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Recall of clinical trial participation and attrition rates in survivors of acute respiratory distress syndrome.
|Title||Recall of clinical trial participation and attrition rates in survivors of acute respiratory distress syndrome.|
|Publication Type||Journal Article|
|Year of Publication||2021|
|Authors||Carlton EF, Ice E, Barbaro RP, Kampuis L, Moss M, Angus DC, Banner-Goodspeed VM, Ginde AA, Gong MN, Grissom CK, Hou PC, Huang DT, Hough CTerri Lee, Talmor DS, B Thompson T, Yealy DM, Couper MP, Iwashyna TJ|
|Corporate Authors||NHLBI Prevention and Early Treatment of Acute Lung Injury(PETAL) Network|
|Journal||J Crit Care|
|Date Published||2021 08|
|Keywords||Clinical Trials as Topic, Humans, Mental Recall, Patient Discharge, Respiratory Distress Syndrome, Survivors|
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.
|Alternate Journal||J Crit Care|
|PubMed Central ID||PMC8222163|
|Grant List||K12 HL138039 / HL / NHLBI NIH HHS / United States |
R01 HL153519 / HL / NHLBI NIH HHS / United States
U01 HL123008 / HL / NHLBI NIH HHS / United States
U01 HL123031 / HL / NHLBI NIH HHS / United States