On the high probability that a perceived lack of value of obtaining a p value will be detrimental to patient care

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/92406/1/j.1537-2995.1997.37897424414.x.pd

Persistence of cefotetan on red blood cells

Cefotetan can cause severe immune hemolytic anemia that may persist long after the drug is discontinued. To study the binding of cefotetan to RBCs, patients who received cefotetan were followed and tested for the presence of antibody to cefotetan. STUDY DESIGN AND METHODS:  Patients receiving cefotetan were identified from pharmacy and nursing records. Blood samples obtained for routine hematology tests were analyzed. Cefotetan binding to patients’ RBCs was tested using a previously characterized high-titer anticefotetan serum by gel technique. To determine the minimum amount of drug necessary for binding to occur, RBCs were incubated with serial dilutions of cefotetan at pH 7.4. RESULTS:  Sixty patients receiving 1 to 25 g IV (median, 2 g) of cefotetan were followed for 1 to 123 days (median, 18 days). All were initially positive, for cefotetan on RBCs. Positivity persisted for up to 98 days after the last dose of drug. Fifteen patients became negative during follow-up. The first negative sample occurred at Day 30 to 123. Using the midpoint between the last positive and first negative to estimate of the duration of positivity, we estimate that cefotetan remains RBC-bound for 16.5 to 92 days (median, 67.5 days). During the follow-up period, five patients developed anticefotetan detectable in the serum. Twenty patients receiving other cephalosporin antibiotics showed no specific reactivity of their RBCs with anticefotetan. In vitro studies showed a minimum necessary drug concentration of 1 µmol/L at physiologic pH, which was not significantly altered by RBC pretreatment with ficin, sialydase, or DTT. CONCLUSIONS:  Cefotetan is tightly bound to RBCs after intravenous administration and remains detectable for weeks after the last dose. Antibodies to cefotetan may occur in about 8 percent of patients receiving the drug. The minimum necessary concentration for RBC binding is low compared to an estimated plasma concentration of 240 µmol/L from a single IV dose of 1 g.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/72360/1/j.1537-2995.2004.03360.x.pd

Where Have All the Scientific Data Gone? LIS Perspective on the Data-At-Risk Predicament

Scientists produce vast amounts of data that often are not preserved properly or do not have inventories, placing them at risk. As part of an effort to more fully understand the data-at-risk predicament, researchers who were engaged in the DARI project at UNC’s Metadata Research Center surveyed information custodians working in a range of settings. The survey collected information on the data characteristics and preservation plans. Forty-three information custodians completed the survey. The results indicate that at-risk data include a variety of formats, subject areas, and ownership status, as well as compliance with a variety of standards. Although a majority of respondents agree that data preservation is important, they caution that time is the greatest barrier to sharing these data. The study has implications for data rescue and for training information custodians

Revisiting the issue: can the reading for serologic reactivity following 37°C incubation be omitted?

Omitting the 37°C reading from screening tests for unexpected antibodies results in failure to detect some Rh, K, and Jk agglutinins of potential significance (wanted positives). However, this measure avoids unwanted positive tests due to cold agglutinins. STUDY DESIGN AND METHODS : Using data from prior publications, actual risk calculations (ARCs) were made to predict the risk of eliminating the 37°C reading, pretransfusion direct antiglobulin test (DAT), and routine indirect antiglobulin crossmatch (IAT-XM). ARCs used the equation: wanted positives missed × 0.34 (or 0.80) × 5 × percent antigen-positive, where 0.34 = percent of patients transfused (ARCs for 37°C reading and DAT); 0.80 = percent of crossmatched patients transfused (ARCs for IAT-XM); 5 = average number of units transfused. Following elimination of the 37°C reading, the impact of this change on patient care was monitored. Antibody detection and identification data and transfusion reaction reports for 6 months after the change were reviewed. Recently transfused patients with new antibodies were evaluated for immune hemolysis by review of clinical and laboratory data. The findings were compared with those from the same dates of the preceding year. RESULTS : The risk of transfusing incompatible blood by eliminating the DAT, IAT-XM, and 37°C reading is approximately 1:13,000, 1:2,000, and 1:2,400 units transfused, respectively. The cumulative risk from eliminating all three tests is approximately. 1:1,000 units. With respect to the 37°C reading, there were no differences between the pre-change and post-change study periods in the incidence of reported transfusion reactions or cases of immune hemolysis associated with newly formed antibodies. However, unwanted positive tests decreased from 162 to 61 following elimination of the 37°C reading. This represents a decrease of 20 percent in the number of samples requiring antibody identification annually. CONCLUSIONS : Eliminating the 37°C reading from pretransfusion antibody screening tests imposes less risk than omitting the routine IAT-XM, and it avoids the time and costs of evaluating unwanted positive tests, thus reducing expenditures and delays in patient care.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/74728/1/j.1537-2995.1999.39399219287.x.pd

Group consensus review minimizes the diagnosis of “follicular lesion of undetermined significance” and improves cytohistologic concordance

