Nurses' perceptions of the design, implementation, and adoption of machine learning clinical decision support: A descriptive qualitative study.

INTRODUCTION: The purpose of this study was to explore nurses' perspectives on Machine Learning Clinical Decision Support (ML CDS) design, development, implementation, and adoption. DESIGN: Qualitative descriptive study. METHODS: Nurses (n = 17) participated in semi-structured interviews. Data were transcribed, coded, and analyzed using Thematic analysis methods as described by Braun and Clarke. RESULTS: Four major themes and 14 sub-themes highlight nurses' perspectives on autonomy in decision-making, the influence of prior experience in shaping their preferences for use of novel CDS tools, the need for clarity in why ML CDS is useful in improving practice/outcomes, and their desire to have nursing integrated in design and implementation of these tools. CONCLUSION: This study provided insights into nurse perceptions regarding the utility and usability of ML CDS as well as the influence of previous experiences with technology and CDS, change management strategies needed at the time of implementation of ML CDS, the importance of nurse-perceived engagement in the development process, nurse information needs at the time of ML CDS deployment, and the perceived impact of ML CDS on nurse decision making autonomy. CLINICAL RELEVANCE: This study contributes to the body of knowledge about the use of AI and machine learning (ML) in nursing practice. Through generation of insights drawn from nurses' perspectives, these findings can inform successful design and adoption of ML Clinical Decision Support.

The influence of the learning health system to address the COVID-19 pandemic: An examination of early literature.

INTRODUCTION: The COVID-19 pandemic has demanded immediate response from healthcare systems around the world. The learning health system (LHS) was created with rapid uptake of the newest evidence in mind, making it essential in the face of a pandemic. The goal of this review is to gain knowledge on the initial impact of the LHS on addressing the COVID-19 pandemic. METHODS: PubMed, Scopus and the Duke University library search tool were used to identify current literature regarding the intersection of the LHS and the COIVD-19 pandemic. Articles were reviewed for their purpose, findings and relation to each component of the LHS. RESULTS: Twelve articles were included in the review. All stages of the LHS were addressed from this sample. Most articles addressed some component of interoperability. Articles that interpreted data unique to COVID-19 and demonstrated specific tools and interventions were least common. CONCLUSIONS: Gaps in interoperability are well known and unlikely to be solved in the coming months. Collaboration between health systems, researchers, governments and professional societies is needed to support a robust LHS which grants the ability to rapidly adapt to global emergencies.

Data Science Methods for Nursing-Relevant Patient Outcomes and Clinical Processes: The 2019 Literature Year in Review.

Data science continues to be recognized and used within healthcare due to the increased availability of large data sets and advanced analytics. It can be challenging for nurse leaders to remain apprised of this rapidly changing landscape. In this article, we describe our findings from a scoping literature review of papers published in 2019 that use data science to explore, explain, and/or predict 15 phenomena of interest to nurses. Fourteen of the 15 phenomena were associated with at least one paper published in 2019. We identified the use of many contemporary data science methods (eg, natural language processing, neural networks) for many of the outcomes. We found many studies exploring Readmissions and Pressure Injuries. The topics of Artificial Intelligence/Machine Learning Acceptance, Burnout, Patient Safety, and Unit Culture were poorly represented. We hope that the studies described in this article help readers: (1) understand the breadth and depth of data science's ability to improve clinical processes and patient outcomes that are relevant to nurses and (2) identify gaps in the literature that are in need of exploration.

Identifying Barriers to The Implementation of Communicating Narrative Concerns Entered by Registered Nurses, An Early Warning System SmartApp.

BACKGROUND: Nurses are at the frontline of detecting patient deterioration. We developed Communicating Narrative Concerns Entered by Registered Nurses (CONCERN), an early warning system for clinical deterioration that generates a risk prediction score utilizing nursing data. CONCERN was implemented as a randomized clinical trial at two health systems in the Northeastern United States. Following the implementation of CONCERN, our team sought to develop the CONCERN Implementation Toolkit to enable other hospital systems to adopt CONCERN. OBJECTIVE: The aim of this study was to identify the optimal resources needed to implement CONCERN and package these resources into the CONCERN Implementation Toolkit to enable the spread of CONCERN to other hospital sites. METHODS: To accomplish this aim, we conducted qualitative interviews with nurses, prescribing providers, and information technology experts in two health systems. We recruited participants from July 2022 to January 2023. We conducted thematic analysis guided by the Donabedian model. Based on the results of the thematic analysis, we updated the α version of the CONCERN Implementation Toolkit. RESULTS: There was a total of 32 participants included in our study. In total, 12 themes were identified, with four themes mapping to each domain in Donabedian's model (i.e., structure, process, and outcome). Eight new resources were added to the CONCERN Implementation Toolkit. CONCLUSIONS: This study validated the α version of the CONCERN Implementation Toolkit. Future studies will focus on returning the results of the Toolkit to the hospital sites to validate the ß version of the CONCERN Implementation Toolkit. As the development of early warning systems continues to increase and clinician workflows evolve, the results of this study will provide considerations for research teams interested in implementing early warning systems in the acute care setting.

