Coerced consent in clinical research: study protocol for a randomized controlled trial.

BACKGROUND: Despite the low-risk nature of participation in most clinical anesthesia trials, subject recruitment on the same day as surgery is often restricted due to the concerns of researchers and local research ethics boards that same-day consent may not afford adequate time and opportunity for patients to weigh and make decisions, as well as perceptions of patient vulnerability immediately prior to surgery that could impact the voluntary nature and the rigor of the informed consent process. However, specialties such as anesthesiology, critical care, interventional radiology, and emergency medicine have a varied pattern of practice and patient acquaintance that does not typically afford the luxury of time or, in many cases, advance consent for participation in research. Indeed, the initial encounter between anesthesiologists and patients undergoing elective procedures routinely occurs on the day of surgery. Concerns of coercion related to same-day consent for clinical anesthesia research trials have not been borne out in the literature, and represent a significant obstacle to clinical researchers, as well as to the patients who are denied opportunities for potential benefit through participation in research studies. METHODS: We describe the protocol for a prospective randomized controlled trial examining the voluntariness of patient consent, solicited either in advance of surgery or on the same day, to participate in an anesthesia research study at Women's College Hospital. One hundred fourteen patients scheduled to undergo ambulatory anterior cruciate ligament repair facilitated by general anesthesia with an adductor canal block will be randomized for recruitment either (a) in the pre-operative assessment clinic before the day of surgery or (b) on the day of surgery, to be approached for consent to participate in a fabricated research study of adjunct medications in adductor canal blocks. Regardless of allocation, patients in both groups will receive the same routine standard of care and will complete a post-operative questionnaire to signal perceptions of undue influence in the process of providing informed consent for the fabricated trial. DISCUSSION: This study will inform trial design and practice guidelines surrounding the amount of time patients ought to be afforded in order to make durable decisions to participate (or not) in clinical research studies. This is expected to impact trial recruitment in a variety of clinical settings where researchers have only brief opportunities to interface with patients. TRIAL REGISTRATION: The trial was registered prospectively on the Open Science Framework (OSF), registration #46twc, on 2023-Mar-17.

Artificial intelligence in nursing: Priorities and opportunities from an international invitational think-tank of the Nursing and Artificial Intelligence Leadership Collaborative.

AIM: To develop a consensus paper on the central points of an international invitational think-tank on nursing and artificial intelligence (AI). METHODS: We established the Nursing and Artificial Intelligence Leadership (NAIL) Collaborative, comprising interdisciplinary experts in AI development, biomedical ethics, AI in primary care, AI legal aspects, philosophy of AI in health, nursing practice, implementation science, leaders in health informatics practice and international health informatics groups, a representative of patients and the public, and the Chair of the ITU/WHO Focus Group on Artificial Intelligence for Health. The NAIL Collaborative convened at a 3-day invitational think tank in autumn 2019. Activities included a pre-event survey, expert presentations and working sessions to identify priority areas for action, opportunities and recommendations to address these. In this paper, we summarize the key discussion points and notes from the aforementioned activities. IMPLICATIONS FOR NURSING: Nursing's limited current engagement with discourses on AI and health posts a risk that the profession is not part of the conversations that have potentially significant impacts on nursing practice. CONCLUSION: There are numerous gaps and a timely need for the nursing profession to be among the leaders and drivers of conversations around AI in health systems. IMPACT: We outline crucial gaps where focused effort is required for nursing to take a leadership role in shaping AI use in health systems. Three priorities were identified that need to be addressed in the near future: (a) Nurses must understand the relationship between the data they collect and AI technologies they use; (b) Nurses need to be meaningfully involved in all stages of AI: from development to implementation; and (c) There is a substantial untapped and an unexplored potential for nursing to contribute to the development of AI technologies for global health and humanitarian efforts.

Determinants of variations in coronary revascularization practices.

