Journal of Clinical Medicine最新文献

{"title":"Accuracy of Navigated High-Speed Drill-Assisted Cervical and Upper Thoracic Pedicle Screw Placement-A Single Center Experience with 1112 Pedicle Screws.","authors":"Stefan Aspalter, Nico Stroh-Holly, Katja Höllmüller, Armin Davachi, Philip Rauch, Stephan Heisinger, Andreas Gruber, Wolfgang Senker","doi":"10.3390/jcm14186597","DOIUrl":"10.3390/jcm14186597","url":null,"abstract":"<p><p><b>Background/Objectives</b>: While biomechanically superior, cervical pedicle screw placement is technically challenging, and therefore typically performed only in centers with the aid of navigation. The purpose of this study was to analyze the accuracy and safety of navigated cervical pedicle screw (CPS) placement using intraoperative imaging with a workflow using a navigated high-speed drill in a large single-center cohort. <b>Methods</b>: We conducted a retrospective analysis of 205 patients undergoing posterior cervical or cervicothoracic instrumentation between January 2018 and June 2024. Accuracy was assessed using the Gertzbein-Robbins classification, with grades 0 and 1 considered satisfactory. Surgical workflow, intraoperative imaging, and complications were analyzed. <b>Results</b>: A total of 1112 pedicle screws, including 888 cervical and 224 upper thoracic screws, were evaluated. 801 were grade 0 (72.0%), 250 grade 1 (22.5%), 56 grade 2 (5.0%), and 5 grade 3 (0.4%). Cervical screws achieved satisfactory placement grades 0 and 1 in 93.1%, and upper thoracic screws in 100% (92.0% grade 0, 8.0% grade 1). Grade 3 breaches occurred in C2, C3, C5, C6, and C7, with one case each. There were no cases of implant-related neurovascular injuries. <b>Conclusions</b>: This study demonstrates high screw accuracy with a low observed complication rate. No revision surgeries were required due to screw malposition, but 7 cases of screw loosening occurred. However, the retrospective design and reliance on intraoperative imaging limit the generalizability of the findings.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 18","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12471098/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cross-Linked Carboxymethyl Cellulose and Silk Proteins in Corneal Re-Epithelialization: A Case Series.","authors":"Francesco Boselli, Fabio Scarinci, Romina Fasciani","doi":"10.3390/jcm14186600","DOIUrl":"10.3390/jcm14186600","url":null,"abstract":"<p><p><b>Background/Objectives:</b> Corneal re-epithelialization is a critical process following surgical procedures such as photorefractive keratectomy (PRK), phototherapeutic keratectomy (PTK), and corneal UV cross-linking (CXL), as well as cases of corneal abrasion. Delayed epithelial healing can lead to increased discomfort, a higher risk of infection, and suboptimal visual outcomes. This retrospective case series aims to evaluate the efficacy of a novel ophthalmic solution containing cross-linked carboxymethyl cellulose (CX-CMC) and silk proteins in promoting corneal re-epithelialization and improving post-surgical recovery. <b>Patients and methods:</b> A total of 15 patients who underwent PRK, PTK, or CXL or who presented with corneal abrasions were included in the study. Along with standard post-surgical treatment, patients received CX-CMC and silk protein-based eye drops (CORDEV, Ophtagon, Rome, Italy) six times a day. Corneal epithelial thickness was assessed using topography at follow-up visits. <b>Results:</b> Corneal re-epithelialization was observed in all subjects within 24 to 48 h post-procedure. The mean corneal epithelial thickness at 48 h was 73.21 µm, which falls within the typical range of a proliferating corneal epithelium. <b>Conclusions</b>: The CX-CMC and silk protein-based formulation accelerated corneal healing, achieving rapid epithelial recovery. This novel ophthalmic solution offers a promising alternative to conventional post-surgical treatments, potentially improving patient outcomes by reducing healing time, minimising discomfort, and lowering the risk of complications associated with delayed re-epithelialization.