HRB open research最新文献

Background: Self-harm in youth is associated with adverse outcomes for many. The age of first self-harm is not often reported in the literature and there is considerable heterogeneity in how it is reported and in the methods used to estimate it. The objective of this study will be to examine the age of first self-harm act in childhood and adolescence and to identify the research methods used to assess this.

Methods: This scoping review will follow JBI guidance. Five electronic databases, Medline, PsycInfo, CINAHL Plus, Embase, and Web of Science will be searched from inception. Grey literature will be searched via Google Scholar. Studies reporting the age of first act of self-harm in young people aged 17 years and younger are of interest. Any study design and methodology will be eligible for inclusion. Included studies may use any self-harm definition, any measures used to assess self-harm and the age of the first act. The focus can be in any context, including health services presenting or community samples. Title and abstract screening and full text screening will be carried out by two reviewers independently. The data extraction tool will be piloted by two reviewers independently, included studies will undergo data extraction by one reviewer and this will be checked by a second, independent reviewer.

Results: The resulting data will be presented using descriptive statistics, in tabular format, and accompanied with a narrative presentation of results. The results of this study will be distributed by publication in an academic journal.

Background: Despite methodological improvements in clinical trial design and conduct more generally, methodological limitations persist in trials concerning mental health care. A qualitative Study Within A Trial (Qual-SWAT), embedded in the KARMA-Dep-2 host trial, will be undertaken to explore and gain an understanding of two methodological questions in randomised trials specific to mental health care: (1) what are the key barriers and enablers of participation in randomised trials in mental health; and (2) how can randomised trials become part of routine mental health care. These issues will be examined from patient-participant and clinician- / researcher-participant perspectives, in alignment with PRioRiTy research themes.

Methods: A descriptive qualitative study design will be used. Data will be collected via one-to-one semi-structured interviews, conducted via Microsoft Teams. The interview data will be analysed using Braun and Clarke's Thematic Analysis approach. One-to-one interviews will be conducted with three participant groups ( N = 30): 1) host trial patient-participants ( n = 10); 2) potentially eligible host trial patient-participants who refused enrolment in the host trial ( n = 10); and 3) clinician- / researcher-participants who are associated with work on the host trial ( n = 10).

Ethics and dissemination: Ethical approval has been granted by St. Patrick's Mental Health Services Research Ethics Committee, Ireland (Ref: Protocol 09/20). When the study is completed, a report will be prepared and submitted to the Health Research Board (HRB). Findings will be shared with the host trial team and study participants, and submitted for publication.

Host trial registration: ClinicalTrials.gov ( NCT04939649); EudraCT ( 2019-003109-92). Official title: Ketamine as an Adjunctive Therapy for Major Depression - A Randomised Controlled Trial: [KARMA-Dep (2)].

Background: Core outcome sets (COS) represent agreed-upon sets of outcomes, which are the minimum that should be measured and reported in all trials in specific health areas. Use of COS can reduce outcome heterogeneity, selective outcome reporting, and research waste, and can facilitate evidence syntheses. Despite benefits of using COS, current use of COS in trials is low. COS use can be understood as a behaviour, in that it is something trialists do, or not do, adequately. The aim of this study is to identify strategies, informed by behaviour change theory, to increase COS use in trials.

Methods: The project will be conducted in two stages, informed by the behaviour change wheel (BCW). The BCW is a theoretically based framework that can be used to classify, identify, and develop behaviour change strategies. In Stage 1, barriers and enablers to COS use will be extracted from published studies that examined trialist's use of COS. Barriers and facilitators will be mapped to the components of COM-B model (capability, opportunity, and motivation), which forms part of the BCW framework. Stage 2 will build on Stage 1 findings to identify and select intervention functions and behaviour change techniques to enhance COS use in trials.

Discussion: The findings of this study will provide an understanding of the behavioural factors that influence COS use in trials and what strategies might be used to target these factors to increase COS use in trials.