President, Nursing Professor LLC

Patricia Camillo PhD,RNC,APRN-BC,NCMP

PO Box 390351

Minneapolis, Minnesota 55439

(952) 303-4421

June 16, 2014

Linda S. Weglicki, PhD, RN

Chief, Office of Extramural Programs

Division of Extramural Science Programs

National Institute of Nursing Research (NINR)

National Institutes of Health

6701 Democracy Blvd, Suite 710

Bethesda, MD 20892

I am writing this letter to appeal the outcome of the initial peer review process for application #1 R43 NRO14995-01A1. The title of this application is “Telehealth Nursing: Managing Risks for Multiple Chronic Conditions.” The RFA for this resubmission was PA 13-234. I am writing this as both the PI the AOR for this proposal.

The reason for this appeal is based on flaws identified within the review process based on (1) lack of appropriate expertise within the SRG and (2) factual errors made by one or two reviewers that substantially altered the outcome of this review. I will address each of these below referencing reviewer 1(R1) and reviewer 2 (R2).

Lack of appropriate expertise within the SRG. This represents a significant flaw in the review process because these reviewers were assigned to review this proposal for which they clearly did not have expertise as evidenced by the following:

R2 states the following: “Says an RCT but then under recruitment says convenience sample.” This is evidence that R2 does not have the appropriate expertise to critique an RCT since a convenience sample is not contraindicated. Many NIH funded RCT’s have used convenience samples.

R2 questioned why Nurse Practitioner (NP) skills were needed. This indicates lack of knowledge regarding the role of an NP since advanced assessment skills are needed for this intervention and would not be appropriate for an RN or any other personnel. In fact, it was noted in the proposal that the Stanford Chronic Disease Self Management Program(SCDSMP) uses trained volunteers but because the proposed intervention would require a higher level of expertise, this would not be appropriate.R2 also showed a total lack of expertise in regards to the term “advanced practice nursing” when stating, “What are NP’s to do to advance their practice?”

R1 also did not have an understanding of the NP role and questioned whether these would be the “right personnel to conduct this work.” There was further evidenced by R1’s confusion regarding the roles of the NP group facilitators described in this proposal.

It was especially disconcerting to have these two reviewers demonstrate this lack of knowledge since the proposal was submitted to NINR and a request was included in the cover letter for nurses to review it since it was a nursing intervention. In researching the background of this review panel, only 2 members were nurses and the vast majority had backgrounds in psychology with little expertise regarding nursing or nursing practice.

R2 uses the phrase “chat room” when identifying both strengths and weaknesses of this proposal. Common usage of this phrase assumesa text based, synchronous or asynchronous, communication. The phrase is never used in this proposal because this is not the technology being implemented. Given the use of this phrase, R2 demonstrated a lack of understanding of the technology being proposed.

R2 also does not seem to comprehend the concept of a “virtual room.” The question was raised regarding why there were “so many group facilities” when in fact, there was only one facility and that was in cyberspace. The NP’s entered this room from various locations as did the participants.R2 also questioned whether “rural areas had adequate numbers of NP’s” further expressing a lack of understanding that this technology would increase access to rural populations since the NP would not have to live in these communities in order to provide care. Once again, this demonstrates a lack of expertise by R2 regarding the technology used in this proposal.

R2 also does not have knowledge regarding Patient Reported Outcomes research (PROR) evidenced by the cited need for a “confirmation of diagnosis.” At the very heart of PROR is the value and validity placed on patient self-report of health status. The protocol used in the NIH PROMIS study included self reported diagnosis. In the absence of this knowledge, R2 is not expert enough in this field to evaluate this proposal.

Factual errors made by one or two reviewers. This represents a significant flaw in the review process because these reviewers did not understand the instructions associated with PA13-234 as evidenced by the following:

R1 cites a lack of pilot data as a weakness in this Phase 1 study. An SBIR I does not require pilot data. Although R1 indicates knowledge of this, it was still noted as a weakness. Instructions for preparing and submitting an SBIR I state: “Preliminary data may be included but are not required. The application should concentrate on R/R&D efforts that will significantly contribute to proving the scientific or technical feasibility of the approach or concept that would be a prerequisite to further support in Phase II.”

Both R1 and R2 cite a need for a commercialization plan. An SBIR I does not require this plan. Additionally, this mixed method, randomized controlled clinical trial is limited to 6 pages. It would be impossible to include a commercialization plan in those 6 pages. This is required for a Phase II proposal with a 12 page limit. SBIR II instructions require a “succinct Commercialization Plan.” The potential for commercialization is briefly discussed within this proposal identifying a business model similar to the SCDSMP using licenses for proprietary videos.

Since both R1 and R2 incorrectly believed that a commercialization plan was needed in Phase I, there were weaknesses noted in the review that did not apply. R1 states: “Concerns remain regarding the feasibility and commercialization of the product if one NP works with only 16 participants. While creating a distribution of effort, the scalability of the program is questionable.” In fact, the design of this study is for the purpose of testing the intervention – not the plan for commercialization that would be the focus of Phase II.

Innovation was ranked a “5” by two reviewers stating that there were “other well established programs” with a similar product (R1) and “only moderately innovative” (R2). The fact is this: a thorough search over at least two years has failed to uncover a similar product. Yes, there are nurse call centers using telehealth and responding to patient questions following prepared algorithms but the proposed product is drastically different! If there is in fact, a similar product I would greatly appreciate knowing what that it is.

The above noted flaws in the review process for this proposal resulted in a significantly lower score than I would have received if these flaws did not exist. The focus of a Phase I, as stated in the instructions, is to “concentrate on R/R&D efforts that will significantly contribute to proving the scientific or technical feasibility of the approach or concept that would be a prerequisite to further support in Phase II.” This was demonstrated and acknowledged by the reviewers who noted strengths related to the theoretical framework of this study, the mixed methods, and the analysis plan.

I believe that given the above flaws in the review process, this proposal merits reconsideration.

Respectfully,

Patricia Camillo PhD,RNC,APRN-BC,NCMP

President and CEO, PI and AOR,

Nursing Professor LLC