Patient and family engagement in patient care and research in Canadian intensive care units: a national survey.

PURPOSE: While patient and family engagement may improve clinical care and research, current practices for engagement in Canadian intensive care units (ICUs) are unknown. METHODS: We developed and administered a cross-sectional questionnaire to ICU leaders of current engagement practices, facilitators, and barriers to engagement, and whether engagement was a priority, using to an ordinal Likert scale from 1 to 10. RESULTS: The response rate was 53.4% (124/232). Respondents were from 11 provinces and territories, mainly from medical surgical ICUs (76%) and community hospitals (70%). Engagement in patient care included bedside care (84%) and bedside rounds (66%), presence during procedures/crises (65%), and survey completion (77%). Research engagement included ethics committees (36%), protocol review (31%), and knowledge translation (30%). Facilitators of engagement in patient care included family meetings (87%), open visitation policies (81%), and engagement as an institutional priority (74%). Support from departmental (43%) and hospital (33%) leadership was facilitator of research engagement. Time was the main barrier to engagement in any capacity. Engagement was a higher priority in patient care vs research (median [interquartile range], 8 [7-9] vs 3 [1-7]; P < 0.001) and in pediatric vs adult ICUs (10 [9-10] vs 8 [7-9]; P = 0.003). Research engagement was significantly higher in academic vs other ICUs (7 [5-8] vs 2 [1-4]; P < 0.001), and pediatric vs adult ICUs (7 [5-8] vs 3 [1-6]; P = 0.01). CONCLUSIONS: Organizational strategies and institutional support were key facilitators of engagement. Engagement in patient care was a higher priority than engagement in research.

RéSUMé: OBJECTIF: Bien que l'engagement des patients et des familles puisse améliorer les soins cliniques et la recherche, les pratiques actuelles en matière d'engagement dans les unités de soins intensifs (USI) canadiennes sont inconnues. MéTHODE: Nous avons élaboré et administré un questionnaire transversal à l'intention des dirigeants des USI portant sur les pratiques d'engagement actuelles, les facilitateurs et les obstacles à l'engagement, ainsi que la priorisation de l'engagement, en utilisant une échelle de Likert ordinale de 1 à 10. RéSULTATS: Le taux de réponse était de 53,4 % (124/232). Les répondants provenaient de 11 provinces et territoires, principalement d'USI médico-chirurgicales (76%) et d'hôpitaux communautaires (70%). L'engagement dans les soins aux patients comprenait les soins au chevet du patient (84%) et les tournées au chevet (66%), la présence pendant les interventions ou les crises (65%), et la complétion des questionnaires (77%). La participation à la recherche comprenait les comités d'éthique (36%), l'examen des protocoles (31%) et le transfert des connaissances (30%). Les facilitateurs à l'engagement dans les soins aux patients comprenaient les réunions familiales (87%), les politiques de visites ouvertes (81%) et l'engagement en tant que priorité institutionnelle (74%). Le soutien des directions de département (43%) et d'hôpital (33%) a été un facilitateur de l'engagement en recherche. Le temps était le principal obstacle à l'engagement à quelque titre que ce soit. L'engagement était une priorité plus élevée dans les soins aux patients qu'en recherche (médiane [écart interquartile], 8 [7­9] vs 3 [1­7]; P < 0,001) et dans les USI pédiatriques vs adultes (10 [9­10] vs 8 [7­9]; P = 0,003). L'engagement en matière de recherche était significativement plus élevé dans les USI universitaires vs autres (7 [5­8] vs 2 [1­4]; P < 0,001), et pédiatriques vs pour adultes (7 [5­8] vs 3 [1­6]; P = 0,01). CONCLUSION: Les stratégies organisationnelles et le soutien institutionnel ont été des facilitateurs clés de l'engagement. L'engagement dans les soins aux patients était une priorité plus élevée que l'engagement dans la recherche.

Chlorhexidine (di)gluconate locking device for central line infection prevention in intensive care unit patients: a multi-unit, pilot randomized controlled trial.

