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Background/objectives: The phase 3 REGAIN study and its open-label extension demonstrated the efficacy of the complement C5 inhibitor eculizumab in patients with treatment-refractory, acetylcholine receptor antibody–positive generalized myasthenia gravis (gMG). The aim of the ELEVATE study was to assess the effectiveness of eculizumab in clinical practice in adults with MG in the United States. Methods: A retrospective chart review was conducted in adults with MG who initiated eculizumab treatment between October 23, 2017 and December 31, 2019. Outcomes assessed before and during eculizumab treatment using a pre- versus post-treatment study design included Myasthenia Gravis–Activities of Daily Living (MG-ADL) total scores; minimal symptom expression (MSE); physician impression of clinical change; minimal manifestation status (MMS); and concomitant medication use. Results: In total, 119 patients were included in the study. A significant reduction was observed in mean MG-ADL total score, from 8.0 before eculizumab initiation to 5.4 at 3 months and to 4.7 at 24 months after eculizumab initiation (both p < 0.001). At 24 months after eculizumab initiation, MSE was achieved by 19% of patients. MMS or better was achieved by 30% of patients at 24 months. Additionally, 64% of patients receiving prednisone at eculizumab initiation had their prednisone dosage reduced during eculizumab treatment and 13% discontinued prednisone; 32% were able to discontinue nonsteroidal immunosuppressant therapy. Discussion: Eculizumab treatment was associated with sustained improvements in MG-ADL total scores through 24 months in adults with MG. Prednisone dosage was reduced in approximately two-thirds of patients, suggesting a steroid-sparing effect for eculizumab. [ABSTRACT FROM AUTHOR]

School absenteeism among children and adolescents has been associated with a myriad of adverse outcomes. Despite a substantial amount of research on school attendance, our understanding of absenteeism in elementary-aged children with mental health difficulties is limited. The current study used a mixed-method sequential explanatory design to gain a better understanding of the links between children's mental health symptoms, age, gender and school absenteeism. The study included two phases: Phase I presented a quantitative investigation of the links between absenteeism and mental health symptoms in a large sample (N = 750) of primarily White (74%) clinic-referred children aged 5–12 years. Phase II used a participant selection model and chart review design to garner a deeper understanding of how school absenteeism presents in children with mental health problems in the elementary years. Results suggested that internalizing symptoms were significantly related to school attendance problems, and this association worsens as children age and as internalizing symptoms increase in severity. Externalizing symptoms were associated with absenteeism as well, but these findings showed that school attendance problems were worse for younger children with low to moderate levels of externalizing symptoms. The qualitative chart review illustrates the complex interplay of school absenteeism and child mental health, particularly for children experiencing co-occurring internalizing and externalizing problems. Children often struggled academically and socially, with some exhibiting increasing levels of school refusal and truancy and others displaying aggressive behaviors resulting in suspensions. Future studies that examine additional contextual factors, such as school and family variables, with longitudinal cross-lagged models and diverse families are needed to develop a comprehensive understanding of causal associations and their impact on children's school attendance across children's development. [ABSTRACT FROM AUTHOR]

Purpose: Lenvatinib was approved for the treatment of patients with radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) in the United States (US) in 2015. The main objective of the current study was to assess real-world clinical effectiveness in RAI-R DTC patients treated with first line lenvatinib monotherapy in the US. Methods: A retrospective chart review was conducted in RAI-R DTC patients who initiated lenvatinib monotherapy as first line treatment between February 2015 and September 2020. Anonymized data were abstracted by prescribing physicians from individual patient's electronic health records. Clinical outcomes included provider-reported real-world best overall response (rwBOR), real-world progression-free survival (rwPFS), and overall survival (OS). Time-to-event endpoints were assessed using Kaplan–Meier methods. Results: Our study included 308 RAI-R DTC patients treated with first line lenvatinib. At lenvatinib initiation, patients' median age was 60 years, 51.6% were female, and 26.0% of patients had an ECOG performance score of ≥2. Over the follow-up period, 32.5% of patients discontinued first line lenvatinib permanently, with others remaining on treatment. The median duration of lenvatinib therapy was 17.5 months overall. Provider-reported rwBOR (complete or partial response) to lenvatinib was 72.4%. Median rwPFS was 49.0 months. Estimated rwPFS rates at 24 and 48 months were 68.5% and 55.0%, respectively. Estimated OS rates at 24 and 72 months were 78.4% and 57.0%, respectively; median OS was not reached. Conclusion: The current study reinforces the clinical effectiveness of first line lenvatinib as standard of care in patients with RAI-R DTC in real-world clinical practice in the US. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to describe the clinical characteristics and wellness programming preferences of cancer survivors from Acres Homes, a historically Black neighborhood in Houston, Texas, with areas of persistent poverty. The goal of this study was to identify opportunities to increase cancer survivor utilization of healthy eating and active living interventions aligned to cancer center community outreach and engagement efforts. Methods: This multiple methods study included a retrospective review of electronic health record data (n = 413) and qualitative interviews with cancer survivors (n = 31) immediately preceding initiation of healthy eating, active living programming in Acres Homes. Results: This study found Acres Homes survivors have high rates of co-occurrent cardiometabolic disease including obesity (45.0%), diabetes (30.8%), and other related risk factors as well as treatment-related symptoms. Four major concepts emerged from interviews: (1) Factors that influence survivors' ability to eat well and exercise, (2) Current usage of community resources, (3) Interest in relevant programming, and (4) Specific programming preferences. Opportunities for current and future health promotion programming for cancer survivors were explored. Conclusion: Strategically tailoring community resources for cancer survivors can provide a more robust network of support to promote healthy eating and active living in this population. This work informed community implementation of evidence-based health interventions in Acres Homes and may support future projects aiming to enhance community-led cancer prevention efforts in historically underserved communities. [ABSTRACT FROM AUTHOR]

