Henry Thomas Stelfox

Many terms have been used to describe interventions that do not involve the use of pharmacological products in the setting of communicable diseases. Terminology has varied, and terms have included physical, non-pharmaceutical, non-drug, non-pharmacologic, and non-pharmacological interventions, as well as public health measures and public health and social measures. The recent COVID-19 pandemic has highlighted the importance of non-pharmacological interventions (NPIs), and the term is now recognized globally. The use of the terms public health measures or public health and social measures has variably been inclusive of the use of vaccines, which would be considered pharmacological products. Given this background and confusion over terminology and descriptions, we have reviewed this topic to provide clarity regarding nomenclature, taxonomy, and definitions, with the aim of ensuring an explicit shared understanding of any interventions that do not involve pharmacological products, given the importance of conducting NPI evaluations for future epidemics and pandemics.

Objectives: Health literacy, the ability to understand and use health information, is important for critically ill patients and their caregivers in the neonatal ICU (NICU), PICU, and adult ICU to make informed decisions and navigate complex care. This review aimed to identify and summarize tools used to assess health literacy in critically ill patients or their caregivers. Data Sources: We searched MEDLINE, Embase, CINAHL, and PsycINFO through July 24, 2025. Study Selection: Included articles reported on tools to assess health literacy in critically ill patients or their caregivers. Two reviewers independently performed screening and data extraction. Data Extraction: Two independent reviewers extracted data in Covidence. Data items included study characteristics (country in which the study was conducted, study funding, study setting) and health literacy tool characteristics (tool user, types of questions in the tool, method of tool administration, if the tool was created by the study team, and if a full version was available in the publication). Data Synthesis: We included 92 articles describing 84 health literacy tools. Tools measured: 1) topic-specific clinical knowledge (e.g., organ donation, cardiopulmonary resuscitation; n = 24/84, 29%; NICU: n = 9; PICU: n = 1; ICU: n = 14); 2) ICU prognosis, diagnosis, and treatment ( n = 23/84, 27%; NICU: 6; PICU: 3; ICU: n = 15); 3) neonatal and parenting ( n = 13/84, 15%; all NICU); 4) general health literacy abilities ( n = 11/84, 13%; NICU: n = 6; PICU: n = 2; ICU: n = 7); 5) information needs ( n = 4/84, 5%; NICU: n = 1; PICU: n = 0; ICU: n = 3); 6) readiness for discharge ( n = 3/84, 4%; all NICU); 7) decision-making ( n = 3/84, 4%; all NICU); 8) health-related behaviors ( n = 2/84, 2%; NICU: n = 1; ICU: n = 1); and 9) research participation ( n = 1/84, 1%; NICU). Conclusions: Although several health literacy tools exist, they often focus on individual knowledge of specific aspects of ICU care, with less attention to how understanding is produced within the clinical context through interactions among patients, caregivers, and healthcare providers. This may limit their ability to reflect how health literacy functions in critical illness. Assessment of health literacy requires pairing the appropriate tools with interaction-focused approaches to guide communication and support informed decision-making in ICU settings.

Background: Reproducible study findings are those that are shown to be identical or nearly identical when an original study is repeated using similar methods. Findings from many randomized controlled trials (RCTs) in cardiovascular surgery have not been reproduced or are small, statistically fragile, and potentially influenced by funding source. They also demonstrate variable end point selection and protocol adherence, all of which may influence reproducibility of their reported results. Objective: This study aims to assess the reproducibility of RCTs conducted in the most commonly studied disease states in cardiovascular surgery that compared at least one open surgical procedure to an alternative open, interventional catheter-based, or sham procedure or medical therapy. Methods: We will conduct a meta-epidemiological study of the reproducibility of RCTs using umbrella review methodology. We designed the study protocol using the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) statement and published recommendations on conducting umbrella reviews. We will search MEDLINE, Embase, and the CENTRAL from their inception for systematic reviews published in the English language that included data from phase 3 RCTs or those with a clinically important primary outcome and compared an open cardiovascular surgery (performed in the most commonly studied disease states across these specialties) to either an alternative open, catheter-based, or sham procedure or medical therapy. Two investigators will independently review the individual RCTs from these systematic reviews and extract data and assess risk of bias (using the Cochrane Risk of Bias-2 tool), the fragility or reverse fragility indices (which provide a measurement of the statistical robustness of the trials), and the authors’ interpretation of the results (also referred to as spin). RCTs will be classified as the original study if it was the first chronological study (based on participant enrollment date) to evaluate the compared interventions and as reproduction attempts if they reevaluate the compared interventions in a different set of participants. The interpretation of a study’s results will be based on the findings of its primary end point and be used to assess reproducibility. We will also create multivariable regression models to determine whether the adjusted odds of reproducibility are independently predicted by 12 different variables. Results: We registered the study protocol but have not yet conducted the search. We aim to complete the study by the end of 2026 and submit for peer review by the summer of 2027. Conclusions: This study protocol may be used as a framework for future reproducibility research. The results will help guide which cardiovascular surgery practices warrant careful interpretation and which are in need of reproduction studies. They will also identify characteristics of an original RCT in this field that predicts future study reproducibility before reproducibility studies are published.

