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Article ; Online: Impact of COVID-19 on Clinical Research and Inclusion of Diverse Populations.

Lackland, Daniel T / Sims-Robinson, Catrina / Jones Buie, Joy N / Voeks, Jenifer H

2020 Volume 30, Issue 3, Page(s) 429–432

Abstract: The randomized clinical trial (RCT) has long been recognized as the 'gold standard' for developing evidence for clinical treatments and vaccines; however, the successful implementation and translation of these findings is predicated upon external ... ...

Abstract	The randomized clinical trial (RCT) has long been recognized as the 'gold standard' for developing evidence for clinical treatments and vaccines; however, the successful implementation and translation of these findings is predicated upon external validity. The generalization of RCT findings are jeopardized by the lack of participation of at-risk groups such as African Americans, with long-recognized disproportional representation. Distinct factors that deter participation in RCTs include distrust, access, recruitment strategies, perceptions of research, and socioeconomic factors. While strategies have been implemented to improve external validity with greater participation among all segments of the population in RCTs, the coronavirus disease 2019 (COVID-19) pandemic may exacerbate disparities in RCT participation with the potential impact of delaying treatment development and vaccine interventions that are applicable and generalizable. Thus, it is essential to include diverse populations in such strategies and RCTs. This Perspective aims to direct attention to the additional harm from the pandemic as well as a refocus on the unresolved lack of inclusion of diverse populations in conducting RCTs.
MeSH term(s)	African Americans ; Betacoronavirus ; COVID-19 ; Coronavirus Infections/ethnology ; Coronavirus Infections/therapy ; Health Status Disparities ; Humans ; Male ; Pandemics ; Patient Participation ; Patient Selection ; Pneumonia, Viral/ethnology ; Pneumonia, Viral/therapy ; Randomized Controlled Trials as Topic/methods ; Randomized Controlled Trials as Topic/standards ; SARS-CoV-2 ; Socioeconomic Factors ; Vulnerable Populations/ethnology
Keywords	covid19
Language	English
Publishing date	2020-07-09
Publishing country	United States
Document type	Editorial
ZDB-ID	1274267-3
ISSN	1945-0826 ; 1049-510X
ISSN (online)	1945-0826
ISSN	1049-510X
DOI	10.18865/ed.30.3.429
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Zs.A 4720: Show issues

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Article ; Online: Metabolic syndrome and hypertension: regular exercise as part of lifestyle management.

Lackland, Daniel T / Voeks, Jenifer H

Current hypertension reports

2014 Volume 16, Issue 11, Page(s) 492

Abstract: The incorporation of physical activity and exercise represents a clinically important aspect in the management of metabolic syndrome, hypertension, and diabetes. While the benefit of exercise and active lifestyles is well documented for prevention and ... ...

Abstract	The incorporation of physical activity and exercise represents a clinically important aspect in the management of metabolic syndrome, hypertension, and diabetes. While the benefit of exercise and active lifestyles is well documented for prevention and risk reduction of cardiovascular and stroke outcomes, the detailed regiment and recommendations are less clear. The components of a prescribed physical activity include consideration of activity type, frequency of an activity, activity duration, and intensity of a specific physical movement. The exercise parameters prescribed as part of the management of metabolic syndrome, diabetes, and elevated blood pressure are most often proposed as separate documents while the general recommendations are similar. The evidence is strong such that physical activity and exercise recommendations in disease management guidelines are considered high quality. The general recommendations for both blood pressure and glycemic management include a regiment of physical activity with moderate- to high-intensity exercise of 30-min bouts on multiple days with a desired goal of a total of 150 min of exercise per week. While additional research is needed to identify the specific exercise/activity mode, frequencies for exercise training, intensity levels, and duration of exercise that achieve maximal blood pressure and glycemic lowering, this general recommendation showed a consistent and significant benefit in risk reduction. Similarly, the current available evidence also indicates that aerobic exercise, dynamic resistance exercise, and isometric exercises can lower blood pressure and improve glycemic control.
MeSH term(s)	Antihypertensive Agents/therapeutic use ; Blood Pressure ; Exercise/physiology ; Humans ; Hypertension/complications ; Hypertension/diagnosis ; Hypertension/prevention & control ; Hypertension/therapy ; Life Style ; Metabolic Syndrome/complications ; Metabolic Syndrome/prevention & control ; Metabolic Syndrome/therapy
Chemical Substances	Antihypertensive Agents
Language	English
Publishing date	2014-09-05
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2057367-4
ISSN	1534-3111 ; 1522-6417
ISSN (online)	1534-3111
ISSN	1522-6417
DOI	10.1007/s11906-014-0492-2
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Zs.A 5522: Show issues

