BACKGROUND: The set-up, activation, and delivery of clinical trials is pivotal for the advancement of medical science, serving as the primary mechanism through which new therapeutic interventions are validated for clinical use. Despite their critical role, the execution of these trials is often encumbered by a multitude of challenges. The North West London Clinical Trials Alliance (The Alliance) was established to address these complexities. It aims to bridge the gap between emerging scientific research and its clinical application through strategic collaborations among healthcare and research entities, thereby enhancing the regional ecosystem for clinical trials.
METHODS: This commentary aims to offer clarity on the fundamental insights that underlie The Alliance, providing a comprehensive understanding of its operational structure and the ecosystem it has fostered to optimise clinical trial delivery and revenue generation. The strategy employed by The Alliance centres on the cultivation of strategic partnerships across a broad spectrum of stakeholders. This approach addresses key operational challenges in clinical trial management, facilitating improvements in the development, setup, activation, and recruitment stages. Notably, The Alliance has reduced the average time to initiate trials to 19 days, compared to the standard 75 days typically observed for commercial setups in North West London. The effectiveness of The Alliance\'s framework was notably demonstrated during the COVID-19 pandemic, particularly with the expedited recruitment performance in the Janssen COVID-19 vaccine study conducted at Charing Cross Hospital. This instance highlighted the Alliance\'s capability to meet and exceed recruitment targets promptly while maintaining diversity within study cohorts. Additionally, The Alliance has effectively harnessed digital technology and infrastructure, enhancing its attractiveness to commercially funded studies and illustrating a sustainable model for clinical trial financing and execution.
CONCLUSIONS: The North West London Clinical Trials Alliance represents a strategic response to the conventional challenges faced in clinical trial management, emphasising the importance of cross-sectoral collaboration and resource optimisation. Its efforts, particularly highlighted by its response to the COVID-19 pandemic, provide a case study in enhancing trial delivery and efficiency with significant implications for both regional and global clinical trials research communities.

BACKGROUND: Digital tools are progressively reshaping the daily work of health care professionals (HCPs) in hospitals. While this transformation holds substantial promise, it leads to frustrating experiences, raising concerns about negative impacts on clinicians\' well-being.
OBJECTIVE: The goal of this study was to comprehensively explore the lived experiences of HCPs navigating digital tools throughout their daily routines.
METHODS: Qualitative in-depth interviews with 52 HCPs representing 24 medical specialties across 14 hospitals in Switzerland were performed.
RESULTS: Inductive thematic analysis revealed 4 main themes: digital tool use, workflow and processes, HCPs\' experience of care delivery, and digital transformation and management of change. Within these themes, 6 intriguing paradoxes emerged, and we hypothesized that these paradoxes might partly explain the persistence of the challenges facing hospital digitalization: the promise of efficiency and the reality of inefficiency, the shift from face to face to interface, juggling frustration and dedication, the illusion of information access and trust, the complexity and intersection of workflows and care paths, and the opportunities and challenges of shadow IT.
CONCLUSIONS: Our study highlights the central importance of acknowledging and considering the experiences of HCPs to support the transformation of health care technology and to avoid or mitigate any potential negative experiences that might arise from digitalization. The viewpoints of HCPs add relevant insights into long-standing informatics problems in health care and may suggest new strategies to follow when tackling future challenges.

While digital tools, such as the Internet, smartphones, and social media, are an important part of modern society, little is known about the specific role they play in the healthcare management of individuals and caregivers affected by rare disease. Collectively, rare diseases directly affect up to 10% of the global population, suggesting that a significant number of individuals might benefit from the use of digital tools. The purpose of this qualitative interview-based study was to explore: (a) the ways in which digital tools help the rare disease community; (b) the healthcare gaps not addressed by current digital tools; and (c) recommended digital tool features. Individuals and caregivers affected by rare disease who were comfortable using a smartphone and at least 18 years old were eligible to participate. We recruited from rare disease organizations using purposive sampling in order to achieve a diverse and information rich sample. Interviews took place over Zoom and reflexive thematic analysis was utilized to conceptualize themes. Eight semistructured interviews took place with four individuals and four caregivers. Three themes were conceptualized which elucidated key aspects of how digital tools were utilized in disease management: (1) digital tools should lessen the burden of managing a rare disease condition; (2) digital tools should foster community building and promote trust; and (3) digital tools should provide trusted and personalized information to understand the condition and what the future may hold. These results suggest that digital tools play a central role in the lives of individuals with rare disease and their caregivers. Digital tools that centralize trustworthy information, and that bring the relevant community together to interact and promote trust are needed. Genetic counselors can consider these ideal attributes of digital tools when providing resources to individuals and caretakers of rare disease.

