Trends in Individual Career Development Awards from National Institutes of Health to Physicians in Departments of Psychiatry (2013-2022).

OBJECTIVE: The authors examined trends of individual career development awards from the National Institutes of Health (NIH) to psychiatry faculty, especially physicians, in comparison to other departments. METHODS: Data were obtained on 33,392 career development awards from 2013 to 2022. We examined the number of awards each year averaged for 46 non-psychiatry departments, and for departments of psychiatry, the number of awards to all faculty, physicians, and physicians without a PhD. Linear regressions determined whether number of career development awards increased with time and if estimated slopes differed between faculty in non-psychiatry departments and other groups. RESULTS: In departments of psychiatry, 534 faculty received an NIH individual career development award during the 10-year period (534/33,392 or 1.6%), with 118 (22%) to physicians. The number of awards increased significantly over time for other departments and departments of psychiatry (estimated slopes of 3.05 and 2.38, respectively) and did not differ from one another. However, the number of awards to physicians and physicians without a PhD in departments of psychiatry (estimated slopes of 0.51 and - 0.07, respectively) have not increased. This lack of growth in awards for physicians and physicians without a PhD in departments of psychiatry differed significantly in comparison with the increase shown in awards to other departments over time (both p < 0.001). CONCLUSIONS: The number of NIH career development awards has increased NIH-wide, and for non-physician faculty but not for physicians in departments of psychiatry. These trends raise concerns for the future of psychiatrists in academic research.

Cannabidiol for treatment of Irritability and Aggressive Behavior in Children and Adolescents with ASD: Background and Methods of the CAnnabidiol Study in Children with Autism Spectrum DisordEr (CASCADE) Study.

Introduction: Autism spectrum disorder (ASD) is a neurodevelopmental disorder commonly associated with behavioral challenges. There are few evidence based pharmacological interventions available for the treatment of behavioral symptoms associated with ASD. Cannabidiol (CBD), the non-psychoactive component of cannabis, has potential neuroprotective, antiepileptic, anxiolytic, and antipsychotic effects and may be useful in treating the behavioral symptoms of ASD. Methods: We describe the research methods of a 27-week double-blind placebo-controlled cross-over trial of cannabidiol for the treatment of irritability and aggression associated with ASD, utilizing the irritability subscale of the Aberrant Behavior Checklist-2nd edition (ABC-2) as the primary outcome measure. Adverse effects and safety monitoring protocols are included. Several secondary and exploratory outcomes measures also include anxiety, communication, repetitive behaviors, attention, hyperactivity, autism family experience, and telehealth functional behavior assessment. Conclusion: There is a significant need for clinical research exploring alternative medications for the treatment of behavioral symptoms of ASD. Cannabidiol (CBD) is being studied for the management of irritability, aggression, and other problem behaviors associated with ASD.

Deep brain stimulation for the treatment of substance use disorders: a promising approach requiring caution.

Substance use disorders are prevalent, causing extensive morbidity and mortality worldwide. Evidence-based treatments are of low to moderate effect size. Growth in the neurobiological understanding of addiction (e.g., craving) along with technological advancements in neuromodulation have enabled an evaluation of neurosurgical treatments for substance use disorders. Deep brain stimulation (DBS) involves surgical implantation of leads into brain targets and subcutaneous tunneling to connect the leads to a programmable implanted pulse generator (IPG) under the skin of the chest. DBS allows direct testing of neurobiologically-guided hypotheses regarding the etiology of substance use disorders in service of developing more effective treatments. Early studies, although with multiple limitations, have been promising. Still the authors express caution regarding implementation of DBS studies in this population and emphasize the importance of safeguards to ensure patient safety and meaningful study results. In this perspectives article, we review lessons learned through the years of planning an ongoing trial of DBS for methamphetamine use disorder.

Cannabidiol-Only Product Use in Pregnancy in the United States and Canada: Findings From the International Cannabis Policy Study.

