scholarly journals Effectiveness of low-dose theophylline for the management of biomass-associated COPD (LODOT-BCOPD): study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Trishul Siddharthan ◽  
Suzanne L. Pollard ◽  
Peter Jackson ◽  
Nicole M. Robertson ◽  
Adaeze C. Wosu ◽  
...  
Keyword(s):  
Air Pollution ◽  
Risk Factor ◽  
Cost Effectiveness ◽  
Low Dose ◽  
Controlled Trial ◽  
High Income ◽  
Household Air Pollution ◽  
Full Time ◽  
Biomass Smoke ◽  
Life Years

Abstract Background COPD is a leading cause of death globally, with the majority of morbidity and mortality occurring in low- and middle-income country (LMIC) settings. While tobacco-smoke exposure is the most important risk factor for COPD in high-income settings, household air pollution from biomass smoke combustion is a leading risk factor for COPD in LMICs. Despite the high burden of biomass smoke-related COPD, few studies have evaluated the efficacy of pharmacotherapy in this context. Currently recommended inhaler-based therapy for COPD is neither available nor affordable in most resource-limited settings. Low-dose theophylline is an oral, once-a-day therapy, long used in high-income countries (HICs), which has been proposed for the management of COPD in LMICs in the absence of inhaled steroids and/or bronchodilators. The Low-dose Theophylline for the Management of Biomass-Associated COPD (LODOT-BCOPD) trial investigates the clinical efficacy and cost-effectiveness of low-dose theophylline for the management of biomass-related COPD in a low-income setting. Methods LODOT-BCOPD is a randomized, double-blind, placebo-controlled trial to test the efficacy of low-dose theophylline in improving respiratory symptoms in 110 participants with moderate to severe COPD in Central Uganda. The inclusion criteria are as follows: (1) age 40 to 80 years, (2) full-time resident of the study area, (3) daily biomass exposure, (4) post-bronchodilator FEV1/FVC below the 5th percentile of the Global Lung Initiative mixed ethnic reference population, and (5) GOLD Grade B-D COPD. Participants will be randomly assigned to receive once daily low-dose theophylline (200 mg ER, Unicontin-E) or placebo for 52 weeks. All participants will receive education about self-management of COPD and rescue salbutamol inhalers. We will measure health status using the St. George’s Respiratory Questionnaire (SGRQ) and quality of life using the EuroQol-5D (EQ-5D) at baseline and every 6 months. In addition, we will assess household air pollution levels, serum inflammatory biomarkers (fibrinogen, hs-CRP), and theophylline levels at baseline, 1 month, and 6 months. The primary outcome is change in SGRQ score at 12 months. Lastly, we will assess the cost-effectiveness of the intervention by calculating quality-adjusted life years (QALYs) from the EQ-5D. Trial registration ClinicalTrials.gov NCT03984188. Registered on June 12, 2019 Trial acronym Low-dose Theophylline for the Management of Biomass-Associated COPD (LODOT-BCOPD)

scholarly journals Effectiveness of Low-dose Theophylline for the Management of Biomass-Associated COPD (LODOT-BCOPD): Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Trishul Siddharthan ◽  
Suzanne L Pollard ◽  
Peter Jackson ◽  
Nicole M Robertson ◽  
Adaeze C Wosu ◽  
...  
Keyword(s):  
Air Pollution ◽  
Risk Factor ◽  
Cost Effectiveness ◽  
Low Dose ◽  
Controlled Trial ◽  
High Income ◽  
Household Air Pollution ◽  
Full Time ◽  
Biomass Smoke ◽  
Life Years

