POC to OMB response Finalcw

Department of
Veterans Affairs

| Memorandum

September 26, 2013
From: Dr. Charlene Weir
To:
OMB Staff

Dear OMB,
We appreciate your review of this work. As you are probably aware, all research
projects go through exhaustive scientific review by the funding agency and by the local
VA scientific review committee. In addition, the governing body of the University of Utah
Institutional Review Board does an extensive review to ensure that we are in
compliance with Human Subjects and ethical considerations. This review board
provides the legal coverage for research projects done at the SLC VA.
Those areas of review have been well covered. The processes in place for scientific
review are comprehensive and done by experts in the field, to ensure that the research
completed is of scientific quality and exceeds all ethical requirements.
Because of the time delays in OMB review, we have lost the funding to complete the
survey as described. As a result, we are going to limit the study population to 1,000
patients. We no longer have money to support staff to work on the project in the scope
planned earlier.
Here is our response to your questions.
A.2. This response addresses the “by whom” but not the “how” or the “for what
purposes.” Please provide more information on these two aspects of the
information collection. What are the major research questions that this
study was designed to address? A literature review was mentioned in A.16;
can a copy of this be provided to us?
We suggest that you read the IRB protocol (attached) as it explains the overall purpose
(the important areas are in yellow). This protocol was developed from the original
funding proposal. The IRB does the reviews with a panel of experts who focus on
Human Subjects, but also assesses the basic logic of the design and rationale for
procedures.
The procedures listed in the IRB are intended to comprehensively cover everything we
might do. IRB does not REQUIRE that we accomplish everything described and the
scope can be limited but not expanded. Researchers are granted some autonomy in
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deciding what specific actions to pursue because of their expertise and experience. We
include procedures that we MIGHT do order to get pre-approval, so the activities
described are broad. OMB approval and available funding determine our actual sample
size and procedures for this study. Below are the aims:
Aim 1. Identify the barriers and facilitators to adoption of a POCR research innovation program.
Assess the perceptions and attitudes of patients, providers, staff and administrators
regarding POCR program.
Aim 2. Produce guidelines for VHA regarding implementation of POCR.
Aim 3: Develop and implement a survey to quantitatively assess providers’ and patients’ beliefs
and perceptions about a perspective POCR program. Explore moderators of attitudes
and beliefs, including age, gender, and geographic location among others variables.

Besides the literature review in the IRB protocol, we are providing you with another
review taken from our report to the scientific funding agency.

LITERATURE REVIEW
Patients
Engagement of patients in clinical studies is challenged by the need to balance patient
participation with the ethical standards of informed consent. Integrating informed consent at the
point of care under clinical states of equipoise becomes even more challenging. Lessons can
be learned from the research literature in shared clinical decision-making, patient preferences,
and the engagement literature of patients in their own healthcare, quality improvement and
patient safety. Clinical decision making is perceived by patients as “shared” in which they are
able to demonstrate expertise in gaining clarification on their condition, participate in the
process of care and negotiate with their provider on specific aspects of their care.[5]
Identifying and integrating patient preferences for involvement in research is key to recruitment
and to ethical informed consent. However, prior studies have identified significant limitations in
patient’s decision-making understanding of the research process. Patients often do not
understand the purpose of the consent process itself.[6] Specifically, several studies and a
review have noted patient’s limited understanding of the purpose of randomization.[7, 8] Most
patients appear to have a good technical understanding of randomization, however, they might
not think random choice is necessarily compatible with a choice that is in their best interest.
They might even view it as unethical for a physician to suggest randomization.[9]
Secondly, patients had a difficult time accepting equipoise. One study found that more than half
of the patients could not believe that a provider would really be unsure of which treatment to
suggest.[8] Another study found that most patients did understood equipoise, but if they found
randomization unacceptable, they were much less likely to enroll.[7]
Variables predictive of patient enrollment include education, prior experience and cognitive
capacity. Vulnerability, either due to physical or psychosocial conditions, may be a particularly
important consideration for enrollment. This finding has implications for the impact of POCR on
the patient-provider relationship and the time needed to adequately address patient concerns.

