scholarly journals Innovators’ views on involving users and patients in surgical device development: a qualitative interview study

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e050801
Author(s):  
Kas Woudstra ◽  
Marcia Tummers ◽  
Maroeska M Rovers ◽  
Rob Reuzel
Keyword(s):  
Patient Involvement ◽  
End Users ◽  
Strategic Choices ◽  
End User ◽  
Structured Interviews ◽  
Device Development ◽  
Surgical Devices ◽  
Qualitative Interview Study ◽  
Surgical Device ◽  
Innovation Practices

ObjectivesInvolving end-users and patients in the development of surgical devices, even when patients are not end-users, is deemed important in policy and in academia since it could improve strategic choices in research and development (R&D). Nonetheless, research into innovators’ views on end-user and patient involvement is rare. This study explores what end-users and patients are being involved by innovators during development, what methods for involvement are being used and what topics are being discussed with these end-users and patients.DesignA qualitative study featuring semi-structured interviews with innovators of surgical devices. Interviews were recorded and a thematic analysis was performed on verbatim transcripts.Participants15 interviews were conducted with 19 innovators of 14 surgical devices.SettingInnovation practices of surgical devices in the Netherlands and Belgium.ResultsEnd-users were engaged in R&D with formal methods and in unsystematic ways. These users all work in the clinical domain, for example, as surgeons or nurses. The innovators engaged users to analyse problems for which a device could be a solution, define functionalities, make design choices, analyse usability, ensure safety and improve aesthetics. Patients were rarely involved. Innovators stated that patients are not considered to be end-users, that physicians can represent patient interests and that involving patients is unethical as false expectations could be raised.ConclusionInnovators involve end-users with methods and unsystematic ways in the development of surgical devices. Despite governmental calls for patient involvement in the development of medical devices and surgical devices, innovators do not generally involve patients.

How and Why to Involve Patients in Drug Development: Perspectives From the Pharmaceutical Industry, Regulatory Authorities, and Patient Organizations

2019 ◽  
pp. 216847901986429
Author(s):  
Marianne Botoft Hansen ◽  
Lotte Stig Nørgaard ◽  
Christine Erikstrup Hallgreen
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Development ◽  
Patient Involvement ◽  
Drug Approval ◽  
Business Failure ◽  
Structured Interviews ◽  
Regulatory Authorities ◽  
Patient Organizations ◽  
Qualitative Interview Study

Background: Despite increasing interest and focus on patient-centric approaches to drug development, there might still be divergent views between key stakeholders in how to perceive patient involvement and how possibly divergent views influence the role of patients in the drug development process. The objective of this study is to explore how the perception of patient organizations, pharmaceutical companies, and regulatory agencies influence the role of patients in drug development. Method: A qualitative interview study based on 12 semi-structured interviews with representatives from the 3 stakeholders. Interviews were transcribed, and data were analyzed using a social constructivist approach in the form of systematic text condensation. Results: Three main perceptions of patient involvement were identified: “a way to improve quality of life,” “a way to avoid business failure,” and “a way to foster a faster drug approval process.” Transparency, trust, and clarification of expectations and roles were factors perceived as prerequisites for a valuable collaboration. Furthermore, a required cultural mindset change in the pharmaceutical industry, the lack of a common framework, patient organizations having limited resources available, and concerns about what to do with patient responsibility were perceived as the most important barriers for patient involvement. Conclusion: Based on the findings, the pharmaceutical industry, patient organizations, and regulatory authorities were labeled as “pioneer/dominant,” “unaware/quiet,” and “hesitant,” respectively. The 3 behavioural descriptors reflect a limited negotiation of the role patients have in drug development. Thus, the pharmaceutical industry appears to be the largest influencer with regard to patients’ role in drug development.

scholarly journals The Implementation of Welfare Technology in Municipal Care: A Qualitative Study of Procurement Practices in Sweden

2021 ◽  
Author(s):  
Sanna Kuoppamäki
Keyword(s):  
Ethical Issues ◽  
End Users ◽  
Political Strategy ◽  
Structured Interviews ◽  
Procurement Process ◽  
Ethical Competence ◽  
Care Services ◽  
Qualitative Interview Study ◽  
Welfare Technology ◽  
The Impact

