Principal Investigators and project directors

ATTACHMENT B

PSLA—WEB BASED SURVEY OF PIS AND PDS.

Research Evaluation and Impact Assessment of American Reinvestment and Recovery Act (ARRA)

Comparative Effectiveness Research Portfolio

Principal Investigator-Project Director Survey

Conducted by:

Mathematica Policy Research

for

Office of the Assistant Secretary for Planning and Evaluation,

U.S. Department of Health and Human Services

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0990- . The time required to complete this information collection is estimated to average 20 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201, Attention: PRA Reports Clearance Officer

A. PROJECT CHARACTERISTICS AND CONTEXT

This section asks you to provide or verify information about your project.

1a. Please review your ARRA-funded CER project name below for accuracy. This is the project that we will be asking about throughout this survey.

Name of Project: (project name)

Is the ARRA-funded CER project name correct?

1 □ Yes GO TO Q.2

0 □ No

1b. In the space provided below, please correct the project name:

Name of Project:	Name of Project:
(project name)

2. In the email invitation you received for this survey, what was the first digit of your identification number?

0 □ 0

1 □ 1

3. After completing your highest level of training, how many years have you been conducting research?

| | | Years

n □ I do not conduct research

4. Comparative effectiveness research (also sometimes called patient-centered outcomes research) can be broadly defined as comparing different interventions or strategies to prevent, diagnose, treat, and monitor health conditions. Although the terminology itself is relatively new, some researchers have been conducting CER-like projects for many years. How many years have you, yourself, conducted comparative effectiveness research?

| | | Years

n □ I do not conduct comparative effectiveness research

5. How would you rate the following?

	Low						High
	1	2	3	4	5	6	7
a. Your own level of CER expertise	1 □	2 □	3 □	4 □	5 □	6 □	7 □
b. Your familiarity with the FCC1 definition of CER	1 □	2 □	3 □	4 □	5 □	6 □	7 □
c. Your familiarity with IOM’s CER priorities2	1 □	2 □	3 □	4 □	5 □	6 □	7 □

¹ FCC = Federal Coordinating Council for Comparative Effectiveness Research

² Institute of Medicine’s Initial National Priorities for Comparative Effectiveness Research

If Q2=1, skip to Q11.

6a. In general, would you say that your ARRA-funded CER project is:

1 □ Part of an ongoing body of research, educational activities, or other project work

that existed in some form before the receipt of ARRA funds

2 □ An original endeavor that did not have any predecessor activity GO TO Q.7

6b. What source of funding supported work that preceded your ARRA-funded CER project?

MARK ALL THAT APPLY

1 □ National Institutes of Health

2 □ Agency for Healthcare Research and Quality

3 □ Other federal government agency (Specify)

4 □ Foundation or other non-profit

5 □ Industry

6 □ Other source (Specify)

7. If the ARRA CER funds had not been available, how likely do you think it is that your project would have been funded through a different mechanism?

1 □ I would not have developed this project

2 □ Very unlikely

3 □ Somewhat likely

4 □ Very likely

8. In what ways did the following stakeholders participate in developing your ARRA-funded CER proposal? In what ways were/are they currently participating in your CER project?

Participated in CER Proposal Development

Participated/Currently Participating in CER Project

Stakeholders

Did Not Participate

Conceptualizing or Prioritizing Research Questions

Selecting or Developing Appropriate Measures

Participating as Research Subjects

Serving in an Advisory Role

Other Involvement (Specify)

Did Not Participate/Not Participating

Conceptualizing or Prioritizing Research Questions

Selecting or Developing Appropriate Measures

Participating as Research Subjects

Serving in an Advisory Role

Other Involvement (Specify)

a. Patients

n □

1 □

2 □

3 □

4 □

5 □

n □

1 □

2 □

3 □

4 □

5 □

b. Community-based practicing clinicians

n □

1 □

2 □

3 □

4 □

5 □

n □

1 □

2 □

3 □

4 □

5 □

c. Payers

n □

1 □

2 □

3 □

4 □

5 □

n □

1 □

2 □

3 □

4 □

5 □

d. Consumer advocates

n □

1 □

2 □

3 □

4 □

5 □

n □

1 □

2 □

3 □

4 □

5 □

e. Policy makers

n □

1 □

2 □

3 □

4 □

5 □

n □

1 □

2 □

3 □

4 □

5 □

f. Drug and device manufacturers

n □

1 □

2 □

3 □

4 □

5 □

n □

1 □

2 □

3 □

4 □

5 □

g. Other stakeholders (Specify)

n □

1 □

2 □

3 □

4 □

5 □

n □

1 □

2 □

3 □

4 □

5 □

9. To what extent has each of the following factors hindered or promoted your ARRA-funded CER project?

	Not Applicable	Greatly Hindered						Greatly Promoted
		1	2	3	4	5	6	7
a. Amount of ARRA grant/contract funding		1 □	2 □	3 □	4 □	5 □	6 □	7 □
b. Other institutional funds to develop CER	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
c. Other extramural funds to develop CER	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
d. Non-financial institutional support	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
e. Data availability	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
f. Data cost	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
g. Patient availability	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
h. Support staff availability	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
i. Investigator time available for the project	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
j. Availability of other local expertise in CER	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
k. Working across multiple institutions or sites	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □

B. PROJECT INTERIM OUTPUT

In this section, we would like to learn more about how your project is proceeding. We understand that most milestones have not yet been realized, and that some may even take years. Please give us your honest assessment of how things are going.

10. What is the status of the following project milestones?

Milestones1	Not Applicable	Not Completed and Not on Schedule	Not Completed Yet but on Schedule	Completed but Not on Schedule	Completed on Schedule
a. Staff hired and/or trained	n □	1 □	2 □	3 □	4 □
b. IRB and/or HIPAA approval	n □	1 □	2 □	3 □	4 □
c. OMB clearance	n □	1 □	2 □	3 □	4 □
d. Interim project documents (e.g., work plan or evaluation design)	n □	1 □	2 □	3 □	4 □
e. Recruitment goals	n □	1 □	2 □	3 □	4 □
f. Data access received	n □	1 □	2 □	3 □	4 □
g. Data analysis	n □	1 □	2 □	3 □	4 □
h. Planned products (e.g., reports, abstracts)	n □	1 □	2 □	3 □	4 □
i. Other milestone (Specify)	n □	1 □	2 □	3 □	4 □
j. Other milestone (Specify)	n □	1 □	2 □	3 □	4 □

¹ IRB = Institutional Review Board; HIPAA = Health Insurance Portability and Accountability Act of 1996; OMB = Office of Management and Budget

11. What barriers have you encountered in trying to conduct your CER project?

If Q2=1, skip to Q13.

12a. ARRA-funded CER projects have diverse goals and products. How many of the following were planned as part of your project? How many are completed to date? If none in a category were planned or completed, please write “0” in the appropriate spaces.

	Number Planned	Number Completed
a. Peer-reviewed scientific papers	| | |	| | |
b. Other publicly available reports	| | |	| | |
c. Conference presentations	| | |	| | |
d. New or linked research datasets for CER	| | |	| | |
e. New data tools (e.g., SAS macros, interactive spreadsheets)	| | |	| | |
f. New or substantially revised courses for CER training programs	| | |	| | |
g. CER workshops or symposia	| | |	| | |
h. Other product (Specify)	| | |	| | |
i. Other product (Specify)	| | |	| | |
j. Other product (Specify)	| | |	| | |

12b. To date, have you expanded, established, or joined any of the following as part of your project?

mark all that apply

	Yes, Expanded Existing	Yes, Established New	Yes, Joined	No
a. Community-based practice network	1 □	2 □	3 □	0 □
b. Institutional CER research center	1 □	2 □	3 □	0 □
c. CER training program	1 □	2 □	3 □	0 □

12c. IF PRODUCTS PLANNED/REALIZED: Do you anticipate that any of the following will continue beyond the period of ARRA funding (e.g., from user fees, tuition, etc.)?

MARK ALL THAT APPLY

1 □ Datasets for CER

2 □ Community-based practice networks

3 □ Institutional CER research centers

4 □ CER training programs

5 □ CER workshops or symposia

6 □ Other products (Specify)

13. If you were conducting your project again, what would you do differently?

If Q2=1, skip to Q16a.

14. Did your ARRA-funded CER project require the following expertise? IF YES: Did you bring additional expertise into your CER team (including consultants from other organizations, adding time for existing scientists elsewhere in your organization, as well as new hires)?

	Expertise Required		Full-Time Equivalents Added
	Yes	No	None	0.01 to 0.25	0.26 to 0.50	0.51 to 1.00	>1.00
a. Clinical practice (e.g., medicine, nursing, pharmacy, physical therapy, clinical psychology)	1 □	0 □	0 □	1 □	2 □	3 □	4 □
b. Clinical trials	1 □	0 □	0 □	1 □	2 □	3 □	4 □
c. Epidemiology	1 □	0 □	0 □	1 □	2 □	3 □	4 □
d. Health services research	1 □	0 □	0 □	1 □	2 □	3 □	4 □
e. Biomedical informatics	1 □	0 □	0 □	1 □	2 □	3 □	4 □
f. Biostatistics	1 □	0 □	0 □	1 □	2 □	3 □	4 □
g. Economics or econometrics	1 □	0 □	0 □	1 □	2 □	3 □	4 □
h. Implementation science (dissemination research)	1 □	0 □	0 □	1 □	2 □	3 □	4 □
i. Survey methodology or psychometrics	1 □	0 □	0 □	1 □	2 □	3 □	4 □
j. Quality improvement research	1 □	0 □	0 □	1 □	2 □	3 □	4 □
k. Decision science	1 □	0 □	0 □	1 □	2 □	3 □	4 □
l. Library science	1 □	0 □	0 □	1 □	2 □	3 □	4 □
m. Communications	1 □	0 □	0 □	1 □	2 □	3 □	4 □
n. Other expertise (Specify)	1 □	0 □	0 □	1 □	2 □	3 □	4 □
o. Other expertise (Specify)	1 □	0 □	0 □	1 □	2 □	3 □	4 □

