Search results

The authors propose a blockchain platform for managing clinical trial data to enhance data validity, integrity, trust and transparency in the pharmaceutical research process. The authors also provide an extensive review of how blockchain technology supports the business processes of clinical trials.

A systematic literature review was conducted to identify the existing applications of blockchain in pharmaceutical process management. A conceptual design for a blockchain infrastructure to address clinical trial challenges is developed by outlining the entire clinical trial value chain and identifying the coordination and communication among its stakeholders. A stakeholder analysis is conducted to ensure that the clinical trial processes satisfy the requirements and preferences of each stakeholder.

The proposed blockchain platform offers a promising solution for enhancing integrity, trust and transparency in the clinical trial process. Additionally, blockchain can help streamline communication and collaboration between stakeholders by enabling multiple parties to access and share data in real time, lowering the possibility of delays or errors in data analysis and reporting.

The proposed blockchain platform can benefit patients by empowering them to have better-controlled access to their data and by allowing researchers to maintain adherence to reporting requirements. Additionally, the platform can benefit granting agencies, researchers and decision-makers by ensuring the integrity of clinical trial data and streamlining communication and collaboration between stakeholders.

This study builds on existing blockchain applications in pharmaceutical process management by developing a blockchain framework that can address clinical trial concerns from an integrated perspective.

This research aims to explore the research data ethics governance framework and collaborative network to optimize research data ethics governance practices, to balance the relationship between data development and utilization, open sharing, data security and to reduce the ethical risks that may arise from data sharing and utilization.

This study explores the framework and collaborative network of research data ethics policies by using the UK as an example. 78 policies from the UK government, university, research institution, funding agency, publisher, database, library and third-party organization are obtained. Adopting grounded theory (GT) and social network analysis (SNA), Nvivo12 is used to analyze these samples and summarize the research data ethics governance framework. Ucinet and Netdraw are used to reveal collaborative networks in policy.

Results indicate that the framework covers governance context, subject and measure. The content of governance context contains context description and data ethics issues analysis. Governance subject consists of defining subjects and facilitating their collaboration. Governance measure includes governance guidance and ethics governance initiatives in the data lifecycle. The collaborative network indicates that research institution plays a central role in ethics governance. The core of the governance content are ethics governance initiatives, governance guidance and governance context description.

This research provides new insights for policy analysis by combining GT and SNA methods. Research data ethics and its governance are conceptualized to complete data governance and research ethics theory.

A research data ethics governance framework and collaborative network are revealed, and actionable guidance for addressing essential aspects of research data ethics and multiple subjects to confer their functions in collaborative governance is provided.

This study analyzes policy text using qualitative and quantitative methods, ensuring fine-grained content profiling and improving policy research. A typical research data ethics governance framework is revealed. Various stakeholders' roles and priorities in collaborative governance are explored. These contribute to improving governance policies and governance levels in both theory and practice.

No study has investigated the effects of different parameters on publication bias in meta-analyses using a machine learning approach. Therefore, this study aims to evaluate the impact of various factors on publication bias in meta-analyses.

An electronic questionnaire was created according to some factors extracted from the Cochrane Handbook and AMSTAR-2 tool to identify factors affecting publication bias. Twelve experts were consulted to determine their opinion on the importance of each factor. Each component was evaluated based on its content validity ratio (CVR). In total, 616 meta-analyses comprising 1893 outcomes from PubMed that assessed the presence of publication bias in their reported outcomes were randomly selected to extract their data. The multilayer perceptron (MLP) technique was used in IBM SPSS Modeler 18.0 to construct a prediction model. 70, 15 and 15% of the data were used for the model's training, testing and validation partitions.

There was a publication bias in 968 (51.14%) outcomes. The established model had an accuracy rate of 86.1%, and all pre-selected nine variables were included in the model. The results showed that the number of databases searched was the most important predictive variable (0.26), followed by the number of searches in the grey literature (0.24), search in Medline (0.17) and advanced search with numerous operators (0.13).

The results of this study can help clinical researchers minimize publication bias in their studies, leading to improved evidence-based medicine.

To the best of the author’s knowledge, this is the first study to model publication bias using machine learning.

Value-based healthcare suggested using patient-reported information to complement the information available in the medical records and administrative healthcare data to provide insights into patients' perceptions of satisfaction, experience and self-reported outcomes. However, little attention has been devoted to questions about factors fostering the use of patient-reported information to create value at the system level.

