Mucosal inflammation predicts response to systemic steroids in immune checkpoint inhibitor colitis

BackgroundImmune-related colitis is a common, often serious complication of immune checkpoint inhibition (ICI). Although endoscopy is not strictly recommended for any grade of diarrhea/colitis, emerging evidence suggests that endoscopic evaluation may have important therapeutic implications. In this retrospective study, we sought to comprehensively characterize the clinical and histologic features of ICI-induced colitis with a specific focus on evaluating the prognostic role of endoscopy.MethodsData were collected from the medical records of 130 patients with confirmed ICI-induced colitis. In a subset of patients (n=44) with endoscopic and pathologic data, endoscopic data were scored using the Mayo Endoscopic Score (MES) with scores ranging from 0 (no inflammation) to 3 (colonic ulceration). The impact of infliximab on antitumor outcomes was evaluated using progression-free survival (PFS) and overall survival (OS).ResultsWe identified 130 patients with ICI-induced colitis across two institutions. All patients were treated with corticosteroids. Additional and/or alternative immunosuppression was employed in 59 cases, with 52 patients (42%) requiring at least one infusion of infliximab 5 mg/kg. Endoscopic assessment with biopsy was performed in 123 cases of suspected colitis (95%), with 44 cases available for MES tabulation. Presence of ulceration (MES 3) was associated with use of infliximab (p=0.008) and MES was significantly higher in patients who received infliximab compared with those who did not (p=0.003) with a median score of 2.5; conversely, those with an MES of zero rarely required secondary immunosuppression. Notably, symptoms of colitis based on Common Terminology Criteria for Adverse Events grade had no association with endoscopic findings based on MES classification. After adjustment for baseline patient and disease characteristics, there was no significant difference in steroid duration or cancer-related outcomes in patients treated with infliximab.ConclusionsIn our study, we demonstrate the association of endoscopic features, specifically the MES, with immunosuppressive needs. Importantly, we also show that MES was not related to severity of patient symptoms. The data suggest that endoscopic features can guide clinical decision-making better than patient symptoms, both identifying high-risk patients who will require infliximab and those who are likely to respond to initial corticosteroids.

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Standardized Synoptic Cancer Pathology Reports — So What and Who Cares?: A Population-Based Satisfaction Survey of 970 Pathologists, Surgeons, and Oncologists

Archives of Pathology & Laboratory Medicine ◽

10.5858/arpa.2012-0656-oa ◽

2013 ◽

Vol 137 (11) ◽

pp. 1599-1602 ◽

Cited By ~ 37

Author(s):

Sara Lankshear ◽

John Srigley ◽

Thomas McGowan ◽

Marta Yurcan ◽

Carol Sawka

Keyword(s):

Decision Making ◽

Clinical Decision Making ◽

Clinical Decision ◽

Physician Satisfaction ◽

Cross Sectional ◽

Cancer Pathology ◽

Report Turnaround Time ◽

Significant Difference ◽

Pathology Reporting ◽

The Impact

Context.—Cancer Care Ontario implemented synoptic pathology reporting across Ontario, impacting the practice of pathologists, surgeons, and medical and radiation oncologists. The benefits of standardized synoptic pathology reporting include enhanced completeness and improved consistency in comparison with narrative reports, with reported challenges including increased workload and report turnaround time. Objective.—To determine the impact of synoptic pathology reporting on physician satisfaction specific to practice and process. Design.—A descriptive, cross-sectional design was utilized involving 970 clinicians across 27 hospitals. An 11-item survey was developed to obtain information regarding timeliness, completeness, clarity, and usability. Open-ended questions were also employed to obtain qualitative comments. Results.—A 51% response rate was obtained, with descriptive statistics reporting that physicians perceive synoptic reports as significantly better than narrative reports. Correlation analysis revealed a moderately strong, positive relationship between respondents' perceptions of overall satisfaction with the level of information provided and perceptions of completeness for clinical decision making (r = 0.750, P < .001) and ease of finding information for clinical decision making (r = 0.663, P < .001). Dependent t tests showed a statistically significant difference in the satisfaction scores of pathologists and oncologists (t169 = 3.044, P = .003). Qualitative comments revealed technology-related issues as the most frequently cited factor impacting timeliness of report completion. Conclusion.—This study provides evidence of strong physician satisfaction with synoptic cancer pathology reporting as a clinical decision support tool in the diagnosis, prognosis, and treatment of cancer patients.

