General DEcIDE Instructions:
Responding to DEcIDE TOs and Conducting DEcIDE Projects

 

HMORN DEcIDE-2 CONTRACT INFORMATION

	Title:	HMORN DEcIDE-2 Center (Developing Evidence to Inform Decisions about Effectiveness Research Network-2)
	Period:	07/23/2010 – 07/24/2013
	PI:	Richard Platt, MD, MSc (Harvard Pilgrim Health Care Institute)
	Prime / Coordinating Center (CC):	Dept. of Population Medicine, HPHCI
	HMORN DEcIDE Coordinating Center PM:	Beth Syat, MPH (beth_syat@harvardpilgrim.org)
	Contract #:	HHSA290201000008I
	Project Officer:	Scott Smith, PhD

PARTICIPATING HMORN DEcIDE SITES

Research Center	Parent Organization
Department of Population Medicine*	Harvard Pilgrim Health Care
Group Health Research Institute	Group Health Cooperative
HealthPartners Research Foundation	HealthPartners
Center for Health Services Research	Henry Ford Health System
Institute for Health Research	Kaiser Permanente Colorado
Center for Health Research—Southeast	Kaiser Permanente Georgia
Center for Health Research—Hawaii	Kaiser Permanente Hawaii
Division of Research	Kaiser Permanente Northern California
Center for Health Research—Northwest	Kaiser Permanente Northwest
Department of Research and Evaluation	Kaiser Permanente Southern California
Lovelace Clinic Foundation	Lovelace Health Systems
Marshfield Clinic Research Foundation	Fallon Community Health Plan
Scott & White Health Care Division of Research	Scott & White Health Care

*Prime/Coordinating Center

RESPONDING TO RFTOs

AHRQ’s DEcIDE program is set up as a contract with each DEcIDE center. All work performed under the DEcIDE contract is authorized through the issuance of task orders (TOs) signed by the Contracting Officer and accepted by the Contractor. TOs may be issued at any time within the contract period. TOs may vary in terms of content, cost and duration, and they often require a quick turn-around, well-defined scope and budget (including an hour limit). Typically, only one response is permitted from each DEcIDE center.  

Below is a description of the process for responding to DEcIDE TOs. NOTE: all correspondence between AHRQ and our HMORN DEcIDE center must go through the HMORN Coordinating Center at HPHCI, unless otherwise noted.

• Coordinating Center (CC) circulates requests for proposals from AHRQ to HMORN DEcIDE center investigators and PMs
• Investigators respond to CC with their interest to participate in or lead the proposal writing process within timeframe provided by CC
• If ≥ 2 investigators are interested in leading, then the Coordinating Center will set up a conference call so all interested parties can discuss and explore the possibility of working together
• If no investigators are interested in leading, then no response is submitted
• CC submits letter of intent, if applicable
• If responding, lead investigator(s) and participating investigators/sites are confirmed by CC
• Participating sites send contact info for PMs/administrators to CC PM
• Lead investigator(s) works to prepare technical proposal and works with CC PM to ensure all additional required documents are being completed
• All site budgets should be prepared using AHRQ’s labor rates and labor categories (classes); draft and final budgets should be sent to CC by the deadlines provided
• Questions about RFTOs are submitted to AHRQ through the CC; anyone with questions should send them to CC by the deadline provided

SUBMISSION

• Prior to submission to AHRQ, the HMORN DEcIDE PI (Rich Platt) and DEcIDE CC review all proposals and check for HMORN DEcIDE consistency, quality of work, and thoroughness (i.e., includes all necessary pieces). Therefore, draft submissions are typically due to the CC approximately 7-10 days prior to due dates to allow for review and revisions.
• Once necessary revisions are made, the CC submits the final proposal to AHRQ
• ALL PROPOSALS ARE SUBMITTED TO AHRQ THROUGH THE CC

REQUIRED SUBMISSION DOCUMENTS (unless otherwise specified):

