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PubMed1994

General principles of surgery quality control.

Randomized clinical trials are currently the most reliable research technique to generate reliable treatment data. Quality control and monitoring with statistical credibility are essential. This requires nurse data managers and coordinators and statisticians, as well as the surgeons and physicians. A well-structured operating infrastructure is key. From the surgical point of view, careful intraoperative staging and standardization of the surgical procedures are a must. Strict eligibility criteria must be documented and enforced. Finally, careful stratification for prognostic variables before randomization in phase 3 trials is essential.

Clinical Trials, Phase III as Topic↗
PubMed2026

Somatic-only SDHD variant with tumor-specific loss of heterozygosity in metastatic carotid body tumor: a case report with review of literature.

Carotid body tumors (CBTs) are rare paragangliomas in which genetic predisposition, particularly pathogenic variants in succinate dehydrogenase (SDHx) genes, plays an important role in tumorigenesis. Previous genetic studies of CBTs have primarily focused on germline SDHx variants, whereas somatic alterations remain poorly characterized. Among SDHx genes, SDHB variants are known to be associated with a higher metastatic risk, while SDHD variants are generally linked to a lower metastatic rate. We report the case of a 41-year-old man who presented with a painless right-sided neck mass. Imaging studies demonstrated a hypervascular tumor located at the carotid bifurcation with circumferential encasement of the carotid artery. During surgery, the tumor was classified as a Shamblin type III CBT, and complete surgical resection with vascular reconstruction was performed. Histopathological examination confirmed paraganglioma with metastasis to a single cervical lymph node. Germline genetic testing did not reveal any pathogenic variants. However, comprehensive tumor genomic profiling identified a somatic SDHD c.304C>G (p.His102Asp) variant accompanied by tumor-specific loss of heterozygosity (LOH) and copy-number loss at the SDHD locus, findings compatible with biallelic SDHD inactivation. The patient remained free of recurrence during follow-up. To our knowledge, this represents the first reported case of metastatic CBT harboring a somatic-only SDHD variant with tumor-specific LOH. This case suggests that reliance on germline testing alone may underestimate the molecular drivers of CBT and highlights the potential clinical value of tumor-based genomic profiling for risk stratification and prognostic assessment.

Carotid body tumor↗
PubMed2004

Noninvasive tests for cardiac risk stratification. Which ones are most prognostic?

Assessment of cardiac risk is an important factor in treatment decision making in patients with coronary artery disease. Once the initial diagnosis has been made, various cardiac tests can be used to obtain pertinent information about risk level and the appropriateness of medical versus more invasive treatments. In this overview, Dr Litchfield describes the available tests for assessing cardiac function and reviews data about the diagnostic accuracy and incremental prognostic value of the most commonly used tests.

Coronary Disease↗
PubMed2001

A micromorphometry-based concept for routine classification of sentinel lymph node metastases and its clinical relevance for patients with melanoma.

BACKGROUND: The sentinel lymph nodes (SLNs) as the primary targets for lymphatic metastases can be removed selectively by gamma probe-guided sentinel lymph nodectomy (SLNE) in nearly all patients with cutaneous melanoma. Correspondingly high standards in terms of specificity, sensitivity, and microstaging are required for the evaluation of SLNs. METHODS: Since 1995, the authors have performed SLNE in 389 lymph node regions (LNRs) on 342 patients with melanoma. The harvested 636 SLNs and a further 1394 nonsentinel lymph nodes (non-SLNs) were evaluated by standardized, semiserial section histology, including immunohistochemistry. For each LNR, this technique permitted routine S classification using two simple morphometric parameters: the number of tumor-involved, 1-mm slices of the SLNs (n) and the centripetal depth of metastatic cell invasion (d). S1 was defined by 1 < or = n < or = 2 and d < or = 1 mm, equivalent to localized peripheral tumor cell deposits; S2 was defined by n > 2 and d < or = 1 mm, indicating more extended peripheral metastases; S3 was defined by d > 1 mm in SNLs with deeper metastatic infiltration; and S0 meant no detectable tumor cells (n = 0). RESULTS: The authors diagnosed 325 SLNs as S0, 24 SLNs as S1, 22 SLNs as S2, and 18 SLNs as S3. The occurrence of at least one melanoma-positive non-SLN subsequent regional completion lymph node dissection (RCLND) significantly increased from 0 of 12 in S1 SLNs to 2 of 13 in S2 SLNs and 9 of 15 in S3 SLNs (P = 0.001; chi-square test). Like the T classification of the primary melanoma, the S classification proved to be a highly significant predictor for distant metastasis (P < 0.001). It turned out to be an independent factor of influence on distant metastasis and survival in multivariate Cox analyses, which included tumor thickness, primary tumor site, patient gender, and patient age as covariates. CONCLUSIONS: The data presented recommend the S-staging concept as a promising option to fill a gap between the T and conventional N component of the pTNM classification. If its predictive capacity can be confirmed in multicenter studies, then the S classification may become the decisive criterion for or against RCLND, and a combined T plus S staging system will help to improve prognostically relevant stratification of melanoma patients in adjuvant therapy trials.

Adult↗
PubMed2003

Predictors of long-term clinical outcome of patients with acute massive pulmonary embolism after thrombolytic therapy.

OBJECTIVE: To assess the in-hospital clinical course and the long-term evolution of acute massive pulmonary embolism after thrombolytic therapy and to identify predictors of adverse clinical outcome. METHODS: A total of 260 patients hospitalized from January 1989 to October 1998 were retrospectively reviewed and followed up for 3.9 to 8.4 years. Baseline characteristics and variables pre- and post-thrombolysis were identified. Particular attention was paid to the clinical events, including death, recurrent thromboembolism, chronic thromboembolic pulmonary hypertension, and major bleeding attributable to the use of anticoagulants. Kaplan-Meier event-free survival curves were generated. Univariate analysis by means of the log-rank test was used to test each candidate variable for association with clinical outcome. Multivariate analysis with the Cox proportional hazard model was used to determine independent predictors of the long-term outcome. RESULTS: The in-hospital mortality rate was 8.5%, with 68.2% due to pulmonary embolism itself, and the follow-up mortality rate was 31.7%, with 29.2% due to recurrent embolism. Factors associated with an adverse outcome in univariate analysis were: (1) prior thromboembolic diseases; (2) duration of anticoagulant therapy < 6 months; (3) inferior vena caval filter placement; (4) acute right ventricular dysfunction/dilation detected echocardiographically after thrombolysis; (5) Doppler recording of pulmonary artery systolic pressure > 50 mmHg after thrombolysis; and (6) greater than 30% obstruction of pulmonary vasculature identified by pulmonary ventilation/perfusion scintigraphy before hospital discharge. Multivariate analysis identified three independent predictors of poor long-term outcome for patients with acute massive pulmonary embolism after thrombolysis; which were: (1) Doppler recording of pulmonary artery systolic pressure > 50 mmHg, with relative risk of 3.78 and a 95% confidence interval of 2.70 to 4.86; (2) echocardiographic evidence of right ventricular dysfunction/dilatation (relative risk: 2.18; 95% confidence interval: 1.48 to 2.88); and (3) greater than 30% obstruction of pulmonary vasculature documented by lung scan (relative risk: 1.99; 95% confidence interval: 1.25 to 2.70). CONCLUSION: The study showed that Doppler echocardiographic assessments after thrombolytic therapy and ventilation/perfusion scintigraphy prior to hospital discharge are valuable to establishment of new baseline characteristics, which is informative for risk stratification and prognostication of the long-term outcome for patients with acute massive pulmonary embolism.

Acute Disease↗
PubMedDate not supplied

[Head trauma in a general surgery department: observations, diagnostic and therapeutic indications].

UNLABELLED: The authors reviewed the records of 927 patients admitted to Surgical Clinic University of L'Aquila from November 1986 to July 1990 with head trauma. The 5.6% (52 patients) had skull fractures. 23 (2.4%) patients sustained significant intracranial sequelae from their injuries, but only 4 (17.3%) of these also sustained fractures, 17 did not. Of the four fractures 1 were simple, 2 was depressed and 1 was basilar. The patients (17) without a skull fracture and positive CT were transferred to a neurosurgical department, where 12 underwent operation. The patients (4) with a skull fracture and positive CT and 2 patients with a depressed skull fracture and negative CT were transferred to a neurosurgical department where 5 (except 1 patient with simple fracture) underwent operation. The severity of coma was evaluated according to Glasgow Coma Scale (G.C.S.). The 2.4% of patients had the Glasgow Coma Scale = or less than 7. The CT or MNR are indicate in the presence of neurologic abnormalities. Overall mortality rate was about 0.53%. In the severe head trauma (G.C.S. = or less than 7) was of 17,3. IN CONCLUSION: the skull radiography is not indicated of routine and are performed for the evaluation of depressed fractures, of fracture of the cranial base and of cervical vertebrae: the MNR was found to be superior to CT and to be very effective in the detection of traumatic head lesions: the Glasgow Coma Scale is important for monitoring, stratification and prognostic evaluation of patients.

Adolescent↗
PubMed2004

The role of implantable sensors for management of heart failure.

Heart failure is a chronic disease with significant morbidity and mortality worldwide. Drugs such as ACE-inhibitors, beta-blockers and diuretics have helped control heart failure but the incidence of hospitalizations remains high. Rigorous continuous monitoring of patients and tailored therapy based on individual clinical and hemodynamic profile has been shown to limit the symptoms of heart failure. Self-monitoring or prescribed frequent in-clinic monitoring is logistically difficult and is fraught with patient non-compliance. Consequently, implantable sensors that can monitor patient's clinical status on a continuous basis are desirable. The disadvantage with an implantable sensor is obviously that the patient has to undergo an invasive procedure, which in itself has a certain risk, although minimal, associated with it. In addition, the risk of having an implantable device has to be weighed against the benefit of monitoring the patient on a continuous basis. The risk benefit question has been answered in part by the recent success of cardiac resynchronization therapy (CRT) in treating symptoms of heart failure. A recent study has performed a meta analysis on major heart failure trials conducted to date and concluded that CRT reduces mortality and morbidity. The CRT device is a specialized pacemaker with capabilities of continuous heart monitoring and embedded therapeutic decisions. A trend of heart rates offers significant insights into the progression of heart failure and patient status. In addition, using complex algorithms, several of the heart rate variability (HRV) parameters, identified in several studies for risk stratification and prognostication, can also be calculated. Furthermore, in recent devices based on heart rate intervals, autonomic balance (critical measure of progression of heart failure) can be estimated with sophisticated algorithms. Finally, technologies that can monitor patients' activity e.g. accelerometers, can be easily incorporated into the device. Such measures may be used to evaluate the efficacy of a new therapy or simply to provide patient status. Based on advances in technology, several patient clinical features can be monitored and trended over time. The measured metrics will help form a comprehensive and objective clinical profile of the patient that the physician can act upon. Prospective studies are needed to answer the efficacy of such diagnostic measures in management of heart failure.

Biosensing Techniques↗
PubMed2005

Troponins: current status in coronary artery disease.

The acute coronary syndromes (ACS) represent a pathological, diagnostic and risk continuum from unstable angina (UA) through myocardial infarction (MI) with or without ST segment elevation. The past 12 years have seen extensive investigations into the use of various cardiac markers to establish the diagnosis and prognosis in ACS and to evaluate perfusion after thrombolysis. The Troponins comprise a group of three proteins (C, I and T) which interact with tropomyosin to form a troponin-tropomyosin complex. Troponin-T is a structural component of the troponin complex and is known to exist in three isoforms. Troponins have both diagnostic, post-event risk stratification and prognostic significance. Apart from myocardial infarction however they are raised in several conditions like Myocarditis, dilated Cardiomyopathy, Severe congestive cardiac failure, severe pulmonary embolism with right ventricular strain and Preterm infants with respiratory distress. False positives have been reported with Angioplasty, cardiac surgery, RF ablation, Allograft rejection following cardiac transplant and seropositive rheumatoid arthritis. False negatives have been reported with early sampling, early reading, use of wrong anticoagulant, clotted blood, careless storage of kits. Significantly, lower troponin values have been reported in heparinised plasma than in serum.

Acute Disease↗
PubMed1986

Significance of perfusion studies in the detection of transient myocardial ischemia.

In summary, myocardial thallium-201 imaging appears to be superior to exercise electrocardiography alone for detection of myocardial ischemia in patients with underlying coronary artery disease and chest pain. Risk stratification and prognostication can also be undertaken utilizing symptom limited stress scintigraphy in patients with stable chest pain syndromes or in conjunction with submaximal exercise thallium-201 scintigraphy after uncomplicated myocardial infarction. Patients with normal perfusion patterns or a single persistent defect have less likelihood of experiencing a subsequent cardiac event compared with patients with high risk scans demonstrating multiple defects in more than one vascular region or redistribution, or both. Thallium-201 imaging can be undertaken in the resting state in patients with unstable angina to detect "resting ischemia" or reversible vasospasm. Finally, the limitations of exercise or rest thallium-201 scintigraphy are discussed.

Angina Pectoris↗
PubMed1994

Design and analysis of prostate cancer trials.

This paper presents an overview of various statistical concepts related to the design and analysis of prostate cancer trials: the need for randomization, stratification for prognostic factors, sample size determination, trial objectives, the choice of a control group, patient entry criteria, the number of treatments to be compared, the choice of endpoints, analysis by the intent to treat principle, interim statistical analysis and early stopping rule, and subgroup analyses.

Clinical Trials as Topic↗
PubMed1996

[Transthoracic echocardiography in the early phase of acute myocardial infarct].

The authors present an article reviewing the fundamental importance of transthoracic echocardiography in the early phase of acute myocardial infarction (AMI). They refer to its significance in the diagnostics and differential diagnostics statements of AMI and its complications, evaluation of left ventricular systolic and diastolic function. The authors emphasize its possibilities in risk stratification and prognostic evaluation of the patients after AMI. Regarding the valuable possibilities of transthoracic echocardiography which in a decisive manner often determine the further diagnostic and therapeutic procedures, the authors postulate that this procedure should be performed in each patient with AMI already in early phase. They consider the inaccessibility of early bed-side transthoracic echocardiography as a management failure. (Fig. 2, Ref. 72.).

Diagnosis, Differential↗
PubMed2001

Waldenström macroglobulinemia. Development of diagnostic criteria and identification of prognostic factors.

To establish whether a combination of morphologic and immunophenotypic criteria could be developed to more precisely define Waldenström macroglobulinemia (WM) and prognostic factors, we retrospectively assessed the clinical and laboratory features of 111 cases of WM. Bone marrow infiltration by small lymphocytes was documented in each case; and diffuse, interstitial, nodular, and paratrabecular patterns of infiltration were documented in 58%, 32%, 6%, and 4% of cases, respectively. Ninety percent were characterized by a surface immunoglobulin-positive, CD19+CD20+CD5-CD10-CD23- immunophenotype. The median overall survival from diagnosis was 60 months; univariate analysis revealed the following adverse prognostic factors: older than 60 years, performance status more than 1, platelet count less than 100 x 10(3)/microL (< 100 x 10(9)/L), pancytopenia, and diffuse bone marrow infiltration. Associated median survival was 40, 38, 46, 28, and 59 months, respectively. Multivariate analysis revealed age, performance status, and platelet count as prognostically significant, but stratification of patients according to the International Prognostic Index had limited value. We suggest defining WM by the following criteria: IgM monoclonal gammopathy; bone marrow infiltration by small lymphocytes, plasmacytoid cells, and plasma cells in a diffuse, interstitial, or nodular pattern; and a surface immunoglobulin-positive, CD19+CD20+CD5-CD10-CD23- immunophenotype.

Adult↗
PubMed2026

Manual, digital, and AI tumour-infiltrating lymphocyte scoring: a secondary analysis of the APHINITY randomised trial.

BACKGROUND: Stromal tumour-infiltrating lymphocytes (sTILs) are prognostic in early-stage HER2-positive breast cancer, but their role in the context of dual HER2 blockade remains undefined. We evaluated manual, digital, and artificial intelligence (AI)-based sTIL quantification, together with AI-derived spatial metrics, for prognostic and treatment-benefit stratification using tumour samples from the phase 3 APHINITY trial. METHODS: In the APHINITY trial, 4805 patients were randomly assigned to receive chemotherapy plus trastuzumab with pertuzumab or chemotherapy plus trastuzumab with placebo. Median follow-up was 74&#xb7;1 months (IQR 68&#xb7;3-75&#xb7;4). We analysed 4262 haematoxylin and eosin-stained images using manual assessment, an automated digital approach, AI-based lymphocyte quantification (AI percentage lymphocytes), and two AI-derived spatial features (AI-TIL and immune hotspot). Interobserver reproducibility was assessed in 262 randomly chosen tumour samples scored independently by five pathologists. Multivariable Cox models were used to assess associations between TIL levels and invasive disease-free survival (primary outcome in APHINITY), distant recurrence-free interval, and overall survival. The heterogeneity of pertuzumab benefit was evaluated using subgroup analyses, subpopulation treatment effect pattern plot analyses, and nested Cox models with treatment-by-biomarker interaction terms. FINDINGS: Manual scoring showed high interobserver reproducibility (intraclass correlation coefficient 0&#xb7;84 [95% CI 0&#xb7;79-0&#xb7;88]). Concordance between manual and automated methods was modest. AI-based scoring (AI percentage lymphocytes) reclassified 120 (11&#xb7;6%) of 1035 node-positive tumours from immune-low (by manual scoring) to immune-high; this subgroup of patients showed greater separation of 5-year invasive disease-free survival curves between pertuzumab and placebo groups compared with patients whose tumours were concordantly classified as immune-low by both manual and AI-based approaches. Higher levels of TILs were associated with improved invasive disease-free survival for all sTIL measurement approaches and spatial measurements (hazard ratios [HRs] 0&#xb7;41-0&#xb7;93). Pertuzumab was associated with improved invasive disease-free survival at higher sTIL levels across all measurement approaches (HRs 0&#xb7;36-0&#xb7;48), but was not associated with higher values of spatial measures. The largest 6-year absolute improvements with pertuzumab were observed in patients with node-positive disease whose tumours scored in the highest level of immune infiltration of manual sTIL scoring (&#x2265;70&#xb7;0%; mean absolute improvement 12&#xb7;1 percentage points [SD 2&#xb7;8]). In nested prognostic and predictive models, AI-based immune hotspot scores provided the most consistent additional information when combined with any sTIL measurement (all p<0&#xb7;010). INTERPRETATION: Standardised manual sTIL scoring was reproducible, and digital and AI-based methods showed consistent prognostic stratification and potential for treatment-benefit stratification despite only modest correlation between platforms. AI spatial metrics provided complementary information beyond sTIL density and could support more scalable immune assessment. Future studies are needed to validate these approaches in independent cohorts and to clarify their clinical utility for stratifying contemporary HER2-directed therapies. FUNDING: None.

Humans↗
PubMed1999

Intensification of therapy using hematopoietic stem-cell support for high-risk neuroblastoma.

The use of new strategies for dose intensification using peripheral blood stem cell or autologous purged bone marrow rescue has raised expectations for cure in advanced neuroblastoma, although conflicting reports exist regarding the efficacy of these approaches. Using risk groups based on both biological and clinical staging, the Children's Cancer Group and the Pediatric Oncology Group have agreed upon common prognostic criteria for treatment stratification. We summarize below the prognostic classification and treatment approaches that have improved the overall outcome for children with advanced neuroblastoma. Intensive induction therapy, myeloablative therapy, hematopoietic stem cell purging, and post-transplant therapy for minimal residual disease all have an important role in the treatment. Possible future improvements may incorporate more tumor-specific therapy with targeted radiotherapy, monoclonal antibodies, tumor vaccines, and differentiating agents.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2006

Immunohistochemical expression of p16INK4A, Ki-67, and Mcm2 proteins in gastrointestinal stromal tumors: prognostic implications and correlations with risk stratification of NIH consensus criteria.

BACKGROUND: Inactivation of p16(INK4A) promotes G1/S progression of cell cycle. Minichromosome maintenance protein-2 (Mcm2), a novel cell proliferation marker, is known to better correlate with clinical outcomes than Ki-67 in many carcinomas. Since gastrointestinal stromal tumors (GISTs) sometimes remains challenging in prognostication, we analyzed the utility of these three markers in GISTs. METHODS: Immunohistochemistry was performed in tissue microarrays of 277 primary GISTs and correlated with NIH consensus criteria and clinical outcomes. RESULTS: The increment of NIH risk levels significantly correlated with increasing labeling indices (LI) of both Ki-67 (P <.001) and Mcm2 (P <.001) and loss of p16(INK4A) expression (P <.035). However, the latter aberration did occur in 23% of very low/low-risk GISTs. The relationship between Mcm2 and Ki-67 LIs could be modeled as linear (P <.001, r = 0.697), while Mcm2 LI was considerably higher (P <.001) with a stepwise escalation related to risk levels. Ki-67 LI >5% (P <.0001) and Mcm2 LI >10% (P <.0001) were strongly predictive of inferior disease-specific survival (DSS), while aberrant loss of p16(INK4A) only reached a trend (P = .0954). In multivariate analyses, independent adverse factors of DSS were high-risk category (RR = 16.93, P <.0001), metastatic disease (RR = 4.12, P = .0015), Ki-67 LI >5% (RR = 3.55, P = .001), and presence of epithelioid histology (RR = 2.17, P = .0308). CONCLUSIONS: Prognostic efficacy of NIH consensus criteria is substantiated. P16(INK4A) deregulation can occur early in GIST tumorigenesis and marginally correlates with patient survival. Despite Ki-67 LI being an independent prognosticator, simultaneous detection of Mcm2 is recommended as a prognostic adjunct of GISTs, given its better sensitivity and stepwise escalation with increasing risk levels.

Adult↗
PubMed2001

[Arrhythmia risk stratification in patients with heart failure: prognostic evaluation of arrhythmia risk].

Sudden cardiac death is one of the more frequent causes of death in patients with heart failure. Thus, identification of patients at risk is a major clinical problem not only for the unpredictability of the event but also for the continuous growth of patients' number. The most widely used parameter for risk stratification is ejection fraction. Unfortunately, its predictive accuracy is limited and often it is impossible to distinguish patients with an increased arrhythmic mortality from those with an increased mortality due to pump failure. Heart rate variability and baroreflex sensitivity analysis has been largely utilized to obtain information on autonomic modulation of sinus node as well as to identify patients at risk. However, at variance with results observed in post-myocardial infarction patients, lower values of both parameters have been reported in patients with either an increased total or arrhythmic mortality. More recently, T wave alternans analysis has been found effective in identifying patients with an increased arrhythmic risk. Ongoing studies will provide evidence to support the use of this non-invasive technique in patients with cardiac insufficiency. Finally, the role of programmed electrical stimulation in heart failure patients appears limited. Inducibility of monomorphic sustained ventricular tachycardia seems to correlate better with the presenting clinical arrhythmia than with patient outcome. In conclusion, our capability of identifying heart failure patients at risk for arrhythmic death is far from being satisfactory. It is possible that the combination of results of multiple non-invasive tests such as reduction in ejection fraction and positivity for T wave alternans may not only provide general prognostic information but also facilitate the appropriate identification of patients at risk who may benefit from antiarrhythmic therapy.

Arrhythmias, Cardiac↗