There is growing evidence that physical activity interventions can contribute to improved mood, quality of life, reduced fatigue and increased vigor among cancer survivors. That’s why researchers with The Miriam Hospital’s Centers for Behavioral and Preventive Medicine are conducting several studies with survivors of all forms of cancer, including breast cancer, to identify effective ways of promoting physical and emotional health following cancer treatment.

Moving Forward Together 2
This study, led by Bernardine Pinto, PhD, is a follow-up to Moving Forward Together, a groundbreaking pilot study that provided some of the first evidence that community volunteers can successfully deliver a research-based physical activity program to breast cancer survivors. In Moving Forward Together 2, researchers from The Miriam Hospital will train community volunteers from the American Cancer Society’s Reach to Recovery program – who are breast cancer survivors themselves – to deliver a telephone-based physical activity intervention to women requesting Reach to Recovery services.

Working in partnership with local American Cancer Society chapters, approximately 15-20 volunteers will be trained to offer the 12-week program, which consists of weekly phone calls with survivors to encourage them to engage in more moderate-intensity physical activity. A comparison group of breast cancer patients will receive emotional and informational support as part of an extended, 12-week version of traditional Reach to Recovery services.

Researchers will assess physical activity, fatigue and other outcomes throughout the program. If the physical activity program is found to be effective, there is a potential for dissemination among the 13,000 Reach to Recovery volunteers across the country. Moving Forward Together 2 is funded by the National Cancer Institute. For more information, contact Gail Agronick, PhD, at 401-793-8162 or Gail Agronick

Stride for Women
This research study, funded by the National Cancer Institute, is designed to help women who have a first degree relative with breast cancer become more physically active. Throughout this 12-week study, participants will regularly receive exercise information that has been shown to be effective in helping people become more physically active.

Women between the ages of 18 and 65 who have a mother, sister or daughter diagnosed with breast cancer are invited to join the study. Participants must be a healthy female who is not a regular exerciser and does not have high blood pressure, diabetes, asthma, heart disease or any type of cancer. For more information, contact Santina Horowitz at 401-793-8124 or Santina Horowittz.

Survivors Step into Motion
This study is testing a website designed to help young adults between the ages of 18-39 who have completed treatment for any form of cancer become more physically active. Young adult cancer survivors who participate are randomly assigned to one of two groups. One group will receive access for 12 weeks to a website that provides them with information about physical activity, including the benefits to cancer survivors who exercise, tips for becoming and staying active and lists of local resources such as hiking trails. The website also provides a way for participants to log their exercise goals and exercise performed. A comparison group will receive information about other cancer-related websites that may be helpful.

To be eligible for the study, participants must have been diagnosed with cancer between the ages of 18 and 39, been diagnosed with cancer in the past 10 years and currently be in remission. This study is funded by the National Cancer Institute. To learn more, contact Santina Horowitz at 401-793-8124 or Santina Horowitz.

Survivors RENEW
The Survivors RENEW study is testing out a combined exercise and relaxation program designed for young adult cancer survivors between the ages of 18 and 39. The program includes weekly telephone coaching to assist participants in becoming more physically active and learning mindfulness meditation – a form of relaxation. Young adult survivors who participate in the study are randomly assigned to either receive this 12-week program right away, or after a delay.

Eligible participants must have been diagnosed with cancer between the ages of 18 and 39, been diagnosed with cancer in the past five years and currently be in remission. This study is funded by the American Cancer Society. To learn more, contact Lynn Bucknam at 401-793-8233 or Lynn Bucknam.

Their study appears in the Volume 54, No. 4 October 2009 edition of Annals of Emergency Medicine and is currently available online in advance of publication. An editorial on the study also appears in the journal.

Treatment of injuries from motor vehicle crashes accounts for four percent of the 120 million ED visits in the United States each year. It is estimated that alcohol is involved in as many as one in eight of these crashes, bringing the total to 600,000 cases each year. Alcohol complicates the clinical assessment of patients within an ED as the patient’s perception of pain may be blunted and a period of observation may be warranted until the patient is judged to be coherent enough for an accurate examination.

