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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.

BackgroundSurvivors of critical illness often experience poor outcomes after hospitalisation, including delayed return to work, which carries substantial economic consequences.ObjectiveTo conduct a systematic review and meta-analysis of return to work after critical illness.MethodsWe searched PubMed, Embase, PsycINFO, CINAHL and Cochrane Library from 1970 to February 2018. Data were extracted, in duplicate, and random-effects meta-regression used to obtain pooled estimates.ResultsFifty-two studies evaluated return to work in 10 015 previously employed survivors of critical illness, over a median (IQR) follow-up of 12 (6.25–38.5) months. By 1–3, 12 and 42–60 months’ follow-up, pooled return to work prevalence (95% CI) was 36% (23% to 49%), 60% (50% to 69%) and 68% (51% to 85%), respectively (τ 2=0.55, I2=87%, p=0.03). No significant difference was observed based on diagnosis (acute respiratory distress syndrome (ARDS) vs non-ARDS) or region (Europe vs North America vs Australia/New Zealand), but was observed when comparing mode of employment evaluation (in-person vs telephone vs mail). Following return to work, 20%–36% of survivors experienced job loss, 17%–66% occupation change and 5%–84% worsening employment status (eg, fewer work hours). Potential risk factors for delayed return to work include pre-existing comorbidities and post-hospital impairments (eg, mental health).ConclusionApproximately two-thirds, two-fifths and one-third of previously employed intensive care unit survivors are jobless up to 3, 12 and 60 months following hospital discharge. Survivors returning to work often experience job loss, occupation change or worse employment status. Interventions should be designed and evaluated to reduce the burden of this common and important problem for survivors of critical illness.Trial registration numberPROSPERO CRD42018093135.

Background Posttraumatic stress disorder (PTSD) symptoms are common in acute respiratory distress syndrome (ARDS) survivors. Brief screening instruments are needed for clinical and research purposes. We evaluated internal consistency, external construct, and criterion validity of the Impact of Event Scale-6 (IES-6; 6 items) compared to the original Impact of Event Scale—Revised (IES-R; 22 items) and to the Clinician Administered PTSD Scale (CAPS) reference standard evaluation in ARDS survivors. Methods This study is a secondary analysis from two independent multi-site, prospective studies of ARDS survivors. Measures of internal consistency, and external construct and criterion validity were evaluated. Results A total of 1001 ARDS survivors (51% female, 76% white, mean (SD) age 49 (14) years) were evaluated. The IES-6 demonstrated internal consistency over multiple time points up to 5 years after ARDS (Cronbach’s alpha = 0.96; 95% confidence interval (CI) 0.94 to 0.97). The IES-6 demonstrated stronger correlations with related constructs (e.g., anxiety and depression; |r| = 0.32 to 0.52) and weaker correlations with unrelated constructs (e.g., physical function and healthcare utilization measures (|r| = 0.02 to 0.27). Criterion validity evaluation with the CAPS diagnosis of PTSD in a subsample of 60 participants yielded an area under receiver operating characteristic curve (95% CI) of 0.93 (0.86, 1.00), with an IES-6 cutoff score of 1.75 yielding 0.88 sensitivity and 0.85 specificity. Conclusions The IES-6 is reliable and valid for screening for PTSD in ARDS survivors and may be useful in clinical and research settings.

PurposeWe aimed to characterize anxiety, depression, and posttraumatic stress disorder (PTSD) symptoms over 5-year follow-up after acute respiratory distress syndrome (ARDS) and determine risk factors for prolonged psychiatric morbidity.MethodsThis prospective cohort study enrolled patients from 13 medical and surgical intensive care units in four hospitals, with follow-up at 3, 6, 12, 24, 36, 48, and 60 months post-ARDS. Trained research staff administered the Hospital Anxiety and Depression Scale (HADS) (scores ≥ 8 on anxiety and depression subscales indicating substantial symptoms) and the Impact of Event Scale-Revised (IES-R, scores ≥ 1.6 indicating substantial PTSD symptoms) at each follow-up visit.ResultsOf 196 consenting survivors, 186 (95%) completed HADS and IES-R assessments; 96 (52%) had any continuous or recurring (prolonged) symptoms, and 71 (38%), 59 (32%), and 43 (23%) had prolonged anxiety, depression, and PTSD symptoms, respectively (median total durations 33–39 months, 71–100% of observed follow-up time). Prolonged psychiatric symptoms tended to co-occur across domains; the most common morbidity pattern involved substantial symptoms in all three domains. Worse pre-ARDS mental health, including prior depression and psychological distress in the period immediately preceding ARDS, was strongly associated with prolonged post-ARDS psychiatric morbidity across symptom domains.ConclusionsClinically significant and long-lasting symptoms of anxiety, depression, and PTSD are common in the first 5 years after ARDS. In-hospital screening of psychiatric history, including recent anxiety and depression symptoms, may be useful for long-term mental health treatment planning after ARDS.

