The Utility and Limitations of Remotely Delivered Feedback Messages Regarding Physical Activity in a 12-Month Weight Loss Intervention: Insights From the SMARTER Trial Focus Groups.

BACKGROUND: The increasing prevalence of obesity necessitates innovative interventions to address this grave public health concern. Standard behavioral therapy has been the mainstay for promoting weight loss, but its access and uptake are limited. The SMARTER randomized controlled trial aimed to explore the effects of self-monitoring with real-time, remotely delivered tailored feedback to recorded physical activity (PA) on weight loss. OBJECTIVE: This qualitative study examined the perceived utility and limitations of key intervention components in promoting PA and weight loss in the SMARTER trial. METHODS: Twenty-three participants who received feedback engaged in Zoom-based focus groups, providing insights into their interactions with the SMARTER app, Fitbit Charge 2 tracker, Aria II scale, and daily weighing. Participants' perspectives on feedback messages, personalized app experiences, and the impact of daily weighing on mental health emerged, providing nuanced insights into the multifaceted nature of success. RESULTS: Themes from the focus group emphasized the importance of tailoring feedback to individual preferences related to message timing, content, and engagement. The challenges that made the participants stop using the program as instructed included disappointment with not losing weight after several weeks of engagement, inability to open feedback messages within the 60-minute window, and environmental situations that prevented them from acting on the feedback received. CONCLUSION: These findings contribute to ongoing efforts geared toward refining interventions targeting PA and weight loss among individuals with obesity and provide important insights for future studies seeking to optimize the design and delivery of remotely delivered feedback messages.

Information and resources VA health system leaders need to manage enrollment and retention for Post-9/11 veterans.

OBJECTIVE: To understand Veterans Health Administration (VA) leaders' information and resource needs for managing post-9/11 Veterans' VA enrollment and retention. DATA SOURCES AND STUDY SETTING: Interviews conducted from March-May 2022 of VA Medical Center (VAMC) leaders (N = 27) across 15 sites, using stratified sampling based on VAMC characteristics: enrollment rates, number of recently separated Veterans in catchment area, and state Medicaid expansion status. STUDY DESIGN: Interview questions were developed using Petersen et al.'s Factors Influencing Choice of Healthcare System framework as a guide. Interviews were transcribed verbatim, and two coders analyzed the interviews using Atlas.ti, a qualitative software program. Coders followed the qualitative coding philosophy developed by Crabtree and Miller, a process of developing codes for salient concepts as they are identified during the analysis process. DATA COLLECTION/EXTRACTION METHODS: Two coders analyzed 22% (N = 6) of the interviews and discussed and adjudicated any discrepancies. One coder independently coded the remainder of the interviews. PRINCIPAL FINDINGS: Several key themes were identified regarding facilitators and barriers for VA enrollment including reputation for high-quality VA care, convenience of VA services, awareness of VA services and benefits, and VA mental health services. Nearly every VA leader actively used tools and data to understand enrollment and retention rates and sought to enroll and retain more Veterans. To improve the management of enrollment and retention, VA leaders would like data shared in an easily understandable format and the capability to share data between the VA and community healthcare systems. CONCLUSIONS: Enrollment and retention information is important for healthcare leaders to guide their health system decisions. Various tools are currently being used to try to understand the data. However, a multifunctional tool is needed to better aggregate the data to provide VA leadership with key information on Veterans' enrollment and retention.

Shallow Subsidies for Veterans Facing Housing Barriers in the VA Supportive Services for Veteran Families Program.

The Department of Veterans Affairs provides a shallow subsidy (i.e., subsidizing 50% of an individual's rent for two years) to Veterans experiencing housing instability. We sought to describe the characteristics of Veterans who received these subsidies. Methods. We conducted a retrospective cohort study of Veterans between 10/2019-9/2021. We identified Veteran-level characteristics associated with receiving a shallow subsidy using a multivariable two-part regression model. We also conducted qualitative interviews to identify how shallow subsidies are allocated. Results Black race, higher income, more education, and older age were positively associated with receiving a shallow subsidy; previous homelessness, prior VA outpatient cost, and participating in permanent supportive housing were negatively associated with receiving a shallow subsidy. Interviews revealed that income was the most influential determinant of whether to give shallow subsidies. Discussion Our mixed methods findings were consistent, indicating that socioeconomic stability is an important driver of shallow subsidy allocation decisions.

