Exclusion criteria of breast cancer research protocols: A descriptive analysis.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 82-82
Author(s):  
Clara Wan ◽  
Nicole E. Caston ◽  
Stacey A. Ingram ◽  
Gabrielle Betty Rocque
Keyword(s):  
Cardiovascular Disease ◽  
Descriptive Analysis ◽  
Comorbid Conditions ◽  
Cns Metastases ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Upper Limit ◽  
Laboratory Values ◽  
History Of ◽  
Substantial Heterogeneity

82 Background: Clinical trials play an important role in advancing cancer treatments. Unfortunately, only about 3% of adults with cancer are enrolled in a clinical trial in the United States due to various barriers to enrollment. This includes restrictive eligibility criteria, which currently have no standard guidelines. The purpose of this study is to evaluate the variability of eligibility criteria. Methods: This descriptive analysis utilized all therapeutic breast protocols offered at the University of Alabama at Birmingham (UAB) between 2004-2020. Exclusion criteria (e.g., laboratory values and comorbidities) were extracted from protocols using OnCore, an online dataset used to manage clinical trials, and ClinicalTrials.gov. Laboratory values or vital signs analyzed included liver function tests, hematologic labs, Eastern Cooperative Oncology Group (ECOG) performance status, and hypertension. Comorbid conditions included congestive heart failure, cardiovascular disease, presence of central nervous system (CNS) metastases, and history of prior cancer. Comorbid conditions were further analyzed by amount of time protocols required participants to be from initial diagnosis or exacerbation-free. Results: There were a total of 102 eligible protocols. Substantial heterogeneity was observed in exclusion criteria across liver/hematologic laboratory values and demographic/comorbidity variables. Among liver laboratory values, most protocols included an upper limit of acceptable for bilirubin (78%): 9% used the institutional upper limit of normal (ULN), 2% used 1.2xULN, 3% used 1.25xULN, 56% used 1.5xULN, 6% used 2xULN, and 2% used 3xULN. Similar variability was observed in protocols that included alanine transaminase and aspartate transaminase. Among hematological labs, 82% of protocols defined a lower limit of acceptable absolute neutrophil count: 1% 500mcL, 11% used 1,000mcL, 4% used 1,200mcL, 1% used 1,250mcL, 64% used 1,500mcL, and 1% used 1,800mcL. Of the comorbid conditions, exclusion criteria varied for congestive heart failure (49%), an acute exacerbation of cardiovascular disease (80%), CNS metastases (59%) and a prior cancer (66%). While most protocols included cardiovascular disease, the allowable timeframe varied between protocols: 4% did not allow an acute exacerbation within the previous 3 months, 32% did not allow within the previous 6 months, 5% did not allow within the previous 12 months, and 38 % did not specify a time frame. Protocols including history of a prior cancer as a criterion similarly had varied definitions based on timeline. Conclusions: Substantial heterogeneity was observed among clinical trial protocols. While exclusion criteria are necessary for patient safety, there is lack of evidence for current parameters. Future research should focus on defining standardized eligibility criteria while allowing for deviation based on drug specificity.

scholarly journals Exclusion Criteria of Breast Cancer Clinical Trial Protocols: A Descriptive Analysis

2021 ◽  
Author(s):  
Clara Wan ◽  
Nicole E. Caston ◽  
Stacey A. Ingram ◽  
Gabrielle B. Rocque
Keyword(s):  
Heart Failure ◽  
Cardiovascular Disease ◽  
Clinical Trial ◽  
Congestive Heart Failure ◽  
Descriptive Analysis ◽  
Comorbid Conditions ◽  
Cns Metastases ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Laboratory Values

