SOURCE: HipSaver, Inc.

June 30, 2011 11:43 ET

U.S. Department of Health and Human Services Determines That University Researchers Deliberately Failed to Disclose Risks Caused by Study Design in Hip Protector Research Project According to HipSaver, Inc.

CANTON, MA--(Marketwire - Jun 30, 2011) - The U.S. Department of Health and Human Services, Office of Human Research Protection (OHRP) has determined that a research study project on hip protectors failed to comply with Department of Health and Human Services regulations for protecting human subjects in government-funded research. The study was conducted by principal investigator Douglas P. Kiel, M.D., a professor of gerontology at Harvard Medical School and researcher at Boston's Hebrew Rehabilitation Center for the Aged, along with co-authors Jay Magaziner of the University of Maryland and Stanley Birge of Washington University, St. Louis. HipSaver, Inc., a hip protector manufacturer, requested this investigation after disturbing documents surfaced in a civil lawsuit relating to the study.

OHRP determined that the research team failed to disclose reasonably foreseeable risks related to the study design to the subjects and also determined that investigators failed to report unanticipated problems. The OHRP findings were posted on OHRP's web site and can be seen at http://www.hhs.gov/ohrp/compliance/letters/index.html

In part the OHRP findings state, "The research study (HIP PRO) was a large, multicenter, randomized controlled clinical trial to study the effect of hip protection underwear on preventing hip fractures. The study involved the use of a type of underwear containing a single pocket and a hip pad covering either the left or right hip of enrolled nursing home residents. The use of this one-sided protection was a departure from the way that hip protection underwear is actually used clinically, where hip protection, if offered, is provided on both hips." The results of the study were published in the Journal of the American Medical Association (JAMA) in 2007.

OHRP is requiring the three research centers involved to contact the research subjects who were enrolled in this study to inform them of the issues caused by the study design, including the risk of increased falls and hip fractures.

The improperly conducted HIP PRO study by was funded by the National Institute on Aging (NIA) and cost the taxpayers $8.5 million.

Hip protectors are an inexpensive intervention designed to prevent hip fractures in elderly men and women who fall. They consist of garments (usually underwear) that have a pad covering each hip to reduce the impact force of a fall to the hip bone. Several major published studies have indicated that hip protectors are highly effective in nursing home settings where nurses encourage residents to wear them.

The HIP PRO study design padded only one hip of each participant with the hypothesis that they would see fewer fractures on the padded hip and thereby prove that the pad is effective in reducing hip fractures. This design ignited controversy in the scientific community relating to the validity and ethics of a study using a one-sided hip protector. In fact, the study was terminated early because of the paradoxical fact that in the 2470 falls in the study, more fractures occurred on the padded hip than on the unpadded hip. When Dr. Kiel published the study in JAMA, he stated that his study of this one-sided hip protector confirmed the ineffectiveness of all hip protectors.

"This was the first study out of about 15 where more fractures occurred on padded hips than non-padded hips, providing a strong indication that something was amiss in the single-pad study design," says Ed Goodwin, president of HipSaver Inc., a hip protector manufacturer.

In 2008 Goodwin sued Dr. Kiel for invalidly generalizing his study results to all hip protectors. In the process of court-ordered discovery in HipSaver vs. Kiel, strong evidence came to light showing the falsity of the general conclusion in the JAMA article. The study design, with padding on only one hip, actually caused a statistically significant tendency for the frail nursing home residents to fall toward the padded side. In contrast, in all previous 15 studies, fall tendency was not affected by wearing a standard two-sided hip protector. Furthermore, email correspondence between the study authors shows they feared the study would be shut down and funding cut off if the safety board was completely informed about the lopsided falls.

In a recent discovery motion hearing, the court fined Dr. Kiel for his false testimony surrounding the analysis of the study data. HipSaver vs. Kiel will be tried before a jury later this year in Norfolk Superior Court in Dedham, Massachusetts.

"The most serious concern arising out of this is, how many of these frail elders, whose average age was 85 years, died or became disabled because of this flawed study design and the conduct of the researchers?" asked Ed Goodwin. "The lawsuit against Kiel is a business civil suit and does not address this concern, so that is why I filed a request with the NIA to investigate the matter. Their independent investigation supports our claim that the study's conclusions about hip protectors are false, along with showing that the researchers knowingly had a callous disregard for these elderly persons."

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