Preliminary clinical testing to inform development of the Critical Care Pain Observation Tool for Families (CPOT-Fam).

Introduction: Many patients in the intensive care unit (ICU) cannot communicate. For these patients, family caregivers (family members/close friends) could assist in pain assessment. We previously adapted the Critical Care Pain Observation Tool (CPOT) for family caregiver use (CPOT-Fam). In this study, we conducted preliminary clinical evaluation of the CPOT-Fam to inform further tool development. Methods: For preliminary testing, we collected (1) pain assessments of patients in the ICU from family caregivers (CPOT-Fam) and nurses (CPOT) and determined the degree of agreement (kappa coefficient, κ) and (2) collected openended feedback on the CPOT-Fam from family caregivers. For refinement, we used preliminary testing data to refine the CPOT-Fam with a multidisciplinary working group. Results: We assessed agreement between family caregiver and nurse pain scores for 29 patients. Binary agreement (κ) between CPOT-Fam and CPOT item scores (scores ≥2 considered indicative of significant pain) was fair, κ = 0.43 (95% confidence interval [CI] 0.18-0.69). Agreement was highest for the CPOT-Fam items ventilator compliance/vocalization (weighted κ = 0.48, 95% CI 0.15-0.80) and lowest for muscle tension (weighted κ = 0.10, 95% [CI] -0.17 to 0.20). Most participants (n = 19; 69.0%) reported a very positive experience using the CPOT-Fam, describing it as "good" and "easy-to-use/clear/straightforward." We iteratively refined the CPOT-Fam over five cycles using the data collected until no further revisions were suggested. Conclusion: Our preliminary clinical testing suggests that family involvement in pain assessment in the ICU is well perceived. The CPOT-Fam has been further refined and is now ready for clinical pilot testing to determine its feasibility and acceptability.

Introduction: De nombreux patients de l'unité de soins intensifs (USI) ne peuvent pas communiquer. Pour cespatients, les aidants familiaux (membres de la famille/amis proches) pourraient aider à l'évaluation de la douleur. Nous avons précédemment adapté l'outil d'observation de la douleur en soins intensifs (CPOT) pour qu'il puisse être utilisé par des aidants familiaux (CPOTFam). Dans cette étude, nous avons mené une évaluation clinique préliminaire du CPOT-Fam afin d'éclairer davantage le développement de l'outil.Méthodes: Pour les tests préliminaires, nous avons recueilli (1) des évaluations de la douleur des patients en unité de soins intensifs auprès d'aidants familiaux (CPOT-Fam) et d'infirmières (CPOT) et déterminé le degré de concordance (coefficient de Kappa, κ) et (2) des commentaires ouverts sur le CPOT-Fam auprès d'aidants familiaux. Nous avons ensuite utilisé les données des tests préliminaires pour affiner le CPOT-Fam avec un groupe de travail multidisciplinaire.Résultats: Nous avons évalué la concordance entre les scores obtenus par des aidants familiaux et des infirmières pour les énoncés portant sur la douleur pour 29 patients. La concordance binaire (κ) entre les scores obtenus pour les énoncés du CPOT-Fam et du CPOT (un score ≥ 2 était considéré comme un indicateur de douleur importante) était passable, κ = 0,43 (intervalle de confiance à 95 % [IC] 0,18-0,69). La concordance était la plus élevée pour les énoncés du CPOT-Fam portant sur l'observance de la ventilation/vocalisation (κ pondéré = 0,48, IC à 95 % 0,15-0,80) et la plus faible pour la tension musculaire (κ pondéré = 0,10, 95% [IC] − 0,17 à 0,20). La plupart des participants (n = 19; 69,0 %) ont fait état d'une expérience très positive de l'utilisation du CPOT-Fam, le décrivant comme « bon ¼ et « facile à utiliser/clair/simple. ¼ Nous avons affiné le CPOT-Fam de manière itérative sur cinq cycles en utilisant les données recueillies jusqu'à ce qu'aucune autre révision ne soit suggérée.Conclusion: Nos tests cliniques préliminaires indiquent que la participation de la famille à l'évaluation de la douleur dans l'unité de soins intensifs est bien perçue. Le CPOT-Fam a été affiné et est maintenant prêt pour le test clinique pilote afin de déterminer sa faisabilité et son acceptabilité.

