A BS TRACT: Background: For several decades, a myriad of factors have contributed to the inadequate diagnosis and management of depression in Parkinson's disease (PD), leaving up to 60% of significantly symptomatic patients untreated. Poor access to evidencebased neuropsychiatric care is one major barrier to achieving optimal Parkinson's outcomes. Objective: The goal of this study was to compare the efficacy of individual Parkinson's-informed, video-tohome cognitive-behavioral therapy (experimental group), to clinic-based treatment as usual (control group), for depression in PD. Method: Ninety United States military veterans with clinical diagnoses of both depression and PD were computer-randomized (1:1) to either the experimental or control group; randomization was stratified by baseline antidepressant use and blind to all other baseline data.The acute treatment period spanned 10 weeks and was followed by a 6-month extension phase. The Hamilton Depression Rating Scale was the a priori primary outcome. Depression treatment response was defined as a score ≤2 on the Clinical Global Impression Improvement Scale. All statistical analyses were intent to treat. Results: Video-to-home cognitive-behavioral therapy outperformed clinic-based treatment as usual across three separate depression measures (P < 0.001). Effects were observed at the end of acute treatment and maintained through 6-month follow-up. Number needed to treat (based on treatment response classification) was 2.5 with an absolute risk reduction of 40%. Conclusion: Video-to-home cognitive-behavioral therapy may be an effective intervention to bypass access barriers to specialized, evidence-based depression care in PD and to address the unmet neuropsychiatric treatment needs of the Parkinson's community.
Efforts to better understand and prevent suicide have increasingly pointed to the prospective assessment of suicidal behaviors in clinical trials. These assessments are aided by instruments such as the Columbia-Suicide Severity Rating Scale (C-SSRS), which have sought to improve the conceptual uniformity and ease by which suicidal behaviors are classified. At the same time, assessment and classification of suicidal behaviors has been a longtime challenge in the field. To aid users of the C-SSRS, this article illustrates the use of the C-SSRS in instances where classification complexities arise. Illustrations are presented based on cases encountered during a clinical trial for a suicide prevention intervention. Key decision points are summarized and classification issues that warrant consideration for future refinement of such decisions are discussed.
Neurocognitive detection of suicidal states has the potential to significantly advance objective risk assessment. This goal requires establishing that neurocognitive deficits fluctuate around the time of a suicide attempt. The current study therefore evaluated whether neurocognitive performance is temporally related to suicide attempt, in a sample at high-risk for suicide (n=141). Evaluations consisted of a clinician-administered interview, self-report questionnaires, and neurocognitive tasks assessing response inhibition, attentional control, and memory recognition. Analyses examined whether neurocognitive scores significantly differed according to the following temporal suicide attempt categories: a) past-week attempt; b) past-year attempt (not in past week); and c) no past-year attempt. Univariate results showed that response inhibition and memory recognition were significantly related to suicide attempt recency. Post-hoc pairwise tests showed that participants with a past-week suicide attempt showed greater impairments than those without a *
Background
Disease-specific patient-reported outcome measures (PROMs) are fundamental to understanding the impact on, and expectations of, patients with genetic disorders, and can facilitate constructive and educated conversations about treatments and outcomes. However, generic PROMs may fail to capture disease-specific concerns. Here we report the development and validation of a Gaucher disease (GD)-specific PROM for patients with type 1 Gaucher disease (GD1) a lysosomal storage disorder characterized by hepatosplenomegaly, thrombocytopenia, anemia, bruising, bone disease, and fatigue.
Results and discussion
The questionnaire was initially developed with input from 85 patients or parents of patients with GD1 or GD3 in Israel. Owing to few participating patients with GD3, content validity was assessed for patients with GD1 only. Content validity of the revised questionnaire was assessed in 33 patients in the US, France, and Israel according to US Food and Drug Administration standards, with input from a panel of six GD experts and one patient advocate representative. Concept elicitation interviews explored patient experience of symptoms and treatments, and a cognitive debriefing exercise explored patients’ understanding and relevance of instructions, items, response scales, and recall period. Two versions of the questionnaire were subsequently developed: a 24-item version for routine monitoring in clinical practice (rmGD1-PROM), and a 17-item version for use in clinical trials (ctGD1-PROM). Psychometric validation of the ctGD1-PROM was assessed in 46 adult patients with GD1 and re-administered two weeks later to examine test–retest reliability. Findings from the psychometric validation study revealed excellent internal consistency and strong evidence of convergent validity of the ctGD1-PROM based on correlations with the 36-item Short Form Health Survey. Most items were found to show moderate, good, or excellent test–retest reliability.
Conclusions
Development of the ctGD1-PROM represents an important step forward for researchers measuring the impact of GD and its respective treatment.
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