BMJ Open

Iversen, Anne Kristine Servais; Lichtenberg, Mads; Fritz, Blaine Gabriel; Díaz-Pinés Cort, Isabel; Al-Zoubaidi, Dania Firas; Gottlieb, Hans; Kirketerp-Møller, Klaus; Bjarnsholt, Thomas; Jakobsen, Tim Holm

doi: 10.1136/bmjopen-2024-084081pmid: 39419618

IntroductionChronic wounds affect 1%–2% of the global population, with rising incidence due to ageing and lifestyle-related diseases. Bacterial biofilms, found in 80% of chronic wounds, and scattered single-cell bacteria may hinder healing. Microbes are believed to negatively impact healing by exacerbating inflammation and host immune response.Methods and analysisThe primary objective of the chronic wound characterisation (CWC) study is to investigate chronic wounds through a prospective observational cohort study exploring bacterial community composition, inflammatory responses and the influence of bacteria on wound-healing trajectories. The CWC study will be investigated through two cohorts: the predictive and in-depth.The predictive cohort includes patients with a chronic wound scheduled for mechanical debridement. The debrided material will be collected for dual RNA sequencing and 16s ribosomal RNA gene sequencing, as well as samples for microbial culturing and a photo to assess the wound. Clinical data is recorded, and healing and/or other clinical endpoints are established through medical records.The in-depth cohort includes and follows patients undergoing split-thickness skin grafting. Extensive sampling (ESwabs, biopsies, tape strips, debrided material and a sample of the skin graft) will be performed on surgery and patients will be seen at two follow-up visits. Samples will be analysed through culturing and next-generation sequencing methods. A biobank will be established comprising longitudinal clinical samples and clinical data.Ethics and disseminationThe study has been approved by the board of health ethics, Capital Region of Denmark, under protocol number H-20032214. The study findings will be disseminated through peer-reviewed publications and showcased at both national and international conferences and meetings within the domains of microbiology, wound healing and infection.

Allen, Kate; Trethewey, Samuel P; Mathews, Frances; Price, Anna; Newlove-Delgado, Tamsin

doi: 10.1136/bmjopen-2024-086403pmid: 39477262

ObjectivesTo explore commissioners’ experiences of commissioning services for child and adolescent mental health, their perspectives on the needs of their populations, the challenges they face and their needs for support and data.DesignQualitative study involving semi-structured interviews. All interviews were audio-recorded and transcribed verbatim. Data were analysed using framework analysis.SettingEngland, UK.Participants12 integrated care board commissioners, responsible for commissioning NHS England Child and Adolescent Mental Health Services (CAMHS).ResultsWe identified five themes: ‘reflections on role’; ‘priorities and tensions: working in a complex and evolving integrated care system’; ‘insights and evidence: the role and use of data and informants’; ‘children’s mental health in the limelight: influences and expectations’; and ‘responding to need "CAMHS as the answer to everything"’. Combined, these themes highlight the integral role commissioners play in providing oversight over the local system and challenges to this role including disproportionate funding for services for child and adolescent mental health, different use and value ascribed to ‘qualitative’ and ‘quantitative’ data, rises in demand and the limited focus on early intervention and prevention.ConclusionsCAMHS commissioners are currently negotiating a complex and changing political, social and economic environment with competing priorities and pressures. Our research indicates that commissioners require greater support as their roles continue to evolve.

van Zadelhoff, Tijmen A; Bos, P Koen; Moelker, Adriaan; Bierma-Zeinstra, Sita M A; van der Heijden, Rianne A; Oei, Edwin H G

