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Importance: Agitation is common in mechanically ventilated ICU patients, but little is known about physician attitudes regarding agitation in this setting. Objectives: To characterize physician attitudes regarding agitation in mechanically ventilated ICU patients. Design, Setting, and Participants: We surveyed critical care physicians within a multicenter health system in Western Pennsylvania, assessing attitudes regarding agitation during mechanical ventilation and use of and confidence in agitation management options. We used quantitative clinical vignettes to determine whether agitation influences confidence regarding readiness for extubation. We sent our survey to 332 critical care physicians, of whom 80 (24%) responded and 69 were eligible (had cared for a mechanically ventilated patient in the preceding three months). Main Outcomes and Measures: Respondent confidence in patient readiness for extubation (0–100%, continuous) and frequency of use and confidence in management options (1–5, Likert). Results: Of 69 eligible responders, 61 (88%) agreed agitation is common and 49 (71%) agreed agitation is a barrier to extubation, but only 27 (39%) agreed their approach to agitation is evidence-based. Attitudes regarding agitation did not differ much by practice setting or physician demographics, though respondents working in medical ICUs were more likely ( P = .04) and respondents trained in surgery or emergency medicine were less likely ( P = .03) than others to indicate that agitation is an extubation barrier. Fifty-three (77%) respondents reported they frequently use non-pharmacologic measures to treat agitation, and 42 (70%) of those who reported they used non-pharmacologic measures during the prior 3 months indicated confidence in their effectiveness. In responses to clinical vignettes, confidence in patient's readiness for extubation was significantly lower if the patient was agitated ( P

International audience; Unique challenges arise when conducting trials to evaluate therapies already in common clinical use, including difficulty enrolling patients owing to widespread open-label use of trial therapies and the need for large sample sizes to detect small but clinically meaningful treatment effects. Despite numerous successes in trials evaluating novel interventions such as vaccines, traditional explanatory trials have struggled to provide definitive answers to time-sensitive questions for acutely ill patients with COVID-19. Pragmatic trials, which can increase efficiency by allowing some or all trial procedures to be embedded into clinical care, are increasingly proposed as a means to evaluate therapies that are in common clinical use. In this Personal View, we use two concurrently conducted COVID-19 trials of hydroxychloroquine (the US ORCHID trial and the UK RECOVERY trial) to contrast the effects of explanatory and pragmatic trial designs on trial conduct, trial results, and the care of patients managed outside of clinical trials. In view of the potential advantages and disadvantages of explanatory and pragmatic trial designs, we make recommendations for their optimal use in the evaluation of therapies in the acute care setting.

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.

Discussion of patient expectations for recovery is a component of intensive care unit (ICU) follow-up clinics. However, few studies have formally evaluated recovery-related expectations of ICU survivors.To estimate the prevalence of unmet expectations for recovery six months after hospital discharge among adult survivors of acute respiratory failure (ARF).Prospective, longitudinal, cohort study of ARF survivors discharged to home from five U.S. medical centers. Expectations for functional recovery were assessed by asking which activities and instrumental activities of daily living (I/ADLs) survivors expected to perform independently at six months. Survivors' expectations for overall health status were assessed using a visual analogue scale (VAS) ranging from 0 - 100. At 6-month follow-up, participants reported which I/ADLs they could perform independently and rated their overall health status using a 100-point VAS. We defined a participant's Functional Expectations as being met if they reported independently performing I/ADLs as expected at hospital discharge. Health Expectations were considered to be met when self-rated health status at six months was no more than eight points lower than expected at enrollment.Among 180 enrollees, 169 (94%) were alive and 160 of these (95%) participated in 6-month follow-up. Functional Expectations were met for 71% of participating survivors, and overall Health Expectations were met for 50%. Expectations for functional independence were high, ranging from 87% (housekeeping) to 99% (using a telephone). General health expectations were variable (median = 85, Interquartile range [IQR] = 75, 95). At 6-month follow-up, self-rated, overall health ranged from 2 to 100 (median = 80, IQR = 60, 85). In exploratory analyses, participants with met vs unmet expectations differed most in formal education (Functional Expectations standardized difference d = 0.88, Health Expectations d = 0.41).ARF survivors' expectations about independent functioning were high and generally met, but half had unmet general health expectations six months after discharge. It is difficult to predict whose health expectations will be unmet, but possessing less formal education may be a risk factor.

Goal concordant care (GCC) is the alignment of care to patient values and preferences. GCC is a major outcome of communication with patients and families in serious/critical illness. Using the electronic health record (EHR) to study the provision of GCC would be pragmatic and cost-effective for research and quality improvement efforts.Do EHRs contain information to identify GCC?This is a feasibility retrospective chart review performed by two independent reviewers. An existing framework containing four questions for identifying GCC was adopted. Two clinicians reviewed multi-disciplinary notes and extracted pertinent information. The primary outcomes were whether the four key questions for determining goal concordance could be answered using information in the EHR. The secondary outcome was the type of goals identified. Cohen's kappa was used to measure agreement between two reviewers.Patient care was considered goal concordant in 35 (85%) of 41 patients in a random sample comprising of 36 survivors and five who died in hospital. Inter-rater agreement on identifying data to determine GCC was excellent (Kappa 0.70). Patient goals were identified in 80% of charts reviewed. Note sources informative of patient preferences, included social work (39%), hospital progress notes (29%), palliative care (20%), and physical/occupational therapy (15%). "Returning home" and "getting better/ stronger" were among the most common patient goals captured in EHR.The EHR can be used to understand patient goals, but the information is scattered across the multi-disciplinary notes. Improving EHR and external validation will facilitate ascertainment of goal concordance as an important outcome measure.

