scholarly journals Oncologists’ reflections on patient rights and access to compassionate use drugs: A qualitative interview study from an academic cancer center

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0261478
Author(s):  
Jeremiah Stout ◽  
Cambray Smith ◽  
Jan Buckner ◽  
Alex A. Adjei ◽  
Mark Wentworth ◽  
...  
Keyword(s):  
Conventional Medicine ◽  
Cancer Center ◽  
Unrealistic Optimism ◽  
Compassionate Use ◽  
Structured Interviews ◽  
Best Interest ◽  
Experimental Drugs ◽  
Investigational Drugs ◽  
Qualitative Interview Study ◽  
Scientific Rationale

The U.S. Food and Drug Administration (FDA) allows patients with serious illnesses to access investigational drugs for “compassionate use” outside of clinical trials through expanded access (EA) Programs. The federal Right-to-Try Act created an additional pathway for non-trial access to experimental drugs without institutional review board or FDA approval. This removal of oversight amplifies the responsibility of physicians, but little is known about the role of practicing physicians in non-trial access to investigational drugs. We undertook semi-structured interviews to capture the experiences and opinions of 21 oncologists all with previous EA experience at a major cancer center. We found five main themes. Participants with greater EA experience reported less difficulty accessing drugs through the myriad of administrative processes and drug company reluctance to provide investigational products while newcomers reported administrative hurdles. Oncologists outlined several rationales patients offered when seeking investigational drugs, including those with stronger health literacy and a good scientific rationale versus others who remained skeptical of conventional medicine. Participants reported that most patients had realistic expectations while some had unrealistic optimism. Given the diverse reasons patients sought investigational drugs, four factors—scientific rationale, risk-benefit ratio, functional status of the patient, and patient motivation—influenced oncologists’ decisions to request compassionate use drugs. Physicians struggled with a “right-to-try” framing of patient access to experimental drugs, noting instead their own responsibility to protect patients’ best interest in the uncertain and risky process of off-protocol access. This study highlights the willingness of oncologists at a major cancer center to pursue non-trial access to experimental treatments for patients while also shedding light on the factors they use when considering such treatment. Our data reveal discrepancies between physicians’ sense of patients’ expectations and their own internal sense of professional obligation to shepherd a safe process for patients at a vulnerable point in their care.

scholarly journals “I Think It’s Been Met With a Shrug:” Oncologists’ Views Toward and Experiences With Right-to-Try

2020 ◽  
Author(s):  
Cambray Smith ◽  
Jeremiah Stout ◽  
Alex A Adjei ◽  
Jan Buckner ◽  
Mark Wentworth ◽  
...  
Keyword(s):  
The United States ◽  
Cancer Center ◽  
Structured Interviews ◽  
Expanded Access ◽  
Medical Centers ◽  
Investigational Drugs ◽  
Regulatory Bodies ◽  
Improve Access ◽  
Access Programs

Abstract Background The federal Right-to-Try (RTT) Act created an alternate regulatory pathway for preapproval access to investigational drugs. A few studies have examined the experiences of physicians with the Food and Drug Administration’s Expanded Access Programs, but to our knowledge, no study has yet to examine their attitudes and experiences toward RTT. Methods This study explored the views of 21 oncologists at a major cancer center with 3 main sites across the United States using semi-structured interviews and qualitative analysis. Participants were selected to have experience with Expanded Access Programs. Results Most oncologists had limited familiarity with RTT, and several reported confusion about the legislation, including whether patients have a right to investigational drugs and an obligation for companies to provide them. Although oncologists were interested in decreased regulatory burdens, 3 areas of concern were articulated: lack of safety and oversight, unclear structure and no provision for data collection, and potential heightening of patient expectations. Only 4 oncologists had experience discussing RTT, and none formally attempted to obtain the drug through this mechanism. Participants questioned the practicality of RTT legislation and suggested alternative ways to improve access. Conclusions The study provides foundational empirical data underlying challenging ambiguities by experienced oncologists familiar with off-trial use of investigational therapeutics and reaffirms the role of physicians and regulatory bodies in mitigating the risks of investigational drugs. Our findings highlight the need for medical centers to inform oncologists about RTT and other preapproval pathways so that they are able to address questions from patients interested in nontrial investigational drugs.

scholarly journals The role of research in improving responsiveness of palliative care to migrants and other underserved populations in the Netherlands: a qualitative interview study

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
M. Torensma ◽  
B. D. Onwuteaka-Philipsen ◽  
X. de Voogd ◽  
D. L. Willems ◽  
J. L. Suurmond
Keyword(s):  
Palliative Care ◽  
Healthcare Professionals ◽  
Underserved Populations ◽  
Ethnic Disparities ◽  
Migration Background ◽  
Structured Interviews ◽  
Migrant Populations ◽  
Funding Agencies ◽  
Qualitative Interview Study ◽  
Palliative Patient