Action research design is carried out to elicit possible triggers using the case of patient-reported experience and outcome data for breast cancer women along their clinical pathway in the clinical breast network of Tuscany (Italy).

The case shows that communication and engagement of multi-stakeholder representation are needed for making information actionable in a multi-level, multispecialty care pathway organized in a clinical network; moreover, political and managerial support from higher level governance is a stimulus for legitimizing the use for quality improvement. At the organizational level, an external facilitator disclosing and discussing real-world uses of collected data is a trigger to link measures to action. Also, clinical champion(s) and clear goals are key success factors. Nonetheless, resource munificent and dedicated information support tools together with education and learning routines are enabling factors.

Current literature focuses on key factors that impact performance information use often considering unidimensional performance and internal sources of information. The use of patient/user-reported information is not yet well-studied especially in supporting quality improvement in multi-stakeholder governance. The work appears relevant for the implications it carries, especially for policymakers and public sector managers when confronting the gap in patient-reported measures for quality improvement.

The purpose of the paper is to present an integrated methodology for identifying trends in a particular subject area based on a combination of advanced text mining and expert methods. The authors aim to test it in an area of clinical psychology and psychotherapy in 2010–2019.

The authors demonstrate the way of applying text-mining and the Word2Vec model to identify hot topics (HT) and emerging trends (ET) in clinical psychology and psychotherapy. The analysis of 11.3 million scientific publications in the Microsoft Academic Graph database revealed the most rapidly growing clinical psychology and psychotherapy terms – those with the largest increase in the number of publications reflecting real or potential trends.

The proposed approach allows one to identify HT and ET for the six thematic clusters related to mental disorders, symptoms, pharmacology, psychotherapy, treatment techniques and important psychological skills.

The developed methodology allows one to see the broad picture of the most dynamic research areas in the field of clinical psychology and psychotherapy in 2010–2019. For clinicians, who are often overwhelmed by practical work, this map of the current research can help identify the areas worthy of further attention to improve the effectiveness of their clinical work. This methodology might be applied for the identification of trends in any other subject area by taking into account its specificity.

The paper demonstrates the value of the advanced text-mining approach for understanding trends in a subject area. To the best of the authors’ knowledge, for the first time, text-mining and the Word2Vec model have been applied to identifying trends in the field of clinical psychology and psychotherapy.

Clinical staff working in mental health services experience high levels of work-related stress, burnout and poor well-being. Increased levels of stress, burnout, depression and anxiety and poorer mental well-being among health-care workers are associated with more sick days, absenteeism, lower work satisfaction, increased staff turnover and reduced quality of patient care. Virtual reality (VR) relaxation is a technique whereby experiences of pleasant and calming environments are accessed through a head-mounted display to promote relaxation. The purpose of this paper is to describe the design of a study that assesses the feasibility and acceptability of implementing a multi-session VR relaxation intervention amongst mental health professionals, to improve their relaxation levels and mental well-being.

The study follows a pre–post-test design. Mental health staff will be recruited for five weeks of VR relaxation. The authors will measure the feasibility and acceptability of the VR relaxation intervention as primary outcomes, alongside secondary outcomes evaluating the benefits of VR relaxation for mental well-being.

The study aims to recruit 20–25 health-care professionals working in both inpatient and specialist community mental health settings.

Research indicates the potential of VR relaxation as a low-intensity intervention to promote relaxation and reduce stress in the workplace. If VR relaxation is shown to be feasible and acceptable, when delivered across multiple sessions, there would be scope for large-scale work to investigate its effectiveness as an approach to enable health-care professionals to de-stress, relax and optimise their mental well-being. In turn, this may consequently reduce turnover and improve stress-related sick leave across health-care services.

The overall aim of this chapter is to focus on the process of, and issues warranting consideration for, the evaluation of educational interventions. In particular, to outline some key considerations for educators to follow when assessing the evidence-base for interventions they might be considering for use in their practice. Also, important considerations for those wishing to evaluate the effectiveness of an intervention they have initiated, as well as a useful checklist which summarises this all. Recognising that some readers of this chapter might be practitioners rather than researchers, it has been written with the practitioner in mind in, hopefully, a simple and practical way. There are, however, further opportunities for additional reading and resources signposted throughout for those who wish to read up on any of these areas more. In addition to those cited throughout and referenced in the Reference List at the end. There is also a section that provides the author’s Additional Recommended Readings and Resources to follow-up on. Readers might also want to refer to Chapter 3 in this book which discusses Single versus Multiple PPI approaches.