Abstract Purpose3% of US adults with cancer are enrolled in a clinical trial due to various barriers to enrollment. The purpose of this study is to evaluate the variability of eligibility criteria, which currently have no standard guidelines. MethodsThis descriptive analysis utilized all therapeutic breast protocols offered at the University of Alabama at Birmingham between 2004-2020. Exclusion criteria were abstracted using OnCore and ClinicalTrials.gov. Laboratory values included liver function tests and hematologic labs. Comorbid conditions included congestive heart failure, cardiovascular disease, central nervous system (CNS) metastases, and prior cancer history. Comorbid conditions were further analyzed by amount of time protocols required participants to be from diagnosis or exacerbation-free. Results102 protocols were eligible. Among liver laboratory values, bilirubin (78%) was included in most protocols ranging from institutional upper limit of normal (ULN) (9%) to 3xULN (2%), with 1.5xULN (56%) being most common. Similar variability was observed in alanine transaminase and aspartate transaminase. Among hematological labs, 82% of protocols defined a lower limit of acceptable absolute neutrophil count ranging from 500μL (1%) to 1,800μL (1%), with 1,500μL (64%) being most common. Of the comorbid conditions, exclusion criteria varied for congestive heart failure (49%), an acute exacerbation of cardiovascular disease (80%), CNS metastases (59%) and a prior cancer (66%). The allowable timeframe varied between protocols for cardiovascular disease and prior cancer. ConclusionSubstantial heterogeneity was observed across laboratory values and comorbid variables among protocols. Future research should focus on defining standardized eligibility criteria while allowing for deviation based on drug specificity.

scholarly journals Exclusion Criteria of Breast Cancer Clinical Trial Protocols: A Descriptive Analysis

2021 ◽  
Author(s):  
Clara Wan ◽  
Nicole E. Caston ◽  
Stacey A. Ingram ◽  
Gabrielle B. Rocque
Keyword(s):  
Heart Failure ◽  
Cardiovascular Disease ◽  
Clinical Trial ◽  
Congestive Heart Failure ◽  
Descriptive Analysis ◽  
Comorbid Conditions ◽  
Cns Metastases ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Laboratory Values

Abstract Purpose: 3-8% of US adults with cancer are enrolled in a clinical trial due to various barriers to enrollment. The purpose of this study is to evaluate the variability of eligibility criteria, which currently have no standard guidelines.Methods: This descriptive analysis utilized all therapeutic breast protocols offered at the University of Alabama at Birmingham between 2004-2020. Exclusion criteria were abstracted using OnCore and ClinicalTrials.gov. Laboratory values included liver function tests and hematologic labs. Comorbid conditions included congestive heart failure, cardiovascular disease, central nervous system (CNS) metastases, and prior cancer history. Comorbid conditions were further analyzed by amount of time protocols required participants to be from diagnosis or exacerbation-free.Results: 102 protocols were eligible. Among liver laboratory values, bilirubin (78%) was included in most protocols ranging from institutional upper limit of normal (ULN) (9%) to 3xULN (2%), with 1.5xULN (56%) being most common. Similar variability was observed in alanine transaminase and aspartate transaminase. Among hematological labs, 82% of protocols defined a lower limit of acceptable absolute neutrophil count ranging from 500μL (1%) to 1,800μL (1%), with 1,500μL (64%) being most common. Of the comorbid conditions, exclusion criteria varied for congestive heart failure (49%), an acute exacerbation of cardiovascular disease (80%), CNS metastases (59%) and a prior cancer (66%). The allowable timeframe varied between protocols for cardiovascular disease and prior cancer.Conclusion: Substantial heterogeneity was observed across laboratory values and comorbid variables among protocols. Future research should focus on defining standardized eligibility criteria while allowing for deviation based on drug specificity.

Eligibility of real-world patients with stage II/III colorectal cancer (CRC) in adjuvant chemotherapy (AC) trials.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 50-50
Author(s):  
Atul Batra ◽  
Shiying Kong ◽  
Winson Y. Cheung
Keyword(s):  
Real World ◽  
Regression Models ◽  
Cox Regression ◽  
Stage Ii ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Uncontrolled Diabetes ◽  
History Of ◽  
Alberta Cancer Registry ◽  
Better Than

