BMJ Open最新文献

Introduction: Micropapillary serous borderline ovarian tumours (MP-SBOTs) are an aggressive subtype of serous borderline ovarian tumours (SBOTs). Surgery is the mainstay of treatment. Radical surgery (RS, including debulking) is an alternative. However, for patients who are of reproductive age, another treatment option is fertility-sparing surgery (FSS). Up to now, the best surgical approach for MP-SBOTs and whether different procedures will have an impact on postoperative recurrence are still up for debate. This protocol outlines a systematic review and meta-analysis to investigate whether FSS adversely affected outcomes compared with RS in patients with MP-SBOTs. Additionally, we will do a prognosis analysis of BOTs with no microcapillary pattern and MP-SOBTs, if possible.

Methods and analysis: This protocol will consider non-randomised studies comparing outcomes in patients with MP-SBOTs treated with RS or FSS. The following databases will be searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, MEDLINE, Embase Medline, PubMed, Web of Science, China Biological Medicine Database, China National Knowledge Infrastructure and Wan Fang database. We will try our best to search the grey literature to avoid missing crucial research. Data collection and extraction will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Risk of Bias in Non-randomised Studies of intervention will be used to assess non-randomized studies. We will assess the certainty of the evidence using the GRADEpro methodology and describe the degree of certainty of our results using suggested wording based on the GRADEpro assessment. We will conduct a meta-analysis and offer summary statistics for each result if there is enough data available. Instead, we will report the findings narratively where the data do not permit a statistical assessment.

Ethics and dissemination: Ethics approval was not required for this study. Results will be published through a peer-reviewed publication and communicated at scientific events once complete.

Prospero registration number: CRD42023439136.

Introduction: Traumatic brain injury (TBI) is one of the prevalent critical illnesses encountered in clinical practice, often resulting in a spectrum of consciousness disorders among survivors. Prolonged states of impaired consciousness can significantly elevate the susceptibility to complications such as urinary tract infections and pulmonary issues, consequently leading to a compromised prognosis and substantially impacting the quality of life for affected individuals. Clinical studies have reported that median nerve electrical stimulation (MNES) may have a therapeutic effect in the treatment of disorders of consciousness (DOC). We plan to conduct a systematic review and meta-analysis to evaluate the efficacy and safety of MNES in the management of DOC subsequent to TBI.

Methods and analysis: We will conduct a comprehensive literature search in the following electronic databases: Web of Science, Embase, PubMed, Cochrane Library, China Biology Medicine, China National Knowledge Infrastructure, Wan Fang Database and Chinese Scientific Journal Database. The search will be performed from the inception of the databases until 30 September 2024. Furthermore, we will search for relevant ongoing trials in the International Clinical Trial Registry Platform, ClinicalTrials.gov and China Clinical Trial Registry. Grey literature will also be sourced from reputable sources like GreyNet International, Open Grey and Google Scholar. We will include eligible randomised controlled trials. The primary outcome of interest will be the assessment of consciousness disorder severity. To ensure rigour and consistency, two independent reviewers will screen the studies for inclusion, extract relevant data and assess the risk of bias. Any discrepancies will be resolved through discussion or consultation with a third reviewer. The quality of evidence will be evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Data synthesis and meta-analysis will be conducted using STATA 15.1 software.

Ethics and dissemination: This systematic review and meta-analysis do not involve the collection or use of any individual patient data, thereby obviating the necessity for ethical review. The research findings will be disseminated through publication in peer-reviewed scientific journals.

Prospero registration number: CRD42024533359.

Introduction: In 2021, among French women who smoked when they knew they were pregnant, 59% still smoked at the end of pregnancy. Support for pregnant women to stop smoking must include a structured organisational perspective. The main objective of the study is to evaluate the effectiveness of the 5A-QUIT-N organisational intervention on smoking cessation at delivery among pregnant women who smoke during pregnancy.

Methods and analysis: The overarching goal of the 5A-QUIT-N intervention, which aims to organise the healthcare professionals monitoring pregnancy, specialists in addiction and tobacco use, and clinical and training tools, using the 5As method. The 5A-QUIT-N intervention will be evaluated in a pragmatic stepped-wedge cluster randomised trial. Within each cluster, during the 6 months before (control) and after (intervention) the intervention, women who smoke tobacco during pregnancy will be enrolled during their maternity stay after delivery. A transition period is planned between the control and intervention periods to deploy the intervention. All participating women will be interviewed using a heteroquestionnaire to assess smoking cessation, tobacco use monitoring by healthcare professionals and individual factors associated with tobacco use during pregnancy. The primary outcome was the point prevalence of abstinence at delivery, which is the proportion of women reporting abstinence from smoking for at least 7 days at delivery. 4200 women who smoked tobacco during pregnancy will be recruited over the entire study period (33 months) to evaluate the effectiveness. An estimated 4585 participants will be included for all aims.