Previous research indicates that vitamin D and omega-3 co-supplementation may benefit overall health, but current evidence regarding its effects on lipid profile remains unclear. The present systematic review and meta-analysis aimed to examine the effects of vitamin D and omega-3 co-supplementation on lipid profile (total cholesterol [TC], low-density lipoprotein [LDL], triglyceride [TG] and high-density lipoprotein [HDL]) in adults.

In this systematic review and meta-analysis, relevant studies were obtained by searching the PubMed, Scopus and Web of Science databases (from inception to January 2022). Weighted mean differences and 95% confidence intervals were estimated via a random-effects model. Heterogeneity, sensitivity analysis and publication bias were reported using standard methods.

Pooled analysis of six randomized controlled trials (RCTs) revealed that vitamin D and omega-3 co-supplementation yielded significant reductions in TG (p = 0.631). A pooled analysis of five trials indicated a significant association between omega-3 and vitamin D treatment and reductions in TC (p = 0.001) and LDL (p = 0.001). Although, pooled analyses of omega-3 and vitamin D did not significantly affect HDL.

The findings suggest that vitamin D and omega-3 co-supplementation lowers TG, TC and LDL in adults. Future, large-scale, RCTs on various populations are needed to elucidate further beneficial effects of vitamin D and omega-3 co-supplementation on lipid profile and establish guidelines for clinical practice.

The objective of this study was to delineate and compare enteral nutrition (EN) practices among neonatal units across the Arabian Gulf countries.

A cross-sectional study was conducted by recruiting 255 clinicians working in neonatal units in the Arabian Gulf countries.

Out of 255 invited clinicians, 73 (29%) participated in the survey. Neonatal units used varied EN strategies, where feeding practices exhibited variability. The majority (74%) of units had a local standard feeding protocol, while 18% followed international protocols, and 8% did not adhere to a specific protocol. When maternal milk was not used, the main alternatives were preterm formula (67%) and predigested formula (14%). The age at which the first EN was commenced and the reported advancement rate showed significant variations among different units (p < 0.001). The initiation of fortification was primarily driven by reaching a specific enteral volume (commonly reported as 100 mL/kg/day) and addressing poor postnatal growth. Fortification practices did not differ significantly among professions, except for the initial fortification strength, where none of the dietitians and only 8.3% of neonatologists preferred full strength, compared to 28.6% and 21.4% of medical residents and nurses, respectively (p = 0.033).

This study marks the first exploration of EN practices in neonatal units, examining their local and cross-country variations. It provides valuable insights to guide local trials and foster global collaboration among neonatal units to establish a unified knowledge base, standardized practices and promote research and innovation, ultimately contributing to optimal feeding practices for very preterm infants.

The purpose of this paper was to gain a qualitative view of the participant experience of using home-based transcranial direct current stimulation (tDCS). Acceptability impacts patient preference, treatment adherence and outcomes. However, acceptability is usually assessed by rates of attrition, while multifaceted constructs are not reflected or given meaningful interpretations. tDCS is a novel non-invasive brain stimulation that is a potential treatment for major depressive disorder (MDD). Most studies have provided tDCS in a research centre. As tDCS is portable, the authors developed a home-based treatment protocol that was associated with clinical improvements that were maintained in the long term.

The authors examined the acceptability of home-based tDCS treatment in MDD through questionnaires and individual interviews at three timepoints: baseline, at a six-week course of treatment, and at six-month follow-up. Twenty-six participants (19 women) with MDD in a current depressive episode of at least moderate severity were enrolled. tDCS was provided in a bifrontal montage with real-time remote supervision by video conference at each session. A thematic analysis was conducted of the individual interviews.

Thematic analysis revealed four main themes: effectiveness, side effects, time commitment and support, feeling held and contained. The themes reflected the high acceptability of tDCS treatment, whereas the theme of feeling contained might be specific to this protocol.

Qualitative analysis methods and individual interviews generated novel insights into the acceptability of tDCS as a potential treatment for MDD. Feelings of containment might be specific to the present protocol, which consisted of real-time supervision at each session. Meaningful interpretation can provide context to a complex construct, which will aid in understanding and clinical applications.