Comparative Effectiveness of a Complex Care Program for High-Cost/High-Need Patients: a Retrospective Cohort Study

BackgroundHigh-cost/high-need (HCHN) adults and the healthcare systems that provide their care may benefit from a new patient-centered model of care involving a dedicated physician and nurse team who coordinate both clinical and social services for a small patient panel.ObjectiveEvaluate the impact of a Complex Care Program (CCP) on likelihood of patient survival and hospital admission in 180 days following empanelment to the CCP.DesignRetrospective cohort study using a quasi-experimental design with CCP patients propensity score matched to a concurrent control group of eligible but unempaneled patients.SettingKaiser Permanente Mid-Atlantic States (KPMAS) during 2017–2018.ParticipantsNine hundred twenty-nine CCP patients empaneled January 2017–June 2018, 929 matched control patients for the same period.InterventionsThe KPMAS CCP is a new program consisting of 8 teams each staffed by a physician and nurse who coordinate care across a continuum of specialty care, tertiary care, and community services for a panel of 200 patients with advanced clinical disease and recent hospitalizations.Main OutcomesTime to death and time to first hospital admission in the 180 days following empanelment or eligibility.ResultsCompared to matched control patients, CCP patients had prolonged time to death (hazard ratio [HR]: 0.577, 95% CI: 0.474, 0.704), and CCP decedents had longer survival (median days 69.5 vs. 53.0, p=0.03). CCP patients had similar time to hospital admission (HR: 1.081, 95% CI: 0.930, 1.258), with similar results when adjusting for competing risk of death (HR: 1.062, 95% CI: 0.914, 1.084).LimitationsNon-randomized intervention; single healthcare system; patient eligibility limited to specific conditions.ConclusionThe KPMAS CCP was associated with significantly reduced short-term mortality risk for eligible patients who volunteered to participate in this intervention.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-021-06676-x.     

The Effect of Statin Therapy on the Incidence of Infections: A Retrospective Cohort Analysis

BackgroundStatins have been postulated to prevent infection through immunomodulatory effects.ObjectivesTo compare the incidence of infections in statin users to that in nonusers within the same health care system.MethodsThis was a retrospective cohort study of patients enrolled as Tricare Prime or Plus in the San Antonio military multimarket. Statin users were patients who received a statin for at least 3 months between October 1, 2004 and September 30, 2005. Nonusers were patients who did not receive a statin within the study period (October 1, 2003-September 30, 2009). Inpatient and outpatient International Classification of Diseases, 9th Revision, Clinical Modification (iCD-9-CM) codes were used to determine the incidence of infections during the follow-up period (October 1, 2005-September 30, 2009) via multivariable regression analysis and time to infection via Cox regression analysis.ResultsOf 45,247 patients who met the study criteria, 12,981 (29%) were statin users and 32,266 were nonusers. After adjustments for age, gender, Charlson Comorbidity Score, tobacco use, alcohol abuse/dependence, health care utilization and use of specific medication classes, statin use was associated with an increased incidence of common infections (odds ratio [OR]: 1.13; 95% confidence interval [CI]: 1.06-1.19) but not influenza or fungal infections (OR: 1.06, 95% CI: 0.80-1.39; OR: 0.97; 95% CI: 0.91-1.04, respectively). Time-to-first infection was similar in statin users and nonusers in all infection categories examined.ConclusionsStatin use was associated with an increased incidence of common infections but not influenza or fungal infections. This study does not support a protective role of statins in infection prevention; however, the influence of potential confounders cannot be excluded.     

Long-Term Outcome of Cystic Lesions in the Pancreas: A Retrospective Cohort Study

Background/Aims

The management guidelines for cystic lesions of the pancreas (CLPs) are not yet well established. This study was performed to document the long-term clinical outcome of CLPs and provide guidelines for the management and surveillance of CLPs.

Methods

In this retrospective cohort study, an additional follow-up was performed in 112 patients with CLPs enrolled from 1998 to 2004 during a previous study.

Results

During follow-up for the median period of 72.3 months, the size of the CLPs increased in 18 patients (16.1%). Six of these patients experienced growth of their CLPs after 5 years of follow-up. Twenty-six patients underwent surgery during follow-up, and four malignant cysts were detected. The overall rate of malignant progression during follow-up was 3.6%. The presence of mural nodules or solid components was independently associated with the presence of malignant CLPs. Seven patients underwent surgery after 5 years of follow-up. The pathologic findings revealed malignancies in two patients. There was only one pancreas-related death during follow-up.

