The Association between Therapeutic Alliance and Parental Health Outcomes following a Child's Death in the Pediatric Intensive Care Unit.

Therapeutic alliance reflects the strength and quality of the physician-patient/family relationship. We investigated the association between therapeutic alliance and bereaved parents' mental health and perceived overall health following their child's death in a pediatric intensive care unit (PICU). Bereaved parents were surveyed 6 months after their child's death in a PICU affiliated with the Collaborative Pediatric Critical Care Research Network. Parents were evaluated for complicated grief, depression, and post-traumatic stress using the Inventory of Complicated Grief (ICG), the Patient Health Questionnaire (PHQ-8), and the Short Post-Traumatic Stress Disorder Rating Interview (SPRINT), respectively. Overall health was evaluated using a single item. Therapeutic alliance between parents and their deceased child's PICU physicians was assessed using the Human Connection scale (HCS). Two hundred and thirty-five parents of 158 deceased children completed surveys. Mean ICG score was 34.4 ± 14.9 with 142 (60.4%) parents screening positive for complicated grief. Mean PHQ-8 score was 9.1 ± 6.2 with 102 (43.4%) screening positive for at least moderate depression. Mean SPRINT score was 14.6 ± 8.2 with 122 (51.9%) screening positive for post-traumatic stress disorder. Overall health was perceived as fair for 47 (20.0%) parents and poor for 10 (4.3%). Using multivariable modeling, higher HCS score (greater therapeutic alliance) was significantly associated with lower (better) ICG score (-0.23, 95% CI -0.42, -0.04, p = 0.018). HCS score was not significantly associated with PHQ-8, SPRINT, or overall health scores. We conclude that bereaved parents experience a high level of adverse mental health symptoms including complicated grief, depression, and post-traumatic stress symptoms. Greater therapeutic alliance with PICU physicians may lessen symptoms of complicated grief during bereavement.

Complicated Grief, Depression and Post-Traumatic Stress Symptoms Among Bereaved Parents following their Child's Death in the Pediatric Intensive Care Unit: A Follow-Up Study.

BACKGROUND: Parents often suffer reduced mental health after their child's death; however, the trajectory and risk factors are not well described. OBJECTIVE: Describe the change in complicated grief, depression, and post-traumatic stress symptoms among parents between 6 and 13 months after their child's death in a pediatric intensive care unit (PICU), and factors associated with 13-month symptoms. METHODS: Parents whose children died in 1 of 8 PICUs affiliated with the Collaborative Pediatric Critical Care Research Network completed surveys 6 and 13 months after their child's death. Surveys included the Inventory of Complicated Grief (ICG), the Patient Health Questionnaire-8 (PHQ-8) for depression, and the Short Post-Traumatic Stress Disorder Rating Interview (SPRINT). Parents provided sociodemographics. Charts were reviewed for child characteristics. RESULTS: One-hundred and fifty seven parents of 104 deceased children completed surveys at both time points. Mental health symptoms declined over time (mean (SD)): ICG (33.8 (15.4) vs. 30.5 (15.2), p < 0.001), PHQ-8 (9.0 (6.4) vs. 7.3 (5.8), p < 0.001), and SPRINT (14.1 (8.3) vs. 12.0 (8.2), p < 0.001). After controlling for 6-month scores, higher 13-month ICG was independently associated with sudden unexpected death; higher PHQ-8 with Black race, insecure attachment style, and sudden unexpected death; and higher SPRINT with having a high school level of education (compared to college degree or higher). CONCLUSION: Mental health symptoms improve among parents during the first 13 months after their child's death; however, symptoms persist for many. Black parents and those whose children die suddenly may be high risk for poor adjustment during bereavement.

Post-Traumatic Growth in Parents following Their Child's Death in a Pediatric Intensive Care Unit.

Background: Although bereaved parents suffer greatly, some may experience positive change referred to as post-traumatic growth. Objective: Explore the extent to which parents perceive post-traumatic growth after their child's death in a pediatric intensive care unit (PICU), and associated factors. Design: Longitudinal parent survey conducted 6 and 13 months after a child's death. Surveys included the Post-traumatic Growth Inventory-Short Form (PTGI-SF), a 10-item measure with range of 0-50 where higher scores indicate more post-traumatic growth. Surveys also included the Inventory of Complicated Grief (ICG), the Patient Health Questionnaire-8 (PHQ-8) for depression, the Short Post-Traumatic Stress Disorder Rating Interview (SPRINT), a single item on perceived overall health, and sociodemographics. Setting/Subjects: One hundred fifty-seven parents of 104 children who died in 1 of 8 PICUs affiliated with the U.S. Collaborative Pediatric Critical Care Research Network. Results: Of participating parents, 62.4% were female, 71.6% White, 82.7% married, and 89.2% had at least a high school education. Mean PTGI-SF scores were 27.5 ± 12.52 (range 5-50) at 6 months and 28.6 ± 11.52 (range 2-49) at 13 months (p = 0.181). On multivariate modeling, higher education (compared with those not completing high school) and higher 6-month ICG scores (reflecting more complicated grief symptoms) were associated with lower 13-month PTGI-SF scores (p = 0.005 and 0.033, respectively). Conclusion: Parents bereaved by their child's PICU death perceive a moderate degree of post-traumatic growth in the first 13 months after the death however variability is wide. Education level and complicated grief symptoms may influence parents' perception of post-traumatic growth.

