Does journal endorsement of reporting guidelines influence the completeness of reporting of health research? A systematic review protocol

Does journal endorsement of reporting guidelines influence the completeness of reporting of health research? A systematic review protocol

Background: Reporting of health research is often inadequate and incomplete. Complete and transparent reporting is imperative to enable readers to assess the validity of research findings for use in healthcare and policy decision-making. To this end, many guidelines, aimed at improving the quality of health research reports, have been developed for reporting a variety of research types. Despite efforts, many reporting guidelines are underused. In order to increase their uptake, evidence of their effectiveness is important and will provide authors, peer reviewers and editors with an important resource for use and implementation of pertinent guidance.....

Healthnewsreview: The limitations of – and explosion in the number of – observational studies

The limitations of – and explosion in the number of – observational studies:

In the Wall Street Journal, Gautam Naik has a thoughtful piece, “Analytical Trend Troubles Scientists,” hitting on the limitations of – and the explosion in the number of – observational studies.  Excerpts:

“While the gold standard of medical research is the randomly controlled experimental study, scientists have recently rushed to pursue observational studies, which are much easier, cheaper and quicker to do. Costs for a typical controlled trial can stretch high into the millions; observational studies can be performed for tens of thousands of dollars.
In an observational study there is no human intervention. Researchers simply observe what is happening during the course of events, or they analyze previously gathered data and draw conclusions. In an experimental study, such as a drug trial, investigators prompt some sort of change—by giving a drug to half the participants, say—and then make inferences.
But observational studies, researchers say, are especially prone to methodological and statistical biases that can render the results unreliable. Their findings are much less replicable than those drawn from controlled research. Worse, few of the flawed findings are spotted—or corrected—in the published literature.
“You can troll the data, slicing and dicing it any way you want,” says S. Stanley Young of the U.S. National Institute of Statistical Sciences. Consequently, “a great deal of irresponsible reporting of results is going on.”
Despite such concerns among researchers, observational studies have never been more popular.
Nearly 80,000 observational studies were published in the period 1990-2000 across all scientific fields, according to an analysis performed for The Wall Street Journal by Thomson Reuters. In the following period, 2001-2011, the number of studies more than tripled to 263,557, based on a search of Thomson Reuters Web of Science, an index of 11,600 peer-reviewed journals world-wide. The analysis likely doesn’t capture every observational study in the literature, but it does indicate a pattern of growth over time.
A vast array of claims made in medicine, public health and nutrition are based on observational studies, as are those about the environment, climate change and psychology.”

The article addresses the “hot area of medical research” – the search for biomarkers.

“The presence or absence of the biomarkers in a patient’s blood, some theorized, could indicate a higher or lower risk for heart disease—the biggest killer in the Western world.
Yet these biomarkers “are either completely worthless or there are only very small effects” in predicting heart disease, says John Ioannidis of Stanford University, who extensively analyzed two decades’ worth of biomarker research and published his findings in Circulation Research journal in March. Many of the studies, he found, were undermined by statistical biases, and many of the biomarkers showed very little predictive ability of heart disease.
His conclusion is widely upheld by other scientists: Just because two events are statistically associated in a study, it doesn’t mean that one necessarily sets off the other. What is merely suggestive can be mistaken as causal.
That partly explains why observational studies in general can be replicated only 20% of the time, versus 80% for large, well-designed randomly controlled trials, says Dr. Ioannidis. Dr. Young, meanwhile, pegs the replication rate for observational data at an even lower 5% to 10%.
Whatever the figure, it suggests that a lot more of these studies are getting published. Those papers can often trigger pointless follow-on research and affect real-world practices.”

But the story also appropriately points out the contribution obervational studies have made:

“Observational studies do have many valuable uses. They can offer early clues about what might be triggering a disease or health outcome. For example, it was data from observational trials that flagged the increased risk of heart attacks posed by the arthritis drug Vioxx. And it was observational data that helped researchers establish the link between smoking and lung cancer.”

