Differences In Eligibility Research Articles

Ambivalence about the selection of cardiovascular risk stratification tools: Evidence in a type 1 diabetes population

BackgroundCardiovascular disease (CVD) is one of the leading causes of death among people with diabetes, however, despite the increasing incidence of CVD, there are few tools for evaluating Cardiovascular Risk (CVR) in the population of patients with Type 1 Diabetes (T1D), with the existing ones diverging in the stratification of risk and in the suggestions for therapeutic conduct. MethodsA cross-sectional study was carried out with 104 participants diagnosed with T1D, aged 18–40, attending specialized services. The Steno Type 1 Risk Engine and the Cardiovascular Risk Stratification Calculator (CRSC) were used to assess the risk of a cardiovascular event over a 10-year period. FindingsOf the total sample selected, 62% were female, with a median age of 32 years (IQ 24; 43). There was a large difference between the stratification of CVR between the calculators, and 65.82% of the patients classified as low risk for CVD according to the Steno were identified as intermediate (30, 38.00%) and high risk (35.44%) by the CRSC. The analysis also highlighted a great difference in eligibility for statin use according to the risk stratification of the tools. ConclusionThe CRSC and Steno tools evaluated and stratified the CVR of the same population with T1D, with there being divergence of the results. It was found that the CRSC tool classified the majority of the sample as high risk. Due to this result, the eligibility to use statins, which is one of the applications of these tools, showed great differences, with the Steno tool presenting less aggressive provisions regarding the prescription of statins in patients with type 1 DM.

Comparison of visual acuity measurement with Landolt rings versus numbers

Landolt rings are commonly used for the measurement of visual acuity, especially for legal purposes. For multiple reasons, in clinical practice these optotypes are not in use and not practical. Therefore, the difference between visual acuity tested with Landolt rings as opposed tonumbers was evaluated. Visual acuity measurements of 2335 eyes from 1394 patients (aged 5-98years, median 51years) were retrospectively analyzed at the Low Vision Department of the University of Heidelberg. The patients had abroad range of ophthalmological disorders. In all patients the measurement of visual acuity was performed with numbers as well as Landolt rings according to DIN58220. Visual acuity was determined in LogMAR and compared between the two optotypes. Correlation between both optotypes was high with r2 = 0.927 but there was apronounced mean difference in visual acuity of 0.13 ± 0.14 LogMAR. Using numbers, visual acuity was 0.13 LogMAR higher, somewhat more than one line. These differences were mostly independent of visual acuity and increased slightly with age; however, the variations were greater for lower visual acuity. Whereas in clinical practice visual acuity is typically determined using numbers and early treatment diabetic retinopathy study (ETDRS) charts are the gold standard for a scientific assessment of visual acuity, only the use of Landolt rings enables an examination without the influence of form recognition. The use of Landolt rings is therefore valid for legal reasons in Europe according to EN ISO 8596 and in Germany according to DIN 58220. Comparing Landolt rings with the SnellenE chart or LEA symbols, these results confirm previous reports that visual acuity measured with Landolt rings results in lower visual acuity. On average visual acuity is approximately one line worse than when tested with numbers, afact that has to be taken into account when comparing different examination results. This may be explained by incorrect correlation of the used numbers exceeding the allowed difference in eligibility of 0.05 LogMAR. Hence, it is important for legal assessment to measure visual acuity correctly with Landolt rings.