In the past, research into the cost of treating alcohol impaired drivers focused on the inpatient population. Researchers at the Injury Prevention Center at Rhode Island Hospital led by emergency medicine physician Michael Lee, MD, felt that this was an incomplete representation of the medical costs of drinking and driving as it is estimated that up to 80 percent of alcohol impaired drivers treated in EDs are discharged to home and are not admitted.

The researchers performed a retrospective study of 1,618 patients who had alcohol in their systemand were treated in an urban Level I trauma center and discharged home directly from the ED. The patients ranged in age from 21 to 65.

The study found that the median charges for patients under the influence of alcohol were higher by $4,538. Lee notes, “A large percentage of that cost can be directly correlated to a higher frequency of and costlier diagnostic imaging studies. Imaging itself represents 69 percent of the charge differential.” In addition, the median length of stay for alcohol-positive patients was higher by 3.3 hours when compared to alcohol-negative patients.

Lee says, “While an alcohol-impaired driver may be treated for only minor injuries and discharged to home, there is still a considerably higher cost to treat that patient in an ED. Further, the time spent on them with a longer length of stay results in delays for other patients who need care in an ED.”

Lee concludes, “The magnitudes are striking for this minimally injured population. This represents a burden of alcohol-impaired driving that was underreported in the past.”

Other researchers working with Lee include Michael Mello, MD, director of the Injury Prevention Center at Rhode Island Hospital and Steven Reinert, MS, of Lifespan’s information systems department.

The investigators report that when individuals who have kept the weight off for several years were shown pictures of food, they were more likely to engage the areas of the brain associated with behavioral control and visual attention, compared to obese and normal weight participants.

Findings from this brain imaging study, published by the American Journal of Clinical Nutrition, suggest that successful weight loss maintainers may learn to respond differently to food cues.

“Our findings shed some light on the biological factors that may contribute to weight loss maintenance. They also provide an intriguing complement to previous behavioral studies that suggest people who have maintained a long-term weight loss monitor their food intake closely and exhibit restraint in their food choices,” said lead author Jeanne McCaffery, PhD, of The Miriam Hospital’s Weight Control and Diabetes Research Center.
Long-term weight loss maintenance continues to be a major problem in obesity treatment. Participants in behavioral weight loss programs lose an average of 8 to 10 percent of their weight during the first six months of treatment and will maintain approximately two-thirds of their weight loss after one year. However, despite intensive efforts, weight regain appears to continue for the next several years, with most patients returning to their baseline weight after five years.

Researchers used functional magnetic resource imaging (fMRI), a non-invasive technique that localizes regions of the brain activated during cognition and experience, to study the brain activity of three groups: 18 individuals of normal weight, 16 obese individuals (defined as a body mass index of at least 30), and 17 participants who have lost at least 30 lbs and have successfully maintained that weight loss for a minimum of three years.

After a four-hour fast, to ensure participants would be hungry, they were shown pictures of food items, including low-calorie foods (such as whole grain cereals, salads, fresh vegetables and fruit); high-calorie foods (including cheeseburgers, hot dogs, French fries, ice cream, cake and cookies), and nonfood objects with similar visual complexity, texture and color (e.g., rocks, shrubs, bricks, trees and flowers). The MRI scan documented brain responses to each image.

Those in the successful weight loss maintenance group responded differently to these pictures compared to the other groups. Specifically, researchers observed strong signals in the left superior frontal region and right middle temporal region of the brain – a pattern consistent with greater inhibitory control in response to food images and greater visual attention to food cues.

“It is possible that these brain responses may lead to preventive or corrective behaviors – particularly greater regulation of eating – that promote long-term weight control,” said McCaffery, who is also an assistant professor of psychiatry and human behavior (research) at The Warren Alpert Medical School of Brown University. “However, future research is needed to determine whether these responses are inherent within an individual or if they can be changed.”

The study was funded by a grant from the National Institutes of Health. Co-authors include Rena Wing and Ron Cohen, both from The Miriam Hospital and Alpert Medical School; Andreana P. Haley from the University of Texas at Austin; Lawrence H. Sweet from Butler Hospital and Alpert Medical School; Suzanne Phelan from California Polytechnic Institute; Hollie A. Raynor from the University of Tennessee at Knoxville; and Angelo Del Parigi from Pfizer, Inc.

