Health and Medical News and Resources

General interest items edited by Janice Flahiff

[News release] First patient-led research registry for arthritis patients launched

First patient-led research registry for arthritis patients launched.

From the 20 May 2015 University of Alabama news release

CreakyJoints, an online, nonprofit, patient support community with more than 80,000 members, has launched Arthritis Power, the first patient-led, patient-generated, patient-centered research registry for arthritis, bone, and inflammatory skin conditions. Focusing on rheumatoid arthritis, psoriasis, psoriatic arthritis as well as numerous other musculoskeletal conditions, the goal of Arthritis Power is to securely collect health data from tens of thousands of arthritis patients to support future research.

achy joints

Arthritis Power includes a steering committee of patients called the Patient Governor Group that identifies research needs for study development and prioritizes research requests from the CreakyJoints patient community around the world. The new initiative is launched in partnership with the University of Alabama at Birmingham. Arthritis Power is supported in part by the Patient Centered Outcomes Research Institute (PCORI), a nonprofit, nongovernmental organization created by Congress as part of the Patient Protection and Affordable Care Act of 2010. Its overall goal is to enhance informed health-care decision-making and to improve health-care delivery.

Usually patients with rheumatoid, psoriatic arthritis or other chronic conditions learn about opportunities to participate in research from their health-care providers. Arthritis Power will offer a variety of clinical trial and other research opportunities, allowing patients to proactively decide when and how to participate. Securely donated data will be used by patients, universities, research facilities, and physicians to better understand how to fight these diseases and perhaps, contribute to finding elusive cures. Arthritis Power data will be collected using a smart phone, laptop, desktop or tablet where there is an Internet connection.

“Patient-centered research means that we can more effectively use big data to answer questions that are important to those living with these illnesses. This opportunity will produce results that help patients weigh the value of health-care options according to their personal circumstances, conditions, and preferences,” says Jeffrey Curtis, M.D., M.S., MPH, William J. Koopman Endowed Professor in Rheumatology and Immunology in the UAB Division of Clinical Immunology and Rheumatology.

 

May 28, 2015 Posted by | Medical and Health Research News | , , , | Leave a comment

[News release] As diagnosis codes change, data lost in translation – both ways

From the 16 March 2015 UIC news release

Changes in how medical diagnoses are coded under the latest international disease classification system – known as the ICD-10 codes – may complicate financial analysis, research projects and training programs that depend on look-back comparisons of health care data, report researchers at the University of Illinois at Chicago.

The report, a collaboration of researchers at UIC and at the University of Arizona, is online in the Journal of the American Medical Informatics Association (JAMIA).

Codes for diagnoses – used to justify payments, among other things – may not translate from ICD-10 back to ICD-9 in a simple way, says Andrew Boyd, assistant professor of biomedical and health information sciences at UIC and first author of the paper.

Boyd and his colleagues have been looking at issues that could come up as physicians and hospitals change from one system to the other. Previously they found that some ICD-9 codes map well to ICD-10, but many more have highly convoluted mappings, and some don’t map at all. This forward-mapping is needed for continuing payments of ongoing medical conditions.

“Now, we are taking the same methodology and looking backward,” Boyd said. Reverse-mapping from ICD-10 back to ICD-9 will be important for all sorts of retrospective analyses, he said, “because we have 30 years of data that we want. We don’t want to lose all this information.”

Clinical researchers and analysts conducting studies across datasets – and hospital administrators who manage growth and watch trends for strategic planning – will need to pull data under both the new and the old codes. Mapping back from ICD-10- to ICD-9 is just as complex as mapping from ICD-9 to ICD-10.

The researchers created a web portal tool and translation tables designed to provide guidance on ambiguous and complex translations and to reveal where analyses may be challenging or impossible. The tool lists all ICD-9-CM diagnosis codes related to the input of ICD-10-CM codes and classifies their level of complexity, which can be a one-to-one “identity,” or reciprocal (the simplest); class-to-subclass; subclass-to-class; “convoluted”; or “no mapping.”

….

 

March 21, 2015 Posted by | Medical and Health Research News | , , , , , | Leave a comment

[News release] Posting of trials results to online public database lagging, say Duke researchers

“What’s published in medical journals doesn’t necessarily match what was reported in clinicaltrials.gov….In a significant proportion of cases, the results on cliniclaltrials.gov were reported more thoroughly than the results in corresponding journal articles,”

Screen Shot 2015-03-15 at 4.57.15 AM

From the March 2015 Medicine News post from Duke University

Despite legal and ethical mandates for disclosure, results from most clinical trials of medical products are not reported promptly atclinicaltrials.govaccording to Duke Medicine researchers.

Among all clinical trials of medical products, those funded by industry were the most likely to be publicly disclosed in a timely fashion, but even then, compliance was poor.

Research funded by the National Institutes of Health and academic institutions lagged further, according to findings published by Monique Anderson, MD, assistant professor of medicine (Cardiology), and her DCRI colleagues in the March 12, 2015, issue of The New England Journal of Medicine.

