BMJ Open

Zhang, Yun Yi; Wang, Gang; Hou, Chunsheng; Xu, Zhi; Wang, Lixin; Cui, Long; Ling, Xiaofeng; Zhang, Lingfu

doi: 10.1136/bmjopen-2024-089540pmid: 40268483

IntroductionSeveral techniques are used for laparoscopic treatment of gallstone disease with biliary duct stone, but each approach has indications and shortcomings. We have developed a modified laparoscopic transcystic biliary drainage for the management of cholecysto-choledocholithiasis. The hypothesis is that the modified laparoscopic transcystic biliary drainage will reduce morbidity from around 15% to less than 5%. The aim of this study is to assess the safety and efficacy of the modified laparoscopic transcystic biliary drainage.Methods and analysisThis is a prospective single-arm clinical trial to evaluate the safety and efficacy of the modified laparoscopic transcystic biliary drainage. The recruited 310 patients will be from Peking University Third Hospital. (Here, patients who meet the inclusion criteria will be included in the study, all patients will undergo laparoscopic cholecystectomy with concomitant laparoscopic exploration of the common bile duct and a modified laparoscopic transcystic drainage.) The primary endpoint is the postoperative morbidity and bile leakage. The secondary endpoints of the study are anchoring time of the C-tube, average daily drainage volume, early dislodgement of the C-tube, removal time of the C-tube, pancreatitis, residual stones and postoperative hospital stay. Recurrent stones and biliary stricture will be recorded during 6 months of follow-up. A two-tailed p<0.05 was considered statistically significant. SPSS for Windows V.21.0 (SPSS) software was used.Ethics and disseminationThis clinical trial was approved by the Medical Science Research Ethics Committee of Peking University Third Hospital (No. M2023223).Trial registration numberNCT06011941.Protocol versionV.2, 23 November 2023.

Davidson, Lydia; Kitikiti, Chikomborero; Blencowe, Hannah; Fitzgerald, Felicity; Moxon, Sarah; Chimhini, Gwendoline; Chingono, Rudo

doi: 10.1136/bmjopen-2024-093967pmid: 40246559

IntroductionNeonatal sepsis is a key contributor to neonatal mortality worldwide, and low- and middle-income countries (LMIC) are disproportionately affected. With antimicrobial resistance challenging effective treatment of neonatal sepsis, it is increasingly urgent to improve infection prevention and control (IPC) in LMIC neonatal units (NNU) and reduce transmission of infections. One pathway to improvement which merits further exploration is the collaboration with families to build an IPC intervention.Families are constantly present on neonatal units, and much of the hands-on care for their newborns is given by them. For IPC to be effective, families must adhere to IPC standards within the NNU, but furthermore, any IPC intervention implemented must be feasible and acceptable for families as well as the hospital staff as this will increase uptake and effectiveness of the intervention. This scoping review aims to provide an overview of parental involvement in infection prevention and control in low- and middle-income setting neonatal units.Methods and analysisThis protocol was developed in line with the Joanna Briggs Institute recommendations. Searches will be carried out on six databases (Medline, CINAHL, Global Health, EMBASE, Web of Science and Global Index Medicus), and reference searching will be carried out on included studies. The search will be carried out from 2000 to present (end date 28/02/2024), and included languages will be English, French, Spanish and Portuguese. Screening and data extraction will be performed independently by two reviewers, with a third reviewer to resolve conflicts. Results will be reported by narrative synthesis of each sub-question in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.Ethics and disseminationThis study will be carried out using already published data exclusively and therefore does not require further ethical approval. Results will be disseminated through peer-reviewed publications and conference presentations and through engagement with peers and relevant stakeholders.Trial registration numberRegistered with Open Science Framework - https://osf.io/snc7a/?view_only=8ffc39d837594b4388c7394a838c3a9e

