Background: There are more than 1.5 million children and young people in England with special educational needs (SEN), with over 160,000 young people in the United Kingdom attending a special school or alternative provision (AP) setting. Young people with SEN have been found to be at risk for poorer mental health and well-being than non-SEN peers. However, there is a range of both school-related and research challenges associated with identifying difficulties in a timely manner.
Objective: This Delphi study aims to determine a list of stakeholder priorities for improving school-based measurement of mental health and well-being among young people with SEN, at an aggregated level, within secondary special school or AP settings. A secondary objective is to inform the implementation of school-based well-being surveys, improve engagement in special schools or AP settings, and improve survey response rates among children and young people with SEN.
Methods: A mixed methods Delphi study will be conducted, including a scoping review and preliminary focus groups with school staff members and researchers to establish key issues. This will be followed by a 2-round Delphi survey to determine a list of stakeholder priorities for improving the measurement of mental health and well-being at an aggregate level within special schools and AP settings. A final stakeholder workshop will be held to discuss the findings. A list of recommendations will be drafted as a report for special schools and AP settings.
Results: The study has received ethical approval from the University College London Research Ethics Committee. The stage 1 scoping review has commenced. Recruitment for focus groups will begin in Autumn 2024. The first round of the Delphi survey will commence in early 2025, and the second round of the Delphi survey in the spring of 2025. The final workshop will commence in mid-2025 with final results expected in late 2025.
Conclusions: There is a need for clear recommendations for special schools and AP settings on priorities for improving the measurement of mental health and well-being problems among young people with SEN. There is also a need for recommendations to researchers implementing school-based well-being surveys, including the #BeeWell program, to enable them to improve their engagement in special schools and AP settings and ensure surveys are accessible.
International registered report identifier (irrid): PRR1-10.2196/58610.
Background: Schizophrenia is a disorder associated with neurocognitive deficits that adversely affect daily functioning and impose an economic burden. Cognitive rehabilitation interventions, particularly during the early phases of illness, have been shown to improve cognition, functionality, and quality of life. The Feuerstein Instrumental Enrichment (FIE) program, based on the Mediated Learning Experience and the Structural Cognitive Modifiability theory, has been applied in various disorders, but its applicability in schizophrenia has not yet been clarified.
Objective: This study aims to investigate the effects of the FIE program on the functionality of patients with first-episode schizophrenia.
Methods: In total, 17 patients will be recruited for an open-label intervention consisting of twice-weekly sessions for 10 weeks. The primary outcome measure will be changes in the Goal Achievement Scale score. Maze task performance from the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery will serve as a secondary outcome measure. At the same time, changes in Positive and Negative Syndrome Scale scores and other MATRICS domains will be analyzed as exploratory outcomes. Assessments will be administered before and after the intervention, with a follow-up period of 6 months.
Results: This trial was preregistered in The Brazilian Registry of Clinical Trials (RBR-4gzhy4s). By February 2024, 11 participants were enrolled in the training. Recruitment is expected to be completed by May 2024. Data analysis will be conducted between May and September 2024. The results are expected to be published in January 2025.
Conclusions: This study may establish a protocol for the FIE program that uses mediation techniques for individuals in the early stages of schizophrenia. The results will add to the knowledge about strategies to promote cognitive skills and functional impairment in daily life.
International registered report identifier (irrid): DERR1-10.2196/57031.
Background: The global community has set an ambitious goal to end HIV/AIDS as a public health threat by 2030. Significant progress has been achieved in pursuing these objectives; however, concerns remain regarding the lack of disaggregated routine data for key populations (KPs) for a targeted HIV response. KPs include female sex workers, transgender populations, gay men and other men who have sex with men, people who are incarcerated, and people who use drugs. From an epidemiological perspective, KPs play a fundamental role in shaping the dynamics of HIV transmission due to specific behaviors. In South Africa, routine health information management systems (RHIMS) do not include a unique identifier code (UIC) for KPs. The purpose of this protocol is to develop the framework for improved HIV monitoring and programming through piloting the inclusion of KPs UIC in the South African RHIMS.
Objective: This paper aims to describe the protocol for a multiphased study to pilot the inclusion of KPs UIC in RHIMS.
Methods: We will conduct a multiphased study to pilot the framework for the inclusion of KPs UIC in the RHIMS. The study has attained the University of Johannesburg Research Ethics Committee approval (REC-2518-2023). This study has four objectives, including a systematic review, according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines (objective 1). Second, policy document review and in-depth stakeholder interviews using semistructured questionnaires (objective 2). Third, exploratory data analysis of deidentified HIV data sets (objective 3), and finally, piloting the framework to assess the feasibility of incorporating KPs UIC in RHIMS using findings from objectives 1, 2, and 3 (objective 4). Qualitative and quantitative data will be analyzed using ATLAS.ti (version 6; ATLAS.ti Scientific Software Development GmbH) and Python (version 3.8; Python Software Foundation) programming language, respectively.
