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Examination criteria and calibration procedures for prevention trials of the E arly C hildhood C aries C ollaborating C enters
Author(s) -
Warren John J.,
WeberGasparoni Karin,
Tinanoff Norman,
Batliner Terence S.,
Jue Bonnie,
Santo William,
Garcia Raul I.,
Gansky Stuart A.
Publication year - 2015
Publication title -
journal of public health dentistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.64
H-Index - 63
eISSN - 1752-7325
pISSN - 0022-4006
DOI - 10.1111/jphd.12102
Subject(s) - calibration , medicine , pilot trial , randomized controlled trial , medical physics , statistics , surgery , mathematics
Objectives To summarize diagnostic criteria and examiner training and calibration of the N ational I nstitute of D ental and C raniofacial R esearch‐funded E arly C hildhood C aries C ollaborating C enters ( EC 4) and report examiner calibration results from 2010 to 2014. The EC 4 at B oston U niversity, U niversity of C olorado, and U niversity of C alifornia S an F rancisco are performing randomized controlled early childhood caries ( ECC ) prevention trials with caries as the main outcome measure. Methods The EC 4 with U niversity of I owa consultants developed standardized tooth and tooth surface status examination criteria for use in field conditions, examiner training materials, and examiner calibration and re‐calibration methodologies. Calibration and re‐calibration were performed with 1‐ to 5‐year‐old children in the S an F rancisco M ission D istrict in which assessments from each examiner to be calibrated were compared with those from a single gold standard examiner from 2010 to 2014. Cohen's kappa statistic was used to determine inter‐examiner agreement. Results A total of seven examiners were successfully (re)calibrated during that period, examining a total of 231 children. Overall unweighted C ohen's kappas for 10 surface conditions exceeded the criterion of 0.70. However, separate agreement for assessment of noncavitated lesions, as in other studies, was lower. Conclusions An experienced multidisciplinary and multi‐institutional team was able to develop criteria and training materials to anticipate situations and field conditions the main trials would encounter. Examiners were successfully trained and (re)calibrated.