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.
OBJECTIVES:To synthesize data on prevalence, natural history, risk factors, and post-ICU interventions for depressive symptoms in ICU survivors.
DATA SOURCES:PubMed, EMBASE, Cumulative Index of ...Nursing and Allied Health Literature, PsycINFO, and Cochrane Controlled Trials Registry (1970–2015).
STUDY SELECTION:Studies measuring depression after hospital discharge using a validated instrument in more than 20 adults from non-specialty ICUs.
DATA EXTRACTION:Duplicate independent review and data abstraction.
DATA SYNTHESIS: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.
CONCLUSIONS: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.
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.
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.
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.
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.
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.
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).
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.
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.
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 = 0.86 to 0.91) and high correlation with the IES-R (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.
The IES-6 is reliable and valid for screening for PTSD in ARDS survivors and may be useful in clinical and research settings.
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.
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.
Patients surviving critical illness frequently experience long-lasting morbidities. Consequently, researchers and clinicians are increasingly focused on evaluating and improving survivors' outcomes ...after hospital discharge. This review synthesizes recent research aimed at understanding the postdischarge outcomes that patients consider important (i.e., patient-important outcomes) for the purpose of advancing future clinical research in the field.
Across multiple types of studies, patients, family members, researchers, and clinicians have consistently endorsed physical function, cognition, and mental health as important outcomes to evaluate in future research. Aspects of social health, such as return to work and changes in interpersonal relationships, also were noted in some research publications. Informed by these recent studies, an international Delphi consensus process (including patient and caregiver representatives) recommended the following core set of outcomes for use in all studies evaluating acute respiratory failure survivors after hospital discharge: survival, physical function (including muscle/nerve function and pulmonary function), cognition, mental health, health-related quality of life, and pain. The Delphi panel also reached consensus on recommended measurement instruments for some of these core outcomes.
Recent studies have made major advances in understanding patient-important outcomes to help guide future clinical research aimed at improving ICU survivors' recovery.
Background and Objectives:
Impaired physical functioning is common and long lasting after an intensive care unit (ICU) admission. The 6-minute walk test (6MWT) is a validated and widely used test of ...functional capacity. This systematic review synthesizes existing data in order to: (1) evaluate 6-minute walk distance (6MWD) in meters over longitudinal follow-up after critical illness, (2) compare 6MWD between acute respiratory distress syndrome (ARDS) versus non-ARDS survivors, and (3) evaluate patient- and ICU-related factors associated with 6MWD.
Data Sources:
Five databases (PubMed, EMBASE, Cumulative Index of Nursing and Allied Health Literature, PsychINFO, and Cochrane Controlled Trials Registry) were searched to identify studies reporting 6MWT after hospital discharge in survivors from general (ie, nonspeciality) ICUs. The last search was run on February 14, 2018. Databases were accessed via Johns Hopkins University Library.
Data Extraction and Synthesis:
Pooled mean 6MWD were reported, with separate linear random effects models used to evaluate associations of 6MWD with ARDS status, and patient- and ICU-related variables. Twenty-six eligible articles on 16 unique participant groups were included. The pooled mean (95% confidence interval CI) 6MWD results at 3- and 12-months post discharge were 361 (321-401) and 436 (391-481) meters, respectively. There was a significant increase in 6MWD at 12 months compared to 3 months (P = .017). In ARDS versus non-ARDS survivors, the mean (95% CI) 6MWD difference over 3-, 6-, and 12-month follow-up was 73 13-133 meters lower. Female sex and preexisting comorbidity also were significantly associated with lower 6MWD, with ICU-related variables having no consistent associations.
Conclusions:
Compared to initial assessment at 3 months, significant improvement in 6MWD was reported at 12 months. Female sex, preexisting comorbidity, and ARDS (vs non-ARDS) were associated with lower 6MWT results. Such factors warrant consideration in the design of clinical research studies and in the interpretation of patient status using the 6MWT.
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