Algorithm Change Protocols in the Regulation of Adaptive Machine Learning–Based Medical Devices

One of the greatest strengths of artificial intelligence (AI) and machine learning (ML) approaches in health care is that their performance can be continually improved based on updates from automated learning from data. However, health care ML models are currently essentially regulated under provisions that were developed for an earlier age of slowly updated medical devices—requiring major documentation reshape and revalidation with every major update of the model generated by the ML algorithm. This creates minor problems for models that will be retrained and updated only occasionally, but major problems for models that will learn from data in real time or near real time. Regulators have announced action plans for fundamental changes in regulatory approaches. In this Viewpoint, we examine the current regulatory frameworks and developments in this domain. The status quo and recent developments are reviewed, and we argue that these innovative approaches to health care need matching innovative approaches to regulation and that these approaches will bring benefits for patients. International perspectives from the World Health Organization, and the Food and Drug Administration’s proposed approach, based around oversight of tool developers’ quality management systems and defined algorithm change protocols, offer a much-needed paradigm shift, and strive for a balanced approach to enabling rapid improvements in health care through AI innovation while simultaneously ensuring patient safety. The draft European Union (EU) regulatory framework indicates similar approaches, but no detail has yet been provided on how algorithm change protocols will be implemented in the EU. We argue that detail must be provided, and we describe how this could be done in a manner that would allow the full benefits of AI/ML-based innovation for EU patients and health care systems to be realized.

Evaluation of An Online Learning Concept For Nursing Students In Caring For Patients With Dementia: Results of A Questionnaire Survey

Background: Dementia is a major public health concern. Nurses have a key role in caring for patients with dementia and to relieve caregivers. To prepare them for adequate demand-oriented nursing care provision, there is a need for training and education. Due to the current Covid-19 pandemic, an online course with focus on a health care need assessment was developed.Methods: The Elaine Study is a quantitative study using questionnaire-based interviews. The recruitment of nursing students for the study was guided by following inclusion criteria (a) second-year nursing students participating in the module ‘caring for elderly patients’, (b) less than three missing lectures. Of all nursing students (N=127), n=48 met the inclusion criteria. Twenty-eight students participated. Quantitative data were analyzed by descriptive statistics. For analyzing possible relations between lectures evaluations aspects among each other, the Spearman correlation was used. Collected qualitative data were analyzed by the Kuckartz suggested qualitative content analysis using the software MAXQDA.Results: Nursing students judged the overall course structure as very well (M 1.36, SD 0.48). Learning aims were clear defined (M 1.61, SD 0.68), learning contents have been properly demonstrated (M 1.68, SD 0.67) and teaching methods contribute the understanding (M 1.63, SD 0.62). The exercise on the Geriatric Assessment promote the internal learning process (M 1.67, SD 1.00) and the final online simulation training made lecture contents easier to understand (M 1.86, SD 0.89). Correlation were determined among the course structure and the (1) clear definition of learning aims (rSp 0.566, p=0.002), (2) presentations and references are made available (rSp 0.514, p=0.005), (3) teaching methods contribute the understanding (rSp 0.535, p= 0.004) and (4) an increase of individual learning ability (rSp 0.573, p=0.001). Implication for improvement proposes a reduction of nursing students team members from four or five to a work in teams of two nursing students.Conclusions: The Elaine study describes the feasibility of an online learning concept for nursing students in caring for patients with dementia. To identify actual impact on patient’s health and on caregiver burden as well, further studies are needed.

The concept of justifiable healthcare and how big data can help us to achieve it

Over the last decades, the face of health care has changed dramatically, with big improvements in what is technically feasible. However, there are indicators that the current approach to evaluating evidence in health care is not holistic and hence in the long run, health care will not be sustainable. New conceptual and normative frameworks for the evaluation of health care need to be developed and investigated. The current paper presents a novel framework of justifiable health care and explores how the use of artificial intelligence and big data can contribute to achieving the goals of this framework.

