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Were patients, health workers, and study personnel “blind” to treatment?. No, since fundoplication is a surgical procedure, the patients, health workers and study personnel were aware of the treatment. Were the groups similar at the start of the trial?. YES All were patients from 1986-1991.
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Were patients, health workers, and study personnel “blind” to treatment? • No, since fundoplication is a surgical procedure, the patients, health workers and study personnel were aware of the treatment.
Were the groups similar at the start of the trial? • YES • All were patients from 1986-1991. • Age 25-75 • The patients were identified as primary or secondary GERD • performed a Cox PH analysis on patients with a diagnosis of GERD complications (which required at least one diagnostic test to make the diagnosis) • No significant difference in age or gender among the groups
There was significantly greater white population among the GERD fundoplication group than the GERD-medical group. • excluded patients with a diagnosis of infectious, radiation-induced, or caustic esophagitis within 5 yr prior to index hospitalization to avoid including patients with nonreflux-related esophagitis and prior fundoplication
Comorbidities of the 3 cohort were identified during a 1-yr period preceding the index hospitalization, and were quantified using the Deyo's modification of the CharlsonComorbidity index.
Aside from the experimental intervention, were the groups treated equally? • Yes, all were followed up after 10 years. • Examined cases of esophageal cancer reported after 1 yr of follow-up thus minimizing the likelihood of including prevalent cases of cancer