50 Background: The results of AC trials in stage II/III CRC are often generalized to real-world patients. However, clinical trials have stringent inclusion and exclusion criteria, which can potentially lead to poor generalizability of results and slow accrual. This study was conducted to determine the proportion of real-world patients with stage II/ III CRC who would be eligible for AC trials based on common eligibility criteria and to compare the outcomes in eligible and ineligible patients. Methods: We identified all patients diagnosed with stage II/III CRC in 2004-2015 from the Alberta Cancer Registry. Patients meeting any one of the following criteria were considered ineligible: age >75 years, anemia, comorbid conditions (heart disease, uncontrolled diabetes, kidney disease, liver disease) and history of a prior malignancy or immunosuppression. Logistic regression was used to describe the likelihood of receiving AC and Cox regression models were constructed to determine overall survival (OS). Results: A total of 7841 patients with stage II/III CRC were identified, of whom 52% were men and median age at diagnosis was 71 years (IQR: 61-79 years). Approximately 59% patients were deemed trial-ineligible and the most common reasons for ineligibility were advanced age (36%), renal dysfunction (27%), and cardiac disease (17%), respectively. In the real-world, 54% of eligible patients received AC as compared to 23% of ineligible patients [odds ratio 3.89, 95% confidence interval (CI) 3.53-4.28, P< 0.0001]. The 5-year OS of trial-ineligible patients who received AC was significantly better than those treated with surgery alone (table). Conclusions: Majority of real-world patients with stage II/ III CRC are unable to participate in AC trials due to strict exclusion criteria, but a fair proportion of these patients still derive some benefit from AC. The eligibility criteria of AC trials in CRC should be broadened to be more representative of real-world patients. [Table: see text]

scholarly journals STATUS PENGGUMPALAN (AGREGASI) TROMBOSIT SEBAGAI FAKTOR PROGNOSTIK TEJADINYA KELUARAN KLINIS STROK INFARK MENDADAK (STROK INFARK AKUT)

2018 ◽  
Vol 17 (2) ◽  
pp. 86 ◽  
Author(s):  
Linda Rosita ◽  
Usi Sukorini ◽  
Budi Mulyono
Keyword(s):  
Cardiovascular Disease ◽  
Prognostic Factors ◽  
Relative Risk ◽  
Previous History ◽  
Exposed Group ◽  
Exclusion Criteria ◽  
Excessive Bleeding ◽  
Acute Infarction ◽  
History Of ◽  
Physical Findings

The propriate management of acute infarction stroke will be able to reduce the morbidity and mortality of the disease. In diagnosingand managing the diseases, for the detection of the risk or prognostic factors information’s such as the history physical findings,confirmation and other supporting tests are needed. One of the supporting test is the laboratory examination i.e. platelet aggregationtest. Platelet aggregation is suggested having an important role in haemostasis especially to prevent excessive bleeding by forming plateletplug. Finally, further hyperactivity of platelet in terms of platelet hyper aggregation can create a thrombus and moreover lead to obstructthe vessels. The occlusion will give a negative outcome of an acute infarction stroke. The aim of this study is to know whether platelethyper aggregation has a contribution in the outcome of the disease or not by certain testing. A prospective cohort study was carried out,to compare between two groups of exposed and non-exposed group in Sardjito hospital Yogyakarta during the period of March up toearly July 2007. Eighty four subjects who met the inclusion and exclusion criteria were involved in this study. The exposed group was agroup of acute infarction stroke patient who were exposed to platelet hyper aggregation 48 (57%), on the other hand, patients who didnot have platelet hyper aggregation was separated as non-exposed group is 36 (43%). Inception of cohort was applied when the patientwas admitted to the emergency unit during 72 hours of the onset, before receiving antithrombotic drugs and had no previous history ofstroke. The patients were followed after 7 days hospitalization in the stroke unit and neurology unit and the outcome was measured byevaluating the score using Gadjah Mada stroke scale. The characteristics of the subjects were grouped by baseline data X2 test. Unvariedanalysis and multivariate analysis were taken to get the relative risk of having acute infarction stroke. In this case logistic regressionanalysis was used to know the relative risk (RR) measurement. Prognostic factors had influenced the outcome of acute infarction strokein patients who had a history of cardiovascular disease and aggregation status. The outcome of the platelet hyper aggregation grouphad a RR=2.15 (95% CI: 2.01–4.07) and the history of cardiovascular disease had a RR=1.78 (95% CI: 1.18–13.28).