This study aimed to characterize pregnant individuals' use of cannabidiol (CBD). Data are from the International Cannabis Policy Study (2019-2021), a repeated cross-sectional survey of individuals aged 16-65 years in the United States and Canada (N=66,457 women, including 1,096 pregnant women). The primary analysis compared pregnant and nonpregnant women's CBD-only product use patterns and reasons for use. The prevalence of CBD-only use in pregnant women was 20.4% compared with 11.3% among nonpregnant women, P <.001. Reasons for CBD use among pregnant women included anxiety (58.4%), depression (40.3%), posttraumatic stress disorder (32.1%); pain (52.3%), headache (35.6%), and nausea or vomiting (31.9%). Thus, CBD-only product use was prevalent in this large sample, with one in five pregnant women reporting use. Characterization of prenatal CBD use is an important first step to exploring potential risks to exposed offspring.

Relationship Status and Quality Are Associated With Perceived Benefits of Caregiving for People With Heart Failure.

BACKGROUND: "Benefit finding" is a strengths-based strategy for coping with medical illness that may be particularly useful for caregivers of people with heart failure given the highly fluctuating disease course. OBJECTIVE: The aim of this study was to investigate benefit finding's association with the caregiver-care recipient relationship, depression, and burden at baseline and longitudinally. METHODS: This is a longitudinal observational study of caregivers' benefit finding, relationship quality, depression, and burden. Correlation and multiple regression analyses identify baseline associations and predictors of 12-month change in benefit finding. RESULTS: At baseline (n = 100; median, 60 years [interquartile range, 46-69]; 81% female, 70% partner/spouse), increased benefit finding correlated with higher relationship quality (r = 0.53; 95% confidence interval [CI], 0.38-0.67), lower depression (r = -0.33; 95% CI, -0.49 to -0.14), and lower burden (r = -0.31; 95% CI, -0.47 to -0.11). Twelve-month change in benefit finding was predicted by change in relationship quality (ß = 7.12; 95% CI, 0.62-13.61) but not depression or burden. CONCLUSIONS: Relationship quality and benefit finding changed together over time. Interventions strengthening the caregiver-care recipient bond may be especially impactful for heart failure caregivers.

The Association Between Sexual Identity, Depression, and Adolescent Substance Use.

Sexual minority youth (SMY) represent a population vulnerable to several adverse health consequences. Specifically, SMY experience depression and substance use at substantially higher rates than heterosexual peers. Better understanding the relationship between depression and substance use among SMY may help reduce morbidity and mortality. We hypothesize that depression will moderate increased substance use rates seen in SMY. Weighted logistical analyses of covariance, adjusted for race/ethnicity, sex, and age, compared the relationship between sexual identity, depression, and substance use (14 outcomes), using data from the 2019 Youth Risk Behavior Survey (n = 13,677) of high school students. SMY reported depression at rates nearly double than heterosexual peers (63.9% vs 33.0%). Except for vaping and alcohol, SMY had significantly higher odds of all SU (aORs 1.41-2.45, p < 0.001-0.0011). After adjusting for depression, odds of all SMY substance use decreased; most relationships remained significant (aORs 0.73-1.89), though the relationship between SMY and lifetime cannabis use became non-significant. The relationship between SMY and current vaping became significant and the relationship between SMY and alcohol and binge-drinking remained non-significant. SMY are at higher risk for use of most substances and depression compared to heterosexual youth. As depression consistently plays a role in the relationship between sexual minority status and adolescent substance use across a wide variety of substances, it may be a modifiable risk factor for substance use among sexual minority youth that should be screened for and treated. This study additionally provides important information for future studies examining nuances of SMY substance use patterns.

Cannabis Use Is Associated With Depression Severity and Suicidality in the National Comorbidity Survey-Adolescent Supplement.

