Outcome Consortium Research Articles

A practical guide for selecting continuous monitoring wearable devices for community-dwelling adults

ImportanceThe burgeoning landscape of wearable devices warrants a guide for the selection of devices. Existing guidelines and recommendations provide evaluation frameworks with theoretical principles but tend to lack a pragmatic application and systematic approach for device selection. While fitness trackers exemplify the convenience of wearable technologies, their selection for specific health monitoring purposes demands a nuanced understanding of varying functionalities and user compatibilities. ObjectiveThe objective is to develop and present a practical guide for researchers, healthcare professionals, and device users to systematically select wearable devices for continuous monitoring in community-dwelling adults. Methods & resultsBased on diverse sources, such as the United States Food and Drug Administration (FDA), the Clinical Trials Transformation Initiative (CTTI), the Electronic Patient-Reported Outcome (ePRO) Consortium, and comparative analyses of wearable technology performances from feasibility and usability studies, the guide incorporates five core criteria: continuous monitoring capability, device availability and suitability, technical performance (accuracy and precision), feasibility of use, and cost evaluation. The structured criteria can be applied in device selection as well as device evaluation. ConclusionsThis practical guide provides a step-by-step solution for researchers, healthcare professionals, and device users to choose suitable wearable devices for continuous monitoring. It provides a comprehensive starting point, outlining how to effectively navigate the selection process for wearable devices amidst a plethora of similar options.

Prehospital Ground and Helicopter-Based Extracorporeal Cardiopulmonary Resuscitation (ECPR) Reduce Barriers to ECPR: A GIS Model

Introduction Evidence suggests that Extracorporeal Cardiopulmonary Resuscitation (ECPR) can improve survival rates for nontraumatic out-of-hospital cardiac arrest (OHCA). However, when ECPR is indicated over 50% of potential candidates are unable to qualify in the current hospital-based system due to geographic limitations. This study employs a Geographic Information System (GIS) model to estimate the number of ECPR eligible patients within the United States in the current hospital-based system, a prehospital ECPR ground-based system, and a prehospital ECPR Helicopter Emergency Medical Services (HEMS)-based system. Methods We constructed a GIS model to estimate ground and helicopter transport times. Time-dependent rates of ECPR eligibility were derived from the Resuscitation Outcome Consortium (ROC) database, while the Cardiac Arrest Registry to Enhance Survival (CARES) registry determined the number of OHCA patients meeting ECPR criteria within designated transportation times. Emergency Medical Services (EMS) response time, ECPR candidacy determination time, and on-scene time were modeled based on data from the EROCA trial. The combined model was used to estimate the total ECPR eligibility in each system. Results The CARES registry recorded 736,066 OHCA patients from 2013 to 2021. After applying clinical criteria, 24,661 (3.4%) ECPR-indicated OHCA were identified. When considering overall ECPR eligibility within 45 min from OHCA to initiation, only 11.76% of OHCA where ECPR was indicated were eligible in the current hospital-based system. The prehospital ECPR HEMS-based system exhibited a four-fold increase in ECPR eligibility (49.3%), while the prehospital ground-based system showed a more than two-fold increase (28.4%). Conclusions The study demonstrates a two-fold increase in ECPR eligibility for a prehospital ECPR ground-based system and a four-fold increase for a prehospital ECPR HEMS-based system compared to the current hospital-based ECPR system. This novel GIS model can inform future ECPR implementation strategies, optimizing systems of care.

The Validity of Muscle Ultrasound in the Diagnostic Workup of Sarcopenia Among Older Adults: A Scoping Review.

Muscle ultrasound has emerged as a promising method in the diagnostic work-up of sarcopenia. The objective of this scoping review was to explore the validity of muscle ultrasound against the latest sarcopenia definitions among older adults. We adhered to the PRISMA guidelines for scoping reviews. A systematic search of databases was performed by two independent reviewers. All articles comparing the performance of ultrasound to an internationally acknowledged sarcopenia definition among older adults (≥60 years) and published between 2019/01/01 (the year updated sarcopenia definitions were introduced) and 2023/11/15 were included. Data were extracted and collated by muscle and muscle parameters. Out of 2290 articles screened, six studies comprising 24 validity tests among a total of 1619 older adults (mean age 74.1 years, 52.2% female) were included. The validity tests investigated the rectus femoris (n = 7), biceps brachii (n = 5), gastrocnemius medialis (n = 4), tibialis anterior (n = 4), soleus (n = 3), and rectus abdominis (n = 1). The parameter muscle thickness (MT) (n = 14) was most commonly measured. The latest European and Asian sarcopenia definitions (EWGSOP2, AWGS2) were applied as reference standards in four validity tests each. None of the studies used the Sarcopenia Definition and Outcome Consortium (SDOC) criteria. The highest area under the curve AUC (0.92, 95% confidence interval [CI] 0.89-0.94) was found for the muscle thickness of the rectus femoris muscle. Due to substantial heterogeneity among the studies, pooling of data using a meta-analytic approach was not feasible. Limited number of studies have examined the validity of muscle ultrasound for diagnosing sarcopenia based on recent definitions among older adults. Thereby, muscle thickness of the rectus femoris showed promising results regarding validity. Further studies are needed to investigate the validity of key muscles and to validate muscle ultrasound among older hospitalized patients.

