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Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol
Short-term studies indicate that bempedoic acid, an ATP citrate lyase inhibitor, reduces LDL cholesterol levels. In a 1-year trial, bempedoic acid added to maximally tolerated statin therapy did not lead to a higher incidence of adverse events than placebo and led to significantly lower LDL cholesterol levels.
Journal Article
Feminist art activisms and artivisms
The first volume in the new Plural series, this publication seeks to critically dissect the term 'activism,' which today seems to have become a catchword for any woman's empowerment through the arts, and reveal the diversity of practices and realities that it comprises. Presenting a range of critical insights, perspectives, and practices from artists, activists, and academics, it reflects on the role of feminist interventions in the field of contemporary art, the public sphere, and politics. In the process, it touches upon broader questions of cultural difference, history, class, economic standing, ecological issues, and sexual orientation, as well as the ways in which these intersect.
Book
Effect of ETC-1002 on Serum Low-Density Lipoprotein Cholesterol in Hypercholesterolemic Patients Receiving Statin Therapy
ETC-1002 is an oral, once-daily medication that inhibits adenosine triphosphate citrate lyase, an enzyme upstream of 3-hydroxy-3-methylglutaryl-coenzyme A reductase, to reduce cholesterol biosynthesis. ETC-1002 monotherapy has demonstrated significant reduction in low-density lipoprotein cholesterol (LDL-C) compared with placebo in phase 2 studies. The objective of this study was to compare the lipid-lowering efficacy of ETC-1002 versus placebo when added to ongoing statin therapy in patients with hypercholesterolemia. This phase 2b, multicenter, double-blind trial (NCT02072161) randomized 134 hypercholesterolemic patients (LDL-C, 115 to 220 mg/dl) on stable background statin therapy to 12 weeks of add-on treatment with ETC-1002 120 mg, ETC-1002 180 mg, or placebo. The primary efficacy end point was the percent change in calculated LDL-C from baseline to week 12. For LDL-C, the least-squares mean percent change ± standard error from baseline to week 12 was significantly greater with ETC-1002 120 mg (−17 ± 4%, p = 0.0055) and ETC-1002 180 mg (−24 ± 4%, p <0.0001) than placebo (−4 ± 4%). ETC-1002 also dose dependently reduced apolipoprotein B by 15% to 17%, non–high-density lipoprotein cholesterol by 14% to 17%, total cholesterol by 13% to 15%, and LDL particle number by 17% to 21%. All these reductions in ETC-1002–treated cohorts were significantly greater than those with placebo. Rates of adverse events (AEs), muscle-related AEs, and discontinuations for AEs with ETC-1002 were similar to placebo. In conclusion, ETC-1002 120 mg or 180 mg added to stable statin therapy significantly reduced LDL-C compared to placebo and has a similar tolerability profile.
Journal Article
Clinical practice guideline recommendation summaries for pediatric oncology health care professionals: A qualitative study
To develop a summary format of clinical practice guideline (CPG) recommendations to improve understandability among health care professionals.
We developed a summary format based on current research and used the \"Think Aloud\" technique in one-on-one cognitive interviews to iteratively improve it. Interviews of health care professionals from Children's Oncology Group-member, National Cancer Institute Community Oncology Research Program sites were conducted. After every five interviews (a round), responses were reviewed, and changes made to the format until it was well understood and no new, substantive suggestions for revision were raised. We took a directed (deductive) approach to content analysis of the interview notes to identify concerns related to recommendation summary usability, understandability, validity, applicability and visual appeal.
During seven rounds of interviews with 33 health care professionals, we identified important factors that influenced understandability. Participants found understanding weak recommendations more challenging than strong recommendations. Understanding was improved when the term 'conditional' recommendation was used instead of 'weak' recommendation. Participants found a Rationale section to be very helpful but desired more information when a recommendation entailed a practice change. In the final format, the recommendation strength is clearly indicated in the title, highlighted, and defined within a text box. The rationale for the recommendation is in a column on the left, with supporting evidence on the right. In a bulleted list, the Rationale section describes the benefits and harms and additional factors, such as implementation, that were considered by the CPG developers. Each bullet under the supporting evidence section indicates the level of evidence with an explanation and the supporting studies with hyperlinks when applicable.
A summary format to present strong and conditional recommendations was created through an iterative interview process. The format is straightforward, making it easy for organizations and CPG developers to use it to communicate recommendations clearly to intended users.
