Clinical trials to go green-A sustainable argument for decentralised digital clinical trials.
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ABSTRACT:
SUBMITTER: Kohl SH
PROVIDER: S-EPMC10597501 | biostudies-literature | 2023 Oct
REPOSITORIES: biostudies-literature
Publications
Clinical trials to go green-A sustainable argument for decentralised digital clinical trials.
Kohl Simon H SH Schmidt-Lucke Caroline C
PLOS digital health 20231024 10
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Project description:Post COVID-19 condition or long COVID is highly prevalent and often debilitating, with key symptoms including fatigue, breathlessness, and brain fog. There is currently a lack of evidence-based treatments for this highly complex syndrome. There is a need for clinical trial platforms to rapidly evaluate nonpharmacological treatments to support affected individuals with symptom management. We co-produced a mixed methods feasibility study to evaluate a multi-arm digital decentralised clinical trial (DCT) platform to assess non-pharmacological interventions for Long COVID, using pacing interventions as an exemplar. The study demonstrated that the platform was able to successfully e-consent participants, randomise them into one of four intervention arms, capture baseline data, and capture outcomes relevant to a health economic evaluation. The study also highlighted several challenges, including difficulties with recruitment, imposter participants, and high attrition rates. We highlight how these challenges can potentially be mitigated to make a fully powered DCT more feasible.
| S-EPMC11436957 | biostudies-literature
Project description:AimsTo evaluate, using quantitative and qualitative approaches, published data on the design and conduct of decentralised clinical trials (DCTs).MethodsWe searched MEDLINE, EMBASE, CENTRAL, PsycINFO, ProQuest Dissertations and Theses, ClinicalTrials.gov, OpenGrey and Google Scholar for publications reporting, discussing, or evaluating decentralised clinical research methods. Reports of randomised clinical trials using decentralised methods were included in a focused quantitative analysis with a primary outcome of number of randomised participants. All publications discussing or evaluating DCTs were included in a wider qualitative analysis to identify advantages, disadvantages, facilitators, barriers and stakeholder opinions of decentralised clinical trials. Quantitative data were summarised using descriptive statistics, and qualitative data analysed using a thematic approach.ResultsInitial searches identified 19 704 articles. After removal of duplicates, 18 553 were screened, resulting in 237 eligible for full-text assessment. Forty-five trials were included in the quantitative analysis; 117 documents were included in the qualitative analysis. Trials were widely heterogeneous in design and reporting, precluding meta-analysis of the effect of DCT methods on the primary recruitment outcome. Qualitative analysis formulated 4 broad themes: value, burden, safety and equity. Participant and stakeholder experiences of DCTs were incompletely represented.ConclusionDCTs are developing rapidly. However, there is insufficient evidence to confirm which methods are most effective in trial recruitment, retention, or overall cost. The identified advantages, disadvantages, facilitators and barriers should inform the development of DCT methods. We recommend further research on how DCTs are experienced and perceived by participants and stakeholders to maximise potential benefits.
| S-EPMC9306873 | biostudies-literature
Project description: Not available
| S-EPMC10119552 | biostudies-literature
Project description:IntroductionDigital health has gained traction in research and development, and clinical decision support systems. The COVID-19 pandemic accelerated the adoption of decentralised clinical trials (DCTs) as a mitigation and efficiency improvement strategy. We assessed the opportunities and challenges of a digital transformation in clinical research in sub-Saharan Africa from different stakeholders' perspectives.MethodsA qualitative study, including 40 in-depth semi structured interviews, was conducted with investigators of three leading research institutions in sub-Saharan Africa and Switzerland, contract research organisations and sponsors managing clinical trials in sub-Saharan Africa. A thematic approach was used for the analysis.ResultsInterviewees perceived DCTs as an opportunity for trial efficiency improvement, quality improvement and reducing the burden of people participating in clinical trials. However, to gain and maintain an optimal quality of clinical trials, a transition period is necessary to tackle contextual challenges before DCTs are being implemented. The main challenges are categorised into four themes: (1) usability and practicability of the technology; (2) paradigm shift and trial data quality; (3) ethical and regulatory hurdles and (4) contextual factors (site-specific research environment and sociocultural aspects).ConclusionThe transformation from a site to a patient-centric model with an increased responsibility of participants should be context adapted. The transformation requires substantial investment, training of the various stakeholders and an efficient communication. Additionally, commitment of sponsors, investigators, ethics and regulatory authorities and the buy-in of the communities are essential for this change.
| S-EPMC10533674 | biostudies-literature
Project description:BackgroundIn the context of increasing environmental consciousness, integrating sustainable practices in healthcare is essential. Nurses' green creativity, defined as their ability to generate innovative, eco-friendly solutions, is pivotal in this transformation. Digital leadership, which leverages technology to guide sustainable practices, plays a critical role in fostering this creativity among nurses.AimThis study aimed to investigate the impact of digital leadership on enhancing nurses' green creativity and to evaluate the effectiveness of digital leadership strategies in promoting sustainability within healthcare settings. Research hypothesis: H1: Participation in a digital leadership program will lead to a significant enhancement in nurses' knowledge about digital leadership.H2: A digital leadership program will have a significantly positive impact on fostering nurses' green creativity.MethodsA quasi-experimental design was employed, involving 128 nurses randomly assigned to intervention and control groups. The intervention group participated in a digital leadership training program. Data were collected using a self-administered questionnaire, the Digital Leadership Competency Scale, and the Green Creativity Scale, before and after the intervention.ResultsThe mean knowledge score in the intervention group increased from 15.21 ± 4.22 pre-intervention to 44.29 ± 2.61 post-intervention (p < 0.001). For digital leadership competency, the mean score in the intervention group rose from 191.67 ± 20.43 to 552.14 ± 16.72 (p < 0.001). The mean score for green creativity in the intervention group significantly improved from 15.58 ± 1.68 to 42.31 ± 2.54 (p < 0.001).ConclusionThe study concluded that digital leadership programs significantly enhance nurses' green creativity. Integrating digital leadership into nursing practice can promote sustainability and innovation in healthcare settings.