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 18","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12470781/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evolution and Comparative Analysis of Clinical Trials on Psilocybin in the Treatment of Psychopathologies: Trends in the EU and the US.","authors":"Anastasia Calin, Ana Flavia Burlec, Cornelia Mircea, Irina Macovei, Monica Hancianu, Andreia Corciova","doi":"10.3390/jcm14186613","DOIUrl":"10.3390/jcm14186613","url":null,"abstract":"<p><p><b>Background/Objectives:</b> This study examines the development of clinical trials investigating psilocybin for the treatment of psychopathologies, with a comparative focus on the United States (US) and the European Union (EU). The objective is to identify regional differences in trial progression, research infrastructure, and regulatory frameworks. <b>Methods</b>: A mixed-methods approach was applied, combining case studies, qualitative and quantitative research. Key variables included trial phase, geographical distribution, demographic factors, funding, governmental support, and public health policies. <b>Results</b>: The US demonstrated a substantially higher number of psilocybin trials across both early and advanced phases. This reflects a strong research infrastructure, growing financial investment, and increasing interest in psychedelic-assisted therapies. In contrast, the EU showed fewer trials and slower advancement, reflecting a more cautious stance that emphasizes patient safety and therapeutic efficacy. These divergences are shaped by differences in regulation, funding mechanisms, and sociocultural attitudes toward psychedelics in psychiatry. <b>Conclusion</b>: This comparative analysis highlights the uneven pace of psilocybin research across different regions. It also emphasizes the importance of international collaboration, harmonization of public health policies, and the development of standardized procedures prioritizing safety and effectiveness. Integrating psilocybin-assisted interventions into psychiatric practice has the potential to expand treatment options and strengthen mental health care, but coordinated global efforts are essential to ensure both scientific rigor and patient protection.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 18","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12470834/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lymph Node Ratio as a Risk Factor for Early Recurrence in Older Patients with Stage II/III Gastric Cancer: A Retrospective Study.","authors":"Yun-Chen Tsai, Hsin-Chen Lin, Chiann-Yi Hsu, Feng-Hsu Wu, Shao-Ciao Luo, Yu-Hsuan Shih","doi":"10.3390/jcm14186609","DOIUrl":"10.3390/jcm14186609","url":null,"abstract":"<p><p><b>Background/Objectives:</b> Older adults with gastric cancer often have poorer prognoses than younger patients. Early recurrence, within two years after curative surgery, is associated with poor outcomes, but its risk factors remain unclear. This study aimed to identify clinicopathological predictors of early recurrence in older patients with stage II/III disease. <b>Methods:</b> We retrospectively reviewed 604 patients with stage II/III gastric cancer who underwent curative surgery from 2009 to 2020. After exclusions, 237 patients aged ≥65 years were analyzed. Clinicopathological variables were compared between those with and without early recurrence, and risk factors were assessed using logistic regression. <b>Results:</b> Among the 237 patients studied, 103 had recurrence following surgery, of whom 72 (69.9%) were categorized as early recurrence. Distant metastasis was the most common pattern (59.7%), followed by peritoneal (45.8%) and locoregional (33.3%) recurrences. Multivariate analysis identified a lymph node ratio (LNR) > 0.17 as an independent risk factor for early recurrence (odds ratio (OR), 5.30; 95% confidence interval (CI), 2.07-13.53; <i>p</i> < 0.001). <b>Conclusions:</b> Early recurrence is frequent among older patients with stage II/III gastric cancer, with distant metastasis as the predominant pattern. An LNR > 0.17 predicts higher recurrence risk. While adjuvant chemotherapy showed a trend toward reduced risk, statistical significance was not reached. Further prospective studies are necessary to confirm these findings.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 18","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12470672/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Dry Needling of the Obliquus Capitis Inferior in Patients with Cervicogenic Headache and Upper Cervical Dysfunction: An Exploratory Randomized Sham-Controlled Trial.","authors":"Marjolein Chys, Kayleigh De Meulemeester, Indra De Greef, Maxim De Sloovere, Barbara Cagnie","doi":"10.3390/jcm14186619","DOIUrl":"10.3390/jcm14186619","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Cervicogenic headache (CeH) is linked to upper cervical dysfunctions. The obliquus capitis inferior (OCI) muscle may contribute to restricted cervical rotation at the C1-C2 level, altered proprioception and pain. Dry needling (DN) of the OCI is hypothesized