The amblyopia treatment study visual acuity testing protocol.

OBJECTIVE: To evaluate the reliability of a new visual acuity testing protocol for children using isolated surrounded HOTV optotypes. METHODS: After initial pilot testing and modification, the protocol was evaluated using the Baylor-Video Acuity Tester (BVAT) to present isolated surrounded HOTV optotypes. At 6 sites, the protocol was evaluated for testability in 178 children aged 2 to 7 years and for reliability in a subset of 88 children. Twenty-eight percent of the 178 children were classified as having amblyopia. RESULTS: Using the modified protocol, testability ranged from 24% in 2-year-olds to 96% in 5- to 7-year-olds. Test-retest reliability was high (r = 0.82), with 93% of retest scores within 0.1 logMAR unit of the initial test score. The 95% confidence interval for an acuity score was calculated to be the score +/-0.125 logMAR unit. For a change between 2 acuity scores, the 95% confidence interval was the difference +/-0.18 logMAR unit. CONCLUSIONS: The visual acuity protocol had a high level of testability in 3- to 7-year-olds and excellent test-retest reliability. The protocol has been incorporated into the multicenter Amblyopia Treatment Study and has wide potential application for standardizing visual acuity testing in children.

Risk factors for the development of adverse drug events in hospitalized patients.

Adverse drug events in hospitalized patients lead to increased morbidity, mortality and costs. Early detection of adverse drug events could aid in the prevention of these adverse outcomes. A cost-effective system for the early detection of adverse drug events should focus on high risk patients. A study was set up with the primary aim to identify characteristics that are associated with the development of adverse drug events (ADEs) in hospitalized patients. ADE reports were gathered from physicians and nurses (spontaneous reports) and from patients after intensive ward interviews by hospital pharmacists. All patients admitted to the internal medicine wards of two Dutch hospitals, during a two month period, were included. The following characteristics were analyzed for their potential relationship to the occurrence of ADEs: age (categorized), gender, number of drugs prescribed during hospital stay, types of drugs used and changes in drug use on admission. Age was found to be inversely associated with the development of ADEs (OR 0.36, CI 0.21-0.61 for age category > 80 years; OR 0.56; CI 0.31-1.02 for age category 75-80 years and OR 0.69; CI 0.42-1.11 for age category 60-74 years). Furthermore, statistically significant associations were found for the number of drugs prescribed per hospitalized patient (for the class of 4-6 drugs per patient OR 2.61, CI 1.32-5.18), for newly prescribed drugs (OR 6.65, CI 2.63-16.81) and for the cessation of drugs on hospital admission (OR 1.50, CI 1.02-2.20). The use of gastrointestinal drugs (OR 2.13, CI 1.32-3.45), central nervous system drugs (OR 1.66, CI 1.07-2.57) and antibiotics (OR 2.44, CI 1.65-3.60) were associated with the development of ADEs, when compared to all other drugs taken by the patients. In this study, the most important risk factors are the number of drugs used per patient and the starting of a new drug during hospitalization. As most hospitalized patients start new drug therapies while in hospital, this seems an inappropriate focus. However, careful monitoring of patients using more than 7 drugs at a time may be possible in a cost-effective system for the early detection of ADEs.

Adverse drug events in hospitalized patients. A comparison of doctors, nurses and patients as sources of reports.

OBJECTIVE: This study investigated the relative value of adverse drug events reported by doctors, nurses and patients. METHODS: The study was conducted on a total of four wards: the paediatric and internal medicine wards (including geriatric patients) of two peripheral hospitals in The Netherlands. Adverse drug events were collected by spontaneous reporting (doctor and nurse reports) and by daily ward visits, during which the patients were interviewed by a hospital pharmacist (patient reports). Criteria for relative value of the reported adverse drug events were the number of potentially serious reactions, the number of reactions not mentioned in the patient information leaflet and the number of reactions reported to new drugs (5 years or less on the Dutch market). No formal causality assessment was applied. RESULTS: Over a period of 2 months in 1996 (Hospital I) and 2 months in 1997 (Hospital II) a total of 620 patients were included in the study and adverse drug events were reported in 179 (29%) of these cases. Doctors reported a statistically significant larger number of serious (26% of all doctor reports; odds ratio (OR) 3.2; confidence interval (CI) 1.2-8.7) and unknown (39%; OR 2.5; CI 1.0-6.0) adverse drug events than patients themselves during the daily ward visit. Doctors also reported more serious and unknown adverse drug events than nurses. Adverse reactions to new drugs were reported during the daily ward visit only (8% of all daily ward visit reports). CONCLUSION: This study reconfirms that doctors are the main source for reports of serious and unknown adverse drug events in hospitalized patients. However, patients themselves seem to report more adverse reactions to new drugs (during the daily ward visit). By focusing on patients using new drugs, the daily ward visit might become cost-effective. This needs to be explored in future studies.

Comparison of two different high doses of metoclopramide in the prevention of chemotherapy-induced emesis.

A randomized double-blind study was conducted to compare the anti-emetic efficacy of 1 mg/kg vs 2 mg/kg metoclopramide, administered 5 times over a period of 8.5 h in 50 cancer patients treated with platinum-containing regimens (cisplatin, ethylenediamine platinum II malonate or spiroplatin). Twenty-six patients were treated with combination chemotherapy, mainly consisting of cisplatin and 5-fluorouracil. No statistically significant differences were observed with respect to the protection against nausea and vomiting between the two dose levels of metoclopramide. However, in the group of patients who received a high dosage of cisplatin (70-100 mg/m2), or ethylenediamine platinum II malonate (800-900 mg/m2), there was a significant difference in nausea and vomiting between patients who had and those who had not received prior chemotherapy, most probably due to anticipation. No difference in the severity of the side effects was observed with the 2 metoclopramide dose levels. Considerable interpatient variation was present in serum metoclopramide levels. No clear correlation was observed between serum metoclopramide levels and prevention of platinum-induced emesis. We conclude that 1 mg/kg of metoclopramide is just as effective as 2 mg/kg as an anti-emetic agent in patients receiving platinum-based chemotherapy, and that metoclopramide serum levels are not related to the anti-emetic effect.