Causal Association of Iron Status With Functional Outcome After Ischemic Stroke.

Iron status has been associated with functional outcomes after ischemic stroke (IS). Nonetheless, this association may be affected by confounders. We perform Mendelian randomization to clarify the causal association between iron status and functional outcome after IS. We obtained summary-level statistics related to iron status biomarkers from a meta-analysis of a gene-wide association study conducted by the Genetics of Iron Status Consortium, which included 11 discovery cohorts and 8 replication cohorts. We also took genetic variants related to 4 biomarkers of iron status from combining gene-wide association study results of Iceland, the United Kingdom, and Denmark to perform a replicate Mendelian randomization analysis. This data set included 4 iron status biomarkers, namely, ferritin, total iron binding capacity, iron, and transferrin saturation (TSAT). The confounders in these data sets have been adjusted to mitigate the collider bias. We acquired summary statistics data sets for functional outcomes following IS from the gene-wide association study meta-analysis conducted by the Genetics of Ischemic Stroke Functional Outcome Consortium. The genetic estimates for functional outcomes at 90 days after IS were evaluated by the modified Rankin Scale score, including 3741 cases with good functional outcomes (modified Rankin Scale score, 0-2) and 2280 subjects with poor functional outcomes poststroke (modified Rankin Scale score, 3-6). Inverse variance weighting was used as the primary method, complemented by sensitivity analyses for pleiotropy and increasing robustness. Reported with odds ratios (ORs) of stroke outcome with per SD unit increase in genetically determined iron status biomarker, TSAT and iron were associated with poor functional outcome after IS (TSAT: OR, 1.36 [95% CI, 1.23-1.50]; P=2.27×10-9; iron: OR, 1.44 [95% CI, 1.13-1.85]; P=0.0033). In replicate Mendelian randomization analysis, the detrimental effects of iron on poor functional outcome after IS remained stable (OR, 1.60 [95% CI, 1.24-2.08]; P=0.0003). In the meta-analysis, iron and TSAT were associated with poor functional outcomes after IS (TSAT: ORmeta, 1.35 [95% CI, 1.23-1.48]; iron: ORmeta, 1.51 [95% CI, 1.27-1.81]). Through sensitivity analyses and reverse Mendelian randomization analyses, we confirmed the robustness of the results. Our study provides evidence suggesting a potential causal relationship between iron status and poor functional outcomes after IS. Future studies are required to illuminate the underlying mechanism.

Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes

Historically, there was a tendency amongst electronic clinical outcome assessment (eCOA) service providers and their sponsor clients to prevent changes to eCOA data, particularly for electronic patient-reported outcome (ePRO) measures, or to allow changes to eCOA data but only after receiving sponsor approval to do so. Further, sponsors were also approving or denying data change requests (DCRs).From 2018 to 2022, 45 representatives of Critical Path (C-Path) Institute’s Patient-Reported Outcome (PRO) Consortium, eCOA Consortium (previously ePRO Consortium), and the eClinical Forum collaborated to develop guidelines on changes to eCOA data. These were compiled into the present manuscript, which outlines best practices aligned to latest health authority guidance, and based on expertise from all three organizations.This work coincided with a shift in clinical trial industry practices and emergence of regulations and quality functions that require that investigative sites, not sponsors, be responsible for the maintenance of accurate source records. In other words, the question was not whether, but how, PRO data should be changed. The resulting set of core principles can become the foundation upon which sponsors, investigators and eCOA providers can work together on DCRs.To achieve that, eCOA studies must:• be setup in a manner that minimizes potential user errors;• have a documented oversight plan and documented site staff training;• follow clearly defined and standard workflows–but also mitigate undefined change types;• allow trial documentation per ALCOA+ principles; and• induce sponsors into timely reviews and reconciliations of discordant data (i.e., via sensitivity analysis) and not by arbitrarily overruling the investigators.

