Knowledge and Attitudes Concerning Aducanumab Among Older Americans After FDA Approval for Treatment of Alzheimer Disease.
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ABSTRACT:
SUBMITTER: Zissimopoulos J
PROVIDER: S-EPMC8845005 | biostudies-literature | 2022 Feb
REPOSITORIES: biostudies-literature
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Knowledge and Attitudes Concerning Aducanumab Among Older Americans After FDA Approval for Treatment of Alzheimer Disease.
Zissimopoulos Julie J Jacobson Mireille M Chen Yi Y Borson Soo S
JAMA network open 20220201 2
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Project description:IntroductionAducanumab was approved in 2021 by the US Food and Drug Administration (FDA) under the accelerated approval pathway. Since then, there have been many misconceptions about the approval decision despite multiple publications from the FDA to explain the rationale.MethodsEven though the FDA's final decision was accelerated approval, the Office of Clinical Pharmacology recommended regular/full approval based on its own analyses. Exposure-response analyses were conducted to quantify the relationship between aducanumab longitudinal exposure and responses (standardized uptake values ratios for amyloid beta and various clinical endpoints) in all clinical trials. To explain the difference between aducanumab and other compounds with negative results in the past, publicly available data were combined with the aducanumab data to demonstrate the relationship between amyloid reduction and clinical endpoint change across multiple compounds with similar mechanism of action. The probability to observe the overall positive findings in the aducanumab program was quantified under the assumption that aducanumab is ineffective.ResultsPositive exposure-response (disease progression) relationship for multiple clinical endpoints from all clinical trials was identified. Positive exposure-amyloid reduction relationship was established. Consistent amyloid reduction-clinical endpoint change relationship across multiple compounds was observed. If aducanumab is assumed to be ineffective, it is extremely unlikely we would observe the overall positive findings in the aducanumab program.ConclusionThese results provided convincing evidence to support aducanumab's effectiveness. In addition, the observed effect size in the studied patient population represents a clinically meaningful benefit given the magnitude of disease progression within the trial duration.HighlightsTotality of evidence supports the Food and Drug Administration (FDA)'s approval decision for aducanumab.Different opinions were clearly explained in the FDA's public reviews from different disciplines.Readers are encouraged to read the FDA's reviews to understand the FDA's rationale to approve aducanumab.
| S-EPMC10193636 | biostudies-literature
Project description:Despite the growing body of evidence demonstrating the positive health effects of the Mediterranean diet, it is not routinely recommended in practice and adherence is low in the general population in Australia. The knowledge-attitude-behaviour model explains how health behaviours are supported through a process of acquiring knowledge, developing attitudes, and forming behaviours. Evidence has suggested that having a high level of nutrition-related knowledge is associated with more positive attitudes, which is directly linked to positive dietary behaviours. However, reports of knowledge and attitudes towards the Mediterranean diet, and how these directly relate to behaviours in older adults, are lacking. This study explored Mediterranean diet-related knowledge, attitudes, and behaviours among community-dwelling older adults in Australia. Participants were adults aged 55 years and older who completed an online survey that contained three parts: (a) knowledge - Mediterranean Diet Nutrition Knowledge Questionnaire (Med-NKQ); (b) nutrition-related attitudes and behaviours, and barriers and enablers to dietary change; (c) demographics. The sample included 61 adults who ranged in age from 55 to 89 years. The overall knowledge score was 30.5 out of a possible 40 points, with 60.7% classified as having a high level of knowledge. Knowledge was lowest for nutrient content and label reading. Attitudes and behaviours were generally positive and were not associated with level of knowledge. The most common barriers to dietary change were perceived cost and lack of knowledge, and motivational factors. There are a number of key gaps in knowledge that should be addressed through targeted educational programs. Strategies and tools to overcome perceived barriers and improve self-efficacy are needed to facilitate positive dietary behaviours.
