PubMed · 14762986
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William L Holden, Juhaeri Juhaeri, Wanju Dai. 2003. Benefit-risk analysis: examples using quantitative methods.. https://doi.org/10.1002/pds.794
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OBJECTIVE: To determine the effect of hydroxychloroquine treatment during pregnancy and lactation on babies of mothers affected by rheumatic diseases. STUDY DESIGN AND METHODS: A total of 40 infants born from mothers affected by rheumatic diseases and treated with hydroxychloroquine during pregnancy were enrolled in a prospective observational study. Main outcome measures at birth were incidence of prematurity, congenital malformations and neonatal infections. Of these babies, including 13 who were breast-fed, 24 were followed up during early infancy for visual function and neurodevelopmental outcome. RESULTS: Preterm delivery was the main complication (20.5%). No significant congenital malformations or neonatal infections were detected. All infants, including those who were breast-fed, had normal visual function and neurodevelopmental outcome. CONCLUSIONS: Hydroxychloroquine treatment during gestation and lactation appeared to be safe. The relatively high incidence of preterm deliveries may reflect the maternal disease state.
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Patient information leaflets are an important adjunct to verbal exchange between doctor and patient. Their value is dependent upon whether they contain useful information from the viewpoint of the patient and are easily understood. We developed a framework based upon linguistic theory for assessing the quality of written patient information and applied it to a set of leaflets about methotrexate treatment. Items included the overall structure of the text, the technicality of the vocabulary used, the number of content words per clause ('lexical density'), and the clarity of the role relationship between author and reader. The leaflets consisted of up to nine identifiable sections (range 3-8): background information about the drug, summary of its use, dosage instructions, outline of benefits and side-effects, monitoring information, constraints on patient behavior, storage instructions, and clinical contact availability. Most leaflets contained a high number of content words per clause and the identity of the author was clear in only three (17%). Linguistic analysis provides highly relevant information about written patient information. Together with critical assessment of factual and visual aspects, consideration of key linguistic features should improve the quality of informational texts for our patients.