Case Report Form Research Articles

Incidence and case fatality rates of cardiovascular diseases in urban and rural community-dwelling populations in eastern, central and western regions of China

Objective: To evaluate the incidence and case fatality rate of cardiovascular disease (CVD) among populations in urban and rural communities in eastern, central and western regions of China. Methods: The present study was based on the data of the Prospective Urban and Rural Epidemiology (PURE)-China cohort, which enrolled participants who had at least one follow-up visit and complete information on age and sex. Information on baseline demographics, cardiovascular risk factors, and prevention and treatment for CVD were collected. CVD and mortality events were documented using the standardized case report form of the PURE Global Study to assess the incidence and case fatality rate of CVD among populations in urban and rural communities in eastern, central and western China. Results: This study included a total of 47 262 community-dwelling participants (age: (51.1±9.6) years; female, n=27 529, 58.2%) from 115 urban and rural communities in 12 provinces across the eastern, central, and western regions of China. Over a follow-up period of 11.9 (9.5, 12.6) years, 2 686 deaths and 5 873 cardiovascular events were documented. The incidence of CVD was 11.90 (95%CI: 11.60-12.21)/1 000 person-years. A significant difference in CVD incidence was observed across regions (Ptrend<0.001), which was highest in the western provinces (13.99 (95%CI: 13.33-14.65)/1 000 person-years), intermediate in the eastern provinces (11.92 (95%CI: 11.52-12.33)/1 000 person-years), and lowest in the central provinces (8.87 (95%CI: 8.25-9.50)/1 000 person-years). The 1-year case fatality rate of CVD demonstrated an increasing trend from eastern to western regions (eastern: 10.20% (95%CI: 6.95-14.73); central: 13.50% (95%CI: 9.90-18.14); western: 18.62% (95%CI: 14.95-22.94); Ptrend<0.001). Moreover, the incidence of major CVD was consistently higher in rural areas compared with urban areas across eastern (P<0.001), central (P=0.01) and western (P<0.001)_regions, respectively. The 1-year case fatality rate in rural areas was also significantly higher compared with that in urban areas in both eastern (P<0.001) and western regions (P=0.02). Conclusions: The incidence and case fatality rate of CVD were high among middle-aged population in China, especially those in western regions with low socioeconomic levels and in rural areas.

Bronchiectasis and asthma: Data from the European Bronchiectasis Registry (EMBARC)

BackgroundAsthma is commonly reported in patients with a diagnosis of bronchiectasis. ObjectiveThe aim of this study was to evaluate if patients with asthma and bronchiectasis had a different clinical phenotype and different outcomes compared to patients with bronchiectasis without concomitant asthma. MethodsProspective observational pan-European registry (EMBARC) enrolling patients across 28 countries. Adult patients with CT confirmed bronchiectasis were reviewed at baseline and annual follow-up visits using an electronic case report form. Asthma was diagnosed by the local investigator. Follow-up data were used to explore differences in exacerbation frequency between groups using a negative binomial regression model. Survival analysis utilised Cox-proportional hazards regression. Results16963 patients with bronchiectasis were included for analysis. 5267 patients (31.0%) had investigator reported asthma. Patients with bronchiectasis and asthma (BE+A) were younger, more likely to be female and never smokers, and had a higher BMI than patients with bronchiectasis without asthma. BE+A was associated with a higher prevalence of rhinosinusitis and nasal polyps as well as eosinophilia and Aspergillus sensitization. BE+A had similar microbiology, but significantly lower severity of disease using the bronchiectasis severity index (BSI). The BE+A group were at increased risk of exacerbation after adjustment for severity of disease and multiple confounders. Inhaled corticosteroid use was associated with reduced mortality in BE+A patients (adjusted hazard ratio 0.78 (0.63-0.95)) and reduced risk of hospitalization, (rate ratio 0.67 (0.67-0.86)) compared to a control population without asthma and not receiving inhaled corticosteroid. ConclusionCombined bronchiectasis and asthma was common and was associated with an increased risk of exacerbations and improved outcomes with inhaled corticosteroid use. Unexpectedly we identified significantly lower mortality in patients with bronchiectasis and asthma.

Diagnosis and Treatment Patterns of Chronic Thromboembolic Pulmonary Hypertension in Russia, Kazakhstan, Turkey, Lebanon, and Saudi Arabia: A Registry Study.

