Recent Publications by CFE Educators

PURPOSE OF REVIEW

Primary thyroid lymphoma (PTL) is a rare but clinically important malignancy of the thyroid. This article reviews the diagnosis, histologic subtypes, pathogenesis, and treatment of PTL, with the objective of optimizing diagnosis and management of the disease.

RECENT FINDINGS

Recent studies have shed light on the clinicopathologic features of the histologic subtypes of PTL. Analysis of the pathogenesis of PTL indicates that both antigenic stimulation in the setting of Hashimoto's thyroiditis and aberrant somatic hypermutation may play a role. The first large, population-based study of PTL indicated that age, stage, histologic subtype, and treatment modality have prognostic implications. The U.S. Food and Drug Administration approval of rituximab for non-Hodgkin's lymphoma has improved standard chemotherapeutic options, as data on efficacy in nodal and other extranodal lymphomas have been extrapolated to PTL.

SUMMARY

Advances in the understanding of the histologic subtypes of PTL have led to more accurate diagnosis and tailored treatments. The introduction of a new chemotherapeutic agent has expanded the treatment paradigm for PTL. Important prognostic indicators of survival for patients with PTL have been confirmed in the first population-based study. This article emphasizes current diagnostic and treatment approaches and discusses the potential for future developments.

Rodeo is one of the few sports still sponsored by the tobacco industry, particularly the US Smokeless Tobacco Company. Rodeo is popular in rural communities, where smokeless tobacco use is more prevalent. We used previously secret tobacco industry documents to examine the history and internal motivations for tobacco company rodeo sponsorship. Rodeos allow tobacco companies to reach rural audiences and young people, enhance brand image, conduct market research, and generate positive press. Relationships with athletes and fans were used to fight proposed restrictions on tobacco sports sponsorship. Rodeo sponsorship was intended to enhance tobacco sales, not the sport. Rural communities should question the tradition of tobacco sponsorship of rodeo sports and reject these predatory marketing practices.

PURPOSE

To directly examine the relationship between commercial support of continuing medical education (CME) and perceived bias in the content of these activities.

METHOD

Cross-sectional study of 213 accredited live educational programs organized by a university provider of CME from 2005 to 2007. A standard question from course evaluations was used to determine the degree to which attendees believed commercial bias was present. Binomial regression models were used to determine the association between course features that may introduce commercial bias and the extent of perceived bias at those CME activities.

RESULTS

Mean response rate for attendee evaluations was 56% (SD 15%). Commercial support covered 20%-49% of costs for 45 (21%) educational activities, and > or = 50% of costs for 46 activities (22%). Few course participants perceived commercial bias, with a median of 97% (interquartile range 95%-99%) of respondents stating that the activity they attended was free of commercial bias. There was no association between extent of commercial support and the degree of perceived bias in CME activities. Similarly, perceived bias did not vary for 11 of 12 event characteristics evaluated as potential sources of commercial bias, or by score on a risk index designed to prospectively assess risk of commercial bias.

CONCLUSIONS

Rates of perceived bias were low for the vast majority of CME activities in the sample and did not differ by the degree of industry support or other event characteristics. Further study is needed to determine whether commercial influence persisted in more subtle forms that were difficult for participants to detect.

CONTEXT

Medical devices are common in clinical practice and have important effects on morbidity and mortality, yet there has not been a systematic examination of evidence used by the US Food and Drug Administration (FDA) for device approval.

OBJECTIVES

To study premarket approval (PMA)--the most stringent FDA review process--of cardiovascular devices and to characterize the type and strength of evidence on which it is based.

DATA SOURCES AND STUDY SELECTION

Systematic review of 78 summaries of safety and effectiveness data for 78 PMAs for high risk cardiovascular devices that received PMA between January 2000 and December 2007 [corrected].

DATA EXTRACTION

Examination of the methodological characteristics considered essential to minimize confounding and bias, as well as the primary end points of the 123 studies supporting the PMAs.

RESULTS

Thirty-three of 123 studies (27%) used to support recent FDA approval of cardiovascular devices were randomized and 17 of 123 (14%) were blinded. Fifty-one of 78 PMAs (65%) were based on a single study. One hundred eleven of 213 primary end points (52%) were compared with controls and 34 of 111 controls (31%) were retrospective. One hundred eighty-seven of 213 primary end points (88%) were surrogate measures and 122 of 157 (78%) had a discrepancy between the number of patients enrolled in the study and the number analyzed.

CONCLUSION

Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias.

PURPOSE

We studied the patient risk factors that promote urethroplasty failure.

MATERIALS AND METHODS

Records of patients who underwent urethroplasty at the University of California, San Francisco Medical Center between 1995 and 2004 were reviewed. Cox proportional hazards regression analysis was used to identify multivariate predictors of urethroplasty outcome.

RESULTS

Between 1995 and 2004, 443 patients of 495 who underwent urethroplasty had complete comorbidity data and were included in analysis. Median patient age was 41 years (range 18 to 90). Median followup was 5.8 years (range 1 month to 10 years). Stricture recurred in 93 patients (21%). Primary estimated stricture-free survival at 1, 3 and 5 years was 88%, 82% and 79%. After multivariate analysis smoking (HR 1.8, 95% CI 1.0-3.1, p = 0.05), prior direct vision internal urethrotomy (HR 1.7, 95% CI 1.0-3.0, p = 0.04) and prior urethroplasty (HR 1.8, 95% CI 1.1-3.1, p = 0.03) were predictive of treatment failure. On multivariate analysis diabetes mellitus showed a trend toward prediction of urethroplasty failure (HR 2.0, 95% CI 0.8-4.9, p = 0.14).

CONCLUSIONS

Length of urethral stricture (greater than 4 cm), prior urethroplasty and failed endoscopic therapy are predictive of failure after urethroplasty. Smoking and diabetes mellitus also may predict failure potentially secondary to microvascular damage.

Cloacal dysgenesis sequence (CDS) is a severe hindgut malformation occurring in 1:50,000 to 250,000 live births (Qureshi et al. Prenatal diagnosis of cloacal dysgenesis sequence: differential diagnosis from other forms of fetal obstructive uropathy. Fetal Diagn Ther 1998;13:69-74; Bargaje et al. Cloacal dysgenesis sequence. Ann Diagn Pathol 2008;12:62-66). It is characterized by a smooth perineum with no urethral, vaginal, or anal openings, and lack of labioscrotal development. Typically, the bladder, vagina, and colon each end blindly, although persistent cloaca without perineal orifice can be seen. With no egress for urine, infants have renal insufficiency and pulmonary hypoplasia, usually making CDS lethal (Sahinoglu Z et al. The prenatal diagnosis of cloacal dysgenesis in six cases: can the termination of pregnancy always be the first choice? Prenat Diagn 2004;24:10-16). Reported survivors have had a persistent urachus or have been spared the effects of oligohydramnios by the presence of a twin (Liang X. Cloacal dysgenesis sequence: observations in four patients, including three fetuses of second trimester gestation. Pediatr Dev Pathol 1998;1:281-288). We report a case of long-term survival, currently to 25 months of age, and renal transplantation in a monochorionic, diamniotic twin girl with CDS.