• Technical proposal that meets the requirements specified in the RFTO
• Signed budgets from all participating sites (prepared using AHRQ’s labor rates and labor categories [classes] as described in LABOR RATES FOR AHRQ’S TASK ORDERS section)
• Budget justifications from all participating sites
• Research Proposal Summary form (refer to template)
• Signed disclosure forms for all participating investigators (refer to template)
• Biosketches in NIH format for all participating investigators (optional for consultants)
• Detailed timeline of deliverables (refer to template)
• Any requirements about terms of payment is handled by the CC

LABOR RATES FOR AHRQ'S TASK ORDERS

Budgets must fall within AHRQ's hourly rate ranges. Please contact Beth Syat for approved ranges for each labor category. Labor categories (class definitions) are below.

AHRQ’S CLASS DEFINITIONS

CLASS I: Senior Management personnel, normally holding an advanced degree, with a minimum of ten years experience in conducting analytical/program research, evaluation, and strategic planning types of activities, preferably with significant experience in health services research and analytical and/or managerial experience. This class of personnel should also have high-level management experience that reflects an ability to command organizational resources and direct staff within the broader organization.

CLASS II: Associate management or professional personnel, normally holding an advanced degree, with a minimum of five years of experience in conducting analytical/program research evaluation, and strategic planning types of activities. This class of personnel should also have experience in health services research.

CLASS III: Intermediate technical personnel, normally holding a BS or BA degree and at least three years experience in technical activities of which at least two are relevant to areas related to AHRQ’s work. The individual is capable of carrying out independent assignments with minimum supervision or acting as leader of small projects. Class III includes specialists in computer programming, survey design, etc.

CLASS IV: Junior Analysts, normally holding a BS or BA degree, with three years or less experience in technical areas. Class IV includes research assistants and junior personnel who regularly assist analysts and specialists on routine technical work, such as a data collection.

CLASS V: Other technical staff such as editors.

CLASS VI: Administrative assistants, project administrators, research assistants.

AWARD PROCESS

• AHRQ awards the Task Order (TO) to the CC
• CC informs participating sites of award and describes next steps
• CC works with AHRQ to get authorized Work Assignment (WA) to authorize the work and initiate the project. Note: many WAs can fall under the same TO; see example below.
• Once WA is authorized, AHRQ will provide the WA #
• NOTE: the TO may be for $100,000, and WA#1 + WA#2 ≤ $100,000 (e.g., WA#1 = $60K and WA#2 = $40K)

AHRQ's TABLE OF DEcIDE RESEARCH PROJECT STAGES*

Abstract	Protocol Development and IRB Review	Research and Report Development	Publication and Posting of Final Reports
-DEcIDE Center prepares and submits an abstract describing the proposed research study; posted on AHRQ’s EHC website	-AHRQ reviews the protocol and submits for external review, if necessary -DEcIDE Center revises protocol and submits to IRB -IRB reviews protocol AHRQ posts protocol summary on AHRQ web site	-DEcIDE Center conducts the research	-Draft reports submitted for external and independent peer review -Manuscripts submitted for journal publication -Final reports posted on AHRQ web site
First Stage ~ 0-1 months to complete	Second Stage ~ 2-6 months to complete	Third Stage ~ 3-24 months to complete	Final Stage ~ 3-12 months to complete

*Based on table presented at DEcIDE Business Meeting at AHRQ on 9/26/10

PROJECT TIMELINE & SUBMISSION OF DELIVERABLES*

• Follow deliverable schedule in the task order and copy Beth Syat at CC on deliverable submissions
• If there are changes in date/quantity of deliverables, you must discuss it with your Task Order Officer prior, and if needed, request a modification to the contract. IF THIS IS THE CASE, YOU MUST WORK WITH BETH SYAT AT THE CC.
• Submission of a deliverable is NOT the same as acceptance by the TOO

*Adapted from presentation at DEcIDE Business Meeting at AHRQ on 9/26/10

DEcIDE PROJECT ABSTRACTS*

General Information

• Completed during the initial start-up of the project
• Describe the entirety of the project: if multiple deliverables are planned, abstract should encompass all of them
• Posted on EHC website (http://effectivehealthcare.ahrq.gov/index.cfm) to inform the public of ongoing research