Abstract Background The aging of migrant populations across Europe challenges researchers in palliative care to produce knowledge that can be used to respond to the needs of the growing group of patients with a migration background and address ethnic disparities in palliative care. The aim of this study was to identify what factors influence researchers’ efforts to address responsiveness of palliative care to patients with a migration background and other underserved populations in their projects. Methods We conducted semi-structured interviews with 11 researchers involved in seven projects under the Dutch national program for palliative care innovation. Results Researchers’ efforts to address responsiveness of palliative care in their projects were influenced by individual factors, i.e. awareness of the need for responsiveness to patients with a migration background; experience with responsiveness; and, differences in perceptions on responsiveness in palliative care. Researchers’ efforts were furthermore influenced by institutional factors, i.e. the interaction with healthcare institutions and healthcare professionals as they rely on their ability to identify the palliative patient with a migration background, address the topic of palliative care, and enrol these patients in research; scientific standards that limit the flexibility needed for responsive research; and, the responsiveness requirements set by funding agencies. Conclusion Researchers play a key role in ensuring research addresses responsiveness to patients with a migration background. Such responsiveness may also benefit other underserved populations. However, at times researchers lack the knowledge and experience needed for responsive research. To address this we recommend training in responsiveness for researchers in the field of palliative care. We also recommend training for healthcare professionals involved in research projects to increase enrolment of patients with a migration background and other underrepresented populations. Lastly, we encourage researchers as well as research institutions and funding agencies to allow flexibility in research practices and set a standard for responsive research practice.

scholarly journals “Smartphone Apps Are Cool, but Do They Help Me?”: A Qualitative Interview Study of Adolescents’ Perspectives on Using Smartphone Interventions to Manage Nonsuicidal Self-Injury

2021 ◽  
Vol 18 (6) ◽  
pp. 3289
Author(s):  
Anja Čuš ◽  
Julian Edbrooke-Childs ◽  
Susanne Ohmann ◽  
Paul L. Plener ◽  
Türkan Akkaya-Kalayci
Keyword(s):  
Mental Health ◽  
Young People ◽  
Mental Health Problems ◽  
Health Interventions ◽  
Structured Interviews ◽  
Related Factors ◽  
Self Injury ◽  
Qualitative Interview Study ◽  
Mental Health Interventions ◽  
Nonsuicidal Self Injury

Nonsuicidal self-injury (NSSI) is a major mental health problem associated with negative psychosocial outcomes and it most often starts in early adolescence. Despite this, adolescents are rarely involved in informing the development of interventions designed to address their mental health problems. This study aimed to (1) assess adolescents’ needs and preferences about future interventions that are delivered through smartphones and (2) develop a framework with implications for designing engaging digital mental health interventions. Fifteen adolescent girls, aged 12–18 years, who met diagnostic criteria for a current NSSI disorder and were in contact with mental health services, participated in semi-structured interviews. Following a reflexive thematic analysis approach, this study identified two main themes: (1) Experiences of NSSI (depicts the needs of young people related to their everyday experiences of managing NSSI) and (2) App in Context (portrays preferences of young people about smartphone interventions and reflects adolescents’ views on how technology itself can improve or hinder engaging with these interventions). Adolescent patients expressed interest in using smartphone mental health interventions if they recognize them as helpful, relevant for their life situation and easy to use. The developed framework suggests that digital mental health interventions are embedded in three contexts (i.e., person using the intervention, mental health condition, and technology-related factors) which together need to inform the development of engaging digital resources. To achieve this, the cooperation among people with lived experience, mental health experts, and human computer interaction professionals is vital.

scholarly journals How are patients with rare diseases and their carers in the UK impacted by the way care is coordinated? An exploratory qualitative interview study

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Amy Simpson ◽  
Lara Bloom ◽  
Naomi J. Fulop ◽  
Emma Hudson ◽  
Kerry Leeson-Beevers ◽  
...  
Keyword(s):  
Care Coordination ◽  
Structured Interviews ◽  
School Work ◽  
Travel Costs ◽  
Care Plans ◽  
Use Of Technology ◽  
Number Of Factors ◽  
Qualitative Interview Study ◽  
The Uk ◽  
The Impact

