Interrater Agreement between Bedside and Video Raters Using the CPOT-Neuro for Pain Assessment in Critically Ill Patients with a Brain Injury.

This study aimed to examine the interrater agreement of Critical-Care Pain Observation Tool-Neuro (CPOT-Neuro) scores as a newly developed tool for pain assessment in patients with critical illness and brain injury between raters using two methods of rating (bedside versus video) during standard care procedures (i.e., non-invasive blood pressure and turning). The bedside raters were research staff, and the two video raters had different backgrounds (health and non-health disciplines). Raters received standardized 45 min training by the principal investigator. Video recordings of 56 patient participants with a brain injury at different levels of consciousness were included. Interrater agreement was supported with an Intraclass Correlation Coefficient (ICC) > 0.65 for all pairs of raters and for each procedure. Interrater agreement was highest during turning in the conscious group, with ICCs ranging from 0.79 to 0.90. The use of video recordings was challenging for the observation of some behaviors (i.e., tearing, face flushing), which were influenced by factors such as lighting and the angle of the camera. Ventilator alarms were also challenging to distinguish from other sources for the video rater from a non-health discipline. Following standardized training, video technology was useful in achieving an acceptable interrater agreement of CPOT-Neuro scores between bedside and video raters for research purposes.

Level of implementation of pain management and early mobilization strategies to prevent delirium in geriatric trauma patients: A mixed-methods study.

BACKGROUND: Pain management and early mobilization strategies are recommended in clinical practice guidelines for the prevention of delirium in older adults. However, available data on the implementation of these strategies in trauma are limited. AIMS: To describe the use of pain management and early mobilization strategies in older adults at a level I trauma center, as well as the facilitators and barriers to their implementation. METHODS: A convergent mixed methods study was used. Quantitative data were collected from sixty medical records. Qualitative data was collected through a focus group with healthcare providers to explore their perspectives regarding the use of the target practices and on barriers and facilitators to their implementation. Descriptive statistics were calculated, and a thematic analysis using an inductive and deductive interpretative descriptive approach was undertaken. RESULTS: A question on the presence/absence of pain was the most frequently documented pain assessment method. Pain assessment was poorly documented. Frequencies of non-opioid and opioid administrations were similar, but non-pharmacological strategies were not widely used. The first mobilization was performed quickly and was most commonly to a chair. The focus group discussion confirmed many of the data collected in the medical records. Barriers to implementing the targeted strategies were primarily related to organizational context and facilitation processes. CONCLUSIONS: Areas for improvement were identified including pain assessment, the use of non-pharmacological pain management strategies and ambulation as a mobilization strategy. Our findings will serve as a starting point for optimizing and adapting practices for geriatric trauma patients and evaluating their impact.

Relationship Between Pain and Delirium in Critically Ill Adults.

OBJECTIVES: Although opioids are frequently used to treat pain, and are an important risk for ICU delirium, the association between ICU pain itself and delirium remains unclear. We sought to evaluate the relationship between ICU pain and delirium. DESIGN: Prospective cohort study. SETTING: A 32-bed academic medical-surgical ICU. PATIENTS: Critically ill adults (n = 4,064) admitted greater than or equal to 24 hours without a condition hampering delirium assessment. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Daily mental status was classified as arousable without delirium, delirium, or unarousable. Pain was assessed six times daily in arousable patients using a 0-10 Numeric Rating Scale (NRS) or the Critical Care Pain Observation Tool (CPOT); daily peak pain score was categorized as no (NRS = 0/CPOT = 0), mild (NRS = 1-3/CPOT = 1-2), moderate (NRS = 4-6/CPOT = 3-4), or severe (NRS = 7-10/CPOT = 5-8) pain. To address missingness, a Multiple Imputation by Chained Equations approach that used available daily pain severity and 19 pain predictors was used to generate 25 complete datasets. Using a first-order Markov model with a multinomial logistic regression analysis, that controlled for 11 baseline/daily delirium risk factors and considered the competing risks of unarousability and ICU discharge/death, the association between peak daily pain and next-day delirium in each complete dataset was evaluated. RESULTS: Among 14,013 ICU days (contributed by 4,064 adults), delirium occurred on 2,749 (19.6%). After pain severity imputation on 1,818 ICU days, mild, moderate, and severe pain were detected on 2,712 (34.1%), 1,682 (21.1%), and 894 (11.2%) of the no-delirium days, respectively, and 992 (36.1%), 513 (18.6%), and 27 (10.1%) of delirium days (p = 0.01). The presence of any pain (mild, moderate, or severe) was not associated with a transition from awake without delirium to delirium (aOR 0.96; 95% CI, 0.76-1.21). This association was similar when days with only mild, moderate, or severe pain were considered. All results were stable after controlling for daily opioid dose. CONCLUSIONS: After controlling for multiple delirium risk factors, including daily opioid use, pain may not be a risk factor for delirium in the ICU. Future prospective research is required.

