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1.
Alexander Liede Sally Wade Jan Lethen Rohini K. Hernandez Douglas Warner Amy P. Abernethy Antonio Finelli 《Clinical therapeutics》2018,40(4):536-549.e3
Purpose
This observational study of oncologic clinical practices was designed to describe real-world patterns of use of emerging therapies (abiraterone acetate, cabazitaxel, enzalutamide, radium-223, sipuleucel-T) in patients with castration-resistant prostate cancer and to characterize their concomitant use with denosumab or zoledronic acid.Methods
A retrospective cohort study was conducted using a database of electronic health records from oncology practices across the United States. Eligible patients had a diagnosis of prostate cancer (International Classification of Diseases, Ninth Revision [ICD-9] code 185/International Classification of Diseases, Tenth Revision [ICD-10] code C61) before or concurrent with a visit between January 1, 2013, and December 31, 2015; follow-up was performed through June 30, 2016. From this population, we identified those who received an emerging therapy and a subset who also received denosumab or zoledronic acid.Findings
A total of 71,606 men met the eligibility criteria, and 5131 (7%) received emerging therapy. In the emerging therapy cohort (at the time of the first use), median age was 75 years, median prostate-specific antigen value was 22.7 ng/mL, 56% had bone metastases, and 80% were docetaxel naive. Abiraterone and enzalutamide were the most commonly used first emerging therapies (52% and 31%, respectively), followed by sipuleucel-T (9%), cabazitaxel (5%), and radium-223 (1.5%). Of the emerging therapy cohort, 3121 patients (61%) received concomitant denosumab (70%) or zoledronic acid (35%); 5% received both.Implications
Among patients with prostate cancer treated in the United States, most of those treated with an emerging therapy between 2013 and 2015 also received denosumab or zoledronic acid, suggesting that the concomitant use of these therapy types is currently a common practice. Use of denosumab or zoledronic acid was higher in patients with verified bone metastases. 相似文献2.
Olga Růžičková Zdenko Killinger Petr Kasalický Lisa Hamilton Roman Tyl Soňa Tomková Lama Kalouche-Khalil 《Advances in therapy》2018,35(10):1713-1728
Introduction
Osteoporosis is characterized by low bone mineral density (BMD) and an increased risk of fracture. In randomized controlled trials, denosumab has been shown to significantly reduce the fracture risk in women with osteoporosis. However, little is known about the real-world management of women who are prescribed denosumab.Methods
This multicenter, prospective, observational real-world study in the Czech Republic and Slovakia evaluated the baseline characteristics and clinical management of women with postmenopausal osteoporosis prescribed denosumab for 24 months.Results
A total of 600 women were included (300 in each country). In the Czech Republic and Slovakia, respectively, mean age at enrollment was 69.0 and 64.3 years, 67.7% and 30.0% of patients had a previous osteoporotic fracture, and 85.0% and 48.7% had previously received osteoporosis medication. In both countries, ‘low BMD T score’ and ‘a history of osteoporotic fracture’ were the main reasons for prescribing denosumab. Most patients received all four post-baseline denosumab injections (Czech Republic, 82.0%; Slovakia, 81.0%), and more than 98% of patients in both countries received all injections at the prescribing center. At 24 months, most patients experienced an increase in BMD T score for the lumbar spine, total hip, or femoral neck (Czech Republic, 69.7–91.7%; Slovakia, 67.1–92.9%). Adverse drug reactions were consistent with the known safety profile of denosumab.Conclusion
Baseline characteristics of patients receiving denosumab in the Czech Republic and Slovakia reflect the reimbursement criteria for this agent in each country. The findings of our study in patients who are at high risk for fracture are consistent with the growing body of evidence demonstrating the effectiveness of denosumab in real-world clinical practice.Trial Registration
ClinicalTrials.gov identifier, NCT01652690.Funding
Amgen Inc.3.
Mohit Kumar Adam Chapman Saad Javed Uazman Alam Rayaz A Malik Shazli Azmi 《Clinical therapeutics》2018,40(6):850-861
Purpose
This review provides an update on the investigations and treatment options for gastroparesis.Methods
A comprehensive literature search of Medline, PubMed, Embase and OVID was conducted which included all systematic reviews and research articles that focused on the diagnosis, investigations and management diabetic gastroparesis.Findings
Dietary modifications and pharmacologic treatment with prokinetics to increase gastric motility form the mainstay of treatment. However, the use of prokinetics is limited by adverse effects and serious adverse effects, leaving metoclopramide as the only drug approved by the US Food and Drug Administration for the treatment of gastroparesis. Newer therapies, including motilin receptor agonists, ghrelin receptor agonists, and neurokinin receptor antagonists, are currently being investigated. Transpyloric stenting, gastric electrical stimulation, and gastric per-oral endoscopic myotomy provide mechanical options for intervention, and surgical interventions in severe intractable gastroparesis include laparoscopic pyloroplasty or gastrectomy.Implications
Advances to better understand the pathophysiology and management of diabetic gastroparesis have been limited, especially with discordance between symptoms and severity of delay in gastric emptying. Established treatment options are limited; however, recent pharmacologic and surgical interventions show promise. 相似文献4.
Rahul P. Patel Jilson Jacob Mohammed Sedeeq Long Chiau Ming Troy Wanandy Syed Tabish R. Zaidi Gregory M. Peterson 《Clinical therapeutics》2018,40(4):664-667
Purpose
The aim was to investigate the stability of cefazolin in elastomeric infusion devices.Methods
Elastomeric devices (Infusor LV) that contain cefazolin (3 g/240 mL and 6 g/240 mL) were prepared and stored at 4°C for 72 hours and then at 35°C for 12 hours, followed by 25°C for 12 hours. An aliquot was withdrawn at predefined time points and analyzed for the concentration of cefazolin. Samples were also assessed for changes in pH, solution color, and particle content.Findings
Cefazolin retained acceptable chemical and physical stability over the studied storage period and conditions.Implications
These findings will allow the administration of cefazolin by the Infusor LV elastomeric device in the outpatient and remote settings. 相似文献5.
Purpose
The ability of sophisticated sensors and medical devices to monitor critical biomarkers has the potential to greatly advance precision medicine initiatives. A stakeholder event was organized to develop working models for the evolution of the field.Methods
A workshop devoted to the subject matter was held at the Tufts Clinical and Translational Science Institute involving clinicians, device developers, regulators, engineers, and scientists.Findings
Several areas for collaborative development were identified and interested teams offered resources for development of research programs.Implications
The diversity of relevant stakeholders presents a major opportunity and challenge in translational research. It is evident that the CTSI national network can take a leadership role in the rapidly advancing and potentially transformative field of digital biomarkers. 相似文献6.
Purpose
The goal of this study was to compile a review of topics pertinent to the use of immune checkpoint inhibitors in gynecologic malignancies, including foundation for use, current agents available and trials in gynecologic cancers, special populations of interest, identification and management of toxicities, and considerations in predictive biomarkers and response assessment.Methods
A literature review of selected topics in reference to immune checkpoint inhibitors and gynecologic cancers was conducted on PubMed and the US Food and Drug Administration drug search application. A review of current and ongoing clinical trials was performed in clinicaltrials.gov, and selected preliminary results reported in PubMed abstracts and through the American Society of Clinical Oncologists were compiled.Findings
Although immunotherapy in gynecologic malignancy is relatively new, 7 agents are currently approved for use in other oncologic indications, and a multitude of trials in gynecologic cancer are ongoing. Immunotherapy has a specific set of drug toxicities that manifest and are managed unlike traditional cytotoxic therapies.Implications
Application of the knowledge of immune checkpoint inhibitor use in gynecologic cancers will improve care for women with cancers of the female reproductive tract. As more complex and newer immunotherapies evolve, it will be vital to accurately characterize each specific drug class and management thereof. 相似文献7.
