Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations.

This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings.

Assessing the prevalence of dental caries among elementary school children in North Korea: a cross-sectional survey in the Kangwon province.

OBJECTIVES: The lack of epidemiological studies has made it difficult to assess the extent of public health problems in North Korea. In the absence of empirical data, less intrusive study designs acceptable to the North Korean government could be developed to gauge the public's health. To this end we developed a basic oral health survey in order to assess the prevalence of untreated dental caries among children. METHODS: A cross-sectional survey of 854 elementary school students was conducted in the city of Wonsan, North Korea. Students were screened and classified into one of three states of oral health: no caries, minor caries or severe dental caries. Verbal surveys were concurrently administered on children to collect basic information on oral health behaviours and demographic characteristics. Statistical analyses were performed to determine if any variables were significant predictors of oral health status category. RESULTS: Among the 854 students screened, we found 255 students with no caries (29.9%), 316 students with minor caries (37.0%), and 283 students with severe caries (33.1%). The majority of students (70.1%) screened had dental caries. Almost all of the students (98.5%) claimed to brush their teeth daily and 71.2% of students visited a dentist in the past year. There were no significant predictors of oral health status. CONCLUSIONS: The oral health of children in Wonsan, North Korea is comparable if not slightly better than the oral health status of children of similar age in countries with similar Social-Economic Status (SES). Basic oral health screens are useful to produce a snapshot of general oral health status among children in North Korea and may provide insight as to the general health of these children.