Randomized Comparison of Every-2-Week Darbepoetin Alfa and Weekly Epoetin Alfa for the Treatment of Chemotherapy-Induced Anemia: The 20030125 Study Group Trial

2006 ◽  
Vol 24 (15) ◽  
pp. 2290-2297 ◽  
Author(s):  
John Glaspy ◽  
Saroj Vadhan-Raj ◽  
Ravi Patel ◽  
Linda Bosserman ◽  
Eddie Hu ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Darbepoetin Alfa ◽  
Study Drug ◽  
The United States ◽  
Phase Iii ◽  
Sensitivity Analyses ◽  
Comparable Efficacy ◽  
Care Providers ◽  
Epoetin Alfa ◽  
Noninferiority Margin

Purpose Chemotherapy-induced anemia is widely treated in the United States with darbepoetin alfa (DA) or epoetin alfa (EA). This noninferiority study systematically compares efficacy and safety of DA and EA using common doses and schedules used in clinical practice. Methods Patients had a diagnosis of nonmyeloid malignancy with ≥ 8 weeks of planned chemotherapy, age ≥ 18 years, and anemia (hemoglobin ≤ 11 g/dL). Patients were randomly assigned 1:1 to DA 200 μg every two weeks (Q2W) or EA 40,000 units every week (QW) for up to 16 weeks with identical dose adjustment rules. Efficacy was assessed by the incidence of RBC transfusion (Kaplan-Meier estimate). The definition of noninferiority was that the upper 95% CI limit of the observed difference in RBC transfusions between groups was less than 11.5%; this noninferiority margin was based on the treatment effect observed in placebo-controlled EA studies. Results Of 1,220 patients randomly assigned, 1,209 received ≥ one dose of the study drug. Common tumor types were lung (26%), breast (21%), and gastrointestinal (18%). Transfusion incidence from week 5 to the end of the treatment phase (the primary end point) was 21% in the DA group and 16% in the EA group; noninferiority was concluded because the upper 95% CI limit of the difference between groups (10.8%) was below the prespecified noninferiority margin. Sensitivity analyses using alternate statistical methods and analysis sets yielded similar results. Hemoglobin, quality of life, and safety end points further support equivalency of the erythropoietic therapies. Conclusion This large, phase III study demonstrates comparable efficacy of DA Q2W and EA QW. Less frequent dosing offers potential benefits for patients, caregivers and health care providers.

Every-Three-Week (Q3W) Maintenance Dosing of Epoetin Alfa in Anemic Cancer Patients Receiving Chemotherapy: 60,000 U SC QW to Target Hb 12 g/dl, Followed by 80,000 U SC Q3W.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4227-4227 ◽  
Author(s):  
Vernon Montoya ◽  
Denise Williams
Keyword(s):  
Health Care Providers ◽  
Response Rate ◽  
Study Drug ◽  
Maintenance Phase ◽  
Care Providers ◽  
Epoetin Alfa ◽  
Open Label ◽  
Serious Adverse Events ◽  
Initiation Phase ◽  
Secondary Endpoints

