Final Rule for Reporting Trial Results to ClinicalTrials.gov Effective January 18

The Final Rule of the FDA Amendments Act of 2007 has updated registration and reporting requirements, effective January 18, 2017, with compliance mandated by April 18, 2017. The purpose of the final rule is to clarify the statutory language, expand the minimum reporting data set, and add critical details throughout the ClinicalTrials.gov record to improve effectiveness and compliance overall.

Important concepts such as “applicable clinical trial,” “secondary outcome measure,” and others have been more clearly defined to better standardize the service, making it easier to comply. The minimum reporting data set has been expanded to include information on race and ethnic background, time frame, adverse effects, statistical analysis plan (SAP), and other details, but the final rule emphasizes that these requirements are a baseline for reporting, and further results are welcome.

Reflecting the Final Rule, the National Institutes of Health (NIH) issued a separate rule, “Clinical Trials Registration and Results Information Submission,” summarizing that NIH-funded investigators must register and report trial results at ClinicalTrials.gov. The new rule emphasizes the role it plays in helping patients finding appropriate clinical trials in which to participate and improves “public trust in clinical research.”

A full analysis of the final rule is available in the New England Journal of Medicine Special Report, Trial Reporting in ClinicalTrials.gov—The Final Rule, in the November 17, 2016, issue.

For more information on data management, refer to the HSLS Data Management Guide, where you will also find contact information for the HSLS Data Management Group members.

~Andrea Ketchum

Director’s Reflections…Leadership Changes at HSLS

BarbaraEpstein2014_gray
Barbara Epstein
HSLS Director
bepstein@pitt.edu

It is with mixed feelings that I announce that Nancy Tannery has resigned as HSLS Senior Associate Director. She will be moving to the Provost’s Office in the Cathedral of Learning to serve as Assistant Provost. While we are happy and proud for her to have this new opportunity, we are also sad that she is leaving HSLS.

Nancy came to HSLS as a Reference Librarian in 1996, having earned her MSLS degree after working as a Research Specialist for several years. She rose very quickly to become Assistant Director in 1998, then Associate Director in 2004, and then Senior Associate Director in 2011. Along the way, she accumulated an impressive list of publications, presentations and honors, including the Medical Library Association’s Brodman Award for the Academic Medical Librarian of the Year in 2011. Continue reading “Director’s Reflections…Leadership Changes at HSLS”

Learn to Love Your Data

LYDW_2017_Heart_LogoThe week of February 13–17, 2017, is Love Your Data (LYD) week, a social media event designed to raise awareness about research data management, sharing, and preservation. This year’s theme is emphasizing data quality for researchers at any stage in their career. Each day of the week will focus on a different topic:

Monday Defining Data Quality: Define data quality, and the criteria for good (and bad) data.
Tuesday Documenting, Describing, Defining: Data documentation as a way to improve and manage data quality.
Wednesday Good Data Examples: Define and share examples of producing good and good enough data.
Thursday Finding the Right Data: Explain and share examples of finding and using good data.
Friday Rescuing Unloved Data: Describe techniques of caring for legacy data and existing data rescue initiatives.

Practical tips, resources, and stories will be shared via Twitter (#LYD17 or #loveyourdata) by librarians, data specialists, and researchers from all over the world. Join the conversation with your Pitt Librarians by following us at:

Health Sciences Library System (HSLS):

University Library System (ULS):

Special in-person and webinar classes will also be held by HSLS and ULS librarians throughout the week. Registration may be required. Classes offer by HSLS at Falk Library include:

  • “Data Visualization for Beginners” – February 13 at 10 a.m.
  • “You do WHAT with your Data?” – February 14 at 10 a.m.
  • “Future Proof your Data: Planning for Reuse” – February 15 at 3 p.m.
  • “Crafting a Data Management Plan (webinar)” – February 17 at noon

 ~ Melissa Ratajeski

Changes to the HSLS Online Collection for 2017

Journals added to the HSLS online collection for 2017 include:

  • Annual Review of Animal Biosciences
  • Annual Review of Cancer Biology
  • Annual Review of Statistics and Its Application
  • Annual Review of Virology
  • Annual Review of Vision Science
  • BMJ Case Reports1
  • European Heart Journal: Quality of Care and Clinical Outcomes
  • Journal of Continuing Education in the Health Professions
  • Journal of Opioid Management
  • Journal of Radiology Nursing
  • JoVE Developmental Biology
  • JoVE Genetics (12-month trial access)
  • Mindfulness1
  • Operative Neurosurgery
  • Rehabilitation Oncology
  • Research in Social and Administrative Pharmacy
  • Science Immunology
  • Spinal Cord Series and Cases
  • Teaching and Learning in Medicine1
  • Trends in Cancer
  1. Availability expected later in 2017.

HSLS continually adds new open-access journals, so check our E-Journals by Subject list for titles in your area of interest.

The journals listed below will no longer be available due to cancellation, ceasing of publication, or other publication change. Note that in many cases, articles from 2016 and earlier will remain accessible. University of Pittsburgh users and UPMC residents/fellows may order individual articles through the HSLS Document Delivery Service.

  • BoneKEy Reports
  • Comparative Immunology, Microbiology, and Infectious Diseases
  • Endodontic Topics
  • Experimental & Translational Stroke Medicine
  • Family Process
  • Fibrogenesis & Tissue Repair
  • In Silico Cell and Tissue Science
  • Infant Mental Health Journal
  • International Nursing Review
  • Investigative Genetics
  • Journal of Computational Surgery
  • Journal of Investigative Medicine
  • Journal of Obsessive-Compulsive and Related Disorders
  • Journal of Structural and Functional Genomics
  • Journal of the Royal Statistical Society, Series B, Statistical Methodology
  • Journal of Trauma Management & Outcomes
  • Molecular and Cellular Therapies
  • Rehabilitation Nursing
  • Reviews in Clinical Gerontology
  • SpringerPlus
  • Ticks and Tick-Borne Diseases
  • Trends in Parasitology
  • Vascular Cell
  • Veterinary Anaesthesia and Analgesia
  • Wiley Interdisciplinary Reviews: Nanomedicine and Nanotechnology
  • Wiley Interdisciplinary Reviews: Systems Biology and Medicine

Our 2-year trial access to the Future Medicine journals collection has ended, so the current content of these journals will no longer be available, with the exception of the following journals:

  • Journal of Comparative Effectiveness Research
  • Personalized Medicine
  • Pharmacogenomics

Please note that Ovid is now the exclusive home for our subscriptions to the JBJS family of journals:

  • Journal of Bone & Joint Surgery [American version]
  • JBJS Case Connector
  • JBJS Essential Surgical Techniques
  • JBJS Reviews

The HSLS subscription to STAT!Ref now includes:

  • American Academy of Pediatrics Textbook of Pediatric Care
  • DeVita, Hellman, and Rosenberg’s Cancer: Principles & Practice of Oncology
  • Lippincott’s Video Series: Nursing Procedures

The HSLS subscription to Cochrane Library now includes Cochrane Clinical Answers, an evidence-based, clinical decision support resource based on trusted Cochrane systematic reviews. This resource was briefly available via HSLS during 2015.

~Jeff Husted

Adaptable Resources for Technology Users

HSLS Technology Services offers a variety of equipment and software that provide better accessibility for HSLS users. Our goal is to provide resources to enhance technology use in a self-service model, where people who want to use these resources have easy access and those who don’t are not hindered by them.

Three computer stations have designated accessible hardware. All public computers on the main floor and upper floor of the library have an Accessible Resources folder on the desktop. The folder contains shortcuts to software and websites that provide assistance.