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.

Adaptation and Validation of the Standardized Swallowing Assessment Tool for Patients With Moderate-Severe Traumatic Brain Injury and Cervical Spinal Cord Injury.

Oropharyngeal dysphagia is common in moderate-severe traumatic brain injury (TBI) and cervical spinal cord injury (SCI) patients and can have serious consequences. Delaying feeding in these patients can also be detrimental. Nonetheless, the psychometric properties of screening tools that can promptly identify dysphagia have never been tested in these neurotrauma populations. This study aimed to: (1) adapt, translate, and validate the content of the French-Canadian version of the the Standardized Swallowing Assessment (SSA) tool to meet the needs of moderate-severe TBI and cervical SCI patients, (2) examine its inter-rater reliability and criterion-concurrent validation, and (3) evaluate its clinical utility from the perspectives of critical care nurses. The SSA tool was adapted and translated using an integrated method for the cultural adaptation and translation of tools. Eleven experts participated in the adaptation of the SSA tool, which led to the clarification of one item, as well as a new step and instructions for the screening procedure. Content validation (i.e., item and scale relevance) was evaluated by multidisciplinary team members (n = 17). The mean content validity index (CVI) score was 0.97 for the entire scale, while the mean CVI scores for individual items ranged from 0.82 to 1.0. A total of 60 neurotrauma patients were enrolled for inter-rater reliability and criterion-concurrent validation. Interrater reliability was determined by comparing two scores: one score from nurses responsible for the care of enrolled patients and one score from the research nurse. The weighted kappa coefficients for inter-rater reliability were 0.86 for moderate-severe TBI patients (n = 30) and 0.73 for cervical SCI patients (n = 30). A speech language therapist (SLT) also assessed dysphagia and results were used as the standard clinical reference criterion to determine concurrent validity (sensibility and specificity) of the adapted SSA tool. The sensitivity and specificity were 92% and 50% for moderate-severe TBI, and 77% and 75% for cervical SCI, respectively. The positive predictive value (PPV) and the negative predictive value (NPV) were 65% and 87% in TBI patients, and 75% and 76% in SCI patients. Test accuracy was 71% and 77% for these same groups. The clinical utility of the tool was evaluated according to the following domains: appropriateness, accessibility of the required material, applicability, perceived effectiveness, and acceptability. Acceptability was the only domain with a level of agreement <80% (74%) among trauma critical care nurses (n = 49). Findings support the content validation and inter-rater reliability of the adapted French-Canadian version of the SSA tool in moderate-severe TBI and cervical SCI patients. Sensitivity was acceptable in both groups, but the specificity was lower, especially in moderate-severe TBI patients. Further validation of the adapted French-Canadian version of the SSA tool is needed in neurotrauma patients to confirm these results and to ensure safe dysphagia screening while avoiding oral feeding deferrals.

International Analgesia and Sedation Weaning and Withdrawal Practices in Critically Ill Adults: The Adult Iatrogenic Withdrawal Study in the ICU.

