Caregiver-reported quality of communication in pancreatic and periampullary cancer.

BACKGROUND: Communication between caregivers and clinical team members is critical for transitional care, but its quality and potential impact on outcomes are not well understood. This study reports on caregiver-reported quality of communication with clinical team members in the postpancreatectomy period and examines associations of these reports with patient and caregiver outcomes. METHODS: Caregivers of patients with pancreatic and periampullary malignancies who had undergone pancreatectomy were surveyed. Instrument measures assessed care experiences using the Caregiver Perceptions About Communication with Clinical Team Members (CAPACITY) instrument. The instrument has two main subscales: communication, assessing the extent to which providers helped caregivers comprehend details of clinical visits, and capacity, defined as the extent to which providers assessed whether caregivers were able to care for patients. RESULTS: Of 265 caregivers who were approached, 240 (90.6%) enrolled in the study. The mean communication and capacity subscale scores were 2.7 ± 0.6 and 1.5 ± 0.6, respectively (range, 0-4 [higher = better]). Communication subscale scores were lower among caregivers of patients who experienced (vs. those who did not experience) a 30-day readmission (2.6 ± 0.5 vs. 2.8 ± 0.6, respectively; p = .047). Capacity subscale scores were inversely associated with restriction in patient daily activities (a 0.04 decrement in the capacity score for every 1 point in daily activity restriction; p = .008). CONCLUSIONS: After pancreatectomy, patients with pancreatic and periampullary cancer whose caregivers reported worse communication with care providers were more likely to experience readmission. Caregivers of patients with greater daily activity restrictions were less likely to report being asked about the caregiver's skill and capacity by clinicians. PLAIN LANGUAGE SUMMARY: This prospective study used a validated survey instrument and reports on the quality of communication between health care providers and caregivers as reported by caregivers of patients with pancreatic and periampullary cancer after pancreatectomy. In an analysis of 240 caregivers enrolled in the study, lower communication scores (the extent to which providers helped caregivers understand clinical details) were associated with higher odds of 30-day patient readmission to the hospital. In addition, lower capacity scores (the extent to which providers assessed caregivers' ability to care for patients) were associated with greater impairment in caregivers. The strikingly low communication quality and capacity assessment scores suggest substantial room for improvement, with the potential to improve both caregiver and patient outcomes.

Hospital-Level Variation in COVID-19 Treatment Among Hospitalized Adults in the United States: A Retrospective Cohort Study.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To characterize variation in dexamethasone and remdesivir use over time among hospitals. BACKGROUND: Little is known about hospital-level variation in COVID-19 drug treatments in a large and diverse network in the United States. METHODS: We selected individuals hospitalized with COVID-19 across 163 hospitals between February 23, 2020 and October 31, 2021 from using the HCA CHARGE, an electronic health record repository from a network of community health care facilities in the United States. We quantified receipt of dexamethasone, remdesivir, and combined use of dexamethasone and remdesivir during the hospital stay. We used 2-level logistic regression models to determine the intraclass correlation coefficient (ICC) at the hospital level, adjusting for patient and hospital characteristics. The ICC shows the proportion of total variation in drug use accounted for by hospitals. RESULTS: Among 161,667 individuals hospitalized with COVID-19, 73.0% were treated with dexamethasone, 49.1% with remdesivir, and 45.0% with both dexamethasone and remdesivir. The proportion of variation in dexamethasone use was 12.7% (adjusted ICC: 0.127), 8.5% for remdesivir, and 11.3% for combined drug use, indicating low interhospital variation. In the fully adjusted models, between-facility variation in dexamethasone use declined from 34.1% in February-March 2020 to 11.3% in January-March 2021 and then increased to 17.3% in July-October 2021. The variation in remdesivir use remained relatively stable during the study period. CONCLUSIONS: During the first 2 years of the pandemic, there was relatively consistent use of dexamethasone and remdesivir across the hospitals examined. Consistent adoption and implementation of treatment guidelines across the hospitals examined may have led to a decrease in variation in drug usage over time.

A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries.

BACKGROUND: Injuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined. METHODS: We conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group. RESULTS: The demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups. CONCLUSIONS: A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).

Screening Second Victims for Emotional Distress: Assessment of the Clinimetric Properties of the WITHSTAND-PSY Questionnaire.