PURPOSE: Intensive care unit (ICU) patients are at risk for central line-associated bloodstream infection (CLABSI) with significant attributable mortality and increased hospital length of stay, readmissions, and costs. Chlorhexidine (di)gluconate (CHG) is used as a disinfectant for central line insertion; however, the feasibility and efficacy of using CHG as a locking solution is unknown. METHODS: Patients with a central venous access device (CVAD) in situ were randomized to standard care or a CHG lock solution (CHGLS) within 72 hours of ICU admission. The CHG solution was instilled in the lumen of venous catheters not actively infusing. CVAD blood cultures were taken at baseline and every 48 hours. The primary outcome was feasibility including recruitment rate, consent rate, protocol adherence, and staff uptake. Secondary outcomes included CVAD colonization, bacteraemia, and clinical endpoints. RESULTS: Of 3,848 patients screened, 122 were eligible for the study and consent was obtained from 82.0% of the patients or substitute decision makers approached. Fifty participants were allocated to each group. Tracking logs indicated that the CHGLS was used per protocol 408 times. Most nurses felt comfortable using the CHGLS. The proportion of central line colonization was significantly higher in the standard care group with 40 (29%) versus 26 (18.7%) in the CHGLS group (P=0.009). CONCLUSIONS: Using a device that delivers CHG into CVADs was feasible in the ICU. Findings from this trial will inform a full-scale randomized controlled trial and provide preliminary data on the effectiveness of CHGLS. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03309137, registered on October 13, 2017.

Needs Assessment Survey Identifying Research Processes Which may be Improved by Automation or Artificial Intelligence: ICU Community Modeling and Artificial Intelligence to Improve Efficiency (ICU-Comma).

BACKGROUND: Critical care research in Canada is conducted primarily in academically-affiliated intensive care units with established research infrastructure, including research coordinators (RCs). Recently, efforts have been made to engage community hospital ICUs in research albeit with barriers. Automation or artificial intelligence (AI) could aid the performance of routine research tasks. It is unclear which research study processes might be improved through AI automation. METHODS: We conducted a cross-sectional survey of Canadian ICU research personnel. The survey contained items characterizing opinions regarding research processes that may be amenable to AI automation. We distributed the questionnaire via email distribution lists of 3 Canadian research societies. Open-ended questions were analyzed using a thematic content analysis approach. RESULTS: A total of 49 survey responses were received (response rate: 8%). Tasks that respondents felt were time-consuming/tedious/tiresome included: screening for potentially eligible patients (74%), inputting data into case report forms (65%), and preparing internal tracking logs (53%). Tasks that respondents felt could be performed by AI automation included: screening for eligible patients (59%), inputting data into case report forms (55%), preparing internal tracking logs (51%), and randomizing patients into studies (45%). Open-ended questions identified enthusiasm for AI automation to improve information accuracy and efficiency while freeing up RCs to perform tasks that require human interaction. This enthusiasm was tempered by the need for proper AI education and oversight. CONCLUSIONS: There were balanced supportive (increased efficiency and re-allocation of tasks) and challenges (informational accuracy and oversight) with regards to AI automation in ICU research.

National Preclinical Sepsis Platform: developing a framework for accelerating innovation in Canadian sepsis research.

Despite decades of preclinical research, no experimentally derived therapies for sepsis have been successfully adopted into routine clinical practice. Factors that contribute to this crisis of translation include poor representation by preclinical models of the complex human condition of sepsis, bias in preclinical studies, as well as limitations of single-laboratory methodology. To overcome some of these shortcomings, multicentre preclinical studies-defined as a research experiment conducted in two or more research laboratories with a common protocol and analysis-are expected to maximize transparency, improve reproducibility, and enhance generalizability. The ultimate objective is to increase the efficiency and efficacy of bench-to-bedside translation for preclinical sepsis research and improve outcomes for patients with life-threatening infection. To this end, we organized the first meeting of the National Preclinical Sepsis Platform (NPSP). This multicentre preclinical  research collaboration of Canadian sepsis researchers and stakeholders was established to study the pathophysiology of sepsis and accelerate movement of promising therapeutics into early phase clinical trials. Integrated knowledge translation and shared decision-making were emphasized to ensure the goals of the platform align with clinical researchers and patient partners. 29 participants from 10 independent labs attended and discussed four main topics: (1) objectives of the platform; (2) animal models of sepsis; (3) multicentre methodology and (4) outcomes for evaluation. A PIRO model (predisposition, insult, response, organ dysfunction) for experimental design was proposed to strengthen linkages with interdisciplinary researchers and key stakeholders. This platform represents an important resource for maximizing translational impact of preclinical sepsis research.

CardiO Cycle: a pilot feasibility study of in-bed cycling in critically ill patients post cardiac surgery.

