Innovators' views on involving users and patients in surgical device development: a qualitative interview study.
Ontology highlight
ABSTRACT: Objectives
Involving 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.Design
A qualitative study featuring semi-structured interviews with innovators of surgical devices. Interviews were recorded and a thematic analysis was performed on verbatim transcripts.Participants
15 interviews were conducted with 19 innovators of 14 surgical devices.Setting
Innovation practices of surgical devices in the Netherlands and Belgium.Results
End-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.Conclusion
Innovators 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.
SUBMITTER: Woudstra K
PROVIDER: S-EPMC8381300 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:OBJECTIVE:The aim of this study was to explore GPs' views and experiences of managing patients with personality disorder (PD), and their views on the role of the Improving Access to Psychological Therapies (IAPT) programme as a support service. DESIGN:In-depth interviews, analysed thematically. PARTICIPANTS:Fifteen GPs (7 women and 8 men) of varying age and clinical experience, working in practices that differed in terms of the socio-demographic characteristics of their patient populations. SETTING:Twelve general practices based in the West of England, UK. RESULTS:GPs described patients with PD as being challenging to work with and that this work required dedicated time and care. They described experiencing particular difficulty with monitoring their patient's mental health, as well as having little knowledge about the efficacy or availability of treatments for their attenders with PD. They were aware that this patient population often experienced poor mental health and reported a propensity for them to fall into the gap between primary and secondary mental health services, leaving GPs with little choice but to improvise their own management plans, which occasionally involved funding third-sector treatment options. In terms of IAPT services' role in managing these patients, GPs wanted shorter waiting times, better inter-agency communication, more highly trained therapists and more treatment options for patients with PD. They also wanted the service to be able to 'hold' patients with PD in treatment over a longer period than currently offered. CONCLUSIONS:Findings suggest that, overall, GPs did not consider National Health Service mental health services to offer an effective treatment for patients with PD. While they considered the IAPT programme to be a valuable service for patients with less complex mental health needs, such as depression and anxiety; they felt that the current service provision struggled to meet the needs of patients with more complex mental health needs, as exemplified by people with PD.
| S-EPMC6398667 | biostudies-other
Project description:BackgroundPatients surviving critical illnesses, such as sepsis, often suffer from long-term complications. After discharge from hospital, most patients are treated in primary care. Little is known how general practitioners (GPs) perform critical illness aftercare and how it can be improved. Within a randomised controlled trial, an outreach training programme has been developed and applied.ObjectivesThe aim of this study is to describe GPs' views and experiences of caring for postsepsis patients and of participating a specific outreach training.DesignSemistructured qualitative interviews.Setting14 primary care practices in the metropolitan area of Berlin, Germany.Participants14 GPs who had participated in a structured sepsis aftercare programme in primary care.ResultsThemes identified in sepsis aftercare were: continuity of care and good relationship with patients, GP's experiences during their patient's critical illness and impact of persisting symptoms. An outreach education as part of the intervention was considered by the GPs to be acceptable, helpful to improve knowledge of the management of postintensive care complications and useful for sepsis aftercare in daily practice.ConclusionsGPs provide continuity of care to patients surviving sepsis. Better communication at the intensive care unit-GP interface and training in management of long-term complications of sepsis may be helpful to improve sepsis aftercare.Trial registration numberISRCTN61744782.
| S-EPMC7878160 | biostudies-literature
Project description:BackgroundGene drive technologies (GDTs) promote the rapid spread of a particular genetic element within a population of non-human organisms. Potential applications of GDTs include the control of insect vectors, invasive species and agricultural pests. Whether, and if so, under what conditions, GDTs should be deployed is hotly debated. Although broad stances in this debate have been described, the convictions that inform the moral views of the experts shaping these technologies and related policies have not been examined in depth in the academic literature.MethodsIn this qualitative study, we interviewed GDT experts (n = 33) from different disciplines to identify and better understand their moral views regarding these technologies. The pseudonymized transcripts were analyzed thematically.ResultsThe respondents' moral views were principally influenced by their attitudes towards (1) the uncertainty related to GDTs; (2) the alternatives to which they should be compared; and (3) the role humans should have in nature. Respondents agreed there is epistemic uncertainty related to GDTs, identified similar knowledge gaps, and stressed the importance of realistic expectations in discussions on GDTs. They disagreed about whether uncertainty provides a rationale to refrain from field trials ('risks of intervention' stance) or to proceed with phased testing to obtain more knowledge given the harms of the status quo ('risks of non-intervention' stance). With regards to alternatives to tackle vector-borne diseases, invasive species and agricultural pests, respondents disagreed about which alternatives should be considered (un)feasible and (in)sufficiently explored: conventional strategies ('downstream solutions' stance) or systematic changes to health care, political and agricultural systems ('upstream solutions' stance). Finally, respondents held different views on nature and whether the use of GDTs is compatible with humans' role in nature ('interference' stance) or not ('non-interference stance').ConclusionsThis interview study helps to disentangle the debate on GDTs by providing a better understanding of the moral views of GDT experts. The obtained insights provide valuable stepping-stones for a constructive debate about underlying value conflicts and call attention to topics that deserve further (normative) reflection. Further evaluation of these issues can facilitate the debate on and responsible development of GDTs.