doi: 10.1136/bmjopen-2024-087047pmid: 39353688

ObjectiveTo determine the efficacy of genicular artery embolisation (GAE) compared with sham GAE for pain reduction in patients with symptomatic mild-to-moderate knee osteoarthritis (KOA).DesignDouble-blind randomised sham-controlled clinical trial conducted from June 2019 to December 2021. The follow-up period was 4 months.SettingSingle-centre study conducted at a university medical centre in Rotterdam, Netherlands.Participants58 adults with symptomatic mild-to-moderate KOA not improving with conservative treatment.InterventionsParticipants were randomised to receive either GAE treatment or a sham GAE treatment.Main outcome measuresThe primary outcome was reduction of pain measured with the Knee Injury and Osteoarthritis Outcome Score pain subscale (0–100, with 0 representing the worst pain outcome and 100 the best) after 4 months. Outcomes were assessed at baseline and 1 and 4 months.ResultsFrom June 2019 to December 2021, 58 patients were included. 29 patients were randomised to the GAE group and 29 to the sham group. All participants completed the study. The mean pain reduction after 4 months was 21.4 (95% CI 13.9 to 28.8) for the GAE group and 18.4 points (95% CI 11.6 to 25.1) for the sham group. The between-group difference for the mean pain reduction was 3.0 (95% CI −7.1 to 13.0) with an estimated Cohen’s d effect size of d = 0.15 (95% CI −0.37 to 0.66). Group allocation was not a significant contributor to pain reduction (p = 0.31). No serious adverse events (AEs) occurred. 23 mild AEs occurred in the GAE group and 5 in the sham group.ConclusionWe did not establish a clinical effect of GAE in patients with mild-to-moderate KOA as GAE produced a similar effect on pain reduction as a sham GAE procedure.Trial registration number NCT03884049.

Yang, Wenmei; Zhao, Xiaoqi; Pan, Jingyi; Zhi, Zhifu

doi: 10.1136/bmjopen-2024-087582pmid: 39486826

AimThe goal of this study is to evaluate the safety of diagnostic hysteroscopy (HSC) in type II endometrial cancer (EC).MethodsWe searched PubMed, the Cochrane Library and the Chinese Medical Journal Full-Text Database until December 2023. Eligible trials were all cohort studies in which patients were allocated to diagnostic HSC group or dilation and curettage (D&C) group. Quality assessments of eligible studies were performed using the Newcastle–Ottawa scales. Risk ratios (RRs) with 95% CIs were calculated as a measure of effects.ResultsThree trials were included in our analysis, which were all retrospective cohort studies. 696 patients with histologically proven type II EC were allocated to HSC or D&C before surgery. 257 patients underwent preoperative HSC, and 439 patients underwent D&C. The positive peritoneal cytology rate did not statistically differ between the groups (RR, 1.9; 95% CI, 1.00 to 3.61; p=0.05). There was no significant difference in the incidence of International Federation of Gynecology and Obstetrics (FIGO) stage between the HSC and D&C groups (stage I/II: RR, 1.08; 95% CI, 0.95 to 1.24; p=0.25; stage III/IV: RR, 0.82; 95% CI, 0.62 to 1.09; p=0.18). There was no significant difference in recurrence between the HSC and D&C groups (RR, 0.92; 95% CI, 0.66 to 1.32; p=0.66); the heterogeneity of the two included studies was acceptable (p=0.54, I2=0%).ConclusionsPreoperative HSC in patients with type II EC does not increase the risk for cancer cell dissemination within the peritoneal cavity. Preoperative HSC does not progress the FIGO staging in patients with type II EC and does not increase the risk of tumour recurrence. There is no reason to avoid HSC for the diagnosis of type II EC currently. However, type II tumours generally are less well differentiated and have poorer prognoses than type I tumours. More prospective and adequately powered trials are required to clarify whether preoperative HSC in patients with type II EC is safe.

van Geffen, Eline G M; Sluckin, Tania C; Hazen, Sanne-Marije J A; Horsthuis, Karin; Intven, Martijn; van Dieren, Susan; Beets, Geerard; Lange, Marilyne M; Taggart, Melissa W; Beets-Tan, Regina G H; Marijnen, Corrie A M; Konishi, Tsuyoshi; Tanis, Pieter J; Kusters, Miranda

doi: 10.1136/bmjopen-2023-083225

Evans, Catrin; Clancy, Georgia; Evans, Kerry; Booth, Andrew; Nazmeen, Benash; Sunney, Candice; Clowes, Mark; Jones, Nia; Timmons, Stephen; Spiby, Helen

doi: 10.1136/bmjopen-2023-079153pmid: 39486829

ObjectivesThe COVID-19 pandemic has led to increased use of digital clinical consultations (phone or video calls) within UK maternity services. This project aimed to review the evidence on digital clinical consultations in maternity systems to illuminate how, for whom and in what contexts, they can be used to support safe, personalised and equitable care.DesignA realist synthesis, drawing on diverse sources of evidence (2010–present) from OECD countries, alongside insights from knowledge user groups (representing healthcare providers and service users).MethodsThe review used three analytical processes (induction, abduction and retroduction) within three iterative stages (development of initial programme theories; evidence retrieval and synthesis; validation and refinement of the programme theories).ResultsNinety-three evidence sources were included in the final synthesis. Fifteen programme theories were developed showing that digital clinical consultations involve different mechanisms operating across five key contexts: the organisation, healthcare providers, the clinical relationship, the reason for consultation and women. The review suggests that digital clinical consultations can be effective and acceptable to stakeholders if there is access to appropriate infrastructure/digital resources and if implementation is able to ensure personalisation, informed choice, professional autonomy and relationship-focused connections. The review found relatively less evidence in relation to safety and equity.ConclusionsDue to the complexity of maternity systems, there can be ‘no one-size fits all’ approach to digital clinical consultations. Nonetheless, the review distills four ‘CORE’ implementation principles: C—creating the right environment, infrastructure and support for staff; O—optimising consultations to be responsive, flexible and personalised to different needs and preferences; R—recognising the importance of access and inclusion; and E—enabling quality and safety through relationship-focused connections. Service innovation and research are needed to operationalise, explore and evaluate these principles, particularly in relation to safety and equity.PROSPERO registration numberCRD42021288702.

Normandin, Louise; Vialaron, Cécile; Guemghar, Imane; Sales, Justine; Fleury, Danielle; Malas, Kathy; Wong, Caroline; Brunet, Fabrice; Pomey, Marie-Pascale

doi: 10.1136/bmjopen-2024-083948pmid: 39433415

ObjectivesThe purpose of this study is to describe and evaluate, in a real-life context, the support and communicate with families (SCF) team’s contribution to maintaining communication and supporting relatives when patients are at the end of their lives by mobilising the points of view of SCF team members, healthcare professionals, managers and the relatives themselves.DesignAn in-depth mixed-method case study (quantitative and qualitative). Individual interviews were conducted with members of the SCF team to assess the activities and areas for improvement and with co-managers of active COVID-19 units. Healthcare professionals and managers completed a questionnaire to assess the contribution made by the SCF team. Hospitalised patients’ relatives completed a questionnaire on their experience with the SCF team.SettingThe study was conducted in a university teaching hospital in the province of Québec, Canada.ParticipantsMembers of the SCF team, healthcare professionals, managers and relatives of hospitalised patients.ResultsBetween April and July 2020, 131 telephone communications with families and healthcare professionals, 43 support sessions for relatives of end-of-life patients and 35 therapeutic humanitarian visits were carried out by members of the SCF team. Team members felt that they had played an active role in humanising care. Fully 83.1% of the healthcare professionals and managers reported that the SCF team’s work had met the relatives’ needs, while 15.1% believed that the SCF team should be maintained after the pandemic. Fully 95% of the relatives appreciated receiving the telephone calls and visits, while 82% felt that the visits had positive effects on hospitalised patients.ConclusionThe COVID-19 pandemic forced the introduction of a social innovation involving support for and communication with families. The intention of this innovation was to support the complexity of highly emotional situations experienced by families during the COVID-19 pandemic.

Espinoza Suarez, Nataly R; Desrosiers, Félix; Prokop, Larry J; Dupéré, Sophie; Diallo, Thierno

