RICK RADER, MD ■ EDITOR-IN-CHIEF

Parachutes, Oranges and Clinical Trials

For those ID/DD clinicians in the trenches we have learned to rely on "our" version of the RCT… "Respect, Compassion and Thoughtfulness."

SLICE OF LIFE: Scottish naval surgeon James Lind "discovered" that using oranges could prevent scurvy in 1747. Lind had been appalled by the high mortality of scurvy among the sailors, more of whom died from scurvy than from battle.

When I was in high school, I was the student athletic trainer for the football team. I learned how to tape ankles, treat bruises, sprains, and athlete's foot. Looking back, I was also a culprit in carrying out the coach's practice of discouraging the players from drinking water during the summer practices leading up to the start of the season. Those were the days when, if you were injured, you heard the mantra of "walk it off." I was under the guidance and tutelage of "Ol' Doc" Greenberg, a cigar-chomping local GP (a general practitioner that we now call a FP or family physician) who served as the volunteer team physician. One of my chores was to slice oranges into four sections and give them to the players during half time. I could never really understand the medical value of having a quarter of an orange in the middle of a game and one day I asked Doc Greenberg why this routine was religiously adhered to. Chomping on his cigar, he shook his head and said, "We don't want them to get scurvy now, do we?" His remark was of course sarcastic, an art form he was famous for. It was sarcastic in that no one in the Flatbush section of Brooklyn was at risk for catching scurvy, and if they were, a quarter of an orange was not the treatment of choice.

The practice of giving oranges to prevent scurvy (a vitamin C deficiency disease) was "discovered" and pro moted by a Scottish naval surgeon, James Lind in 1747. Lind was appalled by the high mortality of scurvy among the sailors. More sailors died from scurvy than from battle. Lind describes "On the 20th of May 1747, I selected twelve patients in the scurvy, on board the Salisbury at sea. Their cases were as similar as I could have them. They all in general had putrid gums, the spots and lassitude, with weakness of the knees. They lay together on one place, being a proper apartment for the sick in the fore-hold, and had one diet common to all, viz, water gruel sweetened with sugar in the morning, fresh mutton-broth, often times for dinner, at other times light puddings. Boiled biscuit with sugar, etc.'' and "for supper, barley and raisins, rice and currants, sago and wine or the like. Two were ordered each a quart of cyder a day." Lind went on to describe the various diets of ten of the sailors and then described the diet of two of sailors, "Two others had each two oranges and one lemon given them every day… The consequence was, that the most sudden and visible good effects were perceived from the use of oranges and lemons, one of those who had taken them, being at the end of six days fit for duty."

Although the results were clear, Lind hesitated to prescribe the use of oranges and lemons because they were too expensive (perhaps one of the first examples of cost cutting due to managed care). Instead, they opted for limes, which proved ineffective but gave birth to the nickname for British sailors, "limeys."

Lind's work with oranges was among the earliest prototypes for the "Randomized Clinical Trial" (RCT), the Gold Standard in evidence-based medicine for evaluating the effects of medical interven tions.

According to Dinethra Menon, "An RCT is a comparative, controlled experiment designed for finding useful information on efficacy (or costs) of one or two medical treatments in different patient groups." The three words represented by RCT pro vide a simple explanation of the research design and methodology.

Randomized relates to how the participants are selected so that "chance" alone ascertains who receives treatments. This removes selection bias which, in turn, makes the results more reliable. Controlled infers that the experimental environment that compares whether an intervention works to a control condition (either placebo or an alternative comparable intervention).

Trial design ensures intervention groups are treated the same. The results define the difference, if any, of outcomes between groups.

RCTs aim to find out which treatment is best by making a fair comparison between three variables. According to the Medical Research Council of "We seem to be successful treating patients with intellectual and developmental disabilites with intuition, parental guidance, hallway consultations, communicating with our patients, feedback from direct support England, these are "A new treatment and an existing treatment; two or more existing treatments and a new treatment and no treatment, or a placebo (where there is no existing treatment)." The first published RCT in medicine appeared in the 1948 paper entitled "Streptomycin treatment of pulmonary tuberculosis."

RCTs are not without their critics. One sarcastic study was published in the British Medical Journal (BMJ) to assess the evidence for using a parachute to prevent death and major injury when jumping from a plane. Since the authors found no RCTs testing of the safety of jumping from an airplane with a parachute; they had to conclude, "As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subject to rigorous evaluation by using randomized controlled trials."

Perhaps nowhere else in medicine is the debate of the utility and application of the RCT is as hot as it is in the field of "developmental medicine." For one thing there are few RCTs that address the unique healthcare needs of individuals with intellectual and developmental disabilities. We very often have to extrapolate, extend, substitute and transpose the elements of an RCT to make it seem appropriate and applicable to our patient population.

And then there's the "no proof that parachutes prevent death from jumping from a plane" position. We don't know of any ID/DD RCTs that prove that treating a patient with dignity, respect and empathy impacts on the clinical outcomes of any given treatment. We don't know that treating patients, specifically with an intellectual and developmental disability, with oranges and lemons will prevent scurvy. We seem to be successful with intuition, parental guidance, hallway consultations, communicating with our patients, feedback from direct support professionals and yes, from time to time, with a "Hail Mary pass." For those ID/DD clinicians in the trenches we have learned to rely on "our" version of the RCT… "Respect, Compassion and Thoughtfulness."

For my money, if the jet I'm riding in is going down and there's a spare parachute, I'm grabbing it; and on the way out, if there's a sliced orange within my reach, it's going with me. •

ANCORA IMPARO

In his 87th year, the artist Michelangelo (1475 -1564) is believed to have said "Ancora imparo" (I am still learning). Hence, the name for my monthly observations and comments. – Rick Rader, MD, Editor-in-Chief, EP Magazine Director, Morton J. Kent Habilitation Center Orange Grove Center, Chattanooga, TN