Abstract Background: Welfare technology has been launched as a concept to accelerate digital transformation in care services, but the implementation of these technologies is still hindered by organisational resistance, lack of infrastructure, and juridical and ethical issues. This paper investigates the decision-making among municipal actors in the implementation of welfare technology in a specific task that is procurement. The study explores the perceptions and negotiations in purchasing welfare technology in each stage of the procurement model revealing the impact of technical, economic, juridical and ethical competence on the mapping and planning, procurement, implementation and management of welfare technology. Methods: The study presents empirical findings from a qualitative interview study for municipal actors in Sweden. Semi-structured interviews were gathered among procurement managers, IT managers, and managers in social administrators in three different municipalities in 2020 (N=8). Inductive content analysis and systematic categorisation were employed resulting to 17 sub-categories, 9 generic categories and 3 main categories of procurement practices. Results: Challenges in the procurement practices occur in all stages of the procurement model. In mapping and planning, municipal actors outline barriers the need analysis, requirement specification and market analysis. In procurement stage, economic resources, standardisation and interoperability hinder the procurement process. Implementation and management is complicated by supplier assessment, legislation, cross-organisational collaboration and political strategy. Building on these findings, the study defines the procurement competence to consist of technical, economic, juridical and ethical expertise to assess and evaluate welfare technology. Technical and ethical competence is needed in early stages of the procurement, whereas juridical and economic competence relates to later stages of the model.Conclusions: Procurement competence is associated with the implementation of welfare technology in 1) assessment of the end-users needs, 2) estimation of the costs and benefits of welfare technology, and 3) management of the juridical and legislation issues in data management. Economic and juridical decisions to purchase welfare technology are not value-neutral, but rather associated with socially shared understandings of technological possibilities in care provision. Optimisation of procurement process requires a combination of capabilities to implement welfare technology that meet the demands and needs of end-users.

scholarly journals Exploring clinicians’ experiences and perceptions of end-user roles in knowledge development: a qualitative study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leslie Verville ◽  
Carol Cancelliere ◽  
Gaelan Connell ◽  
Joyce Lee ◽  
Sarah Munce ◽  
...  
Keyword(s):  
Qualitative Study ◽  
User Involvement ◽  
Phenomenological Approach ◽  
End Users ◽  
Knowledge Development ◽  
Future Research ◽  
Evidence Based ◽  
Thematic Maps ◽  
End User ◽  
Structured Interviews

Abstract Background End-user involvement in developing evidence-based tools for clinical practice may result in increased uptake and improved patient outcomes. Understanding end-user experiences and perceptions about the co-production of knowledge is useful to further the science of integrated knowledge translation (iKT) – a strategy for accelerating the uptake and impact of research. Our study had two main objectives: (1) explore end-user (clinician) experiences of co-producing an evidence-based practice tool; and (2) describe end-user perceptions in knowledge development. Methods We used a qualitative study design. We conducted semi-structured interviews with clinicians and used a transcendental phenomenological approach to analyze themes/phenomena. In addition, we explored the interrelated themes between the thematic maps of each objective. Results Four themes emerged from clinicians’ experiences in co-producing the practice tool: ease/convenience of participating, need for support and encouragement, understanding the value of participating, and individual skillsets yield meaningful contributions. Stakeholder roles in knowledge tool development and improving dissemination of evidence and knowledge tools were themes that related to clinician perceptions in knowledge development. The review of interrelated thematic maps depicts an intertwined relationship between stakeholders and dissemination. Conclusions End-users provide invaluable insight and perspective into the development of evidence-based clinical tools. Exploring the experiences and perceptions of end-users may support future research endeavours involving iKT, such as the co-production of clinical resources, potentially improving uptake and patient health outcomes.

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 The impact of end-userś participation (cancer patients) during the optimization process

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
S Houwaart
Keyword(s):  
End Users ◽  
Public Health Care ◽  
Optimization Process ◽  
Patient Organization ◽  
End User ◽  
The Public ◽  
Patient Organizations ◽  
Crucial Information ◽  
The Individual ◽  
The Impact

Abstract End-user (e.g. patients or the public) testing of information material is becoming more common in the German public health care system. However, including the end-user (in this case patients) in an optimisation process and thus enabling a close collaboration while developing PIMs is still rare. This is surprising, given the fact that patients provide the exact perspective one is trying to address. Within the isPO project, a patient organization is included as a legal project partner to act as the patient representative and provide the patient's perspective. As such, the patient organization was included in the PHR approach as part of the PIM-optimisation team. During the optimisation process, the patients gave practical insights into the procedures of diagnosing and treating different types of cancer as well as into the patient's changing priorities and challenges at different time points. This was crucial information for the envisioned application of the individual PIMs and their hierarchical overview. Moreover, the developed PIM-checklist enabled the patients to give detailed feedback to the PIMs. With their experience of being in the exact situation in which the PIMs will be applied, their recommendations, especially on the wording and layout of the materials, have been a valuable contribution to the PIM optimisation process. In this part of the seminar, we will take a closer look at the following skill building aspects: What is gained from including patients as end-users in the development and optimization of PIM?How can we reach patients to contribute to a PIM optimization process? Which requirements and prerequisites do patients have to provide to successfully work on an optimisation team?How to compromise and weigh opinions when different ideas occur? Altogether, this part will construct a structured path of productive patient involvement and help to overcome uncertainties regarding a collaboration with patient organizations.

