Search

Background: Traditional site-monitoring techniques are not optimal in finding data fabrication and other nonrandom data distributions with the greatest potential for jeopardizing the validity of study results. TransCelerate BioPharma conducted an experiment testing the utility of statistical methods for detecting implanted fabricated data and other signals of noncompliance. Methods: TransCelerate tested statistical monitoring on a data set from a chronic obstructive pulmonary disease (COPD) clinical study with 178 sites and 1554 subjects. Fabricated data were selectively implanted in 7 sites and 43 subjects by expert clinicians in COPD. The data set was partitioned to simulate studies of different sizes. Analyses of vital signs, spirometry, visit dates, and adverse events included distributions of standard deviations, correlations, repeated values, digit preference, and outlier/inlier detection. An interpretation team, including clinicians, statisticians, site monitoring, and data management, reviewed the results and created an algorithm to flag sites for fabricated data. Results: The algorithm identified 11 sites (19%), 19 sites (31%), 28 sites (16%), and 45 sites (25%) as having potentially fabricated data for studies 2A, 2, 1A, and 1, respectively. For study 2A, 3 of 7 sites with fabricated data were detected, 5 of 7 were detected for studies 2 and 1A, and 6 of 7 for study 1. Except for study 2A, the algorithm had good sensitivity and specificity (>70%) for identifying sites with fabricated data. Conclusions: We recommend a cross-functional, collaborative approach to statistical monitoring that can adapt to study design and data source and use a combination of statistical screening techniques and confirmatory graphics. [ABSTRACT FROM AUTHOR]

Accurate detection and classification of aspiration is a critical component of videofluoroscopic swallowing evaluation, the most commonly utilized instrumental method for dysphagia diagnosis and treatment. Currently published literature indicates that interjudge reliability for the identification of aspiration ranges from poor to fairly good depending on the amount of training provided to clinicians. The majority of extant studies compared judgments among clinicians. No studies included judgments made during the use of a postural compensatory strategy. The purpose of this study was to examine the accuracy of judgments made by speech-language pathologists (SLPs) practicing in hospitals compared with unblinded expert judges when identifying aspiration and using the 8-point Penetration/Aspiration Scale. Clinicians received extensive training for the detection of aspiration and minimal training on use of the Penetration/Aspiration Scale. Videofluoroscopic data were collected from 669 patients as part of a large, randomized clinical trial and include judgments of 10,200 swallows made by 76 clinicians from 44 hospitals in 11 states. Judgments were made on swallows during use of dysphagia compensatory strategies: chin-down posture with thin liquids and head-neutral posture with thickened liquids (nectar-thick and honey-thick consistencies). The subject population included patients with Parkinson’s disease and/or dementia. Kappa statistics indicate high accuracy for all interventions by SLPs for identification of aspiration (all κ > 0.86) and variable accuracy (range = 69–76%) using the Penetration/Aspiration Scale when compared to expert judges. It is concluded that while the accuracy of identifying the presence of aspiration by SLPs is excellent, more extensive training and/or image enhancement is recommended for precise use of the Penetration/Aspiration Scale. [ABSTRACT FROM AUTHOR]

Objective: To identify the ethical dilemmas that internists encounter, the strategies they use to address them, and the usefulness of ethics consultation.Design: National telephone survey.Setting: Doctors' offices.Participants: General internists, oncologists, and critical care/pulmonologists (N = 344, 64% response rate).Measurements: Types of ethical dilemmas recently encountered and likelihood of requesting ethics consultation; satisfaction with resolution of ethical dilemmas with and without ethics consultation.Results: Internists most commonly reported dilemmas regarding end-of-life decision making, patient autonomy, justice, and conflict resolution. General internists, oncologists, and critical care specialists reported participating in an average of 1.4, 1.3, and 4.1 consultations in the preceding 2 years, respectively (P <.0001). Physicians with the least ethics training had the least access to and participated in the fewest ethics consultations; 19% reported consultation was unavailable at their predominant practice site. Dilemmas about end-of-life decisions and patient autonomy were often referred for consultation, while dilemmas about justice, such as lack of insurance or limited resources, were rarely referred. While most physicians thought consultations yielded information that would be useful in dealing with future ethical dilemmas (72%), some hesitated to seek ethics consultation because they believed it was too time consuming (29%), might make the situation worse (15%), or that consultants were unqualified (11%).Conclusions: While most internists recall recent ethical dilemmas in their practices, those with the least preparation and experience have the least access to ethics consultation. Health care organizations should emphasize ethics educational activities to prepare physicians for handling ethical dilemmas on their own and should improve the accessibility and responsiveness of ethics consultation when needed. [ABSTRACT FROM AUTHOR]

To identify the ethical dilemmas that internists encounter, the strategies they use to address them, and the usefulness of ethics consultation. National telephone survey. Doctors’ offices. General internists, oncologists, and critical care/pulmonologists ( N = 344, 64% response rate). Types of ethical dilemmas recently encountered and likelihood of requesting ethics consultation; satisfaction with resolution of ethical dilemmas with and without ethics consultation. Internists most commonly reported dilemmas regarding end-of-life decision making, patient autonomy, justice, and conflict resolution. General internists, oncologists, and critical care specialists reported participating in an average of 1.4, 1.3, and 4.1 consultations in the preceding 2 years, respectively ( P < .0001). Physicians with the least ethics training had the least access to and participated in the fewest ethics consultations; 19% reported consultation was unavailable at their predominant practice site. Dilemmas about end-of-life decisions and patient autonomy were often referred for consultation, while dilemmas about justice, such as lack of insurance or limited resources, were rarely referred. While most physicians thought consultations yielded information that would be useful in dealing with future ethical dilemmas (72%), some hesitated to seek ethics consultation because they believed it was too time consuming (29%), might make the situation worse (15%), or that consultants were unqualified (11%). While most internists recall recent ethical dilemmas in their practices, those with the least preparation and experience have the least access to ethics consultation. Health care organizations should emphasize ethics educational activities to prepare physicians for handling ethical dilemmas on their own and should improve the accessibility and responsiveness of ethics consultation when needed. J GEN INTERN MED 2004;19:251–258. [ABSTRACT FROM AUTHOR]

To determine the current immunization recommendations of practicing pediatric nephrologists, a questionnaire was sent to the members of the North American Pediatric Renal Transplant Cooperative Society. Sixty-two percent of the centers responded. The results of the survey suggest that although consensus for approaching immunization does exist, recommendations do vary from center to center. Virtually all centers recommend standard vaccines [DTP, oral poliovirus (OPV), hepatitis B (Hep B), and Haemophilus influenzae B (Hib)] for their renal insufficiency and dialysis patients. Despite the fact that they are not infectious, standard killed vaccines (DTP, Hep B, Hib) are recommended less frequently for transplanted patients (86%) than their renal insufficiency (98%) and dialysis (near 100%) counterparts. Additionally, OPV and measles/mumps/rubella (MMR), both live viral vaccines, are rarely recommended post transplant. Almost 90% of centers recommend the use of influenza vaccine, while only 60% of centers recommend pneumococcal vaccine for children with renal disease. Over 70% of centers recommend the newly licenced varicella vaccine for patients on dialysis and those with renal insufficiency. Between 5% and 12% of centers recommend live viral vaccines, including OPV, MMR, and varicella vaccine, for immunosuppressed patients post renal transplant. [ABSTRACT FROM AUTHOR]

Presents excerpts from the statement given by Gary Gensler, treasury assistant secretary for financial markets on October 8, 1998, focusing on the issuance of United States currency and its role in money laundering.