Purpose: The safety and efficacy of subcutaneous immune globulin 20% (human) solution (Ig20Gly) were demonstrated in clinical trials. However, real-world evidence of the tolerability of self-administered Ig20Gly in elderly patients is lacking. We describe real-world patterns of Ig20Gly usage for 12 months in patients with primary immunodeficiency diseases (PIDD) in the USA. Methods: This retrospective chart review of longitudinal data from 2 centers included patients aged ≥ 2 years with PIDD. Ig20Gly administration parameters, tolerability, and usage patterns were assessed at initial and subsequent 6- and 12-month infusions. Results: Of 47 enrolled patients, 30 (63.8%) received immunoglobulin replacement therapy (IGRT) within 12 months before starting Ig20Gly, and 17 (36.2%) started IGRT de novo. Patients were predominantly White (89.1%), female (85.1%), and elderly (aged > 65 years, 68.1%; median age = 71.0 years). Most adults received at-home treatment during the study, and most self-administered at 6 months (90.0%) and 12 months (88.2%). Across all time points, infusions were administered at a mean rate of 60–90 mL/h/infusion, using a mean of 2 sites per infusion, on a weekly or biweekly frequency. No emergency department visits occurred, and hospital visits were rare (n = 1). Forty-six adverse drug reactions occurred in 36.4% of adults, mostly localized site reactions; none of these or any adverse events led to treatment discontinuation. Conclusion: These findings demonstrate tolerability and successful self-administration of Ig20Gly in PIDD, including elderly patients and patients starting IGRT de novo. [ABSTRACT FROM AUTHOR]

Introduction: This study aimed to examine the reasons underlying treatment changes among pediatric patients with attention-deficit/hyperactivity disorder (ADHD). Methods: Data were obtained through online medical chart abstraction (08/2021–09/2021). Eligible patients with ADHD had initiated a treatment regimen at ages 6–17 and within 1–5 years of chart abstraction. Reasons contributing to treatment changes were analyzed for a randomly selected treatment episode. ADHD/treatment-related complication rate was also described. Results were reported overall and among children (ages 6–12) and adolescents (ages 13–17), separately. Physicians' perspective on adherence among their child, adolescent, and adult patients was assessed through an online survey. Results: A total of 156 physicians abstracted 434 patient charts (235 children + 199 adolescents). Mean patient age was 11.3 years, and 68.7% were male. Inadequate/suboptimal symptom management was the most common reason for treatment discontinuation (50/83 [60.2%]), add-on (17/21 [81.0%]), and dose increase (189/237 [79.7%]). Patient/parent/family attitude/dislike of medication and ADHD/treatment-related complications were common reasons for treatment discontinuation, add-on, switch, and dose decrease. Overall, 42.4% of patients had ≥ 1 documented ADHD/treatment-related complication, insomnia/sleep disturbances being the most common (9.7%). Among patients with ≥ 1 complication, 75.5% reported the experience/fear of complications had a negative impact on their treatment adherence. Results were similar among children and adolescents. Physicians reported taking actions toward patients' non-adherence by further educating patients, closer monitoring, and changing the prescribed ADHD medication. Conclusion: Lack of effectiveness and ADHD/treatment-related complications are important reasons for treatment changes among children and adolescents with ADHD, highlighting the need for more effective and tolerable treatments to mitigate the burden of ADHD. [ABSTRACT FROM AUTHOR]

