The relationship between mean HbA1c and CVD hospitalizations and all-cause mortality was U-shaped, with greater risk at both higher and lower HbA1c levels.

ObjectiveTo evaluate changes in baseline patient characteristics and entry criteria of randomised, controlled studies of tumour necrosis factor alpha (TNFα) inhibitors in rheumatoid arthritis (RA) patients.MethodsA systematic literature review was performed using predefined inclusion criteria to identify randomised, double-blind, controlled trials that evaluated TNFα inhibitors in adult RA patients. Entry criteria and baseline clinical characteristics were evaluated over time for methotrexate-experienced and methotrexate-naive study populations. Enrolment start date for each trial was the time metric. The anchor time was the study with the earliest identifiable enrolment start date.Results44 primary publications (reporting the primary study endpoint) from 1993 to 2008 met the inclusion criteria. Enrolment start dates of August 1993 and May 1997 were identified as time anchors for the 37 methotrexate-experienced studies and the seven methotrexate-naive studies, respectively. In methotrexate-experienced trials, no significant change was observed over the years included in this study in any inclusion criteria (including swollen joint counts and C-reactive protein (CRP)), but a significant decrease over time was observed in the baseline swollen joint count, CRP and total Sharp or van der Heijde modified Sharp score, but not in baseline tender joint counts. In the methotrexate-naive studies, significant decreases over the years were observed in swollen joint and tender joint inclusion criteria, but not in baseline tender joint count, baseline CRP, CRP inclusion criteria or baseline total Sharp or van der Heijde modified Sharp score.ConclusionInclusion criteria and baseline characteristics of RA patients enrolled in studies of TNFα inhibitors have changed, with more recent trials enrolling cohorts with lower disease activity, especially in methotrexate-experienced trials.

Objective. To evaluate the effect of golimumab on sleep disturbance in patients with active ankylosing spondylitis (AS).Methods. Golimumab was studied in a multicenter, randomized, placebo-controlled study (GO-RAISE). At baseline, 356 patients were randomly assigned in a 1.8:1.8:1 ratio to subcutaneous golimumab 50 mg, 100 mg, or placebo every 4 weeks. Sleep disturbance was assessed using the Jenkins Sleep Evaluation Questionnaire (JSEQ), which was administered at baseline, week 14, and week 24. Treatment effect was evaluated using analysis of variance on the van der Waerden normal scores.

BackgroundType 2 diabetes mellitus (T2DM) affects 25.8 million individuals in the United States and exerts a substantial economic burden on patients, health care systems, and society. Few studies have categorized costs and resource use at the patient level. The goals of this study were to assess predictors of being a high-cost (HC) patient and compare HC T2DM patients with not high-cost (NHC) T2DM patients.MethodsUsing managed care administrative claims data, patients with two or more T2DM diagnoses between 2005 and 2010 were selected. Patients were followed for 1 year after their first observed T2DM diagnosis; patients not continuously enrolled during this period were excluded from the study. Study measures included annual health care expenditures by component (i.e., inpatient, outpatient, pharmacy, total). Patients accruing total costs in the top 10% of the overall cost distribution (i.e., patients with costs > $20,528) were classified as HC a priori; all other patients were considered NHC. To assess predictors of being HC, a logistic regression model was estimated, accounting for demographics; underlying comorbidity burden (using the Charlson Comorbidity Index [CCI] score); diagnoses of renal impairment, obesity, or hypertension; and receipt of insulin, oral antidiabetics only, or no antidiabetics.ResultsA total of 1,720,041 patients met the inclusion criteria; 172,004 were HC. The mean (SD) CCI score for HC patients was 4.3 (3.0) versus 2.1 (1.7) for NHC patients. Mean (SD; upper 95% confidence interval-lower 95% confidence interval) annual per-patient costs were $56,468 ($65,604; $56,778-$56,157) among HC patients and $4,674 ($4,504; $4,695-$4,652) among NHC patients. Inpatient care and pharmacy costs were higher for HC patients than for NHC patients. The strongest predictor of being an HC patient was having a CCI score of 2 or greater (odds ratio [OR] = 4.896), followed by a diagnosis of obesity (OR = 2.106), renal impairment (OR = 2.368), and insulin use (OR = 2.098).ConclusionsHigh-cost T2DM patients accrue approximately $52,000 more in total annual health care costs than not high-cost T2DM patients. Patients were significantly more likely to be high-cost if they had comorbid conditions, a diagnosis of obesity, or used insulin.

