data liberation should not have to wait for even more federal regulation. The voluntary adoption of Blue Button + reciprocity by corporations that are not covered by HIPAA and HITECH will bring public pressure to bear on hospitals and state dataholders that we are forced to use to adopt Blue Button +. I expect Blue Button + in my hospital and anyone else that has my personal health data before next year’s Datapalooza.
Adrian Gropper, MD is Chief Technical Officer of Patient Privacy Rights and participates in Blue Button+, Direct secure messaging governance efforts and the evolution of patient-directed health information exchange.
Social Security and Medicare Boards of Trustees
Over four years of Congresses, Sage Bionetworks has drawn together leading thinkers and doers throughout the fields of genetic research and drug development. For two days each year, the conference floor is colonized by clumps of eagerly networking PhDs from academic, pharma, government, non-profits, biotech firms, and patient advocacy groups–people who often glide from one domain to another within this tight-knit cohort.
A cohort, certainly, we can characterize this group of attendees, sharing as they do a mysterious language drawn from years of research most of us will never understand. But is it a community? That will be tested over the following year as Sage Bionetworks lets go of the Congress. Founder Stephen Friend says it is up to others to create the next Congress, and its success or failure will be a measurement of the sweat and passion that Friend and Sage have put into attempts to build a community.
Why should a reader look further at this struggle among a tiny elite, rather than clicking on the next article? Well, first, if you’re one of the 48% of Americans who took a prescription drug this month, you should be concerned about where new breakthrough drugs will emerge. If you visit this web site because you want a more responsive health care system that can match patients to treatments more quickly and cheaply, recognize that new methods are important nowhere as much as at the foundation of the system where new treatments are discovered. And if you are just curious about the potential for global cross-institutional teams and loose networks connecting experts with ordinary members of the public to find creative solutions to old problems, this article will provide insights.
Don’t get too close, you don’t know what I have
The premise on which Friend founded Sage is that research and drug development have stagnated and cannot progress without more collaboration and data sharing. Therefore, with all due regard for the presentations at the recent Sage Congress on cancer research projects and other individual experiments, the real theme of the conference is in the keynotes about open source, the use of social media, and crowdsourcing. The challenge of this community–if we find that it has indeed become a community–is to analyze and deal with the particular challenges that genetic research and drug development inject into trends toward open collaboration.
It’s hard to determine who has a higher aversion to sharing data: pharma or academia. The starter in the pharma compound is their fear that someone else will discover and patent the billion-dollar drug they’ve been sleuthing after, into which they mix in the worry that publicizing negative trials will lead to their drug’s rejection.
Academics mirror these disincentives, panicking that they’ll lose the race to discovery or that their methods of massaging their data will wither under the harsh light of review. Furthermore, academics are acutely aware of the accomplishments that garner promotion, tenure, and the funding of grants. The mundane tasks of preparing and cleaning data earn them nothing in those areas.
What can detoxify these tendencies to remain isolated? Moral persuasion has limited effect, so the main vector of attack is a growing understanding that tried-and-true research methods are petering out and need some radical rethinking. As I reported from last year’s Congress, the costs of drug development are rapidly increasing, and fewer truly novel drugs are being submitted to regulators for approval over the years.
Stung by evidence that many drugs approved for use are not as safe or efficacious as promised, the FDA has tightened its requirements for Phase 3 testing, which taxes the resources drug companies put into development and further lengthens the time between the patenting of a compound and its actual sale. The “patent cliff” that the drug companies are facing, as lucrative compounds enter the public domain and fewer new ones replace them as sources of revenue, has been widely reported.
Researchers in both pharma and academia have started to cast longing glances at the repositories of data and computer code maintained by other researchers. Just as public health can be judged much better from a nationwide database than from an individual hospital’s case load, genetic research can benefit from larger collections of samples. Still, data is finicky. We’ll look further at some of the complications of data sharing and collaboration.
Pharma companies will continue to hold their cards close to the chest when testing compounds (drug products), but will probably share more data about activities that go on outside their core research, such as tests that validate the efficacy and safety of drugs. Public pressure may convince them to release the data from negative trials, which may save researchers a lot of time when looking for other compounds.
