scholarly journals 1468. Culture Conversion and Mortality in Patients With Mycobacterium abscessus (MAB) Lung Disease: A Systematic Literature Review

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S736-S736
Author(s):  
Kevin L Winthrop ◽  
Kevin C Mange ◽  
Zhanna Jumadilova ◽  
Kristan B Cline ◽  
Patrick A Flume
Keyword(s):  
Literature Review ◽  
Lung Disease ◽  
Systematic Literature Review ◽  
Panel Member ◽  
Cochrane Library ◽  
Attributable Mortality ◽  
Research Support ◽  
Persistent Symptoms ◽  
Conversion Rates ◽  
Culture Conversion

Abstract Background Prognosis for patients with MAB lung disease is poor. We sought to examine the potential association between culture conversion and outcomes (progression, mortality) in patients with MAB lung disease. Methods English-language MAB lung disease studies with ≥ 10 patients and reporting mortality and/or microbiological outcomes were identified from Embase, PubMed, relevant congress abstracts, and the Cochrane Library (data cutoff, September 24, 2019) using the National Institute for Health and Clinical Excellence guidance for systematic literature reviews. Two independent reviewers screened 1,551 indexed records; relevant extracted data are expressed as population-weighted means. Results Mean all-cause mortality across 17 studies (N=1,291) was 12.1% (range, 3%–33%); mortality attributable to MAB lung disease was 7.6% (range, 0%–27%; N=526, 9 studies). Culture conversion across 44 studies (N=2,237) was 46.7% (range, 0%–98.6%), with higher rates reported for M. massiliense subspecies (76.9%; N=507,15 studies) than M. abscessus subspecies (35.8%; N=834,18 studies). No direct comparisons were made between mortality and culture conversion; in the 13 studies (N=1,202) that reported both outcomes there was a moderate correlation between increased rate of culture conversion and decreased MAB-attributable mortality (R2=0.60). The most common definition of progression (21 studies) was radiographic worsening supported by persistent symptoms and/or positive cultures. Across 8 studies (N=415) 57.8% patients had improvement while 35.2% progressed with treatment. A broad variance in treatment regimen and duration (range, 32 days to > 3 years) was observed. Limitations include a small number of studies, and inconsistency in methods and outcomes definitions. Conclusion In this systematic literature review, available data suggest that culture conversion was achieved in less than half of patients and was lower in patients with M. abscessus compared with M. massiliense. One third of patients had disease progression despite treatment. Some data suggest lower MAB-attributed mortality outcomes in studies with higher culture conversion rates, more evidence is needed to demonstrate a survival benefit associated with culture conversion. Disclosures Kevin L Winthrop, MD, MPH, Insmed Incorporated (Consultant, Grant/Research Support) Kevin C Mange, MD, MSCE, Insmed Incorporated (Employee) Zhanna Jumadilova, MD, Insmed Incorporated (Employee) Kristan B Cline, PhD, Insmed Incorporated (Employee) Patrick A Flume, MD, Insmed Incorporated (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member)

scholarly journals 1488. Relationship Between Culture Conversion and Clinical Outcomes in Patients With Mycobacterium abscessus (MAB) Lung Disease: A Systematic Literature Review

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S746-S746
Author(s):  
Patrick A Flume ◽  
Kevin C Mange ◽  
Zhanna Jumadilova ◽  
Kristan B Cline ◽  
Kevin L Winthrop
Keyword(s):  
Quality Of Life ◽  
Lung Function ◽  
Literature Review ◽  
Lung Disease ◽  
Clinical Outcomes ◽  
Symptomatic Improvement ◽  
Symptom Improvement ◽  
Research Support ◽  
Culture Conversion

