Conducting a randomized, controlled clinical trial that includes children can be challenging. The disease or condition may not be as common among children as adults, making recruitment in sufficient numbers to power the trial difficult. Parents and guardians may be reluctant to enroll a child in a randomized format, perhaps misperceiving one treatment as inferior or as withholding care. The time and cost of representing such vulnerable patient populations may be prohibitive and threaten the feasibility of completing the trial.
In some cases, the result is a gap in evidence with physicians at a loss about the benefits and risks of prescribing drugs that have been approved for adults to their pediatric patients. Based on clinical judgment and experience, some turn to off-label prescribing as a treatment option. In this issue, we explore off-label usage and technologies, such as EHRs or clinical decision support systems, which may help track the outcomes of children who are administered these drugs to ensure the benefits outweigh the risks.
Our cover story looks at the impending launch of a hospital readmission reduction program that was created through the Patient Protection and Affordable Care Act (PPACA). Beginning in fiscal year 2013, the program penalizes hospitals that perform poorly on readmissions for heart failure, acute MI and pneumonia in an effort to tamp down healthcare costs. The formula relies on risk-adjustment algorithms that account for socioeconomic and health factors related to a hospital’s patient population.
“The risk adjustment allows hospitals with complex patient populations to continue to have an incentive to treat complex patients, without necessarily receiving a large payment penalty,” wrote the authors of the 2010 report “Medicare Hospital Readmissions: Issues, Policy Options and PPACA.” The report was provided through the Congressional Research Service to summarize the approach and possible consequences.
There are competing schools of thought about the best approach for risk adjustment, whose rankings can vary significantly depending on inputs and methodology. The authors caution that despite efforts to properly risk adjust, some hospitals with more complex patient populations may struggle to prevent readmissions and therefore may not succeed at reducing their rates. Other observers fear a spiral effect, where the financial penalty only worsens the burden for these hospitals and their patients.
Perhaps, as with off-label prescribing, IT can serve as a resource by tracking the consequences of this program. At least, let’s hope.