Patients with chronic thromboembolic pulmonary hypertension (CTEPH) in countries with limited resources have, to date, been poorly represented in registries. This work assesses the epidemiology, diagnosis, hemodynamic and functional parameters, and treatment of CTEPH in Russia, Kazakhstan, Turkey, Lebanon, and Saudi Arabia. A prospective, cohort, phase IV, observational registry with 3-year follow-up (n = 212) in patients aged ≥ 18 years diagnosed with CTEPH was created. Clinical, hemodynamic, and functional parameters were obtained at an initial visit, follow-up visits, and a final visit at the end of 3years' observation or end of follow-up. Data were recorded on electronic case report forms. Parameters evaluated included 6-minute walking distance (6MWD), use of pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA), pulmonary hypertension (PH)-targeted therapy, and survival. All statistical analyses were exploratory and descriptive, and were performed in the overall population. The most common symptoms were typical of those expected for CTEPH. Almost 90% of patients underwent right heart catheterization at diagnosis or initial study visit. In total, 66 patients (31%) underwent PEA before the initial visit; 95 patients (45%) were considered operable, 115 (54%) were inoperable, and two (1%) had no operability data. Only 26 patients (12%) had been assessed for BPA at their initial visit. PH-targeted therapy was documented at diagnosis for 77 patients (36%), most commonly a phosphodiesterase type 5 inhibitor (23%). Use of PH-targeted therapy increased to 142patients (67%) at the initial visit, remaining similar after 3 years. Use of riociguat increased from 6% of patients at diagnosis to 38% at 3 years. Between baseline and end of observation, results for patients with paired data showed an increase in 6MWD. Survival at the end of observation was 88%. These data highlight the current diagnosis and management of CTEPH in the participating countries. They show that early CTEPH diagnosis remains challenging, and use of off-label PH-targeted therapy is common. gov: NCT02637050; registered December 2015.

Prevalence of Rifampicin resistance tuberculosis among presumptive tuberculosis patients in Egypt-2021: a national health facility-based survey

BackgroundThe magnitude of MDR-TB cases was noticeable in Egypt. However, the last national survey was 11-years ago. The current survey was conducted to determine the prevalence of rifampicin resistance among sputum smear-positive pulmonary tuberculosis patients in Egypt.MethodsA national health facility-based cross-sectional study was conducted in 14 randomly selected governorates in Egypt between August 2020 and September 2021. All presumptive TB cases, either new or previously treated according to WHO definitions, with no gender, age, or nationality limitations, and provided informed consent were included in the study. Each patient completed a case report form (CRF). The CRF included socio-demographic and clinical data. Sputum samples were collected according to standard techniques and cultured on Lowenstein-Jensen (L-J) medium. Gene X-pert test was carried out first on the samples for simultaneous identification of MTB and rifampicin resistance. The prevalence of RR was calculated using crude, cluster, and weighted methods. Factors associated with RR were analyzed by bivariate and multivariate techniques.ResultsAmong the total 849 presumptive TB patients enrolled in the study, 710 (83.6%) patients were subjected to Gene X-pert testing (MTB/RIF). The crude prevalence of RR was 3.32% (95% CI: 1.89–4.76%) among the new cases and 9.46% (95% CI: 2.63–16.29%) among the retreated cases with an overall estimate of 3.99%; (95% CI: 2.51–5.47%). By cluster analysis the overall prevalence of RR was 5.01% (95% CI: 2.90–7.13). Factors associated with the prevalence of RR were co-morbidity with bronchial asthma, drug abuse and history of contact with a family member with TB.ConclusionThe prevalence of RR among either new or retreated cases TB patients was lower than the previous Egyptian rates in 2010–2012. The strongest predictor associated with RR was comorbidity with bronchial asthma.

A104 ATYPICAL PRESENTATION OF HSD3B7 DEFICIENCY

Abstract Background Bile acid synthesis disorders are the result of deficient activity of one of 17 enzymes required for conversion of cholesterol into bile acids. One such bile acid synthesis disorder is 3β-hydroxy-Δ5-C27-steroid oxidoreductase (HSD3B7) deficiency, an autosomal recessive inherited disorder caused by a defect in 3β-hydroxy-Δ5-C27-steroid dehydrogenase (C27 3β-HSD) enzyme. Ultimately, this bile acid synthesis disorder is due to a HSD3B7 gene mutation. With only 53 cases reported between 1993 and 2015, HSD3B7 deficiency is rare. Additionally, the existing literature is primarily in the form of case reports, with the majority of patients with HSD3B7 deficiency presenting in the neonatal period, often with cholestatic jaundice. Aims To showcase an atypical presentation of HSD3B7 deficiency, in an 11 year old male with recurrent epistaxis and a coagulopathy of vitamin K deficiency. Additionally, to complete a review of the literature available on HSD3B7 deficiency. Methods Case report, chart review, and literature review. Results 11 year old male who initially presented to Pediatric Hematology with prolonged PTT and INR in the context of recurrent epistaxis and easy bruising. Upon further work up, the patient was found to have low levels of vitamin K dependent factors, as well as low vitamin levels of A, D, and E. Additionally, the patient had elevation of AST, ALT, GGT, ALP, and total bilirubin. Normalization of the INR and PTT were achieved with vitamin K supplementation. Genetic testing was sent to work up the abnormal liver enzymes and revealed HSD3B7 deficiency. Fast atom bombardment ionization was subsequently completed and confirmed the diagnosis. Conclusions There is limited clinical data available regarding HSD3B7 deficiency. The classic presentation of this bile acid synthesis disorder is in a neonate with cholestatic jaundice, hepatomegaly, fat-soluble vitamin deficiencies, and lipid malabsorption. Therefore, the initial presentation of an 11 year old with recurrent epistaxis and prolonged INR and PTT is thus an atypical presentation of HSD3B7 deficiency. This case report demonstrates that there is diversity in the age of presentation and accompanying signs and symptoms in HSD3B7 deficiency. Funding Agencies None