We conducted a group consensus review of thyroid aspirates that were previously interpreted as “atypia of undetermined significance/follicular lesion of undetermined significance” (AUS/FLUS) and followed by surgical interventions. The study aimed to investigate if consensus review would minimize the diagnosis of AUS/FLUS with an optimal interobserver agreement and also promote a better cytohistologic concordance. A group of reviewers who were blinded to the corresponding histologic findings simultaneously evaluated a total of 50 aspirates at a multiheaded light microscope. Using the Bethesda System for Reporting Thyroid Cytopathology as a guideline, a consensus interpretation was reached upon review of each aspirate. Interobserver agreement was calculated and recorded. The cytohistologic correlation was then performed between the consensus interpretation and the corresponding histologic diagnosis. The consensus review reclassified 26 (52%) aspirates as non‐neoplasia/benign, 10 (20%) as follicular neoplasm/suspicious for a follicular neoplasm, 1 (2%) as papillary thyroid carcinoma, and 2 (4%) as nondiagnostic. Eleven (22%) aspirates remained AUS/FLUS. The interobserver agreement across the five diagnostic categories ranged from 71.6% to 100% with an average level of 88.8%. Cytohistologic concordance was achieved in 24 of 26 (92.3%) and 9 of 11 (81.8%) aspirates that were reclassified as non‐neoplasia/benign and neoplasia/malignancy, respectively. A diagnostic accuracy of 89.2% (33/37) was obtained in reclassified cases. In conclusion, the group consensus review minimized AUS/FLUS, offered an optimal level of interobserver agreement, and most importantly, promoted excellent cytohistologic concordance in reclassified cases and, therefore, could play a substantial role in the future in reducing reaspiration and/or unnecessary surgeries. Diagn. Cytopathol. 2012. © 2011 Wiley‐Liss, IncPeer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/94484/1/21702_ftp.pd

Exaggerated pigmented granulomatous reaction to the artificial joint implant mimics metastatic melanoma

Total joint replacement is a common orthopedic procedure. An artificial joint implant may fail due to mechanical mishap and a granulomatous reaction can be induced by the artificial joint debris after the mechanical failure. We report a case of an exaggerated pigmented granulomatous tissue response to metallic artificial joint implant debris in a 72-yr-old male that was mistaken for metastatic melanoma. The mass was soft, pigmented, ill-defined, and located in the right inguinal region. Fine-needle aspiration revealed numerous black-pigment laden cells. The cellular features were frequently obscured by the heavy pigmentation. Occasional cells exhibited atypia and prominent nucleoli. There were also abundant extracellular irregular small black particles dispersed in the background. The diagnosis of melanoma involving a lymph node was made. Since there was no prior history of melanoma, it was presumed that this represented metastatic melanoma from an unknown primary. A subsequent exploration of the groin was performed with the intent to resect the disease. At exploration, the mass was found to be contiguous with the hip joint and the frozen section of the mass revealed no evidence of melanoma. The final tissue diagnosis confirmed the frozen section report and showed a granulomatous reaction. This report underscores the diagnostic dilemma associated with the exaggerated pigmented granulomatous reaction due to an artificial prosthesis. Diagn. Cytopathol. 2004;30:198–200. © 2004 Wiley-Liss, Inc.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/35313/1/20006_ftp.pd

Infusion of P‐Capt prion‐filtered red blood cell products demonstrate acceptable in vivo viability and no evidence of neoantigen formation

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/86946/1/j.1537-2995.2011.03133.x.pd

Case report and literature review: transient Inab phenotype and an agglutinating anti-IFC in a patient with a gastrointestinal problem

The Inab phenotype is a rare deficiency of all Cromer antigens. These antigens are carried on the decay-accelerating factor (DAF, CD55) molecule that is attached to the red blood cell (RBC) membrane by a glycosylphosphatidylinositol (GPI) anchor. Although typically inherited, an acquired and transient form of the Inab phenotype also exists. A patient with the triad of transient Inab phenotype, a direct-agglutinating anti-IFC, and gastrointestinal (GI) abnormalities is reported. CASE REPORT: An 18-month-old boy with gastroesophageal reflux disease requiring a feeding tube, milk and soy intolerance, and severe growth retardation, as well as vision and hearing deficits from cytomegalovirus infection, was identified when pretransfusion testing revealed a potent panagglutinin (titer > 2000 at 4°C). This antibody did not react with Dr(a–) and IFC RBCs, and the autocontrol was negative. The patient’s RBCs lacked CD55 by flow cytometric techniques but had normal levels of CD59 and antigens such as Yt a and Emm, carried on GPI-linked proteins, thus excluding paroxysmal nocturnal hemoglobinuria. Several months after initial detection, the anti-IFC was virtually undetectable and his cells reacted weakly with anti-IFC, anti-Dr a , and anti-CD55. RBCs from the propositus’ parents and brother demonstrated normal CD55 and CD59 expression. CONCLUSION: This is the first example of a direct-agglutinating anti-IFC. The cause of the transient depression in CD55 protein (and thus Cromer system antigens) and appearance of anti-IFC remains unknown, as does the relationship between the patient’s GI system abnormalities and these serologic findings.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/71992/1/j.1537-2995.2006.00933.x.pd

‘An almost continuous picture of sordid vice’: The Keeler Affair, the Profumo Scandal and ‘Political’ Film Censorship in the 1960s

In 1963, the Profumo affair brought Christine Keeler to public attention and transformed her, briefly, into one of the most talked about women in the world. Seeking to exploit her notoriety, Topaz Films entered into an agreement with Keeler to make a cinematic version of her life story, The Keeler Affair. This article explores some of the controversies surrounding The Keeler Affair, especially in terms of the way in which the British Board of Film Censors dealt with the film. The Keeler Affair was submitted to the BBFC on two occasions – once when it was completed and then again in 1969 when Keeler's memoirs were serialised in the News of the World – and was rejected both times. On the second occasion, The Keeler Affair was also submitted to, and rejected by, the Greater London Council. The article seeks to establish some of the political factors that shaped the BBFC's and the GLC's attitudes towards politically contentious films, and demonstrates that the decisions made by the censors were guided not simply by the content of The Keeler Affair, but also by personal relationships, shared Establishment attitudes, concerns about public perceptions of the film industry and a desire not to be drawn into political controversies. Consequently, the article serves to reinforce the idea that censorship is best understood as a dynamic process shaped by a host of determining factors, many of which might best be described as extra- or para-cinematic