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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.

PurposeWith improving short-term mortality in acute respiratory distress syndrome (ARDS), understanding survivors’ posthospitalisation outcomes is increasingly important. However, little is known regarding associations among physical, cognitive and mental health outcomes. Identification of outcome subtypes may advance understanding of post-ARDS morbidities.MethodsWe analysed baseline variables and 6-month health status for participants in the ARDS Network Long-Term Outcomes Study. After division into derivation and validation datasets, we used weighted network analysis to identify subtypes from predictors and outcomes in the derivation dataset. We then used recursive partitioning to develop a subtype classification rule and assessed adequacy of the classification rule using a kappa statistic with the validation dataset.ResultsAmong 645 ARDS survivors, 430 were in the derivation and 215 in the validation datasets. Physical and mental health status, but not cognitive status, were closely associated. Four distinct subtypes were apparent (percentages in the derivation cohort): (1) mildly impaired physical and mental health (22% of patients), (2) moderately impaired physical and mental health (39%), (3) severely impaired physical health with moderately impaired mental health (15%) and (4) severely impaired physical and mental health (24%). The classification rule had high agreement (kappa=0.89 in validation dataset). Female Latino smokers had the poorest status, while male, non-Latino non-smokers had the best status.ConclusionsWe identified four post-ARDS outcome subtypes that were predicted by sex, ethnicity, pre-ARDS smoking status and other baseline factors. These subtypes may help develop tailored rehabilitation strategies, including investigation of combined physical and mental health interventions, and distinct interventions to improve cognitive outcomes.

Using a rehabilitation program for the survivors of acute respiratory distress syndrome (ARDS) could be one of the important and fundamental steps to improve the pulmonary function and health-related quality of life (HRQoL) of patients. This study was carried out to evaluate the effect of two rehabilitation techniques (Family-Based Empowerment Model (FECM)/Continuing Care Model (CCM), or both of them) on pulmonary function, and HRQoL in ARDS survivors. From December 2009 to June 2016, ARDS survivors from mixed medical-surgical ICUs at four academic teaching hospitals in Tehran, Iran, were randomly assigned to one of three intervention groups (A, B, or C) or a control group (D). Pre- and post-interventions, pulmonary functions and HRQoL status of patients in all groups were collected 48 times via clinical measurements and various questionnaires during 5 years of follow-up. Significantly improvement was seen in the intervention groups compared to the control group, and the greatest benefit was observed in patients who received mixed of FCEM and CCM rehabilitation techniques. Co-administration of FCEM and CCM can improve pulmonary function as well as the life satisfaction of ARDS survivors. As a result, the execution of the empowerment model by nurses is recommended for ARDS survivors and the participation of their families at the same time. Trial registration: NCT02787720 (ClinicalTrial.gov, 24/05/2016).

Abstract Rationale Psychiatric morbidity after acute respiratory distress syndrome (ARDS) is common, and our current ability to predict psychiatric symptoms based on patient- and illness-specific factors is limited. Objectives We assessed symptoms of anxiety, depression, and posttraumatic stress disorder (PTSD) in long-term survivors of ARDS, as well as the associated changes in cortisol levels. Methods The participants were enrolled in a randomized, double-blind, placebo-controlled trial of granulocyte macrophage–colony stimulating factor (GM-CSF) or placebo conducted at three academic medical centers. There were 132 patients enrolled, and 44 patients completed 6-month follow-up questionnaires (45% of survivors). Results Six months after enrollment, survivors completed the Post-Traumatic Stress Syndrome 10 Questions Inventory, Impact of Event Scale, and Hospital Anxiety and Depression Scale to assess psychiatric symptoms. Plasma cortisol levels during treatment were measured by immunoassay. Thirty-six percent of patients reported significant psychiatric symptoms on at least one scale. GM-CSF–treated patients reported more severe posttraumatic stress and depression symptoms than patients in the placebo group. In multiple regression analyses, younger age, female sex, higher severity of illness, fewer steroid treatment days, and GM-CSF treatment were all independently associated with more severe psychiatric symptoms on at least one scale. Conclusions 6 months after ARDS, age, sex, illness severity, steroids, and GM-CSF treatment were associated with psychiatric symptom scores. These associations should be confirmed in a larger population. Clinical Trial registered with clinicaltrials.gov (NCT00201409)