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Negotiating the consent process is similar to other areas where patient preferences have to be
incorporated into care decisions. Patients exhibit a range of responses from passivity to
autonomy in their willingness to participate.[1] Determining the particular state of willingness to
participate by the patient also impacts the amount and type of information the patient may seek
about his/her condition.
And finally, several studies have been published examining ethical issues relating to consent,
enrollment and the definition of equipoise. Bromage et al[10] described the growing need for
autonomy dominating biomedical ethics and that this principal must be assessed in the clinical
context of other principles. The contextual factors that they assert must be considered include
“the invasiveness of the procedure, equipoise and the importance of the patients’ values.”
Rodrigues et al[11] argue that the differences between clinical care and research must be
thoroughly explained in order to protect the rights of patients and that there has to be clear-cut
equipoise in outcomes across the physician, patient AND investigator.

1.

Benbassat, J., D. Pilpel, and M. Tidhar, Patients' preferences for participation in
clinical decision making: a review of published surveys. Behav Med, 1998. 24(2):
p. 81-8.

2.

Bower, P., et al., Patient preferences in randomised controlled trials: conceptual
framework and implications for research. Soc Sci Med, 2005. 61(3): p. 685-95.

3.

Elwyn, G., et al., Shared decision making and the concept of equipoise: the
competences of involving patients in healthcare choices. Br J Gen Pract, 2000.
50(460): p. 892-9.

4.

Little, P., et al., Preferences of patients for patient centred approach to
consultation in primary care: observational study. BMJ, 2001. 322(7284): p. 46872.

5.

Moreau, A., et al., What perceptions do patients have of decision making (DM)?
Toward an integrative patient-centered care model. A qualitative study using
focus-group interviews. Patient Educ Couns, 2012. 87(2): p. 206-11.

6.

Akkad, A., et al., Informed consent for elective and emergency surgery:
questionnaire study. BJOG, 2004. 111(10): p. 1133-8.

7.

Mills, N., et al., Perceptions of equipoise are crucial to trial participation: a
qualitative study of men in the ProtecT study. Control Clin Trials, 2003. 24(3): p.
272-82.

8.

Robinson, E.J., et al., Lay conceptions of the ethical and scientific justifications
for random allocation in clinical trials. Soc Sci Med, 2004. 58(4): p. 811-24.

9.

Robinson, E.J., et al., Lay public's understanding of equipoise and randomisation
in randomised controlled trials. Health Technol Assess, 2005. 9(8): p. 1-192, iii-iv.

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10.

Bromage, D.I., et al., Improving informed consent in percutaneous coronary
revascularisation. EuroIntervention, 2012. 8(1): p. 146-54.

11.

Rodrigues, H.C., A.J. Oerlemans, and P.P. van den Berg, [The need for
uncertainty in clinical research. Equipoise]. Ned Tijdschr Geneeskd, 2011.
155(49): p. A3846.

12.

Hummers-Pradier, E., et al., Simply no time? Barriers to GPs' participation in
primary health care research. Fam Pract, 2008. 25(2): p. 105-12.

Please provide more information on how you plan to “use the social media site
Facebook to recruit participants.” –
We are no longer making those plans as our recruitment strategies are limited due to
the delay in beginning the project. All participants will now be recruited via email, mail,
and phone calls (please see attached IRB protocol).
A.8b. Please include the names of the representatives from the Boston VA
medical Center and the faculty at the University of Utah.
The names of our Boston collaborators are listed below. In addition, the names of the
individuals in the original approved funding budget are listed. Others listed on the
budget worked on the Focus Groups only.
Boston Maverick Group
Louise Fiore, MD, Executive Director MAVERIC, POCR Principal Investigator
Ryan Ferguson, Program Manager, MAVERIC
John Hermos, MD, Regulatory Advisor, MAVERIC
Pat Woods, Study Nurse/Project Manager
VA Research Representative
Theresa Gleason, Senior Program Manager, VA CSR&D
Local Staff and Researchers
Charlene Weir, PhD, RN, Principal Investigator
Jorie Butler, PhD, Co-Investigator
Brian Sauer, PhD, Co-Investigator
Robyn Barrus, MS, Project Manager
Deborah Hoffman, Research Assistant
Lacey Lewis, Research Assistant
Sophia Lu, PhD, Data Analyst

