US Chart Research Articles

Set that record straight! Cardinal line orientations in music album artwork boost market performance and music consumption

AbstractIn three studies, we examine the effect of music album artwork on album market performance and music consumption. Based on the perceptual preference for visual stimuli with cardinal (orthogonal) over oblique (tilted) line/edge orientations (a phenomenon known as the “oblique effect”), albums with a predominance of cardinal line/edge orientations in their artwork should perform better than albums with more oblique artwork, as indicated by the albums' market performance and consumers' listening behavior. Study 1, using secondary data, shows that the cardinality of album artwork is a positive predictor of the cover's esthetic appeal and of market performance as evinced by its position in the US charts, expert ratings of the album, and the number of weeks the album remained in the US charts. Studies 2 and 3 use experiments to show that consumers listen longer to music when album artwork is relatively more cardinal than oblique. These studies also explore whether the effect is mediated by higher esthetic appreciation of cardinal (vs. oblique) album artwork in turn affecting song liking. Overall, these findings underscore the importance of visual preferences in packaging design for music consumption.

Low Rate of Clinically Evident Extravascular Hemolysis in Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with a Complement C5 Inhibitor: Results from a Large, Multicenter, US Real-World Study.

PurposeMost patients with paroxysmal nocturnal hemoglobinuria (PNH) treated with a complement protein 5 (C5) inhibitor achieve full control of terminal complement activity and intravascular hemolysis. The minority remains anemic and transfusion dependent despite this control. Etiology for ongoing anemia is multifactorial and includes bone marrow failure, breakthrough hemolysis, extravascular hemolysis (EVH) and nutritional deficiencies.Patients and MethodsTo evaluate the potential etiologies of hemoglobin levels <10 g/dL despite receiving C5 inhibitor therapy, we performed a retrospective US chart review of adult patients with PNH and treated for at least 12 months with eculizumab (n=53), ravulizumab (n=32), or eculizumab followed by ravulizumab (n=15). Clinically evident EVH was defined as at least one transfusion, reticulocyte count ≥120×109/L and hemoglobin level ≤9.5 g/dL. Safety data were not collected. Mean treatment duration was 26.5±17.2 months.ResultsTreatment with C5 inhibitors significantly improved hemoglobin, lactate dehydrogenase, and number of transfusions versus baseline. Among the patients with hemoglobin <10 g/dL during the last 6 months of treatment (n=38), one patient (eculizumab) had clinically evident EVH, and 10 patients had active concomitant bone marrow failure. Bone marrow failure was a major contributor to hemoglobin <10 g/dL and transfusion dependence; clinically evident EVH was uncommon.ConclusionA range of hematologic causes need to be considered when evaluating anemia in the presence of treatment with a C5 inhibitor.

SMA - TREATMENT: EP.292 Real-world outcomes of onasemnogene abeparvovec (OA) alone or with prior nusinersen in pediatric SMA: Interim analysis of a US chart review

SMA - TREATMENT: EP.292 Real-world outcomes of onasemnogene abeparvovec (OA) alone or with prior nusinersen in pediatric SMA: Interim analysis of a US chart review

Steroid switching in dystrophinopathy treatment: a USchart review of patient characteristics and clinical outcomes.

Aim: To describe reasons for switching from prednisone/prednisolone to deflazacort and associated clinical outcomes among patients with Duchenne and Becker muscular dystrophy (DMD and BMD, respectively) in theUSA. Methods: A chart review of patients with DMD (n=62) or BMD (n=30) who switched from prednisone to deflazacort (02/2017-12/2018) collected demographic/clinical characteristics, reasons for switching, outcomes and common adverse events. Results: The mean ages at switch were 20.1 (DMD) and 9.2 (BMD) years. The primary physician-reported reasons for switching were 'to slow disease progression' (DMD: 83%, BMD: 79%) and 'tolerability' (67 and 47%). Switching was 'very' or 'somewhat' effective at addressing the primary reasons in 90-95% of patients. Conclusion: Physician-reported outcomes were consistent with deflazacort addressing patients' primary reasons for switching.

Lymphocyte reconstitution after DMF discontinuation in clinical trial and real-world patients with MS.