According to new research from The Miriam Hospital, Brown University and their affiliated Center for Prisoner Health and Human Rights, just half of all federal and state prison systems offer ORT with the medications methadone and buprenorphine, and only in very limited circumstances. Similarly, only twenty-three states provide referrals for some inmates to treatment upon release from prison. These policies are counter to guidelines issued by both the World Health Organization (WHO) and the Centers for Disease Control and Prevention, which say prisoners should be offered ORT for treatment of opiate dependence.

The study’s findings are published online by Drug and Alcohol Dependence.

“Pharmacological treatment of opiate dependence is a proven intervention, is cost-effective and reduces drug-related disease and reincarceration rates, yet it remains underutilized in U.S. prison systems,” said Amy Nunn, ScD, the study’s lead author and an assistant professor of medicine (research) at The Warren Alpert Medical School of Brown University. “Improving correctional policies for addiction treatment could dramatically improve prisoner and community health as well as reduce both taxpayer burden and reincarceration rates.”

“Opiate addiction, like all forms of addiction, causes long-term changes to the structure and functioning of the brain, which is why it is classified as a disease. Addiction requires treatment just as other chronic diseases, like diabetes and cancer, do. Unfortunately, there is a large gap between the number of prisoners who require addiction treatment and those who actually receive it,” added senior author Josiah Rich, MD, MPH, co-director of the Center for Prisoner Health and Human Rights at The Miriam Hospital and Alpert Medical School.

The U.S. has the world’s highest incarceration rate, with approximately 10 million individuals incarcerated each year. More than half of inmates have a history of substance use and more than 200,000 people with heroin addiction are incarcerated annually. Inmates face disproportionately higher burdens of mental illness, substance use and infectious diseases, including HIV/AIDS. Meanwhile, their transition back to their communities is often associated with increased sexual health and drug-related risks, and more than half will relapse within one month of their release.

For the past four decades, methadone has been the treatment of choice for opiate dependence. It prevents withdrawal symptoms and drug cravings, blocks the euphoric effects of other opiates, and reduces the risk of relapse, infectious disease transmission and overdose death. The drug buprenorphine is a newer treatment for opiate replacement that has less likelihood of overdose and is associated with less social stigma. Like methadone, it prevents withdrawal symptoms when an individual stops taking opioid drugs by producing similar effects. Both methadone and buprenorphine are included in WHO’s “Essential Medicines” list of drugs that should be made available at all times by health systems to patients.

The Miriam/Brown research team surveyed the medical directors at the 50 state departments of corrections, along with the Federal Bureau of Prisons and the District of Columbia prison, about their facilities’ ORT prescribing policies and referral programs for inmates leaving prison. They received a total of 51 of 52 responses.

Although it appears methadone is offered more frequently that buprenorphine, only 28 facilities (55 percent) offer it under any circumstances, although more than half of these provide it only to pregnant women or for chronic pain management. Approximately 45 percent of facilities provided some community linkage to methadone treatment post-release. Meanwhile, only seven prison systems (14 percent) offer buprenorphine in some circumstances, while 15 facilities (29 percent) offer referrals for some inmates to community buprenorphine providers upon release.

When asked why these treatments are not available in their prison system, the majority of facilities indicated they prefer drug-free detoxification over ORT. A number of prison systems also cited security concerns about providing methadone and buprenorphine to inmates. Interestingly, 27 percent of medical directors said they did not know how beneficial methadone is for treating inmates with opiate addiction, while half were unaware of the benefits of buprenorphine.

A major barrier to providing ORT after incarceration appears to be the lack of partnerships with community ORT providers. Many providers also cited their focus on inmate health during incarceration, rather than upon release, as another reason for not linking inmates to ORT after they’ve been released.

“In spite of overwhelming scientific evidence demonstrating that pharmacological treatment for addiction has greater health and social benefits than abstinence-only policies, many prison directors are philosophically opposed to treating substance use. Most prisons also do not provide referrals for substance use treatment for prisoners upon release,” said Nunn. “These trends contribute to high reincarceration rates and have detrimental impacts on community health. Our interviews with prison medical directors suggest that changing these policies may require an enormous cultural shift within correctional systems.”

