Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system

The Randomized Embedded Multifactorial Adaptive Platform (REMAP-CAP) adapted for COVID-19) trial is a global adaptive platform trial of hospitalised patients with COVID-19. We describe implementation in three countries under the umbrella of the Wellcome supported Low and Middle Income Country (LMIC) critical care network: Collaboration for Research, Implementation and Training in Asia (CCA). The collaboration sought to overcome known barriers to multi centre-clinical trials in resource-limited settings. Methods described focused on six aspects of implementation: i, Strengthening an existing community of practice; ii, Remote study site recruitment, training and support; iii, Harmonising the REMAP CAP- COVID trial with existing care processes; iv, Embedding REMAP CAP- COVID case report form into the existing CCA registry platform, v, Context specific adaptation and data management; vi, Alignment with existing pandemic and critical care research in the CCA. Methods described here may enable other LMIC sites to participate as equal partners in international critical care trials of urgent public health importance, both during this pandemic and beyond

Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions

\ua9 Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ. OBJECTIVE: International trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them. DESIGN: Systematic review. DATA SOURCES: Medline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023. ELIGIBILITY CRITERIA: All studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included. DATA EXTRACTION AND SYNTHESIS: Search results were independently screened by at least two reviewers and data were extracted into a proforma. RESULTS: 38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332-4056) and median number of sites was 40 (IQR 13-78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport. CONCLUSIONS: International collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach. OPEN SCIENCE FRAMEWORK REGISTRATION NUMBER: osf-registrations-yvtjb-v1

Barriers and Facilitators to Resuming In-Person Psychotherapy with Perinatal Patients amid the COVID-19 Pandemic: A Multistakeholder Perspective

During the COVID-19 pandemic, outpatient psychotherapy transitioned to telemedicine. This study aimed to examine barriers and facilitators to resuming in-person psychotherapy with perinatal patients as the pandemic abates. We conducted focus group and individual interviews with a sample of perinatal participants (n = 23), psychotherapy providers (n = 28), and stakeholders (n = 18) from Canada and the U.S. involved in the SUMMIT trial, which is aimed at improving access to mental healthcare for perinatal patients with depression and anxiety. Content analysis was used to examine perceived barriers and facilitators. Reported barriers included concerns about virus exposure in a hospital setting (77.8% stakeholders, 73.9% perinatal participants, 71.4% providers) or on public transportation (50.0% stakeholders, 26.1% perinatal participants, 25.0% providers), wearing a mask during sessions (50.0% stakeholders, 25.0% providers, 13.0% participants), lack of childcare (66.7% stakeholders, 46.4% providers, 43.5% perinatal participants), general transportation barriers (50.0% stakeholders, 47.8% perinatal participants, 25.0% providers), and the burden of planning and making time for in-person sessions (35.7% providers, 34.8% perinatal participants, 27.8% stakeholders). Reported facilitators included implementing and communicating safety protocols (72.2% stakeholders, 47.8% perinatal participants, 39.3% providers), conducting sessions at alternative or larger locations (44.4% stakeholders, 32.1% providers, 17.4% perinatal participants), providing incentives (34.8% perinatal participants, 21.4% providers, 11.1% stakeholders), and childcare and flexible scheduling options (31.1% perinatal participants, 16.7% stakeholders). This study identified a number of potential barriers and illustrated that COVID-19 has fostered and amplified barriers. Future interventions to facilitate resuming in-person sessions should focus on patient-centered strategies based on empathy regarding ongoing risk-aversion among perinatal patients despite existing safety protocols, and holistic thinking to make access to in-person psychotherapy easier and more accessible for perinatal patients

Navigating data governance associated with real-world data for public benefit: an overview in the UK and future considerations

Real-world data encompass data primarily captured for the provision or operation of services, for example, electronic health records for direct care purposes, but which may have secondary uses for informing research or commissioning. Public benefit is potentially forfeited by the underutilisation of real-world data for secondary uses, in part due to risk aversion when faced with the prospect of navigating necessary and important data governance processes. Such processes can be perceived as complex, daunting, time-consuming and exposing organisations to risk. By providing an overview description and discussion around the role of six key legal and information governance frameworks and their role regarding responsible data access, linkage and sharing, our intention is to make data governance a less daunting prospect and reduce the perception that it is a barrier to secondary uses, thus enabling public benefit