Introduction: Real-world data are needed to understand the effectiveness of new therapeutic options for low-density lipoprotein cholesterol (LDL-C) reduction in Asia–Pacific clinical practice. Description of evolocumab use among adults with establisHed Atherosclerotic cardiovascuLar diseasE or hypercholesterolemia in ASia–Pacific region (HALES) was performed to better understand characteristics of and clinical decision-making for adults with established atherosclerotic cardiovascular disease/hypercholesterolemia after local evolocumab approval.The HALES observational study, conducted at 33 sites (Hong Kong, Thailand, South Korea, Singapore, Taiwan, and Australia) comprised (1) chart review of patients who received evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i), and (2) physician/patient survey and one-time data collection of patients with high cardiovascular risk initiating evolocumab or initiating/continuing non-PCSK9i lipid-lowering therapy. Patients could only enroll in (1) or (2).Chart review included 724 very high-risk patients initiating evolocumab from regulatory approval to 2021. From median baseline LDL-C of 3.2 mmol/L (123.7 mg/dL), patients had a median percent change in LDL-C of − 60.8% at 1–6 months. Goal achievement increased from 7.9% to 69.8% for < 1.8 mmol/L (< 70 mg/dL) and 4.4% to 57.8% for < 1.4 mmol/L (< 55 mg/dL) from baseline to 12 months. In the one-time data collection, more patients had ≥ 1.8 mmol/L (≥ 70 mg/dL) baseline LDL-C in the evolocumab vs non-PCSK9i group (95.2% and 48.5%, respectively). Surveys found that physicians applied guideline-recommended treatment targets, and patients demonstrated gaps in understanding cardiovascular risk.Real-world, Asia–Pacific data showed that LDL-C reduction after initiating evolocumab was consistent with that observed in other clinical trials and patient populations.Graphical abstract available for this article.·Methods: Real-world data are needed to understand the effectiveness of new therapeutic options for low-density lipoprotein cholesterol (LDL-C) reduction in Asia–Pacific clinical practice. Description of evolocumab use among adults with establisHed Atherosclerotic cardiovascuLar diseasE or hypercholesterolemia in ASia–Pacific region (HALES) was performed to better understand characteristics of and clinical decision-making for adults with established atherosclerotic cardiovascular disease/hypercholesterolemia after local evolocumab approval.The HALES observational study, conducted at 33 sites (Hong Kong, Thailand, South Korea, Singapore, Taiwan, and Australia) comprised (1) chart review of patients who received evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i), and (2) physician/patient survey and one-time data collection of patients with high cardiovascular risk initiating evolocumab or initiating/continuing non-PCSK9i lipid-lowering therapy. Patients could only enroll in (1) or (2).Chart review included 724 very high-risk patients initiating evolocumab from regulatory approval to 2021. From median baseline LDL-C of 3.2 mmol/L (123.7 mg/dL), patients had a median percent change in LDL-C of − 60.8% at 1–6 months. Goal achievement increased from 7.9% to 69.8% for < 1.8 mmol/L (< 70 mg/dL) and 4.4% to 57.8% for < 1.4 mmol/L (< 55 mg/dL) from baseline to 12 months. In the one-time data collection, more patients had ≥ 1.8 mmol/L (≥ 70 mg/dL) baseline LDL-C in the evolocumab vs non-PCSK9i group (95.2% and 48.5%, respectively). Surveys found that physicians applied guideline-recommended treatment targets, and patients demonstrated gaps in understanding cardiovascular risk.Real-world, Asia–Pacific data showed that LDL-C reduction after initiating evolocumab was consistent with that observed in other clinical trials and patient populations.Graphical abstract available for this article.·Results: Real-world data are needed to understand the effectiveness of new therapeutic options for low-density lipoprotein cholesterol (LDL-C) reduction in Asia–Pacific clinical practice. Description of evolocumab use among adults with establisHed Atherosclerotic cardiovascuLar diseasE or hypercholesterolemia in ASia–Pacific region (HALES) was performed to better understand characteristics of and clinical decision-making for adults with established atherosclerotic cardiovascular disease/hypercholesterolemia after local evolocumab approval.The HALES observational study, conducted at 33 sites (Hong Kong, Thailand, South Korea, Singapore, Taiwan, and Australia) comprised (1) chart review of patients who received evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i), and (2) physician/patient survey and one-time data collection of patients with high cardiovascular risk initiating evolocumab or initiating/continuing non-PCSK9i lipid-lowering therapy. Patients could only enroll in (1) or (2).Chart review included 724 very high-risk patients initiating evolocumab from regulatory approval to 2021. From median baseline LDL-C of 3.2 mmol/L (123.7 mg/dL), patients had a median percent change in LDL-C of − 60.8% at 1–6 months. Goal achievement increased from 7.9% to 69.8% for < 1.8 mmol/L (< 70 mg/dL) and 4.4% to 57.8% for < 1.4 mmol/L (< 55 mg/dL) from baseline to 12 months. In the one-time data collection, more patients had ≥ 1.8 mmol/L (≥ 70 mg/dL) baseline LDL-C in the evolocumab vs non-PCSK9i group (95.2% and 48.5%, respectively). Surveys found that physicians applied guideline-recommended treatment targets, and patients demonstrated gaps in understanding cardiovascular risk.Real-world, Asia–Pacific data showed that LDL-C reduction after initiating evolocumab was consistent with that observed in other clinical trials and patient populations.Graphical abstract available for this article.·Conclusion: Real-world data are needed to understand the effectiveness of new therapeutic options for low-density lipoprotein cholesterol (LDL-C) reduction in Asia–Pacific clinical practice. Description of evolocumab use among adults with establisHed Atherosclerotic cardiovascuLar diseasE or hypercholesterolemia in ASia–Pacific region (HALES) was performed to better understand characteristics of and clinical decision-making for adults with established atherosclerotic cardiovascular disease/hypercholesterolemia after local evolocumab approval.The HALES observational study, conducted at 33 sites (Hong Kong, Thailand, South Korea, Singapore, Taiwan, and Australia) comprised (1) chart review of patients who received evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i), and (2) physician/patient survey and one-time data collection of patients with high cardiovascular risk initiating evolocumab or initiating/continuing non-PCSK9i lipid-lowering therapy. Patients could only enroll in (1) or (2).Chart review included 724 very high-risk patients initiating evolocumab from regulatory approval to 2021. From median baseline LDL-C of 3.2 mmol/L (123.7 mg/dL), patients had a median percent change in LDL-C of − 60.8% at 1–6 months. Goal achievement increased from 7.9% to 69.8% for < 1.8 mmol/L (< 70 mg/dL) and 4.4% to 57.8% for < 1.4 mmol/L (< 55 mg/dL) from baseline to 12 months. In the one-time data collection, more patients had ≥ 1.8 mmol/L (≥ 70 mg/dL) baseline LDL-C in the evolocumab vs non-PCSK9i group (95.2% and 48.5%, respectively). Surveys found that physicians applied guideline-recommended treatment targets, and patients demonstrated gaps in understanding cardiovascular risk.Real-world, Asia–Pacific data showed that LDL-C reduction after initiating evolocumab was consistent with that observed in other clinical trials and patient populations.Graphical abstract available for this article.· [ABSTRACT FROM AUTHOR]

