Effects of Treatment Setting on Outcomes of Flexibly-Dosed Intensive Cognitive Behavioral Therapy for Pediatric OCD : A Randomized Controlled Pilot Trial

Funding Information: The study authors would like to acknowledge the planning support of Drs. Eric Storch and Katherine Martinez, the recruitment and administrative support of the Provincial OCD Program Team at BC Children's Hospital, and the participation of all families. Funding. This study was supported by postdoctoral awards to RS from the Michael Smith Foundation for Health Research (#17821) and the BC Children's Hospital Research Institute. Both awards provided salary support for RS as well as research funds to support study implementation (e.g., staff salaries, participant reimbursement, etc.). A private donation to the Provincial OCD Program via the BC Children's Hospital Foundation also supported some research costs. Funding Information: This study was supported by postdoctoral awards to RS from the Michael Smith Foundation for Health Research (#17821) and the BC Children’s Hospital Research Institute. Both awards provided salary support for RS as well as research funds to support study implementation (e.g., staff salaries, participant reimbursement, etc.). A private donation to the Provincial OCD Program via the BC Children’s Hospital Foundation also supported some research costs. Publisher Copyright: © Copyright © 2021 Selles, Naqqash, Best, Franco-Yamin, Qiu, Ferreira, Deng, Hannesdottir, Oberth, Belschner, Negreiros, Farrell and Stewart.Introduction: Optimizing individual outcomes of cognitive-behavioral therapy (CBT) remains a priority. Methods: Youth were randomized to receive intensive CBT at a hospital clinic (n = 14) or within their home (n = 12). Youth completed 3 × 3 h sessions (Phase I) and up to four additional 3-h sessions as desired/needed (Phase II). An independent evaluator assessed youth after Phase I, Phase II (when applicable), and at 1- and 6-months post-treatment. A range of OCD-related (e.g., severity, impairment) and secondary (e.g., quality of life, comorbid symptoms) outcomes were assessed. Results: Families' satisfaction with the treatment program was high. Of study completers (n = 22), five youth (23%) utilized no Phase II sessions and 9 (41%) utilized all four (Median Phase II sessions: 2.5). Large improvements in OCD-related outcomes and small-to-moderate benefits across secondary domains were observed. Statistically-significant differences in primary outcomes were not observed between settings; however, minor benefits for home-based treatment were observed (e.g., maintenance of gains, youth comfort with treatment). Discussion: Intensive CBT is an efficacious treatment for pediatric OCD. Families opted for differing doses based on their needs. Home-based treatment, while not substantially superior to hospital care, may offer some value, particularly when desired/relevant. Clinical Trial Registration: www.ClinicalTrials.gov; https://clinicaltrials.gov/ct2/show/NCT03672565, identifier: NCT03672565.Peer reviewe

Effect of aliskiren on post-discharge outcomes among diabetic and non-diabetic patients hospitalized for heart failure: insights from the ASTRONAUT trial

Aims The objective of the Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT) was to determine whether aliskiren, a direct renin inhibitor, would improve post-discharge outcomes in patients with hospitalization for heart failure (HHF) with reduced ejection fraction. Pre-specified subgroup analyses suggested potential heterogeneity in post-discharge outcomes with aliskiren in patients with and without baseline diabetes mellitus (DM). Methods and results ASTRONAUT included 953 patients without DM (aliskiren 489; placebo 464) and 662 patients with DM (aliskiren 319; placebo 343) (as reported by study investigators). Study endpoints included the first occurrence of cardiovascular death or HHF within 6 and 12 months, all-cause death within 6 and 12 months, and change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 1, 6, and 12 months. Data regarding risk of hyperkalaemia, renal impairment, and hypotension, and changes in additional serum biomarkers were collected. The effect of aliskiren on cardiovascular death or HHF within 6 months (primary endpoint) did not significantly differ by baseline DM status (P = 0.08 for interaction), but reached statistical significance at 12 months (non-DM: HR: 0.80, 95% CI: 0.64-0.99; DM: HR: 1.16, 95% CI: 0.91-1.47; P = 0.03 for interaction). Risk of 12-month all-cause death with aliskiren significantly differed by the presence of baseline DM (non-DM: HR: 0.69, 95% CI: 0.50-0.94; DM: HR: 1.64, 95% CI: 1.15-2.33; P < 0.01 for interaction). Among non-diabetics, aliskiren significantly reduced NT-proBNP through 6 months and plasma troponin I and aldosterone through 12 months, as compared to placebo. Among diabetic patients, aliskiren reduced plasma troponin I and aldosterone relative to placebo through 1 month only. There was a trend towards differing risk of post-baseline potassium ≥6 mmol/L with aliskiren by underlying DM status (non-DM: HR: 1.17, 95% CI: 0.71-1.93; DM: HR: 2.39, 95% CI: 1.30-4.42; P = 0.07 for interaction). Conclusion This pre-specified subgroup analysis from the ASTRONAUT trial generates the hypothesis that the addition of aliskiren to standard HHF therapy in non-diabetic patients is generally well-tolerated and improves post-discharge outcomes and biomarker profiles. In contrast, diabetic patients receiving aliskiren appear to have worse post-discharge outcomes. Future prospective investigations are needed to confirm potential benefits of renin inhibition in a large cohort of HHF patients without D