Gender Bias in LVAD Referral Patterns - A Survey of Patients and Providers

Purpose LVADs offer survival benefit to pts with advanced heart failure (HF). Though HF rates are higher in women, female (F) pts remain underrepresented as LVAD recipients and participants in clinical trials. We aimed to evaluate the role of gender bias in referral patterns for LVAD. Methods Separate questionnaires were administered to F and male (M) LVAD pts and to cardiologists. The pt questionnaire consisted of 7 questions about satisfaction with LVAD and perception of gender bias in LVAD referral. The physician questionnaire tested knowledge of gender specific outcomes after LVAD and individual referral practices. The Edmonton Symptom Assessment Score (ESAS) was measured in pts prior to LVAD to assess levels of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath, with higher scores indicating greater symptom burden. Results 28 pts participated; 14 (50%) were F. Indication was bridge to transplant in 18 pts (64.3%), including 9 F and 9 M. Average time on support was 19.1±2.9 mo, which was similar between F and M. Average ESAS prior to LVAD was 16.5±2.9; 19.3±4.0 in F and 13.9±4.1 in M. The majority of F and M did not perceive a gender bias in LVAD referral. However, F overall were less satisfied with the LVAD and were less likely to recommend the procedure to others, with 64.3% reporting that they would recommend LVAD compared to 92.9% of M. F expressed greater improvement in relationships with their partners after LVAD: 36% vs. 25% respectively. Of the 7 cardiologists who participated in the study, none identified a gender difference in eligibility for or mortality after LVAD. However, more cardiologists were “unsure” about complication rates in F than in M (Fig). Conclusion Patients and cardiologists alike do not identify a gender bias in referral patterns for LVADs. However, gender differences exist in patient satisfaction with LVAD therapy and in physicians’ knowledge of complication rates after LVADs. Future studies should continue to explore gender differences in LVAD therapy.

Selective retention bonuses for highly effective teachers in high poverty schools: Evidence from Tennessee

Research has established that racially isolated schools with high concentrations of low-income students disproportionately struggle to recruit and retain highly effective teachers, limiting disadvantaged students’ exposure to high-quality instruction and driving institutional and community instability. This study estimates the effect of selective retention bonuses (SRB) for highly effective teachers on low-performing, high poverty schools’ ability to elevate student performance by increasing access to effective instruction. The theory of action behind the bonus program is simple: SRBs result in greater numbers of highly effective teachers at participating schools, who subsequently drive larger student gains than the teachers who would otherwise fill their positions. To examine whether students in high poverty schools benefit from retention of highly effective teachers, we use differences in eligibility for schools to offer bonuses and the discrete timing of the program in a matched sample, difference-in-differences framework. Results indicate that schools who offered SRBs saw greater test score gains in subsequent years, especially on state reading exams.

RACIAL DISPARITIES IN ELIGIBILITY FOR LOW-DOSE COMPUTED TOMOGRAPHY LUNG CANCER SCREENING AMONG OLDER ADULTS WITH A HISTORY OF SMOKING

Lung cancer early detection screening has been demonstrated to decrease lung cancer mortality among high-risk smokers. This study aimed to examine whether current screening guidelines may disproportionately exclude African American smokers who are at higher overall risk for lung cancer. Data from the 2014 Health and Retirement Study were analyzed. Older African Americans and Whites with a history of smoking were included in the analyses (n = 7,348). Eligibility criteria established by the U.S. Preventive Services Task Force (USPSTF) for LDCT lung cancer screening were used. Multivariate logistic regression analyses were conducted to examine racial differences in eligibility for LDCT lung cancer screening. Overall, 21.1% of current and 10.5% of former smokers met USPSTF’s eligibility criteria for LDCT screening. In multivariate logistic regression analyses, African American smokers were less likely to be eligible for LDCT lung cancer screening compared to Whites (odds ratio = 0.5; p < 0.001). African American smokers were less likely to meet established lung cancer screening eligibility criteria compared to Whites. Current lung cancer screening criteria may not adequately capture African Americans at risk and may widen the health disparities in African Americans. Further longitudinal studies are needed to evaluate the efficacy of current lung cancer screening guideline.

Racial disparities in eligibility for low-dose computed tomography lung cancer screening among older adults with a history of smoking.

