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Triple-drug therapy with Goreisan, tranexamic acid and carbazochrome sodium sulfonate hydrate to prevent recurrence after chronic subdural haematoma surgery: a multicentre, randomised, controlled trial protocol

Por: Negishi · H. · Hirata · K. · Aiyama · H. · Fujita · K. · Komatsu · Y. · Kato · N. · Shibata · Y. · Tsuda · K. · Yamazaki · T. · Sato · M. · Watanabe · S. · Sugii · N. · Konishi · T. · Mathis · B. J. · Ohigashi · T. · Endo · M. · Ishikawa · E. · Matsumaru · Y. · The Triple Study Investigato
Introduction

Chronic subdural haematoma (CSDH) is a common neurosurgical condition in older adults, with a recurrence rate of approximately 7.1–13% after burr-hole drainage. Although surgical adjuncts such as subdural drains and middle meningeal artery embolisation may reduce recurrence, these are not suitable for all patients. Pharmacological strategies, including tranexamic acid, Goreisan and carbazochrome sodium sulfonate hydrate, have shown potential, but high-level evidence remains lacking. A prior retrospective study suggested that a triple oral regimen combining these agents may reduce recurrence. This randomised controlled trial aims to evaluate its efficacy and safety.

Methods and analysis

This is a prospective, multicentre, open-label, randomised controlled trial conducted across six hospitals in Ibaraki, Japan. A total of 180 patients undergoing first-time burr-hole surgery for CSDH will be randomised 1:1 to receive either triple therapy (Goreisan 7.5 g/day, carbazochrome sodium sulfonate hydrate 90 mg/day and tranexamic acid 750 mg/day for up to 90 days) or standard postoperative care. The primary outcome is recurrence requiring reoperation within 90 days. Secondary outcomes include time to recurrence and haematoma volume reduction on serial CT imaging. All analyses will follow the intention-to-treat principle, using logistic regression, Cox proportional hazards models and mixed-effects models.

Ethics and dissemination

Written, informed consent will be obtained from all participants at each participating hospital by trained staff from that hospital. The trial protocol has been approved by the ethics committee of the University of Tsukuba Hospital (approval no. TCRB23-025) and the Institutional Review Boards of all participating centres. Study findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. A summary of the results will also be provided to participating institutions and made publicly available in accordance with the BMJ Open data sharing policy.

Trial registration number

jRCTs031240007.

Drastic reduction in the intensity of Poaceae pollen season in Central Europe (Lublin, Poland) in 22 years

by Krystyna Piotrowska-Weryszko, Agnieszka Kubik-Komar, Elżbieta Weryszko-Chmielewska, Agata Konarska, Aneta Sulborska-Różycka

Grass pollen grains cause allergic reactions in a large portion of the global population. Aerobiological monitoring provides a valuable method for assessing plant responses to climate change. Wind-pollinated plants exhibit varying responses to climate shifts, and this study aimed to analyze long-term trends in Poaceae pollen concentration in Lublin (Poland) from 2001 to 2022. Pollen seasons were analyzed using the volumetric method. The following parameters were assessed for each season: onset, end, duration, peak value, date of peak, number of high-pollen days, and annual pollen sum. Meteorological data were collected for the same period. Statistical analysis was performed using Spearman’s rank correlation to examine relationships between pollen season parameters and meteorological factors, and multivariate regression models were developed to explore the influence of specific climate variables on pollen season dynamics. Additionally, principal component analysis (PCA) was applied for visual comparisons of grass seasons. The analysis revealed a significant decline in the annual pollen sum, the July pollen sum, and the number of high pollen days, with the most substantial changes occurring in July. The decrease in the annual pollen sum was significantly associated with lower humidity in March and May and higher temperatures in June. Peak pollen values were negatively correlated with increased sunshine in March and April and positively correlated with humidity in March and May, while humidity levels strongly influenced the number of high-pollen days. The intensity of the grass pollen season notably weakened after 2011, in alignment with broader trends observed across Europe, attributed to climate change. These findings highlight the substantial influence of climatic variables on the grass pollen season, with implications for individuals with respiratory allergies. The results also underscore the broader public health and ecological impacts of climate change, suggesting the need for continued monitoring and adaptive measures.

Evaluating economic outcomes in the management of temporomandibular disorders: a protocol for a systematic review of randomised controlled trials

Por: Komarraju · P. · AlSabbagh · B. · Ohinmaa · A. · Armijo-Olivo · S. · Morris · M. · Li · J. · Major · P. W. · Goldberg · M. · Naik · A. · Abdelkarim · A. · Velly · A. M.
Introduction

Systematic reviews (SRs) on the management of temporomandibular disorders (TMDs) have predominantly focused on evaluating the effectiveness of various treatments, identifying those that provide the greatest benefits. However, the economic evaluation of these treatments has not been systematically explored. This SR aims to address this gap by evaluating the economic outcomes of the most common treatment modalities for TMDs, including cost-effectiveness, cost-utility, cost-benefit, cost-minimisation and the burden of illness.