Family coaching during Spontaneous Awakening Trials and Spontaneous Breathing Trials (FamCAB): pilot study protocol.

INTRODUCTION: Many patients in the intensive care unit (ICU) require weaning from deep sedation (Spontaneous Awakening Trials, SATs) and mechanical ventilation (Spontaneous Breathing Trials, SBTs) in their journey to recovery. These procedures can be distressing for patients and their families. The presence of family members as 'coaches' during SATs/SBTs could provide patients with reassurance, reduce stress for patients and families and potentially improve procedural success rates. METHODS AND ANALYSIS: This study will be executed in two phases:Development of a coaching module: a working group including patient partners (i.e., former ICU patients or family members of former ICU patients), researchers, and ICU clinicians will develop an educational module on family coaching during SATs/SBTs (FamCAB). This module will provide families of critically ill patients basic information about SATs/SBTs as well as coaching guidance.Pilot testing: family members of ICU patients will complete the FamCAB module and provide information on: (1) demographics, (2) anxiety and (3) satisfaction with care in the ICU. Family members will then coach the patient through the next clinically indicated SATs and/or SBTs. Information around duration of time and success rates of SATs and/or SBTs (ability to conduct a complete assessment) alongside feedback will be collected. ICU clinical staff (including physicians and nurses) will be asked for feedback on practicality and perceived benefits or drawbacks of family coaching during these procedures. Feasibility and acceptability of family coaching in SATs/SBTs will be determined. DISCUSSION: The results of this work will inform whether a larger study to explore family coaching during SATs/SBTs is warranted. ETHICS AND DISSEMINATION: This study has received ethical approval from the University of Calgary Conjoint Health Research Ethics Board. Results from this pilot study will be made available via peer-reviewed journals and presented at critical care conferences on completion.

Development and preclinical testing of the critical care pain observation tool for family caregiver use (CPOT-Fam).

Background and Aims: Pain assessment in noncommunicative intensive care unit (ICU) patients is challenging. For these patients, family caregivers (i.e., family members, friends) may be able to assist in pain assessment by identifying individualistic signs of pain due to their intimate patient knowledge. This study adapted the critical care pain observation tool (CPOT) to facilitate pain assessment in adult ICU patients by family caregivers. Methods: This study was conducted through three distinct phases: (1)CPOT adaptation for family caregiver use (to create the CPOT-Fam): A working group met monthly to adapt the CPOT and develop educational material and sample cases for practice scoring until consensus was reached.(2)CPOT-Fam preclinical testing: Family caregiver study participants viewed educational materials and scored four randomly selected sample cases using the CPOT-Fam. Scores were compared to reference scores to assess agreement and identify CPOT-Fam sections requiring revision. Open-ended feedback on the CPOT-Fam was collected.(3)CPOT-Fam revision: the CPOT-Fam was revised by the working group considering score agreement and feedback received from study participants. Results: Of the n = 30 participants, n = 14 (47.0%) had experience with an ICU patient. Agreement between CPOT-Fam participant scores and reference scores were highest for the vocalization dimension (Is the patient making any sounds?; Intraclass correlation coefficient; ICC = 1.0) and lowest for the body movements dimension (What are the patient's body movements like?; ICC = 0.85. Participants indicated they found the CPOT-Fam to be "informative" and "easy-to-use" but "not graphic enough"; participants also indicated that descriptors like "lack of breath" and "struggling to move" are helpful with identifying individualistic behaviors of pain exhibited by their loved ones. Conclusion: The CPOT-Fam shows ease of use and may be of value in involving family caregivers in ICU care. Clinical pilot testing is needed to determine feasibility and acceptability and identify further areas for refinement.

A scoping review of methods to measure and evaluate citizen engagement in health research.

BACKGROUND: Citizen engagement, or partnering with interested members of the public in health research, is becoming more common. While ongoing assessment of citizen engagement practices is considered important to its success, there is little clarity around aspects of citizen engagement that are important to assess (i.e., what to look for) and methods to assess (i.e., how to measure and/ or evaluate) citizen engagement in health research. METHODS: In this scoping review, we included peer-reviewed literature that focused primarily on method(s) to measure and/or evaluate citizen engagement in health research. Independently and in duplicate, we completed title and abstract screening and full-text screening and extracted data including document characteristics, citizen engagement definitions and goals, and methods to measure or evaluate citizen engagement (including characteristics of these methods). RESULTS: Our search yielded 16,762 records of which 33 records (31 peer-reviewed articles, one government report, one conference proceeding) met our inclusion criteria. Studies discussed engaging citizens (i.e., patients [n = 16], members of the public [n = 7], service users/consumers [n = 4], individuals from specific disease groups [n = 3]) in research processes. Reported methods of citizen engagement measurement and evaluation included frameworks, discussion-based methods (i.e., focus groups, interviews), survey-based methods (e.g., audits, questionnaires), and other methods (e.g., observation, prioritization tasks). Methods to measure and evaluate citizen engagement commonly focused on collecting perceptions of citizens and researchers on aspects of citizen engagement including empowerment, impact, respect, support, and value. DISCUSSION AND CONCLUSION: We found that methods to measure and/or evaluate citizen engagement in health research vary widely but share some similarities in aspect of citizen engagement considered important to measure or evaluate. These aspects could be used to devise a more standardized, modifiable, and widely applicable framework for measuring and evaluating citizen engagement in research. PATIENT OR PUBLIC CONTRIBUTION: Two citizen team members were involved as equal partners in study design and interpretation of its findings. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework (10.17605/OSF.IO/HZCBR).

Involving members of the public (citizens) in health research is important. It helps make sure that research focuses on issues that are most important to citizens. It also helps ensure that the research done is respectful of citizen participation and most likely to provide benefit. However, the best way to engage citizens in research is unclear. In this scoping review, we examined existing studies that assessed citizen engagement in health research. We found that citizen engagement was often assessed by asking for feedback from both citizens and researchers. Feedback was collected in person (one on one interviews or group discussions) or in writing (using surveys or audits). Frameworks (organized ways of thinking about an issue) were also sometimes used to measure empowerment, impact, respect, support, and value of engaging citizens. It was clear from the frameworks that there is a need to develop clearer roles for citizens in research. The two citizen members of our research team who helped interpret our study findings felt that a set of guidelines for citizens to help them best participate in health research needs to be developed. We believe these observations could be used to create a more standard method for assessing citizen engagement in research.

Development and pilot implementation of a patient-oriented discharge summary for critically Ill patients.

BACKGROUND: Patients leaving the intensive care unit (ICU) often experience gaps in care due to deficiencies in discharge communication, leaving them vulnerable to increased stress, adverse events, readmission to ICU, and death. To facilitate discharge communication, written summaries have been implemented to provide patients and their families with information on medications, activity and diet restrictions, follow-up appointments, symptoms to expect, and who to call if there are questions. While written discharge summaries for patients and their families are utilized frequently in surgical, rehabilitation, and pediatric settings, few have been utilized in ICU settings. AIM: To develop an ICU specific patient-oriented discharge summary tool (PODS-ICU), and pilot test the tool to determine acceptability and feasibility. METHODS: Patient-partners (i.e., individuals with lived experience as an ICU patient or family member of an ICU patient), ICU clinicians (i.e., physicians, nurses), and researchers met to discuss ICU patients' specific informational needs and design the PODS-ICU through several cycles of discussion and iterative revisions. Research team nurses piloted the PODS-ICU with patient and family participants in two ICUs in Calgary, Canada. Follow-up surveys on the PODS-ICU and its impact on discharge were administered to patients, family participants, and ICU nurses. RESULTS: Most participants felt that their discharge from the ICU was good or better (n = 13; 87.0%), and some (n = 9; 60.0%) participants reported a good understanding of why the patient was in ICU. Most participants (n = 12; 80.0%) reported that they understood ICU events and impacts on the patient's health. While many patients and family participants indicated the PODS-ICU was informative and useful, ICU nurses reported that the PODS-ICU was "not reasonable" in their daily clinical workflow due to "time constraint". CONCLUSION: The PODS-ICU tool provides patients and their families with essential information as they discharge from the ICU. This tool has the potential to engage and empower patients and their families in ensuring continuity of care beyond ICU discharge. However, the PODS-ICU requires pairing with earlier discharge practices and integration with electronic clinical information systems to fit better into the clinical workflow for ICU nurses. Further refinement and testing of the PODS-ICU tool in diverse critical care settings is needed to better assess its feasibility and its effects on patient health outcomes.

