Simona Maida1, Gloria Dalla Costa2, Mariaemma Rodegher2, Monica Falautano3, Giancarlo Comi2, Vittorio Martinelli2. 1. Department of Neurology, San Raffaele Scientific Institute, Milan, Italy maida.simona@hsr.it. 2. Department of Neurology, San Raffaele Scientific Institute, Milan, Italy. 3. Psychological Service, Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
Abstract
BACKGROUND: Recruiting patients for randomized clinical trials is still extremely difficult. While there has been much research in oncology patients, no previous studies have consistently addressed specific factors affecting the willingness to enroll in multiple sclerosis trials from the patient's perspective. To this end, we conducted an exploratory study to assess the related factors and to find ways to improve recruitment. METHODS: This is a single-center, observational study involving 352 consecutive outpatients followed at one site in Italy. Patients completed the Enrollment Problems Questionnaire and Beck Depression Inventory. RESULTS: Over 50% of the patients would consider participating in a randomized trial. Willing patients are frequently older, with no children, have a diagnosis of secondary progressive multiple sclerosis, and have already participated in clinical trials. Patients' choices were positively influenced by expectations of having (a) a greater chance of cure, (b) an unavailable drug, (c) a specialist's care, and (d) the chance to contribute to medical research. Willingness was significantly increased by the use of optimistic language and practical/psychological assistance during the decision-making process. CONCLUSION: Multiple sclerosis patients' willingness to participate in a randomized trial is mainly related to both altruistic and individual considerations, as well as to a greater chance of specialist/improved care. More effective information flow and an effective, long-standing patient-physician relationship may improve recruitment overall.
BACKGROUND: Recruiting patients for randomized clinical trials is still extremely difficult. While there has been much research in oncology patients, no previous studies have consistently addressed specific factors affecting the willingness to enroll in multiple sclerosis trials from the patient's perspective. To this end, we conducted an exploratory study to assess the related factors and to find ways to improve recruitment. METHODS: This is a single-center, observational study involving 352 consecutive outpatients followed at one site in Italy. Patients completed the Enrollment Problems Questionnaire and Beck Depression Inventory. RESULTS: Over 50% of the patients would consider participating in a randomized trial. Willing patients are frequently older, with no children, have a diagnosis of secondary progressive multiple sclerosis, and have already participated in clinical trials. Patients' choices were positively influenced by expectations of having (a) a greater chance of cure, (b) an unavailable drug, (c) a specialist's care, and (d) the chance to contribute to medical research. Willingness was significantly increased by the use of optimistic language and practical/psychological assistance during the decision-making process. CONCLUSION:Multiple sclerosispatients' willingness to participate in a randomized trial is mainly related to both altruistic and individual considerations, as well as to a greater chance of specialist/improved care. More effective information flow and an effective, long-standing patient-physician relationship may improve recruitment overall.