Negative studies are just as important to consumers as positive studies. They are essential blocks in the evidence base. They help everyone—consumers and health care providers—avoid interventions that don’t help.
A recent study in the New England Journal of Medicine, authored by six researchers at the National Heart, Lung, and Blood Institute (NHLBI), prompts some thoughts about studies with negative outcomes—and their importance in the entire research process.
In this report Dr. David Gordon, Dr. Michael Lauer, and their colleagues analyzed the 244 extramural, randomized clinical trials supported by NHLBI and completed between the years 2000 and 2011. The primary outcome was the time between completion of trials and publication of the main results in a peer-reviewed journal; the secondary outcome was the annual citation rates for these articles—i.e., how many times each article was cited in a given time period. The team also examined a number of trial characteristics that related to these questions, such as budget, number of participants, and whether the result was positive or negative.
Among the many interesting findings are that more than half of the studies analyzed (58 percent) yielded negative results. And intriguingly, of the 31 trials having the highest citation rates, only 8 (26 percent) had positive results. Studies supported by NHLBI, and indeed, studies supported by NCCAM, generally start with enthusiasm of the investigators, peer reviewers, and NIH. They generally start with the expectation (and indeed preliminary data) that the intervention being studied has the potential to improve patient outcomes. By and large, when no benefit is demonstrated, research teams are understandably disappointed. And Gordon and co-authors found that investigators completing negative studies are indeed significantly slower to publish.
Nevertheless, we do the research because we don’t know the answer! Negative studies are just as important to consumers as positive studies. They are essential blocks in the evidence base. They help everyone—consumers and health care providers—avoid interventions that don’t help.
There is an additional “silver lining.” Negative studies are extremely important in the research process. And the high-quality data produced during our well-performed, carefully monitored studies are of enormous value in deciding on follow-on questions and in the design of subsequent studies.
We learn from surprises—from discovering that we don’t always know what we think we know.
- The National Center for Complementary and Alternative Medicine incorporates negative study findings in
many of its products, including Herbs At A Glance
[Reblog] Canadian journalist: every cancer cure claim needs scrutiny (with related critical thinking resources)
Carly Weeks of The Globe and Mail, based in Toronto, writes, “Why every claim of an exciting new cancer cure needs close examination.” She begins:
“The Internet loves a good conspiracy.
Have you heard the one about scientists finding a cure for cancer, but it being blocked from the public because Big Pharma can’t make a cent off it?
Those sensational accusations appear on multiple websites and YouTube videos that purport to expose the “truth” about how a cheap and safe drug that has been around for decades is actually an expert cancer-cell killer. They claim that because the drug, called dichloroacetic acid or dichloroacetate (DCA), is a widely available chemical compound and can’t be patented, drug companies aren’t interested in pursuing it as a cancer treatment. Some conspiracy theorists take it a step further, saying that health organizations and cancer charities are in on the plot to keep this miracle drug out of sight because they have ties to drug firms and want to keep money flowing their way.
It reads like the plot of a cheesy gift-shop thriller.
However, the idea that DCA may be used to eradicate cancer cells originated in respected medical journals, not the bowels of the Internet. Subsequent media attention painted a glowing picture of DCA as a cancer treatment, which led to a frenzy among patients and family members desperately hoping for a cure.
The true picture, however, is far less clear.”
That’s the hook. Now please read the rest of her analysis. But note how she describes media coverage through the years that referred to the drug as “a potentially life-saving treatment” that “astounded” researchers….and “a miracle drug” (including in her own newspaper). She concludes:
“Every week, dozens of press releases cross the news wires, alerting editors and readers to a new “breakthrough” or “landmark discovery” that may forever change the way a disease is treated.
What is often missing from those announcements is that those discoveries may just as likely change nothing. True breakthroughs are rare and the development of important new treatments takes years – decades, even – of rigorous research and study. Overzealous reporting of preliminary findings may generate positive publicity for researchers and institutions, but it does patients no favours.”
Earlier this week I wrote about a fresh New York Times story that referred to a line of cancer research as ““amazing…game-changer…watershed moment.”
Canadians Weeks, her colleague Andre Picard at the same newspaper and rising star Julia Belluz (now on a Knight Science Journalism Fellowship at MIT) seem to scrutinize evidence in media messages and even criticize news coverage more often than any of their U.S. colleagues in mainstream news organizations. And I applaud them for their efforts. Wish we saw more of it down here in the land of guns and Obamacare.
- The Penn State Medical Center Library has a great guide to evaluate health information on the Internet.
The tips include
- Remember, anyone can publish information on the internet!
- If something sounds too good to be true, it probably is.
If the Web site is primarily about selling a product, the information may be worth checking from another source.
- Look for who is publishing the information and their education, credentials, and if they are connected with a trusted coporation, university or agency.
- Check to see how current the information is.
- Check for accuracy. Does the Web site refer to specific studies or organizations?
The Family Caregiver Alliance has a Web page entitled Evaluating Medical Research Findings and Clinical Trials
- General Guidelines for Evaluating Medical Research
- Getting Information from the Web
- Talking with your Health Care Provider
- Consumer’s Guide to Taking Charge of Health Information (Harvard Center for Risk Analysis)
- How to Evaluate Health Information on the Internet (US National Cancer Institute)9iiu9
- Quackwatch (a private corporation operated by Stephen Barrett, MD)
How to Read a Research Paper
Medical research results are increasingly available to all of us. However, caution is urged in interpreting results. For example, be very careful to not confuse causation with association.
Just because two factors occur together does not mean one causes the other. For example, eating fish may result in lower cholesterol levels. But it may just mean one is eating less read meat. Another example is recent news item about insulin use and cancer. Some say insulin use can cause cancer, while others insist insulin users are predisposed to cancers.)
The MedlinePlus Topic Page Understanding Medical Research has links to tutorials, overviews, and more
A sampling of links
Northwestern scientists to meet with EPA to request important changes in guidelines
October 16, 2012 | by Marla Paul
CHICAGO — A team of Northwestern University scientists will meet with Environmental Protection Agency (EPA) administrators in Washington D.C. Oct. 18 to advocate for important changes in the agency’s guidelines for reproductive health research.