Family caregivers (e.g., family members, friends) can recognize behaviors signifying the presence or severity of pain in their loved ones.1,2 This ability can be valuable in the intensive care unit...

Background: Family caregivers (i.e., family members, close friends) may be able to help assess pain in intensive care unit (ICU) patients. However, suitable methods for family caregivers to assess pain in the ICU have yet to be identified. Aim: To evaluate the feasibility and acceptability of independently collecting patient and family caregiver assessments of patient pain and to determine agreement between pain scores. Study Design: Adult patients who could communicate pain ratings and their family caregivers (creating patient–family caregiver dyads) from a single ICU in Calgary, Alberta, Canada were asked to simultaneously provide independent (unaware of the other's response) assessments of the patient's pain (beginning 4 January 2023) using: (1) a yes/no response on the presence of pain, (2) pain intensity on the Numerical Rating Scale, and (3) open text descriptions of pain. The feasibility of obtaining pain assessments from dyads was determined by the percent of dyads recruited compared to dyads approached. Acceptability was determined by calculating completion rates of dyads in this study. Cohen's kappa ( κ ) and intraclass correlation coefficients (ICC) [95% confidence intervals] were used to determine inter‐dyad agreement. Results: Of 458 patients admitted to the study ICU during the recruitment period, 45 dyads were approached for participation. Thirty‐four dyads (75.6%) consented (feasibility outcome) and completed (100%) the study (acceptability outcome). Agreement was moderate between yes/no pain responses ( κ = 0.45 [0.16–0.76]) and good between patient and family caregiver Numerical Pain Scale scores (ICC = 0.75 [0.56–0.87]). Of the 18 dyads who provided open text descriptions of the pain, 13 (72.2%) were similar for patients and family caregivers. Conclusions: Collecting independent, simultaneous pain assessments from patient–family caregiver dyads in the ICU appears feasible and acceptable, and family caregivers appear to provide good proxy reports of the patient's pain. Relevance to Clinical Practice: Family caregiver involvement in pain assessment in the ICU may have the potential to complement clinical pain assessment in select contexts, particularly for patients who are unable to communicate, although further research is needed.

OBJECTIVES (BACKGROUND): Families play an important role in the care of ICU patients, yet their potential to contribute to the detection of delirium—a common and harmful complication—is often underutilized. This study aimed to adapt the Sour Seven to create the Family ICU Delirium Detection Instrument (FIDDI) and to assess its usability, reliability, and construct validity for delirium detection in ICU patients. DESIGN: Cross-sectional. SETTING: Canadian closed 34-bed general systems adult ICU providing tertiary level care. PARTICIPANTS: Patient-family pairs (dyads) were included. Eligible patients had no primary brain injury, a Richmond Agitation-Sedation Scale score of greater than or equal to –3 and were expected to remain in the ICU for at least 24 hours to complete all study assessments. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: The Sour Seven underwent adaptation using data from the Family ICU Delirium Detection Study and input from a multidisciplinary working group. The FIDDI was then tested for internal consistency using Cronbach’s alpha and construct validity through confirmatory factor analysis. Family members provided feedback through surveys on the tool’s usability and their experience with delirium detection. We enrolled 51 patient and family member pairs. Most family members were women ( n = 38, 75%), including spouses ( n = 17, 33%), adult children ( n = 16, 31%), or siblings ( n = 10, 20%). The FIDDI showed strong internal consistency (Cronbach’s alpha = 0.858). The model fit indices indicated acceptable structure validity (Tucker-Lewis index [TLI] = 1.015, comparative fit index = 1.000, root mean square error of approximation = 0.000, and standardized root mean residual = 0.044). Family members reported that the tool was easy to use and helpful for understanding delirium, although some attributed behavioral changes to medical treatments or clinical conditions, highlighting the need for further education on delirium. CONCLUSIONS: The Sour Seven was successfully adapted for the ICU environment (FIDDI) and pre-tested, demonstrating reliability and construct validity for detecting delirium in the ICU. These findings support its potential as a family-engaged assessment tool. Further research is needed to test the value of the FIDDI relative to current delirium detection strategies.

