Race-Ethnic Enrollment Disparities over 15 Years of Alliance/CALGB Acute Myeloid Leukemia Clinical Trials, Biobanks, and Correlative Science Protocols

Introduction Race-ethnic disparities in clinical trial enrollment have the potential to bias findings, limit generalizability, misdirect drug development, and reduce equitable access to novel therapy. The degree to which such disparities exist within acute myeloid leukemia (AML) North American cooperative group trials, biobanks, and correlative studies remain unclear, as are the factors that influence biobank and correlative study participation among trial enrollees. In addition, the National Cancer Institute's (NCI) mandate for Comprehensive Cancer Centers (CCC) to designate catchment areas has not been explored as a mechanism through which AML enrollment disparities can be addressed. Methods We analyzed enrollment data from the 9 Alliance/CALGB AML treatment trials, 2 biobank protocols, and 2 correlative studies active from 1998-2013 and with published results. Trial enrollees could consent to biobank and/or correlative study participation. We compared participation rates of United States (US) enrollees for the mutually exclusive racial-ethnic groups of non-Hispanic (NH)-white, NH-Black, NH-Asian, NH-Native American, and Hispanic using X 2 testing, with NH-white as the comparator and reporting odds ratios (OR) and 95% confidence intervals (CI). Rates were adjusted by national incidence according to the Surveillance, Epidemiology, and End Results program and the US Census. Testing was repeated for the 55% of participants enrolled at 15 NCI CCCs recruiting ≥10 patients, where incidence was adjusted for catchment area size and demographics. Logistic regression models, clustered by trial, were performed to assess the following predictors for biobank and correlative study participation among trial enrollees: race-ethnicity (NH-white vs non-white), site type (CCC status), age (10-year increments), sex, neighborhood urbanity (urban vs rural) and poverty (<20% vs ≥20% below poverty line) by zip code, and distance from site (10-mile increments). Results There were 3041 trial enrollees at US sites; participant characteristics and demographics by race-ethnicity are shown in Table 1. 93.9% of patients participated in a biobanking study and 60.0% in a correlative study. National incidence adjusted enrollment odds by race-ethnicity are shown in the Figure (top); NH-Black, NH-Asian, and Hispanic persons were enrolled at significantly lower rates than NH-whites; NH-Native American enrollment was significantly higher. Enrollment odds were even lower for NH-Black, NH-Asian, and Hispanic enrollees at CCC sites when adjusted by catchment area incidence (Figure; bottom). Among trial enrollees, there were no univariable predictors of biobank participation, however, male sex (OR 1.12; 95% CI 1.01, 1.37; p=0.04) and NH-white race-ethnicity (OR 1.33; 95% CI 1.12,1.57; p<0.001) were associated with correlative study participation. Multivariable models of correlative study participation, with predictors selected based on univariable significance, are shown in Table 2 for all trial enrollees and when restricted to biobank enrollees; in both cases, NH-white race predicted participation. Conclusions Across 15 years of AML cooperative group studies, there were several enrollment disparities by race-ethnicity, which were more pronounced at CCC sites. Over 90% of trial enrollees participated in biobanking, with no race-ethnic differences seen. However, correlative study participation among trial enrollees was higher for NH-whites. Taken together, these data suggest that efforts should focus on increasing trial and correlative study participant diversity-but not biobanking-within NCI-designated CCC catchment areas. Reasonable next steps include identifying key structural, provider, and patient-based barriers to trial and correlative study participation at CCC sites and developing inclusive, multilevel interventions to address them. Figure 1 Figure 1. Disclosures Eisfeld: Karyopharm (spouse): Current Employment. Stock: Pfizer: Consultancy, Honoraria, Research Funding; amgen: Honoraria; agios: Honoraria; jazz: Honoraria; kura: Honoraria; kite: Honoraria; morphosys: Honoraria; servier: Honoraria; syndax: Consultancy, Honoraria; Pluristeem: Consultancy, Honoraria. Stone: AbbVie Inc, Actinium Pharmaceuticals Inc, Aprea Therapeutics, BerGenBio ASA, ElevateBio, Foghorn Therapeutics, GEMoaB, GlaxoSmithKline, Innate Pharma, Syndax Pharmaceuticals Inc, Syros Pharmaceuticals Inc, Takeda Oncology: Other: Advisory Committee; Agios Pharmaceuticals Inc, Novartis;: Research Funding; ACI Clinical, Syntrix Pharmaceuticals, Takeda Oncology: Other: Data Safety & Monitoring. DeAngelo: Abbvie: Research Funding; Blueprint: Research Funding; Takeda: Consultancy; Autolus: Consultancy; Forty-Seven: Consultancy; Incyte: Consultancy; Jazz: Consultancy; Novartis: Consultancy, Research Funding; Pfizer: Consultancy; Servier: Consultancy; Amgen: Consultancy; Agios: Consultancy; Glycomimetrics: Research Funding. Byrd: Newave: Membership on an entity's Board of Directors or advisory committees; Vincerx Pharmaceuticals: Current equity holder in publicly-traded company, Membership on an entity's Board of Directors or advisory committees; Novartis, Trillium, Astellas, AstraZeneca, Pharmacyclics, Syndax: Consultancy, Honoraria.