Study protocol: development and pilot testing of the Critical Care Pain Observation Tool for families (CPOT-Fam).

BACKGROUND: Patients in the intensive care unit (ICU) often have limited ability to communicate making it more difficult to identify and effectively treat their pain. Family caregivers or close friends of critically ill patients may be able to identify signs of pain before the clinical care team and could potentially assist in routine pain assessments. This study will adapt the Critical Care Pain Observation Tool (CPOT) for use by family members to create the CPOT-Fam and compare family CPOT-Fam assessments with nurse-provided CPOT assessments for a given patient. METHODS: This study will be executed in two phases: 1) Development of the CPOT-Fam - A working group of patient partners, ICU clinicians, and researchers will adapt the CPOT for use by family caregivers (creating the CPOT-Fam) and produce an accompanying educational module to deliver information on pain and how to use the tool. The CPOT-Fam will undergo preclinical testing with participants (i.e., members of the public and family caregivers of critically ill adults), who will complete the educational module and provide CPOT-Fam scores on sample cases. Feedback on the CPOT-Fam will be collected. 2) Pilot testing the CPOT - Fam family caregivers of critically ill adults will complete the educational module and provide information on the following: (1) demographics, (2) anxiety, (3) caregiving self-efficacy, and (4) satisfaction with care in the ICU. Family caregivers will then provide a proxy assessment of their critically ill loved one's pain through the CPOT-Fam and also provide a subjective (i.e., questionnaire-based including open-ended responses) account of their loved one's pain status. A comparison (i.e., agreement) will be made between family caregiver provided CPOT-Fam scores and ICU nurse-provided CPOT scores (collected from the provincial health information system), calculated independently and blinded to one another. Feasibility and acceptability of the CPOT-Fam will be determined. DISCUSSION: The results of this work will produce a family caregiver CPOT (i.e., CPOT-Fam), determine feasibility and acceptability of the CPOT-Fam, and compare pain assessments conducted by family caregivers and ICU nurses. The results will inform whether a larger study to determine a role for family caregivers in ICU pain assessment using the CPOT-Fam is warranted.

Co-development of a transitions in care bundle for patient transitions from the intensive care unit: a mixed-methods analysis of a stakeholder consensus meeting.

