scholarly journals Caution is needed in interpreting the results of comparative studies regarding oncological operations by minimally invasive versus laparotomic access

2020 ◽  
Vol 47 ◽  
Author(s):  
PEDRO RICARDO DE OLIVEIRA FERNANDES ◽  
FRANCISCO AMÉRICO FERNANDES NETO ◽  
DURVAL RENATO WOHNRATH ◽  
VINÍCIUS DE LIMA VAZQUEZ
Keyword(s):  
Minimally Invasive ◽  
Clinical Decision Making ◽  
Conflicts Of Interest ◽  
Clinical Decision ◽  
Randomized Controlled Clinical Trials ◽  
Surgical Access ◽  
Comparative Group ◽  
The Difference ◽  
Minimally Invasive Access ◽  
The Comparative Study

ABSTRACT We aim to alert the difference between groups while comparing studies of abdominal oncological operations performed either by minimally invasive or laparotomic approaches and potential conflicts of interest in presenting or interpreting the results. Considering the large volume of scientific articles that are published, there is a need to consider the quality of the scientific production that leads to clinical decision making. In this regards, it is important to take into account the choice of the surgical access route. Randomized, controlled clinical trials are the standard for comparing the effectiveness between these interventions. Although some studies indicate advantages in minimally invasive access, caution is needed when interpreting these findings. There is no detailed observation in each of the comparative study about the real limitations and potential indications for minimally invasive procedures, such as the indications for selected and less advanced cases, in less complex cavities, as well as its elective characteristic. Several abdominal oncological operations via laparotomy would not be plausible to be completely performed through a minimally invasive access. These cases should be carefully selected and excluded from the comparative group. The comparison should be carried out, in a balanced way, with a group that could also have undergone a minimally invasive access, avoiding bias in selecting those cases of minor complexity, placed in the minimally invasive group. It is not a question of criticizing the minimally invasive technologies, but of respecting the surgeon’s clinical decision regarding the most convenient method, revalidating the well-performed traditional laparotomy route, which has been unfairly criticized or downplayed by many people.

Are Gene Expression Signatures Treatment Specific?

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 807-807 ◽  
Author(s):  
Parantu K Shah ◽  
Stephane Minvielle ◽  
Hervé Avet-Loiseau ◽  
Cheng Li ◽  
Nikhil C. Munshi
Keyword(s):  
Gene Expression ◽  
Clinical Decision Making ◽  
Conflicts Of Interest ◽  
Clinical Decision ◽  
Induction Treatment ◽  
P Value ◽  
Newly Diagnosed ◽  
Gene Expression Signatures ◽  
The Difference ◽  
The Impact

Abstract Abstract 807FN2 Gene expression profiling (GEP) of newly-diagnosed cancer patients is now a routine task in the oncogenomic research using functional genomics platforms like microarray and next generation sequencing. These profiles are then utilized to derive gene expression signatures (GES) that can stratify patients according to survival groups using various statistical methodologies. This is an active area of research with important implications on clinical decision making and patient care. It is important to note that the treatment itself probably plays a major role in influencing outcome in cancer. Therefore, the GES may be specific to a particular treatment and may not be universally applicable in predicting survival of patients treated with different therapeutic regimen. We evaluated the impact of therapy on GES utilizing two large publicly available gene expression datasets from newly-diagnosed multiple myeloma (MM) patients generated using Affymetrix U133+2 microarrays. The dataset from University of Arkansas Medical Sciences (UAMS; Shaughnessy et al Blood 2007) has gene expression profile (GEP) from 569 patients treated on total therapy (TT)2 and TT3 protocols while the dataset from HOVON-65 trial contains GEO data from 320 patients treated with either the VAD or PAD regimen in equal numbers. The UAMS dataset was partitioned into training and validation sets. Using a combination of a network inspired univariate ranking procedure and ultra refined methods for variable selection we derived a sparse multivariate survival signature consisting of 40 genes that worked extremely well on the training set (p-value < e-16) as well as the validation set (p-value < e-5). Interestingly we saw the difference of performance between TT2 and TT3 induction arms. The p values were 0.002 for the TT2 induction arm while for the TT3 the p value was 0.02. On applying the signature to the whole HOVON-65 test set our signature worked only moderately well (p-value = 0.003). When the HOVON-65 dataset was split according to the induction treatment arms, the GES worked extremely well (p-value < e-5) in predicting the outcome in patients receiving VAD regimen but had no power to distinguish survival in patients receiving PAD regimen. We have evaluated the results on additional data sets that confirmed our observation from the HOVON study. To our knowledge this is the first clear demonstration of treatment specificity of GES. This data suggest that we may need to derive multiple therapy-specific GES to be applied to the patients to treat the new patient with therapy for which he/she is predicted to have best outcome. Disclosures: No relevant conflicts of interest to declare.