| S-EPMC10248335 | biostudies-literature
Project description:Clinical genetic services are increasingly providing a more nuanced understanding of genetic disease diagnostics and future risk for patients. Effectively conveying genetic information is essential for patients to make informed decisions. This is especially important for survivors of heritable cancers such as retinoblastoma (childhood eye cancer), where survivors who carry a germline mutation in the RB1 gene are at increased risk of second cancers in adulthood, and of passing on the disease risk to future offspring. We conducted focus groups with adult survivors of retinoblastoma and parents of children with retinoblastoma, to uncover their knowledge of, experiences with and attitudes about retinoblastoma genetics and related impacts of the cancer. Results revealed that participants understood that retinoblastoma was a genetic disease, but often misunderstood the implications of genetics on cancer phenotype and risk. Experiences with genetic testing and counseling were generally positive, however, participants reported challenges in accessing genetic information and psychosocial support. Participants suggested more educational resources, peer-to-peer counseling, and psychosocial support would enhance uptake of important genetic information. The results of the study will inform patient-oriented approaches to deliver comprehensive genetic healthcare.
| S-EPMC5891498 | biostudies-literature
Project description:In April 2017, the U.S. Food and Drug Administration granted regular approval to midostaurin for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). Approval was based on results from CPKC412D2201, a single-arm trial of midostaurin (100 mg orally twice daily) in previously treated or untreated patients. For the patients with ASM and SM-AHN, efficacy was established on the basis of confirmed complete remission (CR) plus incomplete remission (ICR) by modified Valent criteria with six cycles of midostaurin. There were no CRs reported; ICR was achieved by 6 of 16 patients (38%; 95% confidence interval [CI]: 15%-65%) with ASM and by 9 of 57 patients (16%; 95% CI: 7%-28%) with SM-AHN. Within the follow-up period, the median duration of response was not reached for the patients with ASM (range, 12.1+ to 36.8+ months) or with SM-AHN (range, 6.6+ to 52.1+ months). For the patients with MCL, efficacy was established on the basis of confirmed CR using modified 2013 International Working Group-Myeloproliferative Neoplasms Research and Treatment-European Competence Network on Mastocytosis criteria. Of 21 patients with MCL, 1 (5%) achieved a CR. Of 142 patients with SM evaluated for safety, 56% had dose modifications for toxicity, and 21% discontinued treatment due to a toxicity. Over 50% reported nausea, vomiting, or diarrhea, and ≥30% reported edema, musculoskeletal pain, fatigue, abdominal pain, or upper respiratory tract infection. New or worsening grade ≥3 lymphopenia, anemia, thrombocytopenia, or neutropenia developed in ≥20%. Although midostaurin is an active drug for treatment of advanced SM, it is not clear that the optimal dose has been identified. IMPLICATIONS FOR PRACTICE: Midostaurin is the only U.S. Food and Drug Administration-approved therapy for patients with systemic mastocytosis with associated hematological neoplasm and mast cell leukemia and is the only therapy approved for patients with aggressive systemic mastocytosis regardless of KIT D816V mutation status. Based on response rate and duration, midostaurin has meaningful clinical activity in these rare, life-threatening diseases.
| S-EPMC6292539 | biostudies-literature
Project description:BackgroundChronic fatigue syndrome (CFS) is a debilitating illness with particular difficulties for healthcare providers because there are no diagnostic signs or laboratory tests and because management aims to merely improve symptoms. Further complicating management, healthcare providers' awareness concerning CFS has not been rigorously assessed. The present study aimed to ascertain United States (U.S.) healthcare providers' awareness of CFS and to assess their knowledge, attitudes, and beliefs (KAB) related to diagnosis and management of the illness. This information forms the foundation for developing CFS educational strategies.MethodsWe combined convenience and probability samples to measure CFS KAB among healthcare providers. In the convenience sample, 1,255 healthcare providers (81% response rate) from 13 professional conferences completed a 12-item form. Descriptive statistics were reported for 9 KAB item responses and chi-square tests were performed for examining their association with giving a diagnosis of CFS. We used principal component analysis to construct multidimensional subscales and perform a general linear model to examine factors associated with subscales. The probability sample involved data on 15 CFS-specific questions from 2006 and 2007 DocStyles web-based panel surveys collected from 2,750 physicians (average response rate 55%). We calculated descriptive and chi-square statistics. The significance was set at two-tailed with the alpha level of 0.05.ResultsHealthcare providers in both samples were aware of CFS and exhibited a high level of knowledge. Overall, 96% of respondents in the DocStyles (probability) sample had heard about CFS. Healthcare providers in the conference (convenience) sample demonstrated good KAB scores; physicians' scores were highest on KAB scales and lowest in perception. Nurses' scores were lowest in knowledge. More than 40% of physicians reported ever giving a CFS diagnosis and in the DocStyles (probability) sample more than 80% of physicians correctly identified CFS symptoms. Physicians reported professional journals, the Internet, and continuing education programs as the top 3 sources from which they obtain CFS information.ConclusionsFindings from these combined samples fill a gap in the evidence-base of U.S. healthcare providers' and knowledge, attitudes, and beliefs concerning CFS. Importantly, respondents in both samples expressed similar knowledge, attitudes, beliefs and perceptions. Awareness was high and negative attitudes were low. The primary areas for future education should address diagnosis and management of CFS and should be delivered through those venues providers indicated they primarily use. Data from this study provide a benchmark for evaluation the success of these future efforts.
