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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.

Background Family and other unpaid caregivers play an active role in the recovery of individuals with pancreatic and periampullary cancer after pancreatectomy. However, little is known about caregivers’ experiences and how to better support them. Methods Caregivers accompanying patients to 1-month postpancreatectomy visits at 3 hospitals completed an electronic survey between November 2018 and February 2020. We examine measures of absenteeism and work productivity loss among the subset of caregivers who reported working for pay and comparatively assess caregiver experiences by employment status. All analyses were performed as 2-sided tests. Results Of 265 caregivers approached for study participation, 240 (90.6%) enrolled. Caregivers were primarily female (70.8% female, 29.2% male) and spouses (58.3%) or adult children (25.8%) of patients, with a median age of 60 years. Of the 240 caregivers included in the study, 107 (44.6%) worked for pay. Nearly half (44.4%) of working caregivers reported being absent from work because of caregiving amounting to a 14% loss in work hours. While at work, 58.9% of working caregivers reported increased work difficulty as a result of caregiving. Taken together, an estimated 59.7% loss in work productivity was experienced because of caregiving in the month following pancreatectomy. After adjustment for sociodemographic factors, working (vs nonworking) caregivers reported increased financial (odds ratio [OR] = 2.32; P = .04) and emotional (OR = 1.93; P = .04) difficulties and daily activity restrictions (OR = 1.85; P = .048). Conclusions Working caregivers of patients with pancreatic and periampullary cancer experience negative impacts on work and productivity, and caregiving-related financial and emotional difficulties may be amplified. This study highlights the need for workplace policies to support unpaid cancer caregiving.

Objective Existing quality of care frameworks insufficiently integrate the perspectives of physicians, nurses and patients. We collected narrative accounts from these three groups to explore if their perspectives might add new content to these existing definitions. Methods Ninety-seven descriptions of “good” and “poor” care episodes were collected from a convenience sample of physicians, nurses and outpatients at eight regional hospitals. Two coders classified the narrative contents into themes related to structures, processes and outcomes of care. Results The physicians, nurses and patients raised the following “quality of care” aspects: Successful communication among staff, with patients and care companions; staff motivation; frequency of knowledge errors; prioritization of patient-preferred outcomes; institutional emphasis on building “quality cultures”; and organizational implementation of fluid system procedures. Conclusion Respondents primarily referred to care processes in their descriptions of “quality of care.” “Hippocratic pride” (in response to care successes) and “Rapid reactivity” (in response to (near) failures) emerged as two new outcome indicators of high-quality care. Practice implications This study provides a first qualitative fundament for understanding the components of “quality of care” from a triangulated frontline perspective. Future research needs to validate our findings with quantitative data to explore their usefulness for completing existing quality frameworks.