Lung cancer early detection screening has been demonstrated to decrease lung cancer mortality among high-risk smokers. This study aimed to examine whether current screening guidelines may disproportionately exclude African American smokers who are at higher overall risk for lung cancer. Data from the 2014 Health and Retirement Study were analyzed. Older African Americans and Whites with a history of smoking were included in the analyses (n = 7,348). Eligibility criteria established by the U.S. Preventive Services Task Force (USPSTF) for LDCT lung cancer screening were used. Multivariate logistic regression analyses were conducted to examine racial differences in eligibility for LDCT lung cancer screening. Overall, 21.1% of current and 10.5% of former smokers met USPSTF's eligibility criteria for LDCT screening. In multivariate logistic regression analyses, African American smokers were less likely to be eligible for LDCT lung cancer screening compared to Whites (odds ratio = 0.5; p < 0.001). African American smokers were less likely to meet established lung cancer screening eligibility criteria compared to Whites. Current lung cancer screening criteria may not adequately capture African Americans at risk and may widen the health disparities in African Americans. Further longitudinal studies are needed to evaluate the efficacy of current lung cancer screening guideline.

Eligibility of real-world patients with chemo-refractory, K-RAS wild-type, metastatic colorectal cancer for palliative intent regorafenib monotherapy.

The CORRECT trial demonstrated survival benefits with regorafenib monotherapy in patients with treatment-refractory, metastatic colorectal cancer (mCRC). However, the trial's stringent eligibility criteria for regorafenib may limit its external validity. We aimed to examine treatment attrition rates and eligibility for regorafenib in routine practice. We identified patients at the British Columbia Cancer Agency diagnosed with mCRC who demonstrated disease progression or intolerable toxicity on 2 or more lines of systemic therapy. During the study timeframe, panitumumab and cetuximab were only used in the chemo-refractory setting. Data on clinicopathologic variables and patient outcomes were ascertained and analyzed. Eligibility was determined using the CORRECT trial criteria. A total of 391 patients were identified, among whom only 39% were eligible for regorafenib: 35% in the panitumumab group and 51% in the cetuximab group. The main reasons for ineligibility in all patients were Eastern Cooperative Oncology Group Performance Status (ECOG PS) > 1 (69%), an elevated total bilirubin (21%), and thromboembolic events in the past 6months (10%). No difference in eligibility for regorafenib was observed between patients previously receiving panitumumab or cetuximab (P = 0.914; 95% CI 0.550-1.951). Kaplan-Meier analyses showed that regorafenib-eligible compared to regorafenib-ineligible patients had an increased median overall survival of 5.3 versus 2.1months, respectively (P < 0.001). However, Cox proportional hazard analyses showed that only ECOG PS rather than trial eligibility was correlated with outcomes. The strict eligibility criteria disqualify most patients with treatment-refractory mCRC for regorafenib therapy. Future trials should broaden the eligibility criteria to improve external validity.

Bismarck's Health Insurance and the Mortality Decline

We investigate the impact on mortality of the world’s first compulsory health insurance, established by Otto von Bismarck, Chancellor of the German Empire, in 1884. Employing a multi-layered empirical setup, we draw on international comparisons and difference-in-differences strategies using Prussian administrative panel data to exploit differences in eligibility for insurance across occupations. All approaches yield a consistent pattern suggesting that Bismarck’s Health Insurance generated a significant mortality reduction. The results are largely driven by a decline of deaths from infectious diseases. We present prima facie evidence that diffusion of new hygiene knowledge through physicians was an important channel.Keywords: health insurance, mortality, demographic transition, Prussia JEL Classification: : I13, I18, N33, J11

Complete right bundle branch block and QRS-T discordance can be the initial clue to detect S-ICD ineligibility

BackgroundIn order to minimize inappropriate shocks of subcutaneous implantable cardioverter-defibrillators (S-ICD), it is important to recognize who is suitable for S-ICD indication. This study aimed to clarify what types of cardiac disease are likely to fulfill the S-ICD screening criteria and ineligible factors for S-ICD in the standard 12-lead electrocardiogram (ECG). MethodsA total of 348 patients with heart disease were enrolled. They were assessed by supine and standing ECG recording to simulate the 3 S-ICD sensing vectors and standard 12-lead ECG, simultaneously. Clinical and ECG characteristics were analyzed to compare the patients who are eligible and ineligible with S-ICD screening ECG indication. ResultsThe mean age of study patients was 49±21 years and 244 (70%) were men. Nineteen percent of patients were unsuitable for S-ICD. There was no significant difference in ineligibility for S-ICD among cardiac diseases (p=0.48). Univariate analysis showed complete right bundle branch block (CRBBB), QRS-T discordance in lead II, and QRS-T discordance in 3 leads (I, II, and aVF) were more frequent in patients who were ineligible for S-ICD than in the eligible group. Multivariate regression analysis showed CRBBB and QRS-T discordance in 3 leads were independent predictors for ineligibility of S-ICD. ConclusionThere are no differences in eligibility of S-ICD among types of cardiac diseases. CRBBB and QRS-T discordance were independent predictors for ineligibility.