Baseline characteristics of systemic sclerosis patients with restrictive lung disease in a multi-center US-based longitudinal registry.

AIM: Interstitial lung disease (ILD) is the leading cause of disease-related death in systemic sclerosis (SSc). Here, we assess baseline characteristics of SSc subjects with and without restrictive lung disease (RLD) in a multi-center, US-based registry. METHODS: SSc patients within 5 years of disease onset were enrolled in the Collaborative National Quality and Efficacy Registry (CONQUER), a multi-center US-based registry of SSc study participants (age ≥ 18 years) enrolled at 13 expert centers. All subjects met 2013 American College of Rheumatology / European League Against Rheumatism criteria. Subjects with a pulmonary function test (PFT) at baseline before April 1, 2020 were included. High-resolution computed tomography scan of the chest was not available to characterize ILD for all subjects. RLD was defined as forced vital capacity (FVC) <80% or total lung capacity (TLC) <80% predicted. RESULTS: There were 160 (45%) SSc subjects characterized as having RLD. There was no significant difference in age, gender or disease duration. RLD subjects had a mean disease duration from date of first non-Raynaud's symptom of 2.6 years and a mean FVC% predicted of 67% at baseline. In multivariable analysis, non-White race, higher physician global health assessment and modified Medical Research Council (mMRC) dyspnea scores, were independently associated with RLD. In the subgroup of RLD subjects with ILD, ILD had a negative correlation with RNA polymerase III antibody. CONCLUSION: CONQUER is the largest, multi-center, prospective cohort of early SSc patients in the US. Non-White race was independently associated with RLD. In addition, 45% of CONQUER subjects already had RLD, highlighting the importance of screening for SSc-ILD at initial diagnosis.

Randomized trial of the feasibility of ED-initiated school-based asthma medication supervision (ED-SAMS).

BACKGROUND: While using an inhaled corticosteroid (ICS) in the weeks after an ED visit reduces repeat visits, few children receive a needed prescription. Because a prescription may not be filled or used, dispensing ICS at discharge and supervising its use at school could overcome both barriers until follow-up care is established. To assess the feasibility of such an intervention, we conducted a pilot study among elementary-age school children with persistent asthma who were discharged from the ED following an asthma exacerbation. METHODS: Eligible children were randomly assigned to ED-dispensing of ICS with home supervision or ED-dispensing of ICS with home and school supervision. The primary outcomes were ability to recruit and retain participants, ability to initiate school-supervised medication administration within 5 days of discharge, and participant satisfaction. RESULTS: Despite identifying 437 potentially eligible children, only 13 (3%) were enrolled with 6 being randomized to the intervention group and 7 to the control group. Eleven (85%) randomized participants completed the 90-day interview (primary outcome) and 8 (62%) completed the 120-day interview (safety endpoint). Four (67%) intervention participants started their school regimen within 5 business days and 2 started within 6 business days. CONCLUSION: While our pilot study did not meet its recruitment goal, it did achieve its primary purpose of assessing feasibility before undertaking a larger, more intensive study. Several major recruitment barriers need to be mitigated before EDs can successfully partner with schools to establish supervised ICS treatment. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03952286 . Registered 16 May 2019.

Therapeutic Alliance Between Bereaved Parents and Physicians in the PICU.

