Recent Publications by CFE Educators

PURPOSE

To quantify the prevalence of social and behavioral sciences (SBS) topics during patient care and to rate team response to these topics once introduced.

METHOD

This cross-sectional study used five independent raters to observe 80 inpatient ward teams on internal medicine and pediatric services during attending rounds at two academic hospitals over a five-month period. Patient-level primary outcomes-prevalence of SBS topic discussions and rate of positive responses to discussions-were captured using an observational tool and summarized at the team level using hierarchical models. Teams were scored on patient- and learner-centered behaviors.

RESULTS

Observations were made of 80 attendings, 83 residents, 75 interns, 78 medical students, and 113 allied health providers. Teams saw a median of 8.0 patients per round (collectively, 622 patients), and 97.1% had at least one SBS topic arise (mean = 5.3 topics per patient). Common topics were pain (62%), nutrition (53%), social support (52%), and resources (39%). After adjusting for team characteristics, the number of discussion topics raised varied significantly among the four services and was associated with greater patient-centeredness. When topics were raised, 38% of teams' responses were positive. Services varied with respect to learner- and patient-centeredness, with most services above average for learner-centered, and below average for patient-centered behaviors.

CONCLUSIONS

Of 30 SBS topics tracked, some were addressed commonly and others rarely. Multivariable analyses suggest that medium-sized teams can address SBS concerns by increasing time per patient and consistently adopting patient-centered behaviors.

IMPORTANCE

Postmarketing surveillance is critical to evaluating the safety and effectiveness of medical devices. The US Food and Drug Administration (FDA) may order the manufacturer of a high-risk device to conduct postmarketing surveillance studies, known as postapproval studies (PASs), at the time of approval.

OBJECTIVES

To understand the characteristics of PASs ordered in recent years and inform discussions about the direction of the PASs program.

DESIGN

Descriptive study of the PASs ordered for medical devices using the FDA's PASs website, the Premarket Approval database, and supplemental information provided by the FDA.

MAIN OUTCOMES AND MEASURES

The proportion of medical devices that received a PAS order and study characteristics.

RESULTS

Between January 1, 2005, and December 31, 2011, the FDA ordered 223 studies of 158 medical devices, including studies for 93 (48%) new high-risk devices approved during this period. The median required sample size for a study was 350 patients (interquartile range, 160-1500). If the protocol of a study was not in place at the time the device was approved, which occurred frequently, a median of 180 days elapsed until the protocol was agreed on. The FDA has never issued a warning letter or penalty owing to study delays, inadequate progress, or any other issue related to a PAS. Of the approved protocols, 41 (19%) were subsequently revised, including 29 (21%) protocols in place by application approval. Some studies generated significant clinical findings. The most common effect of a PAS finding after study completion was that the FDA requested a labeling change for 31 studies (53%).

CONCLUSIONS AND RELEVANCE

Postapproval studies have the potential to provide additional information to better understand medical device performance. However, small sample sizes, delays in reaching protocol agreement, and lack of availability of findings may hinder their ability to be clinically useful. Owing to the lack of information on the effect of studies, it is unclear whether the program achieves its aims. Improved completion and accessibility of PASs could help answer important questions of safety and effectiveness about medical devices. To better understand the real-world performance of these products, they should be better integrated with other sources of information about device performance.

PURPOSE

Faculty developers play a crucial role in preparing faculty members for their instructional responsibilities. In some programs, faculty developers are clinicians and scientists who only occasionally conduct workshops. The authors examine the identity formation of such part-time faculty developers.

METHOD

From April 2012 through March 2012, structured interviews were conducted with full-time faculty members who, from 2007 to 2012, periodically volunteered to teach workshops in the University of California, San Francisco School of Medicine's faculty development program. This qualitative study used a modified grounded theory approach.

RESULTS

The authors interviewed 29 occasional faculty developers who had 1 to 22 years of experience conducting faculty development programs. All faculty had an educator identity along with their professional identity. The additional faculty developer identity generally evolved over time and aligned with their identity in one of four ways: compartmentalized, hierarchical, parallel, or merged. Their roles as faculty developers enhanced their status in their work community and influenced the way they worked with others and advanced their careers. Faculty development influences the institutional culture, and the institutional culture supports faculty development.

CONCLUSIONS

Most occasional faculty developers possessed a merged identity that developed over time and was moderated by the topic that they taught. Although experience contributed to this development, both junior and senior faculty developers could have a merged identity. Those who lead faculty development programs can use these findings to recruit and retain faculty developers.