Abstract P204: Tissue Plasminogen Activator (tPA) Eligibility for Acute Stroke in Urban and Rural Hospitals in North Carolina: The North Carolina Stroke Care Collaborative

Introduction: Thrombolytic therapy was approved over a decade ago for the treatment of acute ischemic stroke, yet administration remains infrequent in clinical practice partly due to pre- and in-hospital delays and patient contraindications. Reports of urban-rural differences in eligibility for and treatment with tPA are few. Understanding differences by hospital location may help identify quality improvement strategies unique to particular hospital systems, particularly those in non-metropolitan areas of North Carolina in which nearly one-third of the population resides. Methods: We included all acute ischemic strokes in the NC Stroke Care Collaborative, a voluntary state-wide quality improvement program, from Jan 2008 - Aug 2012 with valid, non-missing times from symptom onset to hospital arrival. Location of the 60 participating hospitals was classified as metropolitan, micropolitan, or smalltown using Rural-Urban Commuting Area codes. Rates of intravenous tPA eligibility and receipt were calculated by hospital location. Pre-hospital (onset to arrival) and CT (arrival to CT interpretation) delay times were compared using Wilcoxon tests. Reasons for non-eligibility by hospital location were compared using chi-squared statistics. Results: We identified 16,050 ischemic stroke patients (13,913 metropolitan, 1897 micropolitan, and 240 smalltown). Pre-hospital delay was longer among patients treated at smalltown compared with metropolitan hospitals (median hours [IQR] 3.8 [1.0-9.9] vs. 3.3 [1.3-8.2], p=0.04) but the proportion arriving within 2 hours of symptom onset was similar (38%). CT delay was slightly longer for patients at metropolitan compared with smalltown hospitals (1.1 [0.6-1.7] vs. 0.8 [0.5-1.2]; p&lt;0.0001). Thirty-eight percent (2004 of 5276) of patients arriving within 2 hours were eligible for tPA at metropolitan hospitals compared with 41% (304 of 741) at micropolitan and 46% (42 of 92) at smalltown hospitals (p=0.1). Patients in smalltown compared with metropolitan hospitals had higher rates of ineligibility due to advanced age (5% vs. 3%) and family/patient refusal (9% vs. 3%), whereas patients in metropolitan hospitals had higher rates of contraindications (35% vs. 12%) and rapid improvement/symptom resolution (20% vs. 12%). Rece ipt of tPA among eligible patients was highest in metropolitan (70%, 1399 of 2004) compared with micropolitan (37%, 113 of 304) and smalltown hospitals (33%, 14 of 42; p&lt;0.001). Conclusion: Receipt of tPA within 3 hours of symptom onset remains below guideline recommendations. Pre-hospital and CT delay times and eligibility for tPA were largely similar across hospital locations. Despite this, tPA administration was considerably lower at smalltown hospitals compared with hospitals in urban settings, suggesting the need for quality improvements targeted at smalltown hospitals that may have less stroke care capability.

Treatment of Stage I-II A Non-Bulky Hodgkin's Lymphoma (HL): An Individual Patient-Data Comparison of German Hodgkin Study Group (GHSG) HD10 and HD11 Combined-Modality Therapy (CMT) and NCIC Clinical Trials Group (NCIC CTG) HD.6 ABVD Alone

AbstractAbstract 548 Background:Excellent results are seen in HL patients with stage I-IIA disease treated with CMT that includes involved field radiation therapy (IFRT), as per GHSG HD10 [Engert NEJM 2010] and HD11 [Eich JCO 2010] or with ABVD alone, as per NCIC CTG/ECOG HD.6 [Meyer NEJM 2012]. Comparing these reports is complicated by differences in eligibility, staging, endpoints and follow-up duration. Our objectives were to use individual patient data from these 3 trials to compare outcomes after standardizing patient eligibility. Methods:Potentially eligible patients were those treated with 2 cycles of ABVD/20 Gy IFRT on GHSG HD10, 4 cycles of ABVD/30 Gy IFRT on GHSG HD11 and 4–6 cycles of ABVD alone on NCIC CTG HD.6. To be included in analysis, patients were required to be eligible for GHSG HD10 or HD11 and NCIC CTG HD.6. Eligibility of HD10/11 patients for HD.6 was determined by the GHSG by applying HD.6 protocol criteria. Anonymized individual patient data of eligible patients was forwarded to NCIC CTG along with reasons for ineligibility of other patients. Eligibility of HD.6 patients for HD10/11 was determined by NCIC CTG by applying HD10/11 protocol criteria with listing of reasons for ineligibility. Eligibility questions were resolved through consensus. Patients meeting mutually inclusive eligibility criteria were stratified by a propensity score (PSc) based on age, gender, stage, ESR and number of disease sites. Outcomes were based on Revised Response Criteria for Malignant Lymphoma [Cheson JCO 2007]; no trial incorporated PET scanning. The primary outcome measure was progression-free survival (PFS), which includes disease progression and death from any cause as events. Secondary outcomes included overall survival (OS) and time to progression (TTP), which includes disease progression and death from HL as events. A priori subsets for analysis included eligibility for HD10 vs. HD11 and CR/CRu status after 2 cycles of ABVD among those eligible for both HD10 and HD.6. Cox models stratified by PSc were used to obtain hazard ratios (HR) for PFS, OS and TTP; HRs are expressed as GHSG HD10/11 relative to NCIC CTG HD.6. Results:Of 655 patients eligible for selected arms of HD10/HD11, 406 were eligible when applying the inclusion criteria for HD.6 (HD10 = 254; HD11 = 152). Most common reasons for ineligibility were B symptoms (n=127) and large mediastinal mass (n=80). Of 196 HD.6 patients, 182 were eligible for HD10 (n=110) or HD11 (n=71; 1 patient not assignable). Median follow-up for both HD10 and HD11 was 91 months and for HD.6 was 134 months. Results that include all eligible patients are shown in table; TTP was superior in GHSG trials.EndpointGHSG HD10/11NCIC CTG HD.6HR95% CI8-yr PFS89%86%0.710.42-1.188-yr OS95%95%1.090.49-2.408-yr TTP93%87%0.440.24-0.78In the HD10/HD.6 subset, 8-yr PFS was 87% vs 82% (HR=0.58; 95% CI=0.32–1.05) and OS was 96% vs 94% (HR=0.65; 95% CI=0.25–1.72). Among those with CR/CRu after 2 cycles of ABVD, 8-yr PFS was 87% vs 95% (HR=2.8; 95% CI=0.64–12.5) and OS was 96% vs 100%. Among those without CR/CRu after 2 cycles of ABVD, 8-yr PFS was 88% vs 74% (HR=0.35; 95% CI=0.16–0.79) and OS was 95% vs 91% (HR=0.42; 95% CI=0.12–1.44). In the HD11/HD.6 subset, 8-yr PFS was 91% vs 91% (HR=1.15; 95% CI=0.45–2.97) and OS was 95% vs 97% (HR=2.03; 95% CI=0.53–7.79). Among 406 HD10/11 patients, there have been 19 deaths; 7 were attributed to HL or immediate treatment toxicity and 12 to other causes. Among 182 HD.6 patients, there have been 10 deaths; 5 were attributed to HL or immediate treatment toxicity and 5 to other causes. Conclusions:In this non-randomized cohort comparison, TTP was superior and PFS trended to being superior in patients treated with CMT on HD10/11. No differences in OS are evident; longer follow-up is needed to assess trade-offs between disease control and risks of late treatment effects. The role of IFRT in attaining long-term disease control appears to be especially important in those who do not attain CR/CRu status after 2 cycles of ABVD. As outcomes of those eligible for HD10/HD.6 and treated with 4–6 cycles of ABVD alone were excellent if CR/CRu was attained after 2 cycles of ABVD, these data support more recent strategies evaluating response-adapted approaches for use of IFRT. Disclosures:Borchmann:Millenium The Takeda Oncology Company: Research Funding; Takeda Pharma GmbH: Travel Grants, Travel Grants Other. Horning:Genentech: Employment; Roche: Equity Ownership. Engert:Millenium The Takeda Oncology Company: Honoraria. Meyer:Lilly: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Amgen Canada: Research Funding; Ariad Pharma: Research Funding; Astex Therapeutics: Research Funding; AstraZeneca: Research Funding; Bristol-Myers Squibb: Research Funding; GlaxoSmithKline: Research Funding; Janssen Ortho: Research Funding; Novartis: Research Funding; Oncothyreon: Research Funding; Pfizer: Research Funding; Roche: Research Funding; Sanofi-Aventis: Research Funding; Schering Canada: Research Funding.