INTRODUCTION: Adverse events (AEs) are a leading cause of patient morbidity and mortality, greatly impacting healthcare providers' well-being (second victim (SV) phenomenon). Since it is not accurately captured by existing psychometric instruments, we developed a clinimetric instrument for assessing SVs' emotional distress before and after an AE. METHODS: Content validity and clinical utility of the WITHSTAND-PSY Questionnaire (WS-PSY-Q) were examined using cognitive interviews. Rasch analysis (n = 284) was applied for clinimetric assessment (i.e., construct, concurrent, and clinical validity, internal consistency), considering two crucial psychological facets of the SV phenomenon (1st: emotional impact of the AE, 2nd: current emotional state). RESULTS: The Rasch partial credit model was used. The 1st facet demonstrated overall acceptable clinimetric properties with the subscale anxiety meeting clinimetric threshold values (e.g., all items with ordered thresholds, Loevinger's coefficient h ≥ 0.40; Person Separation Reliability Index (PSI) = 0.7). The 2nd facet showed overall better clinimetric properties for both subscales (e.g., h ≥ 0.40, PSI = 0.82 and 0.79, respectively; receiver operating characteristic area of 0.80 and 0.86, respectively). For both datasets, item fit statistics, except those for item 19, were within the critical range (z-score < ±2.5), and meaningful differential functioning analysis was observed for only 4 (out of 24) items. Local dependency was not observed, except for two item couples in the depression subscales. CONCLUSIONS: The WS-PSY-Q is the first clinimetric tool assessing SVs' emotional distress. It should be regarded as part of the armamentarium used by clinicians to assess in-depth healthcare providers' psychological reactions in the aftermath of an AE to mitigate burnout and allostatic overload.

Responsiveness of the Patient-Reported Outcome Measure for Vascular Malformation Questionnaire in Patients with Low-Flow Vascular Malformations.

PURPOSE: To assess the responsiveness, defined as the ability to detect change in a patient's health or function, of the Patient-Reported Outcome Measure for Vascular Malformation (PROVAM) questionnaire in a cohort of patients with low-flow vascular malformations (VMs). MATERIALS AND METHODS: PROVAM was previously developed to assess symptoms, functional limitations, and social/emotional effects experienced by patients with VMs. This is a prospective cohort study of 56 patients with venous and lymphatic VMs who completed at least 2 PROVAM questionnaires, of whom 43 had undergone treatment with sclerotherapy in the interim between questionnaires. External responsiveness was assessed using a receiver operating characteristic (ROC) curve to ascertain whether a change in the total PROVAM score predicts whether patients reported symptom improvement and by correlating the change in the total PROVAM score and change in symptoms reported during clinic visit. Internal responsiveness was evaluated using Wilcoxon signed rank test, Cohen d effect size (ESp), and standard response mean difference (SRM). RESULTS: The total PROVAM score demonstrated excellent discrimination for symptom improvement with an area under the ROC curve of 0.856. There was a statistically significant, moderate positive correlation between the change in the total PROVAM score and the change in patient symptoms as determined from clinical visits (Spearman correlation coefficient [rs] = 0.67, P < .001). The total PROVAM score and all subdomain scores improved significantly after treatment (all P < .05). ESp and SRM were 0.80 and 0.83, respectively. CONCLUSIONS: PROVAM is responsive to improvement after treatment and may be useful to assess health-related quality of life in patients treated for VMs.

The impact of emotional support on healthcare workers and students coping with COVID-19, and other SARS-CoV pandemics - a mixed-methods systematic review.

BACKGROUND: Pandemics such as COVID-19 pose threats to the physical safety of healthcare workers and students. They can have traumatic experiences affecting their personal and professional life. Increasing rates of burnout, substance abuse, depression, and suicide among healthcare workers have already been identified, thus making mental health and psychological wellbeing of the healthcare workers a major issue. The aim of this systematic review is to synthesize the characteristics of emotional support programs and interventions targeted to healthcare workers and students since the onset of COVID-19 and other SARS-CoV pandemics and to describe the effectiveness and experiences of these programs. METHOD: This was a mixed method systematic review. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed, and the review was registered on PROSPERO [CRD42021262837]. Searches were conducted using Medline, CINAHL, PsycINFO, Cochrane Library, and Scopus databases. The COVIDENCE systematic review management system was used for data selection and extraction by two independent reviewers. The JBI (Joanna Briggs Institute) critical appraisal tools were used to assess the quality of selected studies by two additional reviewers. Finally, data extraction and narrative analysis were conducted. RESULTS: The search retrieved 3161 results including 1061 duplicates. After screening, a total of 19 articles were included in this review. Participants in studies were nurses, physicians, other hospital staff, and undergraduate medical students mostly working on the front-line with COVID-19 patients. Publications included RCTs (n = 4), quasi-experimental studies (n = 2), cross-sectional studies (n = 6), qualitative interview studies (n = 3), and systematic reviews (n = 4). Most (63.4%) of the interventions used online or digital solutions. Interventions mostly showed good effectiveness (support-seeking, positive emotions, reduction of distress symptoms etc.) and acceptance and were experienced as helpful, but there were some conflicting results. CONCLUSION: Healthcare organizations have developed support strategies focusing on providing emotional support for these healthcare workers and students, but it is difficult to conclude whether one program offers distinct benefit compared to the others. More research is needed to evaluate the comparative effectiveness of emotional support interventions for health workers.

