What makes a biostatistician?

Biostatisticians play an important role in medical research. They are co-responsible for an appropriate and efficient study design, they are involved in monitoring the study conduct, they plan and perform the data analysis, and they are involved in interpreting and publishing the results. However, how are the biostatisticians prepared for their tasks and responsibilities? Graduate programs in biostatistics are being offered, but some practicing biostatisticians completed their studies in a mathematical or epidemiological program, or obtained their degree in subject-specific fields (such as medicine or biology). Therefore, the expertise and the competencies can vary widely between the individual biostatisticians, also depending on the application field. In this article, focusing on European and US practices, we discuss the required professional expertise for the main areas of applications in the medical field as well as the necessary soft skill competencies of a biostatistician.     

Oral lichenoid drug eruptions

OBJECTIVES: To identify, from amongst drugs reported as causing lichenoid drug eruptions, those affecting the oral mucous membranes and to review the clinical, histo-logical and immunological features of such oral lichenoid drug eruptions in comparison to oral lichen planus, amalgam contact lesions and lichen planus-like eruption in graft-versus-host disease (GVHD).
DATA SOURCES: Ovid® Medline data searches on CD-Rom were carried out for the years 1966–1996 to identify reports of oral lichenoid drug eruptions and their clinical, histological and immunological featureS. Articles retrieved were examined for further appropriate references in the period 1940–1996.
DATA EXTRACTION AND SYNTHESIS: Each paper was critically examined for evidence of a clinically verifiable lichenoid drug eruption affecting the oral mucous membranes and the effects of subsequent drug withdrawal. Available clinical, histological and immunological features were recorded. The papers examined were too diverse in nature to permit a structured criticism. The extracted data have been tabulated where appropriate.
CONCLUSIONS: The reports of oral lichenoid drug eruptions are considerably fewer than those of cutaneous eruptions and fewer drugs have been reported as causing oral rather than cutaneous lichenoid eruptionS. Histology and immunology cannot be used reliably to differentiate lichenoid drug eruptions from idiopathic lichen planus, amalgam contact lesions and lichen planus-like eruption in GVHD. Lichenoid drug eruptions may also show some histological characteristics of oral discoid lupus erythematosuS. An accepted protocol agreed by a number of international centres would permit the gathering of substantial information on LDE and could lead to a greater understanding of the mechanisms involved.     

Placement and Restoration of Implants by Predoctoral Students: The Creighton Experience

Teaching of implant dentistry in the predoctoral dental curriculum has evolved dramatically over the past 20 years. In 1974, only one third of American dental schools addressed the topic of implants. Today, 48 of the 54 American dental schools have predoctoral curricula. The Creighton University experience offers some unique and instructive insights into a 10-year process of developing and implementing a predoctoral implant dentistry curriculum. All interested students may perform both the surgical placement and restoration of implant prostheses. Clinical instruction involves all restorative and surgical faculty members. Favorable 3-year (91%) and 5-year (87%) surgical success rates have been maintained. This article presents one university's program for examination and discussion.     

Exogenous or endogenous reservoirs of nosocomialPseudomonas aeruginosa andStaphylococcus aureus infections in a surgical intensive care unit

Objective A 4 month prospective study was performed to assess the incidence and routes of endogenous or exogenous colonization and nosocomial infection caused byStaphylococcus aureus andPseudomonas aeruginosa in surgical critically ill patients.Design A total of 4634 specimens ware obtained. Patient's nasal, scalp, and rectal swabs as well as tracheal secretion (TS) were cultured every second day beginning on the day of admission. Nasal swabs and hand cultures of the personnel as well as cultures from gowns were also taken. all isolates ofS. aureus were phage typed and 116 of these isolates were also plasmid typed.P. aeruginosa isolates were sero-and pyocin typed. Resistance patterns were determined in all isolates.Setting The suty was carried out in the surgical intensive care unit (SICU) of an teaching hospital.Patients During the study period each patient (a total of 153 patients) admitted to the SICU entered the study.Results P. aeruginosa andS. aureus colonisation rate on admission were 5% and 36.5% respectively. Only 10 patients (6.5%) were colonized withP. aeruginosa during hospitalization, and only 7 patients (4.5%) acquiredS. aureus in the surgical intensive care unit (SICU). The most common primary colonisation site ofP. aeruginosa was the rectum, whereasS. aureus was predominantly found in nasal cultures. Horizontal transmission ofS. aureus occured in only 2 patients.Conclusion The study suggests that colonisation withP. aeruginosa andS. aureus occurs from endogenous rather than from exogenous sources and that the endogenous acquisition of both bacteria play a more important role in development of nosocomial infections than the exogenous route of transmission.     

