Publications by authors named "Dana F Clark"

8 Publications

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EUS-based Pancreatic Cancer Surveillance in Carriers Without a Family History of Pancreatic Cancer.

Cancer Prev Res (Phila) 2021 11 2;14(11):1033-1040. Epub 2021 Aug 2.

Division of Digestive and Liver Diseases, Columbia University Department of Medicine, New York, New York.

Carriers of a pathogenic/likely pathogenic (P/LP) variant are at increased risk of pancreatic ductal adenocarcinoma (PDAC), yet current guidelines recommend surveillance only for those with a family history of PDAC. We aimed to investigate outcomes of endoscopic ultrasound (EUS)-based PDAC surveillance in carriers without a family history of PDAC. We performed a retrospective analysis of all P/LP carriers who underwent EUS at a tertiary care center. Of 194 P/LP carriers who underwent EUS, 64 (33%) had no family history of PDAC and had at least 1 EUS for PDAC surveillance. These individuals underwent 143 total EUSs, were predominantly female (72%), and carriers (73%), with the majority having a personal history of cancer other than PDAC (67%). The median age at time of first EUS was 62 years [interquartile range (IQR), 53-67 years] and a median of 2 EUSs (IQR 1-3) were performed per patient, with a median of 3 years (IQR 2-4.5 years) between the first and last EUS for those with more than 1 EUS. Pancreatic abnormalities were detected in 44%, including cysts in 27%, and incidental luminal abnormalities in 41%. Eight percent developed a new pancreatic mass or cyst during surveillance, 2 individuals developed PDAC, and no serious complications resulted from surveillance. After discussion of the risks, limitations, and potential benefits, PDAC surveillance can be considered in carriers without a family history of PDAC; however, the effectiveness of PDAC surveillance in this population requires further study. PREVENTION RELEVANCE: carriers have increased pancreatic ductal adenocarcinoma (PDAC) risk, yet are typically not eligible for PDAC surveillance in the absence of PDAC family history. Herein we describe outcomes of PDAC surveillance in carriers without a family history of PDAC, showing that PDAC surveillance can be considered in this high-risk group.
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http://dx.doi.org/10.1158/1940-6207.CAPR-21-0161DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8563408PMC
November 2021

Longitudinal follow-up after telephone disclosure in the randomized COGENT study.

Genet Med 2020 08 7;22(8):1401-1406. Epub 2020 May 7.

Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.

Purpose: To better understand the longitudinal risks and benefits of telephone disclosure of genetic test results in the era of multigene panel testing.

Methods: Adults who were proceeding with germline cancer genetic testing were randomized to telephone disclosure (TD) with a genetic counselor or in-person disclosure (IPD) (i.e., usual care) of test results. All participants who received TD were recommended to return to meet with a physician to discuss medical management recommendations.

Results: Four hundred seventy-three participants were randomized to TD and 497 to IPD. There were no differences between arms for any cognitive, affective, or behavioral outcomes at 6 and 12 months. Only 50% of participants in the TD arm returned for the medical follow-up appointment. Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002). Mammography was lower at 12 months among those who had TD and did not return for medical follow-up (70%) compared with those who had TD and returned (86%) and those who had IPD (87%, adjusted p < 0.01).

Conclusion: Telephone disclosure of genetic test results is a reasonable alternative to in-person disclosure, but attention to medical follow-up may remain important for optimizing appropriate use of genetic results.
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http://dx.doi.org/10.1038/s41436-020-0808-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7396300PMC
August 2020

Vascular access in kidney transplant recipients.

Transplant Rev (Orlando) 2020 07 14;34(3):100544. Epub 2020 Mar 14.

Division of Nephrology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States of America. Electronic address:

Vascular access is an important element in the overall care provided to kidney transplant recipients. The transplanted kidney is not indestructible, and chronic kidney disease after transplantation may result in needing another transplant or beginning dialysis. Commonly used vascular accesses, like peripheral and central lines, can preclude the creation of future, permanent dialysis access. Therefore, there is urgent need to preserve vessels for the future access needs for hemodialysis among kidney transplant recipients without functional vascular access for dialysis. Moreover, the proper care of functional vascular access among kidney transplant recipients is crucial. In this review article, we will address the common vascular access procedures and complications among kidney transplant recipients.
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http://dx.doi.org/10.1016/j.trre.2020.100544DOI Listing
July 2020

Preferences for in-person disclosure: Patients declining telephone disclosure characteristics and outcomes in the multicenter Communication Of GENetic Test Results by Telephone study.