Impact of the COVID-19 pandemic on Canadian emergency medical system management of out-of-hospital cardiac arrest: A retrospective cohort study

AimWe sought to describe the impact of the COVID-19 pandemic on the care provided by Canadian emergency medical system (EMS) clinicians to patients suffering out of hospital cardiac arrest (OHCA), and whether any observed changes persisted beyond the initial phase of the pandemic. MethodsWe analysed cases of adult, non-traumatic, OHCA from the Canadian Resuscitation Outcome Consortium (CanROC) registry who were treated between January 27th, 2018, and December 31st, 2021. We used adjusted regression models and interrupted time series analysis to examine the impact of the COVID-19 pandemic (January 27th, 2020 – December 31st, 2021)on the care provided to patients with OHCA by EMS clinicians. ResultsThere were 12,947 cases of OHCA recorded in the CanROC registry in the pre-COVID-19 period and 17,488 during the COVID-19 period. We observed a reduction in the cumulative number of defibrillations provided by EMS (aRR 0.91, 95% CI 0.89 – 0.93, p < 0.01), a reduction in the odds of attempts at intubation (aOR 0.33, 95% CI 0.31 – 0.34, p < 0.01), higher rates of supraglottic airway use (aOR 1.23, 95% CI 1.16–1.30, p < 0.01), a reduction in vascular access (aOR for intravenous access 0.84, 95% CI 0.79 – 0.89, p < 0.01; aOR for intraosseous access 0.89, 95% CI 0.82 – 0.96, p < 0.01), a reduction in the odds of epinephrine administration (aOR 0.89, 95% CI 0.85 – 0.94, p < 0.01), and higher odds of resuscitation termination on scene (aOR 1.38, 95% CI 1.31 – 1.46, p < 0.01). Delays to initiation of chest compressions (2 min. vs. 3 min., p < 0.01), intubation (16 min. vs. 19 min., p = 0.01), and epinephrine administration (11 min. vs. 13 min., p < 0.01) were observed, whilst supraglottic airways were inserted earlier (11 min. vs. 10 min., p < 0.01). ConclusionThe COVID-19 pandemic was associated with substantial changes in EMS management of OHCA. EMS leaders should consider these findings to optimise current OHCA management and prepare for future pandemics.

Abstract 380: Prehospital Ground and Helicopter-Based Extracorporeal Cardiopulmonary Resuscitation (ECPR) Reduce Barriers to ECPR: A GIS Model

Introduction: Evidence suggests that ECPR can improve survival rates for nontraumatic out-of-hospital cardiac arrest (OHCA). However, over 50% of potential ECPR candidates are unable to qualify in the current hospital-based system due to geographic limitations. This study employs a Geographic Information System (GIS) model to estimate the number of ECPR eligible patients within the U.S. in the current hospital-based system, a prehospital ECPR ground-based system, and a prehospital ECPR HEMS-based system (Figure 1). Methods: We constructed a GIS model to estimate ground and helicopter transport times. Time-dependent rates of ECPR eligibility were derived from the Resuscitation Outcome Consortium (ROC) database, while the Cardiac Arrest Registry to Enhance Survival (CARES) registry determined the number of OHCA patients meeting ECPR criteria within designated transportation times. EMS response time, ECPR candidacy determination time, and on-scene time were modeled based on data from the EROCA trial (Figure 1). The combined model was used to estimate the total ECPR candidates in each system. Results: The CARES registry recorded 736,066 OHCA patients from 2013 to 2021. After applying clinical eligibility criteria, 24,661 (3.4%) patients were eligible for ECPR. When considering overall ECPR eligibility within 45 minutes from OHCA to initiation, only 11.76% of clinically eligible patients qualified in the current hospital-based system. The prehospital ECPR HEMS-based system exhibited a four-fold increase in ECPR eligibility (49.3%), while the prehospital ground-based system showed a more than two-fold increase (28.4%). Conclusions: The study demonstrates a two-fold increase in ECPR eligibility for a field-deployable ground-based system and a four-fold increase for a prehospital ECPR HEMS-based system compared to the current hospital-based OHCA system. This novel GIS model can inform future ECPR implementation strategies, optimizing systems of care.

