Non-interventional Cohort Study Research Articles

Abstract PO4-18-12: MELODY: A prospective non-interventional multicenter cohort study to evaluate different imaging-guided methods for localization of malignant breast lesions (EUBREAST-4/iBRA-NET, NCT 05559411)

Abstract Background: In the last decades, the proportion of breast cancer patients receiving breast-conserving surgery has increased, reaching 70-80% in developed countries. In case of non-palpable lesions, surgical excision requires some form of breast localization. While wire-guided localization has long been considered gold standard, it carries several limitations, including logistical difficulties, the potential for displacement and patient discomfort, and re-excision rates reaching 21%. Other techniques (radioactive seed or radio-occult lesion localization, intraoperative ultrasound, magnetic, radiofrequency and radar localization) have been developed with the aim of overcoming these disadvantages. However, comparative data on the rates of successful lesion removal, negative margins and re-operations are limited. In the majority of studies, the patient’s perspective with regard to discomfort and pain level has not been evaluated. The aim of MELODY (MEthods for LOcalization of Different types of breast lesions) is to evaluate different imaging-guided localization methods with regard to oncological safety, patient-reported outcomes, and surgeon and radiologist satisfaction. Methods: The EUBREAST and the iBRA-NET have initiated the MELODY study to assess breast localization techniques and devices from several perspectives (NCT05559411, http://melody.eubreast.com). MELODY is a prospective intergroup cohort study which enrolls female and male pts. requiring breast-conserving surgery and imaging-guided localization for invasive breast cancer or DCIS. Multiple or bilateral lesions and neoadjuvant chemotherapy are allowed. Primary outcomes are: 1) Intended target lesion and/or marker removal, independent of margin status on final histopathology, and 2) Negative resection margin rates at first surgery. Secondary outcomes are, among others: rates of second surgery and secondary mastectomy, Resection Ratio (defined as actual resection volume divided by the calculated optimum specimen volume), duration of surgery, marker dislocation rates, rates of marker placement or localization failure, comparison of patient-reported outcomes, rates of “lost markers” and diagnostician/radiologist’s and surgeon’s satisfaction as well as the health economic evaluation of the different techniques. Target accrual: 7,416 patients. Enrollment started in January 2023. The study will be conducted in 30 countries and is supported by the Oncoplastic Breast Consortium (OPBC), AWOgyn, AGO-B and SENATURK. Financial support will be provided by Endomag, Merit Medical, Sirius Medical and Hologic. Citation Format: Maggie Banys-Paluchowski, Thorsten Kühn, Yazan Masannat, Nina Ditsch, Antonio Esgueva, Neslihan Cabıoğlu, Dawid Murawa, Nuh Zafer Canturk, Isabel Rubio, Jana de Boniface, Andreas Karakatsanis, Rajiv Dave, Shelley Potter, Ashutosh Kothari, Oreste Davide Gentilini, Walter Weber, Natalia Krawczyk, Steffi Hartmann, Guldeniz Karadeniz Cakmak, Markus Hahn, Michael P. Lux, Tove Tvedskov, Lina Pankratjevaite, Michalis Kontos, Florentia Peintinger, Aoife Lowery, Marjolein Smidt, Lia Rebaza, Maria Vasconcelos, Bahadir M. Gulluoglu, Bilge Aktas Sezen, Rosa Di Micco, Sarah Nietz, Francois Malherbe, Maria Luisa Gasparri, Séverine Alran, SVS Deo, Mah Muneer Khan, James Harvey. MELODY: A prospective non-interventional multicenter cohort study to evaluate different imaging-guided methods for localization of malignant breast lesions (EUBREAST-4/iBRA-NET, NCT 05559411) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-18-12.