“The problem is current research assessing the risk of toxins on reproductive health is not being uniformly investigated in both sexes and across the lifespan,” said Kate Timmerman, program director of the Oncofertility Consortium of Northwestern University, who will be one of the scientists meeting with the EPA. The reproductive health guidelines have not been updated since 1996 and need to be revised to reflect new research findings.
The Northwestern team will ask the EPA to expand the definition of reproductive health beyond pregnancy to include the lifespan of an individual.
“Reproductive health is important across the entire lifespan because your endocrine system affects your bone health, cardiovascular health and other systems in the body,” Timmerman said. Endocrine disrupters, sometimes triggered by environmental factors, can lead to increased risk for stroke and heart attack as well as osteoporosis.
The Northwestern scientists also will request that all EPA-sponsored research require appropriate testing in both sexes. Currently many toxicity studies are only conducted in male animal models with the assumption that females are affected the same way, but that isn’t necessarily true.
“What happens now is if researchers don’t see an effect in males, they won’t look in females,” Timmerman said. “But we know certain toxins in the environment can have a significant effect on females and not males and vice versa.”
Timmerman and colleagues will present a white paper to the EPA on how to improve and update the guidelines.
In addition to Timmerman, other Northwestern scientists meeting with the EPA
include Kimberly Gray, professor of civil and environmental engineering at Northwestern’s McCormick School of Engineering and Applied Science; Mary Ellen Pavone, M.D., assistant
professor of obstetrics and gynecology at Northwestern’s Feinberg School of Medicine and a physician at Northwestern Memorial Hospital; and Francesca Duncan, reproductive scientist/research associate in the lab of Teresa Woodruff, chief of fertility preservation at the Feinberg School and director of the Oncofertility Consortium. Woodruff also is a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.
- Scientists to EPA: Include women in reproductive health research (sciencedaily.com)
Some edits made, and new items added, late the same evening.
I’ve recently learned of some well-intentioned medical research that disturbs me so deeply that I think it’s time to get formal about teaching e-patients and their partners how to detect research that misses its target, even if it’s well intentioned.
Doing this responsibly requires a deep understanding of the purpose of research and its methods. So this is the start of a series in which I’ll lay out what I’ve learned so far, describe the problems and challenges and opportunities that I see, and invite dialog on where I’m wrong and your own experiences as patient or clinician or researcher.
If this succeeds we’ll have a new basis for considering questions of what to do and how to prioritize it, in this era of change in medicine – not just in research but in all of medicine, as we work on reducing our spend. My goal in the series will be to be as clear in my writing as I can, while being as verifiably accurate as I can, given that I’m no PhD or Pulitzer laureate. Critique and correction are welcome.
This first post is an introduction, with background reading.
Context: Patient Engagement
The context for this series is patient engagement: patients shifting from being “compliant” cars in a medical car wash to being responsible and engaged.
Empowered, engaged patients take responsibility for their health and their care. One aspect is being responsible for understanding, as best we can, the evidence that a recommended treatment is right for us. Sometimes it’s pretty simple, sometimes not; but the higher the stakes get, the more important it is.
With respect to research, there’s a big challenge: sometimes the published evidence sucks – even though it got through the peer review process and was approved by a big-name journal.
Of course not all evidence sucks. But if you’re considering whether to be cut open or eat chemicals (meds), you have a choice: trust blindly (“whatever you say, doc”) or take responsibility for understanding as much as you can.
As we’ll discuss, one big reason blind trust fails is that the evidence your doctor gets isn’t necessarily great, and most clinicians aren’t rigorously trained in how to scrutinize it. (They too are largely trained to trust the journal process.) So this is for them too.
- Patients and caregivers – the people on the receiving end of the treatment; the ones who make the decision to accept treatment.
- Clinicians, for two reasons:
- In a participatory relationship, the patient and clinician need to be on the same page regarding the basis for decisions, or one will think the other’s crazy
- As I said, in my experience most clinicians haven’t been rigorously schooled in the weakness of the info they were taught to trust. (This isn’t an insult; see homework below.)
- Health policy people (government and non-profits), because they need to be firmly grounded in reality, or they can’t possibly make policies that work in reality (eh?)
- Insurance companies (commonly euphemized as “care plans” or just “the plans”), who decide what will get paid for. (I know some insurance companies don’t mind paying for stuff that doesn’t work; they basically get a commission on all spending. But others do care what works and what doesn’t – some even have staff who help patients understand the options! They need to be well informed too.)
- Others, I’m sure.
This will make some people unhappy.
It’s the unhappiness that comes from realizing the world isn’t what you thought it was. And the unhappiness that comes from realizing you have to adjust.
But ladies and germs, disconnects like that are what keep a dysfunction in place and make problems intractable. So, comfortable or not, let’s get on with it. The unhappiness I anticipate:
- Some clinicians don’t welcome questions from their patients. (Others do.) In my personal experience most of the ones who object don’t realize how weak the evidence is.
- I hope they’ll remember what I learned in school: all science must be open to new information. (As SPM co-founder and ACOR founder Gilles Frydman said in 2010, “All knowledge is in constant beta.”)
- I know clinicians have many pressures including short appointments. This doesn’t have to be done by an MD; in my view of the future, every “medical home” will have coaches who can help assess published material.
- Some patients really don’t want to hear that the science they depend on – which has indeed produced miracles – has also produced crap sometimes. They especially don’t want to hear that clinicians – their clinicians, who they know are good people – aren’t perfect.
- In general, everyone wants certainty – doctors and patients alike – so it’s unsettling to know you can’t have it. (Even the best science has a chance of errors, and all science is subject to correction.)
Important: This is not a “we reject science” series.
- I love science. I personally am alive because of great medical research that created a harsh treatment delivered brilliantly by great clinicians at Beth Israel Deaconess in Boston. I love the training and clinical experience that made them able to save my life!
- It included great laparoscopic surgery and orthopedic surgery developed by great skilled scientists and delivered by skilled, adroit surgeons & teams. Hooray for science!
- But in the end, science knows that there is no certainty. They’re doing the best they can amid uncertainty. Heck, I myself live in uncertainty:
- The best evidence (which is not great) says there’s a 50% chance my cancer will return, which would likely kill me
- At diagnosis the evidence said I had 24 week median survival
- On the flip side, the treatment that did cure me usually doesn’t work.