Introduction Survivors of acute respiratory failure (ARF) commonly experience long-lasting physical, cognitive, and/or mental health impairments. Unmet medication needs occurring immediately after hospital discharge may have an important effect on subsequent recovery. Methods and analysis In this multicenter prospective cohort study, we enrolled ARF survivors who were discharged directly home from their acute care hospitalization. The primary exposure was unmet medication needs. The primary outcome was hospital readmission or death within 3 months after discharge. We performed a propensity score analysis, using inverse probability weighting for the primary exposure, to evaluate the exposure–outcome association, with an a priori sample size of 200 ARF survivors. Results We enrolled 200 ARF survivors, of whom 107 (53%) were female and 77 (39%) were people of color. Median (IQR) age was 55 (43–66) years, APACHE II score 20 (15–26) points, and hospital length of stay 14 (9–21) days. Of the 200 participants, 195 (98%) were in the analytic cohort. One hundred fourteen (57%) patients had at least one unmet medication need; the proportion of medication needs that were unmet was 6% (0–15%). Fifty-six (29%) patients were readmitted or died by 3 months; 10 (5%) died within 3 months. Unmet needs were not associated (risk ratio 1.25; 95% CI 0.75–2.1) with hospital readmission or death, although a higher proportion of unmet needs may have been associated with increased hospital readmission (risk ratio 1.7; 95% CI 0.96–3.1) and decreased mortality (risk ratio 0.13; 95% CI 0.02–0.99). Discussion Unmet medication needs are common among survivors of acute respiratory failure shortly after discharge home. The association of unmet medication needs with 3-month readmission and mortality is complex and requires additional investigation to inform clinical trials of interventions to reduce unmet medication needs. Study registration number: NCT03738774. The study was prospectively registered before enrollment of the first patient.

For more than three decades, both medical professionals and the public have worried that many patients receive non-beneficial care in US intensive care units during their final months of life. Some of these patients wish to avoid severe cognitive and physical impairments, and protracted deaths in the hospital setting. Recognising when intensive care will not restore a person's health, and helping patients and families embrace goals related to symptom relief, interpersonal connection, or spiritual fulfilment are central challenges of critical care practice in the USA. We review trials from the past decade of interventions designed to address these challenges, and present reasons why evaluating, comparing, and implementing these interventions have been difficult. Careful scrutiny of the design and interpretation of past trials can show why improving goal concordant care has been so elusive, and suggest new directions for the next generation of research.

Objectives:The Critical Care Choosing Wisely Task Force recommends that intensivists offer patients at high risk for death or severe functional impairment the option of pursuing care focused on comfort. We tested the a priori hypothesis that intensivists who are prompted to document patient prognosi

PURPOSE: To determine how patients perceive their quality of life (QOL) six months following critical illness and to measure clinicians’ discriminative accuracy of predicting this outcome. MATERIALS AND METHODS: This prospective cohort study of intensive care unit (ICU) survivors asked patients to report their QOL strictly at six months compared to one month before their critical illness as better, the same, or worse. ICU physicians and nurses made six-month QOL predictions for these patients.. RESULTS: Of 162 critical illness survivors, 33% (n=53) of patients reported six-month QOL as better, 33% (n=54) the same, and 34% (n=55) worse. Abnormal cognition and inability to return to primary pastime or original place of residence (p

BACKGROUND: As more individuals survive sepsis, there is an urgent need to understand its effects on patient-reported outcomes. RESEARCH QUESTION: What is the effect of sepsis on self-rated health, and what role, if any, does functional disability play in mediating this effect? STUDY DESIGN AND METHODS: We conducted a survey- and administrative claims-based retrospective cohort study using the US Health and Retirement Study, a nationally representative cohort-based survey of older adults in the United States, from 2000 through 2016. We matched Medicare beneficiaries hospitalized with sepsis in 2000 to 2008 to nonhospitalized individuals. Self-rated health and functional disability were tracked biannually for 8 years. Differences in self-rated health between the cohorts were measured using mixed models with and without controlling for changes in functional disability. RESULTS: Seven hundred fifty-eight individuals with sepsis were matched 1:1 to 758 nonhospitalized individuals, all aged 65 years and older. Among survivors, sepsis was associated with worse self-rated health in years 2 and 4 (adjusted absolute difference in self-rated health on a 5-point scale in year 2: −0.24 [95% CI, −0.38 to −0.10] and year 4: −0.17 [95% CI, −0.33 to −0.02]) but not in years 6 or 8. After accounting for changes in functional status, the association between sepsis and self-rated health was still present but reduced in year 2 (adjusted absolute difference in self-rated health, −0.18 [95% CI, −0.31 to −0.05]) and was not present in years 4, 6, or 8. INTERPRETATION: Self-rated health worsened initially after sepsis but returned to the level of that of nonhospitalized control subjects by year 6. Mitigating sepsis-related functional disability may play a key role in improving self-rated health after sepsis.

Family support is more, not less, important during crisis. However, during the COVID-19 pandemic, maintaining public safety necessitates restricting the physical presence of families for hospitalized patients. In response, health systems must rapidly adapt family-centric procedures and tools to circumvent restrictions on physical presence. Strategies for maintaining family integrity must acknowledge clinicians' limited time and attention to devote to learning new skills. Internet-based solutions can facilitate the routine, predictable, and structured communication, which is central to family-centered care. But the reliance on technology may compromise patient privacy and exacerbate racial, socioeconomic, and geographic disparities for populations that lack access to reliable internet access, devices, or technological literacy. We provide a toolbox of strategies for supporting family-centered inpatient care during physical distancing responsive to the current clinical climate. Innovations in the implementation of family involvement during hospitalizations may lead to long-term progress in the delivery of family-centered care.

