A compound analysis of medical device clinical trials registered in Africa on clinicaltrials.gov.

BACKGROUND: Africa, specifically the Sub-Saharan region, has had numerous medical technology clinical trials to address the various healthcare challenges around infectious diseases, non-communicable diseases, and nutritional disorders it is facing. Medical device clinical trials provide performance data in terms of safety, efficacy, and efficiency, which is a requirement before commercialization. Key players such as academicians, governments, international organizations, and funders collaborate to drive these trials, but their growth in Africa remains slower compared to other parts of the globe. This paper aims to evaluate the number of medical device clinical trials conducted in different African countries that are registered on the clinicaltrials.gov website. METHODS: Data on medical device clinical trials was mined from clinicaltrials.gov website accessed on 22nd September, 2022. The data extracted was analyzed and cleaned in Microsoft Excel and R. Countries were grouped into regions and descriptive statistical analyses for each region were done. Additionally, frequency distributions were also generated and no inferential statistical tests were performed, as the primary focus of this analysis was to describe the distribution of medical conditions across regions. RESULTS: Thirty-one African countries had registered medical device clinical trials on the website with the majority taking place in Egypt and South Africa. Medical device trials for heart related issues took longer to complete compared to other conditions. Malaria, HIV, and male circumcision related device trials were mainly conducted in Eastern and Southern Africa while trials related to dental, fertility, and obesity were concentrated in Northern Africa. Female reproductive health issues were studied equally across all regions. Some African countries did not have any trials registered on clinicaltrials.gov website. CONCLUSION: Findings from this study clearly show the disparity in the number, status, and duration of medical device clinical trials across various African countries.

A longitudinal multi-modal dataset for dementia monitoring and diagnosis.

Dementia affects cognitive functions of adults, including memory, language, and behaviour. Standard diagnostic biomarkers such as MRI are costly, whilst neuropsychological tests suffer from sensitivity issues in detecting dementia onset. The analysis of speech and language has emerged as a promising and non-intrusive technology to diagnose and monitor dementia. Currently, most work in this direction ignores the multi-modal nature of human communication and interactive aspects of everyday conversational interaction. Moreover, most studies ignore changes in cognitive status over time due to the lack of consistent longitudinal data. Here we introduce a novel fine-grained longitudinal multi-modal corpus collected in a natural setting from healthy controls and people with dementia over two phases, each spanning 28 sessions. The corpus consists of spoken conversations, a subset of which are transcribed, as well as typed and written thoughts and associated extra-linguistic information such as pen strokes and keystrokes. We present the data collection process and describe the corpus in detail. Furthermore, we establish baselines for capturing longitudinal changes in language across different modalities for two cohorts, healthy controls and people with dementia, outlining future research directions enabled by the corpus.

The experience sampling methodology as a digital clinical tool for more person-centered mental health care: an implementation research agenda.

This position paper by the international IMMERSE consortium reviews the evidence of a digital mental health solution based on Experience Sampling Methodology (ESM) for advancing person-centered mental health care and outlines a research agenda for implementing innovative digital mental health tools into routine clinical practice. ESM is a structured diary technique recording real-time self-report data about the current mental state using a mobile application. We will review how ESM may contribute to (1) service user engagement and empowerment, (2) self-management and recovery, (3) goal direction in clinical assessment and management of care, and (4) shared decision-making. However, despite the evidence demonstrating the value of ESM-based approaches in enhancing person-centered mental health care, it is hardly integrated into clinical practice. Therefore, we propose a global research agenda for implementing ESM in routine mental health care addressing six key challenges: (1) the motivation and ability of service users to adhere to the ESM monitoring, reporting and feedback, (2) the motivation and competence of clinicians in routine healthcare delivery settings to integrate ESM in the workflow, (3) the technical requirements and (4) governance requirements for integrating these data in the clinical workflow, (5) the financial and competence related resources related to IT-infrastructure and clinician time, and (6) implementation studies that build the evidence-base. While focused on ESM, the research agenda holds broader implications for implementing digital innovations in mental health. This paper calls for a shift in focus from developing new digital interventions to overcoming implementation barriers, essential for achieving a true transformation toward person-centered care in mental health.

Loop diuretic therapy with or without heart failure: impact on prognosis.