Abstract The efficacy of epoetin alfa (EPO) 40,000 U SC once weekly (QW) has been established in clinical studies in anemic patients (pts) with cancer receiving chemotherapy (CT). Higher starting doses of EPO may increase initial hemoglobin (Hb) response and subsequent less frequent maintenance dosing may improve dosing flexibility for pts and health care providers. This ongoing, open-label, multicenter, 24-week (wk) study was designed to evaluate the efficacy and safety of EPO at a starting dose of 60,000 U SC QW to a target Hb of 12 g/dL in the Initiation Phase (IP; maximum of 12 wks), followed by 80,000 U SC every 3 wks (Q3W) in the Maintenance Phase (MP) to maintain Hb in the range 11.5–12.5 g/dL. Eligible pts were ≥18 years with nonmyeloid malignancy, had baseline (BL) Hb <11 g/dL, and were scheduled to receive CT Q3W for ≥15 wks. Pts who achieved Hb ≥12 g/dL during the IP subsequently entered the MP; however, pts did not receive the first Q3W maintenance dose until start of the next Q3W CT cycle. Pts were withdrawn if Hb decreased to <11 g/dL during the MP. The primary endpoint was proportion of pts in the IP who achieved an Hb ≥12 g/dL or an Hb increase ≥2 g/dL from BL. Secondary endpoints included Hb increase ≥1 g/dL but <2.0 g/dL from BL in IP, maintenance of mean Hb 11.5–12.5 g/dL in the MP, maintenance of mean Hb >11.0 g/dL but <11.5 g/dL in MP, Hb over time, and transfusions. All Hb and response rates were independent of RBC transfusion within the previous 28 days. Study enrollment was terminated at 115 pts. In this preliminary analysis, the first 69 pts (mean age, 62 years; 65% women; 87% ECOG 0-1) enrolled and who received ≥1 dose of study drug were evaluable for safety and efficacy. Mean BL Hb was 10.2 ± 0.8 g/dL. The proportion of pts in the IP who achieved an Hb ≥12 g/dL or an Hb increase ≥2 g/dL from BL was 74% (49/69). The proportion of pts in the IP with an Hb increase ≥1 g/dL but <2 g/dL from BL was 9% (6/69). Forty-one (59%) pts entered the MP after a median of 5.0 wks in the IP and spent an average of 7.1 wks in the MP. Of these pts, 33 (80%) maintained an average Hb of 11.5–12.5 g/dL and 3 (7%) maintained an average Hb >11.0 g/dL but <11.5 g/dL over the course of the MP. During the MP, mean Hb was 12.1 ± 0.6 g/dL at entry, 11.8 ± 1.0 g/dL (n=15) after 8 wks of Q3W dosing, and 11.6 ± 1.1 g/dL (n=38) at final value. Eleven (27%) pts were withdrawn during the MP because Hb decreased to <11 g/dL. EPO dose was reduced in 25% (17/69) of pts in the IP and in 39% (16/41) of pts in the MP due to Hb >13 g/dL or Hb increase >1.3-g/dL in 2 wks. Thirty-five percent (24/69) of pts had a dose of EPO held at any time during the study for Hb >13 g/dL or another reason. Five (7%) pts were transfused after study day 28. Twenty-six (38%) pts experienced serious adverse events (AEs). Eight (12%) pts experienced a clinically relevant thrombovascular event. Two (3%) pts discontinued due to AEs. Nine (13%) pts died during the study or within the 90-day follow-up period. These preliminary data suggest that initial dosing of EPO 60,000 U QW is associated with a hematopoietic response rate (Hb ≥12 g/dL or Hb increase ≥2 g/dL from BL) of ~75% in pts with cancer and anemia receiving CT, similar to the response rate reported historically for EPO 40,000 U SC QW with dose escalation to 60,000 U SC QW. In addition, among pts who achieved a target Hb ≥12 g/dL with QW dosing and then received Q3W maintenance dosing, EPO 80,000 U SC Q3W maintained mean Hb above 11 g/dL in >85% of pts.

scholarly journals 897 Infusion episode-related benefits of pembrolizumab Q6W dosing schedule for patients with melanoma treated in the adjuvant and metastatic settings in the United States (US)

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A941-A941
Author(s):  
Raquel Aguiar-Ibanez ◽  
Emilie Scherrer ◽  
Dmitri Grebennik ◽  
Anvi Khandelwal ◽  
John Cook ◽  
...  
Keyword(s):  
Health Care Providers ◽  
The United States ◽  
System Capacity ◽  
Sensitivity Analyses ◽  
Care Providers ◽  
Duration Of Treatment ◽  
Dosing Schedule ◽  
Patient Capacity ◽  
The Us ◽  
The Impact