Objectives The objective of this study was to elicit feedback on consensus methodology used for core outcome set (COS) development. Study Design and Setting An online survey of international Delphi panelists participating in a recent COS for clinical research studies evaluating acute respiratory failure (ARF) survivors was conducted. Panelists represented 14 countries (56% outside the United States). Results Seventy (92%) panelists completed the survey, including 32 researchers, 19 professional association representatives, 4 research funding representatives, and 15 ARF survivors/caregiver members. Among respondents, 91% reported that the time required to participate was appropriate and 96% were not bothered by reminders for timely response. Attributes of measurement instruments and voting results from previous rounds were evaluated differently across stakeholder groups. When measurement properties were explained in the stem of the survey question, 59 (84%) panelists (including 73% of survivors/families) correctly interpreted information about an instrument's reliability. Without a reminder in the stem, only 20 (29%) panelists (including 38% of researchers) correctly identified properties of a COS. Conclusion This international Delphi panel, including >20% patients/caregivers, favorably reported on feasibility of the methodology. Providing all panelists pertinent information/reminders about the project's objective at each voting round is important to informed decision making across all stakeholder groups.

Research evaluating acute respiratory failure (ARF) survivors' outcomes after hospital discharge has substantial heterogeneity in terms of the measurement instruments used, creating barriers to synthesizing study data.To identify a minimum set of core outcome measures that are essential to include in all clinical research studies evaluating ARF survivors after discharge.We conducted a three-round modified Delphi consensus process with 77 participants (47% female, 55% outside the United States), including clinical researchers from more than 16 countries across six continents, patients/caregivers, clinicians, and research funders. Participants reviewed standardized information on measure instruments for seven consensus-derived outcomes plus one recommended outcome.Response rates were 91 to 97% across the three rounds. Among 75 measurement instruments evaluated, the following met a priori consensus criteria: EQ-5D and 36-item Short Form Health Survey version 2 (optional) for the "satisfaction with life and personal enjoyment" and "pain" outcomes, and both the Hospital Anxiety and Depression Scale and the Impact of Events Scale-Revised for the "mental health" outcome. No measures reached consensus for the following outcomes: cognition, muscle and/or nerve function, physical function, and pulmonary function. All measures considered for pulmonary function met consensus criteria for exclusion. The following measures did not reach the threshold for consensus but achieved the highest scores for their respective outcomes: the Montreal Cognitive Assessment (cognition), manual muscle testing and handgrip dynamometry (muscle and/or nerve function), and 6-minute-walk test (physical function).This Core Outcome Measurement Set is recommended for use in all clinical research evaluating ARF survivors after hospital discharge. In the future, researchers should evaluate measures for outcomes not reaching consensus.

To identify the "core domains" (i.e., patient outcomes, health-related conditions, or aspects of health) that relevant stakeholders agree are essential to assess in all clinical research studies evaluating the outcomes of acute respiratory failure survivors after hospital discharge.A two-round consensus process, using a modified Delphi methodology, with participants from 16 countries, including patient and caregiver representatives. Prior to voting, participants were asked to review 1) results from surveys of clinical researchers, acute respiratory failure survivors, and caregivers that rated the importance of 19 preliminary outcome domains and 2) results from a qualitative study of acute respiratory failure survivors' outcomes after hospital discharge, as related to the 19 preliminary outcome domains. Participants also were asked to suggest any additional potential domains for evaluation in the first Delphi survey.Web-based surveys of participants representing four stakeholder groups relevant to clinical research evaluating postdischarge outcomes of acute respiratory failure survivors: clinical researchers, clinicians, patients and caregivers, and U.S. federal research funding organizations.None.None.Survey response rates were 97% and 99% in round 1 and round 2, respectively. There were seven domains that met the a priori consensus criteria to be designated as core domains: physical function, cognition, mental health, survival, pulmonary function, pain, and muscle and/or nerve function.This study generated a consensus-based list of core domains that should be assessed in all clinical research studies evaluating acute respiratory failure survivors after hospital discharge. Identifying appropriate measurement instruments to assess these core domains is an important next step toward developing a set of core outcome measures for this field of research.

Objectives To evaluate the epidemiology of and postintensive care unit (ICU) interventions for anxiety symptoms after critical illness. Methods We searched five databases (1970–2015) to identify studies assessing anxiety symptoms in adult ICU survivors. Data from studies using the most common assessment instrument were meta-analyzed. Results We identified 27 studies (2880 patients) among 27,334 citations. The Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale was the most common instrument (81% of studies). We pooled data at 2–3, 6 and 12–14month time-points, with anxiety symptom prevalences [HADS-A≥8, 95% confidence interval (CI)] of 32%(27–38%), 40%(33–46%) and 34%(25–42%), respectively. In a subset of studies with repeated assessments in the exact same patients, there was no significant change in anxiety score or prevalence over time. Age, gender, severity of illness, diagnosis and length of stay were not associated with anxiety symptoms. Psychiatric symptoms during admission and memories of in-ICU delusional experiences were potential risk factors. Physical rehabilitation and ICU diaries had potential benefit. Conclusions One third of ICU survivors experience anxiety symptoms that are persistent during their first year of recovery. Psychiatric symptoms during admission and memories of in-ICU delusional experiences were associated with post-ICU anxiety. Physical rehabilitation and ICU diaries merit further investigation as possible interventions.

Background There is increasing interest in measuring the quality of survivorship for patients admitted to the intensive care unit for acute respiratory failure (ARF). However, there is substantial variability in patient outcomes reported in studies evaluating these patients, with few data on which outcomes are essential to inform clinical practice. Objective The objectives of this study were to determine clinicians’ perspectives on the outcome domains that should always be reported in studies evaluating people who have had ARF after hospital discharge and to compare findings about US and Australian perspectives. Design A modified Delphi method was used for the study. Methods A survey with 19 possible domains was developed to iteratively elicit clinicians’ perspectives on core outcome domains via a modified Delphi method. The survey was initially administered online. The survey results were then discussed independently at meetings at scientific conferences in the United States and Australia, and the survey was repeated at the meetings after the discussions. Results The numbers of participants who responded to both the online and the real-time polling were 44 of 100 (44%) in the United States and 78 of 85 (92%) in Australia. Most respondents were intensive care unit–based clinicians (United States: 33 [75%]; Australia: 76 [97%]). For the 19 domains evaluated, both US and Australian groups ranked physical function and symptoms as the most important domain, with quality of life, cognitive function and symptoms, and survival being the next 3 most important domains. These data yielded a total of 4 domains meeting the criteria for inclusion as core domains at both meetings. Limitations Several key constituencies, including patients and caregivers, were not represented in this study; their perspectives are also important and ideally should be included in the development of a comprehensive core outcome set. Conclusions Clinicians agreed that physical function and symptoms, quality of life, cognitive function, and survival were domains that should always be measured in research evaluating outcomes for people who have had ARF after hospital discharge.

