A comprehensive prognostic index for patients with CLL.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7015-7015
Author(s):  
Natali Pflug ◽  
Jasmin Bahlo ◽  
Tait D. Shanafelt ◽  
Barbara Eichhorst ◽  
Manuela Bergmann ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Score ◽  
Mayo Clinic ◽  
External Validation ◽  
Prognostic Index ◽  
Observation Time ◽  
Clinical Staging ◽  
Newly Diagnosed ◽  
C Statistic ◽  
Very High

7015 Background: Besides clinical staging, a number of biomarkers predicting OS in CLL have been identified. The multiplicity of markers, limited information on their independent value, and a lack of understanding of how to interpret discordant markers are major barriers to use in routine clinical practice. We developed an integrated prognostic index using the database of the German CLL Study Group (GCLLSG), which was subsequently validated in a cohort of untreated CLL patients (pts) from the Mayo Clinic. Methods: The analysis was based on a dataset collected between 1997 and 2006 in 3 GCLLSG phase III trials. The external validation was performed on a series of newly diagnosed CLL pts managed at Mayo Clinic. Results: The GCLLSG dataset (1,948 physically fit pts at early and advanced stage; median age: 60 yr (range 30-81); median observation time 63.4 mo) was used as a training dataset. 7 parameters were identified as independent predictors for OS: sex, age, ECOG status, del 17p, del 11q, IGHV mutation status, thymidine kinase and β2-microglobulin. By using a weighted grading a prognostic index was derived separating four different pts groups: low risk (score 0 - 2), intermediate risk (score 3-5), high risk (score 6-10) and very high risk (score 11-14) with significant different OS rates (95.2%, 86.9%, 67.7% and 18.7% OS after 5 yr for the low, intermediate, high and very high risk group respectively (p<0.001). This prognostic index was validated in a cohort of 676 newly diagnosed, untreated pts from the Mayo Clinic (median age 61.5 yr (range 32 - 89); median observation time 47.0 mo). The 4 risk groups were reproduced with 98.3%, 95.4%, 75.4% and 10.8% OS after 5 yr. The prognostic index predicts OS independent of Rai/Binet stage and provides accurate estimations regarding time to first treatment (TTF). C-statistic is 0.75. Conclusions: Using a multi-step process including external validation, we developed a comprehensive prognostic index combining clinical, serum, and molecular information into a single risk score for pts with untreated CLL. The prognostic index provides more accurate prediction of both TTF and OS. To our knowledge it is the first prognostic model in CLL to reach the C-statistic threshold (c > 0.70) necessary to have utility at the level of the individual.

scholarly journals A Peri-Implant Disease Risk Score for Patients with Dental Implants: Validation and the Influence of the Interval between Maintenance Appointments

2019 ◽  
Vol 8 (2) ◽  
pp. 252 ◽  
Author(s):  
Miguel de Araújo Nobre ◽  
Francisco Salvado ◽  
Paulo Nogueira ◽  
Evangelista Rocha ◽  
Peter Ilg ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Score ◽  
Disease Risk ◽  
Disease Incidence ◽  
Risk Groups ◽  
Risk Profile ◽  
Moderate Risk ◽  
C Statistic ◽  
Disease Risk Score ◽  
Very High

Background: There is a need for tools that provide prediction of peri-implant disease. The purpose of this study was to validate a risk score for peri-implant disease and to assess the influence of the recall regimen in disease incidence based on a five-year retrospective cohort. Methods: Three hundred and fifty-three patients with 1238 implants were observed. A risk score was calculated from eight predictors and risk groups were established. Relative risk (RR) was estimated using logistic regression, and the c-statistic was calculated. The effect/impact of the recall regimen (≤ six months; > six months) on the incidence of peri-implant disease was evaluated for a subset of cases and matched controls. The RR and the proportional attributable risk (PAR) were estimated. Results: At baseline, patients fell into the following risk profiles: low-risk (n = 102, 28.9%), moderate-risk (n = 68, 19.3%), high-risk (n = 77, 21.8%), and very high-risk (n = 106, 30%). The incidence of peri-implant disease over five years was 24.1% (n = 85 patients). The RR for the risk groups was 5.52 (c-statistic = 0.858). The RR for a longer recall regimen was 1.06, corresponding to a PAR of 5.87%. Conclusions: The risk score for estimating peri-implant disease was validated and showed very good performance. Maintenance appointments of < six months or > six months did not influence the incidence of peri-implant disease when considering the matching of cases and controls by risk profile.

