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1.
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2.
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3.
Basmah Safdar Gail D’Onofrio James Dziura Raymond R. Russell Caitlin Johnson Albert J. Sinusas 《Clinical therapeutics》2017,39(1):55-63
Purpose
Coronary microvascular dysfunction (CMD) is a common but underdiagnosed cause of chest pain. Literature is scant regarding effective treatments. We explored the effect of ranolazine on coronary flow reserve (CFR) among symptomatic patients with CMD.Methods
This pilot double-blinded randomized controlled trial included emergency department patients with chest pain and CMD admitted to an observation unit between June 2014 and November 2015. Participants were assessed by cardiac Rb-82 positron emission tomography and computed tomography imaging at baseline and 30 days. CMD was defined as CFR <2 corrected for rate pressure product or <2.5 uncorrected, with no evidence of obstructive or nonobstructive coronary artery disease or calcification. Patients with infarction, hypertensive urgency, heart failure, or prescribed QTc-prolonging drugs were excluded. Participants were assigned to ranolazine or placebo in a 2:1 ratio. Primary outcome was change in CFR at 30 days.Findings
We enrolled 31 patients (71% female, mean [SD] age 50 [6] years) with CMD (mean [SD] corrected CFR 1.6 [0.3]). Ranolazine improved CFR at 30 days by 17% (P = 0.005) compared with 0% with placebo (P = 0.67). However, there was no significant difference in the primary outcome as measured by mean change in CFR (0.27 ranolazine compared with 0.06 placebo; 95% CI, ?0.08 to 0.62).Implications
The emergency department offers a unique venue to diagnose CMD with acute symptoms. In an exploratory randomized controlled trial of symptomatic patients with CMD and no coronary artery disease, promising results were seem with ranolazine and CFR improving at 30 days. Large robust clinical trials are needed to verify improvement of CMD in a sex-specific model. ClinicalTrials.gov identifier NCT02052011. 相似文献4.
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5.
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6.
Liping Yan Xiaohong Kan Limei Zhu Kaijin Xu Jianjun Yin Li Jie Yong Li Ji Yue Wenyu Cui Juan Du Lihua Wang Shouyong Tan Xiangao Jiang Zhong Zeng Shenghui Xu Lin Wang Yu Chen Weiguo He Heping Xiao 《Clinical therapeutics》2018,40(3):440-449
Purpose
We designed a prospective, multicenter, randomized, controlled study to assess a 5-month regimen compared with the standard regimen on previously treated patients with pulmonary tuberculosis (TB).Methods
We enrolled 917 sputum smear–positive patients undergoing additional treatment in 27 major tuberculosis hospitals in China. Patients were randomly assigned to a test group (n = 626)treated with a 5-month regimen of moxifloxacin, pasiniazid, rifabutin, ethambutol, and pyrazinamide or a reference group (n = 291) treated with an 8-month regimen of isoniazid, rifampicin, and streptomycin. All patients with a favorable response were followed up for 5 years after the end of treatment.Findings
Of the study patients, 61 in the test group and 19 in the reference group had multidrug-resistant (MDR) TB. The treatment success rate in the study group was 74.12%, which was significantly higher than the 67.70% in the reference group (P = 0.04), whereas the treatment success rate of patients with MDR-TB was not significantly different between the test and reference groups (70.5% vs 63.1%, P =0.79). The adverse effects rates in the test and reference groups were 7.4% and 3.1%, respectively (P = .01). The difference in the TB recurrence rates between the group arm (9.6%) and the reference group (21.8%) was statistically significant (P < 0.001).Implications
The moxifloxacin, pasiniazid, rifabutin, ethambutol, and pyrazinamide test regimen yielded higher success and lower recurrence rates than the currently recommended isoniazid, rifampicin, and streptomycin regimen, but the rate of adverse effects was higher. ClinicalTrials.gov identifier: NCT02331823. 相似文献7.