OBJECTIVE Suprasellar meningioma resection via either the transcranial approach (TCA) or the endoscopic endonasal approach (EEA) is an area of controversy and active evaluation. Skull base surgeons increasingly consider patient-reported outcomes (PROs) when choosing an approach. No PRO measure currently exists to assess quality of life for suprasellar meningiomas. METHODS Adult patients undergoing suprasellar meningioma resection between 2013 and 2019 via EEA (n = 14) or TCA (n = 14) underwent semistructured interviews. Transcripts were coded using a grounded theory approach to identify themes as the basis for a PRO measure that includes all uniquely reported symptoms. To assess content validity, 32 patients and 15 surgeons used a Likert scale to rate the relevance of items on the resulting questionnaire and the general Patient-Reported Outcomes Measurement Information System–29 (PROMIS29). The mean scores were calculated for all items and compared for TCA versus EEA patient cohorts by using unpaired t-tests. Items on either questionnaire with mean scores ≥ 2.0 from patients were considered meaningful and were aggregated to form the novel Suprasellar Meningioma Patient-Reported Outcome Survey (SMPRO) instrument. RESULTS Qualitative analyses resulted in 55 candidate items. Relative to patients who underwent the EEA, those who underwent the TCA reported significantly worse future outlook before surgery (p = 0.01), tiredness from medications 2 weeks after surgery (p = 0.001), and word-finding and memory difficulties 3 months after surgery (p = 0.05 and < 0.001, respectively). The items that patients who received a TCA were most concerned about included medication-induced lethargy after surgery (2.9 ± 1.3), blurry vision before surgery (2.7 ± 1.5), and difficulty reading due to blurry vision before surgery (2.7 ± 2.7). Items that patients who received an EEA were most concerned about included blurry vision before surgery (3.5 ± 1.3), difficulty reading due to blurry vision before surgery (2.4 ± 1.3), and problems with smell postsurgery (2.9 ± 1.3). Although surgeons overall overestimated how concerned patients were about questionnaire items (p < 0.0005), the greatest discrepancies between patient and surgeon relevance scores were for blurry vision pre- and postoperatively (p < 0.001 and < 0.001, respectively) and problems with taste postoperatively (p < 0.001). Seventeen meningioma-specific items were considered meaningful, supplementing 8 significant PROMIS29 items to create the novel 25-item SMPRO. CONCLUSIONS The authors developed a disease- and approach-specific measure for suprasellar meningiomas to compare quality of life by operative approach. If demonstrated to be reliable and valid in future studies, this instrument may assist patients and providers in choosing a personalized surgical approach.

PURPOSE Patients with pancreatic and periampullary cancers may experience significant reduction in their quality of life and often rely on family and unpaid caregivers for assistance after surgery. However, as caregivers are not systematically identified, little is known about the nature, difficulty, and personal demands of assistance they provide. We aim to assess the frequency and difficulty of specific assistance caregivers provide and identify potential interventions that could alleviate the caregiving demands. METHODS This was a prospective, multi-institutional study of caregivers accompanying patients with periampullary and pancreatic cancer at their 1-month postpancreatectomy office visit. An instrument that drew heavily on the National Study of Caregiving was administered to caregivers. RESULTS Of 240 caregivers, more than half (58.3%) of caregivers were the patients' spouse, a quarter (25.8%) were daughters or sons, 12.9% other relatives, and 2.9% nonrelatives. Caregivers least frequently provided assistance with transportation (14.6% every day) and most frequently provided assistance with housework (65.0% every day, P = .003) and diet (56.5% every day, P = .004). Caregivers reported the least difficulty helping patients with exercise (1.5% somewhat difficult). Caregivers reported significantly more difficulty with assisting with housework (14.5% somewhat difficult, P < .001) and diet (14.9% somewhat difficult, P < .001). Caregivers identified the immediate postpancreatectomy and early discharge periods as the most stressful phases. They also reported having received very little information about available services that could have supported their efforts. CONCLUSION Caregivers of patients with periampullary or pancreatic cancer provide considerable assistance in the postoperative period and many reported difficulty in assisting with housework and diet. Work is needed to better prepare and support caregivers to better enable them to adequately care for patients with pancreas and periampullary cancer.

Background Perceived health is one of the strongest determinants of subjective well-being, but it has received little attention among survivors of ARDS. Research question How well do self-reported measures of physical, emotional, and social functioning predict perceived overall health (measured using the EQ-5D visual analog scale [EQ-5D-VAS]) among adult survivors of ARDS? Are demographic features, comorbidity, or severity of illness correlated with perceived health after controlling for self-reported functioning? Study Design and Methods We analyzed the ARDSNet Long Term Outcomes Study (ALTOS) and Improving Care of Acute Lung Injury Patients (ICAP) Study, two longitudinal cohorts with a total of 823 survivors from 44 US hospitals, which prospectively assessed survivors at 6 and 12 months after ARDS. Perceived health, evaluated using the EQ-5D-VAS, was predicted using ridge regression and self-reported measures of physical, emotional, and social functioning. The difference between observed and predicted perceived health was termed perspective deviation (PD). Correlations between PD and demographics, comorbidities, and severity of illness were explored. Results The correlation between observed and predicted EQ-5D-VAS scores ranged from 0.68 to 0.73 across the two cohorts and time points. PD ranged from –80 to +34 and was more than the minimum clinically important difference for 52% to 55% of survivors. Neither demographic features, comorbidity, nor severity of illness were correlated strongly with PD, with |r| Interpretation About half of survivors of ARDS showed clinically important differences in actual perceived health vs predicted perceived health based on self-reported measures of functioning. Survivors of ARDS demographic features, comorbidities, and severity of illness were correlated only weakly with perceived health after controlling for measures of perceived functioning, highlighting the challenge of predicting how individual patients will respond psychologically to new impairments after critical illness.