Carey, Mariko L; Kelly, Michelle; Pond, Dimity; Nair, Balakrishnan R; Attia, John; Jeon, Yun-Hee; Deeming, Simon; Rhee, Joel J; Wales, Kylie; Khaing, Kay; Williams, Anna; White, Jennifer; Harden, Mandy; Ford, Claudine; Ward, John; Lithgow, Stephanie; Oldmeadow, Christopher; Jalewa, Jaishree; Smart, Emma; Wood, Kate;

Coulson, Tim G; Paul, Eldho; Miles, Lachlan F; Pilcher, David; Marasco, Silvana F; Frei, Daniel; Bellomo, Rinaldo

doi: 10.1136/bmjopen-2024-095099pmid: 40233952

IntroductionCardiac surgery is frequently associated with vasoplegia and vasopressor treatment. Both may be associated with postoperative complications and prolonged length of stay. The most frequently used vasopressor is norepinephrine. However, in a pilot, double-blind, randomised controlled trial (RCT) in cardiac surgery patients, angiotensin II was effective in maintaining blood pressure and was associated with a shorter duration of hospital stay than norepinephrine. Furthermore, hyperreninaemic patients were more sensitive to angiotensin II. These findings support the need for a larger RCT to determine whether angiotensin II is superior to norepinephrine as a first-line treatment for low blood pressure after cardiac surgery.Methods and analysisWe will conduct a double-blind RCT comparing an infusion of either angiotensin II or norepinephrine intraoperatively and for up to 48 hours after the start of surgery. We will randomly allocate 400 cardiac surgery patients at multiple centres in two countries to either an equipotent angiotensin II or norepinephrine infusion, titrated to a mean arterial pressure of 70–80 mm Hg. The primary outcome will be length of hospital stay. Secondary outcomes will include a composite of renal, cardiovascular and neurological events. A subgroup analysis of patients with elevated baseline renin levels will be undertaken.Ethics and disseminationEthical approval has been granted by the Alfred Human Research Ethics Committee on 14 July 2023 (HREC/97814/Alfred-2023). Results will be published on completion of the trial.Trial registration numberAustralian and New Zealand Clinical Trials Registry: ACTRN12623000848606.

Rajaram, Gowri; Gibson, Kerry L; Kartal, Dzenana; Lamblin, Michelle; Richards, Hannah; Davies, Pemma; Witt, Katrina; Robinson, Jo

doi: 10.1136/bmjopen-2024-093859pmid: 40180398

ObjectivesTo understand the help-seeking experiences of young people from culturally and linguistically diverse (CALD) backgrounds who have experienced suicidal thoughts and behaviours (STB).DesignQualitative study using semistructured interviews and reflexive thematic analysis.SettingA specialist, youth-focused Hospital Outreach Post-suicidal Engagement (HOPE) aftercare service delivered by Orygen in North-West Melbourne, Australia.ParticipantsEight young people aged 16–24 years (mean: 18.7±3.1 years, 50% female) from various CALD backgrounds who had been discharged from the HOPE aftercare service within the past 12 months.ResultsFour themes were identified: (1) cultural taboos and generational differences create challenges in communicating with family; (2) isolation is a barrier to reaching out; (3) it’s hard to disclose and discuss STB with clinicians and (4) not being taken seriously in clinical settings.ConclusionThese findings highlight social, cultural and organisational barriers that shape the help-seeking journeys of young people from CALD backgrounds experiencing STB. Results suggest a need for culturally sensitive suicide prevention strategies, enhanced cultural competency in healthcare settings and efforts to improve mental health literacy within CALD communities.