The burden of cardiovascular disease risk factors in the Middle East: A systematic review and meta-analysis focusing on primary prevention

2020 ◽  
Vol 18 ◽  
Author(s):  
Akshaya Srikanth Bhagavathula ◽  
Abdullah Shehab ◽  
Anhar Ullah ◽  
Jamal Rahmani
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Cardiovascular Disease ◽  
Family History ◽  
Primary Prevention ◽  
Middle East ◽  
Disease Risk ◽  
Meta Analysis ◽  
Middle Eastern ◽  
History Of

Background: The increasing incidence of cardiovascular disease (CVD) threatens the Middle Eastern population. Several epidemiological studies have assessed CVD and its risk factors in terms of the primary prevention of CVD in the Middle East. Therefore, summarizing the information from these studies is essential. Aim: We conducted a systematic review to assess the prevalence of CVD and its major risk factors among Middle Eastern adults based on the literature published between January 1, 2012 and December 31, 2018 and carried out a meta-analysis. Methods: We searched electronic databases such as PubMed/Medline, ScienceDirect, Embase and Google Scholar to identify literature published from January 1, 2012 to December 31, 2018. All the original articles that investigated the prevalence of CVD and reported at least one of the following factors were included: hypertension, diabetes, dyslipidaemia, smoking and family history of CVD. To summarize CVD prevalence, we performed a random-effects meta-analysis. Results: A total of 41 potentially relevant articles were included, and 32 were included in the meta-analysis (n=191,979). The overall prevalence of CVD was 10.1% (95% confidence interval (CI): 7.1-14.3%, p<0.001) in the Middle East. A high prevalence of CVD risk factors, such as dyslipidaemia (43.3%; 95% CI: 21.5-68%), hypertension (26.2%; 95% CI: 19.6-34%) and diabetes (16%; 95% CI: 9.9-24.8%), was observed. The prevalence rates of other risk factors, such as smoking (12.4%; 95% CI: 7.7-19.4%) and family history of CVD (18.7%; 95% CI: 15.4-22.5%), were also high. Conclusion: The prevalence of CVD is high (10.1%) in the Middle East. The burden of dyslipidaemia (43.3%) in this region is twice as high as that of hypertension (26.2%) and diabetes mellitus (16%). Multifaceted interventions are urgently needed for the primary prevention of CVD in this region.

scholarly journals National Estimates of Genetic Testing in Women With a History of Breast or Ovarian Cancer

2017 ◽  
Vol 35 (34) ◽  
pp. 3800-3806 ◽  
Author(s):  
Christopher P. Childers ◽  
Kimberly K. Childers ◽  
Melinda Maggard-Gibbons ◽  
James Macinko
Keyword(s):  
Ovarian Cancer ◽  
Genetic Testing ◽  
Unmet Need ◽  
Cancer Control ◽  
The United States ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
Age Of Diagnosis ◽  
History Of ◽  
Interview Survey

Purpose In the United States, 3.8 million women have a history of breast (BC) or ovarian cancer (OC). Up to 15% of cases are attributable to heritable mutations, which, if identified, provide critical knowledge for treatment and preventive care. It is unknown how many patients who are at high risk for these mutations have not been tested and how rates vary by risk criteria. Methods We used pooled cross-sectional data from three Cancer Control Modules (2005, 2010, 2015) of the National Health Interview Survey, a national in-person household interview survey. Eligible patients were adult females with a history of BC and/or OC meeting select 2017 National Comprehensive Cancer Network eligibility criteria on the basis of age of diagnosis and family history. Outcomes included the proportion of individuals reporting a history of discussing genetic testing with a health professional, being advised to undergo genetic testing, or undergoing genetic testing for BC or OC. Results Of 47,218 women, 2.7% had a BC history and 0.4% had an OC history. For BC, 35.6% met one or more select eligibility criteria; of those, 29.0% discussed, 20.2% were advised to undergo, and 15.3% underwent genetic testing. Testing rates for individual eligibility criteria ranged from 6.2% (relative with OC) to 18.2% (diagnosis ≤ 45 years of age). For OC, 15.1% discussed, 13.1% were advised to undergo, and 10.5% underwent testing. Using only four BC eligibility criteria and all patients with OC, an estimated 1.2 to 1.3 million individuals failed to receive testing. Conclusion Fewer than one in five individuals with a history of BC or OC meeting select National Cancer Comprehensive Network criteria have undergone genetic testing. Most have never discussed testing with a health care provider. Large national efforts are warranted to address this unmet need.