Hubungan Antara Tingkat Pengetahuan Mobilisasi Dini Dengan Perilaku Mobilisasi Dini Pasien Post Operasi Apendik

Introduction: One of the postoperative client care is to do the mobilization. Mobilization exercises are carried out to prevent complications, prevent pressure sores, stimulate peristalsis and reduce pain. Methods: The design of this study is a descriptive correlative study which aims to determine the relationship between the level of knowledge and motivation of nurses on the provision of early mobilization. The population of this research is the appendic patient at RSAL Dr. Mintohardjo. The sample in this study was total sampling, with a sample of 59 respondents. The instrument uses an observation sheet. Results: The results showed that the value of P value = 0.007 means P value <0.05, so it can be concluded that there is a significant relationship between the respondent's level of knowledge and early mobilization behavior. Discussion: There is a significant relationship between the respondent's level of knowledge and early mobilization behavior

Clinical Study on Correlation of HbA1c with Different Grades of Diabetic Retinopathy at S.V.R.R.G.G.H, Tirupati – A Hospital Based Descriptive Correlative Study

BACKGROUND Patients with diabetic retinopathy (DR) are 25 times more likely to become blind than non-diabetics.1 One of the main difficulties in establishing a relationship between the degree of hyperglycemia and the long-term complications of diabetes is the lack of a reliable and objective method for the assessment of diabetic control. Recordings of glycated proteins, serum proteins, and primary hemoglobin, have added a new dimension to glycemia assessment. HbA1c has been known to be a marker to assess the long-term control of diabetes mellitus. Few studies have shown the correlation between HbA1c and different grades of DR in the past. The purpose of this study was to determine the correlation of HbA1c with different grades of diabetic retinopathy. METHODS A descriptive correlative study was conducted among 100 diabetic patients attending the Department of Ophthalmology in S.V.R.R.G.G. Hospital, Tirupathi, for a duration of one year. Relevant history regarding their diabetes was noted. The status of diabetic retinopathy in each patient was diagnosed by comprehensive ophthalmologic examination and classified according to the early treatment diabetic retinopathy study (ETDRS) system. Patients were evaluated for their HbA1c levels. RESULTS Out of 100 patients, 43 % of participants were females, and the remaining 57 % were males. A statistically significant correlation was found between different grades of diabetic retinopathy and HbA1c levels. The other factor which had a significant correlation was the duration of diabetes and grade of retinopathy (P – value < 0.05). Age of the patient, gender of the patient, did not significantly correlate when compared in different grades of diabetic retinopathy (P - value > 0.05). CONCLUSIONS A statistically significant correlation was found between HbA1c levels and the severity of diabetic retinopathy. Higher the level of HbA1c (indicating poor glycaemic control), the more severe is the grade of DR in those set of patients. KEYWORDS Diabetic Retinopathy, HbA1c, CSME

Minimal residual disease assessment by multiparameter flow cytometry in transplant-eligible myeloma in the EMN02/HOVON 95 MM trial

Minimal residual disease (MRD) by multiparameter flow cytometry (MFC) is the most effective tool to define a deep response in multiple myeloma (MM). We conducted an MRD correlative study of the EMN02/HO95 MM phase III trial in newly diagnosed MM patients achieving a suspected complete response before maintenance and every 6 months during maintenance. Patients received high-dose melphalan (HDM) versus bortezomib-melphalan-prednisone (VMP) intensification, followed by bortezomib-lenalidomide-dexamethasone (VRd) versus no consolidation, and lenalidomide maintenance. Bone marrow (BM) samples were processed in three European laboratories, applying EuroFlow-based MFC protocols (eight colors, two tubes) with 10−4−10−5 sensitivity. At enrollment in the MRD correlative study, 76% (244/321) of patients were MRD-negative. In the intention-to-treat analysis, after a median follow-up of 75 months, 5-year progression-free survival was 66% in MRD-negative versus 31% in MRD-positive patients (HR 0.39; p < 0.001), 5-year overall survival was 86% versus 69%, respectively (HR 0.41; p < 0.001). MRD negativity was associated with reduced risk of progression or death in all subgroups, including ISS-III (HR 0.37) and high-risk fluorescence in situ hybridization (FISH) patients (HR 0.38;). In the 1-year maintenance MRD population, 42% of MRD-positive patients at pre-maintenance became MRD-negative after lenalidomide exposure. In conclusion, MRD by MFC is a strong prognostic factor. Lenalidomide maintenance further improved MRD-negativity rate.