Changing the equations for rewarding research
What incentives can the field offer academic researchers whose careers revolve around publishing papers? One tactic can be borrowed from NIH, which now requires all grant recipients to put their data in public repositories. One manager at the National Cancer Institute lamented that although government agencies require grantees to submit a plan for data sharing, the agencies don’t actually follow up to see that the plan was carried out. So journals can do even better than the federal government in this area.
Further incentives for sharing research data include citations for data sets, which are supported in science by the notion of a Digital Object Identifier (DOI). The field can now track the reuse of data just as it tracks citations in journals.
WikiPathways allows researchers to share information they have about relationships between genes and diseases. As a wiki, the site lets the public edit information about these pathways. But visitors can also search for overlaps and other key relationships.
A platform like Synapse can let writers post drafts of papers that are associated with data stores. Publishers can follow these along and benefit from the free peer review provided by comments. Not only do they make papers better, they help the publisher decide what’s worth publishing. Could these ongoing comments–sometimes called pipelined peer review–substitute for formal peer review? One publisher assured us they would not, but the possibility remains that someday they will, cutting publishers totally out of the distribution of research results.
Room for the patient
Arcane and complex as genetic research is, Sage and its collaborators are committed to bringing patients into the planning process. A number of separate efforts aim at maximizing patient control.
The most familiar kind of patient involvement is the militant advocacy seen in the movement of AIDS victims, chronicled in a talk by HIV researcher Joep Lange. Luckily, both the AIDS professionals and other medical researcher have developed more collaborative relationships with patients as well.
Why should patients determine research goals? Surprisingly, perhaps, genetics researchers in their zeal to uncover causes and treatments often miss what the patients feel is most important to them. Take Fanconi Anemia, a terrible condition involving the blood that gives its victims an average life expectancy of 30 years. One of Fanconi Anemia’s most feared impacts is a higher risk of developing cancer that can drastically shorten the patient’s life. So patients would like researchers to focus on ways to predict cancer and catch it early, not a direction that the research community would discover on its own.
Fanconi Anemia is one of the first areas on which Sage is focusing in its Bridge project. Just in its preliminary stages, Bridge aims to tie patients, doctors, and researchers together. Patients will be abloe donate genetic data and information on their conditions, propose and fund trials, and suggest directions for research. If drafts of papers are posted online during development, Bridge members will be abloe comment on them. The hope is that all this will lead to better research and faster cures.
Bridge will provide a platform for sharing and patient participation that is more open than services such as 23andMe and PatientsLikeMe. In his opening remarks, John Wilbanks laid out three models for medical research. The first is a collection of dynamic but independent companies withholding data for competitive reasons. The second model encompasses relatively recent innovations like 23andMe and PatientsLikeMe. The third is the commons that Sage would like to build. This commons is based on a recognition that progress is not just a series of discrete steps that can be monetized or turned into grant opportunities, but an ongoing exploration involving loosely organized groups of people from many backgrounds.
Consent forms are another area of research under Sage’s microscope. Current forms leave much to be desired. Still in recovery from an era many decades ago when patients were mistreated and kept from a full understanding of what researchers were doing, current consent processes are very heavy-weight and hard for patients to understand. Furthermore, they throw up walls against the kind of data-sharing that Sage promotes.
Meanwhile, popular social networks for patients rely on advertising and other services that aggregate patient data for revenue. These raise privacy concerns for some patients, and make them wonder about the motives of the sites’ owners.
Sage has developed a portable legal consent process that steps the patient through the benefits and risks of sharing (including the risk of re-identification) and lets the patient choose the degree of sharing permitted. Many patients are scared off by the process, quite properly, but those who make it through and decide to sign the consent open up their data to a great many more researchers. Portable legal consent was discussed in depth at last year’s Congress.
When ordinary people get involved in experiments, they can measure personal information (phenotypic data) in their homes and vastly increase the quantities of data available to researchers. Quantified Self enters the lab. But such an innovation, of course, raises questions of how trust data submitted by the patient.
The commitment of Sage to patient control was evident in the range of patient advocates and others who spoke of its importance at the conference. Greg Biggers of Genomera was just one of the experts testifying to the possibilities and potential of bringing patients into the process. The paper describing the results of Sage’s successful breast cancer prognosis challenge offered to develop means for patients to “work alongside Challenge participants” in the future.
The power of positive thinking
It’s easy to provide a forum for public comment and input, but usually unproductive to do so. Whether on the White House’s We the People petition site or Wikipedia, the trick is to find a strategy that encourage participants to contribute positively, not just to carp and tear each other apart.