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Clinical value of measurable residual disease testing for assessing depth, duration, and direction of response in multiple myeloma

Blood Advances ◽

10.1182/bloodadvances.2020002037 ◽

2020 ◽

Vol 4 (14) ◽

pp. 3295-3301

Author(s):

Joaquin Martinez-Lopez ◽

Sandy W. Wong ◽

Nina Shah ◽

Natasha Bahri ◽

Kaili Zhou ◽

...

Keyword(s):

Multiple Myeloma ◽

Clinical Decision Making ◽

Residual Disease ◽

Clinical Care ◽

Progression Free Survival ◽

Clinical Decision ◽

Routine Practice ◽

Clinical Value ◽

The Impact ◽

Measurable Residual Disease

Abstract Few clinical studies have reported results of measurable residual disease (MRD) assessments performed as part of routine practice. Herein we present our single-institution experience assessing MRD in 234 multiple myeloma (MM) patients (newly diagnosed [NDMM = 159] and relapsed [RRMM = 75]). We describe the impact of depth, duration, and direction of response on prognosis. MRD assessments were performed by next-generation sequencing of immunoglobulin genes with a sensitivity of 10−6. Those achieving MRD negativity at 10−6, as well as 10−5, had superior median progression-free survival (PFS). In the NDMM cohort, 40% of the patients achieved MRD negativity at 10−6 and 59% at 10−5. Median PFS in the NDMM cohort was superior in those achieving MRD at 10−5 vs <10−5 (PFS: 87 months vs 32 months; P < .001). In the RRMM cohort, 36% achieved MRD negativity at 10−6 and 47% at 10−5. Median PFS was superior for the RRMM achieving MRD at 10−5 vs <10−5 (PFS: 42 months vs 17 months; P < .01). Serial MRD monitoring identified 3 categories of NDMM patients: (A) patients with ≥3 MRD 10−6 negative samples, (B) patients with detectable but continuously declining clonal numbers, and (C) patients with stable or increasing clonal number (≥1 log). PFS was superior in groups A and B vs C (median PFS not reached [NR], NR, 55 respectively; P < .001). This retrospective evaluation of MRD used as part of clinical care validates MRD as an important prognostic marker in NDMM and RRMM and supports its use as an endpoint in future clinical trials as well as for clinical decision making.

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Prediction of benefit from treatment beyond the first line in patients with metastatic breast cancer (MBC).

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e11565 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e11565-e11565

Author(s):

Marta Bonotto ◽

Lorenzo Gerratana ◽

Alessandro Minisini ◽

Elena Poletto ◽

Stefania Russo ◽

...

Keyword(s):

Clinical Decision Making ◽

Statistical Significance ◽

Metastatic Breast ◽

Progression Free Survival ◽

Clinical Decision ◽

Consecutive Series ◽

First Line ◽

Her2 Positive ◽

Free Survival ◽

The Impact

e11565 Background: Despite the availability of several therapeutic options for MBC, palliative treatments beyond 1st line lack of predictive factors that could help clinical decision making. We aimed to determine which is the impact of benefit at 1stline into the benefit from subsequent therapeutic lines. Methods: We analyzed a consecutive series of 472 MBC patients treated with chemotherapy (CT) and/or endocrine therapy (ET) at the Department of Oncology of Udine, Italy, between 2004 and 2012. We evaluated Progression Free Survival at 1st (PFS1), 2nd (PFS2), 3rd (PFS3) and 4th (PFS4) line of treatment. Three distinct analyses were conducted: the first for the lines of CT, the second for the lines of ET and the third by considering both CT and ET as a line of treatment. A PFS longer than 6 months was defined as “6-month benefit". Results: Median Overall Survival was 34.5 mo (25th – 75th percentile: 14.5 – 58.8), median overall PFS1 and PFS2 was 8.9 mo and 4.3 mo respectively. Median PFS1 and PFS2 in CT lines only was 7 mo and 3.7 mo, respectively. Median PFS1 and PFS2 in ET lines only was 9.4 mo and 4.6 mo respectively. Overall, 289 patients (63.5%) presented 6-month benefit at 1st line, 128 (40.5%) at 2nd, 76 (33.8%) at 3rd and 34 (23.3%) at 4th. Not having a 6-month benefit in overall PFS1 was associated with a lack of benefit both at 2nd line (OR=0.48; p=0.0026) and at any line beyond the 1st (OR=0.39; p< 0.0001). Taking into consideration CT lines only, not having a 6-month benefit in CT PFS1 was associated with a lack of benefit both at 2nd line (OR=0.45; p=0.0072) and at any line beyond the 1st (OR=0.43; p=0.0026). A lack of benefit at the 1st ET line was not associated with further ET outcome neither in 2nd line nor in any line beyond the 1st. Stratification according to immunophenotype highlighted a statistical significance only among HER2 positive tumors (OR=0.2; p=0.0152 in 2nd line and OR=0.14; p=0.0036 beyond 1st line). Conclusions: Our results suggest that the absence of a “6-month benefit” in PFS1 predicts a lack of benefit in subsequent therapy lines, especially in HER2 positive disease. However, a lack of benefit at first line ET appears not to be detrimental to further anti-hormonal lines.