BackgroundDelayed-release dimethyl fumarate (DMF) has demonstrated robust efficacy in treating patients with relapsing-remitting multiple sclerosis. Decreases in absolute lymphocyte count (ALC) are a well-known pharmacodynamic effect of DMF treatment, but lymphocyte recovery dynamics are not well characterized after discontinuation of DMF.MethodsData sources included the Biogen DMF integrated clinical trial data set, a retrospective US chart abstraction study, and data from MSBase. We assessed rate and time course of lymphocyte reconstitution after DMF discontinuation.ResultsThe majority of patients who developed lymphopenia while treated with DMF and subsequently discontinued treatment experienced ALC reconstitution. The median time to reach ALC ≥0.8 × 109/L was 2–4 months after discontinuation for patients treated in real-world data sets; the median time to reach ALC ≥0.91 × 109/L was 2 months after discontinuation in DMF clinical trials. Severity of lymphopenia on treatment and decline in ALC within the first 6 months did not affect the ALC reconstitution rate after DMF discontinuation; rather, on-treatment lymphopenia duration influenced the reconstitution rate. In patients with severe, prolonged lymphopenia for ≥3 years, lymphocyte reconstitution to ≥0.91 × 109/L was 12–18 months vs 2–3 months in patients with lymphopenia persisting <6 months.ConclusionsThe majority of patients who discontinued DMF due to lymphopenia experienced ALC reconstitution within 2–4 months following DMF discontinuation. This may help guide clinicians in managing patients who develop lymphopenia during DMF treatment. Prolonged lymphopenia on DMF treatment is associated with slow lymphocyte recovery after DMF discontinuation.

Abstract P4-22-19: Time on treatment of everolimus versus endocrine monotherapy or chemotherapy for early-line treatment of HR+/HER2- metastatic breast cancer: A retrospective chart review study in the US

Abstract Background: Among postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2-negative (HR+/HER2-) metastatic breast cancer (mBC) whose disease progressed on a non-steroidal aromatase inhibitor (NSAI), everolimus-based therapy (EVE), different endocrine monotherapies (ET mono), and chemotherapies (CT) are commonly used. Time on treatment is an outcome primarily determined by a therapy's combined efficacy and safety profile. This study assessed the real-world time on treatment (TOT) among patients receiving these treatments in early-line (i.e., 1st and 2nd) settings. Methods: A nationwide sample of postmenopausal HR+/HER2- mBC patients treated by community oncologists in the US was included in this retrospective chart review. Eligible patients for this study were required to fail NSAI and then receive EVE, ET mono or CT (index therapy) as an early-line therapy for mBC between July 1, 2012 and April 15, 2013. TOT was measured from index therapy initiation to physician-reported treatment discontinuation and compared among treatment groups using Kaplan-Meier analyses with log-rank tests and Cox proportional hazards models adjusting for the line of therapy and baseline characteristics including recurrent or de novo disease status, age, race, insurance type, Charlson comorbidity index, sites of metastases (e.g., bone, any other visceral site), ECOG performance status, previous CT treatment in the mBC setting, and duration from the initiation of the last adjuvant ET to mBC diagnosis. Results: A total of 145 patients treated with EVE, 217 patients treated with ET mono, and 102 patients treated with CT were included in the analysis. Baseline characteristics among the three treatment groups were similar, although EVE-treated patients had higher burden of metastases relative to ET mono-treated patients, but lower burden relative to CT-treated patients. TOT was longer among EVE-treated patients than ET mono- and CT- treated patients (log-rank tests: p=0.01 and p&amp;lt;0.01). For patients who completed their index treatment, the median TOT among EVE, ET mono, and CT treatment groups were 8.9, 5.7, and 6.1 months, respectively. After adjusting for baseline characteristics, EVE was associated with significantly longer TOT compared with ET mono [hazard ratio (HR) = 0.62, 95% confidence interval (CI): 0.45 – 0.85] and with CT (HR = 0.32, 95% CI: 0.22 – 0.46). Conclusions: This real-world US chart review study of postmenopausal women with HR+/HER2- mBC showed that patients receiving EVE in line 1 or 2 experienced significantly longer TOT than those receiving ET mono or CT. Citation Format: Li N, Ohashi E, Koo V, Xie J, Hao Y, Tang DH. Time on treatment of everolimus versus endocrine monotherapy or chemotherapy for early-line treatment of HR+/HER2- metastatic breast cancer: A retrospective chart review study in the US [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 P4-22-19.

