What is a Standard of Care?

Throughout the past century, we’ve seen extraordinary advances in medicine and technology. The ways we detect, diagnose, and treat disease have changed the course of humankind. Among these changes is the method by which we screen for disease in a seemingly healthy population. It’s called preventative medicine.

There is a wide variety of routine screenings to help detect and reduce the risk of disease. They are based on factors like age, sex, and family history. Some of the most common are mammograms, colonoscopy, Pap smear, PSA (prostate cancer), and blood glucose. At birth, we screen for genetic disorders and in schools we assess vision and hearing. Today, these tests are routine – part of our standard of care. However, at their inception, their effectiveness and utility were called into question.

The road to standardization was full of research. There were false positives, false negatives, bad techniques and large sums of money spent. However, the results proved the benefits of early detection and intervention. The process is pretty typical when purusing a new standard of care. Costs and mistakes are high in the beginning as we seek to define and understand the unknown. Over time, as our experience and exposure increases, the costs and mistakes subside. We settle into an affordable and effective outcome.

The United States Army was one of the first to implement health screenings (1940). It utlitized mental health screenings in the application process. A standardized pencil and paper test identified at risk men seeking military service. This initiative established the criteria for developing and vetting screening programs.

Screening programs would need to answer the following questions: (1) Does early treatment improve prognosis; (2) how valid and repeatable is the screening test; and (3) among those with a positive screening, how many of them are true cases? And, there would need to be an effective way to treat the disease. Screenings needed to prove their specificity and sensitivity. Be sensitive enough to detect the condition almost every time, and specific enough to find the condition being sought.

The first breast cancer screening emerged in the 1930s. Dr. Stafford Warren used direct radiographic exposure. This method was successful in identifying malignant and benign breast cancer that were found during an exam, but the technique was not very successful when seeking out less advanced breast cancers that were not detectable during an exam. This was a major flaw. Hence, research and evolution.

Contrast injections were next. This technique improved the outcomes but they caused inflammation, and the images were not clear. Thirty years later, radiologists Gershen-Cohen and Egan discovered a low-contrast technique that could detect unsuspected cancers not discovered during the examination. This became the first reproducible technique for breast cancer screening, but it didn’t stop there. Advancements like film-screen mammography and digital mammography continued to improve the safety, accuracy and outcomes.

Our ability to detect and treat breast cancer has evolved. We experimented using the best, yet flawed, methods known at the time. We learned from our failures to arrive where we are today. This progression took nearly 70 years. We saw countless clinical trials, huge sums of money spent, bad side effects and lots of mistakes.

Critics of early breast cancer screenings questioned whether screenings could change the course of the disease a manner significant enough to warrant the poking, proding and spending. There was no real evidence that an individual’s life would be improved. There was no data showing that the quality and design of the screening had an acceptable sensitivity and specificity to improve outcomes. We did not know how breast cancer looked in different populations. One doctor even proclaimed, “if I can’t feel it on examination, it’s not there.”

As clinical data emerged, these concerns waned. Through trial and error, we simply got smarter. Incidence and mortality rates declined, vital statistics improved, and people shared testimonials of how screening changed their life’s trajectory.

What would life be like today if the critics prevailed? How many friends or family members would you have lost to breast cancer? Would feeling for lumps been sufficient or did they benefit from some improved method of detection?

Medicine is interesting. Every disease and condition requires a unique treatment. Actually, each patient may require a unique treatment. Despite this, the path to discovering treatments is very similar. Idea. Try it out on lots of people. Analyze the results. Repeat. It’s expensive in the beginning. Mistakes are made while we learn. Hopefully, it gets cheaper and more effective.

Sudden Cardiac Arrest is the leading cause of death of adults in the United States. However, it is not just an adult thing. It is the #1 cause of death of student athletes and takes the lives of thousands of children every year. Today, the standard of care is the equivalent of “it’s not there unless I can feel it.” Parents answer a few questions about heart conditions in the family, and a doctor listens to the child’s heart. So, it’s more like “it’s not there unless I can hear it”

Heart screenings using electrocardiograms (ECG) and echocardiograms (echo) have been shown to improve our ability to detect abnormalities. In an evaluation of NCAA student athletes, 72% of heart conditions were found only after the use of the ECG. They were missed by feeling and listening. Additionally, the false positive rate (someone thinks you have a problem only to find out you do not) are quite low at 3.4 percent.

In 1930, in an effort to save lives, we accepted injections of highly toxic materials in the bodies of our mothers and sisters. That was the beginning of a long and uncertain road that has saved countless lives. Today, critics of heart screenings are not willing to accept the placement of stickers or a little gel on a student’s chest. It is too expensive. We don’t know what heart conditions look like in different pediatric popluations. We don’t know if detecting conditions will save lives. Sound familiar?

There is only one path forward. Idea. Try it out on lots of people. Analyze the results. Repeat. It’s expensive in the beginning. Mistakes are made while we learn. We get smarter. Fortunately, the research and future look promising.

A special thanks to our research fellow, Chris Koilor, for educating us about the history of screenings.