Erin F Carlton1, Erin Ice2, Ryan P Barbaro3, Lee Kampuis4, Marc Moss5, Derek C Angus6, Valerie M Banner-Goodspeed7, Adit A Ginde8, Michelle N Gong9, Colin K Grissom10, Peter C Hou11, David T Huang12, Catherine Terri Lee Hough13, Daniel S Talmor14, B Taylor Thompson15, Donald M Yealy16, Mick P Couper17, Theodore J Iwashyna18. 1. Division of Critical Care Medicine, Department of Pediatrics, University of Michigan, Ann Arbor, MI, United States; Susan B. Meister Child Health Evaluation and Research Center, University of Michigan, Ann Arbor, MI, United States. Electronic address: ecarlton@med.umich.edu. 2. Department of Sociology, College of Literature, Science and Arts, University of Michigan, Ann Arbor, MI, United States. 3. Division of Critical Care Medicine, Department of Pediatrics, University of Michigan, Ann Arbor, MI, United States; Susan B. Meister Child Health Evaluation and Research Center, University of Michigan, Ann Arbor, MI, United States. 4. VA Center for Clinical Management Research, Health Services Research and Development Center of Innovation, Ann Arbor, MI, United States. 5. Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States. 6. Department of Critical Care Medicine, UPMC Health System and The University of Pittsburgh School of Medicine, Pittsburgh, PA, United States. 7. Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States. 8. Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, United States. 9. Divisions of Critical Care Medicine and Pulmonary Medicine, Department of Medicine, Department of Epidemiology and Population Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, United States. 10. Critical Care Medicine, Intermountain Medical Center, Murray, UT, United States. 11. Division of Emergency Critical Care Medicine, Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States. 12. Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, United States; Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, United States. 13. Division of Pulmonary and Critical Care Medicine, Oregon Health and Science University, Portland, OR, United States. 14. Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States. 15. Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Boston, MA, United States. 16. Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, United States. 17. Institute for Social Research, University of Michigan, United States; Joint Program in Survey Methodology, United States. 18. VA Center for Clinical Management Research, Health Services Research and Development Center of Innovation, Ann Arbor, MI, United States; Division of Pulmonary and Critical Care, Department of Internal Medicine, University of Michigan, Ann Arbor, United States.
Abstract
PURPOSE: To measure the rate of recall of study participation and study attrition in survivors of acute respiratory distress syndrome(ARDS). MATERIALS/ METHODS: In this ancillary study of the Re-evaluation of Systemic Early neuromuscular blockade(ROSE) trial, we measured the rate of study participation recall 3 months following discharge and subsequent study attrition at 6 months. We compared patient and hospital characteristics, and long-term outcomes by recall. As surrogate decision-makers provided initial consent, we measured the rate of patient reconsent and its association with study recall. RESULTS: Of 487 patients evaluated, recall status was determined in 386(82.7%). Among these, 287(74.4%) patients recalled participation in the ROSE trial, while 99(25.6%) did not. There was no significant difference in 6-month attrition among patients who recalled study participation (9.1%) and those who did not (12.1%) (p = 0.38). Patient characteristics were similar between groups, except SOFA scores, ventilator-free days, and length of stay. 330(68%) were reconsented. Compared to those not reconsented, significantly more patients who were reconsented recalled study participation(78% vs. 66%;p = 0.01). CONCLUSIONS: One in 4 ARDS survivors do not recall their participation in a clinical trial during hospitalization 3 months following hospital discharge, which did not influence 6-month attrition. However, more patients recall study participation if reconsent is obtained.
PURPOSE: To measure the rate of recall of study participation and study attrition in survivors of acute respiratory distress syndrome(ARDS). MATERIALS/ METHODS: In this ancillary study of the Re-evaluation of Systemic Early neuromuscular blockade(ROSE) trial, we measured the rate of study participation recall 3 months following discharge and subsequent study attrition at 6 months. We compared patient and hospital characteristics, and long-term outcomes by recall. As surrogate decision-makers provided initial consent, we measured the rate of patient reconsent and its association with study recall. RESULTS: Of 487 patients evaluated, recall status was determined in 386(82.7%). Among these, 287(74.4%) patients recalled participation in the ROSE trial, while 99(25.6%) did not. There was no significant difference in 6-month attrition among patients who recalled study participation (9.1%) and those who did not (12.1%) (p = 0.38). Patient characteristics were similar between groups, except SOFA scores, ventilator-free days, and length of stay. 330(68%) were reconsented. Compared to those not reconsented, significantly more patients who were reconsented recalled study participation(78% vs. 66%;p = 0.01). CONCLUSIONS: One in 4 ARDS survivors do not recall their participation in a clinical trial during hospitalization 3 months following hospital discharge, which did not influence 6-month attrition. However, more patients recall study participation if reconsent is obtained.
Authors: Alexandra Smart; B Taylor Thompson; Dale M Needham; Ramona O Hopkins; Andre Williams; Ellen L Burnham; Marc Moss Journal: Am J Respir Crit Care Med Date: 2013-12-01 Impact factor: 21.405
Authors: Fernanda Mexas; Anne Efron; Ronir Raggio Luiz; Michelle Cailleaux-Cezar; Richard E Chaisson; Marcus B Conde Journal: Clin Trials Date: 2013-12-02 Impact factor: 2.486
Authors: Neill K J Adhikari; Mary Pat McAndrews; Catherine M Tansey; Andrea Matté; Ruxandra Pinto; Angela M Cheung; Natalia Diaz-Granados; Aiala Barr; Margaret S Herridge Journal: Chest Date: 2009-03 Impact factor: 9.410