BMJ 1997;315:635-640 (13 September)
Papers
Impact of covert duplicate publication on meta-analysis: a case study
Martin R Tramèr,
research
fellow,a
D John M Reynolds,
consultant
physician and clinical pharmacologist,b
R Andrew Moore,
consultant
biochemist,a
Henry J McQuay,
clinical reader
in pain relief aa Pain Research, Nuffield Department of Anaesthetics, Churchill Hospital, Oxford OX3 7LJ,
b John Radcliffe Hospital, Oxford OX3 9DU
Correspondence to: Dr Tramèr martin.tramer%mailgate.jr2@ox.ac.uk
Objective: To quantify the impact of duplicate data
on estimates of efficacy.
Design: Systematic search for published full reports
of randomised controlled trials investigating ondansetron's effect on postoperative
emesis.
Abstracts were not considered.
Data sources: Eighty four trials (11 980 patients
receiving ondansetron) published between 1991 and September 1996.
Main outcome measures: Percentage of duplicated
trials and patient data. Estimation of antiemetic efficacy (prevention of emesis) of the most
duplicated ondansetron regimen. Comparison between the efficacy of non-duplicated and
duplicated data.
Results: Data from nine trials had been published
in
14 further reports, duplicating data from 3335 patients receiving ondansetron; none used a clear
cross reference. Intravenous ondansetron 4 mg versus placebo was investigated in 16 reports not
subject to duplicate publication, three reports subject to duplicate publication, and six duplicates
of
those three reports. The number needed to treat to prevent vomiting within 24 hours was 9.5
(95% confidence interval 6.9 to 15) in the 16 non-duplicated reports and 3.9 (3.3
to
4.8) in the three reports which were duplicated (P<0.00001). When these 19 were combined
the
number needed to treat was 6.4 (5.3 to 7.9). When all original and duplicate reports were
combined
(n=25) the apparent number needed to treat improved to 4.9 (4.4 to 5.6).
Conclusions: By searching systematically we found
17% of published full reports of randomised trials and 28% of the patient data were
duplicated. Trials reporting greater treatment effect were significantly more likely to be
duplicated.
Inclusion of duplicated data in meta-analysis led to a 23% overestimation of
ondansetron's antiemetic efficacy.
|
Key messages
- Although publishing the same data more than once is strongly discouraged, there is no
evidence of the impact of duplicate data on meta-analysis
- Re-analysing an important trial, and cross referencing to original reports (overt
duplication), may be necessary and valuable in some circumstances
- Covert duplication, masked by change of authors, of language, or by adding extra data,
causes problems. One danger is that patient data are analysed more than once in
meta-analysis
- 17% of systematically searched randomised trials of ondansetron as a postoperative
antiemetic were covert duplicates and resulted in 28% of patient data being duplicated.
None
of these reports cross references the original source. Duplication lead to an overestimation of
ondansetron's antiemetic efficacy of 23%. Trials reporting greater treatment effect
were significantly more likely to be duplicated
- Covert duplication of data has major implications for the assessment of drug efficacy and
safety
|

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