BACKGROUND: In-bed cycling is a novel modality for the initiation of early mobilization in the intensive care unit. No study has investigated its use in the critically ill, off-track post cardiac surgery population. Before conducting an effectiveness trial, feasibility data are needed. The aim of this study was to determine the feasibility of in-bed cycling in a population of off-track cardiac surgery patients. METHODS: We conducted a prospective feasibility study in a 16-bed adult cardiac surgery intensive care unit in Ontario, Canada. Previously ambulatory adults (≥ 18 years) who were mechanically ventilated for ≥ 72 h were enrolled within 3 to 7 days post cardiac surgery. Twenty minutes of in-bed cycling was delivered by ICU physiotherapists 5 days/week. The primary outcome, feasibility, was the percent of patient-cycling sessions that occurred when cycling was appropriate. The secondary outcome was cycling safety, measured as cycling discontinuation due to predetermined adverse events. RESULTS: We screened 2074 patients, 29 met eligibility criteria, and 23 (92%) consented. Patients were male (78.26%) with a median [IQR] age of 76 [11] years, underwent isolated coronary bypass (39.1%), and had a median EuroScore II of 5.4 [7.8]. The mean (SD) time post-surgery to start of cycling was 5.9 (1.4) days. Patients were cycled on 80.5% (136/169) of eligible days, with limited physiotherapy staffing accounting for 48.5% of the missed patient-cycling sessions. During 136 sessions of cycling, 3 adverse events occurred in 3 individual patients. The incidence of an adverse event was 2.2 per 100 patient-cycling sessions (95% CI 0.50, 6.4). CONCLUSIONS: In-bed cycling with critically ill cardiac surgery patients is feasible with adequate physiotherapy staffing and appears to be safe. Future studies are needed to determine the effectiveness of this intervention in a larger sample. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov ( NCT02976415 ). Registered November 29, 2016.

Potential Risk Factors Contributing to Development of Venous Thromboembolism for Total Knee Replacements Patients Prophylaxed With Rivaroxaban: A Retrospective Case-Control Study.

Rivaroxaban after total knee arthroplasty (TKA) is used to prevent postoperative venous thromboembolism (VTE); however, despite thromboprophylaxis, some patients still develop postoperative VTE. To determine whether tourniquet time, time to initiate rivaroxaban (TTIRIV), or Body Mass Index (BMI) was associated with postoperative VTE. A retrospective case-control study was conducted. Those patients that developed VTE despite prophylaxis (cases) were compared to controls (no VTE). A univariate analysis was conducted (p < 0.05 statistically significant). Seven VTE cases were identified from 234 TKA-patients. Patients with and without VTE had BMI of 40.1 ± 9.1 and 32.8 ± 7.5, respectively (p = 0.064). TTIRIV in VTE and control group was 28.2 ± 4.7 hours and 26.4 ± 4.2 hours, respectively (p = 0.39). Mean tourniquet time in VTE and control group was 65.0 ± 8.7 minutes and 49 ± 8.8 minutes, respectively (p = 0.0007). Statistically significant differences in tourniquet times were noted between VTE and non-VTE group but not for TTIRIV and BMI. Prolonged tourniquet use could pose a potential risk factor for postoperative VTE. Thromboprophylaxis management may need to be adjusted, based on patient-specific factors that could include increasing doses of oral anticoagulants and/or mechanical prophylaxis. However, further large-scale studies are required to establish pathophysiology.

Role Incongruence and Psychological Stress Symptoms in Substitute Decision Makers of Intensive Care Patients.

BACKGROUND: Most intensive care patients require substitute decision makers (SDMs) to make decisions. The SDMs may prefer an active, shared, or passive decision-making role. Role incongruence is when preferred and actual roles differ. OBJECTIVE: To evaluate the impact of decision-making role preferences and role incongruence on psychological distress symptoms in SDMs. METHODS: A multicenter, interviewer-administered survey was conducted among SDMs of critically ill adults. The Control Preferences Scale was used to evaluate role preferences. Psychological distress was defined as anxiety, depression, or posttraumatic stress symptoms with predefined cut points on the Hospital Anxiety and Depression Scale (score > 10 on the anxiety or the depression subscale) and Impact of Events Scale (score > 30). RESULTS: One hundred eighty SDMs were recruited; 64% responded. Most were white (71%) and female (65%); 46% were spouses. Role preferences varied: active, 24%; shared, 44%; and passive, 31%. Almost half (49%) reported incongruence. Symptom prevalence was 50% for posttraumatic stress, 32% for anxiety, and 16% for depression. Most (56%) reported some psychological distress. In multivariable logistic regression, the composite outcome of psychological distress was independently associated with patient death (odds ratio, 2.95; 95% CI, 1.08-8.02; P = .03), female sex of SDM (odds ratio, 2.96; 95% CI, 1.49-5.89; P = .002), and incongruence (odds ratio, 3.26; 95% CI, 1.67-6.36; P < .001). CONCLUSIONS: Adverse psychological symptoms are prevalent in SDMs of critically ill patients and are related to role incongruence.