Accessibility resources target the following needs:

Low vision/vision enhancement:

  • Enlarged keyboard labels (select computers)
  • Headphones (circulating)
  • NVDA screen reader
  • NaturalReader text-to-speech software
  • Book scanner for image-to-text conversion

Motor function aids:

  • Guards for keyboard to press one key at a time (select computers)
  • Trackball mouse (select computers)
  • Wrist rest and forearm rest (select computers)

Wheelchair accommodations:

  • Height adjustable desk

Hearing enhancement:

  • Headphones (circulating)
  • System provided visual notifications for sounds (flash active title bar, window, or display)

Reading comprehension:

  • Beeline (extension in Chrome) for reading focus
  • Readsy (website) for focusing on one word at a time
  • Rewordify (website) to replace advanced words with more common words
  • Spreeder (website) for speed reading

Learning disability and attention disorders:

  • Earplugs (available at main desk and help desk)
  • Popplet (website) – mind mapping tool
  • StayFocusd (Chrome extension) to discourage time wasting
  • Time Tracker (Chrome extension) to measure time spent on a website

The Accessible Technology Services page provides information on available resources as well as a request form to submit ideas for further software or equipment purchases.

~Julia Dahm

Pitt Researchers’ Article in 2016 Altmetric Top 10

Altmetric, the altmetrics service known for its colorful donut, captures the top major medical stories each year, making their annual Altmetric Top 100 list essential reading. This year, research from the health sciences at the University of Pittsburgh is in the top 10, along with President Obama’s article on health care reform and the BMJ report on medical error.

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Altmetrics for Jakicic’s JAMA article

Pitt’s John Jakicic, Kelliann Davis, Renee Rogers, Wendy King, Marsha Marcus, Abdus Wahed, Steven Belle, and others, authored, “Effect of Wearable Technology Combined With a Lifestyle Intervention on Long-term Weight Loss: The IDEA Randomized Clinical Trial,” published in the September 20, 2016, issue of JAMA, with an Altmetric score of 3,101. The Altmetric donut score represents the sum of social media points, which are weighted according to the category. Click on each category for details, and drill down for the source full text.

What are altmetrics? Why is the Altmetric Top 100 list significant?

  1. Altmetrics reflect the interest in an article or work itself, independent of the journal, book or larger work in which it may appear.
  1. Altmetric indicators usually take the form of widely-available social media, such as Twitter, Facebook, and blog mentions, or Slideshare and YouTube views and downloads, but can also include more academic sites, such as F1000 and Mendeley. Think of the interactivity data as the backbone of altmetrics.
  1. Altmetrics complement traditional citation-based metrics, which can take years to develop: they reflect immediate and short-term responses to and usage of research articles or other work, as opposed to the long-term usage of traditional citations.
  1. Altmetrics broadly measure social impact, communication, and interaction with the public and non-scientists, as well as other researchers. With the popularity of the Altmetric Top 100, altmetrics as outreach may increase visibility, interdisciplinary partnerships, and funding.

For more information, visit the HSLS Research Impact Guide/Altmetrics or contact Andrea Ketchum at ketchum@pitt.edu or 412-648-9757.

~Andrea Ketchum

Remembering June Bandemer

june_bandemerJune Bandemer, former HSLS librarian, passed away Monday, October 24, 2016.

June retired from HSLS in 2006 after almost 40 years in the library. She held various positions during that time including Assistant Director and Head of Public Services, Assistant Director for Access and Administrative Services, and two years as the library’s Acting Director. She was one of three librarians in the late 1970s to be accepted into an Honors Internship sponsored by the Council on Library Resources and the National Library of Medicine. In the mid-1980s, June earned a Juris Doctor from the Duquesne University School of Law. Continue reading “Remembering June Bandemer”

HSLS Staff News

The HSLS Staff News section includes recent HSLS presentations, publications, staff changes, staff promotions, degrees earned, etc.

News

Ansuman Chattopadhyay has been promoted to HSLS Assistant Director for Molecular Biology Information Services. Dr. Chattopadhyay was recruited to HSLS in 2002 to develop the HSLS Information Service in Molecular Biology (MBIS). Continue reading “HSLS Staff News”

Classes for February 2017

HSLS offers classes on database searching, software applications such as Prezi, bibliographic management, and molecular biology and genetics. For more information, visit the online course descriptions.

Classes are held on the first floor of Falk Library (200 Scaife Hall) in Classroom 1 and on the upper floor of the library in Classroom 2. All classes are open to faculty, staff, and students of the schools of the health sciences at the University of Pittsburgh, who will need a valid Pitt ID or e-mail account. They are also open to UPMC residents and fellows, who will need to show their UPMC IDs. Continue reading “Classes for February 2017”