Effects Of Baseline Characteristics Research Articles

Radiosurgery With Prior Embolization Versus Radiosurgery Alone for Intracranial Arteriovenous Malformations: A Systematic Review and Meta-Analysis.

The addition of adjuvant embolization to radiosurgery has been proposed as a means of improving treatment outcomes of intracranial arteriovenous malformations (AVMs). However, the relative efficacy and safety of radiosurgery with adjuvant embolization vs radiosurgery alone remain uncertain. Moreover, previous systematic reviews and meta-analyses have included a limited number of studies and did not consider the effects of baseline characteristics, including AVM volume, on the outcomes. This systematic review aimed to evaluate the efficacy of preradiosurgery embolization for intracranial AVMs with consideration to matching status between participants in each treatment group. A systematic review and meta-analysis were conducted by searching electronic databases, including PubMed, Scopus, and Cochrane Library, up to January 2023. All studies evaluating the utilization of preradiosurgery embolization were included. A total of 70 studies (9 matched and 71 unmatched) with a total of 12 088 patients were included. The mean age of the included patients was 32.41 years, and 48.91% of the patients were female. Preradiosurgery embolization was used for larger AVMs and patients with previous hemorrhage ( P < .01, P = .02, respectively). The obliteration rate for preradiosurgery embolization (49.44%) was lower compared with radiosurgery alone (61.42%, odds ratio = 0.56, P < .01), regardless of the matching status of the analyzed studies. Although prior embolization was associated higher rate of cyst formation ( P = .04), it lowered the odds of radiation-induced changes ( P = .04). The risks of minor and major neurological deficits, postradiosurgery hemorrhage, and mortality were comparable between groups. This study provides evidence that although preradiosurgery embolization is a suitable option to reduce the AVM size for future radiosurgical interventions, it may not be useful for same-sized AVMs eligible for radiosurgery. Utilization of preradiosurgery embolization in suitable lesions for radiosurgery may result in the added cost and burden of an endovascular procedure.

The Repetitive Behavior Scale-Revised: Independent Validation in Children with Autism Spectrum Disorders and a Control Group in Albania

A key feature of autism is restricted repetitive behavior (RRB). Despite the significance of RRBs, little is known about their phenomenology, assessment, and treatment. The objective of this study is the vvalidation of the Albanian version of the RBS-R in an independent sample of ASD children. In order to validate the RBS-R in an independent sample, a survey was conducted in Albania at National Center of Childrens’ Rehabilitation including 30 children with autism spectrum disorders (ASD) and a control group of 30 children without ASD. Factor analyses produced a five-factor solution that was both clinically meaningful and statistically sound, namely: Ritualistic/Sameness Behavior, Stereotypic Behavior, Self-Injurious Behavior, Compulsive Behavior and Restricted Interests. Measures of internal consistency were good for this five-subscale solution. The effects of baseline characteristics (age and gender) were examined. Cronbach’s alpha was used to measure internal consistency. The alpha values for the five subscales, ranged from 0.72 (Stereotypic) to 0.85 (Ritualistic/ Sameness Behavior). All values are within or above the acceptable range for research purposes. The Albanian version of RBS-R appears to have sound psychometric characteristics and can be used to differentiate various types of repetitive behaviors.

26. Risk of Post–COVID-19 Dyspnea and Interstitial Lung Disease (ILD) in a Real-World Cohort of Patients Hospitalized with COVID-19 in the United States