BACKGROUND AND AIMS: Many patients are prescribed loop diuretics without a diagnostic record of heart failure. Little is known about their characteristics and prognosis. METHODS: Glasgow regional health records (2009-16) were obtained for adults with cardiovascular disease or taking loop diuretics. Outcomes were investigated using Cox models with hazard ratios adjusted for age, sex, socioeconomic deprivation, and comorbid disease (adjHR). RESULTS: Of 198 898 patients (median age 65 years; 55% women), 161 935 (81%) neither took loop diuretics nor had a diagnostic record of heart failure (reference group), 23 963 (12%) were taking loop diuretics but had no heart failure recorded, 7844 (4%) had heart failure recorded and took loop diuretics, and 5156 (3%) had heart failure recorded but were not receiving loop diuretics. Compared to the reference group, five-year mortality was only slightly higher for heart failure in the absence of loop diuretics [22%; adjHR 1.2 (95% CI 1.1-1.3)], substantially higher for those taking loop diuretics with no record of heart failure [40%; adjHR 1.8 (95% CI 1.7-1.8)], and highest for heart failure treated with loop diuretics [52%; adjHR 2.2 (95% CI 2.0-2.2)]. CONCLUSIONS: For patients with cardiovascular disease, many are prescribed loop diuretics without a recorded diagnosis of heart failure. Mortality is more strongly associated with loop diuretic use than with a record of heart failure. The diagnosis of heart failure may be often missed, or loop diuretic use is associated with other conditions with a prognosis similar to heart failure, or inappropriate loop diuretic use increases mortality; all might be true.

Strategies, processes, outcomes, and costs of implementing experience sampling-based monitoring in routine mental health care in four European countries: study protocol for the IMMERSE effectiveness-implementation study.

BACKGROUND: Recent years have seen a growing interest in the use of digital tools for delivering person-centred mental health care. Experience Sampling Methodology (ESM), a structured diary technique for capturing moment-to-moment variation in experience and behaviour in service users' daily life, reflects a particularly promising avenue for implementing a person-centred approach. While there is evidence on the effectiveness of ESM-based monitoring, uptake in routine mental health care remains limited. The overarching aim of this hybrid effectiveness-implementation study is to investigate, in detail, reach, effectiveness, adoption, implementation, and maintenance as well as contextual factors, processes, and costs of implementing ESM-based monitoring, reporting, and feedback into routine mental health care in four European countries (i.e., Belgium, Germany, Scotland, Slovakia). METHODS: In this hybrid effectiveness-implementation study, a parallel-group, assessor-blind, multi-centre cluster randomized controlled trial (cRCT) will be conducted, combined with a process and economic evaluation. In the cRCT, 24 clinical units (as the cluster and unit of randomization) at eight sites in four European countries will be randomly allocated using an unbalanced 2:1 ratio to one of two conditions: (a) the experimental condition, in which participants receive a Digital Mobile Mental Health intervention (DMMH) and other implementation strategies in addition to treatment as usual (TAU) or (b) the control condition, in which service users are provided with TAU. Outcome data in service users and clinicians will be collected at four time points: at baseline (t0), 2-month post-baseline (t1), 6-month post-baseline (t2), and 12-month post-baseline (t3). The primary outcome will be patient-reported service engagement assessed with the service attachment questionnaire at 2-month post-baseline. The process and economic evaluation will provide in-depth insights into in-vivo context-mechanism-outcome configurations and economic costs of the DMMH and other implementation strategies in routine care, respectively. DISCUSSION: If this trial provides evidence on reach, effectiveness, adoption, implementation and maintenance of implementing ESM-based monitoring, reporting, and feedback, it will form the basis for establishing its public health impact and has significant potential to bridge the research-to-practice gap and contribute to swifter ecological translation of digital innovations to real-world delivery in routine mental health care. TRIAL REGISTRATION: ISRCTN15109760 (ISRCTN registry, date: 03/08/2022).

Semantic verbal fluency in native speakers of Turkish: a systematic review of category use, scoring metrics and normative data in healthy individuals.