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

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.

Predictive Analytics to Support Clinical Decision Making

2020 ◽  
pp. 271-281
Author(s):  
Nilmini Wickramasinghe
Keyword(s):  
Decision Making ◽  
Clinical Decision Making ◽  
Predictive Analytics ◽  
Complete Information ◽  
Clinical Decision ◽  
Decision Making Process ◽  
The Difference

A key activity in healthcare is clinical decision making. This decision making typically has to be made rapidly and often without complete information. Moreover, the consequences of these decisions could be far reaching including the difference between life or death. Today analytics can assist in clinical decision making as the following chapter highlights. However, to gain the most from any type of analytics, it is first necessary to fully understand the dynamics around the clinical decision making process.

scholarly journals Variations between two 24-hour urine collections in patients

2013 ◽  
Vol 6 (1) ◽  
pp. 30 ◽  
Author(s):  
Madhur Nayan ◽  
Mohamed A. Elkoushy ◽  
Sero Andonian
Keyword(s):  
Clinical Decision Making ◽  
Clinical Decision ◽  
Metabolic Evaluation ◽  
Normal Limits ◽  
A Value ◽  
Two Samples ◽  
History Of ◽  
The Absolute ◽  
The Difference ◽  
Urinary Parameters

Introduction: The current Canadian Urological Association (CUA)guideline recommends two 24-hour urine collections in the metabolic evaluation for patients with urolithiasis. The aim of the present study was to compare two consecutive 24-hour urine collections in patients with a history of urolithiasis presenting to a tertiary stone clinic.Methods: We retrospectively reviewed 188 patients who had two24-hour collections upon presentation between January 2010 and December 2010. Samples were collected on consecutive days and examined for the following 11 urinary parameters: volume, creatinine, sodium, calcium, uric acid, citrate, oxalate, potassium, phosphorous, magnesium and urea nitrogen. For each parameter, the absolute value of the difference between the two samples rather than the direct difference was compared with zero. Similarly, the percent difference between samples was calculated for each parameter.Results: The means of the absolute differences between the twosamples were significantly different for all 11 urinary parameters(p < 0.0001). The percent differences for all urinary parametersranged from 20.5% to 34.2%. Furthermore, 17.1% to 47.6% ofpatients had a change from a value within normal limits to anabnormal value, or vice-versa. Significance was maintained when patients with incomplete or over-collections were excluded.Conclusions: Significant variations among the two 24-hour urinecollections were observed in all of the 11 urinary parameters analyzed. This variation may change clinical decision-making in up to 47.6% of patients if only a single 24-hour urine collection is obtained. The present study supports the CUA guideline of performing two 24-hour urine collections.

Reirradiation and/or surgery for locoregionally recurrent rectal cancer: A systemic review and meta-analyses.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15159-e15159
Author(s):  
Chai Hong Rim ◽  
Jeongshim Lee
Keyword(s):  
Rectal Cancer ◽  
Clinical Decision Making ◽  
Late Complication ◽  
Clinical Decision ◽  
Late Complications ◽  
Local Control Rate ◽  
Systemic Review ◽  
Cochrane Library ◽  
The Difference ◽  
Grade 3

