by Gus Gardner

President Obama threw down the gauntlet at his White House Forum on Health Reform back in March. He called healthcare IT the “low hanging fruit” of healthcare reform; one of the few things both Democrats and Republicans seem to agree on. This is good news for healthcare IT executives and consumers alike.

For our industry to capitalize on this favorable environment we must solve one of healthcare’s biggest challenges – determining what works and what doesn’t work in healthcare.  Amazingly, we lack a scientifically-based, universally available way to measure health and the impact various healthcare treatments have on an individual’s health status. Put another way: how do we measure treatment effectiveness?  As usual, challenge equals opportunity, and for healthcare IT executives that opportunity is delivering standardized treatment effectiveness data to decision-makers and eventually directly to the healthcare consumer.

Defining and Measuring Health

Before we can expect to measure something as complex as health, a clear definition is required. In his 1987 best-seller “Future Perfect” Stan Davis wrote:

“….the only way we have to define health is in terms of the absence of illness.  That is comparable to defining the economy only in terms of debt, never balance or surplus, and business only in terms of loss, never profits or redistribution.  Anyone who can define health can transform medicine.”

Not much has changed since 1987.  Even today, the most widely used definitions for functional health in the healthcare delivery market are merely proxies:

  • Absence of abnormal biological indicators
  • Absence of health related economic data (no claims)
  • Not seeking care = absence of illness
  • Absence of mortality or morbidity

So how do we define health more positively; by what it is rather than what it is not? It’s fairly easy to find precedent methodologies.

How the U.S. Food and Drug Administration Measures Health Status and Treatment Effectiveness

The U.S. Food and Drug Administration (USFDA) has been overseeing the efforts of the pharmaceutical, biotechnology and medical device companies in the design and execution of treatment effectiveness measurement for many years.

Medical products manufacturers have to measure and prove treatment effectiveness (as well as safety and efficacy) in randomized clinical trials (RCT) in order to have their products cleared for sale in the U.S.  Arguably, the USFDA has developed one of the best treatment effectiveness measurement processes in the world.

Increasingly, standardized information technology systems are at the center of the FDA processes.  The complexity and global reach of the modern RCT could not be accomplished without robust and efficient IT integration.

Somewhat incredibly, this proven scientific process of measuring treatment effectiveness stops once the product is cleared by the FDA; treatment effectiveness measurement of “patients in the wild” is relegated to our currently fragmented, decentralized and non-standardized healthcare system without the measurement standards of the RCT environment.

Consumer-focused IT Solutions

As the cost of healthcare continues to shift to consumers, they will demand a standardized, continuous and longitudinal set of treatment effectiveness measurement standards for making treatment decisions.  Development of these standards will likely take the following into account:

  • The measurement criteria used in FDA trial processes must be extended to monitor the effectiveness of treatments over time in patients outside of RCTs.
  • Patient Reported Outcomes (PROs) are a necessary and beneficial component of this measurement process…“the Voice of the Patient.”
  • The information technology infrastructure of the RCT world must be integrated with the IT platforms in the payer/provider space.
  • Consumers/Payers/Providers need aggregated effectiveness and outcomes data to make treatment decisions.

In the next few years, we will see a seismic shift in healthcare decision making in our country as the economics shift our delivery model away from physician and payer preference care to consumer/patient preference care.

Overall, it is a great time to be a consumer!  We have plenty of facts about the “comparative effectiveness” of durable goods like cars, appliances, business equipment and electronics.  The internet and consumer publications offer hundreds of ways to compare features and benefits, warranties and prices.  Even soft goods can be compared and priced with minimal effort.

It is stunning that “comparative effectiveness” is a familiar concept almost everywhere in our lives except healthcare.  Once we have extended the standardized measurement of treatment effectiveness beyond the RCT and integrate these measures into the healthcare system, consumers will be able to purchase healthcare services with the same comparative effectiveness information as they have in buying a new car.

I spoke to a well-placed executive in the payer/provider space just last month.  We were talking about American healthcare policy, and the buzz around the nation regarding reform.  He said, “We all know some tough decisions are going to be made, but who is going to make them?”

I am expecting the informed American consumer to be at the center of most of these decisions….and the Healthcare IT industry to deliver the informatics and decision criteria to enable these consumer choices.  It is time to focus on an end-to-end integration of clinical trial data with observational data from healthcare delivery as the criterion for measuring comparative effectiveness.


About the Author


As President and COO, Gus Gardner is focused on launching QualityMetric’s commercial

business unit, and chartered with creating then translating the company’s visions

and strategies into viable business tactics, effective operational processes, and

scalable methods. His expertise includes the diagnosis and treatment of management

and operational processes/systems in order to streamline communications and enhance

efficiency. Gus also brings integration management, merger/acquisition experience,

sales channel development, and new product introduction experience to his roles

of President and COO.


He joined QualityMetric from Clinical Data, Inc., where he was first Senior Vice

President and COO, and then President of the U.S. In-vitro Diagnostics Division.

He has also served as Vice President-Western Operations for Baxter Perfusion Services,

Baxter International, Inc., where he managed cardiovascular services businesses

with 500+ employees in 28 states. Gus began his career as an officer in the United

States Marine Corps.


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