To synthesize data on prevalence, natural history, risk factors, and post-ICU interventions for depressive symptoms in ICU survivors.PubMed, EMBASE, Cumulative Index of Nursing and Allied Health Literature, PsycINFO, and Cochrane Controlled Trials Registry (1970-2015).Studies measuring depression after hospital discharge using a validated instrument in more than 20 adults from non-specialty ICUs.Duplicate independent review and data abstraction.The search identified 27,334 titles, with 42 eligible articles on 38 unique studies (n = 4,113). The Hospital Anxiety and Depression Scale-Depression subscale was used most commonly (58%). The pooled Hospital Anxiety and Depression Scale-Depression subscale prevalence (95% CI) of depressive symptoms at a threshold score greater than or equal to 8 was 29% (22-36%) at 2-3 months (12 studies; n = 1,078), 34% (24-43%) at 6 months (seven studies; n = 760), and 29% (23-34%) at 12-14 months (six studies; n = 1,041). The prevalence of suprathreshold depressive symptoms (compatible with Hospital Anxiety and Depression Scale-Depression subscale, ≥ 8) across all studies, using all instruments, was between 29% and 30% at all three time points. The pooled change in prevalence (95% CI) from 2-3 to 6 months (four studies; n = 387) was 5% (-1% to +12%), and from 6 to 12 months (three studies; n = 412) was 1% (-6% to +7%). Risk factors included pre-ICU psychologic morbidity and presence of in-ICU psychologic distress symptoms. We did not identify any post-ICU intervention with strong evidence of improvement in depressive symptoms.Clinically important depressive symptoms occurred in approximately one-third of ICU survivors and were persistent through 12-month follow-up. Greater research into treatment is needed for this common and persistent post-ICU morbidity.

Legal documents similar to the Maryland Medical Orders for Life-Sustaining Treatment (MOLST) form requiring physician endorsement are increasingly used by critically ill patients.To evaluate whether an interactive, online training module on completion and interpretation of the MOLST form leads to a sustained increase in knowledge among house staff.Pre/post survey of 329 house staff at Johns Hopkins Hospital who admit and discharge patients between June 2014 and July 2015. House staff were encouraged to complete a voluntary, interactive, online educational module on completing and interpreting MOLST forms. Participants received $25 for accessing the module and $10 for completing each survey.The primary outcome was the change in the number of questions answered correctly on the post- versus presurvey comparing house staff who viewed the module for at least 20 minutes with house staff who never viewed or never completed the module. Overall, 329 (69%) house staff completed the knowledge assessment survey both before and after the module was available, and 201 (61%) of these house staff completed the voluntary module. The median score on the presurvey conducted in July and August of 2014 was 14 out of 21 (interquartile range [IQR] 12, 16). The median (IQR) score on the postsurvey conducted in May and June of 2015 was 15 out of 21 (13, 17). The median (IQR) change in score among those who spent at least 20 minutes completing the module was 1 question (-1, 3), and among those who never viewed or never completed the module it was also 1 (IQR -1, 2). The postsurvey was completed a median (IQR) of 59 (52, 62) days after viewing the module. After adjusting for years of postgraduate clinical training, self-reported baseline experience completing MOLST forms, and self-reported responsibility for discharging patients, viewing the module for at least 20 minutes was associated with a nonsignificant increase in score of 0.41 questions (95% confidence interval, -0.25, 1.06; P = 0.23).An interactive, online educational module had no effect on trainee knowledge of completing and interpreting MOLST forms approximately 2 months after completion. Information conveyed via online modules alone may have minimal sustained impact on house staff knowledge.

OBJECTIVES To characterize intensivist handoff practices and expectations and to explore perceptions of the patient safety implications of attending handoffs. DESIGN Cross-sectional electronic survey administered in 2014. SETTING One hundred sixty-nine U.S. hospitals with critical care training programs accredited by the Accreditation Council for Graduate Medical Education. SUBJECTS Academic intensivists were recruited via e-mail invitation from a database of 1,712 eligible academic intensivists. INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS Six hundred sixty-one intensivists completed the survey (completion rate, 38.6%). Responses were received from at least one individual at 147 of 169 unique hospitals (87.0%) represented in the study database. Five hundred seventy-three (87%) respondents reported participating in handoffs at the end of each ICU rotation. A variety of communication methods were used for end-of-rotation handoffs, including in-person discussion (92.9%), telephone calls (83.9%), e-mail messages (69.0%), computer-generated documents (64.6%), and text messages (23.6%). Mean satisfaction with current handoff process was rated as 68.4 on a scale from 0 to 100 (SD, 22.6). Respondents (55.4%) said that attending handoffs should be standardized, but only 13.3% (76/572) of those participating in end-of-rotation handoffs reported using a standardized process. Specific handoff topics, including active clinical issues and resuscitation status, were reportedly discussed less frequently than would be ideal (p < 0.001 for the difference between reported frequency and ideal frequency). In free-text comments, 76 respondents (11.5%) expressed skepticism that attending handoffs were necessary given the presence of residents and fellows and given a lack of agreement about necessary content. Two hundred respondents (30.8%) reported knowing of an adverse event (inappropriate treatment, cardiac arrest, and death) attributable to inadequate attending handoffs. CONCLUSIONS ICU attending handoffs in the United States exhibit marked heterogeneity, and intensivists do not agree about the value of attending handoffs. In addition, some intensivists perceive a link between suboptimal attending handoffs, inappropriate treatment, and serious adverse events that warrants further study.