Both memory clinic professionals and patients see value in digital tools, yet these hardly find their way to clinical practice. We explored the usability of a digital tool to support the diagnostic work-up in daily memory clinic practice. We evaluated four modules that integrate multi-modal patient data (1.cognitive test; cCOG, and 2. MRI quantification; cMRI) into useful diagnostic information for clinicians (3. cDSI) and understandable and personalized information for patients (4. patient report).
We conducted a mixed-methods study in five Dutch memory clinics. Fourteen clinicians (11 geriatric specialists/residents, two neurologists, one nurse practitioner) were invited to integrate the tool into routine care with 43 new memory clinic patients. We evaluated usability and user experiences through quantitative data from questionnaires (patients, care partners, clinicians), enriched with thematically analyzed qualitative data from interviews (clinicians).
We observed wide variation in tool use among clinicians. Our core findings were that clinicians: 1) were mainly positive about the patient report, since it contributes to patient-centered and personalized communication. This was endorsed by patients and care partners, who indicated that the patient report was useful and understandable and helped them to better understand their diagnosis, 2) considered the tool acceptable in addition to their own clinical competence, 3) indicated that the usefulness of the tool depended on the patient population and purpose of the diagnostic process, 4) addressed facilitators (ease of use, practice makes perfect) and barriers (high workload, lack of experience, data unavailability).
This multicenter usability study revealed a willingness to adopt a digital tool to support the diagnostic process in memory clinics. Clinicians, patients, and care partners appreciated the personalized diagnostic report. More attention to education and training of clinicians is needed to utilize the full functionality of the tool and foster implementation in actual daily practice. These findings provide an important step towards a lasting adoption of digital tools in memory clinic practice.

BACKGROUND: In many large health centers, patients face long appointment wait times and difficulties accessing care. Last-minute cancellations and patient no-shows leave unfilled slots in a clinician\'s schedule, exacerbating delays in care from poor access. The mismatch between the supply of outpatient appointments and patient demand has led health systems to adopt many tools and strategies to minimize appointment no-show rates and fill open slots left by patient cancellations.
OBJECTIVE: We evaluated an electronic health record (EHR)-based self-scheduling tool, Fast Pass, at a large academic medical center to understand the impacts of the tool on the ability to fill cancelled appointment slots, patient access to earlier appointments, and clinical revenue from visits that may otherwise have gone unscheduled.
METHODS: In this retrospective cohort study, we extracted Fast Pass appointment offers and scheduling data, including patient demographics, from the EHR between June 18, 2022, and March 9, 2023. We analyzed the outcomes of Fast Pass offers (accepted, declined, expired, and unavailable) and the outcomes of scheduled appointments resulting from accepted Fast Pass offers (completed, canceled, and no-show). We stratified outcomes based on appointment specialty. For each specialty, the patient service revenue from appointments filled by Fast Pass was calculated using the visit slots filled, the payer mix of the appointments, and the contribution margin by payer.
RESULTS: From June 18 to March 9, 2023, there were a total of 60,660 Fast Pass offers sent to patients for 21,978 available appointments. Of these offers, 6603 (11%) were accepted across all departments, and 5399 (8.9%) visits were completed. Patients were seen a median (IQR) of 14 (4-33) days sooner for their appointments. In a multivariate logistic regression model with primary outcome Fast Pass offer acceptance, patients who were aged 65 years or older (vs 20-40 years; P=.005 odds ratio [OR] 0.86, 95% CI 0.78-0.96), other ethnicity (vs White; P<.001, OR 0.84, 95% CI 0.77-0.91), primarily Chinese speakers (P<.001; OR 0.62, 95% CI 0.49-0.79), and other language speakers (vs English speakers; P=.001; OR 0.71, 95% CI 0.57-0.87) were less likely to accept an offer. Fast Pass added 2576 patient service hours to the clinical schedule, with a median (IQR) of 251 (216-322) hours per month. The estimated value of physician fees from these visits scheduled through 9 months of Fast Pass scheduling in professional fees at our institution was US $3 million.
CONCLUSIONS: Self-scheduling tools that provide patients with an opportunity to schedule into cancelled or unfilled appointment slots have the potential to improve patient access and efficiently capture additional revenue from filling unfilled slots. The demographics of the patients accepting these offers suggest that such digital tools may exacerbate inequities in access.