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Article ; Online: Treatment of carotid stenosis in asymptomatic, nonoctogenarian, standard risk patients with stenting versus endarterectomy trials.

Matsumura, Jon S / Hanlon, Bret M / Rosenfield, Kenneth / Voeks, Jenifer H / Howard, George / Roubin, Gary S / Brott, Thomas G

Journal of vascular surgery

2021 Volume 75, Issue 4, Page(s) 1276–1283.e1

Abstract: Objective: Asymptomatic carotid stenosis is the most frequent indication for carotid endarterectomy (CEA) in the United States. Published trials and guidelines support CEA indications in selected patients with longer projected survival and when ... ...

Abstract	Objective: Asymptomatic carotid stenosis is the most frequent indication for carotid endarterectomy (CEA) in the United States. Published trials and guidelines support CEA indications in selected patients with longer projected survival and when periprocedural complications are low. Transfemoral carotid artery stenting with embolic protection (CAS) is a newer treatment option. The objective of this study was to compare outcomes in asymptomatic, nonoctogenarian patients treated with CAS vs CEA. Methods: Patient-level data was analyzed from 2544 subjects with ≥70% asymptomatic carotid stenosis who were randomized to CAS or CEA in addition to standard medical therapy. One trial enrolled 1091 (548 CAS, 543 CEA) and another enrolled 1453 (1089 CAS, 364 CEA) asymptomatic patients less than 80 years old (upper age eligibility). Independent neurologic assessment and routine cardiac enzyme screening were performed. The prespecified, primary composite endpoint was any stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke within 4 years after randomization. Results: There was no significant difference in the primary endpoint between CAS and CEA (5.3% vs 5.1%; hazard ratio, 1.02; 95% confidence interval, 0.7-1.5; P = .91). Periprocedural rates for the components are (CAS vs CEA): any stroke (2.7% vs 1.5%; P = .07), myocardial infarction (0.6% vs 1.7%; P = .01), death (0.1% vs 0.2%; P = .62), and any stroke or death (2.7% vs 1.6%; P = .07). After this period, the rates of ipsilateral stroke were similar (2.3% vs 2.2%; P = .97). Conclusions: In a pooled analysis of two large randomized trials of CAS and CEA in asymptomatic, nonoctogenarian patients, CAS achieves comparable short- and long-term results to CEA.
MeSH term(s)	Aged, 80 and over ; Humans ; Carotid Stenosis/complications ; Carotid Stenosis/diagnostic imaging ; Carotid Stenosis/surgery ; Endarterectomy, Carotid/adverse effects ; Myocardial Infarction/etiology ; Risk Assessment ; Risk Factors ; Stents/adverse effects ; Stroke/etiology ; Stroke/prevention & control ; Treatment Outcome ; United States
Language	English
Publishing date	2021-10-22
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	605700-7
ISSN	1097-6809 ; 0741-5214
ISSN (online)	1097-6809
ISSN	0741-5214
DOI	10.1016/j.jvs.2021.10.020
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Zs.A 1933: Show issues

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Article ; Online: Stenting versus Surgery for Carotid Stenosis.