BACKGROUND: The ratio of percutaneous coronary interventions to coronary artery bypass graft surgeries (PCI:CABG ratio) varies considerably across hospitals. We conducted a comprehensive study to identify clinical and nonclinical factors associated with variations in the ratio across 17 cardiac centres in the province of Ontario. METHODS: In this retrospective cohort study, we selected a population-based sample of 8972 patients who underwent an index cardiac catheterization between April 2006 and March 2007 at any of 17 hospitals that perform invasive cardiac procedures in the province. We classified the hospitals into four groups by PCI:CABG ratio (low [< 2.0], low-medium [2.0-2.7], medium-high [2.8-3.2] and high [> 3.2]). We explored the relative contribution of patient, physician and hospital factors to variations in the likelihood of patients receiving PCI or CABG surgery within 90 days after the index catheterization. RESULTS: The mean PCI:CABG ratio was 2.7 overall. We observed a threefold variation in the ratios across the four hospital ratio groups, from a mean of 1.6 in the lowest ratio group to a mean of 4.6 in the highest ratio group. Patients with single-vessel disease usually received PCI (88.4%-99.0%) and those with left main artery disease usually underwent CABG (80.8%-94.2%), regardless of the hospital's procedure ratio. Variation in the management of patients with non-emergent multivessel disease accounted for most of the variation in the ratios across hospitals. The mode of revascularization largely reflected the recommendation of the physician performing the diagnostic catheterization and was also influenced by the revascularization "culture" at the treating hospital. INTERPRETATION: The physician performing the diagnostic catheterization and the treating hospital were strong independent predictors of the mode of revascularization. Opportunities exist to improve transparency and consistency around the decision-making process for coronary revascularization, most notably among patients with non-emergent multivessel disease.

Lacosamide, a novel anti-convulsant drug, shows efficacy with a wide safety margin in rodent models for epilepsy.

This paper comprises a series of experiments in rodent models of partial and generalized epilepsy which were designed to describe the anti-convulsant profile of the functionalized amino acid lacosamide. Lacosamide was effective against sound-induced seizures in the genetically susceptible Frings mouse, against maximal electroshock test (MES)-induced seizures in rats and mice, in the rat hippocampal kindling model of partial seizures, and in the 6Hz model of psychomotor seizures in mice. The activity in the MES test in both mice (4.5mg/kg i.p.) and rats (3.9 mg/kg p.o.) fell within the ranges previously reported for most clinically available anti-epileptic drugs. At both the median effective dose for MES protection, as well as the median toxic dose for rotorod impairment, lacosamide elevated the seizure threshold in the i.v. pentylenetetrazol seizure test, suggesting that it is unlikely to be pro-convulsant at high doses. Lacosamide was inactive against clonic seizures induced by subcutaneous administration of the chemoconvulsants pentylenetetrazol, bicuculline, and picrotoxin, but it did inhibit NMDA-induced seizures in mice and showed full efficacy in the homocysteine model of epilepsy. In summary, the overall anti-convulsant profile of lacosamide appeared to be unique, and the drug displayed a good margin of safety in those tests in which it was effective. These results suggest that lacosamide may have the potential to be clinically useful for at least the treatment of generalized tonic-clonic and partial-onset epilepsies, and support ongoing clinical trials in these indications.

Priority setting and cardiac surgery: a qualitative case study.