Objective: To investigate the association of cannabis use with major depression and suicidal behavior in adolescence. Method: Data are from the National Comorbidity Survey-Adolescent Supplement N=10,123, a nationally representative survey of adolescents aged 13 to 18 years. Weighted logistic regression and ordinal regression analyses of major depression and suicidal behavior outcomes were conducted on cannabis variables, incorporating sociodemographic characteristics. Results: Adolescents with lifetime cannabis use have 2.07 times higher odds of mild/moderate (adjusted odds ratio [aOR]; 95% CI=1.69, 2.53) and 3.32 times higher odds of severe major depressive disorder (MDD; aOR; 95% CI=2.31, 4.75). Cannabis use (aOR 6.90, 95% CI=4.67,10.19), mild/moderate MDD (aOR 4.10, 95% CI=2.82, 5.98), and severe MDD (aOR 13.97, 95% CI = 7.59, 25.70) were associated with higher odds of suicide attempt. Past 12-month cannabis use (aOR 3.70, 95% CI = 2.16, 6.32), mild/moderate major depressive episodes (MDE) (aOR 7.85, 95% CI=3.59, 17.17), and severe MDE (aOR 36.36, 95% CI=13.68,96.64) were associated with higher odds of suicide attempt. The frequency of past 12-month cannabis use was associated with higher odds of suicide attempt and with MDE severity, with higher odds among individuals who use cannabis 3 or more days than among individuals who use cannabis less frequently, suggesting a dose effect. Among cannabis users, older age of onset of cannabis use was associated with lower odds of suicidal behaviors. Conclusion: Cannabis use is associated with higher odds of depression and depression severity in adolescence. Furthermore, depression and cannabis use are independently associated with higher odds of suicide attempt. Diversity & Inclusion Statement: We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. The author list of this paper includes contributors from the location and/or community where the research was conducted who participated in the data collection, design, analysis, and/or interpretation of the work. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. We actively worked to promote sex and gender balance in our author group. We actively worked to promote inclusion of historically underrepresented racial and/or ethnic groups in science in our author group.

A revised prosocial behavior game: Testing associations with psychopathic traits and the effects of moral elevation using a randomized clinical trial.

BACKGROUND: Prosocial behavior is negatively associated with psychopathic traits and paradigms which measure prosocial behavior in the laboratory may be useful in better understanding moderators of this association. METHODS: We revised a previously validated game of prosocial behavior by including a new trial type (i.e., trials where the participant will lose money and the charity will gain money). This version of the game was administered online and participants were randomized to group (exposed to a control stimulus video or a video used to elicit moral elevation, i.e. a positive response to witnessing another's act of kindness). We used repeated game administration to test whether a moral elevation stimulus affected game behavior and moderated the negative association between psychopathic traits and prosocial behavior. RESULTS: Prosocial behavior on the new trial types added in this revised game correlated strongly with prosocial behavior on the old trial type (i.e., trials where the participant will gain money and the charity will lose money; r = 0.71; p-value<0.001; n = 485). Graphing trial acceptance rates by trial characteristics demonstrated expected patterns of behavior. Number of prosocial choices on the game correlated with psychopathic trait score (Levenson Factor 1 score; r = -0.52; p-value<0.001). Game repetition with a control stimulus in between runs, supported high immediate test-retest reliability of overall game behavior. Exposure to the moral elevation stimulus in between runs did not affect game behavior nor moderate the association between psychopathic traits and prosocial behavior. CONCLUSIONS: Choices on this revised game of prosocial behavior, which can be administered online, are associated with psychopathic traits scores. The game appears to have high immediate test-retest reliability. Exposure to the moral elevation stimulus did not affect prosocial behavior or impact the relationship between psychopathic trait scores and prosocial behavior. Future research should continue to test potential moderators of this relationship. Limitations of the current study are discussed.

Sex Differences in Effects of Mood, Eating-Related Behaviors, and BMI on Food Appeal and Desire to Eat: A Cross-Sectional Survey Study.

