JEFO_Atrial_Fibrillation.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Agency for Healthcare Research and Quality Division of Contracts Management / OMS PHONE: (301) 427-1364 5600 Fishers Lane FAX: (301) 427-1740 Mailstop: 06N34B WEB: www.ahrq.gov Rockville, Maryland 20857

Justification for an Exception to Fair Opportunity Systematic Evidence Review to Support the USPSTF – Atrial Fibrillation

1. Contracting Activity

Agency for Healthcare Research and Quality (AHRQ): Justification for an Exception to Fair Opportunity

2. Nature of Action

This requirement will be awarded as a logical follow on to Contract HHSA290201500011I/Task Order 5 for a medium systematic review and manuscript preparation for the U.S. Preventative Services Task Force (USPSTF).

3. Description of the Services Being Acquired

This requirement will result in two final products: a medium systematic evidence review ($355,000) and a manuscript preparation ($25,000) based on the systematic evidence review for submission to a peer-reviewed journal. Following the USPSTF processes for making a recommendation, this systematic evidence review and manuscript preparation will take approximately 24 months.

The Task Force makes recommendations based on a rigorous review of existing peer-reviewed evidence, and follows a multistep process when developing each of its recommendations. The process starts with the Task Force and researchers from an Evidence-based Practice Center (EPC) developing a research plan for the topic (topic refinement). The research plan includes key questions to be answered and target populations to be considered. The draft research plan is posted on the Task Force Web site for public comment for 4 weeks, during which time anyone can comment on the plan, including stakeholders and members of the general public. The Task Force and the EPC review all comments and consider them in revising the research plan.

Using the final research plan as a guide, EPC researchers gather, review, and analyze evidence on the topic from studies published in peer-reviewed scientific journals. The EPC summarizes this evidence in a comprehensive evidence review. External subject matter experts review the draft evidence report.

After carefully considering the evidence presented in the draft evidence review and the decision analysis, if available, the Task Force develops a draft recommendation statement based upon the potential benefits and harms of the clinical preventive service.

The Task Force posts the draft recommendation statement along with the draft evidence review for public comment for 4 weeks. The Task Force requests feedback on the completeness of the evidence, its interpretation of the evidence, and the clarity and usefulness of the draft recommendation statement. All comments related to the draft evidence review are considered by the researchers at the EPC and the evidence review is revised as necessary. Members of the Task Force review all comments received on the draft recommendation statement and then revise the recommendation statement.

The final recommendation statement is posted on the USPSTF Web site along with the final evidence review and supporting materials. The recommendation statement and a manuscript based on the full evidence review are often published in a peer-reviewed medical journal.

4. Authority Cited for Exception to Fair Opportunity

FAR 16.505(b)(2)(i)(C). The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to a task order already issued under the contract under which all awardees were given a fair opportunity to be considered for the original order.

This work is a logical follow-on to a task order that has been awarded to Research Triangle Institute (RTI). Each year, AHRQ commissions 10 to 15 new systematic evidence reviews to support the USPSTF in making recommendations on clinical preventive services. Through a competitive process, RTI was awarded one of the two FY 2015 USPSTF Systematic Evidence Review task orders. This award included a topic refinement, a medium-sized systematic evidence review and a manuscript for submission to a peer-reviewed journal on Screening for Coronary Heart Disease (CHD) (including atrial fibrillation (“a-fib”)) with Electrocardiography (ECG). The fundamental work of conducting systematic evidence reviews for the USPSTF, and the science of clinical preventive services has not changed from the task order. As a result of multiple detailed discussions between the Task Force Lead Members and the AHRQ Medical Officer, the Task Force members determined that they would need two separate systematic evidence reviews in order to make a recommendation. The reasons for 2 separate systematic evidence reviews are multifold: 1) the populations in whom screening would be performed for CHD versus a-fib are different – middle age adults with CVD risk factors versus older adults; 2) the screening strategies are slightly different

– ECG or ECG stress test for CHD versus ECG with or without pulse palpation for a-fib;

3) Interventions differ – lifestyle counseling and preventive medications for CHD versus anticoagulation, rate control, and rhythm control for a-fib; and 4) outcomes differ between the topics – risk reclassification and CVD events for CHD compared to arrhythmia identification and stroke prevention for a-fib.

The new requirement includes a medium-sized systematic evidence review and manuscript preparation for Screening for Atrial Fibrillation (AFIB) using Electrocardiography (ECG). The Principle Investigator who is conducting the combined topic refinement and who will be conducting the parallel Screening for Coronary Heart Disease (CHD) with Electrocardiography (ECG) systematic evidence review co-leads the team at RTI and will be available to update this work. Task Force members have expressed the need to have these reviews produced in collaboration in order to enable them to review all the evidence on an important clinical question – should a primary care physician perform an ECG or not in an individual patient – and may issue one recommendation statement. Therefore, it is in the best interest of the government in terms of economy and efficiency to award this work to RTI. RTI staff completed the topic refinement and through this work developed a unique expertise about how the Task Force scoped the topic and arrived at the analytic framework for the research plan. The research plan is the roadmap for the systematic evidence review.

5. Determination from the Contracting Officer that the anticipated cost to the Government will be fair and reasonable

The costs for the additional work are based on prices determined to be fair and reasonable for the items under the IDIQ contract award for each contractor.

6. Any Other Facts Supporting the Justification

It is imperative that the systematic evidence on Screening for Atrial Fibrillation using ECG be coordinated with the systematic evidence review on Screening for CHD.

Commissioning the systematic evidence review on Screening Atrial Fibrillation using ECG from RTI will ensure that one principle investigator and investigative team will conduct this systematic evidence review as well as the one on Screening for CHD.

Having the same team work on the two topics would be a greater benefit to the government as constant communication and crossover will be needed to ensure that the topics are aligned, and the efficiencies in the process are not lost if conducted by different contractors. Alignment and coordination between the two topics would enable the Task Force to deliberate the evidence on both topics during the same meeting and may result in issuing one final recommendation.

7. Actions to Remove and Overcome Barriers

The change in scope was a result of multiple detailed discussions between the Task Force Lead Members and the AHRQ Medical Officer. After much work by RTI EPC performing preliminary literature searches the Task Force members determined that they would need two separate systematic evidence reviews in order to make a recommendation. The Task Force refined the direction and need of the topic at the topic refinement stage and once preliminary literature searches were completed. In the future, AHRQ will work with the USPSTF to help them to the best of their ability to identify these considerations earlier so that final requirements can be included in the request for task order.

8. Certification from the Contracting Officer

The Contracting Officer certifies that the supporting data which is included in this justification for exception to fair opportunity is accurate and complete to the best of their knowledge and belief.

9. Certification from the Program Office

The Program Office certifies that the supporting data which included in this justification to fair opportunity to fair opportunity is accurate and complete to the best of their knowledge and belief.

/s/ Joya Chowdhury, Task Order Officer /s/ Erin Mills, Contracting Officer________ (signature included in AP dated 6/22/2016) (signature included in AP dated 6/24/2016)