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Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer-related mortality. While gender and sex differences in gastric cancer care are underexplored in Germany, international studies have revealed disparities in aspects such as histology, comorbidities, treatment approaches and survival outcomes. This study aims to explore gender/sex-specific variations in clinical management and their impact on mortality, complications and survival rates in gastric carcinoma patients in Germany. The findings may inform revisions to clinical guidelines and support the development of more personalised treatment strategies. This study aims to improve the quality of care for gastric cancer patients and promote more individualised, sex-sensitive medical practices.
This nationwide, retrospective cohort study will analyse data from the German Diagnosis-Related Groups statistic and regional clinical cancer registries from 2017 to 2021. The study will evaluate both datasets separately, providing a comprehensive view of sex differences in gastric cancer care. Primary outcomes include hospital mortality and survival rates, while secondary endpoints include surgical complications, treatment modalities and postoperative outcomes. The analysis will investigate whether sex influences tumour characteristics, access to treatment and therapy effectiveness. Statistical methods such as descriptive analysis, regression models and survival analysis will be applied to identify sex-related variations in diagnosis, treatment and outcomes.
This study uses anonymised secondary data; thus, ethics approval is not necessary. Findings will be submitted to a peer-reviewed journal, reported to the Innovation Fund of the Federal Joint Committee of Germany, and a patient leaflet for the involved self-help groups will be made.
Salivary gland carcinomas (SGC) are rare tumours. The term SGC is not more than an umbrella for a variety of histogenetically, morphologically and biologically distinct entities. Accordingly, SGCs have not been sufficiently investigated to date. Their rarity makes it difficult to reach high patient numbers for individual entities in clinical studies, leading to pooling patients with different histological subtypes to attain sufficient participants. The different histological subtypes of SGC differ significantly in their clinicopathological features, such as their grading, their occurrence and their outcome. SGCs are usually stratified into low-grade, intermediate-grade or high-grade tumours. In most kinds of SGC, specific targetable molecular markers are lacking. The inclusion of immunotherapy (IT), however, might improve the outcome of patients suffering from high-grade SGCs. In order to integrate IT as a therapeutic option for SGC and to facilitate therapeutic decisions based on tumour (immune) biology, predictive and prognostic immunological biomarkers are indispensable.
In this prospective study, 500 patients will be enrolled, who are distributed in three arms. The observational cohort includes patients with malignant salivary gland tumours, whereas patients with benign tumours of a salivary gland are grouped in the control group 1. In the control cohort, 2 patients do not have a salivary gland tumour but have a planned functional surgery of the nose or ear or a maxillofacial surgery. The local immune status from the tumour tissue and the microbiome will be sampled before treatment. In addition, the systemic immune status from peripheral blood will be analysed before and after surgery and after the adjuvant and definitive chemoradiotherapy, if applicable. Clinical baseline characteristics and outcome parameters will additionally be collected. Data mining and modelling approaches will finally be applied to identify interactions of local and systemic immune parameters and to define predictive and prognostic immune signatures based on the evaluated immune markers.
Approval from the institutional review board of the Friedrich-Alexander-Universität Erlangen-Nürnberg was granted in September 2023 (application number 23-292-B). The results will be disseminated to the scientific audience and the general public via presentations at conferences and publication in peer-reviewed journals.
To co-identify adaptations with key stakeholders needed to optimise elements of a video-based intervention (i.e., PREEMIE PROGRESS [PP]), which trains parents in evidence-based family management skills to care for their very preterm infant in the neonatal intensive care unit (NICU).
Descriptive qualitative study oriented with a pragmatic philosophy, informed by the reach, effectiveness, adoption, implementation, maintenance (RE-AIM) framework and the framework for reporting adaptations and modifications-expanded (FRAME).
Semistructured interviews to identify potential adaptations with key stakeholders: family management researchers (n = 5), clinicians (n = 9), technology experts (n = 5) and parents of preterm infants (n = 17). Weekly design team meetings to select and implement high-priority adaptations necessary for the next research phase. Monthly NICU parent partnership meetings to review adaptations and make recommendations for potential adaptations with conflicting data.
Stakeholders (N = 36) suggested 98 potential adaptations: 32 (33.0%) were completed, 8 (8.2%) were abandoned, 5 (5.2%) have work that is ongoing and 52 (53.6%) were tabled for future research phases. Content adaptations (70, 71.4%) were the most frequently suggested adaptation type. Potential adaptations mostly addressed RE-AIM dimensions of effectiveness (43, 43.9%), and implementation (46, 46.9%) and were directed at the parent (i.e., intervention recipient) level (79, 81.4%).
Use of the RE-AIM framework ensured we systematically identified needed adaptations with key stakeholders across a range of dimensions that would improve PP for parents now and in future phases of this research.
Co-identifying potential adaptations with key stakeholders, paired with FRAME documentation, can help nurses prioritise adaptations most appropriate for each phase of implementation.
Our paper highlights for nurse clinicians and researchers how FRAME documentation of potential adaptations can support stakeholder engagement and a systematic approach to incorporating adaptations throughout all phases of the research process, thereby shortening the evidence to practice gap.
COREQ guidelines for qualitative reporting.
The research team was supported by members of the NICU's Parent Partnership Council (PPC), whose mission is to promote family-centred care improvement projects and research within the NICU. This committee is comprised of nursing, physician, allied health leadership and parents of infants previously hospitalised in the NICU. The NICU PPC met monthly to review conflicting data on potential adaptations and provide recommendations on adaptation decisions.
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