The Patient-Reported Outcomes Measurement Information System (PROMIS) has developed item banks, short forms and computer-adaptive tests (CATs) to help standardize measurement for important patient reported outcome (PRO) domains. These tools have the potential to revolutionize outcome measurement in clinical research through greater assessment precision while reducing response burden. Perceived implementation challenges include the need for CAT software, mobile technology and internet access. Here, we present preliminary results examining the feasibility of using PROMIS tools within a large, multi-center clinical trials consortium. The assessment of 10 PROMIS domains was incorporated into the longitudinal data collection of six ongoing orthopaedic trauma clinical trials for participants being evaluated at 3, 6 and 12 months following an orthopaedic injury. Twelve-month assessments included both CAT assessments as well as completion of full item banks for a subset of domains. Data were collected for 1,000 trauma patients at 43 trauma centers using a custom-built application which included an interface with our primary data capture system. Paper short forms were available as backup instruments and used infrequently. Six and 12-month study assessments were conducted for 83% and 77% of patients, respectively. It was feasible to use PROMIS tools in a large multi-center, trauma orthopaedics research setting. The ability to efficiently assess a wide spectrum of domains is critically important to the successful completion of future large-scale trials.

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. 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. 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. 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.

BackgroundFalls are common in older adults and can lead to severe injuries. The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial cluster-randomized 86 primary care practices across 10 health systems to a multifactorial intervention to prevent fall injuries, delivered by registered nurses trained as falls care managers, or enhanced usual care. STRIDE enrolled 5451 community-dwelling older adults age ≥70 at increased fall injury risk.MethodsWe assessed fall-related outcomes via telephone interviews of participants (or proxies) every 4 months. At baseline, 12 and 24 months, we assessed health-related quality of life (HRQOL) using the EQ-5D-5L and EQ-VAS. We used Poisson models to assess intervention effects on falls, fall-related fractures, fall injuries leading to hospital admission, and fall injuries leading to medical attention. We used hierarchical longitudinal linear models to assess HRQOL.ResultsFor recurrent event models, intervention versus control incidence rate ratios were 0.97 (95% confidence interval [CI], 0.93-1.00; p= 0.048) for falls, 0.93 (95% CI, 0.80-1.08; p= 0.337) for self-reported fractures, 0.89 (95% CI, 0.73-1.07; p= 0.205) for adjudicated fractures, 0.91 (95% CI, 0.77-1.07; p= 0.263) for falls leading to hospital admission, and 0.97 (95% CI, 0.89-1.06; p= 0.477) for falls leading to medical attention. Similar effect sizes (non-significant) were obtained for dichotomous outcomes (e.g., participants with ≥1 events). The difference in least square mean change over time in EQ-5D-5L (intervention minus control) was 0.009 (95% CI, -0.002 to 0.019; p= 0.106) at 12 months and 0.005 (95% CI, -0.006 to 0.015; p= 0.384) at 24 months.ConclusionsAcross a standard set of outcomes typically reported in fall prevention studies, we observed modest improvements, one of which was statistically significant. Future work should focus on patient-, practice-, and organization-level operational strategies to increase the real-world effectiveness of interventions, and improving the ability to detect small but potentially meaningful clinical effects.Clinicaltrialsgov identifier: NCT02475850.