The study was supported by grants from the National Institute of Health’s National Institute on Drug Abuse (NIDA/NIH) and Center for AIDS Research (CFAR); and the Tufts Nutrition Collaborative. In addition to Nunn and Rich, co-authors include Nickolas Zeller and Ank Nijhawan from both The Miriam Hospital and Alpert Medical School; Samuel Dickman from Brown University; and Catherine Trimbur from the University of Rochester School of Medicine and Dentistry.

Reichner, who is also an associate professor of surgery at The Warren Alpert Medical School of Brown University, says, “We are trying to better understand how white blood cells in the circulation system can sense that an injury such as a wound or infection has taken place. Within minutes, the cells navigate to the exact location of the problem, where they can begin the healing process.” Reichner continues, “We would like to figure out how white blood cells acquire this sense of direction, and perhaps improve upon it to design new types of therapies.”

The ARRA grant will also allow Reichner to begin a partnership with Art Salomon, PhD, also an assistant professor at Brown, who specializes in deciphering which set of proteins the cells use to react to their environment. In the case of white blood cells, it is to determine which proteins allow them to respond to an injury, obtained through the latest techniques in bioinformatics and biochemistry. This new partnership is just one addition to the many collaborations currently underway among scientists at the various academic and medical institutes in Rhode Island.

“This is a good example of how Recovery Act funds are accelerating the pace of research, in this case by enabling a multi-disciplinary collaboration that removes a roadblock to progress in an important area,” said Jeremy M. Berg, PhD, director of the National Institute of General Medical Sciences. “By capitalizing on his collaborator’s proteomic approach, Dr. Reichner could quickly generate new insights about how white blood cells respond to infection and injury, possibly leading to new strategies for developing immune-enhancing therapeutics.”

The funding will also allow Reichner and Salomon to create a job opportunity for the study. Kebing Yu, PhD, a recent graduate from Brown, will join the research team. Reichner comments, “The ARRA funding is not only helping us to accelerate our research, but overall, it has a positive impact on the economy in Rhode Island as we continue to grow the research sector and establish new job opportunities.” He adds, “We appreciate this funding from the ARRA and the NIH, who saw the value of our research and its potential implications.”

The study described in this release is being funded through the American Recovery and Reinvestment Act. More information about NIH’s ARRA grant funding opportunities can be found at http://grants.nih.gov/recovery/. To track the progress of HHS activities funded through ARRA, visit www.hhs.gov/recovery. To track all federal funds provided through the ARRA, visit www.recovery/gov.

“Rhode Island Hospital has done outstanding work in this field, and I am pleased it will continue to receive federal funds to support cancer research. This federal investment will help Rhode Island Hospital transform lab discoveries into patient treatment and attract more elite researchers to the state,” says U.S. Senator Jack Reed, who supported the program and serves on the Appropriations subcommittee which oversees federal funding for NIH programs.

One area within the COBRE CCRD is proteomics — the identification and quantification of proteins with the goal of determining how they interact, how their expression changes by disease and how they are modified by environmental change. This type of basic research has the potential to go from “bench to bedside,” by identifying breakthroughs that will translate to changes in the treatment of patients with cancer. Another area within the COBRE CCRD is molecular pathology, which deals with the characterization of the molecular and cellular events critical to the development of cancer, with the goal of identifying biomarkers with diagnostic and prognostic potential.

Peter Snyder, Lifespan’s vice president of research, says, “The renewal of this grant shows the NIH’s recognition of the valuable research being performed here at Rhode Island Hospital’s CCRD. In addition, it helps to solidify our role of supporting the Rhode Island economy by increasing the research and biotechnology being done locally.”

Under the leadership of principal investigator Douglas Hixson, PhD, the center received its first grant in 2003. Hixson says, “Over the past five years we have established an infrastructure and the technology to support basic research in the area of gastrointestinal cancer and to engage investigators in developing new research initiatives centered around the role of adult stem cells in the genesis of cancer.” He further notes, “This year we also received a $500,000 economic stimulus fund grant that allowed our proteomics core to purchase a state-of-the art imaging mass spectrometer. By allowing investigators to identify proteins differentially expressed in malignant and normal cells by directly scanning tissue sections, this exciting new technology will accelerate the identification of biomarkers by directly linking the fields of proteomics and molecular pathology.”