Chlorhexidine locking device for central line infection prevention in ICU patients: protocol for an open-label pilot and feasibility randomized controlled trial.

BACKGROUND: Critically ill patients in the intensive care unit (ICU) are at risk for central line-associated bloodstream infection (CLABSI) with an incidence up to 6.9 per 1000 catheter days. CLABSI has a significant attributable mortality and increases in-hospital length of stay, readmissions, and costs. Chlorhexidine gluconate (CHG), a broad-spectrum biocide, has been shown to effectively reduce infections including CLABSI; however, few trials have utilized CHG for prevention of central line infections. Our preclinical work has demonstrated a device that diffuses CHG into the intravenous lock solution of central venous catheters and decreases bacterial growth on the catheter lumen. We designed a clinical trial to test the feasibility of using a CHG device in an ICU patient population. METHODS: The proposed pilot trial will be a single centre, open-label, two-arm, parallel group feasibility randomized controlled trial (RCT). Participants will have a central line in situ and will be enrolled within 72 h of admittance to 3 ICUs at a single academic hospital. Exclusion criteria will include suspected infection, chronic indwelling catheters, and CHG allergy. Informed consent will be obtained from eligible participants or their substitute decision maker prior to randomization. Participants will be randomized to receive either usual care or the CHG locking device. Blood cultures will be drawn from all participants every 48 h. The primary objective of this study will be to determine the feasibility of using this protocol to conduct a larger trial. Feasibility will be assessed through the following outcomes: (1) consent rate, (2) recruitment rate, (3) protocol adherence, and (4) comfort level with the device. The secondary objective of this study will be to establish the preliminary efficacy of the device. DISCUSSION: This study will be the first human RCT to investigate a CHG locking device for the prevention of central line infections. Findings from this trial will inform the feasibility of conducting a large RCT and provide preliminary data on the efficacy of a CHG locking device. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03309137, registered on October 13, 2017.

Motivators and Stressors for Canadian Research Coordinators in Critical Care: The MOTIVATE Survey.

BACKGROUND: Critical care research coordinators implement study protocols in intensive care units, yet little is known about their experiences. OBJECTIVE: To identify the responsibilities, stressors, motivators, and job satisfaction of critical care research coordinators in Canada. METHODS: Responses to a self-administered survey were collected in order to identify and understand factors that motivate and stress research coordinators and enhance their job satisfaction. Items were generated in 5 domains (demographics, job responsibilities, stressors, motivators, and satisfaction). Face validity pretesting was conducted and clinical sensibility was evaluated. Items were rated on 5-point Likert scales. Descriptive analyses were used to report results. RESULTS: The response rate was 78% (66 of 85). Most critical care research coordinators (71%) were employed full time; they were engaged in 9 studies (7 academic, 2 industry); and 49% were nurses. Of 30 work responsibilities, the most frequently cited were submitting ethics applications (89%), performing data entry (89%), and attending meetings (87%). Highest-rated stressors were unrealistic workload and weekend/holiday screening; highest-rated motivators were a positive work environment and team spirit. Overall, 26% were "very satisfied" and 53% were "satisfied" with their jobs. CONCLUSIONS: Critical care research coordinators in Canada indicate that, despite significant work responsibilities, they are satisfied with their jobs thanks to positive work environments and team spirit.

Data initiatives supporting critical care research and quality improvement in Canada: an environmental scan and narrative review.