Conclusions

The majority of CLPs exhibit indolent behavior and are associated with a favorable prognosis. However, long-term surveillance for more than 5 years should be performed because of the potential for growth and malignant transformation in CLPs.     

Factors Associated With Age-related Hearing Impairment: A Retrospective Cohort Study

Age-related hearing impairment (ARHI) is a complex degenerative disease in the elderly. As multiple factors interact during the development of ARHI, it is important to elucidate the major influencing factors to understand and prevent ARHI. We aimed to identify risk factors associated with the development of ARHI with a retrospective cohort from 2001 to 2010. The records of the adult subjects over 40 years of age who consecutively underwent a comprehensive health checkup including pure-tone audiometry at the Health Promotion Center were reviewed. During this period, 1560 subjects who underwent pure-tone audiometry more than twice, had no other otologic diseases, and were followed-up more than 2 years were included. A pure-tone average (PTA: 0.5, 1, 2, 4 kHz) was calculated. Development of ARHI was defined as a PTA at follow-up more than 10 dB greater than the baseline PTA. Times to the first development of ARHI were investigated. Overall, 12.7% of subjects developed ARHI within the first 4 years. High blood ionized calcium (hazard ratio [HR] 0.084), albumin (HR 0.239), systolic blood pressure (HR 0.577), thyroid hormone (T3) (HR 0.593), and alpha fetoprotein levels (HR 0.883) were associated with decreased hazard for the development of ARHI. In contrast, high blood high-density lipoprotein (HR 2.105), uric acid (HR 1.684), total protein (HR 1.423), and total bilirubin levels (HR 1.220) were potential risk factors for the development of ARHI. Development of ARHI is common among the aged population, and a variety of factors may interact during this process. The results of this study can be used for counseling of adults at high-risk of developing ARHI with regard to regular audiological check-up.     

Statin Use in Patients with Cirrhosis: A Retrospective Cohort Study

Background

Statins reduce cardiovascular risk. Patients with cirrhosis have decreased hepatic clearance of statins and potentially increased risk for complications. No studies assess mortality in patients with biopsy-confirmed cirrhosis.

Aim

Compare mortality in patients with cirrhosis on statins to those not on statins.

Methods

A retrospective cohort study evaluated patients from 1988 to 2011 at Partners Healthcare Hospitals. The Partners Research Patient Data Registry identified patients with biopsy-proven cirrhosis on statins at biopsy and at least 3 months following. Controls were matched 1:2 by age, gender and Child–Pugh class. Decompensation was defined as ascites, jaundice/bilirubin >2.5 mg/dL, and/or hepatic encephalopathy or variceal hemorrhage. Primary outcome was mortality. Secondary outcome was decompensation in baseline-compensated patients. Chi-square and two-way ANOVA testing compared groups. Cox proportional hazards models for mortality controlled for age, Child–Pugh class, diabetes, coronary artery disease, non-alcoholic steatohepatitis and hepatocellular carcinoma. Kaplan–Meier curves graphed mortality.

Results

Eighty-one statin users and 162 controls were included. Median follow-up: 36 months in statin users and 30 months in controls. 70.4 % of patients were Child–Pugh A. Model for End-Stage Liver Disease (MELD), albumin, varices and beta-blocker use were not significantly different between groups. Statin users had lower mortality on multivariate analysis (HR 0.53, p = 0.01), and Child–Pugh A patients had longer survival on Kaplan–Meier analysis. Cox multivariate analysis for decompensation showed lower risk of decompensation with statins while increased decompensation with low albumin, high MELD score and beta-blocker use.

Conclusions

In patients with cirrhosis, statin therapy is not associated with increased mortality and may delay decompensation.     

Association of Comorbidities With Postoperative In-Hospital Mortality: A Retrospective Cohort Study

The purpose of this article is to evaluate the American Society of Anesthesiologists Physical Status (ASA PS) and the Charlson comorbidity index (CCI) for the prediction of postoperative mortality.The ASA PS has been suggested to be equally good as the CCI in predicting postoperative outcome. However, these scores have never been compared in a broad surgical population.We conducted a retrospective cohort study in a German tertiary care university hospital. Predictive accuracy was compared using the area under the receiver-operating characteristic curves (AUROC). In a post hoc approach, a regression model was fitted and cross-validated to estimate the association of comorbidities and intraoperative factors with mortality. This model was used to improve prediction by recalibrating the CCI for surgical patients (sCCIs) and constructing a new surgical mortality score (SMS).The data of 182,886 patients with surgical interventions were analyzed. The CCI was superior to the ASA PS in predicting postoperative mortality (AUROC_CCI 0.865 vs AUROC_ASAPS 0.833, P < 0.001). Predictive quality further improved after recalibration of the sCCI and construction of the new SMS (AUROC_SMS 0.928 vs AUROC_sCCI 0.896, P < 0.001). The SMS predicted postoperative mortality especially well in patients never admitted to an intensive care unit.The newly constructed SMS provides a good estimate of patient''s risk of death after surgery. It is capable of identifying those patients at especially high risk and may help reduce postoperative mortality.     

