Browsing by Author "Stelfox, Henry T"

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    7 versus 14 days of antibiotic treatment for critically ill patients with bloodstream infection: a pilot randomized clinical trial
    (2018-02-17) Daneman, Nick; Rishu, Asgar H; Pinto, Ruxandra; Aslanian, Pierre; Bagshaw, Sean M; Carignan, Alex; Charbonney, Emmanuel; Coburn, Bryan; Cook, Deborah J; Detsky, Michael E; Dodek, Peter; Hall, Richard; Kumar, Anand; Lamontagne, Francois; Lauzier, Francois; Marshall, John C; Martin, Claudio M; McIntyre, Lauralyn; Muscedere, John; Reynolds, Steven; Sligl, Wendy; Stelfox, Henry T; Wilcox, M. E; Fowler, Robert A
    Abstract Background Shorter-duration antibiotic treatment is sufficient for a range of bacterial infections, but has not been adequately studied for bloodstream infections. Our systematic review, survey, and observational study indicated equipoise for a trial of 7 versus 14 days of antibiotic treatment for bloodstream infections; a pilot randomized clinical trial (RCT) was a necessary next step to assess feasibility of a larger trial. Methods We conducted an open, pilot RCT of antibiotic treatment duration among critically ill patients with bloodstream infection across 11 intensive care units (ICUs). Antibiotic selection, dosing and route were at the discretion of the treating team; patients were randomized 1:1 to intervention arms consisting of two fixed durations of treatment – 7 versus 14 days. We recruited adults with a positive blood culture yielding pathogenic bacteria identified while in ICU. We excluded patients with severe immunosuppression, foci of infection with an established requirement for prolonged treatment, single cultures with potential contaminants, or cultures yielding Staphylococcus aureus or fungi. The primary feasibility outcomes were recruitment rate and adherence to treatment duration protocol. Secondary outcomes included 90-day, ICU and hospital mortality, relapse of bacteremia, lengths of stay, mechanical ventilation and vasopressor duration, antibiotic-free days, Clostridium difficile, antibiotic adverse events, and secondary infection with antimicrobial-resistant organisms. Results We successfully achieved our target sample size (n = 115) and average recruitment rate of 1 (interquartile range (IQR) 0.3–1.5) patient/ICU/month. Adherence to treatment duration was achieved in 89/115 (77%) patients. Adherence differed by underlying source of infection: 26/31 (84%) lung; 18/29 (62%) intra-abdominal; 20/26 (77%) urinary tract; 8/9 (89%) vascular-catheter; 4/4 (100%) skin/soft tissue; 2/4 (50%) other; and 11/12 (92%) unknown sources. Patients experienced a median (IQR) 14 (8–17) antibiotic-free days (of the 28 days after blood culture collection). Antimicrobial-related adverse events included hepatitis in 1 (1%) patient, Clostridium difficile infection in 4 (4%), and secondary infection with highly resistant microorganisms in 10 (9%). Ascertainment was complete for all study outcomes in ICU, in hospital and at 90 days. Conclusion It is feasible to conduct a RCT to determine whether 7 versus 14 days of antibiotic treatment is associated with comparable 90-day survival. Trial registration ClinicalTrials.gov , identifier: NCT02261506 . Registered on 26 September 2014.
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    A qualitative study of physician perceptions and experiences of caring for critically ill patients in the context of resource strain during the first wave of the COVID-19 pandemic
    (2021-04-22) Parsons Leigh, Jeanna; Kemp, Laryssa G; de Grood, Chloe; Brundin-Mather, Rebecca; Stelfox, Henry T; Ng-Kamstra, Josh S; Fiest, Kirsten M
    Abstract Background The COVID-19 pandemic has led to global shortages in the resources required to care for critically ill patients and to protect frontline healthcare providers. This study investigated physicians’ perceptions and experiences of caring for critically ill patients in the context of actual or anticipated resource strain during the COVID-19 pandemic, and explored implications for the healthcare workforce and the delivery of patient care. Methods We recruited a diverse sample of critical care physicians from 13 Canadian Universities with adult critical care training programs. We conducted semi-structured telephone interviews between March 25–June 25, 2020 and used qualitative thematic analysis to derive primary themes and subthemes. Results Fifteen participants (eight female, seven male; median age = 40) from 14 different intensive care units described three overarching themes related to physicians’ perceptions and experiences of caring for critically ill patients during the pandemic: 1) Conditions contributing to resource strain (e.g., continuously evolving pandemic conditions); 2) Implications of resource strain on critical care physicians personally (e.g., safety concerns) and professionally (e.g. practice change); and 3) Enablers of resource sufficiency (e.g., adequate human resources). Conclusions The COVID-19 pandemic has required health systems and healthcare providers to continuously adapt to rapidly evolving circumstances. Participants’ uncertainty about whether their unit’s planning and resources would be sufficient to ensure the delivery of high quality patient care throughout the pandemic, coupled with fear and anxiety over personal and familial transmission, indicate the need for a unified systemic pandemic response plan for future infectious disease outbreaks.