e15159 Background: Locoregional recurrence of rectal cancer (LRRC) might be occurred even after combination treatments including surgery and pelvic radiotherapy. Re-irradiation might provide the control of recurrence and/or symptomatic palliation, but possible complications are fearful hindrances. This study is to integrate information from various clinical studies, regarding re-irradiation and/or surgery of LRRC, and to provide practical information for clinical decision making. Methods: We searched four databases including pubmed, MEDLINE, Cochrane library, and Embase. The primary endpoint was overall survival (OS), and secondary endpoints were complications of grade ≥3, local control rate (LC), and symptomatic palliation rate. Results: A total of 17 studies, involving 18 cohorts and 744 patients with LRRC were included. Median OS among included studies ranged from 10 to 45 months (median: 24.5 months). Pooled 1-, 2-, and 3- year OS rates for all LRRC patients were 76.1% [95% confidence interval (CI): 61.7-86.3], 49.1% (38.5-59.7), and 38.3% (30.2-47.2), respectively. For patients who underwent re-irradiation and surgery (OP group), pooled 1-, 2-, and 3- year OS rates were 85.9% (95% CI: 74.0-92.9), 71.8% (54.6-84.4), and 51.7% (39.4-63.8). For patients who underwent re-irradiation but not surgery (non-OP group), pooled 1-, 2-, and 3-year OS rates were 63.5% (95% CI: 51.1-74.4), 34.2% (20.4-51.2), and 23.8% (15.4-34.8). The difference between two subgroups were significant for all 3 years analyses. Pooled 1-, 2-, and 3- year LC rates for OP group were 84.4% (95% CI: 75.5-90.4), 63.8% (55.2-71.5), and 46.9% (39.6-54.4), and for non-OP group were 72.0% (95% CI: 48.8-87.4), 54.8% (28.6-78.5), and 44.6% (16.6-76.5). The difference between subgroups were not statistically significant for all 3 years analyses. Pooled overall grade ≥3 acute complication rate was 11.7% (95% CI: 6.7-19.5), and for late complication was 25.5% (95% CI: 16.7-40.0). Patients who underwent surgery had a higher risk of grade ≥3 late complications (OR: 6.39, 95% CI: 3.2-12.7). Pooled symptomatic palliation rate was 75.2% (95% CI: 67.3-81.8). Conclusions: Re-irradiation and/or surgery might be an option with oncologic and palliative efficacies, where combined surgery provided more favorable survival outcome. However, late complication should be carefully considered especially when combined with surgery.

scholarly journals Comparison of Comprehensive Morphological and Radiomics Features of Subsolid Pulmonary Nodules to Distinguish Minimally Invasive Adenocarcinomas and Invasive Adenocarcinomas in CT Scan

2022 ◽  
Vol 11 ◽  
Author(s):  
Lu Qiu ◽  
Xiuping Zhang ◽  
Haixia Mao ◽  
Xiangming Fang ◽  
Wei Ding ◽  
...  
Keyword(s):  
Minimally Invasive ◽  
Clinical Decision Making ◽  
High Efficiency ◽  
Pulmonary Nodules ◽  
Roc Curves ◽  
Clinical Decision ◽  
Gray Level ◽  
Combined Model ◽  
Significant Difference ◽  
Morphological Model

ObjectiveTo investigative the diagnostic performance of the morphological model, radiomics model, and combined model in differentiating invasive adenocarcinomas (IACs) from minimally invasive adenocarcinomas (MIAs).MethodsThis study retrospectively involved 307 patients who underwent chest computed tomography (CT) examination and presented as subsolid pulmonary nodules whose pathological findings were MIAs or IACs from January 2010 to May 2018. These patients were randomly assigned to training and validation groups in a ratio of 4:1 for 10 times. Eighteen categories of morphological features of pulmonary nodules including internal and surrounding structure were labeled. The following radiomics features are extracted: first-order features, shape-based features, gray-level co-occurrence matrix (GLCM) features, gray-level size zone matrix (GLSZM) features, gray-level run length matrix (GLRLM) features, and gray-level dependence matrix (GLDM) features. The chi-square test and F1 test selected morphology features, and LASSO selected radiomics features. Logistic regression was used to establish models. Receiver operating characteristic (ROC) curves evaluated the effectiveness, and Delong analysis compared ROC statistic difference among three models.ResultsIn validation cohorts, areas under the curve (AUC) of the morphological model, radiomics model, and combined model of distinguishing MIAs from IACs were 0.88, 0.87, and 0.89; the sensitivity (SE) was 0.68, 0.81, and 0.83; and the specificity (SP) was 0.93, 0.79, and 0.87. There was no statistically significant difference in AUC between three models (p &gt; 0.05).ConclusionThe morphological model, radiomics model, and combined model all have a high efficiency in the differentiation between MIAs and IACs and have potential to provide non-invasive assistant information for clinical decision-making.