Bottom line: There Is No Certainty.
The art of designing, conducting and reporting research includes dealing accurately with this issue.Whatever you read, there’s always a chance it’s wrong.
In my view, the ultimate responsible patient understands this, accepts the uncertainty (as best a human can), and responds by saying “Okay, what are the options? And what are the chances they’ll work?”
If you fully understand that much research is shaky and deserves questioning, you can skip to the end and wait for round 2. If not, read these past posts, because if you don’t realize there’s weakness, you have no reason to learn what comes next.
Here’s your homework.
Past posts establishing the need to be responsible for our decisions
These posts are from e-patients.net………
Click here for the rest of the post
- Is there hope for clinicians in the digital age? (guardian.co.uk)
- Martine Ehrenclou and “The Take-Charge Patient” (digitaldoorway.blogspot.com)
- Regular patient/clinician interaction can help increase follow-up cancer screening (medicalxpress.com)
- Helping Patients Communicate More Effectively About their Health (thielst.typepad.com)
A good overview of how improved data analysis and presentation is improving health care delivery.
I especially liked the slideshare presentation found below in Related Articles.
The 42 slides in Big data – a brief overview outlines what big data is, its sources and processes, how it is analyzed, current “players”,examples, market analysis, future, and opportunities.
Slowly but surely, health care is becoming a killer app for big data. Whether it’s Hadoop, machine learning, natural-language processing or some other technique, folks in the worlds of medicine and hospital administration understand that new types of data analysis are the key to helping them take their fields to the next level.
Here are some of the interesting use cases we’ve written about over the past year or so, and a few others I’ve just come across recently. If you have a cool one — or a suggestion for a new use of big data within the healthcare space — share it in the comments:Genomics. This is the epitomic case for big data and health care. Genome sequencing isgetting cheaper by the day and produces mountains of data. Companies such asDNAnexus, Bina Technologies, Appistry and NextBio want to make analyzing that data to discover cures for diseases faster, easier and cheaper than ever using lots cutting-edge algorithms and lots of cloud computing cores.BI[definition of business intelligence] for doctors. Doctors and staff at Seattle Children’s Hospital are using Tableau to analyze and visualize terabytes of data dispersed across the institution’s servers and databases. Not only does visualizing the data help reduce medical errors and help the hospital plan trials but, as of this time last year, its focus on data had saved the hospital $3 million on supply chain costs…...Semantic search. Imagine you’re a doctor trying to learn about a new patient or figure out who among your patients might benenfit from a new technique. But patient records have been scattered throughout departments, vary in format and, perhaps worst of all, all use the ontologies of the department that created the record. A startup called Apixio is trying to fix this by centralizing records in the cloud and applying semantic analysis to uncover everything doctors need, regardless who wrote it…..Getting ahead of disease. It’s always good if you figure out how to diagnose diseases early without expensive tests, and that’s just what Seton Healthcare was able to dothanks to its big data efforts…
- Better medicine, brought to you by big data [GigaOM] (gigaom.com)
- Intel and NextBio seek Big Data upgrades in genomics (fiercebiotechit.com)
- Big Changes Are Ahead For The Health Care Industry, Courtesy Of Big Data (fastcompany.com)
Big data – a brief overview (slideshare.net) [a slide presentation, 42 slides]
- Oracle adopts the popular R language for the enterprise and big data. (oracle.com)
- Presentation: Scalability Challenges in Big Data Science (architects.dzone.com)
- Salesforce intros Radian6 Insights for social big data (zdnet.com)
- Big Data Modeling – Part I – Defining “Big Data” and “Data Modeling” (infocus.emc.com)
- NextBio and Intel Announce Collaboration to Optimize Use of Hadoop Stack And Move Forward With Big Data Technologies in Genomics (ducknetweb.blogspot.com)
- A Beautiful Friendship: Big Data and Social Media (blogs.sap.com)
- Stanford rides Big Data wave in medical research (fiercebiotechit.com)
- Big Data? Big Deal! (clean-clouds.com)
he most over-used and under-analyzed statement in the academic vocabulary is surely “more research is needed”.
These four words, occasionally justified when they appear as the last sentence in a Masters dissertation, are as often to be found as the coda for a mega-trial that consumed the lion’s share of a national research budget, or that of a Cochrane review which began with dozens or even hundreds of primary studies and progressively excluded most of them on the grounds that they were “methodologically flawed”.
Yet however large the trial or however comprehensive the review, the answer always seems to lie just around the next empirical corner.
With due respect to all those who have used “more research is needed” to sum up months or years of their own work on a topic, this ultimate academic cliché is usually an indicator that serious scholarly thinking on the topic has ceased. It is almost never the only logical conclusion that can be drawn from a set of negative, ambiguous, incomplete or contradictory data…
- Understanding the nuances of evidence-informed healthcare (thehindu.com)
Looking for historical biomedical information? Try the redesigned IndexCat, a product of the US National Library of Medicine
In my last position as a medical librarian, IndexCat was the first place to go for finding historical biomedical articles and related information. Searches on IndexCat can find in minutes what took up to an hour or more in the print version, providing access to over 3.7 million items as information about books, journal articlesd,issertations, pamphlets, reports, newspaper clippings, case studies, obituary notices, letters, portraits, as well as rare books and manuscripts.
IndexCat has recently been redesigned for even easier access to the records of historical biomedical information.
IndexCat is “the [free!]online version of The Index-Catalogue of the Library of the Surgeon-General’s Office (Index-Catalogue) [, the]..multi-part printed bibliography or list of items in the Library of the Surgeon-General’s Office, U.S. Army. It contains material dated from the 1400s through 1950 and is an important resource for researchers in the history of medicine, history of science, and for clinical research.”[http://www.nlm.nih.gov/hmd/indexcat/abouticatalogue.html]
While IndexCat does not contain the full text of items, it provides enough information on them so they can be located at libraries.
If you need the full text of the items, the best place to start is your local public or academic library. Ask for a reference librarian.
He or she can help you find the item or assist you in getting a copy through interlibrary loan. And remember, most academic libraries will be happy to help those who are not affiliated with their institution. Just call ahead and ask how they assist the public.