e24005 Background: Patients participating in phase I trials represent a population with advanced cancer and symptoms, with QOL implications from both disease and treatment. Transitions to end of life for these patients has received little attention. Good empirical data is needed to better understand the role of advanced care planning (ACP) and palliative care (PC) during phase I trial transitions. We investigated how physician-patient communication at time of progression, patient characteristics, and patterns of care were associated with EOL care. Methods: Retrospective chart review of all patients with solid tumors enrolled in phase I trials at a comprehensive cancer center from Jan 2015 to Dec 2017. We captured physician-patient communication during disease progression, and for all patient deaths, assessed PC referral, ACP, place of death, health care utilization in the final month of life, hospice enrollment and LOS. Factors independently associated with a short hospice LOS (defined as ≤3 days) were estimated from a multivariable model building approach. Results: Among 207 participants, median age was 61 (range 31-91), 48% were female and 20% were ethnic minorities. Predominant diagnoses were GI (40%), GU (14%), and lung cancer (15%). 40% of patients were referred from an outside institution. At the time of disease progression, 64% had goals of care documented, 57% were referred to PC, and 54% discussed hospice with their oncologist. Overall, 82% of patients died within 1 year of study enrollment. Of all patients who died, 85% enrolled in hospice and 76% died at home. In the last 30 days of life, 37% were hospitalized, 21% received chemotherapy, and 8% were admitted to the ICU. 15% had a short hospice LOS. The multivariable model revealed that increased age > 65 was positively associated with short hospice length of service (odds ratio (OR) 1.12 [95% CI 1.01, 1.24], p = 0.03), while remaining at the same institution (OR 0.72 [95% CI 0.65, 0.8], p < 0.001), and referral to PC before progression (OR 0.83 [95% CI 0.75, 0.92], p < 0.001) were associated with a decreased risk of short hospice LOS. Conclusions: This data supports the benefit of PC for patients on phase I trials and the danger of transitions for all patients, with particular attention needed for older adults, regardless of care received. Leaving a clinical trial is a time when clear communication is paramount. Phase 1 studies will continue to be vital in advancing cancer treatment. It is equally important to advance the support provided to patients who transition off these trials.

Key Points Question Does intensivist self-assessment of communication skills endorsed by professional guidelines align with assessments of the same skills by blinded expert colleagues? Findings In this survey, 76 US intensivists read deidentified transcripts from their intensive care unit family meeting and rated themselves as conveying prognosis, highlighting choice, providing recommendations and offering the option of care focused on comfort. Sixty-one of 76 intensivists reported conveying prognosis, and blinded colleagues agreed that 42 of those 61 had conveyed the patient’s risk of death. Meaning Clinicians who lack communication skills endorsed in professional guidelines may also lack the metacognitive skills required to recognize their deficiencies, which makes routine feedback and continuing education on communication and shared decision-making essential at all levels of practice., Importance Professional guidelines have identified key communication skills for shared decision-making for critically ill patients, but it is unclear how intensivists interpret and implement them. Objective To compare the self-evaluations of intensivists reviewing transcripts of their own simulated intensive care unit family meetings with the evaluations of trained expert colleagues. Design, Setting, and Participants A posttrial web-based survey of intensivists was conducted between January and March 2019. Intensivists reviewed transcripts of simulated intensive care unit family meetings in which they participated in a previous trial from October 2016 to November 2017. In the follow-up survey, participants identified if and how they performed key elements of shared decision-making for an intensive care unit patient at high risk of death. Transcript texts that intensivists self-identified as examples of key communication skills recommended by their professional society’s policy on shared decision-making were categorized. Main Outcomes and Measures Comparison of the evaluations of 2 blinded nonparticipant intensivist colleagues with the self-reported responses of the intensivists. Results Of 116 eligible intensivists, 76 (66%) completed the follow-up survey (mean [SD] respondent age was 43.1 [8.1] years; 72% were male). Sixty-one of 76 intensivists reported conveying prognosis; however, blinded colleagues who reviewed the deidentified transcripts were less likely to report that prognosis had been conveyed than intensivists reviewing their own transcripts (42 of 61; odds ratio, 0.10; 95% CI, 0.01-0.44; P, This survey study assesses how the self-assessments of intensivists who read a transcript of their participation in an intensive care family meeting simulation compare with assessments of blinded colleagues reading the same transcript in reporting the performance of key communication skills endorsed by their professional societies.