INTRODUCTION: Semantic verbal fluency (SVF) is a widely used measure of frontal executive function and access to semantic memory. SVF scoring metrics include the number of unique words generated, perseverations, intrusions, semantic cluster size and switching between clusters, and scores vary depending on the language the test is administered in. In this paper, we review the existing normative data for Turkish, the main metrics used for scoring SVF data in Turkish, and the most frequently used categories. METHOD: We conducted a systematic review of peer-reviewed papers using Medline, EMBASE, PsycInfo, Web of Science, and two Turkish databases, TR-Dizin and Yok-Tez. Included papers contained data on the SVF performance of healthy adult native speakers of Turkish, and reported the categories used. Versions of the SVF that required participants to alternate categories were excluded. We extracted and tabulated demographics, descriptions of groups, metrics used, categories used, and sources of normative data. Studies were assessed for level of detail in reporting findings. RESULTS: 1400 studies were retrieved. After deduplication, abstract, full text screening, and merging of theses with their published versions, 121 studies were included. 114 studies used the semantic category "animal", followed by first names (N = 14, 12%). All studies reported word count. More complex measures were rare (perseverations: N = 12, 10%, clustering and switching: N = 5, 4%). Four of seven normative studies reported only word count, two also measured perseverations, and one reported category violations and perseverations. Two normative studies were published in English. CONCLUSIONS: There is a lack of normative Turkish SVF data with more complex metrics, such as clustering and switching, and a lack of normative data published in English. Given the size of the Turkish diaspora, normative SVF data should include monolingual and bilingual speakers. Limitations include a restriction to key English and Turkish databases.

Translating medical device innovations to market - a Ugandan perspective.

There is a disparity between low and middle-income countries (LMICs) and high-income countries (HICs) in translating medical device innovations to the market, affecting health care service delivery. Whereas medical technologies developed in HICs face substantial challenges in getting to the bedside, there are at least clear pathways in most of the major markets, such as the UK, the EU, and the USA. Much less is known about the challenges that innovators of medical technologies face in LMICs. The aim of this study was to map out current bottlenecks in medical device innovation in Uganda, a LMIC in Sub-Saharan East Africa.A cross-sectional survey was carried out using a digital questionnaire. Twenty-one individuals completed the questionnaire, with the majority being medical device innovators (n = 12). Only one of these had undertaken all the innovation stages, up to clinical validation. Very few innovators had established companies, and/or acquired intellectual property. It is evident from similar studies that challenges in medical device translations are multidimensional, and hence interdisciplinary collaborations are key to accelerating translation processes, especially for LMICs.

Improving mental ill-health with psycho-social group interventions in South Asia-A scoping review using a realist lens.

This scoping review aimed to synthesise current evidence related to psycho-social groups as part of community-based mental health interventions in South Asia. We used a realist lens to pay attention to the contexts and mechanisms supporting positive outcomes. We included studies published from January 2007 to February 2022 that: were based in communities in South Asia, included a group component, reported on interventions with a clear psychosocial component, targeted adults and were implemented by lay community health workers. Two reviewers extracted data on intervention components, groups and facilitators, participant demographics and enabling contexts, mechanisms and outcomes. Expert reference panels including people with lived experience of psycho-social disability, mental health professionals and policy makers confirmed the validity and relevance of initial review findings. The review examined 15 interventions represented by 42 papers. Only four interventions were solely psycho-social and nearly all included psychoeducation and economic support. Only 8 of the 46 quantitative outcome measures used were developed in South Asia. In a context of social exclusion and limited autonomy for people with psychosocial disability, psychosocial support groups triggered five key mechanisms. Trusted relationships undergirded all mechanisms, and provided a sense of inclusion, social support and of being able to manage mental distress due to improved skills and knowledge. Over time group members felt a sense of belonging and collective strength meaning they were better able to advocate for their own well-being and address upstream social health determinants. This led to outcomes of improved mental health and social participation across the realms of intrapersonal, interpersonal and community. Psychosocial groups merit greater attention as an active ingredient in community interventions and also as an effective, relevant, acceptable and scalable platform that can promote and increase mental health in communities, through facilitation by lay community health workers.

Acid-base homeostasis orchestrated by NHE1 defines the pancreatic stellate cell phenotype in pancreatic cancer.