Related blog post
How to obtain free/low cost medical and scientific articles (jflahiff.wordpress.com)
A growing concern with fraud and misconduct in published drug studies has led researchers at the University of Illinois at Chicago’s Center for Pharmacoeconomic Research to investigate the extent and reasons for retractions in the research.
“We were surprised to find the proportion of retractions due to scientific misconduct in the drug literature is higher than in general biomedical literature,” said Simon Pickard, associate professor of pharmacy practice and senior author of a study published in the journalPharmacotherapy.
Nearly three-quarters of the retracted drug studies were attributed to scientific misconduct, he said, “which includes data falsification or fabrication, questionable veracity, unethical author conduct, or plagiarism. While these studies comprise a small percentage of the overall literature, health care professionals may rely on this evidence to make treatment recommendations.”
These studies can affect the treatment of thousands of patients, since scientific publications are often printed months in advance. There is an average lag in time of 39 months between the original publication and a retraction notice, Pickard said.
“Once a health care professional changes treatment options, it’s not easy to reverse,” said Jennifer Samp, a fellow in Pickard’s research group and lead author of the study. “Staying current with new findings in scientific literature is a priority for health care practitioners — especially pharmacists — and it is important for them to know when a study has been retracted, especially those with manipulated data.”…
Evaluating Health Information (links)
- Scientific Lies: Facts in scientific drug literature may not be (talesfromthelou.wordpress.com)
- Ethical and Scientific Issues in Studying the Safety of Approved Drugs (jflahiff.wordpress.com)
- Interpreting the Scientific Literature (randi.org)
- How do you follow the scientific literature? (ketyov.com)
- Following the scientific literature through RSS (xcorr.net)
Every day, there is another medical study in the news. There’s another newspaper or TV story telling us that X can cure depression or make you thinner or cause autism or whatever. And since it’s a medical study, we usually think that it’s true. Why wouldn’t it be?
But what most people don’t realize, let alone really think about, is that there might be other studies that show that X does none of those things — and that some of those studies might never have been published.
Just this week, the journal Pediatricsreleased an article that perfectly demonstrates this problem. There have been a number of studies that have shown that a certain type of medication, selective serotonin reuptake inhibitors (SSRIs), can help stop the repetitive behaviors of autism, like hand-flapping or head-banging. If you were to do a search of the medical literature, as doctors and parents and patients often do, you’d think that using SSRIs is a good idea. But when researchers dug deeper, they found that there were just as many unpublished studies that showed that SSRIs didn’t help. If they had all been published (they were all good enough to be published), that same search of the medical literature would have shown that using SSRIs isn’t a good idea.
This is bad. We rely on studies to guide our decisions. What is going on?
The journals that publish articles certainly play a role. After all, it’s cooler to publish a study that has a grabby headline, that promises an answer or a cure. That’s much more likely to get readers than a study that says that something doesn’t do anything at all. But it turns out that the researchers themselves play a bigger role.
Some researchers don’t even write up their studies or try to publish them. ….
- Medical Research We Never Hear About: The Problem of Unpublished Studies (thehealthcareblog.com)
Credit: Wikipedia Commons
A medical doctor (who himself is a big draw at medical conferences) has recently questioned the motives and utility of medical conferences. [Mythbuster Ioannidis: Are Medical Conferences Really Useful?]
He believes much of the presented research findings are not fully peer-reviewed, and thus cannot fully educate, train, or contribute to evidence-based practice. Often findings at medical conferences are seized upon by the popular press and prematurely promoted as having sound scientific evidence. Quite often these findings change with peer review and are later published with the revisions and modified findings in scientific journals.
Excerpt from the 4 April 2012 JAMA (Journal of the American Medical Association) article
(The full text of this article is by subscription only, these excerpts came from a related posting at HealthNewsReview.org)
An estimate of more than 100 000 medical meetings per year may not be unrealistic, when local meetings are also counted. The cumulative cost of these events worldwide is not possible to fathom.
Do medical conferences serve any purpose? In theory, these meetings aim to disseminate and advance research, train, educate, and set evidence-based policy. Although these are worthy goals, there is virtually no evidence supporting the utility of most conferences. Conversely, some accumulating evidence suggests that medical congresses may serve a specific system of questionable values that may be harmful to medicine and health care.
The availability of a plethora of conferences promotes a mode of scientific citizenship in which a bulk production of abstracts, with no or superficial peer review, leads to mediocre curriculum vita building. Even though most research conferences have adopted peer-review processes, the ability to judge an abstract of 150 to 400 words is limited and the process is more of sentimental value.
Moreover, many abstracts reported at the medical meetings are never published as full-text articles even though abstract presentations can nevertheless communicate to wide audiences premature and sometimes inaccurate results. It has long been documented that several findings change when research reports undergo more extensive peer review and are published as completed articles.* Late-breaker sessions in particular have become extremely attractive prominent venues within medical conferences because seemingly they represent the most notable latest research news. However, it is unclear why these data cannot be released immediately when they are ready and it is unclear why attending a meeting far from home is necessary to hear them. A virtual online late-breaker portal could be established for the timely dissemination of important findings….
…Power and influence appear plentiful in many of these meetings. Not surprisingly, the drug, device, biotechnology, and health care–related industries make full use of such opportunities to engage thousands of practicing physicians. Lush exhibitions and infiltration of the scientific program through satellite meetings or even core sessions are common avenues of engagement. Although many meetings require all speakers to disclose all potential conflicts, the majority of speakers often have numerous conflicts, as is also demonstrated in empirical evaluations of similar groups of experts named on authorship lists of influential professional society guidelines.”
Ioannidis doesn’t discard the entire notion of conferences. In fact, he projects what “repurposed” conferences might be like:
“Repurposed conferences could be designed to be entirely committed to academic detailing (ed. note: drug company “educational” outreach to physicians). All their exhibitions and satellite symposia would deal with how to prescribe specific interventions appropriately and how to favor interventions that are inexpensive, well tested, and safe. Such repurposed conferences could also focus on how to use fewer tests and fewer interventions or even no tests and no interventions, when they are not clearly needed.”
