Testing a Cloud-Based Model for Active Surveillance of Medical Devices with Analyses of Coronary Stent Safety Using the Data Extraction and Longitudinal Trend Analysis (DELTA) System.

Objective: To demonstrate the use of the Data Extraction and Longitudinal Trend Analysis (DELTA) system in the National Evaluation System for health Technology's (NEST) medical device surveillance cloud environment by analyzing coronary stent safety using real world clinical data and comparing results to clinical trial findings. Design and Setting: Electronic health record (EHR) data from two health systems, the Social Security Death Master File, and device databases were ingested into the NEST cloud, and safety analyses of two stents were performed using DELTA. Participants and Interventions: This is an observational study of patients receiving zotarolimus drug-eluting coronary stents (ZES) or everolimus eluting coronary stents (EES) between July 1, 2015 and December 31, 2017. Results: After exclusions, 3334 patients receiving EES and 1002 receiving ZES were available for study. Analysis using inverse probability weighting showed no significant difference in one-year mortality or major adverse cardiac events (MACE) for EES compared to ZES [Mortality Odds Ratio 0.94 (95% CI 0.81-1.175); p = 0.780] [MACE Odds Ratio 1.04 (95% CI 0.92-1.16; p = 0.551]). Analysis using propensity matching showed no significant difference in EES one-year mortality (547 of 992 alive and available after censoring) compared to ZES (546 of 992) [Log-Rank statistic 0.3348 (p = 0.563)]. Conclusion: Automated cloud-based medical device safety surveillance using EHR data is feasible and was efficiently performed using DELTA. No statistically significant differences in 1-year safety outcomes between ZES and EES were identified using two statistical approaches, consistent with randomized trial findings.

Spinal Cord Injury-Functional Index/Capacity: Responsiveness to Change Over Time.

OBJECTIVE: To establish responsiveness of 3 Spinal Cord Injury-Functional Index/Capacity (SCI-FI/C) item banks in the first year after spinal cord injury (SCI). DESIGN: Longitudinal patient-reported outcomes assessment replicated through secondary analysis of an independent data set. SETTING: A total of 8 SCI Model Systems rehabilitation hospitals in the United States. PARTICIPANTS: Study 1 participants included 184 adults with recent (≤4 months) traumatic SCI and 221 community-dwelling adults (>1 year post injury) (N=405). Study 2 participants were 418 individuals with recent SCI (≤4 months) (N=418). INTERVENTIONS: In study 1, SCI-FI/C computer adaptive tests were presented in a standardized interview format either in person or by phone call at baseline and 6-month follow-up. Responsiveness was examined by comparing 6-month changes in SCI-FI scores within and across samples (recently injured vs community-dwelling) because only the recent injury sample was expected to exhibit change over time. Effect sizes were also computed. In study 2, the study 1 results were cross-validated in a second sample with recent SCI 1 year after baseline measurement. Study 2 also compared the SCI-FI/C measures' responsiveness to that of the Self-reported Functional Measure (SRFM) and stratified results by injury diagnosis and completeness. MAIN OUTCOME MEASURES: The SCI-FI Basic Mobility/C, Self-care/C and Fine Motor/C item banks (study 1 and study 2); Self-reported Functional Measure SRFM (study 2 only). RESULTS: In study 1, changes in SCI-FI/C scores between baseline and 6-month follow-up were statistically significant (P<.01) for recently injured individuals. SCI-FI Basic Mobility/C, Self-care/C, and Fine Motor/C item banks demonstrated small to medium effect sizes in the recently injured sample. In the community-dwelling sample, all SCI-FI/C effects were negligible (ie, effect size<0.08). Study 2 results were similar to study 1. As expected, SCI-FI Basic Mobility/C and Self-care/C were responsive to change for all individuals in study 2, whereas the SCI-FI Fine Motor/C was responsive only for individuals with tetraplegia and incomplete paraplegia. The SRFM demonstrated a medium effect size for responsiveness (effect size=0.65). CONCLUSIONS: The SCI-FI Basic Mobility/C and Self-care/C banks demonstrate adequate sensitivity to change at 6 months and 1 year for all individuals with SCI, while the SCI-FI/C Fine Motor item bank is sensitive to change in individuals with tetraplegia or incomplete paraplegia. All SCI-FI/C banks demonstrate stability in a sample not expected to change. Results provide support for the use of these measures for research or clinical use.