Brott, Thomas G / Voeks, Jenifer H / Howard, Virginia J

The New England journal of medicine

2016 Volume 375, Issue 6, Page(s) 604–605

MeSH term(s)	Carotid Stenosis/therapy ; Endarterectomy, Carotid ; Female ; Humans ; Male ; Myocardial Infarction/epidemiology ; Stents ; Stroke/epidemiology ; Stroke/prevention & control
Language	English
Publishing date	2016-08-11
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc1605166
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Article ; Online: Hypertension and stroke: an appraisal of the evidence and implications for clinical management.

Lackland, Daniel T / Voeks, Jenifer H / Boan, Andrea D

Expert review of cardiovascular therapy

2016 Volume 14, Issue 5, Page(s) 609–616

Abstract: While elevated blood pressure has long been associated with cardiovascular and renal outcomes, the association of hypertension and increased stroke risks is perhaps the strongest and best recognized. Furthermore, the reduction of blood pressure with ... ...

Abstract	While elevated blood pressure has long been associated with cardiovascular and renal outcomes, the association of hypertension and increased stroke risks is perhaps the strongest and best recognized. Furthermore, the reduction of blood pressure with antihypertensive agents has been well documented with lower stroke risks. The specific recommendations for high blood pressure management for stroke prevention have been somewhat unclear due to the study design and the quality of the evidence based on clinical study results. Further complicating the assessment process is the consideration of stroke as a primary outcome of randomized control trials. This appraisal and review describes the assessment of the evidence and trial results for management of hypertension and stroke risk reduction with consideration of the impact of The Systolic Blood Pressure Intervention Trial (SPRINT). While evidence clearly identifies the benefit of intense hypertension treatment for the primary and secondary prevention of stroke, evidence gaps still remain.
MeSH term(s)	Antihypertensive Agents/therapeutic use ; Blood Pressure/drug effects ; Blood Pressure Determination ; Humans ; Hypertension/drug therapy ; Stroke/prevention & control
Chemical Substances	Antihypertensive Agents
Language	English
Publishing date	2016
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2192343-7
ISSN	1744-8344 ; 1477-9072
ISSN (online)	1744-8344
ISSN	1477-9072
DOI	10.1586/14779072.2016.1143359
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Article ; Online: The Challenge of Examining Social Determinants of Health in People Living With Tourette Syndrome.

Dy-Hollins, Marisela E / Carr, Samuel J / Essa, Angela / Osiecki, Lisa / Lackland, Daniel T / Voeks, Jenifer H / Mejia, Nicte I / Sharma, Nutan / Budman, Cathy L / Cath, Danielle C / Grados, Marco A / King, Robert A / Lyon, Gholson J / Rouleau, Guy A / Sandor, Paul / Singer, Harvey S / Chibnik, Lori B / Mathews, Carol A / Scharf, Jeremiah M

Pediatric neurology

2024 Volume 155, Page(s) 55–61

Abstract: Background: To examine the association between race, ethnicity, and parental educational attainment on tic-related outcomes among Tourette Syndrome (TS) participants in the Tourette Association of America International Consortium for Genetics (TAAICG) ... ...