OBJECTIVES: Iatrogenic withdrawal syndrome (IWS) associated with opioid and sedative use for medical purposes has a reported high prevalence and associated morbidity. This study aimed to determine the prevalence, utilization, and characteristics of opioid and sedative weaning and IWS policies/protocols in the adult ICU population. DESIGN: International, multicenter, observational, point prevalence study. SETTING: Adult ICUs. PATIENTS: All patients aged 18 years and older in the ICU on the date of data collection who received parenteral opioids or sedatives in the previous 24 hours. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: ICUs selected 1 day for data collection between June 1 and September 30, 2021. Patient demographic data, opioid and sedative medication use, and weaning and IWS assessment data were collected for the previous 24 hours. The primary outcome was the proportion of patients weaned from opioids and sedatives using an institutional policy/protocol on the data collection day. There were 2,402 patients in 229 ICUs from 11 countries screened for opioid and sedative use; 1,506 (63%) patients received parenteral opioids, and/or sedatives in the previous 24 hours. There were 90 (39%) ICUs with a weaning policy/protocol which was used in 176 (12%) patients, and 23 (10%) ICUs with an IWS policy/protocol which was used in 9 (0.6%) patients. The weaning policy/protocol for 47 (52%) ICUs did not define when to initiate weaning, and the policy/protocol for 24 (27%) ICUs did not specify the degree of weaning. A weaning policy/protocol was used in 34% (176/521) and IWS policy/protocol in 9% (9/97) of patients admitted to an ICU with such a policy/protocol. Among 485 patients eligible for weaning policy/protocol utilization based on duration of opioid/sedative use initiation criterion within individual ICU policies/protocols 176 (36%) had it used, and among 54 patients on opioids and/or sedatives ≥ 72 hours, 9 (17%) had an IWS policy/protocol used by the data collection day. CONCLUSIONS: This international observational study found that a small proportion of ICUs use policies/protocols for opioid and sedative weaning or IWS, and even when these policies/protocols are in place, they are implemented in a small percentage of patients.

Acceptability and Feasibility of a Patient-Oriented Music Intervention to Reduce Pain in the Intensive Care Unit: Protocol for a Crossover Pilot Randomized Controlled Trial.

BACKGROUND: Many patients experience pain in the intensive care unit (ICU) despite receiving pain medication. Research has shown that music can help reduce pain. Music interventions studied so far have not used music streaming to generate playlists based on patient preferences while incorporating recommended tempo and duration. Previous research has focused on postoperative ICU patients able to self-report, which is underrepresentative of the ICU population that might benefit from a music intervention for pain management. We developed a new patient-oriented music intervention (POMI) that incorporates features based on theoretical, empirical, and experiential data intended to be used in the ICU. Such a music intervention should consider the expertise of ICU patients, family members, and nursing staff, as well as the practicality of the intervention when used in practice. OBJECTIVE: The primary objectives of this study are to (1) evaluate the acceptability and feasibility of the POMI to reduce pain in ICU patients and (2) evaluate the feasibility of conducting a crossover pilot randomized controlled trial (RCT) for intervention testing in the ICU. A secondary objective is to examine the preliminary efficacy of the POMI to reduce pain in ICU patients. METHODS: A single-blind 2×2 crossover pilot RCT will be conducted. Patients will undergo 1 sequence of 2 interventions: the POMI which delivers music based on patients' preferences via headphones or music pillow for 20-30 minutes and the control intervention (headphones or pillow without music). The sequence of the interventions will be inverted with a 4-hour washout period. Timing of the interventions will be before a planned bed turning procedure. Each patient will undergo 1 session of music. Twenty-four patients will be recruited. Patients able to self-report (n=12), family members of patients unable to self-report (n=12), and nursing staff (n=12) involved in the bed turning procedure will be invited to complete a short questionnaire on the POMI acceptability. Data will be collected on the feasibility of the intervention delivery (ie, time spent creating a playlist, any issue related to headphones/pillow or music delivery, environmental noises, and intervention interruptions) and research methods (ie, number of patients screened, recruited, randomized, and included in the analysis). Pain scores will be obtained before and after intervention delivery. RESULTS: Recruitment and data collection began in March 2022. As of July 5, 2022, in total, 22 patients, 12 family members, and 11 nurses were recruited. CONCLUSIONS: Methodological limitations and strengths are discussed. Study limitations include the lack of blinding for patients able to self-report. Strengths include collecting data from various sources, getting a comprehensive evaluation of the intervention, and using a crossover pilot RCT design, where participants act as their own control, thus reducing confounding factors. TRIAL REGISTRATION: ClinicalTrials.gov NCT05320224; https://clinicaltrials.gov/ct2/show/NCT05320224. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40760.

Validation of the Critical-Care Pain Observation Tool (CPOT) in pediatric patients undergoing orthopedic surgery.