Let’s review the article and see some of the ways to make participation bear fruit in medical research:
- Helping people form communities with shared goals, such as Bridge.
- Giving patients more of a say in what research is conducted and how it is conducted.
- Safeguarding patient privacy. This is particularly important for populations whose conditions are stigmatizing, such as veterans suffering from neurological damage.
- Providing clean, reusable data and code to researchers, which involved incentives for them to prepare the data and code and describe its provenance. This involves the adoption of standards.
- Requiring data and code to be shared as a condition for funding or publication.
- Running challenges such as the Sage/DREAM breast cancer challenge
What will the coming year see?
The Sage vision for sharing and collaboration is completely in harmony with famous projects outside medicine, including open source software, Wikipedia, Mechanical Turk, and open government initiatives. The means are often also familiar: code repositories in the style of GitHub, challenges, etc.
But many participants at Sage Congress each year need reassurance that these strategies can work. This seemed to be the goal behind lining up such keynoters as Wadah Khanfar, cofounder of Al Jazeera, who talked about openings and transformations in the middle each, Bob Young, founder of Red Hat, and Jennifer Pahlka, founder of Code for America.
Audience members raised typical worries about being open while raising money to get a project done. John Wilbanks, who came from the Creative Commons foundation to lead Sage’s work on portable legal consent, pointed out that making more code and data into free public resources will drastically reduce costs. Still, the attendees are right to be concerned, because research in genetics runs at several million dollars a pop.
Fluctuating buy-in and resistance raises the question whether Sage’s strategy will break through into the mainstream. The conference ended with announcement that surprised even one of Sage’s advisory board: Sage will no longer organize the Congress it has held for the past four years.
Friend’s stated reason for giving up control over the Congress was that Sage is now a player with its own agenda and that the Congress needs to reflect the needs and input of more stakeholders. I suspect the announcement was also meant to put pressure on organizations that have failed to move as fast as Sage. Sage’s work on Synapse, portable legal consent, challenges, and other areas have outstripped the abilities of potential users. It’s time for them to make similar efforts.
But I think Friend has measured his own prospects carefully, and that the announcement was preceded by behind-the-scenes negotiations with key funders and players in genetics and pharma. I expect to see a Congress next year, and to see progress in community-building for which Sage has laid a foundation.
Parts of Sage Congress were videotaped and posted online.
Andy Oram is an editor at O’Reilly Media, a highly respected book publisher and technology information provider. His work for O’Reilly includes the influential 2001 title Peer-to-Peer, the 2005 ground-breaking book Running Linux, and the 2007 best-seller Beautiful Code.
A new Op-Ed by Kellerman and Jones entitled “IT in health care is MIA“ appeared on Mar. 3, 2013 in the Pittsburgh Post-Gazette.
Because information technology has so quickly transformed people’s daily lives, we tend to forget how much things have changed from the not-so-distant past. Today, millions of people around the world regularly shop online; download entire movies, books and other media onto wireless devices; bank at ATMs wherever they choose; and self-book travel while checking themselves in at airports electronically.
But there is one sector of our lives where adoption of information technology has lagged conspicuously: health care.
Some parts of the world are doing better than others in this respect. Researchers from the Commonwealth Fund recently reported that some high-income countries, including the United Kingdom, Australia and New Zealand, have made great strides in the use of electronic medical records among primary-care physicians. Indeed, in those countries, the practice is now nearly universal.
Yet some other high-income countries, such as the United States and Canada, are not keeping up.
Of course, the U.K. recently suffered a rather severe blow, on the order of 13 billion Pounds’ worth, to its National Programme for Health IT in the NHS (NPfIT). Australia is not exactly an “Emerald City” in terms of health IT, either, as can be seen from numerous links at the blog of Sydneysider Dr. David More, Australian Health Information Technology.
The RAND authors throw in some boilerplate grandiose predictions of certainty about health IT, which seems to have become a common phenomenon in newspapers and even scientific publications of late:
… The U.S. government is trying to help. In 2009, Congress passed the Health Information Technology for Economic and Clinical Health Act. HITECH has undeniably accelerated IT adoption, yet the problems of usability and interoperability persist.
… The sky is the limit when it comes to potential gains from health IT … The payoff will be worth it. Indeed, as with the adoption of IT elsewhere, we may soon wonder how health care could have been delivered any other way.