BackgroundA new dosing schedule for pembrolizumab (400 mg every six weeks (Q6W)) received accelerated FDA approval in 2020 across all approved adult indications. The Q6W dosing schedule provides an opportunity to reduce the number of infusions required over the treatment course, thereby decreasing time and costs for health care providers, patients and their caregivers. This study quantified the potential infusion episode-related benefits of pembrolizumab Q6W regimen for the treatment of patients with melanoma in the adjuvant and metastatic settings in the US.MethodsAn Excel-based tool was developed to quantify the infusion episode-related time and cost of using pembrolizumab Q6W compared to available nivolumab dosing regimens (Q4W/Q2W) to treat patients with melanoma in the adjuvant and metastatic settings from the patient, caregiver, provider, and payer perspectives. The number of infusion visits, time and costs were estimated considering a hypothetical infusion center. Time-related inputs were based on a survey of patients, physicians and nurses; cost-related inputs were obtained from published sources. Sensitivity analyses were performed to assess the robustness of results. Additional analyses assessed the impact of using alternative regimens with different frequencies of administration.ResultsBased on the tool, pembrolizumab Q6W reduced the number of infusion visits (31%), time at the infusion center (41%) and chair time (31%) in total, over one year, versus nivolumab Q4W. Because fewer visits are needed, travel time is estimated to decrease by 31%. The infusion-related direct and indirect costs borne by patients and caregivers are projected to decrease by $1,095 and $2,272, respectively over a treatment course. For a typical US infusion center treating 169 melanoma patients per week over a 1-year period, using pembrolizumab Q6W rather than nivolumab Q4W is estimated to reduce the number of infusions by 2,729 (31% reduction) for a total of 3,802 fewer hours of infusion chair time, allowing the infusion center to increase patient capacity by up to 45% using currently available resources. Time and cost savings are more prominent when comparing with nivolumab Q2W: 5,757 fewer infusion events (66% reduction) and 8,062 less hours of chair time, which would increase the patient capacity by 2.9 times.ConclusionsUtilizing pembrolizumab Q6W to treat patients with melanoma in the US is expected to substantially reduce the number of infusion visits and associated chair time required over the duration of treatment, reducing the time and monetary burden for patients and their caregivers. Additionally, it may also improve system capacity.

The Special Perils of Being Old and Sick in Prison

2020 ◽  
Vol 32 (5) ◽  
pp. 276-284
Author(s):  
William J. Jefferson
Keyword(s):  
United States ◽  
Health Care ◽  
Medical Care ◽  
Health Care Providers ◽  
The United States ◽  
United States Constitution ◽  
Care Providers ◽  
Medical Practitioners ◽  
Medical Needs ◽  
Access To Medical Care

The United States Supreme Court declared in 1976 that deliberate indifference to the serious medical needs of prisoners constitutes the unnecessary and wanton infliction of pain…proscribed by the Eighth Amendment. It matters not whether the indifference is manifested by prison doctors in their response to the prisoner’s needs or by prison guards intentionally denying or delaying access to medical care or intentionally interfering with treatment once prescribed—adequate prisoner medical care is required by the United States Constitution. My incarceration for four years at the Oakdale Satellite Prison Camp, a chronic health care level camp, gives me the perspective to challenge the generally promoted claim of the Bureau of Federal Prisons that it provides decent medical care by competent and caring medical practitioners to chronically unhealthy elderly prisoners. The same observation, to a slightly lesser extent, could be made with respect to deficiencies in the delivery of health care to prisoners of all ages, as it is all significantly deficient in access, competencies, courtesies and treatments extended by prison health care providers at every level of care, without regard to age. However, the frailer the prisoner, the more dangerous these health care deficiencies are to his health and, therefore, I believe, warrant separate attention. This paper uses first-hand experiences of elderly prisoners to dismantle the tale that prisoner healthcare meets constitutional standards.