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The impact of a genomic sequencing classifier (GSC) on clinical decision making in patients with a high-risk lung nodule.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.8549 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 8549-8549

Author(s):

Sonali Sethi ◽

Scott Oh ◽

Alexander Chen ◽

Christina Bellinger ◽

Lori Lofaro ◽

...

Keyword(s):

High Risk ◽

Clinical Decision Making ◽

Lung Nodule ◽

Clinical Decision ◽

Lung Nodules ◽

P Value ◽

Ablative Therapies ◽

Risk Patients ◽

The Impact ◽

Very High

8549 Background: Current guidelines recommend that patients who have lung nodules with high risk of malignancy (ROM) ( > 65%) should undergo surgical and other ablative therapies. However, prior studies have shown that clinicians may opt for more conservative management in these high-risk patients. Percepta Genomic Sequencing Classifier (GSC), a RNA-seq based classifier derived from bronchial epithelial cells to assess risk of lung cancer, was designed to risk stratify lung nodules by both down classifying ROM as a “rule -out“ test with high sensitivity as well as up-classifying ROM as a “rule- in” test with high specificity for malignancy. This study assesses the impact of up-classification of high ROM to very high- risk (ROM > 90%) by Percepta GSC in increasing the number of ablative therapies recommended for high-risk lung nodules. Methods: This prospective randomized decision impact survey included 37 patients from the AEGIS I/ II cohorts and the Percepta Registry who were undergoing work up of a lung nodule and had a high ROM that was up-classified to very high ROM by Percepta GSC. 97 physicians assessed 10 randomly assigned patient cases. They then responded to a survey designed to test the hypothesis that including a Percepta GSC result will increase the recommendation for surgical or other ablative therapy in very high- risk patients as well as their level of confidence of this recommendation. Physicians were first presented with the patient’s clinical information without Percepta GSC and then with Percepta GSC. Results: 97 physicians provided a total of 682 evaluations of 37 patients. In this study, the recommendation for surgical or other ablative therapy increased from 19/341 (5.6%) prior to the Percepta GSC result to 157/341 (46%) after the Percepta GSC result (odds ratio of 4.76, p-value < 0.001). The number of extremely confident recommendations increased from 72/341 (21%) without Percepta GSC to 106/341 (31%) with Percepta GSC. Significantly more physicians had increased confidence in their recommended next step post-Percepta GSC when collapsing the confidence level responses into increased confidence (n = 93) and decreased confidence (n = 44) (p-value = 0.002). Conclusions: Percepta GSC had a quantifiable impact on clinical decision making. It increased the number of surgical and other ablative therapies recommended when patients were re-classified from high to very high- risk of lung cancer with a higher confidence in the recommended next step. By up-classifying nodules from high to very high ROM, Percepta GSC will improve the likelihood and timeliness of appropriate therapies and assist clinicians more effectively manage patients to improve patient outcomes.