Purpose
The extent to which new drug developers can benefit financially from shorter development times has implications for development efficiency and innovation incentives. We provided a real-world example of such gains by using recent estimates of drug development costs and returns.Methods
Time and fee data were obtained on 5 single-source manufacturing projects. Time and fees were modeled for these projects as if the drug substance and drug product processes had been contracted separately from 2 vendors. The multi-vendor model was taken as the base case, and financial impacts from single-source contracting were determined relative to the base case.Findings
The mean and median after-tax financial benefits of shorter development times from single-source contracting were $44.7 million and $34.9 million, respectively (2016 dollars). The after-tax increases in sponsor fees from single-source contracting were small in comparison (mean and median of $0.65 million and $0.25 million).Implications
For the data we examined, single-source contracting yielded substantial financial benefits over multi-source contracting, even after accounting for somewhat higher sponsor fees. 相似文献8.
Objective
The research identified the influence of assertiveness training against teenage depression in high scholars in Kepahiang Regency, Bengkulu, Indonesia.Method
This study used a quasi-experiment approach with pre-test and post-test design and a control group. Eighty students were engaged through simple random sampling.Results
The study found the frequency of depression in teenagers and considered the effect of assertiveness training. 14.10 teens were counted as depressed before assertiveness training provision, while the post-training average was 7.98 (p = .000). Assertiveness training had a significant effect on the prevalence of depression in the intervention group.Conclusions
The study recommends schools to cooperate with health services to increase mental health programs such as building peer groups, delivering assertiveness training, and teaching stress management to prevent depression in teenagers. 相似文献9.
Purpose
The decline of central nervous system (CNS) function is a hallmark characteristic of multiple sclerosis (MS) that can manifest as cognitive impairment. We believe that exercise represents a potential behavioral approach for counteracting the declines in CNS structure and associated function among persons with MS (ie, exercise as a countermeasure of CNS decline). This theory is important because disease-modifying drugs represent a first-line approach for modifying the immune system and its effects on the CNS, but these drugs do not generally demonstrate robust improvements in cognitive performance.Methods
To the best of our knowledge, this article presents the first argument positioning exercise as a countermeasure for CNS decline in MS.Finding
The reviewed research indicates a proliferating body of evidence describing physical fitness, physical activity, and exercise effects on cognitive performance and neuroimaging outcomes (ie, CNS functioning) in MS, with the consistent and strong association between cognitive performance and neuroimaging outcomes in this population as a backdrop.Implications
We further present a framework and future research directions for better positioning exercise as a possible neuroprotective behavior against declining CNS function in MS. 相似文献10.
Naomi C. Sacks Philip L. Cyr Arthur C. Louie Yanmei Liu Michael T. Chiarella Abhishek Sharma Karen C. Chung 《Clinical therapeutics》2018,40(5):692-703.e2
Purpose
Acute myeloid leukemia (AML) disproportionately affects older adults; the prognosis in this subpopulation is generally poor, with variable use of inpatient chemotherapy. This study characterizes treatment patterns, hospitalizations, and outcomes among older patients with AML.Methods
Using the Centers for Medicare & Medicaid Services' 2010–2012 100% Limited Data Set (LDS), data from all hospital claims from fee-for-service Medicare beneficiaries between 60 and 75 years of age with newly diagnosed AML and ≥1 hospitalization were analyzed.Findings
Among 3700 identified patients with AML, 1979 (53.5%) received chemotherapy. Hospitalization rates were highest initially and then declined over time, irrespective of chemotherapy use. The mean length of initial hospital stay was longer in patients receiving chemotherapy. Intensive care unit admissions occurred in 33% of initial hospitalizations. Factors associated with receiving chemotherapy included younger age, fewer comorbidities, and the absence of prior hematologic disorders. Chemotherapy was associated with significantly increased survival compared with no chemotherapy (P < 0.0001).Implications
AML in older patients is associated with frequent hospitalizations and intensive care unit admissions. New treatment options with more favorable risk-to-benefit profiles are needed in this population. 相似文献11.