  • Read the findings: Compliance with Results Reporting at ClinicalTrials.gov.
    From the results section
    “From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions.”
  • Read a blog post about the study at Rethinking Clinical Trials, the NIH Collaboratory’s Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical TrialsExcerpts
    ““We were really surprised at how untimely the reporting was—and that more than 66 percent hadn’t reported at all over the 5 years [of the study interval],””Another unexpected result was the finding that industry-sponsored studies were significantly more likely to have reported timely results than were trials sponsored by the National Institutes of Health (NIH) or by other academic or government funding sources. The authors noted that despite a seemingly widespread lack of compliance with both legal and ethical imperatives for reporting trial results, there has so far been no penalty for failing to meet reporting obligations,””reporting clinical trials results in order to contribute to scientific and medical knowledge is as much an ethical obligation for researchers as a legal one: “It’s something we really promise to every patient when they enroll on a trial.””
  • Listen to a report, with quotes from Dr. Anderson and Mark Stacy, MD, vice dean for clinical research, on National Public Radio: Results Of Many Clinical Trials Not Being ReportedExcerpts
    “Even counting the late entries and allowable exceptions, only about 50 percent of taxpayer-funded research has been reported back to the taxpayers on clinicaltrials.gov, ”
    “The study doesn’t assess why universities are frequently failing to post their results.”
    “scientists are generally more likely to publish good news and ignore bad news, which skews the scientific record.”
    “What’s published in medical journals doesn’t necessarily match whatwas reported in clinicaltrials.gov.”In a significant proportion of cases, the results on cliniclaltrials.gov were reported more thoroughly than the results in corresponding journal articles,” he says.
  • Visit clinicaltrials.gov

March 15, 2015 Posted by | Medical and Health Research News | , , , , | Leave a comment

[Journal article] How Basic Scientists Help the Pharmaceutical Industry Market Drugs

Excerpt from the December 2013 PLoS article by Adriane Fugh-Berman 

In the 1970s, a Baltimore city senator who also owned a tavern backed legislation that helped his business. Accused of having a conflict of interest, Joseph J. Staszak, responded, “What conflict of interest? How does this conflict with my interest?” [1].

According to the Institute of Medicine, a conflict of interest is “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary influence” [2]. More simply, conflicts of interest may be seen as circumstances in which “individuals’ professional responsibilities diverge from their personal interests (or when different professional responsibilities clash)” [3].

In biomedicine, discourse on conflicts of interest (also called competing interests) has focused on relationships between industry and physicians or clinical researchers. However, basic scientists are not immune to industry influence on research and publications, and may be important to industry in the production and dissemination of marketing messages.

Depending on Industry

In 2007, industry was the largest funder of biomedical research, paying for nearly twice as much research (58%) as the federal government (33%) [4]. Most of this funding goes to clinical research; the share of spending by pharmaceutical and device industry on preclinical research has decreased from about half (55%) in 1998 to a quarter (25%) in 2010 [5]. A 2007 survey of 3,080 academic life science researchers found that half (53%) have some form of relationship with industry [6]. Among the 1,663 research faculty at academic medical centers, 42% of basic scientists had a relationship with industry. This number was similar to health services researchers/clinical epidemiologists (40%), but less than clinical researchers (67%) translational researchers (61%), or “multimodal” researchers (71%) [7]. At the 50 universities that received the most NIH research funding, 43% of 2,167 life science researchers reported receiving a research-related gift in the late 1990s [8]. Gifts included biomaterials (24% of respondents), discretionary funds (15%), equipment (11%), travel funds to professional meetings (11%), student support (9%), and other (3%).

Researchers were aware that something was expected in return for the gift. Sponsor expectations that the gift be used for its intended purpose and not be re-gifted, and that the sponsor be acknowledged in publications, are certainly reasonable. Disturbingly, however, about a third (32%) of gift recipients reported that the funder wanted prepublication review of any articles or reports stemming from the use of the gift. This expectation was higher for gifts of biomaterials: 40% of respondents reported that the firm wanted to receive prepublication review of articles or reports. Also, 44% of firms wanted assurances that the biomaterial was not to be used for applications that competed with company products [8].

Industry Funding Affects Results

In clinical research, investigators who receive industry funding are more likely to publish results that favor a sponsor’s marketing goals than are investigators who do not receive industry funding. The Cochrane Collaboration, renowned for creating and publishing high-quality systematic reviews, analyzed 48 clinical studies, systematic reviews, and meta-analyses that compared results from studies of drugs or medical devices based on sponsorship. This systematic review found that industry-sponsored studies, compared to non-industry-sponsored studies, were more likely to report favorable efficacy results for drugs or medical devices; less likely to find harms; and more likely to conclude that a therapy was beneficial [9].

