Development and implementation of a customised rapid syndromic diagnostic test for severe pneumonia

AbstractRationaleThe diagnosis of infectious diseases has been hampered by reliance on microbial culture. Cultures take several days to return a result and organisms frequently fail to grow. In critically ill patients this leads to the use of empiric, broad-spectrum antimicrobials and compromises effective stewardship.ObjectivesTo establish the performance and clinical utility of a syndromic diagnostic for severe pneumonia.MethodsSingle ICU observational cohort study with contemporaneous comparator group. We developed and implemented a TaqMan array card (TAC) covering 52 respiratory pathogens in ventilated patients with suspected pneumonia. The time to result was compared against conventional culture, and sensitivity compared to conventional microbiology and metagenomic sequencing. We observed the clinician decisions in response to array results, comparing antibiotic free days (AFD) between the study cohort and comparator group.Results95 patients were enrolled with 71 forming the comparator group. TAC returned results 61 hours (IQR 42-90) faster than culture. The test had an overall sensitivity of 93% (95% CI 88-97%) compared to a combined standard of conventional culture and metagenomic sequencing, with 100% sensitivity for most individual organisms. In 54% of cases the TAC results altered clinical management, with 62% of changes leading to deescalation, 30% to an increase in spectrum, and investigations for alternative diagnoses in 9%. There was a significant difference in the distribution of AFDs with more AFDs in the TAC group (p=0.02).ConclusionsImplementation of a customised syndromic diagnostic for pneumonia led to faster results, with high sensitivity and measurable impact on clinical decision making.

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Development and implementation of a customised rapid syndromic diagnostic test for severe pneumonia

Wellcome Open Research ◽

10.12688/wellcomeopenres.17099.1 ◽

2021 ◽

Vol 6 ◽

pp. 256

Author(s):

Vilas Navapurkar ◽

Josefin Bartholdson Scott ◽

Mailis Maes ◽

Thomas P Hellyer ◽

Ellen Higginson ◽

...

Keyword(s):

Severe Pneumonia ◽

High Sensitivity ◽

Diagnostic Approach ◽

Molecular Diagnostic ◽

Study Cohort ◽

Antibiotic Prescribing ◽

Respiratory Pathogens ◽

Metagenomic Sequencing ◽

Comparator Group ◽

Significant Difference

Background: The diagnosis of pneumonia has been hampered by a reliance on bacterial cultures which take several days to return a result, and are frequently negative. In critically ill patients this leads to the use of empiric, broad-spectrum antimicrobials and compromises good antimicrobial stewardship. The objective of this study was to establish the performance of a syndromic molecular diagnostic approach, using a custom TaqMan array card (TAC) covering 52 respiratory pathogens, and assess its impact on antimicrobial prescribing. Methods: The TAC was validated against a retrospective multi-centre cohort of broncho-alveolar lavage samples. The TAC was assessed prospectively in patients undergoing investigation for suspected pneumonia, with a comparator cohort formed of patients investigated when the TAC laboratory team were unavailable. Co-primary outcomes were sensitivity compared to conventional microbiology and, for the prospective study, time to result. Metagenomic sequencing was performed to validate findings in prospective samples. Antibiotic free days (AFD) were compared between the study cohort and comparator group. Results: 128 stored samples were tested, with sensitivity of 97% (95% confidence interval (CI) 88-100%). Prospectively, 95 patients were tested by TAC, with 71 forming the comparator group. TAC returned results 51 hours (interquartile range 41-69 hours) faster than culture and with sensitivity of 92% (95% CI 83-98%) compared to conventional microbiology. 94% of organisms identified by sequencing were detected by TAC. There was a significant difference in the distribution of AFDs with more AFDs in the TAC group (p=0.02). TAC group were more likely to experience antimicrobial de-escalation (odds ratio 2.9 (95%1.5-5.5)). Conclusions: Implementation of a syndromic molecular diagnostic approach to pneumonia led to faster results, with high sensitivity and impact on antibiotic prescribing.

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Evaluation of Real-World Smart Sock-Based Temperature Monitoring Data as a Physiological Indicator of Early Diabetic Foot Injury: Case-Control Study (Preprint)

10.2196/preprints.31870 ◽

2021 ◽

Author(s):

Alexander M Reyzelman ◽

Chia-Ding Shih ◽

Gregory Tovmassian ◽

Mohan Nathan ◽

Ran Ma ◽

...

