New and Improved: The Role of Text Augmentation and the Application of Response Interpretation Standards (Coding Schemes) in a Final Iteration of Birth Defects Warnings Development Christopher B. Mayhorn 1 * and Richard C. Goldsworthy 2 1 Department of Psychology, North Carolina State University, Raleigh, North Carolina, USA 2 The Academic Edge, Inc, Blomington, Indiana, USA Received 24 February 2009; Revised 9 April 2009; Accepted 17 April 2009 BACKGROUND: Several birth defects warning symbols identified as most successful in an earlier study (Mayhorn and Goldsworthy, 2007) were further modified and then evaluated within a nationally distributed field trial (n 5 2773). The purpose for the current research was to determine whether symbol warning com- ponents could be improved further, whether the addition of text enhanced comprehension uniformly across symbols, and whether results varied by the application of different interpretation standards (coding schemes). METHOD: A total of 11 warning labels were examined: four new symbols plus the existing base- line symbol, each in versions with and without text, plus a text-only condition. Participant interpretation ac- curacy and preferences were assessed during face-to-face interview sessions. RESULTS: For symbol-only con- ditions, several candidate symbols outperformed the existing symbol, one substantially so. The effect of add- ing text to symbols varied significantly by symbol. Symbol plus text and text-only conditions performed equivalently, generally exceeded symbol-only conditions, and often surpassed the American National Stand- ards Institute benchmark of 85% accurate interpretation. CONCLUSIONS: The research effort has identified a teratogen symbol and warning that outperforms the one currently in use. The effort has also identified im- portant pragmatic and conceptual issues that should inform future work to improve medication labeling and other hazard communication. Birth Defects Research (Part A) 85:864–871, 2009. Ó 2009 Wiley-Liss, Inc. Key words: warnings; symbols; teratogen; birth defects; medications INTRODUCTION To avoid birth defects and other health-related conse- quences, it is essential that patients be warned of the potential hazards of exposure to substances with terato- genic properties (Meadows, 2001; Perlman et al., 2001). To attempt to meet this need for increased patient educa- tion, awareness campaigns and intervention strategies such as the System to Manage Accutane Teratogenicity (Roche Laboratories, 2001) have been implemented. These efforts have proven useful, but gatekeeping mechanisms designed to guard against a particular hazard sometimes fail, and it ultimately falls to medication labels and pack- aging to inform those at risk. Previous research has documented that the teratogen warning in use at the time of the study may be confusing to those who encounter it (Daniel et al., 2001). This warn- ing (illustrated in warnings 3 and 4 of Table 1) consists of a symbol showing a circle and a slash mark superim- posed over a graphic representation of a pregnant woman with the accompanying text ‘‘Do Not Get Preg- nant.’’ y Results reported by Daniel et al. (2001) indicate that only 21% of the women shown the current warning were able to correctly interpret it. As a benchmark for considering these results, the American National Stand- y Since the original Daniel et al. study, manufacturers have replaced this text ‘‘Do not get pregnant,’’ which we have criticized in multiple venues, with a different text warning. Supported by grants 1R43DD00001-01 and 1R44DD00001-01 to the second author from the National Center on Birth Defects and Developmental Disabil- ities (NCBDDD), a part of the Centers for Disease Control and Prevention (CDC). The article’s contents are solely the responsibility of the authors and do not necessarily represent the official views of NCBDDD/CDC. *Correspondence to: Christopher B. Mayhorn, Department of Psychology, North Carolina State University, 640 Poe Hall, Campus Box 7650, Raleigh, NC 27695-7650. E-mail: Chris_Mayhorn@ncsu.edu Published online 23 June 2009 in Wiley InterScience (www.interscience. wiley.com). DOI: 10.1002/bdra.20601 Birth Defects Research (Part A): Clinical and Molecular Teratology 85:864–871 (2009) Ó 2009 Wiley-Liss, Inc. Birth Defects Research (Part A) 85:864–871 (2009)