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Table 6 Overview of primary study selection: comparison of trials excluded by IQWiG but included by at least one other review

From: Disagreement in primary study selection between systematic reviews on negative pressure wound therapy

Systematic review

Search date

Primary study* (Database entry date)†

Personal communication with review authors or other researchers at the publishing institutions

  

Davydov 1994 [14]‡

Catarino 2000 [13]

Song 2003 [26]

Jeschke 2004 [19]

 
  

(M: 1994-09-01; C)

(M: 2001-01-13)

(M: 2002-12-24; E)

(M: 2004-02-06; E; C)

 

Reviews considering RCTs and non-RCTs

      

Costa/MUHC TAU 2005 [30]

3/2005

Not reported (not applicable§)

Non-RCT

Non-RCT

Not reported (PC: excluded)

Jeschke 2004. PC (V. Costa): "Considered not eligible. Although negative pressure was used in one group, we considered that the main intervention studied was the Integra grafting and not vacuum-assisted closure. Moreover, since the group using VAC was a combined intervention (Integra + VAC), we were not sure if this would influence the results making it not an adequate estimate of the results with VAC alone. For these reasons the study was considered ineligible."

IQWiG 2006 [8]

5/2005

Excluded: not NPWT (non-RCT)||

Excluded: historical control (non-RCT)

Excluded: historical control (non-RCT)

Excluded: outcomes in the test group possibly affected by the additional intervention (RCT)

Davydov 1994. A translation of the full text of this Russian-language article showed that the intervention was not a technique comparable to NPWT. Consequently, IQWiG did not include this study. No reference to a randomised allocation was found.

Jeschke 2004. NPWT was applied in combination with fibrin glue-anchored Integra in the test group receiving NPWT, but not in the control group receiving standard therapy; therefore the outcomes in the test group may have been affected by the additional intervention. Consequently, IQWiG did not include this study

Pham/ASERNIP-S 2006 update/[31]¶

10/2004 (RCTs/non-RCTs) 7/2005 (RCTs)

RCT

Non-RCT

Non-RCT

RCT

Davydov 1994. PC (C. Perera): "Allocation not stated, assumed that a valid method of randomisation had been utilised (critical appraisal in the full accelerated systematic review drew attention to this)"

Jeschke 2004. PC (C. Perera): "Agree with IQWiG comments regarding additional intervention. Suggest that this RCT was included due to a paucity of RCT evidence on this indication (skin grafts), and as the other included RCT for skin grafts had only a 7 day follow up."

Reviews considering only RCTs

      

Samson/AHRQ 2004 [29](6/2004; RCT)

6/2004

Not reported (not applicable**)

Not reported (not applicable**)

Not reported (not applicable**)

Not reported (PC: not identified)

Jeschke 2004. PC (D. Samson): "This study did not appear in our literature search, probably because it was not yet entered onto an electronic database by the date of our last search update."

OHTAC [32](3/2006; RCT)

3/2006

Not reported (not applicable**)

Not reported (not applicable**)

Not reported (not applicable**)

Not reported (PC: excluded)

Jeschke 2004. PC (Medical Advisory Secretariat): "...was included in the literature search results, but there were only twelve patients in the study so it was excluded. The exclusion was not documented in the HTA."

  1. *Unless otherwise noted, the language of publication (abstract and full text) is English. For this analysis, all studies not classified as randomised trials in the systematic reviews were classified as non-RCTs by IQWiG. Studies not selected by any review are not listed in this table.
  2. †Databases containing primary studies (entry date: yyyy-mm-dd).
  3. ‡Russian full text.
  4. §Review did not consider non-English or non-French full-text publications.
  5. ||Study type not stated in the IQWiG review.
  6. ¶Where authors had classified studies as RCTs, the studies were also classified as RCTs in the Pham review, regardless of the methods used to randomise patients. Where the method of randomisation was described, this was included in the critical appraisal section of the full systematic review, which is published on the ASERNIP-S website [personal communication: C. Perera, ASERNIP-S]
  7. **Review did not consider non-RCTs.
  8. AHRQ: Agency for Healthcare Research and Quality; ASERNIP-S: Australian Safety and Efficacy Register of New Interventional Procedures – Surgical; C: The Cochrane Library; CIN: CINAHL; E: EMBASE; HTA: health technology assessment; IQWiG: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care); M: MEDLINE; MUHC TAU: McGill University Health Centre Technology Assessment Unit; NPWT: negative pressure wound therapy; OHTAC: Ontario Health Technology Advisory Committee; PC: personal communication; RCT: randomised controlled trial; VAC: vacuum-assisted closure.