Methodology of the SORENTO clinical trial: a prospective, randomised, active-controlled phase 3 trial assessing the efficacy and safety of high exposure octreotide subcutaneous dep... by Simron Singh, Diego Ferone, Jaume Capdevila, Jennifer Ang Chan, Wouter W. de Herder, Daniel Halperin, Josh Mailman, Lisa Hellström, Hanna Liedman, Agneta Svedberg, Fredrik Tiberg

“…Upon confirmation of disease progression (determined by a Blinded Independent Review Committee [BIRC] and defined as per RECIST 1.1), patients may enter an open-label extension treatment period with once weekly dosing, to investigate the effects of higher frequency dosing. …”
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A systematic review of electronic audit and feedback: intervention effectiveness and use of behaviour change theory by Timothy Tuti, Jacinta Nzinga, Martin Njoroge, Benjamin Brown, Niels Peek, Mike English, Chris Paton, Sabine N van der Veer

“…Data on feedback characteristics, underlying theoretical domains, effect size and risk of bias were extracted by two independent review authors, who determined the domains within the Theoretical Domains Framework (TDF). …”
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FREQUENCY OF DIAGNOSTIC CONCORDANCE IN CORE BREAST BIOPSIES OF CATEGORY B3 AND B4 AT A TERTIARY CARE CENTRE by Ghazala Sadaf, Muhammad Tahir Khadim, Rabia Ahmed, Muhammad Asif, Safina Ahmed, Shahid Jamal, Sammeen Salim

“…The selected cases were anonymized and distributed among 3 pathologists for independent review. The participating pathologists were kept unaware of the findings given by fellow participants and previously agreed reference diagnoses. …”
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Clinician consensus on “Inappropriate” presentations to the Emergency Department in the Better Data, Better Planning (BDBP) census: a cross-sectional multi-centre study of emergenc... by Niamh M Cummins, Louise A Barry, Carrie Garavan, Collette Devlin, Gillian Corey, Fergal Cummins, Damien Ryan, Emma Wallace, Conor Deasy, Mary Flynn, Gerard McCarthy, BDBP Team, Rose Galvin

“…In cases where consensus was not reached charts were assessed by an Independent Review Panel (IRP). At each site all files were autonomously assessed by local GP-EMC panels. …”
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Systematic Process to Determine Clinical Harm From Delayed Communication Between Primary and Secondary Healthcare by Mehool Patel, Simon Parton, Elizabeth Aitken

“…There were 367 deaths, and an independent review revealed that no deaths were linked to the nonreceipt of the letter. …”
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Treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma with the BTK inhibitor zanubrutinib: phase 2, single-arm, multicenter study by Wei Xu, Shenmiao Yang, Keshu Zhou, Ling Pan, Zengjun Li, Jianfeng Zhou, Sujun Gao, Daobin Zhou, Jianda Hu, Ru Feng, Haiwen Huang, Meng Ji, Haiyi Guo, Jane Huang, William Novotny, Shibao Feng, Jianyong Li

“…The primary endpoint was overall response rate as assessed by an independent review committee. Results Of the 91 evaluable patients, 77 (84.6%) achieved a response, with three (3.3%), 54 (59.3%), and 20 (22%) patients achieving a complete response, partial response, and partial response with lymphocytosis, respectively, after a median follow-up of 15.1 months. …”
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Advance Statements for Black African and Caribbean people (AdStAC): protocol for an implementation study by Abigail Babatunde, Alex Ruck Keene, Alan Simpson, Steven Gilbert, Lucy Stephenson, Kia-Chong Chua, Gareth Owen, Adelabu Jonathan Simpson, Shubulade Smith, Claire Henderson

“…Abstract Background The UK government committed to legislating for Advance Choice Documents/Advance Statements (ACD/AS) following their recommendation by the Independent Review of the MHA (2018). ACDs/AS are yet to be implemented in routine practice despite evidence and high demand; they are associated with improved therapeutic relationships and a reduction (25%, RR 0.75, CI 0.61–0.93) in compulsory psychiatric admission. …”
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Multicenter diagnostic evaluation of a Novel Coronavirus Antigen Lateral Flow Test among symptomatic individuals in Brazil and the United Kingdom by Faffe, DS, Byrne, RL, Body, R, Castiñeiras, TMP, Castiñeiras, AP, Finch, LS, Kontogianni, K, Bengey, D, Galliez, RM, Ferreira, OC, Mariani, D, da Silva, BO, Ribeiro, SS, de Vos, M, Escadafal, C, Adams, ER, Tanuri, A, Cubas Atienzar, AI

