scholarly journals 1390. Effectiveness of M-M-R® II in outbreaks - a systematic literature review of real-world observational studies

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S704-S705
Author(s):  
Se Li ◽  
Barbara J Kuter ◽  
Elvira Schmidt ◽  
Elizabeth Richardson ◽  
Louise P Saldutti ◽  
...  

Abstract Background M-M-R® II was approved in the US in 1978 and has been used globally for over 40 years. Widespread use of M-M-R® II has resulted in important declines in incidence, morbidity, and mortality of measles, mumps, and rubella in the US and other countries. While vaccine immunogenicity and efficacy were established in multiple placebo-controlled trials of each vaccine component, there are limited studies on vaccine effectiveness (VE) of M-M-R® II. This systematic literature review was conducted to summarize the VE of M-M-R® II from real-world observational studies. Methods The literature search was conducted in Medline and Embase (through May 2019), and grey literature sources (through July 2019). All publications and findings in English language were screened by two independent reviewers. The study characteristics and VE results were extracted for each study. Results Ten full-text publications related to VE of M-M-R® II were all identified from outbreak investigations and mainly in the US (n=8, sample size=318 - 20,496). For measles outbreaks (n=4), VE ranged from 71% to 96% in different age groups. Among high school students, VE of ≥1-dose of M-M-R® II was 94-96%. Among young adolescents, the incremental VE of ≥2-dose vs. 1-dose was 94.1%. When M-M-R® II was used as post-exposure prophylaxis within 72 hours of exposure during an outbreak, the VE was 83.4% among children 6 months to 19 years old. In another study among infants 6-14 months old, VE was 71% against laboratory-confirmed measles. Among mumps outbreaks, the VE of 1-dose, 2-dose, and ≥1-dose M-M-R® II compared to unvaccinated was 83-84%, 80-89%, 83-86% respectively. Three studies evaluating the effectiveness of a third dose of M-M-R® II showed an incremental mumps VE of 60-88% for 3-dose vs. ≤ 2-dose. One study found that individuals who had received a 2nd dose of M-M-R® II ≥13 years (vs. < 13 years) before the outbreak had higher risk for contracting mumps. No study reported VE of M-M-R® II in a rubella outbreak. Conclusion M-M-R® II was found to be effective against measles and mumps during outbreaks. More effectiveness studies are warranted to further address questions on the relationship of VE and time since vaccination as well as the effectiveness of a third dose of M-M-R® II for measles or mumps outbreak control. Disclosures Se Li, PhD, Merck & Co., Inc. (Employee, Shareholder) Barbara J. Kuter, PhD, MPH, Merck (Other Financial or Material Support, Former employee) Elvira Schmidt, MSc, Certara (Employee of Certara, paid contractor to Merck) (Employee, Other Financial or Material Support) Elizabeth Richardson, BS, Merck Sharp & Dohme Corp. (Employee) Louise P. Saldutti, PhD, Mercfk & Co., Inc (Employee) Neumann Monika, Information Specialist, Certara (Employee, Employee of Certara, who was paid contractor to Merck.) Linnea Koller, n/a, Merck (Employee, Other Financial or Material Support, Employee of Certara who was paid contractor to Merck) Manica Agrawal, n/a, Certara (Employee)Merck (Grant/Research Support) Manjiri D. Pawaskar, PhD, Merck & Co., Inc (Employee, Shareholder)

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S221-S222
Author(s):  
Amber Martin ◽  
Fanny S Mitrani-Gold ◽  
Monica Turner ◽  
Emma Schiller ◽  
Ashish V Joshi

Abstract Background In 2016, the World Health Organization estimated the global incidence of gonorrhea (GC) to be 86.9 million, and the reported incidence of GC in 2017 was 145.8 cases per 100,000 females and 212.8 cases per 100,000 males in the US. GC therefore represents a significant global healthcare burden; as the infection can be recurrent, overall costs can accumulate. We undertook a systematic literature review (SLR) to examine the economic burden of illness for GC in key countries. Methods Systematic searches were conducted in MEDLINE, EMBASE, and Cochrane databases to identify English-language articles published from January 1, 2009–December 1, 2019 reporting data on the economic burden of uncomplicated urogenital GC (uuGC) in the US, the UK, Germany, Japan and China. The SLR was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (2009). Articles were evaluated for eligibility using population, intervention, comparison, outcome, study design and time period criteria (Table). Dual-independent screening was used at both the abstract and full-text levels; data were captured by a single reviewer with validation by a second reviewer. Table. PICOS-T Study Selection Criteria Results The SLR identified 27 eligible articles (Figure), of which 17 studies (16 US, 1 UK) reported the economic burden of uuGC. The studies primarily reported cost data, with a subset reporting limited resource use. Lifetime costs for uuGC, when elaborated upon, considered the potential for pelvic inflammatory disease among women, and epididymitis in men, as well as lifetime medical costs associated with human immunodeficiency virus. Among the 16 studies reporting costs, the total estimated lifetime cost of uuGC in the US reached as high as $162.1 million. Costs varied vastly based on sex, with one study reporting lifetime estimates up to $163,433 for men but $7,534,692 for women in 2005. Nine studies described costs per patient/infection and found average costs ranging from $26.92–$438.46, though most fell in the range of $79–$354. Figure. PRISMA flow diagram of study inclusion and exclusion Conclusion We identified a large body of evidence detailing the economic burden of GC. The cost burden varied by sex and was higher for females. However, the vast majority of the evidence came from the US, highlighting the need for more global research. Disclosures Amber Martin, BS, Evidera (Employee)GlaxoSmithKline plc. (Other Financial or Material Support, Funding) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Monica Turner, MPH, Evidera (Employee)GlaxoSmithKline plc. (Other Financial or Material Support, Funding) Emma Schiller, BA, Evidera (Employee)GlaxoSmithKline plc. (Other Financial or Material Support, Funding) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17571-e17571
Author(s):  
Qi Zhao ◽  
Rachel Hughes ◽  
Ishaaq Altaf-Haroon ◽  
Emma Schiller ◽  
Ananth Kadambi