to target these dysfunctions. The aim of this study was to investigate whether a single intervention combining DN and manual therapy (MT) compared to sham needling (SN) and MT, improves C1-C2 rotation, functional, headache-related and psychological outcomes in a subgroup of CeH patients with a positive cervical flexion-rotation test (CFRT). <b>Methods</b>: Thirty-four participants were randomly assigned to (1) DN or (2) SN. The primary outcome was C1-C2 rotational mobility. Secondary outcomes included headache-related parameters (frequency, intensity, duration and perceived effect), functional parameters (cervical mobility, pain pressure thresholds, motor control and proprioception) and psychological parameters (central sensitization, pain catastrophizing, coping strategies and kinesiophobia). Outcomes were re-evaluated at one-week follow-up. <b>Results</b>: Linear mixed-effects models showed a significant and clinically relevant increase of C1-C2 rotation in the DN group compared to the SN group post-intervention (mean difference [MD]: 4.51°; 95% confidence interval [CI]: 1.74; 7.28), which was maintained at the 1-week follow-up (MD: 5.44°; 95% CI: 2.55; 8.33). No clinically relevant changes were observed in other secondary outcome measures. <b>Conclusions</b>: Targeting the OCI may be of added value in restoring atlanto-axial dysfunction. While short-term mobility gains were observed, a single intervention appears insufficient as a stand-alone treatment to impact functional or psychological outcomes. Future research involving larger samples should examine DN effects as part of a multimodal approach with long-term follow-up.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 18","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12471241/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Management of Ventricular Arrhythmias in Patients with Left Ventricular Assist Devices: Pathophysiology, Risk Stratification, and Ablation Strategies.","authors":"Giuseppe Sgarito, Francesco Campo, Sergio Sciacca, Michele Pilato, Manlio Cipriani, Sergio Conti","doi":"10.3390/jcm14186604","DOIUrl":"10.3390/jcm14186604","url":null,"abstract":"<p><p>Ventricular arrhythmias (VAs) are common and clinically important complications in patients supported by left ventricular assist devices (LVADs), occurring in up to 50% of cases within the first year after implantation. Despite the hemodynamic support provided by LVADs, VAs are linked to increased morbidity and mortality, primarily through recurrent implantable cardioverter defibrillator (ICD) shocks and right ventricular failure. The underlying mechanisms of VAs in this population are multifactorial, involving structural myocardial remodeling, device-related factors, and pre-existing arrhythmic substrates. Catheter ablation has become a valuable treatment option when antiarrhythmic drug therapy and device reprogramming are inadequate, though procedural timing (pre-, intra-, or post-implantation) and approaches remain under discussion. Epicardial access during LVAD surgery may provide advantages for selected patients, while ablation after implantation poses technical challenges due to altered anatomy and electromagnetic interference. This review offers a comprehensive overview of the epidemiology, pathophysiology, risk stratification, and management of VAs in LVAD recipients, emphasizing technical considerations, procedural safety, and clinical outcomes of catheter ablation. A multidisciplinary approach remains essential in guiding personalized treatment and optimizing outcomes for this complex population. Undergoing studies will provide more insight into optimal management of arrhythmias, particularly regarding the optimal timing of catheter ablation. The impact of new technologies such as non-invasive mapping alongside pre-procedural imaging needs also to be further evaluated.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 18","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12470985/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gender Differences in Weight Loss Extent Following Bariatric Surgery.","authors":"Santo Colosimo, Federica Sileo, Andrea Gambetti, Francesco Frattini, Amalia Bruno, Sara Mambrini, Luisa Gilardini, Federica Barbera, Alice Gotti, Verdiana Vincenti, Laura Inì, Margherita Novelli, Raffaella Cancello, Gianlorenzo Dionigi, Simona Bertoli","doi":"10.3390/jcm14186605","DOIUrl":"10.3390/jcm14186605","url":null,"abstract":"<p><p><b>Background/Objectives:</b> Metabolic-bariatric surgery (MBS) is a highly effective treatment for severe obesity; however, gender disparities