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BACKGROUND: Community health centers grapple with high no-show rates, posing challenges to patient access and primary care provider (PCP) utilization. AIM: To address these challenges, we implemented a virtual waiting room (VWR) program in April 2023 to enhance patient access and boost PCP utilization. SETTING: Academic community health center in a small urban city in Massachusetts. PARTICIPANTS: Community health patients (n = 8706) and PCP (n = 14). PROGRAM DESCRIPTION: The VWR program, initiated in April 2023, involved nurse triage of same-day visit requests for telehealth appropriateness, then placing patients in a standby pool to fill in as a telehealth visit for no-shows or last-minute cancellations in PCP schedules. PROGRAM EVALUATION: Post-implementation, clinic utilization rates between July and September improved from 75.2% in 2022 to 81.2% in 2023 (p < 0.01). PCP feedback was universally positive. Patients experienced a mean wait time of 1.9 h, offering a timely and convenient alternative to urgent care or the ER. DISCUSSION: The VWR is aligned with the quadruple aim of improving patient experience, population health, cost-effectiveness, and PCP satisfaction through improving same-day access and improving PCP schedule utilization. This innovative and reproducible approach in outpatient offices utilizing telehealth holds the potential for enhancing timely access across various medical disciplines.
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Governments and biopharmaceutical organizations aggressively leveraged expeditious communication capabilities, decision models, and global strategies to make a COVID-19 vaccine happen within a period of 12 months. This was an unusual effort and cannot be transferred to normal times. However, this focus on a single vaccine has also led to other treatments and drug developments being sidelined. Society expects the pharmaceutical industry to provide an uninterrupted supply of medicines. However, it is often overlooked how complex the manufacture of these compounds is and what logistics are required, not to mention the time needed to develop new drugs. The overarching theme, therefore, is patient access and how we can help ensure access and extend it to low- and middle-income countries. Despite unceasing efforts to make medications available to all patient populations, this must never be done at the expense of patient safety. A major fraction of the costs in biopharmaceutical manufacturing are for drug discovery, process development, and clinical studies. Infrastructure costs are very difficult to quantify because they often depend on whether a greenfield facility or an existing, depreciated facility is used or adapted for a new product. To accelerate process development concepts of platform process and prior knowledge are increasingly leveraged. While more traditional protein therapeutics continue to dominate the field, we are also experiencing the exciting emergence and evolution of other therapeutic formats (bispecifics, tetravalent mAbs, antibody-drug conjugates, enzymes, peptides, etc.) that offer unique treatment options for patients. Protein modalities are still dominant, but new modalities are being developed that can be learned from including advanced therapeutics-like cell and gene therapies. The industry must develop a model-based strategy for process development and technologies such as continuous integrated biomanufacturing must be adopted. The overall conclusion is that the pandemic pace was unsustainable, focused on vaccine delivery at the expense of other modalities/disease targets, and had implications for professional and personal life (work-life balance). Routinely reducing development time from 10 years to 1 year is nearly impossible to achieve. Environmental aspects of sustainable downstream processing are also described.
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Produtos Biológicos , COVID-19 , Humanos , Vacinas contra COVID-19 , SARS-CoV-2 , Indústria FarmacêuticaRESUMO
BACKGROUND. To implement provisions of the 21st Century Cures Act that address information blocking, federal regulations mandated that health systems provide patients with immediate access to elements of their electronic health information, including imaging results. OBJECTIVE. The purpose of this study was to compare patient access of radiology reports before and after implementation of the information-blocking provisions of the 21st Century Cures Act. METHODS. This retrospective study included patients who underwent outpatient imaging examinations from January 1, 2021, through December 31, 2022, at three campuses within a large health system. The system implemented policies to comply with the Cures Act information-blocking provisions on January 1, 2022. Imaging results were released in patient portals after a 36-hour embargo period before implementation versus being released immediately after report finalization after implementation. Data regarding patient report access in the portal and report acknowledgment by the ordering provider in the EMR were extracted and compared between periods. RESULTS. The study included reports for 1,188,692 examinations in 388,921 patients (mean age, 58.5 ± 16.6 [SD] years; 209,589 women, 179,290 men, eight nonbinary individuals, and 34 individuals for whom sex information was missing). A total of 77.5% of reports were accessed by the patient before implementation versus 80.4% after implementation. The median time from report finalization to report release in the patient portal was 36.0 hours before implementation versus 0.4 hours after implementation. The median time from report release to first patient access of the report in the portal was 8.7 hours before implementation versus 3.0 hours after implementation. The median time from report finalization to first patient access was 45.0 hours before implementation versus 5.5 hours after implementation. Before implementation, a total of 18.5% of reports were first accessed by the patient before being accessed by the ordering provider versus 44.0% after implementation. After implementation, the median time from report release to first patient access was 1.8 hours for patients with age younger than 60 years old versus 4.3 hours for patients 60 years old or older. CONCLUSION. After implementation of institutional policies to comply with 21st Century Cures Act information-blocking provisions, the length of time until patients accessed imaging results decreased, and the proportion of patients who accessed their reports before the ordering provider increased. CLINICAL IMPACT. Radiologists should consider mechanisms to ensure timely and appropriate communication of important findings to ordering providers.