Aarane M. Ratnaseelan Irene Tsilioni Theoharis C. Theoharides 《Clinical therapeutics》2018,40(6):903-917
Purpose
The effects of air pollutants have been receiving increased attention both clinically and in the media. One such pollutant is mold, fungal growth in the form of multicellular filaments known as hyphae. The growth of molds is omnipresent not only in outdoor settings but also in indoor environments containing excessive amounts of moisture.Methods
PubMed was searched for relevant articles using terms such as mold, mycotoxins, fungi, immunity, inflammation, neurodevelopment, cognition, Alzheimer's, and autism.Findings
Exposure to molds is most commonly associated with allergies and asthma. However, it is now thought to be associated with many complex health problems, since some molds, especially Trichoderma, Fusarium and Stachybotrys spp, produce mycotoxins that are absorbed from the skin, airways, and intestinal lining. People exposed to molds and mycotoxins present with symptoms affecting multiple organs, including the lungs, musculoskeletal system, as well as the central and peripheral nervous systems. Furthermore, evidence has recently implicated exposure to mycotoxins in the pathogenesis of autism spectrum disorder. The effects of mycotoxins can be mediated via different pathways that include the secretion of pro-inflammatory cytokines, especially from mast cells.Implications
The information reviewed indicates that exposure to mold and mycotoxins can affect the nervous system, directly or through immune cell activation, thus contributing to neurodevelopmental disorders such as autism spectrum disorder. 相似文献8.
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9.
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10.
11.
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12.
James A. McKinnell Shelby Corman Dipen Patel Grace H. Leung Lynne M. Gordon Thomas P. Lodise 《Clinical therapeutics》2018,40(3):406-414.e2
Purpose
Clinicians and stewardship programs are challenged with positioning of novel, higher priced antibiotic agents for the treatment of clinical infections. We developed a decision-analytic model to describe costs, including drug, total treatment costs, and health care outcomes, associated with telavancin (TLV) compared with vancomycin (VAN) for patients with Staphylococcus aureus (SA) hospital-acquired bacterial pneumonia (HABP).Methods
This decision-analytic model assessed the treatment of SA-HABP with TLV versus VAN. Data were obtained from the ATTAIN (Assessment of Telavancin for Treatment of Hospital-Acquired Pneumonia) clinical trials on the following: the probability of clinical cure; probability of nephrotoxicity; and prevalence of polymicrobial infection (30%), methicillin-resistant Staphylococcus aureus (MRSA) (68%), and SA with VAN MIC ≥1 µg/mL (85%). Data on length of stay for cure (10 days), failure (10 additional days), and nephrotoxicity (3.5 days) were based on literature. Cost per treated patient and incremental cost-effectiveness ratio (ICER) per additional cure were calculated for SA-HABP and for monomicrobial SA-HABP. One-way sensitivity analyses were performed.Findings
Patients with SA-HABP were sub-grouped by methicillin susceptibility (n = 140, 32%) or resistance (n = 293, 68%), and occurrence of polymicrobial (n = 128, 30%) vs monomicrobial (n = 305, 70%) infections. Under the base case, hospital cost for patients with HABP treated with TLV was $42,564 and with VAN, it was $42,296. Telavancin was associated with higher drug ($2082) and nephrotoxicity ($467) costs and lower intensive care unit (?$1738) and ventilator (?$114) costs. ICER was $4156 per additional cure. ICER was sensitive to probabilities of cure, length of treatment in cures, intensive care unit cost, TLV cost, and additional length of stay due to failure. For monomicrobial SA-HABP, TLV was associated with a net cost savings of $907 per patient and yielded economic dominance.Implications
Our decision-analytic model suggests that TLV for monomicrobial SA-HABP is associated with higher drug acquisition costs but a favorable ICER relative to VAN, provided that effective antimicrobial stewardship limits therapy to 7 days. Sensitivity analyses suggest a potential economic benefit of TLV treatment with appropriate patient selection. Antimicrobial stewardship programs may be able to reduce total costs through judicious use of novel antimicrobial agents. ClinicalTrials.gov identifiers: NCT00107952 and NCT00124020. 相似文献13.
Xiaojie Wu Yunfei Li Jing Zhang Yingyuan Zhang Jicheng Yu Guoying Cao Yuancheng Chen Beining Guo Yaoguo Shi Jun Huang Yuran Cao Xiaofang Liu Jufang Wu Mikhail Fedorovich Gordeev Hong Yuan Wen Wang 《Clinical therapeutics》2018,40(2):322-332.e5
Purpose
This study was designed to evaluate the safety and pharmacokinetic profiles of MRX-I tablet, an oxazolidinone antibacterial agent, in healthy Chinese subjects.Methods
The study was composed of 3 sequential periods. Period 1 was a randomized, double-blind, placebo-controlled, sequential ascending dose (50 to 1800 mg) study. Period 2 included one arm as a randomized, open-label, 3-period, 3 × 3 Latin square single-dose study of 300, 600, and 900 mg MRX-I administration and another arm as a crossover study to evaluate high-fat diet effect. Period 3 was a randomized, double-blind, placebo-controlled multiple-dose study with 600 or 800 mg, q12h regimens over 15 days.Findings
MRX-I was rapidly absorbed and reached peak plasma concentration at about 2 hours post dose. The Cmax was 8.07, 12.24, and 15.25 mg/L and the corresponding AUC0?∞ 29.21, 48.27, and 59.60 mg/h/L, in 300-, 600-, and 900-mg dosing groups, respectively. High-fat diet increased the exposure of MRX-I. No discernable drug accumulation was observed after 15 days of continuous drug administration. About 2% of MRX-I was excreted via kidneys in unchanged form. No obvious hematologic toxicity by MRX-I was observed during the entire study. Based on Monte Carlo simulation, 600 or 800 mg BID can produce satisfactory efficacy against methicillin-resistant Staphylococcus aureus.Implications
MRX-I was well tolerated in healthy Chinese subjects (50–1800 mg). No serious or severe adverse effects were observed. MRX-I 600 or 800 mg BID up to 15 days can be recommended in future clinical trials. Chinese Clinical Trial Registration (http://www.chinadrugtrials.org.cn) identifier: CTR20131214. 相似文献14.