Physicians have many information needs that arise at the point of care yet go unmet for a variety of reasons, including uncertainty about which information resources to select. In this study, we aimed to identify the various types of physician information needs and how these needs relate to physicians' use of the database PubMed and the evidence summary tool UpToDate. We conducted semi-structured interviews with physicians (Stanford University, United States; n = 13; and University Medical Center Utrecht, the Netherlands; n = 9), eliciting participants' descriptions of their information needs and related use of PubMed and/or UpToDate. Using thematic analysis, we identified six information needs: refreshing, confirming, logistics, teaching, idea generating and personal learning. Participants from both institutions similarly described their information needs and selection of resources. The identification of these six information needs and their relation to PubMed and UpToDate expands upon previously identified physician information needs and may be useful to medical educators designing evidence-based practice training for physicians.

PURPOSE

The projected U.S. physician shortage will disproportionately affect underserved areas. This study examined the impact of medical school educational experiences on positive changes in and reaffirmation of students' intention to practice in underserved areas (practice intention).

METHOD

Medical students (n = 7,361) from 113 U.S. MD-granting medical schools who graduated in 2009-2010 and responded to both the Association of American Medical Colleges' 2006 Matriculating Student Questionnaire and 2010 Graduation Questionnaire were included. Multilevel logistic regression analyses were conducted to determine factors associated with change in and reaffirmation of practice intention.

RESULTS

After controlling for individual characteristics, community health field experience (adjusted odds ratio [OR]: 1.36; 95% CI: 1.18, 1.57), learning another language (OR: 1.41; 95% CI: 1.22, 1.63), cultural competence/awareness experience (OR: 1.38; 95% CI: 1.21, 1.58), becoming more aware of perspectives of individuals from different backgrounds (OR: 1.24; 95% CI: 1.04, 1.48), and attending schools with higher social mission scores (OR: 1.66; 95% CI: 1.28, 2.16) were all significantly associated with positive changes in practice intention from matriculation to graduation. Field experience in community health (OR: 1.24; 95% CI: 0.99, 1.53), learning another language (OR: 1.29; 95% CI: 1.01, 1.65), and attending schools with higher social mission scores (OR: 1.62; 95% CI: 1.09, 2.43) were all significantly associated with reaffirmation of practice intention at graduation.

CONCLUSIONS

Multifaceted factors are associated with practice intention. This study suggests medical schools can play active roles in alleviating the physician shortage in underserved areas through targeted curricular interventions and recruitment.

BACKGROUND

Heightened immune activation among human immunodeficiency virus (HIV)-infected persons may contribute to atherosclerosis. We assessed associations of serologic markers of monocyte activation, soluble CD163 (sCD163) and soluble CD14 (sCD14), and monocyte chemoattractant protein 1 (CCL2) with subclinical atherosclerosis among men with and those without HIV infection in the Multicenter AIDS Cohort Study.

METHODS

We performed noncontrast computed tomography on 906 men (566 HIV-infected men and 340 HIV-uninfected men), 709 of whom also underwent coronary computed tomographic angiography. Associations between each biomarker and the prevalence of coronary plaque, the prevalence of stenosis of ≥50%, and the extent of plaque were assessed by logistic and linear regression, adjusting for age, race, HIV serostatus, and cardiovascular risk factors.

RESULTS

Levels of all biomarkers were higher among HIV-infected men, of whom 81% had undetectable HIV RNA, and were associated with lower CD4(+) T-cell counts. In the entire population and among HIV-infected men, higher biomarker levels were associated with a greater prevalence of coronary artery stenosis of ≥50%. Higher sCD163 levels were also associated with greater prevalences of coronary artery calcium, mixed plaque, and calcified plaque; higher CCL2 levels were associated with a greater extent of noncalcified plaque.

CONCLUSIONS

sCD163, sCD14, and CCL2 levels were elevated in treated HIV-infected men and associated with atherosclerosis. Monocyte activation may increase the risk for cardiovascular disease in individuals with HIV infection.

BACKGROUND

The presence and location of regional lymph node metastasis affect the prognosis of patients with thyroid cancer. Lymph node classification of the current TNM system may be inadequate because it insufficiently characterizes the nature and severity of lymph node metastasis that may influence prognosis.