Abstract	Background: To examine the association between race, ethnicity, and parental educational attainment on tic-related outcomes among Tourette Syndrome (TS) participants in the Tourette Association of America International Consortium for Genetics (TAAICG) database. Methods: 723 participants in the TAAICG dataset aged ≤21 years were included. The relationships between tic-related outcomes and race and ethnicity were examined using linear and logistic regressions. Parametric and nonparametric tests were performed to examine the association between parental educational attainment and tic-related outcomes. Results: Race and ethnicity were collapsed as non-Hispanic white (N=566, 88.0%) versus Other (N=77, 12.0%). Tic symptom onset was earlier by 1.1 years (P < 0.0001) and TS diagnosis age was earlier by 0.9 years (P = 0.0045) in the Other group (versus non-Hispanic white). Sex and parental education as covariates did not contribute to the differences observed in TS diagnosis age. There were no significant group differences observed across the tic-related outcomes in parental education variable. Conclusions: Our study was limited by the low number of nonwhite or Hispanic individuals in the cohort. Racial and ethnic minoritized groups experienced an earlier age of TS diagnosis than non-Hispanic white individuals. Tic severity did not differ between the two groups, and parental educational attainment did not affect tic-related outcomes. There remain significant disparities and gaps in knowledge regarding TS and associated comorbid conditions. Our study suggests the need for more proactive steps to engage individuals with tic disorders from all racial and ethnic minoritized groups to participate in research studies.
Language	English
Publishing date	2024-03-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	639164-3
ISSN	1873-5150 ; 0887-8994
ISSN (online)	1873-5150
ISSN	0887-8994
DOI	10.1016/j.pediatrneurol.2024.02.008
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Article ; Online: Hemorrhagic Stroke in Children and Adults With Sickle Cell Anemia: The Post-STOP Cohort.

Fox, Christine K / Leykina, Liza / Hills, Nancy K / Kwiatkowski, Janet L / Kanter, Julie / Strouse, John J / Voeks, Jenifer H / Fullerton, Heather J / Adams, Robert J

Stroke

2022 Volume 53, Issue 11, Page(s) e463–e466

Abstract: Background: Hemorrhagic stroke in young patients with sickle cell anemia remains poorly characterized.: Methods: The Post-STOP (Stroke Prevention Trial in Sickle Cell Anemia) retrospective study collected follow-up data on STOP and STOP II clinical ... ...

Abstract	Background: Hemorrhagic stroke in young patients with sickle cell anemia remains poorly characterized. Methods: The Post-STOP (Stroke Prevention Trial in Sickle Cell Anemia) retrospective study collected follow-up data on STOP and STOP II clinical trial cohorts. From January 2012 to May 2014, a team of analysts abstracted data from medical records of prior participants (all with sickle cell anemia). Two vascular neurologists reviewed data to confirm hemorrhagic strokes defined as spontaneous intracerebral, subarachnoid, or intraventricular hemorrhage. Incidence rates were calculated using survival analysis techniques Results: Follow-up data were collected from 2850 of 3835 STOP or STOP II participants. Patients (51% male) were a median of 19.1 (interquartile range, 16.6-22.6) years old at the time of last known status. The overall hemorrhagic stroke incidence rate was 63 per 100 000 person-years (95% CI, 45-87). Stratified by age, the incidence rate per 100 000 person-years was 50 (95% CI, 34-75) for children and 134 (95% CI, 74-243) for adults >18 years. Vascular abnormalities (moyamoya arteriopathy, aneurysm or cavernous malformation) were identified in 18 of 35 patients with hemorrhagic stroke. Conclusions: The incidence rate of hemorrhagic stroke in patients with sickle cell anemia increases with age. Structural vascular abnormalities such as moyamoya arteriopathy and aneurysms are common etiologies for hemorrhage and screening may be warranted.
MeSH term(s)	Adolescent ; Aged ; Aged, 80 and over ; Female ; Humans ; Male ; Middle Aged ; Young Adult ; Anemia, Sickle Cell/epidemiology ; Hemorrhagic Stroke/epidemiology ; Moyamoya Disease/epidemiology ; Retrospective Studies ; Clinical Trials as Topic
Language	English
Publishing date	2022-10-07
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	80381-9
ISSN	1524-4628 ; 0039-2499 ; 0749-7954
ISSN (online)	1524-4628
ISSN	0039-2499 ; 0749-7954
DOI	10.1161/STROKEAHA.122.038651
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Article: Impact of COVID-19 on Clinical Research and Inclusion of Diverse Populations

Lackland, Daniel T / Sims-Robinson, Catrina / Jones Buie, Joy N / Voeks, Jenifer H