The Volume and Cost of Quality Metric Reporting.

Importance: US hospitals report data on many health care quality metrics to government and independent health care rating organizations, but the annual cost to acute care hospitals of measuring and reporting quality metric data, independent of resources spent on quality interventions, is not well known. Objective: To evaluate externally reported inpatient quality metrics for adult patients and estimate the cost of data collection and reporting, independent of quality-improvement efforts. Design, Setting, and Participants: Retrospective time-driven activity-based costing study at the Johns Hopkins Hospital (Baltimore, Maryland) with hospital personnel involved in quality metric reporting processes interviewed between January 1, 2019, and June 30, 2019, about quality reporting activities in the 2018 calendar year. Main Outcomes and Measures: Outcomes included the number of metrics, annual person-hours per metric type, and annual personnel cost per metric type. Results: A total of 162 unique metrics were identified, of which 96 (59.3%) were claims-based, 107 (66.0%) were outcome metrics, and 101 (62.3%) were related to patient safety. Preparing and reporting data for these metrics required an estimated 108 478 person-hours, with an estimated personnel cost of $5 038 218.28 (2022 USD) plus an additional $602 730.66 in vendor fees. Claims-based (96 metrics; $37 553.58 per metric per year) and chart-abstracted (26 metrics; $33 871.30 per metric per year) metrics used the most resources per metric, while electronic metrics consumed far less (4 metrics; $1901.58 per metric per year). Conclusions and Relevance: Significant resources are expended exclusively for quality reporting, and some methods of quality assessment are far more expensive than others. Claims-based metrics were unexpectedly found to be the most resource intensive of all metric types. Policy makers should consider reducing the number of metrics and shifting to electronic metrics, when possible, to optimize resources spent in the overall pursuit of higher quality.

Barriers experienced by organ procurement organizations in implementing the HOPE act and HIV-positive organ donation.

In the seven years since the HIV Organ Policy Equity (HOPE) Act made HIV-positive organ donation to HIV-positive recipients legally permissible in the United States, there have been fewer HIV-positive organ donations than expected. Organ procurement organizations (OPOs) play a key role in the transplant system and barriers at OPOs may be partly responsible for the relatively low number of HIV-positive donors. To understand potential OPO barriers, we conducted semi-structured interviews with 20 OPO staff members. Interviews were recorded, transcribed, and analyzed using a conventional content analytic approach with two coders. OPO staff had high levels of knowledge about HOPE. Many had evaluated referrals of HIV-positive donors and approached families for authorization. Barriers to HIV-positive organ recovery identified included obtaining authorization for donation, potentially disclosing HIV status to next-of-kin, and fear of HIV infection among those engaged in organ recovery. Strategies to overcome these barriers include providing continuing education about the specific tasks required to procure organs from HIV-positive donors, implementing targeted interventions to reduce fear of infection, and developing partnerships with HIV advocacy and care organizations. Given the central role OPOs play, HIV-positive donations are unlikely to occur in significant numbers unless these barriers can be overcome.

Persons living with HIV treated in acute HIV infection report good health-related quality of life in Thailand.