Percutaneous umbilical blood sampling and umbilical vein transfusions. Rapid serologic differentiation of fetal blood from maternal blood

Percutaneous umbilical blood samples (PUBS), obtained under ultrasound guidance, are used for prenatal diagnosis and management of hemolytic disease of the newborn (HDN) and other fetal disorders. Rapid testing at the time of sampling is vital to distinguish fetal from maternal blood. Blood typing was performed by slide technique in the treatment room during 38 procedures on 25 patients. Anti-I was used to test 50 presumed PUBS; venous I-positive maternal blood was tested in parallel. Because anti-I cannot detect fetal blood after umbilical vein transfusion (UVT) of I-positive donor blood, ABO and Rh blood typing reagents were used to test 29 samples when maternal and fetal or donor blood groups differed. Monoclonal reagents were used for optimal detection of weak AB antigens in fetal blood. Avid, chemically modified anti-D was used for Rh typing. Blood typing showed 27 (34%) of 79 samples to be maternal blood. Fetal blood was obtained in 8 of 10 cases investigated for fetal disorder and in 16 cases of potential HDN (anti-D, 5; -CD, 5; -cE, 2; -K, 2; -c; -E). The absence of HDN (antigen-negative fetus) was determined in 4 cases. UVT afforded live birth of 9 of 10 infants with HDN and was not indicated in two cases.     

Donor screening for antibody to hepatitis B core antigen and hepatitis B virus infection in transfusion recipients

BACKGROUND: Testing for antibody to hepatitis B core antigen (anti-HBc) as a surrogate for hepatitis C viremia is no longer needed for blood donor screening. Currently, the important question is how much its use supplements hepatitis B surface antigen (HBsAg) donor screening in preventing transfusion-transmitted hepatitis B virus (HBV) infection. STUDY DESIGN AND METHODS: In a study conducted in the 1970s, 64 blood donors were associated with 15 cases of HBV (1.0%) in 1533 transfusion recipients. Sera from 61 donors at donation and 29 follow-up visits were available for present-day assays for HBsAg, HBV DNA, anti-HBc, and antibody to HBsAg (anti-HBs). RESULTS: HBsAg was found in four previously negative blood donors; HBV DNA was limited to three of these four. Anti-HBc was detected in six HBsAg-negative donors. Two other donors were negative in all assays at donation, but positive for anti- HBc and anti-HBs 2 to 4 months later. The remaining donors were negative for all HBV markers, which left five recipient cases unexplained. No HBV transmission was observed when anti-HBs sample-to- negative control values were > or = 10. CONCLUSION: Some 33 to 50 percent of cases of hepatitis B that could be transmitted by transfusion of blood from HBsAg-negative donors are prevented by anti- HBc screening. Anti-HBc-positive donors unequivocally positive for anti- HBs should be considered noninfectious for HBV and should be allowed to donate. Anti-HBc screening of paid plasmapheresis donors, supplemented by anti-HBs testing, would reduce the amount of HBV to be processed by virus inactivation and increase the content of anti-HBs in plasma pools.     

Influence of architectural design on nosocomial infections in intensive care units—a prospective 2-year analysis

Nosocomial infection rates in an old intensive care ward constructed in 1924 were compared with those in a new one constructed in 1986. The nosocomial infection rate in the old unit was 34.2% and that in the new unit 31.9%, with an average of 33%. The most frequent infections were: pneumonia, urinary tract infection, septicaemia and wound infection. After transfer of the intensive care unit (ICU) the incidence and profile of nosocomial infections remained the same. These findings suggest that the influence of architectural design has little impact on the incidence of nosocomial infections.