Abstract Background Treatment of MAB lung disease is difficult, and currently there is no consensus on the best course of treatment. We examined the relationship between culture conversion and clinical outcomes among patients with MAB lung disease. Methods English-language MAB lung disease studies with ≥10 patients and reporting culture conversion and/or an outcome of interest (eg, changes in symptoms, lung function, quality of life, and/or radiography) were identified from Embase, PubMed, relevant congress abstracts, and the Cochrane Library (data cutoff, September 24, 2019) using the National Institute for Health and Clinical Excellence guidance for systematic literature reviews. Two independent reviewers screened 1,551 indexed records; relevant data were extracted and are reported as population-weighted means. Results No study directly correlated culture conversion with a change in symptoms. In 10 studies (N=869) reporting overall symptoms and culture conversion separately, 72.5% of patients (range 36%–96%) reported symptom improvement and 56.5% (range, 13%-99%) achieved culture conversion; a weak trend between symptomatic improvement and higher culture conversion rates (R2=0.36) was observed. Three additional studies (N=106) reported symptomatic improvement and culture conversion as a single measurement (49.6%, range, 25%-81%). Limited data indirectly correlated improvement in cough, dyspnea, hemoptysis, sputum production, and fatigue with culture conversion (1-2 studies each). Two studies directly correlated improved lung function (N=62) with culture conversion, and one study indirectly reported improved health-related quality of life (N=47) with culture conversion; no study reported radiology outcomes in relation to culture conversion. Conclusion This systematic literature review underscores the lack of data correlating clinical outcomes and culture conversion in patients with MAB lung disease. Limitations include a small number of studies, inconsistencies/non-reporting of methods, and poorly defined outcomes. Although indirect data indicate a weak correlation between symptom improvement and culture conversion, more evidence is needed to demonstrate a clinical outcome benefit associated with culture conversion. Disclosures Patrick A Flume, MD, Insmed Incorporated (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member) Kevin C Mange, MD, MSCE, Insmed Incorporated (Employee) Zhanna Jumadilova, MD, Insmed Incorporated (Employee) Kristan B Cline, PhD, Insmed Incorporated (Employee) Kevin L Winthrop, MD, MPH, Insmed Incorporated (Consultant, Grant/Research Support)

scholarly journals 805. Amikacin Liposome Inhalation Suspension (ALIS) Add-on Therapy for Refractory Mycobacterium avium Complex (MAC) Lung Disease: Effect of In Vitro Amikacin Susceptibility on Sputum Culture Conversion

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S288-S289 ◽  
Author(s):  
Barbara A Brown-Elliott ◽  
Gina Eagle ◽  
Richard J Wallace ◽  
Jakko Van Ingen ◽  
Lian J Pennings ◽  
...  
Keyword(s):  
Lung Disease ◽  
Systemic Exposure ◽  
Macrolide Resistance ◽  
Sputum Culture ◽  
Research Support ◽  
Sputum Culture Conversion ◽  
Conversion Rates ◽  
The Impact ◽  
Culture Conversion