Although sex differences in food intake have been observed consistently, contributing factors are not well understood. Using a cross-sectional online survey (n = 306; 151 men, 155 women), this study aimed to assess how sex impacts relationships between food ratings (appeal/desire to eat for high-calorie (HC) and low-calorie (LC) food images) and eating-related attitudes/behaviors, body mass index (BMI), and mood. Across participants, increased state- and trait-based hunger, disinhibition, and cravings were associated with both increased HC appeal and desire (p < 0.001). Increased state-based hunger and cravings were associated with greater LC desire (p < 0.001). Greater satiety was associated with decreased desire for both HC and LC (p < 0.001), while greater anxiety was associated with increased desire for both HC and LC (p < 0.001). Significant associations between BMI and food ratings were not observed. Women reported greater dietary restraint, trait-based hunger, disinhibition, eating disorder-related behaviors, depression, and stress compared to men, in addition to greater appeal and familiarity with LC foods (all p < 0.05). Significant effects of sex on the associations between food ratings and eating-related attitudes/behaviors, BMI, and mood were not observed, however. Findings support the importance of considering mood and eating-related attitudes/behaviors in investigations of food cue responsivity.

Association between alcohol use disorder and hospital outcomes in colectomy patients - A retrospective cohort study.

STUDY OBJECTIVE: In the United States, alcohol use disorder adversely affects 5.6% of all adults. Excessive alcohol consumption adversely affects organ functions critical for adaptation to stress induced by surgery. Colorectal resection is one of the most common major surgeries in patients at risk for alcohol use disorder. The objective of this study was to assess the impact of alcohol use disorder on hospital outcomes after colectomy using a population-based discharge database. SETTING: Population-based discharge database. PATIENTS: The Premier Healthcare Database was queried for the 603,730 adult patients who underwent colectomy from 2016 to 2019. INTERVENTIONS: None. MEASUREMENTS: Multiple logistic regressions estimated the associations between in-hospital mortality, length of stay, and hospitalization cost with alcohol use disorder as the primary predictor, adjusting for other substance use disorders, psychotic disorders, depression, other Elixhauser comorbidities, age, payor, race, gender, non-elective surgery, and other unbalanced variables. MAIN RESULTS: A discharge code for alcohol use disorder was identified in 2.9% of colectomy patients and the overall in-hospital mortality rate in all sampled colectomy patients was 1.4%. Alcohol use disorder was associated with a significantly increased risk of in-hospital mortality after adjusting for other factors (AOR 1.36, 95% CI 1.24-1.48, p < 0.0001). Alcohol use disorder was also significantly associated with long length of stay (AOR 1.45, 95% CI 1.39-1.52, p < 0.0001) and high hospitalization costs (AOR 1.63, 95% CI 1.56-1.70, p < 0.0001). CONCLUSIONS: Alcohol use disorder is associated with an increased risk of in-hospital mortality in patients undergoing colectomy, one of the most common major surgeries. Future research should examine if enhanced efforts to identify patients with alcohol use disorder could enable anesthesiologists to provide worthwhile perioperative interventions for this high-risk population.

Association between employment status change and depression and anxiety in allogeneic stem cell transplant caregivers.

PURPOSE: Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is a demanding treatment that requires caregiver support during the first 100 days post-transplant. Little is known about the association between caregivers' employment changes and their well-being during this lengthy and challenging time when caregivers may be balancing work with caregiving responsibilities. METHODS: We used data from employed caregivers of Allo-HSCT patients who participated in two randomized clinical trials (N = 187) of an intervention for caregivers. Caregiver depression and anxiety were assessed using the Center for Epidemiologic Studies Depression and the Spielberger State-Trait Anxiety Inventory. ANCOVA was used to measure the associations between reducing work with depression and anxiety. Caregiver's demographics and baseline employment status were controlled in the analysis along with the patient's transplant conditioning intensity. RESULTS: Approximately 45% of caregivers reduced hours worked following the resumption of their caregiving duties. These caregivers, on average, had 3.49 points higher depression scores than caregivers who did not report a reduction in work (p < 0.01). Similarly, these caregivers also reported, on average, 3.56 higher anxiety scores (p < 0.10). CONCLUSIONS: Caregivers who reduced hours worked while caregiving reported greater distress. The underlying cause of this distress deserves further investigation. IMPLICATIONS FOR CANCER SURVIVORS: Caregivers of patients diagnosed with cancer may experience considerable stress related to work discontinuation and caregiving. Interventions are needed to support caregivers who are trying to balance work and caregiving responsibilities.

