scholarly journals A survey of pediatric hematologists/oncologists’ perspectives on single patient Expanded Access and Right to Try

2021 ◽  
Vol 5 ◽  
pp. 239920262110059
Author(s):  
Carolyn Riley Chapman ◽  
Hayley M Belli ◽  
Danielle Leach ◽  
Lesha D Shah ◽  
Alison Bateman-House
Keyword(s):  
The United States ◽  
Recent Experience ◽  
Single Patient ◽  
Cross Sectional Survey ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
Expanded Access ◽  
Investigational Drugs ◽  
Survey Results ◽  
Physician Support

Introduction: Physicians in the United States play an essential role guiding patients through single patient pre-approval access (PAA) to investigational medical products via either the Food and Drug Administration (FDA)’s Expanded Access (EA) or the federal Right To Try (RTT) pathways. In this study, we sought to better understand pediatric hematologist/oncologists’ attitudes about seeking PAA, on behalf of single patients, to investigational drugs outside of clinical trials. Methods: A cross-sectional survey was developed and sent to pediatric hematologist/oncologists via St. Baldrick’s Foundation’s email distribution list. Results: Of 73 respondents (10.1% of those who received the survey), 56 met eligibility criteria and are included in the analysis. Over 80% ( n = 46) had prior experience with single patient PAA. Respondents were most concerned about the unknown risks and benefits of investigational drugs and financial implications of PAA for patients. One hundred percent and 91.1% of respondents indicated a willingness to support patients through EA and RTT pathways, respectively. When asked about their most recent experience with PAA, 40 out of 46 indicated that they used the FDA’s EA pathway to seek PAA and 4 out of 46 indicated that they used the RTT pathway. Of 44 respondents who had used the EA or RTT pathway, 43 indicated that the biotechnology or pharmaceutical company they solicited granted access to the requested product. Conclusion: Survey results support other findings suggesting a need for additional physician support and education about PAA and that physicians may have unequal access to information about investigational drugs and concerns about financial implications of PAA for their patients.

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 Analyzing Predictors of Control Measures and Psychosocial Problems Associated with COVID-19 Pandemic: Evidence from Eight Countries

2021 ◽  
Vol 11 (8) ◽  
pp. 106
Author(s):  
Sheikh Saifur Rahman Jony ◽  
Ubydul Haque ◽  
Nathaniel J. Webb ◽  
Emily Spence ◽  
Md. Siddikur Rahman ◽  
...  
Keyword(s):  
Psychological Health ◽  
Age Groups ◽  
Psychosocial Problems ◽  
Relevant Information ◽  
The United States ◽  
Control Measures ◽  
Cross Sectional Survey ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Primary Determinant

COVID-19 has harshly impacted communities globally. This study provides relevant information for creating equitable policy interventions to combat the spread of COVID-19. This study aims to predict the knowledge, attitude, and practice (KAP) of the COVID-19 pandemic at a global level to determine control measures and psychosocial problems. A cross-sectional survey was conducted from July to October 2020 using an online questionnaire. Questionnaires were initially distributed to academicians worldwide. These participants distributed the survey among their social, professional, and personal groups. Responses were collected and analyzed from 67 countries, with a sample size of 3031. Finally, based on the number of respondents, eight countries, including Bangladesh, China, Japan, Malaysia, Mexico, Pakistan, the United States, and Zambia were rigorously analyzed. Specifically, questionnaire responses related to COVID-19 accessibility, behavior, knowledge, opinion, psychological health, and susceptibility were collected and analyzed. As per our analysis, age groups were found to be a primary determinant of behavior, knowledge, opinion, psychological health, and susceptibility scores. Gender was the second most influential determinant for all metrics except information about COVID-19 accessibility, for which education was the second most important determinant. Respondent profession was the third most important metric for all scores. Our findings suggest that greater encouragement from government health authorities and the promotion of health education and policies are essential in the dissemination of COVID-19-awareness and increased control of the spread of COVID-19.

scholarly journals The Comparison of Role Conflict Among Registered Nurses and Registered Practical Nurses Working in Acute Care Hospitals in Ontario Canada

2021 ◽  
pp. 084456212110144
Author(s):  
Behdin Nowrouzi-Kia ◽  
Mary T. Fox ◽  
Souraya Sidani ◽  
Sherry Dahlke ◽  
Deborah Tregunno
Keyword(s):  
Emergency Department ◽  
Role Conflict ◽  
Acute Care ◽  
Acute Care Hospitals ◽  
Cross Sectional Survey ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
Medical Unit ◽  
Scale Scores ◽  
Surgical Unit

Objectives The study aimed to describe and compare nurses’ perceptions of role conflict by professional designation [registered nurse (RN) vs registered practical nurse (RPN)] in three primary areas of practice (emergency department, medical unit, and surgical unit). Methods This analysis used data (n = 1,981) from a large cross-sectional survey of a random sample of RNs and RPNs working as staff nurses in acute care hospitals in Ontario, Canada. Role conflict was measured by the Role Conflict Scale. Results A total of 1,981 participants (RN = 1,427, RPN = 554) met this study’s eligibility criteria and provided complete data. In general, RN and RPN mean total scale scores on role conflict hovered around the scale’s mid-point (2.72 to 3.22); however, RNs reported a higher mean score than RPNs in the emergency department (3.22 vs. 2.81), medical unit (2.95 vs 2.81) and surgical unit (2.90 vs 2.72). Where statistically significant differences were found, the effect sizes were negligible to medium in magnitude with the largest differences noted between RNs and RPNs working in the emergency department. Conclusions The results suggest the need to implement strategies that diminish role conflict for both RNs and RPNs.