Clin Genet 2019 02 7;95(2):293-301. Epub 2018 Dec 7.

Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois.

Telephone disclosure of cancer genetic test results is noninferior to in-person disclosure. However, how patients who prefer in-person communication of results differ from those who agree to telephone disclosure is unclear but important when considering delivery models for genetic medicine. Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone to in-person disclosure of genetic test results. We evaluated preferences for in-person disclosure, factors associated with this preference and outcomes compared to those who agreed to randomization. Among 1178 enrolled patients, 208 (18%) declined randomization, largely given a preference for in-person disclosure. These patients were more likely to be older (P = 0.007) and to have had multigene panel testing (P < 0.001). General anxiety (P = 0.007), state anxiety (P = 0.008), depression (P = 0.011), cancer-specific distress (P = 0.021) and uncertainty (P = 0.03) were higher after pretest counseling. After disclosure of results, they also had higher general anxiety (P = 0.003), depression (P = 0.002) and cancer-specific distress (P = 0.043). While telephone disclosure is a reasonable alternative to in-person disclosure in most patients, some patients have a strong preference for in-person communication. Patient age, distress and complexity of testing are important factors to consider and requests for in-person disclosure should be honored when possible.
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http://dx.doi.org/10.1111/cge.13474DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6453119PMC
February 2019

Sleep disorders: Serious threats among kidney transplant recipients.

Transplant Rev (Orlando) 2019 01 26;33(1):9-16. Epub 2018 Sep 26.

Division of Sleep Medicine, William S. Middleton Memorial Veterans Hospital, Madison, WI, United States.

In patients with chronic kidney disease (CKD) and kidney transplant recipients who continue to have some degree of CKD, the prevalence of sleep-related disorders is very high. Common sleep disorders in both groups include insomnia, sleep-disordered breathing (SDB), restless legs syndrome (RLS), excessive daytime sleepiness (EDS), and others. Depending on the kidney graft function, some patients see sleep disorders resolve after kidney transplantation, while others continue to have persistent sleep disorders or develop new ones. Kidney transplant recipients (KTRs) are unique patients due to the presence of a single kidney, the use of immunosuppressive medications, and other comorbidities including obesity, a high risk of cardiovascular disease, malignancy, and the anxiety of losing their allograft. All of these factors contribute to the risk for sleep disorders. CKD and sleep disorders have a bidirectional relationship; that is, CKD may increase the risk of sleep disorders and sleep disorders may increase the risk of CKD. Obstructive sleep apnea (OSA) is the most common form of SDB and is known to alter renal hemodynamics. OSA leads to hypoxemia and sleeps fragmentation, which activates the sympathetic nervous system. This activates the renin-angiotensin-aldosterone system and ultimately alters cardiovascular hemodynamics. Sleep disorders may have deleterious effects on the kidney allograft and proper screening and management are important for both graft and patient survival.
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http://dx.doi.org/10.1016/j.trre.2018.09.002DOI Listing
January 2019

Randomized Noninferiority Trial of Telephone vs In-Person Disclosure of Germline Cancer Genetic Test Results.

J Natl Cancer Inst 2018 09;110(9):985-993

Division of Hematology-Oncology and Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, and Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL.

Background: Germline genetic testing is standard practice in oncology. Outcomes of telephone disclosure of a wide range of cancer genetic test results, including multigene panel testing (MGPT) are unknown.

Methods: Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone disclosure (TD) of genetic test results with usual care, in-person disclosure (IPD) after tiered-binned in-person pretest counseling. Primary noninferiority outcomes included change in knowledge, state anxiety, and general anxiety. Secondary outcomes included cancer-specific distress, depression, uncertainty, satisfaction, and screening and risk-reducing surgery intentions. To declare noninferiority, we calculated the 98.3% one-sided confidence interval of the standardized effect; t tests were used for secondary subgroup analyses. Only noninferiority tests were one-sided, others were two-sided.