The health-related quality of life (HRQoL) among persons living with HIV (PLWHA) who initiate ART during acute HIV infection (AHI) is not well studied. Participants in the SEARCH010/RV254 cohort initiated ART during AHI. They completed the Thai version of the World Health Organisation Quality of Life instrument-BREF (WHOQOL-BREF) and Patient Health Questionnaire-9 (PHQ-9) prior to ART initiation and 24 weeks later. Of 452 participants, 406 (90%) completed the WHOQOL-BREF. The median age was 26 years (IQR 22-31), and 98% were men. All WHOQOL-BREF domains demonstrated good internal consistency (Cronbach's alpha >0.70). Confirmatory factor analysis validated the WHOQOL-BREF model. 90% of Pearson correlations between domain scores and general facet items were >0.50. HRQoL in all domains was worse among those with at least moderately severe depression (PHQ-9 ≥ 10) (p<0.0001), supporting discriminant validity. At 24 weeks, there was an improvement of scores in all domains (physical, psychological, social, and environmental) and general facet items (p<0.0001), and the range of mean domain scores was 14.7-15.6 (SD 2.3-2.8). The majority of participants (58-63%) had improved HRQoL in the physical, psychological and environmental domains. It is concluded that HRQoL improves 6 months after initiation of ART in AHI, suggesting a benefit of early ART initiation.

Patient-level barriers and facilitators to completion of patient-reported outcomes measures.

PURPOSE: To identify patient-level barriers and facilitators to completion of patient-reported outcomes measures (PROMs) in a hand and upper extremity clinic in Baltimore, Maryland. METHODS: We conducted 12 h of direct observation of PROM completion (October-November, 2020). Ethnographic observation memos were qualitatively analyzed for barriers and facilitators using rapid thematic analysis. Informed by observation findings, we conducted 17 semi-structured interviews with mixed-literacy patients, caregivers, and clinic staff to understand the patient experience when completing PROMs (November 2020-March 2021). We identified initial themes through inductive and deductive framework analysis and validated findings through subsequent interviews with member-checking. RESULTS: We identified nine patient-level factors that influence PROM completion: platform design, print literacy, health literacy, technology literacy, language proficiency, physical functioning, vision, cognitive functioning, and time. CONCLUSIONS: There are multiple distinct patient-level factors that affect PROM completion. Failure to consider these factors in PROM design and implementation may lower completion rates or prevent accurate completion, undermining PROM validity. Because certain factors affect minority populations at disproportionate rates, this may also contribute to existing health disparities.

The PROTEUS-Trials Consortium: Optimizing the use of patient-reported outcomes in clinical trials.

BACKGROUND: The assessment of patient-reported outcomes in clinical trials has enormous potential to promote patient-centred care, but for this potential to be realized, the patient-reported outcomes must be captured effectively and communicated clearly. Over the past decade, methodologic tools have been developed to inform the design, analysis, reporting, and interpretation of patient-reported outcome data from clinical trials. We formed the PROTEUS-Trials Consortium (Patient-Reported Outcomes Tools: Engaging Users and Stakeholders) to disseminate and implement these methodologic tools. METHODS: PROTEUS-Trials are engaging with patient, clinician, research, and regulatory stakeholders from 27 organizations in the United States, Canada, Australia, the United Kingdom, and Europe to develop both organization-specific and cross-cutting strategies for implementing and disseminating the methodologic tools. Guided by the Knowledge-to-Action framework, we conducted consortium-wide webinars and meetings, as well as individual calls with participating organizations, to develop a workplan, which we are currently executing. RESULTS: Six methodologic tools serve as the foundation for PROTEUS-Trials dissemination and implementation efforts: the Standard Protocol Items: Recommendations for Interventional Trials-patient-reported outcome extension for writing protocols with patient-reported outcomes, the International Society for Quality of Life Research Minimum Standards for selecting a patient-reported outcome measure, Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium recommendations for patient-reported outcome data analysis, the Consolidated Standards for Reporting of Trials-patient-reported outcome extension for reporting clinical trials with patient-reported outcomes, recommendations for the graphic display of patient-reported outcome data, and a Clinician's Checklist for reading and using an article about patient-reported outcomes. The PROTEUS-Trials website (www.TheProteusConsortium.org) serves as a central repository for the methodologic tools and associated resources. To date, we have developed (1) a roadmap to visually display where each of the six methodologic tools applies along the clinical trial trajectory, (2) web tutorials that provide guidance on the methodologic tools at different levels of detail, (3) checklists to provide brief summaries of each tool's recommendations, (4) a handbook to provide a self-guided approach to learning about the tools and recommendations, and (5) publications that address key topics related to patient-reported outcomes in clinical trials. We are also conducting organization-specific activities, including meetings, presentations, workshops, and webinars to publicize the existence of the methodologic tools and the PROTEUS-Trials resources. Work to develop communications strategies to ensure that PROTEUS-Trials reach key audiences with relevant information about patient-reported outcomes in clinical trials and PROTEUS-Trials is ongoing. DISCUSSION: The PROTEUS-Trials Consortium aims to help researchers generate patient-reported outcome data from clinical trials to (1) enable investigators, regulators, and policy-makers to take the patient perspective into account when conducting research and making decisions; (2) help patients understand treatment options and make treatment decisions; and (3) inform clinicians' discussions with patients regarding treatment options. In these ways, the PROTEUS Consortium promotes patient-centred research and care.