scholarly journals Pre-Exposure Prophylaxis Training among Medical Schools in the United States

2021 ◽  
Vol 12 ◽  
pp. 215013272110287
Author(s):  
Robert L. Cooper ◽  
Mohammad Tabatabai ◽  
Paul D. Juarez ◽  
Aramandla Ramesh ◽  
Matthew C. Morris ◽  
...  
Keyword(s):  
United States ◽  
Hiv Prevention ◽  
Injection Drug Users ◽  
Drug Users ◽  
Healthcare Providers ◽  
Medical Schools ◽  
The United States ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Exposure Prophylaxis

Pre-Exposure Prophylaxis (PrEP) has been shown to be an effective method of HIV prevention for men who have sex with-men (MSM) and -transgender women (MSTGWs), serodiscordant couples, and injection drug users; however fewer than 50 000 individuals currently take this regimen. Knowledge of PrEP is low among healthcare providers and much of this lack of knowledge stems from the lack or exposure to PrEP in medical school. We conducted a cross sectional survey of medical schools in the United States to assess the degree to which PrEP for HIV prevention is taught. The survey consisted Likert scale questions assessing how well the students were prepared to perform each skill associated with PrEP delivery, as well as how PrEP education was delivered to students. We contacted 141 medical schools and 71 responded to the survey (50.4%). PrEP education was only reported to be offered at 38% of schools, and only 15.4% reported specific training for Lesbian, Gay, Bisexual, and Transgender (LGBT) patients. The most common delivery methods of PrEP content were didactic sessions with 11 schools reporting this method followed by problem-based learning, direct patient contact, workshops, and small group discussions. Students were more prepared to provide PrEP to MSM compared to other high-risk patients. Few medical schools are preparing their students to prescribe PrEP upon graduation. Further, there is a need to increase the number of direct patient contacts or simulations for students to be better prepared.

Are Future Doctors Prepared to Address Patients’ Nutritional Needs? Cooking and Nutritional Knowledge and Habits in Medical Students

2021 ◽  
pp. 155982762110181
Author(s):  
Sam Sugimoto ◽  
Drew Recker ◽  
Elizabeth E. Halvorson ◽  
Joseph A. Skelton
Keyword(s):  
Medical Students ◽  
Prior Knowledge ◽  
The United States ◽  
First Year ◽  
Nutritional Knowledge ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Nutritional Needs ◽  
Second Year ◽  
First Year Medical Students

Background. Many diseases are linked to lifestyle in the United States, yet physicians receive little training in nutrition. Medical students’ prior knowledge of nutrition and cooking is unknown. Objective. To determine incoming medical students’ prior nutrition knowledge, culinary skills, and nutrition habits. Methods. A dual-methods study of first-year medical students. Cross-sectional survey assessing prior knowledge, self-efficacy, and previous education of cooking and nutrition. Interviews of second-year medical students explored cooking and nutrition in greater depth. Results. A total of 142 first-year medical students participated; 16% had taken a nutrition course, with majority (66%) learning outside classroom settings. Students had a mean score of 87% on the Nutritional Knowledge Questionnaire versus comparison group (64.9%). Mean cooking and food skills score were lower than comparison scores. Overall, students did not meet guidelines for fiber, fruit, vegetables, and whole grains. Interviews with second-year students revealed most learned to cook from their families; all believed it important for physicians to have this knowledge. Conclusions. Medical students were knowledgeable about nutrition, but typically self-taught. They were not as confident or skilled in cooking, and mostly learned from their family. They expressed interest in learning more about nutrition and cooking.

Strategic Planning in Emergency Management: Evaluating the Impacts on Local Program Quality

2020 ◽  
Vol 17 (3) ◽  
Author(s):  
Scott Robert Manning
Keyword(s):  
Strategic Planning ◽  
Emergency Management ◽  
Survey Design ◽  
Management Practice ◽  
The United States ◽  
Program Quality ◽  
County Level ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Local Program

AbstractThis study examined the strategic planning practices of county-level emergency management agencies (EMAs), with a specific focus on strategic planning adoption and its relationship to local program quality. The study utilized a descriptive, cross-sectional survey design to collect planning- and program-related data from more than 300 county-level EMAs across the United States. The study findings revealed that most of the county EMAs included in the final sample had previously engaged in strategic planning activities, with nearly all of them continuing to use strategic planning as part of their general management practice. The study findings further revealed that strategic planning had a direct and significant impact on the overall quality of local emergency management programs, and that the strategic planning EMAs had significantly higher mean quality scores across all program dimensions when compared to the non-strategic planning EMAs.

