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Volume 53, Issue 4, 2025

Online ISSN: 2560-3310

ISSN: 0350-8773

Volume 53 , Issue 4, (2025)

Published: 30.06.2025.

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01.12.2016.

Professional paper

Randomization techniques in protocols for cluster randomized trials

Introduction: Planning cluster randomized studies requires special attention due to their specific design. To achieve balance on a cluster level as well as on individual level, it is necessary to apply randomization techniques which involve restricted randomization. Objective: Determine randomization techniques as well as their frequency in protocols for cluster randomized trials. Materials and method: Searching the MEDLINE bibliographic database, there were 1020 bibliographic units, the analysis included only the protocols for cluster randomized trials, which was a total of 169 trials. Data on randomization techniques, units of randomization and publication years of protocols were extracted. Results: The randomization technique with most frequency was stratification (35.9%). After stratification the most frequent was simple randomization (13.5%), followed by a combination of block and stratification (10%), block randomization (9.4%) and matching (9.4%). The most frequent units of randomization were health facilities (52%). The number of published protocols statistically increases during time (p<0.01). Conclusion: The most frequent randomization technique used by researchers is restricted randomization

Mirjana Kostic, Dejana Stanisavljevic, Aleksandra Ilic, Zoran Bukumiric, Marija Jovanovic, Goran Trajkovic

01.12.2016.

Professional paper

Systematic review of factor validity of psychiatric scales in longitudinal studies

Validity shows the degree of concurrence between the results received by an actual measuring and that of what an instrument is supposed to measure. There are three main types of validity: content validity, criterion-related validity and construct validity. Factor validity is a special approach to constructive validity, tested by statistical analysis called factor analysis. Hamilton rating scale for depression and Montgomery-Asberg depression scale are the most widely used psychiatric instruments. The aim was to carry out a systematic review of the literature on factor structure of psychiatric scales reported in different times during longitudinal studies. The units of analysis were published papers obtained by searching the two bibliographic databases: MEDLINE and PsycINFO. Factor validity of the HAMD scale was reported in 6 (0.09%) of 6590 studies which used this scale, whereas the factor validity of the MADRS scale was reported in 4 (0.2%) of 2051 studies which used the MADRS scale. The difference between the first and the last measuring in relation to values was not statistically significant: median of the number of extracted factors of the HAMD scale (p=0.371), median of total explained factor variance of the HAMD scale (p=0.250), median of variance explained by the first factor of the HAMD scale (p=0.125). Factor validity of the MADRS scale in repeated measuring also did not have statistically significant difference for the following values: median of the number of extracted factors of the MADRS scale (p=0.174), median of variance explained by the first factor of the MADRS scale (p=0.125). Coefficients of concurrent validity of the HAMD i MADRS depression scales show the trend of increase in longitudinal studies and their values are for about a third higher at the end of studies than in their beginning. Low frequency of reporting the data about reliability and validity of applied rating scales is the main problem in using the meta-analytical methods effectively to study changes in adequacy of measures in longitudinal studies.

Aleksandra Ilic, Zoran Bukumiric, Mirjana Kostic, Marija Jovanovic, Goran Trajkovic

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