Abstract Background Care coordination is considered important for patients with rare conditions, yet research addressing the impact of care coordination is limited. This study aimed to explore how care coordination (or lack of) impacts on patients and carers. Semi-structured interviews were conducted with 15 patients and carers/parents in the UK, representing a range of rare conditions (including undiagnosed conditions). Transcripts were analysed thematically in an iterative process. Results Participants described a range of experiences and views in relation to care coordination. Reports of uncoordinated care emerged: appointments were uncoordinated, communication between key stakeholders was ineffective, patients and carers were required to coordinate their own care, and care was not coordinated to meet the changing needs of patients in different scenarios. As a result, participants experienced an additional burden and barriers/delays to accessing care. The impacts described by patients and carers, either attributed to or exacerbated by uncoordinated care, included: impact on physical health (including fatigue), financial impact (including loss of earnings and travel costs), and psychosocial impact (including disruption to school, work and emotional burden). Overall data highlight the importance of flexible care, which meets individual needs throughout patients’/carers’ journeys. Specifically, study participants suggested that the impacts may be addressed by: having support from a professional to coordinate care, changing the approach of clinics and appointments (where they take place, which professionals/services are available and how they are scheduled), and improving communication through the use of technology, care plans, accessible points of contact and multi-disciplinary team working. Conclusion This study provides further evidence of impacts of uncoordinated care; these may be complex and influenced by a number of factors. Approaches to coordination which improve access to care and lessen the time and burden placed on patients and carers may be particularly beneficial. Findings should influence future service developments (and the evaluation of such developments). This will be achieved, in the first instance, by informing the CONCORD Study in the UK.

scholarly journals Patient factors driving overuse of cardiac catheterisation: a qualitative study with 25 participants from two German teaching practices

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024600 ◽  
Author(s):  
Anna Herwig ◽  
Dorothea Dehnen ◽  
Birgitta Weltermann
Keyword(s):  
Teaching Practices ◽  
Qualitative Content Analysis ◽  
Stable Coronary Artery Disease ◽  
Cardiac Catheterisation ◽  
Structured Interviews ◽  
Patient Factors ◽  
Qualitative Interview Study ◽  
Patient’S Experience ◽  
Artery Disease ◽  
Physician Adherence

ObjectivesPercutaneous coronary interventions do not provide a benefit over medical therapy for stable patients. However, an overuse of cardiac catheterisation (CC) for stable coronary artery disease (CAD) is documented in Germany and other countries. In this study, we aim to understand patient factors that foster this overuse.DesignOur study is an exploratory qualitative interview study with narrative, structured interviews. The interviews were analysed using qualitative content analysis by Mayring.SettingThe interviews were conducted in two German teaching practices.Participants24 interviews with 25 patients were conducted; 17 (68%) patients were male, the average age was 73.9 years (range 53–88 years). All patients suffered from CAD and had undergone at least one CC. Patients with known anxiety disorders were excluded from the study.ResultsThe analysis identified six patient factors which contributed to or prevented the overuse of CC: (1) unquestioned acceptance of prescheduled appointments for procedures/convenience; (2) disinterest in and/or lack of disease-specific knowledge; (3) helplessness in situations with varying opinions on the required care; (4) fear of another cardiac event, (5) patient–physician relationship and (6) the patient’s experience that repeat interventions did not result in a change of health status or care.ConclusionsConducted in a country with documented overuse of CC, we showed that most patients trusted their physicians’ recommendations for repeat coronary angiographies even if they were asymptomatic. Strategies to align physician adherence with guidelines and corresponding patient information are needed to prevent overuse.

scholarly journals Complementary and Alternative Medicine versus Conventional Medicine Use in Thalassemia Patients

2021 ◽  
Vol 6 (16) ◽  
pp. 105-111
Author(s):  
Wan Ismahanisa Ismail ◽  
Mohamed Azmi Ahmad Hassali ◽  
Maryam Farooqui ◽  
Muhammad Nabil Fikri Roslan ◽  
Nazri Che Dom
Keyword(s):  
Alternative Medicine ◽  
Complementary And Alternative Medicine ◽  
Conventional Medicine ◽  
Publishing House ◽  
Medicine Use ◽  
Structured Interviews ◽  
International Publishing ◽  
Treatment Procedures ◽  
Open Access Article ◽  
Complementary And Alternative

Background: This study explores thalassemia patients' perceptions concerning the effectiveness of conventional therapies for Thalassemia healthcare. Method: The semi-structured interviews were audiotaped, transcribed verbatim, and translated into English. Results: Nearly all thalassemia patients reported to have relied on conventional treatment methods to treat and reduce the severity of their disease. Few patients reported not to comply with their treatment procedures due to fear of infection through blood transfusion, surgery and organ failure. Conclusions: In conclusion, patients showed positive views about the conventional therapies carried out for Thalassemia. Keywords:: Thalassemia; qualitative; conventional; complementary and alternative medicine eISSN: 2398-4287© 2021. The Authors. Published for AMER ABRA cE-Bs by e-International Publishing House, Ltd., UK. This is an open access article under the CC BYNC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Peer–review under responsibility of AMER (Association of Malaysian Environment-Behaviour Researchers), ABRA (Association of Behavioural Researchers on Asians/Africans/Arabians) and cE-Bs (Centre for Environment-Behaviour Studies), Faculty of Architecture, Planning & Surveying, Universiti Teknologi MARA, Malaysia. DOI: https://doi.org/10.21834/ebpj.v6i16.2665