Use of diagnostic tests by dermatologists, podiatrists and family practitioners in the United States: pilot data from a cross-sectional survey

Mycoses ◽  
2007 ◽  
Vol 50 (6) ◽  
pp. 463-469 ◽  
Author(s):  
Rebecca L. Koshnick ◽  
Kia K. Lilly ◽  
Katherine St Clair ◽  
Mary T. Finnegan ◽  
Erin M. Warshaw
Keyword(s):  
United States ◽  
Diagnostic Tests ◽  
The United States ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Pilot Data ◽  
Family Practitioners

COVID-19 and the Risk for Increased Intimate Partner Violence Among Gay, Bisexual and Other Men Who Have Sex With Men in the United States

2021 ◽  
pp. 088626052199745
Author(s):  
Rob Stephenson ◽  
Tanaka M.D. Chavanduka ◽  
Matthew T. Rosso ◽  
Stephen P. Sullivan ◽  
Renée A. Pitter ◽  
...  
Keyword(s):  
United States ◽  
Intimate Partner Violence ◽  
Partner Violence ◽  
Social Contact ◽  
The United States ◽  
Intimate Partner ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Sex With Men ◽  
First Time

Stay at home orders–intended to reduce the spread of COVID-19 by limiting social contact–have forced people to remain in their homes. The additional stressors created by the need to stay home and socially isolate may act as triggers to intimate partner violence (IPV). In this article, we present data from a recent online cross-sectional survey with gay, bisexual and other men who have sex with men (GBMSM) in the United States to illustrate changes in IPV risks that have occurred during the U.S. COVID-19 epidemic. The Love and Sex in the Time of COVID-19 survey was conducted online from April to May 2020. GBMSM were recruited through paid banner advertisements featured on social networking platforms, recruiting a sample size of 696 GBMSM. Analysis considers changes in victimization and perpetration of IPV during the 3 months prior to the survey (March-May 2020) that represents the first 3 months of lockdown during the COVID-19 epidemic. During the period March-May 2020, 12.6% of participants reported experiencing any IPV with higher rates of emotional IPV (10.3%) than sexual (2.2%) or physical (1.8%) IPV. Of those who reported IPV victimization during lockdown, for almost half this was their first time experience: 5.3% reported the IPV they experienced happened for the first time during the past 3 months (0.8% physical, 2.13% sexual, and 3.3% emotional). Reporting of perpetration of IPV during lockdown was lower: only 6% reported perpetrating any IPV, with perpetration rates of 1.5% for physical, 0.5% for sexual, and 5.3% for emotional IPV. Of those who reported perpetration of IPV during lockdown, very small percentages reported that this was the first time they had perpetrated IPV: 0.9% for any IPV (0.2% physical, 0.2% sexual, and 0.6% emotional). The results illustrate an increased need for IPV resources for GBMSM during these times of increased stress and uncertainty, and the need to find models of resource and service delivery that can work inside of social distancing guidelines while protecting the confidentiality and safety of those who are experiencing IPV.

scholarly journals Universal PCR and antibody testing demonstrate little to no transmission of SARS-CoV-2 in a rural community

2020 ◽  
Author(s):  
Ayesha Appa ◽  
Saki Takahashi ◽  
Isabel Rodriguez-Barraquer ◽  
Gabriel Chamie ◽  
Aenor Sawyer ◽  
...  
Keyword(s):  
Rural Community ◽  
The United States ◽  
Rural Setting ◽  
Antibody Testing ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Rural Town ◽  
Low Prevalence ◽  
Prior Infection ◽  
Estimate Precision

Abstract Background Limited systematic surveillance for SARS-CoV-2 in the early months of the United States epidemic curtailed accurate appraisal of transmission intensity. Our objective was to perform case detection of an entire rural community to quantify SARS-CoV-2 transmission using PCR and antibody testing. Methods We conducted a cross-sectional survey of SARS-CoV-2 infection in the rural town of Bolinas, California (population 1,620), four weeks following shelter-in-place orders. Participants were tested between April 20 th – 24 th, 2020. Prevalence by PCR and seroprevalence from two forms of antibody testing were performed in parallel (Abbott ARCHITECT IgG and in-house IgG ELISA). Results Of 1,891 participants, 1,312 were confirmed Bolinas residents (>80% community ascertainment). Zero participants were PCR positive. Assuming 80% sensitivity, it would have been unlikely to observe these results (p<0.05) if there were >3 active infections in the community. Based on antibody results, estimated prevalence of prior infection was 0.16% (95% CrI: 0.02%, 0.46%). The positive predictive value (PPV) of a positive result on both tests was 99.11% (95% CrI: 95.75%, 99.94%), compared to PPV 44.19%-63.32% (95% CrI range 3.25%-98.64%) if one test was utilized. Conclusions Four weeks following shelter-in-place, SARS-CoV-2 infection in a rural Northern California community was extremely rare. In this low prevalence setting, use of two antibody tests increased seroprevalence estimate precision. This was one of the first community-wide studies to successfully implement synchronous PCR and antibody testing, particularly in a rural setting. Widespread testing remains an underpinning of effective disease control in conjunction with consistent uptake of public health measures.

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