OBJECTIVES: Therapeutic alliance is the collaborative bond that develops between patients/families and healthcare providers. Our objective is to determine the extent of therapeutic alliance bereaved parents perceive to have occurred with their child's physicians during their child's PICU stay, and associated factors. DESIGN: Multicenter observational study. SETTING: Eight children's hospitals affiliated with the Collaborative Pediatric Critical Care Research Network. PATIENTS: Parents greater than or equal to 18 years old whose child died in a PICU (including cardiac ICU). INTERVENTIONS: Bereaved parents completed the Human Connection Scale, a 16-item measure of therapeutic alliance, 6 months after their child's death. Human Connection Scale scores range from 16 to 64 with higher scores indicating greater alliance. Parents provided sociodemographic data, and medical records were reviewed for the child's clinical characteristics. MEASUREMENTS AND MAIN RESULTS: Two-hundred and thirty-three parents of 157 deceased children responded to the Human Connection Scale with greater than or equal to 80% item completion. Among parents, 146 (62.7%) were female, 155 (66.5%) were White and 46 (19.7%) were Black, 175 (75.1%) were married, and 209 (89.7%) had at least a high-school education. Among children, median age at the time of death was 5.9 years (interquartile range, 0.64-13.9 yr) and 114 (72.6%) died after limitation or withdrawal of life support. Mean Human Connection Scale score was 51.4 ± 11.1 for all parents, 52.6 ± 9.0 for White parents, and 47.0 ± 13.7 for Black parents. In multivariable modeling predicting Human Connection Scale scores, race was the only parent or child characteristic in the final model. Human Connection Scale scores were significantly different (-4.56; 95% CI, -8.53 to -0.6; p = 0.025) between the Black and White parents with items about trust, care, and honest communication showing the greatest mean difference. CONCLUSIONS: Among parents bereaved in the PICU, therapeutic alliance with physicians is moderately high. Future research should identify strategies to strengthen therapeutic alliance with Black parents and examine the role of alliance on bereaved parents' health outcomes.

Does hand involvement in systemic sclerosis limit completion of patient-reported outcome measures?

The objective of this analysis is to examine whether the severity of systemic sclerosis (SSc)-hand involvement influences patient-reported outcome measure (PROM) completion rate in a US cohort of early disease. Participants included SSc patients with less than 5 years disease duration consented and enrolled in the Collaborative, National, Quality, and Efficacy Registry (CONQUER) between June 2018 and December 2019. Participants' socio-demographics, hand clinical features (severe modified Rodnan skin score, presence of small joint contractures, acro-osteolysis, calcinosis, and digital ulcers), and completion rates of seven PROMs including a Resource Use Questionnaire were analyzed. Cohort characteristics and baseline PROM completion were evaluated. Multivariable logistic regression assessed the relationship between hand limitations and PROM incompletion at several time points using generalized estimating equations. At the time of data lock, 339 CONQUER subjects had a total of 600 visits available for analysis. Calcinosis (odds ratio [OR] 6.35, confidence interval [CI] 2.41-16.73 and acro-osteolysis OR 3.88 (1.57-9.55) were significantly associated with incomplete PROM. The Resource Use Questionnaire was the PROM most commonly not completed. Increasing age was correlated with resource use questionnaire incompletion rate. Acro-osteolysis and calcinosis were associated with lower PROM completion rates in a US SSc cohort, independent of the length of the questionnaires or the modality of administration (electronic or paper). Resource Use Questionnaires are important for understanding the economic impact and burden of chronic disease; however, in this study, it had lower completion rates than PROMs devoted to clinical variables. Key points •Multiple strategies are needed to ensure optimal completion of PROM in longitudinal cohort studies. Even if patients request electronic surveys, we have found it is important to follow up incomplete surveys with paper forms provided at the time of a clinical visit. •The Resource Utilization Questionnaire was lengthy and prone to non-completion in the younger population. •Acro-osteolysis and calcinosis were associated with reduced PROM completion rates.

Collaborative National Quality and Efficacy Registry (CONQUER) for Scleroderma: outcomes from a multicenter US-based systemic sclerosis registry.

The Collaborative National Quality and Efficacy Registry (CONQUER) for Scleroderma is a multicenter US-based longitudinal study of patients with systemic sclerosis (SSc) within 5 years of first non-Raynaud's symptom. The data collection methodology incorporates successful models from other SSc registries. The cohort is designed to provide linked bio-specimen and clinical outcomes data on a longitudinal cohort of SSc patients for validation of hypothesis-driven research and to provide a platform for studying patient-reported outcomes in scleroderma. The CONQUER registry was developed using the guidelines of the International Society for Biological Repositories, and was an iterative process between physicians with an expertise in SSc, patient stakeholders, and information technology experts. Enrollment commenced in June 2018. During the first 6 months of the CONQUER Scleroderma study, 151 SSc patients with less than 5 years of disease duration (from first non-Raynaud's symptom) have been recruited. The mean age is 51 ± 14 years, 83% are female, and 60% of patients have diffuse disease. Survey completion rates are above 88% for all patient-reported outcome surveys. Bio-specimen collection rates are over 97%, and disease severity score completion rates are over 98%. Pulmonary function test data is available on 91% of patients, and echocardiography is available 80%. The CONQUER scleroderma study provides a unique and growing resource for studying scleroderma in a longitudinal, US-based population. KEY POINTS : • The Collaborative National Quality and Efficacy Registry (CONQUER) for Scleroderma is a multicenter US-based longitudinal study of patients with systemic sclerosis (SSc) within 5 years of first non-Raynaud's symptom. • The CONQUER scleroderma study provides a unique and growing resource for studying scleroderma in a longitudinal, US-based population. • CONQUER is innovative in its design in that it is focused on prospective collection of paired clinical and patient outcome data with bio-specimens.