METHODS

We retrospectively studied 240 patients with papillary thyroid cancer and node metastases who had undergone total thyroidectomy, lymph node dissection, and postoperative (131) I treatment at the University Cancer Center between 1994 and 2004. We reviewed the status of regional lymph node metastasis, including the location, number, largest size, and extranodal tumor extension and analyzed their effect on the prognosis of the patients.

RESULTS

There were 172 women and 68 men, with a median age of 38 years and median tumor size of 1.9 cm. Thirty-five percent had only central compartment (N1a) nodal metastasis and 65% had involvement of both central and lateral compartments (N1b). There were a median of 4 nodes containing metastasis with a median largest diameter of 1.2 cm. Sixty patients (25%) had extranodal extension of cancer. Multivariate analysis showed that patient age (p = .0017; hazard ratio [HR], 2.156), >3 lymph node metastasis (p = .0316; HR, 1.806), and extranodal extension (p  .0001; HR, 4.027) were independent predictors of disease recurrence. Patient age (p = .0034; HR, 22.068), vascular invasion (p = .01; HR, 8.2), and extranodal extension (p = .022; HR, 12.597) were independent predictors of disease-specific survival (DSS). The DSS and recurrence-free survival curve between patients with and without extranodal extension differ significantly (p  .0001). For those older than 45 years, the 10-year recurrence was 11 of 43 patients for those without extranodal extension and 24 of 27 patients for those with extranodal extension (p  .001). Among patients with stage 4a/4b, those with extranodal extension had a significantly worse DSS and disease-free survival (DFS; p  .001) than those without extranodal extension. The prognosis of patients with stage 4a/4b cancer who had no extranodal extension was the same as patients with stage 3 cancer. The status of extranodal extension seems to be a stronger prognostic predictor than the location of metastatic lymph nodes (N1a/1b).

CONCLUSION

Presence of extranodal extension of metastatic nodes is a significant adverse independent prognostic factor for patients with lymph node metastasis from papillary cancer. This may need to be considered in future updates of the TNM system for thyroid cancer.

BACKGROUND

Recent studies of children and adolescents who were exposed to radioactive iodine-131 (I-131) after the 1986 Chernobyl nuclear accident in Ukraine exhibited a significant dose-related increase in the risk of thyroid cancer, but the association of radiation doses with tumor histologic and morphologic features is not clear.

METHODS

A cohort of 11,664 individuals in Belarus who were aged ≤18 years at the time of the accident underwent 3 cycles of thyroid screening during 1997 to 2008. I-131 thyroid doses were estimated from individual thyroid activity measurements taken within 2 months after the accident and from dosimetric questionnaire data. Demographic, clinical, and tumor pathologic characteristics of the patients with thyroid cancer were analyzed using 1-way analysis of variance, chi-square tests or Fisher exact tests, and logistic regression.

RESULTS

In total, 158 thyroid cancers were identified as a result of screening. The majority of patients had T1a and T1b tumors (93.7%), with many positive regional lymph nodes (N1; 60.6%) but few distant metastases (M1; 1%). Higher I-131 doses were associated with higher frequency of solid and diffuse sclerosing variants of thyroid cancer (P  .01) and histologic features of cancer aggressiveness, such as lymphatic vessel invasion, intrathyroidal infiltration, and multifocality (all P  .03). Latency was not correlated with radiation dose. Fifty-two patients with self-reported thyroid cancers which were diagnosed before 1997 were younger at the time of the accident and had a higher percentage of solid variant cancers compared with patients who had screening-detected thyroid cancers (all P  .0001).

CONCLUSIONS

I-131 thyroid radiation doses were associated with a significantly greater frequency of solid and diffuse sclerosing variants of thyroid cancer and various features of tumor aggressiveness.

A case of false-negative serum latex agglutination cryptococcal antigen (CRAG) test in a 45-year-old HIV-positive male with Cryptococcus-positive culture is described. The patient was presented to a hospital in Botswana, with breathlessness and a diffuse papular rash. His CD4 count was 25 cells/μL. Despite the suspicion for disseminated cryptococcal disease, an initial serum CRAG latex test was negative. Results of subsequent Indian ink staining, culture of cerebrospinal fluid and skin scrapings, and serum lateral flow immunoassay (LFA) were all positive for Cryptococcus neoformans. There are several possible explanations for the false-negative CRAG latex test. Given the positive LFA result, we speculate that disease may have been caused by Cryptococcus gattii, which is estimated to be responsible for between 15% and 30% of all cryptococcal diseases in Botswana. Reduced sensitivity of CRAG latex assays for detecting C gattii may lead to underdiagnosis of cryptococcal infection.