Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spina... by Daniel K. Park, Joshua J. Wind, Todd Lansford, Pierce Nunley, Timothy A. Peppers, Anthony Russo, Hamid Hassanzadeh, Jonathan Sembrano, Jung Yoo, Jonathan Sales

“…Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. …”
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Qualitative inquiry with persons with obesity about weight management in primary care and referrals by Lisa Bailey-Davis, Lisa Bailey-Davis, Angela Marinilli Pinto, David J. Hanna, Michelle I. Cardel, Chad D. Rethorst, Kelsey Matta, Christopher D. Still, Christopher D. Still, Gary D. Foster, Gary D. Foster

“…Audiotape transcripts, interviewer notes, and independent review of data by two investigators allowed for data and investigator triangulation. …”
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A structured, journal-led peer-review mentoring program enhances peer review training by Ariel Maia Lyons-Warren, Whitley W. Aamodt, Kathleen M. Pieper, Roy E. Strowd

“…Mentees reported improved perception of review (median (IQR) pre = 4 (3–4), post = 5 (4–5)) and editorial processes (pre = 3 (2–4), post = 4 (4–5)) as well as self-perceived confidence in completing an independent review of both scientific (median (IQR) pre = 2 (2–3), post = 4 (4–4)) and non-scientific (pre = 3 (2–4), post = 4 (4–5)) manuscripts following program participation. p < 0.0001 for all scores noted. …”
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A multi-attribute value assessment method for the early product development phase with application to the business airplane industry by Downen, Troy Douglas

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Ultrasound core laboratory for the Household Air Pollution Intervention Network trial: standardized training and image management for field studies using portable ultrasound in fet... by Dávila-Román, VG, Toenjes, AK, Meyers, RM, Lenzen, PM, Simkovich, SM, Herrera, P, Fung, E, Papageorghiou, AT, Craik, R, McCracken, JP, Thompson, LM, Balakrishnan, K, Rosa, G, Peel, J, Clasen, TF, Hossen, S, Checkley, W, Fuentes, LDL

“…Ultrasound Core Laboratories (UCL) are used in multicenter trials to assess imaging biomarkers to define robust phenotypes, to reduce imaging variability and to allow blinded independent review with the purpose of optimizing endpoint measurement precision. …”

Bendamustine treatment of Chinese patients with relapsed indolent non-Hodgkin lymphoma: a multicenter, open-label, single-arm, phase 3 study by Yuan-Kai Shi, Xiao-Nan Hong, Jian-Liang Yang, Wei Xu, Hui-Qiang Huang, Xiu-Bin Xiao, Jun Zhu, Dao-Bin Zhou, Xiao-Hong Han, Jian-Qiu Wu, Ming-Zhi Zhang, Jie Jin, Xiao-Yan Ke, Wei Li, De-Pei Wu, Shen-Miao Yang, Xin Du, Yong-Qian Jia, Ai-Chun Liu, Dai-Hong Liu, Zhi-Xiang Shen, Lian-Sheng Zhang, Leonard James, Edward Hellriegel, Peng Lyu

“…At the time of the primary analysis, the ORR was 73% (95% CI: 63%–81%) per Independent Review Committee (IRC) including 19% CR and 54% PR. …”
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Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review by Hao Luo, Hao Luo, Oliver Schumacher, Oliver Schumacher, Daniel A. Galvão, Daniel A. Galvão, Robert U. Newton, Robert U. Newton, Dennis R. Taaffe, Dennis R. Taaffe

“…Six electronic databases (Embase, PubMed, Google Scholar, Web of Science Core Collection, SPORTDiscus, and CINAHL Plus) will be searched for studies. Two independent review authors will assess eligibility of identified studies, chart data using pre-established extraction forms, and evaluate adequacy of reporting of AEs-related data against a 20-item scoring checklist derived from the CONSORT (Consolidated Standards of Reporting Trials) harms extension. …”
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Using a standalone ear-EEG device for focal-onset seizure detection by McGregor Joyner, Sheng-Hsiou Hsu, Stephanie Martin, Jennifer Dwyer, Denise Fay Chen, Reza Sameni, Samuel H. Waters, Konstantin Borodin, Gari D. Clifford, Allan I. Levey, John Hixson, Daniel Winkel, Jonathan Berent