exist in access and postoperative outcomes. Despite men presenting with higher baseline weight and comorbidity burden, they are significantly underrepresented among MBS patients. Existing evidence on gender-specific outcomes remains inconclusive, particularly within Mediterranean populations under updated clinical guidelines. To evaluate gender differences in weight loss outcomes following sleeve gastrectomy in an Italian cohort managed under current multidisciplinary protocols. <b>Methods:</b> A prospective observational study was conducted and a total of 131 patients (109 females, 22 males) underwent sleeve gastrectomy at a single center. Anthropometric and metabolic parameters were assessed at baseline and 12 months postoperatively. Outcomes included absolute weight loss (TWL%), percentage of initial and excess body weight lost (EWL%), and waist circumference. Group comparisons used <i>t</i>-tests (with Welch's correction if variances were unequal) and regression models adjusted for baseline BMI and age. <b>Results:</b> At 12 months, men achieved significantly greater absolute weight loss than women (-36.6 kg vs. -31.2 kg; <i>p</i> = 0.028), although no significant differences were observed for TWL%, EWL%, or waist circumference reduction. Gender remained a significant predictor of absolute weight loss in multivariate analysis, but not of proportional weight loss. Both genders showed similar rates of achieving clinically significant weight loss thresholds. <b>Conclusions:</b> While men exhibited greater absolute weight loss, relative weight loss outcomes were comparable between sexes. Gender disparity is observed in the utilization of MBS. These findings highlight the importance of equitable surgical access and tailored postoperative care.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 18","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12470947/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reimbursement Policies of Swiss Health Insurances for the Surgical Treatment of Symptomatic Abdominal Tissue Excess After Massive Weight Loss: A Retrospective Cohort Study.","authors":"Valeria Pruzzo, Francesca Bonomi, Leon Guggenheim, Astrid Navarra, Daniel Schmauss, Reto Wettstein, Yves Harder","doi":"10.3390/jcm14186617","DOIUrl":"10.3390/jcm14186617","url":null,"abstract":"<p><p><b>Background</b>: Patients with symptomatic abdominal tissue excess following massive weight loss (MWL) often experience skin affections associated with hygiene challenges, functional impairments, and psychological distress, all of which significantly impact their quality of life (QoL). Abdominoplasty effectively addresses these issues when conservative treatments prove ineffective. However, health insurance companies (HICs) in Switzerland frequently deny reimbursement. This study aimed to evaluate HIC's reimbursement policies for abdominoplasty, quantifying time delays and additional costs generated by reconsideration due to initial rejections while assessing postoperative QoL of patients. <b>Methods</b>: A retrospective cohort study was conducted including patients undergoing abdominoplasty for symptomatic abdominal tissue excess after MWL between July 2019 and December 2023. Eligibility required HIC approval, informed consent, and legal age. Primary outcomes measured the number of reimbursement requests needed per patient, duration until approval, and additional diagnostic and therapeutic interventions following rejection. Secondary outcomes focused on additional consequent costs, differences in baseline characteristics and symptomatology, as well as QoL improvements using a non-validated, study-specific questionnaire. <b>Results</b>: Of 52 patients included, 33 received cost approval after a single request, whereas 19 required multiple submissions. The mean duration until approval was 15 weeks, with a 26-week delay for the multiple-request group, generating additional costs of CHF 715 per patient. Moreover, abdominoplasty significantly improved QoL in all patients, with no differences between groups. <b>Conclusions</b>: Initial reimbursement denials caused treatment delays, prolonged symptomatology, and increased healthcare costs, despite clear surgical indications. However, future studies involving larger cohorts are needed to support these findings.