The knowledge and practices of urologists in the United States (US) about standardization of PSA assays.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 207-207
Author(s):  
A. Gupta ◽  
S. F. Shariat ◽  
J. A. Eastham ◽  
P. T. Scardino ◽  
A. J. Vickers ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Decision Making ◽  
Reference Range ◽  
Prostate Cancer Screening ◽  
Prostate Cancer Risk ◽  
Clinical Decision ◽  
The United States ◽  
Web Based ◽  
The Us ◽  
The Difference

207 Background: PSA assays can be calibrated to either the WHO or the Hybritech standard. Studies of PSA-based prostate cancer screening have used Hybritech-standardized assays and prostate cancer risk calculators are based on these studies. Testing of patient samples with a WHO calibrated assay gives values that are 22% lower than from those with Hybritech-calibrated assays. Up to 60% of the labs in the US use WHO calibrated assays. We evaluated whether US urologists are aware of the different calibrators and the differences in PSA values. Methods: A random sample of 1,742 US urologists were invited by email to participate in a web-based survey of their knowledge and practices regarding PSA assay standardization. No mention was made of assays or calibration in the invitation. 419 responses were received. Results: Many (56%) US urologists thought that different standards may lead to clinically relevant differences in PSA values. Although 62% reported awareness of the two PSA calibrators, 67% did not know the difference between the two. Only 17% correctly reported the difference between the two standards. Nationally almost 60% of the labs use WHO standardized assays, but in this survey only 5% of the urologists thought that the hospital where they practice used a WHO standardized assay. The rest reported either not knowing the standard (46%) or use of the Hybritech standard (49%). The majority of urologists did not look at the reference range (64%) or for the PSA standard (74%) in the lab reports. Only 25% reported considering the PSA-calibration in their clinical decisions about prostate biopsy, but only a third of them correctly knew the difference between the calibrators. Conclusions: Many US urologists are unaware of the difference caused by WHO versus Hybritech based PSA-assay calibration. Although 60% of clinical laboratories use WHO-calibrated assays, only 5% of urologists are aware of this use in their practice, and a majority of urologists could not correctly explain the difference between the different calibrators. A greater awareness is needed amongst US urologists about the different PSA calibrators, the calibrator in use at their practice, and means to account for different calibrators in clinical decision making. [Table: see text]

Ability of multiparametric magnetic resonance imaging (MRI) to predict prostate tumor heterogeneity on targeted biopsy.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 113-113 ◽  
Author(s):  
Samuel Gold ◽  
Jonathan Bloom ◽  
Graham R. Hale ◽  
Kareem Rayn ◽  
Sherif Mehralivand ◽  
...  
Keyword(s):  
Clinical Decision Making ◽  
Clinical Decision ◽  
Lesion Size ◽  
Future Research ◽  
Imaging Features ◽  
Targeted Biopsy ◽  
Impact Risk ◽  
The Difference ◽  
Magnetic Resonance Imaging Mri ◽  
Grade 3

113 Background: Prostate cancer (PCa) can show heterogeneous histology within lesions. MRI-targeted biopsy (Tbx) of the prostate improves PCa detection, but sampling within lesions has yet to be standardized. Furthermore, Tbx results are often heterogeneous as evidenced by differing histologic grades of Tbx cores within the same lesion. This introduces potential variability in biopsy results, on which clinical decisions are made. Here we aim to characterize lesion heterogeneity and identify predictive multiparametric MRI (mpMRI) features. Methods: A cohort of men who underwent mpMRI and Tbx between 2014-2017 were selected for analysis from a prospectively maintained database. To characterize lesion heterogeneity, only men with ≥2 positive Tbx cores were included. Histologic grades were scored according to International Society of Urological Pathology (ISUP) grades. Lesion heterogeneity, reported as a heterogeneity index (HI), was calculated as the difference of the average ISUP grades of Tbx cores per lesion from the maximum sampled ISUP grade of that lesion. Statistical analyses identified associations between imaging features and lesion heterogeneity. Results: 157 lesions in 114 patients met inclusion criteria. Maximum ISUP grade ranged from 1 to 5, with a median ISUP grade of 2. Higher ISUP grades were associated with greater lesion heterogeneity, HI for ISUP grade ≥3 = 0.58±0.11 vs <3 = 0.29±0.08, p = 0.0001. In addition, increasing lesion size on mpMRI was associated with greater lesion heterogeneity, HI for ≥2cm = 0.52±0.14 vs <2cm = 0.32±0.08, p = 0.0096. Finally, higher mpMRI suspicion scores were associated with increased heterogeneity vs lower suspicion scores, p = 0.048. Conclusions: mpMRI aids in characterizing PCa lesion heterogeneity to predict variability of histologic grades on Tbx. This information can assist Tbx planning to potentially reduce risks of upgrading on final pathology. Future research will examine how lesion heterogeneity can impact risk stratification and clinical decision-making for patients and practitioners. This research was supported by the Intramural Research Program of the National Cancer Institute, NIH and NIH Medical Research Scholars Program.