- Tips on Locating Conference Proceedings
Includes advice on searching the Internet, databases, and contacting librarians and conference presentation authors
- Posters from Life Sciences and Medicine Conferences and Meetings
Not comprehensive, but worth checking
- The Missing Outcry – Are the NIH and Its Researchers Shirking Their Obligations? (scholarlykitchen.sspnet.org)
- Lessons for journalists and the public about all the news we hear from medical conferences (HealthNewsReview.org)
- Mythbuster Ioannidis: Are Medical Conferences Really Useful? (Common Health-Reform and Reality)
From the 21 March 2012 article by Gary Schwitzer at HealthNewsReviews.org
That’s what one author writes in a series of papers published in Circulation: Cardiovascular Quality and Outcomes this month addressing issues involving the integrity of research data.
Yale’s Harlan Krumholz writes: “Patients facing a decision deserve information that is based on all of the evidence.” Further excerpt:
Every day, patients and their caregivers are faced with difficult decisions about treatment. They turn to physicians and other healthcare professionals to interpret the medical evidence and assist them in making individualized decisions.
Unfortunately, we are learning that what is published in the medical literature represents only a portion of the evidence that is relevant to the risks and benefits of available treatments. In a profession that seeks to rely on evidence, it is ironic that we tolerate a system that enables evidence to be outside of public view. Those who own data, usually scientists or industry, have the choice of what, where, and when to publish. As a result, our medical literature portrays only a partial picture of the evidence about clinical strategies, including drugs and devices. Experts have recently drawn attention to this issue, including contributions in this issue of our journal, but there is resistance to change….
The article goes on outline how sharing of clinical trial and research data could be shared for the common good.
- Bias and error are rampant in medical literature (kevinmd.com)
- Data sharing as a moral imperative (Marilyn Mann’s blog)
- Open Science and Data Sharing in Clinical Research
Basing Informed Decisions on the Totality of the Evidence (Circulation)
- Strengthening and Opening Up Health Research by Sharing Our Raw Data (Circulation)
- The Importance of Clinical Trial Data Sharing (Circulation)
- Scientific evidence (sixpointnineme.wordpress.com)
- Many NIH-funded clinical trials go unpublished over 2 years after completion (eurekalert.org)
From the 2 March 2012 article at Medical News Today
Political Studies professor Colin Farrelly wants to see more research into remarkable examples of health – such as why some people live 100 years disease-free.
He describes the current pathology-based approach that emphasizes what causes specific diseases as “negative biology” and suggest more resources should be focused on “positive biology.”
“Currently the medical sciences presume that answering the question ‘what causes disease?’ is the most significant question to ask and answer,” says Professor Farrelly. “Positive biology encourages us to invest just as much time, energy and resources into understanding the causes of health and happiness. This more balanced approach might lead to significant medical breakthroughs.”
His research is currently focused on aging and longevity, an area he says is underfunded and often misunderstood. One of his recent papers urges the scientific community to address the obstacles facing researchers studying the biology of aging, because this research could help us learn how to slow the process down.
“Periodically we should stand back and consider the possibility that the questions we are trying the hardest to answer (such as what causes disease) are perhaps not the most important questions to answer.”
- Queen’s professor urges health research to focus on the positive (eurekalert.org)
- New Conscious Aging Education Program to Present Latest Health Research, Self-Discovery Exercises, and Peer Group Discussion To Guide Elders In Positive Transformation (prweb.com)
In a move to re-engineer the process of translating scientific discoveries into new drugs, diagnostics, and devices, the National Institutes of Health has established the National Center for Advancing Translational Sciences (NCATS). The action was made possible by Congress’ approval of a fiscal year 2012 spending bill and the president’s signing of the bill, which includes the establishment of NCATS with a budget of $575 million.
NCATS will serve as the nation’s hub for catalyzing innovations in translational science. Working closely with partners in the regulatory, academic, nonprofit, and private sectors, NCATS will strive to identify and overcome hurdles that slow the development of effective treatments and cures.
“Congressional support for the National Center for Advancing Translational Sciences marks a major milestone in mobilizing the community effort required to revolutionize the science of translation,” said NIH Director Dr. Francis S. Collins, M.D., Ph.D. “Patients suffering from debilitating and life threatening diseases do not have the luxury to wait the 13 years it currently takes to translate new scientific discoveries into treatments that could save or improve the quality of their lives. The entire community must work together to forge a new paradigm, and NCATS aims to catalyze this effort.”
A prime example of the type of innovative projects that will be led by NCATS is the new initiative between NIH, the Defense Advanced Research Projects Agency, and the U.S. Food and Drug Administration to develop cutting-edge chip technology. This new technology will allow researchers to screen for safe and effective drugs far more swiftly and efficiently than current methods. A great deal of time and money can be saved testing drug safety and effectiveness much earlier in the process.
To meet the goals of NCATS, NIH is reorganizing a wide range of preclinical and clinical translational science capabilities within NIH into an integrated scientific enterprise with new leadership and a bold new agenda. While the effort to recruit an NCATS director continues, organizational changes and realignment of resources will move forward under the leadership of Acting Director Thomas R. Insel, M.D., and Acting Deputy Director Kathy Hudson, Ph.D. Dr. Insel is the director of the National Institutes of Mental Health and Dr. Hudson is the deputy director for science, outreach, and policy at the National Institutes of Health.
The following programs will comprise NCATS:
- Bridging Interventional Development Gaps, which makes available critical resources needed for the development of new therapeutic agents
- Clinical and Translational Science Awards, which fund a national consortium of medical research institutions working together to improve the way clinical and translational research is conducted nationwide
- Cures Acceleration Network, which enables NCATS to fund research in new and innovative ways
- FDA-NIH Regulatory Science, which is an interagency partnership that aims to accelerate the development and use of better tools, standards and approaches for developing and evaluating diagnostic and therapeutic products
- Office of Rare Diseases Research, which coordinates and supports rare diseases research
- Components of the Molecular Libraries, which is an initiative that provides researchers with access to the large-scale screening capacity necessary to identify compounds that can be used as chemical probes to validate new therapeutic targets
- Therapeutics for Rare and Neglected Diseases, which is a program to encourage and speed the development of new drugs for rare and neglected diseases
The budget for NCATS is primarily a reallocation of funds from programs previously located in the NIH Office of the Director, National Human Genome Research Institute, and National Center for Research Resources. NIH is committed to both basic and applied research and has maintained a relatively stable ratio of funding across these two areas of focus. The funding ratio will not be disturbed by the establishment of this new center.