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Acesso dos Pacientes aos Registros , Humanos , Masculino , Feminino , Estudos Retrospectivos , Pessoa de Meia-Idade , Adulto , Acesso dos Pacientes aos Registros/legislação & jurisprudência , Idoso , Estados Unidos , Registros Eletrônicos de Saúde/legislação & jurisprudência , Adolescente , Portais do Paciente/legislação & jurisprudência , Criança , Sistemas de Informação em Radiologia/legislação & jurisprudência , Adulto Jovem , Idoso de 80 Anos ou mais , Pré-EscolarRESUMO
BACKGROUND: Despite efforts to view electronic health records (EHR) data through an equity lens, crucial contextual information regarding patients' social environments remains limited. Integrating EHR data and Geographic Information Systems (GIS) technology can give deeper insights into the relationships between patients' social environments, health outcomes, and geographic factors. This study aims to identify regions with the fastest and slowest access to outpatient physical therapy services using bivariate choropleth maps to provide contextual insights that may contribute to health disparity in access. METHODS: This was a retrospective cohort study of patients' access timelines for the first visit to outpatient physical therapy services (n = 10,363). The three timelines evaluated were (1) referral-to-scheduled appointment time, (2) scheduled appointment to first visit time, and (3) referral to first visit time. Hot and coldspot analyses (CI 95%) determined the fastest and slowest access times with patient-level characteristics and bivariate choropleth maps that were developed to visualize associations between access patterns and disadvantaged areas using Area Deprivation Index scores. Data were collected between January 1, 2016 and January 1, 2020. EHR data were geocoded via GIS technology to calculate geospatial statistics (Gi∗ statistic from ArcGIS Pro) in an urban area. RESULTS: Statistically significant differences were found for all three access timelines between coldspot (i.e., fast access group) and hotspot (i.e., slow access group) comparisons (p < .05). The hotspot regions had higher deprivation scores; higher proportions of residents who were older, privately insured, female, lived further from clinics; and a higher proportion of Black patients with orthopaedic diagnoses compared to the coldspot regions. CONCLUSIONS: Our study identified and described local areas with higher densities of patients that experienced longer access times to outpatient physical therapy services. Integration of EHR and GIS data is a more robust method to identify health disparities in access to care. With this approach, we can better understand the intricate interplay between social, economic, and environmental factors contributing to health disparities in access to care.
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Mapeamento Geográfico , Medicina , Humanos , Feminino , Registros Eletrônicos de Saúde , Estudos Retrospectivos , Sistemas de Informação GeográficaRESUMO
BACKGROUND: Despite growing evidence of the potential of arts-based modalities to translate knowledge and spark discussion on complex issues, applications to health policy are rare. This study explored the potential of a research-based theatrical video to increase public capacity and motivation to engage with the complex issues that make Emergency Department wait times such an intractable problem. METHODS: Larry Saves the Canadian Healthcare System is a digital musical micro-series developed from extensive research examining system-level causes of Emergency crowding and the ineffectiveness of prevailing approaches. We released individual episodes and a revised full-length version on YouTube, using organic promotion strategies and paid advertising. We used YouTube Analytics to track views, engagement and viewer demographics, and content-analyzed viewer comments. We also conducted five university-based screenings; 92 students completed questionnaires, rating Larry on 16 descriptors using a 7-point Likert scale. RESULTS: From June 2022 through May 2023, Larry garnered over 100,000 views (76,752 of the full-length version, 35,535 of episodes), 1329 likes, 2780 shares, and 139 comments. Views and watch time were higher among women and positively associated with age. Among YouTube comments, the predominating themes were praise for the video and criticism of the healthcare system. Many commenters applauded the show's accuracy, humor, and/or resonance with their experience; several shared healthcare horror stories. Students overwhelmingly agreed with all positive and disagreed with all negative descriptors, and nearly unanimously deemed the video informative, thought-provoking, and entertaining. Most also affirmed that it had increased their knowledge, interest, and confidence to participate in discussions about healthcare issues. Neither gender, primary language, nor employment in healthcare predicted ratings, but graduate students and those 25+ years old evaluated the video most positively. DISCUSSION: These findings highlight the promise of research-informed musical satire to inform and invigorate discourse on an urgent health policy problem. Larry has reached tens of thousands of viewers, garnered excellent feedback, and received high student ratings. Further research should directly assess educational and behavioural outcomes and explore what facilitative strategies could maximize this knowledge translation product's potential to foster informed, impactful policy dialogue.