Pancreatic ductal adenocarcinoma (PDAC) progresses in an organ with a unique pH landscape, where the stroma acidifies after each meal. We hypothesized that disrupting this pH landscape during PDAC progression triggers pancreatic stellate cells (PSCs) and cancer-associated fibroblasts (CAFs) to induce PDAC fibrosis. We revealed that alkaline environmental pH was sufficient to induce PSC differentiation to a myofibroblastic phenotype. We then mechanistically dissected this finding, focusing on the involvement of the Na+/H+ exchanger NHE1. Perturbing cellular pH homeostasis by inhibiting NHE1 with cariporide partially altered the myofibroblastic PSC phenotype. To show the relevance of this finding in vivo, we targeted NHE1 in murine PDAC (KPfC). Indeed, tumor fibrosis decreased when mice received the NHE1-inhibitor cariporide in addition to gemcitabine treatment. Moreover, the tumor immune infiltrate shifted from granulocyte rich to more lymphocytic. Taken together, our study provides mechanistic evidence on how the pancreatic pH landscape shapes pancreatic cancer through tuning PSC differentiation.

Smokers' user experience of smoking cessation apps: A systematic review.

OBJECTIVES: To explore how smokers view common functions and characteristics of smoking cessation apps. DESIGN: Systematic review. SEARCH SOURCES: CINAHL PLUS, MEDLINE, PsycINFO, EMBASE, IEEE Xplore, ACM Digital Library, and Google Scholar. REVIEW METHODS: Seven digital databases were searched separately using relevant search terms. Search results were uploaded to Covidence. Inclusion and exclusion criteria were identified with the expert team in advance. Titles, abstracts, and full texts were screened by two reviewers independently. Any disagreements were discussed in research meetings. Pertinent data were extracted and analysed using qualitative content analysis. Findings were presented in a narrative approach. RESULTS: 28 studies were included in this review. The overarching themes were app functionality and app characteristics. Under app "functionality", six subthemes emerged: 1) education; 2) tracking; 3) social support; 4) compensation; 5) distraction, and 6) reminding. Under "app characteristics", five subthemes emerged: 1) simplification, 2) personalisation, 3) diverse content forms, 4) interactivity, and 5) privacy and security. CONCLUSION: Understanding user needs and expectations is crucial for developing a programme theory for smoking cessation app interventions. Relevant needs identified in this review should be linked to broader theories of smoking cessation and app-based intervention.

Factors affecting public access defibrillator placement decisions in the United Kingdom: A survey study.

Aim: This study aimed to understand current community PAD placement strategies and identify factors which influence PAD placement decision-making in the United Kingdom (UK). Methods: Individuals, groups and organisations involved in PAD placement in the UK were invited to participate in an online survey collecting demographic information, facilitators and barriers to community PAD placement and information used to decide where a PAD is installed in their experiences. Survey responses were analysed through descriptive statistical analysis and thematic analysis. Results: There were 106 included responses. Distance from another PAD (66%) and availability of a power source (63%) were most frequently used when respondents are deciding where best to install a PAD and historical occurrence of cardiac arrest (29%) was used the least. Three main themes were identified influencing PAD placement: (i) the relationship between the community and PADs emphasising community engagement to create buy-in; (ii) practical barriers and facilitators to PAD placement including securing consent, powering the cabinet, accessibility, security, funding, and guardianship; and (iii) 'risk assessment' methods to estimate the need for PADs including areas of high footfall, population density and type, areas experiencing health inequalities, areas with delayed ambulance response and current PAD provision. Conclusion: Decision-makers want to install PADs in locations that maximise impact and benefit to the community, but this can be constrained by numerous social and infrastructural factors. The best location to install a PAD depends on local context; work is required to determine how to overcome barriers to optimal community PAD placement.

Learning with friends and strangers: partner familiarity does not improve collaborative learning performance in younger and older adults.

Collaborative learning with a familiar partner can reduce age-related differences in learning and memory compared to learning alone. This study compares younger and older adults' learning with familiar and unfamiliar partners to determine whether familiarity is beneficial for collaborative learning. Twenty-four younger adults aged 18-28 years and 24 older adults aged 60-80 years participated in familiar and unfamiliar pairs. Participants were asked to arrange abstract tangram shapes in a specific order on a grid over multiple trials; the directors' tangram cards were arranged in a specific order on the grid and this order was communicated to the matcher. Older adults initially took longer to complete the task, using more words to correctly arrange the tangrams. Over multiple trials, a learning effect was observed in both groups, although older adults did not perform with similar efficiency to younger adults. Familiarity had no effect on performance. These findings suggest that the familiarity of a partner does not affect learning outcomes in younger or older adults when learning in a social context. Collaborative learning may be beneficial for older adults, even if they do not know their learning partner, which may have implications for adult education and lifelong learning.

