Statistical methods for establishing quality control ranges for antibacterial agents in Clinical and Laboratory Standards Institute susceptibility testing

Quality control (QC) ranges for antimicrobial agents against QC strains for both dilution and disk diffusion testing are currently set by the Clinical and Laboratory Standards Institute (CLSI), using data gathered in predefined structured multilaboratory studies, so-called tier 2 studies. The ranges are finally selected by the relevant CLSI subcommittee, based largely on visual inspection and a few simple rules. We have developed statistical methods for analyzing the data from tier 2 studies and applied them to QC strain-antimicrobial agent combinations from 178 dilution testing data sets and 48 disk diffusion data sets, including a method for identifying possible outlier data from individual laboratories. The methods are based on the fact that dilution testing MIC data were log normally distributed and disk diffusion zone diameter data were normally distributed. For dilution testing, compared to QC ranges actually set by CLSI, calculated ranges were identical in 68% of cases, narrower in 7% of cases, and wider in 14% of cases. For disk diffusion testing, calculated ranges were identical to CLSI ranges in 33% of cases, narrower in 8% of cases, and 1 to 2 mm wider in 58% of cases. Possible outliers were detected in 8% of diffusion test data but none of the disk diffusion data. Application of statistical techniques to the analysis of QC tier 2 data and the setting of QC ranges is relatively simple to perform on spreadsheets, and the output enhances the current CLSI methods for setting of QC ranges.     

Evaluation of aesthetics of implant-supported single-tooth replacements using different bone augmentation procedures: a prospective randomized clinical study

OBJECTIVES: The aim of this study was to evaluate the aesthetics of implant-supported single-tooth replacements using different augmentation procedures in a prospective study with the use of an objective rating index and with a subjective patient questionnaire, and to compare the results with each other. MATERIAL AND METHODS: Ninety-three patients with a single-tooth gap in the anterior zone of the maxilla were selected for the study. All patients had a local bone defect that needed augmentation before placement of an endosseous implant with sufficient initial stability. Aesthetics of the implant-supported crown and adjacent mucosa was rated by a prosthodontist 1 year after placement of the porcelain crown. Aesthetics was rated using the Implant Crown Aesthetic Index. A subjective appreciation of the final result was assessed with a patient questionnaire. RESULTS: The Implant Crown Aesthetic Index reveals a mean overall score of 4.8, with an acceptable result in 66% of the cases. Results of the satisfaction questionnaire reveal a mean overall score of 8.5 with an acceptable result in 100% of the cases. There is no correlation between results of the Index and the questionnaire for the overall and the crown score. The patients' opinion and the professionals' opinion about the peri-implant mucosa do show a significant correlation. CONCLUSIONS: The peri-implant mucosa is rated as less satisfactory than the implant-supported crown by both the dental professional and patients. The dental professional was less satisfied with respect to the total result and results of the crown than the patients.     

Treatment of peripheral neuropathic pain: a simulation model.

OBJECTIVE: To describe the use of a generalizable stochastic-simulation model of the treatment of neuropathic pain associated with peripheral neuropathies. METHODS: We developed a model to simulate treatment outcomes in a hypothetical cohort of patients with peripheral neuropathies. Each patient was randomly assigned an average pretreatment daily pain score (on a 0-10 scale), based on an assumed distribution of mean pretreatment pain scores in the cohort. Patients were randomly assigned daily pain scores, based on their pretreatment average and an assumed distribution of daily pain scores around this mean. Treatment outcomes were then simulated using the expected mean change (vs. baseline) in pain scores. Model outcomes include the expected increase in days with no or mild pain (score < or = 3), days with > or = 30% and > or = 50% reductions in pain intensity, and days with 2- and 3-point absolute reductions in pain intensity. To illustrate its use, the model was estimated over a 12-week period using data from a recent clinical trial of a new antiepileptic (pregabalin). RESULTS: Treatment over 12 weeks (84 days) was projected to result in 26 (+/-0.4) (mean [+/-SE]) additional (vs. no treatment) days with no or mild pain, 33 (+/-0.5) days with a > or = 30% reduction in pain intensity, 28 (+/-0.4) days with > or = 50% reduction in pain intensity, and 34 (+/-0.5) and 30 (+/-0.5) days with > or = 2-point and > or = 3-point absolute reductions in pain intensity. CONCLUSIONS: When combined with data on health-state utilities and treatment costs, this new analytical tool can provide a foundation for formal cost-effectiveness evaluations of interventions for painful peripheral neuropathies.     

Connection Versus Disconnection: Examining Culturally Competent Care in the Neonatal Intensive Care Unit

Culturally competent health care is of critical importance; however, it is presented as a frequent challenge in health care settings. This study explored cross-cultural care from the health care provider perspective within two tertiary level Neonatal Intensive Care Units (NICUs). Fifty eight inter-professional health care providers (HCP) participated in focus groups. Participants identified perceived care-related experiences of newly immigrated parents whose infant received care in the NICU as well as health care provider perspectives on delivering that care. Results identified core processes of “connection” and “disconnection,” which appeared to have a substantial bearing on NICU experience and interaction. Connection comprised congruity, synergy, and “fit,” and resulted in an enhanced relationship between the family and HCP. Disconnection, in contrast, entailed a lack of “fit” and in some cases, misunderstanding and/or conflict between the family and a member or members of the health care team. Connection and disconnection occurred at various junctures of NICU care. These junctures reflected interaction between the family and HCP at the bedside and/or at the level of the unit, hospital, or community at large. Implications for practice, policy, and research are discussed.