Guillemin, Francis; Casey, Romain; Epstein, Jonathan; Foucher, Yohann; Laplaud, David; Achit, Hamza; Rollot, Fabien; Leray, Emmanuelle; Vukusic, Sandra

doi: 10.1136/bmjopen-2024-094688pmid: 40194873

PurposeTo determine prognostic factors of disability in multiple sclerosis (MS), that is, (1) identify determinants of the dynamics of disability progression; (2) study the effectiveness of disease-modifying treatments (DMTs); (3) merge determinants and DMTs for creating patient-centred prognostic tools and (4) conduct an economic analysis.ParticipantsIndividuals registered in the French Observatoire Français de la Sclérose en Plaques (OFSEP) database were included in this OFSEP-high definition cohort if they had a diagnosis of MS, were ≥15 years old and had an Expanded Disability Status Scale (EDSS) score <7. The outcomes will be assessed annually: (1) time to reach irreversible EDSS scores of 4, 6 and 7; (2) relapses and disease progression; (3) MRI-based progression, patient-reported outcomes, social consequences; and (4) combined outcomes on activity and progression. Clinical and quality-of-life data, MRI results and biological (blood, serum) samples will be collected at each follow-up.Findings to dateA cohort of 2842 individuals, 73.4% women, mean (SD) age of 42.7 (11.6) years, median disease duration of 8.8 years, has been recruited from July 2018 to September 2020. The course of MS was relapsing remitting in 67.7%, secondary progressive in 11.9%. The mean annual relapse rate was 0.98. The disease-modifying treatment received was highly effective therapy in 50.3% and moderately effective therapy in 30.7%.Future plansThe participants will be followed until December 2026. Disease course up to four landmarks will be examined as predictors of disease progression: (1) diagnosis of MS; (2) relapse activity worsening and independent progression; (3) any recent disease activity and (4) any visit with absence of disease activity in the past 5 years. The marginal effectiveness and tolerability of treatments will be assessed. Stratified algorithms will be proposed for medical decision-making. Economic evaluation of disease cost and cost-effectiveness of new DMTs will be conducted from a public payer perspective.Trial registration numberNCT03603457.

Smit, Michel Sebastiaan; Mölenberg, Famke; Mensink-Bout, Rosalie; Nieboer, Daan; Voortman, Trudy; Duijts, Liesbeth; Raat, Hein; Jansen, Wilma

doi: 10.1136/bmjopen-2024-088272pmid: 40204310

ObjectivesIn this study, we evaluate the long-term effects (±1.5 years postintervention) of 6-year exposure to the Lekker Fit! intervention on physical fitness and physical activity (PA).DesignThe retrospective intervention evaluation is embedded within the Generation R Study in Rotterdam, the Netherlands, a population-based prospective birth cohort study.SettingMeasurements took place in the research centre of the Generation R cohort study.Participants5489 adolescents from the Generation R Study were eligible for inclusion within this study. Successful linking to school career data was possible for 4129 adolescents who were then retrospectively subdivided into a Lekker Fit! group, mixed group and regular school group based on their primary school career.InterventionsThe Lekker Fit! intervention is a multicomponent primary school-based intervention for the prevention of overweight. It focuses on a healthy diet and healthy lifestyle rather than focusing directly on the reduction of overweight. The intervention targets individual behaviour of children as well as their obesogenic environment and parental engagement in shaping their children’s behaviour.Primary and secondary outcome measuresAged 13/14 years old, physical fitness was measured with an incremental ergometer test. The actual highest achieved work rate was divided by the expected highest achieved work rate (age- and sex-related Dutch population-based reference data), and converted into z-scores. PA was determined by the number of days with at least 1 hour of PA, obtained by a self-reported questionnaire. Propensity score matching was performed to correct for non-random selection bias. Linear regression analyses were performed to estimate intervention effects.ResultsChildren from the Lekker Fit! group had significantly lower fitness z-scores (−0.18 (95% CI −0.29 to –0.06), n=1826) compared with children from the matched regular school group. No Lekker Fit! intervention effect was found on PA (−0.12 (95% CI −0.36 to 0.12), n=1258).ConclusionsNo evidence was found for long-term favourable effects of a school-based multicomponent intervention on physical fitness and PA. Recommendations for policy and future research are discussed.