An editorial is presented on the mitigating the July effect. Topics include the arrival of a crop of newly graduated medical students beginning their internships, the influx of so many freshly trained physicians arriving at the same time always triggers concern, and the belief in a July effect with presumed adverse consequences for patient safety and quality of care.

Background and MethodsWe conducted a single center cross-sectional study to investigate racial disparities in the hesitancy and utilization of monoclonal antibody (mAb) treatment of COVID-19 among treatment eligible patients who were referred to the infusion center between January 4, 2021 and May 14, 2021.ResultsAmong the 2,406 eligible participants, African Americans were significantly more likely to underutilize mAb treatment (OR 1.8; 95% CI 1.5-2.1) and miss treatment opportunities due to monoclonal hesitancy (OR 1.7, 95% CI 1.3-2.1).ConclusionAddressing racial disparities in mAb delivery is an opportunity to bridge the racial inequities in COVID-19 care.

Randomized clinical trials are critical for evaluating the safety and efficacy of interventions in oncology and informing regulatory decisions, practice guidelines, and health policy. Patient-reported outcomes (PROs) are increasingly used in randomized trials to reflect the impact of receiving cancer therapies from the patient perspective and can inform evaluations of interventions by providing evidence that cannot be obtained or deduced from clinicians’ reports or from other biomedical measures. This commentary focuses on how PROs add value to clinical trials by representing the patient voice. We employed 2 previously published descriptive frameworks (addressing how PROs are used in clinical trials and how PROs have an impact, respectively) and selected 9 clinical trial publications that illustrate the value of PROs according to the framework categories. These include 3 trials where PROs were a primary trial endpoint, 3 trials where PROs as secondary endpoints supported the primary endpoint, and 3 trials where PROs as secondary endpoints contrast the primary endpoint findings in clinically important ways. The 9 examples illustrate that PROs add valuable data to the care and treatment context by informing future patients about how they may feel and function on different treatments and by providing clinicians with evidence to support changes to clinical practice and shared decision making. Beyond the patient and clinician, PROs can enable administrators to consider the cost-effectiveness of implementing new interventions and contribute vital information to policy makers, health technology assessors, and regulators. These examples provide a strong case for the wider implementation of PROs in cancer trials.

The Patient-Reported Outcomes Measurement Information System Upper Extremity (PROMIS-UE) is frequently used in research/clinical care, but how it is understood by patients is unknown. We conducted a qualitative study including 12 cognitive interviews with patients with hand/upper extremity conditions and those purposively sampled for mixed literacy. Using framework analysis, we identified six themes total: difficulty answering questions due to insufficient information; uncertainty about whether to respond with the ability to perform the task with the injured extremity alone, either the injured or healthy extremity, or both; lack of experience doing certain tasks; uncertainty about whether to answer questions based on ability to perform the task with or without adaptive techniques; answering questions based on limitations not related to upper extremity function; and uncertainty regarding whether to answer questions on the basis of ability or pain. This study demonstrates the challenges in completing questionnaires and that variability may limit the reliability, validity and responsiveness of the PROMIS-UE.

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.

Objective: To explore the putative phases of the psychological response to disaster: preimpact, impact, heroic, honeymoon, disillusionment, and recovery, and make recommendations for corresponding interventions.Conclusions: Disasters such as the COVID-19 pandemic are often characterized by chaos and uncertainty. As a result, public health disaster planning and response represent formidable challenges. Although disasters can result from a wide array of hazards, regardless of the agent at work, they may follow a rather predictable trajectory of psychological phases. A heuristic of those phases can provide an opportunity for a more organized disaster mental health response and more efficient utilization of scarce resources.

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.

At a time when patient-centered care is a goal and patient safety is a paramount concern across the spectrum of health care, renewed and rigorous attention to interpersonal communication skills makes good sense. In this interdisciplinary article, we share lessons from communication science that can help clinicians communicate more appropriately and effectively with each other and with their patients in healthcare encounters.

