Recent Publications by CFE Educators

Recent large-scale genetic-based studies have transformed the field of pharmacogenetics to identify, characterize and leverage genetic information to inform patient care. Genetic testing can be used to alter drug selection, optimize drug dosing and prevent unnecessary adverse events. As precision medicine becomes the mainstay in the clinic, it becomes critical for clinicians to utilize pharmacogenetics to guide patient care. One primary challenge is identifying patients where genetic tests that can potentially impact patient care. To address this challenge, our review highlights many practical issues clinicians may encounter: identifying candidate patients and clinical laboratories for pharmacogenetic testing, selecting highly curated resources to help asses test validity, reimbursing costs of pharmacogenetic tests, and interpreting of pharmacogenetic test results.

BACKGROUND

Data on the importance of margin status after total thyroidectomy for papillary thyroid cancer (PTC) remain limited. This study sought to identify factors associated with positive margins and to determine the impact of positive margins on survival for patients with PTC.

METHODS

The National Cancer Data Base (1998-2006) was queried for patients with PTC who had undergone total thyroidectomy. The patients were divided into three groups based on margin status (negative, microscopically positive, and macroscopically positive). Patient demographic, clinical, and pathologic features were evaluated. A binary logistic regression model was developed to identify factors associated with positive margins. A Cox proportional hazards model was developed to identify factors associated with survival.

RESULTS

Of the 31,129 patients enrolled in the study, 91.3 % had negative margins, 8.1 % had microscopically positive margins, and 0.6 % had macroscopically positive margins. The patients with negative margins were younger and more likely to be female, white, covered by private insurance, and treated at an academic or high-volume center (p 0.05). They had smaller tumors and were less likely to have advanced-stage disease. After multivariable adjustment, increasing patient age [odds ratio (OR) = 1.02; p 0.01], government insurance (OR = 1.20; p 0.01), and no insurance (OR = 1.34; p = 0.01) were associated with positive margins. Reception of surgery at a high-volume facility (OR = 0.72; p 0.01) was protective. After multivariable adjustment, both microscopically [hazard ratio (HR), 1.49; p 0.01] and macroscopically positive margins (HR = 2.38; p 0.01) were associated with compromised survival.

CONCLUSIONS

Several vulnerable patient populations have a higher risk of incomplete resection after thyroidectomy for PTC. High-risk thyroid cancer patients should be referred to high-volume centers to optimize outcomes.

PURPOSE

Radiation oncology curriculum development is challenging because of limited numbers of trainees at any single institution. The goal of this project is to implement and evaluate a standardized medical student clerkship curriculum following the multi-institutional cooperative group research model.

METHODS

During the 2013 academic year, a standardized curriculum was implemented at 11 academic medical centers consisting of three 1-hour lectures and a hands-on radiation treatment planning workshop. After the curriculum, students completed anonymous evaluations using Likert-type scales (1 = "not at all" to 5 = "extremely") and free responses. Evaluations asked students to rate their comfort, before and after the curriculum, with radiation oncology as a specialty, knowledge of radiotherapy planning methods, and ability to function as a radiation oncology resident. Nonparametric statistical tests were used in the analysis.

RESULTS

Eighty-eight students at 11 academic medical centers completed the curriculum de novo, with a 72.7% (64 of 88) survey response rate. Fifty-seven students (89.1%) reported intent to pursue radiation oncology as their specialty. Median (interquartile range) student ratings of the importance of curricular content were as follows: overview, 4 (4-5); radiation biology/physics, 5 (4-5); practical aspects/emergencies, 5 (4-5); and planning workshop, 4 (4-5). Students reported that the curriculum helped them better understand radiation oncology as a specialty (5 [4-5]), increased specialty decision comfort (4 [3-5]), and would help the transition to radiation oncology residency (4 [4-5]). Students rated their specialty decision comfort significantly higher after completing the curriculum (4 [4-5] versus 5 [5-5]; P .001).

CONCLUSIONS

A national standardized curriculum was successfully implemented at 11 academic medical centers, providing proof of principle that curriculum development can follow the multi-institutional cooperative group research model.

OBJECTIVES/HYPOTHESIS

Benign midmembranous vocal fold lesions (BMVFLs) are common voice disorders, but interpretation of outcomes following treatment is difficult due to the lack of a standardized nomenclature system for these lesions. Outcome results are increasingly important to third party payers. This study aimed to investigate the outcomes of patients with BMVFLs using a previously validated nomenclature, and to provide incidences and outcome results for each diagnosis.

