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Biomedical subjects

M McGann

Publications and source records attributed to M McGann.

7 recordsLinked to original sources
PubMed2004

Comparison of automated culture systems with a CFR/USP-compliant method for sterility testing of cell-therapy products.

BACKGROUND: Although widely used, commercially available automated culture methods are not US Food and Drug Administration-approved for sterility testing of cell-therapy products. For cell-therapy products regulated under Section 351 of the Public Health Service Act, sterility testing must be performed by the methods described in 21 CFR 610.12 and USP <71> (CFR/USP method), or by methods demonstrated to be equivalent. METHODS: Two automated methods, BacT/Alert (BTA; bioMerieux) and Bactec (Becton Dickinson), were compared with the CFR/USP method. Representative mononuclear cell (MNC) products were formulated using six different product media. MNC product aliquots containing 10-50 x 10(6) cells in a 0.5 mL volume were seeded with organisms, and cultured for 14 days in aerobic and anaerobic bottles of each system. Ten different organisms at target concentrations of 10 and 50 colony-forming units (CFU) per bottle were tested. RESULTS: Positives were detected in a mean (range) of 72% (7-100%) of cultures for CFR/USP, 82% (0-100%) for BTA, and 93% (57-100%) for Bactec. For nine of the 10 organisms tested, overall detection rates for BTA and Bactec were equivalent to or higher than CFR/USP. Of the six product media tested, detection of organisms was impaired only by the medium containing multiple antibiotics: this occurred in all three systems. Both BTA and Bactec had shorter times to detection than the CFR/USP method, with overall means (ranges) of 87 (24-264) h for CFR/USP, 24 (12-54) h for BTA, and 33 (12-80) h for Bactec. Detection occurred consistently within 7 days for both BTA and Bactec, but not for CFR/USP. DISCUSSION: Both BTA and Bactec are superior to the CFR/USP method for overall detection and time to detection of organisms in MNC products suspended in commonly used media. These data support general use of either BTA or Bactec for sterility testing of a variety of cell-therapy products, and suggest that a 7-day culture period is sufficient to detect clinically relevant organisms. These results confirm the need for bacteriostasis and fungistasis testing of antibiotic-containing products, even when antibiotic-binding substances are used.

Anti-Bacterial Agents↗
PubMed1999

The relation of patient satisfaction with treatment of otitis externa to clinical outcomes: development of an instrument.

This survey was undertaken to develop a short, comprehensive measure of patient satisfaction with pharmacologic treatment for otitis externa and to assess the relationships between satisfaction, disease symptoms, and medication side effects. Otitis externa was diagnosed in 41 patients recruited from 6 sites; 34 patients completed and returned the study instruments and were included in the study. Patients or their caregivers administered polymyxin/neomycin/hydrocortisone ear drops prescribed by a physician and completed a daily diary for 10 days and a satisfaction questionnaire at the end of the treatment period. The main outcome measures were the subscale scores for patient satisfaction and their relation to medication side effects, symptoms of ear infection, activity limitations, pain, and adherence to prescription regimens. The questionnaire and its subscales demonstrated good psychometric properties (ie, reliability coefficients >0.75, except for 1 subscale). Overall satisfaction was found to be significantly correlated with relief of symptoms, ability to return to normal activities, ease of administration, and medication side effects. Satisfaction subscale scores were correlated with patient-reported severity of medication side effects and disease symptoms. More than half the patients took drops for more than the prescribed number of days, and one third took more than the prescribed number of drops per administration (ie, overadherence). The relation between satisfaction and adherence was weak, perhaps due to the high rates of overadherence. Our results demonstrate that patient satisfaction with otic medication can be assessed across various aspects of satisfaction and that it is correlated with reported disease symptoms and medication side effects. This type of multifaceted assessment may help physicians select between medications with different side-effect profiles and administration schedules. Larger studies are needed to evaluate the relationship between satisfaction with an otic medication and adherence to a medication regimen.

Adolescent↗
PubMed1999

Health research in the commonwealth Caribbean.

Health research and the dissemination of its findings are important to healthcare development. It is therefore useful to monitor the productivity of scientists and to examine the difficulties which affect their ability to conduct and publish research findings. This study aimed to examine these factors in six Caribbean countries. Health researchers publishing two or more papers in referred professional journals between 1987 and 1990 were interviewed to determine area of research, number of publications and research constraints. In those four years, 427 first authored articles were published by those interviewed. University of the West Indies (UWI) researchers in the three campus territories published most of the articles, with little research being done in noncampus territories. Of seven priority areas defined by Caribbean Health Ministers, most researchers were interested in chronic diseases, maternal and child health, followed by nutrition and the acquired immunodeficiency syndrome (AIDS). There was not much research on human resource development and strengthening of health care systems. Major constraints to research were lack of resources including funding, time, staff and equipment. Despite this, only 54% had applied for funding. There were few posts for research at the UWI. Notwithstanding these constraints, researchers were conducting several projects simultaneously and were involved with more projects than would be expected from the number of publications. Many expressed the need for experienced advice and assistance in writing protocols and analyzing data. At the UWI it might be helpful to appoint a senior person or group in each department with specific responsibility for promoting research.

Caribbean Region↗
PubMed1998

The need for a thoughtful deployment strategy: evaluating clinicians' perceptions of critical deployment issues.

This paper presents data collected from 899 clinicians across three Department of Veterans Affairs (VA) medical centers where existing terminal-based architecture was being replaced with client-server architecture. Surveys were conducted with physicians (n = 184), nurses (n = 355) and other clinicians (n = 360) gathering user characteristics and their perceptions of five deployment issues (e.g. adequacy of technical and institutional support and perceptions of the soon-to-be-implemented clinical workstation). Mean scores for the five deployment issues for all clinicians indicates perceptions are somewhat neutral. However, when data is analyzed according to job classification, significant (p = 0.05) differences in perceptions were noted among groups of clinicians (e.g., physicians and registered nurses). Results of analyzing data grouped by VA site (n = 3) indicates significant (p = 0.05) differences exist among sites in clinicians' perceptions of the deployment issues. A thoughtful deployment strategy including an in-depth assessment of clinician users by job classification and by location may produce important information, critical to the successful deployment of new technologies, in very large health management institutions.

Attitude to Computers↗