Parents' Experiences Caring for a Child after a Critical Illness: A Qualitative Study.

Objectives This article described parents' experience and identifies outcomes important to parents following their child's critical illness. Methods Semistructured interviews with 22 female and 4 male parents representing 26 critically ill children with predominately neurologic and respiratory diagnoses. Most children were younger than 5 years at discharge with a median (interquartile range) of 2 (2.0-3.0) years from discharge to interview. Results Many children returned home with life-altering physical and cognitive disabilities requiring months to years of rehabilitation. Parents remembered feeling unprepared and facing an intense, chaotic time when the child first returned home. They described how they suddenly had to center their daily activities around the child's needs amidst competing needs of siblings and partners, and in some cases, the medicalization of the home. They recounted negotiating adjustments almost daily with insurance agencies, medical doctors and therapists, employers, the child, and other family members to keep the family functioning. In the long term, families developed a new norm, choosing to focus on what the child could still do rather than what they could not. Even if the child returned to baseline, parents remembered the adjustments made to keep the child alive and the family functioning. Conclusion Heightened awareness of family experiences after pediatric critical illness will allow health care providers to improve family preparedness for the transition from hospital to home.

Challenges and Opportunities in the Elective Management of Diverticulitis: Perspectives From a National Sample of Colorectal Surgeons.

BACKGROUND: Diverticulitis is a complex, heterogeneous disease process that affects a diverse population of patients. In the elective management of this disease, treatment guidelines have shifted toward patient-centered, individualized decision-making. It is not known what challenges surgeons face as they approach these nuanced treatment decisions in practice. OBJECTIVE: This study aimed to identify opportunities to support colorectal surgeons in elective diverticulitis treatment. DESIGN: This was a qualitative study using standardized, semistructured interviews to explore the perspectives of 29 colorectal surgeons recruited using a purposive sampling technique. Data were analyzed using an "open-coding" approach. SETTINGS: Interviews with a national sample of colorectal surgeons were conducted from a single center using an online video platform. PATIENTS: This study did not involve patients. MAIN OUTCOME MEASURES: Interviews explored surgeons' experiences treating diverticulitis in the elective setting, focusing on perceived challenges in providing patient-centered care as well as opportunities to improve treatment decisions. RESULTS: Our qualitative analysis identified an overarching challenge in elective diverticulitis management for surgeons: difficulty ensuring adequate patient understanding of the risks and benefits of various treatments. This was thought to be due to 1) preexisting patient expectations about treatment and 2) lack of data regarding long-term treatment outcomes. Surgeons identified 2 potential opportunities to combat these challenges: 1) patient education and 2) additional research regarding treatment outcomes, with potential for the development of diverticulitis-specific decision support tools. LIMITATIONS: These results are based on a national sample of colorectal surgeons, but they capture qualitative data that is not intended to provide generalizable findings. CONCLUSIONS: As surgeons work toward providing individualized care for diverticulitis patients, they find it difficult to adequately counsel patients regarding the patient-specific risks of various treatments. The results of this study identify specific contributors to this problem as well as potential targets for intervention, which can guide future efforts to support surgeons in providing patient-centered care. See Video Abstract . DESAFOS Y OPORTUNIDADES EN EL MANEJO ELECTIVO DE LA DIVERTICULITIS PERSPECTIVAS DE UNA MUESTRA NACIONAL DE CIRUJANOS COLORRECTALES: ANTECEDENTES:La diverticulitis es un proceso patológico complejo y heterogéneo que afecta a una población diversa de pacientes. En el manejo electivo de esta enfermedad, las pautas de tratamiento se han desplazado hacia una toma de decisiones individualizada y centrada en el paciente. No se sabe qué desafíos enfrentan los cirujanos al abordar estas decisiones de tratamiento matizadas en la práctica.OBJETIVO:Identificar oportunidades para apoyar a los cirujanos colorrectales en el tratamiento electivo de la diverticulitis.DISEÑO:Este fue un estudio cualitativo que utilizó entrevistas semiestructuradas estandarizadas para explorar las perspectivas de 29 cirujanos colorrectales reclutados mediante una técnica de muestreo intencional. Los datos se analizaron utilizando un enfoque de "codificación abierta".ESCENARIO:Las entrevistas con una muestra nacional de cirujanos colorrectales se realizaron desde un solo centro utilizando una plataforma de video en línea.PRINCIPALES MEDIDAS DE RESULTADO:Las entrevistas exploraron las experiencias de los cirujanos en el tratamiento de la diverticulitis en el entorno electivo, centrándose en los desafíos percibidos en la prestación de atención centrada en el paciente, así como en las oportunidades para mejorar las decisiones de tratamiento.RESULTADOS:Nuestro análisis cualitativo identificó un desafío general en el manejo de la diverticulitis electiva para los cirujanos: la dificultad para asegurar que el paciente comprenda adecuadamente los riesgos y beneficios de los diversos tratamientos. Se pensó que esto se debía a 1) las expectativas preexistentes del paciente sobre el tratamiento y 2) la falta de datos sobre los resultados del tratamiento a largo plazo. Los cirujanos identificaron dos oportunidades potenciales para combatir estos desafíos: 1) educación del paciente y 2) investigación adicional sobre los resultados del tratamiento, con potencial para el desarrollo de herramientas de apoyo a la toma de decisiones específicas para la diverticulitis.LIMITACIONES:Estos resultados se basan en una muestra nacional de cirujanos colorrectales, pero capturan datos cualitativos que no pretenden proporcionar hallazgos generalizables.CONCLUSIONES:A medida que los cirujanos trabajan para brindar atención individualizada a los pacientes con diverticulitis, les resulta difícil aconsejar adecuadamente a los pacientes sobre los riesgos específicos de los pacientes para los diversos tratamientos. Los resultados de este estudio identifican contribuyentes específicos a este problema, así como objetivos potenciales para la intervención, que pueden guiar los esfuerzos futuros para ayudar a los cirujanos a brindar atención centrada en el paciente. (Traducción-Dr. Felipe Bellolio ).