Ethn Dis

Abstract	The randomized clinical trial (RCT) has long been recognized as the 'gold standard' for developing evidence for clinical treatments and vaccines; however, the successful implementation and translation of these findings is predicated upon external validity. The generalization of RCT findings are jeopardized by the lack of participation of at-risk groups such as African Americans, with long-recognized disproportional representation. Distinct factors that deter participation in RCTs include distrust, access, recruitment strategies, perceptions of research, and socioeconomic factors. While strategies have been implemented to improve external validity with greater participation among all segments of the population in RCTs, the coronavirus disease 2019 (COVID-19) pandemic may exacerbate disparities in RCT participation with the potential impact of delaying treatment development and vaccine interventions that are applicable and generalizable. Thus, it is essential to include diverse populations in such strategies and RCTs. This Perspective aims to direct attention to the additional harm from the pandemic as well as a refocus on the unresolved lack of inclusion of diverse populations in conducting RCTs.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #703902
Database	COVID19

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Article ; Online: Duration of asymptomatic status and outcomes following carotid endarterectomy and carotid artery stenting in the Carotid Revascularization Endarterectomy vs Stenting Trial.

Moore, Wesley S / Voeks, Jenifer H / Roubin, Gary S / Clark, Wayne M / Howard, Virginia J / Jones, Michael R / Brott, Thomas G

Journal of vascular surgery

2019 Volume 69, Issue 6, Page(s) 1797–1800

Abstract: Background: Most carotid revascularization studies define asymptomatic as symptom-free for more than 180 days; however, it is unknown if intervention carries similar risk among those currently asymptomatic but with previous symptoms (PS) vs those who ... ...

Abstract	Background: Most carotid revascularization studies define asymptomatic as symptom-free for more than 180 days; however, it is unknown if intervention carries similar risk among those currently asymptomatic but with previous symptoms (PS) vs those who were always asymptomatic (AA). Methods: We compared the periprocedural and 4-year risks of PS vs AA patients in the Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) randomized to carotid endarterectomy (CEA) or carotid artery stenting (CAS)/angioplasty. Proportional hazards models adjusting for age, sex, and treatment were used to assess the risk of periprocedural stroke and/or death (S+D; any S+D during periprocedural period), stroke and death at 4 years (any S+D within the periprocedural period and ipsilateral stroke out to 4 years) and the primary end point at 4 years (any stroke, death, and myocardial infarction within the periprocedural period and ipsilateral stroke out to 4 years). Analysis was performed pooling the CEA-treated and CAS-treated patients, and separately for each treatment. Results: Of 1181 asymptomatic patients randomized in CREST, 1104 (93%) were AA and 77 (7%) were PS. There was no difference in risk when comparing the AA and PS cohorts in the pooled CAS+CEA population for periprocedural S+D (2.0% vs 1.3%), S+D at 4 years (3.6% vs 3.2%), or the primary end point (5.2% vs 5.8%). There were also no differences among those assigned to CEA (periprocedural S+D, 1.5% vs 0%; S+D at 4 years, 2.7% vs 0%; or primary end point, 5.1% vs 2.4%) or CAS (periprocedural S+D, 2.5% vs 2.8%; S+D at 4 years, 4.4% vs 6.9%; or primary end point, 5.3% vs 9.8%) when analyzed separately. Conclusions: In CREST, only a small minority of asymptomatic patients had previous ipsilateral symptoms. The outcomes of periprocedural S+D, periprocedural S+D, and ipsilateral stroke up to 4 years, and the primary end point did not differ for AA patients compared with PS patients.
MeSH term(s)	Aged ; Asymptomatic Diseases ; Carotid Stenosis/complications ; Carotid Stenosis/mortality ; Carotid Stenosis/surgery ; Carotid Stenosis/therapy ; Endarterectomy, Carotid/adverse effects ; Endovascular Procedures/adverse effects ; Endovascular Procedures/instrumentation ; Female ; Humans ; Male ; Middle Aged ; Myocardial Infarction/etiology ; Myocardial Infarction/mortality ; Prospective Studies ; Risk Assessment ; Risk Factors ; Stents ; Stroke/etiology ; Stroke/mortality ; Time Factors ; Treatment Outcome
Language	English
Publishing date	2019-01-08
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	605700-7
ISSN	1097-6809 ; 0741-5214
ISSN (online)	1097-6809
ISSN	0741-5214
DOI	10.1016/j.jvs.2018.09.054
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Article ; Online: Ischemic stroke in children and young adults with sickle cell disease in the post-STOP era.