Ethics and dissemination: The study will be implemented in accordance with French regulations. The study including the consent process has been independently reviewed and approved by the French ethical board 'CPP Ile de France I' on 10 February 2022 (No CPPIDF1-2022-DI08-cat.2). The results will be disseminated on various academic and non-academic platforms. The results will be reported in international peer-reviewed journals and presented at international and national conferences.

Objectives: Data on the rate of comorbidities in Arab patients with rheumatoid arthritis (RA) are limited, and extrapolating the prevalence of comorbidities from international studies is challenging. This study aimed to investigate the prevalence of comorbidities in patients with RA, compare it with that in non-RA controls and explore the association between the body mass index of patients with RA and comorbidities.

Design: This is a retrospective, case-control study.

Setting: This study included patients receiving secondary care at the Rheumatology Department of a public hospital in the Emirate of Dubai. The controls were recruited from patients receiving primary and secondary care at the Dubai Academic Health Corporation in the fourth quarter of 2022.

Participants: This study included all consecutive UAE national patients with RA who visited the rheumatology clinic. The study included 1756 participants in an age-matched and sex-matched control group and 439 patients with RA. Of these, 88.6% were female, and the median age was 55 years. Each RA case was randomly matched with four controls of the same age and sex. All relevant information, including case and control demographics and comorbidities, was retrieved from the electronic medical record.

Primary and secondary outcome measures: The relative risk of comorbidities was compared between patients with RA and age-matched controls. The relationship between obesity in RA and the frequency of comorbidities was determined.

Results: This study revealed that 188 (42.8%) patients with RA had at least one comorbidity, whereas only 636 (36.2%) individuals in the control group had at least one comorbidity (OR 1.3; 95% CI 1.1 to 1.6, p<0.01). Patients with RA were more likely to have ischaemic heart disease (OR 3.9; 95% CI 2.3 to 6.6, p<0.0001), fibromyalgia (OR 25; 95% CI 13 to 34, p<0.0001), cataract (OR 5.8; 95% CI 4 to 8.5, p<0.0001), osteoporosis (OR 6.8; 95% CI 4.6 to 10, p<0.0001) and knee osteoarthritis (OR 6.1; 95% CI 4.8 to 7.8, p<0.0001).

Conclusions: Patients with RA were more likely to have cardiovascular, pulmonary and musculoskeletal comorbidities compared with the control group. Obese patients with RA had a higher incidence of comorbidity than non-obese patients with RA.

Background: A decrease in obtaining quality healthcare is a major cause of maternal and newborn deaths in low-income and middle-income countries. Ethiopia has one of the highest neonatal mortality rates. Increasing mothers' health-seeking practices related to neonatal danger signs is an essential strategy for reducing the death rate of newborns. However, the pooled prevalence of mothers' health-seeking practices related to neonatal danger signs is not well known in Ethiopia.

Objective: The main aim of this systematic review and meta-analysis is to assess the mothers' health-seeking practices and associated factors towards neonatal danger signs in Ethiopia.

Design: Systematic review and meta-analysis.

Primary and secondary outcomes: The primary outcome was to assess the mothers' health-seeking practices towards neonatal danger signs and the secondary outcome was to identify factors associated with health-seeking practices.

Methods: In total, comprehensive literature was searched in the PubMed, Google Scholar, HINARI, Embase and CINAHL databases published up to 30 December 2023. A random effect model was used to estimate the pooled prevalence and adjusted OR (AOR). Stata (V.17.0) was used to analyse the data. I² statistics were computed to assess heterogeneity among studies. To minimise the underlying heterogeneity, a subgroup analysis was conducted based on the study region and year of publication. To assess publication bias, Egger's test and funnel plots were used.

Results: Overall, 1011 articles were retrieved, and 11 cross-sectional studies, with a total of 5066 study participants, were included in this systematic review. The overall pooled prevalence of mothers' health-seeking practices for neonatal danger signs in Ethiopia was 52.15%. Postnatal care follow-up (AOR 2.72; 95% CI 1.62 to 4.56), good maternal knowledge (AOR 3.20, 95% CI 2.24 to 4.56), educational status of secondary school and above (AOR 4.17, 95% CI 2.04 to 8.55), women's decision-making autonomy (AOR 3.59, 95% CI 1.60 to 8.06) and place of delivery (AOR 2.71, 95% CI 1.21 to 6.04) were significantly associated with mothers' health-seeking practices for neonatal danger signs.