Right gastroepiploic artery length determined anastomotic leakage after minimally invasive esophagectomy for esophageal cancer: a prospective cohort study.

This prospective cohort study, conducted at a high-volume esophageal cancer center from July 2019 to July 2022, aimed to investigate the link between the right gastroepiploic artery (RGEA) length and anastomotic leakage (AL) rates following minimally invasive esophagectomy (MIE). Real-world data on stomach blood supply in the Chinese population were examined. A total of 516 cases were enrolled, categorized into two groups based on the Youden index-determined optimal cut-off value for the relative length of RGEA (length of RGEA/length of gastric conduit, 64.69%) through ROC analysis: Group SR (short RGEA) and Group LR (long RGEA). The primary observation parameter was the relationship between AL incidence and the ratio of direct blood supply from RGEA. Secondary parameters included the mean length of the right gastroepiploic artery, greater curvature, and the connection type between right and left gastroepiploic vessels. Patient data were prospectively recorded in electronic case report forms. The study revealed median lengths of 43.60cm for greater curvature, 43.16cm for the gastric conduit, and 26.75cm for RGEA. AL, the most common postoperative complication, showed a significant difference between groups (16.88 vs. 8.84%, P =0.01). Multivariable binary logistic regression identified Group SR and LR (odds ratio: 2.651, 95% CI: 1.124-6.250, P =0.03) and Neoadjuvant therapy (odds ratio: 2.479, 95% CI: 1.374-4.473, P =0.00) as independent predictors of AL. The study emphasizes the crucial role of RGEA length in determining AL incidence in MIE for esophageal cancer. Preserving RGEA and fostering capillary arches between RGEA and LGEA are recommended strategies to mitigate AL risk.

Nationwide Etoricoxib Injection Clinical Experience (NICE): Real-World Evidence in Indian Patients.

Introduction Pain is a major health issue globally. Etoricoxib, a highly selective COX-2 inhibitor, given orally, has been found to be efficacious and safe in the management of acute and chronic pain. Oral etoricoxib has been extensively studied; however, there is a lack of research exploring the use of etoricoxib via alternative routes, specifically intramuscular (IM) injection. This study aimed to evaluate the effectiveness and safety of an innovative and novel formulation of IM etoricoxib injection 90 mg/mL in the management of patients with acute pain in India. Method This was a real-world, multicenter, retrospective, observational study to investigate the effectiveness and safety of IM etoricoxib injection in the management of patients with acute pain in India (outpatient setting). The clinical data of 383 patients from 42 centers across India were collected from November 2022 to April 2023. Following approval from the site investigator, comprehensive patient-level information encompassing demographic and clinical variables as well as comorbidities was collected and entered into a case report form. Approval from the Independent Ethics Committee (IEC) and Institutional Review Board (IRB) was sought. The safety and effectiveness at 30 minutes and 60 minutes of IM etoricoxib injection were then analyzed. Results Among the studied patients, etoricoxib was used for the management of knee arthritis, fracture, post-traumatic pain, postoperative cases, acute back pain, back injury, torn ligament, and muscle strain and sprain. Of 383 patients, 98.17% had moderate-to-severe pain at baseline on the visual analogue scale (VAS) (0 being no pain and 10 being severe unbearable pain). The percentage of patients with severe pain reduced to only 6.78% and 4.17% at 30 minutes and 60 minutes, respectively. The improvement in the VAS score was statistically significant from baseline to 30 minutes and 60 minutes, and at 60 minutes compared to 30 minutes (p < 0.0001). More than half the patients (56.91%) had no pain at the site of the injection. Most of the doctors (70.23%) opined that the IM etoricoxib injection was better than their currently used NSAID injections for pain relief. Only 12.79% of patients required rescue analgesia post-IM etoricoxib injection. IM etoricoxib injection was well tolerated as 98.69% of the patients did not experience or report any adverse events post-IM injection. Conclusion This real-world, multicenter, retrospective, observational study across India demonstrated that the innovative and novel formulation of etoricoxib (90 mg/mL IM injection) was effective and well-tolerated in the management of acute pain. Overall, this study provides valuable insights into the real-world effectiveness and safety of IM etoricoxib injections, suggesting it could be a promising therapy for the management of acute pain for optimal patient benefit.

A Prospective Observational Study of the Prevalence, Risk Factors, Management and Types of Anaemia in Hospitalized Patients in Surat, India

Background: Anaemia is a common condition in hospitalized patients and is associated with adverse clinical outcomes, such as increased morbidity, mortality, and length of hospital stay. However, there is limited research on the prevalence, types, risk factors, and management of anaemia in Surat, India. Methods: We conducted a prospective observational study of 407 hospitalized patients in Surat, India, to investigate the prevalence, types, risk factors, and management of anaemia. Data were collected through case report forms. Hemoglobin levels were used to diagnose anaemia, and the World Health Organization (WHO) criteria were used to classify the severity of anaemia. Results: The results showed that the prevalence of anaemia was highest in the pediatric ward, with microcytic normochromic anaemia being the most common type of anaemia in male and female patients. Moderate anaemia was found to be the most common among the study population. The majority of patients were transfused with RBC for severe anaemia. Conclusion: The findings of this study have implications for the management of anaemia in hospital populations, highlighting the need for targeted interventions for different patient groups and emphasizing the need for improved screening and management of anaemia, particularly in high-risk populations such as pediatric and female patient.

Clinicopathologic Features and Outcome of COVID-19 Patients Attended at a Secondary Hospital in Bangladesh during the Pandemic

Background: Coronavirus Disease 2019 (COVID-19) is an acute respiratory diseasethat can present varieties of clinical and pathologic manifestation. Sometimes it presentwith severe manifestation which ultimately lead to respiratory failure and death.COVID-19 patients with other comorbidities may develop a life-threatening situation.Objective: To describe the clinicopathologic features and outcome of COVID-19patients admitted in Combined Military Hospital (CMH) Rangpur, Bangladesh.Materials and method: This cross-sectional study was conducted at CMH Rangpur,Bangladesh, from 1 May 2021 to 30 August 2021 among purposively selected 416 casesof COVID-19 positive patients. Data were collected from the medical records of thehospital admitted patients in a structured case report form. Results: Highest numbers ofthe respondents were in the age group of 31-50 years (49.03%) with male predominance(72.28%). About 89% were Muslim and 54.81% were educated up to higher secondarylevel. Fever (90.86%) was the common presenting symptoms followed by cough(73.55%), sore throat (30.28%). About 24.51%, 23.07%, 11.05% had hypertension,diabetes mellitus and respiratory comorbidities respectively. Lymphopenia (75.24%)and elevated C-Reactive Protein (54.08%) were observed in most of the cases. Only8.17% patients had critical illness that needed intensive care unit admission. Majority(91.82%) fully recovered from the illness while 1.92% expired. Conclusions: The mostcommonly reported symptom was fever (90.86%) among all the COVID-19 positivepatients. Majority (62.25%) of the patients belonged to mild cases. Overall mortalitywas 1.92%. In most cases the clinical presentation is that of a respiratory infection withsymptom severity ranging from a mild influenza like illness.&#x0D; Delta Med Col J. Jan 2021;9(1):3-8

Real-world observations and impacts of Chinese herbal medicine for migraine: results of a registry-based cohort study.

Background: Migraine is a prevalent, recurrent condition with substantial disease burden. Chinese herbal medicine (CHM) has been used frequently for migraine in controlled clinical settings. This study is to summarise the characteristics of patients who seek clinical care in a tertiary Chinese medicine hospital in China; to gather their preferences and values of using CHM; to explore the effect of CHM for migraine and its comorbidities in a real-world setting, and to collect first-hand expertise of clinicians' practice pattern in prescribing CHM for migraine. Methods: This registry-based cohort study was prospectively conducted at Guangdong Provincial Hospital of Chinese Medicine from December 2020 to May 2022. Adult migraine patients seeking their initial anti-migraine clinical care at the hospital were consecutively recruited and followed up for 12weeks. Practitioners specialised in headache management prescribed individualised treatments without research interference. Standardised case report forms were employed to gather information on patients' preferences and perspective of seeking clinical care, as well as to assess participants' migraine severity, comorbidities, and quality of life, at 4-weeks intervals. Various analytical methods were utilised based on the computed data. Results: In this study, we observed 248 participants. Of these, 73 received CHM treatment for 28days or longer. Notably, these participants exhibited a greater disease severity, compared to those treated with CHM for less than 28days. Of the 248 participants, 83.47% of them expected CHM would effectively reduce the severity of their migraine, around 50% expected effects for migraine-associated comorbidities, while 51.61% expressing concerns about potential side effects. CHM appeared to be effective in reducing monthly migraine days and pain intensity, improving patients' quality of life, and potentially reducing comorbid anxiety, with a minimum of 28days CHM treatment. Herbs such as gan cao, gui zhi, chuan xiong, fu ling, bai zhu, yan hu suo, etc. were frequently prescribed for migraine, based on patients' specific symptoms. Conclusion: CHM appeared to be beneficial for migraine and comorbid anxiety in real-world clinical practice when used continuously for 28 days or more. Clinical Trial Registration: clinicaltrials.gov, identifier ChiCTR2000041003.

Optimization of sensitivity and specificity of a biomarker-based blood test (LVOCheck-Opti): A protocol for a multicenter prospective observational study of patients suspected of having a stroke.

Acute ischemic stroke (AIS) is a time-critical medical emergency. For patients with large-vessel occlusions (LVO), mechanical thrombectomy (MT) is the gold-standard treatment. Mobile Stroke Units (MSUs) provide on-site diagnostic capabilities via computed tomography (CT) and have been shown to improve functional outcomes in stroke patients, but are cost-efficient only in urban areas. Blood biomarkers have recently emerged as possible alternative to cerebral imaging for LVO diagnosis. Prehospital LVO diagnosis offers the potential to transport patients directly to centers that have MT treatment available. In this study, we assess the accuracy of combining two biomarkers, HFABP and NT-proBNP, with clinical indicators to detect LVO using ultra-early prehospital blood samples. The study was registered in the German Clinical Trials Register (DRKS-ID: DRKS00030399). We plan a multicenter prospective observational study with 800 patients with suspected stroke enrolled within 24 h of symptom onset. Study participants will be recruited at three sites (MSUs) in Berlin, Germany. Blood-samples will be taken pre-hospitally at the scene and tested for HFABP and NT-proBNP levels. Additional clinical data and information on final diagnosis will be collected and documented in an electronic case report form (eCRF). Sensitivity and specificity of the combination will be calculated through iterative permutation-response calculations. This study aims to evaluate the diagnostic capabilities of a combination of the biomarkers HFABP and NT-proBNP in LVO prediction. In contrast to most other biomarker studies to date, by employing MSUs as study centers, ultra-early levels of biomarkers can be analyzed. Point-of-care LVO detection in suspected stroke could lead to faster treatment in both urban and rural settings and thus improve functional outcomes on a broader scale. Deutsches Register klinischer Studien https://drks.de/search/de/trial/DRKS00030399, DRKS00030399.

Validity and reliability of the Turkish version of the Difficult Intravenous Access Scale for adult patients.

Difficult intravenous access is a condition that decreases the first-attempt success rate of intravenous catheterisation. It is important to evaluate patients with difficult vascular access using a standardised scale. This study was carried out to establish the Turkish validity and reliability of the 'Adult Difficult Intravenous Access Scale'. The methodological descriptive study was carried out in the Adult Emergency Department. The research sample consisted of 100 patients over 18 years of age, who were conscious, whose condition was not critical or who did not require resuscitation. 'Case Report Form' and 'Adult Difficult Intravenous Access Scale' were used. The mean age of the patients was 57.54 ± 19.44 years, and 55% (n = 55) were female and 77% (n = 77) had a chronic disease. The factor loads of the scale items are between 0.366 and 0.852. The Cronbach's alpha coefficient was found to be 0.708. The Turkish version of the scale is a valid and reliable scale for determining the risk of difficult intravenous access. The practical use of this scale by healthcare professionals will enable earlier diagnosis of patients with difficult vascular access.

Ultrasound in addition to clinical assessment of acute musculoskeletal complaints in bleeding disorders: impact on patient management

BackgroundUltrasound is increasingly used for musculoskeletal assessment in hemophilia care. ObjectivesTo evaluate the impact of point-of-care ultrasound added to clinical assessment for diagnosis and treatment of acute musculoskeletal episodes in a heterogeneous cohort of children and adults with hemophilia and von Willebrand disease (VWD). MethodsThis prospective cross-sectional study consecutively included children and adults with hemophilia or VWD who visited the outpatient clinic with acute musculoskeletal complaints between March 2020 and May 2023. For all episodes, initial diagnosis and treatment determined by clinical assessment were recorded on a case report form. Subsequently, a physiotherapist (M.A.T. and J.B.) with knowledge of the clinical diagnosis performed point-of-care ultrasound. After ultrasound, updated diagnosis and treatment were recorded. Diagnosis and treatment before and after ultrasound were compared, and proportions of change with 95% CIs were determined. ResultsWe evaluated 77 episodes in 67 patients (median age, 24 years; IQR, 13-42 years). Before ultrasound, 37 joint bleeds, 13 muscle bleeds, and 27 other diagnoses were diagnosed. After ultrasound, 33 joint bleeds, 11 muscle bleeds, and 33 other diagnoses were confirmed. The diagnosis changed in 28 of 77 episodes (36%; 95% CI, 26%-48%). Nine joint bleeds and 2 muscle bleeds were missed by clinical assessment. Ultrasound findings changed treatment strategy in 30 of 77 episodes (39%; 95% CI, 28%-51%). ConclusionUltrasound in addition to clinical assessment of acute musculoskeletal complaints in people with hemophilia and VWD has an impact on diagnosis (36%) and treatment (39%), which supports the use of ultrasound in acute musculoskeletal complaints in hemophilia and VWD.

Data management plan and REDCap mobile data capture for a multi-country Household Air Pollution Intervention Network (HAPIN) trial.

Household air pollution (HAP) is a leading environmental risk factor accounting for about 1.6 million premature deaths mainly in low- and middle-income countries (LMICs). However, no multicounty randomized controlled trials have assessed the effect of liquefied petroleum gas (LPG) stove intervention on HAP and maternal and child health outcomes. The Household Air Pollution Intervention Network (HAPIN) was the first to assess this by implementing a common protocol in four LMICs. This manuscript describes the implementation of the HAPIN data management protocol via Research Electronic Data Capture (REDCap) used to collect over 50 million data points in more than 4000 variables from 80 case report forms (CRFs). We recruited 800 pregnant women in each study country (Guatemala, India, Peru, and Rwanda) who used biomass fuels in their households. Households were randomly assigned to receive LPG stoves and 18 months of free LPG supply (intervention) or to continue using biomass fuels (control). Households were followed for 18 months and assessed for primary health outcomes: low birth weight, severe pneumonia, and stunting. The HAPIN Data Management Core (DMC) implemented identical REDCap projects for each study site using shared variable names and timelines in local languages. Field staff collected data offline using tablets on the REDCap Mobile Application. Utilizing the REDCap application allowed the HAPIN DMC to collect and store data securely, access data (near real-time), create reports, perform quality control, update questionnaires, and provide timely feedback to local data management teams. Additional REDCap functionalities (e.g. scheduling, data validation, and barcode scanning) supported the study. While the HAPIN trial experienced some challenges, REDCap effectively met HAPIN study goals, including quality data collection and timely reporting and analysis on this important global health trial, and supported more than 40 peer-reviewed scientific publications to date.

Development of the EULAT eCollect application for electronic data collection within the European-Latin American consortium towards eradication of preventable gallbladder cancer - EULAT Eradicate GBC

The European-Latin American Consortium towards Eradication of Preventable Gallbladder Cancer (GBC) - EULAT Eradicate CVB is collecting high-quality data and samples in four Latin American countries with a high incidence of GBC: Argentina, Bolivia, Chile and Peru. The goal is to build a unique biorepository integrated with a customized informatics platform, identify, validate, and functionally characterize novel GBC risk biomarkers, and develop GBC prediction models integrating epidemiological and genetic-molecular risk factors. We decided to develop the electronic data collection application EULAT eCollect to facilitate the retrieval of socio-demographic, clinical, lifestyle, nutritional, and sample information from the 15,000 Latin Americans we are enrolling. The EULAT eCollect app reduces the time spent by study participants, limits the use of paper and ink, minimizes the costs and errors associated with completing written forms and their subsequent digitization, and allows close monitoring of local recruitment rates and data quality. We describe in this article the design and implementation of EULAT eCollect, which started with the specification of functional and non-functional requirements and ended with the implementation and subsequent validation of the four application modules: I Socio-demographic interview, II Sample information, III Case report form, and IV Food frequency questionnaire. We present both general and technical results and our experience with the Open Data Kit software, which may be of interest for future research projects, especially those on personalized cancer prevention conducted in low- and middle-income regions.

Reasons for refusal of or ineligibility for radical cystectomy (RC) in patients (Pts) with bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC) from the SunRISe-1 study.

701 Background: RC is the recommended treatment (tx) option for pts with BCG-unresponsive HR NMIBC. However, RC is associated with significant risk of morbidity, mortality, and impact on quality of life (QoL); some patients may refuse/be ineligible for RC. In a systemic review of 160 real-world studies, &lt;20% of pts with HR NMIBC recurrent after BCG underwent RC (PMID 35046678). For RC-ineligible pts, bladder-sparing tx is recommended. TAR-200, a novel intravesical drug delivery system that provides sustained release of gemcitabine within the bladder, is under investigation in pts with BCG-unresponsive HR NMIBC who are ineligible for/refuse RC in the ongoing ph 2b SunRISe-1 (SR-1) study (NCT04640623). Preliminary results showed a promising complete response (CR) rate of 73% and durable responses in pts with BCG-unresponsive HR NMIBC treated with TAR-200 (Daneshmand et al. AUA 2023). We report reasons for refusal/ineligibility for RC in pts enrolled in the TAR-200 monotherapy cohort of SR-1. Methods: SR-1 is evaluating the efficacy and safety of TAR-200 + cetrelimab (CET; anti–PD-1) (Cohort 1 [C1]), TAR-200 alone (C2), or CET alone (C3). Pts ≥18 y with histologically confirmed carcinoma in situ (CIS) ± papillary disease (T1, high-grade Ta) who completed adequate BCG and recurred ≤12 mo since last BCG dose with ECOG performance status (PS) of 0-2 are randomized to C1, C2, or C3. As of Amendment 4, pts with papillary disease only will be enrolled in C4 with TAR-200 alone. The primary end point is overall CR rate at any time. Refusal/ineligibility for RC was documented in the electronic case report form. Results: As of Aug 24, 2023, 54 pts were treated in C2. Median age was 71 y (range 40-85). Pts had a median of 12 (range 7-42) prior BCG doses with a median of 3.0 mo (range 0.2-22.0) from last BCG dose to recurrence. Most pts (96%) had ECOG PS 0; 33% had CIS with papillary disease. 50%, 48%, and 19% of pts had a medical history of Gr ≥2 metabolic, vascular, and cardiac conditions, respectively, and 9% were current nicotine users. Overall, 51 (94%) pts refused RC; 3 (6%) were ineligible (Table). The most common reason for refusal was a preference for bladder preservation (52%), followed by concern about QoL (37%). Pts were ineligible for RC due to medical/surgical comorbidities (4%) and age (2%). Conclusions: Most pts enrolled in C2 of SR-1 refused RC, with preference for bladder preservation and QoL concerns being the most common reason for refusal. This highlights the need for bladder-sparing tx options for pts with HR NMIBC recurrent after BCG. Clinical trial information: NCT04640623 . [Table: see text]

Tularemia Clinical Manifestations, Antimicrobial Treatment, and Outcomes: An Analysis of US Surveillance Data, 2006-2021.

Tularemia, a potentially fatal zoonosis caused by Francisella tularensis, has been reported from nearly all US states. Information on relative effectiveness of various antimicrobials for treatment of tularemia is limited, particularly for newer classes such as fluoroquinolones. Data on clinical manifestations, antimicrobial treatment, and illness outcome of patients with tularemia are provided voluntarily through case report forms to the US Centers for Disease Control and Prevention by state and local health departments. We summarized available demographic and clinical information submitted during 2006-2021 and evaluated survival according to antimicrobial treatment. We grouped administered antimicrobials into those considered effective for treatment of tularemia (aminoglycosides, fluoroquinolones, and tetracyclines) and those with limited efficacy. Logistic regression models with a bias-reduced estimation method were used to evaluate associations between antimicrobial treatment and survival. Case report forms were available for 1163 US patients with tularemia. Francisella tularensis was cultured from a clinical specimen (eg, blood, pleural fluid) in approximately half of patients (592; 50.9%). Nearly three-quarters (853; 73.3%) of patients were treated with a high-efficacy antimicrobial. A total of 27 patients (2.3%) died. After controlling for positive culture as a proxy for illness severity, use of aminoglycosides, fluoroquinolones, and tetracyclines was independently associated with increased odds of survival. Most US patients with tularemia received high-efficacy antimicrobials; their use was associated with improved odds of survival regardless of antimicrobial class. Our findings provide supportive evidence that fluoroquinolones are an effective option for treatment of tularemia.