Background: Postoperative pain cannot be measured accurately among many children with intellectual and developmental disabilities, resulting in underrecognition or delay in recognition of pain. The Critical-Care Pain Observation Tool (CPOT) is a pain assessment tool that has been widely validated in critically ill and postoperative adults. Aims: The objective of this study was to validate the CPOT for use with pediatric patients able to self-report and undergoing posterior spinal fusion surgery. Methods: Twenty-four patients (10-18 years old) scheduled to undergo surgery were consented to this repeated-measure, within-subject study. To examine discriminative and criterion validation, CPOT scores and patients' self-reports of pain intensity were collected prospectively by a bedside rater before, during, and after a nonnociceptive and nociceptive procedure on the day following surgery. Patients' behavioral reactions were video recorded at the bedside and retrospectively viewed by two independent video raters to examine interrater and intrarater reliability of CPOT scores. Results: Discriminative validation was supported with higher CPOT scores during the nociceptive procedure than during the nonnociceptive procedure. Criterion validation was supported with a moderate positive correlation between the CPOT scores and the patients' self-reported pain intensity during the nociceptive procedure. A CPOT cutoff score of ≥2 was associated with the maximum sensitivity (61.3%) and specificity (94.1%). Reliability analyses revealed poor to moderate agreement between bedside and video raters and moderate to excellent consistency within video raters. Conclusions: These findings suggest that the CPOT may be a valid tool to detect pain in pediatric patients in the acute postoperative inpatient care unit after posterior spinal fusion.

Contexte: La douleur postopératoire ne peut pas être mesurée avec précision chez de nombreux enfants atteints de déficience intellectuelle et développementale, entraînant ainsi une méconnaissance ou un retard dans la reconnaissance de la douleur. Le Critical-Care Pain Observation Tool (CPOT) est un outil d'évaluation de la douleur qui a été largement validé chez les adultes gravement malades et postopératoires.Objectifs: L'objectif de cette étude était de valider le CPOT pour une utilisation auprès de patients pédiatriques capables d'autoévaluation et subissant une chirurgie de fusion vertébrale postérieure.Méthodes: Dans le cadre d'une étude intra-sujet, un consentement à cette mesure répétée a été obtenu pour vingt-quatre patients (10­18 ans) devant subir une intervention chirurgicale. Pour examiner la validation discriminante et de critère, les scores CPOT et les autoévaluations des patients concernant l'intensité de la douleur ont été collectés de manière prospective par un évaluateur au chevet du patient avant, pendant et après une procédure non nociceptive et nociceptive le lendemain de la chirurgie. Les réactions comportementales des patients ont été enregistrées sur vidéo au chevet du patient et visionnées rétrospectivement par deux des évaluateurs vidéo indépendants pour examiner la fiabilité des scores CPOT inter-évaluateurs et intra-évaluateurs.Résultats: La validation discriminante a été confirmée par l'obtention de scores plus élevés à l'échelle CPOT pendant la procédure nociceptive que pendant la procédure non nociceptive. La validation de critère a été confirmée par une corrélation positive modérée entre les scores sur l'échelle CPOT et l'intensité de la douleur autoévaluée par les patients pendant la procédure nociceptive. Un score-seuil ≥ 2 sur l'échelle CPOT a été associé à la sensibilité et la spécificité maximales (61,3 % et 94,1 %, respectivement). Les analyses de fiabilité ont révélé une concordance faible à modérée entre les évaluateurs de chevet et les évaluateurs vidéo, et une cocordance modérée à excellente parmi les évaluateurs vidéo.Conclusions: Ces résultats indiquent que le CPOT peut être un outil valide pour détecter la douleur chez les enfants patients de l'unité de soins hospitaliers postopératoires aigus après une fusion rachidienne postérieure.

Symptom Assessment for Mechanically Ventilated Patients: Principles and Priorities: An Official American Thoracic Society Workshop Report.

Mechanically ventilated patients experience many adverse symptoms, such as anxiety, thirst, and dyspnea. However, these common symptoms are not included in practice guideline recommendations for routine assessment of mechanically ventilated patients. An American Thoracic Society-sponsored workshop with researchers and clinicians with expertise in critical care and symptom management was convened for a discussion of symptom assessment in mechanically ventilated patients. Members included nurses, physicians, a respiratory therapist, a speech-language pathologist, a critical care pharmacist, and a former intensive care unit patient. This report summarizes existing evidence and consensus among workshop participants regarding 1) symptoms that should be considered for routine assessment of adult patients receiving mechanical ventilation; 2) key symptom assessment principles; 3) strategies that support symptom assessment in nonvocal patients; and 4) areas for future clinical practice development and research. Systematic patient-centered assessment of multiple symptoms has great potential to minimize patient distress and improve the patient experience. A culture shift is necessary to promote ongoing holistic symptom assessment with valid and reliable instruments. This report represents our workgroup consensus on symptom assessment for mechanically ventilated patients. Future work should address how holistic, patient-centered symptom assessment can be embedded into clinical practice.