Conclusion: The maternal health-seeking practices of women towards neonatal danger signs were found to be low in Ethiopia. When barriers to seeking care for newborn danger signs are successfully removed, women's practices for seeking care for neonatal danger signs could decrease perinatal mortality.

Objectives: Target trial emulation is an approach that is increasingly used to improve transparency in observational studies and help mitigate biases. For studies declaring that they emulated a target trial, we aimed to evaluate the specification of the target trial, examine its consistency with the observational emulation and assess the risk of bias in the observational analysis.

Design: Methodological systematic review reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.

Data sources: The database MEDLINE (Medical Literature Analysis and Retrieval System Online) was interrogated for all studies published from 1 January 2021 to 3 July 2022. We performed an additional manual search of 20 general medical and specialised journals that spanned the same period.

Eligibility criteria: All studies that declared emulating a hypothetical or real randomised trial were eligible.

Data extraction and synthesis: Two independent reviewers performed the whole systematic review process (screening and selection of studies, data extraction and risk of bias assessment). The main outcomes were the definition of the key protocol components of the target trial and its emulation, consistency between the target trial and its emulation and risk of bias according to the ROBINS-I (Risk Of Bias In Non-randomised Studies - of Interventions) tool.

Results: Among the selected sample of 100 studies, 24 (24%) did not specify the target trial. Only 40 studies (40%) provided detailed information on all components of the target trial protocol. Eligibility criteria, intervention strategies and outcomes were consistent between the target trial and its emulation in 35 studies (46% of those specifying the target trial). Overall, 28 studies (28%) exhibited serious risk of bias and 41 (41%) had misalignments in the timing of eligibility assessment, treatment assignment and the start of follow-up (time-zero). As compared with studies that did not specify the target trial, those that did specify the trial less frequently seemed to have both time-zero issues (39% vs 52%) and serious risk of bias (26% vs 33%).

Conclusions: One-quarter of studies declaring that they emulated a target trial did not specify the trial. Target trials and their emulations were particularly inconsistent for studies emulating a real randomised trial. Risk of methodological issues seemed lower in observational analyses that specified versus did not specify the target trial.

Introduction: Olfactory dysfunction (OD) is a prevalent nasal affliction that has detrimental effects on the patients' quality of life and safety. Conventional therapeutic strategies have various limitations such as high costs, prolonged treatment durations and adverse side effects. Intranasal insulin is a novel intervention for the management of OD. To date, few systematic reviews have been conducted to evaluate the efficacy of this intervention. This study aims to critically assess the therapeutic efficacy and safety profile of intranasal insulin administration in patients with OD.

Methods and analysis: A systematic literature search will be performed on several databases, including PubMed, the Cochrane Central Register of Controlled Trials, Embase, SinoMed and China National Knowledge Infrastructure (CNKI), to identify studies investigating the efficacy of intranasal insulin in treating OD. The search will span from database inception to 1 April 2024, including publication in Chinese and English languages. Data will be retrieved from the literature by two independent investigators. Subsequently, the data will be processed using RevMan V.5.3.5. The meta-analysis will be performed in line with the Cochrane Handbook guidelines. The clinical efficacy and safety of intranasal insulin for OD will be appraised based on various outcomes, including overall symptom improvement, the Connecticut Chemosensory Clinical Research Center score, variations in serum glucose levels, body mass index variations and the incidence of adverse events.

Ethics and dissemination: This will be a systematic review of available literature; thus, no ethical clearance is required. The results of this study will be shared through journal publication or presented at an academic conference.

Trial registration number: According to the guidelines, our systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 16 May 2024 (registration number CRD42024543438).

Objectives: To explore the postsurgery lived experiences of patients with colorectal cancer with a permanent ostomy for informing initiatives to improve patient care and future quantitative research.

Design: A descriptive qualitative phenomenological study.

Setting: We conducted this study in the Colorectal Cancer Division at the Cancer Center of West China Hospital, Sichuan University, a premier institution renowned for its comprehensive cancer care and research.

Participants: 12 patients who had undergone surgeries for colorectal cancer with a permanent ostomy.

Results: Our interviews revealed profound adjustments in the lives of colorectal cancer survivors living with permanent ostomies. Participants articulated a transition to a 'new normal', characterised by extensive daily life adjustments, psychological adaptation and ongoing management challenges. Key themes identified included the adaptation to a reshaped daily routine and altered perceptions of quality of life. Many faced substantial challenges in stoma care, requiring significant learning and adaptation. Psychological adaptations were marked by a redefinition of body autonomy and personal identity, alongside a recalibration of social interactions and privacy. The need for robust professional guidance and a comprehensive social support system was universally emphasised.