Abstract Background ALIS (590 mg amikacin base) is liposome-encapsulated amikacin for inhalation, which delivers amikacin directly to the lung and limits systemic exposure. In the CONVERT phase 3 trial, significantly more adults with treatment-refractory MAC lung disease receiving ALIS plus guideline-based therapy (GBT) vs. GBT alone achieved sputum culture conversion by month 6 (29.0% vs. 8.9%, P < 0.0001). Amikacin treatment failure has previously been reported in patients with amikacin minimum inhibitory concentrations (MIC) >64 µg/mL. We analyzed the impact of amikacin MIC on culture conversion during treatment with add-on ALIS. Methods In CONVERT, patients were randomly assigned (2:1) to receive once daily ALIS+GBT (n = 224) or GBT alone (n = 112). Patients with amikacin-resistant MAC isolates (MICs >64 μg/mL by broth microdilution) were excluded prior to randomization. The primary endpoint was culture conversion, defined as 3 consecutive monthly MAC-negative sputum cultures by month 6. Amikacin MICs were correlated with culture conversion rates. Results Amikacin MIC distributions at baseline (day 1) were similar in both groups (Figure 1). Conversion rates in the ALIS+GBT arm were 28.6–34.5% for MAC with amikacin MICs of 8–64 µg/mL (Figure 2). Overall, 28 patients developed post-screening amikacin MIC >64 µg/mL, 4/112 in the GBT alone arm (post-baseline), and 24/224 in the ALIS+GBT arm (1 at baseline and 23 post-baseline after adding ALIS). Most of these (18/24) had MAC isolates with persistent amikacin MIC >64 µg/mL. Only 1/24 patients in the ALIS+GBT arm with amikacin MIC >64 µg/mL achieved culture conversion. No patient with both macrolide resistance and persistent amikacin MIC >64 µg/mL (8/24) converted. Conclusion In the ALIS+GBT arm of CONVERT, culture conversion rates were similar for amikacin MICs ranging from 8–64 µg/mL at baseline. Amikacin MIC >64 µg/mL emerged in 10.3% of patients after initiation of add-on ALIS treatment, and 3.6% in the GBT alone arm. Emergent amikacin MIC >64 µg/mL was associated with failure to convert, particularly with concurrent macrolide resistance. Determining amikacin susceptibility at both treatment initiation and during treatment may have utility for guiding treatment decisions. Disclosures B. A. Brown-Elliott, Insmed: Investigator, Research support. G. Eagle, Insmed Incorporated: Employee, Salary. R. J. Wallace, Insmed: Investigator, Research support. J. Van Ingen, Insmed: Investigator, Research support. L. J. Pennings, Insmed: Investigator, Research support. B. Berry, Insmed: Investigator, Research support. S. Pandey, Insmed: Investigator, Research support. C. Coulter, Insmed: Investigator, Research support. M. Syrmis, Insmed: Investigator, Research support. K. L. Winthrop, Insmed Incorporated: Consultant and Scientific Advisor, Consulting fee and Research grant. D. E. Griffith, Aradigm Corporation: Advisor/consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. Bayer Healthcare Pharmaceuticals: Advisor/consultant, Consulting fee. Grifols: Advisor/consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. Insmed Incorporated: Advisor/consultant, Grant Investigator and Speaker’s Bureau, Consulting fee, Grant recipient and Speaker honorarium.

AB0820 COMPARATIVE EFFICACY OF GUSELKUMAB IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS FROM SYSTEMATIC LITERATURE REVIEW AND NETWORK META-ANALYSIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1713-1714
Author(s):  
I. Mcinnes ◽  
P. J. Mease ◽  
K. Eaton ◽  
A. Schubert ◽  
S. Peterson ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Literature Review ◽  
Adverse Events ◽  
Systematic Literature Review ◽  
Targeted Therapies ◽  
Meta Analysis ◽  
Tumor Necrosis Factor Inhibitor ◽  
Forest Plot ◽  
Research Support ◽  
Phase 3