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 18","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12470673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Robotic-Assisted Total Pelvic Exenteration for Rectal Cancer Using the Hugo™ RAS System: First Case Report.","authors":"Kosuke Hiramatsu, Shigeo Toda, Shuichiro Matoba, Daisuke Tomita, Yusuke Maeda, Naoto Okazaki, Yudai Fukui, Yutaka Hanaoka, Masashi Ueno, Suguru Oka, Tomoaki Eguchi, Hiroya Kuroyanagi","doi":"10.3390/jcm14186603","DOIUrl":"10.3390/jcm14186603","url":null,"abstract":"<p><p><b>Introduction</b>: Total pelvic exenteration (TPE) is a radical procedure for advanced pelvic malignancies involving adjacent organs. The Hugo™ RAS System is a novel robotic platform, but its application in TPE has not previously been reported. We describe the first case of robotic-assisted TPE using Hugo™ RAS in a patient with locally advanced rectal cancer invading the prostate. <b>Methods</b>: A 69-year-old male with mucous and bloody stools was diagnosed with cT4b (prostate, levator ani muscle) N0M0 rectal cancer. After short-course radiotherapy (25 Gy/5 fractions), robotic-assisted TPE was performed. Port placement was planned to coincide with future colostomy and urostomy sites to minimize abdominal wall trauma. En bloc resection was achieved, followed by pelvic reconstruction with a gluteus maximus musculocutaneous flap and fascia lata autograft. Urinary diversion was completed with a robotic intracorporeal Wallace-type ileal conduit. <b>Results</b>: The operation lasted 17 h 56 min, with 175 mL blood loss. Postoperatively, Clavien-Dindo grade IIIa paralytic ileus occurred but was managed conservatively. Pathology revealed pT4b (prostate) N1a M0 disease with negative circumferential margin (11 mm). No recurrence was observed at 9 months. <b>Conclusions</b>: This case highlights the technical feasibility and safety of Hugo™ RAS-assisted TPE. Further clinical experience is needed to confirm reproducibility and oncologic safety.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 18","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12471104/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hypertension, Diabetes and Depression as Modifiable Risk Factors for Dementia: A Common Data Model Approach in a Population-Based Cohort, with Study Protocol and Preliminary Results.","authors":"Corrado Zenesini, Silvia Cascini, Roberta Picariello, Francesco Profili, Laura Maria Beatrice Belotti, Laura Maniscalco, Anna Acampora, Roberto Gnavi, Paolo Francesconi, Luca Vignatelli, Francesco Nonino, Annamaria Bargagli, Domenico Tarantino, Giuseppe Salemi, Nicola Vanacore, Domenica Matranga","doi":"10.3390/jcm14186622","DOIUrl":"10.3390/jcm14186622","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Dementia is a major public health challenge, with age as its primary non-modifiable risk factor. Several modifiable conditions, such as hypertension, diabetes, and depression, have been identified as potential targets for prevention. The aim is to describe the methodology and preliminary results of a study that will be conducted within the Italian National Health Service (INHS), designed to assess the impact of hypertension, diabetes, depression, and their interactions on the onset of dementia. <b>Methods</b>: This population-based cohort study, part of the PREV-ITA-DEM project, was conducted using a Common Data Model (CDM) approach across five Italian regions and cities participating in the NeuroEpiNet network. Individuals aged ≥ 50 years without prior diagnoses of dementia, depression, diabetes, or hypertension were followed from cohort entry (2011-2013) until dementia diagnosis, death, emigration, or study end (2019-2022). Exposures were time-dependent and defined using validated algorithms applied to Healthcare Utilization Databases (HUDs). Associations between chronic conditions and dementia risk will be estimated using competing risks regression models adjusted for confounders. <b>Results</b>: The final cohort comprised more than 3 million individuals, with a mean baseline age of 63-65 years and a female proportion of 52-55%. On 1 January 2011, the prevalence of individuals aged ≥ 50 years with dementia ranged from 8.7 to 14.7 per 1000 population. A harmonized methodological framework based on a CDM was developed and implemented across all sites, incorporating a shared protocol, standardized local databases, and uniform analytic scripts, and the results will be pooled using meta-analytic techniques. <b>Conclusions</b>: Preliminary findings confirm the feasibility of a standardized, multi-regional CDM approach and the potential for HUDs to support large-scale dementia prevention studies in real-world settings.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 18","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12470793/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}