Read the whole Op-Ed at the Gazette.
(My mother, an unwitting expert with significant experience on health IT adverse effects, is unavailable for comment, as she is dead due to a HIT-related accident.)
However, another expert is available:
Reed D. Gelzer, MD, MPH is an EHR/HIT systems and policy analyst for private and Federal agency clients, primarily in program integrity and clinical quality support. In clinical practice for 11 years before transitioning into health IT, he also co-chairs the HL7 Records Management and Evidentiary Support (RMES) Workgroup. He served US Navy Medicine’s Data Quality Office, various private insurers, as well as three years on CCHIT workgroups. He was the Prevention Workgroup Chair for the 2007 ONC study on mitigation of EHR mediated waste fraud and abuse.
I find his opinions posted at the Gazette comment board of interest. Some of the themes are very familiar. His comments are reproduced here with just a few comments of mine interjected:
Good afternoon Mr. Kellerman and Mr. Jones,
Thank you for the recitation of the arguments for HIT. I am particularly pleased that you note that a principle block to advancing HIT in the US is the fact that systems are not standardized.
One of the reasons many of our Industrialized Nation peers are far ahead of us is that they, in effect, standardized their systems by having one customer, a government entity operating health care. I assume you are not proposing that. If not then what, in the absence of regulation, will achieve your proper objective of standardizing HIT?
Well, we could simply let the market decide among the current non-standardized, non-regulated systems by accepting the accompanying burdens of cost, patient harms, and highly variable to unreliable data, and so on, in a nationwide experiment using the citizens of the U.S. as the test subjects [without informed consent or opt-out provisions, I might add - ed.] . A free market though would necessitate an absence of market-corrupting subsidies and transparency on comparing products, so that we can all equally hear when systems don’t work as expected or cause problems for users, clinics, hospitals, and patients. No subsidies, no advantage to legacy vendors, and publicly available information about system problems, defects, and harms for a free market in HIT seems as unlikely as a single payer, government run system in the U.S., so what other options do we have?
We could say, we as a country want to improve this faulty and expensive industry, and so that is what we will hold providers responsible for. Doctors, hospitals, nurses, clinics, everybody -You have a duty to achieve better. IT is a means, not the end. Purchase and apply the tools you decide you need to fix the problems you see. If you find you cannot do it, then close your doors and go to work for someone who can.
In support of this, as we do with drugs, we do not expect doctors, hospitals, nurses, clinics to independently research what is safe, what is usable in medications, in lab and imaging equipment and medical devices. We make sure that the tools available are safe, reliable, and do what they are intended to do. We do not de-regulate pharmaceuticals to speed innovation [due to the common claim by HIT hyper-enthusiasts that regulation would harm IT innovation, one might surmise they presumably would support pharma deregulation as well - ed.], we regulate minimum requirements of safety and efficacy so that such tools of medicine can be delivered to the bedside without the clinicians having to spend hours worrying about whether they’re even fit for use.
Improving the safety, value, and effectiveness of patient care is not dependent on HIT. Fit HIT is an indispensable enabler of KNOWING that we are doing our best and KNOWING where we are falling short and where improvements can best be directed.
Meanwhile, there can be no doubt that we will increasingly regulate HIT simply because it is the only way we can ever have non-anecdotal and systematic reporting on what HIT actually does (or doesn’t do) for benefiting patients. Otherwise we will continue to be stuck where we are now: between a defective government policy that has bought the vision and promise (and there’s a “no return” policy) without evidence, and the accumulating evidence of the difficulty, complexity, costs, and harms rendered by the current national experiment. [This evidence is often ignored or denied by the hyper-enthusiasts - ed.]
Again, thank you for reiterating the necessity of standardization. This should progressively elevate the attention to the vast library of HIT standards existent (and still evolving) that remain unused by vendors. Not just vendors, though. Standards also remain unused by doctors, nurses, hospitals, and clinics (and their organizational advocates) who still, amazingly do little, if any due diligence on the fitness of HIT to their use as patient care tools and records thereof. [This is known as "negligence" and perhaps "gross negligence" - ed.] Given that Meaningful Use has lowered the Certification bar so much lower than it was in 2009 and since subsidies have made it a Sellers market (and a race to avoid penalties) it is hard to imagine how the geometric progression of risk of non-standardized [systems] untested for safety, usability, or fitness will not assure pain and suffering of many kinds for years to come.
