Clinical significance criteria in the ICSD and DSM sleep disorder classifications: a content overlap analysis using the Jaccard index.

Study Objectives: Both the (ICSD) and the sleep-wake disorders section of the (DSM) emphasize the importance of clinical judgment in distinguishing the normal from the pathological in sleep medicine. The fourth edition of the DSM (DSM-IV, 1994) introduced the clinical significance criterion (CSC) to standardize this judgment and enhance diagnostic reliability.

Methods: This review conducts a theoretical and historical content analysis of CSC presence, frequency, and formulation in the diagnostic criteria of sleep disorders.

Determinants of Dropout From a Virtual Agent-Based App for Insomnia Management in a Self-Selected Sample of Users With Insomnia Symptoms: Longitudinal Study.

Background: Fully automated digital interventions delivered via smartphone apps have proven efficacious for a wide variety of mental health outcomes. An important aspect is that they are accessible at a low cost, thereby increasing their potential public impact and reducing disparities. However, a major challenge to their successful implementation is the phenomenon of users dropping out early.

Trastuzumab Plus Pertuzumab Versus Cetuximab Plus Irinotecan in Patients With Wild-Type, HER2-Positive, Metastatic Colorectal Cancer (S1613): A Randomized Phase II Trial.

Purpose: overexpression/amplification in wild-type (WT) metastatic colorectal cancer (mCRC; human epidermal growth factor receptor 2 [HER2]-positive mCRC) appears to be associated with limited benefit from anti-EGFR antibodies and promising responses to dual-HER2 inhibition; however, comparative efficacy has not been investigated. We conducted a randomized phase II trial to evaluate efficacy and safety of dual-HER2 inhibition against standard-of-care anti-EGFR antibody-based therapy as second/third-line treatment in HER2-positive mCRC.

Methods: Patients with -WT mCRC after central confirmation of HER2 positivity (immunohistochemistry 3+ or 2+ and in situ hybridization amplified [HER2/CEP17 ratio >2.

SWOG S1815: A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers.

Purpose: SWOG S1815 was a randomized, open label phase III trial, evaluating gemcitabine, nab-paclitaxel, and cisplatin (GAP) versus gemcitabine and cisplatin (GC) in patients with newly diagnosed advanced biliary tract cancers (BTCs).

Methods: Patients with newly diagnosed locally advanced unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (ICC) and extrahepatic cholangiocarcinoma (ECC) and gallbladder carcinoma (GBC), were randomly assigned 2:1 to either GAP (gemcitabine 800 mg/m, cisplatin 25 mg/m, and nab-paclitaxel 100 mg/m intravenously once per day on days 1 and 8 of a 21-day cycle) or GC (gemcitabine 1,000 mg/m and cisplatin 25 mg/m intravenously once per day on days 1 and 8 of a 21-day cycle).

Results: Among 452 randomly assigned participants, 441 were eligible and analyzable, 67% with ICC, 16% with GBC, and 17% with ECC.

Best Practices for Delivering Neoadjuvant Therapy in Pancreatic Ductal Adenocarcinoma.

Importance: Neoadjuvant therapy (NT) is an increasingly used treatment strategy for patients with localized pancreatic ductal adenocarcinoma (PDAC). Little research has been conducted on cancer care delivery during NT, and the standards for optimal delivery of NT have not been defined.

Objective: To develop consensus best practices for delivering NT to patients with localized PDAC.