Journal Article
Galactomannan, β-D-Glucan, and Polymerase Chain Reaction–Based Assays for the Diagnosis of Invasive Fungal Disease in Pediatric Cancer and Hematopoietic Stem Cell Transplantation: A Systematic Review and Meta-Analysis
We systematically reviewed and analyzed the available data for galactomannan (GM), β-D-glucan (BG), and polymerase chain reaction (PCR)–based assays to detect invasive fungal disease (IFD) in patients with pediatric cancer or undergoing hematopoietic stem cell transplantation when used as screening tools during immunosuppression or as diagnostic tests in patients presenting with symptoms such as fever during neutropenia (FN). Of 1532 studies screened, 25 studies reported on GM (n = 19), BG (n = 3), and PCR (n = 11). All fungal biomarkers demonstrated highly variable sensitivity, specificity, and positive predictive values, and these were generally poor in both clinical settings. GM negative predictive values were high, ranging from 85% to 100% for screening and 70% to 100% in the diagnostic setting, but failure to identify non-Aspergillus molds limits its usefulness. Future work could focus on the usefulness of combinations of fungal biomarkers in pediatric cancer and HSCT.
Journal Article
Optimizing symptom control in children and adolescents with cancer
There is growing recognition of the degree to which symptoms negatively impact on children receiving cancer treatments. A recent study described that almost all inpatient pediatric oncology patients are experiencing at least one bothersome symptom and almost 60% are experiencing at least one severely bothersome symptom. Poor symptom control occurs because of challenges with communication of bothersome symptoms to clinicians, lack of clinical practice guidelines (CPGs) for most of these symptoms, and failure to administer preventative and therapeutic interventions known to be effective for symptom control. This article reviews approaches used to improve symptom control for children receiving cancer treatments. Areas addressed include systematic symptom screening and creation of CPGs for symptom management. Challenges with electronic health integration are also addressed. Several multi-symptom assessment scales have been developed but none have yet been used to directly influence patient management. The number of CPGs applicable to symptom control in pediatric oncology is increasing but remains small. Improving the creation of and adherence to CPGs for symptom management is an important priority. Finally, identifying ways that symptom management systems can be integrated into clinical work flows is essential; these will likely need to focus on electronic health records.
Journal Article
Efficacy of antibiotic prophylaxis in patients with cancer and hematopoietic stem cell transplantation recipients: A systematic review of randomized trials
Purpose To determine the efficacy and safety of different prophylactic systemic antibiotics in adult and pediatric patients receiving chemotherapy or undergoing hematopoietic stem cell transplantation (HSCT). Methods We conducted a systematic review and performed searches of Ovid MEDLINE, MEDLINE in‐process and Embase; and Cochrane Central Register of Controlled Trials. Studies were included if patients had cancer or were HSCT recipients with anticipated neutropenia, and the intervention was systemic antibacterial prophylaxis. Strategies synthesized included fluoroquinolone vs no antibiotic/nonabsorbable antibiotic; fluoroquinolone vs trimethoprim‐sulfamethoxazole; trimethoprim‐sulfamethoxazole vs no antibiotic; and cephalosporin vs. no antibiotic. Fluoroquinolone vs cephalosporin and levofloxacin vs ciprofloxacin were compared by network meta‐analysis. Primary outcome was bacteremia. Results Of 20 984 citations screened, 113 studies comparing prophylactic antibiotic to control were included. The following were effective in reducing bacteremia: fluoroquinolone vs no antibiotic/nonabsorbable antibiotic (risk ratio (RR) 0.56, 95% confidence interval (CI) 0.41‐0.76), trimethoprim‐sulfamethoxazole vs no antibiotic (RR 0.59, 95% CI 0.41‐0.85) and cephalosporin vs no antibiotic (RR 0.30, 95% CI 0.16‐0.58). Fluoroquinolone was not significantly associated with increased Clostridium difficile infection (RR 0.62, 95% CI 0.31‐1.24) or invasive fungal disease (RR 1.28, 95% CI 0.79‐2.08) but did increase resistance to fluoroquinolone among bacteremia isolates (RR 3.35, 95% CI 1.12 to 10.03). Heterogeneity in fluoroquinolone effect on bacteremia was not explained by evaluated study, population, or methodological factors. Network meta‐analysis revealed no direct comparisons for pre‐specified analyses; superior regimens were not identified. Conclusions Fluoroquinolone, trimethoprim‐sulfamethoxazole, and cephalosporin prophylaxis reduced bacteremia. A clinical practice guideline to facilitate prophylactic antibiotic decision‐making is required. A systematic review was conducted to determine the efficacy and safety of antibiotic prophylaxis in patients with cancer and hematopoietic stem cell transplantation recipients. Heterogeneity in the effect of fluoroquinolone prophylaxis was evaluated and a network meta‐analysis was performed to contrast therapies in which no direct comparative trials exist. The systematic review results indicate fluoroquinolone, trimethoprim‐sulfamethoxazole, and cephalosporin prophylaxis reduce bacteremia but do not reduce overall mortality.