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Atenção à Saúde , Serviço Hospitalar de Emergência , Mídias Sociais , Humanos , Canadá , Gravação em Vídeo , Salas de EsperaRESUMO
BACKGROUND: In many large health centers, patients face long appointment wait times and difficulties accessing care. Last-minute cancellations and patient no-shows leave unfilled slots in a clinician's schedule, exacerbating delays in care from poor access. The mismatch between the supply of outpatient appointments and patient demand has led health systems to adopt many tools and strategies to minimize appointment no-show rates and fill open slots left by patient cancellations. OBJECTIVE: We evaluated an electronic health record (EHR)-based self-scheduling tool, Fast Pass, at a large academic medical center to understand the impacts of the tool on the ability to fill cancelled appointment slots, patient access to earlier appointments, and clinical revenue from visits that may otherwise have gone unscheduled. METHODS: In this retrospective cohort study, we extracted Fast Pass appointment offers and scheduling data, including patient demographics, from the EHR between June 18, 2022, and March 9, 2023. We analyzed the outcomes of Fast Pass offers (accepted, declined, expired, and unavailable) and the outcomes of scheduled appointments resulting from accepted Fast Pass offers (completed, canceled, and no-show). We stratified outcomes based on appointment specialty. For each specialty, the patient service revenue from appointments filled by Fast Pass was calculated using the visit slots filled, the payer mix of the appointments, and the contribution margin by payer. RESULTS: From June 18 to March 9, 2023, there were a total of 60,660 Fast Pass offers sent to patients for 21,978 available appointments. Of these offers, 6603 (11%) were accepted across all departments, and 5399 (8.9%) visits were completed. Patients were seen a median (IQR) of 14 (4-33) days sooner for their appointments. In a multivariate logistic regression model with primary outcome Fast Pass offer acceptance, patients who were aged 65 years or older (vs 20-40 years; P=.005 odds ratio [OR] 0.86, 95% CI 0.78-0.96), other ethnicity (vs White; P<.001, OR 0.84, 95% CI 0.77-0.91), primarily Chinese speakers (P<.001; OR 0.62, 95% CI 0.49-0.79), and other language speakers (vs English speakers; P=.001; OR 0.71, 95% CI 0.57-0.87) were less likely to accept an offer. Fast Pass added 2576 patient service hours to the clinical schedule, with a median (IQR) of 251 (216-322) hours per month. The estimated value of physician fees from these visits scheduled through 9 months of Fast Pass scheduling in professional fees at our institution was US $3 million. CONCLUSIONS: Self-scheduling tools that provide patients with an opportunity to schedule into cancelled or unfilled appointment slots have the potential to improve patient access and efficiently capture additional revenue from filling unfilled slots. The demographics of the patients accepting these offers suggest that such digital tools may exacerbate inequities in access.
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Registros Eletrônicos de Saúde , Pacientes Ambulatoriais , Humanos , Centros Médicos Acadêmicos , Povo Asiático , Estudos Retrospectivos , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Asiático , Brancos , EtnicidadeRESUMO
BACKGROUND: Direct access of patients to their web-based patient portal, including laboratory test results, has become increasingly common. Numeric laboratory results can be challenging to interpret for patients, which may lead to anxiety, confusion, and unnecessary doctor consultations. Laboratory results can be presented in different formats, but there is limited evidence regarding how these presentation formats impact patients' processing of the information. OBJECTIVE: This study aims to synthesize the evidence on effective formats for presenting numeric laboratory test results with a focus on outcomes related to patients' information processing, including affective perception, perceived magnitude, cognitive perception, perception of communication, decision, action, and memory. METHODS: The search was conducted in 3 databases (PubMed, Web of Science, and Embase) from inception until May 31, 2023. We included quantitative, qualitative, and mixed methods articles describing or comparing formats for presenting diagnostic laboratory test results to patients. Two reviewers independently extracted and synthesized the characteristics of the articles and presentation formats used. The quality of the included articles was assessed by 2 independent reviewers using the Mixed Methods Appraisal Tool. RESULTS: A total of 18 studies were included, which were heterogeneous in terms of study design and primary outcomes used. The quality of the articles ranged from poor to excellent. Most studies (n=16, 89%) used mock test results. The most frequently used presentation formats were numerical values with reference ranges (n=12), horizontal line bars with colored blocks (n=12), or a combination of horizontal line bars with numerical values (n=8). All studies examined perception as an outcome, while action and memory were studied in 1 and 3 articles, respectively. In general, participants' satisfaction and usability were the highest when test results were presented using horizontal line bars with colored blocks. Adding reference ranges or personalized information (eg, goal ranges) further increased participants' perception. Additionally, horizontal line bars significantly decreased participants' tendency to search for information or to contact their physician, compared with numerical values with reference ranges. CONCLUSIONS: In this review, we synthesized available evidence on effective presentation formats for laboratory test results. The use of horizontal line bars with reference ranges or personalized goal ranges increased participants' cognitive perception and perception of communication while decreasing participants' tendency to contact their physicians. Action and memory were less frequently studied, so no conclusion could be drawn about a single preferred format regarding these outcomes. Therefore, the use of horizontal line bars with reference ranges or personalized goal ranges is recommended to enhance patients' information processing of laboratory test results. Further research should focus on real-life settings and diverse presentation formats in combination with outcomes related to patients' information processing.