Key Points Question Do intensivist communication patterns affect the way family members understand their loved one’s prognosis in the intensive care unit? Findings In this randomized trial of 302 family members of people with chronic obstructive pulmonary disease receiving long-term oxygen therapy, participants were asked to imagine their family member was in the intensive care unit, and the participants were presented video vignettes of an intensivist who expected a patient to die answering the prognostic question “What do you think is most likely to happen?” Participants who viewed videos of the intensivist using indirect or redirection language perceived the intensivist to be more optimistic than participants who viewed a video of the intensivist answering the question directly. Meaning These findings suggest that family members interpret physicians’ indirect responses to questions about prognosis as more optimistic than direct responses., This randomized trial examines the effects of 4 types of intensivist responses to the question “What do you think is most likely to happen?” among family members of people with chronic obstructive pulmonary disease in a hypothetical intensive care unit setting., Importance Discordance about prognosis between a patient’s health care decision-making surrogate and the treating intensivist is common in the intensive care unit (ICU). Empowering families, friends, and caregivers of patients who are critically ill to make informed decisions about care is important, but it is unclear how best to communicate prognostic information to surrogates when a patient is expected to die. Objective To determine whether family members, who are often health care decision-making surrogates, interpret intensivists as being more optimistic when questions about prognosis in the ICU are answered indirectly. Design, Setting, and Participants This web-based randomized trial was conducted between September 27, 2019, and October 17, 2019, among a national sample of adult children, spouses, partners, or siblings of people with chronic obstructive pulmonary disease who were receiving long-term oxygen therapy. Participants were shown video vignettes depicting an intensivist answering a standardized question about the prognosis of a patient at high risk of death on day 3 of ICU admission. Participants were excluded if they had worked as a physician, nurse, or advanced health care practitioner. Data were analyzed from October 18, 2019, to November 12, 2019. Interventions Participants were randomized to view 1 of 4 intensivist communication styles in response to the question “What do you think is most likely to happen?”: (1) a direct response (control), (2) an indirect response comparing the patient’s condition with that of other patients, (3) an indirect response describing the patient’s deteriorating physiological condition, or (4) redirection to a discussion of the patient’s values and goals. Main Outcomes and Measures Participant responses to 2 questions: (1) “If you had to guess, what do you think the doctor thinks is the chance that your loved one will survive this hospitalization?” and (2) “What do you think are the chances that your loved one will survive this hospitalization?” answered using a 0% to 100% probability scale. Results Among 302 participants (median [interquartile range] age, 49 [38-59] years; 204 [68%] women) included in the trial, 165 (55%) were adult children of the individual with chronic obstructive pulmonary disease; 77 participants were randomized to view a direct response, 77 participants were randomized to view an indirect response referencing other patients, 68 participants were randomized to view an indirect response referencing physiological condition, and 80 participants were randomized to view a redirection response. Compared with participants who viewed a direct response, participants who viewed an indirect response referencing other patients (β = 10 [95% CI, 1-19]; P = .03), physiological condition (β = 10 [95% CI, 0-19]; P = .04), or redirection to a discussion of the patient’s values and goals (β = 19 [95% CI, 10-28]; P

Context Conflict is frequently reported by both clinicians and surrogate decision makers for adult patients in intensive care units. Because religious clinicians view religion as an important dimension of end-of-life care, we hypothesized that religious critical care attendings (intensivists) would be more comfortable and perceive less conflict when discussing a patient's critical illness with a religious surrogate. Objectives The objective of this study was to assess if religious intensivists are more or less likely to perceive conflict during a simulated family meeting than secular colleagues. Methods Intensivists were recruited to participate in a standardized, simulated family meeting with an actor portraying a family member of a critically ill patient. Intensivists provided demographic information including their current religion and the importance of religion in their lives. After the simulation, intensivists rated the amount of conflict they perceived during the simulation. The association between intensivist's self-reported religiosity and perceived conflict was estimated using both univariate analysis and multivariable logistic regression. Results Among 112 participating intensivists, 43 (38%) perceived conflict during the simulation. Among intensivists who perceived conflict, 49% were religious, and among those who did not perceive conflict, 35% were religious. After adjusting for physician race, gender, years in practice, intensive care unit weeks worked per year and actor, physician religiosity was associated with greater odds of perceiving conflict during the simulated family meeting (adjusted prevalence ratio = 2.77, [95% CI 1.12–7.16], P = 0.03). Conclusion Religious intensivists were more likely to perceive conflict during a simulated family meeting.

Context Goal-concordant care has been identified as an important outcome of advance care planning and shared decision-making initiatives. However, validated methods for measuring goal concordance are needed. Objectives To estimate the inter-rater reliability of senior critical care fellows rating the goal concordance of preference-sensitive interventions performed in intensive care units (ICUs) while considering patient-specific circumstances as described in a previously proposed methodology. Methods We identified ICU patients receiving preference-sensitive interventions in three adult ICUs at Johns Hopkins Hospital. A simulated cohort was created by randomly assigning each patient one of 10 sets of goals and preferences about limiting life support. Critical care fellows then independently reviewed patient charts and answered two questions: 1) Is this patient's goal achievable? and 2) Will performing this intervention help achieve the patient's goal? When the answer to both questions was yes, the intervention was rated as goal concordant. Inter-rater agreement was summarized by estimating intraclass correlation coefficient using mixed-effects models. Results Six raters reviewed the charts of 201 patients. Interventions were rated as goal concordant 22%–92% of the time depending on the patient's goal-limitation combination. Percent agreement between pairs of raters ranged from 59% to 86%. The intraclass correlation coefficient for ratings of goal concordance was 0.50 (95% CI 0.31–0.69) and was robust to patient age, gender, ICU, severity of illness, and lengths of stay. Conclusion Inter-rater agreement between intensivists using a standardized methodology to evaluate the goal concordance of preference-sensitive ICU interventions was moderate. Further testing is needed before this methodology can be recommended as a clinical research outcome.

BACKGROUND: As mortality rates for patients treated in intensive care units decrease, greater understanding of the impact of critical illness on patients’ well-being is needed. OBJECTIVE: To describe the survivorship experience of patients who had acute respiratory failure by using the Patient Reported Outcomes Measurement Information System (PROMIS) framework. METHODS: A total of 48 adult patients who had acute respiratory failure completed at least 1 semistructured telephone-based interview between 5 and 18 months after their stay in the intensive care unit. Participants were asked about overall well-being and important health outcomes. RESULTS: Major themes were identified within each of the 3 PROMIS components: physical health, mental health, and social health.The following themes were particularly prominent: mobility impairments, pulmonary symptoms, fatigue, anxiety and depression symptoms, and decreased ability to work and participate in valued activities. Impacts on overall well-being and on relationships with friends and family members varied among the survivors. Some survivors reported gratitude, increased appreciation of life, and closer relationships to loved ones. Other survivors reported boredom, social isolation, and wishing they had not survived. CONCLUSIONS: Survivors of acute respiratory failure reported substantial issues with their physical, mental, and social health. Holistic assessments of outcomes of survivors of critical illness should capture the complex beneficial and adverse impacts of critical illness on survivors’ well-being and social health. (American Journal of Critical Care. 2017;26:456-465)