BackgroundWhile COVID-19 carries substantial morbidity and mortality, the extent of long-term complications remains unclear. Reports suggest that acute lung damage associated with severe COVID-19 can result in chronic respiratory dysfunction. This study: (1) estimated the incidence of dyspnea and ILD after COVID-19 hospitalization, and (2) assessed risk factors for developing dyspnea and ILD in a real-world cohort of patients hospitalized with COVID-19 using US electronic health records (EHR).MethodsPatients in the Optum de-identified COVID-19 EHR database who were hospitalized for COVID-19 (lab confirmed or diagnosis code) between February 20 and July 2020 and had at least 6 months of follow-up were eligible for analysis. Dyspnea and ILD were identified using diagnosis codes. The effects of baseline characteristics and hospitalization factors on the risk of incident dyspnea or ILD 3 to 6 months’ post discharge were evaluated. ResultsAmong eligible patients (n=26,339), 1705 (6.5%) had dyspnea and 220 (0.8%) had ILD 3 to 6 months after discharge. Among patients without prior dyspnea or ILD (n=22,613), 110 (0.5%) had incident ILD (Table 1) and 1036 (4.6%) had incident dyspnea (Table 2) 3 to 6 months after discharge. In multivariate analyses, median (IQR) length of stay (LOS; 5.0 [3.0, 9.0] days in patients who did not develop ILD vs 14.5 [6.0, 26.0] days in patients who developed ILD; RR: 1.12, 95% CI: 1.08, 1.15; P=4.34 x 10-10) and age (RR: 1.02, 95% CI: 1.01, 1.03; P=4.63 x 10-3) were significantly associated with ILD. Median (IQR) LOS (5.0 [3.0, 9.0] days in patients who did not develop dyspnea vs 7 [4.0, 14.0] days in patients who developed dyspnea; RR: 1.04, 95% CI: 1.02, 1.06; P=8.52 x 10-4), number of high-risk comorbidities (RR: 1.18, 95% CI: 1.12, 1.24; P=3.85 x 10-9), and obesity (RR: 1.52, 95% CI: 1.25, 1.86; P=2.59 x 10-4) were significantly associated with dyspnea.Table 1. Selected Baseline Risk Factors for Incident ILD Table 2. Selected Baseline Risk Factors for Incident Dyspnea ConclusionIn a real-world cohort, 4.6% and 0.5% of patients developed dyspnea and ILD, respectively, after COVID-19 hospitalization. Multivariate analyses suggested that LOS, age, obesity, and comorbidity burden may be risk factors for post-COVID-19 respiratory complications. Limitations included sensitivity of diagnosis codes, availability of labs, and care-seeking bias.Disclosures Kelly Zalocusky, PhD, F. Hoffmann-La Roche Ltd (Shareholder)Genentech, Inc. (Employee) Devika Chawla, PhD MSPH, F. Hoffmann-La Roche Ltd. (Shareholder)Genentech, Inc. (Employee) Margaret Neighbors, PhD, F. Hoffmann-La Roche Ltd (Shareholder)Genentech, Inc. (Employee) Shemra Rizzo, PhD, F. Hoffmann-La Roche Ltd. (Shareholder)Genentech, Inc. (Employee) Larry Tsai, MD, F. Hoffmann-La Roche Ltd (Shareholder)Genentech, Inc. (Employee)

68 Ga-DOTATATE Positron Emission Tomography-Computed Tomography Quantification Predicts Response to Somatostatin Analog Therapy in Gastroenteropancreatic Neuroendocrine Tumors.

Somatostatin analogs (SSAs) are the frontline antitumor therapy in advanced well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs). A subset of patients demonstrate early disease progression on SSA therapy, yet the currently known predictors for treatment failure lack specificity to affect therapeutic decision. SSAs target tumor somatostatin receptors, the level of which can be quantitatively assessed with 68 Ga-DOTATATE positron emission tomography-computed tomography (PET/CT). We investigated the ability of 68 Ga-DOTATATE PET/CT to predict response to SSA therapy. The records of 108 consecutive patients with well-differentiated grade 1-2 GEP-NETs on SSA monotherapy who received 68 Ga-DOTATATE PET/CT scans were retrospectively reviewed to obtain baseline characteristics, 68 Ga-DOTATATE maximum standardized uptake value (SUVmax), and progression-free survival (PFS) data. The optimal SUVmax cutoff for patient stratification was obtained with receiver operating characteristic curve analysis. PFS in the high versus low SUVmax groups was compared with Kaplan-Meier survival analysis. The effects of baseline characteristics and SUVmax on PFS were examined with univariate and multivariate Cox regression. 68 Ga-DOTATATE SUVmax predicted therapeutic failure with sensitivity and specificity of 39% and 98%, respectively. SUVmax of <18.35 was associated with shorter PFS, which was reproduced in the subgroup analysis of SSA-naïve patients. Low SUVmax was the only predictor of early treatment failure (hazard ratio, 6.85) in multivariate analysis, as well as in the subgroup analysis of grade 2 GEP-NETs. Low SUVmax on 68 Ga-DOTATATE PET/CT independently predicts early failure on SSA monotherapy in patients with well-differentiated grade 1-2 GEP-NET. Patients with lack of expected benefit from SSA therapy can be readily identified using routine 68 Ga-DOTATATE PET/CT with very high specificity. Based on 68 Ga-DOTATATE positron emission tomography-computed tomography imaging, clinicians can better inform patients on the expected benefit of somatostatin analog therapy for gastroenteropancreatic neuroendocrine tumors, especially when access to the therapy is difficult, and offer proactive discussion on alternative management options.