Gaia Focused Product Release: A catalogue of sources around quasars to search for strongly lensed quasars

Context. Strongly lensed quasars are fundamental sources for cosmology. The Gaia space mission covers the entire sky with the unprecedented resolution of $0.18$" in the optical, making it an ideal instrument to search for gravitational lenses down to the limiting magnitude of 21. Nevertheless, the previous Gaia Data Releases are known to be incomplete for small angular separations such as those expected for most lenses. Aims. We present the Data Processing and Analysis Consortium GravLens pipeline, which was built to analyse all Gaia detections around quasars and to cluster them into sources, thus producing a catalogue of secondary sources around each quasar. We analysed the resulting catalogue to produce scores that indicate source configurations that are compatible with strongly lensed quasars. Methods. GravLens uses the DBSCAN unsupervised clustering algorithm to detect sources around quasars. The resulting catalogue of multiplets is then analysed with several methods to identify potential gravitational lenses. We developed and applied an outlier scoring method, a comparison between the average BP and RP spectra of the components, and we also used an extremely randomised tree algorithm. These methods produce scores to identify the most probable configurations and to establish a list of lens candidates. Results. We analysed the environment of 3 760 032 quasars. A total of 4 760 920 sources, including the quasars, were found within 6" of the quasar positions. This list is given in the Gaia archive. In 87\% of cases, the quasar remains a single source, and in 501 385 cases neighbouring sources were detected. We propose a list of 381 lensed candidates, of which we identified 49 as the most promising. Beyond these candidates, the associate tables in this Focused Product Release allow the entire community to explore the unique Gaia data for strong lensing studies further.Comment: 35 pages, 60 figures, accepted for publication by Astronomy and Astrophysic

Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure &lt; 100 mmHg (n = 1127), estimated glomerular filtration rate &lt; 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

A Psychometric Evaluation of a Measure for Evaluating Youth’s and their Parent’s Worries about Psychosocial Treatment

INTRODUCTION: Initial examination of treatment worries suggest they may represent an important construct; however, previously used measures were limited by their specificity, scale format, and lack of parent report. Therefore the present study sought to examine the initial outcomes and psychometrics of newly developed corresponding measures of treatment worries in youth (Treatment Worries Questionnaire – Child; TWQ-C) and their parents (Treatment Worries Questionnaire – Parent; TWQ-P). METHODS: Participants were 94 youth (7-17-years old) and parent dyads presenting for psychosocial treatment of an anxiety disorder. Prior to initiation of treatment, dyads completed the TWQ-C and TWQ-P along with a host of additional child and parent report measures, and three clinician-rated measures. RESULTS: Treatment worries were endorsed in the mild-moderate range by youth and the TWQ-C demonstrated good-excellent internal consistency and test-retest reliability, a strong three-factor structure, and consistent convergent and divergent relationships. Treatment worries were endorsed in the low mild range by parents and the TWQ-P demonstrated fair-good internal consistency and test-retest reliability, a less empirically, but theoretically, supported four-factor structure, and consistent divergent relationships, but variable (by factor) convergent relationships. DISCUSSION: The results of the present study provide information on the concept of treatment worries and support the use of the TWQ-C and TWQ-P as broad assessments of the concept in a variety of populations. Low endorsement of worries among parents likely relates to the nature of the present sample (treatment-seeking) and may have contributed significantly to the less ideal psychometrics of the TWQ-P in comparison to the TWQ-C. Future investigation of treatment worries using the TWQ-C and TWQ-P in a variety of samples is warranted

Treatment Maintenance of Cognitive-Behavioral Therapy for Anxiety in Youth with Autism Spectrum Disorders

