Rationale, objectives, and design of the EUTrigTreat clinical study: a prospective observational study for arrhythmia risk stratification and assessment of interrelationships among repolarization markers and genotype

IntroductionFrailty is of increasing importance to perioperative and critical care medicine, as the proportion of older patients increases globally. Evidence continues to emerge of the considerable impact frailty has on adverse outcomes from both surgery and critical care, which has led to a proliferation of different frailty measurement tools in recent years. Despite this, there remains a lack of easily implemented, comprehensive frailty assessment tools specific to these complex populations. Development of a frailty index using routinely collected hospital data, able to leverage the automated aspects of an electronic medical record, would aid risk stratification and benefit clinicians and patients alike.Methods and analysisThis is a prospective observational study. 150 intensive care unit (ICU) patients aged ≥50 years and 200 surgical patients aged ≥65 years will be enrolled. The primary objective is to develop a frailty index. Secondary objectives include assessing its ability to predict in-hospital mortality and/or discharge to a new non-home location; the performance of the frailty index in predicting postoperative and ICU complications, as well as health-related quality of life at 6 months; to compare the performance of the frailty index against existing frailty measurement and risk stratification tools; and to assess its modification by patients’ health assets.Ethics and disseminationThis study has been approved by the Melbourne Health Human Research Ethics Committee(20 January 2017, HREC/16/MH/321). Dissemination will be via international and national anaesthetic and critical care conferences, and publication in the peer-reviewed literature.

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Admission of patients with chest pain and/or breathlessness from the emergency department in relation to risk stratification and Copeptin; a prospective observational study

Endocrine Abstracts ◽

10.1530/endoabs.73.aep789 ◽

2021 ◽

Author(s):

Davidson Lee Ti ◽

Emilia Gauffin ◽

Preben Henanger ◽

Maciej Wajda ◽

Daniel Wilhelms ◽

...

Keyword(s):

Emergency Department ◽

Chest Pain ◽

Observational Study ◽

Risk Stratification ◽

Prospective Observational Study

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An observational study evaluating the expression of HER2 (1+, 2+, and 3+) with HLA A2/A3+ in gastric adenocarcinoma patients.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.4_suppl.18 ◽

2016 ◽

Vol 34 (4_suppl) ◽

pp. 18-18

Author(s):

Ashis Patnaik ◽

Shyam Parvatini ◽

Shalabh Sachdeva ◽

Gavin S. Choy ◽

Akhilesh Sharma ◽

...

Keyword(s):

Gastric Cancer ◽

Clinical Study ◽

Observational Study ◽

Prospective Observational Study ◽

Disease Free Survival ◽

Cytotoxic T Cell ◽

Cell Immune Response ◽

Her2 Expression ◽

Peptide Epitope ◽

Study Results

18 Background: Gastric cancer remains a major health issue and results in 800,000 annual deaths worldwide. Despite approximately 50% of the gastric and gastroesophageal (GE) junction adenocarcinomas are diagnosed with resectable disease, 40% of disease recurrence is observed in 24 months. While trastuzumab has shown to increase overall survival in HER2 IHC3+ metastatic disease, no current therapies are available for low expressing, or IHC 1+ or 2+ patients. NeuVax (nelipepimut-S) is an immunogenic peptide epitope derived from the extracellular domain of HER2/nu protein administered in combination with rhGM-CSF. NeuVax binds to HLA-A2 and A3 on tumor and antigen presenting cells (APC) and elicits a proliferation of CD8+ (cytotoxic) T-cell immune response against HER2 expressing cancer cells. A proof of concept clinical study will be conducted to assess the effectiveness of nelipepimut-S to prevent recurrence and increase disease free survival in gastric cancer patients with all levels of HER2 expression with HLA A2+/A3+. This prospective observational study was undertaken to estimate the HLA A2/A3+ and HER2 expression status in the Indian population. Methods: Tumor tissue samples from gastric or GE junction adenocarcinoma patients were collected from S. L. Raheja Hospital, Mumbai, India. A serum sample was collected for HLA testing by quantitative PCR. IHC (DAKO, 1:600 dilution) was employed for detection of HER2. All patients were consented for the study. Results: Of the 50 patients evaluated, 12 (24%) were positive for HER2 (1+, 2+, 3+) with HLA2/A3 alleles, meeting the defined projected clinical protocol population of all levels of expression of HER2 and HLA A2+ and/or A3+. Of the 12 patients, 9 (75%) and 3 (25%) expressed HLA A2 and A3, respectively, with no patient demonstrating HER2 3+ expression. Conclusions: Results from this prospective observational study suggest patients with gastric and GE junction adenocarcinoma have HLA A2+ and/or A3+ expressing tumors with mostly HER2 1+, 2+ expression. The estimated incidence of HER2 3+ expression in this population may be limited by size of current study. Results will inform the screen failure rate of the planned Phase 2 clinical study.

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Application of BAP-65 Score for Risk Stratification of Acute Exacerbation of Chronic Obstructive Pulmonary Disease - A Prospective Observational Study in a Tertiary Care Institute in Telangana

Journal of Evidence Based Medicine and Healthcare ◽

10.18410/jebmh/2021/491 ◽

2021 ◽

Vol 8 (29) ◽

pp. 2667-2673

Author(s):

Deepika Shree Balaram ◽

Narendra Kumar Narahari ◽

Bhaskar Kakarla ◽

Rajasekhar Varma Gande ◽

Paramjyothi Kruparao Gongati

Keyword(s):

Chronic Obstructive Pulmonary Disease ◽

Mechanical Ventilation ◽

Observational Study ◽

Risk Stratification ◽

Pulmonary Disease ◽

Acute Exacerbation ◽

Prospective Observational Study ◽

Chronic Obstructive ◽

Obstructive Pulmonary Disease ◽

Group 4

BACKGROUND Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) carries a significant morbidity and mortality with a need for frequent hospitalizations and mechanical ventilation. Thus, a model was searched that required simple information that was consistently available in emergency department, upon the presentation of the patient which allowed risk stratification and to identify patients who might potentially benefit from early intervention. METHODS This was a prospective observational study conducted over a period of 6 months, from May 2018 to December 2018 with a study sample of 136 patients. The primary objective was aimed to validate the BAP-65 score system in predicting the need for ventilatory support and mortality in patients who presented with acute exacerbation of COPD. RESULTS Mean age of the study population was 64.13 ± 9.7 and 29 (21.32 %) were females with obvious male predominance. It was observed that as the BAP-65 score increases, the mortality increases. Mortality among the score groups 0, 1 and 2 was one, zero, one respectively. The mortality is about 37.5 % in the score group 3 and it increased to 90.9 % in the score group 4. The patients who needed mechanical ventilation were about 4 % in the score group 2 and it increased to 100 % in the score group 4. BAP-65 scoring system had a sensitivity of 88.89 % and specificity of 90.68 % in predicting the in-hospital mortality, and a sensitivity of 84 % and specificity of 94.59 % in predicting the need for mechanical ventilation during hospital stay. CONCLUSIONS The BAP-65 scoring system seems to be a promising tool which is simple and accurate. The score correlated well with both the mortality and also the need for mechanical ventilation, thus helping in decision making at triage level and also in prognostication of the disease. KEYWORDS Chronic Obstructive Pulmonary Disease, Acute Exacerbation, BAP-65, AECOPD, Mortality, Mechanical Ventilation

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