Implementable Prediction of Pressure Injuries in Hospitalized Adults: Model Development and Validation.

Background: Numerous pressure injury prediction models have been developed using electronic health record data, yet hospital-acquired pressure injuries (HAPIs) are increasing, which demonstrates the critical challenge of implementing these models in routine care. Objective: To help bridge the gap between development and implementation, we sought to create a model that was feasible, broadly applicable, dynamic, actionable, and rigorously validated and then compare its performance to usual care (ie, the Braden scale). Methods: We extracted electronic health record data from 197,991 adult hospital admissions with 51 candidate features. For risk prediction and feature selection, we used logistic regression with a least absolute shrinkage and selection operator (LASSO) approach. To compare the model with usual care, we used the area under the receiver operating curve (AUC), Brier score, slope, intercept, and integrated calibration index. The model was validated using a temporally staggered cohort. Results: A total of 5458 HAPIs were identified between January 2018 and July 2022. We determined 22 features were necessary to achieve a parsimonious and highly accurate model. The top 5 features included tracheostomy, edema, central line, first albumin measure, and age. Our model achieved higher discrimination than the Braden scale (AUC 0.897, 95% CI 0.893-0.901 vs AUC 0.798, 95% CI 0.791-0.803). Conclusions: We developed and validated an accurate prediction model for HAPIs that surpassed the standard-of-care risk assessment and fulfilled necessary elements for implementation. Future work includes a pragmatic randomized trial to assess whether our model improves patient outcomes.

Defining documentation burden (DocBurden) and excess DocBurden for all health professionals: A scoping review.

OBJECTIVE: Efforts to reduce documentation burden (DocBurden) for all health professionals (HP) are aligned with national initiatives to improve clinician wellness and patient safety. Yet DocBurden has not been precisely defined, limiting national conversations and rigorous, reproducible, and meaningful measures. Increasing attention to DocBurden motivated this work to establish a standard definition of DocBurden, with the emergence of excessive DocBurden as a term. METHODS: We conducted a scoping review of DocBurden definitions and descriptions, searching six databases for scholarly, peer-reviewed, and gray literature sources, using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extensions for Scoping Review (PRISMA-ScR) guidance. For the concept clarification phase of work, we used the American Nursing Informatics Association (ANIA)'s 6-Domains of Burden Framework. RESULTS: A total of 153 articles were included based on a priori criteria. Most articles described a focus on DocBurden, but only 18% (n=28) provided a definition. We define excessive DocBurden as the stress and unnecessarily heavy work a HP or healthcare team experiences when usability of documentation systems and documentation activities (i.e., generation, review, analysis and synthesis of patient data) are not aligned in support of care delivery. A negative connotation was attached to burden without a neutral state in included sources, which does not align with dictionary definitions of burden. CONCLUSIONS: Existing literature does not distinguish between a baseline or required task load to conduct patient care resulting from usability issues(DocBurden), and the unnecessarily heavy tasks and requirements that contribute to excessive DocBurden. Our definition of excessive DocBurden explicitly acknowledges this distinction, to support development of meaningful measures for understanding and intervening on excessive DocBurden locally, nationally and internationally.

The Impact of Clinical Decision Support on Health Disparities and the Digital Divide.