Characteristics and predicted outcome of patients lost to follow-up after degenerative lumbar spine surgery

PurposeThe relatively large number of participants lost to follow-up (attrition) in spinal registers calls for studies that investigate the features of these individuals and their possible outcome. The aim was to explore the effect of attrition on patient-reported outcome in patients undergoing degenerative lumbar spine surgery. Three groups were studied: spinal stenosis (LSS), disc herniation (LDH) and degenerative disc disorder (DDD).MethodsPatients who underwent surgery for degenerative lumbar spine conditions during 2008–2012 according to registration in the Swespine national register were eligible for the study. Non-respondents were registered in Swespine prior to surgery, but not at follow-up. Swespine data were merged with hospital data from seven Swedish regions (65% of the population), Statistics Sweden, the National Patient Register and the Social Insurance Agency.Baseline characteristics of non-respondents were described and compared to those of the respondents. Coefficients from regression analyses on PROM values for respondents were used to estimate the levels of PROM values for non-respondents, assuming the same effects of baseline characteristics for the two subgroups. Regression analyses were then conducted to identify variables associated with non-response. The results from the regression analyses were used to predict outcomes for patients with the characteristics of a non-respondent. Primary outcome variable in LSS and LDH was Global Assessment for leg pain, and in DDD, Global Assessment for back pain.ResultsAge, sex, educational level, smoking, living alone, being born outside the EU, previous spine surgery and unexpected events before follow-up were factors that were significantly associated with non-response. Being born inside, the EU was important in all of the studied groups (LSS: OR 0.61 p = < 0.000; LDH: OR 0.68 p = 0.001; DDD: OR 0.58 p = 0.04). For spinal stenosis patients, an unexpected event appeared particularly important (OR 3.40, p = 0.000). The predicted outcome of non-respondents was significantly worse than for respondents (LSS: 75.4% successful outcome vs. 78.7%; LDH: 53.9% vs. 58.2%; DDD: 62.7% vs. 67.5%. P-value in all groups = < 0.000).ConclusionAttrition in Swespine cannot be ignored, as non-respondents were predicted to have worse outcome. The effect of attrition bias should always be considered when contemplating outcome recorded in a quality register with patients lost to follow-up.

Sustained virological response to hepatitis C therapy does not decrease the incidence of systemic lupus erythematosus or rheumatoid arthritis

In patients with chronic hepatitis C (CHC), the effects of baseline characteristics, virological profiles, and therapeutic outcome to pegylated interferon plus ribavirin (PR) therapy on autoimmune diseases are unknown. Taiwanese Chronic Hepatitis C Cohort is a nationwide hepatitis C virus registry cohort comprising 23 hospitals of Taiwan. A total of 12,770 CHC patients receiving PR therapy for at least 4 weeks between January 2003 and December 2015 were enrolled and their data were linked to the Taiwan National Health Insurance Research Database for studying the development of 10 autoimmune diseases. The mean follow-up duration was 5.3 ± 2.9 years with a total of 67,930 person-years, and the annual incidence of systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA) was 0.03%. Other autoimmune diseases were not assessable due to few events. Body mass index ≥24 kg/m2 was an independent predictor of the low incidence of SLE or RA (hazard ratio 0.40, 95% confidence interval 0.17–0.93, p = 0.034). A sustained virological response (SVR) to PR therapy was not associated with the low incidence of SLE or RA in any subgroup analysis. CHC patients achieving SVR to PR therapy did not exhibit an impact on the incidence of SLE or RA compared with non-SVR patients.