Can Proxy Ratings Supplement Patient Report to Assess Functional Domains Among Hospitalized Patients?

OBJECTIVE: To (1) characterize the agreement between patient and proxy responses on a multidimensional computerized adaptive testing measure of function, and to (2) determine whether patient, proxy, or multidimensional computerized adaptive testing score characteristics identify when a proxy report can be used as a substitute for patient report in clinical decision making. DESIGN: A psychometric study of the Functional Assessment in Acute Care Multidimensional Computerized Adaptive Testing (FAMCAT) and its 3 scales (Applied Cognition, Daily Activity, and Basic Mobility). SETTING: An upper midwestern quaternary academic medical center PARTICIPANTS: A total of 300 pairs of patients (average age 60.9 years; range, 19-89) hospitalized on general medical services or readmitted to surgical services for postoperative complications and their proxies (average age 60.5 years; range, 20-88). INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: There were 3 outcomes: (1) agreement between patient and proxy scores on the FAMCAT domains, as well as age and sex, analyzed with univariate and multivariate analysis of variance (MANOVA); (2) associations of patient-proxy relationship and FAMCAT score characteristics with patient-proxy score agreement; and (3) presence of psychometrically significant intra-dyad differences in FAMCAT scores. RESULTS: The results of the MANOVA and follow-up ANOVAs indicated that there were no statistically significant differences in FAMCAT scale scores between patient and proxy estimates for either the Daily Activity or Basic Mobility scales. There were significant differences for the Applied Cognition scale (P<.005) between mean patient and proxy scores, with proxies rating patients as functioning at a higher level (mean=0.42) than patients did themselves (mean=0.00). However, psychometrically significant intra-dyadic Applied Cognition score differences occurred in only 14% of dyads, compared with 25% in the other 2 scales. Sex and age were associated with patient-proxy agreement, but the patterns were not sufficiently consistent to permit generalizations regarding the likely validity of a proxy's scores. CONCLUSIONS: Patient and proxy FAMCAT Daily Activity and Basic Mobility scores did not differ significantly, and proxy reporting offers a creditable surrogate for patient report on these domains. Low rates of psychometrically significant intra-dyadic score differences suggest that proxy report may serve as a low-resolution screen for functional deficits in all FAMCAT domains. Approximately half the proxies provided multi-domain profile ratings on the 3 scales that did not differ significantly from these of the associated patients, but more research is needed to identify situations in which proxy profiles could be used in place of those provided by patients.

Clot-Based Radiomics Predict a Mechanical Thrombectomy Strategy for Successful Recanalization in Acute Ischemic Stroke.

BACKGROUND AND PURPOSE: Mechanical thrombectomy (MTB) is a reference treatment for acute ischemic stroke, with several endovascular strategies currently available. However, no quantitative methods are available for the selection of the best endovascular strategy or to predict the difficulty of clot removal. We aimed to investigate the predictive value of an endovascular strategy based on radiomic features extracted from the clot on preinterventional, noncontrast computed tomography to identify patients with first-attempt recanalization with thromboaspiration and to predict the overall number of passages needed with an MTB device for successful recanalization. METHODS: We performed a study including 2 cohorts of patients admitted to our hospital: a retrospective training cohort (n=109) and a prospective validation cohort (n=47). Thrombi were segmented on noncontrast computed tomography, followed by the automatic computation of 1485 thrombus-related radiomic features. After selection of the relevant features, 2 machine learning models were developed on the training cohort to predict (1) first-attempt recanalization with thromboaspiration and (2) the overall number of passages with MTB devices for successful recanalization. The performance of the models was evaluated on the prospective validation cohort. RESULTS: A small subset of radiomic features (n=9) was predictive of first-attempt recanalization with thromboaspiration (receiver operating characteristic curve-area under the curve, 0.88). The same subset also predicted the overall number of passages required for successful recanalization (explained variance, 0.70; mean squared error, 0.76; Pearson correlation coefficient, 0.73; P<0.05). CONCLUSIONS: Clot-based radiomics have the ability to predict an MTB strategy for successful recanalization in acute ischemic stroke, thus allowing a potentially better selection of the MTB strategy, as well as patients who are most likely to benefit from the intervention.

Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings From the EXTEND Study.

BACKGROUND: Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known. METHODS: We linked adults ≥65 years of age in the HiR (US CoreValve Pivotal High Risk) and SURTAVI trials (Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients) to 100% Medicare inpatient claims, January 1, 2011, to December 31, 2016. Primary (eg, death and stroke) and secondary trial end points were compared across treatment arms (eg, transcatheter aortic valve replacement [TAVR] versus surgical aortic valve replacement [SAVR]) using trial-adjudicated outcomes versus outcomes derived from claims at 1 year (HiR) or 2 years (SURTAVI). RESULTS: Among 600 linked HiR participants (linkage rate, 80.0%), the rate of the trial's primary end point of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1 year by using both trial data (hazard ratio, 0.84 [95% CI, 0.65-1.09]; P=0.33) and claims data (hazard ratio, 0.86 [95% CI, 0.66-1.11]; P=0.34; interaction P value=0.80). Noninferiority of TAVR relative to SAVR was seen by using both trial- and claims-based outcomes (Pnoninferiority<0.001 for both). Among 1005 linked SURTAVI trial participants (linkage rate, 60.5%), the trial's primary end point was 12.9% for TAVR and 13.1% for SAVR using trial data (hazard ratio, 1.08 [95% CI, 0.79-1.48]; P=0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (hazard ratio, 1.02 [95% CI, 0.73-1.41]; P=0.58; interaction P value=0.89). TAVR was noninferior to SAVR when compared using both trial and claims (Pnoninferiority<0.001 for both). Rates of procedural secondary outcomes (eg, aortic valve reintervention, pacemaker rates) were more closely concordant between trial and claims data than nonprocedural outcomes (eg, stroke, bleeding, cardiogenic shock). CONCLUSIONS: In the HiR and SURTAVI trials, ascertainment of trial primary end points using claims reproduced both the magnitude and direction of treatment effect in comparison with adjudicated event data, but nonfatal and nonprocedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes but may be less suitable for other end points.

Assessment of variation in 30-day mortality following cancer surgeries among older adults across US hospitals.

BACKGROUND: While public reporting of surgical outcomes for noncancer conditions is common, cancer surgeries have generally been excluded. This is true despite numerous studies showing outcomes to differ between hospitals based on their characteristics. Our objective was to assess whether three prerequisites for quality assessment and reporting are present for 30-day mortality after cancer surgery: low burden for timely reporting, hospital variation, and potential for public health gains. STUDY DESIGN: We used Fee-for-Service (FFS) Medicare claims to examine the extent of variation in 30-day cancer surgical mortality between 3860 US hospitals. We included 340 489 surgeries for 12 cancer types for FFS Medicare beneficiaries aged ≥66 years, 2011-2013. Hierarchical mixed-effects logistic regression models adjusted for patient and hospital characteristics and with a random hospital effect were fit to obtain hospital-specific risk-standardized mortality rates (RSMRs) and 99% confidence intervals (CI). We calculated a hospital odds ratio to describe the difference in mortality risk for a hospital above vs below average quality and estimated the potential mortality reduction. RESULTS: The median number of cancer surgeries per hospital was 34. The median RSMR overall was 2.41% (99% CI 2.28%, 2.66%). In aggregate and for most cancers, variation between hospitals exceeded that due to differences in patient and hospital characteristics. For individual cancers, relative differences exceeded 20% in mortality risk between patients undergoing surgery at a hospital below vs above average quality, with the potential for an estimated 500 deaths prevented annually given hypothetical improvements. CONCLUSION: Quality measurement and reporting of 30-day mortality for cancer surgery is worthy of consideration.

Core Domain Set Selection According to OMERACT Filter 2.1: The OMERACT Methodology.

