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Concept: Documents

157

Mindfulness-based therapy (MBT) has become a popular form of intervention. However, the existing reviews report inconsistent findings.

Concepts: Documents, Coda

99

Evidence shows that research abstracts are commonly inconsistent with their corresponding full reports, and may mislead readers. In this scoping review, which is part of our series on the state of reporting of primary biomedical research, we summarized the evidence from systematic reviews and surveys, to investigate the current state of inconsistent abstract reporting, and to evaluate factors associated with improved reporting by comparing abstracts and their full reports.

Concepts: Medical research, Documents

47

Details about the type of analysis (e.g., intent to treat [ITT]) and definitions (i.e., criteria for including participants in the analysis) are necessary for interpreting a clinical trial’s findings. Our objective was to compare the description of types of analyses and criteria for including participants in the publication (i.e., what was reported) with descriptions in the corresponding internal company documents (i.e., what was planned and what was done). Trials were for off-label uses of gabapentin sponsored by Pfizer and Parke-Davis, and documents were obtained through litigation.

Concepts: Clinical trial, ClinicalTrials.gov, Report, Pfizer, Analysis, Gabapentin, Documents, Description logic

28

To document the first report of intra-articular, non-weight-bearing, impaction fractures of the lateral femoral condyle.

Concepts: Bone, Documents

26

24

The purpose of this document is to describe behaviors, including the elements and controls, to ensure the integrity of GxP data in pharmaceutical manufacturing operations. Fundamental concepts such as ALCOA (attributable, legible, contemporaneous, original, and accurate) and the prevent/detect/respond approach to a data integrity program are defined and discussed. This paper was developed through the PDA Data Integrity Task Force and reviewed and approved by the PDA Regulatory and Quality Advisory Board as well as the PDA Board of Directors. Data integrity is a significant component of a company’s Quality System, providing foundational assurance of the data a company uses to operate in compliance with regulatory requirements and to demonstrate its products are safe and effective for their intended use. Through data integrity the company recognizes its responsibility to prove the origin, transmission, and content of the company’s data and that data is what it is purported to be. To holistically address Data Integrity, the Parenteral Drug Association (PDA) is developing a set of tools in the form of PDA Technical Reports, PDA Training, Data Integrity Workshops, and Points to Consider documents that can be used by industry to address this serious issue. This document serves as an introduction to that suite of tools to follow.

Concepts: Pharmacology, Quality, Data, Board of directors, Data management, Document, Documents

24

23

The analysis of questioned documents printed with monochromatic toner has been a great challenge to document examiners. Banding artifacts, which are often perceived in the outputs of laser printers, could be a solution to the identification of printers. In this study, sources other than the gear transmission errors were discovered for some primary banding frequency components. By detecting the angular velocity variation of photosensitive drums and other rotating parts of the tested printers and comparing them with the banding signals extracted from the printouts, the authors located the sources of banding frequency components. It was shown that the sources of some primary and persistent banding signals, which were previously unknown, were traced to the periodic velocity variations of the motors or the timing belts. As inherent signatures, banding artifacts could be promising features for discriminating documents printed by individual laser printers.

Concepts: Angular momentum, Laser, Document, Laser printer, Documents, Authentication, Information science, Toner

22

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist and explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included herein. This document, as well as the accompanying website and message board (http://www.record-statement.org), will enhance the implementation and understanding of RECORD. Through implementation of RECORD, authors, journals editors, and peer reviewers can encourage transparency of research reporting.

Concepts: Scientific method, Epidemiology, Observational study, Knowledge, A priori, A priori and a posteriori, Documents

19

To investigate characteristics of clinical trials and results on safety and effectiveness reported in US Food and Drug Administration (FDA) documents for recently approved high risk cardiovascular devices compared with the characteristics and results reported in peer reviewed publications.

Concepts: Pharmacology, Clinical trial, The Canon of Medicine, Report, Academic publishing, Food and Drug Administration, Documents, Federal Food, Drug, and Cosmetic Act