Background There is a need for improving cohort retention in longitudinal studies. Our objective was to identify cohort retention strategies and implementation approaches used in studies with high retention rates. Methods Longitudinal studies with ≥200 participants, ≥80% retention rates over ≥1 year of follow-up were queried from an Institutional Review Board database at a large research-intensive U.S. university; additional studies were identified through networking. Nineteen (86%) of 22 eligible studies agreed to participate. Through in-depth semi-structured interviews, participants provided retention strategies based on themes identified from previous literature reviews. Synthesis of data was completed by a multidisciplinary team. Results The most commonly used retention strategies were: study reminders, study visit characteristics, emphasizing study benefits, and contact/scheduling strategies. The research teams were well-functioning, organized, and persistent. Additionally, teams tailored their strategies to their participants, often adapting and innovating their approaches. Conclusions These studies included specialized and persistent teams and utilized tailored strategies specific to their cohort and individual participants. Studies’ written protocols and published manuscripts often did not reflect the varied strategies employed and adapted through the duration of study. Appropriate retention strategy use requires cultural sensitivity and more research is needed to identify how strategy use varies globally.

Background There is growing interest in patient outcomes following critical illness, with an increasing number and different types of studies conducted, and a need for synthesis of existing findings to help inform the field. For this purpose we conducted a systematic review of qualitative studies evaluating patient outcomes after hospital discharge for survivors of critical illness. Methods We searched the PubMed, EMBASE, CINAHL, PsycINFO, and CENTRAL databases from inception to June 2015. Studies were eligible for inclusion if the study population was >50 % adults discharged from the ICU, with qualitative evaluation of patient outcomes. Studies were excluded if they focused on specific ICU patient populations or specialty ICUs. Citations were screened in duplicate, and two reviewers extracted data sequentially for each eligible article. Themes related to patient outcome domains were coded and categorized based on the main domains of the Patient Reported Outcomes Measurement Information System (PROMIS) framework. Results A total of 2735 citations were screened, and 22 full-text articles were eligible, with year of publication ranging from 1995 to 2015. All of the qualitative themes were extracted from eligible studies and then categorized using PROMIS descriptors: satisfaction with life (16 studies), including positive outlook, acceptance, gratitude, independence, boredom, loneliness, and wishing they had not lived; mental health (15 articles), including symptoms of post-traumatic stress disorder, anxiety, depression, and irritability/anger; physical health (14 articles), including mobility, activities of daily living, fatigue, appetite, sensory changes, muscle weakness, and sleep disturbances; social health (seven articles), including changes in friends/family relationships; and ability to participate in social roles and activities (six articles), including hobbies and disability. Conclusion ICU survivors may experience positive emotions and life satisfaction; however, a wide range of mental, physical, social, and functional sequelae occur after hospital discharge. These findings are important for understanding patient-centered outcomes in critical care and providing focus for future interventional studies aimed at improving outcomes of importance to ICU survivors.

Reducing tidal volume decreases mortality in acute respiratory distress syndrome (ARDS). However, the effect of the timing of low tidal volume ventilation is not well understood. To evaluate the association of intensive care unit (ICU) mortality with initial tidal volume and with tidal volume change over time. Multivariable, time-varying Cox regression analysis of a multisite, prospective study of 482 patients with ARDS with 11,558 twice-daily tidal volume assessments (evaluated in milliliter per kilogram of predicted body weight [PBW]) and daily assessment of other mortality predictors. An increase of 1 ml/kg PBW in initial tidal volume was associated with a 23% increase in ICU mortality risk (adjusted hazard ratio, 1.23; 95% confidence interval [CI], 1.06-1.44; P = 0.008). Moreover, a 1 ml/kg PBW increase in subsequent tidal volumes compared with the initial tidal volume was associated with a 15% increase in mortality risk (adjusted hazard ratio, 1.15; 95% CI, 1.02-1.29; P = 0.019). Compared with a prototypical patient receiving 8 days with a tidal volume of 6 ml/kg PBW, the absolute increase in ICU mortality (95% CI) of receiving 10 and 8 ml/kg PBW, respectively, across all 8 days was 7.2% (3.0-13.0%) and 2.7% (1.2-4.6%). In scenarios with variation in tidal volume over the 8-day period, mortality was higher when a larger volume was used earlier. Higher tidal volumes shortly after ARDS onset were associated with a greater risk of ICU mortality compared with subsequent tidal volumes. Timely recognition of ARDS and adherence to low tidal volume ventilation is important for reducing mortality. Clinical trial registered with www.clinicaltrials.gov (NCT 00300248).