Excellence in Antibiotic Stewardship: A mixed methods study comparing High, Medium, and Low Performing Hospitals.

BACKGROUND: Despite antibiotic stewardship programs existing in most acute care hospitals, there continues to be variation in appropriate antibiotic use. While existing research examines individual prescriber behavior, contextual reasons for variation are poorly understood. METHODS: We conducted an explanatory, sequential mixed methods study of a purposeful sample of 7 hospitals with varying discharge antibiotic overuse. For each hospital, we conducted surveys, document analysis, and semi-structured interviews with antibiotic stewardship and clinical stakeholders. Data were analyzed separately and mixed during the interpretation phase, where each hospital was examined as a case, with findings organized across cases using a strengths, weaknesses, opportunities, and threats framework to identify factors accounting for differences in antibiotic overuse across hospitals. RESULTS: Surveys included 85 respondents. Interviews included 90 respondents (31 hospitalists, 33 clinical pharmacists, 14 stewardship leaders, 12 hospital leaders). On surveys, clinical pharmacists at hospitals with lower antibiotic overuse were more likely to report feeling: respected by hospitalist colleagues (p=0.001), considered valuable team members (p=0.001), comfortable recommending antibiotic changes (p=0.02). Based on mixed-methods analysis, hospitals with low antibiotic overuse had four distinguishing characteristics: a) robust knowledge of and access to antibiotic stewardship guidance, b) high quality clinical pharmacist-physician relationships, c) tools and infrastructure to support stewardship, and d) highly engaged Infectious Diseases physicians who advocated stewardship principles. CONCLUSION: This mixed-method study demonstrates the importance of organizational context for high performance in stewardship and suggests improving antimicrobial stewardship requires attention to knowledge, interactions, and relationships between clinical teams and infrastructure that supports stewardship and team interactions.

Cancer Treatment Decision-Making for People Living With HIV: Physician-Reported Barriers, Facilitators, and Recommendations.

