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2 "Clinical trial"
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Original Article
Intervention to Improve Menstrual Health Among Adolescent Girls Based on the Theory of Planned Behavior in Iran: A Cluster-randomized Controlled Trial
Fatemeh Darabi, Mehdi Yaseri
J Prev Med Public Health. 2022;55(6):595-603.   Published online November 30, 2022
DOI: https://doi.org/10.3961/jpmph.22.365
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AbstractAbstract PDF
Objectives
Poor menstrual health may lead to school absenteeism and adverse health outcomes for adolescents. The purpose of this study was to determine the effect of pubertal and menstrual health education on health and preventive behaviors among Iranian secondary school girls.
Methods
A quasi-experimental study was conducted to evaluate the effectiveness of a health intervention program. A total of 578 students (including intervention and control participants) in 12 schools in Tehran Province, Iran were included by multistage random sampling. The program comprised seven 2-hour educational sessions. After confirming the reliability and validity of a researcher-made questionnaire, that questionnaire was used to collect the required data, and the groups were followed up with after 6 months.
Results
After the educational intervention, the mean scores of menstrual health-related knowledge and constructs of the theory of planned behavior were significantly higher in the intervention group than in the control group (p<0.001 for all dimensions).
Conclusions
The results of this study emphasize the effectiveness of menstrual health interventions in schools. These findings should also encourage health policy-makers to take committed action to improve performance in schools.
Summary
Clinical Trial
Analysis of Repeated Measured VAS in a Clinical Trial for Evaluating a New NSAID with GEE Method.
Hoi Jeong Lim, Yooni Kim, Young Bok Jung, Sang Cheol Seong, Jin Hwan Ahn, Kwon Jae Roh, Jung Man Kim, Byung Joo Park
J Prev Med Public Health. 2004;37(4):381-389.   Published online November 30, 2014
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AbstractAbstract PDF
OBJECTIVE
: To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. METHODS: A randomized, double-blind, active comparator controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent (or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. RESULTS: While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT: aOR=1.37, 95% CI= (0.8200, 2.26), PP: aOR=1.47, 95% CI= (0.73, 2.95) ). The goodness-off it statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. CONCLUSIONS: Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.
Summary

JPMPH : Journal of Preventive Medicine and Public Health