| S-EPMC7938529 | biostudies-literature
Project description:ObjectivesLittle is known about how innovative surgical procedures are introduced and discussed with patients. This qualitative study aimed to explore perspectives on information provision and consent prior to innovative surgical procedures.DesignQualitative study involving semi-structured interviews. Interviews were audio recorded, transcribed and analysed thematically.Participants42 interviews were conducted (26 surgeons and 16 governance representatives).SettingSurgeons and governance representatives recruited from various surgical specialties and National Health Service (NHS) Trusts across England, UK.ResultsParticipants stated that if a procedure was innovative, patients should be provided with additional information extending beyond that given during routine surgical consultations. However, difficulty defining innovation had implications for whether patients were informed about novel components of surgery and how the procedure was introduced (ie, as part of a research study, trust approval or in routine clinical practice). Furthermore, data suggest surgeons found it difficult to establish what information is essential and how much detail is sufficient, and governance surrounding written and verbal information provision differed between NHS Trusts. Generally, surgeons believed patients held a view that 'new' was best and reported that managing these expectations could be difficult, particularly if patient views aligned with their own.ConclusionsThis study highlights the challenges of information provision and obtaining informed consent in the context of innovative surgery, including establishing if and how a procedure is truly innovative, determining the key information to discuss with patients, ensuring information provision is objective and balanced, and managing patient expectations and preferences. This suggests that surgeons may require support and training to discuss novel procedures with patients. Further work should capture consultations where new procedures are discussed with patients and patients' views of these information exchanges.
| S-EPMC7651722 | biostudies-literature
Project description:BackgroundMedical device certification has undergone significant changes in recent years. However, exploration of stakeholder experiences remains relatively limited, particularly in the context of software as a medical device. This study sought to explore stakeholder experiences of medical device certification across both the UK and EU.MethodsSemi-structured interviews (n = 22) analysed using inductive-thematic analysis, synthesised using activity theory.ResultsInnovators, consultants and notified bodies share more similarities than differences when discussing barriers and enablers to achieving medical device certification. Systemic tensions between existing rules, tools, community understanding and division of labour currently undermine the intended aim of certification processes. Existing rules are considered complex, with small and medium-sized enterprises considered disproportionality affected, resulting in several unintended outcomes including the perceived 'killing' of innovation. Existing certification processes are described as unfit for purpose, unethical and unsustainable.ConclusionStakeholder experiences suggest that the intention of establishing a robust and sustainable regulatory framework capable of ensuring a high level of safety whilst also supporting innovation is not yet being realised. Failure to enact desired changes may further jeopardise future innovations, outcomes and care quality.
| S-EPMC9531632 | biostudies-literature
Project description:ObjectivesTo ascertain what meaning individuals attach to perceiving images of their own interior body and how the images and their meanings affect the clinical consultation.DesignFace-to-face semistructured interviews.Participants25 adult patients in southern England who, within the preceding 12?months, had been referred for diagnostic imaging.SettingCommunity.ResultsFor patients, being shown their own X-rays, MRIs or CT images creates a variety of effects: (1) a sense of better understanding of the diagnosis; (2) validation of their sensory and emotional response to the illness or injury and (3) an alteration to the tenor and nature of the clinical encounter between patient and physician. In addition to meanings attached to these images, patients also impute meaning to the physician's decision not to share an image with them. The desire to see their image was greater in those patients with a skeletal injury; patients are less keen on viewing abdominal or other soft tissue images.ConclusionsViewing images of one's interior, invisible body is powerful and resonant in a number of ways. The experience of not seeing, whether through the patient's or the physician's choice, is also fraught with meaning.
| S-EPMC4120403 | biostudies-literature
Project description:BackgroundThe use of artificial intelligence (AI) in decision-making around knee replacement surgery is increasing, and this technology holds promise to improve the prediction of patient outcomes. Ambiguity surrounds the definition of AI, and there are mixed views on its application in clinical settings.ObjectiveIn this study, we aimed to explore the understanding and attitudes of patients who underwent knee replacement surgery regarding AI in the context of risk prediction for shared clinical decision-making.MethodsThis qualitative study involved patients who underwent knee replacement surgery at a tertiary referral center for joint replacement surgery. The participants were selected based on their age and sex. Semistructured interviews explored the participants' understanding of AI and their opinions on its use in shared clinical decision-making. Data collection and reflexive thematic analyses were conducted concurrently. Recruitment continued until thematic saturation was achieved.ResultsThematic saturation was achieved with 19 interviews and confirmed with 1 additional interview, resulting in 20 participants being interviewed (female participants: n=11, 55%; male participants: n=9, 45%; median age: 66 years). A total of 11 (55%) participants had a substantial postoperative complication. Three themes captured the participants' understanding of AI and their perceptions of its use in shared clinical decision-making. The theme Expectations captured the participants' views of themselves as individuals with the right to self-determination as they sought therapeutic solutions tailored to their circumstances, needs, and desires, including whether to use AI at all. The theme Empowerment highlighted the potential of AI to enable patients to develop realistic expectations and equip them with personalized risk information to discuss in shared decision-making conversations with the surgeon. The theme Partnership captured the importance of symbiosis between AI and clinicians because AI has varied levels of interpretability and understanding of human emotions and empathy.ConclusionsPatients who underwent knee replacement surgery in this study had varied levels of familiarity with AI and diverse conceptualizations of its definitions and capabilities. Educating patients about AI through nontechnical explanations and illustrative scenarios could help inform their decision to use it for risk prediction in the shared decision-making process with their surgeon. These findings could be used in the process of developing a questionnaire to ascertain the views of patients undergoing knee replacement surgery on the acceptability of AI in shared clinical decision-making. Future work could investigate the accuracy of this patient group's understanding of AI, beyond their familiarity with it, and how this influences their acceptance of its use. Surgeons may play a key role in finding a place for AI in the clinical setting as the uptake of this technology in health care continues to grow.