Abstract P6-09-29: Clinicopathological characteristics and survival outcomes in invasive papillary carcinoma of the breast: A population-based study

Abstract Background Invasive papillary carcinoma (IPC) is defined as having papillary architecture in &amp;gt;90% of the invasive component. The overall incidence of IPC is low, accounting for less than 1-2% of all newly diagnosed cases of invasive breast cancer. Limited data are available that contribute to a comprehensive summarization of the clinicopathological characteristics and prognostic factors that are associated with IPC. We aimed to determine the clinicopathological characteristics and prognostic factors of IPC in a large population and help physicians to acquire a better understanding of the disease and make better informed therapeutic decisions. Methods We identified 233,171 female patients in the Surveillance, Epidemiology, and End Results (SEER) database who had IPC (n = 524) or infiltrating ductal carcinoma (IDC) (n = 232,647). The demographics and tumour and treatment characteristics of IPC were compared to those of IDC. A Cox proportional hazards model was used to investigate the effects of baseline characteristics on disease-specific survival (DSS). We performed a 1:1 (IPC: IDC) matched case-control analysis using the propensity score-matching method. A forest plot of hazard ratios (HRs) that was used to illustrate the exploratory subgroup analyses. Results Generally, IPCs occurred in older women (≥50 years old) and presented with smaller sizes, lower grades, higher rates of oestrogen receptor (ER) and progesterone receptor (PR) positivity, and reduced lymph node (LN) involvement and were less likely to be treated with mastectomy than patients with IDC. The five-year DSS rates were significantly better in IPC than in IDC (97.5% vs. 93%, respectively; P &amp;lt; 0.001). In the multivariate analysis, patients with IPC showed a DSS that was similar to that of IDC (HR = 0.556, 95% confidence interval 0.289–1.070, P = 0.079). No significant difference was observed in DSS between matched IPC and IDC groups (P = 0.085). Subgroup analyses suggested that differences in outcomes may be partially explained by differences in tumour grade, LN status, and ER and PR status between the 2 groups. Most IPCs are ER-positive tumours. When the analysis was limited to 178,755 ER-positive IPC and IDC patients (457 IPCs and 178,298 IDCs), similar results were observed. Conclusions This study is currently the largest analysis of IPC. We investigated a large cohort of patients with IPC and found that this rare tumour type presents unique clinicopathological characteristics and is associated with a higher rate of breast-conserving surgery and favourable prognoses than are observed in the overall IDC population. However, this advantage was diminished after we adjusted for demographic and clinicopathological factors. Therefore, patients diagnosed with this rare variant should be made aware that its biological features are not as favourable as once thought. Therapeutic decisions should not be made based solely on this rare entity and evidence-based treatment guidelines should be strictly followed. Improving our understanding of the clinical and biological features of IPC may lead to more individualized and tailored therapies for breast cancer patients. Citation Format: Zheng Y-Z, Hu X, Shao Z-M. Clinicopathological characteristics and survival outcomes in invasive papillary carcinoma of the breast: A population-based study [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P6-09-29.

Mid-Term Remission of Type 2 Diabetes Mellitus After Laparoscopic Roux En-Y Gastric Bypass.