BACKGROUND: Compared with the general cancer population, people living with HIV (PLWH) and cancer are less likely to receive treatment and have significantly elevated cancer-specific mortality for many common cancer types. Physician recommendations drive the cancer therapy that patients receive, yet there is limited information assessing how cancer treatment decisions are made for people living with HIV and cancer. We sought to understand oncologist decision-making in PLWH and cancer by eliciting barriers, facilitators, and recommendations for enhancing care delivery. SETTING: Participants were recruited between May 2019 and May 2021 from one academic medical center in the western United States (n = 13), another in the southeastern United States (n = 7), and community practices nationwide (n = 5). METHODS: Using an inductive qualitative approach, we conducted in-depth interviews with 25 oncologists from two academic medical centers and community practices. RESULTS: Facilitators of cancer care delivery included readily available information regarding HIV status and stage, interdepartmental communication, and antiviral therapy adherence. Barriers included a lack of formal education on HIV malignancies, perceptions of decreased life expectancy, fear of inadvertent disclosure, and drug-drug interactions. Recommendations included improved provider communication, patient social and mental health resources, and continuing education opportunities. CONCLUSION: The study revealed drivers of cancer treatment decision-making, highlighting physician-reported barriers and facilitators, and recommendations to support treatment decision-making. This is the first known study examining oncologists' perceptions of caring for PLWH. Given that cancer is a leading cause of death among PLWH, there is an urgent need to improve care and outcomes.

Differences in perceptions and acceptance of COVID-19 vaccination between vaccine hesitant and non-hesitant persons.

Acceptance of the COVID-19 vaccination becomes more critical as new variants continue to evolve and the United States (US) attempts to move from pandemic response to management and control. COVID-19 stands out in the unique way it has polarized patients and generated sustained vaccine hesitancy over time. We sought to understand differences in perceptions and acceptance of COVID-19 vaccination between vaccine hesitant and non-hesitant patients, with the goal of informing communication and implementation strategies to increase uptake of COVID-19 vaccines in Veteran and non-Veteran communities. This qualitative study used interview data from focus groups conducted by the Department of Veterans Affairs (VA) and the University of Utah; all focus groups were conducted using the same script March-July 2021. Groups included forty-six United States Veterans receiving care at 28 VA facilities across the country and 166 non-Veterans across Utah for a total of 36 one-hour focus groups. We identified perceptions and attitudes toward COVID-19 vaccination through qualitative analysis of focus group participant remarks, grouping connections with identified themes within domains developed based on the questions asked in the focus group guide. Responses suggest participant attitudes toward the COVID-19 vaccine were shaped primarily by vaccine attitude changes over time, impacted by perceived vaccine benefits, risks, differing sources of vaccine information and political ideology. Veterans appeared more polarized, being either largely non-hesitant, or hesitant, whereas non-Veterans had a wider range of hesitancy, with more participants identifying minor doubts and concerns about receiving the vaccine, or simply being altogether unsure about receiving it. Development of COVID-19 vaccine communication strategies in Veteran and non-Veteran communities should anticipate incongruous sources of information and explicitly target community differences in perceptions of risks and benefits associated with the vaccine to generate candid discussions and repair individuals' trust. We believe this could accelerate vaccine acceptance over time.

Examining the Primary Care Experience of Patients With Opioid Use Disorder: A Qualitative Study.

OBJECTIVES: Despite substantial investment in expanding access to treatment for opioid use disorder (OUD), overdose deaths continue to increase. Primary care holds enormous potential to expand access to OUD treatment, but few patients receive medications for OUD (MOUD) in primary care. Understanding both patient and clinician experiences is critical to expanding access to patient-centered MOUD care, yet relatively little research has examined patient perspectives on primary care-based MOUD. We sought to examine the care experiences of patients with OUD receiving medication-based treatment in a primary care setting. METHODS: We conducted semistructured interviews with patients receiving MOUD at a single primary care site at the University of Utah. Interviews were performed and transcribed by qualitative researchers, who used rapid qualitative analysis using a grounded theory-based approach to identify key themes pertaining to patient experiences receiving medication-based OUD treatment in primary care. RESULTS: Twenty-one patients were screened, and 14 completed the interview. In general, participants had numerous medical and psychiatric comorbidities. The following key themes pertaining to primary care-based OUD treatment were identified: (1) overall health improvement, (2) team-based care, (3) comparing primary care to specialty addiction treatment, (4) access to medications for OUD, and (5) discrimination and stigma. CONCLUSIONS: Patients reported many advantages to receiving primary care-based MOUD treatment. In particular, the flexibility and added support of team-based care along with the convenience of receiving addiction treatment alongside regular medical care were highly valued. These findings can be used to develop patient-centered initiatives aimed at expanding OUD treatment within primary care.

Women's Health Provider Perspectives on Reproductive Services Provision in the Veterans Health Administration.