Delivering Complex Care: Designing for Patients and Physicians.

The management of high-utilizing patients is an area of active research with broad implications for the healthcare system. There are significant operational challenges to designing primary care models for these medically complex, high-needs patients. Although it is crucial to provide a high degree of continuity of care for this population, managing a cohort of these patients can lead to provider over-work and attrition. This may be magnified by the lack of training dedicated to addressing the unique care needs of these patients. While academic medical centers would seem well suited to care for individuals with multimorbidity needing intensive and specialized treatment, primary care providers in this setting need additional support to be clinically available for patients while pursuing scholarship and teaching. Formally recognizing intensive outpatient care as a specialty within internal medicine would help overcome some of these challenges. This would require a committed effort to high-level systems changes including a new focus on graduate medical education, the creation of division-level infrastructure within academic departments of medicine, and realistic levels of financial support to make this a viable career path.

What We Have Learned from Two Decades of Epidemics and Pandemics: A Systematic Review and Meta-Analysis of the Psychological Burden of Frontline Healthcare Workers.

In light of the current coronavirus disease 2019 (COVID-19) pandemic and potential future infectious disease outbreaks, a comprehensive understanding of the negative effects of epidemics and pandemics on healthcare workers' mental health could inform appropriate support interventions. Thus, we aimed to synthesize and quantify the psychological and psychosomatic symptoms among frontline medical staff. We searched four databases up to March 19, 2020 and additional literature, with daily search alerts set up until October 26, 2020. Studies reporting psychological and/or psychosomatic symptoms of healthcare workers caring for patients with severe acute respiratory syndrome, H1N1, Ebola, Middle East respiratory syndrome, or COVID-19 were eligible for inclusion. Two reviewers independently conducted the search, study selection, quality appraisal, data extraction, and synthesis and involved a third reviewer in case of disagreement. We used random effects modeling to estimate the overall prevalence rates of psychological/psychosomatic symptoms and the I2 statistic. We included 86 studies, reporting data from 75,991 participants. Frontline staff showed a wide range of symptoms, including concern about transmitting the virus to the family (60.39%, 95% CI 42.53-76.96), perceived stress (56.77%, 95% CI 34.21-77.95), concerns about own health (45.97%, 95% CI 31.08-61.23), sleeping difficulties (39.88%, 95% CI 27.70-52.72), burnout (31.81%, 95% CI 13.32-53.89), symptoms of depression (25.72%, 95% CI 18.34-33.86), symptoms of anxiety (25.36%, 95% CI 17.90-33.64), symptoms of posttraumatic stress disorder (24.51%, 95% CI 18.16-31.46), mental health issues (23.11%, 95% CI 15.98-31.10), and symptoms of somatization (14.68%, 95% CI 10.67-19.18). We found consistent evidence for the pervasive and profound impact of large-scale outbreaks on the mental health of frontline healthcare workers. As the CO-VID-19 crisis continues to unfold, guaranteeing easy access to support structures for the entire healthcare workforce is vitally important.

Development and Preliminary Validation of the Patient-Reported Outcome Measure for Vascular Malformation Questionnaire: A Prospective Cohort Study.