Laparoscopic Roux en-Y gastric bypass (LRYGB) is an established therapeutic modality for type 2 diabetes mellitus (T2DM). However, there is paucity of data on the outcomes of LRYGB on T2DM beyond 2years. This study aimed to examine the medium-term effects of LRYGB on T2DM and determine the predictors of T2DM resolution. Prospective data were collected for all consecutive LRYGB performed from September 2009 to November 2010. The American Diabetes Association guidelines were used to define complete (CR) or partial (PR) remission of diabetes. Diabetes status was considered improved when there was >50% reduction in the dose of medications or when glycaemic control was achieved after stopping insulin. The effects of baseline characteristics, diabetes data and weight loss data at 4 years on T2DM remission were studied. Forty-six patients with T2DM underwent LRYGB with mean±SD age and body mass index (BMI) of 48.6±9.6 years and 50.4±6.5kg/m2, respectively. Median (IQR, interquartile range) duration of T2DM preoperatively was 60 (36-126) months. Median (IQR) follow-up was 52 (50-57) months. T2DM remission was achieved in 64% of patients (44% CR, 20% PR), and a further 28% of patients had improvement in their diabetes status. Multivariate analyses demonstrated significant excess weight loss (EWL) [P=0.008] and lower BMI [P=0.04] at 4 years to be the only independent predictors of T2DM medium-term outcomes. The medium-term effects of LRYGB on T2DM remission/improvement were maintained in 92% of patients. EWL and lower BMI at 4years were independent predictors of T2DM remission.

POPULATION-BASED OUTCOMES OF ICD THERAPY IN WOMEN

Although randomized controlled trials have established the survival benefit of implantable cardioverter-defibrillators (ICDs) in the prevention of sudden cardiac death, controversy remains as to whether this benefit applies equally to women and men. Due to the low enrolment of women in the ICD trials, population-based data examining sex differences in ICD outcomes may provide further clarification. Study data were derived from a provincial registry in British Columbia (BC) - the Cardiac Services BC Registry. All recipients of an ICD in BC are recorded in the Registry. Patients ≥18 years with a new ICD implant from Jan 2003 to Dec 2012 were included and linked with data from BC Vital Statistics to determine all-cause mortality. Survival was assessed using Kaplan-Meier (KM) methods stratified by sex and compared using the log-rank test. The Cox proportional-hazards model was used to estimate the hazard ratios (HR) and 95% confidence intervals (CI) between sexes. The effects of baseline characteristics (demographics, comorbidities and medication use) were explored and only factors with a p-value < 0.15 were included in the final adjusted model. Statistical analyses were performed using SAS software, version 9.3 (Cary, NC). During the study period, 3905 new ICD implants were performed. Of these, 704 (18%) were women. Women in the cohort, compared to men, were younger (59.6 vs. 63.5 years), respectively, and had a lower prevalence of comorbid conditions (Table). Except for beta-blocker use, women were less likely to be prescribed cardiac medications such as ACE inhibitors and anti-arrhythmics. The KM survival estimates were 0.95 at 1-year for both sexes, 0.79 for women and 0.73 for men at 5 years, and 0.70 for women and 0.57 for men at 8 years; the overall survival of women was greater than men (Figure). After adjusting for age, diabetes, coronary artery disease, congestive cardiomyopathy, peripheral vascular disease, acquired heart surgery, and anti-arrhythmic drug use, in the Cox proportional-hazards model, the sex difference in mortality was attenuated and no longer significant, adjusted HR 0.91, (95% CI: 0.75,1.12). Mortality trends from our population reveal that there is no difference in survival between women and men with ICDs. This may imply that women with ICDs derive the same benefit as men. Ongoing analyses will determine whether the impact of sex on mortality is different among patients receiving an ICD for primary versus secondary prevention and among those with ICDs compared to a similar population without ICDs.View Large Image Figure ViewerDownload (PPT)

Multiple Myeloma and Plasmactyoma-Like Post-Transplant Lymphoproliferative Disorders (PTLD): Examination of Outcomes and Prognostication in the Modern Era