I have written many times about the weakness of news stories that fail to point out the limitations of observational studies and – more specifically – stories that use causal language to describe the findings from observational studies that can “only” point to statistical associations.
News consumers and health care consumers need to better understand the limitations of all studies – including randomized clinical trials.

Blogger's Opinion: repost (2011) : Proteomic biomarkers in combination with CA 125 for detection of epithelial ovarian cancer using prediagnostic serum samples from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial - Moore - 2011 - Cancer - Wiley Online Library

Blogger's Note/Opinion:  
efforts to improve on the existing CA125 biomarkers remain elusive, as we speak;  this may be confirmed by the multitude of research studies/meta-analsyes (known issues); we, as patients/survivors, all have examples which are contrary, or exceptions,  to what is presently known and therefore the issue of 'personalized medicine'; biomarker banking (tissues from surgery for research) is an important key element for those diagnosed so that we may move forward beyond the standard CA125 (as one example); on the bonus side - research is moving forward at a greatly accelerated pace (molecular/proteomics...) but the research is still in the phase/s of being brought to the 'clinic',  meaning what actually works for our ovarian cancer women pre-present-post diagnosis; it is a common philosophy in ovarian cancer research that due to our low numbers (relative to other cancers) that we must have global research (not least of which is to mention global economics); as patients you can make a difference by ensuring that the clinical studies which you enroll will make a difference in these efforts as opposed to small isolated studies - specifically those that continue to regurgitate past studies which do not move forward beyond the existing eg. psychosocial aspects of prophlactic surgery


Proteomic biomarkers in combination with CA 125 for detection of epithelial ovarian cancer using prediagnostic serum samples from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial - Moore - 2011 - Cancer

RESULTS (abstract):

"CA 125 levels were elevated (≥35 U/mL) in 61.5% of 65 patients who had CA 125 data available from samples that were collected <12 months before cancer diagnosis; however, levels of the additional 7 biomarkers were not different between cases and the 3 control groups individually or combined. Two panels that combined CA 125 and the 7 biomarkers failed to improve the sensitivity of CA 125 alone."

DISCUSSION

 ".....Although a marginally better performance was observed for the identification of cases at least 6 months before diagnosis using an all-site multimarker panel (which included CA 125, HE4, tumor-associated glycoprotein 72 [CA 72-4], substance P-like immunoreactivity, andβ2M) were observed compared with CA 125 alone, the increase was not statistically significant.²¹ In addition to the current study, 5 additional panels were evaluated, none of which improved on the results with CA 125 alone.8 Considering the failure of multiple biomarkers to improve upon CA 125 in prediagnostic samples, new approaches are badly needed for biomarker discovery. One weakness of the current study is that we were unable to evaluate markers in nonwhite populations because of a very small number of nonwhite cases in the PLCO trial. The results of this combined effort will likely reshape our approach to biomarker discovery and validation. In addition to searching for protein analytes, autoantibodies also may be sought. Finally, previous studies have had limited success in identifying and evaluated autoantibodies of human proteins expressed in bacteria or insect cells. Recent advances in expressing human proteins in human cells could allow the identification of new epitopes that are selective for altered tertiary structure and glycosylation status of selected protein targets."

open access: Open science versus commercialization: a modern research conflict?

pdf: Open science versus commercialization: a modern research conflict?

 Open debate

Open science versus commercialization: a modern research c

Abstract (provisional)

Background

Efforts to improve research outcomes have resulted in genomic researchers being confronted with complex and seemingly contradictory instructions about how to perform their tasks. Over the past decade, there has been increasing pressure on university researchers to commercialize their work. Concurrently, they are encouraged to collaborate, share data and disseminate new knowledge quickly (i.e., to adopt an open science model) in order to foster scientific progress, meet humanitarian goals, and to maximize the impact of their research.