Protocol for metadata and image collection at diabetic foot ulcer clinics: enabling research in wound analytics and deep learning

BackgroundThe escalating impact of diabetes and its complications, including diabetic foot ulcers (DFUs), presents global challenges in quality of life, economics, and resources, affecting around half a billion people. DFU healing is hindered by hyperglycemia-related issues and diverse diabetes-related physiological changes, necessitating ongoing personalized care. Artificial intelligence and clinical research strive to address these challenges by facilitating early detection and efficient treatments despite resource constraints. This study establishes a standardized framework for DFU data collection, introducing a dedicated case report form, a comprehensive dataset named Zivot with patient population clinical feature breakdowns and a baseline for DFU detection using this dataset and a UNet architecture.ResultsFollowing this protocol, we created the Zivot dataset consisting of 269 patients with active DFUs, and about 3700 RGB images and corresponding thermal and depth maps for the DFUs. The effectiveness of collecting a consistent and clean dataset was demonstrated using a bounding box prediction deep learning network that was constructed with EfficientNet as the feature extractor and UNet architecture. The network was trained on the Zivot dataset, and the evaluation metrics showed promising values of 0.79 and 0.86 for F1-score and mAP segmentation metrics.ConclusionsThis work and the Zivot database offer a foundation for further exploration of holistic and multimodal approaches to DFU research.

Short anesthesia without intravenous fluid therapy in children: Results of a prospective non-interventional multicenter observational study.

The German guidelines recommend that intravenous fluid therapy should not be mandatorily performed in children with short fasting times undergoing short anesthesia, but there is a lack of clinical studies including a large number of pediatric patients. Therefore, we performed a prospective non-interventional multicenter observational study to evaluate the perioperative hemodynamic and metabolic stability of children undergoing short anesthesia without intravenous fluid therapy. The primary aim was to assess the incidence of hypotension and the secondary aim was to assess the real preoperative fasting times, the incidence of hypoglycemia and the impact on ketone bodies and acid-base balance. Children aged 1 month-18 years undergoing short anesthesia (<1 h) without intravenous fluid therapy were enrolled. Patient demographics, the surgical or diagnostic procedure performed, anesthesia, hemodynamic, laboratory data, and adverse events were documented using a standardized case report form. Four hundred and twenty seven children that were investigated at three pediatric centers from July 2021 to June 2022 (mean age 83.4 ± 58.9 months, body weight 27.9 ± 19.8 kg) were included in the analysis. The real preoperative fasting times were 14.2 ± 3.6 h for solids, 7.2 ± 3.5 h for milk and 5 ± 4.8 h for clear fluids. During the course of anesthesia, hypotension (<2.5th percentile) was detected in 3 of 427 cases (0.7%), hypoglycemia (glucose <3.0 mmol L-1) in 1 of 355 cases (0.3%), and ketosis (ketone bodies ≥0.6 mmol L-1) in 51 of 233 cases (21.9%). The occurrence of ketosis was associated with lower body weight (p <.001) and longer fasting times for solids or milk (p =.021), but not for clear fluids (p =.69). Our study supported the German guidelines recommendation that perioperative intravenous fluid therapy is not mandatory in children beyond the neonatal period with short pre- and postoperative fasting times undergoing short anesthesia (<1 h).

Multicentric Study on the Clinical Mycology Capacity and Access to Antifungal Treatment in Portugal

The success of the clinical management of invasive fungal diseases (IFD) is highly dependent on suitable tools for timely and accurate diagnosis for effective treatment. An in-depth analysis of the ability of European institutions to promptly and accurately diagnose IFD was previously conducted to identify limitations and aspects to improve. Here, we evaluated and discussed the specific case of Portugal, for which, to our knowledge, there are no reports describing the national mycological diagnostic capacity and access to antifungal treatment. Data from 16 Portuguese medical institutions were collected via an online electronic case report form covering different parameters, including institution profile, self-perceived IFD incidence, target patients, diagnostic methods and reagents, and available antifungals. The majority of participating institutions (69%) reported a low-very low incidence of IFD, with Candida spp. indicated as the most relevant fungal pathogen, followed by Aspergillus spp. and Cryptococcus spp. All institutions had access to culture and microscopy, whereas 94 and 88% were able to run antigen-detection assays and molecular tests, respectively. All of the institutions capable of providing antifungal therapy declared to have access to at least one antifungal. However, echinocandins were only available at 85% of the sites. Therapeutic drug monitoring (TDM) was reported to remain a very restricted practice in Portugal, being available in 19% of the institutions, with the TDM of itraconazole and posaconazole performed in only 6% of them. Importantly, several of these resources are outsourced to external entities. Except for TDM, Portugal appears to be well-prepared concerning the overall capacity to diagnose and treat IFD. Future efforts should focus on promoting the widespread availability of TDM and improved access to multiple classes of antifungals, to further improve patient outcomes.