Conclusions: Patients with colorectal cancer with permanent ostomies navigate significant changes in their lives postsurgery, undertaking a complex process of reconstructing and adapting to a new normalcy. They recalibrate their physical, psychological and social well-being, demonstrating resilience and adaptability in the face of these challenges. Their pervasive expression of needs for information and support may reflect gaps in the existing patient education and support measures and communication strategies. Healthcare professionals and policy-makers should adopt a patient-centred approach acknowledging the multifaceted nature of postsurgery recovery and adaptation by fostering open communication, tailoring personalised education and facilitating supportive community networks.

Background: Scabies is a skin infestation caused by the human itch mite, affecting people globally across all demographics. However, it is more prevalent among children, individuals with poor hygiene, those in overcrowded or slum areas and people affected by drought and war. There is limited research on scabies in Ethiopia and none specifically focused on marginalised communities. This study aimed to assess the burden of scabies and its contributing factors among pastoralist communities in Ethiopia.

Methods: A community-based, unmatched case-control study (1:2 ratio) was conducted in Meinit Goldiya District to assess risk factors for scabies. The researchers collected line-listed data on scabies and conducted face-to-face interviews from January to February 2023, with a sample of 156 cases and 312 controls. Data were gathered using a structured questionnaire and analysed with SPSS V.22. OR, p values and 95% CI were calculated to identify associated factors. Independent factors were determined using a p value of <0.05 and the corresponding 95% CI in the multivariable model.

Results: A total of 4269 scabies cases were reported in the district, with an attack rate of 7.9%. Of the reported cases, 52.8% (2254 cases) were male. The multivariable analysis identified several factors significantly associated with scabies: sleeping with infected individuals (adjusted OR (AOR)=3.70 (2.08, 6.61)), sharing washing facilities with patients with scabies in the past 6 months (AOR=4.05 (2.30, 7.13)), placing clothes together with infected individuals' clothes (AOR=4.71 (2.64, 8.42)) and households with a daily water consumption of ≥25 L per person per day, which was a protective factor (AOR=0.06 (0.03, 0.12)).

Conclusion: Scabies is a public health issue in the district, with significant risk factors including sleeping, washing and contact with patients with scabies, as well as daily water consumption levels. To address this, the study recommends strengthening active case surveillance, offering health education and ensuring health facilities are stocked with treatment medications.

Background: Acute pulmonary embolism (PE) mortality is linked to abrupt rises in pulmonary artery (PA) pressure due to mechanical obstruction and pulmonary vasoconstriction, leading to right ventricular (RV) dilation, increased RV wall tension and oxygen demand, but compromised right coronary artery oxygen supply. Oxygen is a known pulmonary vasodilator, and in preclinical animal models of PE, supplemental oxygen reduces PA pressures and improves RV function. However, the mechanisms driving these interactions, especially in humans, remain poorly understood. The overall objective of the supplemental oxygen in pulmonary embolism (SO-PE) study is to investigate the mechanisms of supplemental oxygen in patients with acute PE.

Methods and analysis: This randomised, double-blind, cross-over trial at Massachusetts General Hospital will include adult patients with acute PE and evidence of RV dysfunction but without hypoxaemia (SaO₂ ≥90% on room air). We will enrol 80 patients, each serving as their own control, with 40 randomised to start on supplemental oxygen, and 40 randomised to start on room air. Over 180 min, patients will alternate between supplemental oxygen delivered by non-rebreather mask (60% FiO₂) and room air (21% FiO₂). The primary outcome will be the difference in pulmonary artery systolic pressure with and without oxygen. Secondary outcomes include additional echocardiographic measures, metabolomic profiles, vital signs and dyspnoea scores. Echocardiographic data will be compared by a paired t-test or Wilcoxon signed-rank test. For metabolomic analyses, we will perform multivariable mixed effects logistic regression models and calculate false discovery rate (q-value ≤0.05) to account for multiple comparisons. Data will be collected in compliance with National Institutes of Health and National Heart Lung and Blood Institute (NHLBI) policies for data and safety monitoring.

Ethics and dissemination: The SO-PE study is funded by the NHLBI and has been approved by the Institutional Review Board of Mass General Brigham (no. 2023P000252). The study will comply with the Helsinki Declaration on medical research involving human subjects. All participants will provide prospective, written informed consent.

Trial registration number: NCT05891886.