BACKGROUND: Intensive care unit (ICU) patients undergoing transitions in care are at increased risk of adverse events and gaps in medical care. We evaluated existing patient- and family-centered transitions in care tools and identified facilitators, barriers, and implementation considerations for the application of a transitions in care bundle in critically ill adults (i.e., a collection of evidence-based patient- and family-centred tools to improve outcomes during and after transitions from the intensive care unit [ICU] to hospital ward or community). METHODS: We conducted a concurrent mixed methods (quan + QUAL) study, including stakeholders with experience in ICU transitions in care (i.e., patient/family partners, researchers, decision-makers, providers, and other knowledge-users). First, participants scored existing transitions in care tools using the modified Appraisal of Guidelines, Research and Evaluation (AGREE-II) framework. Transitions in care tools were discussed by stakeholders and either accepted, accepted with modifications, or rejected if consensus was achieved (≥70% agreement). We summarized quantitative results using frequencies and medians. Second, we conducted a qualitative analysis of participant discussions using grounded theory principles to elicit factors influencing AGREE-II scores, and to identify barriers, facilitators, and implementation considerations for the application of a transitions in care bundle. RESULTS: Twenty-nine stakeholders attended. Of 18 transitions in care tools evaluated, seven (39%) tools were accepted with modifications, one (6%) tool was rejected, and consensus was not reached for ten (55%) tools. Qualitative analysis found that participants' AGREE-II rankings were influenced by: 1) language (e.g., inclusive, balance of jargon and lay language); 2) if the tool was comprehensive (i.e., could stand alone); 3) if the tool could be individualized for each patient; 4) impact to clinical workflow; and 5) how the tool was presented (e.g., brochure, video). Participants discussed implementation considerations for a patient- and family-centered transitions in care bundle: 1) delivery (e.g., tool format and timing); 2) continuity (e.g., follow-up after ICU discharge); and 3) continuous evaluation and improvement (e.g., frequency of tool use). Participants discussed existing facilitators (e.g., collaboration and co-design) and barriers (e.g., health system capacity) that would impact application of a transitions in care bundle. CONCLUSIONS: Findings will inform future research to develop a transitions in care bundle for transitions from the ICU, co-designed with patients, families, providers, researchers, decision-makers, and knowledge-users.

Incorporating and evaluating citizen engagement in health research: a scoping review protocol.

BACKGROUND: Citizen engagement in research is an emerging practice that involves members of the general public in research processes such as priority setting, planning, decision-making, research conduct, implementation, evaluation, and dissemination. Engaging citizens in research, particularly health research, increases the relevance of study findings, minimizes waste by facilitating stewardship over resources, and builds public trust in the research. While several existing frameworks guide the application of citizen engagement principles to health research, it is unclear how citizen engagement can be utilized to maximize benefits and minimize risks and challenges in health research. To address the gaps in knowledge around citizen engagement in health research, we propose a scoping review to synthesize the state of knowledge on methods to incorporate and evaluate citizen engagement in research. A protocol is presented in this manuscript. METHODS: The methodology for our scoping review is guided by Arksey and O' Malley's framework for scoping reviews, and additional recommendations by Levac and colleagues. We will include peer-reviewed and gray literature that report on citizen engagement in health research (including biomedical, clinical, health systems and services, and social, cultural, environmental and population health) and report method(s) to conduct, measure, or evaluate citizen engagement. We will systematically search electronic databases (MEDLINE, EMBASE, CINAHL, JSTOR, PsycINFO, Scopus, and Science Direct) from inception onwards and search relevant organizations' websites for additional studies, frameworks, and reports on citizen engagement. Title and abstract and full-text citations will be screened independently and in duplicate. Data will be extracted independently and in duplicate, including document characteristics, citizen engagement definitions and goals, and outcomes of citizen engagement (e.g., barriers, facilitators). DISCUSSION: This review will synthesize the definitions, goals, methods, outcomes, and significance of citizen engagement in health research, as well as any potential barriers, facilitators, and challenges outlined in existing literature. The findings will provide an evidence-based foundation for developing new or improved guidance for citizen engagement in health research. Overall, we anticipate that our scoping review will be a preliminary step to meaningful engagement of citizens in research and strengthen the relationship between the scientific community and the public through transparency and collaboration. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework  https://osf.io/hzcbr .

Normoxic low-altitude simulation (at 714 mmHg) improves limb blood perfusion in mice with hindlimb ischemia.

