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Recall of clinical trial participation and attrition rates in survivors of acute respiratory distress syndrome.

TitleRecall of clinical trial participation and attrition rates in survivors of acute respiratory distress syndrome.
Publication TypeJournal Article
Year of Publication2021
AuthorsCarlton 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 AuthorsNHLBI Prevention and Early Treatment of Acute Lung Injury(PETAL) Network
JournalJ Crit Care
Volume64
Pagination160-164
Date Published2021 08
ISSN1557-8615
KeywordsClinical Trials as Topic, Humans, Mental Recall, Patient Discharge, Respiratory Distress Syndrome, Survivors
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.

DOI10.1016/j.jcrc.2021.04.006
Alternate JournalJ Crit Care
PubMed ID33906105
PubMed Central IDPMC8222163
Grant ListK12 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