OBJECTIVE: To describe the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 methodology for core domain set selection. METHODS: The "OMERACT Way for Core Domain Set selection" framework consists of 3 stages: first, generating candidate domains through literature reviews and qualitative work, then a process of consensus to obtain agreement from those involved, and finally formal voting on the OMERACT Onion. The OMERACT Onion describes the placement of domains in layers/circles: mandatory in all trials/mandatory in specific circumstances (inner circle); important but optional (middle circle); or research agenda (outer circle). Five OMERACT working groups presented their core domain sets for endorsement by the OMERACT community. Tools including a workbook and whiteboard video were created to assist the process. The methods workshop at OMERACT 2018 introduced participants to this framework. RESULTS: The 5 OMERACT working groups achieved consensus on their proposed core domain sets. After the Methodology Workshop training exercise at OMERACT 2018, over 90% of participants voted that they were confident that they understood the process of core domain set selection. CONCLUSION: The methods described in this paper were successfully used by the 5 working groups voting on domains at the OMERACT 2018 meeting, demonstrating the feasibility of the process. In addition, participants at OMERACT 2018 expressed increased confidence and understanding of the core domain set selection process after the training exercise. This methodology will continue to evolve, and we will use innovative technology such as whiteboard videos as a key part of our dissemination and implementation strategy for new methods.

Preliminary reliability and validity of the shoulder functional reach score.

OBJECTIVE: The purpose of this study was to determine (a) if the newly developed shoulder functional reach score (SFRS) is reliable; (b) if the SFRS demonstrates construct validity by being able to differentiate between patients' symptomatic and asymptomatic shoulders; (c) if the SFRS is able to detect changes over time; and (d) if the potential changes in the SFRS demonstrated criterion validity at three different time intervals by being associated the Numeric Pain Rating Scale (NPRS) and Shoulder Pain and Disability Index (SPADI). METHODS: Patients were consecutively screened for consultation related to complaints of shoulder pain. Thirty-eight subjects agreed to participate and signed informed consent. Twenty-nine subjects fulfilled the study after the 4 weeks of follow-up. Outcome measures were collected at the initial evaluation and at the first follow-up visit prior to the initiation of treatment. Data were then collected after 2 and 4 weeks of treatment. RESULTS: There were statistically significant differences between symptomatic and asymptomatic shoulders on the SFRS. Intratester reliability of the SFRS was intraclass correlation coefficient (ICC2,1 ) = 0.94. Intertester reliability of the SFRS was ICC2,1  = 0.92. Statistically significant differences were observed between the initial evaluation, 2 and 4 weeks for the SFRS, SPADI, and NPRS. Moderate (rs  = 0.62) to strong (rs  = 0.87) positive correlations were observed between the NPRS and SPADI. Moderate negative (rs  = -0.50-0.51) correlations were found between the SFRS and the SPADI. Moderate negative (rs  = -0.36-0.54) statistically significant (p < 0.05) correlations were found between the SFRS and the NPRS. CONCLUSION: In this small sample, the SFRS was an objective, reliable, and valid tool for assessing shoulder active range of motion in a clinical setting.

Validation of the NIH Toolbox in Individuals with Neurologic Disorders.

OBJECTIVE: Individuals with spinal cord injury (SCI), traumatic brain injury (TBI), and stroke experience a variety of neurologically related deficits across multiple domains of function. The NIH Toolbox for the Assessment of Neurological and Behavioral Function (NIHTB) examines motor, sensation, cognition, and emotional functioning. The purpose of this paper is to establish the validity of the NIHTB in individuals with neurologic conditions. METHODS: Community-dwelling individuals with SCI (n = 209), TBI (n = 184), or stroke (n = 211) completed the NIHTB. Relative risks for impaired performance were examined relative to a matched control groups. RESULTS: The largest group differences were observed on the Motor domain and for the Fluid Cognition measures. All groups were at increased risk for motor impairment relative to normative standards and matched controls. Fluid cognitive abilities varied across groups such that individuals with stroke and TBI performed more poorly than individuals with SCI; increased relative risks for impaired fluid cognition were seen for individuals in the stroke and TBI groups, but not for those in the SCI group. All three neurologic groups performed normally on most measures in the Sensation Battery, although TBI participants evidenced increased risk for impaired odor identification and the stroke group showed more vision difficulties. On the Emotion Battery, participants in all three groups showed comparably poor psychological well-being, social satisfaction, and self-efficacy, whereas the TBI group also evidenced slightly increased negative affect. CONCLUSIONS: Data provide support for the validity of the NIHTB in individuals with neurologic conditions.