Introduction Although PTLD is a well described complication of solid organ transplantation (SOT), relatively little is known about multiple myeloma and plasmacytoma-like PTLD (PTLD-MM). We examined a large cohort of PTLD-MM patients (pts) in the Scientific Registry of Transplant Recipients (SRTR) investigating overall survival (OS) and the associated predictors of outcome. Methods The SRTR is a pt-level prospective database of all SOT recipients in the United States. Pts diagnosed with PTLD-MM in 1999-2011 were identified in text and standardized diagnosis fields. Baseline pt characteristics were obtained at the time of SOT and diagnosis. OS estimates were calculated using the Kaplan-Meier method, with follow up times censored at 4.5 years. Effects of baseline characteristics on survival were estimated in univariate analysis using Cox proportional hazards models; those with a p-value ≤ 0.10 were included in a multivariable model. January 1, 2006 was used to divide the data into two equal cohorts to ascertain the effect of diagnosis date on survival. Results We identified 217 pts with PTLD-MM. Disease characteristics are outlined in [Table 1][1]. Median time from SOT to PTLD-MM diagnosis was 4.8 years (range 0-21); 18% of pts were diagnosed within 1 year of SOT, while 23% were diagnosed 10 years or more from SOT. In the cohort diagnosed 1999-2005, median time to PTLD-MM was significantly shorter than in the cohort diagnosed 2006-2011 (3.8 vs 5.2 years respectively, p = 0.048). Of those with complete data on performance status (PS), pts in the earlier cohort were more likely to have PS of 80-100 when compared to the later cohort (68% vs 52%, p=0.04). Therapy was detailed in 181 pts: 118 had immunosuppression reduced; 26 received corticosteroids; 62 received cytotoxic therapy; 3 received immunomodulatory agents; 44 received one of the novel agents thalidomide, lenalidomide or bortezomib; 56 underwent radiation therapy and 24 underwent debulking surgery. Median OS for the entire cohort, excluding 2 pts with unknown survival time, was 2.2 years (95% CI 1.7 - 3.0). Male gender, increased age, worse PS, hepatitis C infection at time of SOT, and diagnosis in the earlier cohort were all associated with worse OS in univariate analysis ([Table 1][1]). Therapy was not associated with OS in this study. Median OS was longer in those pts diagnosed 2006 – 2011 compared with those diagnosed 1999-2005 (2.9 vs 1.7 years, p=0.04 Figure 1). In multivariable analysis increased age (adjusted HR (aHR) 1.2 per decade, 95% CI 1.1 - 1.5, p=0.009), PS < 80 (aHR 2.1, 95% CI 1.4 - 3.2, p<0.001) and diagnosis 1999-2005 compared with 2006-2011 (aHR 1.8, 95% CI 1.2 - 2.7, p=0.006) remained significantly associated with decreased OS. Excluding date of diagnosis from the multivariable model did not change effect estimates of other baseline characteristics. View this table: Table 1 Baseline Characteristics and Univariate Analysis Conclusions To the best of our knowledge, this is the largest series of PTLD-MM reported to date. In contrast to prior reports (Blood 2013; 121: 1377-83, Haematologica, 2011; 96: 1067-71), outcomes of PTLD-MM were modest, with a median OS of only 2.2 years. Notably, OS has improved over time; those diagnosed in the latter half of our cohort had a 43% decrease in the risk of death compared to the earlier half. Trends in treatment and supportive care are likely to explain this improvement. Several prognostic factors identified pts with markedly divergent outcomes. Time from SOT to PTLD-MM was not associated with OS. Age and PS at diagnosis strongly predicted OS; risk of death increased by 20% for each decade of increased age, and doubled in pts with poor PS compared to those with preserved PS. Further examination of PTLD-MM is warranted to better understand these effects. ![Figure][2] Disclosures: No relevant conflicts of interest to declare. [1]: #T1 [2]: pending:yes

Multiple Myeloma and Plasmactyoma-Like Post-Transplant Lymphoproliferative Disorders (PTLD): Examination Of Outcomes and Prognostication In The Modern Era

