Disposition of Comments
Negative Pressure Wound Therapy Devices
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 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.
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 CMS.
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 D for additional details on individual submissions and subsequent disposition in the report.
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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