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    A retrospective observational analysis of red blood cell transfusion practices in stable, non-bleeding adult patients admitted to nine medical-surgical intensive care units
    (2019-04-04) Soril, Lesley J J; Noseworthy, Tom W; Stelfox, Henry T; Zygun, David A; Clement, Fiona M
    Abstract Background Red blood cell (RBC) transfusions are common procedures performed in the intensive care unit (ICU). However, conservative transfusion approaches have been recommended to avoid RBC transfusions that are not clinically necessary and to achieve optimal patient outcomes. The objective of this study was to examine the utilization and costs of RBC transfusions in medical-surgical ICUs and to compare this information against clinical guideline recommendations for best practice. Methods Retrospective observational analysis of RBC transfusions in stable, non-bleeding adult patients was examined in a geographically-defined, population-based cohort of nine integrated ICUs between April 1, 2014 and December 31, 2016. RBC transfusions associated with a pre-transfusion hemoglobin value of 70 g/L or more were examined through linear and logistic regression. The total costs of RBC transfusions, based on the RBC unit cost, were estimated. Results A total of 4632 RBC transfusions (2287 ICU admissions) were included. Pre-transfusion hemoglobin values were identified for 4487 transfusions. On average, 61% occurred at or above a hemoglobin value of 70 g/L (mean 73.4 ± 9.2 g/L). Factors associated with such transfusions included being male, age over 75, Sequential Organ Failure Assessment (SOFA) score greater or equal to 10, transfer from operating room, gastrointestinal bleeding, and trauma. A pre-transfusion hemoglobin value at or above 70 g/L was associated with increased odds of ICU mortality; there was no impact on overall hospital mortality. The total estimated cost of RBC transfusions was $2.99M Canadian dollars (CAD), with $1.82M CAD attributed to those with a hemoglobin value at or above 70 g/L. Conclusions Over half of the examined RBC transfusions may not have aligned with recommended best practice; this suggests significant opportunity for improvement. The present findings are an essential step towards optimizing RBC transfusions in the ICU.
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    A study protocol for a randomized controlled trial of family-partnered delirium prevention, detection, and management in critically ill adults: the ACTIVATE study
    (2020-05-24) Fiest, Kirsten M; Krewulak, Karla D; Sept, Bonnie G; Spence, Krista L; Davidson, Judy E; Ely, E. W; Soo, Andrea; Stelfox, Henry T
    Abstract Background Delirium is very common in critically ill patients admitted to the intensive care unit (ICU) and results in negative long-term outcomes. Family members are also at risk of long-term complications, including depression and anxiety. Family members are frequently at the bedside and want to be engaged; they know the patient best and may notice subtle changes prior to the care team. By engaging family members in delirium care, we may be able to improve both patient and family outcomes by identifying delirium sooner and capacitating family members in care. Methods The primary aim of this study is to determine the effect of family-administered delirium prevention, detection, and management in critically ill patients on family member symptoms of depression and anxiety, compared to usual care. One-hundred and ninety-eight patient-family dyads will be recruited from four medical-surgical ICUs in Calgary, Canada. Dyads will be randomized 1:1 to the intervention or control group. The intervention consists of family-partnered delirium prevention, detection, and management, while the control group will receive usual care. Delirium, depression, and anxiety will be measured using validated tools, and participants will be followed for 1- and 3-months post-ICU discharge. All analyses will be intention-to-treat and adjusted for pre-identified covariates. Ethical approval has been granted by the University of Calgary Conjoint Health Research Ethics Board (REB19–1000) and the trial registered. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. Discussion Critically ill patients are frequently unable to participate in their own care, and partnering with their family members is particularly important for improving experiences and outcomes of care for both patients and families. Trial registration Registered September 23, 2019 on Clinicaltrials.gov NCT04099472.