Background The aim of this study was to assess the psychometric properties of the EQ-5D-3 L, the SF-12 v2 and its preference based derivative the SF-6D, and the St Georges Respiratory Questionnaire (SGRQ), in patients diagnosed with Acute Respiratory Distress Syndrome (ARDS). Methods Data from the Oscillation in ARDS (OSCAR) randomised unblinded clinical trial of 795 patients diagnosed with ARDS provided the foundation of this secondary psychometric analysis. The three source patient reported outcome measures (PROMs) (EQ-5D-3 L, SF-12 and SGRQ) were collected at both 6 and 12 months post randomisation. All measures were tested for acceptability, reliability, internal consistency, validity and responsiveness. Data from responders at 6 months was used to test for acceptability, reliability, known groups validity and internal responsiveness. Data from patients who responded at both 6 and 12 months was used to test for convergent validity and external responsiveness. Results Rates of response at both 6 and 12 months post randomisation were 89.88 % for the EQ-5D-3 L, 77.38 % for the SF-6D, 71.43 % for both the physical and mental components of the SF-12 and 38.10 % for the SGRQ. All measures had a Cronbach’s Alpha statistic higher than 0.7. For known group’s validity, there was no difference in mean summary or utility scores between known groups for all PROMs with minimal effect sizes. All three source measures showed strong convergent and discriminant validity. There was consistent evidence that the SF-6D is an empirically valid and efficient alternative to the EQ-5D-3 L. The EQ-5D-3 L and SGRQ were more responsive compared to the SF-12 and SF-6D with the EQ-5D-3 L generating greater effect sizes than the SGRQ. Conclusion The PROMs explored in this study displayed varying psychometric properties in the context of ARDS. Further research should focus on shortening the SGRQ whilst still maintaining its psychometric properties and mapping between the SGRQ and preference-based measures for future application within economic evaluations of respiratory focused interventions. The selection ofa preferred PROM for evaluative studies within the ARDS context should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purposes.

Outcomes after acute respiratory distress syndrome (ARDS) are similar to those of other survivors of critical illness and largely affect the nerve, muscle, and central nervous system but also include a constellation of varied physical devastations ranging from contractures and frozen joints to tooth loss and cosmesis. Compromised quality of life is related to a spectrum of impairment of physical, social, emotional, and neurocognitive function and to a much lesser extent discrete pulmonary disability. Intensive care unit-acquired weakness (ICUAW) is ubiquitous and includes contributions from both critical illness polyneuropathy and myopathy, and recovery from these lesions may be incomplete at 5 years after ICU discharge. Cognitive impairment in ARDS survivors ranges from 70 to 100 % at hospital discharge, 46 to 80 % at 1 year, and 20 % at 5 years, and mood disorders including depression and post-traumatic stress disorder (PTSD) are also sustained and prevalent. Robust multidisciplinary and longitudinal interventions that improve these outcomes are still uncertain and data in our literature are conflicting. Studies are needed in family members of ARDS survivors to better understand long-term outcomes of the post-ICU family syndrome and to evaluate how it affects patient recovery.

Abstract Although survival rates for acute respiratory distress syndrome have increased, there is only limited information regarding the quality of life and the relationship between quality of life and pulmonary function after survival. We prospectively measured pulmonary function, emotional function, and health-related quality of life in a cohort of acute respiratory distress syndrome survivors recruited from patients who were enrolled in a randomized clinical trial of high versus low tidal volume mechanical ventilation at 1 year after their recovery. No significant differences were found between the patients treated with high and low tidal volumes on any pulmonary function measure. Approximately 80% of the patients in both groups demonstrated reduced diffusing capacity; 20% had airflow obstruction, and 20% had chest restriction. Scores on measures of depression and anxiety were within the normal ranges, suggesting that they did not have significant affective symptoms. However, both groups reported decreased health-related quality of life in physical functioning, physical ability to maintain their roles (role-physical), bodily pain, general health, and vitality (energy) on the Medical Outcome Study Short Form Health Survey with similar physical limitations reported on the Sickness Impact Profile questionnaire. The pulmonary function abnormalities correlated with decreased health-related quality of life for domains reflecting physical function. Acute respiratory distress syndrome survivors treated with high and low tidal volumes have abnormal pulmonary function that was related to decreased health-related quality of life 1 year after hospital discharge.