A survey of Instagram users with asthma to evaluate the acceptability of a planned clinical trial intervention (Preprint)

2020 ◽  
Author(s):  
Kerry Spitzer ◽  
Brent Heineman ◽  
Marcella Jewell ◽  
Michael Moran ◽  
Peter Lindenauer
Keyword(s):  
United States ◽  
Social Media ◽  
Health Care Providers ◽  
College Education ◽  
The United States ◽  
Survey Study ◽  
Care Providers ◽  
Healthy Behaviors ◽  
Social Media Platforms ◽  
Hispanic White

BACKGROUND Asthma is a chronic lung disease that affects nearly 25 million individuals in the United States. There is a need for more research into the potential for health care providers to leverage existing social media platforms to improve healthy behaviors and support individuals living with chronic health conditions. OBJECTIVE In this study, we assess the willingness of Instagram users with poorly controlled asthma to participate in a pilot study that uses Instagram as a means of providing social and informational support. In addition, we explore the potential for adapting photovoice and digital storytelling to social media. METHODS A survey study of Instagram users living with asthma in the United States, between the ages of 18 to 40. RESULTS Over 3 weeks of recruitment, 457 individuals completed the pre-survey screener; 347 were excluded. Of the 110 people who were eligible and agreed to participate in the study, 82 completed the study survey. Respondents mean age was 21(SD = 5.3). Respondents were 56% female (n=46), 65% (n=53) non-Hispanic white, and 72% (n=59) had at least some college education. The majority of respondents (n = 66, 81%) indicated that they would be willing to participate in the study. CONCLUSIONS Among young-adult Instagram users with asthma there is substantial interest in participating in a study that uses Instagram to connect participants with peers and a health coach in order to share information about self-management of asthma and build social connection.

Effects of Cardiovascular Disease and Related Risk Factors on Neurocognition

2019 ◽  
pp. 83-116
Author(s):  
Spencer W. Liebel ◽  
Lawrence H. Sweet
Keyword(s):  
Cardiovascular Disease ◽  
Older Adults ◽  
Cognitive Processing ◽  
Health Care Providers ◽  
The United States ◽  
Research Literature ◽  
Neurocognitive Functioning ◽  
Care Providers ◽  
Cardiac Events ◽  
Related Risk

Cardiovascular disease (CVD) affects approximately 44 million American adults older than age 60 years and remains the leading cause of death in the United States, with approximately 610,000 each year. With improved survival from acute cardiac events, older adults are often faced with the prospect of living with CVD, which causes significant psychological, social, and economic hardship. The various disease processes that constitute CVD also exert a deleterious effect on neurocognitive functioning. Although existing knowledge of neurocognitive functioning in CVD and its subtypes is substantial, a review of these findings by CVD type and neurocognitive domain does not exist, despite the potential impact of this information for patients, health care providers, and clinical researchers. This chapter provides a resource for clinicians and researchers on the epidemiology, mechanisms, and neurocognitive effects of CVDs. This chapter includes a discussion of neurocognitive consequences of CVD subtypes by neuropsychological domain and recommendations for assessment. Overall, the CVD subtypes that have the most findings available on specific neurocognitive domains are heart failure, hypertension, and atrial fibrillation. Despite a large discrepancy between the number of available studies across CVD subtypes, existing literature on neurocognitive effects by domain is consistent with the literature on the neurocognitive sequelae of unspecified CVD. Specifically, the research literature suggests that cognitive processing speed, attention, executive functioning, and memory are the domains most frequently affected. Given the prevalence of CVDs, neuropsychological assessment of older adults should include instruments that allow consideration of these potential neurocognitive consequences of CVD.

Nurse Practitioner Challenges to the Orthodox Structure of Health Care Delivery: Regulation and Restraints on Trade

1985 ◽  
Vol 11 (2) ◽  
pp. 195-225
Author(s):  
Karla Kelly
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Health Care Delivery ◽  
Nurse Practitioners ◽  
Nurse Practitioner ◽  
Allied Health ◽  
Care Delivery ◽  
The United States ◽  
Care Providers ◽  
Allied Health Care

AbstractUntil recently, physicians have been the primary health care providers in the United States. In response to the rising health care costs and public demand of the past decade, allied health care providers have challenged this orthodox structure of health care delivery. Among these allied health care providers are nurse practitioners, who have attempted to expand traditional roles of the registered nurse.This article focuses on the legal issues raised by several major obstacles to the expansion of nurse practitioner services: licensing restrictions, third party reimbursement policies, and denial of access to medical facilities and physician back-up services. The successful judicial challenges to discriminatory practices against other allied health care providers will be explored as a solution to the nurse practitioners’ dilemma.