Abstract Background: COPD is a leading cause of death globally, with the majority of morbidity and mortality occurring in low- and middle-income country (LMIC) settings. While tobacco-smoke exposure is the most important risk factor for COPD in high-income settings, household air pollution from biomass-smoke combustion is a leading risk factor for COPD in LMICs. Despite the high burden of biomass smoke-related COPD, few studies have evaluated the efficacy of pharmacotherapy in this context. Currently recommended inhaler-based therapy for COPD is neither available nor affordable in most resource-limited settings. Low-dose theophylline is an oral, once-a-day therapy, long used in high-income countries (HIC), which has been proposed for the management of COPD in LMICs in the absence of inhaled steroids and/or bronchodilators. The Low-dose Theophylline for the Management of Biomass-Associated COPD (LODOT-BCOPD) trial investigates the clinical efficacy and cost-effectiveness of low-dose theophylline for the management of biomass-related COPD in a low-income setting. Methods: LODOT-BCOPD is a randomized, double-blind, placebo-controlled trial to test the efficacy of low-dose theophylline in improving respiratory symptoms in 110 participants with moderate to severe COPD in central Uganda. The inclusion criteria are as follows: (1) age 40 to 80 years; (2) full-time resident of the study area; (3) daily biomass exposure, (4) post-bronchodilator FEV1/FVC below the 5th percentile of the Global Lung Initiative mixed ethnic reference population; (5) GOLD Grade B-D COPD. Participants will be randomly assigned to receive once daily, low-dose theophylline (200 mg ER, Unicontin-E) or placebo for 52 weeks. All participants will receive education about self-management of COPD and rescue salbutamol inhalers. We will measure health status using the St. George’s Respiratory Questionnaire (SGRQ) and quality of life using the EuroQol-5D (EQ-5D) at baseline and every six months. In addition, we will assess household air pollution levels, serum inflammatory biomarkers (fibrinogen, hs-CRP) and theophylline levels at baseline, one month and 6 months. The primary outcome is change in SGRQ score at 12 months. Lastly, we will assess the cost-effectiveness of the intervention by calculating quality-adjusted life years (QALYs) from the EQ-5D.Trial Registration: NCT03984188 Registered June 12, 2019Trial acronym: Low-dose Theophylline for the Management of Biomass-Associated COPD (LODOT-BCOPD)

scholarly journals Exposure contrasts of pregnant women during the Household Air Pollution Intervention Network randomized controlled trial

2021 ◽  
Author(s):  
Michael Johnson ◽  
Ajay Pillarisetti ◽  
Ricardo Piedrahita ◽  
Kalpana Balakrishnan ◽  
Jennifer L Peel ◽  
...  
Keyword(s):  
Air Pollution ◽  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Household Air Pollution ◽  
Liquefied Petroleum Gas ◽  
Mixed Effect ◽  
Randomized Controlled ◽  
Life Years ◽  
The Impact

Background: Exposure to PM2.5 arising from solid fuel combustion is estimated to result in approximately 2.3 million premature deaths and 90 million lost disability-adjusted life years annually. 'Clean' cooking interventions attempting to mitigate this burden have had limited success in reducing exposures to levels that may yield improved health outcomes. Objectives: This paper reports exposure reductions achieved by a liquified petroleum gas (LPG) stove and fuel intervention for pregnant mothers in the Household Air Pollution Intervention Network (HAPIN) randomized controlled trial. Methods: The HAPIN trial included 3195 households primarily using biomass for cooking in Guatemala, India, Peru, and Rwanda. 24-hour exposures to PM2.5, carbon monoxide (CO), and black carbon (BC) were measured for pregnant women once before randomization into control (n=1605) and LPG arms (n=1590) and twice thereafter (aligned with trimester). Changes in exposure were estimated by directly comparing exposures between intervention and control arms and by using linear mixed-effect models to estimate the impact of the intervention on exposure levels. Results: Median exposures of PM2.5, BC, and CO post-randomization in the intervention arm were lower by 66% (70.7 versus 24.0 µg/m3), 71% (9.6 versus 2.8 µg/m3), and 83% (1.2 versus 0.2 ppm), respectively, compared to the control arm. Exposure reductions were similar across research locations. Post-intervention PM2.5 exposures in the intervention arm were at the lower end of what has been reported for LPG and other clean fuel interventions, with 69% of PM2.5 samples falling below the WHO Annual Interim Target 1 of 35 µg/m3. Discussion: This study indicates that an LPG intervention with high displacement of traditional cooking can reduce exposures to levels thought to be associated with health benefits. Success in reducing exposures was likely due to strong performance of, and high adherence to the intervention. Keywords (5-8): Liquefied petroleum gas, clean cooking, intervention, exposure assessment, PM2.5

