OHAT Implementation of Systematic Review
The NTP Office of Health Assessment and Translation 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.
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 http://ntp.niehs.nih.gov/go/9741 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.
- Federal Register Notice (78 FR 37 published February 25, 2013)
Draft Case-Study ProtocolsTo 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.
- Download the Draft OHAT Approach for Systematic Review and Evidence Integration for Literature-Based Health Assessments – February 2013
- Draft Protocol for Systematic Review to Evaluate the Evidence for an Association Between Bisphenol A (BPA) Exposure and Obesity
- Draft Protocol for Systematic Review to Evaluate the Evidence for an Association Between Perfluorooctanoic Acid (PFOA) or Perfluorooctane Sulfonate (PFOS) Exposure and Immunotoxicity
Public CommentsThe 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 2013The NTP held a web-based public meeting on March 20, 2013, 2:00-4:00 p.m. Eastern Daylight Time 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 2013The NTP held a public, web-based, informational meeting on April 23, 2013, 12:00-4:00 p.m. Eastern Daylight Time 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
The NTP held a public webinar on September 26, 2013 from 1:00 – 4:00 p.m. Eastern Daylight Time 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.
- Meeting page for Webinar on OHAT Approach for Systematic Review
- NTP Listserv Announcement (August 6, 2013)
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 (http://ntp.niehs.nih.gov/go/getnews).
Discussions with the NTP Board of Scientific CounselorsThe 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 can be found at http://ntp.niehs.nih.gov/go/9741.
- 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.
Web page last updated on March 18, 2014