This study aims to investigate the dosage pattern, efficacy, and safety of sacubitril/valsartan (Sac/Val) in Chinese heart failure with reduced ejection fraction (HFrEF) patients regarding real-world settings. Patients from 27 centers with a confirmed diagnosis of HFrEF and initiated Sac/Val treatment were enrolled. The primary objective was to evaluate the dosage pattern and change of heart failure status. In a final cohort of 983 patients, outpatient Sac/Val treatment demonstrated a similar beneficial effect in NT-proBNP and cardiac function. After initiating the treatment, overall and sub-population showed similar safety and efficacy. Patients who received a higher dose of Sac/Val (> 200 mg/d) demonstrated better improvement in LV function and reduction of NT-proBNP regardless of adjustment. Among Chinese HFrEF patients, Sac/Val showed a comparable reduction in NT-proBNP and improvement in cardiac function. Data further support guideline recommendations of Sac/Val in Chinese population. Optimal up-titration might provide further benefits. Further long-term and prognostic studies are needed. [ABSTRACT FROM AUTHOR]

Retrospective chart review is an accessible form of research that is commonly used across medical fields but is underutilized in behavioral health. As a relatively newer area of research, the field of pediatric integrated primary care (IPC) would particularly benefit from guidelines for conducting a methodologically sound chart review study. Here, we use our experiences building a chart review procedure for a pediatric IPC research project to offer strategies for optimizing reliability (consistency), validity (accuracy), and efficiency. We aim to provide guidance for conducting a chart review study in the specific setting of pediatric IPC so that researchers can apply this methodology toward generating research in this field. [ABSTRACT FROM AUTHOR]

Background: Fremanezumab, a fully humanized monoclonal antibody (mAb; IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved for the preventive treatment of migraine in adults. The efficacy and safety of fremanezumab for migraine prevention have been demonstrated in randomized, double-blind, placebo-controlled trials. Real-world effectiveness data are needed to complement clinical trial data. This study assessed the effectiveness of fremanezumab across different subgroups of adult patients with episodic migraine (EM), chronic migraine (CM), or difficult-to-treat (DTT) migraine in real-world clinical settings. Methods: This retrospective, panel-based online chart review used electronic case report forms. Patient inclusion criteria were a physician diagnosis of EM or CM; age ≥ 18 years at the time of first fremanezumab initiation; ≥ 1 dose of fremanezumab treatment; ≥ 1 follow-up visit since first initiation; and ≥ 2 measurements of monthly migraine days (MMD; with 1 within a month before or at first initiation and ≥ 1 after first initiation). Changes in MMD and monthly headache days were assessed during the follow-up period. These endpoints were evaluated in subgroups of patients by migraine type (EM/CM) and in subgroups with DTT migraine (diagnosis of medication overuse [MO], major depressive disorder [MDD], generalized anxiety disorder [GAD], or prior exposure to a different CGRP pathway–targeted mAb [CGRP mAb]). Results: Data were collected from 421 clinicians and 1003 patients. Mean (percent) reductions from baseline in MMD at Month 6 were − 7.7 (77.0%) in EM patients, − 10.1 (68.7%) in CM patients, − 10.8 (80.6%) in the MO subgroup, − 9.9 (68.3%) in the MDD subgroup, − 9.5 (66.4%) in the GAD subgroup, and − 9.0 (68.7%) in the prior CGRP mAb exposure subgroup. Improvements in MDD or GAD severity were reported by 45.5% and 45.8% of patients with comorbid MDD or GAD, respectively. Conclusions: In this real-world study, fremanezumab demonstrated effectiveness for migraine regardless of migraine type or the presence of factors contributing to DTT migraine (MO, GAD, MDD, or prior exposure to a different CGRP mAb). [ABSTRACT FROM AUTHOR]

