Donna Niedzwiecki

Overview:

Primary interests include clinical trials design and the design and analysis of biomarker and imaging studies especially in the areas of GI cancer, lymphoma, melanoma, transplant and cancer immunotherapy.

Positions:

Professor of Biostatistics & Bioinformatics

Biostatistics & Bioinformatics
School of Medicine

Director, DCI Biostatistics

Biostatistics & Bioinformatics
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

Ph.D. 1984

Yale University

Grants:

Planning a Duke Academic Public Private Partnership Program (AP4) Center

Administered By
Duke Cancer Institute
Awarded By
National Cancer Institute
Role
Biostatistician
Start Date
End Date

Role for TbetaRIII Shedding in the Tumor Microenvironment

Administered By
Medicine, Medical Oncology
Awarded By
National Institutes of Health
Role
Collaborator
Start Date
End Date

Graft Engineering and Immunotherapy After Unrelated Cord Blood Transplantation

Administered By
Pediatrics, Transplant and Cellular Therapy
Awarded By
National Institutes of Health
Role
Co Investigator
Start Date
End Date

Dexasome Based Immunotherapy of Lung Cancer

Administered By
Medicine, Medical Oncology
Awarded By
National Institutes of Health
Role
Statistician
Start Date
End Date

The Impact of Race, Ethnicity, and Socioeconomic Status on Listing for Liver Transplant after Referral

Administered By
Medicine, Gastroenterology
Awarded By
American Association for the Study of Liver Diseases
Role
Statistician
Start Date
End Date

Publications:

Clinical Utility of Near-Infrared Device in Detecting Traumatic Intracranial Hemorrhage: A Pilot Study toward Application as an Emergent Diagnostic Modality in a Low-Resource Setting.

Limited computed tomography (CT) availability in low- and middle-income countries frequently impedes life-saving neurosurgical decompression for traumatic brain injury. A reliable, accessible, cost-effective solution is necessary to detect and localize bleeds. We report the largest study to date using a near-infrared device (NIRD) to detect traumatic intracranial bleeds. Patients with confirmed or suspected head trauma who received a head CT scan were included. Within 30 min of the initial head CT scan, a blinded examiner scanned each patient's cranium with a NIRD, interrogating bilaterally the frontal, parietal, temporal, and occipital quadrants Sensitivity, specificity, accuracy, and precision were investigated. We recruited 500 consecutive patients; 104 patients had intracranial bleeding. For all patients with CT-proven bleeds, irrespective of size, initial NIRD scans localized the bleed to the appropriate quadrant with a sensitivity of 86% and specificity of 96% compared with CT. For extra-axial bleeds >3.5mL, sensitivity and specificity were 94% and 96%, respectively. For longitudinal serial rescans with the NIRD, sensitivity was 89% (< 4 days from injury: sensitivity: 99%), and specificity was 96%. For all patients who required craniectomy or craniotomy, the device demonstrated 100% sensitivity. NIRD is highly sensitive, specific, and reproducible over time in diagnosing intracranial bleeds. NIRD may inform neurosurgical decision making in settings where CT scanning is unavailable or impractical.
Authors
Gramer, R; Shlobin, NA; Yang, Z; Niedzwiecki, D; Haglund, MM; Fuller, AT
URI
https://scholars.duke.edu/individual/pub1529338
PMID
35856820
Source
pubmed
Published In
J Neurotrauma
Published Date
DOI
10.1089/neu.2021.0342

Current approach to health care transition and integration into adult care for pediatric liver transplant recipients: A call for partnership.

Despite the increased risk of non-adherence, allograft rejection, and mortality following transfer from pediatric to adult care in liver transplantation (LT), there is no standardized approach to health care transition (HCT). Two electronic national surveys were developed and distributed to members of the Society for Pediatric Liver Transplantation and all adult LT programs in the United States to examine current HCT practices. Responses were received from 40 pediatric and 79 adult centers. Pediatric centers were more likely to focus on HCT noting the presence of a transition/transfer policy (60.2% vs. 39.2%), transition clinic (51.6% vs. 16.5%), and the routine use of transition readiness assessment tools (54.8% vs. 10.2%). Perceived barriers to HCT were similar among pediatric and adult respondents and included patient willingness to transfer and participate in care, failure to show for appointments, and lack of sufficient time and staffing. These results highlight the need for an increased awareness of HCT at both pediatric and adult LT centers. The path to improvement requires a partnership between pediatric and adult providers. Recognizing the importance of a comprehensive HCT program initiated in pediatrics and continued throughout young adulthood with ongoing support by the adult team is essential.
Authors
King, LY; Kosmach-Park, B; Parish, A; Niedzwiecki, D; Jackson, WE; Vittorio, JM
MLA Citation
King, Lindsay Yount, et al. “Current approach to health care transition and integration into adult care for pediatric liver transplant recipients: A call for partnership.Clin Transplant, 2023, p. e14990. Pubmed, doi:10.1111/ctr.14990.
URI
https://scholars.duke.edu/individual/pub1502965
PMID
37105553
Source
pubmed
Published In
Clin Transplant
Published Date
Start Page
e14990
DOI
10.1111/ctr.14990