Stacy M. Harnish Amy D. Rodriguez Deena Schwen Blackett Christopher Gregory Lauren Seeds Jeffrey H. Boatright Bruce Crosson 《Clinical therapeutics》2018,40(1):35-48.e6
Purpose
This study investigated whether participation in aerobic exercise enhances the effects of aphasia therapy, and the degree to which basal serum brain-derived neurotropic factor (BDNF) concentrations fluctuate after the beginning of aerobic exercise or stretching activities in individuals with poststroke aphasia.Methods
The study used a single-subject, multiple-baseline design. Seven individuals with chronic poststroke aphasia participated in 2 Blocks of aphasia therapy: aphasia therapy alone (Block 1), followed by aphasia therapy with the addition of aerobic activity via bicycle ergometer (n = 5) or stretching (n = 2) (Block 2). Serum BDNF concentrations from blood draws were analyzed in 4 participants who exercised and in 1 participant who stretched.Findings
Three of the five exercise participants demonstrated larger Tau-U effects when aphasia therapy was paired with aerobic exercise, whereas 1 of the 2 stretching participants demonstrated a larger effect size when aphasia therapy was paired with stretching. Group-level comparisons revealed a greater overall increase in effect size in the aerobic exercise group, as indicated by differences in Tau-U weighted means. BDNF data showed that all 4 exercise participants demonstrated a decrease in BDNF concentrations during the first 6 weeks of exercise and an increase in BDNF levels near or at baseline during the last 6 weeks of exercise. The stretching participant did not show the same pattern.Implications
Additional research is needed to understand the mechanism of effect and to identify the factors that mediate response to exercise interventions, specifically the optimal dose of exercise and timing of language intervention with exercise. ClinicalTrials.gov identifier: NCT01113879. 相似文献15.
Chee Hae Kim Kyung Ah Han Jaemyung Yu Sang Hak Lee Hui Kyung Jeon Sang Hyun Kim Seok Yeon Kim Ki Hoon Han Kyungheon Won Dong-Bin Kim Kwang-Jae Lee Kyungwan Min Dong Won Byun Sang-Wook Lim Chul Woo Ahn SeongHwan Kim Young Joon Hong Jidong Sung Hyo-Soo Kim 《Clinical therapeutics》2018,40(1):83-94
Purpose
The purpose of this study was to examine the efficacy and safety of adding ω-3 fatty acids to rosuvastatin in patients with residual hypertriglyceridemia despite statin treatment.Methods
This study was a multicenter, randomized, double-blind, placebo-controlled study. After a 4-week run-in period of rosuvastatin treatment, the patients who had residual hypertriglyceridemia were randomized to receive rosuvastatin 20 mg/d plus ω-3 fatty acids 4 g/d (ROSUMEGA group) or rosuvastatin 20 mg/d (rosuvastatin group) with a 1:1 ratio and were prescribed each medication for 8 weeks.Findings
A total of 201 patients were analyzed (mean [SD] age, 58.1 [10.7] years; 62.7% male). After 8 weeks of treatment, the percentage change from baseline in triglycerides (TGs) and non–HDL-C was significantly greater in the ROSUMEGA group than in the rosuvastatin group (TGs: ?26.3% vs ?11.4%, P < 0.001; non–HDL-C: ?10.7% vs ?2.2%, P = 0.001). In the linear regression analysis, the lipid-lowering effect of ω-3 fatty acids was greater when baseline TG or non?HDL-C levels were high and body mass index was low. The incidence of adverse events was not significantly different between the 2 groups.Implications
In patients with residual hypertriglyceridemia despite statin treatment, a combination of ω-3 fatty acids and rosuvastatin produced a greater reduction of TGs and non?HDL-C than rosuvastatin alone. Further study is needed to determine whether the advantages of this lipid profile of ω-3 fatty acids actually leads to the prevention of cardiovascular event. ClinicalTrials.gov identifier: NCT03026933. 相似文献16.