Background:The efficacy of the interleukin (IL)-23 subunit p19 inhibitor guselkumab (GUS) for psoriatic arthritis (PsA) has recently been demonstrated in two Phase 3 trials (DISCOVER-1 & -2) but has not been evaluated versus existing targeted therapies for PsA.Objectives:To compare GUS to targeted therapies for PsA through network meta-analysis (NMA).Methods:A systematic literature review was performed to identify PsA randomized controlled trials from 2000 to 2018. Bayesian NMAs were performed to compare treatments on American College of Rheumatology (ACR) 20/50/70 response, Psoriasis Area Severity Index (PASI) 75/90/100 response, Health Assessment Questionnaire Disability Index (HAQ-DI) score, resolution of enthesitis (RoE), resolution of dactylitis (RoD), adverse events (AEs) and serious adverse events (SAEs). Analyses used random effects models that adjusted for placebo response via meta-regression on baseline risk when feasible. Results are summarized by ranking treatments according to median absolute probabilities of response derived from NMAs.Results:Twenty-six Phase 3 studies were included in the quantitative synthesis. Studies were placebo-controlled up to 24 weeks and evaluated 13 targeted therapies for PsA. Absolute probabilities are reported for PASI 90 & ACR 20 responses according toFigure 1,and a forest plot of relative risks versus placebo for AEs is reported according toFigure 2. For ACR 20 response, GUS 100 mg every 4 weeks (Q4W) and every 8 weeks (Q8W) ranked 5th and 8th out of 20 interventions and were comparable to IL-17A inhibitor (IL-17Ai) and most tumor necrosis factor inhibitor (TNFi) agents. Similar findings were observed for ACR 50 and 70 responses. For PASI 90 response, GUS Q4W and Q8W ranked 1st and 2nd out of 15 interventions and were highly likely to provide a greater benefit than most other agents. Similar findings were observed for PASI 75 and 100 responses. For HAQ-DI score, GUS Q4W and Q8W ranked 6th and 10th out of 20 interventions and were comparable to IL-17Ai and most TNFi agents. For RoE, GUS Q4W and Q8W ranked 8th and 6th out of 13 interventions and were comparable to IL-17Ai and TNFi agents. For RoD, GUS Q4W and Q8W ranked 8th and 9th out of 13 interventions and were comparable to most IL-17Ai and TNFi agents. For AEs, GUS Q4W and Q8W ranked 3rd and 2nd out of 19 interventions and were comparable to IL-17Ai and TNFi agents. Likewise, for SAEs, GUS Q4W and Q8W ranked 4th and 5th out of 20 interventions and were comparable to IL-17Ai and TNFi agents. Analyses that controlled for previous exposure to biologics or assessed outcomes at alternative timepoints were broadly consistent with primary analysis results.Conclusion:NMA results indicate that GUS is comparable to most targeted PsA treatments for improvement in arthritis, soft tissue damage, physical function, and safety outcomes. For PASI outcomes, GUS is highly likely to provide a greater benefit than other targeted PsA treatments.Disclosure of Interests:Iain McInnes Grant/research support from: Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, Novartis, Pfizer, and UCB, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau, Kiefer Eaton Shareholder of: Test Pharma, Consultant of: Janssen, Agata Schubert Employee of: Janssen-Cilag, Steve Peterson Employee of: Janssen Research & Development, LLC, Tim Disher Consultant of: Janssen, Wim Noel Employee of: Janssen Pharmaceuticals NV, Hassan Fareen Employee of: Janssen, Chetan Karyekar Shareholder of: Johnson & Johnson, Consultant of: Janssen, Employee of: Janssen Global Services, LLC. Previously, Novartis, Bristol-Myers Squibb, and Abbott Labs., Suzy Van Sanden Employee of: Janssen, Christopher T. Ritchlin Grant/research support from: UCB Pharma, AbbVie, Amgen, Consultant of: UCB Pharma, Amgen, AbbVie, Lilly, Pfizer, Novartis, Gilead, Janssen, Wolf-Henning Boehncke Grant/research support from: Janssen Research & Development, LLC, Consultant of: Janssen

Arachnoid web of the spine: a systematic literature review

2019 ◽  
Vol 31 (2) ◽  
pp. 175-184 ◽  
Author(s):  
Peyton L. Nisson ◽  
Ibrahim Hussain ◽  
Roger Härtl ◽  
Samuel Kim ◽  
Ali A. Baaj
Keyword(s):  
Literature Review ◽  
Systematic Literature Review ◽  
Thoracic Spine ◽  
Case Reports ◽  
Neurological Function ◽  
Sensory Loss ◽  
Cochrane Library ◽  
Radiographic Findings ◽  
Ovid Medline ◽  
The Mean