Humans have fewer cardiovascular events and improved outcomes after cardiovascular events when living at low and moderate altitudes (<3000 m) above sea level. We have previously shown that low-altitude simulation using reductions in barometric pressure enhances vasodilation ex vivo in arterial segments and reduces systemic vascular resistance in vivo and can also improve left ventricular function after a myocardial infarction. We hypothesize that low-altitude simulation could also improve hindlimb ischemia, a model of peripheral artery disease in humans. We performed femoral artery ligation to generate hindlimb ischemia in 3-month-old C57BL6 mice. Control group mice (n = 10) recovered at 754 mmHg (control) for 14 days. Treatment group mice (n = 15) were placed in a low-altitude simulation chamber (at 714 mmHg) to recover from surgery for 3-hours daily for 14 days. Hindlimb perfusion imaging using a laser Doppler line scanner was performed for all mice prior to the surgery, and then on days 1, 3, 7, and 14 post-surgery. At 2 weeks, ischemic reserve was significantly higher in the treatment group mice (0.50 ± 0.13 vs. 0.20 ± 0.06; p = 0.01). Treatment mice had higher functional scores and were able to walk better at two weeks. There was approximately three times less HIF1α found via western blotting and a small but statistically significant improvement of lectin perfusion in calf tissue of treatment mice. We conclude that low-altitude simulation improves blood perfusion in murine hindlimb ischemia. This approach may have therapeutic implications for humans with peripheral artery disease.

Low altitude simulation without hypoxia improves left ventricular function after myocardial infarction by reducing ventricular afterload.

Humans have a lower risk of death from myocardial infarction (MI) living at low elevations (<2500 m), which are not high enough to induce hypoxia. Both chronic hypoxia pre-MI, achieved by altitude simulation >5000 m, and intermittent hypobaric hypoxia post-MI can reduce MI size in rodents, and it is believed that hypoxia is the key stimulus. To explore mechanisms beyond hypoxia we studied whether altitude simulation <2500 m would also be associated with reduced infarct size. We performed left-anterior descending artery ligation on C57BL6 mice. Control mice (n = 12) recovered at 754 mmHg (atmospheric pressure, control), and treatment group mice (n = 13) were placed in a hypobaric chamber to recover 3-hours daily at 714 mmHg for 1 week. Echocardiographic evaluation of left ventricular function was performed on Day 0, Day 1 and Day 8. Intermittent hypobaric treatment was associated with a 14.2±5.3% improvement in ejection fraction for treatment group mice (p<0.01 vs. Day 1), with no change observed in control mice. Cardiac output, stroke volume, and infarct size were also improved in treated mice, but no changes were observed in HIF-1 activation or neovascularization. Next, we studied the acute hemodynamic effects of low altitude stimulation in intact mice breathing 100% oxygen using left ventricular catheterization and recording of pressure-volume loops. Acute reductions in barometric pressure from 754 mmHg to 714 mmHg and 674 mmHg were associated with reduced systemic vascular resistance, increased stroke volume and cardiac output, and no change in blood pressure or heart rate. Ex-vivo vascular function was studied using murine mesenteric artery segments. Acute reductions in barometric pressure were associated with greater vascular distensibility. We conclude that intermittent hypobaric treatment using simulated altitudes <2500 m reduces infarct size and increases ventricular function post-MI, and that these changes are related to altered arterial function and not hypoxia-associated neovascularization.

A scoping review of interventions to promote the adoption of shared decision-making (SDM) among health care professionals in clinical practice.

OBJECTIVES: To identify and summarize evidence on interventions to promote the adoption of shared decision-making (SDM) among health care professionals (HCPs) in clinical practice. METHODS: Electronic databases including: MEDLINE, EMBASE, CINAHL, PsycINFO and Cochrane library were searched to determine eligible peer-reviewed articles. Grey literature was searched for additional interventions. Eligibility screening and data extraction were independently completed. Results are presented as written evidence summaries and tables. RESULTS: Our search yielded 238 articles that met our inclusion criteria. Interventions mostly targeted physicians (46%), had multiple educational modalities (46%), and were administered in group settings (44%) before the clinical encounter (71%). Very few were developed based on the learning needs of targeted HCPs (24%). Many of the SDM outcome tools used for evaluation were developed for the respective study and lacked evidence of validity and reliability (30%). CONCLUSION: We identified a sizable number of interventions to promote the adoption of SDM, however, these interventions were heterogeneous in their assessments for effectiveness and implementation. Therefore, it is a challenge to infer which strategies and practices are best to promote SDM adoption. PRACTICE IMPLICATIONS: The need for evidence-based standards for developing SDM interventions targeting HCPs and assessing acceptability, effectiveness and implementation is suggested.