Assessing asthma symptoms in children: qualitative research supporting the development of the Pediatric Asthma Diary—Child (PAD-C) and Pediatric Asthma Diary—Observer (PAD-O)

BackgroundPediatric asthma has been identified by regulators, clinicians, clinical trial sponsors, and caregivers as an area in need of novel fit-for-purpose clinical outcome assessments (COAs) developed in accordance with the U.S. Food and Drug Administration’s (FDA’s) regulatory guidance for evaluating clinical benefit in treatment trials. To address this gap, the Patient-Reported Outcome (PRO) Consortium’s Pediatric Asthma Working Group has continued development of 2 COAs to assess asthma signs and symptoms in pediatric asthma clinical trials to support efficacy endpoints: a PRO measure, the Pediatric Asthma Diary—Child (PAD-C) for children 8–11 years old (y.o.) and an observer-reported outcome measure, the Pediatric Asthma Diary-Observer (PAD—O) for caregivers of children 4–11 y.o. This qualitative research aimed to generate evidence regarding the content validity of the PAD-C and PAD-O.MethodsSemi-structured combined concept elicitation and cognitive interviews were conducted with a diverse sample of U.S. participants (15 children 8–11 y.o. and 30 caregivers of children 4–11 y.o.). All children had clinician-diagnosed mild to severe asthma. Interviews explored the experience of pediatric asthma and assessed the understanding and relevance of both measures. Interviews were conducted across 3 iterative rounds to allow for modifications.ResultsConcept elicitation findings demonstrated that the core sign/symptom and impact concepts assessed in the PAD-C (cough, hard to breathe, out of breath, wheezing, chest tightness, and nighttime awakenings/symptoms) and PAD-O (cough, difficulty breathing, short of breath, wheezing, and nighttime awakenings/signs) correspond to those most frequently reported by participants; concept saturation was achieved. All PAD-C and PAD-O instructions and core items were well understood and considered relevant by most participants. Feedback from participants, the Pediatric Asthma Working Group, advisory panel, and FDA supported modifications to the measures, including addition of 1 new item to both measures and removal of 1 caregiver item.ConclusionsFindings provide strong support for the content validity of both measures. The cross-sectional measurement properties of both measures and their user experience and feasibility in electronic format will be assessed in a future quantitative pilot study with qualitative exit interviews, intended to support the reliability, construct validity, final content, and, ultimately, FDA qualification of the measures.

Desenvolvimento da Versão Portuguesa do Questionário ESF-1: Rastreio para Síndrome Metabólica

Introduction Metabolic Syndrome is a cluster of alterations, a consequence of a continuum of insulin resistance and chronic inflammation, being a predisposing factor for the development of several pathologies, including Type 2 Diabetes Mellitus and cardiovascular diseases. Due to the challenges inherent to organizing screenings in large populations, and the fact that recent biochemical parameters are not always available in different contexts, there is a tendency to use simple and cost-effective techniques, such as quick-administered questionnaires. The advantages relate to the ease of administration, the relatively short time, the need for blood samples and lower associated costs. There are several validated instruments for metabolic syndrome screening, although none are yet used in Portugal. One of those available is the “Encuesta de Identificación de Sujetos Metabólicamente Comprometidos en Fase-I”, and the present work aims to produce a linguistically and culturally adapted version for the Portuguese language, maintaining the conceptual equivalence of the original. Methodology For the translation, the procedures standardized by the Patient Reported Outcome Consortium were followed (Preparation, Translation, Reconciliation, Back-translation, Harmonization, Review, Cognitive Interview, Analysis, Final Review). Critical analysis The translated tool was applied to a convenience sample of the target population consisting of five individuals, and it was easy to understand and apply, with good acceptability, with only the need for minor adjustments to two questions. Conclusion This tool can be applied in a clinical and/or community setting for metabolic syndrome screening, proving to be of special interest in occupational health services, since it’s in the workplace that the population spends most of their adult life, optimizing resources, and promoting increasingly early referral and treatment. Furthermore, the healthier the workers, the more satisfied and productive they are. Keywords: Metabolic Syndrome; screening tool; Occupational Health.

Arrest Outcome Consortium Registry Analysis [AOCRA 2022]: Outcome Statistics of Cardiac Arrest in Tertiary Care Hospitals in India, Analysis of Five Year Data of Indian Online Cardiac Arrest Registry, www.aocregistry.com.