New models of primary care include patient-reported outcome measures (PROMs) to promote patient-centered care. PROMs provide information on patient functional status and well-being, can be used to enhance care quality, and are proposed for use in assessing performance. Our objective was to identify a short list of candidate PROMs for use in primary care practice and to serve as a basis for performance measures (PMs). We used qualitative and quantitative methods to identify relevant patient-reported outcome (PRO) domains for use in performance measurement (PRO-PM) and their associated PROMs. We collected data from key informant groups: patients (n = 13; one-on-one and group interviews; concept saturation analysis), clinical thought leaders (n = 9; group discussions; thematic analysis), primary care practices representatives (n = 37; six focus groups; thematic analysis), and primary care payer representatives (n = 10; 12-question survey; frequencies of responses). We merged the key informant group information with findings from environmental literature scans. We conducted a targeted evidence review of measurement properties for candidate PROMs. We used a scoping review and key informant groups to identify PROM evaluation criteria, which were linked to the National Quality Forum measure evaluation criteria. We developed a de novo schema to score candidate PROMs against our criteria. We identified four PRO domains and 10 candidate PROMs: 3 for depressive symptoms, 2 for physical function, 3 for self-efficacy, 2 for ability to participate. Five PROMs met ≥ 70% of the evidence criteria for three PRO domains: PHQ-9 or PROMIS Depression (depression), PF-10 or PROMIS-PF (physical functioning), and PROMIS Self-Efficacy for Managing Treatments and Medications (self-efficacy). The PROMIS Ability to Participate in Social Roles and Activities met 68% of our criteria and might be considered for inclusion. Existing evidence and key informant data identified 5 candidate PROMs to use in primary care. These instruments can be used to develop PRO-PMs. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-020-05811-4) contains supplementary material, which is available to authorized users.

Objectives In an adverse event investigation, the patients have the potential to add a unique perspective because they can identify contributing factors that providers may miss. However, patients are rarely included in patient safety investigations. We aimed to identify the barriers to patient involvement in patient safety investigations and propose strategies to overcome them. Methods We reviewed literature on active participation by patients in safety investigations to construct a framework for healthcare institutions to use in approaching patients about a potential role in investigating an error in their care. We searched 3 electronic databases (PubMed, PSNet, Web of Science) for the years 1990 to 2018, without restrictions to language. Search terms included: "patient empowerment, "patient involvement," "patient participation," "patient safety investigation," "root cause analysis," "error analysis." We also examined reference lists of relevant studies to identify additional articles. Results Our electronic search produced 10,624 records with 30 potentially eligible articles. However, we identified only 6 relevant published articles. We used these as the basis for a proposed framework that is predicated on the thoughtful disclosure of adverse events and has 3 main levels (i.e., patient, clinician, and institutional level). For each level, we identify barriers to patient participation and potential strategies to overcome them. Conclusions The proposed framework can be used as a starting point to promote patient involvement in error investigations. Involving patients in patient safety investigations could increase patient centeredness, patient autonomy, and transparency and make analyses more effective by adding unique and potentially actionable information.

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.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.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.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.

The concept of second victims (SV) was introduced 20 years ago to draw attention to healthcare professionals involved in patient safety incidents. The objective of this paper is to advance the theoretical conceptualization and to develop a common definition. A literature search was performed in Medline, EMBASE and CINAHL (October 2010 to November 2020). The description of SV was extracted regarding three concepts: (1) involved persons, (2) content of action and (3) impact. Based on these concepts, a definition was proposed and discussed within the ERNST-COST consortium in 2021 and 2022. An international group of experts finalized the definition. In total, 83 publications were reviewed. Based on expert consensus, a second victim was defined as: "Any health care worker, directly or indirectly involved in an unanticipated adverse patient event, unintentional healthcare error, or patient injury and who becomes victimized in the sense that they are also negatively impacted". The proposed definition can be used to help to reduce the impact of incidents on both healthcare professionals and organizations, thereby indirectly improve healthcare quality, patient safety, person-centeredness and human resource management. ispartof: International Journal Of Environmental Research And Public Health vol:19 issue:24 ispartof: location:Switzerland status: Published online