Closed Incision Negative Pressure Therapy to Reduce Surgical Site Infection in High-Risk Gastrointestinal Surgery: A Randomized Controlled Trial.

BACKGROUND: Despite institutional perioperative bundles and national infection prevention guidelines, surgical site infection (SSI) after a major abdominal operation remains a significant source of morbidity. Negative pressure therapy (NPT) has revolutionized care for open wounds but the role of closed incision NPT (ciNPT) remains unclear. STUDY DESIGN: We conducted a multi-institutional randomized controlled trial evaluating SSI after major elective colorectal or hepatopancreatobiliary surgery (Clinical Trial Registration: NCT01905397). Patients were randomized to receive conventional wound care vs ciNPT (Prevena Incision Management System, 3M Health Care, San Antonio, TX). The primary endpoint was postoperative incisional SSI. SSI incidence was evaluated at inpatient days 4 or 5 and again at postoperative day 30. With 144 patients studied, the estimated power was 85% for detecting a difference in SSIs between 17% and 5% (conventional vs ciNPT; 1-sided α = 0.1). Secondary endpoints included SSI type, length of stay, 30-day readmission, and mortality. T-tests were used to compare continuous variables between treatments; similarly, chi-square tests were used to compare categorical variables. A p value of <0.05 was considered significant, except in the primary comparison of incisional and organ SSIs. RESULTS: During the 2013 to 2021 time period, 164 patients were randomized, and of those, 138 were evaluable (ciNPT n = 63; conventional n = 75). Incisional SSIs occurred in 9 (14%) patients in the ciNPT group and 13 (17%) patients in the conventional group (p = 0.31). Organ or space SSIs occurred in 7 (11%) patients in the ciNPT group and 10 (13%) in the conventional therapy group (p = 0.35). CONCLUSIONS: In this multi-institutional, randomized controlled trial of patients undergoing colorectal or hepatopancreatobiliary surgery, incidence of incisional SSIs between ciNPT and conventional wound therapy was not statistically significant. Future trials should focus on patient populations undergoing specific procedures types that have the highest risk for SSI.
Authors
Ceppa, EP; Kim, RC; Niedzwiecki, D; Lowe, ME; Warren, DA; House, MG; Nakeeb, A; Zani, S; Moyer, AN; Blazer, DG; Closed Incision Negative Pressure Therapy (ciNPT) Investigators,
MLA Citation
Ceppa, Eugene P., et al. “Closed Incision Negative Pressure Therapy to Reduce Surgical Site Infection in High-Risk Gastrointestinal Surgery: A Randomized Controlled Trial.J Am Coll Surg, vol. 236, no. 4, Apr. 2023, pp. 698–708. Pubmed, doi:10.1097/XCS.0000000000000547.
URI
https://scholars.duke.edu/individual/pub1565160
PMID
36728375
Source
pubmed
Published In
J Am Coll Surg
Volume
236
Published Date
Start Page
698
End Page
708
DOI
10.1097/XCS.0000000000000547

Low contralateral neck recurrence risk with ipsilateral neck radiotherapy in N2b tonsillar squamous cell carcinoma.