“…Results In a blinded, independent review of the ear-EEG signals, two epileptologists were able to detect 86.4% of the seizures that were subsequently identified using the clinical gold standard EEG modalities, with a false detection rate of 0.1 per day, well below what has been reported for ambulatory monitoring. …”
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Tislelizumab in Patients with Previously Treated Advanced Hepatocellular Carcinoma (RATIONALE-208): A Multicenter, Non-Randomized, Open-Label, Phase 2 Trial by Zhenggang Ren, Michel Ducreux, Ghassan K. Abou-Alfa, Philippe Merle, Weijia Fang, Julien Edeline, Zhiwei Li, Lihua Wu, Eric Assenat, Sheng Hu, Lorenza Rimassa, Tao Zhang, Jean-Frédéric Blanc, Hongming Pan, Paul Ross, Chia-Jui Yen, Albert Tran, Guoliang Shao, Mohamed Bouattour, Yajin Chen, Tim Meyer, Jinlin Hou, David Tougeron, Yuxian Bai, Ming-Mo Hou, Zhiqiang Meng, John Wu, Vincent Li, Sandra Chica-Duque, Ann-Lii Cheng

“…The primary endpoint was objective response rate (ORR), radiologically confirmed per Response Evaluation Criteria in Solid Tumors version 1.1 by Independent Review Committee. Safety was assessed in patients who received ≥1 dose of tislelizumab. …”
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Detecting the Effects of Deep-Seabed Nodule Mining: Simulations Using Megafaunal Data From the Clarion-Clipperton Zone by Jeff A. Ardron, Jeff A. Ardron, Erik Simon-Lledó, Daniel O. B. Jones, Henry A. Ruhl, Henry A. Ruhl

“…Monitoring details, data, and results including power analyses should be made fully available, to facilitate independent review and informed policy discussions.…”
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Pazopanib versus sunitinib in Chinese patients with locally advanced or metastatic renal cell carcinoma: pooled subgroup analysis from the randomized, COMPARZ studies by Xinan Sheng, Jie Jin, Zhisong He, Yiran Huang, Aiping Zhou, Jinwan Wang, Xiubao Ren, Dingwei Ye, Xu Zhang, Shukui Qin, Fangjian Zhou, Binhui Wang, Jun Guo

“…PFS and ORR were assessed by independent review committee (IRC) and local investigators. …”
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Oral care for intensive care unit patients without mechanical ventilation: protocol for a systematic review and meta-analysis by Xiaoxia Tang, Yunxia Shen, Xuejiao Pan, Jianglong Liao, Yanfei Xu, Wen Luo, Xiaolin Zhang, Chun’e Li, Qing Wan, Xin Cai, Xiaomei Zhang, Tao Wang, Guilan Zhang

“…All literature will be selected following pre-established inclusion criteria by two independent review authors to obtain quality trials. The quality of the included records will be evaluated according to the “risk of bias table”, recommended by the Cochrane Handbook for Systematic Reviews of Interventions. …”
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Identity development, attraction, and behaviour of heterosexually identified men who have sex with men: scoping review protocol by Andrew D. Eaton, Travis R. Scheadler, Cara Bradley, Lauren B. McInroy, Oliver W. J. Beer, Erin Beckwell, Adam Busch, Paul A. Shuper

“…Thematic content analysis will guide the review; through independent review and reviewer meetings, themes and subthemes will be identified and reported from the extracted literature. …”
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AI as a Medical Device for Ophthalmic Imaging in Europe, Australia, and the United States: Protocol for a Systematic Scoping Review of Regulated Devices by Ariel Yuhan Ong, Henry David Jeffry Hogg, Aditya U Kale, Priyal Taribagil, Ashley Kras, Eliot Dow, Trystan Macdonald, Xiaoxuan Liu, Pearse A Keane, Alastair K Denniston