Keyword(s):

Diabetic Foot ◽

Monitoring Program ◽

Temperature Monitoring ◽

Lower Extremity Injury ◽

Study Cohort ◽

Temperature Differential ◽

Comparator Group ◽

Foot Injury ◽

Useful Signal ◽

Significant Difference

BACKGROUND Diabetic foot ulcers represent major health care complications both in terms of cost and impact to quality of life for patients with diabetic peripheral neuropathy. Temperature monitoring has been shown in previous studies to provide a useful signal of inflammation that may indicate the early presence of a foot injury. OBJECTIVE In this study we evaluated the temperature data for patients that presented with a diabetic foot injury while utilizing a sock-based remote temperature monitoring device. METHODS The study abstracted data from patients enrolled in a remote temperature monitoring program in year 2020-2021 using a smart sock (Siren Care, San Francisco, California, USA). In the study cohort, a total of 5 participants with a diabetes-related lower extremity injury during study period were identified. In the second comparison cohort, a total of 26 patients met the criteria for monitoring by the same methods that did not present with a diabetes-related podiatric injury during the same period. The 15-day temperature differential between six defined locations on each foot was the primary outcome measure among subjects who presented a diagnosed foot injury. Paired t-tests were used to compare the differences between the two groups. RESULTS A significant difference in temperature differential was observed in the group that presented with a podiatric injury over the course of evaluation vs. the comparator group that did not present with a podiatric injury with temperature measured in °F. The average difference from all six measured points was 1.4°F between the injury group (mean 3.6 +/- 3.0) and the comparator group (mean 2.2 +/- 2.5, t=-71.4; P<.000). CONCLUSIONS The presented study demonstrated significant temperature difference for patients presenting with a foot injury in a 15-day period prior to the diagnosis of an injury compared with a similar period for patients without an injury. The findings suggest temperature monitoring may be a predictor of a developing foot injury. The continuous temperature monitoring system employed has implications for further algorithm development to enable early detection. The study was limited by a nonrandomized, observational design with limited injuries present in the study period.

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Prognostic value of subclinical myocardial necrosis using high-sensitivity cardiac troponin T in patients with prediabetes

Cardiovascular Diabetology ◽

10.1186/s12933-021-01365-9 ◽

2021 ◽

Vol 20 (1) ◽

Author(s):

Marco Witkowski ◽

Yuping Wu ◽

Stanley L. Hazen ◽

W. H. Wilson Tang

Keyword(s):

Cardiac Troponin ◽

Clinical Decision Making ◽

Troponin T ◽

Myocardial Necrosis ◽

High Sensitivity ◽

Study Cohort ◽

Cardiac Troponin T ◽

Adverse Cardiovascular Event ◽

Event Risk ◽

All Cause Mortality

Abstract Background Risk stratification of patients with prediabetes is an unmet clinical need. Here, we examine the utility of subclinical myocardial necrosis assessed by high-sensitivity cardiac troponin T (hs-cTnT) in predicting health outcomes in stable subjects with prediabetes. Methods hs-cTnT was analyzed by a high-sensitivity assay (Roche 5th generation) in 2631 stable subjects with prediabetes (HbA1c 5.7–6.4% or fasting glucose 100–125 mg/dL without previous diagnosis of diabetes or glucose-lowering therapy) who underwent elective coronary angiography for cardiac evaluation, and followed for major adverse cardiac events (MACE; death, myocardial infarction, stroke) over 3 years and all-cause mortality over 5 years. Results In our study cohort, hs-cTnT was highly prevalent with a median level of 13 ng/L (interquartile range 8.2–21.6 ng/L). Hs-cTnT was independently associated with incident MACE at 3 years (Q4 vs. Q1 adjusted hazard ratio (HR) 2.42 [95% CI 1.69–3.46], P < 0.001) and 5-year mortality (adjusted HR 3.8 [95% CI 2.55–5.67], P < 0.001). This association remained significant in all subsets after adjustment for traditional risk factors and multiple factors known to increase hs-cTnT levels. Moreover, hs-cTnT independently predicted event risk in primary prevention subjects (n = 557, HR 5.46 [95% CI 1.50–19.89), p < 0.01) for MACE; HR 9.53 [95% CI 2.08–43.73] for all-cause mortality) and secondary prevention subjects (n = 2074, HR 1.86 [95% CI 1.31–2.66], P < 0.001 for MACE; and 2.7 [95% CI 1.79–4.08), P < 0.001 for all-cause mortality). Conclusions In stable prediabetic subjects, the presence of subclinical myocardial necrosis as detected by hs-cTnT portends heightened long-term adverse cardiovascular event risk. Hs-cTnT levels may help to stratify risk and improve clinical decision making in patients with prediabetes. Trial registration ClinicalTrials.gov Identifier: NCT00590200.