Journal Article
The role of surgical resection in the management of newly diagnosed brain metastases: a systematic review and evidence-based clinical practice guideline
Question
Should patients with newly-diagnosed metastatic brain tumors undergo open surgical resection versus whole brain radiation therapy (WBRT) and/or other treatment modalities such as radiosurgery, and in what clinical settings?
Target population
These recommendations apply to adults with a newly diagnosed single brain metastasis amenable to surgical resection.
Recommendations
Surgical resection plus WBRT versus surgical resection alone
Level 1
Surgical resection followed by WBRT represents a superior treatment modality, in terms of improving tumor control at the original site of the metastasis and in the brain overall, when compared to surgical resection alone.
Surgical resection plus WBRT versus SRS ± WBRT
Level 2
Surgical resection plus WBRT, versus stereotactic radiosurgery (SRS) plus WBRT, both represent effective treatment strategies, resulting in relatively equal survival rates. SRS has not been assessed from an evidence-based standpoint for larger lesions (>3 cm) or for those causing significant mass effect (>1 cm midline shift).
Level 3
Underpowered class I evidence along with the preponderance of conflicting class II evidence suggests that SRS
alone
may provide equivalent functional and survival outcomes compared with resection + WBRT for patients with single brain metastases, so long as ready detection of distant site failure and salvage SRS are possible.
Note
The following question is fully addressed in the WBRT guideline paper within this series by Gaspar et al. Given that the recommendation resulting from the systematic review of the literature on this topic is also highly relevant to the discussion of the role of surgical resection in the management of brain metastases, this recommendation has been included below.
Question
Does surgical resection in addition to WBRT improve outcomes when compared with WBRT alone?
Target population
This recommendation applies to adults with a newly diagnosed single brain metastasis amenable to surgical resection; however, the recommendation does not apply to relatively radiosensitive tumors histologies (i.e., small cell lung cancer, leukemia, lymphoma, germ cell tumors and multiple myeloma).
Recommendation
Surgical resection plus WBRT versus WBRT alone
Level 1
Class I evidence supports the use of surgical resection plus post-operative WBRT, as compared to WBRT alone, in patients with good performance status (functionally independent and spending less than 50% of time in bed) and limited extra-cranial disease. There is insufficient evidence to make a recommendation for patients with poor performance scores, advanced systemic disease, or multiple brain metastases.
Journal Article
Third-Wave Therapies for Long-Term Neurological Conditions: A Systematic Review to Evaluate the Status and Quality of Evidence
Background: Adults with long-term neurological conditions can face complex challenges including anxiety and depression. Emerging research suggests the utility of third-wave approaches (the third development of psychotherapies) in working transdiagnostically with these difficulties. Aims: This systematic review sought to summarise and appraise the quality of published empirical studies using third-wave therapies such as Compassion Focused Therapy; Acceptance and Commitment Therapy; and Mindfulness-Based Cognitive Therapy or Mindfulness-Based Stress Reduction. Method: Review procedures followed PRISMA guidelines, with 437 abstracts screened, 24 full-text articles retrieved and 19 studies found to meet inclusion criteria. Six out of seven randomised studies had unclear or high risk of bias, whilst the majority of non-randomised studies were considered moderate quality. Results: Overall, studies reported a statistically significant reduction in emotional distress. Of the 13 studies that used model-specific process measures, 10 found statistically significant improvements in transdiagnostic factors. Discussion: The findings indicate that third-wave therapies show promise in addressing transdiagnostic difficulties within neurological conditions. A number of methodological and conceptual issues for the included studies were highlighted during the quality appraisal process. Clinical implications include consideration of intervention length and use of outcome measures. Research implications are discussed by considering the progressive stages of development for behavioural treatments.
Journal Article