Abstract Guidance

• Title of study: clear, succinct, and descriptive title of the project or study
• Background: description of the importance/purpose of the project or study
• Objective/research questions: main objectives and research questions that the study will address
• Study design: description of study design

• Methods
  • Data source
  • Participants, setting, and expected sample size: eligibility criteria for participants and settings where data was collected
  • Interventions: interventions studied
  • Outcome: clearly defined primary outcome for this report
  • Statistical methods: general approach, including methods to address confounding
  • Comparator groups: what is specifically being compared (e.g., drug A vs. drug B vs. drug C; surgical approach A vs. surgical approach B)

• Expected outputs: e.g., four scientific reports addressing each main objective, a research protocol, a SAS macro and user manual for public distribution
• Expected date of project completion in month, year format
• EHC priority condition(s): include which priority condition(s) is/are studied
• 500 word limit
• Write out full name before using acronym
• The center doing the work should generally not be identified to protect the integrity of the study. Use words like, “this DEcIDE study” instead of the “University of Texas DEcIDE Center…”

* Based on presentation at DEcIDE Business Meeting at AHRQ on 9/26/10

REPORT SUBMISSION

ScholarOne

Unless otherwise specified, all draft, final, and revised reports should be submitted through ScholarOne: AHRQ’s online report submission system. Once reports are submitted, please notify Beth Syat at the CC.

Final reports need to be 508 compliant and in MS Word format (see PROCEDURES RELATED TO ACHIEVING 508-COMPLIANCE section)

The lead investigator and/or project manager for each project should register at ScholarOne

New users should go to http://mc.manuscriptcentral.com/decide to create a new user account. You will find the"Register here" link on the right side of the screen.

DEcIDE EXTRANET*

The DEcIDE Extranet is an electronic collaborative working space that is restricted to authorized members. You must use your personal ID and Password to gain access.

The URL is: https://ahrqdecide.webexone.com

The purpose of the Extranet is to:

Extranet Structure:

The Extranet provides one global DEcIDE workspace. This workspace can be accessed by all authorized members. The gloabal workspace may also be segmented and organized by shared job responsibilities or around shared research interests. A community can be established for each research center in the network, and there will be one AHRQ-specific community (reserved for AHRQ staff).

Available Functionalities:

Each community and sub-group will be able to select the functionalities that serve their particular needs:

First Steps:

Each authorized member will be invited to join and issued individual credentials. This Extranet is a secure environment with role-based authority and access, and your login name and password should not be shared or used by others. Members will receive online training in using the features of the Extranet, creating sub-group folders, and updating relevant content for global and specific-community workspaces.

Contacts for Help with the Extranet:
Please contact Beth Syat at the CC with any questions regarding use of the Extranet or becoming a member.

* Based on presentation at DEcIDE Business Meeting at AHRQ on 9/26/10

PRESENTATIONS AND JOURNAL PUBLICATIONS: STEPS FOR REQUESTING COPYRIGHT ASSERTION AND DISSEMINATION

If a journal publication or meeting presentation is planned, the project’s lead investigator or PM must inform Beth Syat at the CC. BEFORE you submit the manuscript to the target journal, Beth will work with you to complete the copyright assertion request form and submit it to AHRQ on the HMORN project’s behalf (see steps below).

1. After the final report is submitted AND approved by the AHRQ Program Official (i.e., the task order officer), a request for copyright assertion and dissemination may be made. If a journal publication or meeting presentation is planned, the HMORN DEcIDE CC center (via Beth Syat) communicates that immediately to the AHRQ TOO.
   1. Please note studies with significant public health implications may be sent directly to other government agencies or officials.
2. The HMORN DEcIDE CC center (via Beth Syat) submits an email to the Contracting Officer requesting a) copyright assertion and b) report dissemination. The email request includes:
   1. The MS Word copy of the manuscript that will be submitted to the journal (or the abstract that will be submitted to a scientific meeting);
   2. A manuscript that includes the standard acknowledgement for funding source required by the AHRQ DEcIDE contract (first bullet below);
      1. "This project was funded under Contract No. 290-05-00XX from the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services as part of the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) program. The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services."
      2. In most cases, DEcIDE projects are completely funded by the AHRQ DEcIDE contract. If investigators had concurrent work underway that was funded by other organizations, that funding may need to be disclosed per the journal requirements. However, this disclosure is generally part of the financial or intellectual conflict of interest statement. Please avoid adding statements that may be misinterpreted to mean that a study was jointly funded or co-funded by organizations other than the AHRQ DEcIDE contract.
   3. The completed DEcIDE Submission Form (see template).
3. If copyright assertion is granted, the Contracting Officer will provide an official letter to the HMORN DEcIDE CC center. AHRQ does not waive government rights or government license to the work, (FAR Clause 52.227-17, June 1987) SO A COPY OF THIS OFFICAL LETTER MUST BE SUBMITTED TO THE JOURNAL. This letter will alert the journal that exclusive rights to the work are not provided. Most but not all journals accept this arrangement.
4. Include the letter of copyright assertion provided by the AHRQ contracting officer to the journal.
   
   In addition, AHRQ would like authors to include the following language in their cover letters to the journals:
   1. 'This research was conducted through a Government contract with the Agency of Healthcare Research and Quality (AHRQ), an operating division of the U.S. Department of Health and Human Services. Approval to assert copyright by the authors on the manuscript has been granted by the Government through the attached letter signed by the AHRQ Contracting Official. As stated in the letter, the Government retains rights to the use of the manuscript according to the contract and the Federal Acquisition Regulations (FAR). To meet the need for public accessibility to works funded by the Government, the authors request that the journal provide "open access" to the article if it is accepted for publication. Open access means that the final journal article is available electronically for free at the time of publication through the journal’s website. If this is not possible, the authors remain interested in having the manuscript be considered for journal publication.'
5. If the manuscript is accepted for journal publication, alert Beth Syat at the HMORN DEcIDE CC so that she can alert the Task Order Officer immediately.
   1. Please send Beth Syat the version of the manuscript that was accepted and the journal citation so this can be added to the DEcIDE report that AHRQ posts on its website. (If the journal does not give you a date, please instead alert Beth Syat when the galley proofs are received—as this is a good indicator of a forthcoming publication.)
   2. Upload accepted manuscript to ScholarOne
6. If any changes are made to the manuscript in the journal review process, please resubmit the final Word document to Beth Syat at the HMORN DEcIDE CC; she will relay the information / updated document to AHRQ. This avoids inconsistencies of having two versions of the same study publicly available (i.e., the AHRQ publication and the journal publication).
7. If a journal rejects the manuscript, please notify Beth Syat at the HMORN DEcIDE CC so that she can notify AHRQ through the TOO.  
8. If you wish to send the manuscript to another journal, please re-submit the copyright assertion request and accompany documents to Beth Syat at the HMORN DEcIDE CC; she will update the Contracting Officer (i.e., start over with Step #2 above).
9. If no publication is in press after ~6 months of the final report, please schedule a meeting with the TOO to develop a plan. Every attempt should be made to get the study information to users. Journal review and publication time is unpredictable, sometimes creating long delays in release of important information.

The revised final report will be posted on the AHRQ Effective Health Care program website (http://effectivehealthcare.ahrq.gov/) at the same time as the journal publishes the article. If the journal citation was provided, this will be referenced in the AHRQ publication.

PROCEDURES RELATED TO ACHIEVING 508-COMPLIANCE

All final reports need to be 508 compliant. Please see instructions below.

I. Background:

Section 508 of the Rehabilitation Act (29 U.S.C. 794d) sets forth that information and data provided by the Federal government must be accessible by disabled individuals. (See http://www.access-board.gov/sec508/standards.htm.) One of the requirements within this act is to “tag” figures with alternative text descriptions (“figure tags”). These descriptions are read aloud by assistive devices, thereby allowing the greater than 10 million visually impaired people to have access to figures.

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II. Figures

Creating Alternate Text for Figures:

The EPCs will be responsible for providing alternate text descriptions for figures. Figure 1 displays a sample figure and its accompanying Alternate Text Figure Tag. Note that the description would not be visually present in the document. Rather, it would be within a hidden tag that would be read aloud by an assistive device. (Note that a second example is listed in Appendix 1.)

Figure 1. Sample graph with accompanying alternate text.

Description: Figure 1 is a bar graph depicting the percentage of total U.S. non-institutionalized population age 16-64 declaring one or more disabilities. The percentage value for each category is as follows: Total declaring one or more disabilities was 18.6 percent; Sensory (visual and hearing) was 2.3 percent; Physical was 6.2 percent; Mental was 3.8 percent; Self-care was 1.8 percent; Difficulty going outside the home was 6.4 percent; and Employment disability was 11.9 percent.

The protocol for creating Alternate Text Figure Tags for TA reports is as follows:

It is important to note that a picture is worth a thousand words; some complex pictures would actually require a thousand words to be textually duplicated. Please remember that this is not necessary, and it may actually add confusion rather than clarification! In addition, remember that a reasonable, best effort is sufficient.

Submitting Alternate Text for Figures:

List alternate text for all figures in an MS Excel document that is separate from the report. Please use the attached template and follow these steps:

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Figure Guidance Summary:

Composition:
1) For all figures:	Figure ___ is a ___ (metagraph, scatterplot) type of diagram, depicting ___ (a trend that ___, a positive correlation between___, etc.).
2) For some complex       figures:	This figure is described further in Section ____ as follows:________________.
3) Summarize data:	List ≤ 10 representative data items in the alternate text description.   ___ (item 1) was ___ (value 1); ___ (item 2) was ___ (value 2); etc.
Submission:	Save the figure tags within a MS Excel document labeled “Project ID Project Name Alternate Text.”

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Equations

Creating Alternate Text for Equations:

If equations are inserted into a document as an image, they must be labeled with a title (“Equation 1. _______(insert title).”), and they will require alternate text tags. The EPCs will be responsible for providing alternate text descriptions for equations.

The protocol for creating Alternate Text Equation Tags is as follows:

Submitting Alternate Text for Equations:

List equation tags within the same MS Excel document as the figure tags. Simply list the equation tags below the figure tags, labeling each equation tag (i.e. “Equation 1,” “Equation 2,” etc.) in the first column.

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Designing Tables

Appendix 1: An example of a succinct figure tag, capturing the significance of a figure in textual form.

Figure 2. Meta-analysis of the negative LR of ¹⁸FDG-PET versus histology/biopsy or clinical follow up for detecting recurrences of cervical cancer (retrospective studies)

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Figure Tag Description:

Figure 2 is a meta-graph depicting the negative likelihood ratio of ¹⁸FDG-PET versus histology/biopsy or clinical follow up for detecting recurrences of cervical cancer based on retrospective studies. ¹⁸FDG-PET had a pooled negative likelihood ration of 0.11 (95% CI = 0.04, 0.28) to accurately detect recurrences of cervical cancer. The negative likelihood ratio was statistically significant and therefore, ¹⁸FDG-PET/CT seems to be helpful to identify recurrences of the disease. However, the negative (p = 0.12; I2 = 53 percent) likelihood ration was heterogeneous across the studies precluding firm conclusions based on these results.

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PLEASE NOTE: Tables shall be separated from graphs so that cells within the tables can be properly formatted and completely accessible. (The only exception is when a graphing program is used that is only able to produce a table/figure combination as an image that cannot be edited.) When using a graphing program that can produce a graph by itself (rather than a graph/table image), produce the graph by itself. Then insert the table separately into the document next to the graph, either side-by-side or one on top of the other.