OBJECTIVES: This literature review summarizes relevant studies from the last three years (2020-2022) related to clinical decision support (CDS) and CDS impact on health disparities and the digital divide. This survey identifies current trends and synthesizes evidence-based recommendations and considerations for future development and implementation of CDS tools. METHODS: We conducted a search in PubMed for literature published between 2020 and 2022. Our search strategy was constructed as a combination of the MEDLINE®/PubMed® Health Disparities and Minority Health Search Strategy and relevant CDS MeSH terms and phrases. We then extracted relevant data from the studies, including priority population when applicable, domain of influence on the disparity being addressed, and the type of CDS being used. We also made note of when a study discussed the digital divide in some capacity and organized the comments into general themes through group discussion. RESULTS: Our search yielded 520 studies, with 45 included at the conclusion of screening. The most frequent CDS type in this review was point-of-care alerts/reminders (33.3%). Health Care System was the most frequent domain of influence (71.1%), and Blacks/African Americans were the most frequently included priority population (42.2%). Throughout the literature, we found four general themes related to the technology divide: inaccessibility of technology, access to care, trust of technology, and technology literacy.This survey revealed the diversity of CDS being used to address health disparities and several barriers which may make CDS less effective or potentially harmful to certain populations. Regular examinations of literature that feature CDS and address health disparities can help to reveal new strategies and patterns for improving healthcare.

Data Science Implementation Trends in Nursing Practice: A Review of the 2021 Literature.

OBJECTIVES: The goal of this work was to provide a review of the implementation of data science-driven applications focused on structural or outcome-related nurse-sensitive indicators in the literature in 2021. By conducting this review, we aim to inform readers of trends in the nursing indicators being addressed, the patient populations and settings of focus, and lessons and challenges identified during the implementation of these tools. METHODS: We conducted a rigorous descriptive review of the literature to identify relevant research published in 2021. We extracted data on model development, implementation-related strategies and measures, lessons learned, and challenges and stakeholder involvement. We also assessed whether reports of data science application implementations currently follow the guidelines of the Developmental and Exploratory Clinical Investigations of DEcision support systems driven by AI (DECIDE-AI) framework. RESULTS: Of 4,943 articles found in PubMed (NLM) and CINAHL (EBSCOhost), 11 were included in the final review and data extraction. Systems leveraging data science were developed for adult patient populations and were primarily deployed in hospital settings. The clinical domains targeted included mortality/deterioration, utilization/resource allocation, and hospital-acquired infections/COVID-19. The composition of development teams and types of stakeholders involved varied. Research teams more frequently reported on implementation methods than implementation results. Most studies provided lessons learned that could help inform future implementations of data science systems in health care. CONCLUSION: In 2021, very few studies report on the implementation of data science-driven applications focused on structural- or outcome-related nurse-sensitive indicators. This gap in the sharing of implementation strategies needs to be addressed in order for these systems to be successfully adopted in health care settings.

Clinical, technical, and implementation characteristics of real-world health applications using FHIR.

Objective: Understanding the current state of real-world Fast Healthcare Interoperability Resources (FHIR) applications (apps) will benefit biomedical research and clinical care and facilitate advancement of the standard. This study aimed to provide a preliminary assessment of these apps' clinical, technical, and implementation characteristics. Materials and Methods: We searched public repositories for potentially eligible FHIR apps and surveyed app implementers and other stakeholders. Results: Of the 112 apps surveyed, most focused on clinical care (74) or research (45); were implemented across multiple sites (56); and used SMART-on-FHIR (55) and FHIR version R4 (69). Apps were primarily stand-alone web-based (67) or electronic health record (EHR)-embedded (51), although 49 were not listed in an EHR app gallery. Discussion: Though limited in scope, our results show FHIR apps encompass various domains and characteristics. Conclusion: As FHIR use expands, this study-one of the first to characterize FHIR apps at large-highlights the need for systematic, comprehensive methods to assess their characteristics.

Data Science Trends Relevant to Nursing Practice: A Rapid Review of the 2020 Literature.

BACKGROUND: The term "data science" encompasses several methods, many of which are considered cutting edge and are being used to influence care processes across the world. Nursing is an applied science and a key discipline in health care systems in both clinical and administrative areas, making the profession increasingly influenced by the latest advances in data science. The greater informatics community should be aware of current trends regarding the intersection of nursing and data science, as developments in nursing practice have cross-professional implications. OBJECTIVES: This study aimed to summarize the latest (calendar year 2020) research and applications of nursing-relevant patient outcomes and clinical processes in the data science literature. METHODS: We conducted a rapid review of the literature to identify relevant research published during the year 2020. We explored the following 16 topics: (1) artificial intelligence/machine learning credibility and acceptance, (2) burnout, (3) complex care (outpatient), (4) emergency department visits, (5) falls, (6) health care-acquired infections, (7) health care utilization and costs, (8) hospitalization, (9) in-hospital mortality, (10) length of stay, (11) pain, (12) patient safety, (13) pressure injuries, (14) readmissions, (15) staffing, and (16) unit culture. RESULTS: Of 16,589 articles, 244 were included in the review. All topics were represented by literature published in 2020, ranging from 1 article to 59 articles. Numerous contemporary data science methods were represented in the literature including the use of machine learning, neural networks, and natural language processing. CONCLUSION: This review provides an overview of the data science trends that were relevant to nursing practice in 2020. Examinations of such literature are important to monitor the status of data science's influence in nursing practice.