Despite increasing attention on suicidality in autistic people, we know little about suicidal presentations when autistic individuals present to hospital emergency departments (ED). We conducted an exploratory retrospective chart review of suicidal thoughts and behaviours (STB) of autistic adults who presented to a psychiatric ED. The analysis included 16 charts over a 10-week period. Findings highlight that reported STB were not always the presenting issue. Life transitions and interpersonal conflicts were common antecedents, and active rumination about STB was distressing and fatiguing. Findings imply that ED visits serve as important opportunities for suicidal risk reduction for autistic individuals, through implementation of strategies for identification of STB such as active screening, and the provision of suicide resources tailored to autistic people. [ABSTRACT FROM AUTHOR]

This article describes the rate of suicidal ideation (SI) across three timepoints among treatment-seeking patients recently discharged from psychiatric hospitalization—a group that is at ultrahigh-risk for suicide. Retrospective chart review was used to quantify the rate of SI in 252 consecutive patients discharged to a post-hospital mental health clinic. Data include patients' lifetime history of SI, SI at the time of hospital intake, and SI at post-hospital outpatient clinic intake, as well as demographics and diagnosis. Overall, 67% of the sample reported a lifetime history of SI, 49% reported SI during hospital intake, and 6% reported SI at post-hospital clinic intake. Age was the only variable associated with history of SI (p =.04), with younger patients more likely (OR = 1.85) to report a history of SI. These results may help inform the development of interventions for the population of ultrahigh-risk patients being discharged from hospital after psychiatric care. [ABSTRACT FROM AUTHOR]

Purpose: Little is known about non-tobacco substance use (SU) and its treatment in cancer patients. National guidelines address tobacco only, and assessment of SU in cancer patients is not standardized. It is not clear how oncology clinicians assess, document, and follow-up on SU.Methods: We conducted an electronic health record review of patients enrolled in a smoking cessation trial at one large hospital site (N = 176). Chart review of oncology treatment notes assessed whether SU assessment was documented, the content of the documentation/assessment (e.g., frequency of use), and details about documentation (e.g., where/who documented).Results: Sixty-nine percent (121/176) of cancer patients had SU documented. Many patients (42%, 74/176) had only one substance documented; 66% (116/176) had alcohol use documented. For a substantial minority of patients (43/176; 24%), the provider did not specify the substance assessed (e.g., "drug use," "illicits"). SU was primarily documented by physicians (84%, 102/121), in routine progress notes (56%, 68/121), in the "social history" section of the note (84%, 102/121). Only 4 patients had a documented SU follow-up plan. When examining the subset of patients who reported problematic alcohol use (N = 27), the content of documentation was inconsistent (e.g., number of drinks/day vs. qualitative descriptors of use).Conclusions: About 1/3 of oncology patients did not have SU assessment documented. SU other than alcohol use was infrequently documented, many clinicians documented SU but did not specify substance type, and few clinicians documented a follow-up plan for problematic SU. Oncology settings should utilize standardized assessment and referral for SU treatment. [ABSTRACT FROM AUTHOR]

Background: The efficacy and tolerability of fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP) and is approved for the preventive treatment of migraine in adults, have been demonstrated in randomized, double-blind, placebo-controlled trials. Real-world data can further support those clinical trial data and demonstrate the full clinical benefits of fremanezumab. This chart review assessed the effectiveness of fremanezumab for improving clinical outcomes in adult patients with migraine treated according to real-world clinical practice. Methods: This retrospective, panel-based, online physician chart review study used electronic case report forms with US physicians. Patient inclusion criteria were a physician diagnosis of migraine, fremanezumab treatment initiation at ≥ 18 years of age after US Food and Drug Administration approval, ≥ 1 dose of fremanezumab treatment, and ≥ 2 assessments of monthly migraine days (MMD; 1 within 30 days before treatment initiation and ≥ 1 after initiation). Changes from baseline in MMD, monthly headache days (MHD), and Migraine Disability Assessment (MIDAS) and 6-item Headache Impact Test (HIT-6) scores were assessed over 6 months. These endpoints were evaluated in the overall population and subgroups divided by dosing schedule and number of prior migraine preventive treatment failures. Results: This study included data from 421 clinicians and 1003 patients. Mean age at fremanezumab initiation was 39.7 years, and most patients were female (75.8%). In the overall population, mean baseline MMD and MHD were 12.7 and 14.0, respectively. Mean (percent) reductions from baseline in MMD and MHD, respectively, were − 4.6 (36.2%) and − 4.7 (33.6%) at Month 1, − 6.7 (52.8%) and − 6.8 (48.6%) at Month 3, and − 9.2 (72.4%) and − 9.8 (70.0%) at Month 6. Mean (percent) reductions from baseline in MIDAS and HIT-6 scores also increased over the 6-month study period, from − 6.2 (21.6%) and − 8.4 (14.0%) at Month 1 to − 18.1 (63.1%) and − 16.2 (27.0%) at Month 6, respectively. Improvements in these outcomes over 6 months were observed across all evaluated subgroups. Conclusions: This real-world study demonstrated effectiveness of fremanezumab treatment for up to 6 months, irrespective of dosing regimen or number of prior migraine preventive treatment failures, reflecting ongoing, clinically meaningful improvements in patient outcomes. [ABSTRACT FROM AUTHOR]