Treatment patterns, symptom reduction, quality of life, and resource use associated with lubiprostone in irritable bowel syndrome constipation subtype

Objectives Real-world patient outcomes data is scarce concerning the high disease burden of IBS-C. The aim of this study was to compare patient-reported symptom control, health-related quality of life (HRQoL), resource utilization, and treatment satisfaction of lubiprostone vs non-lubiprostone treatment for irritable bowel syndrome–constipation (IBS-C).Research design and methods An observational, retrospective US chart review and computer-assisted telephone patient survey was conducted March to August 2013 recruiting women over 18 years old with physician-confirmed IBS-C who had initiated new treatment from inadequate relief of previous treatments and who had been on the new treatment ≥3 months. Multiple IBS-C treatments were permitted. IBS-C severity, time since diagnosis, age, and race were controlled using inverse probability of treatment weighting. Weighted outcomes were compared using t-tests (continuous outcomes) and chi-squared tests (categorical outcomes).Main outcomes measures Instruments included Patient Assessment of Constipation Symptoms (PAC-SYM) and IBS quality of life (IBS-QoL). A single item assessed current treatment satisfaction.Results Of 162 patients (mean age 45.9 [SD 15.3] years old, 71% white, 61.1% with moderate IBS-C), 76 switched to lubiprostone and 86 to non-lubiprostone. Groups were similar in clinical and demographic characteristics and previous 30 day IBS-C treatment. After weighting, all PAC-SYM scores were lower for lubiprostone (P < 0.05). All IBS-QoL subscales were higher for lubiprostone including overall, dysphoria, social reaction, sexual, and relationship scores (P < 0.05.) More lubiprostone patients reported positive treatment satisfaction (92.3% vs 71.0%, P < 0.001).Conclusions In IBS-C patients with inadequate response to previous therapies, lubiprostone improved patient-reported symptom control, treatment satisfaction, and HRQoL. Key limitations include lack of measurement of patient-reported outcomes at treatment start and potential data gaps in chart documentation.

Growth Charts for Children With Down Syndrome in the United States.

Children with Down syndrome (DS) have lower birth weights and grow more slowly than children without DS. Advances in and increased access to medical care have improved the health and well-being of individuals with DS; however, it is unknown whether their growth has also improved. Our objective was to develop new growth charts for children with DS and compare them to older charts from the United States and more contemporary charts from the United Kingdom. The Down Syndrome Growing Up Study (DSGS) enrolled a convenience sample of children with DS up to 20 years of age and followed them longitudinally. Growth parameters were measured by research anthropometrists. Sex-specific growth charts were generated for the age ranges birth to 36 months and 2 to 20 years using the LMS method. Weight-for-length and BMI charts were also generated. Comparisons with other curves were presented graphically. New DSGS growth charts were developed by using 1520 measurements on 637 participants. DSGS growth charts for children <36 months of age showed marked improvements in weight compared with older US charts. DSGS charts for 2- to 20-year-olds showed that contemporary males are taller than previous charts showed. Generally, the DSGS growth charts are similar to the UK charts. The DSGS growth charts can be used as screening tools to assess growth and nutritional status and to provide indications of how growth of an individual child compares with peers of the same age and sex with DS.

This much is true

This section is dedicated to the review of ideas, articles, books, films and other media. It will include replies (and rejoinders) to articles, the evaluation of new ideas or proposals, and reviews of books and articles both directly and indirectly related to intellectual property law. It's 1982. Members of the British musical group Spandau Ballet are in Nassau, the Bahamas, at Compass Point Studios, recording their third album. The group's songwriter, Gary Kemp, wrote a love song to singer Clare Grogan of the band Altered Images, whom he met while both were performing on Top of the Pops. The backing tracks are in place and the time has come for the newest member of the band, Steve Norman, to record his solo. Though Norman has only been playing saxophone for a year, the musical statement he's about to create will play a significant role in launching the song ‘True’ to the number one spot on the UK charts, the number four spot on the US charts and into heads of innumerable listeners for years to come.

Has there been any progress in improving the quality of hospitalised death? Replication of a US chart audit study

ObjectiveTo describe the experience of dying in a US tertiary academic medical centre and to compare this experience with a historical decedent sample.DesignA retrospective, observational, chart audit study of adults...

