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become a part of a scientific investigation requires a clear sense of what participation means. Currently, Hospital for Special Surgery is busy with over 400 active human studies and preparing for more to come. The Patient Perspective Weighing the pros and cons of study participation requires careful consideration and information. Prospective candidates should learn as much as possible about the study, including facts about trial protocol, length and design, tests involved, randomization, potential risks and side effects, hospitalization, reimbursement for medical and related expenses, and how participation will affect everyday life. “Some patients who enroll do not fully understand the commitment that is necessary,” notes Dr. Hotchkiss. “Study participation can be time consuming and inconvenient, a fact that can pose a problem in recruitment and in patients opting out.” For many patients who decide to sign up for a clinical study, however, the benefits outweigh the risks or interruption of daily routine. Patients may volunteer for a clinical trial when standard treatment options are unsuccessful and with the expectation that, if proven effective, they will be “first in line” for a new therapy. Others hope to participate in the research “As a clinician and researcher, I have to be interested in the investigative aspect and also believe that I would be willing to subject myself or my family to the randomization process, even if I’m not sure if the treatment will work,” says Dr. Hotchkiss. “If it doesn’t pass that test [for me], then participation is most likely not possible.” This approach to decision-making, known as clinical equipoise (or principle of equipoise), provides the ethical basis for medical research involving patients assigned to different treatment arms of a clinical study. For treating physicians considering participation in a trial, it raises important questions about study purpose, design, safety, bias, and research intent. Therefore, based on equipoise, if a clinician is contemplating research of a drug or treatment versus placebo control, and strongly believes that the study treatment is better than placebo, then the clinician is ethically bound not to participate in that study.1 An objective, unbiased study and its conclusions are achieved only when a clinician-researcher sets out not to prove a theory, but to challenge it.1 Using equipoise as a guide, Dr. Hotchkiss also advises health professionals to practice vigilance and choose words carefully when speaking to their patients about trial enrollment. “It should be presented as an opportunity to participate in a study of a drug or treatment, regulated by the FDA, that may show promise.” Accordingly, Dr. Hotchkiss stresses that “patient care comes first.” Thus, when interacting with an individual who is your patient and also a study subject, it is important to always be mindful of preserving the doctor-patient relationship. l 1 Kraemer, Helena. 2006. “Understanding Clinical Equipoise.” Available from 4researchers.org [cited 20 July 2006]; INTERNET. “ Robert Hotchkiss, MD Following successful non-surgical treatment at HSS for Dupuytren’s contracture in her right hand, singer and vocal coach Beverly Lambert can once again play the piano (top) and extend her fingers (right). A male study participant’s hands before (top), during (middle), and following (bottom) collagenase treatment for Dupuytren’s contracture. 4 Happenings around the hospital HSS Medical Team in Haiti HSS anesthesiologists, nurses and orthopedic trauma surgeons (pictured above) were one of the first orthopedic teams to arrive in Haiti just a few days after the catastrophic earthquake. They performed over 120 surgeries in four days before returning home. Led by David Helfet, MD, Director of the Orthopedic Trauma Service at HSS, and with physicians from NewYork-Presbyterian Hospital, the With the mutual goal of preventing injury and discomfort, Hospital for Special Surgery partnered with SmartFish Technologies to study the effects of motion while computing. SmartFish focuses on the development of smart technology and true ergonomic innovation for electronics. The HSS Rehabilitation Department helped SmartFish create the breakthrough ErgoMotion™ technology. By applying motion to computer peripherals, ErgoMotion makes subtle, incremental changes to a user’s hand and wrist positions to help team performed surgeries at Hopital de la Communaute Haitienne, a few miles from the earthquake’s epicenter. With air transport provided by global medical device company Synthes – and surgical supplies donated by Synthes, HSS, and NewYork-Presbyterian – the team worked to save lives and limbs. Seth Sherman, MD, HSS Orthopedic Surgery Resident, joined a second team to Haiti soon afterwards. Big Apple Circus Benefit for Pediatrics Hospital for Special Surgery held its Third Annual Benefit at Big Apple Circus on Sunday, December 6, 2009, raising $164,000 in support of pediatric care and research. This year’s family event featured a silent auction, face painting for children, and a dessert reception with Grandma the Clown. Serving as honorary chair for the benefit was Susan Rose, HSS Trustee, along with co-chairs Michelle Carlson, MD, an orthopedic surgeon who is the Director and founder of the Children and Adolescent Hand and Arm (CHArm) Center at HSS, and Daniel Green, MD, an orthopedic
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