scholarly journals The CLL-international prognostic index (CLL-IPI) predicts outcomes in monoclonal B-cell lymphocytosis and Rai 0 CLL

Blood ◽  
2021 ◽  
Author(s):  
Sameer A Parikh ◽  
Kari G. Rabe ◽  
Neil E. Kay ◽  
Timothy G. Call ◽  
Wei Ding ◽  
...  
Keyword(s):  
High Risk ◽  
B Cell ◽  
Cell Count ◽  
International Prognostic Index ◽  
Multivariable Analysis ◽  
Prognostic Index ◽  
Lymphocytic Leukemia ◽  
Entire Cohort ◽  
C Statistic ◽  
Very High

The utility of the chronic lymphocytic leukemia - international prognostic index (CLL-IPI) in predicting outcomes of individuals with Rai 0 stage CLL and monoclonal B-cell lymphocytosis (MBL) is unclear. We identified 969 individuals (415 MBL and 554 Rai 0 CLL; median age=64 years, 65% men) seen at Mayo Clinic between 1/1/2001 and 10/1/2018, and ascertained time to first therapy (TTFT) and overall survival (OS). After a median follow up of 7 years, the risk of disease progression needing therapy was 2.9%/year for MBL (median=not reached) and 5%/year for Rai 0 CLL (median=10.4 years). Among patients with low, intermediate and high/very high risk CLL-IPI risk groups, the estimated 5-year risk of TTFT was 13.5%, 30%, and 58%, respectively, p&lt;0.0001 (c-statistic=0.69); and the estimated 5-year OS was 96.3%, 91.5%, and 76%, respectively, p&lt;0.0001 (c-statistic:0.65). In a multivariable analysis of absolute B-cell count with individual factors of the CLL-IPI, the absolute B-cell count was associated with shorter TTFT (hazard ratio [HR] for each 10 x 109/L increase: 1.31; p&lt;0.0001), and shorter OS (HR: 1.1; p=0.02). The OS of the entire cohort was similar to age- and sex-matched general population of Minnesota (p=0.17), although Rai 0 CLL patients with high and very high risk CLL-IPI score had significantly shorter OS (p=0.01, and p=0.0001, respectively). The results of this study demonstrate the ability of CLL-IPI to predict time from diagnosis to first treatment (an endpoint not impacted by therapy) in a large cohort of patients whose only manifestation of disease is a circulating clonal lymphocyte population.

Cause of death in patients with newly diagnosed chronic lymphocytic leukemia (CLL) stratified by the CLL-International Prognostic Index (CLL-IPI).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 8026-8026
Author(s):  
Yucai Wang ◽  
Sara J Achenbach ◽  
Kari G. Rabe ◽  
Tait D. Shanafelt ◽  
Timothy Call ◽  
...  
Keyword(s):  
High Risk ◽  
Cause Of Death ◽  
Risk Group ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Lymphocytic Leukemia ◽  
Intermediate Risk ◽  
Newly Diagnosed ◽  
Second Malignancies ◽  
Very High

8026 Background: CLL progression and CLL-related complications (infections and second malignancies) were the leading cause of death (COD) in a prospective cohort of CLL patients (Strati, BJH 2017). The CLL-IPI integrates major clinical and molecular prognostic factors and stratifies patients into 4 risk groups with distinct prognosis. It is unknown if COD differs according to CLL-IPI risk group in patients with newly diagnosed CLL. Methods: Patients diagnosed with CLL between 1/2000-12/2019 and seen within 1 year of diagnosis were identified from the Mayo Clinic CLL database. Cumulative incidences of cause-specific death were analyzed using Gray’s test, with deaths from different causes treated as competing events and deaths from unknown causes excluded. Results: 1276 patients were included in this study. The median age at diagnosis was 63 years (range 24-92), and 880 (69%) were male. Based on CLL-IPI score, 449 (35%) had low risk disease, 443 (35%) had intermediate risk disease, and 384 (30%) had high/very high risk disease. Median follow-up time for the study was 6 years; 286 deaths occurred. The COD was CLL progression in 99 (35%), infection in 16 (6%), second malignancy in 47 (16%), CLL-unrelated in 59 (21%), and unknown in 65 (23%) patients. The rates of death due to CLL progression were higher (17.3% at 5 years; 30.3% at 10 years) than the rates due to CLL-related complications (5.7% at 5 years; 12.9% at 10 years) or due to CLL-unrelated causes (8.6% at 5 years; 16.9% at 10 years) in the CLL-IPI high/very high risk group, but not the CLL-IPI low or intermediate risk group (Table). A higher CLL-IPI risk group was associated with a higher rate of death due to CLL progression ( P < 0.001), as well as a higher rate of death due to CLL-related complications ( P = 0.013), and CLL-unrelated causes ( P < 0.001). Conclusions: Causes of death in newly diagnosed CLL patients differ according to their CLL-IPI risk group. In patients with high/very high risk CLL, improving CLL disease control with novel agents seems justified. In patients with low/intermediate risk CLL, there should be increased efforts to reverse immune dysfunction to reduce infections and second malignancies. [Table: see text]

scholarly journals CLL: A Prognostic Model Comprising Only Two Biomarkers (IGHV Mutational Status and FISH-Cytogenetics) Separates Patients with Different Prognosis and Simplifies the CLL-IPI.

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3205-3205 ◽  
Author(s):  
Julio Delgado ◽  
Michael Doubek ◽  
Tycho Baumann ◽  
Jana Kotaskova ◽  
Pablo Mozas ◽  
...  
Keyword(s):  
High Risk ◽  
Expert Testimony ◽  
Prognostic Model ◽  
Prognostic Index ◽  
Continuous Variables ◽  
Fish Cytogenetics ◽  
C Statistic ◽  
Mutational Status ◽  
Clinical Stages ◽  
Very High

Abstract Background: Survival of pts with chronic lymphocytic leukemia (CLL) ranges from a few years to a normal lifespan. Clinical stages (i.e. Rai, Binet) are the basis for CLL prognostication but do not reflect the complex biology of CLL, which ultimately shapes the disease heterogeneity. Recently, a CLL-International Prognostic Index (CLL-IPI) which includes five clinical and biological variables (i.e. age, IGHV mutational status, del(17p), beta2-microglobulin [B2M] and Rai or Binet stages) and stratifies pts into four different categories has been proposed. This prognostic index is obtained by the sum of the score given to each parameter and includes dichotomized continuous variables. The aim of this study was to determine whether a prognostic model based only on biomarkers could separate CLL patients with different outcomes and simplify the CLL-IPI. Material and Methods: Five hundred twenty-four CLL pts from the Hospital Clínic, Barcelona, in whom information at diagnosis included age, clinical stage (Rai and Binet), IGHV mutational status, B2M, and FISH-cytogenetics were analyzed. For validation purposes a cohort of 417 pts from the Brno Hospital, Czech Republic was used. The two series included patients as seen in clinical practice. Primary endpoints were overall survival (OS) and time to first treatment (TTFT). The internal validity of the models was evaluated using bootstrapping, and the discriminatory value by c-statistics. Double sided P values < .05 were considered significant. Results: First, we confirmed that all five covariates included in the CLL-IPI were independently predictive of OS. Both sets of five covariates (age + B2M + IGHV + FISH + Rai or Binet) were incorporated into the regression models. All four patient subgroups had a significantly different survival (c-statistic: 0.72), although the high- and very-high risk groups overlapped and the number of patients in the very-high-risk group was small. We then evaluated all possible combinations of these five covariates to identify the simplest model with robust discriminatory value. A prognostic model based on IGHV mutational status + FISH [del(17p) and/or del(11q)] separated three subgroups of pts [i.e, good-biomarkers (mutated IGHV + no poor FISH cytogenetics), intermediate-biomarkers (either unmutated IGHV or poor FISH cytogenetics), and poor biomarkers (unmutated IGHV + poor FISH cytogenetics)] with different prognosis (c-statistic: 0.68). In the Barcelona series, the good-biomarkers category identified around 50% of pts from the whole series whose survival did not differ from the general population; patients with intermediate-biomarkers had a projected 10-year survival of 68%. Finally, the poor-biomarkers category captured pts with a projected 10-year survival of 17%. The corresponding TTFTs at 3 years from diagnosis were 16%, 50% and 63%, respectively (Figure). Furthermore, it separated patients with different outcome within clinical stages, notably Binet A or Rai 0, and across all age groups. This model was fully validated in the Brno series. Conclusions: The biomarkers-only CLL prognostic model presented here is based on the two most important CLL biomarkers (i.e. IGHV mutational status and FISH cytogenetics) which are included as a backbone in the CLL-IPI and other CLL prognostic systems. This model is simple, easy to apply and to remember; it separates three groups of pts rather than four; it does not contain continuous variables; it can be applied to younger and older pts, and has clinical implications. This prognostic model could be useful in CLL prognostication either alone or in combination with clinical stages and warrants prospective validation, including in patients receiving targeted therapies. Figure Figure. Disclosures Montserrat: Pharmacyclics: Consultancy; Vivia Biotech: Equity Ownership; Janssen: Honoraria, Other: travel, accommodations, expenses; Gilead: Consultancy, Other: Expert Testimony; Morphosys: Other: Expert Testimony.

Validation Of The Revised International Prognostic Scoring System (IPSS-R) In 1000 Newly Diagnosed MDS Patients With Low- and Intermediate-1 Risk MDS In The European Leukemianet MDS (EUMDS) Registry

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2770-2770 ◽  
Author(s):  
Louise de Swart ◽  
Alex Smith ◽  
Tom Johnston ◽  
Detlef Haase ◽  
Jackie Droste ◽  
...  
Keyword(s):  
High Risk ◽  
Mortality Rate ◽  
Risk Score ◽  
Scoring System ◽  
Scoring Systems ◽  
International Prognostic Scoring System ◽  
Newly Diagnosed ◽  
High Age ◽  
Very High

Abstract Background The EUMDS registry was initiated to provide an overview of the real-world demographics, diagnostics and disease-management of MDS. The first patient was registered in December 2007 and today 16 countries and 131 centers are participating. In 1997 the International Prognostic Scoring System (IPSS) was developed to predict clinical outcomes for patients with MDS and is still the most widely used prognostic scoring system. Recently, the IPSS has been revised (IPSS-R). Objective To validate the prognostic discrimination of the IPSS and IPSS-R in the first 1000 newly diagnosed lower risk MDS patients. Results The median age of the population at diagnosis was 75 years (range 19-95). WHO 2001 classification was RCMD (35%), RARS (18%), RA (18%), RAEB-1 (12%), RCMD-RS (7%), 5q- syndrome (6%), MDS-U (3%) and RAEB-2 (0.4%). Within the first two years of follow-up 57% of the patients received MDS specific treatment: 48% received erythropoiesis stimulating agents (ESA), 11% granulocyte colony-stimulating factor (G-CSF), 51% received at least one red blood cell transfusion and 8% iron chelation therapy. IPSS risk score was Low in 49%, Intermediate-1 in 45% (0.5=32%, 1=13%) and unknown in 6% (no cytogenetic analysis) of the patients. IPSS-R risk score was Very Low in 25%, Low in 44%, Intermediate in 16%, High/Very high in 4% of the patients, and 10% unknown (Figure 1; Table 1). 77% of IPSS karyotypes were Good, 15% Intermediate, 1% Poor and unknown in 6%. 7% of the IPSS-R cytogenetic groups were Very good, 72% Good, 11% Intermediate, 1% were each Poor or Very poor and 8% unknown. Overall survival (OS) and disease progression (DP) (high risk MDS/Leukaemia) were both evaluated. Median follow-up time was 2.1 years (range 0 - 4.9 years). The mortality rate in patients with IPSS Low was 23% and 38% among those with an Intermediate IPSS (HR 2.09, 95%CI: 1.64-2.66; Figure 2A). The mortality rate in patients according to the IPSS-R was Very Low (21%; HR 0.77, 95%CI: 0.55-1.07), Low (26%; HR 1), Intermediate (51%; HR 2.53, 95%CI: 1.90-3.38) and High/Very high (65%; HR 4.47, 95%CI: 2.94-6.78) (Figure 2B). The prognostic discrimination of the scoring systems was assessed using the Akaike Information Criterion (AIC) from univariate proportional hazards models; the lower the AIC value the more informative the prognostic scoring system. The AIC of the IPSS and IPSS-R models were 3198.77 and 3154.48, respectively for OS and 1323.16 and 1274.19, respectively for DP (Table 1). A similar assessment of the components of the IPSS and IPSS-R scores revealed comparable fits to both OS and DP, regardless of which component was considered (Table 2). Conclusion IPSS and IPSS-R both predict OS and DP very well. IPSS-R was slightly superior in evaluating the clinical outcome, but it identified a subgroup (4.5% of all patients) of High and Very High-risk patients with a very poor prognosis, and another subgroup of good prognosis patients (IPSS-R Very Low) within the IPSS INT-1 cohort (13.6% of IPSS INT-1). Both scoring systems appear to be more strongly associated with predicting the risk of developing DP than OS. This observation may be due to the average high age at diagnosis of MDS reflecting the effect of competing causes of death associated with high age. Disclosures: Guerci-Bresler: Novartis: Honoraria; BMS: Honoraria; Celgene: Honoraria; Amgen: Honoraria.

scholarly journals The Intracranial-B2LEED3S Score and the Risk of Intracranial Hemorrhage in Ischemic Stroke Patients Under Antiplatelet Treatment

2017 ◽  
Vol 43 (3-4) ◽  
pp. 145-151 ◽  
Author(s):  
Pierre Amarenco ◽  
Leila Sissani ◽  
Julien Labreuche ◽  
Eric Vicaut ◽  
Marie Germaine Bousser ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
High Risk ◽  
Intracranial Hemorrhage ◽  
Risk Score ◽  
External Validation ◽  
Antithrombotic Agent ◽  
Clinical Trial Registration ◽  
Asian Ethnicity ◽  
C Statistic ◽  
Cox Proportional Hazard Regression

Background: Chronic antiplatelet therapy in the post-acute phase of non-cardioembolic ischemic stroke is limited by the risk of intracranial hemorrhage (ICH) complications. Methods: We developed an ICH risk score based on the PERFORM trial cohort (n = 19,100), which included patients with a non-cardioembolic ischemic stroke or transient ischemic attack, and externally validated this score in one contemporary trial of very similar size and inclusion criteria, the PRoFESS trial (n = 20,332 patients). Outcome was ICH over 2 years. A Cox proportional-hazard regression analysis identified risk factors. Discrimination was quantified with c-statistics and calibration was assessed by comparing predicted and observed ICH risk in PERFORM and PRoFESS. Results: ICH occurred within 2 years in 263 (1.4%) patients in PERFORM trial and in 246 (1.2%) patients in PRoFESS trial. A 13-point score based on 9 items (Intracranial-B2LEED3S score - low body mass index, blood pressure, lacune, elderly, Asian ethnicity, coronary artery or cerebrovascular disease history, dual antithrombotic agent or oral anticoagulant, gender) was derived from the PERFORM trial. In PERFORM, the observed 2-year ICH risk varied from 0.75% in low-risk (score ≤2) to 2.44% in high-risk patients (score ≥5) with an acceptable calibration but a low discrimination both in PERFORM (c-statistic 0.64, 95% CI 0.61-0.68) and on external validation in PRoFESS (0.58, 95% CI 0.55-0.62). Conclusion: The Intracranial-B2LEED3S score helps identify patients who are at a high risk of bleeding. However, other variables need to be identified to improve the score (e.g., microbleeds) (Clinical Trial Registration Information ISRCTN66157730). URL: http://www.isrctn.com/ISRCTN66157730?totalResults=5&amp;pageSize=10&amp;page=1&amp;searchType=basic-search&amp;offset=3&amp;q=&amp;filters=conditionCategory%3ACirculatory+System%2CrecruitmentCountry%3ATaiwan%2CrecruitmentCountry%3AAustria&amp;sort=.

scholarly journals Chinese External Validation of the Cochrane Haematological Malignancies Group Prognostic Index for Chronic Lymphocytic Leukemia Patients

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5280-5280
Author(s):  
Shu Chao Qin ◽  
Wei Xu ◽  
Yi Xia ◽  
Chun Qiao ◽  
Lei Fan ◽  
...  
Keyword(s):  
Overall Survival ◽  
High Risk ◽  
Prognostic Index ◽  
Risk Groups ◽  
Low Risk ◽  
Clinical Staging ◽  
Intermediate Risk ◽  
Haematological Malignancies ◽  
Risk Scoring ◽  
Very High

Abstract Objection: Chronic lymphocytic leukemia (CLL) is a chronic lymphoproliferative disease characterized by highly clinical and biological heterogeneity. A number of biomarkers have been identified in predicting the overall survival (OS) over the last decades besides the traditional clinical staging. Recently, an international prognostic index (IPI) combing clinical staging and biomarkers was developed by the investigators of the Cochrane Haematological Malignancies Group. Due to genetic differences between Caucasic and Chinese CLL patients, our study was to validate the guiding function of IPI on Chinese CLL cases. Method: We performed a validation of the IPI proposed by the Cochrane Haematological Malignancies Group to stratify Chinese CLL patients prognostically in 225 CLL cases registered at our center. The five parameters (age, TP53 abnormalities, IGHV mutation status, b2-microglobulin and Binet stage) involved in the IPI were collected by clinical data, serum test, PCR and fluorescence in situ hybridization (FISH). Chi-square test, survival analysis, log-rank test and cox hazard regression analysis were utilized in the validation. Result: In the 225 Chinese CLL cases analysed in the validation, all five parameters involved in the IPI were associated with overall survival (OS) independently. The multivariate analysis demonstrated that age above 65 years old (HR 2.22; [1.15-4.30]; P=0.018), b2-microglobulin over 3.5 mg/L (HR 2.46; [1.22-4.94]; P=0.001), Binet staging B/C (HR 3.40; [1.02-11.33]; P=0.046), TP53 abnormalities (HR 2.72; [1.50-4.94]; P=0.012) and IGHV unmutation (HR 5.19; [2.51-10.77]; P<0.001) were OS related risk factors respectively. Then a total point score was calculated for each patient according to the grading system proposed by the Cochrane Haematological Malignancies Group investigators. There were 60 (26.7%) patients at low-risk (scoring 0-1), 57 (25.3%) patients at intermediate-risk (scoring 2-3), 65(28.9%) patients at high-risk (scoring 4-6) and 43 (19.1%) patients at very high-risk (scoring 7-10). The IPI allowed different prediction of time to treatment (TTT) in all groups (Fig. 1). The estimated median TTT were: 102 months for low-risk, 12 months for intermediate-risk and 1 month for high-risk group. However, the low-risk and intermediate-risk groups showed similar overall survival (P=0.424). Beyond that, significant difference was found between the intermediate, high and very high-risk groups. We combined the low-risk and the intermediate-risk groups into one to accommodate to the Chinese CLL cases. 117 (52%) patients were at low & intermediate-risk (scoring 0-3), thus leading to the significantly different prognostic value between groups (Fig. 1) . The estimated median survival times were: not reached for low&intermediate-risk, 63 months for high-risk and 128 months for very high-risk group. Conclusion: Our results basically validated the IPI proposed by the Cochrane Haematological Malignancies Group to prognostically stratify CLL patients in China, which confirmed the value of the novel prognostic index externally. However, a slight adaption was made to accommodate the Chinese cases better via the combination of the low-risk and intermediate-risk groups. We considered that a universally recognized prognostic model would be utilized to predict the disease progression and guide the treatment when initially diagnosed. Disclosures No relevant conflicts of interest to declare.

Development and Validation of Nomograms to Predict Local, Regional, and Distant Recurrence in Patients With Thin (T1) Melanomas

2021 ◽  
Vol 39 (11) ◽  
pp. 1243-1252
Author(s):  
Mary-Ann El Sharouni ◽  
Tasnia Ahmed ◽  
Alexander H. R. Varey ◽  
Sjoerd G. Elias ◽  
Arjen J. Witkamp ◽  
...  
Keyword(s):  
High Risk ◽  
Sentinel Node ◽  
External Validation ◽  
Distant Recurrence ◽  
Treatment Center ◽  
Cox Models ◽  
T Stage ◽  
Node Status ◽  
C Statistic ◽  
Sentinel Node Status

PURPOSE Although the prognosis of patients with thin primary cutaneous melanomas (T1, ≤ 1.0 mm) is generally excellent, some develop recurrence. We sought to develop and validate a model predicting recurrences in patients with thin melanomas. METHODS A Dutch population-based cohort (n = 25,930, development set) and a cohort from an Australian melanoma treatment center (n = 2,968, validation set) were analyzed (median follow-up 6.7 and 12.0 years, respectively). Multivariable Cox models were generated for local, regional, and distant recurrence-free survival (RFS). Discrimination was assessed using Harrell's C-statistic for each outcome. Each nomogram performance was evaluated using calibration plots defining low-risk and high-risk groups as the lowest and top 5% of the nomogram risk score, respectively. The nomograms' C-statistics were compared with those of a model including the current American Joint Committee on Cancer staging parameters (T-stage and sentinel node status). RESULTS Local, regional, and distant recurrences were found in 209 (0.8%), 503 (1.9%), and 203 (0.8%) Dutch patients, respectively, and 23 (0.8%), 61 (2.1%), and 75 (2.5%) Australian patients, respectively. C-statistics of 0.79 (95% CI, 0.75 to 0.82) for local RFS, 0.77 (95% CI, 0.75 to 0.78) for regional RFS, and 0.80 (95% CI, 0.77 to 0.83) for distant RFS were obtained for the development model. External validation showed C-statistics of 0.80 (95% CI, 0.69 to 0.90), 0.76 (95% CI, 0.70 to 0.82), and 0.74 (95% CI, 0.69 to 0.80), respectively. Calibration plots showed a good match between predicted and observed rates. Using the nomogram, the C-statistic was increased by 9%-12% for the development cohort and by 11%-15% for the validation cohort, compared with a model including only T-stage and sentinel node status. CONCLUSION Most patients with thin melanomas have an excellent prognosis, but some develop recurrence. The presented nomograms can accurately identify a subgroup at high risk. An online calculator is available at www.melanomarisk.org.au .

A Risk Score for Predicting the Incidence of Hemorrhage in Critically Ill Neonates: Development and Validation Study

2020 ◽  
Author(s):  
Rozeta Sokou ◽  
Daniele Piovani ◽  
Aikaterini Konstantinidi ◽  
Andreas G. Tsantes ◽  
Stavroula Parastatidou ◽  
...  
Keyword(s):  
Prediction Model ◽  
Critically Ill ◽  
Risk Score ◽  
External Validation ◽  
Prognostic Index ◽  
Bleeding Risk ◽  
Outcome Variable ◽  
Calibration Plot ◽  
Characteristic Analysis ◽  
Critically Ill Neonates

AbstractThe aim of the study was to develop and validate a prediction model for hemorrhage in critically ill neonates which combines rotational thromboelastometry (ROTEM) parameters and clinical variables. This cohort study included 332 consecutive full-term and preterm critically ill neonates. We performed ROTEM and used the neonatal bleeding assessment tool (NeoBAT) to record bleeding events. We fitted double selection least absolute shrinkage and selection operator logit regression to build our prediction model. Bleeding within 24 hours of the ROTEM testing was the outcome variable, while patient characteristics, biochemical, hematological, and thromboelastometry parameters were the candidate predictors of bleeding. We used both cross-validation and bootstrap as internal validation techniques. Then, we built a prognostic index of bleeding by converting the coefficients from the final multivariable model of relevant prognostic variables into a risk score. A receiver operating characteristic analysis was used to calculate the area under curve (AUC) of our prediction index. EXTEM A10 and LI60, platelet counts, and creatinine levels were identified as the most robust predictors of bleeding and included them into a Neonatal Bleeding Risk (NeoBRis) index. The NeoBRis index demonstrated excellent model performance with an AUC of 0.908 (95% confidence interval [CI]: 0.870–0.946). Calibration plot displayed optimal calibration and discrimination of the index, while bootstrap resampling ensured internal validity by showing an AUC of 0.907 (95% CI: 0.868–0.947). We developed and internally validated an easy-to-apply prediction model of hemorrhage in critically ill neonates. After external validation, this model will enable clinicians to quantify the 24-hour bleeding risk.

A practical composite risk score for the development of Haemolytic Uraemic Syndrome from Shiga toxin-producing Escherichia coli

2019 ◽  
Vol 29 (5) ◽  
pp. 861-868 ◽  
Author(s):  
Douglas Hamilton ◽  
John Cullinan
Keyword(s):  
Escherichia Coli ◽  
High Risk ◽  
Risk Score ◽  
Shiga Toxin ◽  
Haemolytic Uraemic Syndrome ◽  
Low Risk ◽  
Medium Risk ◽  
Composite Risk ◽  
Very High ◽  
Estimation Of Risk

Abstract Background Haemolytic Uraemic Syndrome (HUS) is a serious complication of Shiga toxin-producing Escherichia coli (STEC) infection and the key reason why intensive health protection against STEC is required. However, although many potential risk factors have been identified, accurate estimation of risk of HUS from STEC remains challenging. Therefore, we aimed to develop a practical composite score to promptly estimate the risk of developing HUS from STEC. Methods This was a retrospective cohort study where data for all confirmed STEC infections in Ireland during 2013–15 were subjected to statistical analysis with respect to predicting HUS. Multivariable logistic regression was used to develop a composite risk score, segregating risk of HUS into ‘very low risk’ (0–0.4%), ‘low risk’ (0.5–0.9%), ‘medium risk’ (1.0–4.4%), ‘high risk’ (4.5–9.9%) and ‘very high risk’ (10.0% and over). Results There were 1397 STEC notifications with complete information regarding HUS, of whom 5.1% developed HUS. Young age, vomiting, bloody diarrhoea, Shiga toxin 2, infection during April to November, and infection in Eastern and North-Eastern regions of Ireland, were all statistically significant independent predictors of HUS. Demonstration of a risk gradient provided internal validity to the risk score: 0.2% in the cohort with ‘very low risk’ (1/430), 1.1% with ‘low risk’ (2/182), 2.3% with ‘medium risk’ (8/345), 3.1% with ‘high risk’ (3/98) and 22.2% with ‘very high risk’ (43/194) scores, respectively, developed HUS. Conclusion We have developed a composite risk score which may be of practical value, once externally validated, in prompt estimation of risk of HUS from STEC infection.

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