Objective: Acute graft-versus-host disease (aGVHD) is a common and life-threatening complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT). The extent to which aGVHD increases inpatient costs associated with allo-HSCT has not been thoroughly evaluated. In this analysis, mortality, hospital length of stay (LOS) and costs associated with aGVHD during allo-HSCT admissions are evaluated. Methods: This is a retrospective analysis of discharge records from the National Inpatient Sample database for patients receiving allo-HSCT between 1 January 2009 and 31 December 2013. Allo-HSCT discharges with an aGVHD diagnosis were included in the aGVHD group and those without any graftversus-host disease (GVHD) diagnosis comprised the non-GVHD group. Mortality, LOS and costs were compared between the two groups, as well as within subgroups, including age (<18 vs. !18 years) and survival status (alive vs. deceased) at discharge. Results: Overall, mortality (16.2% vs. 5.3%; p < .01), median hospital LOS (42.0 vs. 26.0 days; p < .01) and median total costs ($173,144 vs. $98,982; p < .01) were significantly increased in patients with aGVHD versus those without GVHD during hospitalizations for allo-HSCT, irrespective of age group. Patients with aGVHD who were <18 years of age had a lower mortality rate but greater hospital LOS and total costs versus patients aged !18 years. Patients who died during allo-HSCT hospitalization had longer LOS and incurred greater costs than those who survived in both the aGVHD and non-GVHD groups. Conclusion: Occurrence of aGVHD during allo-HSCT admissions resulted in a tripling of the mortality rate and a near doubling of hospital LOS and total costs. In addition, death during allo-HSCT hospitalizations was associated with greater healthcare utilization and costs. Effectively mitigating aGVHD may improve survival and substantially reduce hospital LOS and costs for allo-HSCT.

BACKGROUNDThis analysis of the myeloproliferative neoplasm (MPN) Landmark survey evaluated gaps between patient perceptions of their disease management and physician self‐reported practices.METHODSThe survey included 813 patient respondents who had MPNs (myelofibrosis [MF], polycythemia vera [PV], or essential thrombocythemia [ET]) and 457 hematologist/oncologist respondents who treated patients with these conditions.RESULTSGreater proportions of physician respondents reported using prognostic risk classifications (MF, 83%; PV, 59%; ET, 77%) compared with patient recollections (MF, 54%; PV, 17%; ET, 31%). Most physician respondents reported that their typical symptom assessments included asking patients about the most important symptoms or a full list of symptoms, whereas many patient respondents reported less specific assessments (eg, they were asked how they were feeling). Many patient respondents did not recognize common symptoms as MPN‐related. For example, approximately one‐half or more did not believe difficulty sleeping resulted from their MPN (MF, 49%; PV, 64%; ET, 76%). Physician respondents underestimated the proportion of patients who had symptomatic PV or ET at diagnosis compared with patient respondents. There was discordance regarding treatment goals: among patient respondents with MF or PV, “slow/delay progression of condition” was the most important treatment goal, whereas physician respondents reported “symptom improvement” and “prevention of vascular/thrombotic events,” respectively. Finally, more than one‐third of patient respondents were not “very satisfied” with their physician's overall management/communication.CONCLUSIONSThe care and satisfaction of patients with MPN may be improved with increased patient education and improved patient‐physician communication. Cancer 2017;123:449–458. © 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

BACKGROUNDCardiovascular disease (CVD) prevention in diabetes requires broad-based treatment of dyslipidemia, hypertension, and hyperglycemia. The independent contribution of all combinations of risk factor control to CVD risk has not been evaluated.OBJECTIVETo estimate the independent association of control of glycosylated hemoglobin (A1C), systolic blood pressure (SBP), and low-density lipoprotein cholesterol (LDL-C) with risk of cardiovascular disease hospitalization.DESIGNNon-concurrent longitudinal cohort study.PATIENTSThe study included 26,636 patients with type 2 diabetes who were members of an integrated group model HMO with multiple A1C, SBP, and LDL-C measurements.MAIN MEASURESPatients were followed for a mean (SD) of 5.6 (2.5) years until they died or disenrolled, or until 31 December 2010. The outcome was a first-observed CVD hospitalization. Using the mean of all A1C, SBP, and LDL-C measures during follow-up, we created dichotomous categories of A1C control (< 7 %), SBP control (< 130 mmHg), and LDL-C control (< 100 mg/dL) to estimate the incidence rate of CVD hospitalization associated with all combinations of risk factor control adjusting for demographic and clinical characteristics.KEY RESULTSPatients with no controlled risk factors (18.2/1,000 person-years, 95 % CI 16.5−20.2) or with only A1C in control (16.9, 15.0−19.0) had the highest rate of CVD hospitalization, whereas those with all three risk factors controlled (7.2, 6.2−8.4) or with SBP and LDL-C in control (6.1, 5.1−7.2) had the lowest rates. Those with only SBP or LDL-C in control, A1C and SBP controlled, or A1C and LDL-C controlled had statistically similar incidence between the highest and lowest rates.CONCLUSIONSMaintaining SBP < 130 mmHg or LDL-C < 100 mg/dL was significantly associated with reduced CVD hospitalization risk, especially when both risk factors were well controlled. Maintaining A1C < 7 % was not independently associated with reduced CVD hospitalization risk.Electronic supplementary materialThe online version of this article (doi:10.1007/s11606-012-2320-1) contains supplementary material, which is available to authorized users.

These data confirm that many patients with PV experience symptoms, QoL impairments, and work productivity impairments that negatively affect their lives. Longitudinal data from REVEAL will be important for evaluating how PROs change over time in these patients.