February 26, 2020         
BBVA USA January Recap: Workplace equality, industry recognitions, and renewed sponsorship   •   Baby Making After Valentine’s Day Means a Turkey Time Baby: Preparing for a Summer Bump & Thanksgiving Wobble   •   Mattel Announces Ruth Handler Mentorship Program for Women in Toys Timed to Company’s 75th Anniversary   •   TherapeuticsMD and Afaxys Enter Into Agreement to Expand Access to ANNOVERA® in the U.S. Public Health Sector   •   Author Sam Van Galder's new book "Ethan's Animal Alphabet" is a vividly illustrated book featuring a menagerie of colorful anima   •   “The 51st NAACP Image Awards” Illuminated the Airwaves With Black Excellence and Lit Up the Ratings With 1.8 Million   •   Columbus Crew SC Announces Founding Partnership With OhioHealth and Naming Rights for Future Training Facility   •   Discover Recognized as a Best Place to Work for LGBTQ Equality For Seventh Consecutive Year   •   Michelle Lynn VanMeter's newly released "The Old Rag Doll" is a heartwarming tale of a rag doll who brings joy to children   •   Guard your state-of-the-art Samsung Galaxy S20 phone with Gadget Guard Black Ice Flex screen protector   •   ARC Makes Strong Debut on HRC’s 2020 Corporate Equality Index   •   Persecution of the Local Church: Long Beach, California   •   Greenberg Traurig's Christopher A. Mair Named to The National Black Lawyers 'Top 40 Under 40' in Illinois   •   K.L. Keltre's newly released "I Was There...: when baby Jesus was born" is an enthralling account that shows readers the series   •   Corporate Social Responsibility Related News Releases and Story Ideas for Reporters, Bloggers and Media Outlets   •   Greenberg Traurig Represents Iraqi Refugee in Successful Pro Bono Case   •   Washington Prime Group Announces HomeGoods to Open at Mesa Mall   •   United States Supreme Court Rules Against 15-Year-Old Mexican National Killed By Border Patrol Agent   •   Small Business Trends Report Rebased by Guidant Financial Finds Number of Profitable Black-Owned Small Businesses Rises 5% Year   •   FIBRA Prologis Declares Quarterly Distribution
Bookmark and Share

Bias Found In Pediatric Studies

BALTIMORE — A Johns Hopkins review of nearly 150 randomized controlled trials on children — all published in well-regarded medical journals — reveals that 40 to 60 percent of the studies either failed to take steps to minimize risk for bias or to at least properly describe those measures.


A report of the team’s findings in the August issue of Pediatrics shows that experimental trials sponsored by pharmaceutical or medical-device makers, along with studies that are not registered in a public-access database, had higher risk for bias. So were trials that evaluate the effects of behavioral therapies rather than medication, the report states.

“There are thousands of pediatric trials going on in the world right now and given the risk that comes from distorted findings, we must ensure vigilance in how these studies are designed, conducted and judged,” says lead investigator Michael Crocetti, M.D., M.P.H., a pediatrician at Johns Hopkins Children’s Center. “Our review is intended as a step in that direction.”

Considered the gold standard of medical research, the hallmark of double-blind randomized controlled trials (RTC) is a design that rules out or accounts for actual or potential bias. Results of such studies, when peer-reviewed and published in reputable medical journals, can influence the practice of medicine and patient care. A poorly designed or executed trial can therefore lead researchers to erroneous conclusions about the effectiveness of a drug or a procedure.

Citing the degree of bias risk in the studies they reviewed, the researchers caution pediatricians to be critical readers of studies, even in highly respected journals.
The investigators advise that when reading a report on a trial, pediatricians should not merely look at the bottom line but ask two essential questions: How did the researchers reach the conclusion? and Was their analysis unbiased?

Doctors should apply “smell tests,” common sense and skeptical judgment about whether the conclusions fit the data, especially when a study boasts dramatic effects or drastic improvement.

Crocetti and colleagues used the Cochrane Collaboration tool, which assesses risk for bias along six critical aspects including randomization — randomly assigning patients to different treatments — and masking, the degree to which neither the patient nor the doctor knows which group of patients is receiving an active drug or intervention versus a placebo.

Investigators say that by analyzing each clinical trial along these and four other dimensions, the Cochrane Collaboration can answer what are perhaps the most important questions in medical research: How strong is the causal relationship between the therapy and the effect? and How valid are the conclusions made about the effect of the therapy?

Overall, 41 percent of the 146 trials in the review had improper or poorly described randomization techniques. Industry-funded trials were six times more likely to have high risk for biased randomization than government-funded trials or those funded by nonprofit organizations. And past research, the investigators point out, has shown that industry-funded trials are four to five times more likely to recommend an experimental drug.

“Industry funding is an important driver of medical discovery, but it is critical for investigators involved in such trials to ensure not only that the studies are conceived and executed cautiously with minimum risk for bias, but that any precautions taken against bias are also reported transparently,” Crocetti says.

Trial registration — and the transparency commitment it reflects — is a key step in reducing bias or its influence, the researchers say. In their evaluation, registered trials were nearly 70 percent more likely to have robust randomization than non-registered trials, probably because the registration process itself forces researchers to answer many questions related to trial design and execution. Therefore, the investigators say, registering pediatric trials in the public domain will not only increase transparency but, in the long run, improve the validity of their results. In 2005, the International Committee of Medical Journal Editors called for registering all medical trials involving human subjects withwww.ClinicalTrials.gov, a massive public repository of more than 70,000 trials from all over the world. However, less than 60 percent of the pediatric trials in the review were registered there.

The researchers also found that most of the trials (57 percent) either failed to use proper techniques that ensure anonymity or “blinding” to the type of treatment a patient gets, or they failed to clearly describe these techniques. The technique, called allocation concealment, ensures that neither the researcher nor the patient can guess which treatment they will get. The method also helps ensure that the treatment of one subject will not reveal to either scientists or the patients clues about the treatment of the next subject. Trials involving behavioral therapies were four times more likely to have this problem.

Overall, nearly 20 percent of the trials used improper masking techniques to ensure that neither the patient nor the researchers know which treatment went to which patient.

The 146 trials in the review appeared between 2007 and 2008 in the five leading pediatric journals — Pediatrics, Pediatric Infectious Diseases, Journal of Pediatrics, Archives of Pediatrics and Adolescent Medicine and the Journal of the American Academy of Child and Adolescent Psychiatry — and the three highest-ranked general medical journals —JAMA, The New England Journal of Medicine and The Lancet.

Co-investigators on the research: Roberta Scherer, Ph.D., of the Johns Hopkins Bloomberg School of Public Health and Diane Amin, PA-C., of Hopkins.

 



Back to top
| Back to home page
Video

White House Live Stream
LIVE VIDEO EVERY SATURDAY
alsharpton Rev. Al Sharpton
9 to 11 am EST
jjackson Rev. Jesse Jackson
10 to noon CST


Video

LIVE BROADCASTS
Sounds Make the News ®
WAOK-Urban
Atlanta - WAOK-Urban
KPFA-Progressive
Berkley / San Francisco - KPFA-Progressive
WVON-Urban
Chicago - WVON-Urban
KJLH - Urban
Los Angeles - KJLH - Urban
WKDM-Mandarin Chinese
New York - WKDM-Mandarin Chinese
WADO-Spanish
New York - WADO-Spanish
WBAI - Progressive
New York - WBAI - Progressive
WOL-Urban
Washington - WOL-Urban

Listen to United Natiosns News