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  6. 5. Included and excluded references

4. Included and excluded references

(1)Relations among included references, included studies, and excluded references

SAs were prepared for the 653 references selected. The 494 references included 55 cases of “2 papers for 1 study,” 10 cases of “3 papers for 1 study,” 3 cases of “4 papers for 1 study,” 2 cases of “5 papers for 1 study,” and also 2 cases of “1 paper for 2 studies,” resulting in 494 SAs (selected studies) (including 493 RCTs and 1 meta-analysis). The number of excluded references deviating from the inclusion criteria was 159 (Table 3).

Table 3

Here, duplicate publication disclosed in the process of reference gathering for the present evidence report preparation is discussed. The guideline for manuscript submission, published by the International Committee of Medical Journal Editors (ICMJE), Uniform Requirements for Manuscripts Submitted to Biomedical Journals (URM), has been employed by many journals in the world since its first issue in 1979. The revisions in and after 1984 mention duplicate publication and require that submission of already published study contents be approved by the editorial committee. The URM permits secondary publication for the following cases: editors of both journals concerned have accepted; the second publication targets different readers from those of the first publication; the second publication faithfully reflects the data and interpretations in the first publication; and the second publication specifies that it is a “secondary publication.”

Among references used for preparation of structured abstracts were some duplicate publications that did not specify that they were secondary publications. Submitting already published contents without permission of the editorial committee constitutes not only ethical but also copyright issues. With rising interests in publication-related ethics at home and abroad, consideration should be given to duplicate publication in papers on Kampo as well. These findings were published as study results in the following reference:

Kitagawa S, Tsutani K. Ebidensu repoto purojekuto: Kampo no RCT ronbun niokeru “Duplicate publication”, Dai 60-kai Nihon Toyo Igakkai Gakujutsusokai foramu “Kampo no ebidensu wo tsutaeru” (Evidence Report Project: “Duplicate publication” in Kampo RCT papers, the Japan Society for Oriental Medicine 60th Annual Meeting Forum “Transfer” Kampo evidence), 21 Jun. 2009, Tokyo. Nihon Toyo Igaku Zasshi [Kampo Medicine] 2009; 60 suppl.: 162 (in Japanese).

Kitagawa S, Tsutani K. Ebidensu repoto purojekuto: Kampo no RCT ronbun niokeru "Duplicate publication", Dai 60-kai Nihon Toyo Igakkai Gakujutsusokai foramu "Kampo no ebidensu wo tsutaeru" (Evidence Report Project: "Duplicate publication" in Kampo RCT papers, the Japan Society for Oriental Medicine 60th Annual Meeting Forum "Transfer" Kampo evidence), 21 Jun. 2009, Tokyo. Nihon Toyo Igaku Zasshi [Kampo Medicine] 2009; 60 suppl.: 162 (in Japanese).

In the following symposium, the issue of duplicate publication was addressed from the perspective of the above study:

Tsutani K. Publish or perish: tajusyuppan ni tsuite (Publish or perish: duplicate publication). The Japanese Association of Medical Journal Editors (JAMJE) 2nd symposium (7 Jul. 2009, Tokyo)

(2) Studies compiled as structured abstracts

For the studies shown in Table 4, structured abstracts were prepared.

Although two references termed “meta-analysis” were identified, one of them was not actually a meta-analysis and was therefore not compiled as a structured abstract, but instead listed as an excluded reference along with bibliographic items, resulting in a structured abstract prepared with only 1 reference.

Table 4

For studies compiled as structured abstracts, the following items were indicated in the structured abstract and included the reference list: 1) SA No.; 2) ICD10 (2003 revision) code of disease; 3) research question; 4) name of Kampo formula; 5) bibliographic items of the reference; 6) study design; and 7) search source.

Research questions were supposed to be formulated with 4 items of patient, intervention, control, and outcome (PICO), but were simplified here.

(3) Preparation of excluded references list

The references not compiled as structured abstracts but listed as excluded references along with bibliographic items and the reason for exclusion were:

  1. 1) Clinical articles but not RCTs or meta-analyses
  2. 2) Those using formulations not approved for manufacture and sale in Japan as Kampo extract formulations (ex. Kampo decoctions, Chinese formulations)
  3. 3) Those using Kampo formulations in or before 1985 (with different quality from the current standards)
  4. 4) Citations of existing RCT articles.
  5. 5) Indicated with insufficient clarity to prepare the structured abstract
  6. 6) Others

Finally, 159 references were listed on the excluded references list.

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