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Memória , Humanos , Tomada de Decisões , Compreensão , Percepção , Portais do Paciente , ComunicaçãoRESUMO
The Nordic countries are, together with the United States, forerunners in online record access (ORA), which has now become widespread. The importance of accessible and structured health data has also been highlighted by policy makers internationally. To ensure the full realization of ORA's potential in the short and long term, there is a pressing need to study ORA from a cross-disciplinary, clinical, humanistic, and social sciences perspective that looks beyond strictly technical aspects. In this viewpoint paper, we explore the policy changes in the European Health Data Space (EHDS) proposal to advance ORA across the European Union, informed by our research in a Nordic-led project that carries out the first of its kind, large-scale international investigation of patients' ORA-NORDeHEALTH (Nordic eHealth for Patients: Benchmarking and Developing for the Future). We argue that the EHDS proposal will pave the way for patients to access and control third-party access to their electronic health records. In our analysis of the proposal, we have identified five key principles for ORA: (1) the right to access, (2) proxy access, (3) patient input of their own data, (4) error and omission rectification, and (5) access control. ORA implementation today is fragmented throughout Europe, and the EHDS proposal aims to ensure all European citizens have equal online access to their health data. However, we argue that in order to implement the EHDS, we need more research evidence on the key ORA principles we have identified in our analysis. Results from the NORDeHEALTH project provide some of that evidence, but we have also identified important knowledge gaps that still need further exploration.
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Registros Eletrônicos de Saúde , Humanos , Países Escandinavos e Nórdicos , Europa (Continente) , União EuropeiaRESUMO
BACKGROUND: Patient-accessible electronic health records (PAEHRs) hold promise for empowering patients, but their impact may vary between mental and somatic health care. Medical professionals and ethicists have expressed concerns about the potential challenges of PAEHRs for patients, especially those receiving mental health care. OBJECTIVE: This study aims to investigate variations in the experiences of online access to electronic health records (EHRs) among persons receiving mental and somatic health care, as well as to understand how these experiences and perceptions vary among those receiving mental health care at different levels of point of care. METHODS: Using Norwegian data from the NORDeHEALTH 2022 Patient Survey, we conducted a cross-sectional descriptive analysis of service use and perceptions of perceived mistakes, omissions, and offensive comments by mental and somatic health care respondents. Content analysis was used to analyze free-text responses to understand how respondents experienced the most serious errors in their EHR. RESULTS: Among 9505 survey participants, we identified 2008 mental health care respondents and 7086 somatic health care respondents. A higher percentage of mental health care respondents (1385/2008, 68.97%) reported that using PAEHR increased their trust in health care professionals compared with somatic health care respondents (4251/7086, 59.99%). However, a significantly larger proportion (P<.001) of mental health care respondents (976/2008, 48.61%) reported perceiving errors in their EHR compared with somatic health care respondents (1893/7086, 26.71%). Mental health care respondents also reported significantly higher odds (P<.001) of identifying omissions (758/2008, 37.75%) and offensive comments (729/2008, 36.3%) in their EHR compared with the somatic health care group (1867/7086, 26.35% and 826/7086, 11.66%, respectively). Mental health care respondents in hospital inpatient settings were more likely to identify errors (398/588, 67.7%; P<.001) and omissions (251/588, 42.7%; P<.001) than those in outpatient care (errors: 422/837, 50.4% and omissions: 336/837, 40.1%; P<.001) and primary care (errors: 32/100, 32% and omissions: 29/100, 29%; P<.001). Hospital inpatients also reported feeling more offended (344/588, 58.5%; P<.001) by certain content in their EHR compared with respondents in primary (21/100, 21%) and outpatient care (287/837, 34.3%) settings. Our qualitative findings showed that both mental and somatic health care respondents identified the most serious errors in their EHR in terms of medical history, communication, diagnosis, and medication. CONCLUSIONS: Most mental and somatic health care respondents showed a positive attitude toward PAEHRs. However, mental health care respondents, especially those with severe and chronic concerns, expressed a more critical attitude toward certain content in their EHR compared with somatic health care respondents. A PAEHR can provide valuable information and foster trust, but it requires careful attention to the use of clinical terminology to ensure accurate, nonjudgmental documentation, especially for persons belonging to health care groups with unique sensitivities.