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    Adverse events associated with administration of vasopressor medications through a peripheral intravenous catheter: a systematic review and meta-analysis
    (2021-04-16) Owen, Victoria S; Rosgen, Brianna K; Cherak, Stephana J; Ferland, Andre; Stelfox, Henry T; Fiest, Kirsten M; Niven, Daniel J
    Abstract Background It is unclear whether vasopressors can be safely administered through a peripheral intravenous (PIV). Systematic review and meta-analysis methodology was used to examine the incidence of local anatomic adverse events associated with PIV vasopressor administration in patients of any age cared for in any acute care environment. Methods MEDLINE, EMBASE, CINAHL, the Cochrane Central Register of controlled trials, and the Database of Abstracts of Reviews of Effects were searched without restriction from inception to October 2019. References of included studies and related reviews, as well as relevant conference proceedings were also searched. Studies were included if they were: (1) cohort, quasi-experimental, or randomized controlled trial study design; (2) conducted in humans of any age or clinical setting; and (3) reported on local anatomic adverse events associated with PIV vasopressor administration. Risk of bias was assessed using the Revised Cochrane risk-of-bias tool for randomized trials or the Joanna Briggs Institute checklist for prevalence studies where appropriate. Incidence estimates were pooled using random effects meta-analysis. Subgroup analyses were used to explore sources of heterogeneity. Results Twenty-three studies were included in the systematic review, of which 16 and 7 described adults and children, respectively. Meta-analysis from 11 adult studies including 16,055 patients demonstrated a pooled incidence proportion of adverse events associated with PIV vasopressor administration as 1.8% (95% CI 0.1–4.8%, I2 = 93.7%). In children, meta-analysis from four studies and 388 patients demonstrated a pooled incidence proportion of adverse events as 3.3% (95% CI 0.0–10.1%, I2 = 82.4%). Subgroup analyses did not detect any statistically significant effects associated with stratification based on differences in clinical location, risk of bias or design between studies, PIV location and size, or vasopressor type or duration. Most studies had high or some concern for risk of bias. Conclusion The incidence of adverse events associated with PIV vasopressor administration is low. Additional research is required to examine the effects of PIV location and size, vasopressor type and dose, and patient characteristics on the safety of PIV vasopressor administration.
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    Allocation of intensive care resources during an infectious disease outbreak: a rapid review to inform practice
    (2020-12-18) Fiest, Kirsten M; Krewulak, Karla D; Plotnikoff, Kara M; Kemp, Laryssa G; Parhar, Ken K S; Niven, Daniel J; Kortbeek, John B; Stelfox, Henry T; Parsons Leigh, Jeanna
    Abstract Background The COVID-19 pandemic has placed sustained demand on health systems globally, and the capacity to provide critical care has been overwhelmed in some jurisdictions. It is unknown which triage criteria for allocation of resources perform best to inform health system decision-making. We sought to summarize and describe existing triage tools and ethical frameworks to aid healthcare decision-making during infectious disease outbreaks. Methods We conducted a rapid review of triage criteria and ethical frameworks for the allocation of critical care resources during epidemics and pandemics. We searched Medline, EMBASE, and SCOPUS from inception to November 3, 2020. Full-text screening and data abstraction were conducted independently and in duplicate by three reviewers. Articles were included if they were primary research, an adult critical care setting, and the framework described was related to an infectious disease outbreak. We summarized each triage tool and ethical guidelines or framework including their elements and operating characteristics using descriptive statistics. We assessed the quality of each article with applicable checklists tailored to each study design. Results From 11,539 unique citations, 697 full-text articles were reviewed and 83 articles were included. Fifty-nine described critical care triage protocols and 25 described ethical frameworks. Of these, four articles described both a protocol and ethical framework. Sixty articles described 52 unique triage criteria (29 algorithm-based, 23 point-based). Few algorithmic- or point-based triage protocols were good predictors of mortality with AUCs ranging from 0.51 (PMEWS) to 0.85 (admitting SOFA > 11). Most published triage protocols included the substantive values of duty to provide care, equity, stewardship and trust, and the procedural value of reason. Conclusions This review summarizes available triage protocols and ethical guidelines to provide decision-makers with data to help select and tailor triage tools. Given the uncertainty about how the COVID-19 pandemic will progress and any future pandemics, jurisdictions should prepare by selecting and adapting a triage tool that works best for their circumstances.
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    Association between afterhours admission to the intensive care unit, strained capacity, and mortality: a retrospective cohort study
    (2018-04-17) Hall, Adam M; Stelfox, Henry T; Wang, Xioaming; Chen, Guanmin; Zuege, Danny J; Dodek, Peter; Garland, Allan; Scales, Damon C; Berthiaume, Luc; Zygun, David A; Bagshaw, Sean M
    Abstract Background Admission to the intensive care unit (ICU) outside daytime hours has been shown to be variably associated with increased morbidity and mortality. We aimed to describe the characteristics and outcomes of patients admitted to the ICU afterhours (22:00–06:59 h) in a large Canadian health region. We further hypothesized that the association between afterhours admission and mortality would be modified by indicators of strained ICU capacity. Methods This is a population-based cohort study of 12,265 adults admitted to nine ICUs in Alberta from June 2012 to December 2014. We used a path-analysis modeling strategy and mixed-effects multivariate regression analysis to evaluate direct and integrated associations (mediated through Acute Physiology and Chronic Health Evaluation (APACHE) II score) between afterhours admission (22:00–06:59 h) and ICU mortality. Further analysis examined the effects of strained ICU capacity and varied definitions of afterhours and weekend admissions. ICU occupancy ≥ 90% or clustering of admissions (≥ 0.15, defined as number of admissions 2 h before or after the index admission, divided by the number of ICU beds) were used as indicators of strained capacity. Results Of 12,265 admissions, 34.7% (n = 4251) occurred afterhours. The proportion of afterhours admissions varied amongst ICUs (range 26.7–37.8%). Patients admitted afterhours were younger (median (IQR) 58 (44–70) vs 60 (47–70) years, p < 0.0001), more likely to have a medical diagnosis (75.9% vs 72.1%, p < 0.0001), and had higher APACHE II scores (20.9 (8.6) vs 19.9 (8.3), p < 0.0001). Crude ICU mortality was greater for those admitted afterhours (15.9% vs 14.1%, p = 0.007), but following multivariate adjustment there was no direct or integrated effect on ICU mortality (odds ratio (OR) 1.024; 95% confidence interval (CI) 0.923–1.135, p = 0.658). Furthermore, direct and integrated analysis showed no association of afterhours admission and hospital mortality (p = 0.90) or hospital length of stay (LOS) (p = 0.27), although ICU LOS was shorter (p = 0.049). Early-morning admission (00:00–06:59 h) with ICU occupancy ≥ 90% was associated with short-term (≤ 7 days) and all-cause ICU mortality. Conclusions One-third of critically ill patients are admitted to the ICU afterhours. Afterhours ICU admission was not associated with greater mortality risk in most circumstances but was sensitive to strained ICU capacity.
