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ObjectiveTo develop and demonstrate early feasibility of a goals-of-care decision aid for surrogates of patients who are critically ill with traumatic brain injury (ciTBI) that meets accepted international decision aid guidelines.MethodsWe developed the decision aid in 4 stages: (1) qualitative study of goals-of-care communication and decision needs of 36 stakeholders of ciTBI (surrogates and physicians), which informed (2) development of paper-based decision aid with iterative revisions after feedback from 52 stakeholders; (3) acceptability and usability testing in 18 neurologic intensive care unit (neuroICU) family members recruited from 2 neuroICU waiting rooms using validated scales; and (4) open-label, randomized controlled feasibility trial in surrogates of ciTBI. We performed an interim analysis of 16 surrogates of 12 consecutive patients who are ciTBI to confirm early feasibility of the study protocol and report recruitment, participation, and retention rates to date.ResultsThe resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0–100]) and acceptability (97% graded the tool's content as “good” or “excellent”). Early feasibility of the decision aid and the feasibility trial protocol was demonstrated by high rates of recruitment (73% consented), participation (100%), and retention (100% both after the goals-of-care clinician–family meeting and at 3 months) and complete data for the measurements of all secondary decision-related and behavioral outcomes to date.ConclusionsOur systematic development process resulted in a novel goals-of-care decision aid for surrogates of patients who are ciTBI with excellent usability, acceptability, and early feasibility in the neuroICU environment, and meets international decision aid standards. This methodology may be a development model for other decision aids in neurology to promote shared decision-making.

This research followed a longitudinal pre- and posttest mixed methods design. An investigator-developed questionnaire collected qualitative (distress screening goals, institutional barriers and facilitators, facilitators associated with participation in the SPDP) and quantitative (level of goal achievement) data at 6, 12, and 24 months of participation in the SPDP. Conventional content analysis was applied to qualitative data. Mixed methods data analysis in Dedoose evaluated (1) types and number of distress screening goals, barriers, and facilitators, and (2) goal achievement at 6, 12, and 24 months of participation.ResultNinety-five percent of distress screening implementation goals were completed after 2 years of participation. Most common institutional barriers to distress screening implementation were "lack of staff," "competing demands," and "staff turn-over." Most common institutional facilitators were "buy-in," "institutional support," and "recognition of participants' expertise." The number of reported facilitators associated with SPDP participation was higher than the number associated with any institutional factor, and increased over time of participation.Significance of resultsParticipating in training programs to implement distress screening may facilitate successful achievement of the Commission on Cancer's distress screening standard, and benefits seem to increase with time of participation. Training programs are needed to promote facilitators and overcome barriers to distress screening.

Dedicated afternoon rounds for families twice a week may not necessarily improve an ICU's overall family satisfaction. Increased dissatisfaction among families who do not or cannot participate is possible.

Background Chronic insomnia is associated with disabling symptoms and decrements in functional performance. It may contribute to the development of heart failure (HF) and incident mortality. In our previous work, cognitive-behavioral therapy for insomnia (CBT-I), compared to HF self-management education, provided as an attention control condition, was feasible, acceptable, and had large effects on insomnia and fatigue among HF patients. Objectives The purpose of this randomized controlled trial (RCT) is to evaluate the sustained effects of group CBT-I compared with HF self-management education (attention control) on insomnia severity, sleep characteristics, daytime symptoms, symptom clusters, functional performance, and health care utilization among patients with stable HF. We will estimate the cost-effectiveness of CBT-I and explore the effects of CBT-I on event-free survival (EFS). Methods Two hundred participants will be randomized in clusters to a single center parallel group (CBT-I vs. attention control) RCT. Wrist actigraphy and self-report will elicit insomnia, sleep characteristics, symptoms, and functional performance. We will use the psychomotor vigilance test to evaluate sleep loss effects and the Six Minute Walk Test to evaluate effects on daytime function. Medical record review and interviews will elicit health care utilization and EFS. Statistical methods will include general linear mixed models and latent transition analysis. Stochastic cost-effectiveness analysis with a competing risk approach will be employed to conduct the cost-effectiveness analysis. Discussion The results will be generalizable to HF patients with chronic comorbid insomnia and pave the way for future research focused on the dissemination and translation of CBT-I into HF settings.

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Summary SARS‐CoV‐2 continues to leave its toll on global health and the economy. Management of the pandemic will rely heavily on the degree of adaptive immunity persistence following natural SARS‐CoV‐2 infection. Along with the progression of the pandemic, more literature on the persistence of the SARS‐CoV‐2‐specific antibody response is becoming available. Here, we summarize findings on the persistence of the humoral, including neutralizing antibody, response at three to eight months post SARS‐CoV‐2 infection in non‐pregnant adults. While the comparability of the literature is limited, findings on the detectability of immunoglobulin G class of antibodies (IgG) were most consistent and were reported in most studies to last for six to eight months. Studies investigating the response of immunoglobins M and A (IgM, IgA) were limited and reported mixed results, in particular, for IgM. The majority of studies observed neutralizing antibodies at all time points tested, which in some studies lasted up to eight months. The presence of neutralizing antibodies has been linked to protection from re‐infection, suggesting long‐term immunity to SARS‐CoV‐2. These neutralizing capacities may be challenged by emerging virus variants, but mucosal antibodies as well as memory B and T cells may optimize future immune responses. Thus, further longitudinal investigation of PCR‐confirmed seropositive individuals using sensitive assays is warranted to elucidate the nature and duration of a more long‐term humoral response.

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