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Registros Eletrônicos de Saúde , Registros de Saúde Pessoal , Humanos , Estudos Transversais , Emoções , Assistência AmbulatorialRESUMO
Introduction: As the shortage of primary care providers widens nationwide, access to care utilizing non-physician providers is one strategy to ensure equitable access to care. This study aimed to compare community pharmacist-provided care for minor ailments to care provided at three traditional sites of care: primary care, urgent care, and emergency department, to determine if care provided by pharmacists improved access with comparable quality and reduced financial strain on the healthcare system. Methods: Pharmacy data was provided from 46 pharmacies and 175 pharmacists who participated across five pharmacy corporations over a 3-year period (2016-2019). Data for non-pharmacy sites of care was provided by a large health plan, matching episodes of care for conditions seen in the community pharmacy. Cost-of-care analysis was conducted using superiority study design and revisit data analysis was conducted using noninferiority study design. Results: Median cost-of-care across traditional sites of care was $277.78 higher than care provided at the pharmacies, showing superiority. Noninferiority was demonstrated for revisit care when the initial visit was conducted by a pharmacist compared to traditional sites. Discussion: The authors conclude community pharmacist-provided care for minor ailments improved cost-effective access for patients with comparable quality and reduced financial strains on the healthcare system.
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BACKGROUND: In 2017, we published an article addressing drug shortages (DS) in Israel, exploring regulatory perspectives, challenges, and potential solutions. Since then, DS remain a significant concern for patients, healthcare providers, and policymakers globally. In this updated article, we revisit the topic, providing new insights, data, and analysis on the current DS landscape in Israel, efforts to mitigate them, and propose strategies to combat this escalating issue. METHODS: We conducted a comprehensive search of the Israeli Ministry of Health (MOH) DS database, spanning from 2014 to the present. We extracted DS numbers and their reasons. Further searches on the Israeli MOH website, pharmaceutical division archives, and the internet yielded official MOH publications and correspondence regarding regulatory responses to DS from 2017 onwards. Additionally, two specific cases of DS were examined to analyze their handling. Recent activities and publications from the Israeli MOH aimed at reducing DS were also reviewed. RESULTS: Between 2014 and 2022, DS surged 2.66-fold. Total DS were 3228; 672 due to commercial reasons, and 2556 to operational reasons (20.5% and 79.5% respectively). The average duration of intermittent DS increased 1.56-fold, from 85 to 133 days. Manufacturers informed the MOH 22 days prior to actual shortage on average. Analyzing 2022's DS (640) by ATC groups, prominent categories included nervous system drugs (18%), drugs acting on the alimentary tract and metabolism (14%), and dermatologicals (11%). Operational DS in 2022 (n = 564) were primarily due to stock delivery delays (38%), stock over-utilization (12%), and raw material shortages (9%). Sixteen official MOH publications on DS were identified from 2017 onwards. Moreover, two high-impact DS case studies were examined. CONCLUSION: Despite routine monitoring by the Israeli MOH and updating the DS policy throughout this period, DS persist, intensifying annually and posing serious health risks. This trend mirrors international patterns, affecting countries globally. In Israel's uniquely structured healthcare system, with its swift stakeholder cooperation and implementation capabilities, more effective DS management is conceivable. We propose ten universally applicable rules to address DS challenges.