OBJECTIVES: To characterize factors including nodal burden, pre-treatment imaging, and other patient factors which may influence the role of ipsilateral neck radiotherapy (IRT) in tonsillar squamous cell carcinoma (SCC) with multiple involved ipsilateral nodes. METHODS: Patients with cT1-2N0-2bM0 (AJCC 7th edition) tonsillar SCC treated with definitive radiation therapy (RT) at Duke University Medical Center from 1/1/1990-10/1/2019 were identified. Patient, tumor, and treatment characteristics were compared between those that received bilateral neck RT (BRT) versus IRT. Recurrence-free survival (RFS) was estimated with Kaplan-Meier method. A subset analysis of patients with N2b disease was performed. Patterns of recurrence were analyzed. RESULTS: 120 patients with cT1-2N0-2b tonsillar SCC were identified, including 71 with N2b disease (BRT: n = 30; IRT: n = 41). Median follow-up was 80 months (range: 7-209). No N2b patients who received IRT had > 1 cm of soft palate/base of tongue extension. N2b patients treated with IRT had a median of 3 (range 2-9) involved lymph nodes, with median largest nodal dimension of 2.8 cm (range 1.3-4.8 cm). 93 % of N2b patients who received IRT had staging by PET/CT, and 100 % received IMRT. For N2b patients treated with IRT, there were no contralateral neck recurrences, and 10 year RFS was 95 % (95 % CI 82 %-98 %). CONCLUSIONS: For patients treated with IRT for well-lateralized N2b tonsillar SCC, we observed high rates of local control with no observed contralateral neck recurrence. These data suggest that BRT is not universally necessary for patients with multiple involved ipsilateral nodes, particularly in the setting of baseline staging with PET/CT.
Authors
Natesan, D; Cramer, CK; Oyekunle, T; Niedzwiecki, D; Brizel, DM; Mowery, YM
MLA Citation
Natesan, Divya, et al. “Low contralateral neck recurrence risk with ipsilateral neck radiotherapy in N2b tonsillar squamous cell carcinoma.Oral Oncol, vol. 139, Apr. 2023, p. 106362. Pubmed, doi:10.1016/j.oraloncology.2023.106362.
URI
https://scholars.duke.edu/individual/pub1569213
PMID
36931141
Source
pubmed
Published In
Oral Oncol
Volume
139
Published Date
Start Page
106362
DOI
10.1016/j.oraloncology.2023.106362

Uncertainties in the dosimetric heterogeneity correction and its potential effect on local control in lung SBRT.

Objective. Dose calculation in lung stereotactic body radiation therapy (SBRT) is challenging due to the low density of the lungs and small volumes. Here we assess uncertainties associated with tissue heterogeneities using different dose calculation algorithms and quantify potential associations with local failure for lung SBRT.Approach. 164 lung SBRT plans were used. The original plans were prepared using Pencil Beam Convolution (PBC, n = 8) or Anisotropic Analytical Algorithm (AAA, n = 156). Each plan was recalculated with AcurosXB (AXB) leaving all plan parameters unchanged. A subset (n = 89) was calculated with Monte Carlo to verify accuracy. Differences were calculated for the planning target volume (PTV) and internal target volume (ITV) Dmean[Gy], D99%[Gy], D95%[Gy], D1%[Gy], and V100%[%]. Dose metrics were converted to biologically effective doses (BED) usingα/β= 10Gy. Regression analysis was performed for AAA plans investigating the effects of various parameters on the extent of the dosimetric differences. Associations between the magnitude of the differences for all plans and outcome were investigated using sub-distribution hazards analysis.Main results. For AAA cases, higher energies increased the magnitude of the difference (ΔDmean of -3.6%, -5.9%, and -9.1% for 6X, 10X, and 15X, respectively), as did lung volume (ΔD99% of -1.6% per 500cc). Regarding outcome, significant hazard ratios (HR) were observed for the change in the PTV and ITV D1% BEDs upon univariate analysis (p = 0.042, 0.023, respectively). When adjusting for PTV volume and prescription, the HRs for the change in the ITV D1% BED remained significant (p = 0.039, 0.037, respectively).Significance. Large differences in dosimetric indices for lung SBRT can occur when transitioning to advanced algorithms. The majority of the differences were not associated with local failure, although differences in PTV and ITV D1% BEDs were associated upon univariate analysis. This shows uncertainty in near maximal tumor dose to potentially be predictive of treatment outcome.
Authors
MLA Citation
Erickson, Brett G., et al. “Uncertainties in the dosimetric heterogeneity correction and its potential effect on local control in lung SBRT.Biomed Phys Eng Express, vol. 9, no. 3, Mar. 2023. Pubmed, doi:10.1088/2057-1976/acbeae.
URI
https://scholars.duke.edu/individual/pub1566979
PMID
36827685
Source
pubmed
Published In
Biomedical Physics & Engineering Express
Volume
9
Published Date
DOI
10.1088/2057-1976/acbeae