A pilot study of mobilized intervention to help caregivers of oncology patients manage distress.

OBJECTIVE: Caregivers of patients with advanced cancer experience significant anxiety, depression, and distress. Caregivers have barriers to accessing in-person treatment to manage stress. Technology allows for the dissemination of evidence-based interventions in a convenient way. This study examined usage rates of Pep-Pal (an evidence-based mobilized intervention to help caregivers of patients with advanced cancer manage distress) and estimates of efficacy on anxiety, depression, stress, and sexual dysfunction. METHODS: Fifty-six primary caregivers of patients with advanced cancer were recruited through oncology clinics and randomized to either Pep-Pal (a mobilized psychoeducation and skills-based intervention for caregivers, n = 26) or treatment as usual (TAU; n = 30). All were screened for moderate anxiety on the Hospital Anxiety and Depression Scale-Anxiety screening assessment (A ≥ 8) at baseline. RESULTS: Participants randomized to Pep-Pal experienced greater reductions in perceived stress (PSS; F = 3.91, p = .05), greater increases in ability to learn and use stress management skills (F = 6.16, p = 0.01), and greater increases in sexual function (women only; F = 5.07, p = 0.03) compared to participants in TAU. Of Pep-Pal participants, only 10 (38.5%) watched at least 7/9 full-length sessions. The a priori hypothesis and criterion that participants would watch at least 75% full-length sessions were not met. CONCLUSIONS: A brief, easily disseminated mobile intervention showed poor adherence, but had limited estimates of efficacy for secondary outcomes; perceived stress, learning stress management skills, and sexual functioning (women only). Future directions are discussed.

Predicting Opioid Use Following Discharge After Cesarean Delivery.

PURPOSE: Although cesarean delivery is the most common surgical procedure in the United States, postoperative opioid prescribing varies greatly. We hypothesized that patient characteristics, procedural characteristics, or both would be associated with high vs low opioid use after discharge. This information could help individualize prescriptions. METHODS: In this prospective cohort study, we quantified opioid use for 4 weeks following hospital discharge after cesarean delivery. Predischarge characteristics were obtained from health records, and patients self-reported total opioid use postdischarge on weekly questionnaires. Opioid use was quantified in milligram morphine equivalents (MMEs). Binomial and Poisson regression analyses were performed to assess predictors of opioid use after discharge. RESULTS: Of the 233 patients starting the study, 203 (87.1%) completed at least 1 questionnaire and were included in analyses (86.3% completed all 4 questionnaires). A total of 113 patients were high users (>75 MMEs) and 90 patients were low users (≤75 MMEs) of opioids postdischarge. The group reporting low opioid use received on average 44% fewer opioids in the 24 hours before discharge compared with the group reporting high opioid use (mean = 33.0 vs 59.3 MMEs, P <.001). Only a minority of patients (11.4% to 15.8%) stored leftover opioids in a locked location, and just 31 patients disposed of leftover opioids. CONCLUSIONS: Knowledge of predischarge opioid use can be useful as a tool to inform individualized opioid prescriptions, help optimize nonopioid analgesia, and reduce opioid use. Additional studies are needed to evaluate the impact of implementing such measures on prescribing practices, pain, and functional outcomes.

Prescription Opioid Misuse and Risky Adolescent Behavior.

