scholarly journals Why Are Women Less Represented in Intracerebral Hemorrhage Trials?

Stroke ◽  
2021 ◽  
Vol 52 (2) ◽  
pp. 442-446
Author(s):  
Tatiana Greige ◽  
Casey Norton ◽  
Lydia D. Foster ◽  
Sharon D. Yeatts ◽  
Andre Thornhill ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Intracerebral Hemorrhage ◽  
Selection Bias ◽  
Older Age ◽  
Lower Prevalence ◽  
Do Not Resuscitate ◽  
Chi Square ◽  
Men And Women ◽  
Poor Recruitment ◽  
Screen Failure

Background and Purpose: Fewer women than men tend to be enrolled in clinical trials of intracerebral hemorrhage. It is unclear whether this reflects lower prevalence of intracerebral hemorrhage in women, selection bias, or poor recruitment efforts. We undertook this study to examine differences between men and women in the reasons for exclusion from the iDEF trial (Intracerebral Hemorrhage Deferoxamine). Methods: The screen failure log included 29 different reasons for exclusion. Chi-square statistics were used to evaluate the differences in reasons for exclusion between men and women. Results: A total of 38.2% of participants in iDEF were women. Three thousand nine hundred eighty-two women (45.7%) and 4736 men (54.3%) were screen failures ( P <0.0001). Similar proportions of women (1.28%) and men (1.73%) were excluded due to inability to obtain consent ( P =0.1). Patients or families declined participation in 1.26% of women versus 1.31% of men ( P =0.9). More women than men failed screening because of age>80 (22.40% versus 12.61%; adjusted P =0.0007) and preexisting do-not-resuscitate/do-not-intubate (3.69% versus 2.83%; adjusted P =0.067). Conclusions: Lower rates of women enrollment in the iDEF trial may be attributed to older age. Inability to obtain consent or declining participation was similar between women and men, arguing against selection bias. Our findings should be confirmed in other intracerebral hemorrhage trials to determine best strategies to improve women’s representation in future trials.

Abstract WMP106: Why Are Women Less Represented in ICH Trials?

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Casey Norton ◽  
Sharon Yeatts ◽  
Lydia Foster ◽  
Andre Thornhill ◽  
Jessica Griffin ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Selection Bias ◽  
Study Drug ◽  
Late Presentation ◽  
National Institutes Of Health ◽  
Chi Square ◽  
Women's Participation ◽  
Enrollment Rates ◽  
Poor Recruitment ◽  
Screen Failure

Background: Fewer women than men tend to be enrolled in clinical trials of intracerebral hemorrhage (ICH). It is unclear whether this reflects lower prevalence of ICH in women, selection bias, poor recruitment efforts, or other factors. We undertook this study to examine differences between women and men in the reasons for exclusion from the iDEF (Intracerebral hemorrhage Deferoxamine) trial. Methods: The screen failure log included 29 different reasons for exclusion. Chi square statistics and p-values were used to evaluate whether women and men differed with regard to reason for screen failure. Findings: The iDEF trial enrolled 294 subjects; 38.5% were women. A total of 8776 subjects were screen failures. Sex was missing in 58. The remaining 8718 were included in this analysis; 3982 women (45.7%) and 4736 men (54.3%) (p<0.0001). The enrollment rates were 2.8% in women vs. 3.7% in men (p=0.01). We were unable to obtain consent in 1.3% of women vs 1.7% of men (p=0.1), and patients/families declined participation in 1.3% of women vs. 1.3% of men (p=0.9). More women than men failed screening because of age >80 (22.4% vs 12.6%) and pre-existing DNR/DNI (3.7% vs. 2.8%). Conversely, fewer women than men failed screening because inability to administer study drug within 24 hour due to late presentation (6.6% vs 7.8%), admission NIHSS score <6 (10.2% vs 13.2%), coagulopathy (5.3% vs 7.5%), inability to comply with the protocol (0.7% vs 1.3%), abnormal renal function (1.9% vs 2.9%), drug/alcohol abuse (1.7% vs 3.7%), and presentation with confirmed aspiration or pneumonia (1.1% vs 1.8%).These differences were statistically significant. Interpretation: Results from this multi-center, prospective, ICH trial indicate that lower rates of women enrollment may be attributed to older age and higher rates of pre-existing DNR/DNI orders. Inability to obtain consent or declining participation was similar between women and men, arguing against selection bias. Our findings should be confirmed in other ICH trials to determine if additional efforts are needed to improve women’s participation in future studies. Funding: US National Institutes of Health and US National Institute of Neurological Disorders and Stroke (U01NS074425)

scholarly journals EQ-5D-3L full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus

Rheumatology ◽  
2021 ◽  
Author(s):  
Julius Lindblom ◽  
Alvaro Gomez ◽  
Alexander Borg ◽  
Sharzad Emamikia ◽  
Dimitris Ladakis ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Lupus Erythematosus ◽  
Damage Index ◽  
Patient Reported Outcome ◽  
Health State ◽  
Full Health ◽  
Chi Square ◽  
Discriminative Ability ◽  
Exact Test ◽  
Patient Reported

Abstract Objectives To investigate the discriminative ability of EQ-5D-3L full health state (FHS) in clinical trials of SLE, and identify factors associated with FHS after treatment. Methods Data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials of belimumab (N = 1684) were utilised. FHS was defined as a response of no problems in all five EQ-5D-3L dimensions, yielding an index score of 1. The Pearson’s chi-square or Fisher’s exact test was employed for comparisons, and logistic regression for adjustments and assessment of independence. Results We demonstrated higher EQ-5D-3L FHS frequencies among patients given standard therapy (ST) plus the licensed belimumab dose versus ST alone (26.1% versus 19.4%; P = 0.001; week 52), and within SRI-4 responders versus non-responders (27.0% versus 19.8%; P &lt; 0.001; week 52) from week 36 to 52. In multivariable regression analysis, SLEDAI-2K (OR: 0.90; 95% CI: 0.87 − 0.94; P &lt; 0.001) and SLICC/ACR Damage Index (OR: 0.79; 95% CI: 0.69 − 0.91; P = 0.001) scores were independently associated with lower FHS frequencies at week 52, while adding monthly infusions of belimumab 10 mg/kg to ST favoured FHS perception (OR: 1.60; 95% CI: 1.15 − 2.24; P = 0.006). Add-on belimumab 10 mg/kg yielded higher FHS frequencies in antimalarial users versus non-users (29.9% versus 20.1%; P = 0.011), and in anti-dsDNA and anti-Sm positive versus negative patients (31.4% versus 13.4%; P &lt; 0.001 and 33.0% versus 22.6%; P = 0.010, respectively), whereas no significant differences were observed in patients given ST alone. Conclusion EQ-5D-3L FHS distinguished belimumab from placebo and responders from non-responders, and exhibited known-group validity in subgroup analysis. FHS may prove a useful patient-reported outcome in SLE studies.

scholarly journals Reducing research waste by promoting informed responses to invitations to participate in clinical trials

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Katie Gillies ◽  
Iain Chalmers ◽  
Paul Glasziou ◽  
Diana Elbourne ◽  
Jim Elliott ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Trial Participation ◽  
Specific Information ◽  
Recruitment And Retention ◽  
Research Waste ◽  
Informed Decisions ◽  
Participation Barriers ◽  
Poor Recruitment

Abstract Poor recruitment to, and retention in, clinical trials is a source of research waste that could be reduced by more informed choices about participation. Barriers to effective recruitment and retention can be wide-ranging but relevance of the questions being addressed by trials and the outcomes that they are assessing are key for potential participants. Decisions about trial participation should be informed by general and trial-specific information and by considering broader assessments of ‘informedness’ and how they impact on both recruitment and retention. We suggest that more informed decisions about trial participation should encourage personally appropriate decisions, increase recruitment and retention, and reduce research waste and increase its value.

scholarly journals Effect of reasons for screen failure (RFSF) on standard of care in cancer patients screened for clinical trials