International reports highlight important impacts of the COVID-19 pandemic on the wellbeing of youth. There is limited knowledge of the experiences and per

OBJECTIVES (BACKGROUND): Delirium remains frequently undetected by healthcare providers; partnering with family may be a novel way to identify and manage delirium. This study explores the feasibility of a family-administered intervention for delirium prevention, detection, and management. DESIGN: Pilot randomized controlled trial. SETTING: Two Canadian ICUs. SUBJECTS: Patient-family pairs (dyads) were included. Eligible patients had no primary brain injury, a Richmond Agitation-Sedation Scale score of greater than or equal to –3, and were expected to remain in the ICU for at least 24 hours to complete all study assessments. INTERVENTIONS: Dyads were randomly assigned to either standard care (control) or the intervention, which included delirium education and family-administered checklists with prevention/management strategies and a detection tool (“Sour Seven”). MEASUREMENTS AND MAIN RESULTS: Outcomes included feasibility indicators, enrollment and completion rates, and psychological outcomes (Generalized Anxiety Disorder-7, Patient Health Questionnaire-9, and the Kessler Psychologic Distress (K-10) scales in the ICU and at 1- and 3-month follow-ups. Between January 2020 and June 2023, during the height of the COVID pandemic, 197 patient–family pairs were approached, with 64 (32%) consenting to participate; participation required both the patient and a family member. Despite recruitment challenges, 75% of families completed in-ICU questionnaires, and 38% completed all follow-ups. The family members in the intervention group demonstrated increased delirium knowledge compared with baseline delirium knowledge, and engagement in prevention strategies, with 8 of 19 (42%) family members identifying delirium using the Sour Seven. At the 3-month follow-up, seven family members showed significant anxiety, and five showed significant depression. Observations of ICU rounds revealed limited delirium discussions. CONCLUSIONS: This pilot study demonstrated the feasibility of family-administered delirium care in ICU settings. However, the likely impact of the COVID-19 pandemic cannot be overlooked. The study faced recruitment challenges and demonstrated the difficulties of family involvement in delirium care, particularly during restricted family presence. A full evaluation of effectiveness requires a hypothesis-testing trial with procedural adjustments to streamline data collection and strengthen family-care team partnerships. TRIAL REGISTRATION: Clinicaltrials.gov (NCT04099472).

Background: ICU patients are weaned from sedation and mechanical ventilation through spontaneous awakening trials (SATs) and spontaneous breathing trials (SBTs). Weaning can be distressing for patients and their families. Family-led coaching could reassure patients and reduce stress for families by engaging them in patient care. This study developed and piloted a family-led coaching tool to support patients undergoing SATs/SBTs. Methods: Patient and family member dyads were recruited from 2 medical-surgical ICUs in Calgary, Canada (February 3–August 1, 2023). Surveys were administered to collect family (1) demographics, (2) anxiety and satisfaction with ICU care, (3) feedback on the tool, and (4) attitudes about family presence during SATs/SBTs (also collected from clinicians). Tool feasibility was determined by calculating the proportions of (1) eligible patients who were recommended for participation in the study by clinicians and (2) families approached who consented to participate in the study. Results: One thousand one hundred fifty patients were admitted to the study ICUs during the study period of which 819 received mechanical ventilation, and 42 were recommended by bedside clinicians for participation in the study. Twenty-five dyads were approached, 21 dyads consented to participate, and one withdrew consent before data collection. Of the enrolled families, 12 (60%) reported the coaching tool to be useful, and 5 (25%) recommended minor suggestions such as “shortening” the tool. Fourteen (70%) families reported positive experiences (through open-ended feedback) with being present for the SAT/SBT. State-Trait Anxiety Inventory (Y1) scores (scale range 20–80 points) significantly decreased in families from the first (pre coaching) to the second (post coaching) measures (mean decrease 8.2 points, SD 10.3, P = .001). All clinicians indicated they were comfortable with family presence and/or coaching during SATs/SBTs. Conclusion: Family-led coaching of patients during SATs/SBTs appears to be feasible, favorably perceived by families and clinicians, and potentially associated with lower family anxiety.