PURPOSE: Collection and analysis of health data are crucial to achieving high-quality clinical care, research, and quality improvement. This review explores existing hospital, regional, provincial and national data platforms in Canada to identify gaps and barriers, and recommend improvements for data science. SOURCE: The Canadian Critical Care Trials Group and the Canadian Critical Care Translational Biology Group undertook an environmental survey using list-identified names and keywords in PubMed and the grey literature, from the Canadian context. Findings were grouped into sections, corresponding to geography, purpose, and patient sub-group initiatives, using a narrative qualitative approach. Emerging themes, impressions, and recommendations towards improving data initiatives were generated. PRINCIPAL FINDINGS: In Canada, the Canadian Institute for Health Information Discharge Abstract Database contains high-level clinical data on every adult and child discharged from acute care facilities; however, it does not contain data from Quebec, critical care-specific severity of illness risk-adjustment scores, physiologic data, or data pertaining to medication use. Provincially mandated critical care platforms in four provinces contain more granular data, and can be used to risk adjust and link to within-province data sets; however, no inter-provincial collaborative mechanism exists. There is very limited infrastructure to collect and link biological samples from critically ill patients nationally. Comprehensive international clinical data sets may inform future Canadian initiatives. CONCLUSION: Clinical and biological data collection among critically ill patients in Canada is not sufficiently coordinated, and lags behind other jurisdictions. An integrated and inclusive critical care data platform is a key clinical and scientific priority in Canada.

Comparison of the source and prognostic utility of cfDNA in trauma and sepsis.

BACKGROUND: Circulating cell-free DNA (cfDNA) may contribute to the pathophysiology of post-injury inflammation and coagulation in trauma. However, the source and mechanism of release of cfDNA in trauma is not well understood. One potential source of cfDNA is from Neutrophil Extracellular Traps (NETs), released by activated neutrophils during the process of NETosis. The primary objective of our study was to determine if cfDNA has prognostic utility in trauma. The secondary objective of this study was to determine the source of cfDNA in trauma compared to sepsis. METHODS: We studied trauma patients from two prospective observational cohort studies: the DNA as a Prognostic Marker in ICU Patients (DYNAMICS) study and the Endotoxin in Polytrauma (ENPOLY) study. We also studied septic patients from the DYNAMICS study. Citrated plasma samples were collected longitudinally from the patients (days 1 to 7). The following molecules were measured in the plasma samples: cfDNA, protein C (PC), myeloperoxidase (MPO) (a marker of neutrophil activation), citrullinated Histone H3 (H3Cit, a marker of NETosis), cyclophilin A (a marker of necrosis), and caspase-cleaved K18 (a marker of apoptosis). RESULTS: A total of 77 trauma patients were included (n = 38 from DYNAMICS and n = 39 from ENPOLY). The median age was 49 years; 27.3% were female, and mortality was 16.9% at 28 days. Levels of cfDNA were elevated compared to healthy values but not significantly different between survivors and non-survivors. There was a positive correlation between MPO and cfDNA in septic patients (r = 0.424, p < 0.001). In contrast, there was no correlation between MPO and cfDNA in trauma patients (r = - 0.192, p = 0.115). Levels of H3Cit, a marker of NETosis, were significantly elevated in septic patients compared to trauma patients (p < 0.01) while apoptosis and necrosis markers did not differ between the two groups. CONCLUSION: Our studies suggest that the source and mechanism of release of cfDNA differ between trauma and sepsis patients. In sepsis, cfDNA is likely primarily released by activated neutrophils via the process of NETosis. In contrast, cfDNA in trauma appears to originate mainly from injured or necrotic cells. Although cfDNA is elevated in trauma and sepsis patients compared to healthy controls, cfDNA does not appear to have prognostic utility in trauma patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01355042 . Registered May 17, 2011.

Mortality Risk Profiles for Sepsis: A Novel Longitudinal and Multivariable Approach.

To determine if a set of time-varying biological indicators can be used to: 1) predict the sepsis mortality risk over time and 2) generate mortality risk profiles. DESIGN: Prospective observational study. SETTING: Nine Canadian ICUs. SUBJECTS: Three-hundred fifty-six septic patients. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Clinical data and plasma levels of biomarkers were collected longitudinally. We used a complementary log-log model to account for the daily mortality risk of each patient until death in ICU/hospital, discharge, or 28 days after admission. The model, which is a versatile version of the Cox model for gaining longitudinal insights, created a composite indicator (the daily hazard of dying) from the "day 1" and "change" variables of six time-varying biological indicators (cell-free DNA, protein C, platelet count, creatinine, Glasgow Coma Scale score, and lactate) and a set of contextual variables (age, presence of chronic lung disease or previous brain injury, and duration of stay), achieving a high predictive power (conventional area under the curve, 0.90; 95% CI, 0.86-0.94). Including change variables avoided misleading inferences about the effects of day 1 variables, signifying the importance of the longitudinal approach. We then generated mortality risk profiles that highlight the relative contributions among the time-varying biological indicators to overall mortality risk. The tool was validated in 28 nonseptic patients from the same ICUs who became septic later and was subject to 10-fold cross-validation, achieving similarly high area under the curve. CONCLUSIONS: Using a novel version of the Cox model, we created a prognostic tool for septic patients that yields not only a predicted probability of dying but also a mortality risk profile that reveals how six time-varying biological indicators differentially and longitudinally account for the patient's overall daily mortality risk.