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Religion and Medicine

10.1093/oso/9780190867355.001.0001 ◽

2020 ◽

Author(s):

Jeff Levin ◽

Stephen G. Post

Keyword(s):

Clinical Decision Making ◽

Well Being ◽

Clinical Decision ◽

Religion And Medicine ◽

Physical And Mental Health ◽

Faith Based ◽

Baylor University ◽

Wide Range ◽

History Of ◽

The Impact

In Religion and Medicine, Dr. Jeff Levin, distinguished Baylor University epidemiologist, outlines the longstanding history of multifaceted interconnections between the institutions of religion and medicine. He traces the history of the encounter between these two institutions from antiquity through to the present day, highlighting a myriad of contemporary alliances between the faith-based and medical sectors. Religion and Medicine tells the story of: religious healers and religiously branded hospitals and healthcare institutions; pastoral professionals involved in medical missions, healthcare chaplaincy, and psychological counseling; congregational health promotion and disease prevention programs and global health initiatives; research studies on the impact of religious and spiritual beliefs and practices on physical and mental health, well-being, and healing; programs and centers for medical research and education within major universities and academic institutions; religiously informed bioethics and clinical decision-making; and faith-based health policy initiatives and advocacy for healthcare reform. Religion and Medicine is the first book to cover the full breadth of this subject. It documents religion-medicine alliances across religious traditions, throughout the world, and over the course of history. It summarizes a wide range of material of relevance to historians, medical professionals, pastors and theologians, bioethicists, scientists, public health educators, and policymakers. The product of decades of rigorous and focused research, Dr. Levin has produced the most comprehensive history of these developments and the finest introduction to this emerging field of scholarship.

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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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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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Clinical Conundrums When Integrating the QbTest into a Standard ADHD Assessment of Children and Young People

Neuropediatrics ◽

10.1055/s-0040-1722674 ◽

2021 ◽

Author(s):

Carsten Vogt

Keyword(s):

Clinical Practice ◽

Clinical Decision Making ◽

Ecological Validity ◽

Neuropsychological Test ◽

Real Life ◽

Clinical Decision ◽

Hyperactivity Disorder ◽

Standard Clinical Practice ◽

Novel Method ◽

The Impact

AbstractThe uptake of the QbTest in clinical practice is increasing and has recently been supported by research evidence proposing its effectiveness in relation to clinical decision-making. However, the exact underlying process leading to this clinical benefit is currently not well established and requires further clarification. For the clinician, certain challenges arise when adding the QbTest as a novel method to standard clinical practice, such as having the skills required to interpret neuropsychological test information and assess for diagnostically relevant neurocognitive domains that are related to attention-deficit hyperactivity disorder (ADHD), or how neurocognitive domains express themselves within the behavioral classifications of ADHD and how the quantitative measurement of activity in a laboratory setting compares with real-life (ecological validity) situations as well as the impact of comorbidity on test results. This article aims to address these clinical conundrums in aid of developing a consistent approach and future guidelines in clinical practice.

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Multimodal imaging patterns predict survival in recurrent glioblastoma patients treated with bevacizumab

Neuro-Oncology ◽

10.1093/neuonc/now086 ◽

2016 ◽

Vol 18 (12) ◽

pp. 1680-1687 ◽

Cited By ~ 46

Author(s):

Ken Chang ◽

Biqi Zhang ◽

Xiaotao Guo ◽

Min Zong ◽

Rifaquat Rahman ◽

...

Keyword(s):

Clinical Decision Making ◽

Progression Free Survival ◽

Clinical Decision ◽

Recurrent Glioblastoma ◽

Machine Learning Techniques ◽

Imaging Biomarkers ◽

Imaging Features ◽

Mri Features ◽

Fluid Attenuated Inversion Recovery ◽

Multimodal Mri

Abstract Background Bevacizumab is a humanized antibody against vascular endothelial growth factor approved for treatment of recurrent glioblastoma. There is a need to discover imaging biomarkers that can aid in the selection of patients who will likely derive the most survival benefit from bevacizumab. Methods The aim of the study was to examine if pre- and posttherapy multimodal MRI features could predict progression-free survival and overall survival (OS) for patients with recurrent glioblastoma treated with bevacizumab. The patient population included 84 patients in a training cohort and 42 patients in a testing cohort, separated based on pretherapy imaging date. Tumor volumes of interest were segmented from contrast-enhanced T1-weighted and fluid attenuated inversion recovery images and were used to derive volumetric, shape, texture, parametric, and histogram features. A total of 2293 pretherapy and 9811 posttherapy features were used to generate the model. Results Using standard radiographic assessment criteria, the hazard ratio for predicting OS was 3.38 (P < .001). The hazard ratios for pre- and posttherapy features predicting OS were 5.10 (P < .001) and 3.64 (P < .005) for the training and testing cohorts, respectively. Conclusion With the use of machine learning techniques to analyze imaging features derived from pre- and posttherapy multimodal MRI, we were able to develop a predictive model for patient OS that could potentially assist clinical decision making.

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