The miscarriage circle of care: towards leveraging online spaces for social support.

BACKGROUND: Lack of social support during and after miscarriage can greatly affect mental wellbeing. With miscarriages being a common experience, there remains a discrepancy in the social support received after a pregnancy is lost. METHOD: 42 people who had experienced at least one miscarriage took part in an Asynchronous Remote Community (ARC) study. The study involved 16 activities (discussions, creative tasks, and surveys) in two closed, secret Facebook groups over eight weeks. Descriptive statistics were used to analyse quantitative data, and content analysis was used for qualitative data. RESULTS: There were two main miscarriage care networks, formal (health care providers) and informal (friends, family, work colleagues). The formal care network was the most trusted informational support source, while the informal care network was the main source of tangible support. However, often, participants' care networks were unable to provide sufficient informational, emotional, esteem, and network support. Peers who also had experienced miscarriage played a crucial role in addressing these gaps in social support. Technology use varied greatly, with smartphone use as the only common denominator. While there was a range of online support sources, participants tended to focus on only a few, and there was no single common preferred source. DISCUSSION: We propose a Miscarriage Circle of Care Model (MCCM), with peer advisors playing a central role in improving communication channels and social support provision. We show how the MCCM can be used to identify gaps in service provision and opportunities where technology can be leveraged to fill those gaps.

Systems and processes for regulation of investigational medical devices in Uganda.

Background: In many parts of the world, medical devices and the processes of their development are tightly regulated. However, the current regulatory landscape in Uganda like other developing countries is weak and poorly defined, which creates significant barriers to innovation, clinical evaluation, and translation of medical devices. Aim: To evaluate current knowledge, systems and infrastructure for medical devices regulation and innovation in Uganda. Methods: A mixed methods study design using the methods triangulation strategy was employed in this study. Data of equal weight were collected sequentially. First, a digital structured questionnaire was sent out to innovators to establish individual knowledge and experience with medical device innovation and regulation. Then, a single focus group discussion involving both medical device innovators and regulators to collect data about the current regulatory practices for medical devices in Uganda. Univariate and bivariate analysis was done for the quantitative data to summarize results in graphs and tables. Qualitative data was analyzed using thematic analysis. Ethical review and approval were obtained from the Makerere University School of Biomedical Sciences, Research and Ethics Committee, and the Uganda National Council for Science and Technology. Results: A total of 47 innovators responded to the questionnaire. 14 respondents were excluded since they were not medical device innovators. Majority (76%) of individuals had been innovators for more than a year, held a bachelor's degree with a background in Engineering and applied sciences, and worked in an academic research institute. 22 of the 33 medical device innovators had stopped working on their innovations and had stalled at the proof-of-concept stage. Insufficient funding, inadequate technical expertise and confusing regulatory landscape were major challenges to innovation. The two themes that emerged from the discussion were "developing standards for medical devices regulation" and "implementation of regulations in practical processes". Legal limitations, lengthy processes, and low demand were identified as challenges to developing medical device regulations. Conclusions: Efforts have been taken by government to create a pathway for medical device innovations to be translated to the market. More work needs to be done to coordinate efforts among stakeholders to build effective medical device regulations in Uganda.

The Effect of User Psychology on the Content of Social Media Posts: Originality and Transitions Matter.

Multiple studies suggest that frequencies of affective words in social media text are associated with the user's personality and mental health. In this study, we re-examine these associations by looking at the transition patterns of affect. We analyzed the content originality and affect polarity of 4,086 posts from 70 adult Facebook users contributed over 2 months. We studied posting behavior, including silent periods when the user does not post any content. Our results show that more extroverted participants tend to post positive content continuously and that more agreeable participants tend to avoid posting negative content. We also observe that participants with stronger depression symptoms posted more non-original content. We recommend that transitions of affect pattern derived from social media text and content originality should be considered in further studies on mental health, personality, and social media.

Automatic Scoring of Semantic Fluency.