Akira Iwama Junichi Hirayama Masayuki Nogawa Masayuki Shiba Masahiro Satake Shigeru Takamoto Kenji Tadokoro 《Transfusion and apheresis science》2017,56(2):241-244
Background
Washed platelet concentrate (WPC) is prepared manually in general, but automated preparation is desirable to minimize variation in the WPC quality and enhance WPC production. Recently, the software was improved for an automated cell processor (ACP) to control all processes of WPC preparation. M-sol and BRS-A, which are mixtures of medical solutions, are widely used for WPC preparation with a manual method in Japan. In this study, we prepared WPC suspended in M-sol (WPC-M) or BRS-A (WPC-B) with the ACP, and compared their in vitro properties during 7-day storage.Study design and methods
PC was divided into two equal aliquots for WPC-M and WPC-B. A divided PC, medical solutions and disposable materials were set in the ACP, and it was started to prepare WPC-M or WPC-B on Day 0. Prepared WPC was stored on a flatbed shaker until Day 7.Results
The pH of WPC-M and WPC-B was maintained above 6.8 during the 7-day storage. The differences in aggregation (%), HSR (%), P-selectin expression, GPIbα expression, and phosphatidylserine expression between WPC-M and WPC-B were minimal until Day 3.Conclusion
The in vitro properties of WPC-B are not markedly different from those of WPC-M until Day 3. 相似文献12.
Tasneem Islam Alison M. Hutchinson Tracey K. Bucknall 《Collegian (Royal College of Nursing, Australia)》2018,25(4):401-407
Background
Nurse managers enact changes to practice based on information collected from the local ward environment with the aid of electronic risk management and incident reporting systems. Despite being key users of electronic risk management and incident reporting systems, little knowledge exists on nurse managers’ use and communication of information derived from these systems.Aim
This qualitative study aimed to explore nurse manager information requirements, risk management practices, and influences on decision-making when interacting with an electronic risk management and incident reporting system.Methods
Focus groups with eight nurse managers were conducted at a teaching hospital in Melbourne, Australia.Findings
Decision-making and information management approaches varied depending on whether the nurse manager investigated a single incident report or viewed summarised incident reports. Thematic and content analysis produced three themes: navigating the system, relying on data, and communication and feedback.Discussion
Nurse managers faced individual and organisational barriers preventing them from using the risk management and incident reporting system to its full potential.Conclusion
The findings from this study will assist nursing and health care administrators in identifying ineffective practice and meeting nurse manager information requirements. 相似文献13.
Diana Gritsenko Marianna Fedorenko Jorg J. Ruhe Jerry Altshuler 《Clinical therapeutics》2017,39(1):212-218
Purpose
Although vancomycin has been the mainstay of therapy for methicillin-resistant Staphylococcus aureus (MRSA) infections, its effectiveness has been challenged. Combination therapy may be used for patients with persistent MRSA bacteremia refractory to initial therapy. Studies have reported in vitro synergy between vancomycin and ceftaroline; however, clinical experience with this therapy is limited. Here, we report our experience with 5 cases of vancomycin-refractory MRSA bacteremia treated with the combination of vancomycin and ceftaroline.Methods
Between January 2014 and August 2016, 5 patients were identified who received vancomycin and ceftaroline combination therapy due to persistent bacteremia or deterioration of their clinical status on vancomycin alone (despite a vancomycin MIC within the susceptible range).Findings
Five patients presented with MRSA bacteremia secondary to endocarditis (n = 2), epidural abscess (n = 2), or left iliopsoas abscess (n = 1). Four of the 5 patients experienced microbiologic cure, and 1 patient transitioned to palliative care.Implications
This case series serves to describe additional clinical experience with vancomycin and ceftaroline combination therapy. This combination may be considered when vancomycin monotherapy does not lead to microbiological and/or clinical improvement in patients with metastatic MRSA bacteremia. Additional studies are warranted to further define its role in salvage therapy for persistent MRSA bacteremia. 相似文献14.
Objective
This study aimed to identify the association between stereotyping and professional intercollaborative practice.Method
This study used a cross-sectional analytical study involving physicians, nurses, pharmacists, and dietitians in a hospital in Jakarta, Indonesia, who were selected using the stratified random sampling method. Data was collected using the Student Stereotypes Rating Questionnaire (SSRQ) and the Assessment of Interprofessional Team Collaboration Scale (AITCS). The stereotyping level was analyzed based on a nine-point SSRQ, while interprofessional collaborative practice was scored based on partnership/shared decision-making, cooperation, and coordination.Results
Stereotyping was shown to significantly correlate with interprofessional collaborative practice as measured by the SSRQ and AITCS.Conclusions
Poor interprofessional collaborative practice in subscale partnership/decision-making was dominant. Also, low-rating stereotyping was shown to be dominant with poor interprofessional collaborative practice.Recommendation
The research recommends that health care providers improve partnership/ decision-making skills for better interprofessional collaboration. For further research, it's recommended to explore another barrier of interprofessional collaborative practice. 相似文献15.