EXPLORING CREATIVE ARTS THERAPISTS\u27 EXPERIENCES WITH ONLINE THERAPY IN SOUTH KOREA DURING COVID-19

This study explored the experiences of creative arts therapists (CATs) in South Korea who conducted online therapy sessions during the COVID-19 pandemic. The global crisis forced a rapid shift to virtual platforms, raising concerns about the effectiveness of online creative arts therapy (OCAT) and its impact on therapeutic relationships. Grounded in phenomenological and arts-based research (ABR), this study examined the challenges, adaptations, and effectiveness of OCAT. The research addressed the following questions: (1) How did CATs experience the transition to online therapy? (2) What challenges did they encounter, and how did they adapt? (3) How did online therapy affect therapeutic relationships? (4) What ethical considerations emerged in OCAT practice? Six female CATs, aged 30s to 40s, participated in this qualitative study. They had professional experience in music, art, or drama therapy and conducted online sessions in diverse settings, including schools, hospitals, and private practice. Data collection included semi-structured interviews, participant-created artwork, and reflective writing. Thematic analysis revealed key findings: initial resistance and concerns about the limitations of virtual platforms, the adoption of digital tools for creative engagement, evolving strategies to maintain therapeutic presence, and ethical considerations regarding privacy and accessibility. Participants identified OCAT’s unique potential beyond crisis adaptation, emphasizing its long-term value in expanding access to therapy. Keywords: online creative arts therapy, telehealth, COVID-19, creative arts therapists, arts-based research, South Korea The author identifies as a straight, Asian man from South Korea of Han ethnicity

ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic

Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) was initiated by the US government to rapidly develop and test vaccines and therapeutics against COVID-19 in 2020. The ACTIV Therapeutics-Clinical Working Group selected ACTIV trial teams and clinical networks to expeditiously develop and launch master protocols based on therapeutic targets and patient populations. The suite of clinical trials was designed to collectively inform therapeutic care for COVID-19 outpatient, inpatient, and intensive care populations globally. In this report, we highlight challenges, strategies, and solutions around clinical protocol development and regulatory approval to document our experience and propose plans for future similar healthcare emergencies

ACTIV trials : Lessons learned in trial design in the setting of an emergent pandemic

Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) was initiated by the US government to rapidly develop and test vaccines and therapeutics against COVID-19 in 2020. The ACTIV Therapeutics-Clinical Working Group selected ACTIV trial teams and clinical networks to expeditiously develop and launch master protocols based on therapeutic targets and patient populations. The suite of clinical trials was designed to collectively inform therapeutic care for COVID-19 outpatient, inpatient, and intensive care populations globally. In this report, we highlight challenges, strategies, and solutions around clinical protocol development and regulatory approval to document our experience and propose plans for future similar healthcare emergencies

Subcutaneous ketamine infusion in palliative patients for major depressive disorder (SKIPMDD)—Phase II single-arm open-label feasibility study

Background Ketamine at subanaesthetic dosages ( 18-years-old) with advanced life-limiting illnesses referred to four palliative care services in Sydney, Australia, diagnosed with major depressive disorder from any care setting. Participants received weekly subcutaneous ketamine infusion (0.1–0.4mg/kg) over two hours using individual dose-titration design. Outcomes assessed were feasibility, safety, tolerability and antidepressant activity. Results Out of ninety-nine referrals, ten participants received ketamine and were analysed for responses. Accrual rate was 0.54 participants/month across sites with 50% of treated participants achieving > 50% reduction in baseline Montgomery-Åsberg Depression Rating Scale, meeting feasibility criteria set a priori. There were no clinically relevant harms encountered. Conclusions A future definitive trial exploring the effectiveness of subcutaneous infusion of ketamine for major depressive disorder in the palliative care setting may be feasible by addressing identified study barriers. Individual dose-titration of subcutaneous ketamine infusions over two hours from 0.1mg/kg can be well-tolerated and appears to produce transient antidepressant signals over hours to days