| S-EPMC2875206 | biostudies-literature
Project description:Understanding physicians' antibiotic-prescribing behaviour is fundamental when it comes to improving antibiotic use and tackling the growing rates of antimicrobial resistance. The aim of the study was to develop and validate--in terms of face validity, content validity and reliability--an instrument designed to assess the attitudes and knowledge underlying physician antibiotic prescribing.The questionnaire development and validation process comprised two different steps, namely: (1) content and face validation, which included a literature review and validation both by physicians and by Portuguese language and clinical psychology experts; and (2) reliability analysis, using the test-retest method, to assess the questionnaire's internal consistency (Cronbach's alpha) and reproducibility (intraclass correlation coefficient--ICC). The questionnaire includes 17 items assessing attitudes and knowledge about antibiotic prescribing and resistances and 9 items evaluating the importance of different sources of knowledge. The study was conducted in the catchment area covered by Portugal's Northern Regional Health Administration and used a convenience sample of 61 primary-care and 50 hospital-care physicians.Response rate was 64% (49% to retest) for primary-care physicians and 66% (60% to retest) for hospital-care physicians. Content validity resulted in 9 changes to professional concepts. Face validity assessment resulted in 19 changes to linguistic and interpretative terms. In the case of the reliability analysis, the ICC values indicated a minimum of fair to good reproducibility (ICC > 0.4), and the Cronbach alpha values were satisfactory (α > 0.70).The questionnaire developed is valid--in terms of face validity, content validity and reliability--for assessing physicians' attitudes to and knowledge of antibiotic prescribing and resistance, in both hospital and primary-care settings, and could be a very useful tool for characterising physicians' antibiotic-prescribing behaviour.
| S-EPMC4705586 | biostudies-other
Project description:On August 16, 2018, the U.S. Food and Drug Administration approved lenvatinib (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open-label, noninferiority trial (REFLECT; NCT01761266) conducted in 954 patients with previously untreated metastatic or unresectable HCC. Patients were randomized (1:1) to receive lenvatinib (12 mg orally once daily for patients with a baseline body weight ≥60 kg and 8 mg orally once daily for patients with a baseline body weight <60 kg) or sorafenib (400 mg orally twice daily) until radiological disease progression or unacceptable toxicity. REFLECT demonstrated that lenvatinib was noninferior but not statistically superior to sorafenib for overall survival (OS; hazard ratio, [HR] 0.92; 95% confidence intervals [CI], 0.79-1.06), with median OS of 13.6 and 12.3 months in the lenvatinib and sorafenib arms, respectively. REFLECT also demonstrated statistically significant improvements in investigator-assessed progression-free survival (PFS; HR, 0.66; 95% CI, 0.57-0.77]; p < 0.001), corresponding to median PFS of 7.4 and 3.7 months and overall response rate of 24.1% vs 9.2% per modified RECIST for HCC (mRECIST) in the lenvatinib and sorafenib arms, respectively. Consistent results were observed by an independent review facility per RECISTv1.1 and per mRECIST. The most common adverse reactions observed in the lenvatinib-treated patients (≥20%) in decreasing frequency were hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea. IMPLICATIONS FOR PRACTICE: This article describes the U.S. Food and Drug Administration's review of data from a single trial, REFLECT, that supported the approval of lenvatinib, as a single agent, for the first-line treatment of unresectable hepatocellular carcinoma (HCC). REFLECT was an open-label, noninferiority trial that randomized 954 patients with HCC who were ineligible for liver-directed therapy with no prior systemic therapy for HCC to lenvatinib or sorafenib. REFLECT demonstrated that lenvatinib-treated patients had similar survival, more responses, and longer time to progression than those receiving sorafenib. Serious side effects were more common among lenvatinib-treated patients. Lenvatinib is an effective treatment for patients with previously untreated HCC.