OBJECTIVES: Misuse of opioid medications (ie, using opioids differently than how a doctor prescribed the medication) is common among US adolescents and associated with preventable health consequences (eg, severe respiratory depression, seizures, heart failure, and death).1 New guidelines and recommendations have made providers more attuned to overprescribing and more vigilant about screening for opioid misuse.2 We hypothesized that youth who misused prescription opioids were more likely to report engaging in a broad range of other risky behaviors. METHODS: We used the Centers for Disease Control and Prevention's 2017 Youth Risk Behavior Surveillance Survey (n = 14 765), a cross-sectional, nationally representative survey of high school students. Students were sampled by using a 3-stage random cluster design. We conducted weighted logistic regressions to determine the strength of the association between our independent variable, ever misusing prescription opioids, and 22 dependent variables in the following categories: risky driving behaviors (4 variables), violent behaviors (3 variables), risky sexual behaviors (4 variables), substance use (10 variables), and suicide attempt (1 variable). RESULTS: In 2017, 14% of US adolescents reported ever misusing opioids. Those who misused prescription opioids were significantly more likely to have engaged in all 22 risky behaviors (adjusted odds ratios ranged from 2.0 to 22.3; P < .0001 for all tests) compared with other adolescents. CONCLUSIONS: Adolescents reporting ever misusing prescription opioids were more likely to have engaged in a broad range of risky behaviors. Health care providers screening for prescription opioid misuse may be ideally positioned to identify these high-risk youth and initiate early interventions.

Population pharmacokinetic modeling of plasma Δ9-tetrahydrocannabinol and an active and inactive metabolite following controlled smoked cannabis administration.

AIMS: Population pharmacokinetic models of Δ9-tetrahydrocannabinol (THC) have been developed for THC plasma and blood concentration data. Often, only the metabolites of THC are measurable when blood samples are obtained. Therefore, we performed a population pharmacokinetic analysis of THC, 11-OH-THC and THCCOOH plasma concentration data from a Phase I clinical trial of THC smoking. METHODS: Frequently obtained plasma THC, 11-OH-THC and THCCOOH concentration data were obtained over 168 h from 6 subjects who smoked low (15.8 mg) and high dose (33.8 mg) THC cigarettes on 2 occasions. Bayesian estimates of the THC pharmacokinetic model from each individual for each dose were fixed prior to the sequential pharmacokinetic analysis of the metabolites. RESULTS: A 3-compartment model of THC was developed that has a steady-state volume of distribution (VdSS ) of 3401 ± 788 L and a clearance of 0.72 ± 0.10 L/min. 11-OH-THC was characterized by 50 ± 6% of the THC being directly cleared to a 3-compartment model with a VdSS of 415.2 ± 4.3 L and clearance of 0.78 ± 0.05 L/min. The THCCOOH model shared the central compartment of the 11-OH-THC model with a VdSS of 29.1 ± 0.05 L and a clearance of 0.12 ± 0.02 L/min. First order kinetics were observed for THC and THCCOOH between the low and high doses, but a nonlinear pattern was observed for 11-OH-THC. CONCLUSION: We describe the pharmacokinetics of THC, 11-OH-THC and THCCOOH including inter- and intraindividual variability of the parameter estimates of the model.

Opioid and non-opioid utilization at home following gastrointestinal procedures: a prospective cohort study.

BACKGROUND: Overprescribing of opioid medications for patients to be used at home after surgery is common. We sought to ascertain important patient and procedural characteristics that are associated with low versus high rates of self-reported utilization of opioids at home, 1-4 weeks after discharge following gastrointestinal surgery. METHODS: We developed a survey consisting of questions from NIH PROMIS tools for pain intensity/interference and queries on postoperative analgesic use. Adult patients completed the survey weekly during the first month after discharge. Using regression procedures we determined the patient and procedure characteristics that predicted high post-discharge opioid use operationalized as 75 mg oral morphine equivalents/50 mg oxycodone reported taken. RESULTS: The survey response rate was 86% (201/233). High opioid use was reported by 52.7% of patients (106/201). Median reported intake of opioid pain pills was 7 for week #1 and 0 for weeks #2-4. Combinations of acetaminophen and non-steroidal and anti-inflammatory drugs were used by 8.9%-12.5% of patients after discharge. Following adjustment for significant variables of the univariate analysis, last 24-h in-hospital opioid intake remained as a significant co-variate for post-discharge opioid intake. CONCLUSIONS: After gastrointestinal surgery, the equivalent of each oxycodone 5 mg tablet taken in the last 24 h before discharge increases the likelihood of taking the equivalent of > 10 oxycodone 5 mg tablets by 5%. Non-opioid analgesia was utilized in less than half of the cases. Maximizing non-opioid analgesic therapy and basing opioid prescriptions on 24-h pre-discharge opioid intake may improve the quality of post-discharge pain management.