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    Association between delirium in the intensive care unit and subsequent neuropsychiatric disorders
    (2020-07-31) Brown, Kyla N; Soo, Andrea; Faris, Peter; Patten, Scott B; Fiest, Kirsten M; Stelfox, Henry T
    Abstract Background Patients in the intensive care unit (ICU) are known to be at increased risk of developing delirium, but the risk of subsequent neuropsychiatric disorders is unclear. We therefore sought to examine the association between the presence of delirium in the ICU and incident neuropsychiatric disorders (including depressive, anxiety, trauma-and-stressor-related, and neurocognitive disorders) post-ICU stay among adult medical-surgical ICU patients. Methods Retrospective cohort study utilizing clinical and administrative data from both inpatient and outpatient healthcare visits to identify the ICU cohort and diagnostic information 5 years prior to and 1 year post-ICU stay. Patients ≥ 18 years of age admitted to one of 14 medical-surgical ICUs across Alberta, Canada, January 1, 2014–June 30, 2016, and survived to hospital discharge were included. The main outcome of interest was a new diagnosis of any neuropsychiatric disorder 1 year post-ICU stay. The exposure variable was delirium during the ICU stay identified through any positive delirium screen by the Intensive Care Unit Delirium Screening Checklist (ICDSC) during the ICU stay. Results Of 16,005 unique patients with at least one ICU admission, 4033 patients were included in the study of which 1792 (44%) experienced delirium during their ICU stay. The overall cumulative incidence of any neuropsychiatric disorder during the subsequent year was 19.7% for ICU patients. After adjusting for hospital characteristics using log-binomial regression, patients with delirium during the ICU stay had a risk ratio (RR) of 1.14 (95% confidence interval [CI] 0.98–1.33) of developing any neuropsychiatric disorder within 1 year post-ICU compared to those who did not experience delirium. Delirium was significantly associated with neurocognitive disorders (RR 1.59, 95% CI 1.08–2.35), but not depressive disorders (RR 1.16, 95% CI 0.92–1.45), anxiety (RR 1.16, 95% CI 0.92–1.47), and trauma-and-stressor-related (RR 0.82, 95% CI 0.53–1.28) disorders. Conclusions The diagnosis of new onset of neurocognitive disorders is associated with ICU-acquired delirium. In this study, significant associations were not observed for depressive, anxiety, and trauma-and-stressor-related disorders.
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    Associations between caregiver-detected delirium and symptoms of depression and anxiety in family caregivers of critically ill patients: a cross-sectional study
    (2021-04-09) Rosgen, Brianna K; Krewulak, Karla D; Davidson, Judy E; Ely, E. W; Stelfox, Henry T; Fiest, Kirsten M
    Abstract Background Witnessing delirium can be distressing for family caregivers (i.e., relatives or friends) of critically ill patients. This study aimed to evaluate associations between caregiver-detected delirium in critically ill patients and depression and anxiety symptoms in their family caregivers. Methods Consecutive adult patient-caregiver dyads were enrolled from a 28-bed medical-surgical intensive care unit. Patient delirium was screened for daily by family caregivers using the Sour Seven instrument. Family caregivers completed the Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) instruments daily to assess their own depression and anxiety symptoms. Response feature analysis was used to handle repeated measures. Descriptive statistics and regression analyses were completed. Results One hundred forty-seven patient-caregiver dyads were enrolled. Clinically significant symptoms of depression and anxiety occurred in 27% and 35% of family caregivers, respectively. Caregiver-detected delirium occurred in 65% of patients, and was not associated with clinically significant caregiver depression (Odds Ratio [OR] 1.4, 95% Confidence Interval [95%CI] 0.6–3.1) or anxiety (OR 1.2, 95%CI 0.6–2.6) symptoms. When stratified by Sour Seven scores, scores 1–3 and 4–9 were associated with increased symptoms of anxiety (OR 3.1, 95%CI 1.3–7.0) and depression (OR 2.6, 95%CI 1.1–6.1) in family caregivers. Caregiver-detected delirium score was associated with severity of family caregiver anxiety symptoms (coefficient 0.2, 95%CI 0.1–0.4), but not depression symptoms (coefficient 0.2, 95%CI -0.0–0.3). Conclusions Caregiver-detected patient delirium was associated with increased depression and anxiety symptoms in family caregivers of critically ill patients. Further randomized research is required to confirm these associations.