Myelofibrosis (MF) is a chronic myeloproliferative neoplasm with a prevalence of 4 to 6 per 100,000 people in the USA. Treatment recommendations are risk-adapted. This study was conducted to evaluate how physicians risk-stratify patients at the time of MF diagnosis, the accuracy of the risk stratification, and its effect on treatment selection. Medical charts were reviewed at US community hematology/oncology practices in the Cardinal Health Oncology Provider Extended Network; patient clinical characteristics, risk stratification, and treatment data were collected. Physician-assigned risk categorizations were compared with data-derived risk categorizations based on the International Prognostic Scoring System, the system recommended at diagnosis. A total of 491 patients diagnosed with MF between 2012 and 2016 (mean [SD] age at diagnosis, 65.4 [11.8] years; 54.8% male, 69.2% with primary MF) were included. Risk categorization was not assigned for 30.1% of patients. Of the patients with a physician-assigned risk categorization (n = 343), a scoring system was used in 49.9%. Compared with data-derived risk categorizations, 42.9% of physician-assigned risk categorizations were incorrect; 85.0% of incorrect physician-assigned risk categorizations were underestimations. Notably, 38.5% of patients with data-derived intermediate- or high-risk categorizations did not initiate treatment within 120 days of diagnosis. Among patients with data-derived intermediate risk, those with an underestimated physician-assigned risk categorization were significantly less likely to receive treatment within 120 days of diagnosis (51.6% with correct physician-assigned categorization vs 18.5% with underestimated risk categorization; P = 0.0023). These results highlight the gap in risk assessment and the importance of accurate risk stratification at diagnosis. [ABSTRACT FROM AUTHOR]

Introduction: Pazopanib is approved in Latin America as first targeted therapy for patients with metastatic renal cell carcinoma (mRCC).Methods: A retrospective chart review of adult patients with mRCC who initiated pazopanib as first targeted therapy between January 2011 and March 2016 was conducted among oncology care centers in Argentina, Brazil, Chile, Colombia, and Mexico. Patient characteristics, treatment patterns, overall survival (OS), progression-free survival (PFS), and adverse events were summarized.Results: A total of 156 charts of patients with mRCC receiving first-line pazopanib were reviewed (29, 54, 27, 28, and 18 patients from Argentina, Brazil, Chile, Colombia, and Mexico, respectively). The mean age at initial mRCC diagnosis was 61.6 years, 73.7% were male, and 51.3% were Hispanic. The median dose of pazopanib was 800 mg and the median time from initial mRCC diagnosis to pazopanib start was 2.2 months. The median time on treatment was 10.0 months. At the time of data extraction, 16.7% of patients remained on pazopanib, with clinical progression listed as the main reason for discontinuation. Subsequent therapy was received by 25.6% of patients; the most common were everolimus (9.6%) and axitinib (5.8%). Overall, median PFS and OS were 10.8 and 16.9 months, respectively, and varied across countries. The most common all-grade adverse events were diarrhea (44.9%), asthenia/fatigue (43.6%), and nausea (28.8%).Conclusions: Pazopanib was used for first-line mRCC treatment in a clinically diverse patient population across Latin America. Real-world PFS and tolerability were similar to clinical studies of pazopanib.Funding: Novartis Pharmaceuticals Corporation, Inc. [ABSTRACT FROM AUTHOR]

Purpose: To describe patient characteristics by disease stage, resectability status and current treatment management after first diagnosis of IIIB to IV1c advanced (AM)/metastatic melanoma (MM). Methods/patients: Multicentre, retrospective study based on data from medical charts of patients > 18 years at MM first diagnosis, visited by oncologists at 4 reference centres in Spain: Hospital Universitario Gregorio Marañón (Madrid), Hospital General de Valencia (Valencia), Clínica Universidad de Navarra (Pamplona), and Hospital Clínic (Barcelona). Results: Metastatic non-visceral melanoma (IIIB, IIIC, IV M1a) was reported in 139 (48.6%) patients and 40.9% (n = 117) were diagnosed with IV-M1c disease. 160 (55.9%) metastases were resectable. Available therapies under clinical practice were used in 210 patients; 74 were treated under clinical trials (CT). Intention-to-cure surgery (47.6%) was the most common treatment at time of MM diagnosis. Systemic (45.1% overall) therapy included chemo-, targeted- and immunotherapy (19.6%, 14.3%, 8.4%, respectively). At time of data collection, 26 patients were still alive and 120 had progressed to IV-M1c. Median overall survival (OS) was significantly larger in IIIB patients, 28.9 m (25.2–32.7); the shortest for IV-M1c patients, 11.0 m (8.7–13.3). Conclusions: Novel treatments are undoubtedly a major step forward in AM/MM, however these are often only available in the CT setting because early stages of development or country-specific regulations. Further prospective studies and multifactorial analysis should be performed to clearly identify possible clinical associations for outcome in Spanish patients with AM/MM. [ABSTRACT FROM AUTHOR]