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 Leadership assumptions on implementation of patient involvement methods

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kathrine Håland Jeppesen ◽  
Kirsten Frederiksen ◽  
Marianne Johansson Joergensen ◽  
Kirsten Beedholm
Keyword(s):  
Health Care ◽  
Organizational Learning ◽  
Health Care Professionals ◽  
Large Scale ◽  
Patient Involvement ◽  
Hospital Setting ◽  
Implementation Process ◽  
University Hospital ◽  
Structured Interviews ◽  
Implementation Processes

Abstract Background From 2014 to 17, a large-scale project, ‘The User-involving Hospital’, was implemented at a Danish university hospital. Research highlights leadership as crucial for the outcome of change processes in general and for implementation processes in particular. According to the theory on organizational learning by Agyris and Schön, successful change requires organizational learning. Argyris and Schön consider that the assumptions of involved participants play an important role in organizational learning and processes. The purpose was to explore leaders’ assumptions concerning implementation of patient involvement methods in a hospital setting. Methods Qualitative explorative interview study with the six top leaders in the implementation project. The semi-structured interviews were conducted and analyzed in accordance with Kvale and Brinkmanns’ seven stages of interview research. Result The main leadership assumptions on what is needed in the implementation process are in line with the perceived elements in organizational learning according to the theory of Argyris and Schön. Hence, they argued that implementation of patient involvement requires a culture change among health care professionals. Two aspects on how to obtain success in the implementation process were identified based on leadership assumptions: “The health care professionals’ roles in the implementation process” and “The leaders’ own roles in the implementation process”. Conclusion The top leaders considered implementation of patient involvement a change process that necessitates a change in culture with health care professionals as crucial actors. Furthermore, the top leaders considered themselves important facilitators of this implementation process.

scholarly journals Modelling End-User Behavior and Behavioral Change in Smart Grids. An Application of the Model of Frame Selection

Energies ◽  
2020 ◽  
Vol 13 (24) ◽  
pp. 6674
Author(s):  
Sebastian Hoffmann ◽  
Fabian Adelt ◽  
Johannes Weyer
Keyword(s):  
Smart Grids ◽  
Online Survey ◽  
End Users ◽  
Influential Factors ◽  
System Stability ◽  
End User ◽  
Frame Selection ◽  
Model Of Frame Selection ◽  
Modes Of Governance ◽  
Strong Control

This paper presents an agent-based model (ABM) for residential end-users, which is part of a larger, interdisciplinary co-simulation framework that helps to investigate the performance of future power distribution grids (i.e., smart grid scenarios). Different modes of governance (strong, soft and self-organization) as well as end-users’ heterogeneous behavior represent key influential factors. Feedback was implemented as a measure to foster grid-beneficial behavior, which encompasses a range of monetary and non-monetary incentives (e.g., via social comparison). The model of frame selection (MFS) serves as theoretical background for modelling end-users’ decision-making. Additionally, we conducted an online survey to ground the end-user sub-model on empirical data. Despite these empirical and theoretical foundations, the model presented should be viewed as a conceptual framework, which requires further data collection. Using an example scenario, representing a lowly populated residential area (167 households) with a high share of photovoltaic systems (30%), different modes of governance were compared with regard to their suitability for improving system stability (measured in cumulated load). Both soft and strong control were able to decrease overall fluctuations as well as the mean cumulated load (by approx. 10%, based on weekly observation). However, we argue that soft control could be sufficient and more societally desirable.

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.

SECURITY IN CLOUD COMPUTING IN INDIAN GOVERNMENT

2021 ◽  
Vol 12 (3) ◽  
Author(s):  
Nitin Vishnu Choudhari ◽  
Dr. Ashish B Sasankar
Keyword(s):  
Cloud Computing ◽  
Service Delivery ◽  
Service Providers ◽  
Cloud Service ◽  
Cloud Security ◽  
End Users ◽  
Security Architecture ◽  
Security Measures ◽  
End User ◽  
Cloud Service Providers

Abstract –Today Security issue is the topmost problem in the cloud computing environment. It leads to serious discomfort to the Governance and end-users. Numerous security solutions and policies are available however practically ineffective in use. Most of the security solutions are centered towards cloud technology and cloud service providers only and no consideration has been given to the Network, accessing, and device securities at the end-user level. The discomfort at the end-user level was left untreated. The security of the various public, private networks, variety of devices used by end-users, accessibility, and capacity of end-users is left untreated. This leads towards the strong need for the possible modification of the security architecture for data security at all levels and secured service delivery. This leads towards the strong need for the possible adaption of modified security measures and provisions, which shall provide secured hosting and service delivery at all levels and reduce the security gap between the cloud service providers and end-users. This paper investigates the study and analyze the security architecture in the Cloud environment of Govt. of India and suggest the modifications in the security architecture as per the changing scenario and to fulfill the future needs for the secured service delivery from central up to the end-user level. Keywords: Cloud Security, Security in GI Cloud, Cloud Security measures, Security Assessment in GI Cloud, Proposed Security for GI cloud

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