METHODS

A retrospective chart review of BMVFL patients was performed. Treatment was individualized but typically involved implementation of nonsurgical therapy followed by phonomicrosurgery as needed. A previously reported BMVFL stratification system was used.

RESULTS

A total of 224 patients with BMVFLs were studied. Sixty-seven percent of all patients with a BMVFL underwent phonomicrosurgery. The most common BMVFL types were polyp and nonspecific vocal fold lesion. Pseudocyst represented 0.9% of the cohort. The Voice Handicap Index-10 (VHI-10) and acoustic data demonstrate a high degree of treatment success. The mean change in VHI-10 was greatest for cyst-subepithelial and polyp. Fibrous mass-ligamentous patients had the smallest mean change in VHI-10. Mean post-treatment VHI-10 scores of all the lesions except fibrous mass-ligamentous were within normal limits (11).

CONCLUSIONS

This study represents the first outcomes-based report of BMVFLs using a strictly defined nomenclature system for stratification of lesions. Ligamentous fibrous mass lesions have a decreased response to treatment compared to all other lesions. This study demonstrates the ability to return most BMVFL patients to normal speaking voice capabilities following treatment.

LEVEL OF EVIDENCE

4.

With high rates of unintended pregnancy in sub-Saharan Africa, integration of family planning (FP) into HIV care is being explored as a strategy to reduce unmet need for contraception. Perspectives and experiences of healthcare providers are critical in order to create sustainable models of integrated care. This qualitative study offers insight into how HIV care providers view and experience the benefits and challenges of providing integrated FP/HIV services in Nyanza Province, Kenya. Sixteen individual interviews were conducted among healthcare workers at six public sector HIV care facilities one year after the implementation of integrated FP and HIV services. Data were transcribed and analyzed qualitatively using grounded theory methods and Atlas.ti. Providers reported a number of benefits of integrated services that they believed increased the uptake and continuation of contraceptive methods. They felt that integrated services enabled them to reach a larger number of female and male patients and in a more efficient way for patients compared to non-integrated services. Availability of FP services in the same place as HIV care also eliminated the need for most referrals, which many providers saw as a barrier for patients seeking FP. Providers reported many challenges to providing integrated services, including the lack of space, time, and sufficient staff, inadequate training, and commodity shortages. Despite these challenges, the vast majority of providers was supportive of FP/HIV integration and found integrated services to be beneficial to HIV-infected patients. Providers' concerns relating to staffing, infrastructure, and training need to be addressed in order to create sustainable, cost-effective FP/HIV integrated service models.

OBJECTIVE

To provide evidence-based recommendations for the treatment of patients with ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (SpA).

METHODS

A core group led the development of the recommendations, starting with the treatment questions. A literature review group conducted systematic literature reviews of studies that addressed 57 specific treatment questions, based on searches conducted in OVID Medline (1946-2014), PubMed (1966-2014), and the Cochrane Library. We assessed the quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method. A separate voting group reviewed the evidence and voted on recommendations for each question using the GRADE framework.

RESULTS

In patients with active AS, the strong recommendations included use of nonsteroidal antiinflammatory drugs (NSAIDs), use of tumor necrosis factor inhibitors (TNFi) when activity persists despite NSAID treatment, not to use systemic glucocorticoids, use of physical therapy, and use of hip arthroplasty for patients with advanced hip arthritis. Among the conditional recommendations was that no particular TNFi was preferred except in patients with concomitant inflammatory bowel disease or recurrent iritis, in whom TNFi monoclonal antibodies should be used. In patients with active nonradiographic axial SpA despite treatment with NSAIDs, we conditionally recommend treatment with TNFi. Other recommendations for patients with nonradiographic axial SpA were based on indirect evidence and were the same as for patients with AS.

CONCLUSION

These recommendations provide guidance for the management of common clinical questions in AS and nonradiographic axial SpA. Additional research on optimal medication management over time, disease monitoring, and preventive care is needed to help establish best practices in these areas.

OBJECTIVE

To provide evidence-based recommendations for the treatment of patients with ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (SpA).