“…Thus, there is now a need for a transparent evaluation of Ag-RDTs with both analytical and clinical evaluation. We present an independent review of the Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Beijing Hotgen Biotech Co., Ltd.), at two sites within Brazil and one in the United Kingdom.…”

First-line erlotinib versus gemcitabine/cisplatin in patients with advancedEGFRmutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, EN... by Wu, Y.L., Zhou, C., Liam, Chong Kin, Wu, G., Liu, X., Zhong, Z., Lu, S., Cheng, Y., Han, B., Chen, L., Huang, C., Qin, S., Zhu, Y., Pan, H., Liang, H., Li, E., Jiang, G., How, S.H., Fernando, M.C.L., Zhang, Y., Xia, F., Zuo, Y.

“…Investigator-assessed median PFS was 11.0 months versus 5.5 months, erlotinib versus GP, respectively [hazard ratio (HR), 0.34, 95% confidence interval (CI) 0.22-0.51; log-rank P < 0.0001]. Independent Review Committee-assessed median PFS was consistent (HR, 0.42). …”

Identification of HMGA2 as a predictive biomarker of response to bintrafusp alfa in a phase 1 trial in patients with advanced triple-negative breast cancer by Alexander Spira, Alexander Spira, Ahmad Awada, Nicolas Isambert, David Lorente, Nicolas Penel, Nicolas Penel, Yue Zhang, Laureen S. Ojalvo, Christine Hicking, P. Alexander Rolfe, Christian Ihling, Isabelle Dussault, George Locke, Christian Borel

“…The primary objective was confirmed best overall response by RECIST 1.1 assessed per independent review committee (IRC).ResultsAs of May 15, 2020, a total of 33 patients had received bintrafusp alfa, for a median of 6.0 (range, 2.0-48.1) weeks. …”
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Hypersensitivity reactions, hepatotoxicity, and other discontinuations in persons receiving integrase strand transfer inhibitors: results from the EuroSIDA study by Annegret Pelchen-Matthews, Jakob Friis Larsen, Leah Shepherd, Josip Begovac, Karen Pedersen, Stéphane De Wit, Andrzej Horban, Elzbieta Jablonowska, Margaret Johnson, Irina Khromova, Marcelo H. Losso, Lars N. Nielsen, Anna Lisa Ridolfo, Brigitte Schmied, Christoph Stephan, Israel Yust, Lloyd Curtis, Vani Vannappagari, Leigh Ragone, Ashley Roen, Dorthe Raben, Ole Kirk, Lars Peters, Amanda Mocroft, for the EuroSIDA Study Group

“…Conclusion: During 5 years of observations in the EuroSIDA cohort independently reviewed discontinuations due to HSR or hepatotoxicity were very rare, indicating a low rate of SAEs.…”
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Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma in Patients With Child-Pugh B or C Cirrhosis by Peter Lee, BS, Yunsheng Ma, MD, PhD, MPH, Isabel Zacharias, MD, Adel Bozorgzadeh, MD, Sean Wilson, MD, Kim Foley, NP, Paul Rava, MD, PhD, Mark Masciocchi, MD, Linda Ding, PhD, Jacob Bledsoe, MD, Thomas J. Fitzgerald, MD, Shirin Sioshansi, MD

“…There were 7 liver-related deaths, and based on independent review by a hepatologist, 1 of these deaths may have been attributable to SBRT-related liver injury. …”
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ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS by Mehmut TURGUT, Roman HAJEK, Tomas JELÍNEK, Philippe MOREAU, Thomas MARTIN, Ludek POUR, Gabor MIKALA, Argiris SYMEONIDIS, Sara BRINGHEN, Andreea RAWLINGS, Marie Laure RISSE, Helgi VAN DE VELDE, Ivan SPICKA

“…Doses: Isa: 10 mg/kg IV QW for 4 weeks, then Q2W; K 20 mg/m² days 1–2, then 56 mg/m² twice-weekly 3 of 4 weeks; d: 20 mg twice-weekly. Independent review committee assessed response based on central radiology review and central lab M-protein using International Myeloma Working Group criteria. …”
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SG-APSIC1035: Prospective safety surveillance study of ACAM2000 smallpox vaccine in deployed military personnel by Kevin Yeo, Daniel Gordon, Lori Perry, Ilfra Raymond-Loher, Nita Tati, Kevin Yeo, Grace Lin, Gina DiPietro, Alex Selmani, Michael Decker