Microbial dysbiosis and mortality during mechanical ventilation: a prospective observational study.

BACKGROUND: Host-associated microbial communities have important roles in tissue homeostasis and overall health. Severe perturbations can occur within these microbial communities during critical illness due to underlying diseases and clinical interventions, potentially influencing patient outcomes. We sought to profile the microbial composition of critically ill mechanically ventilated patients, and to determine whether microbial diversity is associated with illness severity and mortality. METHODS: We conducted a prospective, observational study of mechanically ventilated critically ill patients with a high incidence of pneumonia in 2 intensive care units (ICUs) in Hamilton, Canada, nested within a randomized trial for the prevention of healthcare-associated infections. The microbial profiles of specimens from 3 anatomical sites (respiratory, and upper and lower gastrointestinal tracts) were characterized using 16S ribosomal RNA gene sequencing. RESULTS: We collected 65 specimens from 34 ICU patients enrolled in the trial (29 endotracheal aspirates, 26 gastric aspirates and 10 stool specimens). Specimens were collected at a median time of 3 days (lower respiratory tract and gastric aspirates; interquartile range [IQR] 2-4) and 6 days (stool; IQR 4.25-6.75) following ICU admission. We observed a loss of biogeographical distinction between the lower respiratory tract and gastrointestinal tract microbiota during critical illness. Moreover, microbial diversity in the respiratory tract was inversely correlated with APACHE II score (r = - 0.46, p = 0.013) and was associated with hospital mortality (Median Shannon index: Discharged alive; 1.964 vs. Deceased; 1.348, p = 0.045). CONCLUSIONS: The composition of the host-associated microbial communities is severely perturbed during critical illness. Reduced microbial diversity reflects high illness severity and is associated with mortality. Microbial diversity may be a biomarker of prognostic value in mechanically ventilated patients. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT01782755 . Registered February 4 2013.

Principles and theory guiding development and delivery of patient education in disorders of thrombosis and hemostasis: Reviewing the current literature.

Prior work regarding patient education has identified the importance of using learning theory and educational models to develop and deliver content that will improve patient outcomes. Current literature appears to examine implementation of teaching strategies without clear identification of educational principles. This review aimed to identify educational principles and theory currently utilized in the planning and delivery of patient education in disorders of thrombosis and hemostasis. The majority of articles reviewed evaluated the impact of educational interventions on patient outcomes; links between educational principles and changes in outcomes was lacking. Few articles clearly referenced theory in development of patient education; fewer focussed on the population of interest. The lack of literature demonstrates the need for multi-center collaborative research aimed at generation of an improved level of evidence regarding the most effective theoretical framework for the development, delivery and evaluation of patient education for patients with disorders of thrombosis and hemostasis. Once a theoretical framework for patient education is developed and tested, the unique contribution of patient education to both knowledge and clinical outcomes can be robustly evaluated.

Community-based adaptation research in the Canadian Arctic.

Community-based adaptation (CBA) has emerged over the last decade as an approach to empowering communities to plan for and cope with the impacts of climate change. While such approaches have been widely advocated, few have critically examined the tensions and challenges that CBA brings. Responding to this gap, this article critically examines the use of CBA approaches with Inuit communities in Canada. We suggest that CBA holds significant promise to make adaptation research more democratic and responsive to local needs, providing a basis for developing locally appropriate adaptations based on local/indigenous and Western knowledge. Yet, we argue that CBA is not a panacea, and its common portrayal as such obscures its limitations, nuances, and challenges. Indeed, if uncritically adopted, CBA can potentially lead to maladaptation, may be inappropriate in some instances, can legitimize outside intervention and control, and may further marginalize communities. We identify responsibilities for researchers engaging in CBA work to manage these challenges, emphasizing the centrality of how knowledge is generated, the need for project flexibility and openness to change, and the importance of ensuring partnerships between researchers and communities are transparent. Researchers also need to be realistic about what CBA can achieve, and should not assume that research has a positive role to play in community adaptation just because it utilizes participatory approaches. WIREs Clim Change 2016, 7:175-191. doi: 10.1002/wcc.376 For further resources related to this article, please visit the WIREs website.