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    Bereavement interventions to support informal caregivers in the intensive care unit: a systematic review
    (2021-05-12) Moss, Stephana J; Wollny, Krista; Poulin, Therese G; Cook, Deborah J; Stelfox, Henry T; Ordons, Amanda R d; Fiest, Kirsten M
    Abstract Background Informal caregivers of critically ill patients in intensive care unit (ICUs) experience negative psychological sequelae that worsen after death. We synthesized outcomes reported from ICU bereavement interventions intended to improve informal caregivers’ ability to cope with grief. Data sources MEDLINE, EMBASE, CINAHL and PsycINFO from inception to October 2020. Study selection Randomized controlled trials (RCTs) of bereavement interventions to support informal caregivers of adult patients who died in ICU. Data extraction Two reviewers independently extracted data in duplicate. Narrative synthesis was conducted. Data synthesis Bereavement interventions were categorized according to the UK National Institute for Health and Clinical Excellence three-tiered model of bereavement support according to the level of need: (1) Universal information provided to all those bereaved; (2) Selected or targeted non-specialist support provided to those who are at-risk of developing complex needs; and/or (3) Professional specialist interventions provided to those with a high level of complex needs. Outcome measures were synthesized according to core outcomes established for evaluating bereavement support for adults who have lost other adults to illness. Results Three studies of ICU bereavement interventions from 31 ICUs across 26 hospitals were included. One trial examining the effect of family presence at brain death assessment integrated all three categories of support but did not report significant improvement in emotional or psychological distress. Two other trials assessed a condolence letter intervention, which did not decrease grief symptoms and may have increased symptoms of depression and post-traumatic stress disorder, and a storytelling intervention that found no significant improvements in anxiety, depression, post-traumatic stress, or complicated grief. Four of nine core bereavement outcomes were not assessed anytime in follow-up. Conclusions Currently available trial evidence is sparse and does not support the use of bereavement interventions for informal caregivers of critically ill patients who die in the ICU.
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    Canadian in-hospital mortality for patients with emergency-sensitive conditions: a retrospective cohort study
    (2019-10-22) Berthelot, Simon; Lang, Eddy S; Quan, Hude; Stelfox, Henry T
    Abstract Background The emergency department (ED) sensitive hospital standardized mortality ratio (ED-HSMR) measures risk-adjusted mortality for patients admitted to hospital with conditions for which ED care may improve health outcomes. This study aimed to describe in-hospital mortality across Canadian provinces using the ED-HSMR. Methods Hospital discharge data were analyzed from April 2009 to March 2012. The ED-HSMR was calculated as the ratio of observed deaths among patients with emergency-sensitive conditions in a hospital during a year (2010–11 or 2011–12) to the expected deaths for the same patients during the reference year (2009–10), multiplied by 100. The expected deaths were estimated using predictive models fitted from the reference year. Aggregated provincial ED-HSMR values were calculated. A HSMR value above or below 100 respectively means that more or fewer deaths than expected occurred within a province. Results During the study period, 1,335,379 patients were admitted to hospital in Canada with an emergency-sensitive condition as the most responsible diagnosis. More in-hospital deaths (95% confidence interval) than expected were respectively observed for the years 2010–11 and 2011–12 in Newfoundland [124.3 (116.3–132.6); & 117.6 (110.1–125.5)] and Nova Scotia [116.4 (110.7–122.5) & 108.7 (103.0–114.5)], while mortality was as expected in Prince Edward Island [99.9 (86.5–114.8) & 100.7 (87.5–115.3)] and Manitoba [99.2 (94.5–104.1) & 98.3 (93.5–103.3)], and less than expected in all other provinces and territories. Conclusions Our study revealed important variation in risk-adjusted mortality for patients admitted to hospital with emergency-sensitive conditions among Canadian provinces. The ED-HSMR may be a useful outcome indicator to complement existing process indicators in measuring ED performance. Trial registration N/A – Retrospective cohort study.