Objective To assess how enhanced postdischarge telephone follow-up calls would improve case finding for surgical site infection (SSI) surveillance after cesarean section. Methods We conducted a prospective cohort study of all patients who delivered by cesarean section between April 22 and August 22, 2010. In addition to our routine surveillance, using clinical databases and electronic patient records, we also made follow-up calls to the patients at 7, 14, and 30 days postoperation. A standard questionnaire with questions about symptoms of SSI, health-seeking behaviors, and treatment received was administered. Descriptive statistics and univariate analysis were performed to assess the effect of the enhanced surveillance. Results One hundred ninety-three patients underwent cesarean section during this study period. Standard surveillance identified 14 infections with telephone follow-ups identifying an additional 5 infections. Using the call as a gold standard, the sensitivity of the standard methodology to capture SSI was 73.3%. The duration of the calls ranged from 1 to 5 minutes and were well received by the patients. Conclusions Results suggest that follow-up telephone calls to patients following cesarean section identifies 26.3% of the total SSIs. Enhanced surveillance can provide more informed data to enhance performance and avoid underestimation of rates.

Rationale The majority of ICU patients lack decision-making capacity at some point during their ICU stay. However the extent to which proxy decision-makers are engaged in decisions about their patient’s care is challenging to quantify. Objectives To assess 1)whether proxies know their patient’s actual code status as recorded in the electronic medical record (EMR), and 2)whether code status orders reflect ICU patient preferences as reported by proxy decision-makers. Methods We enrolled proxy decision-makers for 96 days starting January 4, 2016. Proxies were asked about the patient’s goals of care, preferred code status, and actual code status. Responses were compared to code status orders in the EMR at the time of interview. Characteristics of patients and proxies who correctly vs incorrectly identified actual code status were compared, as were characteristics of proxies who reported a preferred code status that did vs did not match actual code status. Measurements and main results Among 111 proxies, 42 (38%) were incorrect or unsure about the patient’s actual code status and those who were correct vs. incorrect or unsure were similar in age, race, and years of education (P>0.20 for all comparisons). Twenty-nine percent reported a preferred code status that did not match the patient’s code status in the EMR. Matching preferred and actual code status was not associated with a patient’s age, gender, income, admission diagnosis, or subsequent in-hospital mortality or with proxy age, gender, race, education level, or relation to the patient (P>0.20 for all comparisons). Conclusions More than 1 in 3 proxies is incorrect or unsure about their patient’s actual code status and more than 1 in 4 proxies reported that a preferred code status that did not match orders in the EMR. Proxy age, race, gender and education level were not associated with correctly identifying code status or code status concordance.

To evaluate the effect of 1) patient values as expressed by family members and 2) a requirement to document patients' functional prognosis on intensivists' intention to discuss withdrawal of life support in a hypothetical family meeting.A three-armed, randomized trial.One hundred seventy-nine U.S. hospitals with training programs in critical care accredited by the Accreditation Council for Graduate Medical Education.Six hundred thirty intensivists recruited via e-mail invitation from a database of 1,850 eligible academic intensivists.Each intensivist was randomized to review 10, online, clinical scenarios with a range of illness severities involving a hypothetical patient (Mrs. X). In control-group scenarios, the patient did not want continued life support without a reasonable chance of independent living. In the first experimental arm, the patient wanted life support regardless of functional outcome. In the second experimental arm, patient values were identical to the control group, but intensivists were required to record the patient's estimated 3-month functional prognosis.Response to the question: "Would you bring up the possibility of withdrawing life support with Mrs. X's family?" answered using a five-point Likert scale. There was no effect of patient values on whether intensivists intended to discuss withdrawal of life support (p = 0.81), but intensivists randomized to record functional prognosis were 49% more likely (95% CI, 20-85%) to discuss withdrawal.In this national, scenario-based, randomized trial, patient values had no effect on intensivists' decisions to discuss withdrawal of life support with family. However, requiring intensivists to record patients' estimated 3-month functional outcome substantially increased their intention to discuss withdrawal.

BACKGROUND: Empirical combination antibiotic regimens consisting of a β-lactam and an aminoglycoside are frequently employed in the pediatric population. Data to demonstrate the comparative benefit of empirical β-lactam combination therapy relative to monotherapy for culture-proven Gram-negative bacteremia are lacking in the pediatric population. METHODS: We conducted a retrospective cohort study of children treated for Gram-negative bacteremia at The Johns Hopkins Hospital from 2004 through 2012. We compared the estimated odds of 10-day mortality and the relative duration of bacteremia for children receiving empirical combination therapy versus empirical monotherapy using 1:1 nearest-neighbor propensity-score matching without replacement, before performing regression analysis. RESULTS: We identified 226 matched pairs of patients well balanced on baseline covariates. Ten-day mortality was similar between the groups (odds ratio, 0.84; 95% confidence interval [CI], 0.28 to 1.71). Use of empirical combination therapy was not associated with a decrease in the duration of bacteremia (−0.51 days; 95% CI, −2.22 to 1.48 days). There was no survival benefit when evaluating 10-day mortality for the severely ill (pediatric risk of mortality III score ≥15) or profoundly neutropenic patients (absolute neutrophil count ≤100 cells/mL) receiving combination therapy. However, a survival benefit was observed when empirical combination therapy was prescribed for children growing multidrug-resistant Gram-negative organisms from the bloodstream (odds ratio, 0.70; 95% CI, 0.51 to 0.84). CONCLUSIONS: Although there appears to be no advantage to the routine addition of an aminoglycoside to a β-lactam as empirical therapy for children who have Gram-negative bacteremia, children who have risk factors for MDRGN organisms appear to benefit from this practice.