I look to you RAND to project your dynamic model for how Standardization will be achieved. In the meantime, of course this means that, among other things, they are not standardized for fitness in use for patient care.
RDGelzer, MD, MPH.
These are good thoughts.
I repeat my warnings that until sanity and caution is restored to the health IT sector (or started, as it may never have existed) it is not likely that “we may soon wonder how health care could have been delivered any other way.”
Health Care Renewal
An often repeated saying in health care goes that patients lose about 80% of the information they heard during a doctor’s appointment by the time they reach the parking lot. It emphasizes that patients aren’t able to put followup care instructions into practice when they either forget or don’t comprehend what was said during a visit. Whatever the actual percentage might be, a guaranteed way to ensure that patients take home 0% of that information is to talk to them in a language they don’t understand.
Twenty percent of the United States population reported that they speak a language other than English at home, according to the U.S. Census Bureau. Many health care workers see limited English proficient patients every day, and within Accountable Care Organizations (ACOs) and Patient-Centered Medical Homes (PCMHs) it will be up to these workers to make sure that patients have the best health outcomes, no matter how high the language barriers are.
Today HealthEd Academy released the results of a survey that looked at the way non-MD health care professionals interact with their patients from multicultural backgrounds. The report examined responses from a survey of 192 health care extenders, which included nurses, social workers, pharmacists, patient educators, and more. One in five of those surveyed were part of an ACO or PCMH.
The respondents reported working with a huge array of languages. They were asked to name the most common languages spoken by their patient populations, and four out of 10 checked “other,” despite being able to choose from 10 languages identified by the Census Bureau as the most commonly spoken. Among the languages respondents wrote in were Arabic, Yiddish, several Indian/Pakistani languages, and sign language.
“An alarming finding is there is such a large potential for miscommunication between health care extenders and patients, and that can have all sorts of health and safety ramifications,” said Katherine Margolis, PhD, one of the lead analysts of the survey and director of health behavior strategy and research at HealthEd Academy. And health care workers certainly don’t have all of the patient education materials they need in each of the languages they need them in. Margolis said that materials are typically developed in English first, then in Spanish, but it usually ends there.
Another interesting but not entirely surprising finding from the report was a statistic about the respondents themselves. More than 80% are Caucasian. HealthEd Academy said this reflects the current racial profile of health care extenders in the U.S., citing other national surveys like ones that found that 83% of registered nurses are white, and so are 82% of registered dietitians.
Half of HealthEd’s survey respondents reported that they are making an effort to recruit staff that better reflect the populations they serve. “I think it will be interesting to see how the demographics shift in time because I think it’s only a matter of time before they do. The U.S. Census has reported that over 50% of people under the age of one are from a minority group,” Margolis said.
Some of HealthEd Academy’s other findings from this report include that:
- Health care extenders usually forgo technology and primarily deliver education materials in print or in person
- Health care extenders involve minority community members less often than they involve health care providers when designing patient education materials
- Patient education is provided at many community locations, but it’s rarely provided at pharmacies
The report is full of examples of what health care professionals are doing to better care for their patients from minority populations. For example, in addition to using interpreters, many said that they are currently working on translating patient education materials into other languages. HealthEd Academy pointed to existing resource Healthy Roads Media for help with this. Healthy Roads is a grant-supported organization, which creates materials in all different languages in written, audio and mobile formats. The report highlights other tools health care extenders can use to serve all of their subpopulations and concludes that providing this kind of tailored care is complex, but it’s critical.
What If the Institute of Medicine Wrote a Report and Nobody Followed it? – the Case of the Standards for Developing Trustworthy Guidelines
For over 20 years, clinical practice guidelines (CPGs) have been touted to improve health care quality and control costs. Enormous numbers of guidelines have been developed, but with seemingly little impact on health outcomes. While some of those leading health care organizations have predictably blamed individual practitioners for obstinately ignoring or challenging guidelines, there is increasing evidence that maybe the guidelines themselves are part of the problem.