The formation of NCATS has been a methodical process highlighted by the recommendation of the NIH Scientific Management Review Board in December 2010 to create a new center dedicated to advancing translational science. This recommendation was followed by a year of intensive feedback and expert insight from all sectors of translational science through advisory meetings and extensive public consultation.
“I am deeply grateful for the expertise and insight provided by the many researchers, industry executives, patients, voluntary organizations, and NIH staff that helped NIH evaluate NCATS’ purpose and crystallize its vision,” said Dr. Collins.
To learn more about the impetus and development of NCATS, go to:
- NCATS web page: http://www.nih.gov/about/director/ncats/index.htm.
- NCATS on the Feedback NIH website: http://feedback.nih.gov/index.php/category/ncats/
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visitwww.nih.gov.
- NIH Director Jumps the Gun With Memo Announcing New Center (news.sciencemag.org)
- NIH Chided on Translational Center, Warned of More Budget Cuts (news.sciencemag.org)
- NIH centre faces spell in limbo (nature.com)
- White House Boosts Translational Medicine, Drug Chip Project (news.sciencemag.org)
- US biomedical and energy budgets inch toward resolution (blogs.nature.com)
- Senate Panel Trims NIH Budget By $190 Million (news.sciencemag.org)
- New drug-discovery center lost in translation (fiercebiotechresearch.com)
- NIH launches $140M drug tox project, hunts for translational R&D chief (fiercebiotechresearch.com)
- Departing Director Reflects on NCRR Breakup (news.sciencemag.org)
- IEA Places 18 Employees within the National Institutes of Health (NIH) (prnewswire.com)
Click on figure to enlarge
Copy of Figure 1 describing the health care model of Health 2.0
|Emerging Patient-Driven Health Care Models: An Examination of Health Social Networks, Consumer Personalized Medicine and Quantified Self-Tracking, Int. J. Environ. Res. Public Health 2009, 6, 492-525; doi:10.3390/ijerph6020492Author – Swan M|
Whether you call it Health 2.0, Medicine 2.0, or e-Health 2.0, the Internet is changing medicine in ways that challenge the status quo. This article explores how a group of amateurs who call themselves “health hackers” and “citizen scientists” are trying to use the Internet to connect with other patients, run experiments, and conduct clinical trials on their own diseases.
Dr. Gunther Eysenbach states “Medicine 2.0 applications, services and tools are Web-based services for health care consumers, caregivers, patients, health professionals, and biomedical researchers, that use Web 2.0 technologies as well as semantic web and virtual reality tools, to enable and facilitate specifically social networking, participation, apomediation, collaboration, and openness within and between these user groups.” One review examined 46 different definitions of Health 2.0, and Eysenbach’s definition does not emphasize a key component of the concept:amateurs can use these new Internet tools to do work that in the past was only done by professionals. (1)…
The tension between the traditional approach to medical research and patient-initiated research can only be resolved by cooperation and two-way communication between the two groups. The Mayo Clinic and PXE examples clearly show that both groups can benefit by meaningful and respectful partnership. The AIDS and ALS examples demonstrate that patients with few options and new Internet tools will continue to push the traditional research community to be open to new ideas, new approaches, and new possibilities. Gilles Frydman, founder of the Association of Cancer Online Resources, has stated, “Better-informed people are more willing to participate in the advancement of science. Those patients taking Gleevec do not consider themselves guinea pigs. They are recipients of experimental medicine.” (8)
- The rise of citizen scientists and patient initiated research (jflahiff.wordpress.com)
- The rise of citizen scientists and patient initiated research (kevinmd.com)
Concerns are being raised as to how modern lifestyles may cause physiological defense mechanisms in light of the dramatic increase of people suffering from chronic inflammatory diseases, such as allergies,asthma and irritable bowel syndrome.
Researchers have conducted a perspective foresight study along the lines of the European Science Foundation’s (ESF) predictions, evaluating the challenges linked to chronic inflammatory diseases. Their findings, published in a supplement to The Journal of Allergy and Clinical Immunology(JACI), the official journal of the American Academy of Allergy, Asthma & Immunology (AAAAI), report details of 10 key areas with the highest priority for research. …
…Determining the factors responsible for the development of chronic inflammatory diseases remains challenging. Even though epidemiological evidence clearly indicates environmental influence as being responsible, not everyone within these environments develops diseases; and despite the fact that susceptibility to chronic inflammatory disease evidently play an important role, genetics alone may not be the only determining factor, as susceptibility to disease in later life can be influenced by prenatal exposures. Another influencing factor that determines the likelihood of a person developing diseases like asthma and allergies in later life is whether or not a person is breastfed and exposed to microorganisms after birth. …
The supplement called “Gene-Environment Interaction in Chronic Disease – An ESF Forward Look,” by H. Renz, I.B. Autenrieth, P. Brandtzaeg, W.O. Cookson, S. Holgate, E. von Mutius, R. Valenta, and D. Haller appears as The Journal of Allergy and Clinical Immunology, Volume 128, Supplement (December 2011) published by Elsevier. It is freely available via the JACI website.
- Scientists identify strategies to conquer lifestyle and genetic factors related to chronic diseases (medicalxpress.com)
- Scientists identify strategies to conquer lifestyle and genetic factors related to chronic diseases (eurekalert.org)
- Scientists Identify Strategies To Conquer Lifestyle And Genetic Factors Related To Chronic Diseases (medicalnewstoday.com)
- Few Allergies In Unstressed Babies (medicalnewstoday.com)
- Personalized Treatment For Crohn’s Disease A Step Closer Following Gene Mapping (medicalnewstoday.com)
- The Asthma-Thrush Link (everydayhealth.com)
- Breastfeeding reduces the risk of suffering allergy (fidest.wordpress.com)
- World Allergy Congress Presents Scientific Advancements in Allergy, Asthma, and Clinical Immunology (prweb.com)
Whether you call it Health 2.0, Medicine 2.0, or e-Health 2.0, the Internet is changing medicine in ways that challenge the status quo. This article explores how a group of amateurs who call themselves “health hackers” and “citizen scientists” are trying to use the Internet to connect with other patients, run experiments, and conduct clinical trials on their own diseases.
