46 research outputs found

    Perinatal mental health during the COVID-19 pandemic

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    The COVID-19 pandemic has influenced many aspects of life, including women's pregnancy, birth and postnatal period. Due to physically and immunologically adaptive perinatal changes, it is well known that pregnant women usually have an increased susceptibility to infection. Despite this, the majority of women affected by COVID-19 to date have exhibited mild symptoms and make a good recovery. However, there is no reliable evidence for transmission of COVID-19 from mother to infant during pregnancy. COVID-19 infection does not seem to increase likelihood of need for obstetric intervention at birth, with healthy infants born vaginally to mothers with the infection

    A study protocol of qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance [version 2; peer review: 2 approved]

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    BACKGROUND: Data sharing enables researchers to conduct novel research with previously collected data sets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing anonymised data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to data sharing remain, there are additional challenges for qualitative data. Qualitative data including videos, interviews, and observations are often more readily identifiable than quantitative data. Existing guidance from UK Economic and Social Research Council applies to sharing qualitative data but does not address the additional challenges related to sharing qualitative data collected within trials, including the need to incorporate the necessary information and consent into already complex recruitment processes, with the additional sensitive nature of health-related data. METHODS: Work package 1 will involve separate focus group interviews with members of each stakeholder group: trial managers, clinical trialists, qualitative researchers, members of research funding bodies and trial participants who have been involved in qualitative research. Data will be analysed using thematic analysis and managed within QSR NVivo to enhance transparency. Work package 2 will involve a documentary analysis of current consent procedures for qualitative data collected as part of the conduct of clinical trials. We will include documents such as participant information leaflets and consent forms for the qualitative components in trials. We will extract data such as whether specific clauses for data sharing are included in the consent form. Content analysis will be used to analyse whether and how consent is being obtained for qualitative data sharing. CONCLUSIONS: This study will provide insight into the existing practice of sharing of qualitative data in clinical trials and the current issues and opportunities, to help shape future research and development of guidance to encourage maximum learning to be gained from this valuable dat

    Addressing fidelity within complex health behaviour change interventions: A protocol of a scoping review of intervention fidelity frameworks and models

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    Intervention fidelity is crucial to facilitate accurate interpretation of research outcomes, but has been inadequately addressed within complex health behaviour change interventions. Recent research has highlighted a need for practical guidance to improve understanding and use of existing fidelity frameworks and models within complex health behaviour change intervention research. The aim of this paper is to present a protocol for a scoping review of existing intervention fidelity frameworks and models. // In accordance with scoping review guidelines, the following stages will be conducted: (1) identifying the research question, (2) identifying potentially relevant studies of fidelity frameworks and models, (3) study screening and selection, (4) charting and extracting data from identified frameworks and models, (5) collating, summarising and reporting the results and (6) consultation with stakeholders. Two reviewers will independently conduct the screening and extraction stages. Identified frameworks will be collated, summarized and categorized iteratively by one reviewer in consultation with the review team. // The findings of this review will provide a useful resource by identifying and comparing existing fidelity frameworks and models. It is intended that increased clarity and understanding in this area will facilitate the appropriate selection and application of fidelity frameworks for complex health behaviour change interventions, inform areas for future research, and ultimately contribute towards improving how intervention fidelity is addressed in this area

    Selective outcome reporting in trials of behavioural health interventions in health psychology and behavioural medicine journals: a review

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    Selective outcome reporting can result in overestimation of treatment effects, research waste, and reduced openness and transparency. This review aimed to examine selective outcome reporting in trials of behavioural health interventions and determine potential outcome reporting bias. A review of nine health psychology and behavioural medicine journals was conducted to identify randomised controlled trials of behavioural health interventions published since 2019. Discrepancies in outcome reporting were observed in 90% of the 29 trials with corresponding registrations/protocols. Discrepancies included 72% of trials omitting prespecified outcomes; 55% of trials introduced new outcomes. Thirty-eight percent of trials omitted prespecified and introduced new outcomes. Three trials (10%) downgraded primary outcomes in registrations/protocols to secondary outcomes in final reports; downgraded outcomes were not statistically significant in two trials. Five trials (17%) upgraded secondary outcomes to primary outcomes; upgraded outcomes were statistically significant in all trials. In final reports, three trials (7%) omitted outcomes from the methods section; three trials (7%) introduced new outcomes in results that were not in the methods. These findings indicate that selective outcome reporting is a problem in behavioural health intervention trials. Journal- and trialist-level approaches are needed to minimise selective outcome reporting in health psychology and behavioural medicine

    Which outcome measurement instruments are used to measure core infant feeding outcomes in children up to 1 year of age? A scoping review protocol

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    BackgroundHow, what, and when infants are fed plays a role in the aetiology of childhood obesity. Heterogeneity in how infant feeding outcomes are measured in trials of interventions to prevent childhood obesity limits evidence syntheses and understanding of intervention effectiveness. An infant feeding core outcome set (COS) was previously developed to standardised outcome measurement and reporting. The COS represents what to measure; determining how best to measure these outcomes is the next essential step to improve intervention evaluations. The aim of this scoping review is therefore to identify what outcome measurement instruments have been used in trials, and how they have been used, to measure the core infant feeding outcomes.MethodsA scoping review will be conducted. MEDLINE, EMBASE, CINAHL, PsychINFO, the Cochrane Central Register of Controlled Trials, OpenGrey and GreyNet will be searched from inception. Papers areeligible for inclusion if they report trials involving primary data collection that measure and report at least one core infant feeding outcome in infants ≤one year of age. Following searching and screening, eligible studies will be categorised into the following four overarching categories for data extraction, synthesis and write-up: caregiver-related outcomes; diet-related outcomes; feeding environment outcomes; child weight outcomes. Data will be narratively described and presented in tabular format, with findings presented in four separate review papers delineated by the four overarching categories.DiscussionThis scoping review forms part of the Standardised measurement for Childhood Obesity Prevention (SCOPE) study (www.eiascope.com). Evidence from this scoping review on what measurement instruments are used, and how they are used, represents an essential first step in developing recommendations and guidance about how best to measure core infant feeding outcomes for childhood obesity prevention. This can improve evidence syntheses and understanding of what infant feeding interventions are most effective for childhood obesity prevention
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