Methods and analysis

This SR will be conducted using the following electronic databases Business Source Complete, CINAHL, EconLit (ProQuest), Embase (Ovid), MEDLINE (PubMed), MEDLINE (Ovid) and Scopus to identify studies evaluating the economic outcomes of treatments for TMDs. The eligibility criteria are as follows: (1) studies examining the costs and/or impact of treatments for TMDs and (2) articles published between 2000 and 2025. The primary outcomes of interest are the economic findings outlined earlier. Data extraction will include the following: author(s), year of publication, country, study objectives, study design, eligibility criteria, TMD diagnosis and screening, study groups, randomisation, blinding, sample size, number of participants invited, enrolled and completed, duration of treatment, follow-up, study duration, settings, assessment instruments, study outcomes, statistical analyses, results, limitations, strengths and funding sources. The quality of studies will be evaluated using the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist, with risk of bias assessed using the Cochrane Effective Practice and Organization of Care’s risk-of-bias tool; where applicable, the Outcome Reporting Bias in Trials will be used to detect reporting biases. A narrative synthesis and summary tables will outline study characteristics, economic outcomes and the overall quality of evidence. We will conduct qualitative secondary and sensitivity analyses.

Ethics and dissemination

This SR does not require an ethics approval. The results will be disseminated through international and national conferences and peer-reviewed journals.

PROSPERO registration number

CRD42024613553.

Randomised, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of antibiotic faecal microbiota transplantation in patients with Parkinsons disease (FLORA-PD): a study protocol

Por: Takeshige-Amano · H. · Igami · E. · Okuzumi · A. · Kamo · R. · Iseki · M. · Tsuyama · K. · Wakamori · R. · Okada · H. · Taniguchi · D. · Ueno · S.-I. · Oji · Y. · Ishikawa · K.-i. · Nishikawa · N. · Orikasa · M. · Odakura · R. · Koma · M. · Maruyama · T. · Nomura · K. · Ishikawa · D. · Shibu
Introduction

The intestinal microbiota of people with Parkinson’s disease (PwP) differs significantly from that of healthy individuals. Given that altered microbiota may play a role in the pathogenesis of Parkinson’s disease, faecal microbiota transplantation (FMT) has been proposed as a potential therapeutic approach. However, the efficacy of FMT in improving motor symptoms in PwP has been inconclusive in some pilot randomised controlled trials (RCT). Previous RCTs on PwP employed simple FMT, but our modified approach—pretreatment with antibiotics before FMT (A-FMT)—has been shown to improve the engraftment rate of given species and the beneficial effects of FMT. This study aims to evaluate the efficacy and safety of A-FMT for PwP, particularly in those with motor fluctuations.

Methods and analysis

This study is a randomised, double-blind, placebo-controlled, parallel-group study with an 8-week observation period following a single A-FMT. Thirty clinically established PwP with prominent motor fluctuation episodes will be randomised 1:1 to FMT or placebo. Participants in both groups will receive antibiotic treatment prior to colonoscopy for FMT or placebo treatment. Primary and secondary endpoints will include subjective and objective evaluations of motor and non-motor symptoms and will be evaluated before and after antibiotic treatment and at 4 and 8 weeks after the procedure. Exploratory endpoints will include blood and faecal sample analyses, advanced brain MRI and pharmacokinetic assessment of levodopa concentrations during a levodopa challenge test.

Ethics and dissemination

This study has been approved by the ethical committee of Juntendo University in August 2024 (J24-005) and will be conducted in accordance with the Declaration of Helsinki, the Japan Ministry of Health, Labour and Welfare Clinical Trials Act and related laws and regulations. All patient data will be anonymised to protect privacy and used solely for study purposes. Results will be published in academic journals and presented at conferences.

Trial registration number

jRCTs031240344.

Evolving roles of hospital administrators in India: a qualitative study on health information technology competencies for improved healthcare delivery

Por: Gnanadhas · J. · Komattu Chacko · J. · Ravichandran · A.
Background

Hospital administrators (HAs) aim to strike a balance between providing efficient and compassionate treatment. Health informatics and service management abilities are two areas that are evolving alongside digital health. This study outlines the health information technology (IT) competencies necessary for sustainability in the healthcare industry and looks at the competencies needed for HAs to manage everyday responsibilities.

Methods

Grounded theory is used in this qualitative study and reported based on the Standards for Reporting Qualitative Research guidelines. The participants were HAs who worked in different healthcare fields and held MBAs from the same private university. Respondents were selected through purposeful sampling, and consent was obtained before conducting telephone conversations. Data were gathered until the point of theoretical saturation. Every theme was outlined in a thematic framework.

Results

Healthcare administrators gain knowledge about using applications and technology through the service. A hospital setting is a good place for healthcare administrators to begin their careers to fully understand the intricacies of the field. The key findings of the study indicate that HAs recognised policies and procedures as important areas of competency that required focused attention. HAs are increasingly relying on mid- to advanced-level healthcare technologies in their daily work. Each administrator has gained competencies according to their experience and opportunities. A few years of domain expertise make healthcare administrators competent and educated about every aspect of their profession.

