Methodological index for non‐randomized studies (MINORS): development and validation of a new instrument
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- 8 September 2003
- journal article
- website
- Published by Wiley in Anz Journal of Surgery
- Vol. 73 (9) , 712-716
- https://doi.org/10.1046/j.1445-2197.2003.02748.x
Abstract
Background: Because of specific methodological difficulties in conducting randomized trials, surgical research remains dependent predominantly on observational or non‐randomized studies. Few validated instruments are available to determine the methodological quality of such studies either from the reader's perspective or for the purpose of meta‐analysis. The aim of the present study was to develop and validate such an instrument.Methods: After an initial conceptualization phase of a methodological index for non‐randomized studies (MINORS), a list of 12 potential items was sent to 100 experts from different surgical specialities for evaluation and was also assessed by 10 clinical methodologists. Subsequent testing involved the assessment of inter‐reviewer agreement, test‐retest reliability at 2 months, internal consistency reliability and external validity.Results: The final version of MINORS contained 12 items, the first eight being specifically for non‐comparative studies. Reliability was established on the basis of good inter‐reviewer agreement, high test‐retest reliability by the κ‐coefficient and good internal consistency by a high Cronbach's α‐coefficient. External validity was established in terms of the ability of MINORS to identify excellent trials.Conclusions: MINORS is a valid instrument designed to assess the methodological quality of non‐randomized surgical studies, whether comparative or non‐comparative. The next step will be to determine its external validity when used in a large number of studies and to compare it with other existing instruments.Keywords
This publication has 15 references indexed in Scilit:
- Randomised trials in surgery: problems and possible solutionsBMJ, 2002
- Statistics Notes: Validating scales and indexesBMJ, 2002
- A generalized concordance correlation coefficient for continuous and categorical dataStatistics in Medicine, 2001
- Treatment of open fractures of the shaft of the tibiaThe Journal of Bone and Joint Surgery. British volume, 2001
- Ten-year audit of randomized trials in digestive surgery from EuropeBritish Journal of Surgery, 2000
- Meta-analysis of Observational Studies in EpidemiologyA Proposal for ReportingJAMA, 2000
- Statistics notes: Cronbach's alphaBMJ, 1997
- Empirical Evidence of BiasJAMA, 1995
- Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trialsJAMA, 1995
- Validation of an index of the quality of review articlesPublished by Elsevier ,1991