OBJECTIVES: Women veterans are a fast-growing population in the Veterans Health Administration (VHA), and ensuring reproductive service availability is a VHA priority. As such, we sought to explore barriers and facilitators to VHA reproductive service provision across a catchment area from women's health providers' perspectives. METHODS: We performed a mixed-methods study, including semistructured, qualitative provider interviews with a quantitative survey on training, comfort, and knowledge of reproductive services. All women's health providers and their support staff from the Salt Lake City Veterans Affairs Medical Center and nine VHA community-based outpatient clinics were asked to participate. We conducted qualitative interviews and knowledge surveys with providers and staff to explore training, care processes, and improvement opportunities in reproductive service provision. We completed descriptive analyses of all of the quantitative data and used an open, iterative process to analyze provider interviews for emergent themes. RESULTS: We interviewed 15 providers (7 advanced practice nurses, 4 registered nurses, and 4 physicians) across nine sites (50% response rate). The commonly identified barriers included provider training and staffing, scheduling/referral processes, inconsistent services/supplies, and lack of veteran awareness of reproductive services. Facilitators included prior non-VHA reproductive health experience among providers, invested support staff, and the integrated VHA health system. CONCLUSIONS: Addressing barriers to VHA reproductive healthcare provision may overcome reproductive service variations related to clinic location and improve reproductive health outcomes for women veterans.

Improving Cancer Care for People Living With HIV: A Qualitative Study of Provider Knowledge, Attitudes, and Practice.

PURPOSE: Cancer is now the leading cause of non-AIDS death in the US population with HIV. People living with HIV (PLWH) are known to have lower cancer treatment rates and worse cancer outcomes. Disparate cancer treatment is driven by health system, patient, and clinician factors. Little attention has been given to the factors oncologists consider when making cancer treatment recommendations to PLWH. This study sought to examine oncologists' knowledge, attitudes, and practices that influence cancer treatment decision-making. METHODS AND MATERIALS: This study used qualitative methods to explore oncologists' treatment decision-making processes for PLWH and cancer. The sample included 25 radiation, medical, and surgical oncologists from 2 academic centers and 5 community practices. The interview domains were developed from the Andersen Healthcare Utilization Model, the Health Belief Model, and the PEN-3 Model, as well as our prior survey research. RESULTS: This study describes elements of cancer treatment decision-making for PLWH. Oncologists highlighted the need for formal HIV education to support cancer treatment. One main concern with patient-provider interactions pertained to maintaining patient confidentiality during clinical encounters. Lastly, the importance of multidisciplinary care among health care providers allowed oncologists to facilitate both cancer care and logistical support. CONCLUSIONS: As cancer becomes an increasingly common cause of death among PLWH, it is critical to understand the drivers of the observed disparities in cancer treatment. To our knowledge, this is the first qualitative study to describe oncologists' knowledge, attitudes, and practices toward patients who have a comorbid diagnosis of HIV and cancer. Several themes for future interventions emerge, including HIV training for cancer care providers, fostering interdisciplinary collaboration, enhancing HIV education for oncology learners and clinicians, and minimizing implicit bias.

Supporting families during pediatric critical illness: Opportunities identified in a multicenter, qualitative study.

Critical illness resulting in a pediatric intensive care unit (PICU) admission is a profoundly stressful experience for a child and their family. Increasing evidence for emotional and behavioral sequelae post-PICU emphasizes a need to provide better support for families throughout this period of care and recovery. The aim of this qualitative investigation was to identify salient and modifiable aspects of a critical care experience that can be addressed to better support families of critically ill children. Individual semi-structured interviews were conducted with 26 caregivers of children who survived a PICU admission. Interviews were audio-recorded and transcribed verbatim; themes were identified via thematic analysis. Caregivers were enrolled using convenience sampling from seven tertiary care PICUs in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Themes from caregiver interviews were identified within two overarching categories containing three themes each. Advice for future PICU families: (1) Be intentional about caring for your own well-being, (2) speak up, ask questions, and challenge decisions you're not comfortable with, and (3) continue to engage with your child. Characteristics of a satisfactory PICU experience: (1) A caregiver-provider relationship of mutual trust established through clear communication and respectful collaboration, (2) hospital environments that provide physical and social supports to maintain humanity in healthcare, and (3) preparing families for care transitions. Targeted, interdisciplinary approaches to partner with families during critical care may improve their PICU experience and contribute to improved long-term outcomes for PICU survivors.