Unsuccessful Dietetic Internship Applicants: A Descriptive Survey

We examined the demographic characteristics of applicants who applied and were unsuccessful in securing an internship position, what these applicants did afterward in their efforts to obtain an internship position, and which career paths they pursued. We also searched for any differences in eligibility between applicants who had not obtained an internship position and those who eventually were successful. A 68-item online survey was administered. The study sample (n=84) was relatively homogeneous: female (99%), heterosexual (98%), Caucasian (70%), Canadian-born (75%), having English as a first language (73%), multilingual (40%), and having completed a previous degree (29%). Mean self-reported cumulative grade point average (3.35) exceeded the minimum (3.0) required by most Ontario internship programs. Over 25% eventually secured an internship position. Applicants who rated their packages strong in community nutrition were less successful in attaining an internship. Little difference in qualification was found between those who were eventually successful and not-yet-successful applicants. Unsuccessful applicants met academic and other requirements for admission to dietetic internship programs in Ontario. Insufficient training opportunities, costs associated with internship, and competition may be contributing to a loss of human potential in dietetics.

Racial differences in eligibility and enrollment in a smoking cessation clinical trial.

The purpose of this study was to compare the recruitment, eligibility screening, and enrollment of African American and White smokers into an intensive smoking cessation intervention trial [The Chicago STOP Smoking Trial (C-STOP)]. We compared demographic, smoking, substance use, and medical/psychiatric screening data from the recruitment records of 1,189 non-Hispanic, African American and White smokers screened for eligibility in the last year of a randomized pharmacological and behavioral smoking cessation trial. The study took place at a large urban medical center and two satellite locations within the Chicago metropolitan area. Interest levels in the study were high among African American smokers, with twice as many African Americans as Whites contacting study staff for information and an initial screening. However, African Americans were nearly three times as likely not to be enrolled in the trial as Whites, because of higher ineligibility rates, failure to attend a screening session, and lower participation rates even among those meeting eligibility requirements. Racial differences were observed nearly at all levels of enrollment determination. These critical barriers to inclusion of African Americans in smoking cessation research limit our understanding of treatment efficacy and ultimately the ability to reduce the health disparities in tobacco-related disease experienced by African Americans.