The Validity of Vital Signs for Pain Assessment in Critically Ill Adults: A Narrative Review.

OBJECTIVES: Pain assessment in the intensive care unit (ICU) is challenging because many patients are unable to self-report or exhibit pain-related behaviors. In such situations, vital signs (VS) through continuous monitoring are alternative cues for pain assessment. This review aimed to describe the reliability and validity of VS for ICU pain assessment. DESIGN: Narrative review of the literature. DATA SOURCES: Medline, Embase, CINAHL, Cochrane. REVIEW/ANALYSIS METHODS: A narrative review was conducted with a comprehensive search in four databases. Search terms included VS, pain assessment, and ICU. RESULTS: Out of 1,359 results, 30 studies from 17 countries were included. Heart rate, blood pressure, and respiratory rate were most used for ICU pain assessment. Assessments were performed at rest before procedures, during nociceptive and non-nociceptive procedures, and after procedures. Increases in respiratory rate were clinically significant by more than 25% during nociceptive procedures (e.g., endotracheal suctioning, turning) compared with rest/pre-procedures in five studies. Correlations of VS with self-reported pain (reference standard measure) and behavioral pain scores (alternative measure) were absent or weak. CONCLUSIONS: VS are not valid indicators for ICU pain assessment. Increases of respiratory rate may be a cue for the detection of pain. However, fluctuations in respiratory rate can be influenced by opioids or controlled ventilation mode. Our results dissuade the use of VS for pain assessment because of the lack of association with ICU pain reference standards. Other physiologic measures of pain in critically ill adults should be explored.

Strategies to improve the quality of nurse triage in emergency departments: A realist review protocol.

AIM: The purpose of this realist review was to assess what works, for whom and in what context, regarding strategies that influence nurses' behaviour to improve triage quality in emergency departments (ED). DESIGN: Realist review protocol. METHODS: This protocol follows the PRISMA-P statement and will include any type of study on strategies to improve the triage process in the ED (using recognized and validated triage scales). The included studies were examined for scientific quality using the Mixed Methods Appraisal Tool. The framework for this realist review is based on the Behaviour Change Wheel (BCW) and the context-mechanism-outcome (CMO) models. DISCUSSION: Nurses and ED decision makers will be informed on the evidence regarding strategies to improve the quality of triage and the factors required to maximize their effectiveness. Research gaps may also be identified to guide future research projects on the adoption of best practices in ED nursing triage.

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.

Prediction of acute postoperative pain based on intraoperative nociception level (NOL) index values: the impact of machine learning-based analysis.

The relationship between intraoperative nociception and acute postoperative pain is still not well established. The nociception level (NOL) Index (Medasense, Ramat Gan, Israel) uses a multiparametric approach to provide a 0-100 nociception score. The objective of the ancillary analysis of the NOLGYN study was to evaluate the ability of a machine-learning aglorithm to predict moderate to severe acute postoperative pain based on intraoperative NOL values. Our study uses the data from the NOLGYN study, a randomized controlled trial that evaluated the impact of NOL-guided intraoperative administration of fentanyl on overall fentanyl consumption compared to standard of care. Seventy patients (ASA class I-III, aged 18-75 years) scheduled for gynecological laparoscopic surgery were enrolled. Variables included baseline demographics, NOL reaction to incision or intubation, median NOL during surgery, NOL time-weighted average (TWA) above or under manufacturers' recommended thresholds (10-25), and percentage of surgical time spent with NOL > 25 or < 10. We evaluated different machine learning algorithms to predict postoperative pain. Performance was assessed using cross-validated area under the ROC curve (CV-AUC). Of the 66 patients analyzed, 42 (63.6%) experienced moderate to severe pain. NOL post-intubation (42.8 (31.8-50.6) vs. 34.8 (25.6-41.3), p = 0.05), median NOL during surgery (13 (11-15) vs. 11 (8-13), p = 0.027), percentage of surgical time spent with NOL > 25 (23% (18-18) vs. 20% (15-24), p = 0.036), NOL TWA < 10 (2.54 (2.1-3.0) vs. 2.86 (2.48-3.62), p = 0.044) and percentage of surgical time spent with NOL < 10 (41% (36-47) vs. 47% (40-55), p = 0.022) were associated with moderate to severe PACU pain. Corresponding ROC AUC for the prediction of moderate to severe PACU pain were 0.65 [0.51-0.79], 0.66 [0.52-0.81], 0.66 [0.52-0.79], 0.65 [0.51-0.79] and 0.67 [0.53-0.81]. Penalized logistic regression achieved the best performance with a 0.753 (0.718-0.788) CV-AUC. Our results, even if limited by the small number of patients, suggest that acute postoperative pain is better predicted by a multivariate machine-learning algorithm rather than individual intraoperative nociception variables. Further larger multicentric trials are highly recommended to better understand the relationship between intraoperative nociception and acute postoperative pain.Trial registration Registered on ClinicalTrials.gov in October 2018 (NCT03776838).