In neuropsychological assessment, semantic fluency is a widely accepted measure of executive function and access to semantic memory. While fluency scores are typically reported as the number of unique words produced, several alternative manual scoring methods have been proposed that provide additional insights into performance, such as clusters of semantically related items. Many automatic scoring methods yield metrics that are difficult to relate to the theories behind manual scoring methods, and most require manually-curated linguistic ontologies or large corpus infrastructure. In this paper, we propose a novel automatic scoring method based on Wikipedia, Backlink-VSM, which is easily adaptable to any of the 61 languages with more than 100k Wikipedia entries, can account for cultural differences in semantic relatedness, and covers a wide range of item categories. Our Backlink-VSM method combines relational knowledge as represented by links between Wikipedia entries (Backlink model) with a semantic proximity metric derived from distributional representations (vector space model; VSM). Backlink-VSM yields measures that approximate manual clustering and switching analyses, providing a straightforward link to the substantial literature that uses these metrics. We illustrate our approach with examples from two languages (English and Korean), and two commonly used categories of items (animals and fruits). For both Korean and English, we show that the measures generated by our automatic scoring procedure correlate well with manual annotations. We also successfully replicate findings that older adults produce significantly fewer switches compared to younger adults. Furthermore, our automatic scoring procedure outperforms the manual scoring method and a WordNet-based model in separating younger and older participants measured by binary classification accuracy for both English and Korean datasets. Our method also generalizes to a different category (fruit), demonstrating its adaptability.

Five key strategic priorities of integrating patient generated health data into United Kingdom electronic health records.

The integration of patient/person generated health data into clinical applications is a key strategic priority internationally. However, despite agreement on the overall direction of travel, there are still a range of challenges that inhibit progress in this area. These include technology-related factors (such as interoperability), use-related factors (such as data overload) and characteristics of the strategic environment (such as existing standards). Building on important policy deliberations from the United States that aim to navigate these challenges, we here apply emerging policy frameworks to the United Kingdom and outline five key priority areas that are intended to help policy makers make important strategic decisions in attempting to integrate patient/person generated data into electronic health records.

Fully Automatic Speech-Based Analysis of the Semantic Verbal Fluency Task.

BACKGROUND: Semantic verbal fluency (SVF) tests are routinely used in screening for mild cognitive impairment (MCI). In this task, participants name as many items as possible of a semantic category under a time constraint. Clinicians measure task performance manually by summing the number of correct words and errors. More fine-grained variables add valuable information to clinical assessment, but are time-consuming. Therefore, the aim of this study is to investigate whether automatic analysis of the SVF could provide these as accurate as manual and thus, support qualitative screening of neurocognitive impairment. METHODS: SVF data were collected from 95 older people with MCI (n = 47), Alzheimer's or related dementias (ADRD; n = 24), and healthy controls (HC; n = 24). All data were annotated manually and automatically with clusters and switches. The obtained metrics were validated using a classifier to distinguish HC, MCI, and ADRD. RESULTS: Automatically extracted clusters and switches were highly correlated (r = 0.9) with manually established values, and performed as well on the classification task separating HC from persons with ADRD (area under curve [AUC] = 0.939) and MCI (AUC = 0.758). CONCLUSION: The results show that it is possible to automate fine-grained analyses of SVF data for the assessment of cognitive decline.

A cluster-based approach to selecting representative stimuli from the International Affective Picture System (IAPS) database.

The International Affective Picture System (IAPS; Lang, Bradley, & Cuthbert, 2008) is a stimulus database that is frequently used to investigate various aspects of emotional processing. Despite its extensive use, selecting IAPS stimuli for a research project is not usually done according to an established strategy, but rather is tailored to individual studies. Here we propose a standard, replicable method for stimulus selection based on cluster analysis, which re-creates the group structure that is most likely to have produced the valence arousal, and dominance norms associated with the IAPS images. Our method includes screening the database for outliers, identifying a suitable clustering solution, and then extracting the desired number of stimuli on the basis of their level of certainty of belonging to the cluster they were assigned to. Our method preserves statistical power in studies by maximizing the likelihood that the stimuli belong to the cluster structure fitted to them, and by filtering stimuli according to their certainty of cluster membership. In addition, although our cluster-based method is illustrated using the IAPS, it can be extended to other stimulus databases.