An Example of a Guideline that Apparently was Not Trusted
One example Dr Wally Smith and I have taught in our recurring mini-course on why physicians fail to follow guidelines (and otherwise appear not to practice in accord with others’ wishes) is that of the guidelines on management of depression in primary care. Most existing guidelines urge physicians to screen patients for (presumably mild-to-moderate) depression and treat them aggressively, with emphasis on the use of the newer anti-depressants. These guidelines, in turn, were based on numerous published randomized clinical trials that showed that these drugs were safe and efficacious. Yet multiple studies showed that physicians failed to follow these guidelines, and various attempts to improve their adherence did little. So for years the assumption was that physicians at best experienced practical and system barriers to follow these guidelines, and at worst were ill-informed or irrational.
However, information that came out gradually during the early part of the 21st century suggested that perhaps the problem was within the guidelines, not the health care professionals. First, documents produced during New York Attorney General Eliot Spitzer’s lawsuit against GlaxoSmithKline about the marketing of one of these drugs (Paxil, paroxetine) suggested that the company had suppressed clinical trial data that reflected poorly on the drug (See Kondro W. Drug company experts advised staff to withold data about SSRI use in children. Can Med Assoc J 2004; 170: 783. Link here.) These suspicions were later fleshed out by consideration of documents further disclosed in litigation (e.g., see this post and its links). Then several studies, most particularly that by Erick Turner and colleagues, showed that numerous trials of new anti-depressants had been suppressed, that is, never published (Turner et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008; 358:252-260. Link here). When the results of these trials were added to those that were published, the efficacy of anti-depressants was no longer so clear. So maybe the guidelines that physicians did not follow were not trustworthy, and should not have been followed in the first place.
Would IOM Standards to Improve Guideline Trustworthiness Help?
So in 2011, the prestigious Institute of Medicine released a report on the development of better standards to produce more trustworthy guidelines (Clinical Practice Guidelines We Can Trust. Link here.) We posted about that report here, but noted that it was receiving little other attention, an example of the anechoic effect.
A few weeks ago, an article appeared documenting a study meant to assess the the trustworthiness of clinical practice guidelines published soon after the IOM report. Its title telegraphs the results. ( Kung J, Miller RR, Mackowiak PA. Failure of clinical practice guidelines to meet Institute of Medicine standards: two more decades of little, if any progress. Arch Intern Med 2012. Link here.)
Methods and Results
The investigators selected a random sample of 114 individual guidelines available during June, 2011 stratified by 26 clinical topics. The versions of the guidelines used were those archived in the National Guideline Clearinghouse (NGC) maintained by the Agency for Healthcare Research and Quality (AHRQ).
The goal of the study was to “examine adherence to the IOM standards” by guidelines published after the standards were published. Actually, the study only assessed adherence to 18 of the 25 standards espoused by the IOM (because the remaining seven were “too vague and subjective to be analyzed.”)
Furthermore, the criteria used to determine if a specific guideline met each of the three items above were rather lax:
In evaluating each guideline summary, care was taken to be as liberal as possible in considering that a standard was met when the individual guideline summary provided any information pertaining to that particular standard.
Nevertheless, using these lax standards to only evaluate adherence to 18/25 guidelines, the authors found that “the overall median number of IOM standards satisfied (out of 18) was 8 (44.4%) …. Fewer than half of the guidelines surveyed met more than 50% of the IOM standards.”
An examination of the details of the study’s methods reveals things are even worse than that.
Analyzing the Study’s Methods to Find that Things Are Worse Than They Seem
Review of the study’s methods show that they provided a very optimistic view of adherence to the IOM standards. As noted above, the study did not look for adherence to all of the IOM standards. Moreover, those they did consider were simplified and made less rigorous. For example, Standard 2 from the IOM on management of conflict of interest (COI) was:
Management of conflict of interest (COI)
Prior to selection of the Guideline Development Group (GDG), individuals being considered for membership should declare all interests and activities potentially resulting in COI with development group activity, by written disclosure to those convening the GDG.
- Disclosure should reflect all current and planned commercial (including services from which a clinician derives a substantial proportion of income), non-commercial, intellectual, institutional, and patient/public activities pertinent to the potential scope of the CPG.
Disclosure of COIs within GDG
- All COI of each GDG member should be reported and discussed by the prospective development group prior to the onset of their work.
- Each panel member should explain how their • COI could influence the CPG development process or specific recommendations.
- Members of the GDG should divest themselves of financial investments they or their family members have in, and not participate in marketing activities or advisory boards of, entities whose interests could be affected by CPG recommendations.
- Whenever possible GDG members should not have COI.