PURPOSE: To develop and validate the Patient-Reported Outcome Measure for Vascular Malformation (PROVAM) questionnaire to assess the health-related quality of life in patients with vascular malformations. MATERIALS AND METHODS: We developed and validated PROVAM using a mixed methods design during a prospective clinical trial at a vascular anomalies clinic. From July 2019 to February 2020, 108 consecutive patients completed 130 questionnaires. The 30-item instrument assessed the domains of pain, emotional/social well-being, functional impact, and treatment satisfaction. Two additional items assessed ease of understanding and relevance. The primary outcomes of instrument reliability and validity were evaluated across several indices. The secondary outcome of responsiveness evaluated total score changes for patients who completed questionnaires both before and after treatment. RESULTS: Instrument reliability, as measured by Cronbach alpha, was ≥0.79 for pain, emotional/social well-being, and functional impact domains. Primary domain structure was confirmed by factor analysis (P <. 001) and convergent construct validity for all but 1 Likert scale item. In the subgroup analysis of 13 participants who completed PROVAM before and after treatment, instrument responsiveness, as measured by the total score, showed a significant decrease (median, -10 points; interquartile range [IQR], -3 to -16; P = .04). Participants found the questions easy to understand (median, 5 points; IQR, 4-5 on a 5-point scale) and relevant (median score, 4; IQR, 3-5). CONCLUSIONS: Preliminary data support the reliability and validity of PROVAM in measuring the health-related quality of life in patients with vascular malformations.

Potential donor characteristics and decisions made by organ procurement organization staff: Results of a discrete choice experiment.

Organ procurement organizations (OPOs) evaluate referrals for deceased organ donation in the United States. Efforts to expand the donor pool, such as the HIV organ policy equity (HOPE) Act that permits transplants from HIV-positive donors to HIV-positive recipients, can only succeed if OPOs pursue referrals. However, relatively little is known about how OPO staff evaluate referrals. To better understand this process, OPO staff completed a discrete choice experiment to quantify the relative importance of seven donor characteristics on the decision to pursue a theoretical donor. Relative importance was defined by Partworth utility using a hierarchical Bayesian conditional logit model. There were 51 respondents from 36 of 58 OPOs in the United States. Of the seven attributes, organ and tissue potential were the most influential, followed by age, type of death, HIV status, donor registration, and Hepatitis C status. To be preferred to an HIV-negative donor, an HIV-positive donor needed to have the potential to donate two additional organs. These data provide insight into the preferences of OPO referral staff and may help explain the lower than expected number of HIV-positive transplants performed since the passage of the HOPE Act.

International guidance on the selection of patient-reported outcome measures in clinical trials: a review.

PURPOSE: Patient-reported outcomes (PROs) are increasingly used in clinical trials to provide patients' perspectives regarding symptoms, health-related quality of life, and satisfaction with treatments. A range of guidance documents exist for the selection of patient-reported outcome measures (PROMs) in clinical trials, and it is unclear to what extent these documents present consistent recommendations. METHODS: We conducted a targeted review of publications and regulatory guidance documents that advise on the selection of PROMs for use in clinical trials. A total of seven guidance documents from the US Food and Drug Administration, European Medicines Agency, and scientific consortia from professional societies were included in the final review. Guidance documents were analyzed using a content analysis approach comparing them with minimum standards recommended by the International Society for Quality of Life Research. RESULTS: Overall there was substantial agreement between guidance regarding the appropriate considerations for PROM selection within a clinical trial. Variations among the guidance primarily related to differences in their format and differences in the perspectives and mandates of their respective organizations. Whereas scientific consortia tended to produce checklist or rating-type guidance, regulatory groups tended to use more narrative-based approaches sometimes supplemented with lists of criteria. CONCLUSION: The consistency in recommendations suggests an emerging consensus in the field and supports use of any of the major guidance documents available to guide PROM selection for clinical trials without concern of conflicting recommendations. This work represents an important first step in the international PROTEUS Consortium's ongoing efforts to optimize the use of PROs in clinical trials.

Adapting RISE: meeting the needs of healthcare workers during the COVID-19 pandemic.

The COVID-19 pandemic has placed extraordinary stresses on healthcare workers. Combined with disruptions to daily life outside of work, health care professionals experience a high prevalence of anxiety, depression, acute stress reaction, burnout, and PTSD. Top leaders at Johns Hopkins Medicine appreciated the mission-critical importance of maintaining the well-being and resilience of its essential workers. In March 2020 they asked the Johns Hopkins RISE (Resilience in Stressful Events) peer support program to help organize support for all staff. RISE made several adjustments, including adding virtual encounters to the usual in-person support, training additional peer responders, and rounding proactively on active units. Communication was broadened to reach less visible and lower wage workers. RISE collaborated actively with hospital epidemiology and infection control and began reporting regularly at incident command centre briefings. RISE also began to coordinate efforts with the other helping programs within the institution including the Office of Well-being, Employee Assistance, Spiritual Care, and Psychiatry. The number of calls and staff supported rose sharply. RISE supported over 4226 workers in the first 9 months of the pandemic. The adoption of RISE programs was accelerated at affiliated hospitals, as well as at other hospitals across the country in partnership with the Maryland Patient Safety Center. Experience with large scale disasters predicted correctly that worker distress would increase and persist beyond the initial wave of the pandemic. With subsequent surges of COVID-19, exhaustion and moral distress became nearly universal among workers. It is urgent for institutions to provide mechanisms to help their workers cope with the ongoing crisis and other crises that will inevitably occur in the future.