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    Challenges and potential solutions to the evaluation, monitoring, and regulation of surgical innovations
    (2019-08-27) Roberts, Derek J; Zygun, David A; Ball, Chad G; Kirkpatrick, Andrew W; Faris, Peter D; James, Matthew T; Mrklas, Kelly J; Hemmelgarn, Brenda D; Manns, Braden; Stelfox, Henry T
    Abstract Background As it may be argued that many surgical interventions provide obvious patient benefits, formal, staged assessment of the efficacy and safety of surgical procedures has historically been and remains uncommon. The majority of innovative surgical procedures have therefore often been developed based on anatomical and pathophysiological principles in an attempt to better manage clinical problems. Main Body In this manuscript, we sought to review and contrast the models for pharmaceutical and surgical innovation in North America, including their stages of development and methods of evaluation, monitoring, and regulation. We also aimed to review the present structure of academic surgery, the role of methodological experts and funding in conducting surgical research, and the current system of regulation of innovative surgical procedures. Finally, we highlight the influence that evidence and surgical history, education, training, and culture have on elective and emergency surgical decision-making. The above discussion is used to support the argument that the model used for assessment of innovative pharmaceuticals cannot be applied to that for evaluating surgical innovations. It is also used to support our position that although the evaluation and monitoring of innovative surgical procedures requires a rigorous, fit-for-purpose, and formal system of assessment to protect patient safety and prevent unexpected adverse health outcomes, it will only succeed if it is supported and championed by surgical practice leaders and respects surgical history, education, training, and culture. Conclusion We conclude the above debate by providing a recommended approach to the evaluation, monitoring, and regulation of surgical innovations, which we hope may be used as a guide for all stakeholders involved in interpreting and/or conducting future surgical research.
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    Correction to: Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial
    (2020-03-19) Benzies, Karen M; Shah, Vibhuti; Aziz, Khalid; Isaranuwatchai, Wanrudee; Palacio-Derflingher, Luz; Scotland, Jeanne; Larocque, Jill; Mrklas, Kelly; Suter, Esther; Naugler, Christopher; Stelfox, Henry T; Chari, Radha; Lodha, Abhay
    After publication of our article [1], the authors have reported mathematical errors made in the sample size calculation for this cluster randomized controlled trial (cRCT) (Benzies et al. 2017).
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    Deidentified dataset from Time spent formatting research manuscripts for submission annually
    (2018-10-21) Fiest, Kirsten M; Stelfox, Henry T
    Data from journals studied to determine how long it takes to complete the formatting and submission process. No patient data is in this dataset. Data was generated by two research assistants who timed how long it took them to format and submit papers for publication to the top 10 general internal medicine journals. Other data came from publicly available websites.
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    Describing organ dysfunction in the intensive care unit: a cohort study of 20,000 patients
    (2019-05-23) Soo, Andrea; Zuege, Danny J; Fick, Gordon H; Niven, Daniel J; Berthiaume, Luc R; Stelfox, Henry T; Doig, Christopher J
    Abstract Background Multiple organ dysfunction is a common cause of morbidity and mortality in intensive care units (ICUs). Original development of the Sequential Organ Failure Assessment (SOFA) score was not to predict outcome, but to describe temporal changes in organ dysfunction in critically ill patients. Organ dysfunction scoring may be a reasonable surrogate outcome in clinical trials but further exploration of the impact of case mix on the temporal sequence of organ dysfunction is required. Our aim was to compare temporal changes in SOFA scores between hospital survivors and non-survivors. Methods We performed a population-based observational retrospective cohort study of critically ill patients admitted from January 1, 2004, to December 31, 2013, to 4 multisystem adult intensive care units (ICUs) in Calgary, Canada. The primary outcome was temporal changes in daily SOFA scores during the first 14 days of ICU admission. SOFA scores were modeled between hospital survivors and non-survivors using generalized estimating equations (GEE) and were also stratified by admission SOFA (≤ 11 versus > 11). Results The cohort consisted of 20,007 patients with at least one SOFA score and was mostly male (58.2%) with a median age of 59 (interquartile range [IQR] 44–72). Median ICU length of stay was 3.5 (IQR 1.7–7.5) days. ICU and hospital mortality were 18.5% and 25.5%, respectively. Temporal change in SOFA scores varied by survival and admission SOFA score in a complicated relationship. Area under the receiver operating characteristic (ROC) curve using admission SOFA as a predictor of hospital mortality was 0.77. The hospital mortality rate was 5.6% for patients with an admission SOFA of 0–2 and 94.4% with an admission SOFA of 20–24. There was an approximately linear increase in hospital mortality for SOFA scores of 3–19 (range 8.7–84.7%). Conclusions Examining the clinical course of organ dysfunction in a large non-selective cohort of patients provides insight into the utility of SOFA. We have demonstrated that hospital outcome is associated with both admission SOFA and the temporal rate of change in SOFA after admission. It is necessary to further explore the impact of additional clinical factors on the clinical course of SOFA with large datasets.
