AJG Co-Editors-in-Chief Brennan M.R. Spiegel, MD, MSHS, FACG, of Cedars-Sinai Health System, and Brian E. Lacy, PhD, MD, FACG, of Dartmouth-Hitchcock Medical Center, share in an introductory column that the trend of publishing positive studies can lead to “publication bias,” where “important yet negative studies” are not published.
“We recognize that medical journals like ours are quick to publish studies about what we should do to patients, but are generally less willing to publish high-quality research about what we 'should not’ do in clinical practice,” the Co-Editors write.
How The Negative Issue Came to FruitionEarlier this year Dr. Spiegel and Dr. Lacy released a request for manuscripts. They eagerly sought studies that investigators might not have envisioned finding a home in a medical journal.
“We want to know what medicines don’t work, what diets miss the mark, what risk factors are irrelevant, what supplements are no better than placebo, what diagnostic tests are unrevealing, unhelpful, or even harmful, and anything else that may be terrifically non-contributory in gastroenterology and liver diseases,” the Co-Editors asked in the request for manuscripts.
Their call generated more than 100 submissions, which they pared down to a selection of 25 high-impact studies for The Negative Issue, which is free and has no paywall during the month of November. Access the issue by visiting this page and clicking on "Current Issue" on the left-side toolbar.
“The whole idea behind dedicating an entire edition to negative studies is to provide license – to allow people to feel comfortable to contribute their highest-quality negative studies,” Dr. Spiegel recently told Gastroenterology & Endoscopy News in a video interview.
The Significance of The Negative IssueIt is not only significant for a medical journal to publish negative results because of its rarity, but also because null findings can substantially impact clinical practice. Negative findings can provide helpful caution to those in the research community, or even bring studies to a halt. Sharing these studies also has the potential for immediate impact on practice.
“They [negative studies] often have higher impact on science and clinical practice than positive studies; they can potentially prevent researchers, participants, lab animals, and resources from being consumed by further futile research, and save parents, clinicians, and healthcare payers from ineffective practices,” Grigorios I. Leontiadis, MD, PhD, writes in “How to Interpret a Negative Study,” a paper in the issue.
In a recent article on The AJG Negative Issue, Dr. Lacy told STAT News that certain articles in The Negative Issue “will actually change how people will practice.”
What Are the Key Findings?The following are some of the highlighted negative findings across this selection of impactful studies:
• There are no significantly increased risks of adverse birth outcomes in the children of men exposed to antiTNF-α medications within three months prior to conception compared with the children of men not exposed.
• Supplementary, video-based education on clear liquid diet alone does not improve bowel preparation quality.
• Use of NSAIDs is not associated with a reduced risk of Barrett’s esophagus. The findings from this large pooled analysis suggest that the likely protective mechanism of NSAIDs on esophageal adenocarcinoma occurs after the development of Barrett’s esophagus.
• Researchers at Duke University found that neither Vitamin D deficiency, nor hepatic expression of Vitamin D-related genes, associate with the presence or histologic severity of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients. Hence, despite preclinical evidence implicating Vitamin D in NAFLD pathogenesis, Vitamin D deficiency does not appear to be associated with NAFLD severity in humans.
Although there is much excitement about The Negative Issue, the editors only see this as the beginning.
“Keep the null results coming. Remember that ‘negative is positive,’” the Co-Editors advise in their column.
About The American Journal of GastroenterologyPublished monthly since 1934, The American Journal of Gastroenterology (AJG) is the official peer-reviewed journal of the American College of Gastroenterology. The goal of the Journal is to publish scientific papers relevant to the practice of clinical gastroenterology. It features original research, review articles and consensus papers related to new drugs and therapeutic modalities. The AJG Editorial Board encourages submission of original manuscripts, review articles and letters to the editor from members and non-members. AJG is published by Springer Nature. www.nature.com/ajg/index.html
About the American College of GastroenterologyFounded in 1932, the American College of Gastroenterology (ACG) is an organization with an international membership of almost 14,000 individuals from 86 countries. The College's vision is to be the pre-eminent professional organization that champions the evolving needs of clinicians in the delivery of high-quality, evidence-based and compassionate health care to gastroenterology patients. The mission of the College is to advance world-class care for patients with gastrointestinal disorders through excellence, innovation and advocacy in the areas of scientific investigation, education, prevention and treatment. www.gi.org
Visit the ACG Blog for all news, featured research and expert insights related to the ACG Annual Scientific Meeting. Follow ACG on Twitter.
RSS