Elizabeth M. Hines

Bio: Elizabeth M. Hines is an academic researcher from Amherst College. The author has contributed to research in topics: Medicine & Radiology. The author has an hindex of 1, co-authored 1 publications receiving 334 citations.

Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis

Abstract: Background ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.

Acute carpal tunnel syndrome from thrombosed persistent median artery in a patient with congenitally absent radial artery.

Abstract: OBJECTIVES Thrombosis of the persistent median artery (PMA) is a rare cause of acute carpal tunnel syndrome (ACTS). Existence of a congenitally absent radial artery in this setting has not been described in the literature. METHODS Computed Tomography Angiography (CTA) and doppler screening were used in pre surgical planning. Open surgical decompression was achieved through the release of the flexor retinaculum in the left hand. A regimen of 100 mg of Aspirin for 3 months time was initiated to encourage clot resolution and recanalization of the thrombosed artery. RESULTS The PMA was found to be abnormally large measuring approximately 4 mm in diameter. Visible clotting off of the PMA in keeping with the doppler scans with maintenance of distal flow and was left intact with the hopes that it would recanalize over time. At the 3-month post-op review the antiplatelet therapy was ceased and the patient was symptom free, demonstrated no signs of ischaemia in the hand, and had returned to full functionality and physical activity. CONCLUSIONS Although infrequently encountered, the knowledge of the anatomical variations of the forearm and hand together with doppler screening and CTA is essential to the surgical management of ACTS.

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

Abstract: High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

The ClinicalTrials.gov results database--update and key issues.

Abstract: BACKGROUND The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. METHODS We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. RESULTS As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. CONCLUSIONS ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data.

Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis

Abstract: Objective To review patterns of publication of clinical trials funded by US National Institutes of Health (NIH) in peer reviewed biomedical journals indexed by Medline. Design Cross sectional analysis. Setting Clinical trials funded by NIH and registered within ClinicalTrials.gov (clinicaltrials.gov), a trial registry and results database maintained by the US National Library of Medicine, after 30 September 2005 and updated as having been completed by 31 December 2008, allowing at least 30 months for publication after completion of the trial. Main outcome measures Publication and time to publication in the biomedical literature, as determined through Medline searches, the last of which was performed in June 2011. Results Among 635 clinical trials completed by 31 December 2008, 294 (46%) were published in a peer reviewed biomedical journal, indexed by Medline, within 30 months of trial completion. The median period of follow-up after trial completion was 51 months (25th-75th centiles 40-68 months), and 432 (68%) were published overall. Among published trials, the median time to publication was 23 months (14-36 months). Trials completed in either 2007 or 2008 were more likely to be published within 30 months of study completion compared with trials completed before 2007 (54% (196/366) v 36% (98/269); P Conclusions Despite recent improvement in timely publication, fewer than half of trials funded by NIH are published in a peer reviewed biomedical journal indexed by Medline within 30 months of trial completion. Moreover, after a median of 51 months after trial completion, a third of trials remained unpublished.

Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov

Abstract: This study examined associations between the funding sources of 546 registered trials of drugs in 5 commonly prescribed classes and published outcomes that favored the new intervention over the con...