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    Developing a framework to guide the de-adoption of low-value clinical practices in acute care medicine: a study protocol
    (2017-01-19) Parsons Leigh, Jeanna; Niven, Daniel J; Boyd, Jamie M; Stelfox, Henry T
    Abstract Background Healthcare systems have difficulty incorporating scientific evidence into clinical practice, especially when science suggests that existing clinical practices are of low-value (e.g. ineffective or harmful to patients). While a number of lists outlining low-value practices in acute care medicine currently exist, less is known about how best to initiate and sustain the removal of low-value clinical practices (i.e. de-adoption). This study will develop a comprehensive list of barriers and facilitators to the de-adoption of low-value clinical practices in acute care facilities to inform the development of a framework to guide the de-adoption process. Methods The proposed project is a multi-stage mixed methods study to develop a framework to guide the de-adoption of low-value clinical practices in acute care medicine that will be tested in a representative sample of acute care settings in Alberta, Canada. Specifically, we will: 1) conduct a systematic review of the de-adoption literature to identify published barriers and facilitators to the de-adoption of low-value clinical practices in acute care medicine and any associated interventions proposed (Phase one); 2) conduct focus groups with acute care stakeholders to identify important themes not published in the literature and obtain a comprehensive appreciation of stakeholder perspectives (Phase two); 3) extend the generalizability of focus group findings by conducting individual stakeholder surveys with a representative sample of acute care providers throughout the province to determine which barriers and facilitators identified in Phases one and two are most relevant in their clinical setting (Phase three). Identified barriers and facilitators will be catalogued and integrated with targeted interventions in a framework to guide the process of de-adoption in each of four targeted areas of acute care medicine (Emergency Medicine, Cardiovascular Health and Stroke, Surgery and Critical Care Medicine). Analyses will be descriptive using a combination of qualitative and quantitative analyses. Discussion There is a growing body of literature suggesting that the de-adoption of ineffective or harmful practices from patient care is integral to the delivery of high quality care and healthcare sustainability. The framework developed in this study will map barriers and facilitators to de-adoption to the most appropriate interventions, allowing stakeholders to effectively initiate, execute and sustain this process in an evidence-based manner.
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    Development of the major trauma case review tool
    (2017-02-28) Curtis, Kate; Mitchell, Rebecca; McCarthy, Amy; Wilson, Kellie; Van, Connie; Kennedy, Belinda; Tall, Gary; Holland, Andrew; Foster, Kim; Dickinson, Stuart; Stelfox, Henry T
    Abstract Background As many as half of all patients with major traumatic injuries do not receive the recommended care, with variance in preventable mortality reported across the globe. This variance highlights the need for a comprehensive process for monitoring and reviewing patient care, central to which is a consistent peer-review process that includes trauma system safety and human factors. There is no published, evidence-informed standardised tool that considers these factors for use in adult or paediatric trauma case peer-review. The aim of this research was to develop and validate a trauma case review tool to facilitate clinical review of paediatric trauma patient care in extracting information to facilitate monitoring, inform change and enable loop closure. Methods Development of the trauma case review tool was multi-faceted, beginning with a review of the trauma audit tool literature. Data were extracted from the literature to inform iterative tool development using a consensus approach. Inter-rater agreement was assessed for both the pilot and finalised versions of the tool. Results The final trauma case review tool contained ten sections, including patient factors (such as pre-existing conditions), presenting problem, a timeline of events, factors contributing to the care delivery problem (including equipment, work environment, staff action, organizational factors), positive aspects of care and the outcome of panel discussion. After refinement, the inter-rater reliability of the human factors and outcome components of the tool improved with an average 86% agreement between raters. Discussion This research developed an evidence-informed tool for use in paediatric trauma case review that considers both system safety and human factors to facilitate clinical review of trauma patient care. Conclusions This tool can be used to identify opportunities for improvement in trauma care and guide quality assurance activities. Validation is required in the adult population.
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    Engaging patients in de-implementation interventions to reduce low-value clinical care: a systematic review and meta-analysis
    (2020-05-08) Sypes, Emma E; de Grood, Chloe; Whalen-Browne, Liam; Clement, Fiona M; Parsons Leigh, Jeanna; Niven, Daniel J; Stelfox, Henry T