Exploring the experiences of changes to support access to primary health care services and the impact on the quality and safety of care for homeless people during the COVID-19 pandemic: a study protocol for a qualitative mixed methods approach

Background Despite high level of health care need amongst people experiencing homelessness, poor access is a major concern. This is sometimes due to organisational and bureaucratic barriers, but also because they often feel stigmatised and treated badly when they do seek health care. The COVID-19 pandemic and the required social distancing measures have caused unprecedented disruption and change for the organisation of primary care, particularly for people experiencing homelessness. Against this backdrop there are many questions to address regarding whether the recent changes required to deliver services to people experiencing homelessness in the context of COVID-19 will help to address or compound problems in accessing care and inequalities in health outcomes. Methods An action led and participatory research methodology will be employed to address the study objectives. Interviews with people experiencing homelessness were will be conducted by a researcher with lived experience of homelessness. Researchers with lived experience are able to engage with vulnerable communities in an empathetic, non-judgemental way as their shared experience promotes a sense of trust and integrity, which in turn encourages participation in research and may help people speak more openly about their experience. The experiences of health professionals and stakeholders delivering and facilitating care for people experiencing homelessness during the pandemic will also be explored. Discussion It is important to explore whether recent changes to the delivery of primary care in response to the COVID-19 pandemic compromise the safety of people experiencing homelessness and exacerbate health inequalities. This could have implications for how primary healthcare is delivered to those experiencing homelessness not only for the duration of the pandemic but in the future.

The Impact of Intergenerational Engagement on Social Work Students’ Attitudes toward Aging: The Example of Clermont College

As a response to our rapidly aging society, professional training programs in health care need to offer rich applied learning experiences with older adults and educate students about ageist attitudes. Health care professionals are likely to work with older adults in a variety of settings, yet ageist attitudes continue to be a barrier to workforce development. This study evaluated the effects of an intergenerational lifelong learning initiative as a way to decrease ageist attitudes in social work students. The research hypothesis was that intergenerational engagement would help reduce ageist attitudes of social work students. Paired samples t tests were conducted with 32 students through pre- and post-surveys of the ROPE (Relating to Old People Evaluation). Results indicated a significant decrease in ageist attitudes overall, in negative ageism, and in students’ self-report of behaviors such as complimenting older adults “despite their age” and avoiding older adults. Qualitative comments indicated significant changes in perception about the aging experience and increased awareness of ageist stereotypes. Overall, this pilot study offers an encouraging model that can be applied through future partnerships to reduce ageism of students in health care–related fields.

Experiences of psychotherapists working with refugees in Germany: a qualitative study

Background Despite a high burden of mental health problems among refugees, there is limited knowledge about effective mental health care provision for this group. Although substantial efforts in understanding the complexity of cross-cultural psychotherapy – which in the context of this study we use to refer to therapy with client and therapist of different cultural backgrounds – have been made, there remains a dearth of research exploring barriers for effective cross-cultural psychotherapy. This study aimed at narrowing this gap in knowledge by exploring major challenges encountered by psychotherapists in cross-cultural psychotherapy and strategies which have proven useful in overcoming such challenges. Methods We employed a qualitative study design, conducting semi-structured in-depth interviews with 10 purposely selected psychotherapists working with refugees in Germany. Respondents were from varying theoretical background and had varying levels of experience. Data were analyzed using a thematic approach, following a mix of deductive and inductive coding. Results Respondents reported three main challenges in their cross-cultural practice: different or unrealistic expectations of clients towards what psychotherapy would offer them; challenges grounded in different illness explanatory models; and communication challenges. In dealing with these challenges, respondents recommended psychoeducation to overcome issues related to problematic expectations towards psychotherapy; “imagining the real”, identifying “counter magic” and other client-appropriate resources to deal with issues related to clients’ foreign illness attributions; and translators in dealing with communication barriers, though the latter not univocally. Conclusions Results show that psychotherapy with refugees can be very successful, at least from the psychotherapist perspective, but also poses significant challenges. Our findings underline the importance of developing, testing, and institutionalizing structured and structural approaches to training psychotherapists in cross-cultural therapy at scale, to accommodate the rising mental health care need of refugees as a client group.