scholarly journals Protocol for an economic evaluation of the randomised controlled trial of culprit lesion only PCI versus immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: CULPRIT-SHOCK trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e014849 ◽  
Author(s):  
Zahidul Quayyum ◽  
Andrew Briggs ◽  
Jose Robles-Zurita ◽  
Keith Oldroyd ◽  
Uwe Zeymer ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Cardiogenic Shock ◽  
Controlled Trial ◽  
Culprit Lesion ◽  
Link Type ◽  
Trial Analysis ◽  
Life Years ◽  
Randomised Controlled

IntroductionEmergency percutaneous coronary intervention (PCI) of the culprit lesion for patients with acute myocardial infarctions is an accepted practice. A majority of patients present with multivessel disease with additional relevant stenoses apart from the culprit lesion. In haemodynamically stable patients, there is increasing evidence from randomised trials to support the practice of immediate complete revascularisation. However, in the presence of cardiogenic shock, the optimal management strategy for additional non-culprit lesions is unknown. A multicentre randomised controlled trial, CULPRIT-SHOCK, is examining whether culprit vessel only PCI with potentially subsequent staged revascularisation is more effective than immediate multivessel PCI. This paper describes the intended economic evaluation of the trial.Methods and analysisThe economic evaluation will be conducted using a pre-trial decision model and within-trial analysis. The modelling-based analysis will provide expected costs and health outcomes, and incremental cost-effectiveness ratio over the lifetime for the cohort of patients included in the trial. The within-trial analysis will provide estimates of cost per life saved at 30 days and in 1 year, and estimates of health-related quality of life. Bootstrapping and cost-effectiveness acceptability curves will be used to address any uncertainty around these estimates. Different types of regression models within a generalised estimating equation framework will be used to examine how the total cost and quality-adjusted life years are explained by patients’ characteristics, revascularisation strategy, country and centre. The cost-effectiveness analysis will be from the perspective of each country’s national health services, where costs will be expressed in euros adjusted for purchasing power parity.Ethics and disseminationEthical approval for the study was granted by the local Ethics Committee at each recruiting centre. The economic evaluation analyses will be published in peer-reviewed journals of the concerned literature and communicated through the profiles of the authors atwww.twitter.comandwww.researchgate.net.Trial registration numberNCT01927549; Pre-results.

scholarly journals Effectiveness and cost-effectiveness of Improving clinicians’ diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): study protocol for a cluster randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Rafa Ruiz ◽  
Ana Moragas ◽  
Marta Trapero-Bertran ◽  
Antoni Sisó ◽  
Anna Berenguera ◽  
...  
Keyword(s):  
Primary Care ◽  
Cost Effectiveness ◽  
Communication Skills ◽  
Controlled Trial ◽  
Sensitivity Analyses ◽  
Antibiotic Prescribing ◽  
Cluster Randomised ◽  
Life Years ◽  
Effectiveness And Efficiency ◽  
Tract Infections