“How I kept track of it of course was my business”: Cancer patient self-monitoring as self-stylized work

2013 ◽  
Vol 12 (5) ◽  
pp. 355-361 ◽  
Author(s):  
Carol J. Hermansen-Kobulnicky ◽  
Mary Anne Purtzer
Keyword(s):  
Cancer Patient ◽  
Cancer Patients ◽  
Cancer Center ◽  
Structured Interviews ◽  
Patient Centered ◽  
Work Lives ◽  
Self Monitoring ◽  
Centered Care ◽  
Cancer Experience ◽  
Present Opportunity

AbstractObjectives:Self-monitoring behaviors of cancer patients benefit patients, caregivers, and providers, and yet the phenomenon of self-monitoring from the cancer-patient perspective has not been studied. We examined cancer patients' self-monitoring preferences and practices, focusing on the meaning of self-monitoring within the cancer experience.Methods:Semi-structured interviews were conducted among adult cancer patients who had been seen at least once at a rural United States cancer center. Questions sought out the meaning of self-monitoring and its practical aspects. Qualitative data were analyzed by adapting the four-stepped method by Giorgi for empirical phenomenological analysis.Results:Twenty participants were interviewed (11 women and 9 men). Transcribed interviews revealed that cancer patient self-monitoring is self-stylized work that ranges from simple to complex, while being both idiosyncratic and routine. Participants reported using tools with systems for use that fit their distinctive lives for the purpose of understanding and using information they deemed to be important in their cancer care. Three conceptual categories were discerned from the data that help to elucidate this self-stylized work as fitting their individual priorities and preferences, reflecting their identities, and being born of their work lives.Significance of results:Findings highlight patients' unique self-monitoring preferences and practices, calling into question the assumption that the sole use of standardized tools are the most effective approach to engaging patients in this practice. Self-monitoring efforts can be validated when providers welcome or adapt to patients' self-stylized tools and systems. Doing so may present opportunity for improved communications and patient-centered care.

scholarly journals Fair, just and compassionate: A pilot for making allocation decisions for patients requesting experimental drugs outside of clinical trials

2018 ◽  
Vol 44 (11) ◽  
pp. 761-767 ◽  
Author(s):  
Arthur L Caplan ◽  
J Russell Teagarden ◽  
Lisa Kearns ◽  
Alison S Bateman-House ◽  
Edith Mitchell ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Healthcare Providers ◽  
Best Interests ◽  
Ethical Framework ◽  
Compassionate Use ◽  
Medical Needs ◽  
Experimental Drugs ◽  
The Status ◽  
Patient Representatives ◽  
New Treatments

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee (CompAC). Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice.

Understanding barriers and facilitators to compliance with UK social distancing guidelines during the COVID-19 pandemic: A qualitative interview study

2021 ◽  
Author(s):  
Alexandra Burton ◽  
Alison McKinlay ◽  
Joanna Dawes ◽  
Anna Roberts ◽  
Wendy Fynn ◽  
...  
Keyword(s):  
Social Support ◽  
Emotional Support ◽  
Unintended Consequences ◽  
Control Measures ◽  
Barriers And Facilitators ◽  
Structured Interviews ◽  
Social Distancing ◽  
Shared Spaces ◽  
Qualitative Interview Study ◽  
Motivation Model

ObjectivesWhen followed, there is evidence that social distancing measures play a major role in reducing the transmission of viruses such as COVID-19. However, not all individuals follow the guidance. This study aimed to explore barriers and facilitators to compliance with United Kingdom social distancing guidelines during the COVID-19 pandemic.MethodSemi-structured interviews with 116 adults. Data were analysed using reflexive thematic analysis and themes mapped to domains of the Capability, Opportunity and Motivation Model of Behaviour (COM-B).Main Outcome MeasuresWe identified 12 themes affecting compliance to UK social distancing guidelines.ResultsBarriers to compliance included inconsistent rules, caring responsibilities, fatigue, unintended consequences of control measures, and the need for emotional support. Facilitators were informational support and social responsibility. Six themes acted both as a barrier or facilitator: lived environment and shared spaces, beliefs about consequences of non-compliance, influence of others, practical social support, and trust in government. Conclusions Participants experienced a range of barriers and facilitators to compliance, often dependent on individual circumstances. Reflective motivation, psychological capability and social opportunity were important drivers for compliance. Measures that enable social support alongside strategies that help maintain motivation to comply, provide clear guidance and optimise social cohesion should be promoted.

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