A thematic analysis to examine the feasibility of EHR-based clinical decision support for implementing Choosing Wisely ® guidelines.

OBJECTIVE: To identify important barriers and facilitators relating to the feasibility of implementing clinical practice guidelines (CPGs) as clinical decision support (CDS). MATERIALS AND METHODS: We conducted a qualitative, thematic analysis of interviews from seven interviews with dyads (one clinical expert and one systems analyst) who discussed the feasibility of implementing 10 Choosing Wisely® guidelines at their institutions. We conducted a content analysis to extract salient themes describing facilitators, challenges, and other feasibility considerations regarding implementing CPGs as CDS. RESULTS: We identified five themes: concern about data quality impacts implementation planning; the availability of data in a computable format is a primary factor for implementation feasibility; customized strategies are needed to mitigate uncertainty and ambiguity when translating CPGs to an electronic health record-based tool; misalignment of expected CDS with pre-existing clinical workflows impact implementation; and individual level factors of end-users must be considered when selecting and implementing CDS tools. DISCUSSION: The themes reveal several considerations for CPG as CDS implementations regarding data quality, knowledge representation, and sociotechnical issues. Guideline authors should be aware that using CDS to implement CPGs is becoming increasingly popular and should consider providing clear guidelines to aid implementation. The complex nature of CPG as CDS implementation necessitates a unified effort to overcome these challenges. CONCLUSION: Our analysis highlights the importance of cooperation and co-development of standards, strategies, and infrastructure to address the difficulties of implementing CPGs as CDS. The complex interactions between the concepts revealed in the interviews necessitates the need that such work should not be conducted in silos. We also implore that implementers disseminate their experiences.

A Conceptual Framework of Data Readiness: The Contextual Intersection of Quality, Availability, Interoperability, and Provenance.

BACKGROUND: Data readiness is a concept often used when referring to health information technology applications in the informatics disciplines, but it is not clearly defined in the literature. To avoid misinterpretations in research and implementation, a formal definition should be developed. OBJECTIVES: The objective of this research is to provide a conceptual definition and framework for the term data readiness that can be used to guide research and development related to data-based applications in health care. METHODS: PubMed, the National Institutes of Health RePORTER, Scopus, the Cochrane Library, and Duke University Library databases for business and information sciences were queried for formal mentions of the term "data readiness." Manuscripts found in the search were reviewed, and relevant information was extracted, evaluated, and assimilated into a framework for data readiness. RESULTS: Of the 264 manuscripts found in the database searches, 20 were included in the final synthesis to define data readiness. In these 20 manuscripts, the term data readiness was revealed to encompass the constructs of data quality, data availability, interoperability, and data provenance. DISCUSSION: Based upon our review of the literature, we define data readiness as the application-specific intersection of data quality, data availability, interoperability, and data provenance. While these concepts are not new, the combination of these factors in a novel data readiness model may help guide future informatics research and implementation science. CONCLUSION: This analysis provides a definition to guide research and development related to data-based applications in health care. Future work should be done to validate this definition, and to apply the components of data readiness to real-world applications so that specific metrics may be developed and disseminated.

Machine Learning Algorithms to Predict Mortality and Allocate Palliative Care for Older Patients With Hip Fracture.