Abstract Background Despite their marginal benefit, about 60% of acute lower respiratory tract infections (ALRTIs) are currently treated with antibiotics in Catalonia. This study aims to evaluate the effectiveness and efficiency of a continuous disease-focused intervention (C-reactive protein [CRP]) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations) on antibiotic prescribing in patients with ALRTIs in Catalan primary care centres. Methods/design A cluster randomised, factorial, controlled trial aimed at including 20 primary care centres (N = 2940 patients) with patients older than 18 years of age presenting for a first consultation with an ALRTI will be included in the study. Primary care centres will be identified on the basis of socioeconomic data and antibiotic consumption. Centres will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions. A cost-effectiveness and cost-utility analysis will be performed from the societal and national healthcare system perspectives, and the time horizon of the analysis will be 1 year. Two qualitative studies (pre- and post-clinical trial) aimed to identify the expectations and concerns of patients with ALRTIs and the barriers and facilitators of each intervention arm will be run. Family doctors and nurses assigned to the interventions will participate in a 2-h training workshop before the inception of the trial and will receive a monthly intervention-tailored training module during the year of the trial period. Primary outcomes will be antibiotic use within the first 6 weeks, duration of moderate to severe cough, and the quality-adjusted life-years. Secondary outcomes will be duration of illness and severity of cough measured using a symptom diary, healthcare re-consultations, hospital admissions, and complications. Healthcare costs will be considered and expressed in 2021 euros (year foreseen to finalise the study) of the current year of the analysis. Univariate and multivariate sensitivity analyses will be carried out. Discussion The ISAAC-CAT project will contribute to evaluate the effectiveness and efficiency of different strategies for more appropriate antibiotic prescribing that are currently out of the scope of the actual clinical guidelines. Trial registration ClinicalTrials.gov, NCT03931577.

scholarly journals Electroacupuncture with Usual Care for Patients with Non-Acute Pain after Back Surgery: Cost-Effectiveness Analysis Alongside a Randomized Controlled Trial

2020 ◽  
Vol 12 (12) ◽  
pp. 5033
Author(s):  
NamKwen Kim ◽  
Kyung-Min Shin ◽  
Eun-Sung Seo ◽  
Minjung Park ◽  
Hye-Yoon Lee
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Societal Perspective ◽  
National Health ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Acute Low Back Pain ◽  
Life Years ◽  
Back Surgery ◽  
The Cost

Electroacupuncture (EA) is used to treat pain after back surgery. Although this treatment is covered by national health insurance in Korea, evidence supporting its cost-effectiveness and contribution to the sustainability of the national health care system has yet to be published. Therefore, an economic evaluation, alongside a clinical trial, was conducted to estimate the cost-effectiveness of EA and usual care (UC) versus UC alone to treat non-acute low back pain (LBP). In total, 108 patients were recruited and randomly assigned to treatment groups; 106 were included in the final cost utility analysis. The incremental cost-effectiveness ratio of EA plus UC was estimated as 7,048,602 Korean Rate Won (KRW) per quality-adjusted life years (QALYs) from the societal perspective (SP). If the national threshold was KRW 30 million per QALY, the cost-effectiveness probability of EA plus UC was an estimated 85.9%; and, if the national threshold was over KRW 42,496,372 per QALY, the cost-effectiveness probability would be over 95% percent statistical significance. Based on these results, EA plus UC combination therapy for patients with non-acute LBP may be cost-effective from a societal perspective in Korea.

scholarly journals Cost-effectiveness of neuromuscular ultrasound in focal neuropathies

Neurology ◽  
2019 ◽  
Vol 92 (23) ◽  
pp. e2674-e2678 ◽  
Author(s):  
Ross Mandeville ◽  
Arvin Wali ◽  
Charlie Park ◽  
Erik Groessl ◽  
Francis O. Walker ◽  
...  
Keyword(s):  
Health Care ◽  
Cost Effectiveness ◽  
Societal Perspective ◽  
Short Form ◽  
Controlled Trial ◽  
Health Care Use ◽  
Sensitivity Analyses ◽  
Electrodiagnostic Testing ◽  
Life Years