Patients' Perceptions of Different Information Exchange Mechanisms: An Exploratory Study in the United States

2020 ◽  
Vol 59 (04/05) ◽  
pp. 162-178
Author(s):  
Pouyan Esmaeilzadeh
Keyword(s):  
United States ◽  
Health Care ◽  
Health Information ◽  
Health Care Providers ◽  
Information Exchange ◽  
The United States ◽  
Exchange Mechanism ◽  
Care Providers ◽  
Security Risks ◽  
Direct Exchange

Abstract Background Patients may seek health care services from various providers during treatment. These providers could serve in a network (affiliated) or practice separately (unaffiliated). Thus, using secure and reliable health information exchange (HIE) mechanisms would be critical to transfer sensitive personal health information (PHI) across distances. Studying patients' perceptions and opinions about exchange mechanisms could help health care providers build more complete HIEs' databases and develop robust privacy policies, consent processes, and patient education programs. Objectives Due to the exploratory nature of this study, we aim to shed more light on public perspectives (benefits, concerns, and risks) associated with the four data exchange practices in the health care sector. Methods In this study, we compared public perceptions and expectations regarding four common types of exchange mechanisms used in the United States (i.e., traditional, direct, query-based, patient-mediated exchange mechanisms). Traditional is an exchange through fax, paper mailing, or phone calls, direct is a provider-to-provider exchange, query-based is sharing patient data with a central repository, and patient-mediated is an exchange mechanism in which patients can access data and monitor sharing. Data were collected from 1,624 subjects using an online survey to examine the benefits, risks, and concerns associated with the four exchange mechanisms from patients' perspectives. Results Findings indicate that several concerns and risks such as privacy concerns, security risks, trust issues, and psychological risks are raised. Besides, multiple benefits such as access to complete information, communication improvement, timely and convenient information sharing, cost-saving, and medical error reduction are highlighted by respondents. Through consideration of all risks and benefits associated with the four exchange mechanisms, the direct HIE mechanism was selected by respondents as the most preferred mechanism of information exchange among providers. More than half of the respondents (56.18%) stated that overall they favored direct exchange over the other mechanisms. 42.70% of respondents expected to be more likely to share their PHI with health care providers who implemented and utilized a direct exchange mechanism. 43.26% of respondents believed that they would support health care providers to leverage a direct HIE mechanism for sharing their PHI with other providers. The results exhibit that individuals expect greater benefits and fewer adverse effects from direct HIE among health care providers. Overall, the general public sentiment is more in favor of direct data transfer. Our results highlight that greater public trust in exchange mechanisms is required, and information privacy and security risks must be addressed before the widespread implementation of such mechanisms. Conclusion This exploratory study's findings could be interesting for health care providers and HIE policymakers to analyze how consumers perceive the current exchange mechanisms, what concerns should be addressed, and how the exchange mechanisms could be modified to meet consumers' needs.

scholarly journals Patient Suffering in Chronic Digestive Diseases: Will Primary Care-Specialist Collaboration With Effective Interactive Communication and Integrative Medicine in the Plan of Care Improve Quality of Life?

2020 ◽  
Vol 7 (6) ◽  
pp. 989-993
Author(s):  
Andrew Thomas ◽  
Annie Thomas
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Health Care ◽  
Health Care Providers ◽  
The United States ◽  
Care Providers ◽  
Physician Visits ◽  
Digestive Diseases ◽  
Care Specialist

Acute and chronic digestive diseases are causing increased burden to patients and are increasing the United States health care spending. The purpose of this case report was to present how nonconfirmatory and conflicting diagnoses led to increased burden and suffering for a patient thus affecting quality of life. There were many physician visits and multiple tests performed on the patient. However, the primary care physician and specialists could not reach a confirmatory diagnosis. The treatment plans did not offer relief of symptoms, and the patient continues to experience digestive symptoms, enduring this burden for over 2 years. The central theme of this paper is to inform health care providers the importance of utilizing evidence-based primary care specialist collaboration models for better digestive disease outcomes. Consistent with patient’s experience, the authors propose to pilot/adopt the integrative health care approaches that are proven effective for treating digestive diseases.