Avaliação dos 12 anos da campanha de acesso público a desfibrilação / Evaluation of ten years of the Campaign for public access defibrillation

JUSTIFICATIVA: Campanhas públicas e leis que visam desenvolver métodos de esclarecimento e incentivo na busca de informações sobre o tratamento da parada cardiorrespiratória devem ser objetivo de todos e implicam em excelentes resultados em todas as esferas de leigos, gestores e profissionais de saúde. OBJETIVO: Avaliar o impacto de uma Campanha de Acesso Público a Desfibrilação na população leiga, profissionais de saúde e gestores. MÉTODO: A pesquisa quantitativa foi desenvolvida após a avaliação de 12 anos das atividades efetuadas por uma Comissão de Ressuscitação Cardiopulmonar sobre a Campanha de Acesso Público a Desfibrilação voltada para as manobras de ressuscitação cardiopulmonar. RESULTADOS: Como principais resultados diretos e indiretos nos 12 anos de análise, promoveu-se a realização de cursos de suporte básico de vida para profissionais de saúde e leigos, cursos de suporte avançado de vida em cardiologia para profissionais de saúde, treinamento em massa para a população geral, implantação da temática no currículo da Faculdade de Medicina e a primeira lei de Acesso Público a Desfibrilação da América Latina, assim como o modelo para a lei federal que se encontra em tramitação. CONCLUSÕES: É evidente que mesmo com os resultados positivos ainda há necessidade real de maior número de profissionais e leigos treinados, assim como o amplo estabelecimento dos cinco elos atuais da corrente de sobrevivência em nosso território nacional, podendo outras campanhas, espelhadas nesta, serem implantadas.

BACKGROUND: Public campaigns and laws developing methods of enlightenment and encouragement in finding information on the treatment of cardiac arrest should be the objective of all and imply excellent results in all spheres of lay people, government managers and health professionals. OBJECTIVE: To evaluate the impact of a Public Access Defibrillation Campaign implementation in the lay population, health professionals and government managers. METHODS: The quantitative study was conducted after the 12 year review of the activities undertaken by a Hospital Committee of Cardiopulmonary Resuscitation and a Campaign for Public Access Defibrillation geared toward cardiopulmonary resuscitation. RESULTS: The main direct and indirect results in the 12 years of analysis promoted courses in basic life support for health professionals and lay public, courses of advanced cardiac life support for health professionals, mass training for general population, implementation of the thematic curriculum in the School of Medicine and the first law of Public Access Defibrillation in Latin America as well as the model for the federal law that steel in progress. CONCLUSIONS: It is clear that with the direct and indirect experiences of these 12 years of Public Access Defibrillation Campaign we shown positive results. There is real need for more professionals and trained lay people as well as the extensive establishment of five current links in the chain of survival in our Nationwide.

Calidad en cirugía: hacia una mejor comprensión de las complicaciones quirúrgicas / Quality assessment in surgery

This paper deals with quality from the perspective of structure, processes and indicators in surgery. In this specialty, there is a close relationship between effectiveness and quality. We review the definition and classification of surgical complications as an objective means of assessing quality. The great diversity of definitions and risk assessments of surgical complications hampered the comparisons of different surgical centers or the evaluation of a single center along time. We discuss the different factors associated with surgical risk and some of the predictive systems for complications and mortality. At the present time, standarized definitions and comparisons are carried out correcting for risk factors. Thus, indicators of mortality, complications, hospitalization length, postoperative quality of life and costs become comparable between different groups. The volume of procedures of a determinate center or surgeon as a quality indicator is emphasized.

Multicentre prospective clinical application of the T14 paediatric outcome tool.