- In some circumstances, a GDG may not be able to perform its work without members who have COIs, such as relevant clinical specialists who receive a substantial portion of their incomes from services pertinent to the CPG.
- Members with COIs should represent not more than a minority of the GDG.
- The chair or co-chairs should not be a person(s) with COI.
- Funders should have no role in CPG development.
However, the study boiled all this down to three items:
- COIs stated
- Chair has COI
- Co-chairperson has COI
Thus the study did not address standards requiring full and complete disclosure (not just some disclosure) of all COIs; consideration of how the COIs might influence the particular guideline; divestment of specific types of conflicts of interest, that is, financial investments, and cessation of participation in marketing activities or advisor boards; minimization of conflicts of all members of the committee; and barring of participation of funders in guideline development.
Even so, the guidelines assessed did a very poor job upholding even these few liberalized standards regarding conflicts of interest. Of the guidelines assessed, less than half, 46.8% provided ANY disclosure of conflicts of interest. Those written by sub-specialty societies were particularly opaque in this regard. Less than one-third, 29.3%, provided any disclosure. Thus the majority of guidelines assessed were not at all transparent about conflicts of interest affecting the guideline development process.
Furthermore, of the 46.8% of all the guidelines which made any disclosures of conflicts of interest, 71.4% admitted their chair people HAD a conflict of interest. Thus, only (0.468 * [1 - .714]) = 13.3% provided assurance that they fulfilled the single requirement (from standard 2.4 above) that the chair person did not have a COI. For the guidelines written by sub-specialty societies, by a similar calculation, only 12.2% provided an assurance that the chair had no COI. (The proportions providing assurance that the co-chair people had no COI were even lower.) Thus the vast majority of guidelines did not clearly follow two straight-forward standards for minimizing the effects of conflict of interest, that the guideline committee chair and co-chair should not have any relevant conflicts.
Given the miserable results concerning even minimal adherence to some of the IOM report’s conflict of interest standards, it is likely that almost no published guidelines from 2011 came close to fulfilling the full set of IOM standards. Despite the best efforts of the IOM, it appears that guideline developers have not progressed at all towards providing trustworthy guidelines.
An editorial (Shaneyfelt T. In guidelines we cannot trust. Arch Intern Med 2012) accompanying the article by Kung and colleagues summarized its results thus:
The same problems that have plagued guideline development continue to plague guideline development; namely, their variable and opaque development methods, their often conflicted and limited panel composition, and their lack of significant external review by stakeholders throughout the development process. As a result, the trustworthiness of guidelines is limited.
While guidelines may have seemed to be a promising method to improve health care in the early 1990s, they have failed to live up to that promise. Shaneyfelt was not optimistic they would improve in the future:
I am not optimistic that much will improve. No one seems interested in curtailing the out-of-control guideline industry.
On the other hand, in my humble opinion, it is not that on one is interested in better guidelines. It would clearly be in the best interests of patients and the public, and of health care professionals who care about the quality of their practice and the outcomes of their patients to curtail that industry. The issue is why patients’, the public’s, and professional’s interests were ignored.
Neither Shaneyfelt nor Kung et al discussed why there has been so little attention to patients’ and the public’s health, and to health care professionalism in all this. For a quick answer, we do not have to look far on Health Care Renewal.
In fact, the IOM report on guideline development from 2011 was a serious challenge to the powers that be in health care. In particular, it challenged the cozy relationships that had grown up among the organizations that undertook guideline development and the health care professionals on guideline panels on one hand and organizations that stand to gain were specific guidelines to favor their products, services, and agendas on the other. The standards mandated transparency and honesty about conflicts of interest affecting guideline committees and the organizations which assembled them, and if upheld would have greatly reduced these relationships.
Now it turns out that the guideline standards have been honored mainly in the breach. Of course, these standards, while increasing trustworthiness, would have cost a lot of medical societies considerable commercial funding, and would have cost a lot of health care professionals on guideline panels considerable personal wealth. These standards would probably also have cost a lot of companies whose products and services were addressed by guidelines to lose revenue. So it is not surprising that the IOM standards were ignored. Their implementation would have cost too many people who are financially benefiting from the status quo too much money. And these people, that is, leaders of professional societies dependent on commercial outside funding, health care professionals and academic used to financial support from commercial interests, and health care corporations are good at making sure their interests are not ignored, even if their interests conflict with those of patients, the public, and well-intentioned health care professionals.