OBJECTIVEAn arachnoid web of the spine (AWS) is a rare and oftentimes challenging lesion to diagnose, given its subtle radiographic findings. However, when left untreated, this lesion can have devastating effects on a patient’s neurological function. To date, only limited case reports and series have been published on this topic. In this study, the authors sought to better describe this lesion, performing a systematic literature review and including 2 cases from their institution’s experience.METHODSA systematic literature search was performed in September 2018 that queried Ovid MEDLINE (1946–2018), PubMed (1946–2018), Wiley Cochrane Library: Central Register of Controlled Trials (1898–2018), and Thompson Reuters Web of Science: Citation Index (1900–2018), per PRISMA guidelines. Inclusion criteria specified all studies and case reports of patients with an AWS in which any relevant surgery types were considered and applied. Studies on arachnoid cysts and nonhuman populations, and those that did not report patient treatments or outcomes were excluded from the focus review.RESULTSA total of 19 records and 2 patients treated by the senior authors were included in the systematic review, providing a total of 43 patients with AWS. The mean age was 52 years (range 28–77 years), and the majority of patients were male (72%, 31/43). A syrinx was present in 67% (29/43) of the cases. All AWSs were located in the thoracic spine, and all but 2 (95%) were located dorsally (1 ventrally and 1 circumferentially). Weakness was the most frequently reported symptom (67%, 29/43), followed by numbness and/or sensory loss (65%, 28/43). Symptoms predominated in the lower extremities (81%, 35/43). It was found that nearly half (47%, 20/43) of patients had been experiencing symptoms for 1 year or longer before surgical intervention was performed, and 35% (15/43) of reports stated that symptoms were progressive in nature. The most commonly used surgical technique was a laminectomy with intradural excision of the arachnoid web (86%, 36/42). Following surgery, 91% (39/43) of patients had reported improvement in their neurological symptoms. The mean follow-up was 9.2 months (range 0–51 months).CONCLUSIONSAWS of the spine can be a debilitating disease of the spine with no more than an indentation of the spinal cord found on advanced imaging studies. The authors found this lesion to be reported in twice as many males than females, to be associated with a syrinx more than two-thirds of the time, and to only have been reported in the thoracic spine; over 90% of patients experienced improvement in their neurological function following surgery.

scholarly journals PRS1 Systematic Literature Review of Treatments for Interstitial Lung Disease in Patients with a Progressive Fibrosing Phenotype

2020 ◽  
Vol 23 ◽  
pp. S716
Author(s):  
K.B. Rohr ◽  
M. Baldwin ◽  
C. Sabry-Grant ◽  
B. Langford ◽  
F. Salih ◽  
...  
Keyword(s):  
Interstitial Lung Disease ◽  
Literature Review ◽  
Lung Disease ◽  
Systematic Literature Review

scholarly journals Symptom prevalence of patients with fibrotic interstitial lung disease: a systematic literature review

2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Sabrina Carvajalino ◽  
Carla Reigada ◽  
Miriam J. Johnson ◽  
Mendwas Dzingina ◽  
Sabrina Bajwah
Keyword(s):  
Interstitial Lung Disease ◽  
Literature Review ◽  
Lung Disease ◽  
Systematic Literature Review ◽  
Symptom Prevalence

scholarly journals Who Should Discuss Advance Directives With Patients With Cancer and When? A Systematic Literature Review

2020 ◽  
Author(s):  
Pierre Boyer ◽  
Laëtitia Gimenez ◽  
Vladimir Druel ◽  
Alicia Marcaud ◽  
Marie-Eve Rougé-Bugat
Keyword(s):  
Literature Review ◽  
Advance Directives ◽  
Systematic Literature Review ◽  
Data Bank ◽  
Cochrane Library ◽  
Patients With Cancer ◽  
Public Health Data ◽  
Opportune Time ◽  
The Subject ◽  
Methodological Aspects

Abstract Background Among patients with cancer, discussion about the desired care is important, because progression of the disease, particularly signs of impaired consciousness, can lead to unwanted care in situations where no advance directives (ADs) have been provided. The aim of this study was to identify the most appropriate individual and time for addressing the subject of ADs with patients with cancer.Methods A systematic literature review was carried out between September 2014 and August 2015, using the following databases or sets of databases: PubMed, Web of Science, Cochrane Library, EM Premium, and the French database Public Health Data Bank. The methodological aspects of the articles were selected and evaluated with the help of PRISMA international guidelines.Results Of the 1170 articles identified, 7 were included (6 descriptive studies, 1 interventional study). A doctor was cited as the preferred individual for discussing the subject of advance directives with the patient. In 3 studies, this was listed as a general practitioner, whereas in the other 3 studies, it was an oncologist. The most opportune time was during the absence of a serious pathology (3 studies) and at the time the disease was diagnosed (2 studies).Conclusions Our results support the goals of Claeys-Leonetti, a 2016 French law concerned with the rights of patients receiving end-of-life care, and they suggest the implementation of a consultation for discussing and drafting ADs.