Quality improvement strategies and tools: A comparative analysis between Italy and the United States

2018 ◽  
Vol 31 (4) ◽  
pp. 205-217 ◽  
Author(s):  
Stefano Villa ◽  
Joseph D Restuccia ◽  
Eugenio Anessi-Pessina ◽  
Marco Giovanni Rizzo ◽  
Alan B Cohen
Keyword(s):  
United States ◽  
Quality Improvement ◽  
Clinical Decision Making ◽  
Clinical Pathways ◽  
Clinical Decision ◽  
The United States ◽  
Quality Performance ◽  
Report Quality ◽  
Improvement Strategies ◽  
The Difference

Italian and American hospitals, in two different periods, have been urged by external circumstances to extensively redesign their quality improvement strategies. This paper, through the use of a survey administered to chief quality officers in both countries, aims to identify commonalities and differences between the two systems and to understand which approaches are effective in improving quality of care. In both countries chief quality officers report quality improvement has become a strategic priority, clinical governance approaches, and tools—such as disease-specific quality improvement projects and clinical pathways—are commonly used, and there is widespread awareness that clinical decision making must be supported by protocols and guidelines. Furthermore, the study clearly outlines the critical importance of adopting a system-wide approach to quality improvement. To this extent Italy seems lagging behind compared to US in fact: (i) responsibilities for different dimensions of quality are spread across different organizational units; (ii) quality improvement strategies do not typically involve administrative staff; and (iii) quality performance measures are not disseminated widely within the organization but are reported primarily to top management. On the other hand, in Italy chief quality officers perceive that the typical hospital organizational structure, which is based on clinical directories, allows better coordination between clinical specialties than in the United States. In both countries, the results of the study show that it is not the single methodology/model that makes the difference but how the different quality improvement strategies and tools interact to each other and how they are coherently embedded with the overall organizational strategy.

scholarly journals The difference between a clinical technician and clinical practitioner is in the scope of practice: the need for a bioscience understanding in paramedicine

2019 ◽  
Vol 43 (4) ◽  
pp. 541-545
Author(s):  
Joseph A. Rathner ◽  
Christine Kettle
Keyword(s):  
Health Care Providers ◽  
Allied Health ◽  
Clinical Decision Making ◽  
Clinical Care ◽  
Clinical Decision ◽  
Complex Case ◽  
Care Providers ◽  
Anatomy And Physiology ◽  
Coronary Syndrome ◽  
The Difference

“Only teach me what I need to know!” This commonly heard refrain is often spoken by allied health students while studying preclinical sciences (physiology, anatomy, pharmacology). Here we use a clinical scenario undertaken by second-year Bachelor of Paramedic Practice students of acute coronary syndrome to demonstrate the difference in clinical decision making when using a clinical reasoning approach to treatment rather than relying exclusively on a practice guidelines approach. We hope to demonstrate that understanding basic bioscience concepts, such as the Frank-Starling mechanism and the anatomy and physiology of the autonomic nervous system, are key to providing good clinical care in response to ambiguous patient symptoms. Students who understand these concepts underlying their patient care guideline will make better clinical decisions and better provide quality of care than students who follow the guideline exclusively. We aim this as a practical demonstration of the value of detailed understanding of human bioscience in allied health education. As health care providers transition from “technician” to “practitioner,” the key distinguishing feature of the role is the ability to practice independently, using “best judgment” rather than clinical guidelines (alone). Evidence suggests that complex case management requires detailed bioscience understanding.

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