2018 ◽  
Vol 29 ◽  
pp. ix170-ix171
Author(s):  
C. Tiu ◽  
Z. Loh ◽  
C. Gan ◽  
J. Hakanson ◽  
H. Gan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Standard Of Care ◽  
Screen Failure

Abstract 052: Improved Hospital Outcomes With Hypokalemia on Admission in Cardiac Arrest Survivors Treated With Therapeutic Hypothermia

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Angelo de la Rosa ◽  
Manuel Tapia ◽  
Yong Ji ◽  
Basil Saour ◽  
Mikhail Torosoff
Keyword(s):  
Logistic Regression ◽  
Cardiac Arrest ◽  
Ventricular Fibrillation ◽  
Hospital Mortality ◽  
Electrical Activity ◽  
Therapeutic Hypothermia ◽  
Multivariate Logistic Regression Analysis ◽  
Pulseless Electrical Activity ◽  
Older Age ◽  
Chi Square

Purpose: We hypothesized that advanced circulatory compromise, as manifested by acidosis and hyperkalemia should be associated with worsened clinical outcomes in cardiac arrest patients treated with therapeutic hypothermia. Methods: Results of initial admission laboratory studies, medical history, and echocardiogram in 203 consecutive cardiac arrest patients (59 females, 59+/- 15 years old) undergoing therapeutic hypothermia were reviewed. Mortality was ascertained through hospital records. ANOVA, chi-square, Kaplan-Meier, and logistic regression analyses were used. The study was approved by the institutional IRB. Results: Increased mortality was noted with older age, decreased admission pH, elevated admission lactate, lower admission hemoglobin, and pulseless electrical activity or asystole as presenting rhythms (Table). Admission hypokalemia and ventricular fibrillation/tachycardia were associated with improved hospital mortality (Table). Potassium was significantly lower in patients admitted with ventricular fibrillation/tachycardia (3.897+/-0.92) as compared to patients with asystole (4.674+/-1.377) or pulseless electrical activity (4.491+/-1.055 mEq/dL, p<0.0001). In multivariate logistic regression analysis, independent predictors of increased hospital mortality included increased admission potassium (OR 2.0, 95%CI 1.291-3.170, p=0.002)), older age (OR 1.04, 95%CI 1.007-1.071, p=0.017), admission PEA (OR 3.7, 95%CI 1.358-10.282, p=0.011 when compared to ventricular fibrillation/tachycardia) or asystole (OR 17.2, 95%CI 4.423-66.810, p<0.001 when compared to ventricular fibrillation/tachycardia); while decreased mortality was associated with higher hemoglobin (OR 0.8, 95%CI 0.665-0.997, p=0.047). Conclusions: Hyperkalemia, pulseless electrical activity, and asystole are predictive of increased hospital mortality in survivors of cardiac arrest. An association between low or low-normal potassium, observed VT-VF, and better outcomes is unexpected and may be used for prognostic purposes. More prospective investigations of mortality predictors in these critically ill patients are needed.

Abstract TP409: Reporting of Key Demographic Characteristics in Neurological Trials Registered on ClinicalTrials.gov

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Kush Fansiwala ◽  
Lauren Southwick ◽  
Emily Goldmann ◽  
Nina S Parikh ◽  
Joy Madubuonwu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Race And Ethnicity ◽  
Neurological Diseases ◽  
Demographic Characteristics ◽  
Mandatory Reporting ◽  
Trial Participation ◽  
Limited Participation ◽  
Chi Square ◽  
Before And After ◽  
Race Ethnicity