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The Effectiveness of Using a Mobile Messenger as an Educational Supporting Tool among Nursing Students

Asian Journal of Medicine and Biomedicine ◽

10.37231/ajmb.2020.4.1.333 ◽

2020 ◽

Vol 4 (1) ◽

pp. 67-77

Author(s):

Rohimah Ismail ◽

Chong Mei Chan ◽

Wan Muhammad Azly W. Zulkafli ◽

Hasnah Zani ◽

Zainab Mohd Shafie

Keyword(s):

Nursing Education ◽

Nursing Students ◽

Clinical Decision Making ◽

Intervention Group ◽

Great Influence ◽

Control Group ◽

P Value ◽

Significant Difference ◽

Supporting Tool ◽

Nursing College

The evolution of information technology has exerted great influence on nursing education via new pedagogy of knowledge delivery without time and place restriction. Mobile technology revolutionises nursing education and clinical practice via empowering skills of critical thinking and clinical decision-making through learning. The aim of this study is to evaluate the effectiveness of using mobile messenger (Whatsapp) as an educational supporting tool among nursing students. The study design used is a Cluster Randomized Control Trail. Two nursing colleges were selected. Sample size was 93 participants, 48 from the Kuala Terengganu Nursing College Kuala Terengganu as the intervention group while the control group were recruited among 45 participants from UniSZA Nursing College. There is a significant difference in the level of knowledge between pre and posttest among intervention group (mean difference was -8.70 with a standard deviation 8.42, p-value< 0.001) and 93.8 percent of the respondents perceived the usefulness of using WhatsApp mobile messenger to enhance learning. This demonstrates that learning through mobile messenger (WhatsApp) enhances learning and is well received as a new method of learning by almost all students. Keywords: Mobile learning, WhatsApp messenger, Social Interaction

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Laboratory predictors of death from coronavirus disease 2019 (COVID-19) in the area of Valcamonica, Italy

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2020-0459 ◽

2020 ◽

Vol 58 (7) ◽

pp. 1100-1105 ◽

Cited By ~ 16

Author(s):

Graziella Bonetti ◽

Filippo Manelli ◽

Andrea Patroni ◽

Alessandra Bettinardi ◽

Gianluca Borrelli ◽

...

Keyword(s):

Hospital Stay ◽

Clinical Decision Making ◽

Troponin I ◽

Laboratory Data ◽

High Sensitivity ◽

Clinical Decision ◽

International Normalized Ratio ◽

Serum Glucose ◽

Hospital Death ◽

Laboratory Findings

AbstractBackgroundComprehensive information has been published on laboratory tests which may predict worse outcome in Asian populations with coronavirus disease 2019 (COVID-19). The aim of this study is to describe laboratory findings in a group of Italian COVID-19 patients in the area of Valcamonica, and correlate abnormalities with disease severity.MethodsThe final study population consisted of 144 patients diagnosed with COVID-19 (70 who died during hospital stay and 74 who survived and could be discharged) between March 1 and 30, 2020, in Valcamonica Hospital. Demographical, clinical and laboratory data were collected upon hospital admission and were then correlated with outcome (i.e. in-hospital death vs. discharge).ResultsCompared to patients who could be finally discharged, those who died during hospital stay displayed significantly higher values of serum glucose, aspartate aminotransferase (AST), creatine kinase (CK), lactate dehydrogenase (LDH), urea, creatinine, high-sensitivity cardiac troponin I (hscTnI), prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (APTT), D-dimer, C reactive protein (CRP), ferritin and leukocytes (especially neutrophils), whilst values of albumin, hemoglobin and lymphocytes were significantly decreased. In multiple regression analysis, LDH, CRP, neutrophils, lymphocytes, albumin, APTT and age remained significant predictors of in-hospital death. A regression model incorporating these variables explained 80% of overall variance of in-hospital death.ConclusionsThe most important laboratory abnormalities described here in a subset of European COVID-19 patients residing in Valcamonica are highly predictive of in-hospital death and may be useful for guiding risk assessment and clinical decision-making.

