Disposition of Comments
Project ID: WNDT1108
The Agency for Healthcare Research and Quality's (AHRQ) Technology
Assessment (TA) Program supports and is committed to the transparency of its review process. Therefore, invited peer review comments and public review comments are publicly posted on the TA Program Web site at http://www.ahrq.gov/clinic/techix.htm within 3 months after the associated final report is posted on this Web site.
This document presents the peer review comments and public review comments sent in response to the draft report, Negative Pressure Wound Therapy Devices, posted on the AHRQ Web site from April 10 to April 24, 2009. The final version of the report is available online.
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Summary of Other Comments
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1. Negative Pressure Wound Therapy (NPWT) Peer Reviewer Comments
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2. Response to Public Comments on Negative Pressure Wound Therapy Devices
Report (308 KB)
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Summary of Other Comments
A total of 46 individuals did not use the mechanism established by AHRQ to
submit their reviews and thus did not sign the disclosure statement. Their
comments and our responses are presented in summary form.
Of these 46 reviewers, 35 reported having used more than one NPWT system,
seven reported experience only with V.A.C.® Therapy while four made no
report. A majority of the anonymous reviewers (n = 44 [96%]) specifically
expressed support for V.A.C.® Therapy.
Most reviewers did not express concern with the NPWT report but did report
their day-to-day experience with NPWT systems (n = 38 [83%]). Of the reviewers
that expressed concern with the report; three reviewers only reported concern
that the inclusion criteria were too restrictive. Two reviewers expressed
support for the competitive bidding process. One reviewer only expressed concern
that the lack of evidence on other NPWT systems did not extrapolate to superiority
by V.A.C.® Therapy. One reviewer expressed concern with both the inclusion
criteria and lack of superiority reported for V.A.C.® Therapy. Lastly,
one reviewer provided attachments for possible inclusion in the report however
did not provide comments regarding the report or experience with NPWT. Of
the two submissions provided for possible inclusion in the report, one comparison
study(54) was subsequently included in the discussion
of Key Question 1 of the final report.
For those reviewers that reported anecdotal experience with NPWT systems,
we would like to express our thanks for providing us with this important information.
We will share this information with the Center for Medicare Management at
Some reviewers expressed concern that the inclusion/exclusion criteria for
the report were too restrictive. Key questions were formulated for the report
to test the hypothesis that a NPWT system or its components provided a significant
therapeutic distinction compared to other NPWT systems or their components.
These questions were structured using the "PICO" framework: patients,
intervention of interest, comparator, and outcomes (go to Figure
1 of the report). Inclusion and exclusion criteria were methodically developed
based on each key question prior to an examination of the evidence. Twelve
inclusion criteria were established for this technology assessment (TA). In
a TA, the inclusion criteria determine whether a study is "relevant" to
the key questions. Studies that do not meet the inclusion criteria are excluded
from the TA. Exclusion from the TA does not imply that the studies have no
scientific merit, just that their findings are not applicable to answering
a key question within the specific report. Next, we undertook an extensive
search of the literature from which we identified over 1,000 potential articles.
In the interest of identifying all clinically relevant materials for this
report, we also invited interested stakeholders to submit information regarding
any published, unpublished, or currently registered studies for possible inclusion
in the report. We received over 1,400 submissions by the February 6, 2009
deadline. Each submission was reviewed for possible inclusion in the report
(go to Appendix D).
The screening of all identified materials is a two-step process. An initial
evaluation is done at the abstract level at which items may be excluded, used
in our Background section or passed to the next level of evaluation.
During the evaluation of all stakeholder submissions, we excluded 638 (44%)
of the 1,435 submissions due to duplication alone (go to Figure 5 in Appendix
D). Of the 797 (55% of original) unique submissions; 29 (4%) were included
in our Background section and 269 (33%) items were excluded; 147
(56%) were case reports, abstracts or poster presentations given at conferences.
Of the 499 (35%) remaining articles, 354 (71%) were excluded at the article
level. Based on the a priori inclusion/exclusion criteria, narrative reviews
(k = 152 [43%]); animal studies (k = 39 [11%]); and studies with fewer than
five patients in each arm (k = 30 [8%]) were excluded.
Of the 144 (10%) original submissions that met inclusion criteria, 117 (81%)
were previously identified by the ECRI Institute literature searches. We subsequently
included 28 studies not previously identified in our searches in the final
report. Please go to Appendix
additional details on individual submissions and subsequent disposition in
The draft report has been thoroughly reviewed by four outside specialists
in wound care. They have concurred that the report provides a thorough evaluation
of the current evidence for NPWT systems.
Lastly, reviewers were concerned that the lack of evidence from other NPWT
systems should demonstrate the superiority of V.A.C.® Therapy. It is important
to note that due to the lack of published or unpublished studies that evaluated
other NPWT systems we were unable to perform either direct or indirect comparisons.
In the absence of such comparisons, ECRI Institute was unable to draw conclusions
about the superiority or equivalence of any NPWT system or its components
compared to another NPWT system or its components.
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Current as of September 2009
Negative Pressure Wound Therapy. Disposition of Comments. September 2009. Rockville, MD: Agency for Healthcare Research and Quality. http://www.ahrq.gov/clinic/ta/comments/npwt/