“…Study participants with evidence, either clinical or laboratory, of possible myopericarditis were referred to a blinded independent review committee for further evaluation and adjudication. …”
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XENERA-1: a randomised double-blind Phase II trial of xentuzumab in combination with everolimus and exemestane versus everolimus and exemestane in patients with hormone receptor-po... by Peter Schmid, Javier Cortes, Ana Joaquim, Noelia Martínez Jañez, Serafín Morales, Tamara Díaz-Redondo, Sibel Blau, Patrick Neven, Julie Lemieux, José Ángel García-Sáenz, Lowell Hart, Tsvetan Biyukov, Navid Baktash, Dan Massey, Howard A. Burris, Hope S. Rugo

“…The primary endpoint was progression-free survival (PFS) per independent review. Results A total of 103 patients were randomised and 101 were treated (n = 50 in the xentuzumab arm and n = 51 in the placebo arm). …”
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Digital and online symptom checkers and assessment services for urgent care to inform a new digital platform: a systematic review by Duncan Chambers, Anna Cantrell, Maxine Johnson, Louise Preston, Susan K Baxter, Andrew Booth, Janette Turner

“…Objectives: This systematic review was commissioned to provide NHS England with an independent review of previous research in this area to inform strategic decision-making and service design. …”
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Low‐dose gemcitabine plus nab‐paclitaxel versus standard‐dose gemcitabine plus nab‐paclitaxel in elderly patients with metastatic pancreatic cancer: A randomized Phase II trial... by Ken Kamata, Hajime Imai, Hisakazu Matsumoto, Yukitaka Yamashita, Takao Kato, Katsuhisa Nishi, Shunsuke Omoto, Kosuke Minaga, Kentaro Yamao, Tomoko Hyodo, Sung‐Woon Im, Akane Hara, Tomoe Yoshikawa, Rei Ishikawa, Ayana Okamoto, Tomohiro Yamazaki, Atsushi Nakai, Kazuomi Ueshima, Yasutaka Chiba, Mamoru Takenaka, Tomohiro Watanabe, Masayuki Kitano, Masatoshi Kudo

“…The response rate (36.7% vs 33.3%) and progression‐free survival (7.3 vs 8 months) were comparable between the low‐ and standard‐dose groups as determined by independent review. The difference in the median overall survival between the two groups was not significant (7.9 vs 12 months). …”
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Application of a Novel 68Ga-HER2 Affibody PET/CT Imaging in Breast Cancer Patients by Haitao Miao, Haitao Miao, Yuyun Sun, Yuyun Sun, Yizi Jin, Yizi Jin, Xichun Hu, Xichun Hu, Shaoli Song, Shaoli Song, Jian Zhang, Jian Zhang, Jian Zhang

“…All available images for each patient were evaluated through an independent review of two committee-certified radiologists with nuclear medicine expertise. …”
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Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer by Mark A. Socinski, Cornelius F. Waller, Tazeen Idris, Igor Bondarenko, Alexander Luft, Katrin Beckmann, Ashwini Vishweswaramurthy, Subramanian Loganathan, Charles Donnelly, Matthew A. Hummel, Roxann Shapiro, Melody Woods, Anita Rao, Vivek G Nayak, Gopinath Ranganna, Abhijit Barve

“…The primary objective was comparison of overall response rate (ORR), based on independently reviewed best tumor responses as assessed during the first 18 weeks. …”
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A Protocol for the Use of Case Reports/Studies and Case Series in Systematic Reviews for Clinical Toxicology by Aboubakari Nambiema, Grace Sembajwe, Juleen Lam, Tracey Woodruff, Daniele Mandrioli, Nicholas Chartres, Marc Fadel, Adrien Le Guillou, Remi Valter, Marie Deguigne, Marion Legeay, Chloe Bruneau, Gaël Le Roux, Gaël Le Roux, Alexis Descatha, Alexis Descatha

“…The risk of bias, quality of evidence and the strength of recommendations will be assessed by two independent review teams that are blinded to each other.Conclusion: This is a protocol specified for systematic reviews that use case reports/studies and case series to evaluate the quality of evidence and strength of recommendations in disciplines like clinical toxicology, where case reports/studies are the norm.…”
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