| S-EPMC11883943 | biostudies-literature
Project description:ObjectiveTo comprehensively elucidate the current landscape of decentralised clinical trials (DCTs) and identify notable aspects that can facilitate DCT implementation.DesignCross-sectional analysis.SettingData were extracted using selected DCT-specific search terms on 4 June 2022, from the ClinicalTrials.gov database and on 2 September 2022, from the Japan Registry of Clinical Trials and Japic Clinical Trials Information.Primary outcome measureWe characterised trials based on the four components of DCT: telemedicine, home healthcare, direct-to-patient and the Internet of Healthcare Things (IoHTs)/Internet of Medical Things.ResultsData obtained from ClinicalTrials.gov indicated that the number of DCTs has increased annually and exponentially since 2020. DCTs for cardiovascular diseases are the most common, and the digital platform for patient monitoring is used the most in DCTs. The Japanese databases also showed that DCTs have increased in recent years, and the data on disease areas and IoHTs were similar to those obtained from the ClinicalTrials.gov database, except for the number of studies. Approximately 9.2% of DCTs were conducted across multiple regions, whereas over 80% were conducted within a single country.ConclusionsThis study revealed the comprehensive trend of DCTs in the USA and Japan and helped identify widely implemented DCT components and the therapeutic areas in which they are implemented. International consensus guidelines for DCTs are necessary to promote multiregional clinical trials with DCT components.
| S-EPMC10582843 | biostudies-literature
Project description:We report on the preparation of a biopolymer thin film by hydroxypropyl methylcellulose (HPMC), which can be used as a dry green lubricant in sustainable manufacturing. The thin films were characterized through scanning electron microscopy, energy-dispersive spectroscopy, and Raman spectroscopy; the films showed desirable levels of thickness, controllability, and uniformity. Tribology tests also showed desirable tribological and antiwear behaviors, caused by the formation of transfer layers. Zebrafish embryo toxicity studies showed that HPMC has excellent solubility and biocompatibility, which may show outstanding potential for applications as a green lubricant. The results of the present study show that these techniques for biopolymer HPMC provide an ecologically responsible and convenient method for preparing functional thin films, which is particularly applicable to sustainable manufacturing.
| S-EPMC5503078 | biostudies-other
Project description:The modern age has heralded a shift from the industrial society, in which natural resources are crucial input factors for the economy, towards a knowledge society. To date, sustainability literature has treated knowledge-and in particular digital artifacts-mainly as a means to the end of achieving sustainable development. In this conceptual paper, we argue that digital artifacts themselves ought also to be considered as resources, which also need to be sustainable. While over-consumption is a problem facing natural resources, with sustainable digital artifacts, underproduction, and underuse are the biggest challenges. In our view, the sustainability of digital artifacts improves their potential impact on sustainable development. A theoretical foundation for digital artifacts and their ecosystem allows us to present the relevant research on digital information, knowledge management, digital goods, and innovation literature. Based on these insights, we propose ten basic conditions for sustainable digital artifacts and their ecosystem to ensure that they provide the greatest possible benefit for sustainable development. We then apply those characteristics to four exemplary cases: Linux kernel development, Bitcoin cryptocurrency, the Wikipedia project, and the Linking Open Drug Data repositories. The paper concludes with a research agenda identifying topics for sustainability scholars and information systems academics, as well as practitioners. A number of suggestions for future studies on digital sustainability are also put forward.
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Project description:In the past few years, there have been rapid advances in technology and the use of digital tools in health care and clinical research. Although these innovations have immense potential to improve health care delivery and outcomes, there are genuine concerns related to inadvertent widening of the digital gap consequentially exacerbating health disparities. As such, it is important that we critically evaluate the impact of expansive digital transformation in medicine and clinical research on health equity. For digital solutions to truly improve the landscape of health care and clinical trial participation for all persons in an equitable way, targeted interventions to address historic injustices, structural racism, and social and digital determinants of health are essential. The urgent need to focus on interventions to promote health equity was made abundantly clear with the coronavirus disease 2019 pandemic, which magnified long-standing social and racial health disparities. Novel digital technologies present a unique opportunity to embed equity ideals into the ecosystem of health care and clinical research. In this review, we examine racial and ethnic diversity in clinical trials, historic instances of unethical research practices in biomedical research and its impact on clinical trial participation, and the digital divide in health care and clinical research, and we propose suggestions to achieve digital health equity in clinical trials. We also highlight key digital health opportunities in cardiovascular medicine and dermatology as exemplars, and we offer future directions for development and adoption of patient-centric interventions aimed at narrowing the digital divide and mitigating health inequities.
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Project description:Digital approaches are increasingly common in clinical trial recruitment, retention, analysis, and dissemination. Community engagement processes have contributed to the successful implementation of clinical trials and are crucial in enhancing equity in trials. However, few studies focus on how digital approaches can be implemented to enhance community engagement in clinical trials. This narrative review examines three key areas for digital approaches to deepen community engagement in clinical trials-the use of digital technology for trial processes to decentralize trials, digital crowdsourcing to develop trial components, and digital qualitative research methods. We highlight how digital approaches enhanced community engagement through a greater diversity of participants, and deepened community engagement through the decentralization of research processes. We discuss new possibilities that digital technologies offer for community engagement, and highlight potential strengths, weaknesses, and practical considerations. We argue that strengthening community engagement using a digital approach can enhance equity and improve health outcomes.
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