Anxiety disorders commonly co-occur in children and adolescents with an autism spectrum disorder (ASD). Recently, treatment of anxiety using cognitive behavioral therapy (CBT) has been modified and studied in youth with ASD, with results consistently demonstrating positive treatment outcomes. In typically developing populations, CBT gains are well maintained as long as 14-years post-treatment; however, maintenance of CBT has not yet been studied in anxious youth with ASD. Using a sample of 32 youth who previously completed one of three CBT for anxiety in ASD treatment studies, the present study re-assessed parent report of anxiety symptoms in youth, 12-26 months (M = 17.16 Months; SD = 4.32) following treatment completion. Retrospective data from the original studies\u27 screening/baseline and post-treatment time points were used in combination with newly obtained follow-up data to determine treatment maintenance. Compared to baseline, follow-up scores on all measures of anxiety were associated with large effects for treatment. Compared to post-treatment, no significant differences in scores were observed; however, scores on the Pediatric Anxiety Rating Scale suggested a small effect for return in symptoms. While the percentage of individuals with remission of their primary anxiety diagnosis was identical at post-treatment and follow-up, significantly fewer individuals were rated as responders at follow-up as compared to post-treatment. Similar to CBT for anxiety in neurotypical youth, CBT for anxiety in youth with ASD appears to be relatively durable over a one to two year interval. Despite this, a significant portion of participants demonstrate some level of symptom regression. Future study should investigate factors associated with poor treatment maintenance, as well as modifications or additions to treatment protocols (e.g., booster sessions) that may help maintain treatment gains

A Psychometric Evaluation of a Measure for Evaluating Youth’s and their Parent’s Worries about Psychosocial Treatment

INTRODUCTION: Initial examination of treatment worries suggest they may represent an important construct; however, previously used measures were limited by their specificity, scale format, and lack of parent report. Therefore the present study sought to examine the initial outcomes and psychometrics of newly developed corresponding measures of treatment worries in youth (Treatment Worries Questionnaire – Child; TWQ-C) and their parents (Treatment Worries Questionnaire – Parent; TWQ-P). METHODS: Participants were 94 youth (7-17-years old) and parent dyads presenting for psychosocial treatment of an anxiety disorder. Prior to initiation of treatment, dyads completed the TWQ-C and TWQ-P along with a host of additional child and parent report measures, and three clinician-rated measures. RESULTS: Treatment worries were endorsed in the mild-moderate range by youth and the TWQ-C demonstrated good-excellent internal consistency and test-retest reliability, a strong three-factor structure, and consistent convergent and divergent relationships. Treatment worries were endorsed in the low mild range by parents and the TWQ-P demonstrated fair-good internal consistency and test-retest reliability, a less empirically, but theoretically, supported four-factor structure, and consistent divergent relationships, but variable (by factor) convergent relationships. DISCUSSION: The results of the present study provide information on the concept of treatment worries and support the use of the TWQ-C and TWQ-P as broad assessments of the concept in a variety of populations. Low endorsement of worries among parents likely relates to the nature of the present sample (treatment-seeking) and may have contributed significantly to the less ideal psychometrics of the TWQ-P in comparison to the TWQ-C. Future investigation of treatment worries using the TWQ-C and TWQ-P in a variety of samples is warranted

Comparison of Functional Outcome Scores in Radial Polydactyly

Background: A wide range of outcome assessment systems have been used to describe the results and evaluate residual impairment after surgery for radial polydactyly. We conducted a study to determine which of these assessment systems should be considered superior for the most common types of radial polydactyly (types ll and IV). Methods: Ten outcome assessment systems were selected. Three examiners independently evaluated thirty-seven patients, aged four to twenty-two years, with radial polydactyly. Patients completed two manual activity questionnaires. lnterobserver reliability was determined with use of an intraclass correlation coefficient (ICC). Validity was assessed by correlating the results derived with the outcome assessment systems with functional visual analog scale (VAS), aesthetic VAS, and manual activity questionnaire scores. Results: Thirty-seven patients (forty-one hands with radial polydactyly) were evaluated. All patients were assessed by at least two examiners. Reliability was highest for the Japanese Society for Surgery of the Hand (JSSH), Cheng et al., and Tada et al. assessment systems (overall ICCs >= 0.70). The JSSH system had the highest overall correlations (r(s) ranging from 0.48 to 0.80 and 0.45 to 0.63) with functional and aesthetic VAS scores. No significant correlations were found between the outcome scores and the results of the manual activity questionnaires after an average follow-up time of 112 months. Conclusions: Interobserver reliability was highest for the JSSH classification, which also showed superior correlations with both examiner-rated and patient-rated VAS scores for functional and aesthetic outcome compared with the other nine assessment systems. The finding of a poor correlation between the outcome scores and the results of manual activity questionnaires is in agreement with findings in published literature. We recommend the JSSH assessment method for the scientific evaluation of the outcomes, in terms of body structure and function, of the treatment of radial polydactyly