“This award will enable these investigators to continue to build their capacity to perform state-of-the-art research in specific cancers, such as in gastrointestinal tumors,” said NCRR Director Barbara Alving, MD. “The center will also provide excellent opportunities to train new generations of biomedical researchers.”

Since its opening in 2003, the center has already made discoveries that have broadened knowledge of different types of cancer. Hixson explains, “We’ve identified a new mode of transmitting signals regulating the growth and spread of cancer, a new gene that determines sensitivity to anti cancer drugs, another gene elevated by acid reflux that increases the risk of esophageal cancer and two novel tumor suppressor genes whose loss elevates the risk of stomach cancer.

“The renewal of our grant provides us with an outstanding potential for groundbreaking research in our center,” he comments. Over the next five years, the center will focus its efforts on generating new avenues of research by facilitating collaboration among cancer investigators within the CCRD and at other universities and hospitals in Rhode Island. Hixson says, “Of particular interest will be research aimed at identifying characteristics of cancer stem cells that could serve as therapeutic targets. We also expect our new imaging mass spectrometer to become a catalyst for collaborative interactions aimed at developing novel clinical and basic research applications for this largely unexplored technology.”

Snyder concludes, “Not only are we helping to fuel our local economy, but overall, our research may someday prove to be the key to unlocking medical breakthroughs that may completely change the course of cancer treatment to improve outcomes. We look forward to that day.”

As a result, physicians and researchers at Rhode Island Hospital’s Injury Prevention Center set out to identify a model that could integrate screening and brief interventions (SBI) for alcohol misuse into a community hospital environment. The study was published in the August 2009 issue of the journal Substance Abuse. Their goal was to develop, implement and evaluate the adoption of a model of SBI, using feedback from the community hospital ED. This would then allow them to create a delivery method for the toolkit for SBI developed by the American College of Emergency Physicians (ACEP) and the National Highway Traffic Safety Administration.

Under the direction of lead author Michael Mello, MD, MPH, director of the Injury Prevention Center and an emergency medicine physician at Rhode Island and The Miriam hospitals, the researchers worked with Robert Dinwoodie, DO, MBA, an emergency medicine physician at Kent Hospital as a pilot site.

The project was divided into two phases over a year. The first phase involved meeting with key stakeholders to gather information and feedback on the SBI delivery model design and implementation. The feedback was then used to adapt the proposed SBI model design for the community hospital and train the staff. Phase two focused on the implementation and adoption of the SBI into the ED setting in the community hospital over a 6-month period. The research study design team included ED physicians, a clinical psychologist, experimental psychologist, and project coordinator, along with a research assistant who was present in the ED to record the extent of adoption into the ED’s practice.

Mello says, “Our research identified numerous barriers, with key stakeholders expressing concern over potential disruption to the clinical practice and patient flow; the burden of SBI on staff time, particularly nurses; the willingness of nursing and physician staff to accept the SBI; and staff reluctance to speak to patients about alcohol-related issues when not directly related to a patient’s chief complaint. These are all understandable concerns.”

As a result, the SBI model was modified to address the concerns. The implementation was limited to an area of the ED for non-critical patients, active participation was limited to physicians only who would evaluate using the screening tool and then refer patients screening positive to a research assistant who would then perform the 5- to 10-minute brief intervention.

Prior to the adoption of the SBI model in the community hospital ED, a medical record review revealed that alcohol screening only occurred in 50 percent of patients, and of those, only 23 percent of the positive screens were referred for an alcohol intervention. In the study, during the time period when the research assistant was present in the ED, 90 percent of eligible patients were screened, and 71 percent of those patients were then evaluated by ED staff. Further, 38 percent of screened patients met the screening criteria, with 77 percent of the patients who met the criteria being correctly identified by ED staff and referred to the research assistant for the brief intervention. One month after the research assistant was no longer present in the ED, a repeat medical record review found documented alcohol screening had returned to the 50 percent level.