Pelvic Fractures in Children Results from the German Pelvic Trauma Registry: A Cohort Study

As pelvic fractures in children and adolescents are very rare, the surgical management is not well delineated nor are the postoperative complications. The aim of this study using the prospective data from German Pelvic Trauma Registry study was to evaluate the various treatment approaches compared to adults and delineated the differences in postoperative complications after pelvic injuries.Using the prospective pelvic trauma registry established by the German Society of Traumatology and the German Section of the Arbeitsgemeinschaft für Osteosynthesefragen (AO), International in 1991, patients with pelvic fractures over a 12-year time frame submitted by any 1 of the 23 member level I trauma centers were reviewed.We identified a total of 13,525 patients including pelvic fractures in 13,317 adults and 208 children aged ≤14 years and compared these 2 groups. The 2 groups’ Injury Severitiy Score (ISS) did not differ statistically. Lethality in the pediatric group was 6.3%, not statistically different from the adults’ 4.6%. In all, 18.3% of the pediatric pelvic fractures were treated surgically as compared to 22.7% in the adult group. No child suffered any thrombosis/embolism, acute respiratory distress syndrome (ARDS), multiorgan failure (MOF), or neurologic deficit, nor was any septic MOF detected. The differences between adults and children were statistically significant in that the children suffered less frequently from thrombosis/embolism (P = 0.041) and ARDS and MOF (P = 0.006).This prospective multicenter study addressing patients with pelvic fractures reveals that the risk for a thrombosis/embolism, ARDS, and MOF is significant lower in pediatric patients than in adults. No statistical differences could be found in the ratios of operative therapy of the pelvic fractures in children compared to adults.     

The Risk of Cancer in Patients With Obsessive-Compulsive Disorder: A Nationwide Population-Based Retrospective Cohort Study

Previous studies suggest a link between anxiety disorders and cancer. The aim of the study was to evaluate the risk of cancer among patients with obsessive-compulsive disorder (OCD) using a nationwide population-based dataset.We recruited newly diagnosed OCD patients without antecedent cancer from the Taiwan National Health Insurance Research Database between 2002 and 2011. The standardized incidence ratios (SIRs) were estimated for 22 specific cancer types among OCD patients and we determined the SIRs for subgroups according to age and sex group. In addition, because of a potential detection bias, a subgroup analysis stratified with the duration of the OCD diagnosis was carried out.Among the 52,656 OCD patients, who were followed up for 259,945 person-years (median follow-up = 4.9 years), there were 718 cases of cancer. Patients with OCD did not exhibit an increased overall cancer risk relative to the general population (SIR 1.05, 95% confidence interval [CI] 0.98–1.13). An increased SIR was observed among OCD patients only within the first year of OCD diagnosis (SIR 1.21, 95% CI 1.01–1.43).This study indicated that the overall cancer risk was not elevated among OCD patients. An increased SIR observed among OCD patients within the first year of OCD diagnosis may be caused by a surveillance bias, and because paraneoplastic manifestations presented with obsessive-compulsive behaviors. Prospective study is necessary to confirm these findings.     

Pleural Empyema and Aortic Aneurysm: A Retrospective National Population-Based Cohort Study

Pleural empyema (PE) may evolve into necrosis, fistula in the thorax, and sepsis; thus, it is also associated with high mortality.We investigated and analyzed the risk of aortic aneurysm (AA) in a cohort study of patients with PE.A total of 34,250 patients diagnosed with PE were identified as the PE cohort, and 137,000 patients without PE were selected randomly as the control group and matched by sex, age, and index year of PE diagnosis. Patients ages 20 years and younger with a history of AA were excluded. The risk of AA was analyzed using a Cox proportional hazards regression model.Excess risk of AA development was 1.69-fold higher in PE patients (adjusted hazard ratio [aHR] = 1.69; 95% confidence interval [CI] = 1.39–2.05) compared with non-PE patients. The patients with PE exhibited a greater adjusted risk of AA (aHR = 2.01; CI = 1.44–2.81) even if they did not have any of the 9 comorbidities included in our analysis (diabetes, hypertension, hyperlipidemia, chronic obstructive pulmonary disease, heart failure, cardiac artery disease, stroke, bacterial endocarditis, and rheumatic endocarditis). Compared with the patients without any of the 9 comorbidities or PE, the patients with only PE had a greater risk of developing AA (aHR = 2.00; CI = 1.43–2.79). The PE cohort had a significantly higher cumulative incidence of AA than the non-PE cohort did during 12 years of follow-up.In a large-scale cohort, patients with PE are linked with an increased risk of AA.     