Introduction: To increase the transparency of clinical trial information, U.S. Congress passed the Food and Drug Administration (FDA) Amendments Act of 2007, which expanded prior legislation to mandate inclusion of specific trial characteristics, such as funding source and gender demographics, in a new basic results section on ClinicalTrials.gov. Few studies have examined the extent to which key demographic characteristics such as sex and race/ethnicity are reported for neurological trials on ClinicalTrials.gov. Methods: As part of the National Initiative for Minority Involvement in Neurological Clinical Trials (NIMICT), we systematically identified neurological clinical trials on ClinicalTrials.gov (for stroke, epilepsy, Alzheimer’s Disease [AD]) and examined the proportion that reported sex, race, and ethnicity (Hispanic/Latino or not) of study participants. We used the website’s advanced search feature to evaluate demographic information reported from trials conducted between 1999 and 2015. We first calculated frequencies of trials reporting these characteristics, then assessed differences in reporting of each characteristic (yes/no) by condition (stroke, epilepsy, AD) and between trials conducted before and after the basic results section update (pre- and post-2008) using chi-square tests. Results: Our sample comprised 251,847 subjects across 393 trials (147 stroke, 127 epilepsy, 115 AD). Overall, sex was reported for nearly all trials (99.0%), while reporting of race and ethnicity was low (ethnicity: 14.0%, race: 19.8%). Reporting of these characteristics did not differ significantly across the three conditions or between periods preceding and following the FDA act. Conclusion: While ClinicalTrials.gov mandates reporting of sex, it does not require reporting of race/ethnicity, and few trials report these characteristics. This lack of information prevents understanding of neurological trial participation and how interventions might impact patients differently by race/ethnicity. Mandatory reporting of race/ethnicity would enhance transparency and increase awareness of the limited participation of racial/ethnic minorities-who suffer disproportionately from neurological diseases-in neurological trials.

Abstract W MP54: Risk Factors for Nosocomial Infections after Intracerebral Hemorrhage and Their Impact on Outcome: The Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) Study

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Aaron S Lord ◽  
Mitchell S Elkind ◽  
Carl D Langefeld ◽  
Charles J Moomaw ◽  
Neeraj Badjatia ◽  
...  
Keyword(s):  
Risk Factors ◽  
Intracerebral Hemorrhage ◽  
Pulmonary Edema ◽  
Nosocomial Infections ◽  
Fold Increase ◽  
Cns Infection ◽  
Neurosurgical Procedures ◽  
Chi Square ◽  
Factors Associated ◽  
Ct Data

Background: Risk factors for nosocomial infections and their impact on ICH outcomes are unclear. We hypothesized that factors present on admission are associated with developing infection, and patients who develop infections have worse outcomes. Methods: We determined prevalence of infections among patients in ERICH, a multicenter, triethnic case-control study of ICH. Exclusion criteria specific to this analysis were incomplete CT data and death/withdrawal of care <72 hours after admission. Patients with infection <two weeks before ICH were excluded from risk factor analyses, but included for outcomes assessments. We compared prevalence of risk factors for infections using chi-square and non-parametric tests, and performed multivariate logistic regression for risk of infection. Results: We enrolled 1397 individuals, 144 of whom died/had withdrawal of care within 72 hours and 210 with incomplete CT data, leaving 1043 patients. Nosocomial infections occurred in 300 patients (29%). Factors associated with presence of infections included ICH volume (13mL vs. 7mL, p <0.0001), GCS on admission (13 vs. 15, p <0.0001), WBC > 10 (42% vs. 32%), and higher CRP levels (4.9 vs. 1.8, p=0.01). Blacks had higher infection rates versus whites and Hispanics (33% vs. 27% and 24%, p=0.06). Procedural factors associated with infection included ventriculostomy, intrathecal-tPA, and intubation, while major neurosurgical procedures were associated with a 10-fold increase in CNS infection (all p <0.001). Infections were associated with bowel-bladder dysfunction, CHF/pulmonary edema, decubiti, DVT, dysphagia requiring PEG, and MI. Patients with infection were more likely to have DNR/DNI orders or to be dead at discharge (12.3% vs. 6.5%, p=0.0017). In a multivariate model for factors associated with infection, ICH volume, HIV history, intubation, CHF/pulmonary edema, and dysphagia requiring PEG were all associated with infection. Conclusion: There are identifiable risk factors associated with nosocomial infection after ICH, and infections are associated with mortality. Identification of patients at risk for infections may improve outcomes after ICH.

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