Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery.

PURPOSE: To assess the efficacy and safety of a sustained-release intracanalicular dexamethasone insert for the treatment of postoperative ocular inflammation and pain in patients having cataract surgery. SETTING: Twenty-one United States sites. DESIGN: Prospective multicenter randomized parallel-arm double-masked vehicle-controlled phase 3 study. METHODS: Patients with planned clear corneal cataract surgery were randomized (1:1) to receive dexamethasone insert or placebo, and the treatment was placed in the canaliculus of the eye immediately after surgery (Day 1). The primary efficacy endpoints were complete absence of anterior chamber cells at Day 14 and complete absence of pain at Day 8. RESULTS: The study comprised 438 adult patients (216 in the treatment arm and 222 in the placebo arm). At Day 14, significantly more patients had an absence of anterior chamber cells in the dexamethasone insert arm compared with placebo (52.3% versus 31.1%; P < .0001). At Day 8, significantly more patients had an absence of ocular pain in the dexamethasone insert arm compared with placebo (79.6% versus 61.3%; P < .0001). The dexamethasone insert arm showed no increase compared with placebo in incidence of all adverse events or ocular adverse events. Twice as many placebo patients required rescue therapy, compared with treated patients at Day 14. CONCLUSIONS: Both primary endpoints were successfully met. In addition, patients receiving the dexamethasone insert experienced a decrease in inflammation after surgery as early as Day 4 through Day 45, and a decrease in pain as early as one day after surgery (Day 2) through Day 45. The dexamethasone insert was well-tolerated, and the adverse events profile was similar to placebo.

Loss of the extra chromosome 21 in a patient with Down syndrome and myelodysplasia.

Monosomy 21 is a rare acquired karyotypic abnormality associated with myeloid disorders. Occurrence of loss of one chromosome 21 in the background of trisomy 21 in Down syndrome, resulting in the pseudo-normalization of trisomy 21, is a novel finding. The case is described of a patient with Down syndrome who acquired such a genetic abnormality as a result of myelodysplastic syndrome.

The new and old definitions of acute myocardial infarction: a data-based comparison.

PURPOSE: To measure the agreement between the newer European Society of Cardiology-American College of Cardiology (ESC-ACC) definition of acute myocardial infarction (AMI) and the traditional definition established by the World Health Organization (WHO). BASIC PROCEDURES: All adult ED patients admitted to our institution with at least one abnormally elevated cardiac biomarker were determined to have had an AMI by either or both definitions. The degree of agreement and the frequency of the reasons for disagreement between these 2 definitions were measured. MAIN FINDINGS: A final study population consisted of 339 patients; 196 (58%) had an AMI by one or both definitions. Among them, 126 (64%; 95% confidence interval [CI], 57-71) were discordant for these 2 definitions: 104 (53%; 95% CI, 46-60) met only the ESC-ACC, whereas 22 (11%; 95% CI, 6-16) met only the WHO definition. Among those who met only the ESC-ACC definition, 37 (36%; 95% CI, 27-45) met none of the 3 traditional WHO criteria. PRINCIPAL CONCLUSIONS: More patients are discordant than concordant for the 2 standard definitions of AMI. Among them, a large majority meet only the new ESC-ACC definition.

Use of diagnostic testing in the emergency department for patients presenting with non-traumatic abdominal pain.

The objective of the study was to measure the utilization and diagnostic value of tests used in the Emergency Department (ED) on patients with undifferentiated non-traumatic abdominal or flank pain. Specific goals were to measure how often these tests led to changes in diagnosis or disposition, which tests were most commonly used, and which tests providers considered most helpful. We conducted a pilot single-center, prospective descriptive study, enrolling all eligible adult patients who presented to our ED with non-traumatic abdominal or flank pain during defined hours of our intake period. Based on serial provider interviews pre- and post-testing, we measured the frequency of change of most likely diagnosis and disposition, which tests were performed, and the provider-perceived value of tests. We enrolled 124 subjects with a mean age of 44 years; 27% were admitted. Testing led to a change in most likely diagnosis in 37% of subjects, and in disposition in 41%. Frequency of diagnostic test use varied from a high of 93% for CBC to 6% for a blood or urine culture. Overall, 65% of patients had at least one imaging study performed, and 39% had an abdominal/pelvic computed tomography (CT) scan. Over all subjects, providers identified the most useful tests as the CT scan (31%) and urinalysis (17%). In conclusion, among ED patients who presented with non-traumatic abdominal or flank pain to one academic center, the pre-test most likely diagnosis and disposition were changed based on the ED evaluation in over one-third of subjects. Almost all received blood tests and two-thirds received one or more imaging studies. Based on providers' subjective opinions, the most valuable tests were the abdomino/pelvic CT scan and the urinalysis.

The accuracy and completeness of data collected by prospective and retrospective methods.

OBJECTIVES: To describe and test a model that compares the accuracy of data gathered prospectively versus retrospectively among adult emergency department patients admitted with chest pain. METHODS: The authors developed a model of information flow from subject to medical record to the clinical study case report form, based on a literature review. To test this model, a bidirectional (prospective and retrospective) study was conducted, enrolling all eligible adult patients who were admitted with a chief complaint of chest pain. The authors interviewed patients in the emergency department to determine their chest pain history and established a prospective database; this was considered the criterion standard. Then, patient medical records were reviewed to determine the accuracy and completeness of the information available through a retrospective medical record review. RESULTS: The model described applies the concepts of reliability and validity to information passed on by the study subject, the clinician, and the medical record abstractor. This study was comprised of 104 subjects, of which 63% were men and the median age was 63 years. Subjects were uncertain of responses for 0-8% of questions and responded differently upon reinterview for subsets of questions 0-30% of the time. The sensitivity of the medical record for risk factors for coronary artery disease was 0.77 to 0.93. Among the 88 subjects (85%) who indicated that their chest pain was substernal or left chest, the medical record described this location in 44%. Timing of the chest pain was the most difficult item to accurately capture from the medical record. CONCLUSIONS: Information obtained retrospectively from the abstraction of medical records is measurably less accurate than information obtained prospectively from research subjects. For certain items, more than half of the information is not available. This loss of information is related to the data types included in the study and by the assumptions that a researcher performing a retrospective study makes about implied versus explicitly stated responses. A model of information flow that incorporates the concepts of reliability and validity can be used to measure some of the loss of information that occurs at each step along the way from subject to clinician to medical record abstractor.

Duration of symptoms and follow-up patterns of patients discharged from the emergency department after presenting with abdominal or flank pain.

BACKGROUND: Little is known about the duration of symptoms and follow-up patterns of patients seen in emergency departments for abdominal or flank pain. OBJECTIVE: We aimed to measure the duration of symptoms and follow-up rate of patients discharged home from the emergency department after presenting with non-traumatic abdominal or flank pain. METHODS: We conducted a single-centre, prospective descriptive study of adult patients who presented to our emergency department with non-traumatic abdominal or flank pain and were discharged from the emergency department. We gathered clinical data during the index emergency department visit and conducted telephone interviews of subjects 2-5 weeks later. RESULTS: We reached 63 of 90 subjects (70%). The median duration of pain was 3 days after the emergency department visit. During the follow-up period, only 41% had followed-up with their family physician or primary care provider, although an additional 21% had planned to. Persistence of symptoms was common in the 37% of subjects who did not follow-up. CONCLUSION: Of subjects discharged from the emergency department after visits for non-traumatic abdominal or flank pain, most improve within several days. Fewer than half follow-up with a family practitioner or a primary care provider. Emergency department revisits are uncommon and often for unrelated problems.