To publish data with outcome statistics from our online cardiac arrest (CA) outcome consortium (AOC) online registry. Data on cardiac arrest (CA) from tertiary care hospitals were collected on the AOC registry online portal from January 2017 to May 2022. Survival endpoints from cardiac arrest events like ROSC, and survival at hospital discharge with neurological status at discharge were analyzed and presented. Studies of demographics, the association of outcome with age, gender, bystander CPR, low and no flow times, and admission lactate were also done along with suitable statistical analysis. Out of 2,235 CA, 2,121 received CPR (1,998 IHCA, 123 Out of hospital Cardiac Arrest (OHCA)) as 114 were DNR. The males-female ratio was 70:30. Average age at arrest was 58.7 years. 26% OHCA received bystander CPR but survival advantage was not significant. (with 16%, without 14% p = 0.78). Asystole (67.7%), Pulseless Electrical Activity (PEA) (25.6%), and VF/pVT (6.7%) as first rhythm significantly influence survival (4.9, 8.6 and 39.4%: p < 0.001) ROSC was achieved in 355 (16.7%), with 173 (8.2%) alive and 141 (6.6%) having good (CPC ≤ 2) neurological state at discharge. At discharge, survival as well as CPC ≤ 2 outcomes were significantly better in females. On multivariate regression analysis, first rhythm and low flow time influence survival at discharge. Admission lactate (available only in 102 OHCA) was lower in survivors than non-survivors 10.3 vs 11.5 mmol/L but the difference was not statistically significant (p = 0.397]. Data from our AOC registry shows poor overall survival from CA. The Female gender had a higher survival rate. Ventricular Fibrillation/Pulseless Ventricular Tachycardia (VF/pVT) as first rhythm and low flow time influence the survival to discharge (CTRI/2022/11/047140). Clerk AM, Patel K, Shah BA, Prajapati D, Shah RJ, Rachhadia J, et al. Arrest Outcome Consortium Registry Analysis [AOCRA 2022]: Outcome Statistics of Cardiac Arrest in Tertiary Care Hospitals in India, Analysis of Five Year Data of Indian Online Cardiac Arrest Registry, www.aocregistry.com. Indian J Crit Care Med 2023;27(5):322-329.

Sarcopenia Definition Outcome Consortium - defined Weakness and Risk of Falls: The National Health and Aging Trends Survey.

The prevalence of obesity continues to rise, as does that of weakness. However, it is unclear how this impacts the risk of falling. We aimed to ascertain the risk of falls using new definitions of clinically defined weakness. We applied clinically defined weakness definitions to the National Health and Aging Trends Survey using the Sarcopenia Definitions Outcomes Consortium cutpoints. Three exposure variables were created: grip-strength-defined weakness and body mass index [GS/BMI]-defined obesity; weakness and obesity, weakness and waist circumference-derived obesity (GS/WC); and weakness defined by a ratio of GS÷BMI. Proportional hazards modeled incident falls as a function of weakness with/without obesity (hazard ratio [HR] [95% confidence intervals]). Of 4906 respondents aged ≥ 65 years (54.5% female), the mean ± SD grip strength, BMI, and WC were 26.7 ± 10.6kg, 27.4 ± 5.4kg/m2 , and 99.5 ± 16.3cm, respectively. Using the neither weakness/obesity as the referent, weakness was associated with incident falls across all definitions (GS/BMI: HR 1.19 [1.07, 1.33]; GS/WC: HR 1.39 [1.19, 1.62]; GS ÷ BMI: HR 1.16 [1.05, 1.28]). Weakness with obesity was associated with falls using GS/WC (HR 1.28 [1.11, 1.48]). Obesity status was associated with falls in both the BMI and the WC definition (1.17 [1.02-1.35], 1.16 [1.05-1.28]). Our findings further evaluate the definitions of clinically defined weakness with and without obesity in older adults. As falls are an important patient outcome, establishing this relationship is critical for both clinicians and researchers. Future study should identify high-risk individuals in order to direct specific interventions to them. Geriatr Gerontol Int 2023; 23: 213-220.

Predictive validity of current sarcopenia definitions (EWGSOP2, SDOC, and AWGS2) for clinical outcomes: A scoping review.

Over the last 3years new definitions of sarcopenia by the Sarcopenia Definition and Outcome Consortium (2020, SDOC), European Working Group on Sarcopenia in Older People (2019, EWGSOP2) and Asian Working Group on Sarcopenia (2019, AWGS2) have been proposed. The objective of this scoping review was to explore predictive validity of these current sarcopenia definitions for clinical outcomes. We followed the PRISMA checklist for scoping reviews. Based on a systematic search performed by two independent reviewers of databases (Pubmed and Embase) articles comparing predictive validity of two or more sarcopenia definitions on prospective clinical outcomes published since January 2019 (the year these definitions were introduced) were included. Data were extracted and results collated by clinical outcomes and by sarcopenia definitions, respectively. Of 4493 articles screened, 11 studies (mean age of participants 77.6 (SD 5.7) years and 50.0% female) comprising 82 validity tests were included. Overall, validity tests on the following categories of clinical outcomes were performed: fracture (n=40, assessed in one study), mortality (n=18), function (n=11), institutionalization (n=7), falls (n=4), and hospitalization (n=2). Thereby, EWGSOP2 was investigated in 15 validity tests (18.3%) on all categories of clinical outcomes, whereas SDOC was investigated in four validity tests (4.9%) in one study on fractures in men only, and none of the validity tests investigated predictive validity by the AWGS2. However, we were not able to pool the data using a meta-analytic approach due to important methodological heterogeneity between the studies. We identified various definitions of clinical outcomes that were used to test predictive validity of sarcopenia definitions suggesting that an agreement on an operational definition of a clinical outcome is key to advance in the field of sarcopenia. Moreover, data on predictive validity using the sarcopenia definitions by the SDOC and AWGS2 are still scarce and lacking, respectively. In a next step, prospective studies including both women and men are needed to compare predictive validity of current sarcopenia definitions on defined key clinical outcomes.