scholarly journals Efficiency measures of emergency departments: an Italian systematic literature review

2021 ◽  
Vol 10 (3) ◽  
pp. e001058
Author(s):  
Danilo Di Laura ◽  
Lucia D'Angiolella ◽  
Lorenzo Mantovani ◽  
Ginevra Squassabia ◽  
Francesco Clemente ◽  
...  
Keyword(s):  
Literature Review ◽  
Systematic Literature Review ◽  
Emergency Departments ◽  
Critical Role ◽  
Evidence Base ◽  
Healthcare Systems ◽  
Cochrane Library ◽  
Number Of Patients ◽  
The World

Life expectancy globally increased in the last decades: the number of people aged 65 or older is consequently projected to grow, and healthcare demand will increase as well. In the recent years, the number of patients visiting the hospital emergency departments (EDs) rocked in almost all countries of the world. These departments are crucial in all healthcare systems and play a critical role in providing an efficient assistance to all patients. A systematic literature review covering PubMed, Scopus and the Cochrane Library was performed from 2009 to 2019. Of the 718 references found in the literature research, more than 25 studies were included in the current review. Different predictors were associated with the quality of EDs care, which may help to define and implement preventive strategies in the near future. There is no harmonisation in efficiency measurements reflecting the performance in the ED setting. The identification of consistent measures of efficiency is crucial to build an evidence base for future initiatives. The aim of this study is to review the literature on the problems encountered in the efficiency of EDs around the world in order to identify an organisational model or guidelines that can be implemented in EDs to fill inefficiencies and ensure access optimal treatment both in terms of resources and timing. This review will support policy makers to improve the quality of health facilities, and, consequently of the entire healthcare systems.

scholarly journals Monitoring of Systemic Lupus Erythematosus Pregnancies: A Systematic Literature Review

2018 ◽  
Vol 45 (10) ◽  
pp. 1477-1490 ◽  
Author(s):  
Emily G. McDonald ◽  
Lyne Bissonette ◽  
Stephanie Ensworth ◽  
Natalie Dayan ◽  
Ann E. Clarke ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Lupus Erythematosus ◽  
Umbilical Artery ◽  
Grey Literature ◽  
Cochrane Library ◽  
Doppler Studies ◽  
Systemic Lupus ◽  
Umbilical Artery Doppler

Objective.Few data exist to guide the frequency and type of monitoring in systemic lupus erythematosus (SLE) pregnancies. A systematic literature review was performed to address this gap in the literature.Methods.A systematic review of original articles (1975–2015) was performed using Medline, Embase, and Cochrane Library. We included search terms for SLE, pregnancy, and monitoring. We also hand-searched reference lists, review articles, and grey literature for additional relevant articles.Results.The search yielded a total of 1106 articles. After removing 117 duplicates, 929 articles that were evidently unrelated to our topic based on title and/or abstract, and 7 that were in a language other than English or French, 53 articles were included for full-text review. Following a more in-depth review, 15 were excluded: 6 did not use any measure of SLE activity and 6 did not specifically address SLE monitoring in pregnancy; 1 case series, 1 review, and 1 metaanalysis were removed. Among the 38 included studies, presence of active disease, antiphospholipid (aPL) antibodies positivity, and abnormal uterine and umbilical artery Doppler studies predicted poor pregnancy outcomes. No studies evaluated an evidence-based approach to the frequency of monitoring.Conclusion.Few existing studies address monitoring for optimal care during SLE pregnancies. The available data imply roles for aPL antibodies measurement (prior to pregnancy and/or during the first trimester), uterine and umbilical artery Doppler studies in the second trimester, and following disease activity. Optimal frequency of monitoring is not addressed in the existing literature.

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