Ryan Jajosky Mark Floyd Thomas Thompson James Shikle 《Transfusion and apheresis science》2017,56(4):591-594
Background
The PLASMIC score was recently described as a convenient tool for predicting ADAMTS13 activity ≤10% in patients with possible thrombotic thrombocytopenic purpura (TTP), while awaiting the results of this send-out test. The purpose of this study was to validate the PLASMIC score at our University Medical Center.Methods
Apheresis records were reviewed from 2008 to 2017 to identify patients who received plasma exchange (PLEX) for suspected TTP. The ADAMTS13 activity and PLASMIC scoring criteria were recorded, and the PLASMIC score was calculated.Results
Of the 41 patients identified, 20 met inclusion criteria, of which 7 patients had ADAMTS13 activity ≤10%. Intermediate and high PLASMIC scores had 100% sensitivity, 46.2% specificity, 50% positive predictive value (PPV), and 100% negative predictive value (NPV).Conclusion
These results are consistent with the original validation study of the PLASMIC score, supporting the efficacy of the PLASMIC score and validating its use at our institution. 相似文献17.
Purpose
Techniques used to identify AmpC β-lactamases in SPICE (Serratia, Pseudomonas, indole-positive Proteus, Citrobacter, and Enterobacter) organisms are not yet optimized for the clinical laboratory and are not routinely used. Clinicians are often left with an uncertainty on the choice of antibiotic when a SPICE organism is isolated. The purpose of this study was to evaluate the outcomes of carbapenem versus noncarbapenem regimens in treating bacteremia or urinary tract infection from a SPICE organism in clinical practice.Methods
This single-center, retrospective, cohort study analyzed data from adult patients who had clinical infection with a SPICE organism isolated from blood or urine cultures. Patients were assigned to a carbapenem- or noncarbapenem-treated group. The primary end point was clinical response, defined as a resolution of signs and symptoms of infection at the end of therapy.Findings
A total of 332 patients were assessed, and 145 patients met the inclusion criteria for the study. There were 20 patients who received a carbapenem, while 125 received a noncarbapenem regimen. The percentage of patients who were bacteremic was 46.2%. Clinical response overall was achieved in 80% of patients on a carbapenem versus 90.3% of patients on a noncarbapenem regimen (P = 0.24). The rate of microbiologic cure was 90% in patients on a carbapenem versus 91.2% in patients on a noncarbapenem regimen (P = 1).Implications
In this study in patients treated for infection with a SPICE organism in clinical practice, the rates of clinical response did not differ significantly between the carbapenem and noncarbapenem groups. Current CLSI breakpoints set for SPICE organisms may still be reliable and may not require additional testing for AmpC β-lactamases. 相似文献18.
Kathryn Wirtz Rugen Mary A. Dolansky Maya Dulay Samuel King Nancy Harada 《Nursing outlook》2018,66(1):25-34
Background
The Institute of Medicine has recommended the establishment of residency programs for advanced practice nursing graduates. Currently, the evidence about program effectiveness is limited.Purpose
To describe the nurse practitioner (NP) resident outcomes on seven competency domains established by the VA Centers of Excellence in Primary Care Education (VA CoEPCE).Methods
We evaluated mean NP resident competency self-ratings and mean mentor ratings over the 12-month program across NP residency programs at five sites. Highest and lowest rated items and differences between NP resident self-ratings and mentor ratings were analyzed.Results
Mean NP resident self-ratings and mean mentor ratings demonstrated statistically significant improvement in all domains (p < .0001). At 12 months, NP residents were rated by their mentors as able to practice without supervision in all competency domains. At 1 and 12 months, clinical, leadership and quality improvement/population management competencies were the lowest scored domains while patient-centered care, interprofessional team collaboration, shared decision-making and sustained relationships competencies were highest.Conclusions
These results provide initial evidence for the effectiveness of VA CoEPCE NP residency programs and also highlight areas of needed improvement. 相似文献19.
Kathryn Wirtz Rugen Nancy Harada Faith Harrington Mary A. Dolansky Judith L. Bowen 《Nursing outlook》2018,66(4):352-364