“…Preliminary regulatory database searches, evidence searches, screening, data extraction, and methodological quality assessment will be undertaken by 2 independent review authors and arbitrated by a third at each stage of the process. …”
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Nationwide incidence of sarcomas and connective tissue tumors of intermediate malignancy over four years using an expert pathology review network. by Gonzague de Pinieux, Marie Karanian, Francois Le Loarer, Sophie Le Guellec, Sylvie Chabaud, Philippe Terrier, Corinne Bouvier, Maxime Batistella, Agnès Neuville, Yves-Marie Robin, Jean-Francois Emile, Anne Moreau, Frederique Larousserie, Agnes Leroux, Nathalie Stock, Marick Lae, Francoise Collin, Nicolas Weinbreck, Sebastien Aubert, Florence Mishellany, Celine Charon-Barra, Sabrina Croce, Laurent Doucet, Isabelle Quintin-Rouet, Marie-Christine Chateau, Celine Bazille, Isabelle Valo, Bruno Chetaille, Nicolas Ortonne, Anne Brouchet, Philippe Rochaix, Anne Demuret, Jean-Pierre Ghnassia, Lenaig Mescam, Nicolas Macagno, Isabelle Birtwisle-Peyrottes, Christophe Delfour, Emilie Angot, Isabelle Pommepuy, Dominique Ranchere, Claire Chemin-Airiau, Myriam Jean-Denis, Yohan Fayet, Jean-Baptiste Courrèges, Nouria Mesli, Juliane Berchoud, Maud Toulmonde, Antoine Italiano, Axel Le Cesne, Nicolas Penel, Francoise Ducimetiere, Francois Gouin, Jean-Michel Coindre, Jean-Yves Blay, NetSarc/RePPS/ResSos and French Sarcoma Group- Groupe d’Etude des Tumeurs Osseuses (GSF-GETO) networks

“…<h4>Methods</h4>The nationwide incidence of sarcoma or TIM (2013-2016) was measured using the 2013 WHO classification and confirmed by a second independent review by expert pathologists. Simple clinical characteristics, yearly variations and correlation of incidence with published clinical trials are presented and analyzed.…”
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Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees by Alice Faust, Anna Sierawska, Katharina Krüger, Anne Wisgalla, Joerg Hasford, Daniel Strech

“…For the review of these proposals the RECs indicated a broad spectrum of challenges regarding (1) social value (e.g. lack of coordination), (2) scientific validity (e.g. provisional study planning), (3) favourable risk–benefit ratio (e.g. difficult benefit assessment), (4) informed consent (e.g. strict isolation measures), (5) independent review (e.g. lack of time), (6) fair selection of trial participants (e.g. inclusion of vulnerable groups), and (7) respect for study participants (e.g. data security). …”
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Evaluation of methods for assigning causes of death from verbal autopsies in India by Sudhir K. Benara, Saurabh Sharma, Atul Juneja, Saritha Nair, B. K. Gulati, Kh. Jitenkumar Singh, Lucky Singh, Ved Prakash Yadav, Chalapati Rao, M. Vishnu Vardhana Rao

“…PCVA methodology involved dual independent review with adjudication, where required. Metrics to assess performance were Cause Specific Mortality Fraction (CSMF), sensitivity, positive predictive value (PPV), CSMF Accuracy, and Kappa statistic.ResultsIn terms of the measures of the overall performance of COD assignment methods, for CSMF Accuracy, the PCVA method achieved the highest score of 0.79, followed by 0.67 for Tariff_2.0, 0.66 for Inter-VA and 0.62 for InSilicoVA. …”
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Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CT... by Tempei Miyaji, Yukiko Iioka, Yujiro Kuroda, Daigo Yamamoto, Satoru Iwase, Yasushi Goto, Masahiro Tsuboi, Hiroki Odagiri, Yu Tsubota, Takashi Kawaguchi, Naoko Sakata, Ethan Basch, Takuhiro Yamaguchi

“…Forward- and back-translations were produced, and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee and the US NCI. …”
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Pregabalin for acute and chronic pain in adults. by Moore, R, Straube, S, Wiffen, P, Derry, S, McQuay, H

“…DATA COLLECTION AND ANALYSIS: Two independent review authors extracted data and assessed trial quality. …”

A systematic review of electronic audit and feedback: intervention effectiveness and use of behaviour change theory by Tuti, T, Nzinga, J, Njoroge, M, Brown, B, Peek, N, English, M, Paton, C, van der Veer, S

“…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). …”