Browsing by Subject "Single-blind method"

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Decreasing Delirium Through Music: A Randomized Pilot Trial
    (American Association of Critical-Care Nurses, 2020-03-01) Khan, Sikandar H.; Xu, Chenjia; Purpura, Russell; Durrani, Sana; Lindroth, Heidi; Wang, Sophia; Gao, Sujuan; Heiderscheit, Annie; Chlan, Linda; Boustani, Malaz; Khan, Babar A.; Medicine, School of Medicine
    Background: Management of delirium in intensive care units is challenging because effective therapies are lacking. Music is a promising nonpharmacological intervention. Objectives: To determine the feasibility and acceptability of personalized music (PM), slow-tempo music (STM), and attention control (AC) in patients receiving mechanical ventilation in an intensive care unit, and to estimate the effect of music on delirium. Methods: A randomized controlled trial was performed in an academic medical-surgical intensive care unit. After particular inclusion and exclusion criteria were applied, patients were randomized to groups listening to PM, relaxing STM, or an audiobook (AC group). Sessions lasted 1 hour and were given twice daily for up to 7 days. Patients wore noise-canceling headphones and used mp3 players to listen to their music/audiobook. Delirium and delirium severity were assessed twice daily by using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and the CAM-ICU-7, respectively. Results: Of the 1589 patients screened, 117 (7.4%) were eligible. Of those, 52 (44.4%) were randomized, with a recruitment rate of 5 patients per month. Adherence was higher in the groups listening to music (80% in the PM and STM groups vs 30% in the AC group; P = .01), and 80% of patients surveyed rated the music as enjoyable. The median number (interquartile range) of delirium/coma-free days by day 7 was 2 (1-6) for PM, 3 (1-6) for STM, and 2 (0-3) for AC (P = .32). Median delirium severity was 5.5 (1-7) for PM, 3.5 (0-7) for STM, and 4 (1-6.5) for AC (P = .78). Conclusions: Music delivery is acceptable to patients and is feasible in intensive care units. Further research testing use of this promising intervention to reduce delirium is warranted.
  • Thumbnail Image
    Item
    Whole Slide Imaging Versus Microscopy for Primary Diagnosis in Surgical Pathology: A Multicenter Blinded Randomized Noninferiority Study of 1992 Cases (Pivotal Study)
    (Wolters Kluwer, 2018-01) Mukhopadhyay, Sanjay; Feldman, Michael D.; Abels, Esther; Ashfaq, Raheela; Beltaifa, Senda; Cacciabeve, Nicolas G.; Cathro, Helen P.; Cheng, Liang; Cooper, Kumarasen; Dickey, Glenn E.; Gill, Ryan M.; Heaton, Robert P., Jr.; Kerstens, René; Lindberg, Guy M.; Malhotra, Reenu K.; Mandell, James W.; Manlucu, Ellen D.; Mills, Anne M.; Mills, Stacey E.; Moskaluk, Christopher A.; Nelis, Mischa; Patil, Deepa T.; Przybycin, Christopher G.; Reynolds, Jordan P.; Rubin, Brian P.; Saboorian, Mohammad H.; Salicru, Mauricio; Samols, Mark A.; Sturgis, Charles D.; Turner, Kevin O.; Wick, Mark R.; Yoon, Ji Y.; Zhao, Po; Taylor, Clive R.; Pathology and Laboratory Medicine, School of Medicine
    Most prior studies of primary diagnosis in surgical pathology using whole slide imaging (WSI) versus microscopy have focused on specific organ systems or included relatively few cases. The objective of this study was to demonstrate that WSI is noninferior to microscopy for primary diagnosis in surgical pathology. A blinded randomized noninferiority study was conducted across the entire range of surgical pathology cases (biopsies and resections, including hematoxylin and eosin, immunohistochemistry, and special stains) from 4 institutions using the original sign-out diagnosis (baseline diagnosis) as the reference standard. Cases were scanned, converted to WSI and randomized. Sixteen pathologists interpreted cases by microscopy or WSI, followed by a wash-out period of ≥4 weeks, after which cases were read by the same observers using the other modality. Major discordances were identified by an adjudication panel, and the differences between major discordance rates for both microscopy (against the reference standard) and WSI (against the reference standard) were calculated. A total of 1992 cases were included, resulting in 15,925 reads. The major discordance rate with the reference standard diagnosis was 4.9% for WSI and 4.6% for microscopy. The difference between major discordance rates for microscopy and WSI was 0.4% (95% confidence interval, -0.30% to 1.01%). The difference in major discordance rates for WSI and microscopy was highest in endocrine pathology (1.8%), neoplastic kidney pathology (1.5%), urinary bladder pathology (1.3%), and gynecologic pathology (1.2%). Detailed analysis of these cases revealed no instances where interpretation by WSI was consistently inaccurate compared with microscopy for multiple observers. We conclude that WSI is noninferior to microscopy for primary diagnosis in surgical pathology, including biopsies and resections stained with hematoxylin and eosin, immunohistochemistry and special stains. This conclusion is valid across a wide variety of organ systems and specimen types.