So, the flouting of the well reasoned IOM guideline standards adds one more reason for patients and the general public to distrust modern health care and all those who “deliver” it, even to distrust well-intentioned health care professionals who have not been able to distinguish themselves from their colleagues who are too happy to help commercial interests while taking commercial money. If health care professionals want to regain the public’s trust, they could do worse than publicly declaring their intention to show that their practice in the future will be guided by trustworthy guidelines based on clinical research evidence and knowledge of biomedical science, drawn up by health care professionals independent of commercial interests.
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In September 2012, the Joint Commission recognized 620 hospitals (about 18% of the total number of accredited American hospitals) as “top performers,” but many were surprised when some of the biggest names in academic medical centers failed to make the cut. Johns Hopkins, Massachusetts General Hospital, and the Cleveland Clinic (perennial winners in the US News & World Report best hospital competition) did not qualify when the Joint Commission based their ranking not on reputation but on specific actions that “add up to millions of opportunities ‘to provide the right care to the patients at American hospitals.’”
The gap between the perceived reputation of America’s “best” hospitals and medical schools and their performance on an evidence-based medicine report card provides an interesting lens through which to understand the role and performance of America’s academic medical centers in the 21stcentury.
The most pressing challenge for American medicine has been summarized in the triple aim: how to cut the per-capita cost of healthcare, how to increase the quality and experience of the care for the patient, and how to improve the health and wellness of specific populations.
Can we expect academic medical centers to lead the country in meeting the challenge? If history is any guide, the answer may be no. In a 2001 article titled “Improving the Quality of Health Care: Who Will Lead?” the authors write:
“We see few signs that academic medical leaders are prepared to expend much effect on health care issues outside the realms of biomedical research and medical education. They exerted little leadership in what may arguably be characterized as the most important health policy debates of the past thirty years: tobacco control, health care cost containment, and universal access.”
Having been a professor at several medical schools (UCSF, University of Iowa, Allegheny University of the Health Sciences, and Michigan State), I learned early on that the key to academic advancement was NIH funded basic science research. While lip service was paid to the ideal triple threat professor (great clinician, superb teacher, and peer reviewed published investigator), the results of the tenure process clearly resulted in a culture where funded research counted far more than teaching and clinical care delivery.
This gap between what the country needs and what medical schools traditionally emphasize was demonstrated when researchers studied more than 60,000 medical school graduates from 1999 to 2001. As Pauline W. Chen, MD wrote in the New York Times:
“Putting the issues of primary care shortage, underserved communities and workforce diversity under the banner of ‘social mission,’ the researchers found that many of the schools that were traditionally ranked highly were also among those least focused and least successful in addressing the most pressing issues facing the country right now.”
A recent report from the Lucien Institute at the National Patient Safety Foundation describes the kind of culture required to achieve the goals of the triple aim.
“Achieving safety in the work environment requires much more than implementing new rules and procedures. It requires developing and sustaining cultures of safety that engender trust and embrace reporting, transparency, and disciplined practices. It also requires an atmosphere of respect among the health care disciplines and a fundamental ability of all practitioners to work together in teams.”
The Association of American Medical Colleges survey on medical school culture reveals a culture that does little to encourage trust and transparency. From 2004 to 2008, 12.7% to 16.7% of students reported being publicly belittled or humiliated. The best program for implementing a culture of safety I have seen did not originate in an academic medical center; it was developed and implemented at the Sentara Healthcare System in Virginia.
Academic medical center hospitals often save the lives of patients with complicated conditions who benefit from cutting edge treatments supported by basic science research. However, it is revealing that the community Holy Cross Hospital in Silver Spring, Maryland made the Joint Commission’s list of “top performers” and the famed Johns Hopkins did not do as well on the quality scoring report card.
The 2009 Report on Accident and Health Insurance and Medical Service Plans: World Market Segmentation by City Reviews
The 2009 Report on Accident and Health Insurance and Medical Service Plans: World Market Segmentation by City
This report was created for global strategic planners who cannot be content with traditional methods of segmenting world markets. With the advent of a “borderless world”, cities become a more important criteria in prioritizing markets, as opposed to regions, continents, or countries. This report covers the top 2000 cities in over 200 countries. It does so by reporting the estimated market size (in terms of latent demand) for each major city of the world. It then ranks these cities and reports th
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