BACKGROUND: Digital tools may support people to self-manage their heart failure (HF). Having previously outlined the human-centered design development of a digital tool to support self-care of HF, the next step was to pilot the tool over a period of time to establish people\'s acceptance of it in practice.
OBJECTIVE: This study aims to conduct an observational pilot study to examine the usability, adherence, and feasibility of a digital health tool for HF within the Irish health care system.
METHODS: A total of 19 participants with HF were provided with a digital tool comprising a mobile app and the Fitbit Charge 4 and Aria Air smart scales for a period of 6 months. Changes to their self-care were assessed before and after the study with the 9-item European HF Self-care Behavior Scale (EHFScBS) and the Minnesota Living with HF Questionnaire (MLwHFQ) using a Wilcoxon signed rank test. After the study, 3 usability questionnaires were implemented and descriptively analyzed: the System Usability Scale (SUS), Wearable Technology Motivation Scale (WTMS), and Comfort Rating Scale (CRS). Participants also undertook a semistructured interview regarding their experiences with the digital tool. Interviews were analyzed deductively using the Theoretical Domains Framework.
RESULTS: Participants wore their devices for an average of 86.2% of the days in the 6-month testing period ranging from 40.6% to 98%. Although improvements in the EHFScBS and MLwHFQ were seen, these changes were not significant (P=.10 and P=.70, respectively, where P>.03, after a Bonferroni correction). SUS results suggest that the usability of this system was not acceptable with a median score of 58.8 (IQR 55.0-60.0; range 45.0-67.5). Participants demonstrated a strong motivation to use the system according to the WTMS (median 6.0, IQR 5.0-7.0; range 1.0-7.0), whereas the Fitbit was considered very comfortable as demonstrated by the low CRS results (median 0.0, IQR 0.0-0.0; range 0.0-2.0). According to participant interviews, the digital tool supported self-management through increased knowledge, improved awareness, decision-making, and confidence in their own data, and improving their social support through a feeling of comfort in being watched.
CONCLUSIONS: The digital health tool demonstrated high levels of adherence and acceptance among participants. Although the SUS results suggest low usability, this may be explained by participants uncertainty that they were using it fully, rather than it being unusable, especially given the experiences documented in their interviews. The digital tool targeted key self-management behaviors and feelings of social support. However, a number of changes to the tool, and the health service, are required before it can be implemented at scale. A full-scale feasibility trial conducted at a wider level is required to fully determine its potential effectiveness and wider implementation needs.

This study explores orthodontists\' perspectives on risks associated with orthodontic treatment, as described by Greek and Slovak orthodontists. Informed by the foundational importance of effective communication of risk perspectives in health sciences, particularly in facilitating valid consent and shared decision-making, this research addresses gaps identified in the literature concerning the consistent communication of potential treatment risks based on demographic and cultural characteristics. This study identifies 15 potential critical risks during orthodontic treatment. These risks include root resorption; temporary undesired changes to the occlusion; sleep difficulties; not achieving an ideal result; development of black triangles between teeth; taking additional X-rays; speech difficulties; using a protective splint during sports; duration of treatment; number of visits; transmission of infectious diseases; and swallowing orthodontic appliances. A questionnaire, distributed electronically to orthodontists in Greece (N1 = 570) and Slovakia (N2 = 210) from September 2022 to December 2022, aimed to assess risk communication practices, taking into consideration socio-demographic factors, such as country, gender, age, and academic-degree-related variations. A total of 168 valid questionnaires (91 from Slovakia and 77 from Greece) were obtained, indicating significant disparities in the risks emphasized and preferred forms of consent. The Greek orthodontists focused more on the risks involved, such as relapse, root resorption, temporal occlusal changes, and failure of desired movement, while the Slovak practitioners tended to be more interested in sleeping difficulties, temporal occlusal changes, and not achieving an ideal result. They also obtained written or digital consent from patients or their parents/guardians more frequently than the Greek team. Male orthodontists discussed specific risks more frequently, including relapse and extractions, whereas females preferred written or digital consent. PhD-trained orthodontists prioritized certain risks, indicating the need for tailored approaches. This study underscores the dynamic nature of risk assessment in orthodontic practice, emphasizing its ethical and strategic dimensions. The findings advocate for tailored risk communication strategies that recognize individual, contextual, and cultural factors, and the need for an orthodontic informed consent protocol for a tailored communication approach for patients to elevate the standard of care in European orthodontics. The reliance on digital tools reflects contemporary trends in enhancing patient understanding, thereby supporting ongoing innovation in orthodontic practices.

