Exploration of patients and healthcare professionals perspectives on kidney failure risk and the use of the kidney failure risk equation in MULTIPle lOng-term condItions aNd frailTy (MULTIPOINT) study: a qualitative interview and focus group study protocol

Introduction
Clinical guidelines recommend the use of the kidney failure risk equation (KFRE) to guide the referral of individuals with chronic kidney disease (CKD) to secondary kidney care services. People living with CKD frequently experience multiple long-term conditions (multimorbidity) and/or frailty. This may impact patients’ or carers’ perceptions of kidney failure in the context of other health problems and associated risks and emphasises the need for shared decision-making. This paper presents the research protocol for the exploration of patients’ and healthcare professionals’ perspectives on kidney failure risk and the use of the KFRE in the MULTIPle lOng-term condItions aNd frailTy study. This study aims to investigate patient and healthcare professionals’ perspectives and expectations of the use of KFRE in individuals with CKD and multimorbidity and/or frailty, with a focus on shared decision-making.

Methods and analysis
Analysis of semistructured interviews with adults who have CKD and multimorbidity and/or frailty and focus groups with healthcare professionals (who are involved in caring for patients with CKD). Framework analysis, underpinned by normalisation process theory, will be used to develop codes and explore themes from the interviews and focus groups. Patient and public involvement has been pivotal to the study conceptualisation and will continue to be embedded throughout the study.

Ethics and dissemination
The study protocol has undergone peer review by the NHS Greater Glasgow and Clyde Research and Innovation team and has been granted ethical approval in August 2023 by the NHS Health Research Authority following a favourable opinion from the West of Scotland Research Ethics Committee (REC) 3 (IRAS ID: 325848, REC reference: 23WS/0119, Protocol number GN22RE559).
The results of the research will be disseminated through peer-reviewed publications and conferences, as well as to patient and public involvement groups who have been involved in the study and through knowledge exchange events.

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Ottobre 2024

Mapping resilience: a scoping review on mediators and moderators of childhood adversity with a focus on gender patterns

Background
Childhood adversity is associated with a host of negative health and socioeconomic outcomes far into adulthood. The process of avoiding such outcomes is often referred to as resilience. Mapping resilience comprehensively and across contexts is highly relevant to public health, as it is a step towards understanding environments and interventions that contribute to preventing or reversing negative outcomes after early adverse experiences.

Objectives
This review scoped out the literature on resilience factors in relation to adulthood outcomes as diverse as mental health and educational attainment. Our aim was to understand where there is untapped research potential, by examining the current evidence base on resilience factors in terms of (a) resources that can buffer the impact of childhood adversity and (b) the pathways linking adversity to long-term outcomes. Furthermore, we aimed to identify gender patterns in these resources and pathways, which has not been a primary interest of reviews on resilience to date, and which can add to our understanding of the different ways in which resilience may unfold.

Eligibility criteria
Studies had to include an adversity experienced in childhood, an outcome considered indicative of resilience in adulthood, and at least one putative resilience factor, which had to be approached via mediation or moderation analysis. We considered cohort, case–control and cross-sectional studies.

Sources of evidence
We searched PubMed, Scopus and PsycINFO and included original, peer-reviewed articles published before 20 July 2023 in English, German, French, Spanish, Dutch and Swedish.

Charting methods
All three authors collaborated on the extraction of information relevant to answering the research questions. The results were visually and narratively summarised.

Results
We included 102 studies. Traditionally anchored in the field of psychology, the resilience literature focuses heavily on individual-level resilience factors. Gender was considered in approximately 22% of included studies and was always limited to comparisons between men and women. There is no evidence that childhood adversity impacts men and women differently in the long term, but there is some evidence for gender differences in resilience factors.

Conclusions
There is untapped potential in resilience research. By considering structural-level factors simultaneously with individual-level factors, and including gender as one of the elements that shape resilience, we can map resilience as a heterogeneous, multilevel process from a public health perspective. This would complement the extensive existing literature on individual-level factors and help reframe resilience as a concept that can be intervened on at a structural level, and that is subject to societal norms and forces, such as gender. There is a lack of quantitative studies including transgender and gender-non-conforming persons.