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A.10. Is any assurance of confidentiality being given to respondents (if so, it must
be backed up by a statute). The cover letter refers to answers being kept “secret,”
but it is not clear what this is supposed to mean. Was a PIA done for this
collection?
The University of Utah and VA Institutional Review Board, that has the salutatory
authority to cover research projects for Human Subject Review, extensively reviewed
this proposal. We have complied with their rules for confidentiality and privacy in that
review. These include the security measures described in the attached IRB protocol for
data collection and storage. Our institution has adopted those rules for privacy and
confidentiality (including data security procedures). Our VA Privacy Officer reviews
every IRB application as part of our local scientific review. In addition, we all have
undergone extensive required training in that regard.
The language “kept secret” was designed to meet a 6th grade reading level and was
approved by our research office as being appropriate.
A.14. The annual cost to the Federal Government, according to the OIRA
worksheet, is $0. Please include the grant funding, staff time, and any other
resources that are needed to conduct this collection, even if the funds were
already allocated.
The original funding for the project was $425,000 for a one-year study that included
focus groups for providers and patients as well as a national survey for both of those
groups. Attached is the original approved budget.
A.16. Please provide the time schedule for this collection and reporting of the
results.
Our original time frame was for one year. The delay in this component of the project
was due to delays in achieving OMB approval.
If we receive OMB approval, we will begin data collection within a few weeks and
expect to finish data collection within 3 months. Data analysis will take another month.
B.1. What is the sampling frame for this study? Is the study being conducted
only at the one site? This appears to be a 2 X 3 design, but it wasn’t clear from
our conference call whether low utilizers were be included in the study; please
clarify. Also please clarify the rationale for the 3 age groups and what research
questions/hypotheses are driving the comparisons that you plan to make by age
and utilization status (as noted earlier, these should be in A.2).
We are randomly sampling from all veterans from a national database (VINCI). We are

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measuring their age in order to do internal comparisons across age groups. We believe
that age makes a difference in attitudes toward research, but that question is
exploratory. It is relatively standard in survey research to explore the moderating effects
of certain demographic variables, such as geography, age and gender.
It is our goal and the goal of the funding agency to include only those who use the VA
sufficiently to have some experience with the institution. We did a data pull of visits per
veteran and 65% of those veterans who have been to the VA at least once in the last 3
years have at least 3 visits in the last 2 years. We feel completely justified in that cutoff
as we want to include those individuals who know the VA and since 2 visits per year is
the recommended time frame for primary care, we saw this cutoff as a minimum figure.
Of course, the mean the number of visits was much higher.
B.1. It was noted that: “In order to achieve a response rate of 2,000, 4,000 patients
will be invited to complete the questionnaire.” However, A.12 lists 8,000
respondents; please make these consistent. What is the basis for the anticipated
50% response rate?
As noted above, we no longer have the funds available to conduct the survey as
described. We failed to meet the deadline that we informed you about. Now, the number
of patients we will attempt to contact is limited to 1,000 with the hope of getting a
response from 500-600.
Survey response rates vary and the true response rate is unknown. A 50% response
rate for surveys is a good estimate. The National VA Westat survey achieved 66.7%,
but the effective coverage rate was 38.8%. As you can see, estimating response rates
is a very difficult. We actually do not know what it will be. Here are some websites that
discuss the issue. Also, if you want to learn more about the topic, the work done by Don
Dillman and explained in his book, Tailored Design Method.
http://www.practicalsurveys.com/respondents/typicalresponserates.php
http://www.va.gov/SURVIVORS/docs/NVSSurveyFinalWeightedReport.pdf
B.2a Please clarify how the 4,000 patients invited to participate will be selected?
The procedures are described in detail in the approved IRB protocol and since that is
the currently approved process, we believe that you will have the most confidence in
getting it from that source. It is attached and the relevant procedures are highlighted in
yellow.

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B.2b Are you planning exploratory or confirmatory factor analyses? What
constructs is survey designed to measure? Please identify specific items
intended to measure each construct.
The constructs were adapted from Theory of Planned Behavior and our prior focus
groups. The Theory of Planned Behavior manual is attached. The recommended and
well-accepted procedure is to use qualitative work to identify the exact content
regarding beliefs and attitudes and compose items based on the general constructs of:
Normative Beliefs (what others think of us doing the action), behavioral beliefs (attitudes
towards the expected outcomes) and control beliefs (self-efficacy and/or general control
beliefs). We focused on expected outcomes as derived from the focus groups and direct
attitudes only. We were going to conduct a factor analyses, but because of a now small
sample size, the data analysis will be descriptive only with some correlations within
subgroups.

http://people.umass.edu/aizen/tpb.diag.html
B.3. During our call, telephone follow up was mentioned, but it’s not described
here. Is telephone follow-up still part of the nonresponse follow-up plan? Please
describe this in Part B.
Yes, we are going to do a phone call. Please see the approved IRB protocol.

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