IntroductionAlthough PTLD is a well described complication of solid organ transplantation (SOT), relatively little is known about multiple myeloma and plasmacytoma-like PTLD (PTLD-MM). We examined a large cohort of PTLD-MM patients (pts) in the Scientific Registry of Transplant Recipients (SRTR) investigating overall survival (OS) and the associated predictors of outcome. MethodsThe SRTR is a pt-level prospective database of all SOT recipients in the United States. Pts diagnosed with PTLD-MM in 1999-2011 were identified in text and standardized diagnosis fields. Baseline pt characteristics were obtained at the time of SOT and diagnosis. OS estimates were calculated using the Kaplan-Meier method, with follow up times censored at 4.5 years. Effects of baseline characteristics on survival were estimated in univariate analysis using Cox proportional hazards models; those with a p-value ≤ 0.10 were included in a multivariable model. January 1, 2006 was used to divide the data into two equal cohorts to ascertain the effect of diagnosis date on survival. ResultsWe identified 217 pts with PTLD-MM. Disease characteristics are outlined in Table 1. Median time from SOT to PTLD-MM diagnosis was 4.8 years (range 0-21); 18% of pts were diagnosed within 1 year of SOT, while 23% were diagnosed 10 years or more from SOT. In the cohort diagnosed 1999-2005, median time to PTLD-MM was significantly shorter than in the cohort diagnosed 2006-2011 (3.8 vs 5.2 years respectively, p = 0.048). Of those with complete data on performance status (PS), pts in the earlier cohort were more likely to have PS of 80-100 when compared to the later cohort (68% vs 52%, p=0.04). Therapy was detailed in 181 pts: 118 had immunosuppression reduced; 26 received corticosteroids; 62 received cytotoxic therapy; 3 received immunomodulatory agents; 44 received one of the novel agents thalidomide, lenalidomide or bortezomib; 56 underwent radiation therapy and 24 underwent debulking surgery. Median OS for the entire cohort, excluding 2 pts with unknown survival time, was 2.2 years (95% CI 1.7 - 3.0). Male gender, increased age, worse PS, hepatitis C infection at time of SOT, and diagnosis in the earlier cohort were all associated with worse OS in univariate analysis (Table 1). Therapy was not associated with OS in this study. Median OS was longer in those pts diagnosed 2006 – 2011 compared with those diagnosed 1999-2005 (2.9 vs 1.7 years, p=0.04 Figure 1). In multivariable analysis increased age (adjusted HR (aHR) 1.2 per decade, 95% CI 1.1 - 1.5, p=0.009), PS < 80 (aHR 2.1, 95% CI 1.4 - 3.2, p<0.001) and diagnosis 1999-2005 compared with 2006-2011 (aHR 1.8, 95% CI 1.2 - 2.7, p=0.006) remained significantly associated with decreased OS. Excluding date of diagnosis from the multivariable model did not change effect estimates of other baseline characteristics. ConclusionsTo the best of our knowledge, this is the largest series of PTLD-MM reported to date. In contrast to prior reports (Blood 2013; 121: 1377-83, Haematologica, 2011; 96: 1067-71), outcomes of PTLD-MM were modest, with a median OS of only 2.2 years. Notably, OS has improved over time; those diagnosed in the latter half of our cohort had a 43% decrease in the risk of death compared to the earlier half. Trends in treatment and supportive care are likely to explain this improvement. Several prognostic factors identified pts with markedly divergent outcomes. Time from SOT to PTLD-MM was not associated with OS. Age and PS at diagnosis strongly predicted OS; risk of death increased by 20% for each decade of increased age, and doubled in pts with poor PS compared to those with preserved PS. Further examination of PTLD-MM is warranted to better understand these effects. [Display omitted] Disclosures:No relevant conflicts of interest to declare.

Severe hypoglycemia was associated with increased risk for adverse clinical outcomes in type 2 diabetes