Critical illness can be lethal and devastating to survivors. Improvements in acute care have increased the number of intensive care unit (ICU) survivors. These survivors confront a range of new or worsened health states that collectively are commonly denominated post-intensive care syndrome (PICS). These problems include physical, cognitive, psychological, and existential aspects, among others. Burgeoning interest in improving long-term outcomes for ICU survivors has driven an array of potential interventions to improve outcomes associated with PICS. To date, the most promising interventions appear to relate to very early physical rehabilitation. Late interventions within aftercare and recovery clinics have yielded mixed results, although experience in heart failure programs suggests the possibility that very early case management interventions may help improve intermediate-term outcomes, including mortality and hospital readmission. Predictive models have tended to underperform, complicating study design and clinical referral. The complexity of the health states associated with PICS suggests that careful and rigorous evaluation of multidisciplinary, multimodality interventions-tied to the specific conditions of interest-will be required to address these important problems.

BackgroundDelayed return to work is common after acute respiratory distress syndrome (ARDS), but has undergone little detailed evaluation. We examined factors associated with the timing of return to work after ARDS, along with lost earnings and shifts in healthcare coverage.MethodsFive-year, multisite prospective, longitudinal cohort study of 138 2-year ARDS survivors hospitalised between 2004 and 2007. Employment and healthcare coverage were collected via structured interview. Predictors of time to return to work were evaluated using Fine and Grey regression analysis. Lost earnings were estimated using Bureau of Labor Statistics data.ResultsSixty-seven (49%) of the 138 2-year survivors were employed prior to ARDS. Among 64 5-year survivors, 20 (31%) never returned to work across 5-year follow-up. Predictors of delayed return to work (HR (95% CI)) included baseline Charlson Comorbidity Index (0.77 (0.59 to 0.99) per point; p=0.04), mechanical ventilation duration (0.67 (0.55 to 0.82) per day up to 5 days; p<0.001) and discharge to a healthcare facility (0.49 (0.26 to 0.93); p=0.03). Forty-nine of 64 (77%) 5-year survivors incurred lost earnings, with average (SD) losses ranging from US$38 354 (21,533) to US$43 510 (25,753) per person per year. Jobless, non-retired survivors experienced a 33% decrease in private health insurance and concomitant 37% rise in government-funded coverage.ConclusionsAcross 5-year follow-up, nearly one-third of previously employed ARDS survivors never returned to work. Delayed return to work was associated with patient-related and intensive care unit/hospital-related factors, substantial lost earnings and a marked rise in government-funded healthcare coverage. These important consequences emphasise the need to design and evaluate vocation-based interventions to assist ARDS survivors return to work.

Existing studies of risk factors for physical impairments in acute lung injury (ALI) survivors were potentially limited by single-center design or relatively small sample size. To evaluate risk factors for three measures of physical impairments commonly experienced by survivors of ALI in the first year after hospitalization. A prospective, longitudinal study of 6- and 12-month physical outcomes (muscle strength, 6-minute-walk distance, and Short Form [SF]-36 Physical Function score) for 203 survivors of ALI enrolled from 12 hospitals participating in the ARDS Network randomized trials. Multivariable regression analyses evaluated the independent association of critical illness-related variables and intensive care interventions with impairments in each physical outcome measure, after adjusting for patient demographics, comorbidities, and baseline functional status. At 6 and 12 months, respectively, mean (± SD) values for strength (presented as proportion of maximum strength score evaluated using manual muscle testing) was 92% (± 8%) and 93% (± 9%), 6-minute-walk distance (as percent-predicted) was 64% (± 22%) and 67% (± 26%), and SF-36 Physical Function score (as percent-predicted) was 61% (± 36%) and 67% (± 37%). After accounting for patient baseline status, there was significant association and statistical interaction of mean daily dose of corticosteroids and intensive care unit length of stay with impairments in physical outcomes. Patients had substantial impairments, from predicted values, for 6-minute-walk distance and SF-36 Physical Function outcome measures. Minimizing corticosteroid dose and implementing existing evidence-based methods to reduce duration of intensive care unit stay and associated patient immobilization may be important interventions for improving ALI survivors' physical outcomes.