ObjectiveTo evaluate the cost-effectiveness of neuromuscular ultrasound (NMUS) for the evaluation of focal neuropathies.MethodsA prior prospective, randomized, double-blind controlled trial demonstrated that NMUS, when added to electrodiagnostic testing, resulted in improved clinical outcomes after 6 months of follow-up. From this study, we abstracted quality-adjusted life-years (QALYs) from the 36-item Short Form Health Survey and entered this health-utility estimate into a mixed trial and model-based cost-effectiveness analysis from the societal perspective. Costs of intervention (NMUS) were estimated from Medicare payment rates for Current Procedural Terminology codes. Health care use was otherwise estimated to be equal, but sensitivity analyses further examined this and other key assumptions. Incremental cost-effectiveness ratio (ICER) was used as the primary outcome with a willingness-to-pay threshold of $50,000 per QALY.ResultsThe predicted mean health outcome associated with use of NMUS was 0.079 QALY, and the mean cost was $37, resulting in an ICER of $463 per QALY. Results and conclusions remained robust across all sensitivity analyses, including variations in time horizon, initial distribution of health states, costs, and effectiveness.ConclusionsFrom a societal perspective, the addition of NMUS to electrodiagnostic testing when evaluating a focal neuropathy is cost-effective. A study of longer follow-up incorporating total health care use would further quantify the value of NMUS.ClinicalTrials.gov identifier:NCT01394822.

scholarly journals Cost-effectiveness of using recombinant human TSH prior to radioiodine ablation for thyroid cancer, compared with treating patients in a hypothyroid state: the German perspective

2006 ◽  
Vol 155 (3) ◽  
pp. 405-414 ◽  
Author(s):  
P Mernagh ◽  
S Campbell ◽  
M Dietlein ◽  
M Luster ◽  
E Mazzaferri ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Work Productivity ◽  
Sensitivity Analyses ◽  
Secondary Malignancy ◽  
Remnant Ablation ◽  
Recombinant Human Tsh ◽  
Radioiodine Ablation ◽  
Life Years

Objective: This investigation evaluated the cost-effectiveness of radioiodine remnant ablation following preparation with recombinant human TSH (rhTSH), compared with the standard preparation, whereby patients are rendered hypothyroid. Design: The economic evaluation relates to patients with well differentiated thyroid cancer who have undergone thyroidectomy, but have no metastases. The evaluation takes a societal perspective, considering costs and benefits to all parties. The benefits were expressed in units of quality-adjusted life years (QALY), so differences in life expectancy were captured with consideration of quality of life. Methods: A lifetime Markov model with Monte Carlo simulation of 100 000 patients was used to assess cost per QALY gained. The clinical inputs were sourced from a multi-centre, randomised controlled trial comparing remnant ablation success after rhTSH-preparation with hypothyroid preparation. The model applied German unit costs, however, the structure is generalisable to other jurisdictions. The additional cost of rhTSH procurement and administration is considered relative to the clinical benefits and cost offsets. These included avoidance of hypothyroidism, increased work productivity, earlier discharge from radioprotection and a theoretical reduction in the risk of secondary malignancy. The latter two benefits relate to faster radioiodine clearance after rhTSH preparation. Results: The additional benefits of rhTSH (0.0495 QALY) are obtained with an incremental societal cost of €47, equating to an incremental cost per QALYof €958. Sensitivity analyses had only a modest impact upon cost-effectiveness, with all one-way sensitivity results remaining under €15 000/QALY. Conclusions: The use of rhTSH prior to radioiodine ablation represents good value-for-money with the benefits to patient and society obtained at modest net cost.

scholarly journals Long-Term Functional Patency and Cost-Effectiveness of Arteriovenous Fistula Creation under Regional Anesthesia: a Randomized Controlled Trial

2020 ◽  
Vol 31 (8) ◽  
pp. 1871-1882
Author(s):  
Emma Aitken ◽  
Rachel Kearns ◽  
Lucian Gaianu ◽  
Andrew Jackson ◽  
Mark Steven ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Local Anesthesia ◽  
Regional Anesthesia ◽  
Controlled Trial ◽  
Secondary Patency ◽  
University Hospitals ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Life Years