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Settembre 2024

Time to focus on the real potential benefit of endobiliary radiofrequency ablation: stent patency in patients with cholangiocarcinoma

We were delighted to read the article by Jarosova et al, which presents the results of a randomised controlled trial investigating the efficacy of endobiliary radiofrequency ablation (eRFA).1 The authors should be commended for conducting this large trial not only in pancreatic cancer but also, much rarer, perihilar cholangiocarcinoma (pCCA) patients. Endobiliary RFA uses high frequency current to generate heat, which results in coagulation and local tumour necrosis, possibly leading to delayed tumour growth. Theoretically, the potential benefit of eRFA is larger in tumours that originate from the bile duct itself rather than compressing the bile duct, such as pancreatic cancer. The safety and feasibility have been shown in multiple studies, but the efficacy has not been sufficiently studied in randomised trials yet.2–4 Unfortunately, current trial has not been able to show the superiority of eRFA prior to stent placement over…

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Settembre 2024

Identifying microbiome-based changes and biomarkers prior to disease development in mother and child, with a focus on gestational diabetes mellitus: protocol for the DANish Maternal and Offspring Microbiome (DANMOM) cohort study

Introduction
The human gut microbiota is associated with gestational diabetes mellitus (GDM), which imposes a risk of developing long-term health problems for mother and child. Most studies on GDM and microbiota have been cross-sectional, which makes it difficult to make any conclusions on causality. Furthermore, it is important to assess if a dysbiotic microbiota is passed from the mother to the child, and then being at risk of developing metabolic health problems later in life. The DANish Maternal and Offspring Microbiome study aims to identify gut microbiota-related factors involved in metabolic dysfunction in women with GDM and their offspring. Importantly, the study design allows for early detection of biological changes associated with later development of metabolic disease. This could provide us with unique tools to support early diagnosis or implement preventative measures.

Methods and analysis
Pregnant women are included in the study after the 11–14 weeks’ prenatal ultrasound scan and followed throughout pregnancy with enrolment of the offspring at birth. 202 women and 112 children have been included from North Denmark Regional Hospital and Aalborg University Hospital in Denmark. Mother and child are followed until the children reach the age of 5 years. From the mother, we collect faeces, urine, blood, saliva, vaginal fluid and breast milk samples, in addition to faeces and a blood sample from the child. Microbiota composition in biological samples will be analysed using 16S rRNA gene sequencing and compared with demographic and clinical data from medical charts, registers and questionnaires. Sample and data collection will continue until July 2028.

Ethics and dissemination
The study protocol has been approved by the North Denmark Region Committee on Health Research Ethics (N20190007). Written informed consent is obtained from all participants prior to study participation. Study results will be published in international peer-reviewed journals and presented at international conferences. The results will also be presented to the funders of the study and study participants.

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Settembre 2024

Mapping review of 'proof-of-concept in mental health implementation research using the TRL framework: a need for a better focus and conceptual clarification

Background
Proof-of-concept (PoC) development is a key step in implementation sciences. However, there is a dearth of studies in this area and the use of this term in health and social sciences is ambiguous.

Objective
The objective was to remove the ambiguity surrounding the PoC and pilot study stage in the research development process using a standard system to rate the development of projects and applications provided by the Technology Readiness Levels (TRL) framework.

Design
Mapping review and critical analysis using TRL as the standard measure.

Search strategy and charting method
PubMed and PsycInfo databases were searched for papers that reported PoC studies of mental health interventions up to August 2023. Data were extracted, described and tabulated.

Eligibility criteria
Included were PoC studies in mental health implementation research. Exclusion criteria were research relating to biomedical (drugs) development, neurocognitive tools, neuropsychology, medical devices, literature reviews or discussion papers or that did not include the term ‘proof-of-concept’ in the title, abstract or text.

Results
From the 83 citations generated from the database search, 22 studies were included in this mapping review. Based on the study title, abstract and text, studies were categorised by research development stage according to the TRL framework. This review showed 95% of the studies used PoC incorrectly to describe the development stage of their research but which were not at this specific level of project development.

Conclusions
The TRL was a useful reference framework to improve terminological clarity around the term ‘proof-of-concept’ in implementation research. To extend the use of TRL in implementation sciences, this framework has now been adapted and validated to a health and social science-related research context accompanied by a health-related glossary of research process terms and definitions to promote a common vocabulary and shared understanding in implementation sciences.

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Agosto 2024