Maternal serum vasohibin-1 and vasohibin-2 concentrations in pregnant women diagnosed with late fetal growth restriction or small for gestational age fetus

Aims: Vasohibin 1, a member of the vasohibin family, is an inhibitor of angiogenesis, while vasohibin 2 stimulates angiogenesis. Placental expressions of vasohibins and their relationship with preeclampsia have been investigated, but their effects on intrauterine fetal growth are unknown. In this context, we aimed to investigate the concentrations of vasohibin 1 and 2 in the serum of pregnant women diagnosed with late fetal growth restriction (FGR) or small for gestational age (SGA) in the third trimester. Methods: This prospective non-interventional cohort study was conducted on 81 pregnant women, 26 of whom were diagnosed with late FGR, 28 were SGA, and 27 were healthy controls. Three groups were compared in terms of serum vasohibin 1 and 2 concentrations in the third trimester. Results: Three groups were similar in terms of demographic characteristics and gestational age at blood sampling for vasohibin 1 and 2 (p < 0.05). The median vasohibin 1 concentration was determined as 1227.41 ng/mL in the late FGR group, 1311.15 ng/mL in the SGA group, and 1391.38 ng/mL in the control group (p = 0.139). The median vasohibin 2 concentration was determined as 11.24 ng/mL in the late FGR group, 11.86 ng/mL in the SGA group, and 14.34 ng/mL in the control group (p = 0.198). Conclusion: Serum vasohibin 1 and 2 concentrations were found to be similar in pregnant women diagnosed with late FGR and SGA and pregnant women with AGA fetuses. Vasohibin 1 and 2 are involved in the regulation of placental angiogenesis, but their roles in intrauterine fetal growth remain unclear.

Investigation of Serum Cartonectin Concentrations in Pregnant Women with Gestational Diabetes Mellitus; a Prospective Non-Interventional Cohort Study

OBJECTIVE: To investigate serum cartonectin concentrations in pregnant women diagnosed with Gestational Diabetes Mellitus (GDM). STUDY DESIGN: This prospective non-interventional cohort study was conducted on 176 pregnant women. The study group consisted of 88 pregnant women diagnosed with GDM, and the control group consisted of 88 pregnant women with normal 75-g OGTT results. First, the study and control groups, and then the subgroups were compared in terms of serum cartonectin concentrations. RESULTS: The study and control groups were similar in terms of BMI and gestational age at blood sampling (p=0.599, p=0.854). The study and control groups were similar in terms of median serum cartonectin concentrations (6.28 ng/ml and 7.13 ng/ml, respectively, p=0.165). In the subgroup analysis, the normal weight control group, overweight control group, normal weight study group, and overweight study group were compared in terms of serum cartonectin concentrations. The lowest median cartonectin concentration was detected in the overweight study group, followed by the overweight control group, normal weight study group, and normal weight control group (5.8 ng/ml, 6.5 ng/ml, 6.9 ng/ml, and 8.2 ng/ml, respectively, p=0.235). CONCLUSION: Serum cartonectin concentrations were found to be similar in the GDM and control groups. However, the number of participants in this study is limited to draw a definitive conclusion. Many studies with larger series are needed to reveal whether serum cartonectin is involved in the pathophysiology of GDM.

Baseline Characteristics and mNAPSI Change from Baseline Scores Through Month12 for Patients with Moderate-to-Severe Plaque Psoriasis and Concomitant Nail Psoriasis Treated with Biologics from PSoHO.

Nail psoriasis is highly prevalent among patients with psoriasis yet remains one of the most challenging areas to treat. To better understand the treatment landscape for psoriatic nail disease, more studies are needed that compare the effectiveness of different biologics for patients with nail psoriasis. This study contributes to this objective by directly comparing the effectiveness of approved biologics in improving nail psoriasis for patients up to month12 in a real-world setting. Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year, prospective, non-interventional cohort study of adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. This study assessed the change in modified Nail Psoriasis Severity Index (mNAPSI) score from baseline to months3, 6 and 12 for 763 patients and compared the effectiveness of anti-interleukin (IL)-17A biologics versus other approved biologics, as well as ixekizumab versus secukinumab, guselkumab, risankizumab and adalimumab. Comparative adjusted analyses used frequentist model averaging (FMA). Least square mean difference (LSMD) in mNAPSI scores are presented as observed. Irrespective of the severity of nail psoriasis at baseline, the anti-IL-17A cohort had greater mean mNAPSI reductions from baseline compared to the other biologics cohort through month12, reaching significance at months3 and 6 in the adjusted analysis. For patients with moderate-to-severe nail psoriasis, ixekizumab showed numerically higher mean reductions in mNAPSI scores compared to all other studied biologics, reaching significance versus guselkumab at all timepoints and risankizumab at month6. This real-world study showed that patients with moderate-to-severe psoriasis and any severity of concomitant nail involvement had significantly faster and more substantial improvements in nail psoriasis up to month6 in the anti-IL-17A cohort compared to the other biologics cohort. Of the individual biologics studied, ixekizumab showed the highest numerical improvements in nail psoriasis at month12. EUPAS24207.