OBJECTIVE: This study aimed to measure changes in disease-specific quality of life in children following tonsillectomy or adenotonsillectomy. METHODS: A multicentre prospective cohort study was performed involving seven ENT departments in England. A total of 276 children entered the study over a 2-month period: 107 underwent tonsillectomy and 128 adenotonsillectomy. Forty-one children referred with throat problems initially managed by watchful waiting were also recruited. The follow-up period was 12 months. Outcome measures were the T14, parental impressions of their child's quality of life and the number of days absent from school. RESULTS: One-year follow-up data were obtained from 150 patients (52 per cent). The mean baseline T14 score in the non-surgical group was significantly lower (T14 = 23) than in the tonsillectomy group (T14 = 31) or the adenotonsillectomy group (T14 = 35; p < 0.001). There was a significant improvement in the T14 scores of responders in all groups at follow up. The effect size was 1.3 standard deviations (SD) for the non-surgical group, 2.1 SD for the tonsillectomy group and 1.9 SD for the adenotonsillectomy group. Between-group differences did not reach statistical significance. A third of children in the non-surgical group underwent surgery during the follow-up period. CONCLUSION: Children who underwent surgical intervention achieved a significant improvement in disease-specific quality of life. Less severely affected children were managed conservatively and also improved over 12 months, but 1 in 3 crossed over to surgical intervention.

Work disability functional assessment battery: feasibility and psychometric properties.

OBJECTIVE: To assess the feasibility and psychometric properties of 8 scales covering 2 domains of the newly developed Work Disability Functional Assessment Battery (WD-FAB): physical function (PF) and behavioral health (BH) function. DESIGN: Cross-sectional study. SETTING: Community. PARTICIPANTS: Adults (N=973) unable to work because of a physical (n=497) or a mental (n=476) disability. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Each disability group responded to a survey consisting of the relevant WD-FAB scales and existing measures of established validity. The WD-FAB scales were evaluated with regard to data quality (score distribution, percentage of "I don't know" responses), efficiency of administration (number of items required to achieve reliability criterion, time required to complete the scale) by computerized adaptive testing (CAT), and measurement accuracy as tested by person fit. Construct validity was assessed by examining both convergent and discriminant correlations between the WD-FAB scales and scores on same-domain and cross-domain established measures. RESULTS: Data quality was good, and CAT efficiency was high across both WD-FAB domains. Measurement accuracy was very good for PF scales; BH scales demonstrated more variability. Construct validity correlations, both convergent and divergent, between all WD-FAB scales and established measures were in the expected direction and range of magnitude. CONCLUSIONS: The data quality, CAT efficiency, person fit, and construct validity of the WD-FAB scales were well supported and suggest that the WD-FAB could be used to assess PF and BH function related to work disability. Variation in scale performance suggests the need for future work on item replenishment and refinement, particularly with regard to the Self-Efficacy scale.

Infection after intracerebral hemorrhage: risk factors and association with outcomes in the ethnic/racial variations of intracerebral hemorrhage study.

BACKGROUND AND PURPOSE: Risk factors for infections after intracerebral hemorrhage (ICH) and their association with outcomes are unknown. We hypothesized there are predictors of poststroke infection and infections drive worse outcomes. METHODS: We determined prevalence of infections in a multicenter, triethnic study of ICH. We performed univariate and multivariate analyses to determine the association of infection with admission characteristics and hospital complications. We performed logistic regression on association of infection with outcomes after controlling for known determinants of prognosis after ICH (volume, age, infratentorial location, intraventricular hemorrhage, and Glasgow Coma Scale). RESULTS: Among 800 patients, infections occurred in 245 (31%). Admission characteristics associated with infection in multivariable models were ICH volume (odds ratio [OR], 1.02/mL; 95% confidence interval [CI], 1.01-1.03), lower Glasgow Coma Scale (OR, 0.91 per point; 95% CI, 0.87-0.95), deep location (reference lobar: OR, 1.90; 95% CI, 1.28-2.88), and black race (reference white: OR, 1.53; 95% CI, 1.01-2.32). In a logistic regression of admission and hospital factors, infections were associated with intubation (OR, 3.1; 95% CI, 2.1-4.5), dysphagia (with percutaneous endoscopic gastrostomy: OR, 3.19; 95% CI, 2.03-5.05 and without percutaneous endoscopic gastrostomy: OR, 2.11; 95% CI, 1.04-4.23), pulmonary edema (OR, 3.71; 95% CI, 1.29-12.33), and deep vein thrombosis (OR, 5.6; 95% CI, 1.86-21.02), but not ICH volume or Glasgow Coma Scale. Infected patients had higher discharge mortality (16% versus 8%; P=0.001) and worse 3-month outcomes (modified Rankin Scale ≥3; 80% versus 51%; P<0.001). Infection was an independent predictor of poor 3-month outcome (OR, 2.6; 95% CI, 1.8-3.9). CONCLUSIONS: There are identifiable risk factors for infection after ICH, and infections predict poor outcomes.