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.

Validation Testing of the European Portuguese Critical-Care Pain Observation Tool.

Aim. The study aim was to validate the Portuguese version of the Critical-Care Pain Observation Tool (CPOT) in the critically ill adult population of Portugal. Methods. A prospective, observational cohort study was conducted to evaluate the CPOT in mechanically ventilated patients who were admitted to an intensive care unit. A consecutive sample of 110 patients was observed at rest pre-procedure, during a nociceptive procedure (NP) which includes turning/positioning and endotracheal or tracheal suctioning and 20 min post-procedure. Two raters participated in the data collection. The discriminative validity, criterion validity, convergent validity and inter-rater reliability of the CPOT were examined. Results. The inter-rater reliability was excellent (0.93 ≤ α ≤ 1.00) at rest and fair to moderate (0.39 ≤ α ≤ 0.60) during the NP. The CPOT could discriminate between conditions with higher scores during the NP when compared to CPOT scores at rest (p < 0.001). The optimal CPOT cut-off score was >2, with a sensitivity of 71% and a specificity of 80%, and self-reported pain was the gold standard criterion. Significant correlations (<0.40) were found between CPOT scores, the heart rate and the respiratory rate during the nociceptive procedure. Conclusions. The CPOT appears to be a valid alternative for both ventilated and non-ventilated patients who are unable to communicate.

The NJ Alliance for Clinical and Translational Science (NJ ACTS) experience: Responding at "warp speed" to COVID-19.

Introduction: The COVID-19 pandemic's need for life-saving treatments and a "warp speed" vaccine challenged the National Institutes of Health's Clinical and Translational Science Award (CTSA) recipients to improve their methods and processes in conducting clinical research. While CTSA recipient, New Jersey Alliance for Clinical and Translational Science (NJ ACTS), responded to this call to action with significant clinical research milestones, a comprehensive understanding of regulatory metrics during the COVID-19 pandemic is uncertain. The objective of this research is to identify, compare, and contrast metrics that illustrate the effectiveness of NJ ACTS's research mobilization efforts during COVID-19. Methods: Data were collected from the Institutional Review Board (IRB), the Clinical Research Units (CRUs), and the Office of Research and Sponsored Programs (ORSP). IRB data detailed the volume and types of protocols approved and turnaround time (TAT) for approval in 2020 vs. 2019. CRU data examined study metrics of adult and pediatric clinical trials across 2018-2020. ORSP data documented awards received in 2019 and 2020. Results: Analysis revealed a 95% increase in IRB-approved studies in 2020, with a significant decrease in TAT for COVID-19 studies. All CRUs observed a median 5.2-fold increase in the enrollment of adult and pediatric participants for COVID-19-related research. Study income was 106% and 196% greater than 2019 and 2018, respectively, with more than half funded through federal sponsors and 89% for COVID-19 trials. ORSP data revealed that 9% of awards and 26% of 2020 funding were COVID-19 studies. Conclusion: This study demonstrates that NJACTS effectively responded to challenges posed by the pandemic.

