National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/38673

OHAT Implementation of Systematic Review

 

The NTP Office of Health Assessment and Translation (OHAT) develops literature-based evaluations to reach conclusions about potential human health hazards and to examine the state of the science. In 2012, OHAT began exploring and developing an approach for implementation of systematic review methodology to carry out these evaluations (Birnbaum et al. 2013). The output from an evaluation can vary including, but not limited to: NTP Monograph, state-of-the-science workshop report, or peer-reviewed journal publication. All evaluations follow a similar process, the OHAT Evaluation Process, with opportunities for external scientific, public, and interagency input.


Webinar on Lessons Learned in Application of the OHAT Framework for Systematic Review and Evidence Integration to Case Studies

NTP will hold a web-based public meeting on July 31, 2014, 12:30-3:30 p.m. EDT focused on lessons learned during the case-study process. The first part of the webinar will consist of a series of topic or “lesson” focused presentations, followed by a short question-and-answer period. The second part of the webinar will be a general discussion period when the public can make brief comments on or ask questions about the application of the OHAT Approach to the case studies and lessons learned.


OHAT Systematic Review Publications

Systematic review and evidence integration for literature-based environmental health science assessments.
Rooney AA, Boyles AL, Wolfe MS, Bucher JR, Thayer KA. Environ Health Perspect. 2014 Jul;122(7):711-8. doi: 10.1289/ehp.1307972. Epub 2014 Apr 18.
PMID: 24755067

Intersection of Systematic Review Methodology with the NIH Reproducibility Initiative.
Thayer KA, Wolfe MS, Rooney AA, Boyles AL, Bucher JR, Birnbaum LS.
Environ Health Perspect. 2014 Jul 1;122(7):A176-7. doi: 10.1289/ehp.1408671. No abstract available.
PMID:24984224

Implementing systematic review at the National Toxicology Program: status and next steps.
Birnbaum LS, Thayer KA, Bucher JR, Wolfe MS.
Environ Health Perspect. 2013 Apr;121(4):A108-9. doi: 10.1289/ehp.1306711. No abstract available.
PMID: 23548834


Draft OHAT Approach - February 2013

The Draft OHAT Approach for Systematic Review and Evidence Integration for Literature-based Health Assessments – February 2013 (“Draft OHAT Approach – February 2013”) provides a seven-step framework for conducting evaluations using principles of systematic review. The Draft OHAT Approach – February 2013 reflects consideration of input from a working group of the NTP Board of Scientific Counselors (BSC), the BSC, and the public (see for information, presentations, and minutes from the June 21-22 and December 11, 2012 meetings). This framework for conducting evaluations integrates within the OHAT Evaluation Process and includes multiple opportunities for external scientific, public, and interagency input.


Draft Case-Study Protocols

To assist with determining if additional refinement or revision to the Draft OHAT Approach – February 2013 might be needed, OHAT plans to apply it to several case-study evaluations. The first two case studies evaluate the evidence regarding the association of (1) bisphenol A (BPA) exposure with obesity and (2) perfluorooctanoic acid (PFOA) or perfluorooctane sulfonate (PFOS) exposure with immunotoxicity. Prior to initiating these evaluations, OHAT has developed protocols that include specific elements for how the seven steps in the Draft OHAT Approach – February 2013 would be carried out. The protocols on BPA exposure and obesity and PFOA or PFOS exposure and immunotoxicity were released on April 9, 2013. Persons interested in the Draft OHAT Approach – February 2013 and the protocols are encouraged to access this website to stay abreast of the most current information.

Public Comments 

NTP invited public comments on the Draft OHAT Approach – February 2013. Two protocols were released to illustrate the application of this framework: (1) BPA exposure and obesity and (2) PFOA or PFOS exposure and immunotoxicity. The deadline for submission of public comments was June 11, 2013. The comments are posted on the NTP website and persons submitting them are identified by their name and affiliation and/or sponsoring organization, if applicable.

Webinar on the Assessment of Data Quality in Animal Studies – March 2013

NTP held a web-based public meeting on March 20, 2013, 2:00-4:00 p.m. EDT focused on assessment of data quality in animal studies. The meeting began with invited presentations related to the assessment of study quality and was followed by a general discussion period.

Web-Based Informational Meeting - April 2013

NTP held a public, web-based, informational meeting on April 23, 2013, 12:00-4:00 p.m. EDT to provide an overview of the Draft OHAT Approach – February 2013, describe the contents in the two case-study protocols, and respond to questions from the public on any of the documents.

Webinar on OHAT Approach for Systematic Review - September 2013

NTP held a public webinar on September 26, 2013 from 1:00 – 4:00 p.m. EDT to gain additional clarity on issues raised in public comments. For each topic covered, there was a brief presentation by OHAT staff and then the opportunity for discussion in a question and answer session. The webinar also included a general discussion period for any additional comments or questions from the attendees.


Future updates on the Draft OHAT Approach for Systematic Review and Evidence Integration for Literature-Based Health Assessments will be posted on this webpage. Persons interested in the Draft OHAT Approach – February 2013 and the protocols are encouraged to access this website to stay abreast of the most current information.

Individuals interested in receiving updates on this project are encouraged to register to the NTP Listserv.

Discussions with the NTP Board of Scientific Counselors

NTP presented and discussed the Draft OHAT Approach at several BSC meetings (listed below). A BSC working group was formed to provide input on the Draft OHAT Approach. Minutes, presentations, and other meeting materials from past BSC meetings.
  • June 22, 2012: BSC meeting with presentation and discussion on Systematic Review and New Tools for Information Management and Data Display.
  • August 28–29, 2012: BSC Working Group met to evaluate the suitability and transparency of the proposed approach for reaching evidence assessment conclusions from a body of evidence for non-cancer health effects.
  • December 11, 2012: BSC Working Group released and discussed their draft report at the BSC meeting.
  • December 11, 2012: BSC meeting with presentations and discussions on (1) NTP Approach for Systematic Review and Evidence Integration for Literature-based Health Assessments, (2) NTP BSC Working Group Report on the Draft NTP Approach, and (3) Implementation of the NTP Approach in Office of Hazard Assessment and Translation (OHAT) Evaluations.
  • June 25, 2013: BSC meeting with presentation and discussion on Systematic Review and Evidence Integration for Literature-Based Health Assessments.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.