Results: The results will encompass a systematic review of literature, qualitative interviews, and document reviews, along with exploratory analysis of deidentified routine program data and findings from the pilot study. The systematic review has been registered in PROSPERO (International Prospective Register of Systematic Reviews; CRD42023440656). Data collection is planned to commence in September 2024 and expected results for all objectives will be published by December 2025.
Conclusions: The study will produce a framework to be recommended for the inclusion of the KP UIC national rollout. The study results will contribute to the knowledge base around the inclusion of KPs UIC in RHIMS data.
Trial registration: PROSPERO CRD42023440656; https://tinyurl.com/msnppany.
International registered report identifier (irrid): PRR1-10.2196/55092.
Background: In the last few years, there has been an increasing interest in the development of artificial intelligence (AI)-based clinical decision support systems (CDSS). However, there are barriers to the successful implementation of such systems in practice, including the lack of acceptance of these systems. Participatory approaches aim to involve future users in designing applications such as CDSS to be more acceptable, feasible, and fundamentally more relevant for practice. The development of technologies based on AI, however, challenges the process of user involvement and related methods.
Objective: The aim of this review is to summarize and present the main approaches, methods, practices, and specific challenges for participatory research and development of AI-based decision support systems involving clinicians.
Methods: This scoping review will follow the Joanna Briggs Institute approach to scoping reviews. The search for eligible studies was conducted in the databases MEDLINE via PubMed; ACM Digital Library; Cumulative Index to Nursing and Allied Health; and PsycInfo. The following search filters, adapted to each database, were used: Period January 01, 2012, to October 31, 2023, English and German studies only, abstract available. The scoping review will include studies that involve the development, piloting, implementation, and evaluation of AI-based CDSS (hybrid and data-driven AI approaches). Clinical staff must be involved in a participatory manner. Data retrieval will be accompanied by a manual gray literature search. Potential publications will then be exported into reference management software, and duplicates will be removed. Afterward, the obtained set of papers will be transferred into a systematic review management tool. All publications will be screened, extracted, and analyzed: title and abstract screening will be carried out by 2 independent reviewers. Disagreements will be resolved by involving a third reviewer. Data will be extracted using a data extraction tool prepared for the study.
Results: This scoping review protocol was registered on March 11, 2023, at the Open Science Framework. The full-text screening had already started at that time. Of the 3,118 studies screened by title and abstract, 31 were included in the full-text screening. Data collection and analysis as well as manuscript preparation are planned for the second and third quarter of 2024. The manuscript should be submitted towards the end of 2024.
Conclusions: This review will describe the current state of knowledge on participatory development of AI-based decision support systems. The aim is to identify knowledge gaps and provide research impetus. It also aims to provide relevant information for policy makers and practitioners.
International registered report identifier (irrid): DERR1-10.2196/58185.
Background: Understanding the similarities of patients with cancer is essential to advancing personalized medicine, improving patient outcomes, and developing more effective and individualized treatments. It enables researchers to discover important patterns, biomarkers, and treatment strategies that can have a significant impact on cancer research and oncology. In addition, the identification of previously successfully treated patients supports oncologists in making treatment decisions for a new patient who is clinically or molecularly similar to the previous patient.
Objective: The planned review aims to systematically summarize, map, and describe existing evidence to understand how patient similarity is defined and used in cancer research and clinical care.
Methods: To systematically identify relevant studies and to ensure reproducibility and transparency of the review process, a comprehensive literature search will be conducted in several bibliographic databases, including Web of Science, PubMed, LIVIVIVO, and MEDLINE, covering the period from 1998 to February 2024. After the initial duplicate deletion phase, a study selection phase will be applied using Rayyan, which consists of 3 distinct steps: title and abstract screening, disagreement resolution, and full-text screening. To ensure the integrity and quality of the selection process, each of these steps is preceded by a pilot testing phase. This methodological process will culminate in the presentation of the final research results in a structured form according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) flowchart. The protocol has been registered in the Journal of Medical Internet Research.
Results: This protocol outlines the methodologies used in conducting the scoping review. A search of the specified electronic databases and after removing duplicates resulted in 1183 unique records. As of March 2024, the review process has moved to the full-text evaluation phase. At this stage, data extraction will be conducted using a pretested chart template.
Conclusions: The scoping review protocol, centered on these main concepts, aims to systematically map the available evidence on patient similarity among patients with cancer. By defining the types of data sources, approaches, and methods used in the field, and aligning these with the research questions, the review will provide a foundation for future research and clinical application in personalized cancer care. This protocol will guide the literature search, data extraction, and synthesis of findings to achieve the review's objectives.
International registered report identifier (irrid): DERR1-10.2196/58705.
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