Nursing Home Fall Study May Have Put Seniors At Risk

A prominent medical journal indicates that a group of scientists may have exposed nursing home patients to potential harm during a study published five years ago.  

A report released online by the Journal of the American Medical Association on October 4, highlights concerns surrounding a study that placed elderly patients at risk for a nursing home fall.

The statement, a first in the 129 year history of the prominent medical journal, detailed problems with a Harvard led study, “Efficacy of a Hip Protector to Prevent Hip Fracture in Nursing Home Residents: The HIP PRO Randomized Controlled Trial”, which was first published in 2007.

The study was conducted at Hebrew Senior Life in Boston, the University of Maryland School of Medicine and Washington University School of Medicine between 2002 to 2006. It was led by Dr. Douglas P. Kiel, a Harvard Medical School gerontologist, involving more than 2,000 senior citizens to evaluate the effect of hip protection underwear and the prevention of hip fractures.

Scientists at the three research institutions became aware of a higher risk for the elderly residents, discussed the risks, but failed to inform patients, safety boards or the federal agency that funded the research, the Office for Human Research Protection (OHRP). They also were not entirely honest with JAMA regarding safety concerns of the patients in the study prior to publication of the findings.

Patients often wear padded underwear to protect hips from injury during a fall. The underwear is typically padded on both sides, but this study assessed underwear padded only on one side.

The study may have exposed more than 1,000 elderly nursing home residents to an increased risk of serious injury from a fall. The one sided underwear may have increased the resident’s risk of falling to one side, making them more susceptible to hip fractures than they normally would have been.

Federal regulators from the OHRP conducted a yearlong investigation into researchers who participated in the study at the three different institutions. Findings of the investigation determined researchers were “sufficiently aware of the risk of increased falling on the protected side” and still failed to disclose the risk to the patients involved, according to a letter written by the Department of Health and Human Services to the three medical institutions involved in the study.

The facilities were then required to develop corrective action plans to protect patients and alert officials when problems arise. The institutions were also ordered to send letters to the more than 1,300 patients who participated in the study after August 1, 2004, when scientists first became aware of potential risks, detailing the risks to which they were exposed.