Spectrum of Steroid-Resistant and Congenital Nephrotic Syndrome in Children: The PodoNet Registry Cohort

Background and objectives

Steroid-resistant nephrotic syndrome is a rare kidney disease involving either immune-mediated or genetic alterations of podocyte structure and function. The rare nature, heterogeneity, and slow evolution of the disorder are major obstacles to systematic genotype-phenotype, intervention, and outcome studies, hampering the development of evidence-based diagnostic and therapeutic concepts. To overcome these limitations, the PodoNet Consortium has created an international registry for congenital nephrotic syndrome and childhood-onset steroid-resistant nephrotic syndrome.

Design, setting, participants, & measurements

Since August of 2009, clinical, biochemical, genetic, and histopathologic information was collected both retrospectively and prospectively from 1655 patients with childhood-onset steroid-resistant nephrotic syndrome, congenital nephrotic syndrome, or persistent subnephrotic proteinuria of likely genetic origin at 67 centers in 21 countries through an online portal.

Results

Steroid-resistant nephrotic syndrome manifested in the first 5 years of life in 64% of the patients. Congenital nephrotic syndrome accounted for 6% of all patients. Extrarenal abnormalities were reported in 17% of patients. The most common histopathologic diagnoses were FSGS (56%), minimal change nephropathy (21%), and mesangioproliferative GN (12%). Mutation screening was performed in 1174 patients, and a genetic disease cause was identified in 23.6% of the screened patients. Among 14 genes with reported mutations, abnormalities in NPHS2 (n=138), WT1 (n=48), and NPHS1 (n=41) were most commonly identified. The proportion of patients with a genetic disease cause decreased with increasing manifestation age: from 66% in congenital nephrotic syndrome to 15%–16% in schoolchildren and adolescents. Among various intensified immunosuppressive therapy protocols, calcineurin inhibitors and rituximab yielded consistently high response rates, with 40%–45% of patients achieving complete remission. Confirmation of a genetic diagnosis but not the histopathologic disease type was strongly predictive of intensified immunosuppressive therapy responsiveness. Post-transplant disease recurrence was noted in 25.8% of patients without compared with 4.5% (n=4) of patients with a genetic diagnosis.

Conclusions

The PodoNet cohort may serve as a source of reference for future clinical and genetic research in this rare but significant kidney disease.     

Cerebrovascular Events Post-Transcatheter Aortic Valve Replacement in a Large Cohort of Patients: A FRANCE-2 Registry Substudy

ObjectivesThe aim of this study was to analyze the incidence, impact, and predictors of cerebrovascular events (CVEs) in patients undergoing transcatheter aortic valve replacement (TAVR).BackgroundSeveral issues remain unresolved post-TAVR, including CVEs.MethodsThe FRANCE-2 (French Aortic Nation CoreValve and Edwards-2) registry prospectively included all patients who underwent TAVR in France and Monaco from January 2010 to October 2011. A total of 3,191 patients were analyzed. Six-month follow-up data were obtained. Events were adjudicated according to Valve Academic Research Consortium (VARC)-1 definition.ResultsOf the cohort, 3.98% experienced a CVE: 55% were major strokes, 14.5% minor strokes, and 30.5% transient ischemic attacks. The mean delay for CVE occurrence was 2 days (interquartile range: 0 to 7 days) with 48.5% of CVEs occurring within 2 days. There was no statistically significant difference in CVE rate with regard to the type of valve (p = 0.899) and the access route (p = 0.128). Patients with a CVE more frequently had new-onset paroxysmal atrial fibrillation (13.6% vs. 7.6%; p = 0.015). During follow-up, the unadjusted mortality rate was higher in patients with a CVE (26% vs. 16.5%; p = 0.002). By multivariate analysis, only advanced age (odds ratio: 1.05; 95% confidence interval: 1.02 to 1.08; p = 0.02) and having 2 valves implanted (odds ratio: 3.13; 95 confidence interval: 1.40 to 7.05; p = 0.006) were associated with a significant risk of CVEs.ConclusionsCVEs occur frequently after TAVR and are associated with an increased mortality rate. No difference exists in the CVE rate when exploring the type of valve or the access route. Advanced age and multiple valves implanted during the same procedure are predictors of CVE.