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Pessoal de Saúde , Humanos , Israel , Preparações FarmacêuticasRESUMO
BACKGROUND: First Contact Physiotherapy Practitioners (FCPPs) provide expert care for patients with musculoskeletal (MSK) conditions in General Practice. Access to FCPPs can facilitate timely care and efficient use of health services. However, there is little evidence about patient experiences of accessing FCPP appointments. OBJECTIVE: To explore the experiences of patients with MSK conditions who have accessed an FCPP appointment in a General Practice setting in the UK. DESIGN: Exploratory qualitative design. METHODS: Patients with MSK conditions who had experience of accessing FCPP appointments were recruited via social media. Semi-structured interviews were conducted and recorded via MS Teams. Data were analysed using thematic analysis. RESULTS: Of 13 patients interviewed, there were 10 females and three males, with an age range between 20 and 80 years. The main themes identified were: (1) Awareness of FCPP, (2) Access routes, (3) Facilitators to access, (4) Barriers to access, (5) Likelihood of re-accessing FCPP. Awareness of FCPP was generally low amongst participants. There were a variety of routes to access FCPP appointments; some were felt to be sub-optimal by participants. Facilitators included quick/easy access to FCPP. Barriers included difficulty contacting General Practitioner (GP) surgeries and public perception of needing to see a GP initially. The likelihood of re-consultation with a FCPP was low when participants had disappointing care experiences. CONCLUSION: This study provides new evidence about patient experiences of accessing FCPP. It explores positive and negative aspects of access from patients' perspectives. It also highlights areas for improvement in terms of GP staff/patient awareness and understanding of FCPP.
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Medicina Geral , Acessibilidade aos Serviços de Saúde , Doenças Musculoesqueléticas , Pesquisa Qualitativa , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Adulto , Idoso , Doenças Musculoesqueléticas/terapia , Doenças Musculoesqueléticas/reabilitação , Reino Unido , Idoso de 80 Anos ou mais , Agendamento de Consultas , Adulto Jovem , Modalidades de FisioterapiaRESUMO
Purpose: An expanded access clinical trials (EACTs) provides exceptional patient access to investigational new drugs for life-threatening diseases for which no effective treatment exists. Based on public information, we have studied EACTs since 2016, when the EACT system was launched in Japan. In this study, we investigated the reality of EACTs by interviewing pharmaceutical companies and clarifying how they view them. Patients and Methods: We conducted semi-structured interviews with 10 pharmaceutical companies developing new drugs. This study aims to clarify the status of EACTs, so we selected pharmaceutical companies that develop innovative drugs for which they may perform EACTs (however, experience in conducting EACTs was optional). Results: All those surveyed were aware of EACTs. Twelve access clinical trials were conducted, and the EACT implementation rate for pivotal clinical trials was 2.5%. The most common reason for implementing an EACT was "requests from physicians and medical institutions" (nine companies, 90.0%), and the most common reason for not implementing an EACT was "the applicability of the system" (five companies). Improvements to EACTs were identified by eight companies (80.0%); financial assistance by six companies (60.0%); reducing the scope of data to be collected and simplifying the procedure by six companies (60.0%). Seven companies (70.0%) responded that a Single Patient Investigational New Drug Application should be conducted, suggesting that the system should be revised. Conclusion: An interview survey of ten pharmaceutical companies developing new drugs in Japan regarding expanded access clinical trials indicated that there were issues with the system. Many wished to improve the system by establishing a single patient access system, supporting resources, and simplifying procedures. Based on our interviews with 10 Japanese pharmaceutical companies, it was found that the system needed to be improved by introducing a single patient access system, providing supporting resources, and simplifying procedures. In Japan, about eight years have passed since EACT was established, and it appears a revision of the EACT legislation is due.
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OBJECTIVE: This exploratory study examines a rural critical access hospital (CAH) staff's perception of current obstacles and needs concerning the physical environment. BACKGROUND: CAH intends to improve access to healthcare, coordinate with experts and providers, and serve as the rural population's healthcare hub. It is imperative to understand environmental qualities that impact the quality of care to develop effective policies and design guidelines for rural healthcare. Nevertheless, a limited number of studies have focused on user or organizational outcomes related to the physical environment of rural healthcare settings. METHODS: This cross-sectional exploratory qualitative case study was conducted as part of the facility planning process for a CAH in rural North Carolina. Hospital staff participated in a survey exploring their satisfaction with the overall physical environment privacy, space allocation, and department adjacency. An open-ended question asked staff to elaborate on needed improvements and changes in their department. RESULTS: Findings show low satisfaction levels for space allocations for emergency department, lab, surgery, and wound care. Safety and quality were the two emerging outcomes of the physical environment's shortcomings. Two clusters emerged from the content analysis, representing facility needs (rightly sized spaces, functional needs, COVID-19 needs, and improved access) and ambient conditions (clutter, visibility, flooring quality, noise, privacy, cleanliness, aesthetics, and temperature). CONCLUSION: The findings from this study suggest that the interior and exterior facility and ambient conditions of the CAH play a key role in quality and safety outcomes.