Background Drug-related problems have been identified as a major contributor to emergency room visits, hospitalizations, and death. The most commonly implicated medications are nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelets, and anticoagulants. Considering a significant proportion of these harms are preventable, indicators to identify risky prescribing before they lead to harm have been developed. Objective To examine the prevalence and patterns of potentially inappropriate prescriptions (PIPs) in a primary care population who are using high-risk medications. Setting This study was performed within two multi-disciplinary family medicine teaching clinics in Winnipeg, Canada. Method A cross-sectional electronic/paper chart audit was conducted within two multi-disciplinary family medicine teaching clinics to evaluate the prevalence of 13 evidence-based high-risk prescriptions. Patients were included if they were prescribed an oral NSAID, antiplatelet, or an anticoagulant within the 12 month period between June 2012 and June 2013. Main outcome measure The proportion of PIPs associated with an increased bleeding risk for NSAIDs, antiplatelets, and anticoagulants. Results Of the 567 patients included in the review, 198 (35 %) patients had received at least 1 PIP in the past year. The most common PIP was the use of an oral NSAID with one or more GI risk factors without adequate gastro-protection. Only 34 (6 %) of these patients received a full medication review performed by a pharmacist. Although not statistically significant, patients who received a medication review had fewer inappropriate prescriptions (27 % with review, 35 % without). Conclusion Over one-third of the patients who were using high-risk medications were using them potentially inappropriately. Although pharmacists have been shown to reduce the amount of inappropriate prescribing, very few patients using these medications were referred to the pharmacist for a full medication review. These data suggest that there is opportunity for the identification and assessment of these patients when prescribing or dispensing these high-risk medications. [ABSTRACT FROM AUTHOR]

To identify factors associated with valid Autism Spectrum Disorder (ASD) diagnoses from electronic sources in large healthcare systems. We examined 1,272 charts from ASD diagnosed youth <18 years old. Expert reviewers classified diagnoses as confirmed, probable, possible, ruled out, or not enough information. A total of 845 were classified with 81 % as a confirmed, probable, or possible ASD diagnosis. The predictors of valid ASD diagnoses were >2 diagnoses in the medical record (OR 2.94; 95 % CI 2.03-4.25; p < 0.001) and being male (OR 1.51; 95 % CI 1.05-2.17; p = 0.03). In large integrated healthcare settings, at least two diagnoses can be used to identify ASD patients for population-based research. [ABSTRACT FROM AUTHOR]

Depression, a frequent concomitant disorder in multiple sclerosis (MS), can impact MS treatment adherence and quality of life. Depression screening in MS care settings may facilitate needed intervention when providers are responsive to screening findings. This study sought to examine the relationship between depression screening results and provider depression treatment recommendations documented in the medical records of 283 patients receiving care in an integrated MS clinic. Forty-six percent of patients screening positive for depression received a treatment recommendation; females, those with past mental health diagnoses, on psychotropic medications, and those with higher symptom severity were more likely to receive a treatment recommendation. On subsequent screenings, patients reported fewer depressive symptoms regardless of whether a formal treatment recommendation was documented. These findings suggest that while depression screening does lead to depression related intervention in many cases, more research is necessary to determine who is most likely to benefit and under what conditions. [ABSTRACT FROM AUTHOR]

Learning from error is not just an individual endeavour. Organisations also learn from error. Hospitals provide many learning opportunities, which can be formal or informal. Informal learning from error in hospitals has not been researched in much depth so this narrative review focuses on five learning opportunities: morbidity and mortality conferences, incident reporting systems, patient claims and complaints, chart review and prospective risk analysis. For each of them we describe: (1) what can be learnt, categorised according to the seven CanMEDS competencies; (2) how it is possible to learn from them, analysed against a model of informal and incidental learning; and (3) how this learning can be enhanced. All CanMEDS competencies could be enhanced, but there was a particular focus on the roles of medical expert and manager. Informal learning occurred mostly through reflection and action and was often linked to the learning of others. Most important to enhance informal learning from these learning opportunities was the realisation of a climate of collaboration and trust. Possible new directions for future research on informal learning from error in hospitals might focus on ways to measure informal learning and the balance between formal and informal learning. Finally, 12 recommendations about how hospitals could enhance informal learning within their organisation are given. [ABSTRACT FROM AUTHOR]