Abstract 270: Eligibility Of Out-of-hospital Cardiac Arrest Patients For Extracorporeal Cardiopulmonary Resuscitation In The United States: A Geographic Information System Model

Introduction: Recent evidence suggest that ECPR may improve survival rates for nontraumatic out-of-hospital cardiac arrest (OHCA). Eligibility criteria for ECPR are often based on patient age, clinical variables, and facility capabilities. Expanding access to ECPR across the U.S. requires a better understanding of how these factors interact with transport time to ECPR centers. Methods: We constructed a Geographic Information System (GIS) model to estimate the number of ECPR candidates in the U.S. We utilized a Resuscitation Outcome Consortium (ROC) database to model time-dependent rates of ECPR eligibility and the Cardiac Arrest Registry to Enhance Survival (CARES) registry to determine the total number of OHCA patients who meet pre-specified ECPR criteria within designated transportation times. Potential ECPR centers were categorized as Extracorporeal Membrane Oxygenation (ECMO)-ready, ECMO-capable, or percutaneous coronary intervention (PCI)-capable centers using data from the Extracorporeal Life Support Organization and the American Hospital Directory. The combined model was used to estimate the total ECPR candidates and the effects of patient and hospital factors on ECPR eligibility. Results: There were 588,203 OHCA patients in the CARES registry from 2013 to 2020. After applying clinical eligibility criteria, 22,104 (3.76%) OHCA patients were eligible for ECPR. The rate of ROSC increased with longer resuscitation time, which resulted in fewer ECPR candidates. The proportion of OHCA patients eligible for ECPR increased with older age cutoffs. Only 1.68% (9,889/588,203) of OHCA patients in the U.S. were eligible for ECPR based on a 45-minute transportation time to an ECMO-ready center model, representing the current state of ECPR in the U.S. The proportion of OHCA patients eligible for ECPR ranged from 0.68% (4,027 patients in the 15-minute transportation time to ECMO-ready center model) to 2.81% (16,558 patients in the 45-minute transportation time to PCI-capable center model). Conclusions: Less than 2% of OHCA patients are eligible for ECPR in the U.S. GIS models can identify the impact of clinical criteria, transportation time, and hospital capabilities on ECPR eligibility to inform future implementation strategies.

Eligibility of out-of-hospital cardiac arrest patients for extracorporeal cardiopulmonary resuscitation in the United States: A geographic information system model

BackgroundRecent evidence suggest that extracorporeal cardiopulmonary resuscitation (ECPR) may improve survival rates for nontraumatic out-of-hospital cardiac arrest (OHCA). Eligibility criteria for ECPR are often based on patient age, clinical variables, and facility capabilities. Expanding access to ECPR across the U.S. requires a better understanding of how these factors interact with transport time to ECPR centers. MethodsWe constructed a Geographic Information System (GIS) model to estimate the number of ECPR candidates in the U.S. We utilized a Resuscitation Outcome Consortium (ROC) database to model time-dependent rates of ECPR eligibility and the Cardiac Arrest Registry to Enhance Survival (CARES) registry to determine the total number of OHCA patients who meet pre-specified ECPR criteria within designated transportation times. The combined model was used to estimate the total number of ECPR candidates. ResultsThere were 588,203 OHCA patients in the CARES registry from 2013 to 2020. After applying clinical eligibility criteria, 22,104 (3.76%) OHCA patients were deemed eligible for ECPR. The rate of ROSC increased with longer resuscitation time, which resulted in fewer ECPR candidates. The proportion of OHCA patients eligible for ECPR increased with older age cutoffs. Only 1.68% (9,889/588,203) of OHCA patients in the U.S. were eligible for ECPR based on a 45-minute transportation time to an ECMO-ready center model. ConclusionsLess than 2% of OHCA patients are eligible for ECPR in the U.S. GIS models can identify the impact of clinical criteria, transportation time, and hospital capabilities on ECPR eligibility to inform future implementation strategies.