Assessment of Postresuscitation Volume Status by Bioimpedance Analysis in Patients with Sepsis in the Intensive Care Unit: A Pilot Observational Study.

Background. Bioimpedance analysis (BIA) is a novel method of assessing a patient's volume status. Objective. We sought to determine the feasibility of using vector length (VL), derived from bioimpedance analysis (BIA), in the assessment of postresuscitation volume status in intensive care unit (ICU) patients with sepsis. Method. This was a prospective observational single-center study. Our primary outcome was feasibility. Secondary clinical outcomes included ventilator status and acute kidney injury. Proof of concept was sought by correlating baseline VL measurements with other known measures of volume status. Results. BIA was feasible to perform in the ICU. We screened 655 patients, identified 78 eligible patients, and approached 64 for consent. We enrolled 60 patients (consent rate of 93.8%) over 12 months. For each 50-unit increase in VL, there was an associated 22% increase in the probability of not requiring invasive mechanical ventilation (IMV) (p = 0.13). Baseline VL correlated with other measures of volume expansion including serum pro-BNP levels, peripheral edema, and central venous pressure (CVP). Conclusion. It is feasible to use BIA to predict postresuscitation volume status and patient-important outcomes in septic ICU patients. Trial Registration. This trial is registered with clinicaltrials.gov NCT01379404 registered on June 7, 2011.

Heparin-induced thrombocytopenia in the critically ill: interpreting the 4Ts test in a randomized trial.

BACKGROUND: Thrombocytopenia occurs in 20% to 45% of critically ill medical-surgical patients. The 4Ts heparin-induced thrombocytopenia (HIT) score (with 4 domains: Thrombocytopenia, Timing of thrombocytopenia, Thrombosis and oTher reason[s] for thrombocytopenia) might reliably identify patients at low risk for HIT. Interobserver agreement on 4Ts scoring is uncertain in this setting. OBJECTIVE: To evaluate whether a published clinical prediction rule (the "4Ts score") reliably rules out HIT in "low-risk" intensive care unit (ICU) patients as assessed by research coordinators (who prospectively scored) and 2 adjudicators (who scored retrospectively) during an international heparin thromboprophylaxis trial (PROTECT, NCT00182143). METHODS: Of 3746 medical-surgical ICU patients in PROTECT, 794 met the enrollment criteria for this HIT substudy. Enrollment was predicated on one of the following occurring in ICU: platelets less than 50×10(9)/L, platelets decreased to 50% of ICU admission value (if admission value<100×10(9)/L), any venous thrombosis, or if HIT was otherwise clinically suspected. Independently, 4Ts scores were completed in real time by research coordinators blinded to study drug and laboratory HIT results, and retrospectively by 2 adjudicators blinded to study drug, laboratory HIT results, and research coordinators' scores; the adjudicators arrived at consensus in all cases. Of the 763 patients, 474 had a central or local laboratory HIT test performed and had 4Ts scoring by adjudicators; 432 were scored by trained research coordinators. Heparin-induced thrombocytopenia was defined by a centrally performed positive serotonin release assay (SRA). RESULTS: Of the 474 patients with central adjudication, 407 (85.9%) had a 4Ts score of 3 or lower, conferring a low pretest probability (PTP) of HIT; of these, 6 (1.5% [95% confidence interval, 0.7%-3.2%) had a positive SRA. Fifty-nine (12.4%) had a moderate PTP (4Ts score of 4-5); of these, 4 (6.8%) had a positive SRA. Eight patients had a high PTP (4Ts score of ≥6); of these, 1 (12.5%) had a positive SRA. Raw agreement between research coordinators and central adjudication on each domain of the 4Ts score and low, intermediate, and high PTP was good. However, chance-corrected agreement was variable between adjudicators (weighted κ values of 0.31-0.93) and between the adjudicator consensus and research coordinators (weighted κ values of 0.13 and 0.78). Post hoc review of the 6 SRA-positive cases with an adjudicated low PTP demonstrated that their scores would have been increased if the adjudicators had had additional information on heparin exposure prior to ICU admission. In general, the fourth domain of 4Ts (oTher causes of thrombocytopenia) generated the most disagreement. CONCLUSIONS: Real-time 4Ts scoring by research coordinators at the time of testing for HIT was not consistent with 4Ts scores obtained by central adjudicators. The results of this comprehensive HIT testing highlight the need for further research to improve the assessment of PTP scoring of HIT for critically ill patients.

