Atomoxetine monotherapy compared with combination therapy for the treatment of ADHD: a retrospective chart review study.

OBJECTIVE: To analyze Clinical Global Impression-Severity (CGI-S) in ADHD patients treated with atomoxetine (ATX) monotherapy versus ATX combination therapy with another ADHD-indicated medication. METHODS: This was a 2-site retrospective observational chart review study of child and adult ADHD patients, not necessarily treatment naïve, but treated ≥50 days post baseline with an endpoint assessment. To adjust for measured confounders, monotherapy (n = 77) versus combination (n = 108) cohort comparisons were performed using propensity score stratification and adjusted ANCOVA. RESULTS: There were no significant baseline cohort differences after propensity stratification. CGI-S scores after a mean 264 days of treatment were not statistically significantly different between cohorts, with no cohort differences observed in any assessed symptom subcategory. The cohorts were similar in discontinuation due to any reason, adverse event, and lack of efficacy. CONCLUSION: ATX combination therapy showed no evidence of additional benefit over ATX monotherapy in the treatment of ADHD in a community-based setting.

Hemolytic disease of the fetus and newborn caused by an antibody to a low-prevalence antigen, anti-SARA.

BACKGROUND: The first case describing the SARAH (SARA) antigen occurred in 1990, in an Australian blood donor. Hemolytic disease of the fetus and newborn (HDFN) due to anti-SARA has not been previously described. CASE REPORT: We report a case of HDFN in a multiparous female. The pregnancy was unremarkable except that she was involved in a seemingly minor motor vehicle accident at 25 weeks' gestation. Routine prenatal antibody screening was negative throughout the pregnancy. She presented at 37 weeks' gestation because of decreased fetal movements. Labor was induced and a 2702-g infant male was delivered. The infant's hemoglobin was 49 g/L and the bilirubin was 153 µmol/L. RESULTS: Blood samples from the parents and infant were referred to Canadian Blood Services National Immunohematology Reference Laboratory and subsequently to the Australian Red Cross Red Cell Reference Service. The father's and infant's red blood cells were confirmed to be SARA positive, and the mother's plasma contained anti-SARA. CONCLUSION: The infant was successfully treated with a double-volume exchange transfusion. This is the first example of HDFN associated with this antibody.

Integrating incident data from five reporting systems to assess patient safety: making sense of the elephant.

BACKGROUND: A study was conducted to examine and compare information gleaned from five different reporting systems within one institution: incident reporting, patient complaints, risk management, medical malpractice claims, and executive walk rounds. These data sources vary in the timing of the reporting (retrospective or prospective), severity of the events, and profession of the reporters. METHODS: A common methodology was developed for classifying incidents. Data specific to each incident were abstracted from each system and then categorized using the same framework into one of 23 categories. RESULTS: Overall, there was little overlap, although each reporting system identified important safety issues. Communication problems were common among patient complaints and malpractice claims; malpractice claims' leading category was clinical judgement. Walk rounds identified issues with equipment and supplies. Adverse event reporting systems highlighted identification issues, especially mislabelled specimens. The frequency of contributions of reports by provider group varied substantially by system. Physicians accounted for 50% of risk management reports, but in adverse event reporting, where nurses were the main reporters, physicians accounted for only 2.5% of reports. Complaints and malpractice claims come primarily from patients. CONCLUSIONS: The five reporting systems each identified different yet complementary patient safety issues. To obtain a comprehensive picture of their patient safety problems and to develop priorities for improving safety, hospitals should use a broad portfolio of approaches and then synthesize the messages from all individual approaches into a collated and cohesive whole.

Three new high-prevalence antigens in the Cromer blood group system.

BACKGROUND: The Cromer blood group system consists of nine high-prevalence and three low-prevalence antigens carried on decay-accelerating factor (DAF). This report describes three new Cromer high-prevalence antigens, named ZENA, CROV, and CRAM. STUDY DESIGN AND METHODS: Sequence analyses were performed on DNA from three probands whose serum samples each contained an alloantibody to a high-prevalence antigen in the Cromer blood group system. Polymerase chain reaction-restriction fragment length polymorphism analysis to detect the mutation encoding the CROV- phenotype was performed on 100 Croatian donors. To map the respective epitopes, DAF deletion mutants were tested by immunoblotting with eluates containing the antibodies. RESULTS: In each proband, sequence analysis revealed a single-nucleotide substitution in DAF: ZENA, 726T>G mutation, predicted change His242Gln; CROV, 466G>A mutation, predicted change Glu156Lys; and CRAM, 740A>G mutation, predicted change Gln247Arg. By analysis of DAF deletion mutants, the CROV antigenic determinant mapped to the complement control protein (CCP) domain 2, which is encoded by exon 3, whereas ZENA and CRAM mapped to CCP4, which is encoded by exon 6. CONCLUSION: This study describes three novel high-prevalence antigens in the Cromer blood group system each characterized by a predicted single-amino-acid substitution. The antigens have been assigned the following International Society of Blood Transfusion (ISBT) numbers: ZENA is CROM13, CROV is CROM14, and CRAM is CROM15.

Best practice guidelines on informed consent for weight loss surgery patients.

OBJECTIVE: To provide evidence-based guidelines on informed consent and the education that underlies it for legally competent, severely obese weight loss surgery (WLS) patients. RESEARCH METHODS AND PROCEDURES: We conducted a systematic review of the scientific literature published on MEDLINE between 1984 and 2004. Three articles focused on informed consent for WLS; none was based on empirical studies. We summarized each paper and assigned evidence categories according to a grading system derived from established evidence-based models. We also relied on informed consent and educational materials from six WLS programs in Massachusetts. All evidence is Category D. Recommendations were based on a review of the available literature, informed consent materials from WLS programs, and expert opinion. RESULTS: This Task Group found that the informed consent process contributes to long-term outcome in multiple ways but is governed by limited legal requirements. We focused our report on the legal and ethical issues related to informed consent, i.e., disclosure vs. comprehension. Recommendations centered on the importance of assessing patient comprehension of informed consent materials, the content of those materials, and the use of active teaching/learning techniques to promote understanding. DISCUSSION: Although demonstrated comprehension is not a legal requirement for informed consent in Massachusetts or other states, the members of this Task Group found that the best interests of WLS patients, providers, and facilities are served when clinicians engage patients in active learning and collaborative decision making.

Creating an integrated patient safety team.

UNLABELLED: CREATING A PATIENT SAFETY TEAM: In May 2001 Brigham and Women's Hospital (Boston) created the Patient Safety Team, which was incorporated into the pre-existing safety and quality infrastructure. ESTABLISHING THE PATIENT SAFETY TEAM'S GOALS AND INITIATIVES: The goal was to create the safest possible environment for patients and staff by creating a culture of safety, increasing the capacity to measure and evaluate processes, committing to change unsafe processes, and adopting new technologies. To achieve this mission, the following initiatives were established: create a culture of safety, increase event identification, improve event analysis, close the feedback loop, assess risk proactively, improve medication safety, and involve the patient. DISCUSSION: Integrating the Patient Safety Team into pre-existing committees and departments facilitated its work while helping to reinforce the multidisciplinary nature of safety efforts. It is critical that pre-existing groups feel that patient safety represents value added and is not a threat to their current roles. SUMMARY AND CONCLUSIONS: If a patient safety strategy and team are to be effective, commitment from the organization's leaders is essential. This team should also work with individual departments and pre-existing quality structures to drive changes to the systems of care to enable health care to become as safe as possible.