| S-EPMC7930400 | biostudies-literature
Project description:Maternal gum disease is associated with adverse pregnancy outcomes such as preterm birth and low birthweight. This study aims to evaluate the knowledge, attitudes and practice behaviour of Australian midwives regarding the periodontal health of pregnant women to inform interprofessional antenatal care. This was an observational, cross-sectional study. We circulated an online questionnaire to Australian midwives from August 2018 to February 2019. Key outcome variables were knowledge, attitudes, and practice behaviours related to oral health. Key predictor variables were years of practice, practice location, and dental history. We summarized responses with frequency tables and assigned tallied scores for analysis using non-parametric statistical tests. 100 responses were analysed, including from rural (n = 23) and urban (n = 77) midwives. Eighty percent of midwives agreed that maternal dental care can positively affect pregnancy outcomes. Fluoridated toothpaste use (19.1%) was incorrectly answered to prevent gum disease more often than psychological stress control (7.9%), a correct answer. Rural midwives demonstrated a significantly higher knowledge score (p = 0.001) and significantly more positive practice behaviours towards oral health (p = 0.014) than urban midwives. Australian midwives have positive attitudes towards antenatal oral health but misunderstand gum disease aetiology and prevention. This study highlights areas to improve interprofessional education for optimal oral health and pregnancy outcomes.
| S-EPMC7177424 | biostudies-literature
Project description:Alzheimer's Disease (AD) and Related Dementias (ADRD) are a growing concern across the globe. Unfortunately, racial/ethnic minorities in the United States (U.S.), such as Chinese Americans, have lower ADRD knowledge, and these individuals are less likely to be targeted and engaged in recommended dementia prevention and care. The objective of this study is to examine knowledge, attitudes, and beliefs about healthy aging and ADRD among older Chinese Americans living in New York City. Chinese Americans with very low English proficiency were recruited from a senior center in New York City. Accordingly, surveys were translated and focus groups were conducted in Mandarin or Cantonese. Questionnaires assessed demographic and health characteristics. Focus groups followed an open-ended protocol which was guided by the published literature. Focus group discussions were audio recorded, transcribed, and translated to English for qualitative analysis. Analysis of qualitative data proceeded according to the constant comparative method. A total of 18 participants were recruited. Average age of participants was 76.4 years and participants were 72.2% female. The majority were married (72.2%). Participants reported chronic conditions, including diabetes (38.9%) and dyslipidemia (22.2%). Participants commonly reported that their health limited their ability to accomplish things (66.7%) and achieve things (66.7%). While 16.7% of participants reported no bodily pain, slight pain was reported by 44.4%, moderate pain by 33.3%, and extreme pain by 5.6%. Qualitative analysis revealed several prominent themes, including: (1) perceptions about normal aging; (2) fears about loneliness and cognitive decline; (3) understanding of healthy aging; (4) cultural influences on aging; and (5) perceptions of ADRD. Results from this study highlight a set of cultural beliefs about healthy aging as well as knowledge, attitudes, and beliefs pertaining to ADRD. These results may inform opportunities for increasing healthy aging practices and knowledge about dementia among underserved older Chinese Americans.
| S-EPMC9262861 | biostudies-literature
Project description:On June 15, 2020, the FDA granted accelerated approval to lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was granted on the basis of the clinically meaningful effects on overall response rate (ORR) and duration of response (DOR), and the safety profile observed in a multicenter, open-label, multicohort clinical trial (PM1183-B-005-14, NCT02454972), referred to as Study B-005, in patients with advanced solid tumors. The trial included a cohort of 105 patients with metastatic SCLC who had disease progression on or after platinum-based chemotherapy. The confirmed ORR determined by investigator assessment using RECIST 1.1 in the approved SCLC patient population was 35% [95% confidence interval (CI): 26-45], with a median DOR of 5.3 (95% CI: 4.1-6.4) months. The drug label includes warnings and precautions for myelosuppression, hepatotoxicity, and embryo-fetal toxicity. This is the first drug approved by the FDA in over 20 years in the second line for patients with metastatic SCLC. Importantly, this approval includes an indication for patients who have platinum-resistant disease, representing an area of particular unmet need.
| S-EPMC9532454 | biostudies-literature