Dinwoodie, of Kent Hospital, says, “The research was done to look at the feasibility and impact of implementing an alcohol abuse screening and brief intervention program into a community hospital emergency department setting. The results of the study suggest that implementing such a program is possible by training staff such as emergency department nursing personnel, however, implementation will potentially be more successful if additional staff trained to conduct the screening and intervention are utilized.”

Mello and the researchers comment that the return of the alcohol screenings to the 50 percent level when the research assistant was no longer in the ED suggests that the program did not create a sustainable change. Mello says, “Our study shows, however, that with the appropriate training and tools, combined with additional resources devoted to this effort, SBI can be successfully transitioned and integrated into community hospital EDs. Additional research would help to further refine the SBI model so that it would work in different types of community hospitals.”

Mello concludes, “In the end, if the identified barriers can be overcome, we believe that a refined model will result in higher levels of screening for alcohol problems and appropriate referrals for help with many patients.”

The study was funded by a grant from the Emergency Medicine Foundation through a grant from the Highway Traffic Safety Administration. Other researchers involved in the study with Mello and Dinwoodie include Janette Baird, PhD, Ted Nirenberg, PhD, Jennifer Smith, EdM of the Injury Prevent Center at Rhode Island Hospital and Robert Woolard, MD, of Texas Tech University Health Sciences Center, and formerly of Rhode Island Hospital.

More than 800 volunteers in 250 study sites across the United States and Canada will take part in the trial, known as the ICARA study. The study will last up to 83 weeks and all study-related procedures and medication will be provided at no cost to participants. A medical team of a physician, nurse, neuropsychologist and study coordinator will monitor each participant during the study. Participants will be compensated for their travel.

To be eligible, participants must be between the ages of 50 and 88, have a diagnosis of probable Alzheimer’s disease and have a caregiver who is willing to be involved in the study.

The trial will be led locally by Brian R. Ott, MD. He is a neurologist and the director of the Alzheimer’s Disease and Memory Disorders Center as well as a professor of medicine at The Warren Alpert Medical School of Brown University. He is board certified in neurology, geriatric medicine and internal medicine.

The Alzheimer’s Disease and Memory Disorders Center is located on the sixth floor of the Ambulatory Patient Center (APC) at Rhode Island Hospital. Free valet parking service is available at the APC entrance.

For more information, call research coordinator Michele Astphan at 401-444-2484.

Under the direction of Howard Safran, MD, a specialist in pancreatic cancer, Lifespan’s oncology clinical research department will recruit patients from both Rhode Island Hospital and its partner, The Miriam Hospital, to evaluate a new vaccine designed to activate the immune system. The vaccine, called NewLink Genetics’ HyperAcute Pancreatic Cancer Vaccine, will be used in patients who have already been treated surgically, and will be used along with conventional therapy.

The clinical trial will allow Safran and other researchers to evaluate treatment response and monitor any side effects. It will examine the potential of the vaccine to stimulate the immune system to respond to the patient’s own cancer cells, with the hope of extending survival rates, improving quality of life and reducing the chance for tumor recurrence.

Traditionally, the body’s immune system does not fight cancer cells on its own because cancer cells differ only slightly from normal cells. As a result, it is difficult for the body’s immune system to identify and attack the cancer cells’ abnormal proteins. Vaccines such as the one used in this study are meant to boost the immune system’s ability to identify “foreign invaders,” and generate an immune response.

Individuals who are 18 years and older who have been diagnosed with Stage I or II pancreatic cancer, have undergone surgical resection of the pancreas and show no evidence of disease following surgery may be eligible to participate in the trial. Additional criteria must also be met and eligibility for participation will be determined by the research team. Participants will receive vaccine treatment for six months, during which blood samples will be drawn on a monthly basis. Patient follow-up visits will be scheduled every two months for the remainder of the first year, and every three months for the next two years.

The trial is sponsored by NewLink Genetics, located in Ames, IA. For more information, patients should call Howard Safran, MD, through the Lifespan Oncology Clinical Research Office at Rhode Island Hospital at 401-444-8856.