BackgroundRegional anesthesia improves short-term blood flow through arteriovenous fistulas (AVFs). We previously demonstrated that, compared with local anesthesia, regional anesthesia improves primary AVF patency at 3 months.MethodsTo study the effects of regional versus local anesthesia on longer-term AVF patency, we performed an observer-blinded randomized controlled trial at three university hospitals in Glasgow, United Kingdom. We randomly assigned 126 patients undergoing primary radiocephalic or brachiocephalic AVF creation to receive regional anesthesia (brachial plexus block; 0.5% L-bupivacaine and 1.5% lidocaine with epinephrine) or local anesthesia (0.5% L-bupivacaine and 1% lidocaine). This report includes findings on primary, functional, and secondary patency at 12 months; reinterventions; and additional access procedures (primary outcome measures were previously reported). We analyzed data by intention to treat, and also performed cost-effectiveness analyses.ResultsAt 12 months, we found higher primary patency among patients receiving regional versus local anesthesia (50 of 63 [79%] versus 37 of 63 [59%] patients; odds ratio [OR], 2.7; 95% confidence interval [95% CI], 1.6 to 3.8; P=0.02) as well as higher functional patency (43 of 63 [68%] versus 31 of 63 [49%] patients; OR, 2.1; 95% CI, 1.5 to 2.7; P=0.008). In 12 months, 21 revisional procedures, 53 new AVFs, and 50 temporary dialysis catheters were required. Regional anesthesia resulted in net savings of £195.10 (US$237.36) per patient at 1 year, and an incremental cost-effectiveness ratio of approximately £12,900 (US$15,694.20) per quality-adjusted life years over a 5-year time horizon. Results were robust after extensive sensitivity and scenario analyses.ConclusionsCompared with local anesthesia, regional anesthesia significantly improved both primary and functional AVF patency at 1 year and is cost-effective.Clinical Trial registry name and registration numberLocal Anaesthesia versus Regional Block for Arteriovenous Fistulae, NCT01706354

Simulating the cost-effectiveness of lung cancer screening by low-dose CT scan in Canada.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6550-6550
Author(s):  
John R. Goffin ◽  
William M Flanagan ◽  
Anthony Miller ◽  
Fei Fei Liu ◽  
Sonya Cressman ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Smoking Cessation ◽  
Cost Effectiveness ◽  
Cancer Risk ◽  
Low Dose ◽  
Ct Screening ◽  
Low Dose Ct ◽  
Eligible Population ◽  
Life Years ◽  
Annual Screening

6550 Background: The National Lung Screening Trial (NLST) demonstrated that low-dose CT screening diminishes the risk of death among smokers. A cost-effectiveness analysis was undertaken in the context of the Canadian publically funded healthcare system. Methods: Microsimulation of CT screening was undertaken using the Cancer Risk Management Model, which incorporates demographic data, cancer risk factors, cancer registry data, diagnostic and treatment algorithms and health utilities. Simulations were performed at the individual level for a cohort incepted during the period 2012-2032. The criteria for the screen-eligible population, CT scan test characteristics, and screened cohort outcomes were derived from NLST and Canadian data. The baseline screening scenario was annual CT screening for ≥30 pack-year smokers, age 55 to 74. Simulation assumed 60% of the eligible population participates by 10 years, 70% adhere to the screening regimen, and smoking cessation rates are unchanged. One-way sensitivity analyses were performed. Costs and life-years lived were discounted at 3% annually. Results: Compared to no screening, annual screening results in incremental system costs of $2.97 billion (Cdn), 149,000 life-years saved (LYS) or 55,000 quality-adjusted life-years saved (QALYS), an incremental cost-effectiveness ratio (ICER) of $19,900/LYS, and $53,700/QALYS. With participation rates from 40% to 80%, ICER /QALYS remained within the range of $53,700 to $58,200. Increases in screening adherence from 50% through 90% increased the ICER /QALY from $50,400 to $58,800. Higher rates of smoking cessation led to improvements in ICER /QALY (150% of background cessation rate of 3.2-5.3%, $47,000; 200%, $41,500; 300%, $32,900). A system of biennial screening had a net cost of $1.81 billion, resulting in an ICER of $19,600 /LYS, and $54,800 /QALYS. Conclusions: Screening for lung cancer with low-dose CT scans could be cost-effective, but requires substantial system costs. The smoking cessation rate greatly impacts the ICER and a cessation program should be considered if screening is implemented. Compared to annual screening, biennial screening costs less and produces a similar ICER. Further analyses will be detailed.

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