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Predicting mortality in adults with suspected infection in a Rwandan hospital: an evaluation of the adapted MEWS, qSOFA and UVA scores

BMJ Open ◽

10.1136/bmjopen-2020-040361 ◽

2021 ◽

Vol 11 (2) ◽

pp. e040361

Author(s):

Amanda Klinger ◽

Ariel Mueller ◽

Tori Sutherland ◽

Christophe Mpirimbanyi ◽

Elie Nziyomaze ◽

...

Keyword(s):

Decision Making ◽

Quality Improvement ◽

Clinical Decision Making ◽

Clinical Decision ◽

Tertiary Hospital ◽

Early Warning Score ◽

Receiver Operating Curve ◽

Predictive Capacity ◽

Suspected Infection ◽

Significant Difference

RationaleMortality prediction scores are increasingly being evaluated in low and middle income countries (LMICs) for research comparisons, quality improvement and clinical decision-making. The modified early warning score (MEWS), quick Sequential (Sepsis-Related) Organ Failure Assessment (qSOFA), and Universal Vital Assessment (UVA) score use variables that are feasible to obtain, and have demonstrated potential to predict mortality in LMIC cohorts.ObjectiveTo determine the predictive capacity of adapted MEWS, qSOFA and UVA in a Rwandan hospital.Design, setting, participants and outcome measuresWe prospectively collected data on all adult patients admitted to a tertiary hospital in Rwanda with suspected infection over 7 months. We calculated an adapted MEWS, qSOFA and UVA score for each participant. The predictive capacity of each score was assessed including sensitivity, specificity, positive and negative predictive value, OR, area under the receiver operating curve (AUROC) and performance by underlying risk quartile.ResultsWe screened 19 178 patient days, and enrolled 647 unique patients. Median age was 35 years, and in-hospital mortality was 18.1%. The proportion of data missing for each variable ranged from 0% to 11.7%. The sensitivities and specificities of the scores were: adapted MEWS >4, 50.4% and 74.9%, respectively; qSOFA >2, 24.8% and 90.4%, respectively; and UVA >4, 28.2% and 91.1%, respectively. The scores as continuous variables demonstrated the following AUROCs: adapted MEWS 0.69 (95% CI 0.64 to 0.74), qSOFA 0.65 (95% CI 0.60 to 0.70), and UVA 0.71 (95% CI 0.66 to 0.76); there was no statistically significant difference between the discriminative capacities of the scores.ConclusionThree scores demonstrated a modest ability to predict mortality in a prospective study of inpatients with suspected infection at a Rwandan tertiary hospital. Careful consideration must be given to their adequacy before using them in research comparisons, quality improvement or clinical decision-making.

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Complete remission of metastatic osteosarcoma using combined modality therapy: a retrospective analysis of unselected patients in China

BMC Cancer ◽

10.1186/s12885-021-08071-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Lu Xie ◽

Jie Xu ◽

Xiaowei Li ◽

Zuli Zhou ◽

Hongqing Zhuang ◽

...

Keyword(s):

