Rates and determinants of informed consent: A case study of an international thromboprophylaxis trial

Smith, Orla M.; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matté, Andrea; Clarke, France; Meade, Laurie; O'Callaghan, Nicole; Vallance, Shirley; Galt, Pauline; Rajbhandari, Dorrilyn; Rocha, Marcelo G.; Mehta, Sangeeta; Ferguson, Niall D.; Hall, Richard; Fowler, Robert; Burns, Karen E. A.; Qushmaq, Ismael; Ostermann, Marlies; Heels‐Ansdell, Diane; Cook, Deborah J.

doi:10.1016/j.jcrc.2012.08.005

Cited by 20 publications

(16 citation statements)

References 38 publications

(51 reference statements)

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“…The Consent study reported a 15.4% refusal rate when study enrollment occurred within 24 hours of admission. 1 Smith et al 7 reported a 17.8% refusal rate in an international thromboprophylaxis trial. Our rates of decline were lower, as only 13% of patients approached (47 of 366) declined to participate.…”

Section: Discussionmentioning

confidence: 99%

Enrollment Challenges in Critical Care Nursing Research

Sole¹,

Middleton²,

Deaton³

et al. 2017

Am J Crit Care

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Background Enrollment challenges for critical care research are common. Contributing factors include short enrollment windows, the crisis nature of critical illness, lack of research staff, unavailable legal proxy, family dynamics, and language barriers. Objective To describe enrollment statistics for an ongoing critical care nursing trial, barriers to recruitment, and strategies to enhance enrollment. Methods Two years’ worth of recruitment and enrollment data from an oral care intervention trial in critically ill adults receiving mechanical ventilation at 1 hospital were analyzed. Recruitment logs include number of patients screened, eligible, enrolled, and declined and patients’ sex, race, and ethnicity. Results Target enrollment (15.5 patients per month) was based on experience and historical data. Strategies implemented to promote enrollment included providing study personnel at least 18 hours per day for 7 days per week, regular rounds, communication with direct care staff, and Spanish consent processes. In 2 years, 6963 patients were screened; 1551 (22%) were eligible. Consent was sought from 366 (24% of eligible patients). Enrollment averaged 13.3 patients per month (86% of projected target). The main factor impeding enrollment was unavailability of a legal proxy to provide consent (88%). The refusal rates of white (11%), black (13%), and Hispanic (16%) patients did not differ significantly. However, those classified as Asian or as more than 1 race declined significantly more often (35%) than did white or black patients (P=.02). Conclusions Unavailability of a legal proxy within a short enrollment window was the major challenge to enrollment. Various factors influenced consent decisions. Clinical study design requires more conservative estimates.

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Section: Discussionmentioning

confidence: 99%

Enrollment Challenges in Critical Care Nursing Research

Sole¹,

Middleton²,

Deaton³

et al. 2017

Am J Crit Care

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show abstract

“…However, this feeling increased the desire to have more than one person to give consent and decreased the rate of acceptance of deferred or two-step consent. These results should remind researchers that their attitude during the procedure of seeking consent can have an impact on inclusion rates [15].…”

Section: Discussionmentioning

confidence: 91%

“…If the patient lacks competency to give consent, the Good Clinical Practice and most national laws refer investigators to a surrogate-a legal representative, relative, or close friend, depending on the country [8,11]. However, finding available surrogates in emergency settings and obtaining their informed consent for research is difficult [15,16]. Moreover, their ability or willingness to take on such a responsibility has not been demonstrated, a challenge in which emotional burden plays a role [17][18][19][20][21].…”

Section: Introductionmentioning

confidence: 99%

ICU research: the impact of invasiveness on informed consent

et al. 2013

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“…Understanding and reducing potential barriers to enrolment is a critical aim of the PROSPECT Pilot Trial. Rates of consent are influenced by the institutional setting, research infrastructure, and experience of the investigators and research staff [36] as well as physician-specific concerns [37]. It is therefore essential to carefully record and monitor enrolment practices and make improvements where possible.…”

Section: Discussionmentioning

confidence: 99%

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial—PROSPECT: protocol for a feasibility randomized pilot trial

Johnstone

Meade

Marshall

et al. 2015

Pilot Feasibility Stud

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BackgroundProbiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate.Methods/designPatients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 1010 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded.DiscussionThe primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and hospital length of stay, and mortality.The morbidity, mortality, and cost of VAP underscore the need for cost-effective prophylactic interventions. The PROSPECT Pilot Trial is the initial step toward rigorously evaluating whether probiotics decrease nosocomial infections, have no effect, or actually cause infections in critically ill patients.Trial registrationClinicalTrials.gov. NCT01782755

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Rates and determinants of informed consent: A case study of an international thromboprophylaxis trial

Cited by 20 publications

References 38 publications

Enrollment Challenges in Critical Care Nursing Research

Enrollment Challenges in Critical Care Nursing Research

ICU research: the impact of invasiveness on informed consent

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial—PROSPECT: protocol for a feasibility randomized pilot trial

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