doi: 10.1136/bmjopen-2023-078396pmid: 39414271

IntroductionDespite the increasingly evidenced positive impacts of green space on human physical and mental health, green spaces remain inequitably distributed across different socioeconomic groups. Urban planning and design should prioritise the development and maintenance of urban green spaces, especially for vulnerable and marginalised populations while thinking about protecting them from the effects of green gentrification. This scoping review will explore how the concepts of equity, diversity and inclusion are integrated into the design, the planning and policy development of urban green spaces. Also, we will explore what are the efforts made to incorporate equity, diversity, and inclusion concepts into the planning, design and policy development of urban green spaces to make them equitable for vulnerable and marginalised populations.Methods and analysisThis protocol is based on the methodology developed by Arksey and O’Malley and improved by Levac et al. The search will be done in conjunction with a professional librarian, to include studies in all languages. The review will include multidisciplinary databases: Ovid MEDLINE, Ovid EMBASE, CINAHL, Web of Science and GeoBase. The search will be done from each database’s inception to February 2024. We will present our results narratively and will conduct a thematic analysis using the urban green equity framework. This framework will guide our understanding of the interplay between the spatial distribution of urban green spaces and the recognition of diverse voices in urban greening decision-making.Ethics and disseminationThis scoping review will not require ethical approval since it will be collected from publicly available documents. The results of this scoping review will be presented as a scientific article, social media and public health or environmental conferences organised by environmental organisations or academic institutions.

Orsatti, Amy; Bowden, Jocelyn L; Naylor, Justine M; Boland, Robert; Pardey, Margery; Descallar, Joseph; Mills, Kathryn

doi: 10.1136/bmjopen-2024-090360pmid: 39375185

IntroductionFirst steps for knee osteoarthritis (OA) is a cluster randomised implementation trial examining the effect of an educational reminder message included in knee X-ray reports on the proportion of people subsequently referred to exercise professionals for their knee OA. Evaluating the processes supporting the completion of the study and the efficacy of the reminder message is essential to interpreting the outcomes of the study and aiding translation into practice.Methods and analysisWe will conduct a concurrent process evaluation throughout the current study using a previously published framework for examining cluster randomised trials. This framework divides processes into those occurring at the cluster level and those at the target population level. For the current study, the cluster level is within radiology clinics. The target population is people with newly diagnosed radiologically evident, structural knee OA. A mixed methods design, incorporating survey data, administrative records, field notes and semi-structured interviews with representatives from radiology clinics and people with knee OA, will evaluate these processes. The focus of the evaluation will be recruitment and response processes of the radiology clinics and delivery and response processes for the people with knee OA. We will also describe the context and explore how the nudge theory of behavioural change influences the outcome of the study.Ethics and disseminationThe study protocol, inclusive of the process evaluation, was approved by Macquarie University Human Research Ethics Committee (#520221190343842). Findings will be disseminated through national and international conferences, national industry stakeholders and patient advocacy groups to reach all levels of healthcare. Staff at radiology clinics and people with knee OA involved in interviews provide written, informed consent to participate in the process evaluation. Specific findings will be incorporated into training modules aimed at radiology clinics and will be developed by our industry partners.Trial registrationProspectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622001414707p). Registration occurred in December 2022

Ponce Rodriguez, Lucia; Fuentes Rueda, Carmen M; Rojo Franconetti, Maria; Esteban, Laura; Ibáñez-Alfonso, Joaquín A

doi: 10.1136/bmjopen-2023-083266pmid: 39384242

IntroductionSeveral studies have highlighted the role of temperament as a relevant construct to understand the wide variability observed in neurodevelopmental disorders (NDDs) such as autism spectrum disorder and attention deficit hyperactivity disorder. Some studies have pointed to temperamental traits such as strained control as possible precursors to the development of these disorders. In addition, how temperament influences high-risk populations, as well as intervention programmes aimed at families, has been investigated.Methods and analysisThis paper presents the protocol that will be followed to carry out a systematic review, the objective of which is to know how child temperament is related to the different domains of development in children with NDD or the risk of suffering from it. The search strategy will be implemented in Web of Science (WoS Core Collection), PubMed, ERIC, PsycINFO and Cochrane databases. The risk of bias will be measured by the Newcastle-Ottawa Scale to carry out the integration of the results obtained to synthesis without meta-analysis will be used. This systematic review aims to improve scientific evidence for institutions and professionals and enhance the effectiveness of early care programmes for children with NDD and their families.Ethics and disseminationNo express approval has been sought from any ethics committee because there is no primary data involved and no access to confidential patient information.PROSPERO registration numberCRD42023445173.