After the sample size of a randomized clinical trial (RCT) is set by the power requirement of its primary endpoint, investigators select secondary endpoints while unable to further adjust sample size. How the sensitivity and specificity of an instrument used to measure these outcomes, together with their expected underlying event rates, affect an RCT's power to measure significant differences in these outcomes is poorly understood. Motivated by the design of an RCT of neuromuscular blockade in acute respiratory distress syndrome, we examined how power to detect a difference in secondary endpoints varies with the sensitivity and specificity of the instrument used to measure such outcomes. We derived a general formula and Stata code for calculating an RCT's power to detect differences in binary outcomes when such outcomes are measured with imperfect sensitivity and specificity. The formula informed the choice of instrument for measuring post-traumatic stress-like symptoms in the Reevaluation of Systemic Early Neuromuscular Blockade RCT ( www.clinicaltrials.gov identifier NCT02509078). On the basis of published sensitivities and specificities, the Impact of Events Scale-Revised was predicted to measure a 36% symptom rate, whereas the Post-Traumatic Stress Symptoms instrument was predicted to measure a 23% rate, if the true underlying rate of post-traumatic stress symptoms were 25%. Despite its lower sensitivity, the briefer Post-Traumatic Stress Symptoms instrument provided superior power to detect a difference in rates between trial arms, owing to its higher specificity. Examining instruments' power to detect differences in outcomes may guide their selection when multiple instruments exist, each with different sensitivities and specificities.

Abstract Rationale Cognitive and psychiatric morbidity is common and potentially modifiable after acute lung injury (ALI). However, practical measures of neuropsychological function for use in multicenter trials are lacking. Objectives To determine whether a validated telephone-based neuropsychological test battery is feasible in a multicenter trial. To determine the frequency and risk factors for long-term neuropsychological impairment. Methods As an adjunct study to the Acute Respiratory Distress Syndrome Clinical Trials Network Fluid and Catheter Treatment Trial, we assessed neuropsychological function at 2 and 12 months post–hospital discharge. Measurements and Main Results Of 406 eligible survivors, we approached 261 to participate and 213 consented. We tested 122 subjects at least once, including 102 subjects at 12 months. Memory, verbal fluency, and executive function were impaired in 13% (12 of 92), 16% (15 of 96), and 49% (37 of 76) of long-term survivors. Long-term cognitive impairment was present in 41 of the 75 (55%) survivors who completed cognitive testing. Depression, post-traumatic stress disorder, or anxiety was present in 36% (37 of 102), 39% (40 of 102), and 62% (63 of 102) of long-term survivors. Enrollment in a conservative fluid-management strategy (P = 0.005) was associated with cognitive impairment and lower partial pressure of arterial oxygen during the trial was associated with cognitive (P = 0.02) and psychiatric impairment (P = 0.02). Conclusions Neuropsychological function can be assessed by telephone in a multicenter trial. Long-term neuropsychological impairment is common in survivors of ALI. Hypoxemia is a risk factor for long-term neuropsychological impairment. Fluid management strategy is a potential risk factor for long-term cognitive impairment; however, given the select population studied and an unclear mechanism, this finding requires confirmation.

Objective: For the premature infant, extrauterine life is a pathological condition, which greatly amplifies the challenges to the brain in establishing functional oromotor behaviors. The extent to which suck can be entrained using a synthetically patterned orocutaneous input to promote its development in preterm infants who manifest chronic lung disease (CLD) is unknown. The objective of this study was to evaluate the effects of a frequency-modulated (FM) orocutaneous pulse train delivered through a pneumatically charged pacifier capable of enhancing non-nutritive suck (NNS) activity in tube-fed premature infants. Study Design: A randomized trial to evaluate the efficacy of pneumatic orocutaneous stimulation 3 × per day on NNS development and length of stay (LOS) in the neonatal intensive care unit among 160 newborn infants distributed among three sub-populations, including healthy preterm infants, respiratory distress syndrome (RDS) and CLD. Study infants received a regimen of orocutaneous pulse trains through a PULSED pressurized silicone pacifier or a SHAM control (blind pacifier) during gavage feeds for up to 10 days. Result: Mixed modeling, adjusted for the infant’s gender, gestational age, postmenstrual age and birth weight, was used to handle interdependency among repeated measures within subjects. A significant main effect for stimulation mode (SHAM pacifier vs PULSED orosensory) was found among preterm infants for NNS bursts per min ( P =0.003), NNS events per min ( P =0.033) and for total oral compressions per min (NNS+nonNNS) ( P =0.016). Pairwise comparison of adjusted means using Bonferroni adjustment indicated RDS and CLD infants showed the most significant gains on these NNS performance indices. CLD infants in the treatment group showed significantly shorter LOS by an average of 2.5 days. Conclusion: FM PULSED orocutaneous pulse train stimuli delivered through a silicone pacifier are effective in facilitating NNS burst development in tube-fed RDS and CLD preterm infants, with an added benefit of reduced LOS for CLD infants.