Hog, Liv; Fundin, Bengt T; Everett Palm, Erik; Billger, Annelie; Bulik, Cynthia M; Abbaspour, Afrouz; Dinkler, Lisa

doi: 10.1136/bmjopen-2024-095559pmid: 40246566

IntroductionThe ARFID InitiativE Sweden (ARIES) investigates the genetic and environmental factors contributing to avoidant/restrictive food intake disorder (ARFID) in children and adolescents aged 6–14 years. ARIES will establish a national biobank and research registry. It aims to provide data for immediate research and track ARFID outcomes and clarify genetic links between ARFID and other conditions and analyse the gut microbiome to guide nutrition interventions.Methods and analysisThe study will involve 1500 Swedish children and adolescents with ARFID and a control group of 500 Swedish children and adolescents without ARFID. Parents/guardians and their children will complete online questionnaires assessing ARFID and other eating disorder (ED) pathology, co-occurring conditions, quality of life and parental stress and ED pathology. All participants will provide a saliva sample for comprehensive genetic analyses. Additionally, a subset of participants will provide a stool sample to investigate the gut microbiome in ARFID.Ethics and disseminationARIES was approved by the Swedish Ethical Review Authority (Dnr 2023-04638). All participants will give assent and their parents will complete informed consent. Data will be made available by the authors on reasonable request. Findings will be published in scientific journals and shared with the public and stakeholders in accessible ways, for example, via social media.

Coulibaly, Karna; Schantz, Clémence; Teixeira, Luis; Desgrées du Loû, Annabel; Des Guetz, Gaëtan; Hocini, Hamid; Zelek, Laurent; Larmarange, Joseph; Gosselin, Anne

doi: 10.1136/bmjopen-2024-095759pmid: 40180375

IntroductionBreast cancer is a global public health challenge. It is the most commonly diagnosed cancer and the leading cause of cancer-related death in women. Several inequalities remain among women facing this disease, depending on their country of birth and their sociodemographic characteristics. The SENOVIE study (Therapeutic mobility and breast cancer) aims to understand the life trajectories of women born in France and in sub-Saharan Africa treated for breast cancer in four hospitals in the greater Paris area.Methods and analysisThe SENOVIE study is a mixed methods study, combining a quantitative and a qualitative approach. A quantitative retrospective life-event survey is conducted in four hospital centres in the greater Paris area, France, to (1) understand how breast cancer (diagnosis, treatment and possibly reconstruction) impacts the life trajectories of women in many spheres (migration, family life, professional life, financial situation, etc); (2) study the access to healthcare by women living with breast cancer and their determinants; and (3) examine how gender relations may shape breast cancer experience. Women born in France and women born in sub-Saharan Africa are recruited: 1000 women, including 500 per group. In the standardised, face-to-face questionnaire, each dimension of interest is collected year by year from birth until the time of the survey. Clinical and laboratory information is documented with a short medical questionnaire filled out by the medical teams. The qualitative survey is conducted specifically with women born in sub-Saharan Africa who came to France for treatment to better understand their trajectories and the specific obstacles they faced. To analyse the quantitative data collected, descriptive analyses will be used to visualise trajectories (sequence analysis), along with longitudinal analysis methods (survival models and duration models).Ethics and disseminationThe study is conducted in accordance with the Declaration of Helsinki. The French Data Protection Authority (Commission Nationale de l’Informatique et des Libertés, declaration number 2231238) and the Committee for Persons’ Protection East I (Comité de Protection des Personnes Est I, national number 2023-A01311-44) approved it. We will disseminate the findings through scientific publications, policy briefs, conferences and workshops.Trial registration numberThe SENOVIE France study is registered on Clinicaltrial.gov (NCT06503393; registration date: 7 September 2024; https://clinicaltrials.gov/study/NCT06503393).

McCabe, Ronan; Kibuchi, Eliud; Amele, Sarah; Irizar, Patricia; Sheikh, Aziz; Jeffrey, Karen; Ruden, Igor; Simpson, Colin R; McCowan, Colin; Ritchie, Lewis; Robertson, Chris; Leyland, Alastair H; Demou, Evangelia; Pearce, Anna; Katikireddi, Srinivasa Vittal

doi: 10.1136/bmjopen-2024-092727pmid: