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THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO CANCER OF THE PROSTATE RISK ASSESSMENT SCORE: A STRAIGHTFORWARD AND RELIABLE PREOPERATIVE PREDICTOR OF DISEASE RECURRENCE AFTER RADICAL PROSTATECTOMY

Matthew Cooperberg et al.May 3, 2005

Oncology

Paleontology

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Trends in Management and Outcomes of Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock

Anvar Babaev et al.Jul 26, 2005

ContextEarly mechanical revascularization in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock is a therapeutic strategy that reduces mortality. It has been a class I recommendation in guidelines from the American College of Cardiology and the American Heart Association since 1999 for patients younger than 75 years. However, little is known about implementation of these guidelines in practice.ObjectivesTo assess trends in early revascularization and mortality for patients with cardiogenic shock complicating AMI and to determine whether the national guidelines affect revascularization rates.Design, Setting, and PatientsProspective, observational study of 293 633 patients with ST-elevation myocardial infarction (25 311 [8.6%] had cardiogenic shock; 7356 [29%] had cardiogenic shock at hospital presentation) enrolled in the National Registry of Myocardial Infarction (NRMI) from January 1995 to May 2004 at 775 US hospitals with revascularization capability (defined as the capability to perform cardiac catheterization, percutaneous coronary intervention [PCI], and open-heart surgery).Main Outcome MeasuresManagement patterns and in-hospital mortality rates.ResultsThere was an increase in primary PCI rates from 27.4% to 54.4% (P<.001) in hospitals with revascularization capability that paralleled the change in PCI for ST-elevation myocardial infarction. There was no significant change in rates of immediate coronary artery bypass graft surgery (from 2.1% to 3.2%). Propensity-adjusted multivariable analyses demonstrated that primary PCI was associated with a decreased odds of death during hospitalization (odds ratio, 0.46; 95% confidence interval, 0.40-0.53). There were no differences in the rates of change in revascularization rates based on the date when the guidelines were released regardless of patient age. Overall in-hospital cardiogenic shock mortality decreased from 60.3% in 1995 to 47.9% in 2004 (P<.001).ConclusionsThe use of PCI for patients with cardiogenic shock was associated with improved survival in a large group of hospitals with revascularization capability. The American College of Cardiology and American Heart Association guidelines had no detectable temporal impact on revascularization rates. These findings support the need for increased adherence to these guidelines.

Internal Medicine

Emergency Medicine

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Educational video game for juvenile diabetes: results of a controlled trial

Stephanie Brown et al.Jan 1, 1997

AbstractPacky & Marlon®, an interactive video game designed to improve self-care among children and adolescents with diabetes, was evaluated in a six-month randomized controlled trial. In the game, players take the role of animated characters who manage their diabetes by monitoring blood glucose, taking insulin injections, and choosing foods, while setting out to save a diabetes summer camp from marauding rats and mice who have stolen the diabetes supplies. Study participants were patients aged 8 to 16 from two separate diabetes clinics. Each participant received a Super Nintendo® video game system at an initial clinic visit and was randomly assigned to receive either Packy Sf Marlon (treatment group, N = 31) or an entertainment video game containing no diabetes-related content (control group, N = 28). Participants were interviewed and a parent filled out a questionnaire at baseline, three months, and six months. The findings in this study indicate that well-designed, educational video games can be effective interventions. There was improvement in the treatment group relative to the control group in terms of diabetes-related self-efficacy (p = 007), communication with parents about diabetes (p = 0025), and self-care behaviours (p = 0003), and a decrease in unscheduled urgent doctor visits (p = 0–08). There were no significant differences between the groups in knowledge about diabetes or in glycated haemoglobin (HbAlc) levels. Since participants in the study were in general well-controlled patients who were receiving excellent medical care, future research is contemplated involving youngsters who are not under good glycaemic control.Key Words: DiabetesBehaviourSelf-careSelf-efficacyPatient educationVideo gameSoftwareDisease managementChild healthPaediatrics

Genetics

Endocrinology

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Predicting Survival in Patients With Pulmonary Arterial Hypertension

Raymond Benza et al.Feb 14, 2019

BackgroundPulmonary arterial hypertension is a progressive, fatal disease. Published treatment guidelines recommend treatment escalation on the basis of regular patient assessment with the goal of achieving or maintaining low-risk status. Various strategies are available to determine risk status. This analysis describes an update of the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) risk calculator (REVEAL 2.0) and compares it with recently published European Society of Cardiology/Respiratory Society guideline-derived risk assessment strategies.MethodsA subpopulation from the US-based registry REVEAL that survived ≥ 1 year postenrollment (baseline for this cohort) was analyzed. For REVEAL 2.0, point values and cutpoints were reassessed, and new variables were evaluated. The Kaplan-Meier method was used to estimate survival at 12 months postbaseline; discrimination was quantified using the c-statistic. Mortality estimates and discrimination were compared between REVEAL 2.0 and Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) and French Pulmonary Hypertension Registry (FPHR) risk assessment strategies. For this comparison, a three-category REVEAL 2.0 score was computed in which patients were classified as low-, intermediate-, or high-risk.ResultsREVEAL 2.0 demonstrated similar discrimination as the original calculator in this subpopulation (c-statistic = 0.76 vs 0.74), provided excellent separation of risk among the risk categories, and predicted clinical worsening as well as mortality in patients who were followed ≥ 1 year. The REVEAL 2.0 three-category score had greater discrimination (c-statistic = 0.73) than COMPERA (c-statistic = 0.62) or FPHR (c-statistic = 0.64). Compared with REVEAL 2.0, COMPERA and FPHR both underestimated and overestimated risk.ConclusionsREVEAL 2.0 demonstrates greater risk discrimination than the COMPERA and FPHR risk assessment strategies in patients enrolled in REVEAL. After external validation, the REVEAL 2.0 calculator can assist clinicians and patients in making informed treatment decisions on the basis of individual risk profiles.Trial RegistryClinicalTrials.gov; No. NCT00370214; URL: www.clinicaltrials.gov. Pulmonary arterial hypertension is a progressive, fatal disease. Published treatment guidelines recommend treatment escalation on the basis of regular patient assessment with the goal of achieving or maintaining low-risk status. Various strategies are available to determine risk status. This analysis describes an update of the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) risk calculator (REVEAL 2.0) and compares it with recently published European Society of Cardiology/Respiratory Society guideline-derived risk assessment strategies. A subpopulation from the US-based registry REVEAL that survived ≥ 1 year postenrollment (baseline for this cohort) was analyzed. For REVEAL 2.0, point values and cutpoints were reassessed, and new variables were evaluated. The Kaplan-Meier method was used to estimate survival at 12 months postbaseline; discrimination was quantified using the c-statistic. Mortality estimates and discrimination were compared between REVEAL 2.0 and Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) and French Pulmonary Hypertension Registry (FPHR) risk assessment strategies. For this comparison, a three-category REVEAL 2.0 score was computed in which patients were classified as low-, intermediate-, or high-risk. REVEAL 2.0 demonstrated similar discrimination as the original calculator in this subpopulation (c-statistic = 0.76 vs 0.74), provided excellent separation of risk among the risk categories, and predicted clinical worsening as well as mortality in patients who were followed ≥ 1 year. The REVEAL 2.0 three-category score had greater discrimination (c-statistic = 0.73) than COMPERA (c-statistic = 0.62) or FPHR (c-statistic = 0.64). Compared with REVEAL 2.0, COMPERA and FPHR both underestimated and overestimated risk. REVEAL 2.0 demonstrates greater risk discrimination than the COMPERA and FPHR risk assessment strategies in patients enrolled in REVEAL. After external validation, the REVEAL 2.0 calculator can assist clinicians and patients in making informed treatment decisions on the basis of individual risk profiles.

Internal Medicine

Emergency Medicine

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Risk Factors For Rate of Decline in Forced Expiratory Volume in One Second in Children and Adolescents with Cystic Fibrosis

Michael Konstan et al.Jun 26, 2007

Objectives To characterize the rate of decline of forced expiratory volume in 1 second (FEV1) in children and adolescents with cystic fibrosis and to identify and compare risk factors associated with FEV1 decline. Study design The rate of decline in FEV1% predicted over 3 to 6 years in 3 different age groups was determined. Risk factors for decline were identified and compared among and within age groups as a function of disease severity with repeated-measures, mixed-model regression. Results Mean (±SD) baseline FEV1% predicted was 88.4% ± 20.5% for 6- to 8-year-olds (n = 1811), 85.3% ± 20.8% for 9- to 12-year-olds (n = 1696), and 78.4% ± 22.0% for 13- to 17-year-olds (n = 1359). Decline in FEV1% predicted/year was −1.12, −2.39, and −2.34, respectively. High baseline FEV1 and persistent crackles were significant independent risk factors for decline across all age groups. Female sex, Pseudomonas aeruginosa infection, low weight-for-age, sputum, wheezing, sinusitis, pulmonary exacerbations treated with intravenous antibiotics, elevated liver test results, and pancreatic insufficiency were also identified as independent risk factors in some age groups. Conclusions This study identifies risk factors for FEV1 decline in children and adolescents with cystic fibrosis. Clinicians should not be reassured by high lung function, particularly in young children, because this factor, among others, is independently associated with steeper decline in FEV1. To characterize the rate of decline of forced expiratory volume in 1 second (FEV1) in children and adolescents with cystic fibrosis and to identify and compare risk factors associated with FEV1 decline. The rate of decline in FEV1% predicted over 3 to 6 years in 3 different age groups was determined. Risk factors for decline were identified and compared among and within age groups as a function of disease severity with repeated-measures, mixed-model regression. Mean (±SD) baseline FEV1% predicted was 88.4% ± 20.5% for 6- to 8-year-olds (n = 1811), 85.3% ± 20.8% for 9- to 12-year-olds (n = 1696), and 78.4% ± 22.0% for 13- to 17-year-olds (n = 1359). Decline in FEV1% predicted/year was −1.12, −2.39, and −2.34, respectively. High baseline FEV1 and persistent crackles were significant independent risk factors for decline across all age groups. Female sex, Pseudomonas aeruginosa infection, low weight-for-age, sputum, wheezing, sinusitis, pulmonary exacerbations treated with intravenous antibiotics, elevated liver test results, and pancreatic insufficiency were also identified as independent risk factors in some age groups. This study identifies risk factors for FEV1 decline in children and adolescents with cystic fibrosis. Clinicians should not be reassured by high lung function, particularly in young children, because this factor, among others, is independently associated with steeper decline in FEV1.

Internal Medicine

Pulmonary And Respiratory Medicine

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Endometriosis fertility index: the new, validated endometriosis staging system

G. Adamson et al.Nov 20, 2009

ObjectiveTo develop a clinical tool that predicts pregnancy rates (PRs) in patients with surgically documented endometriosis who attempt non-IVF conception.DesignProspective data collection on 579 patients and comprehensive statistical analysis to derive a new staging system—the endometriosis fertility index (EFI)—from data rather than a priori assumptions, followed by testing the EFI prospectively on 222 additional patients for correlation of predicted and actual outcomes.SettingPrivate reproductive endocrinology practice.Patient(s)A total of 801 consecutively diagnosed and treated infertile patients with endometriosis.Intervention(s)Surgical diagnosis and treatment followed by non-IVF fertility management.Main Outcome Measure(s)The EFI and life table PRs.Result(s)A statistically significant variable used to create the EFI was the least function score (i.e., the sum of those scores determined intraoperatively after surgical intervention that describe the function of the tube, fimbria, and ovary on both sides). Sensitivity analysis showed that the EFI varies little, even with variation in the assignment of functional scores, and predicted PRs.Conclusion(s)The EFI is a simple, robust, and validated clinical tool that predicts PRs after endometriosis surgical staging. Its use provides reassurance to those patients with good prognoses and avoids wasted time and treatment for those with poor prognoses. To develop a clinical tool that predicts pregnancy rates (PRs) in patients with surgically documented endometriosis who attempt non-IVF conception. Prospective data collection on 579 patients and comprehensive statistical analysis to derive a new staging system—the endometriosis fertility index (EFI)—from data rather than a priori assumptions, followed by testing the EFI prospectively on 222 additional patients for correlation of predicted and actual outcomes. Private reproductive endocrinology practice. A total of 801 consecutively diagnosed and treated infertile patients with endometriosis. Surgical diagnosis and treatment followed by non-IVF fertility management. The EFI and life table PRs. A statistically significant variable used to create the EFI was the least function score (i.e., the sum of those scores determined intraoperatively after surgical intervention that describe the function of the tube, fimbria, and ovary on both sides). Sensitivity analysis showed that the EFI varies little, even with variation in the assignment of functional scores, and predicted PRs. The EFI is a simple, robust, and validated clinical tool that predicts PRs after endometriosis surgical staging. Its use provides reassurance to those patients with good prognoses and avoids wasted time and treatment for those with poor prognoses.

Genetics

Reproductive Medicine

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Alternative Methods for Defining Osteoarthritis and the Impact on Estimating Prevalence in a US Population‐Based Survey

Miriam Cisternas et al.Aug 28, 2015

Objective Provide a contemporary estimate of osteoarthritis (OA) by comparing the accuracy and prevalence of alternative definitions of OA. Methods The Medical Expenditure Panel Survey (MEPS) household component (HC) records respondent‐reported medical conditions as open‐ended responses; professional coders translate these responses into International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) codes for the medical conditions files. Using these codes and other data from the MEPS‐HC medical conditions files, we constructed 3 case definitions of OA and assessed them against medical provider diagnoses of ICD‐9‐CM 715 (osteoarthrosis and allied disorders) in a MEPS subsample. The 3 definitions were 1) strict = ICD‐9‐CM 715; 2) expanded = ICD‐9‐CM 715, 716 (other and unspecified arthropathies) OR 719 (other and unspecified disorders of joint); and 3) probable = strict OR expanded + respondent‐reported prior diagnosis of OA or other arthritis excluding rheumatoid arthritis. Results Sensitivity and specificity of the 3 definitions, respectively, were 34.6% and 97.5% for strict, 73.8% and 90.5% for expanded, and 62.9% and 93.5% for probable. Conclusion The strict definition for OA (ICD‐9‐CM 715) excludes many individuals with OA. The probable definition of OA has the optimal combination of sensitivity and specificity relative to the 2 other MEPS‐based definitions and yields a national annual estimate of 30.8 million adults with OA (13.4% of US adult population) for 2008–2011.

Pharmacology

Law

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Assessment of safety and efficacy of long-term treatment with combination lumacaftor and ivacaftor therapy in patients with cystic fibrosis homozygous for the F508del-CFTR mutation (PROGRESS): a phase 3, extension study

Michael Konstan et al.Dec 21, 2016

Internal Medicine

Pulmonary And Respiratory Medicine

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Sustained Benefit from Ivacaftor Demonstrated by Combining Clinical Trial and Cystic Fibrosis Patient Registry Data

Gregory Sawicki et al.Jul 1, 2015

In clinical trials, patients with cystic fibrosis and a G551D mutation who received ivacaftor experienced improvements in pulmonary and nutritional outcomes. However, whether these improvements reflect a change in disease trajectory cannot be determined without longer-term analyses with an appropriate comparator population.To examine, over a 3-year period, whether ivacaftor therapy affects pulmonary function and nutritional measures in patients with CF with a G551D mutation compared with patients with CF who are homozygous for the F508del mutation.A propensity score was used to match patients with CF greater than or equal to 6 years of age who have a G551D mutation and received ivacaftor in clinical trials for up to 144 weeks with data from patients in the U.S. Cystic Fibrosis Foundation Patient Registry who are homozygous for the F508del mutation. Matching was based on variables including age, sex, weight for age, height for age, body mass index for age, % predicted FEV1, and chronic therapies (dornase alfa, inhaled antibiotics, inhaled and oral corticosteroids).By calculating the annual estimated rate of decline in lung function for G551D patients receiving ivacaftor and comparing it with the rate of decline in lung function for matched F508del control patients, we show that the rate of lung function decline in G551D ivacaftor-treated patients was slower by nearly half. Moreover, treatment with ivacaftor is shown to improve body mass index and weight-for-age z scores for G551D patients over the 3-year analysis period.These findings suggest that ivacaftor is a disease-modifying therapy for the treatment of cystic fibrosis.

Internal Medicine

Pulmonary And Respiratory Medicine

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Paper

Internal Medicine

220

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