ACP Journal Club15 February 2011Severe hypoglycemia was associated with increased risk for adverse clinical outcomes in type 2 diabetesRozalina Grubina, MD, Steven A. Smith, MDRozalina Grubina, MDMayo Clinic, Rochester, Minnesota, USA (R.G., S.A.S.)Search for more papers by this author, Steven A. Smith, MDMayo Clinic, Rochester, Minnesota, USA (R.G., S.A.S.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-154-4-201102150-02013 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Source CitationZoungas S, Patel A, Chalmers J, et al. Severe hypoglycemia and risks of vascular events and death. N Engl J Med. 2010;363:1410-8. https://pubmed.ncbi.nlm.nih.gov/20925543Clinical Impact RatingsGIM/FP/GP: Neurology: References1 Bonds DE, Miller ME, Bergenstal RM, et al. The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ. 2010;340:b4909. [PMID: 20061358] Google Scholar2 Miller ME, Bonds DE, Gerstein HC, et al. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ. 2010;340:b5444. [PMID: 20061360] Google Scholar3 American Diabetes Association. Executive summary: Standards of medical care in diabetes—2010. Diabetes Care. 2010;33 Suppl 1:S4-10. [PMID: 20042774] Google Scholar Author, Article, and Disclosure InformationAffiliations: Mayo Clinic, Rochester, Minnesota, USA (R.G., S.A.S.)This article was published at Annals.org on 1 February 2011. Previousarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited bySevere Hypoglycemia and Risk of Subsequent Cardiovascular Events: Systematic Review and Meta-Analysis of Randomized Controlled Trials 15 February 2011Volume 154, Issue 4Page: JC2-13KeywordsCardiovascular disease riskCreatinineGlucoseHypoglycemiaInsulinMyocardial infarctionRenal diseasesRetinopathySystolic pressureType 2 diabetes ePublished: 15 February 2011 Issue Published: 15 February 2011 Copyright & PermissionsCopyright © 2011 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...

The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study

The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study

The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study

Objectives To investigate potential determinants of severe hypoglycaemia, including baseline characteristics, in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial and the association of severe hypoglycaemia with levels...

Betting on change: Modeling transitional probabilities to guide therapy development for opioid dependence.

This study investigated the process of change by modeling transitions among four clinical states encountered in 64 detoxified opiate-dependent individuals treated with daily oral naltrexone: no opiate use, blocked opiate use (i.e., opiate use while adhering to oral naltrexone), unblocked opiate use (i.e., opiate use after having discontinued oral naltrexone), and treatment dropout. The effects of baseline characteristics and two psychosocial interventions of differing intensity, behavioral naltrexone therapy (BNT) and compliance enhancement (CE), on these transitions were studied. Participants using greater quantities of opiates were more likely than other participants to be retained in BNT relative to CE. Markov modeling indicated a transition from abstinence to treatment dropout was approximately 3.56 times greater among participants in CE relative to participants in BNT, indicating the more comprehensive psychosocial intervention kept participants engaged in treatment longer. Transitions to stopping treatment were more likely to occur after unblocked opiate use in both treatments. Continued opiate use while being blocked accounted for a relatively low proportion of transitions to abstinence and may have more deleterious effects later in a treatment episode. (PsycINFO Database Record (c) 2009 APA, all rights reserved).

Discontinuation and switching of therapy after initiation of lipid-lowering drugs: the effects of comorbidities and patient characteristics.

To evaluate the effects of comorbidities and patient characteristics on treatment continuation among patients starting their first course of lipid-lowering drug (LLD) therapy. Within the UK General Practice Research Database (GPRD), we identified 22 408 patients who started LLD therapy due to coronary heart disease, hyperlipidaemia, or other atherosclerotic diseases, and who received > or = two prescriptions for LLD between January 1 1990 and December 31 1997. Differences in potential predictors of treatment continuation between patients who continued, and patients who discontinued/switched lipid-lowering therapy within 1 year after treatment initiation were compared by fitting multivariate logistic regression models. The effects of baseline characteristics on treatment continuation after switching of LLDs were also analysed. Discontinuation/switching of lipid-lowering therapy was common during the study period, especially among patients who received nonstatin, nonfibrate LLDs (log-rank test P = 0.0001). Statin use, more frequent physician visits, more concurrent cardiovascular medications, diabetes, and fewer noncardiovascular medications were associated with treatment continuation of LLDs. Among patients who switched therapy, prescribing of a statin as the substituted LLD, more concurrent cardiovascular medications, and later treatment switching were related to a higher probability of treatment continuation after switching LLDs. Treatment continuation after initiation or switching of lipid-lowering therapy largely increased with concomitant cardiovascular comorbidities, and more health care utilization, and is more common for statins than for other LLDs. Practice guidelines, patient education, and quality of care assessment for lipid-lowering therapy should emphasize factors that predispose patients to discontinuation/switching, in an effort to optimize the choice of therapeutic regimens and to improve patient adherence.