Variability of Creatinine Measurements in Clinical Laboratories: Results from the CRIC Study

Objectives: Estimating equations using serum creatinine (SCr) are often used to assess glomerular filtration rate (GFR). Such creatinine (Cr)-based formulae may produce biased estimates of GFR when using Cr measurements that have not been calibrated to reference laboratories. In this paper, we sought to examine the degree of this variation in Cr assays in several laboratories associated with academic medical centers affiliated with the Chronic Renal Insufficiency Cohort (CRIC) Study; to consider how best to correct for this variation, and to quantify the impact of such corrections on eligibility for participation in CRIC. Variability of Cr is of particular concern in the conduct of CRIC, a large multicenter study of subjects with chronic renal disease, because eligibility for the study depends on Cr-based assessment of GFR. Methods: A library of 5 large volume plasma specimens from apheresis patients was assembled, representing levels of plasma Cr from 0.8 to 2.4 mg/dl. Samples from this library were used for measurement of Cr at each of the 14 CRIC laboratories repetitively over time. We used graphical displays and linear regression methods to examine the variability in Cr, and used linear regression to develop calibration equations. We also examined the impact of the various calibration equations on the proportion of subjects screened as potential participants who were actually eligible for the study. Results: There was substantial variability in Cr assays across laboratories and over time. We developed calibration equations for each laboratory; these equations varied substantially among laboratories and somewhat over time in some laboratories. The laboratory site contributed the most to variability (51% of the variance unexplained by the specimen) and variation with time accounted for another 15%. In some laboratories, calibration equations resulted in differences in eligibility for CRIC of as much as 20%. Conclusions: The substantial variability in SCr assays across laboratories necessitates calibration of SCr measures to a common standard. Failing to do so may substantially affect study eligibility and clinical interpretations when they are determined by Cr-based estimates of GFR.

Enrollment of lung cancer patients on clinical trials at an NCI comprehensive cancer center

6633 Background: Enrollment of cancer patients (pt) in clinical trials is considered essential in order to improve cancer care. However, cancer clinical trials participation remains low. Understanding barriers to pt enrollment is necessary to overcome this problem. Previous reports have identified pt age, race, and ethnicity, disease stage, performance status (PS) and relationship with their health care provider as factors that can influence the enrollment of pts in clinical trials. Methods: We conducted a retrospective review of the charts of all lung cancer pts seen in the Thoracic Oncology Clinic at Vanderbilt Ingram Cancer Center between November 2005 and November 2008. A total of 1075 lung cancer pts were seen. Results: 577 charts (of a planned 1075) have been audited to date. Pt demographics: median age = 64 yrs; male = 54%; Caucasian = 92%, African American = 4%, and Asian = 1%; NSCLC = 80%, SCLC = 17%. Male pts were more likely than females to be eligible for a clinical trial (p = 0.056). A study protocol was available for 57% of pts; 52% of pts proved eligible; 36% were entered into a study (11% total population). Significantly more protocols were available for NSCLC pts compared to pts with SCLC (p ≤ 0.001); there was also a non-significant trend towards higher enrollment of eligible NSCLC pts. There was no difference in eligibility between ethnicity; the percentage of eligible pts enrolling on trials was similar between Caucasian &amp; African American pts (46% and 43%); no Asian pts were enrolled. The most common reasons for not enrolling included a preference for treatment closer to home (29%), patient refusal (19%), PS (19%), and co-morbidities (17%). The distance pts traveled was inversely correlated with likelihood of study participation. Conclusions: A total of 11% of lung cancer pt evaluated in our Thoracic Oncology Clinic were enrolled in clinical trials. Our data suggest additional strategies are needed to attract minority groups, increase enrollment of women and pts with comorbidities and poor PS. Travel distances influence pt willingness to participate in clinical trials. Strategies are needed to overcome this factor. No significant financial relationships to disclose.

Rates of Part C Eligibility for Young Children Investigated by Child Welfare

Using data from the National Survey of Child and Adolescent Well-Being (NSCAW), this study examined rates of developmental delays and Part C eligibility for 1,997 children younger than 3 years who were investigated for possible maltreatment by child welfare. Developmental delays that make children eligible for Part C early intervention occurred in 47% of this population. The rates of Part C eligibility for children with substantiated abuse or neglect were not different from those whose maltreatment was not substantiated. Similarly, no differences in eligibility were observed for children in out-of-home placement as compared to those living with parents. No statistically significant differences in rates were associated with differing types of maltreatment.