Real-world evidence from a European cohort study of patients with treatment resistant depression: Country-specific data for Portugal

BackgroundTreatment resistant depression (TRD; failure to respond to ≥2 treatments in the same major depressive episode) affects 10–30 % of patients with major depressive disorder. In Portugal, the disease burden is estimated to exceed that of heart failure, highlighting the critical unmet needs of these patients. MethodsA non-interventional cohort study of patients with TRD collected real-world data from several European countries. All patients started a new antidepressant treatment at baseline. We present a sub-analysis of baseline characteristics and Month 6 treatment outcomes in Portuguese patients. ResultsAmong 411 patients enrolled, 37 were Portuguese. At baseline, 45.9 % of Portuguese patients had severe depression versus 32.6 % of the total study population. Portuguese patients had numerically greater impairments in work and productivity, measured by the Work Productivity and Activity Impairment questionnaire and the Sheehan Disability Scale. There was considerable heterogeneity in treatments used in the Portuguese subgroup, with 31 different treatment strategies reported. At Month 6, a greater proportion of Portuguese patients (n = 27) achieved either response or remission (40.7 %) compared with the total study population (n = 306; 26.5 %). LimitationSmall patient numbers in the Portuguese subgroup. ConclusionsThe higher baseline disease severity and productivity impairment in the Portuguese subgroup relative to the total study population suggests notable societal disease burden, whilst the heterogeneity of treatments used indicates a lack of clinical consensus. Despite Portuguese patients reporting higher rates of response and remission than the overall study population, most patients failed to respond to treatment, highlighting an unmet need for TRD in Portugal.

174 (PB-081) Poster - MELODY: A prospective non-interventional multicenter cohort study to evaluate different imaging-guided methods for localization of malignant breast lesions (EUBREAST-4/iBRA-NET, NCT 0555941 1)

174 (PB-081) Poster - MELODY: A prospective non-interventional multicenter cohort study to evaluate different imaging-guided methods for localization of malignant breast lesions (EUBREAST-4/iBRA-NET, NCT 0555941 1)

Real-world use and clinical impact of an electronic patient-reported outcome tool in patients with solid tumors treated with immuno-oncology therapy

BackgroundUtilization of electronic patient-reported outcome (ePRO) tools to monitor symptoms in patients undergoing cancer treatment has shown clinical benefits. Tennessee Oncology (TO) implemented an ePRO platform in 2019, allowing patients to report their health status online. We conducted a real-world, multicenter, observational, non-interventional cohort study to evaluate utilization of this platform in adults with solid tumors who initiated immuno-oncology (IO) therapy as monotherapy or in combination at TO clinics.MethodsPatients initiating IO therapy prior to platform implementation were included in a historical control (HC) cohort; those initiating treatment after implementation were included in the ePRO cohort, which was further divided into ePRO users (platform enrollment ≤ 45 days from IO initiation) and non-users. Data were extracted from electronic medical records; patients were followed for up to 6 months (no minimum follow up). Outcomes included patient characteristics, treatment patterns, duration of therapy (DoT), and overall survival (OS).ResultsData were collected for 538 patients in the HC and 1014 in the ePRO cohort; 319 in the ePRO cohort were ePRO users (uptake rate 31%). Baseline age was higher, more patients had stage IV disease at diagnosis, and more received monotherapy (82 vs 52%, respectively) in the HC vs the ePRO cohort. Median follow-up was 181.0 days (range 0.0–182.6) in the HC and 175.0 (0.0–184.0) in the ePRO cohort. Median DoT of index IO regimen was 5.1 months (95% confidence interval [CI], 4.4–NE) in the HC cohort vs not estimable (NE) in the ePRO cohort. Multivariable regression adjusting for baseline differences confirmed lower risk of treatment discontinuation in the ePRO vs HC cohort: hazard ratio (HR) 0.83 (95% CI, 0.71–0.97); p < 0.05. The estimated 6-month OS rate was 65.5% in the HC vs 72.4% in the ePRO cohort (p < 0 .01). Within the ePRO cohort, DoT of index IO regimen and OS did not differ between users and non-users. In ePRO users, patient platform use was durable over 6 months.ConclusionImprovements in DoT and OS were seen after ePRO platform implementation. Conclusions are limited by challenges in separating the impact of platform implementation from other changes affecting outcomes.

Evaluation of the Effectiveness of Teduglutide Treatment in Patients with Short Bowel Syndrome in Slovakia-Multicenter Real-World Study.

(1) Background: We present the first real-world-data study on teduglutide-treated SBS patients in the Slovak Republic and the first study to enable the comparison of the effects of teduglutide treatment between the adult and pediatric populations. (2) Methods: This was a non-interventional retrospective cohort study of adult and pediatric SBS patients treated with teduglutide. Primary and secondary endpoints were the results of teduglutide use at 12 weeks and 6 months after the initiation of treatment, compared to baseline. (3) Results: Teduglutide treatment led to a statistically significant reduction in the volume of intravenous hydration, HPN caloric intake, HPN and intravenous hydration applications per week and to increased urine output in adult patients. The results in the pediatric population were similar, but not statistically significant. A complete weaning off HPN was achieved in 57.14% of all patients (50.00% of children; 62.50% of adults) after a median of 0.99 years of teduglutide treatment (1.07 and 0.98 years for children and adults, respectively). (4) Conclusions: Teduglutide treatment in SBS patients leads to considerable reduction in or even weaning off PN in both pediatric and adult patients.

Real Life Data and Outcome of FOLFIRINOX Use in Metastatic Pancreatic Cancer Patients in General Hospitals in the Netherlands.

Pancreatic cancer is one of the five most common causes of cancer mortality in developed countries. In patients with metastatic disease, the most frequent treatment used is FOLFIRINOX, which is associated with moderate toxicity which could influence quality of life. The efficacy of FOLFIRINOX in a general population in the Netherlands has not been subject of research before, and therefore, this research has been set up in order to investigate what the real-life benefits of FOLFIRINOX are in a population with metastatic pancreatic cancer (mPC) treated in three general hospitals in the Netherlands. The data used in this study was collected by patient records leading to a noninterventional retrospective cohort study. Eighty-six patients, over 18years of age, diagnosed with mPC between the years 2015 and 2022 and treated with FOLFIRINOX at Maasstad Hospital in Rotterdam, Amphia Hospital in Breda, or Catharina Hospital in Eindhoven, were included in the study. Kaplan-Meier models were used in order to represent survival outcomes. The results showed a median overall survival of 228days (IQR 118-355). Only 14.0% (n = 12) completed the first-line treatment, and 51.2% (n = 44) of patients stopped treatment before or during cycle 6. Toxicity is highest, grade 3, after the first cycle but remains high for grade 1 and 2 during all treatment cycles. Survival rates for patient with metastatic pancreatic cancer treated with FOLFIRINOX were worse in our study population than in comparative studies.

Six-Year Outcomes in Subjects with Polypoidal Choroidal Vasculopathy in the EVERESTII Study.

The EVERESTII study previously reported that intravitreally administered ranibizumab (IVR) combined with photodynamic therapy (PDT) achieved superior visual gain and polypoidal lesion closure compared to IVR alone in patients with polypoidal choroidal vasculopathy (PCV). This follow-up study reports the long-term outcomes 6years after initiation of the EVERESTII study. This is a non-interventional cohort study of 90 patients with PCV from 16 international trial sites who originally completed the EVERESTII study. The long-term outcomes were assessed during a recall visit at about 6years from commencement of EVERESTII. The monotherapy and combination groups contained 41 and 49 participants, respectively. The change in best-corrected visual acuity (BCVA) from baseline to year6 was not different between the monotherapy and combination groups; - 7.4 ± 23.0 versus - 6.1 ± 22.4 letters, respectively. The combination group had greater central subfield thickness (CST) reduction compared to the monotherapy group at year6 (- 179.9 vs - 74.2µm, p = 0.011). Fewer eyes had subretinal fluid (SRF)/intraretinal fluid (IRF) in the combination versus monotherapy group at year6 (35.4% vs 57.5%, p = 0.032). Factors associated with BCVA at year6 include BCVA (year2), CST (year2), presence of SRF/IRF at year2, and number of anti-VEGF treatments (years2-6). Factors associated with presence of SRF/IRF at year6 include combination arm (OR 0.45, p = 0.033), BCVA (year2) (OR 1.53, p = 0.046), and presence of SRF/IRF (year2) (OR 2.59, p = 0.042). At 6years following the EVERESTII study, one-third of participants still maintained good vision. As most participants continued to require treatment after exiting the initial trial, ongoing monitoring and re-treatment regardless of polypoidal lesion status are necessary in PCV. ClinicalTrials.gov identifier, NCT01846273.

Analysis of feeding and eating disorders in 191 children according to psychiatric or gastroenterological recruitment: The PEDIAFED cohort study.

The DSM-5 classification introduced new Feeding and Eating Disorders (FED) diagnostic categories, notably Avoidant and Restrictive Food Intake Disorder (ARFID), which, like other FED, can present psychiatric and gastrointestinal symptoms. However, paediatric clinical research that focuses on children below the age of 12years remains scarce. The aim of this study was first to investigate the clinical features of FED in a cohort of children, second to compare them according to their recruitment (gastroenterology or psychiatry unit). This non-interventional retrospective cohort study analysed 191 patients in a French paediatric tertiary care centre (gastroenterology n=100, psychiatry n=91). The main outcome variables were clinical data (type of FED, BMI, nutritional support, chronic diseases, psychiatric comorbidities, sensory, sleep, language disorders, gastrointestinal complaints, adverse life events, family history). The outcome was defined by a Clinical Global Impression of Change-score. FED diagnoses were ARFID (n=100), Unspecified FED (UFED, n=57), anorexia nervosa (AN, n=33) and one pica/rumination. Mean follow-up was 3.28years (SD 1.91). ARFID was associated with selective and sensory disorders (p<0.001); they had more anxiety disorders than patients with UFED (p<0.001). Patients with UFED had more chewing difficulties, language disorder (p<0.001), and more FED related to chronic disease (p<0.05) than patients with ARFID and AN. Patients with AN were female, underweight, referred exclusively to the psychiatrist, and had more depression than patients with ARFID and UFED (p<0.001). The gastroenterology cohort included more UFED, while the psychiatry cohort included more psychiatric comorbidities (p<0.001). A worse clinical outcome was associated with ARFID, a younger age at onset (p<0.001), selective/sensory disorders and nutritional support (p<0.05). ARFID and UFED children were diagnosed either by gastroenterologists or psychiatrists. Due to frequently associated somatic and psychiatric comorbidities, children with FED should benefit from a multidisciplinary assessment and care.

Long-term therapy with dienogest or other oral cyclic estrogen-progestogen can reduce the need for ovarian endometrioma surgery.

Almost 10% of women in reproductive age are diagnosed with ovarian endometriomas and can experience symptoms and infertility disorders. Ovarian endometriomas can be treated with medical or surgical therapy. To assess whether long-term therapy with dienogest or oral cyclic estrogen-progestogens is effective in reducing the size of ovarian endometriomas, alleviating associated symptoms, and reducing the requirement for surgery. Prospective non-interventional cohort study. We enrolled childbearing women diagnosed with ovarian endometriomas. We collected demographic, clinical, and surgical data, including the evaluation of ovarian endometrioma-associated symptoms and pain using the visual analog scale. We grouped the women according to treatment regimen into dienogest, estrogen-progestogens, and no-treatment. Patient's assessment was performed at baseline and after 12 months evaluating the largest ovarian endometrioma diameter (in millimeters) and the associated symptoms. Furthermore, we analyzed the impact of hormonal treatment in a sub-group of women fulfilling at baseline the criteria for a first-line surgical approach (ovarian endometrioma > 30 mm with visual analog scale > 8 or ovarian endometrioma > 40 mm before assisted reproductive treatments or any ovarian endometrioma(s) > 60 mm). We enrolled 142 patients: 62, 38, and 42 in dienogest, estrogen-progestogens, and no-treatment groups, respectively. No significant differences were found regarding baseline characteristics. After 12 months, the mean largest ovarian endometrioma diameter increased in the no-treatment group (31.1 versus 33.8; p < 0.01), while a significant reduction was registered in the dienogest (35.1 versus 25.8; p < 0.01) and estrogen-progestogens (28.4 versus 16.7; p < 0.01) groups; no significant difference in ovarian endometrioma diameter reduction between these two latter groups was noted (p = 0.18). Ovarian endometrioma-associated symptoms and pain improved in dienogest and estrogen-progestogens groups, with a significantly greater effect for dienogest than for estrogen-progestogens for dysmenorrhea (74% versus 59%; p < 0.01). In the sub-group of women eligible for first-line surgery at baseline, long-term treatment with dienogest and estrogen-progestogens reduced surgical eligibility by 30%. Decreased mean largest ovarian endometriomas'diameter after 12 months and reduction of the need for surgical treatment by 30% were observed in dienogest and estrogen-progestogens groups. Long-term treatment with dienogest had a greater effect in alleviating dysmenorrhea and pain.

Fumadores y riesgo de muerte hospitalaria por COVID calculado con el procesamiento de lenguaje natural de SAVANA en el ámbito de Castilla-La Mancha

IntroductionDuring the COVID pandemic, it was speculated that patients with the virus who were smoking-related might have a lower likelihood of disease exacerbation or death. To assess whether there is an association between smoking and risk of in-hospital mortality, SAVANA's big data and natural language processing (NLP) technology is used. MethodA retrospective, observational, non-interventional cohort study was conducted based on real-life data extracted from medical records throughout Castilla-La Mancha using natural language processing and artificial intelligence techniques developed by SAVANA. The study covered the entire population of this region with Electronic Medical Records in SESCAM presenting with a diagnosis of COVID from March 1, 2020 to February 28, 2021. ResultsSmokers had a significantly higher percentage of cardiovascular risk factors (hypertension, dyslipidemia and diabetes), COPD, asthma, IDP, IC, CVD, PTE, cancer in general and lung cancer in particular, bronchiectasis, heart failure and a history of pneumonia (P<.0001). Former smokers, current smokers and non-smokers have a significant age difference. As for in-hospital deaths, they were more frequent in the case of ex-smokers, followed by smokers and then non-smokers (P<.0001). ConclusionThere is an increased risk of dying in hospital in SARS-CoV-2-infected patients who are active smokers or have smoked in the past.

Influence of the physical pressure of an ultrasound probe on shear-wave elastography measurements of the gastrocnemius muscle in a paediatric population: a non-interventional cohort study.

The aim of our study is to evaluate the impact of ultrasound probe mechanical pressure on the stiffness of the gastrocnemius muscle in a healthy paediatric population. As far as we know, there has been no previous qualitative in vivo study on the impact of probe pressure on muscle shear-wave elastography results with objective evaluation of compression in the paediatric population. In this cohort study, a group of 22 children (mean age 8.99 years, SD 2.74, 11 males) underwent elastography of the gastrocnemius muscle of the dominant leg. A custom-made, 3-dimensional printed probe cover was used to measure the mechanical pressure of the probe on tissues. The obtained results were related to the age, sex, BMI, and calf circumference of the subjects. We observed a significant difference in the stiffness parameter at a pressure of 1 N, with a further increase if force was increased (p < 0.001). A significant, very weak positive correlation of age and stiffness was observed (p < 0.001, r2 = 0.022). There was no significant correlation of stiffness, BMI, and calf circumference. The use of compression during muscle elastography in children causes a significant bias in results, regardless of age, sex, BMI, or calf size.

Characteristics and outcomes of patients enrolled in the Connect 360 benralizumab patient support programme in the UK: a retrospective cohort study

BackgroundPatient support programmes (PSPs) allow patients with chronic diseases to receive treatment and support at home. This study describes the Connect 360 PSP delivery and impact on patient-reported outcomes, satisfaction...

Smokers and risk of hospital death by COVID calculated with SAVANA’s natural language processing in the Castilla-La Mancha area

IntroductionDuring the COVID pandemic, it was speculated that patients with the virus who were smoking-related might have a lower likelihood of disease exacerbation or death. To assess whether there is an association between smoking and risk of in-hospital mortality, SAVANA's big data and Natural Language Processing (NLP) technology is used. MethodA retrospective, observational, non-interventional cohort study was conducted based on real-life data extracted from medical records throughout Castilla La Mancha using Natural Language Processing and Artificial Intelligence techniques developed by SAVANA. The study covered the entire population of this region with Electronic Medical Records in SESCAM presenting with a diagnosis of COVID from March 1, 2020 to February 28, 2021. ResultsSmokers had a significantly higher percentage of cardiovascular risk factors (hypertension, dyslipidemia and diabetes), COPD, asthma, IDP, IC, CVD, PTE, cancer in general and lung cancer in particular, bronchiectasis, heart failure and a history of pneumonia (p < 0.0001).Former smokers, current smokers and non-smokers have a significant age difference. As for in-hospital deaths, they were more frequent in the case of ex-smokers, followed by smokers and then non-smokers (p < 0.0001). ConclusionThere is an increased risk of dying in hospital in SARS-COV2-infected patients who are active smokers or have smoked in the past.

Step Serial Sectioning in Head and Neck Squamous Cell Carcinoma of Unknown Primary

Patients with suspected head and neck squamous cell carcinoma of unknown primary (HNSCCUP) may undergo tonsillectomy and tongue base mucosectomy (TBM) to help identify clinicoradiologically occult primary disease. It is hypothesized that when these diagnostic specimens are analyzed, conventional histopathological (CH) techniques risk missing small primary tumors that may be hidden in the tissue blocks. To establish the outcomes of a step serial sectioning (SSS) histopathological technique vs CH when analyzing diagnostic tissue specimens from TBM and tonsillectomy performed for HNSCCUP. The MOSES prospective multicenter noninterventional cohort study was conducted over a 25-month period from November 2019 at secondary and tertiary care ear, nose, and throat departments in the United Kingdom and included adults with clinicoradiologically occult HNSCCUP who were undergoing TBM. Conventional histopathological techniques performed on TBM and tonsillectomy specimens at participating centers, followed by SSS performed at the central laboratory. Identification of cancer on central histopathological review of TBM and tonsillectomy specimens. Tissue from 58 eligible patients was analyzed (median [range] age, 58 [47-82] years; 10 women [17%]), with 20 480 sections cut in the laboratory and 4096 sections directly examined by a pathologist (median [range], 64 [28-135] per patient). The overall identification rate for TBM following SSS according to study protocol was 50.0% (95% CI, 37.5%-62.5%) and by subgroups was 42.9% (95% CI, 21.4%-67.4%) when performed following a negative bilateral tonsillectomy, 46.7% (95% CI, 24.8%-69.9%) at the same time as bilateral tonsillectomy, and 57.1% (95% CI, 36.5%-75.5%) following historic tonsillectomy. Conventional histopathological techniques at central review identified 2 undiagnosed primary tumors and revised the diagnosis of 2 other cases (1 nonmalignant and another down staged). Step serial sectioning identified a single additional tumor: an ipsilateral synchronous tongue base tumor for which a contralateral tumor had been identified on CH. Multifocal disease was seen in 5 (8.6%); all were human papillomavirus-related and in the tongue base. In this multicenter cohort study of patients undergoing TBM for HNSCCUP, SSS was associated with added considerable histopathological workload with minimal additional diagnostic benefit. A second opinion for conventional histological techniques may be more beneficial. Synchronous primary disease should be considered when planning diagnostic oropharyngeal surgery for these patients.

Investigation of Serum Cardiotrophin-1 Concentrations in Pregnant Women with Gestational Diabetes Mellitus.

We aimed to investigate cardiotrophin-1 (CT-1) concentrations in the serum of pregnant women with gestational diabetes mellitus (GDM). This prospective non-interventional cohort study was conducted with 160 pregnant women who applied to the Umraniye Training and Research Hospital, Department of Obstetrics and Gynecology between October 2022 and May 2023. The GDM group was formed from 80 pregnant women who were diagnosed with GDM according to the 75-g OGTT. The control group consisted of 80 healthy pregnant women who were matched with the GDM group in terms of age and body mass index and had a normal 75-g OGTT result. Two groups were compared in terms of maternal serum CT-1 concentrations. Both groups were similar in terms of demographic features and the gestational week at blood sampling for CT-1 (p>0.05 for each). The mean maternal serum CT-1 concentration was found to be 1420.9 pg/ml in the GDM group, while it was determined as 1455 pg/ml in the control group (p=0.738). When the GDM and control groups were divided into two subgroups, normal weight and overweight according to the participants' BMI, serum CT-1 concentrations were found to be similar in these four groups (p=0.084). When the GDM group was divided into two groups of diet-only and the insulin-using group for blood glucose regulation and compared with the control group, the three groups were also similar in terms of serum CT-1 concentrations (p=0.189). CT-1 is an adipokine involved in the regulation of glucose metabolism and has been suggested to be associated with the pathophysiology of diabetes mellitus. In this study, serum CT-1 concentrations were found to be similar in the group with GDM and the group with normal glucose tolerance. Whether CT-1 contributes to the development of GDM is currently unclear and requires further investigation.

Comparative Effectiveness and Durability of Biologics in Clinical Practice: Month12 Outcomes from the International, Observational Psoriasis Study of Health Outcomes (PSoHO).

Given the chronic nature of psoriasis (PsO), more studies are needed that directly compare the effectiveness of different biologics over long observation periods. This study compares the effectiveness and durability through 12months of anti-interleukin (IL)-17A biologics relative to other approved biologics in patients with moderate-to-severe psoriasis in a real-world setting. The Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year, prospective, non-interventional cohort study of 1981 adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. The study compares the effectiveness of anti-IL-17A biologics with other approved biologics and provides pairwise comparisons of seven individual biologics versus ixekizumab. The primary outcome was defined as the proportion of patients who had at least a 90% improvement in Psoriasis Area and Severity Index score (PASI90) and/or a score of 0 or 1 in static Physician Global Assessment (sPGA). Secondary objective comparisons included the proportion of patients who achieved PASI90, PASI100, a Dermatology Life Quality Index (DLQI) score of 0 or 1, and three different actions of durability of treatment response. Unadjusted response rates are presented alongside the primary analysis, which uses frequentist model averaging (FMA) to evaluate the adjusted comparative effectiveness. Compared to the other biologics cohort, the anti-IL-17A cohort had a higher response rate (68.0% vs. 65.1%) and significantly higher odds of achieving the primary outcome at month12. The two cohorts had similar response rates for PASI100 (40.5% and 37.1%) and PASI90 (53.9% and 51.7%) at month12, with no significant differences between the cohorts in the adjusted analyses. At month12, the response rates across the individual biologics were 53.5-72.6% for the primary outcome, 27.6-48.3% for PASI100, and 41.7-61.4% for PASI90. These results show the comparative effectiveness of biologics at 6 and 12months in the real-world setting. ClinicalTrials.gov identifier EUPAS24207.

Resource utilisation and outcomes of people with heart failure in England: a descriptive analysis of linked primary and secondary care data – the PULSE study

BackgroundHeart failure (HF) is associated with high levels of resource use and mortality, but prior UK studies have not compared outcomes by HF subtype (HF with reduced ejection fraction (HFrEF)...