Selective Publication

Selective presentations and publications are important tactics for industry. Industry relies on abstracts and posters to convey marketing messages at scientific meetings, because abstracts and posters are usually not peer-reviewed and can be easily altered up to the time of presentation. Posters and abstracts are often used for preclinical studies, case reports, or preliminary results of clinical trials. Promising preliminary results might be presented as a poster, and the results may be publicized, but if the final results of the study do not support commercial goals, the full study may never be published – or may be buried in an obscure, low-impact journal. In either case, scientists may have a positive impression of a therapy from a poster, and never learn that the therapy failed to show efficacy in the final study.

Perhaps because negative outcomes from industry-funded studies are less likely to be submitted for publication, industry-funded clinical trials overall are less likely to be published. An analysis of 546 drug trials listed in ClinicalTrials.gov found that within two years of study completion, about a third of studies that received full (32%) or partial (39%) industry support were published. In contrast, more than half (54%) of trials funded by government, and 56% of trials funded entirely through nonprofit/nonfederal funds, were published [19].

The majority of meeting abstracts and posters are never published. Posters and abstracts with positive results are far more likely to be published than negative studies [14],[15].

..

Once a drug is on the market, it can be prescribed “off-label” – that is, for any condition other than that for which the drug was approved. Although it is legal for physicians and other prescribers to prescribe a drug off-label, it is illegal for pharmaceutical companies to promote drugs off-label. Off-label use is common, accounting for about one in five prescriptions [23]. It is unknown how much off-label use is due to promotion.

Pharmaceutical companies use paid speakers, consultants, and researchers to promote off-label use [24].

,,,

Companies have paid billions of dollars in fines for off-label promotion, often using company-generated research, company-paid speakers, and ghostwritten articles to imply clinical benefits in the absence of clinical trials (or the presence of negative trials); fines have also been imposed for suppressing risks or misleading clinicians about risks [34].

Read the entire article here

 

December 8, 2013 Posted by | Biomedical Research Resources | , , , , , , , | Leave a comment

Scientists to EPA: Include Women in Reproductive Health Research

Oncofertility Consortium Logo

Oncofertility Consortium Logo (Photo credit: Wikipedia)

 

From the Northwestern University press release (October 17, 2012)

 

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.

 

 

 

 

October 18, 2012 Posted by | Medical and Health Research News | , , , , , , , , | Leave a comment

New Style and New Content for ClinicalTrials.gov

From the US National Library of Medicine August 2012 press release

ClinicalTrials.gov is the NLM-developed Web-based registry and results database of clinical research studies. The Web site provides patients, clinicians, researchers, and the public with access to information about interventional and observational studies. As of August 2012, ClinicalTrials.gov contained over 130,000 clinical research studies in all fifty states and in 179 countries.

On August 13, 2012, visitors to the ClinicalTrials.gov Web site and the accompanying Protocol Registration System (PRS) Information Web site (designed for data providers) saw a link to a beta site including a new integrated homepage and updated graphic design for the site (http://clinicaltrials.gov/beta/).

Visitors will also have access to new and reorganized written content about clinical research, background information about the site, searching for studies, and maintaining study records.

However, core functions of the site — including the basic and advanced search, search results options, and the study record data – will remain the same. The new site interface will run in parallel with the previous version for approximately four weeks after launch. After appropriate testing and additional minor changes it will permanently replace the previous interface.

The New Homepage

The homepage (see Figure 1) showcases the study search options and search help resources in one location, the “Search for Studies” area. Site visitors can begin a basic search here, go to the advanced search form, or begin browsing for studies by topic or on a world map. Site visitors can also get help with searching, finding studies with summary results posted on ClinicalTrials.gov, and reading study records.

A new menu bar provides direct access to each area of content on the site (See Navigating the Site). Custom views of this content have been created for different user groups. Patients and families, researchers, and study record managers are three significant groups that visit ClinicalTrials.gov. The homepage areas for these audiences provide an introduction to content for each user group, and the “Learn more” link in each area goes to an orientation page that highlights relevant resources on the site. For example, study record managers can find out which clinical trials should be registered with ClinicalTrials.gov and get help with setting up accounts, registering studies and updating records. Members of the press also have a new page with background information and statistics about the site (see the “Media/Press Resources” page under “About Us” in the menu bar).

Data about the site are highlighted in the right column of the homepage. Users can access “Trends, charts, and maps” content for more statistics. An enhanced Glossary provides descriptions of clinical research terms commonly used on ClinicalTrials.gov and “Using our RSS Feeds” explains how to get notification of new and updated study records.

Screen capture of citationcontext menu.
Figure 1: New ClinicalTrials.gov homepage.

 

Please click here for more figures on how to

  • How to search for clinical trials
  • How to find information on study records (clinical trial sites and study organizers)
  • How to find selected outreach and scholarly publications related to ClinicalTrials.gov and clinical research

August 27, 2012 Posted by | Finding Aids/Directories, Medical and Health Research News | , , | Leave a comment

   

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