Background: Currently available technologies for performing aesthetic body sculpting are either noninvasive but require multiple treatments to achieve relatively superficial effects or very effective but also invasive and sometimes associated with serious complications. A new, noninvasive alternative is to ablate adipose tissue using high-intensity focused ultrasound (HIFU). When focused within subcutaneous adipose tissue, HIFU quickly raises the local temperature, resulting in instantaneous cell death via coagulative necrosis within the targeted area but no damage to the surrounding tissue. Methods: A new HIFU device, the LipoSonix system (Medicis Technologies Corporation, Bothell, WA, USA), was used by our clinic staff to reduce waist circumference via removal of excess adipose tissue from the anterior abdomen and flank areas. This report describes the results of a retrospective chart review of patients at one clinic who underwent HIFU treatment of the anterior abdomen and flank areas. Results: A total of 85 men and women with a mean age of 43.8 years underwent a single HIFU treatment session. The time required to complete treatment was approximately 1 to 1.5 h. Using a mean energy level of 134.8 J/cm and a focal depth of 1.1 to 1.6 cm, the waist circumference was decreased by an average of 4.6 cm after 3 months. Of the 85 patients, 10 (11.8%) reported adverse events including prolonged tenderness ( n = 3), ecchymosis ( n = 3), hard lumps ( n = 2), edema ( n = 1), and pain ( n = 1), which resolved spontaneously. Conclusions: The authors conclude from their experience that HIFU represents a safe and effective means for performing noninvasive body sculpting. [ABSTRACT FROM AUTHOR]

Background: Chart review represents a critical cornerstone for practice-based learning and improvement in our internal medicine residency program.Objective: To document residents' performance monitoring and improvement skills in their continuity clinics, their satisfaction with practice-based learning and improvement, and their ability to self-reflect on their performance.Design: Retrospective longitudinal design with repeated measures.Participants: Eighty Internal Medicine residents abstracted data for 3 consecutive years from the medical records of their 4,390 patients in the University of Wisconsin-Madison (UW) Hospital and Clinics and William S. Middleton Veterans Administration (VA) outpatient clinics.Measurement: Logistic modeling was used to determine the effect of postgraduate year, resident sex, graduation cohort, and clinic setting on residents' "compliance rate" on 17 nationally recognized health screening and chronic disease management parameters from 2003 to 2007.Results: Residents' adherence to national preventive and chronic disease standards increased significantly from intern to subsequent years for administering immunizations, screening for diabetes, cholesterol, cancer, and behavioral risks, and for management of diabetes. Of the residents, 92% found the chart review exercise beneficial, with 63% reporting gains in understanding about their medical practices, 26% reflecting on specific gaps in their practices, and 8% taking critical action to improve their patient outcomes.Conclusions: This paper provides support for the feasibility and practicality of this limited-cost method of chart review. It also directs our residency program's attention in the continuity clinic to a key area important to internal medicine training programs by highlighting the potential benefit of enhancing residents' self-reflection skills. [ABSTRACT FROM AUTHOR]

To assess the methodology of surveys of psychoactive medication treatment, we administered the Psychoactive Medication Quality Assurance Rating Survey (PQRS), a reliable instrument for assessing the quality of the utilization of psychoactive medication via chart review by trained raters, to a simple random sample of 78 residents of an intermediate care facility for persons with mental retardation. By evaluating the clinical information, decision processes, and provisions for monitoring treatment outcome with the use of psychoactive medication, this survey utilizing the PQRS revealed multiple serious deficiencies indicating the need for immediate intervention at the institution consistent with other surveys utilizing different methods. However, a simple screening of residents for excessive dosages and inappropriate combinations of psychoactive agents detected no serious errors. Thus, we demonstrated that the PQRS fulfills its purpose to identify deficits in the utilization of psychoactive medication that are overlooked by mere determination of high doses and atypical combinations. We conclude that the PQRS is a reliable and valid instrument for surveys of the administration of psychoactive medications. [ABSTRACT FROM AUTHOR]

To facilitate surveys of psychoactive medication treatment, we developed the Psychoactive Medication Quality Assurance Rating Survey (PQRS), a 140-item chart review instrument for trained raters. Although the PQRS is appropriate for annual surveys, it is too long for regular monthly reviews. Therefore, we developed the PQRS Screening Criteria composed of 22 independent categorical items of the PQRS and two transformed items. These 24 categorical items exhibit sound reliability in the form of Cohen's kappa (κ) ≥.4 and Cronbach's α of .938. The PQRS Screening Criteria are a reliable tool for frequent clinical reviews. [ABSTRACT FROM AUTHOR]

This study examines the feasibility of using automated computer data versus written medical record data to identify patients receiving guideline concordant treatment for schizophrenia. Central elements of care derived from published practice guidelines for schizophrenia were examined for a convenience sample of 28 patients who received acute inpatient treatment. The results showed that automated data were superior to medical record data for identifying some elements of guideline-concordant treatment. Not only were the elements of care examined in this study clinically significant and within the current capabilities of the existing computer information system, but they are also likely related to patient outcomes. Implications for clinical care, future research, and health care quality improvement efforts are discussed. [ABSTRACT FROM AUTHOR]