METHODS

A core group led the development of the recommendations, starting with the treatment questions. A literature review group conducted systematic literature reviews of studies that addressed 57 specific treatment questions, based on searches conducted in OVID Medline (1946-2014), PubMed (1966-2014), and the Cochrane Library. We assessed the quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method. A separate voting group reviewed the evidence and voted on recommendations for each question using the GRADE framework.

RESULTS

In patients with active AS, the strong recommendations included use of nonsteroidal antiinflammatory drugs (NSAIDs), use of tumor necrosis factor inhibitors (TNFi) when activity persists despite NSAID treatment, not to use systemic glucocorticoids, use of physical therapy, and use of hip arthroplasty for patients with advanced hip arthritis. Among the conditional recommendations was that no particular TNFi was preferred except in patients with concomitant inflammatory bowel disease or recurrent iritis, in whom TNFi monoclonal antibodies should be used. In patients with active nonradiographic axial SpA despite treatment with NSAIDs, we conditionally recommend treatment with TNFi. Other recommendations for patients with nonradiographic axial SpA were based on indirect evidence and were the same as for patients with AS.

CONCLUSION

These recommendations provide guidance for the management of common clinical questions in AS and nonradiographic axial SpA. Additional research on optimal medication management over time, disease monitoring, and preventive care is needed to help establish best practices in these areas.

BACKGROUND

We examined whether self-reported employee health status data can improve the performance of administrative data-based models for predicting future high health costs, and develop a predictive model for predicting new high cost individuals.

METHODS

This retrospective cohort study used data from 8,917 Safeway employees self-insured by Safeway during 2008 and 2009. We created models using step-wise multivariable logistic regression starting with health services use data, then socio-demographic data, and finally adding the self-reported health status data to the model.

RESULTS

Adding self-reported health data to the baseline model that included only administrative data (health services use and demographic variables; c-statistic = 0.63) increased the model" predictive power (c-statistic = 0.70). Risk factors associated with being a new high cost individual in 2009 were: 1) had one or more ED visits in 2008 (adjusted OR: 1.87, 95 % CI: 1.52, 2.30), 2) had one or more hospitalizations in 2008 (adjusted OR: 1.95, 95 % CI: 1.38, 2.77), 3) being female (adjusted OR: 1.34, 95 % CI: 1.16, 1.55), 4) increasing age (compared with age 18-35, adjusted OR for 36-49 years: 1.28; 95 % CI: 1.03, 1.60; adjusted OR for 50-64 years: 1.92, 95 % CI: 1.55, 2.39; adjusted OR for 65+ years: 3.75, 95 % CI: 2.67, 2.23), 5) the presence of self-reported depression (adjusted OR: 1.53, 95 % CI: 1.29, 1.81), 6) chronic pain (adjusted OR: 2.22, 95 % CI: 1.81, 2.72), 7) diabetes (adjusted OR: 1.73, 95 % CI: 1.35, 2.23), 8) high blood pressure (adjusted OR: 1.42, 95 % CI: 1.21, 1.67), and 9) above average BMI (adjusted OR: 1.20, 95 % CI: 1.04, 1.38).

DISCUSSION

The comparison of the models between the full sample and the sample without theprevious high cost members indicated significant differences in the predictors. This has importantimplications for models using only the health service use (administrative data) given that the past high costis significantly correlated with future high cost and often drive the predictive models.

CONCLUSIONS

Self-reported health data improved the ability of our model to identify individuals at risk for being high cost beyond what was possible with administrative data alone.

Cardiovascular morbidity and mortality as a result of inhaled tobacco products continues to be a global healthcare crisis, particularly in low- and middle-income nations lacking the infrastructure to develop and implement effective public health policies limiting tobacco use. Following initiation of public awareness campaigns 50 years ago in the United States, considerable success has been achieved in reducing the prevalence of cigarette smoking and exposure to secondhand smoke. However, there has been a slowing of cessation rates in the United States during recent years, possibly caused by high residual addiction or fatigue from cessation messaging. Furthermore, tobacco products have continued to evolve faster than the scientific understanding of their biological effects. This review considers selected updates on the genetics and epigenetics of smoking behavior and associated cardiovascular risk, mechanisms of atherogenesis and thrombosis, clinical effects of smoking and benefits of cessation, and potential impact of electronic cigarettes on cardiovascular health.