Identification of the intraoperative antinociceptive effect of intravenous fentanyl using the Nociception Level (NOL) index versus clinical parameters in patients undergoing gynecological laparoscopic surgery: A secondary analysis of the NOLGYN study.

BACKGROUND: While we typically assess nociception balance during general anesthesia through clinical parameters such as heart rate (HR) and mean arterial pressure (MAP) variation, these parameters are not specific to nociception. OBJECTIVE: We hypothesized that using the Nociception Level (NOL) index to assess the analgesic effect of a fentanyl bolus would be superior to standard clinical parameters. DESIGN: Ancillary study of the NOLGYN study, a randomized controlled trial comparing intraoperative NOL-guided administration of fentanyl (NOL group) versus standardized care (SC group). SETTING: University hospital in Montréal, Canada between November 2018, and December 2019. PATIENTS: Women undergoing gynecological laparoscopic surgery. INTERVENTION: In our evaluation of intraoperative nociception, we analyzed the analgesic effect of fentanyl using three parameters: MAP, HR, and the Nociception Level (NOL) index. All fentanyl injection events were extracted from the database. MAIN OUTCOME MEASURE: The primary endpoint was the difference between values before and after each injection. RESULTS: The median of the NOL index before fentanyl injection was 30.5 (IQR 19.4 to 40.7) versus 18.9 (IQR 11.5 to 27.4) after (P < 0.001). The median of MAP was 106.4 mmHg (IQR 99.9 to 113.4) before injection versus 103.2 mmHg (IQR 97.5-110.7) after (P < 0.001). The median of HR before injection was 74.2 (IQR 64.2-83.8) versus 72.4 (IQR 63.4-81.3) after (P < 0.001). CONCLUSIONS: The NOL index, HR, and MAP all statistically discriminated the analgesic effect of fentanyl but only the NOL index proved clinically relevant to identify the analgesic effect of one fentanyl injection. TRIAL REGISTRATION: www. CLINICALTRIALS: gov (NCT03776838) registered in October 2018.

French-Canadian Translation and Cultural Adaptation of the Clinical Opiate Withdrawal Scale: The COWS-FC.

OBJECTIVE: The main objective of the present study was to develop a French-Canadian translation and adaptation of the COWS (i.e., the COWS-FC) for the assessment of opioid withdrawal symptoms in clinical and research settings. METHODS: The French-Canadian translation and cultural adaptation of the COWS was performed following guidelines for the translation and cross-cultural adaptation of self-report measures. The steps consisted of (1) initial translation from English to French, (2) synthesis of the translation, (3) back-translation from French to English, (4) expert committee meeting, (5) test of the prefinal version among healthcare professionals and (6) review of final version by the expert committee. The expert committee considered four major areas where the French-Canadian version should achieve equivalence with the original English-version of the COWS. These areas were (1) semantic equivalence; (2) idiomatic equivalence; (3) experiential equivalence and (4) conceptual equivalence. RESULTS: Rigorous steps based on the guidelines for the translation and cultural adaptation of assessment tools were followed, which led to a semantically equivalent version of the COWS. After a pretest among healthcare professionals, members from the expert committee agreed upon slight modifications to the French-Canadian version of the COWS to yield a final COWS-FC version. CONCLUSIONS: A French-Canadian translation and adaptation of the COWS (i.e., the COWS-FC) was developed. The COWS-FC could be used for the assessment of opioid withdrawal symptoms in clinical and research settings.

Psychological distress, depression symptoms and fatigue among Quebec nursing staff during the COVID-19 pandemic: A cross-sectional study.

AIM: To describe the state of health of Quebec nursing staff during the pandemic according to their exposure to COVID-19, work-related characteristics and sociodemographic factors (gender, generational age group). State of health was captured essentially by assessing psychological distress, depression symptoms and fatigue. DESIGN AND METHODS: A large-scale cross-sectional study was conducted with 1,708 nurses and licenced practical nurses in Quebec (87% women, mean age of 41 ± 11 years). The survey included several questionnaires and validated health-related scales (psychological distress, depression symptoms and fatigue). The STROBE guidelines were followed in reporting the study's findings. RESULTS: Results showed that the prevalence of psychological distress and depression symptoms was moderate to severe. Women, generation Xers and Yers, nurses who cared for COVID-19 patients and those with a colleague who was infected with COVID-19 at work scored higher for fatigue, psychological distress and depression.