    Abstract Background Many decisions regarding health resource utilization flow through the patient-clinician interaction. Thus, it represents a place where de-implementation interventions may have considerable effect on reducing the use of clinical interventions that lack efficacy, have risks that outweigh benefits, or are not cost-effective (i.e., low-value care). The objective of this systematic review with meta-analysis was to determine the effect of de-implementation interventions that engage patients within the patient-clinician interaction on use of low-value care. Methods MEDLINE, EMBASE, and CINAHL were searched from inception to November 2019. Gray literature was searched using the CADTH tool. Studies were screened independently by two reviewers and were included if they (1) described an intervention that engaged patients in an initiative to reduce low-value care, (2) reported the use of low-value care with and without the intervention, and (3) were randomized clinical trials (RCTs) or quasi-experimental designs. Studies describing interventions solely focused on clinicians or published in a language other than English were excluded. Data was extracted independently in duplicate and pertained to the low-value clinical intervention of interest, components of the strategy for patient engagement, and study outcomes. Quality of included studies was assessed using the Cochrane Risk of Bias tool for RCTs and a modified Downs and Black checklist for quasi-experimental studies. Random effects meta-analysis (reported as risk ratio, RR) was used to examine the effect of de-implementation interventions on the use of low-value care. Results From 6736 unique citations, 9 RCTs and 13 quasi-experimental studies were included in the systematic review. Studies mostly originated from the USA (n = 13, 59%), targeted treatments (n = 17, 77%), and took place in primary care (n = 10, 45%). The most common intervention was patient-oriented educational material (n = 18, 82%), followed by tools for shared decision-making (n = 5, 23%). Random effects meta-analysis demonstrated that de-implementation interventions that engage patients within the patient-clinician interaction led to a significant reduction in low-value care in both RCTs (RR 0.74; 95% CI 0.66–0.84) and quasi-experimental studies (RR 0.61; 95% CI 0.43–0.87). There was significant inter-study heterogeneity; however, intervention effects were consistent across subgroups defined by low-value practice and patient-engagement strategy. Conclusions De-implementation interventions that engage patients within the patient-clinician interaction through patient-targeted educational materials or shared decision-making tools are effective in decreasing the use of low-value care. Clinicians and policymakers should consider engaging patients within initiatives that seek to reduce low-value care. Registration Open Science Framework (https://osf.io/6fsxm)
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    Experiences and management of physician psychological symptoms during infectious disease outbreaks: a rapid review
    (2021-02-10) Fiest, Kirsten M; Parsons Leigh, Jeanna; Krewulak, Karla D; Plotnikoff, Kara M; Kemp, Laryssa G; Ng-Kamstra, Joshua; Stelfox, Henry T
    Abstract Background Prior to the COVID-19 pandemic, physicians experienced unprecedented levels of burnout. The uncertainty of the ongoing COVID-19 pandemic along with increased workload and difficult medical triage decisions may lead to a further decline in physician psychological health. Methods We searched Medline, EMBASE, and PsycINFO for primary research from database inception (Medline [1946], EMBASE [1974], PsycINFO [1806]) to November 17, 2020. Titles and abstracts were screened by one of three reviewers and full-text article screening and data abstraction were conducted independently, and in duplicate, by three reviewers. Results From 6223 unique citations, 480 articles were reviewed in full-text, with 193 studies (of 90,499 physicians) included in the final review. Studies reported on physician psychological symptoms and management during seven infectious disease outbreaks (severe acute respiratory syndrome [SARS], three strains of Influenza A virus [H1N1, H5N1, H7N9], Ebola, Middle East respiratory syndrome [MERS], and COVID-19) in 57 countries. Psychological symptoms of anxiety (14.3–92.3%), stress (11.9–93.7%), depression (17–80.5%), post-traumatic stress disorder (13.2–75.2%) and burnout (14.7–76%) were commonly reported among physicians, regardless of infectious disease outbreak or country. Younger, female (vs. male), single (vs. married), early career physicians, and those providing direct care to infected patients were associated with worse psychological symptoms. Interpretation Physicians should be aware that psychological symptoms of anxiety, depression, fear and distress are common, manifest differently and self-management strategies to improve psychological well-being exist. Health systems should implement short and long-term psychological supports for physicians caring for patients with COVID-19.
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    Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial
    (2017-10-10) Benzies, Karen M; Shah, Vibhuti; Aziz, Khalid; Isaranuwatchai, Wanrudee; Palacio-Derflingher, Luz; Scotland, Jeanne; Larocque, Jill; Mrklas, Kelly; Suter, Esther; Naugler, Christopher; Stelfox, Henry T; Chari, Radha; Lodha, Abhay
    Abstract Background Every year, about 15 million of the world’s infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [320/7] to 336/7 weeks) and late preterm (340/7 to 366/7 weeks), and require care in a Level II NICU. Preterm birth and experiences in the NICU disrupt early parent-infant relationships and induce parental psychosocial distress. Family Integrated Care (FICare) shows promise as a model of care in Level III NICUs. The purpose of this study is to evaluate length of stay, infant and maternal clinical outcomes, and costs following adaptation and implementation of FICare in Level II NICUs. Methods We will conduct a pragmatic, cluster randomized controlled trial (cRCT) in ten Alberta Level II NICUs allocated to one of two groups: FICare or standard care. The FICare Alberta model involves three theoretically-based, standardized components: information sharing, parenting education, and family support. Our sample size of 181 mother-infant dyads per group is based on the primary outcome of NICU length of stay, 80% participation, and 80% retention at follow-up. Secondary outcomes (e.g., infant clinical outcomes and maternal psychosocial distress) will be assessed shortly after admission to NICU, at discharge and 2 months corrected age. We will conduct economic analysis from two perspectives: the public healthcare payer and society. To understand the utility, acceptability, and impact of FICare, qualitative interviews will be conducted with a subset of mothers at the 2-month follow-up, and with hospital administrators and healthcare providers near the end of the study. Discussion Results of this pragmatic cRCT of FICare in Alberta Level II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare. Trial registration ClinicalTrials.gov, ID: NCT02879799 . Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.