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Atenção à Saúde , Recursos Humanos em Hospital , Humanos , Estudos Transversais , Serviço Hospitalar de Emergência , HospitaisRESUMO
Objective: To evaluate the potential impact of cell and gene therapies (CGTs) in France by forecasting the number of patients that will be treated with CGTs over the period 2023-2030 by therapeutic area and region. Methods: A review of CGTs in clinical development and related disease epidemiology was conducted to forecast the number of CGT launches and patient population between 2023 and 2030. The number of expected launches was identified by filtering the clinical development pipeline with estimated time to launch and probability of success values from Project ALPHA. Disease prevalence and incidence in France were combined with projected adoption rates derived from historical data to forecast the patient population to be treated. Results: Up to 44 new CGTs are forecasted to launch in France in the period 2023-2030, which translates into more than 69,400 newly treated patients in 2030. Leading indications in terms of newly treated patients per year include cardiovascular disease, hematological cancers and solid tumors with 27,300, 15,200 and 13,000 newly treated patients in 2030, respectively. Discussion: The forecast suggests that the future landscape of CGTs will undergo a shift, moving from CGTs targeting (ultra) rare diseases to more prevalent diseases. In France, this will likely pose organizational challenges hindering patient access to these transformative therapies. Further research and planning around network organization and patient distribution are needed to assess and improve the readiness of the French healthcare system for ensuring access for this growing number of patients to be treated with CGTs.
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OBJECTIVE: Online access to medical records is expected to foster patient empowerment and patient-centred healthcare. However, data on actual experienced effects remain limited. We aimed to examine the development of effects patients perceive from online access. METHODS: A nationwide online survey (N = 1769) evaluated Dutch patients' use of online access and beliefs about its effects on 16 outcomes at baseline and one-year follow-up. Analyses of Variance (ANOVA) were used to examine within-person belief changes across three user groups: patients who 1) used online access before the study, 2) started use during the study, and 3) did not use it at all. RESULTS: There was a small decline in five beliefs around online access facilitating patient empowerment and participation in participants who started using online access during the study compared to at least one other user group. Most changes in beliefs did not differ between groups. CONCLUSION: No evidence of benefits from online access was found. The findings might indicate inadequacies in the current system of online access. Possibly, the benefits of online access are contingent upon portal improvements and changes in documentation practices. PRACTICE IMPLICATION: Records need to be easily accessible and comprehensible for patients. Consultation practices should enable patient participation.
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Medicina Geral , Participação do Paciente , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Países Baixos , Inquéritos e Questionários , Seguimentos , Internet , Registros Eletrônicos de Saúde , Acesso dos Pacientes aos Registros , Idoso , Percepção , Assistência Centrada no PacienteRESUMO
California like many other states is facing a severe shortage of primary care physicians and access to primary care is uneven across the state. It is well documented that California has the highest number of designated primary care health professional shortage areas in the country. Although physician assistants (PAs) and nurse practitioners (NPs) are estimated to make up a large portion of California's primary care workforce by 2030, outdated and unnecessary statutory requirements such as the physician-to-PA supervision ratio requirement represent a practice barrier in expanding access to care. Other states have either eliminated or revised their physician-to-PA supervision ratios in favor of expanding access to health care services. Therefore, this editorial represents a call for coordinated actions from local and state entities to address California's outdated physician-to-PA supervision ratio requirement. NPs are mentioned briefly as they have achieved a pathway to full practice authority in California.
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Background: The significance of geographic barriers to receiving inflatable penile prosthesis (IPP) treatment is uncertain according to the existing medical literature. Aim: To describe the travel patterns of men with erectile dysfunction (ED) in the United States who underwent IPP surgery. Methods: This retrospective cohort study utilized data from the 100% Medicare Standard Analytical Files. Men aged ≥65 years with an ED diagnosis who underwent IPP surgery between January 2016 and December 2021 were identified from the database. Federal Information Processing Series codes from the National Bureau of Economic Research's County Distance Database were used to determine geographic distances from patients' homes to the facilities at which surgery was performed. Outcomes: Evaluations included the proportions of men who traveled outside their county of residence or state for IPP treatment and the average distances in miles traveled. Results: Among 15 954 men with ED undergoing IPP treatment, 56.4% received care out of their county for IPP, at a mean distance of 125.6 miles (range, 3.8-4935.0). Although patients aged ≥80 years were less likely to travel outside their county as compared with men aged 65 to 69 years (48.1% vs 57.1%, P < .001), if they traveled, they were likely to travel farther (mean, 171.8 vs 117.7 miles; P < .001). South Dakota had the highest proportion of men traveling outside their county for IPP treatment (91.3%; mean, 514.2 miles), while Vermont had the highest proportion traveling outside their home state (73.7%). Clinical Implications: By unveiling disparities in access, this study will potentially lead to tailored interventions that enhance patient care and health outcomes. Strengths and Limitations: Strengths include the uniqueness in (1) evaluating the proportions of patients who travel out of their county of residence or home state for IPP treatment and (2) quantifying the average distances that patients traveled. An additional strength is the large sample size due to the retrospective design and database used. The analysis did not capture all Medicare enrollees; however, it did encompass all traditional Medicare enrollees, representing approximately half of all men in the US aged ≥65 years. Limitations include not being generalizable to entire population of the US, as the study examined only Medicare enrollees. In addition, the study period includes the pandemic, which could have affected travel patterns. Furthermore, the coding and accuracy of the data are limitations of using administrative claims data for research. Conclusion: Study findings showed that many men with Medicare and ED traveled from their home geographic location for IPP treatment.