PROTOCOL: Personal assistance for adults (19‐64) with physical impairments

PROTOCOL: Personal assistance for adults (19‐64) with physical impairments

PROTOCOL: Personal assistance for non‐demented older adults (65+) with impairments

PROTOCOL: Personal assistance for non‐demented older adults (65+) with impairments

Recruitment of ethnic minority patients to a cardiac rehabilitation trial: The Birmingham Rehabilitation Uptake Maximisation (BRUM) study [ISRCTN72884263

BackgroundConcerns have been raised about low participation rates of people from minority ethnic groups in clinical trials. However, the evidence is unclear as many studies do not report the ethnicity of participants and there is insufficient information about the reasons for ineligibility by ethnic group. Where there are data, there remains the key question as to whether ethnic minorities more likely to be ineligible (e.g. due to language) or decline to participate. We have addressed these questions in relation to the Birmingham Rehabilitation Uptake Maximisation (BRUM) study, a randomized controlled trial (RCT) comparing a home-based with a hospital-based cardiac rehabilitation programme in a multi-ethnic population in the UK.MethodsAnalysis of the ethnicity, age and sex of presenting and recruited subjects for a trial of cardiac rehabilitation in the West-Midlands, UK.Participants: 1997 patients presenting post-myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery.Data collected: exclusion rates, reasons for exclusion and reasons for declining to participate in the trial by ethnic group.ResultsSignificantly more patients of South Asian ethnicity were excluded (52% of 'South Asian' v 36% 'White European' and 36% 'Other', p < 0.001). This difference in eligibility was primarily due to exclusion on the basis of language (i.e. the inability to speak English or Punjabi). Of those eligible, similar proportions were recruited from the different ethnic groups (white, South Asian and other). There was a marked difference in eligibility between people of Indian, Pakistani or Bangladeshi origin.ConclusionOnce eligible for this trial, people from different ethnic groups were recruited in similar proportions. The reason for ineligibility in the BRUM study was the inability to support the range of minority languages.

Initial plasma HIV-1 RNA levels and progression to AIDS in women and men.

It is unclear whether there are differences between men and women with human immunodeficiency virus type 1 (HIV-1) infection in the plasma level of viral RNA (the viral load). In men, the initial viral load after seroconversion predicts the likelihood of progression to the acquired immunodeficiency syndrome (AIDS), but the relation between the two has not been assessed in women. Currently, the guidelines for initiating antiretroviral therapy are applied uniformly to women and men. From 1988 through 1998, the viral load and the CD4+ lymphocyte count were measured approximately every six months in 156 male and 46 female injection-drug users who were followed prospectively after HIV-1 seroconversion. The median initial viral load was 50,766 copies of HIV-1 RNA per milliliter in the men but only 15,103 copies per milliliter in the women (P<0.001). The median initial CD4+ count did not differ significantly according to sex (659 and 672 cells per cubic millimeter, respectively). HIV-1 infection progressed to AIDS in 29 men and 15 women, and the risk of progression did not differ significantly according to sex. For each increase of 1 log in the viral load (on a base 10 scale), the hazard ratio for progression to AIDS was 1.55 (95 percent confidence interval, 0.97 to 2.47) among the men and 1.43 (95 percent confidence interval, 0.76 to 2.69) among the women. The median initial viral load was 77,822 HIV-1 RNA copies per milliliter in the men in whom AIDS developed and 40,634 copies per milliliter in the men in whom it did not; the corresponding values in the women were 17,149 and 12,043 copies per milliliter. Given the recommendation that treatment should be initiated when the viral load reaches 20,000 copies per milliliter, 74 percent of the men but only 37 percent of the women in our study would have been eligible for therapy at the first visit after seroconversion (P<0.001). Although the initial level of HIV-1 RNA was lower in women than in men, the rates of progression to AIDS were similar. Treatment guidelines that are based on the viral load, rather than the CD4+ lymphocyte count, will lead to differences in eligibility for antiretroviral treatment according to sex.