Kwiatkowski, Janet L / Voeks, Jenifer H / Kanter, Julie / Fullerton, Heather J / Debenham, Ellen / Brown, Lynette / Adams, Robert J

American journal of hematology

2019 Volume 94, Issue 12, Page(s) 1335–1343

Abstract: The Stroke Prevention Trial in Sickle Cell Anemia (STOP) and Optimizing Primary Stroke Prevention in Sickle Cell Anemia (STOP 2) trials established routine transcranial Doppler ultrasound (TCD) screening, with indefinite chronic red cell transfusions ( ... ...

Abstract	The Stroke Prevention Trial in Sickle Cell Anemia (STOP) and Optimizing Primary Stroke Prevention in Sickle Cell Anemia (STOP 2) trials established routine transcranial Doppler ultrasound (TCD) screening, with indefinite chronic red cell transfusions (CRCT) for children with abnormal TCD as standard of care. Implementation failures and limitations to the STOP protocol may contribute to continued ischemic stroke occurrence. In the "Post-STOP" study, we sought to assess the impact of the STOP protocol on the incidence of ischemic stroke in a multicenter cohort of former STOP and/or STOP 2 trial participants. A central team abstracted data for 2851 (74%) of the 3835 children who took part in STOP and/or STOP 2. Data included TCD and neuroimaging results, treatment, laboratory data, and detailed clinical information pertaining to the stroke. Two stroke neurologists independently confirmed each stroke using pre-specified imaging and clinical criteria and came to consensus. Among the 2808 patients who were stroke-free at the start of Post-STOP with available follow-up, the incidence of first ischemic stroke was 0.24 per 100 patient-years (95% CI, 0.18, 0.31), with a mean (SD) duration of follow-up of 9.1 (3.4) [median 10.3, range (0-15.4)] years. Most (63%) strokes occurred in patients in whom the STOP protocol had not been properly implemented, either failure to screen appropriately with TCD (38%) or failure to transfuse adequately patients with abnormal TCD (25%). This study shows that substantial opportunities for ischemic stroke prevention remain by more complete implementation of the STOP Protocol.
MeSH term(s)	Adolescent ; Anemia, Sickle Cell/blood ; Anemia, Sickle Cell/complications ; Anemia, Sickle Cell/drug therapy ; Anemia, Sickle Cell/therapy ; Brain Ischemia/diagnostic imaging ; Brain Ischemia/epidemiology ; Brain Ischemia/etiology ; Brain Ischemia/prevention & control ; Child ; Child, Preschool ; Combined Modality Therapy ; Computed Tomography Angiography ; Erythrocyte Transfusion ; Female ; Follow-Up Studies ; Humans ; Hydroxyurea/therapeutic use ; Incidence ; Magnetic Resonance Angiography ; Male ; Multicenter Studies as Topic/methods ; Multicenter Studies as Topic/statistics & numerical data ; Neuroimaging ; Observational Studies as Topic/methods ; Observational Studies as Topic/statistics & numerical data ; Randomized Controlled Trials as Topic/methods ; Randomized Controlled Trials as Topic/statistics & numerical data ; Risk Factors ; Ultrasonography, Doppler, Transcranial ; Young Adult
Chemical Substances	Hydroxyurea (X6Q56QN5QC)
Language	English
Publishing date	2019-11-01
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural
ZDB-ID	196767-8
ISSN	1096-8652 ; 0361-8609
ISSN (online)	1096-8652
ISSN	0361-8609
DOI	10.1002/ajh.25635
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