RISE: Exploring Volunteer Retention and Sustainability of a Second Victim Support Program.

EXECUTIVE SUMMARY: The Resilience In Stressful Events (RISE) program that supports healthcare professionals traumatized by stressful clinical events has had a stable, volunteer-based membership since its inception in 2011 at Johns Hopkins Hospital. For this study, we explored RISE members' perceptions of the program that contribute to their retention and the program's sustainability. We distributed a survey with quantitative and qualitative elements to assess perceptions in seven domains of interest. The response rate was 100%. Pearson chi-squared tests established statistical associations among quantitative variables. Qualitative data were explored using content analysis. Of 27 respondents, 19 had been members for 3 or more years. The training completion percentage was 100%, and the annual turnover percentage was 12%. Members found their duties to be meaningful (100%), personally satisfying (96%), and positively impactful (93%). A total of 89% reported confidence in their competency to perform RISE duties, 84% in their autonomy, and 56% in their personal resilience; 28% reported some burnout from RISE duties. Cronbach's α for these domain scores ranged from 0.65 to 0.97. Content analysis also revealed positive perceptions of RISE volunteering and personal empowerment. Members indicated a personal affinity with RISE and gains in energy and enjoyment from their membership. Contributing factors to volunteer retention may include members' perceptions that RISE builds valued skills and supports their affinity for others.

A PRO-cision Medicine Methods Toolkit to Address the Challenges of Personalizing Cancer Care Using Patient-Reported Outcomes: Introduction to the Supplement.

Patients are increasingly being asked to complete standardized, validated questionnaires with regard to their symptoms, functioning, and well-being [ie, patient-reported outcomes (PROs)] as part of routine care. These PROs can be used to inform patients' care and management, which we refer to as "PRO-cision Medicine." For PRO-cision Medicine to be most effective, clinicians and patients need to be able to understand what the PRO scores mean and how to act on the PRO results. The papers in this supplement to Medical Care describe various methods that have been used to address these issues. Specifically, the supplement includes 14 papers: 6 describe different methods for interpreting PROs and 8 describe how different PRO systems have addressed interpreting PRO scores and/or acting on PRO results. As such, this "Methods Toolkit" can inform clinicians and researchers aiming to implement routine PRO reporting into clinical practice by providing methodological fundamentals and real-world examples to promote personalized patient care.

Interpreting and Acting on PRO Results in Clinical Practice: Lessons Learned From the PatientViewpoint System and Beyond.

INTRODUCTION: We have used several methods to aid in the interpretation of patient-reported outcome (PRO) scores, and to suggest recommendations for acting on them, both within the PatientViewpoint system and in work done since. METHODS FOR INTERPRETING PRO SCORES: For identifying possibly concerning change scores, PatientViewpoint uses questionnaires' minimally important differences or score worsening >½ SD. For poor scores in absolute terms, PatientViewpoint primarily uses distributions based on normative data (eg, worst quartile, >2 SD from the mean). To advance methods for score interpretation, we explored using needs assessments to identify health-related quality-of-life scores associated with unmet needs and requiring follow-up. We also investigated the ability of PRO scores to predict patients' most bothersome issues. METHODS FOR ADDRESSING PRO RESULTS: To develop suggestions for addressing issues identified by PRO questionnaires, we conducted a targeted literature review, interviewed experts from different disciplines, developed draft recommendations based on the literature and interviews, and finalized the recommendations in a consensus meeting with all experts. DISCUSSION: The needs assessment method requires strongly correlated content in the needs assessment and health-related quality-of-life questionnaire. Additional research is needed to explore using the worst scores in absolute terms to identify patients' most bothersome issues. The approach described for developing suggestions for addressing PRO results focuses on local resources and is best-suited for a local context. KEY POINTS: A combination of pragmatic solutions and exploratory research can inform interpreting and acting on PRO scores.