Identifying Perceptions, Experiences, and Recommendations of Telehealth Physical Therapy for Patients With Chronic Low Back Pain: A Mixed Methods Survey.

OBJECTIVE: To describe concerns, advantages, and disadvantages encountered in an evidence-based physical therapy (PT) program for persons with chronic low back pain (CLBP) delivered by telehealth. DESIGN: Mixed methods survey and semistructured interview of persons with CLBP. SETTING: Prospective observational cohort study of persons with CLBP from 3 health care systems receiving 8 sessions of evidence-based telehealth PT. PARTICIPANTS: Participants were selected after completing week 10 (from baseline) assessment from an ongoing cohort study. We enrolled 31 of 126 participants (mean age, 42.4 years; 71.0% female) from the cohort study (N=31). INTERVENTIONS: Participants had completed 8 sessions of evidence-based telehealth PT and participated in semistructured interviews. MAIN OUTCOME MEASURES: Baseline and week 10 and 26 assessments assessed psychosocial risk (StarTBack Screening Tool), working alliance (Working Alliance Inventory-Short Form), pain (Oswestry Disability Index), and health-related quality of life (Patient-Reported Outcomes Measurement Information System-29 profile, version 2). Semistructured interviews were conducted by telephone and consisted of open-ended questions assessing perception, satisfaction, and likelihood of recommending telehealth PT. Participants identified advantages and disadvantages to telehealth PT. Interviews were recorded, transcribed, and coded using an iterative qualitative process. Statistical comparisons by experience were made using analysis of variance (continuous) and Fisher exact test (categorical). RESULTS: Compared with the negative experience group (n=5), participants in positive (n=16) and neutral (n=10) experience groups endorsed higher bond working alliance with their therapist. Participants with a positive experience were more likely to view telehealth PT as cost-saving (n=10, 62.5%) compared with those with a neutral (n=1, 10.0%) or negative (n=1, 20.0%) experience and less likely to view telehealth PT as lower quality (n=0, 0.0%; n=1, 10.0%; n=2, 40.0%, respectively). Prior to starting telehealth, based on semistructured interviews, 18 participants (58.1%) had concerns and these persisted after starting in half of this group. Concerns regarded telehealth being different from or inferior to in-person PT, lack of physical correction, and worries of not using technology appropriately. Convenience, time savings, and personalization were seen as advantages. Difficulty making a personal connection with the therapist, lack of physical correction, and problems with technology were seen as disadvantages. Many participants endorsed a hybrid approach that included in-person and telehealth PT. Providing necessary equipment and technology assistance was seen as ways to improve telehealth PT experience. CONCLUSIONS: Telehealth is an acceptable modality to deliver PT for patients with CLBP with most having a positive experience and reporting advantages. Improvements could include offering a hybrid approach (in-person and telehealth combined) and providing necessary equipment and technical support. More research is needed to optimize the most effective strategies for providing telehealth PT for patients with CLBP.

Development of a core outcome set for pediatric critical care outcomes research.

BACKGROUND: Pediatric Intensive Care Unit (PICU) teams provide care for critically ill children with diverse and often complex medical and surgical conditions. Researchers often lack guidance on an approach to select the best outcomes when evaluating this critically ill population. Studies would be enhanced by incorporating multi-stakeholder preferences to better evaluate clinical care. This manuscript outlines the methodology currently being used to develop a PICU Core Outcome Set (COS). This PICU COS utilizes mixed methods, an inclusive stakeholder approach, and a modified Delphi consensus process that will serve as a resource for PICU research programs. METHODS: A Scoping Review of the PICU literature evaluating outcomes after pediatric critical illness, a qualitative study interviewing PICU survivors and their parents, and other relevant literature will serve to inform a modified, international Delphi consensus process. The Delphi process will derive a set of minimum domains for evaluation of outcomes of critically ill children and their families. Delphi respondents include researchers, multidisciplinary clinicians, families and former patients, research funding agencies, payors, and advocates. Consensus meetings will refine and finalize the domains of the COS, outline a battery instruments for use in future studies, and prepare for extensive dissemination for broad implementation. DISCUSSION: The PICU COS will be a guideline resource for investigators to assure that outcomes most important to all stakeholders are considered in PICU clinical research in addition to those deemed most important to individual scientists. TRIAL REGISTRATION: COMET database (http://www.comet-initiative.org/, Record ID 1131, 01/01/18).