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Erschienen in: Hernia 4/2013

01.08.2013 | Review

Recommendations for reporting outcome results in abdominal wall repair

Results of a Consensus meeting in Palermo, Italy, 28–30 June 2012

verfasst von: F. E. Muysoms, E. B. Deerenberg, E. Peeters, F. Agresta, F. Berrevoet, G. Campanelli, W. Ceelen, G. G. Champault, F. Corcione, D. Cuccurullo, A. C. DeBeaux, U. A. Dietz, R. J. Fitzgibbons Jr, J. F. Gillion, R.-D. Hilgers, J. Jeekel, I. Kyle-Leinhase, F. Köckerling, V. Mandala, A. Montgomery, S. Morales-Conde, R. K. J. Simmermacher, V. Schumpelick, M. Śmietański, M. Walgenbach, M. Miserez

Erschienen in: Hernia | Ausgabe 4/2013

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Abstract

Background

The literature dealing with abdominal wall surgery is often flawed due to lack of adherence to accepted reporting standards and statistical methodology.

Materials and methods

The EuraHS Working Group (European Registry of Abdominal Wall Hernias) organised a consensus meeting of surgical experts and researchers with an interest in abdominal wall surgery, including a statistician, the editors of the journal Hernia and scientists experienced in meta-analysis. Detailed discussions took place to identify the basic ground rules necessary to improve the quality of research reports related to abdominal wall reconstruction.

Results

A list of recommendations was formulated including more general issues on the scientific methodology and statistical approach. Standards and statements are available, each depending on the type of study that is being reported: the CONSORT statement for the Randomised Controlled Trials, the TREND statement for non randomised interventional studies, the STROBE statement for observational studies, the STARLITE statement for literature searches, the MOOSE statement for metaanalyses of observational studies and the PRISMA statement for systematic reviews and meta-analyses. A number of recommendations were made, including the use of previously published standard definitions and classifications relating to hernia variables and treatment; the use of the validated Clavien-Dindo classification to report complications in hernia surgery; the use of “time-to-event analysis” to report data on “freedom-of-recurrence” rather than the use of recurrence rates, because it is more sensitive and accounts for the patients that are lost to follow-up compared with other reporting methods.

Conclusion

A set of recommendations for reporting outcome results of abdominal wall surgery was formulated as guidance for researchers. It is anticipated that the use of these recommendations will increase the quality and meaning of abdominal wall surgery research.
Fußnoten
1
At the initiative of the first author, Filip Muysoms, current chairman of the EuraHS working group, and of Vincenzo Mandala, current president of the European Hernia Society, a consensus meeting was organised in Palermo, Italy, from June 28th till June 30th 2012. The participants to this consensus discussion and meeting were the EuraHS Working Group members and some other experts, editors and a statistician. The participants to the consensus discussions are the authors of this manuscript.
 
2
For taxonomy of the statistical items two basic textbooks on medical statistics were used as references: Everitt, Palmer [2] and Hulley et al. [3].
 
3
Example of a hernia related cohort study: Dietz et al. [4].
 
4
Example of a hernia related comparative cohort study: Kurian et al. [5].
 
5
Example of results from a hernia related registry: Helgstrand et al. [6].
 
6
Example of a hernia related randomized controlled trial: Bloemen et al. [7].
 
7
Example of a prospective non-randomized clinical trial: Feliu et al. [8].
 
8
Example of a hernia related systematic review: Hansson et al. [9].
 
9
Example of a hernia related meta-analysis: Aslani et al. [10].
 
10
According to the International Conference on Harmonisation (ICH) guidelines of Good Clinical Practice (GCP) a statistical test decision of a study should be conservative [18]. This is the rationale to use the ITT population for superiority studies and the PP population for equivalence studies. For non-inferiority trials the correspondence between ITT and PP should be used or a hybrid population.
 
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Metadaten
Titel
Recommendations for reporting outcome results in abdominal wall repair
Results of a Consensus meeting in Palermo, Italy, 28–30 June 2012
verfasst von
F. E. Muysoms
E. B. Deerenberg
E. Peeters
F. Agresta
F. Berrevoet
G. Campanelli
W. Ceelen
G. G. Champault
F. Corcione
D. Cuccurullo
A. C. DeBeaux
U. A. Dietz
R. J. Fitzgibbons Jr
J. F. Gillion
R.-D. Hilgers
J. Jeekel
I. Kyle-Leinhase
F. Köckerling
V. Mandala
A. Montgomery
S. Morales-Conde
R. K. J. Simmermacher
V. Schumpelick
M. Śmietański
M. Walgenbach
M. Miserez
Publikationsdatum
01.08.2013
Verlag
Springer Paris
Erschienen in
Hernia / Ausgabe 4/2013
Print ISSN: 1265-4906
Elektronische ISSN: 1248-9204
DOI
https://doi.org/10.1007/s10029-013-1108-5

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