Discussion

We present selected guidelines from three countries (Canada, United States, and United Kingdom) situated at the forefront of genomics to illustrate this potential policy conflict. Examining the innovation ecosystem and the messages conveyed by the different policies surveyed, we further investigate the inconsistencies between open science and commercialization policies.

Summary

Commercialization and open science are not necessarily irreconcilable and could instead be envisioned as complementary elements of a more holistic innovation framework. Given the exploratory nature of our study, we wish to point out the need to gather additional evidence on the coexistence of open science and commercialization policies and on its impact, both positive and negative, on genomics academic research.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

open access: PLoS Medicine: A Comparison of DSM-IV and DSM-5 Panel Members' Financial Associations with Industry: A Pernicious Problem Persists

PLoS Medicine: A Comparison of DSM-IV and DSM-5 Panel Members' Financial Associations with Industry: A Pernicious Problem Persists

 Introduction

All medical subspecialties have been subject to increased scrutiny about the ways by which their financial associations with industry, such as pharmaceutical companies, may influence, or give the appearance of influencing, recommendations in review articles [1] and clinical practice guidelines [2]. Psychiatry has been at the epicenter of these concerns, in part because of high-profile cases involving ghostwriting [3],[4] and failure to report industry-related income [5], and studies highlighting conflicts of interest in promoting psychotropic drugs [6],[7]. The revised Diagnostic and Statistical Manual of Mental Disorders (DSM), scheduled for publication in May 2013 by the American Psychiatric Association (APA), has created a firestorm of controversy because of questions about undue industry influence. Some have questioned whether the inclusion of new disorders (e.g., Attenuated Psychotic Risk Syndrome) and widening of the boundaries of current disorders (e.g., Adjustment Disorder Related to Bereavement) reflects corporate interests [8],[9]. These concerns have been raised because the nomenclature, criteria, and standardization of psychiatric disorders codified in the DSM have a large public impact in a diverse set of areas ranging from insurance claims to jurisprudence. Moreover, through its relationship to the International Classification of Diseases [10], the system used for classification by many countries around the world, the DSM has a global reach.........

Summary Points

• The American Psychiatric Association (APA) instituted a financial conflict of interest disclosure policy for the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
• The new disclosure policy has not been accompanied by a reduction in the financial conflicts of interest of DSM panel members.
• Transparency alone cannot mitigate the potential for bias and is an insufficient solution for protecting the integrity of the revision process.
• Gaps in APA's disclosure policy are identified and recommendations for more stringent safeguards are offered.

abstract: Profiling clinical cancer research across the Atlantic: A review of research and its characteristics presented at ASCO and ESMO Congresses during the last decade

Conclusions

Cancer clinical research is a complex scientific activity with common global but also distinct characteristics at the two sides of the Atlantic.

Keywords

• Clinical research;
• Trials;
• Oncology Congresses;
• ASCO;
• ESMO

full free access: Research output on primary care in Australia, Canada, Germany, the Netherlands, the United Kingdom, and the United States: bibliometric analysis - bmj.com

What is already known on this topic

• The UK Research Assessment Exercise in 2008 rated 50% of UK primary care research as world class or internationally excellent, but no direct international comparisons exist

What this study adds

• In six countries with strong primary care, the United Kingdom and the Netherlands produce the most cited primary care led primary care research
• Identifying research on primary care that is carried out by primary care researchers is difficult using routine bibliometric methods
• Only 29% of research papers on primary care had at least one primary care researcher as author

Helping social research make a difference - full free access (science and the arts)

full free access: How Research Influences Policy Makers: Still Hazy After All These Years — J. Natl. Cancer Inst. Steven Lewis (author)