Evidence against the involvement of chronic cerebrospinal venous abnormalities in multiple sclerosis. A case-control study.

OBJECTIVE: Multiple sclerosis (MS) is a chronic neurodegenerative disease of the CNS. Recently a controversial vascular hypothesis for MS, termed chronic cerebrospinal venous insufficiency (CCSVI), has been advanced. The objective of this study was to evaluate the relative prevalence of the venous abnormalities that define CCSVI. METHODS: A case-control study was conducted in which 100 MS patients aged between 18-65 y meeting the revised McDonald criteria were randomly selected and stratified into one of four MS subtypes: relapsing/remitting, secondary progressive, primary progressive and benign. Control subjects (16-70 y) with no known history of MS or other neurological condition were matched with the MS cases. All cases and controls underwent ultrasound imaging of the veins of the neck plus the deep cerebral veins, and magnetic resonance imaging of the neck veins and brain. These procedures were performed on each participant on the same day. RESULTS: On ultrasound we found no evidence of reflux, stenosis or blockage in the internal jugular veins (IJV) or vertebral veins (VV) in any study participant. Similarly, there was no evidence of either reflux or cessation of flow in the deep cerebral veins in any subject. Flow was detected in the IJV and VV in all study participants. Amongst 199 participants there was one MS subject who fulfilled the minimum two ultrasound criteria for CCSVI. Using MRI we found no significant differences in either the intra- or extra-cranial venous flow velocity or venous architecture between cases and controls. CONCLUSION: This case-control study provides compelling evidence against the involvement of CCSVI in multiple sclerosis.

Enhancing the informed consent process for critical care research: strategies from a thromboprophylaxis trial.

BACKGROUND: Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers. OBJECTIVE: To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for participation of critically ill patients in trials. We use examples from a randomised trial of heparin thromboprophylaxis in the intensive care unit (PROTECT, clinicaltrials.gov NCT00182143). METHODS: 3764 patients were randomised, with an informed consent rate of 82%; 90% of consents were obtained from substitute decision-makers. North American PROTECT research coordinators attended three meetings to discuss enrolment: (1) Trial start-up (January 2006); (2) Near trial closure (January 2010); and (3) Post-publication (April 2011). Data were derived from slide presentations, field notes from break-out groups and plenary discussions, then analysed inductively. RESULTS: We derived three phases for the informed consent process: (1) Preparation for the Consent Encounter; (2) The Consent Encounter; and (3) Follow-up to the Consent Encounter. Specific strategies emerged for each phase: Phase 1 (four strategies); Phase 2 (six strategies); and Phase 3 (three strategies). CONCLUSION: We identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies.

Research recruitment practices and critically ill patients. A multicenter, cross-sectional study (the Consent Study).

RATIONALE: Limited cross-sectional data exist to characterize the challenges of enrolling critically ill patients into research studies. OBJECTIVES: We aimed to describe recruitment practices, document factors that impact recruitment, and identify factors that may enhance future research feasibility. METHODS: We conducted a prospective, observational study of all critically ill adults eligible to participate in research studies at 23 Canadian intensive care units. We characterized eligibility events into one of five consent outcomes, identified reasons why opportunities to recruit were missed or infeasible, and documented decision maker's rationale for providing or declining consent. MEASUREMENTS AND MAIN RESULTS: Patients made decisions for themselves in 8.9% of encounters. In 452 eligibility events, consent was not required in 14 (3.1%), missed in 130 (28.8%), infeasible due to operational reasons in 129 (28.5%), obtained in 140 (31.0%), and declined in 39 (8.6%). More than half (57.3%) of all opportunities to recruit patients were missed or infeasible, largely because of research team workload, limited availability, narrow time windows for inclusion, difficulties in contacting families, nonexistent substitute decision makers (SDMs), physician refusals, and protocols prohibiting coenrollment. The rationale for providing consent differed between patients and SDMs. Greater research coordinator experience and site research volume and broader time windows for inclusion were significant predictors of fewer declined consents. CONCLUSIONS: A large gap exists between eligibility and the frequency with which consent encounters occur in intensive care unit research. Recruitment is susceptible to design and procedural inefficiencies that hinder recruitment and to personnel availability, given the need to interact with SDMs. Current enrollment practices may underrepresent potential study populations.