scholarly journals Deferred Consent in a Minimal-Risk Study Involving Critically Ill Subarachnoid Hemorrhage Patients

2014 ◽  
Vol 21 (5) ◽  
pp. 293-296 ◽  
Author(s):  
Jane Topolovec-Vranic ◽  
Marlene Santos ◽  
Andrew J Baker ◽  
Orla M Smith ◽  
Karen EA Burns

INTRODUCTION: Alterations from first-party and surrogate decision-maker consent can enhance the feasibility of research involving critically ill patients.OBJECTIVE: To describe the use of a deferred-consent model to enable participation of critically ill patients in a minimal-risk biomarker study.METHODS: A prospective observational study was conducted in which serum biomarker samples were collected three times daily over the first 14 days following aneurysmal subarachnoid hemorrhage. Sample collection was initiated on intensive care unit admission and consent was obtained when research personnel could approach the patient or the patient’s surrogate decision maker.RESULTS: Twenty-seven patients were eligible for the study, of whom only five were capable of providing informed consent. Full consent was obtained for 21 (78%) patients through self- (n=4) and surrogate (n=17) consent. Partial consent or refusal (only permitting the collection of blood samples as a part of routine care or use of data) occurred in three patients. Among the 22 consents sought from surrogates, three (11%) refused participation. The refusals included the sickest patients in the cohort. Once consent was provided, no patient or surrogate withdrew consent before study completion.DISCUSSION: Use of a deferred consent model enabled participation of critically ill patients in a minimal-risk biomarker study with no withdrawals.CONCLUSIONS: Further research and enhanced awareness of the potential utility of hybrid models, including deferred consent in addition to patient or surrogate consent, in the conduct of low-risk and minimally interventional time-sensitive studies of critically ill patients are required.

Author(s):  
Cian J. O'Kelly ◽  
Julian Spears ◽  
David Urbach ◽  
M. Christopher Wallace

Abstract:Background:In the management of subarachnoid hemorrhage (SAH), the potential for early complications and the centralization of limited resources often challenge the delivery of timely neurosurgical care. We sought to determine the impact of proximity to the accepting neurosurgical centre on outcomes following aneurysmal SAH.Methods:Using administrative data, we analyzed patients undergoing treatment for aneurysmal subarachnoid hemorrhage at neurosurgical centres in Ontario between 1995 and 2004. We compared mortality for patients receiving treatment at a centre in their county (in-county) versus those treated from outside counties (out-of-county). We also examined the impact of distance from the patient's residence to the treating centre.Results:The mortality rates were significantly lower for in-county versus out-of-county patients (23.5% vs. 27.6%, p=0.009). This advantage remained significant after adjusting for potential confounders (HR=0.84, p=0.01). The relationship between distance from the treating centre and mortality was biphasic. Under 300km, mortality increased with increasing distance. Over 300km, a survival benefit was observed.Conclusions:Proximity to the treating neurosurgical centre impacts survival after aneurysmal SAH. These results have significant implications for the triage of these critically ill patients.


2021 ◽  
pp. 1-11
Author(s):  
Wendy G. Lichtenthal ◽  
Martin Viola ◽  
Madeline Rogers ◽  
Kailey E. Roberts ◽  
Lindsay Lief ◽  
...  

Abstract Objective The objectives of this study were to develop and refine EMPOWER (Enhancing and Mobilizing the POtential for Wellness and Resilience), a brief manualized cognitive-behavioral, acceptance-based intervention for surrogate decision-makers of critically ill patients and to evaluate its preliminary feasibility, acceptability, and promise in improving surrogates’ mental health and patient outcomes. Method Part 1 involved obtaining qualitative stakeholder feedback from 5 bereaved surrogates and 10 critical care and mental health clinicians. Stakeholders were provided with the manual and prompted for feedback on its content, format, and language. Feedback was organized and incorporated into the manual, which was then re-circulated until consensus. In Part 2, surrogates of critically ill patients admitted to an intensive care unit (ICU) reporting moderate anxiety or close attachment were enrolled in an open trial of EMPOWER. Surrogates completed six, 15–20 min modules, totaling 1.5–2 h. Surrogates were administered measures of peritraumatic distress, experiential avoidance, prolonged grief, distress tolerance, anxiety, and depression at pre-intervention, post-intervention, and at 1-month and 3-month follow-up assessments. Results Part 1 resulted in changes to the EMPOWER manual, including reducing jargon, improving navigability, making EMPOWER applicable for a range of illness scenarios, rearranging the modules, and adding further instructions and psychoeducation. Part 2 findings suggested that EMPOWER is feasible, with 100% of participants completing all modules. The acceptability of EMPOWER appeared strong, with high ratings of effectiveness and helpfulness (M = 8/10). Results showed immediate post-intervention improvements in anxiety (d = −0.41), peritraumatic distress (d = −0.24), and experiential avoidance (d = −0.23). At the 3-month follow-up assessments, surrogates exhibited improvements in prolonged grief symptoms (d = −0.94), depression (d = −0.23), anxiety (d = −0.29), and experiential avoidance (d = −0.30). Significance of results Preliminary data suggest that EMPOWER is feasible, acceptable, and associated with notable improvements in psychological symptoms among surrogates. Future research should examine EMPOWER with a larger sample in a randomized controlled trial.


2003 ◽  
Vol 9 (2) ◽  
pp. 55-59 ◽  
Author(s):  
Paula K. Vuckovich

Psychiatric advance directives (PADs) have been legally defined in 12 states and implemented in all but 9. PADs may prevent unwanted treatment and identify preferred treatment. They may also allow mentally ill persons to exercise autonomous control over care even during periods of illness-induced incompetence. PADs can be beneficial for intermittently psychotic patients who have a trusted health care provider and a surrogate decision maker. Because of the growing interest in the use of PADs, nurses should be informed about the intended purposes, benefits, and drawbacks of them.


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