Zohaib Iqbal Shazli Azmi Rahul Yadav Maryam Ferdousi Mohit Kumar Daniel J. Cuthbertson Jonathan Lim Rayaz A. Malik Uazman Alam 《Clinical therapeutics》2018,40(6):828-849
Purpose
Diabetic peripheral neuropathy (DPN) is the commonest cause of neuropathy worldwide, and its prevalence increases with the duration of diabetes. It affects approximately half of patients with diabetes. DPN is symmetric and predominantly sensory, starting distally and gradually spreading proximally in a glove-and-stocking distribution. It causes substantial morbidity and is associated with increased mortality. The unrelenting nature of pain in this condition can negatively affect a patient's sleep, mood, and functionality and result in a poor quality of life. The purpose of this review was to critically review the current literature on the diagnosis and treatment of DPN, with a focus on the treatment of neuropathic pain in DPN.Methods
A comprehensive literature review was undertaken, incorporating article searches in electronic databases (EMBASE, PubMed, OVID) and reference lists of relevant articles with the authors' expertise in DPN. This review considers seminal and novel research in epidemiology; diagnosis, especially in relation to novel surrogate end points; and the treatment of neuropathic pain in DPN. We also consider potential new pharmacotherapies for painful DPN.Findings
DPN is often misdiagnosed and inadequately treated. Other than improving glycemic control, there is no licensed pathogenetic treatment for diabetic neuropathy. Management of painful DPN remains challenging due to difficulties in personalizing therapy and ascertaining the best dosing strategy, choice of initial pharmacotherapy, consideration of combination therapy, and deciding on defining treatment for poor analgesic responders. Duloxetine and pregabalin remain first-line therapy for neuropathic pain in DPN in all 5 of the major published guidelines by the American Association of Clinical Endocrinologists, American Academy of Neurology, European Federation of Neurological Societies, National Institute of Clinical Excellence (United Kingdom), and the American Diabetes Association, and their use has been approved by the US Food and Drug Administration.Implications
Clinical recognition of DPN is imperative for allowing timely symptom management to reduce the morbidity associated with this condition. 相似文献16.
Marguerite Littleton-Kearney 《Nursing outlook》2018,66(5):470-472
Background
Pragmatic clinical trials are used to test the efficacy of interventions in a real-world clinical practice setting.Purpose
The purpose of this article was to summarize the presentation given at the Council on Advancement of Nursing Science 2017 Meeting.Methods
Key science focus areas of the National Institute of Nursing Research (NINR) and the National Institutes of Health (NIH) guidelines relevant to pragmatic clinical trials were reviewed.Discussion
The NIH supports some large-scale pragmatic trials and NINR participates in two of them. Generally, the NINR supports small-scale pragmatic trials that are a mission fit with the NINR. Now pragmatic trials are subject to the new NIH clinical trial requirements.Conclusion
Investigators must respond to a specific clinical trial announcement and use the new clinical trial application forms. The NINR program staff are a valuable resource to answer questions that investigators may have regarding their pragmatic clinical trial proposal. 相似文献17.
