We Keep Talking About Evidence…So What Is It?

evidence_1200.jpgIf you are a subscriber to our blog or any of our services (and if you aren’t, what are you waiting for?), it is no secret that we talk quite a bit about evidence and its vital necessity to the advancement of healthcare delivery. But without establishing some context by defining it, exploring what makes good evidence, and why it is important, our conversations about evidence can seem empty; the word becomes just another term in our promotional materials. With that, let us take a deeper look at what scientific evidence is and why it is the foundation of what we do here at Hayes.

In healthcare practice, we gather evidence from many sources such as:

  • well-designed randomized clinical trials
  • cohort studies
  • observational case studies
  • retrospective data reviews

clinical trials_1200.jpgNot all evidence is created equal; it varies in quality. The gold standard in the scientific community has been and continues to be evidence derived from randomized controlled clinical trials (RCTs). Ideally, these are multicenter, double-blind, RCTs with large enough study populations to control for bias and confounding variables, including:

  • comorbidities
  • prior treatments
  • the individual health status of the subjects
  • the skill of the treating physician or surgeon

In the absence of RCTs, we turn to other evidence such as cohort studies, epidemiological studies, case studies, and retrospective data analyses using both administrative and public data sets.

“RCTs are not without their limitations. They are expensive to conduct, and with skyrocketing healthcare costs, the expense may not be justified—or necessary—depending on the questions that need to be answered.”

These other forms of evidence do provide value—when and if they are used appropriately. Then the question becomes: “How do we use the various forms of evidence and data for which questions or problems exist?”

It is important to note that RCTs are not without their limitations. They are expensive to conduct, and with skyrocketing healthcare costs, the expense may not be justified—or necessary—depending on the questions that need to be answered.

For example, if you’re trying to answer questions about a drug’s safety and efficacy, you need an RCT. If, however, you want to know how well a hospital is complying with an evidence-based guideline, i.e., sending patients home after a myocardial infarction (MI) with a prescription for a beta-blocker, then you can rely on other forms of evidence or data.

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Furthermore, because RCTs are conducted under well-controlled (some might say ideal) experimental conditions, they may not offer a real-world perspective on patient outcomes. How a patient takes a drug or uses a treatment in a supervised experimental situation will not always predict how the patient will use the treatment in real life.

“Good evidence allows us to evaluate the actual effect of a health technology on patient outcomes and to make recommendations about adopting and using it. Still, RCTs won’t always give us what we need.”

adverse event_1200.jpgLikewise, unintended adverse events and outcomes often don’t become apparent until a treatment has been used by large numbers of heterogeneous patients for a long period of time. RCTs that examine the effects of an experimental treatment for 6 weeks, or even 6 months, often won’t provide adequate efficacy and safety data to allow us to draw reasonable conclusions regarding the treatment’s long-term safety and efficacy. Consider some of the agents (such as Vioxx and Bextra) that were extensively evaluated in RCTs but eventually were removed from the market due to safety concerns that arose after physicians began prescribing them widely to their patients. Study design is important—but so is study execution. Studies may have multiple problems associated with their execution that seriously compromise the quality of the study and its findings. For example, high subject dropout rates, insufficient study size, and inadequate study duration just to name 3 variables that might compromise findings.

There can be no debate that evidence is important. We need to use evidence-based practices in healthcare. Good evidence allows us to evaluate the actual effect of a health technology on patient outcomes and to make recommendations about adopting and using it. Still, RCTs won’t always give us what we need.

In the current climate, when healthcare payers and providers are scrutinizing costs and making tough decisions about which health technologies to pay for, we need to start the debate and come to some conclusions about what is good evidence. We need to come to some kind of agreement about which types of evidence are appropriate to answer which kinds of questions.

research_1200-2.jpgThe Hayes evidence solution does just that. Our health technology assessments (HTAs) are free from manufacturer bias and examine the full body of published, peer-reviewed literature reflecting the best available evidence. We apply a scientific rigor to our evidence evaluations to provide you with the information you need to assist your coverage policy determinations and best practice decisions.

Don’t just take our word for it. See our blog, 3 Questions with Dr. Nierman of Tufts Health Plan to hear how our evidence solutions worked for them. Then click below to see an example of our comprehensive HTAs.

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