Perceptions of Contexts of Intimate Partner Violence Among Young, Partnered Gay, Bisexual and Other Men Who Have Sex With Men in the United States

2021 ◽  
pp. 088626052110014
Author(s):  
Rob Stephenson ◽  
Lynae A. Darbes ◽  
Matthew T Rosso ◽  
Catherine Washington ◽  
Lisa Hightow-Weidman ◽  
...  
Keyword(s):  
Intimate Partner Violence ◽  
Health Care Providers ◽  
Partner Violence ◽  
The United States ◽  
Intimate Partner ◽  
Care Providers ◽  
Male Couples ◽  
Younger Men ◽  
Sex With Men ◽  
Controlling Behaviors

There has been a growth in research illustrating that gay, bisexual, and other men who have sex with men (GBMSM) experience intimate partner violence (IPV) at rates that are comparable to those among heterosexual women. However, the majority of research on IPV among same-sex male couples has focused on adults, and research on the experience of IPV among younger men (those aged under 18), remains at a nascent stage, despite knowledge that IPV is often common among younger men. This article adds to the growing body of literature on IPV among young GBMSM (YGBMSM) through of an analysis of qualitative data from in-depth interviews (IDI) with GBMSM aged 15–19 ( n = 30) in romantic relationships partnerships. The study sought to explore issues of relationship development, relationship contexts, and understandings of IPV. More than one-half of the sample reported experiencing some form of IPV in their current or past relationships. Participants described a range of experiences of IPV, including physical IPV, emotional IPV, sexual IPV, and controlling behaviors. Emotional IPV in the form of negative comments and controlling behaviors such as jealousy were the most commonly reported forms of violence behaviors. Although few participants reported experiencing physical or sexual IPV, several discussed concerns about giving, and partners’ acknowledging, sexual consent. Antecedents to IPV included wanting or feeling pressured to participate in normative development milestones, short-lived relationships, and societal stigma. Interventions that develop content on IPV and that reflect the lived realities of YGBMSM who are experiencing their first relationships are urgently needed. Study findings also support the need for training teachers, health care providers, and parents to identify signs of IPV and provide them with the knowledge and skills to talk to YGBMSM about relationships and violence to reduce IPV.

Searching and Making Meaning of the COVID-19 Pandemic: Perspectives of African Immigrants in the United States

2021 ◽  
pp. 002216782110224
Author(s):  
Angela U. Ekwonye ◽  
Nina Truong
Keyword(s):  
United States ◽  
Health Care Providers ◽  
Meaning Making ◽  
Democratic Republic Of Congo ◽  
Central Africa ◽  
African Immigrants ◽  
The United States ◽  
Care Providers ◽  
Making Meaning ◽  
The Impact

African immigrants continue to be disproportionately affected by the COVID-19 pandemic. It is unclear how they are searching for and finding meaning in the face of this adversity. This study sought to understand how African immigrants in the United States are searching for and making meaning of the COVID-19 pandemic. We conducted in-depth interviews remotely with 20 immigrants from West Africa (Nigeria and Ghana), East Africa (Somali and Rwanda), and Central Africa (Democratic Republic of Congo). The meaning-making model was used as a framework to understand the processes of coping during a significant, adverse life event. The study found that some participants attempted to reduce the impact of the COVID-19 pandemic on their global meaning by seeking answers as to why the pandemic occurred and creating positive illusions. Some redefined their priorities and reframed the pandemic in a positive light. Participants found meaning in the form of accepting the pandemic as a reality of life, appreciating events previously taken for granted, and making positive changes in their lives. This study’s findings can inform health care providers of the meaning-making processes of African immigrants’ and the need to assist them in their search for meaning.

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