Procainamide for shockable rhythm cardiac arrest in the Resuscitation Outcome Consortium

BackgroundWith recent negative studies of amiodarone and lidocaine for cardiac arrest, research into other antiarrhythmics is warranted. Literature on procainamide in cardiac arrest is limited. We evaluated procainamide for out-of-hospital cardiac arrests (OHCA) from the Resuscitation Outcomes Consortium (ROC). MethodsWe included all ROC Epistry 3 OHCAs with an initial shockable rhythm that received an antiarrhythmic. We stratified cases by antiarrhythmic: procainamide, amiodarone, or lidocaine. The outcomes were prehospital return of spontaneous circulation (ROSC), ROSC in the ED, and survival to hospital discharge. We defined propensity scores based on possible confounders utilizing 1:1 propensity score matching to compare procainamide to amiodarone and lidocaine. We analyzed the matched data using logistic regression. We also used multivariable logistic regression to evaluate the association between antiarrhythmic and outcomes. Results3087 subjects met inclusion criteria; 51 patients received only procainamide, 1776 received amiodarone, and 1418 received lidocaine. On propensity score analysis and compared to procainamide, amiodarone had similar prehospital ROSC (OR 0.7, 95% CI 0.3–1.8), ED ROSC (OR 0.6, 95% CI 0.3–1.3), and survival (OR 1.0, 95% CI 0.3–3.1). Lidocaine also had a similar prehospital ROSC (OR 0.9, 95% CI 0.4–2.2), ED ROSC (OR 1.2, 95% CI 0.5–2.7), and survival (OR 1.4, 95% CI 0.5–4.0). However, using multivariable regression, amiodarone had lower prehospital ROSC than procainamide (aOR 0.3, 95% CI 0.1–0.6). ConclusionsWhile associated with increased prehospital ROSC when compared with amiodarone using multivariable regression, procainamide otherwise had similar prehospital ROSC, ED ROSC, and survival. The role of procainamide in OHCA remains unclear.

The research progress on the registration database of out-of-hospital cardiac arrest

Out-of-hospital cardiac arrest (OHCA) with high mortality and disable rate is a public health problem of common concern all over the world. In order to improve the survival rate of OHCA, developed countries such as Europe and the United States have established regional and even national OHCA registration database for continuous monitoring and quality improvement of OHCA, identifying the weaknesses in each link of the survival chain, and evaluating effective measures to enhance the survival rate. At present, China still lacks of registration database that can comprehensively collect the information of OHCA and effectively reflect the treatment status and research direction of OHCA. In order to shorten the huge gap of OHCA survival rate between China and developed countries such as Europe and the United States, we should learn from the experience of foreign registration databases and establish OHCA registration database suitable for China's national conditions, so as to promote the improvement of OHCA survival rate in China. This paper presents several major OHCA registry databases of the internationally recognized,such as cardiac arrest registry to enhance survival (CARES), resuscitation outcomes consortium (ROC), European registry of cardiac arrest (EuReCa), Pan-Asian resuscitation outcomes registry (PAROS), and Australian resuscitation outcome consortium (Aus-ROC), aims to provide a reference for promoting the construction of the cardiac arrest registration database in China.

Translation and Cultural Adaptation of the Patient Self-Administered Financial Effects (P-SAFE) Questionnaire to Assess the Financial Burden of Cancer in French-Speaking Patients.

People living with and beyond cancer (PLC) experience financial hardship associated with the disease and its treatment. Research demonstrates that the “economic toxicity” of cancer can cause distress and impair well-being, health-related quality of life and, ultimately, survival. The Patient Self-Administered Financial Effects (P-SAFE) questionnaire was created in Canada and tested in English. The objective of this study is to describe the processes of translation and cultural adaptation of the P-SAFE for use with French speaking PLC in Canada. The Canadian P-SAFE questionnaire was translated from English to French in collaboration with the developer of the initial version, according to the 12-step process recommended by the Patient-Reported Outcome (PRO) Consortium. These steps include forward and backward translation, a multidisciplinary expert committee, and cross-cultural validation using think-aloud, probing techniques, and clarity scoring during cognitive interviewing. Translation and validation of the P-SAFE questionnaire were performed without major difficulties. Minor changes were made to better fit with the vocabulary used in the public healthcare system in Quebec. The mean score for clarity of questions was 6.4 out of a possible 7 (totally clear) Cognitive interviewing revealed that lengthy questionnaire instructions could be confusing. Our team produced a Canadian-French version of the P-SAFE. After minor rewording in the instructions, the P-SAFE questionnaire appears culturally appropriate for use with French-speaking PLC in Canada. Further testing of the French version will require evaluation of psychometric properties of validity and reliability.

Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop

The US Food and Drug Administration and the Critical Path Institute’s Patient-Reported Outcome (PRO) Consortium convened a cosponsored workshop on the use of PRO measures to inform the assessment of safety and tolerability in cancer clinical trials. A broad array of international stakeholders involved in oncology drug development and PRO measurement science provided perspectives on the role of PRO measures to provide complementary clinical data on the symptomatic side effects of anticancer agents. Speakers and panelists explored the utility of information derived from existing and emerging PRO measures, focusing on the PRO version of the National Cancer Institute’s Common Terminology Criteria for Adverse Events. Panelists and speakers discussed potential ways to improve the collection, analysis, and presentation of PRO data describing symptomatic adverse events to support drug development and better inform regulatory and treatment decisions. Workshop participants concluded the day with a discussion of possible approaches to the patient-reported assessment of an investigational drug’s overall side effect burden as a potential clinical trial end point. The Food and Drug Administration reiterated its commitment to collaborate with international drug development stakeholders to identify rigorous methods to incorporate the patient perspective into the development of cancer therapeutics.

Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium

BackgroundWearable devices offer huge potential to collect rich sources of data to provide insights into the effects of treatment interventions. Despite this, at the time of writing this report, limited regulatory guidance on the use of wearables in clinical trial programs has been published. ObjectivesTo present recommendations from the Critical Path Institute’s Electronic Patient-Reported Outcome Consortium regarding the selection and evaluation of wearable devices and their measurements for use in regulatory trials and to support labeling claims. MethodsThe evaluation group was composed of Critical Path Institute’s clinical outcome assessment (COA) scientists and COA specialists from pharmaceutical trial eCOA solution providers, including COA development and validation specialists. The resulting recommendations were drawn from a broad range of backgrounds, perspectives, and expertise that enriched the development of this report. Recommendations were developed through analysis of existing regulatory guidance relating to COA development and use in clinical trials, medical device certification/clearance regulations, literature-reported best practice, and practical experience of wearable technology application in clinical trials. ResultsWe identify the essential properties of fit-for-purpose wearables and propose evidence needed to support their use. In addition, we overview the activities required to establish clinical endpoints derived from wearables data. ConclusionsUsing this framework, we believe there is enough current understanding to promote the appropriate use of wearables in study protocols. We hope this will provide a basis for discussion among clinical trial stakeholders and catalyze the development of more robust regulatory guidance.

Prehospital parameters can help to predict coagulopathy and massive transfusion in trauma patients.

This study aimed to evaluate the accuracy of prehospital parameters, including vital signs and resuscitation (fluids, vasopressor), to predict trauma-induced coagulopathy (TIC, fibrinogen <1·5 g/l or PTratio > 1·5 or platelet count <100 × 109 /l), and a massive transfusion (MT, ≥10 RBC units within the first 24 h). From a trauma registry (2011-2015), in which patients are prospectively included, we retrospectively retrieved the heart rate (HR), systolic blood pressure (SBP), volume of prehospital fluids and administration of noradrenaline. We calculated the shock index (SI: HR/SBP), the MGAP prehospital triage score and the Injury Severity Score (ISS). We also identified patients who had positive criteria from the Resuscitation Outcome Consortium (ROC, SBP < 70 mmHg or SBP 70-90 and HR > 107 pulse/min). For these parameters, we drew a ROC curve and defined a cut-off value to predict TIC or MT. The strength of association between prehospital parameters and TIC as well as MT was assessed using logistic regression, and cut-off values were determined using ROC curves. Among the 485 patients included in the study, TIC was observed in 112 patients (23%) and MT in 22 patients (5%). For the prediction of TIC, ISS had good accuracy (AUC: 0·844, 95% confidence interval, CI: 0·799-0·879), as did the volume of fluids (>1000 ml) given during prehospital care (AUC: 0·801, 95% CI: 0·752-0·842). For the prediction of MT, ISS had excellent accuracy (AUC: 0·932, 95% CI: 0·866-0·966), whereas good accuracy was found for SI (> 0·9; AUC: 0·859, 95% CI: 0·705-0·936), vasopressor administration (AUC: 0·828, 95% CI: 0·736-0·890) and fluids (>1000 ml; AUC: 0·811, 95% CI: 0·737-0·867). Vasopressor administration, ISS and SI were independent predictors of TIC and MT, whereas fluid volume and ROC criteria were independent predictor of TIC but not MT. No independent relationship was found between MGAP and TIC or MT. Prehospital parameters including the SI and resuscitation may help to better identify the severity of bleeding in trauma patients and the need for blood product administration at admission.