Results: A total of 1178 patients enrolled in the study. Two hundred eight (17.7%) participants declined random assignment due to a preference for in-person disclosure; 473 participants were randomly assigned to TD and 497 to IPD; 291 (30.0%) had MGPT. TD was noninferior to IPD for general and state anxiety and all secondary outcomes immediately postdisclosure. TD did not meet the noninferiority threshold for knowledge in the primary analysis, but it did meet the threshold in the multiple imputation analysis. In secondary analyses, there were no statistically significant differences between arms in screening and risk-reducing surgery intentions, and no statistically significant differences in outcomes by arm among those who had MGPT. In subgroup analyses, patients with a positive result had statistically significantly greater decreases in general anxiety with telephone disclosure (TD -0.37 vs IPD +0.87, P = .02).

Conclusions: Even in the era of multigene panel testing, these data suggest that telephone disclosure of cancer genetic test results is as an alternative to in-person disclosure for interested patients after in-person pretest counseling with a genetic counselor.
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http://dx.doi.org/10.1093/jnci/djy015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6136932PMC
September 2018

Use and Patient-Reported Outcomes of Clinical Multigene Panel Testing for Cancer Susceptibility in the Multicenter Communication of Genetic Test Results by Telephone Study.

JCO Precis Oncol 2018 18;2. Epub 2018 Dec 18.

University of Pennsylvania.

Purpose: Multigene panels (MGPs) are increasingly being used despite questions regarding their clinical utility and no standard approach to genetic counseling. How frequently genetic providers use MGP testing and how patient-reported outcomes (PROs) differ from targeted testing (eg, only) are unknown.

Methods: We evaluated use of MGP testing and PROs in participants undergoing cancer genetic testing in the multicenter Communication of Genetic Test Results by Telephone study (ClinicalTrials.gov identifier: ), a randomized study of telephone versus in-person disclosure of genetic test results. PROs included genetic knowledge, general and state anxiety, depression, cancer-specific distress, uncertainty, and satisfaction. Genetic providers offered targeted or MGP testing based on clinical assessment.

Results: Since the inclusion of MGP testing in 2014, 395 patients (66%) were offered MGP testing. MGP testing increased over time from 57% in 2014 to 66% in 2015 ( = .02) and varied by site (46% to 78%; < .01). Being offered MGP testing was significantly associated with not having Ashkenazi Jewish ancestry, having a history of cancer, not having a mutation in the family, not having made a treatment decision, and study site. After demographic adjustment, patients offered MGP testing had lower general anxiety ( = .04), state anxiety ( = .03), depression ( = .04), and uncertainty ( = .05) pre-disclosure compared with patients offered targeted testing. State anxiety ( = .05) and cancer-specific distress ( = .05) were lower at disclosure in the MGP group. There was a greater increase in change in uncertainty ( = .04) among patients who underwent MGP testing.

Conclusion: MGP testing was more frequently offered to patients with lower anxiety, depression, and uncertainty and was associated with favorable outcomes, with the exception of a greater increase in uncertainty compared with patients who had targeted testing. Addressing uncertainty may be important as MGP testing is increasingly adopted.
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http://dx.doi.org/10.1200/PO.18.00199DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6901130PMC
December 2018

Is Kidney Transplantation a Better State of CKD? Impact on Diagnosis and Management.

Adv Chronic Kidney Dis 2016 09;23(5):287-294

Division of Nephrology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI. Electronic address:

Patients with CKD are at increased risk for cardiovascular events, hospitalizations, and mortality. Kidney transplantation (KTx) is the preferred treatment for end-stage kidney disease. Although comorbidities including anemia and bone and mineral disease improve or are even halted after KTx, kidney transplant recipients carry higher cardiovascular mortality risk than the general population, as well as an increased risk of infections, malignancies, fractures, and obesity. When comparing CKD with CKD after transplantation (CKD-T), the rate of decline of estimated glomerular filtration rate (eGFR) is significantly lower in CKD-T. Higher rate of decline of eGFR has been associated with increased risk of mortality. However, due to the significant increased risk of mortality due to cardiovascular events, infections, and malignancies, many kidney transplant recipients may not benefit of decline in the rate of eGFR. Patients with CKD-T are a unique subset of patients with multiple traditional and transplant-specific risk factors. Proper management and appropriate preventive health measures may improve long-term patient and allograft survival in patients with CKD-T.
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http://dx.doi.org/10.1053/j.ackd.2016.09.006DOI Listing
September 2016
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