Conclusions

According to healthcare administrators, practice and experience serve as the cornerstones on which their competencies are built. In the rapidly changing environment of digital healthcare, interdepartmental collaboration is essential for long-term success and adaptability, especially between HAs, IT personnel and medical specialists. Developing capabilities and resilience in this dynamic environment requires a diverse approach.

Community mobilisation for adoption of clean cookstoves and clean fuel to reduce household air pollution and blood pressure in Lagos, Nigeria: protocol for a cluster-randomised trial

Por: Wright · O. · Olopade · C. O. · Aifah · A. A. · Fagbemi · T. · Hade · E. M. · Mishra · S. · Onakomaiya · D. O. · Kanneh · N. · Chen · W. · Colvin · C. L. · Ogunyemi · R. · Sogbossi · E. · Erinosho · E. · Ojengbede · O. · Taiwo · O. · Johnson · M. A. · Vedanthan · R. · Wall · S. · lwelunmor
Introduction

In Africa, 75% of households are exposed to household air pollution (HAP), a key contributor to cardiovascular disease (CVD). In Nigeria, 90 million households rely on solid fuels for cooking, and 40% of adults have hypertension. Though clean fuel and clean stove (CF-CS) technologies can reduce HAP and CVD risk, their adoption in Africa remains limited.

Methods and analysis

Using the Exploration, Preparation, Implementation and Sustainment framework, this cluster-randomised controlled trial evaluates the implementation and effectiveness of a community mobilisation (CM) strategy versus a self-directed condition (i.e., receipt of information on CF-CS use without CM) on adoption of CF-CS technologies and systolic blood pressure (SBP) reduction among 1248 adults from 624 households across 32 peri-urban communities in Lagos, Nigeria. The primary outcome is CF-CS adoption at 12 months; secondary outcomes are SBP reduction at 12 months and sustainability of CF-CS use at 24 months. Adoption is assessed via objective monitoring of stove usage with temperature-triggered iButton sensors. SBP is assessed in 2 adults per household using validated automated blood pressure monitor. Generalised linear mixed-effects regression models will be used to assess study outcomes, accounting for clustering at the level of the peri-urban communities (unit of randomisation) and households. To date, randomisation is completed, and a total of 1248 households have enrolled in the study. The final completion of the study is expected in June 2026.

Ethics and dissemination

The study was approved by the Institutional Review Boards (IRB) of NYU Grossman School of Medicine (primary IRB of record; protocol ID: i21-00586; Version 6.0 approved on 4 June 2024), and Lagos State University Teaching Hospital (protocol ID: LREC 06/10/1621). Written consent was obtained from all participants. Findings will inform scalable and culturally appropriate strategies for reducing HAP and CVD risk in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagements.

Trial registration number

NCT05048147

Assessment of regional variation in the management of heart failure with a preserved ejection fraction between the Russian Federation and the European Union: the results of the international survey

Por: Kuzheleva · E. · Saldarriaga · C. · Mewton · N. · Komarova · I. · Mukhina · N. · Cherkasova · N. · Sitnikova · V. · Anzhela · S. · Novitsky · N. · Baglikov · A. · Dyachuk · I. · Bibarsova · A. · Rogova · A. · Lezhneva · V. · Stepanenko · E. · Goldfeder de Gracia · S. · Giverts · I. · Tun
Objectives

Regional differences in heart failure with preserved ejection fraction (HFpEF) care have been reported. We aimed to assess a physician-reported HFpEF management in the Russian Federation (RF) and a variation in the diagnosis and treatment of HFpEF between the RF and the European Union (EU).

Design/settings

It is a post hoc analysis of an academic web-based international HFpEF designed as a cross-sectional survey and conducted between May 2023 and July 2023.

Participants

Medical doctors who work in the fields of cardiology and general medicine.

Results

Among 1460 medical doctors who completed the study were 166 Russian and 646 European specialists. The responders were comparable across the groups in most of the baseline characteristics, except that RF specialists were less likely to be heart failure specialists (RF: 2% vs EU: 26%) and less often worked in academic environments (RF: 17% vs EU: 61%). The utilisation of specific echocardiography parameters (RF: 66% vs EU: 80%) and natriuretic peptides (RF: 83% vs EU: 91%) to establish a diagnosis of HFpEF was less frequent in RF compared with EU, while HFpEF scores were more likely to be used by Russian physicians (RF: 58% vs EU: 40%). In the settings when all HF medications are available, responders of both regions prioritised sodium-glucose co-transporter type 2 inhibitors (SGLT2is) (mean rank: RF: 2.6 (IQR: 2.3–3) vs EU: 2.3 (IQR: 2.2–2.5)), followed by diuretics in the EU and ACE inhibitors in the RF. Every second responder in both regions preferred SGLT-2is if only one drug was available (RF: 57% vs EU 51%).

Conclusions

The results reveal discrepancies in physician-reported HFpEF management between RF and EU responders, particularly in the diagnostic workup. Although the utilisation of relevant diagnostic tests was lower in the RF compared with the EU, these were used by two-thirds of Russian respondents. Nevertheless, further measures are required to improve the care of HFpEF patients in the RF.

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