15. Please rate the availability to your project of appropriately trained researchers with the following expertise.

	Not Applicable for Project	No Availability						High Availability
		1	2	3	4	5	6	7
a. Clinical practice	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
b. Clinical trials	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
c. Epidemiology	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
d. Health services research	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
e. Biomedical informatics	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
f. Biostatistics	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
g. Economics or econometrics	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
h. Implementation science (dissemination research)	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
i. Survey methodology or psychometrics	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
j. Quality improvement research	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
k. Decision science	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
l. Library science	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
m. Communications	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
n. Other researchers (Specify)	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □
o. Other researchers (Specify)	n □	1 □	2 □	3 □	4 □	5 □	6 □	7 □

C. PROJECT INTERIM OUTCOMES

This section asks how your ongoing ARRA-funded CER project may have already impacted your research and funding planning.

16a. Have you received a commitment for continued funding for your CER project after its ARRA-funding is concluded?

1 □ Yes

0 □ No GO TO Q.16c

16b. What is the source of this continued funding?

MARK ALL THAT APPLY

1 □ National Institutes of Health

2 □ Agency for Healthcare Research and Quality

3 □ Other federal government agency (Specify)

4 □ Foundation or other non-profit

5 □ Industry

6 □ Other source (Specify)

Go to Q17.

16c. How likely are you to pursue continued funding for your project?

1 □ Not at all likely

2 □ Somewhat likely

3 □ Very likely

4 □ I am actively seeking continued funding

17. To what extent do you think ARRA funding for CER has negatively or positively affected the following:

	Very Negatively Affected						Very Positively Affected
	1	2	3	4	5	6	7
a. Your CER research priorities	1 □	2 □	3 □	4 □	5 □	6 □	7 □
b. Your CER research collaborations	1 □	2 □	3 □	4 □	5 □	6 □	7 □
c. Your career plans	1 □	2 □	3 □	4 □	5 □	6 □	7 □
d. Your field or discipline	1 □	2 □	3 □	4 □	5 □	6 □	7 □
e. CER capabilities at your institution	1 □	2 □	3 □	4 □	5 □	6 □	7 □

18. How likely are you to be involved in future CER projects?

1 □ Not at all likely

2 □ Somewhat likely

3 □ Very likely

4 □ I am already conducting a CER project that started after ARRA

19a. The federal government has recognized the following areas of investment as key to developing national CER capabilities. Please choose the two that you feel are most important to advancing the goals of CER, where 1=highest priority area and 2=second highest priority area.

	Two Highest Priorities
a. Synthesizing existing CER evidence	| |
b. CER methods development	| |
c. Research training to develop new CER investigators	| |
d. CER career development for trained investigators	| |
e. Identifying priority research topics (e.g., interventions, conditions, or populations) for CER	| |
f. Dissemination and translation of CER evidence for clinicians, patients, and other decision makers	| |
g. Stakeholder involvement in CER	| |
h. Creating, linking, or making available datasets and data tools for observational CER of CER	| |
i. Generating new CER evidence	| |

19b. For your area of highest priority identified above, what do you see as the critical next steps to advance the goals of CER?

19c. For your area of second highest priority identified above, what do you see as the critical next steps to advance the goals of CER?

If Q2=1, skip to Q21.

20. If there is a co-investigator or other collaborator working closely with you on your ARRA CER project, please provide his or her name and email address. We would like to send him or her a shortened version of this questionnaire to learn more about the ARRA-funded CER portfolio.

Name:	Email:

21. Please share any other comments you have about your experiences with ARRA-funded comparative effectiveness research that you think are relevant for this evaluation.

Thank you for completing this survey.

MPR DOCUMENTATION:

/home/ec2-user/sec/disk/omb/icr/201105-0990-004/doc/24959101

(12-14-10)

Lynne formatted for Danna Basson

(03-15-11)

Sarah Forrestal revised

Shading is Custom 232, 232, 232

ACERE PSLA – 06812.841