Lishi Wang Yanhong Cao Mingji Ren Amei Chen Jinglin Cui DiaJun Sun Weikuan Gu 《Clinical therapeutics》2017,39(1):34-54
Purpose
Understanding how sex impacts the efficacy of anticancer agents is a crucial step toward personalized and precision medicine. This review and meta-analysis evaluated sex differences in hazard ratios (HRs) of progression-free survival and overall survival in representative Phase III clinical trials of non–small-cell lung cancer (NSCLC).Methods
Data were extracted from 24 large-scale clinical trials that included 12,000 male and 7000 female patients. The data were examined for HR differences between subgroups by sex, smoking status, and age, and for potential sex–smoking status, sex–age, and sex–drug interactions, during cancer treatment.Findings
Summarized information revealed variations in the influences of sex, smoking status, and age on the efficacy of drugs used for the treatment of NSCLC. The male and female subgroups had different HR values. Smoking status, age, and the percentage of female patients in a treatment group had no influence on the sex HR. The sex difference was supported by a set of data collected from all journals.Implications
The findings from this meta-analysis are important for assessing potential toxicity during drug treatment in both sexes. The outcomes measures of a drug in clinical application should be specified by subpopulation, such as males versus females, as a first step in personalized medicine. 相似文献18.
Marie-Ève Bérubé Stéphane Poitras Marc Bastien Lydie-Anne Laliberté Anyck Lacharité Douglas P. Gross 《Physiotherapy》2018,104(1):1-8
Background
Many physiotherapists underuse evidence-based practice guidelines or recommendations when treating patients with musculoskeletal disorders, yet synthesis of knowledge translation interventions used within the field of physiotherapy fails to offer clear conclusions to guide the implementation of clinical practice guidelines.Objectives
To evaluate the effectiveness of various knowledge translation interventions used to implement changes in the practice of current physiotherapists treating common musculoskeletal issues.Data sources
A computerized literature search of MEDLINE, CINHAL and ProQuest of systematic reviews (from inception until May 2016) and primary research studies (from January 2010 until June 2016).Study selection and eligibility criteria
Eligibility criteria specified articles evaluating interventions for translating knowledge into physiotherapy practice.Data extraction and data synthesis
Two reviewers independently screened the titles and abstracts, reviewed full-text articles, performed data extraction, and performed quality assessment. Of a total of 13 014 articles located and titles and abstracts screened, 34 studies met the inclusion criteria, including three overlapping publications, resulting in 31 individual studies.Results
Knowledge translation interventions appear to have resulted in a positive change in physiotherapist beliefs, attitudes, skills and guideline awareness. However, no consistent improvement in clinical practice, patient and economic outcomes were observed.Limitations
The studies included had small sample sizes and low methodological quality. The heterogeneity of the studies was not conducive to pooling the data.Conclusions and implication of key findings
The intensity and type of knowledge translation intervention seem to have an effect on practice change. More research targeting financial, organizational and regulatory knowledge translation interventions is needed. 相似文献19.
Stefano Raffaele Giannubilo Angela Pasculli Chiara Ballatori Alessandra Biagini Andrea Ciavattini 《Clinical therapeutics》2018,40(4):587-592
Purpose
This was a prospective observational cohort study that aimed to determine whether fetal sex influences the maternal and fetal outcomes of gestational diabetes mellitus (GDM).Methods
In this study, 327 European primiparous women were consecutively recruited after diagnosis of GDM. AUC on the oral glucose tolerance test (OGTT), need for insulin therapy, maternal and obstetrical outcomes, and fetal fat mass (by measuring the thickness of the anterior abdominal subcutaneous tissue) were recorded and compared between the two subgroups of female and male fetuses.Findings
Despite the absence of differences in multiple comparisons of the OGTT, the AUC–OGTT was significantly higher in women carrying a male fetus (22.6 [3.2] mmol/L vs 19.7 [2.8] mmol/L). The abdominal fat thickness appeared to increase with gestational age, with higher growth in male fetuses than in female fetuses. The overall risk of need for insulin therapy was significantly higher in women carrying a male fetus (odds ratio = 1.837). At delivery, birthweight was higher in males than in females only if adjusted for gestational age, similarly for placental weight, otherwise there were no significant differences between the groups in total length of gestation, rates of cesarean delivery, and Apgar scores.Implications
Overall, our data propose an association between fetal sex and GDM outcomes, suggesting the hypothesis that in maternal–fetal interactions, the fetus can affect maternal glucose metabolism. 相似文献20.
Carla J. Jonker Marcel S.G. Kwa H. Marijke van den Berg Arno W. Hoes Peter G.M. Mol 《Clinical therapeutics》2018,40(5):768-773