Diagnoses of early and late readmissions after hospitalization for pneumonia. A systematic review.

RATIONALE: Pneumonia is a frequent cause of hospitalization, yet drivers of post-pneumonia morbidity remain poorly characterized. Causes of hospital readmissions may elucidate important sources of morbidity and are of particular interest given the U.S. Hospital Readmission Reductions Program. OBJECTIVES: To review the primary diagnoses of early (≤30 d) and late (≥31 d) readmissions after pneumonia hospitalization. METHODS: Systematic review of MEDLINE, Embase, and CINAHL databases. We identified original research studies of adults aged 18 years or older, hospitalized for pneumonia, and for whom cause-specific readmission rates were reported. Two authors abstracted study results and assessed study quality. MEASUREMENTS AND MAIN RESULTS: Of the 1,243 citations identified, 12 met eligibility criteria. Included studies were conducted in the United States, Spain, Canada, Croatia, and Sweden. All-cause 30-day readmission rates ranged from 16.8 to 20.1% across administrative studies; the weighted average for the studies using chart review was 11.6% (15.6% in United States-based studies). Pneumonia, heart failure/cardiovascular causes, and chronic obstructive pulmonary disease/pulmonary causes are the most common reasons for early readmission after pneumonia hospitalization. Although it was the single most common cause for readmission, pneumonia accounted for only 17.9 to 29.4% of all 30-day readmissions in administrative studies and a weighted average of 23.0% in chart review studies. After accounting for study population, there was no clear difference in findings between claims-based versus chart-review studies. Few studies assessed readmissions beyond 30 days, although the limited available data suggest similar primary diagnoses for early and late readmissions. No studies assessed whether reasons for readmission were similar to patients' reasons for healthcare use before hospitalization. CONCLUSIONS: Pneumonia, heart failure/cardiovascular disease, and chronic obstructive pulmonary disease/pulmonary disease are the most common readmission diagnoses after pneumonia hospitalization. Although pneumonia was the most common readmission diagnosis, it accounted for only a minority of all readmissions. Late readmission diagnoses are less thoroughly described, and further research is needed to understand how hospitalization for pneumonia fits within the broader context of patients' health trajectory.

Do the benefits of participation in a hypertension self-management trial persist after patients resume usual care?

BACKGROUND: Hypertension self-management has been shown to improve systolic blood pressure (BP) control, but longer-term economic and clinical impacts are unknown. The purpose of this article is to examine clinical and economic outcomes 18 months after completion of a hypertension self-management trial. METHODS AND RESULTS: This study is a follow-up analysis of an 18-month, 4-arm, hypertension self-management trial of 591 veterans with hypertension who were randomized to usual care or 1 of 3 interventions. Clinic-derived systolic blood pressure obtained before, during, and after the trial were estimated using linear mixed models. Inpatient admissions, outpatient expenditures, and total expenditures were estimated using generalized estimating equations. The 3 telephone-based interventions were nurse-administered health behavior promotion, provider-administered medication adjustments based on hypertension treatment guidelines, or a combination of both. Intervention calls were triggered by home BP values transmitted via telemonitoring devices. Clinical and economic outcomes were examined 12 months before, 18 months during, and 18 months after trial completion. Compared with usual care, patients randomized to the combined arm had greater improvement in proportion of BP control during and after the 18-month trial and estimated proportion of BP control improved 18 months after trial completion for patients in the behavioral and medication management arms. Among the patients with inadequate baseline BP control, estimated mean systolic BP was significantly lower in the combined arm as compared with usual care during and after the 18-month trial. Utilization and expenditure trends were similar for patients in all 4 arms. CONCLUSIONS: Behavioral and medication management can generate systolic BP improvements that are sustained 18 months after trial completion. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00237692.