Pulmonary Metastases ◽

Local Therapy ◽

Hypofractionated Radiotherapy ◽

Study Cohort ◽

Sufficient Information ◽

Progression Rate ◽

Entire Study ◽

Pulmonary Lesions ◽

Metastatic Osteosarcoma ◽

Significant Difference

Abstract Background Complete surgical remission (CSR) is the best predictor of overall survival (OS) for patients with metastatic osteosarcoma. However, metastasectomy has not been widely implemented in China in the last decade due to various factors, and instead, most physicians choose hypofractionated radiotherapy to treat pulmonary lesions. This study aimed to retrospectively evaluate the outcomes of different local treatments for pulmonary lesions and identify the best local therapy strategies for these patients. Methods We reviewed the clinical courses of osteosarcoma patients with pulmonary metastases who were initially treated in two sarcoma centres in Beijing, China, from June 1st, 2009, to March 26th, 2020. With a median follow-up of 32.4 (95% confidence interval (CI): 30.8, 36.1) months, a total of 127 patients with 605 pulmonary nodules, all of whom had received local therapy and firstly achieved CSR or complete radiated/metabolic remission (CRR), were included in the analysis. A total of 102 patients with 525 nodules were initially diagnosed with resectable lung metastases, while 25 patients had 80 indeterminate nodules at presentation and relapsed with pulmonary metastases within 6 months after the completion of adjuvant chemotherapy. Results Eighty-eight of 127 (69.3%) patients had fewer than 5 nodules at the time of local therapy, with 48 of 127 (37.8%) located in the unilateral pleura. No patient underwent thoracotomy, and 42 of 127 patients (85 nodules) received video-assisted thoracoscopic surgery (VATS). In addition, 79 of 127 patients (520 nodules) received hypofractionated stereotactic body radiotherapy (RT), such as Gamma Knife radiosurgery or CyberKnife radiosurgery. The twelve-month event-free survival (EFS) (from local therapy to progression) rate of this entire study cohort was 35.6% (95% CI: 26.8, 44.4%), without a significant difference between the two groups (44.7% for VATS vs. 28.4% for RT, P = 0.755). Radiation-induced pneumonitis was observed in 62 of 86 (72.1%) patients, with one patient (1/86, 1.2%) in grade 4. Conclusions Our past data showed a similar prognosis with the use of hypofractionated radiotherapy and VATS for the treatment of pulmonary metastasis and no inferiority to thoracotomy regarding historical outcomes. Currently, high-resolution chest computed tomography (CT) provides sufficient information on nodules, and less invasive modalities can thus be considered for treatment.

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4971Blood viscosity and its relevance to the diagnosis and management of pulmonary hypertension: a new elephant in the cathlab

European Heart Journal ◽

10.1093/eurheartj/ehz746.0030 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

A Kempny ◽

K Dimopoulos ◽

A E Fraisse ◽

G P Diller ◽

L C Price ◽

...

Keyword(s):

Pulmonary Hypertension ◽

Cardiac Catheterization ◽

Clinical Decision Making ◽

Clinical Decision ◽

Pulmonary Vasculature ◽

Pulmonary Vascular Disease ◽

Significant Difference ◽

The Difference ◽

Clinically Significant ◽

The Relationship

Abstract Background Pulmonary vascular resistance (PVR) is an essential parameter assessed during cardiac catheterization. It is used to confirm pulmonary vascular disease, to assess response to targeted pulmonary hypertension (PH) therapy and to determine the possibility of surgery, such as closure of intra-cardiac shunt or transplantation. While PVR is believed to mainly reflect the properties of the pulmonary vasculature, it is also related to blood viscosity (BV). Objectives We aimed to assess the relationship between measured (mPVR) and viscosity-corrected PVR (cPVR) and its impact on clinical decision-making. Methods We assessed consecutive PH patients undergoing cardiac catheterization. BV was assessed using the Hutton method. Results We included 465 patients (56.6% female, median age 63y). The difference between mPVR and cPVR was highest in patients with abnormal Hb levels (anemic patients: 5.6 [3.4–8.0] vs 7.8Wood Units (WU) [5.1–11.9], P<0.001; patients with raised Hb: 10.8 [6.9–15.4] vs. 7.6WU [4.6–10.8], P<0.001, respectively). Overall, 33.3% patients had a clinically significant (>2.0WU) difference between mPVR and cPVR, and this was more pronounced in those with anemia (52.9%) or raised Hb (77.6%). In patients in the upper quartile for this difference, mPVR and cPVR differed by 4.0WU [3.4–5.2]. Adjustment of PVR required Conclusions We report, herewith, a clinically significant difference between mPVR and cPVR in a third of contemporary patients assessed for PH. This difference is most pronounced in patients with anemia, in whom mPVR significantly underestimates PVR, whereas in most patients with raised Hb, mPVR overestimates it. Our data suggest that routine adjustment for BV is necessary.