| S-EPMC10546266 | biostudies-literature
Project description:ObjectivesPatient lead users can be defined as patients or relatives who use their knowledge and experience to improve their own or a relative's care situation and/or the healthcare system, and who are active beyond what is usually expected. The objective of this study is to explore patient lead users' experiences and engagement during the early COVID-19 pandemic.DesignQualitative in-depth interviews with a cross-sectional time horizon.SettingThe early COVID-19 pandemic in Sweden, from 1 June through 14 September, 2020.ParticipantsA total of 10 patient lead users were recruited from the Swedish patient lead users (spetspatient) network. All participants were living with different long-term conditions and matched the definition of being patient lead users.ResultsWe found that during the early pandemic, patient lead users experienced that they no longer knew how to best manage their own health and care situations. On an individual level, they described an initial lack of knowledge, new routines, including a change in their health and an experience of people without a disease being in the same situation as them, for a while. On a systemic level, they described a fear of imminent unmet-care backlogs and decreased opportunities for sharing patient perspectives in care organisation, but also described increased networking.ConclusionsPatient lead users can be seen as an emerging community of practice, and as such could be a valuable resource as a complementary communication channel for an improved health system. The health systems were not able to fully acknowledge and engage with the resource of patient lead users during the pandemic.
| S-EPMC9388713 | biostudies-literature
Project description:BackgroundHope for future treatments to prevent or slow down dementia motivates researchers to strive for ever-earlier diagnoses of Alzheimer's disease (AD) based on biomarkers, even before symptoms occur. But is a biomarker-based early diagnosis desirable in clinical practice?ObjectiveThis study explores the ethical considerations that shape current clinical practice regarding early AD diagnostics and the use of biomarkers.MethodsIn this qualitative study, Dutch physicians were interviewed. Topics included physicians' views concerning early AD diagnosis in persons with no or mild cognitive impairment, physicians' considerations regarding current and expected future practices of early AD diagnosis, the use of biomarkers, and the use of the concepts preclinical and prodromal AD. We analyzed the transcripts using directed content analysis.Results15 general practitioners, neurologists, and geriatricians in the Netherlands were interviewed. Most of them interpreted an early AD diagnosis with an early diagnosis of dementia. We identified six clusters of considerations sometimes in favor but most often against pursuing an early AD diagnosis in people with no or mild cognitive impairment that influence physicians' diagnostic decision-making: preferences and characteristics of persons, test characteristics, impact on care, type of setting, disease concepts, and issues on a societal level.ConclusionThe discussion concerning an early AD diagnosis based on biomarkers which is widely held in the scientific field, has not entered clinical practice structurally. A biomarker-based early diagnosis does not fit within Dutch physicians' views on what good care for people with no, subjective, or mild cognitive impairment should entail.
| S-EPMC7902965 | biostudies-literature
Project description:COVID-19-related restrictions may have a serious impact on patients with eating disorders. We conducted semistructured interviews with female adolescent patients with anorexia nervosa (AN) (n = 13, 13-18 years) currently receiving inpatient or outpatient treatment and their parents (n = 10). We asked for their experiences during COVID-19 confinement regarding everyday life, AN symptoms, and treatment. We used thematic analysis to interpret the data. The main themes identified from the patients' interviews involved restrictions of personal freedom (i.e., leading to tension between patients and family members, reduced motivation to work on recovery), interruption of the treatment routine (emerging risks through self-monitored weight, challenges/opportunities of teletherapy), changes in AN symptoms (more exposure to triggering situations), COVID-19-related fears, and compulsions but also potential opportunities (less stress, better family relationships). The parents discussed changes in daily routines as negative (challenges in maintaining day structures) and positive (more family time, "slowing down"). They expressed reservations about reduced outpatient monitoring and increased teletherapy and discussed challenges in keeping contact with the child and clinicians during inpatient treatment. Moreover, the parents discussed deteriorations and improvements in the patients' psychopathology. Clinical implications from these in-depth insights include the importance of strengthening communication between changing staff cohorts, patients, and parents; motivational work; and joint weight monitoring with the therapist.
| S-EPMC8074137 | biostudies-literature