Dr. Gunther Eysenbach states “Medicine 2.0 applications, services and tools are Web-based services for health care consumers, caregivers, patients, health professionals, and biomedical researchers, that use Web 2.0 technologies as well as semantic web and virtual reality tools, to enable and facilitate specifically social networking, participation, apomediation, collaboration, and openness within and between these user groups.” One review examined 46 different definitions of Health 2.0, and Eysenbach’s definition does not emphasize a key component of the concept: amateurs can use these new Internet tools to do work that in the past was only done by professionals….
Charles Blanke, MD, Director of Gastrointestinal Oncology at the Oregon Cancer Institute summarizes the advantages and disadvantages of their patient-initiated approach:
This is powerful and compelling work! I remain incredibly impressed by the data-coordinating abilities of the Life Raft personnel. I see the major purpose of this sort of data as hypothesis generating. Unfortunately, it cannot be free of bias and thus cannot stand by itself, but it certainly can point investigators and the Company in the right direction and let us know what we need to be looking at more closely. Thus, its importance cannot be overstated….
,,,The tension between the traditional approach to medical research and patient-initiated research can only be resolved by cooperation and two-way communication between the two groups. The Mayo Clinic and PXE examples clearly show that both groups can benefit by meaningful and respectful partnership. The AIDS and ALS examples demonstrate that patients with few options and new Internet tools will continue to push the traditional research community to be open to new ideas, new approaches, and new possibilities. Gilles Frydman, founder of the Association of Cancer Online Resources, has stated, “Better-informed people are more willing to participate in the advancement of science. Those patients taking Gleevec do not consider themselves guinea pigs. They are recipients of experimental medicine.”…
- DocGreet Steadily Grows as the Leader in Health 2.0 and Medical Social Media (prweb.com)
- Connect with Project HealthDesign at Health 2.0 (projecthealthdesign.typepad.com)
- Reflections on the Medicine 2.0 conference at Stanford #med2 (medicineandtechnology.com)
- Health IT and Patient Safety: Building Safer Systems for Better Care (jflahiff.wordpress.com)
- During the Fifth Annual Health 2.0 Conference, Dr. James Mault of HealthyCircles will Showcase Innovative Technology that will Help Transform Health Care (prweb.com)
Findings of a recent study by JISC:
Publishing a lay summary alongside every research article could be the answer to assisting in the wider understanding of health-related information.
Patients Participate! asked patients, the public, medical research charities and the research community, ‘How can we work together in making sense of scientific literature, to truly open up research findings for everyone who is interested?’ The answer came from patients who explained that they want easy-to-understand, evidence-based information relating to biomedical and health research.
Some universities now offer researchers training in communicating with lay audiences. (…)
JISC believes that publicly-funded research should be made available for everyone and be easy to find. JISC funded this work to show how making access to scientific literature enables citizen-patients to participate in the research process, therefore providing mutual understanding and better links between scientists, medic, patients and the general public.
“Summaries for Patients” and other plain language summaries help patients and others understand medical studies and guidelines
“Summaries for Patients” are brief, non-technical summaries of studies and clinical guidelines published inAnnals of Internal Medicine. The Summaries aim to explain these published articles to people who are not health care providers.
- Summaries about studies describe how researchers did the published study and what they found.
- Summaries about clinical guidelines describe the official recommendations for patient care developed by official groups such as the US Preventive Services Task Force or the American College of Physicians.
To search for summaries, click on New Search (top of middle column) at “Summaries for Patients”
Once at the New Search Page (http://www.annals.org/search), be sure to check Summaries for Patients , under Limit Results by Section (Articles Published After 1927)
Here are excerpts from a recent Summaries for Patients, Who Reports Having More Pain at the End of Life?
What is the problem and what is known about it so far?
Pain at the end of life is everyone’s great fear, but we still do not know enough about what makes pain worse at the end of life. Studies of pain near death have mostly looked at specific types of patients, such as those with cancer or those who are in a hospice program in which a patient’s comfort and reducing pain is a main focus of care. Other studies have asked family members about their deceased or dying relative’s experience of pain in the last months of life, but these reports are affected by their feelings about the pain of their loved one. In addition, studies have generally not examined patients from national surveys that offer broader understanding of patients’ experience of moderate to clinically significant pain at the end of life.
What did the researchers find?
Among the more than 4700 patients in the study, about 25% had clinically significant pain. However, the proportion experiencing significant pain increased to nearly 50% in the last 4 months before death. One of the most important things that affected the amount of pain was having arthritis. Surprisingly, the reason that a person was dying, such as heart disease or cancer, was not associated with important differences in the amount of pain.
What were the limitations of the study?
No information about treatment for pain was provided, and the study did not follow specific patients over time to see how their pain changed. Some people with arthritis might have had pain from something else that they mistakenly thought was arthritis.
What are the implications of the study?
Physicians and patients are not good at knowing when death is close, so it is important long before the last few months of life to discuss pain and ways to reduce it. Arthritis may be an important cause of pain or death that could be reduced by lifestyle changes long before death.
patientINFORM plain language summary Web sites are provided by participating publishers to help patients or their caregivers more fully understand the implications of research and to provide links to the full text of research articles they’ve selected from participating journals. The publishers allow readers following links from patientINFORM material on the health organizations’ sites to access the full text of these articles without a subscription, and they provide patients and caregivers with free or reduced-fee access to other articles in participating journals.
- American Cancer Society (News Center)
- American Association for the Advancement of Science (Eureka Alert- Medicine and Health)
- American Diabetes Association (Access: Diabetes Research)
- American Heart Association
- Lupus Foundation of America (Research Summaries)
- National Breast Cancer Coalition
- National Organization for Rare Disorders
- American Society of Hematology Articles for patients from the ASH education book can be accessed via the patient section of ASH’s web site under Other Resources.