PURPOSE: The purpose of this study is to describe priority setting in cardiac surgery and evaluate it using an ethical framework, "accountability for reasonableness". INTRODUCTION: Cardiac surgery is an expensive part of hospital budgets. Priority setting decisions are made daily regarding ever increasing volumes of patients. While much attention has been paid to the management of cardiac surgery waiting lists, little empirical research exists into the way actual decision makers deliberate upon and resolve priority setting decisions on a daily basis. A key goal of priority setting, in cardiac surgical areas as well as others, is fairness. "Accountability for reasonableness" is a leading ethical framework for fair priority setting, and can be used to identify opportunities for improvement (i.e. make it fairer) and highlight good practices. METHODS: A case study was conducted to examine the process of priority setting processes at three University of Toronto affiliated cardiac surgery centres. Relevant documents were examined, weekly triage rounds were observed for 27 months, and interviews were carried out with 23 key participants including cardiac surgeons, cardiologists, and triage nurses. In data analysis, the conditions of "accountability for reasonableness" (relevance, publicity, appeals and enforcement) were used as an analytic lens. RELEVANCE: While decisions may appear to be based strictly upon clinical criteria (e.g. coronary anatomy); non-clinical criteria also have an impact upon decision-making (e.g. patients' lifestyle choices, type of surgical practice and departmental constraints on resource use). Participants stated that these factors influence their decision-making and can result in unfair and inconsistent decisions. PUBLICITY: Non-clinical reasons are not publicly accessible, nor are they clearly acknowledged in discussions between cardiac clinicians. APPEALS: There are mechanisms for challenging decisions however without access to the non-clinical reasons, this can be problematic. Enforcement: Participants cite little departmental or institutional support to engage in fairer priority setting. CONCLUSIONS: To our knowledge, this is the first study to describe actual priority setting practices for cardiac surgery practices and evaluate them using an ethical framework, in this case, "accountability for reasonableness". Priority setting decision making in cardiac surgery has been described and evaluated with lessons learned include specific findings regarding the contextual and dynamic nature of decision making in cardiac surgery. The approach of combining a descriptive case study with the ethical framework of "accountability for reasonableness" is a useful tool for identifying good practices and highlighting areas for improvement. The good practices (including surgeons strongly facilitating patients seeking second opinions and approaching patients from a holistic perspective in consideration for surgery) and areas for improvement (including lack of transparency and lack of institutional support for "fair" decision making) that we have identified in this case study can be used to reflect upon the present tool used in priority setting and improve the fairness and legitimacy of priority setting decision making in cardiac surgery.

Evaluation of a novel sutureless anastomotic connector: from endothelial function to mid-term clinical and angiographic follow-up.

OBJECTIVES: We evaluated the effect of the St Jude Medical sutureless anastomotic connector on endothelium-dependent and -independent saphenous vein graft relaxation, as well as on clinical outcomes and graft patency in patients. METHODS: Human saphenous vein grafts were assigned to control or connector groups (loaded for 1 or 5 minutes; n = 18). Isometric dose-response curves to endothelium-dependent and -independent (sodium nitroprusside) vasodilators were constructed in saphenous vein grafts precontracted with phenylephrine. Thrombin-mediated vasorelaxation, an early determinant of saphenous vein graft failure, was also evaluated. Percent maximum relaxation was compared between groups. Patients in whom the St Jude Medical connector was employed underwent clinical follow-up, stress tests, and angiography 6 to 12 months postoperatively. RESULTS: A23187-induced endothelium-mediated relaxation, sodium nitroprusside-induced endothelium-independent relaxation, and thrombin-mediated vasorelaxation did not differ between control and connector saphenous vein grafts at either time point studied. Twenty-seven patients received St Jude Medical connectors. There was no hospital mortality; patients were followed for 679 +/- 241 days. There was 1 late death; the connector saphenous vein graft was patent at postmortem. All connector saphenous vein grafts were patent at follow-up angiography. Four grafts had stenoses (30%-60%), without symptoms or requirement for intervention. All hand-sewn saphenous vein grafts were also patent. CONCLUSIONS: The St Jude Medical connector does not impair endothelium-dependent vasorelaxation. In patients, patency of the connector saphenous vein grafts 6 to 12 months postoperatively was 100% but 22% of grafts had non-flow-limiting stenoses at or near the connector. Further long-term studies are required to confirm the safety of the St Jude Medical connector with regards to endothelial function and restenosis.

Priority setting in surgery: improve the process and share the learning.

Surgeons and surgical programs encounter priority-setting challenges every day, such as in regard to purchasing new technologies or managing waiting lists for elective surgery. The purpose of this paper was to explore priority setting in surgery. Traditionally in surgery, priority-setting decisions for new technologies have been based on evidence of effectiveness and cost-effectiveness; and decisions about managing waiting lists for elective surgery have been based on urgency rating scores. The fairness of priority-setting processes in surgical programs should be enhanced to permit all relevant information and values to be considered. The quality of these decisions can be improved by using an approach that captures and shares lessons from each priority-setting experience. The approach we propose in this paper- describe, evaluate, and improve using a leading conceptual framework for priority setting, called "accountability for reasonableness"-can be used by any surgical program to improve its priority setting, share lessons with others, and develop an evidence base for how these important health policy decisions should be made.