RESUMO
Este artigo apresenta algumas características organizativas e operacionais da Atenção Primária à Saúde (APS) inglesa. Seu objetivo é evidenciar pontos relevantes no funcionamento das clínicas da APS que facilitam o equilíbrio dinâmico entre o atendimento à demanda espontânea e as ações programáticas em saúde. Ele tem como base um estudo etnográfico, realizado no Reino Unido no período de 2013/14, no qual se analisou o modelo de pagamento por desempenho no país. Os tópicos abordados incluem: (a) composição das equipes da APS inglesa; (b) organograma funcional de uma clínica de APS; (c) consulta de 10 minutos dos médicos de família e horário de funcionamento da clínica; (d) recepção; (e) equipe de enfermagem; e (f) sistema de tecnologia da informação. Cada um desses itens possui referências para as quais é possível explorar websites e tutoriais de modo a compreender melhor alguns aspectos das clínicas da APS inglesa. O Reino Unido profissionalizou o acesso dos pacientes aos serviços da APS. Isto ocorreu por meio de um contingente maior de pessoal administrativo, menor proporção população/médico de família, maior autonomia da equipe de enfermagem e um robusto sistema de tecnologia da informação. No Brasil, a Estratégia Saúde da Família (ESF) necessita percorrer caminho semelhante a fim de aprimorar a qualidade da APS no país
This article presents some organizational and operational characteristics of UK Primary Health Care (PHC). The objective is to show relevant points in the functioning of PHC clinics that facilitate the dynamic balance between same-day appointments and programmatic health actions. It derives from empirical material of an ethnographic study, conducted in the United Kingdom in the period of 2013/14, which analyzed the pay-for-performance model in the country. The issues covered include: (a) composition of English PHC teams; (b) PHC clinic functional organogram; (c) 10 minute consultation of family physician and clinic opening hours; (d) reception; (e) nursing team; and (f) information technology system. The supporting references allow to simultaneously explore websites and tutorials to better understand some aspects of the English PHC dynamics. The UK has professionalized patients' access to PHC. This has entailed larger number of administrative personnel, a smaller population/family physician ratio, greater autonomy of the nursing team and a robust information technology system. In Brazil, the Family Health Strategy (FHS) needs to follow a similar path in order to improve the primary healthcare quality in the country
Este artículo presenta algunas características organizativas y operativas de la atención primaria de salud (APS) en el Reino Unido. El objetivo es presentar los puntos relevantes en las clínicas de la APS que articulados facilitan el equilibrio dinámico entre citas el mismo día y acciones programáticas de salud. Tiene como base material empírico de un estudio etnográfico, realizado en el Reino Unido en el período de 2013/14, que analizó el modelo de pago por desempeño en el país. Los temas cubiertos incluyen: (a) la composición de los equipos de APS inglesa; b) organograma funcional de una clínica de APS; (c) consulta de 10 minutos consulta del médico de familia y horario de funcionamiento de las clínicas de APS; (d) recepción; (e) equipo de enfermería; y (f) sistema de tecnología de la información. Las referencias de apoyo permiten explorar simultáneamente webpage y tutoriales para comprender mejor algunos aspectos de la dinámica de la APS. El Reino Unido ha profe ionalizado el acceso de los pacientes a la APS. Esto ha implicado un mayor número de personal administrativo, una proporción menor de población/médicos de familia, una mayor autonomía del equipo de enfermería y un sistema robusto de tecnología de la información. En Brasil, la Estrategia de Salud Familiar (ESF) necesita seguir un camino similar para mejorar la calidad de la APS en el país.