- Journal of Rehabilitation Research and DevelopmentFor its nontechnical readers (e.g., veterans, patients, and caregivers), JRRD publishes plain-language summaries in each issue that describe the purpose and explain who may benefit from the research. These summaries are useful tools that keep patients and interested individuals informed of current research and encourage discussion of research between patients and their healthcare providers.
Cochrane Collaboration provides systematic reviews of the strongest evidence available about healthcare interventions (as drugs and medical procedures). It does not cover all interventions, but those covered were reviewed in-depth by experts in the medical and library fields.
The main activity of the Collaboration is the preparation of Cochrane reviews that are published electronically in successive issues of The Cochrane Library. These Cochrane reviews investigate the effects of interventions for prevention, treatment and rehabilitation. They also assess the accuracy of a diagnostic test for a given condition in a specific patient group and setting.
[Click here to find more information about the use of the evidence to inform decision making in health care ]
Here is how to find plain language and audio summaries of Cochrane reviews
- Go to the Cochrane Collaboration home page and scroll down to Browse Free Summaries.
Topics include Breast Cancer, Dementia and Cognitive Improvement, and Complementary Medicine.
- Click on To the Cochrane Library in the upper right corner of the Cochrance Collaboration home page.
This Cochrane Library search page has a Help page , and an Advanced Search option.
Related Blog Items
Cannot find a plain language summary with the above resources?
Consider asking a reference librarian for help at your local public, academic, or hospital library. Many academic and hospital libraries provide at least limited reference service to the public.
Call or email them for information about their services.
You may also contact me at jmflahiff@msncom. I will do my best to reply within 48 hours.
From the 8 August 2011 Science Intelligence and InfoPros blog posting
In this podcast from Copyright Clearance Center, Rafael Sidi, Elsevier talks about a new app ecosystem.
Sidi explains that “as a scientific publishing company, we are moving to a solution space and we don’t want to be just an information provider, but we want to also provide solutions to our customers, to our market… We want to go to the community, collaborate with the community and build the solutions together with the community.”
In order to have their “data easily remixable, reusable,” they are “going to the crowd. We are letting them play with our data and build on top of our data stuff that they need to build, because at the end, scientists and researchers, they know their problem better than us.”
With the main goal to accelerate science, Elsevier reaches out to the community in hopes to collaborate to find new solutions. “We want to create an incubation environment for the scientific and research community. [In some case], we providing some seed funding to startup companies… Our goal for the future, definitely, we want to create an Elsevier incubation environment.”
The podcast and transcript are available at:
- New Study on Integrated Oil Reservoirs Pushes Science Forward (prweb.com)
- Elsevier Announces Winners of the Executable Paper Grand Challenge (prnewswire.com)
- Elsevier Introduces Genome Viewer (prnewswire.com)
- Elsevier Upgrades Illumin8, Enhancing Access To Critical Information At The Front End Of Innovation (dailymarkets.com)
- New: Elsevier Enriches Online Articles with Google Maps ” INFOdocket (infodocket.com)
Academics ‘guest authoring’ ghostwritten medical journal articles should be charged with fraud, legal experts argue
ScienceDaily (Aug. 3, 2011) — Two University of Toronto Faculty of Law professors argue that academics who ‘lend’ their names, and receive substantial credit, as guest authors of medical and scientific articles ghostwritten by industry writers, should be charged with professional and academic misconduct and fraud, even if they contain factually correct information.
In an article published in PLoS Medicine, Professors Simon Stern and Trudo Lemmens argue “Guest authorship is a disturbing violation of academic integrity standards, which form the basis of scientific reliability.” In addition, “The false respectability afforded to claims of safety and effectiveness through the use of academic investigators risks undermining the integrity of biomedical research and patient care.”
In “Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles,” Stern and Lemmens argue that since medical journals, academic institutions, and professional disciplinary bodies have not succeeded in enforcing effective sanctions, a more successful deterrence would be through the imposition of legal liability on the guest authors, “and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO).”…
Read the entire news article
Simon Stern, Trudo Lemmens. Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles. PLoS Medicine, 2011; 8 (8): e1001070 DOI: 10.1371/journal.pmed.1001070
Adding research-centred approaches into the day-to-day life of the doctor’s clinic strengthens clinical decisions, according to a new report by the European Medical Research Councils. The “Implementation of Medical Research in Clinical Practice” report launched at the European School of Management and Technology in Berlin, Germany.
The report examines the quality of clinical research, and how using research in clinical practice can improve treatment. An important theme is tightening the relationship between doctors, patients and researchers, such as involving GPs in clinical trials to get a better idea of how treatments work in a wider range of patients, beyond the controlled environment of a hospital.
“Medical care has improved greatly in the last 50 years, underpinned by progress in clinical research,” said Professor Liselotte Højgaard, chair of the European Medical Research Councils, part of the European Science Foundation (ESF). “But we cannot be complacent. We want new findings to be introduced into clinical practice as speedily and efficiently as possible, so that evidence-based medicine is used in each and every patient treatment.”…
Greater international collaboration between countries could help with systematically reviewing treatments, through shared databases on protocols, data, and health technology assessments. The report recommends actively using evidence-based clinical practice guidelines, as well as promoting rigorous reporting for clinical studies. Health technology assessment reports and clinical guidelines are strongly advised for hospitals and primary care facilities, as well as for administrative processes including financing of treatment and technologies. ….
- Do Doctors Resist Reform? The Case of Evidence-Based Medical Practice (larrycuban.wordpress.com)
- IOM recommends standards to achieve reliable clinical practice guidelines (eurekalert.org)
Summaries of supported public health initiatives may be found at Public Health Impacts.
“Discoveries by NIEHS-funded scientists have led to the development of prevention strategies, health and safety guidelines, and potential treatments for asthma, cardiovascular disease, cancer, and other environmentally-related diseases..”
This research has yielded numerous studies on indoor pollution and respiratory health, and led to the development of air sampling techniques used in research settings worldwide.
- Children’s Environmental Health
Research on the annual costs of environmentally-related diseases in American children will be useful in developing new strategies and guidelines for the detection and prevention of childhood illnesses.
- Pesticides & Neurodevelopment
The discovery of an enzyme that provides protection against the toxicity of pesticide compounds has led to the development of new treatments for nerve agent exposures.