Direct care nurses' perceptions of their roles in clinical research: An integrated review of the literature.

PURPOSE: To review the extant literature relevant to perceptions by direct care nurses toward clinical research endeavors. DESIGN: An integrative review guided by the socioecological model was conducted. METHODS: Five databases were searched to identify relevant peer-reviewed articles; there was no limitation on publication date. FINDINGS: The final sample (N = 9) was systematically appraised. Numerous barriers to direct care nurses' ability to perform study activities on clinical research trials were encountered at all levels: (1) personal-comprehension, education, and training; (2) interpersonal-communication issues within or from the study team, failure to advocate for the patient; (3) organizational-lack of leadership support, knowledge, and time; and (4) community-insufficient guidance and oversight by research-governing bodies. CONCLUSIONS: Direct care nurses report numerous barriers to completing protocol-administered activities for their patients participating in clinical research. A dearth of robust research exists in describing the reasons for, or persistence of, barriers faced by direct care nurses to assisting with research, and there have been little to no interventions to address them. CLINICAL RELEVANCE: As translational research evolves and becomes more complex, there is the need to ensure both the care of clinical research participants and the integrity of the research. Direct care nurses are critical to this endeavor, and potential barriers they face may have significant ramifications for the research enterprise. Recognition of these barriers and eventual interventions designed to address them are needed.

Adverse drug events in pediatric outpatients.

OBJECTIVE: To determine rates and types of adverse drug events (ADEs) in the pediatric ambulatory setting. METHODS: A prospective cohort study at 6 office practices in the greater Boston area was conducted over 2-month periods. Duplicate prescription review, telephone surveys 10 days and 2 months after visit, and chart reviews were done. A 2-physician panel classified the severity, preventability, and ability to ameliorate (ie, if the severity or duration of the side effect could have been mitigated by improved communication) ADEs. RESULTS: We identified 57 preventable ADEs (rate 3%; 95% confidence intervals [CI], 3%-4%) and 226 nonpreventable ADEs (rate 13%; 95% CI, 11%-15%) in the medical care of 1788 patients. Of the ADEs, 152 (54%) were able to be ameliorated. None of the preventable ADEs were life threatening, although 8 (14%) were serious. Forty (70%) of the preventable ADEs were related to parent drug administration. Improved communication between health care providers and parents and improved communication between pharmacists and parents, whether in the office or in the pharmacy, were judged to be the prevention strategies with greatest potential. CONCLUSIONS: Patient harm from medication use was common in the pediatric ambulatory setting. Errors in home medication administration resulted in the majority of preventable ADEs. Approximately one fifth of ADEs were potentially preventable and many more were potentially able to be ameliorated. Rates of ADEs due to errors are comparable in children and adults despite less medication utilization in children.

No difference in urinary iodine concentrations between Boston-area breastfed and formula-fed infants.

BACKGROUND: Thyroid hormone is essential for normal mental and physical development in infancy and childhood and is dependent on adequate iodine intake. During the first few months of life, infants are reliant on breastmilk and/or infant formula as their sole sources of dietary iodine. The iodine status of U.S. infants has not been well studied. METHODS: This was a cross-sectional study of 95 breastfed and/or formula-fed infants less than 3 months of age in the Boston area. We measured iodine content from infants' single spot urine samples and assessed associations with infant feeding type as well as maternal demographic data, salt and multivitamin use, smoking status, and diet. RESULTS: The median infant urine iodine concentration was 197.5 µg/L (range 40-897.5 µg/L). Median infant urine iodine concentrations were similar between infants who were exclusively breastfed (n=39, 203.5 µg/L; range 61.5-395.5 µg/L), formula-fed (n=44, 182.5 µg/L; range 40-897.5 µg/L), and mixed (n=10, 197.8 µg/L; range 123-592.5) (p=0.88). There were no significant correlations of infant urinary iodine with maternal salt or multivitamin use (regularly or in the past 24 hours), active or secondhand cigarette smoke exposures, infant weight, infant length, or recent maternal ingestion of common iodine-containing foods, although the correlations with iodine-containing foods are difficult to accurately determine due to the small sample sizes of these variables. CONCLUSIONS: Both breastfed and formula-fed infants less than 3 months of age in the Boston area were generally iodine sufficient. Larger studies are needed to confirm these observations among infants nationwide and elucidate other factors that may contribute to infant iodine nutrition.

Generic and brand-name L-thyroxine are not bioequivalent for children with severe congenital hypothyroidism.

CONTEXT: In the United States, generic substitution of levothyroxine (L-T(4)) by pharmacists is permitted if the formulations are deemed to be bioequivalent by the Federal Drug Administration, but there is widespread concern that the pharmacokinetic standard used is too insensitive. OBJECTIVE: We aimed to evaluate the bioequivalence of a brand-name L-T(4) (Synthroid) and an AB-rated generic formulation (Sandoz, Princeton, NJ) in children with severe hypothyroidism. DESIGN: This was a prospective randomized crossover study in which patients received 8 weeks of one L-T(4) formulation followed by 8 weeks of the other. SETTING: The setting was an academic medical center. PATIENTS: Of 31 children with an initial serum TSH concentration >100 mU/L, 20 had congenital hypothyroidism (CH), and 11 had autoimmune thyroiditis. MAIN OUTCOME MEASURES: The primary endpoint was the serum TSH concentration. Secondary endpoints were the free T(4) and total T(3) concentrations. RESULTS: The serum TSH concentration was significantly lower after 8 weeks of Synthroid than after generic drug (P = .002), but thyroid hormone levels did not differ significantly. Subgroup analysis revealed that the difference in TSH was restricted to patients with CH (P = .0005). Patients with CH required a higher L-T(4) dose (P < .0004) and were younger (P = .003) but were not resistant to thyroid hormone; 15 of 16 CH patients had severe thyroid dysgenesis or agenesis on imaging. The response to generic vs brand-name preparation remained significant when adjusted for age. CONCLUSIONS: Synthroid and an AB-rated generic L-T(4) are not bioequivalent for patients with severe hypothyroidism due to CH, probably because of diminished thyroid reserve. It would therefore seem prudent not to substitute L-T(4) formulations in patients with severe CH, particularly in those <3 yr of age. Our results may have important implications for other severely hypothyroid patients in whom precise titration of L-T(4) is necessary.