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Role of confirmed and potential predictors of an unfavorable outcome in heart failure in everyday clinical practice

Irish Journal of Medical Science (1971 -) ◽

10.1007/s11845-020-02477-z ◽

2021 ◽

Author(s):

Anna Chuda ◽

Maciej Banach ◽

Marek Maciejewski ◽

Agata Bielecka-Dabrowa

Keyword(s):

Heart Failure ◽

Exercise Testing ◽

Clinical Decision Making ◽

Cardiopulmonary Exercise Testing ◽

High Sensitivity ◽

Left Ventricular ◽

Unfavorable Outcome ◽

Left Ventricular Ejection ◽

Monitoring Method ◽

Ventricular Ejection Fraction

AbstractHeart failure (HF) is the only cardiovascular disease with an ever increasing incidence. HF, through reduced functional capacity, frequent exacerbations of disease, and repeated hospitalizations, results in poorer quality of life, decreased work productivity, and significantly increased costs of the public health system. The main challenge in the treatment of HF is the availability of reliable prognostic models that would allow patients and doctors to develop realistic expectations about the prognosis and to choose the appropriate therapy and monitoring method. At this moment, there is a lack of universal parameters or scales on the basis of which we could easily capture the moment of deterioration of HF patients’ condition. Hence, it is crucial to identify such factors which at the same time will be widely available, cheap, and easy to use. We can find many studies showing different predictors of unfavorable outcome in HF patients: thorough assessment with echocardiography imaging, exercise testing (e.g., 6-min walk test, cardiopulmonary exercise testing), and biomarkers (e.g., N-terminal pro-brain type natriuretic peptide, high-sensitivity troponin T, galectin-3, high-sensitivity C-reactive protein). Some of them are very promising, but more research is needed to create a specific panel on the basis of which we will be able to assess HF patients. At this moment despite identification of many markers of adverse outcomes, clinical decision-making in HF is still predominantly based on a few basic parameters, such as the presence of HF symptoms (NYHA class), left ventricular ejection fraction, and QRS complex duration and morphology.

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Adaptation and Validation of the Mini-Addenbrooke’s Cognitive Examination in Dementia in Arabic Speakers in Egypt

Dementia and Geriatric Cognitive Disorders ◽

10.1159/000513411 ◽

2020 ◽

Vol 49 (6) ◽

pp. 611-616

Author(s):

Tarik Qassem ◽

Mohamed S. Khater ◽

Tamer Emara ◽

Doha Rasheedy ◽

Heba M. Tawfik ◽

...

Keyword(s):

Screening Tool ◽

Characteristic Curve ◽

High Sensitivity ◽

Receiver Operator Characteristic Curve ◽

Cutoff Score ◽

Arabic Speakers ◽

Dementia Patients ◽

Significant Difference ◽

Sensitivity Specificity ◽

Addenbrooke’S Cognitive Examination

Background: The mini-Addenbrooke’s Cognitive Examination (m-ACE) is a brief cognitive battery that assesses 5 subdomains of cognition (attention, memory, verbal fluency, visuospatial abilities, and memory recall). It is scored out of 30 and can be administered in under 5 min providing a quick screening tool for assessment of cognition. Objectives: We aimed to adapt the m-ACE in Arabic speakers in Egypt and to validate it in dementia patients to provide cutoff scores. Methods: We included 37 patients with dementia (Alzheimer’s disease [n = 25], vascular dementia [n = 8], and dementia with Lewy body [n = 4]) and 43 controls. Results: There was a statistically significant difference (p < 0.001) on the total m-ACE score between dementia patients (mean 10.54 and standard deviation [SD] 5.83) and controls (mean 24.02 and SD 2.75). There was also a statistically significant difference between dementia patients and controls on all sub-score domains of the m-ACE (p < 0.05). Performance on the m-ACE significantly correlated with both the Mini-Mental State Examination (MMSE) and the Addenbrooke’s Cognitive Examination-III (ACE-III). Using a receiver operator characteristic curve, the optimal cutoff score for dementia on the m-ACE total score was found to be 18 (92% sensitivity, 95% specificity, and 94% accuracy). Conclusions: We adapted the m-ACE in Arabic speakers in Egypt and provided objective validation of it as a screening tool for dementia, with high sensitivity, specificity, and accuracy.

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