OBJECTIVES: To evaluate a machine learning model designed to predict mortality for Medicare beneficiaries aged >65 years treated for hip fracture in Inpatient Rehabilitation Facilities (IRFs). DESIGN: Retrospective design/cohort analysis of Centers for Medicare & Medicaid Services Inpatient Rehabilitation Facility-Patient Assessment Instrument data. SETTING AND PARTICIPANTS: A total of 17,140 persons admitted to Medicare-certified IRFs in 2015 following hospitalization for hip fracture. MEASURES: Patient characteristics include sociodemographic (age, gender, race, and social support) and clinical factors (functional status at admission, chronic conditions) and IRF length of stay. Outcomes were 30-day and 1-year all-cause mortality. We trained and evaluated 2 classification models, logistic regression and a multilayer perceptron (MLP), to predict the probability of 30-day and 1-year mortality and evaluated the calibration, discrimination, and precision of the models. RESULTS: For 30-day mortality, MLP performed well [acc = 0.74, area under the receiver operating characteristic curve (AUROC) = 0.76, avg prec = 0.10, slope = 1.14] as did logistic regression (acc = 0.78, AUROC = 0.76, avg prec = 0.09, slope = 1.20). For 1-year mortality, the performances were similar for both MLP (acc = 0.68, AUROC = 0.75, avg prec = 0.32, slope = 0.96) and logistic regression (acc = 0.68, AUROC = 0.75, avg prec = 0.32, slope = 0.95). CONCLUSION AND IMPLICATIONS: A scoring system based on logistic regression may be more feasible to run in current electronic medical records. But MLP models may reduce cognitive burden and increase ability to calibrate to local data, yielding clinical specificity in mortality prediction so that palliative care resources may be allocated more effectively.

Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory.

OBJECTIVE: We identified challenges and solutions to using electronic health record (EHR) systems for the design and conduct of pragmatic research. MATERIALS AND METHODS: Since 2012, the Health Care Systems Research Collaboratory has served as the resource coordinating center for 21 pragmatic clinical trial demonstration projects. The EHR Core working group invited these demonstration projects to complete a written semistructured survey and used an inductive approach to review responses and identify EHR-related challenges and suggested EHR enhancements. RESULTS: We received survey responses from 20 projects and identified 21 challenges that fell into 6 broad themes: (1) inadequate collection of patient-reported outcome data, (2) lack of structured data collection, (3) data standardization, (4) resources to support customization of EHRs, (5) difficulties aggregating data across sites, and (6) accessing EHR data. DISCUSSION: Based on these findings, we formulated 6 prerequisites for PCTs that would enable the conduct of pragmatic research: (1) integrate the collection of patient-centered data into EHR systems, (2) facilitate structured research data collection by leveraging standard EHR functions, usable interfaces, and standard workflows, (3) support the creation of high-quality research data by using standards, (4) ensure adequate IT staff to support embedded research, (5) create aggregate, multidata type resources for multisite trials, and (6) create re-usable and automated queries. CONCLUSION: We are hopeful our collection of specific EHR challenges and research needs will drive health system leaders, policymakers, and EHR designers to support these suggestions to improve our national capacity for generating real-world evidence.

A Closer Look at the "Right" Format for Clinical Decision Support: Methods for Evaluating a Storyboard BestPractice Advisory.

(1) Background: The five rights of clinical decision support (CDS) are a well-known framework for planning the nuances of CDS, but recent advancements have given us more options to modify the format of the alert. One-size-fits-all assessments fail to capture the nuance of different BestPractice Advisory (BPA) formats. To demonstrate a tailored evaluation methodology, we assessed a BPA after implementation of Storyboard for changes in alert fatigue, behavior influence, and task completion; (2) Methods: Data from 19 weeks before and after implementation were used to evaluate differences in each domain. Individual clinics were evaluated for task completion and compared for changes pre- and post-redesign; (3) Results: The change in format was correlated with an increase in alert fatigue, a decrease in erroneous free text answers, and worsened task completion at a system level. At a local level, however, 14% of clinics had improved task completion; (4) Conclusions: While the change in BPA format was correlated with decreased performance, the changes may have been driven primarily by the COVID-19 pandemic. The framework and metrics proposed can be used in future studies to assess the impact of new CDS formats. Although the changes in this study seemed undesirable in aggregate, some positive changes were observed at the level of individual clinics. Personalized implementations of CDS tools based on local need should be considered.

Measuring implementation feasibility of clinical decision support alerts for clinical practice recommendations.

OBJECTIVE: The study sought to describe key features of clinical concepts and data required to implement clinical practice recommendations as clinical decision support (CDS) tools in electronic health record systems and to identify recommendation features that predict feasibility of implementation. MATERIALS AND METHODS: Using semistructured interviews, CDS implementers and clinician subject matter experts from 7 academic medical centers rated the feasibility of implementing 10 American College of Emergency Physicians Choosing Wisely Recommendations as electronic health record-embedded CDS and estimated the need for additional data collection. Ratings were combined with objective features of the guidelines to develop a predictive model for technical implementation feasibility. RESULTS: A linear mixed model showed that the need for new data collection was predictive of lower implementation feasibility. The number of clinical concepts in each recommendation, need for historical data, and ambiguity of clinical concepts were not predictive of implementation feasibility. CONCLUSIONS: The availability of data and need for additional data collection are essential to assess the feasibility of CDS implementation. Authors of practice recommendations and guidelines can enable organizations to more rapidly assess data availability and feasibility of implementation by including operational definitions for required data.