Clinical Outcomes Using Long-Term Combination Therapy with Insulin Glargine and Exenatide in Patients with Type 2 Diabetes Mellitus

To examine the long-term effects of combination insulin glargine/exenatide treatment on glycemic control. We conducted a 24-month retrospective US chart review of patients with inadequately controlled type 2 diabetes (T2DM) and hemoglobin A1c (A1C) levels >7.0% for whom glargine and exenatide were coprescribed in differing order (glargine added after exenatide [exenatide/glargine]; exenatide added after glargine [glargine/exenatide]). Treatment order groups were combined to form a pooled treatment group. Changes from baseline in A1C, patients with A1C ≤7.0%, body weight, glargine/exenatide daily dose, oral antidiabetic drug (OAD) use, and hypoglycemia were evaluated. Treatment groups were similar at baseline; however, patients in the glargine/exenatide group (n = 121) (vs exenatide/glargine group [n = 44]) had longer disease duration (11.8 vs 8.0 years) and took fewer OADs (1.7 vs 2.3). Overall, baseline A1C was 8.8 ± 1.3% and weight was 109.5 ± 25.3 kg. Significant A1C reductions emerged at month 6 and persisted throughout 24 months (vs baseline) in both treatment groups (pooled: -0.7 ± 1.6; P<.001), and 33.0% of patients achieved an A1C level ≤7.0%. After 24 months of exenatide/glargine, body weight remained unchanged (0.7 ± 8.3 kg; P = .640). With glargine/exenatide, body weight decreased (-2.5 ± 6.7 kg; P = .001). At month 24, daily glargine dose was 0.40 ± 0.23 units/kg for the exenatide/glargine group and 0.47 ± 0.30 units/kg for the glargine/exenatide group. Hypoglycemia frequency was similar in both treatment groups. Regardless of treatment order, long-term combined therapy with glargine and exenatide for up to 24 months in patients with inadequately controlled T2DM suggests reduction of A1C without significant weight gain or increased hypoglycemia risk.

Stability of infliximab dosing in inflammatory bowel disease: results from a multicenter US chart review

Objective:Infliximab dosing for inflammatory bowel disease (IBD) is based on patient weight and treatment response. Understanding dosing patterns may provide insight into treatment response and predictability of treatment cost. The purpose of this medical record review was to assess dose and dose frequency of infliximab maintenance treatment in patients with IBD using patient chart data.Methods:A retrospective chart review was conducted at 14 community gastroenterology clinics (GI clinics). Patients were aged ≥18 years, diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC), and had a first infliximab administration (index date) between January 1, 2005 and September 30, 2007. At least 24 months of continuous data availability were required with dosing data collected for 12 months after initiation of infliximab therapy. Patients with biologic use and/or participation in an IBD clinical trial within 12 months before the index date were excluded.Results:Charts from 182 CD patients and 86 UC patients were analyzed. About half of the patients were female. Over 90% of patients initiated treatment with infliximab 5 mg/kg. Among CD patients and UC patients, respectively, 79% and 61% continued receiving this dose for maintenance therapy at stable intervals.Limitations:This retrospective descriptive study is limited by the type and quantity of information available in patient charts from 14 GI clinics during the first year of infliximab treatment. Further, non-anti-tumor necrosis factor medication data were intermittently collected in some charts and, therefore, did not allow for analysis.Conclusions:Weight-based dosing and, presumably, patient response enabled providers to find the effective infliximab dose for IBD patients. The maintenance dose and administration frequency remained stable during the initial year.

Glaucoma in the United States and Europe

Primary open-angle glaucoma is a significant health-economic burden in both the United States and Europe that is likely to increase. This study compared treatment patterns and cost among patients with primary open-angle glaucoma in these locations. Retrospective medical chart reviews were conducted in the United States (1990 to 2002) and Europe (1995 to 2003). A total sample of 151 US charts and 194 European charts was studied, and patients were assigned a baseline intraocular pressure (IOP) and baseline stage, using a 6-stage visual functional glaucoma staging algorithm. Resource utilization and direct costs were assessed by stage of disease using publicly available United States and European costs. Cox Proportional Hazards modeling were used to examine covariates predicting glaucoma surgery. Total cost was predicted, adjusting for covariates using Generalized Linear Models, with baseline stage as the independent variable. Glaucoma surgery requirement was highly associated with baseline disease stage and IOP increase before surgery in the United States and somewhat associated with these factors in Europe. Within both locations, baseline IOP was highly associated with glaucoma surgery requirement. Controlling for covariates, patients at higher baseline stages incurred greater costs in the United States (P=0.0017) and Europe (P=0.0715). Surgery and medication were also highly predictive of increased cost (P<0.0001). Cost of care differed greatly between the European countries, with costs lowest in Italy. Increases in annual cost were related to higher baseline IOP, higher baseline stage, medication, and surgery. Thus, significant potential savings and reductions in annual healthcare burden are possible if patients are diagnosed and treated at earlier stages of glaucoma.