"Libraries have been written about the theory and practice of public policy making. Yet, this enormous scholarship has proved insufficient to lift the veil of mystery and idiosyncrasy that shrouds the art of decision making. The heady ambition to turn both clinical practice and health policy into evidence-based bastions of rationalist decision making has been downgraded; the vocabulary is now “evidence-informed,” and the realm of admissible evidence has been greatly expanded to include preferences, political contingencies, and psychology (1). This newfound conceptual modesty and nuance does not suggest that we should abandon efforts to understand decision-making processes and to enhance the role of research-based evidence in policy. It merely confirms the complexity, contingency, and messiness of the terrain............This leads to a second issue: the definition of “use.” The questionnaires simply asked whether the respondents intended to use the brief. We do not know what “use” means.." cont'd

in research: Generic drug (Losartan) may improve the effectiveness of cancer nanotherapies

"Low doses of an inexpensive, FDA-approved hypertension medication may improve the results of nanotherapeutic approaches to cancer treatment. In a report in the early edition of Proceedings of the National Academy of Sciences, Massachusetts General Hospital (MGH) investigators describe experiments showing that the generic drug losartan, by modifying the network of collagen fibers that characterizes most solid tumors, improved the effectiveness of two nanotherapeutics against several types of cancer....."

"....Experiments with two nanotherapeutics – liposomes containing the chemotherapy drug doxorubicin and a virus designed to infect and destroy cancer cells – showed that combining each treatment with losartan significantly reduced the size or delayed the growth of implanted tumors...."

free full access: WHO/PLoS Collection “No Health Without Research”

"It seems astonishing that in the 21st century decisions on health care can still be made without a solid grounding in research evidence. This is true even in clinical research, whether for simple or complex interventions [1], where systematic reviews time and time again conclude that the evidence base is inadequate [2]. It is even more true in the areas of health policy and health systems, where quality research is hampered further by a lack of shared definitions, a lack of consensus on guiding principles, poor capacity (especially in low-resource regions), and methodological challenges [3],[4].
The World Health Report (WHR) for 2012 will be on the theme of “No Health without Research”. This flagship report from WHO will, for the first time in its history, focus on research for better health. The primary target audience of the report will be ministers of health in the WHO member states, and the goal of the report is to provide new ideas, innovative thinking, and pragmatic advice for member states on how to strengthen their own health research systems. The report will have the three following aims.

1. To show that research is important for meeting health needs and improving health outcomes;
2. To encourage countries to therefore invest more resources in developing and strengthening their national health research systems;
3. To argue that countries should not see research as an expense or as an afterthought, but as an investment for a better, healthier future.....cont'd

Research and Markets: Ovarian Cancer Therapeutics - Pipeline Assessment and Market Forecasts to 2017

Business

Research and Markets: Ovarian Cancer Therapeutics - Pipeline Assessment

and Market Forecasts to 2017

© Business Wire 2011
2011-01-20 16:11:16 -

Shattered Chromosome Can Lead to Cancer - NYTimes.com (reference to bone/breast...cancers + commentary link)

Note: theories/research regarding how cancer develops eg; 'one-hit' theory vs multi-step process of malignancy.

Cell (journal link):  Featured Article Free  

Massive Genomic Rearrangement Acquired in a Single Catastrophic Event during Cancer Development

NCI Cancer Bulletin: How to Strengthen Research Partnerships

science article: Duke continues investigation as geneticist's work retracted (ovarian cancer patients to cisplatin drug therapy)

Advancing Ethical Research Conference - December 2010

Research integrity: Sabotage! : Nature News

Maven Semantic: Ovarian Cancer Research Database - media

Note: see website/link for details by individual name and/or country etc

DUBLIN--(BUSINESS WIRE)--Maven Semantic (http://www.mavensemantic.com) announces updates to their Ovarian Cancer research database.
The new database is now available to marketing, business development, competitor intelligence, KOL, medical affairs and related departments in the life sciences sector.
The database currently tags 42,000 individuals working in Ovarian Cancer. http://bit.ly/d0aEsH

What makes a good doctor? The Lancet

Blogger's Note: the discussion regarding education/system/research/focus would be an appropriate concern for all those involved with direct patient care and not exclusive to doctors

Research Ethics Law Blog