Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review. Outcome reporting among drug trials registered in. Comparison of registered and published primary outcomes in randomized controlled trials. (26) Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P.
NORTON GHOST 9 SYSTEM REQUIREMENTS TRIAL
Clinical trial registration: a statement from the International Committee of Medical Journal Editors. (25) DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R et al. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). (24) Krleža-Jerić K, Chan A-W, Dickersin K, Sim I, Grimshaw J, Gluud C for the Ottawa Group. Clinical trial registration: transparency is the watchword. (22) Sim I, Chan A-W, Gülmezoglu AM, Evans T, Pang T. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial. (21) Shaw L, Price C, McLure S, Howel D, McColl E, Ford GA. Development of the Cochrane Collaboration’s CENTRAL Register of controlled clinical trials. (20) Dickersin K, Manheimer E, Wieland S, Robinson KA, Lefebvre C, McDonald S. Available from: NLM Identifier: NCT00505778. Bethesda (MD): National Library of Medicine (US). A comparison of once a day dose compared to 2 doses/day.
The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. (18) Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. (17) Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ et al. Guidance for developers of health research reporting guidelines.
(16) Moher D, Schulz KF, Simera I, Altman DG. Developing a guideline for reporting clinical trial protocols: Delphi consensus survey. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. (14) Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K et al. Guidelines for randomized controlled trial protocol content: a systematic review. (13) Tetzlaff JM, Chan A-W, Kitchen J, Sampson M, Tricco AC, Moher D. Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. (12) Smyth RM, Kirkham JJ, Jacoby A, Altman DG, Gamble C, Williamson PR. Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols. (11) Mhaskar R, Djulbegovic B, Magazin A, Soares HP, Kumar A. Constraints on publication rights in industry-initiated clinical trials. (10) Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Ghost authorship in industry-initiated randomised trials. (9) Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Subgroup analysis and covariate adjustment in randomized clinical trials of traumatic brain injury: a systematic review. (8) Hernández AV, Steyerberg EW, Taylor GS, Marmarou A, Habbema JD, Maas AI. Selective reporting in clinical trials: analysis of trial protocols accepted by the Lancet. (7) Al-Marzouki S, Roberts I, Evans S, Marshall T. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. (6) Chan A-W, Hróbjartsson A, Jørgensen KJ, Gøtzsche PC, Altman DG. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. (4) Chan A-W, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory. (3) Hróbjartsson A, Pildal J, Chan A-W, Haahr MT, Altman DG, Gøtzsche PC. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. (2) Pildal J, Chan A-W, Hróbjartsson A, Forfang E, Altman DG, Gøtzsche PC. WMA Declaration of Helsinki – Ethical principles for medical research involving human subjects.
This list reflects the citations made throughout the SPIRIT 2013 Checklist section of the website, and replicates the published SPIRIT 2013 Explanation & Elaboration paper.
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