Physicians declining patient enrollment in a critical care trial: a case study in thromboprophylaxis

Cook, Deborah J.; Arabi, Yaseen M.; Ferguson, Niall D.; Heels‐Ansdell, Diane; Freitag, Andreas; McDonald, Ellen; Clarke, France; Keenan, Sean; Pagliarello, Giuseppe; Plaxton, W; Herridge, Margaret S.; Karachi, Tim; Vallance, Shirley; Cade, J. F.; Crozier, Tim M.; Silva, S. Alves da; Filho, Rubens Costa; Brandão, Nilton; Watpool, Irene; McArdle, Tracy; Hollinger, G.; Mandourah, Yasser; Alhazmi, Mohammad A.; Zytaruk, Nicole; Adhikari, Neill K. J.; Investigators, Protect

doi:10.1007/s00134-013-3074-x

Cited by 12 publications

(9 citation statements)

References 23 publications

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“…The intensive care community must be centrally involved in these decisions to allow us to provide protection for our vulnerable population of critically ill patients and their families while at the same time ensuring we are able to conduct timely and efficient research that is valid and generalizable in order to improve outcomes for all critically patients and their families. Interestingly, Cook et al [68] stressed how tracking, analyzing, interpreting, and reporting the rates and reasons for physicians declining to allow their patients to be approached for enrollment provides insights into clinicians' concerns and attitudes to trials. Last, Sprung and the Eldicus investigators, consultants, and experts provided an updated consensus statement on the triage of patients for ICU beds.…”

Section: Incidence Of Potential Missed Organ Donors In the Icu And Emmentioning

confidence: 99%

Year in review in Intensive Care Medicine 2013: II. Sedation, invasive and noninvasive ventilation, airways, ARDS, ECMO, family satisfaction, end-of-life care, organ donation, informed consent, safety, hematological issues in critically ill patients

et al. 2014

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Section: Incidence Of Potential Missed Organ Donors In the Icu And Emmentioning

confidence: 99%

Year in review in Intensive Care Medicine 2013: II. Sedation, invasive and noninvasive ventilation, airways, ARDS, ECMO, family satisfaction, end-of-life care, organ donation, informed consent, safety, hematological issues in critically ill patients

et al. 2014

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“…Physicians declining to enroll particular patients may be an important factor here, although it is often neglected [12]. As an example, in the ProMISe trial, 449 patients were excluded by the clinician.…”

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confidence: 99%

Early goal-directed therapy: do we have a definitive answer?

Backer

Vincent

2016

Intensive Care Med

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Early goal-directed therapy (EGDT) for the treatment of septic shock was first proposed in 2001 by Rivers et al. [1]. These authors reported that patients with hypotension refractory to a fluid challenge of 20-30 ml/kg of crystalloids over 30 min or with plasma lactate levels of at least 4 mEq/l and who were treated to restore and maintain a central venous oxygen saturation (ScvO 2 ) of greater than 70 % had lower 28-day mortality rates than control patients (33 vs 49 %). That publication generated considerable enthusiasm but also much debate. The resuscitation protocol was incorporated into the Surviving Sepsis Campaign (SSC) guidelines [2] and several uncontrolled studies reported similar improvements in outcome [3][4][5]. However, concerns were raised about the single-center nature of the trial, the limited sample size (263 patients), the multiple interventions proposed in the EGDT package making it difficult to differentiate which was most effective, and the potential influence of confounding factors including the increased presence of doctors at the bedside of patients randomized to the intervention.Three large-scale multicenter studies published in 2014 and 2015 [6][7][8] were unable to replicate the results of the Rivers study, but is there a plausible explanation for this? Among the important differences between the trials, the mortality rate in the control groups in the recent trials was markedly lower than that in the Rivers study (Table 1). In addition, ScvO 2 values in the study groups were markedly reduced (to an average of 49 %) in the Rivers trial but were already within the greater than 70 % target zone in the three other trials. One explanation may be that Rivers et al. treated a special patient population with severe comorbidities and/or who presented quite late to the emergency department. Another possible explanation is that there has been a marked improvement in prehospital and initial care of patients with septic shock, maybe as a direct result of the Rivers trial and the SSC guidelines. However, adequacy of antibiotic treatment and amounts of fluid administered prior to randomization do not seem to account for these differences (Table 1).A third explanation may be that the patients included in the more recent trials were quite selected and may not have been as sick as many other patients who presented at the same time to these emergency departments. Several indices suggest that these populations were indeed quite specific. The inclusion rate was 7.4 patients per month in the Rivers trial [1], but only 0.5-0.9 patients per center per month in ProCESS [6], ARISE [7], and ProMISe [8]. Do these findings suggest that admissions with septic shock requiring resuscitation are no longer an issue? Of course not! Indeed, these numbers contrast with the increased incidence of sepsis admissions in observational studies [9]. Moreover, most of the screened patients were included in the Rivers trial but only 20-30 % in the subsequent studies (Table 1).The patients enrolled in the recent multicenter trials...

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“…For example, it was reported in 1,679 (15.9 %) of the 10,511 patients not included in the FACTT trial [8], in 130 (22.9 %) of the 574 patients not enrolled in the OSCILLATE trial [9], and in 27 (33.7 %) of the 80 not enrolled in a trial on external cooling in septic shock [10]. In the December 2013 issue of Intensive Care Medicine, Cook et al [11] further identified the factors advanced by physicians unwilling to enroll patients in a trial on prophylaxis of thromboembolism (PROTECT study) even though they accepted to contribute to the trial.…”

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confidence: 99%

“…In some cases, it may reflect the fact that exclusion criteria were not explicit enough. For example, in the PROTECT study, bleeding risks (bleeding risk, perceived bleeding risk, and peridural catheter) sound like adequate exclusion criteria and these accounted for the first reason for physician refusals (51 %) [11]. Similarly, in a trial focusing on patients with septic shock treated with high doses of vasopressor agents, physicians were reluctant to enroll socalled moribund patients even though this criterion was not defined in the exclusion criteria [10].…”

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confidence: 99%

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Physicians declining patient enrollment in clinical trials: what are the implications?

Backer

Schortgen²

2013

Intensive Care Med

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Physicians declining patient enrollment in a critical care trial: a case study in thromboprophylaxis

Cited by 12 publications

References 23 publications

Year in review in Intensive Care Medicine 2013: II. Sedation, invasive and noninvasive ventilation, airways, ARDS, ECMO, family satisfaction, end-of-life care, organ donation, informed consent, safety, hematological issues in critically ill patients

Year in review in Intensive Care Medicine 2013: II. Sedation, invasive and noninvasive ventilation, airways, ARDS, ECMO, family satisfaction, end-of-life care, organ donation, informed consent, safety, hematological issues in critically ill patients

Early goal-directed therapy: do we have a definitive answer?

Physicians declining patient enrollment in clinical trials: what are the implications?

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