We evaluated 222 hospitalized patients whose clinical isolates were tested using standard methods and matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF). MALDI-TOF could have reduced time to appropriate therapy for 28.8% and 44.6% patients based on the treating physician's choices and stewardship team recommendations, respectively. Clinicians should be aware of scenarios in which MALDI-TOF can optimize antibiotic therapy.

To evaluate the study designs and measurement instruments used to assess physical, cognitive, mental health, and quality of life outcomes of survivors of critical illness over more than 40 years old as a first step toward developing a core outcome set of measures for future trials to improve outcomes in ICU survivors.Scoping review.Published articles that included greater than or equal to one postdischarge measure of a physical, cognitive, mental health, or quality of life outcome in more than or equal to 20 survivors of critical illness published between 1970 and 2013. Instruments were classified using the World Health Organization's International Classification of Functioning, Disability, and Health framework.ICU survivors.None.We reviewed 15,464 abstracts, and identified 425 eligible articles, including 31 randomized trials (7%), 116 cross-sectional studies (27%), and 278 cohort studies (65%). Cohort studies had a median (interquartile range) sample size of 96 survivors (52-209), with 38% not fully reporting loss to follow-up. A total of 250 different measurement instruments were used in these 425 articles. Among eligible articles, 25 measured physical activity limitations (6%), 40 measured cognitive activity limitations (9%), 114 measured mental health impairment (27%), 196 measured participation restriction (46%), and 276 measured quality of life (65%).Peer-reviewed publications reporting patient outcomes after hospital discharge for ICU survivors have grown from 3 in the 1970s to more than 300 since 2000. Although there is evidence of consolidation in the instruments used for measuring participation restriction and quality of life, the ability to compare results across studies remains impaired by the 250 different instruments used. Most articles described cohort studies of modest size with a single follow-up assessment using patient-reported measures of participation restriction and quality of life. Development of a core outcome set of valid, reliable, and feasible measures is essential to improving the outcomes of critical illness survivors.

The role of cefepime for extended-spectrum β-lactamase (ESBL) bacteremia is unclear if susceptible in vitro. In a propensity score-matched study of patients with ESBL bacteremia, risk of death was 2.87 times higher for patients receiving cefepime compared with carbapenems (95% confidence interval [CI], .88–9.41). We compared 14-day mortality of patients with ESBL bacteremia receiving empiric cefepime versus empiric carbapenem therapy in a propensity score-matched cohort. There was a trend towards increased mortality in the cefepime group (hazard ratio, 2.87; 95% CI, .88–9.41), which enhances the existing literature suggesting that cefepime may be suboptimal for invasive ESBL infections.

Delirium is associated with impaired outcome, but it is unclear whether this relationship is limited to in-hospital outcomes and whether this relationship is independent of the severity of underlying conditions. The aim of this study was to investigate the association between delirium in the intensive care unit (ICU) and long-term mortality, self-reported health-related quality of life (HRQoL), and self-reported problems with cognitive functioning in survivors of critical illness, taking severity of illness at baseline and throughout ICU stay into account.A prospective cohort study was conducted. We included patients who survived an ICU stay of at least a day; exclusions were neurocritical care patients and patients who sustained deep sedation during the entire ICU stay. Delirium was assessed twice daily with the Confusion Assessment Method for the ICU (CAM-ICU) and additionally, patients who received haloperidol were considered delirious. Twelve months after ICU admission, data on mortality were obtained and HRQoL and cognitive functioning were measured with the European Quality of Life - Six dimensions self-classifier (EQ-6D). Regression analyses were used to assess the associations between delirium and the outcome measures adjusted for gender, type of admission, the Acute Physiology And Chronic Health Evaluation IV (APACHE IV) score, and the cumulative Sequential Organ Failure Assessment (SOFA) score throughout ICU stay.Of 1101 survivors of critical illness, 412 persons (37%) had been delirious during ICU stay, and 198 (18%) died within twelve months. When correcting for confounders, no significant association between delirium and long-term mortality was found (hazard ratio: 1.26; 95% confidence interval (CI) 0.93 to 1.71). In multivariable analysis, delirium was not associated with HRQoL either (regression coefficient: -0.04; 95% CI -0.10 to 0.01). Yet, delirium remained associated with mild and severe problems with cognitive functioning in multivariable analysis (odds ratios: 2.41; 95% CI 1.57 to 3.69 and 3.10; 95% CI 1.10 to 8.74, respectively).In this group of survivors of critical illness, delirium during ICU stay was not associated with long-term mortality or HRQoL after adjusting for confounding, including severity of illness throughout ICU stay. In contrast, delirium appears to be an independent risk factor for long-term self-reported problems with cognitive functioning.

There is a growing number of studies evaluating the physical, cognitive, mental health, and health-related quality of life (HRQOL) outcomes of adults surviving critical illness. However, there is little consensus on the most appropriate instruments to measure these outcomes. To inform the development of such consensus, we conducted a systematic review of the performance characteristics of instruments measuring physical, cognitive, mental health, and HRQOL outcomes in adult intensive care unit (ICU) survivors.We searched PubMed, Embase, PsycInfo, Cumulative Index of Nursing and Allied Health Literature, and The Cochrane Library in March 2015. We also conducted manual searches of reference lists of eligible studies and relevant review articles. Two people independently selected studies, completed data abstraction, and assessed the quality of eligible studies using the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) initiative checklist.We identified 20 studies which explicitly evaluated measurement properties for 21 different instruments assessing outcomes in ICU survivors. Eleven of the instruments assessed quality of life, with few instruments assessing other domains. Of the nine measurement properties evaluated on the COSMIN checklist, six were assessed in10% of the evaluations. Overall quality of eligible studies was generally poor to fair based on the COSMIN checklist.Although an increasing number of studies measure physical, cognitive, mental health, and HRQOL outcomes in adult ICU survivors, data on the measurement properties of such instruments are sparse and generally of poor to fair quality. Empirical analyses evaluating the performance of instruments in adult ICU survivors are needed to advance research in this field.