Data and knowledge standards for learning health: A population management example using chronic kidney disease.

The widespread creation of learning health care systems (LHSs) will depend upon the use of standards for data and knowledge representation. Standards can facilitate the reuse of approaches for the identification of patient cohorts and the implementation of interventions. Standards also support rapid evaluation and dissemination across organizations. Building upon widely-used models for process improvement, we identify specific LHS activities that will require data and knowledge standards. Using chronic kidney disease (CKD) as an example, we highlight the specific data and knowledge requirements for a disease-specific LHS cycle, and subsequently identify areas where standards specifications, clarification, and tools are needed. The current data standards for CKD population management recommendations were found to be partially ambiguous, leading to barriers in phenotyping, risk identification, patient-centered clinical decision support, patient education needs, and care planning. Robust tools are needed to effectively identify patient health care needs and preferences and to measure outcomes that accurately depict the multiple facets of CKD. This example presents an approach for defining the specific data and knowledge representation standards required to implement condition-specific population health management programs. These standards specifications can be promoted by disease advocacy and professional societies to enable the widespread design, implementation, and evaluation of evidence-based health interventions, and the subsequent dissemination of experience in different settings and populations.

Emergency Department Clinician Perspectives on the Data Availability to Implement Clinical Decision Support Tools for Five Clinical Practice Guidelines.

Clinical practice guidelines (CPGs) often serve as the knowledge base for clinical decision support (CDS). While CPGs are rigorously created by medical professional societies, the concepts in each guideline may not be sufficient for translation into CDS applications. In addition, clinicians' perceptions of these concepts may differ greatly, affecting the implementation and impact of CDS within an organization. Five guidelines developed by the American College of Emergency Physicians were systematically explored, generating fifty-one unique clinical concepts. These concepts were presented to two nurses and two physicians, whom were asked to assess and comment on the capture of each clinical concept in the electronic health record (EHR) and the subsequent availability of the data for CDS. Nurses and physicians showed differing perceptions of data availability. These differing perceptions may influence an organizational approach to developing and implementing CDS, potentially informing our understanding of why CDS may not achieve the intended impact.

Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery.

INTRODUCTION: The transfusion-related respiratory complications, transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO), are leading causes of transfusion-related morbidity and mortality. At present, there are no effective preventive strategies with red blood cell (RBC) transfusion. Although mechanisms remain incompletely defined, soluble biological response modifiers (BRMs) within the RBC storage solution may play an important role. Point-of-care (POC) washing of allogeneic RBCs may remove these BRMs, thereby mitigating their impact on post-transfusion respiratory complications. METHODS AND ANALYSIS: This is a multicenter randomised clinical trial of standard allogeneic versus washed allogeneic RBC transfusion for adult patients undergoing cardiac surgery testing the hypothesis that POC RBC washing is feasible, safe, and efficacious and will reduce recipient immune and physiologic responses associated with transfusion-related respiratory complications. Relevant clinical outcomes will also be assessed. This investigation will enrol 170 patients at two hospitals in the USA. Simon's two-stage design will be used to assess the feasibility of POC RBC washing. The primary safety outcomes will be assessed using Wilcoxon Rank-Sum tests for continuous variables and Pearson chi-square test for categorical variables. Standard mixed modelling practices will be employed to test for changes in biomarkers of lung injury following transfusion. Linear regression will assess relationships between randomised group and post-transfusion physiologic measures. ETHICS AND DISSEMINATION: Safety oversight will be conducted under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained by the DSMB as well as the institutional review boards at each institution prior to enrolling the first study participant. This study aims to provide important information regarding the feasibility of POC washing of allogeneic RBCs and its potential impact on ameliorating post-transfusion respiratory complications. Additionally, it will inform the feasibility and scientific merit of pursuing a more definitive phase II/III clinical trial. REGISTRATION: ClinicalTrials.gov registration number is NCT02094118 (Pre-results).