scholarly journals The association of triglyceride levels with the incidence of initial and recurrent acute pancreatitis

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Robert J. Sanchez ◽  
Wenzhen Ge ◽  
Wenhui Wei ◽  
Manish P. Ponda ◽  
Robert S. Rosenson
Keyword(s):  
Acute Pancreatitis ◽  
Medical Records ◽  
Adult Population ◽  
Baseline Period ◽  
Prior History ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Recurrent Acute Pancreatitis ◽  
History Of ◽  
Nationally Representative

Abstract Background This retrospective cohort study assessed the annualized incidence rate (IR) of acute pancreatitis (AP) in a nationally representative US adult population, as well as the variation in the risk of AP events across strata of triglyceride (TG) levels. Methods Data were obtained from IQVIA’s US Ambulatory Electronic Medical Records (EMR) database linked with its LRxDx Open Claims database. Inclusion criteria included ≥1 serum TG value during the overlapping study period of the EMR and claims databases, ≥1 claim in the 12-month baseline period, and ≥ 1 claim in the 12 months post index. All TG measurements were assigned to the highest category reached: < 2.26, ≥2.26 to ≤5.65, > 5.65 to ≤9.94, > 9.94, and > 11.29 mmol/L (< 200, ≥200 to ≤500, > 500 to ≤880, > 880, and > 1000 mg/dL, respectively). The outcome of interest was AP, defined as a hospitalization event with AP as the principal diagnosis. Results In total, 7,119,195 patients met the inclusion/exclusion criteria, of whom 4158 (0.058%) had ≥1 AP events in the prior 12 months. Most patients (83%) had TGs < 2.26 mmol/L (< 200 mg/dL), while < 1% had TGs > 9.94 mmol/L (> 880 mg/dL). Overall, the IR of AP was low (0.08%; 95% confidence internal [CI], 0.08–0.08%), but increased with increasing TGs (0.08% in TGs < 2.26 mmol/L [< 200 mg/dL] to 1.21% in TGs > 11.29 mmol/L [> 1000 mg/dL]). In patients with a prior history of AP, the IR of AP increased dramatically; patients with ≥2 AP events at baseline had an IR of 29.98% (95% CI, 25.1–34.9%). Conclusion The risk of AP increases with increasing TG strata; however, the risk increases dramatically among patients with a recent history of AP.

Anterior approach levator plication for congenital ptosis, absorpable versus non absorpable sutures

2021 ◽  
pp. 112067212110053
Author(s):  
Moustafa Salamah ◽  
Ashraf Mahrous Eid ◽  
Hani Albialy ◽  
Sherif Sharaf EL Deen
Keyword(s):  
Randomized Study ◽  
Early Postoperative Period ◽  
Polyglactin 910 ◽  
Exclusion Criteria ◽  
Congenital Ptosis ◽  
History Of ◽  
Group A ◽  
Group B ◽  
Over Time

Purpose: To compare the efficacy of two different suture types in levator plication for correction of congenital ptosis. Subjects and methods: Prospective comparative interventional randomized study involving 42 eyes of 42 patients aged more than 6 years with congenital ptosis and good levator action. The exclusion criteria were as follows: bilateral ptosis, history of previous surgery, fair or poor levator action, and associated other ocular diseases. Patients were randomized into group A, in which double-armed 5/0 polyester Ethibond were used, and group B, in which double-armed 5/0 Coated Vicryl® (polyglactin 910) suture material we used. Outcomes including eyelid height and stability of eyelid height over time were compared with follow-up data. The MRD was 4.05 ± 0.36 mm and 3.95 ± 0.34 after 1 week for both groups A and B, respectively. At the end of study follow up period (24 weeks), the MRD was 3.60 ± 0.42 mm in group A, and 2.52 ± 0.85 mm in group B. Conclusion: No difference in eyelid height between two groups in early postoperative period, but the postoperative eyelid height was more stable over time in the 5/0 polyester Ethibond group (group A) than in the 5/0 Coated Vicryl® (polyglactin 910) group (group B).

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