BACKGROUND: The reasons for mental health consultations are becoming increasingly relevant in primary care. The Catalan health care system is undergoing a process of digital transformation, where eHealth is becoming increasingly relevant in routine clinical practice.
OBJECTIVE: This study aimed to analyze the approach to depressive episodes and the role of eHealth in the Catalan health care system from 2017 to 2022.
METHODS: A retrospective observational study was conducted on diagnostic codes related to depressive episodes and mood disorders between 2017 and 2022 using data from the Catalan Institute of Health. The sociodemographic evolution and prevalence of depression and mood disorders in Catalonia were analyzed between 2017 and 2022. Sociodemographic variables were analyzed using absolute frequency and percentage. The prevalence of depressive episodes was calculated, highlighting the year-to-year changes. The use of eHealth for related consultations was assessed by comparing the percentages of eHealth and face-to-face consultations. A comparison of sociodemographic variables based on attendance type was conducted. Additionally, a logistic regression model was used to explore factors influencing face-to-face attendance. The analysis used R software (version 4.2.1), with all differences examined using 95% CIs.
RESULTS: From 2017 to 2022, there was an 86.6% increase in the prevalence of depression and mood disorders, with women consistently more affected (20,950/31,197, 67.2% in 2017 and 22,078/33,169, 66.6% in 2022). In 2022, a significant rise in depression diagnoses was observed in rural areas (difference 0.71%, 95% CI 0.04%-1.43%), contrasting with a significant decrease in urban settings (difference -0.7%, 95% CI -1.35% to -0.05%). There was a significant increase in antidepressant use in 2022 compared to 2017 (difference 2.4%, 95% CI 1.87%-3.06%) and the proportion of eHealth visits rose from 4.34% (1240/28,561) in 2017 to 26.3% (8501/32,267) in 2022. Logistic regression analysis indicated that men (odds ratio [OR] 1.06, 95% CI 1.04-1.09) and younger individuals had a higher likelihood of eHealth consultations in 2022. Furthermore, individuals using eHealth consultations were more likely to use antidepressants (OR 1.54, 95% CI 1.50-1.57) and anxiolytics (OR 1.06, 95% CI 1.03-1.09).
CONCLUSIONS: The prevalence of depression in Catalonia has significantly increased in the last 6 years, likely influenced by the COVID-19 pandemic. Despite ongoing digital transformation since 2011, eHealth usage remained limited as of 2017. During the lockdown period, eHealth accounted for nearly half of all health care consultations, representing a quarter of consultations by 2022. In the immediate aftermath of the COVID-19 pandemic, emerging evidence suggests a significant role of eHealth in managing depression-related consultations, along with an apparent likelihood of patients being prescribed antidepressants and anxiolytics. Further research is needed to understand the long-term impact of eHealth on diagnostic practices and medication use.

OBJECTIVE: The purpose of this study was to understand the needs of youth and young adults, current gaps around safeguarding social media, and factors affecting adoption of data-driven auto-detection or software tools.
METHODS: This qualitative study is the first step of a larger initiative that aims to use participatory action research and co-design principles to develop a digital tool that targets cyberbullying. Youth and young adults aged 16-21 years were recruited to participate in semistructured focus groups between March 2020 and November 2021. Thematic analysis was used to develop themes, with a member-checking process to validate the findings.
RESULTS: Six focus groups were completed with 39 participants and five themes were generated from the analysis. Participants described the mental health impacts of cyberbullying on young people, the stigma associated with it, and the need for more mental health resources. They felt that additional efforts are needed to improve the school environment, school-based interventions, and training protocols to ensure that youth feel safe reporting cyberbullying. Most participants were open to using a digital solution but raised concerns around the trustworthiness of artificial intelligence and wanted it to be co-designed with young people, integrated across platforms, informed by data-driven decisions, and transparent with users.
CONCLUSIONS: Youth and young adults are accepting of a low-risk digital cyberbullying solution as current interventions are not meeting their needs.

While the COVID-19 pandemic has greatly exacerbated the mental health challenges of transition-aged youth (TAY) between 17 and 29 years old, it has also led to the rapid adoption of digital tools for mental health help-seeking and treatment. However, to date, there has been limited work focusing on how this shift has impacted perceptions, needs and challenges of this population in using digital tools. The current study aims to understand their perspectives on mental health help-seeking during the pandemic and emerging issues related to digital tools (e.g., digital health equity, inclusivity). A total of 16 TAY were invited from three post-secondary institutions in the Greater Toronto Area. A total of two streams of focus groups were held and participants were invited to share their perceptions, needs and experiences. Five main themes were identified: 1) Helpfulness of a centralized resource encompassing a variety of diverse mental health supports help-seeking; 2) The impact of the shift to online mental health support on the use of informal supports; 3) Digital tool affordability and availability; 4) Importance of inclusivity for digital tools; and 5) Need for additional support for mental health seeking and digital tool navigation. Future work should examine how these needs can be addressed through new and existing digital mental health help-seeking tools for TAY.