The current definition of major depressive disorder in the fourth edition of the DSM (DSM-IV) includes nine symptoms — a definition that has remained essentially unchanged since the 1970s. With preparations for the fifth edition of the DSM underway, the researchers propose that there are two practical problems with the symptom criteria: the length of the definition and the difficulty in applying some of the criteria to patients with co-morbid medical illnesses. The researchers’ proposal recommends a shortened list of symptom criteria that includes only low mood, loss of interest or pleasure, guilt/worthlessness, impaired concentration/indecision and suicidal thoughts. It would exclude the somatic criteria of fatigue, appetite disturbance and sleep disturbance (increased sleep or insomnia) as these may be associated with medical illnesses other than depression. Their proposal is called the “simpler definition of MDD.”

Lead author Mark Zimmerman, MD, director of outpatient psychiatry at Rhode Island Hospital, says, “While the principles guiding criteria revision have not been clearly explained, we believe that existing diagnostic criteria should be revised when a conceptual problem is identified, or a more valid or simpler method of defining a disorder is developed. The reason for even considering a change to the symptom criteria for major depressive disorder after all these years is two-fold.”

Zimmerman, who is also an associate professor of psychiatry and human behavior at The Warren Alpert Medical School of Brown University, continues, “First, studies have indicated that there are significant gaps in the knowledge or application of the MDD criteria among practitioners. Second, somatic criteria that are currently part of the DSM-IV definition such as fatigue or sleep or appetite disturbances are also symptoms of other medical illnesses and may not be indicative of a major depressive episode.”

Under Zimmerman’s direction, researchers from Rhode Island Hospital and The Warren Alpert Medical School of Brown University previously developed the simpler definition of MDD for a project known as the Rhode Island Methods to Improve Diagnostic Assessment and Services (RI MIDAS) project, an integration of research quality diagnostic methods into a community-based outpatient practice affiliated with an academic medical center.

Zimmerman says, “In our previous report from the RI MIDAS project, we developed a briefer list of the symptom criteria of MDD that was composed entirely of the DSM-IV mood and cognitive symptoms. That simplified definition did not include the somatic symptoms.” He continues, “Our initial research found high levels of agreement in diagnosing MDD between the simplified and DSM-IV definitions of MDD. Our goal in this study was to replicate these findings in a large sample of psychiatric outpatients, and to extend the findings to other patient populations, including those presenting for treatment of pathological gambling and candidates for bariatric surgery.”

Zimmerman says, “After eliminating the four somatic criteria from the DSM-IV definition of MDD, leaving the five mood and cognitive features, a high level of concordance was found between this simpler definition of MDD with the original classification in all three patient samples studied.” He adds, “This new definition offers two advantages over the DSM-IV definition – it is briefer and therefore more likely to be recalled and correctly applied in clinical practice, and it is free of somatic symptoms, thereby making it easier to apply with medically ill patients.”

Using the Structured Clinical Interview for DSM-IV (SCID), the researchers conducted a study of more than 2,500 patients. The patient population consisted of 1,100 psychiatric outpatients, 210 pathological gamblers who presented for treatment and 1,200 candidates for bariatric surgery. Across all patients, the level of agreement between the simplified definition and the DSM-IV definition was more than 95 percent.

The researchers note that there are implications to changing the criteria for MDD. Because their findings indicate that the simpler definition is highly concordant with the current version, there would be no meaningful impact on prevalence rates. Reducing the number of criteria, however, would reduce the time needed to fully assess criteria in patients and diagnostic interviews could be shortened.

Zimmerman and the researchers conclude, “In deciding how to proceed in the next version of the DSM, the conceptual and practical advantages of a briefer set of criteria that is easy to apply to all patients, particularly medically ill patients, needs to be weighted against the disadvantages of deviation from tradition.”

Along with Zimmerman, other researchers involved in the study include Janine Galione, PhD; Iwona Chelminski, PhD; Joseph McGlinchey, PhD; Diane Young, PhD; Kristy Dalrymple, PhD; Camile Ruggero, PhD; and Caren Francione Witt, PhD; all of Rhode Island Hospital and Brown University.