Neostigmine Versus Sugammadex for Reversal of Neuromuscular Blockade and Effects on Reintubation for Respiratory Failure or Newly Initiated Noninvasive Ventilation: An Interrupted Time Series Design.

BACKGROUND: Pulmonary complications related to residual neuromuscular blockade lead to morbidity and mortality. Using an interrupted time series design, we tested whether proportions of reintubation for respiratory failure or new noninvasive ventilation were changed after a system-wide transition of the standard reversal agent from neostigmine to sugammadex. METHODS: Adult patients undergoing a procedure with general anesthesia that included pharmacologic reversal of neuromuscular blockade and admission ≥1 night were eligible. Groups were determined by date of surgery: August 15, 2015 to May 10, 2016 (presugammadex), and August 15, 2016 to May 11, 2017 (postsugammadex). The period from May 11, 2016 to August 14, 2016 marked the institutional transition (washout/wash-in) from neostigmine to sugammadex. The primary outcome was defined as a composite of reintubation for respiratory failure or new noninvasive ventilation. Event proportions were parsed into 10-day intervals in each cohort, and trend lines were fitted. Segmented logistic regression models appropriate for an interrupted time series design and adjusting for potential confounders were utilized to evaluate the immediate effect of the implementation of sugammadex and on the difference between preintervention and postintervention slopes of the outcomes. Models containing all parameters (full) and only significant parameters (parsimonious) were fitted and are reported. RESULTS: Of 13,031 screened patients, 7316 patients were included. The composite respiratory outcome occurred in 6.1% of the presugammadex group and 4.2% of the postsugammadex group. Adjusted odds ratio (OR) and 95% confidence intervals (CIs) for the composite respiratory outcome were 0.795 (95% CI, 0.523-1.208) for the immediate effect of intervention, 0.986 (95% CI, 0.959-1.013) for the difference between preintervention and postintervention slopes in the full model, and 0.667 (95% CI, 0.536-0.830) for the immediate effect of the intervention in the parsimonious model. CONCLUSIONS: The system-wide transition of the standard pharmacologic reversal agent from neostigmine to sugammadex was associated with a reduction in the odds of the composite respiratory outcome. This observation is supported by nonsignificant within-group time trends and a significant reduction in intercept/level from presugammadex to postsugammadex in a parsimonious logistic regression model adjusting for covariates.

A randomized control trial of stress management for caregivers of stem cell transplant patients: Effect on patient quality of life and caregiver distress.

BACKGROUND: Psychological interventions reduce caregiver distress (CG-distress). Less distress in caregivers may contribute to improved patient quality of life (QoL), but empirical evidence is lacking. Will a caregiver stress management intervention improve patient QoL? METHODS: In this replication study, we randomized 155 allogeneic hematopoietic stem cell transplant (Allo-HSCT) patients and caregivers to PsychoEducation, Paced Respiration, and Relaxation (PEPRR) or enhanced treatment as usual (eTAU). We provided PEPRR over 3 months following transplant. Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) evaluated patient QoL, and CG-distress was based on depressive, anxious, and stress symptoms. Hierarchical linear models tested intervention, time, and interactions as fixed effects with participant as random effects. RESULTS: Patients whose caregivers received PEPRR did not differ on FACT-BMT between baseline and 6 months (mean = +3.74; 95% CI, -3.54 to 11.02) compared with patients of caregivers in eTAU (mean = +3.16; 95% CI, -2.88 to 9.20) even though CG-distress was decreased by PEPRR (mean = -0.23; 95% CI, -0.448 to -0.010) compared with those receiving eTAU (mean = +0.27; 95% CI, 0.033-0.504) at 6 months. CONCLUSIONS: PEPRR reduced CG-distress without affecting their patient's FACT-BMT score. The FACT-BMT may not have distinguished unique psychological changes associated with their caregiver receiving PEPRR.