e17571 Background: Women diagnosed with advanced or recurrent endometrial cancer (EC) have a poor prognosis, with a 5-year survival of only 15% to 17%. While a multi-modality approach is often used for newly diagnosed EC including platinum-based chemotherapy, there are no definitively approved standard treatment options for advanced or recurrent EC following prior systemic therapy (FPST). The real-world evidence surrounding the effectiveness of chemotherapies in this setting is not well characterized. We conducted a systematic literature review to attempt to fill this evidence gap. Methods: Systematic searches were run in Embase, MEDLINE, and the Cochrane Library to identify English-language publications from January 2000 to July 2020. Additional hand searches of 5 key conferences held from 2018 to 2020 were also conducted. The review included observational studies reporting the clinical effectiveness, safety, or treatment patterns of pharmacological treatments in adult women with advanced or recurrent EC. Results: Seventy-seven observational studies met the inclusion criteria, of these 63 studies reported on the effectiveness of chemotherapies. While 57 studies described adjuvant chemotherapy use, 6 described use of chemotherapies FPST, including 1 study in the second line or later. Only one of these 6 studies reported a sample size greater than 100 patients. Chemotherapy FPST included paclitaxel/carboplatin (3 studies), doxorubicin (2 studies), etoposide (1 study), or any platinum-based chemotherapy (1 study). Shorter median overall survival (OS) was observed in patients with treatment-free intervals (TFI) < 6 months from prior systemic therapy (5.5-11.3 months; 2 studies) compared to those with TFI > 6 months (13.0-27.0 months; 3 studies). Similarly, shorter median progression-free survival (PFS) was seen in patients with TFI < 6 months from prior systemic therapy (2.0-3.2 months; 2 studies) vs. those with TFI > 6 months (6.0-10.0 months; 3 studies). Conclusions: Women with advanced or recurrent EC have poor OS and PFS with current chemotherapy regimens, especially for those with TFI < 6 months. The time at recurrence from prior systemic therapy seems to correlate with the outcomes of subsequent treatment. Novel efficacious treatment strategies are required to improve patients’ outcomes in the FPST setting. While extensive real-world evidence exists for patients with EC receiving adjuvant chemotherapy, real world data is limited for use of chemotherapy in advanced or recurrent setting, warranting further research in larger samples of patients.


RMD Open ◽  
2020 ◽  
Vol 6 (2) ◽  
pp. e001227 ◽  
Author(s):  
Jasmin Beate Kuemmerle-Deschner ◽  
Raju Gautam ◽  
Aneesh Thomas George ◽  
Syed Raza ◽  
Kathleen Graham Lomax ◽  
...  

ObjectivesSeveral therapies are used for the treatment of rareautoinflammatory conditions like cryopyrin-associated periodic fever syndromes (CAPS), hyperimmunoglobulin Dsyndrome (HIDS)/mevalonate kinase deficiency (MKD) and tumour necrosis factor receptor-associated periodic syndrome (TRAPS). However, reviews reporting on treatment outcomes of these therapies are lacking.MethodsA systematic literature review was conducted using Embase, MEDLINE, MEDLINE-In Process and Cochrane databases to identify the randomised/non-randomised controlled trials (RCTs/non-RCTs) and real-world observational studies of CAPS, HIDS/MKD and TRAPS published as full-texts (January 2000–September 2017) or conference abstracts (January 2014–September 2017). Studies with data for ≥1 biologic were included. Studies with <5 patients were excluded.ResultsOf the 3 342 retrieved publications, 72 studies were included (CAPS, n=43; HIDS/MKD, n=9; TRAPS, n=7; studies with ≥2 cohorts, n=13). Most studies were full-text (n=56), published after 2010 (n=56) and real-world observational studies (n=58). Among included studies, four were RCTs (canakinumab, n=2 (CAPS, n=1; HIDS/MKD and TRAPS, n=1); rilonacept, n=1 (in CAPS); simvastatin, n=1 (in HIDS/MKD)). Canakinumab and anakinra were the most commonly used therapies for CAPS and HIDS/MKD, whereas etanercept, canakinumab and anakinra were the most common for TRAPS. The available evidence suggested the efficacy or effectiveness of canakinumab and anakinra in CAPS, HIDS/MKD and TRAPS, and of etanercept in TRAPS; asingle RCT demonstrated the efficacy of rilonacept in CAPS.ConclusionsCanakinumab, anakinra, etanercept and rilonacept were reported to be well tolerated; however, injection-site reactions were observed frequently with anakinra, rilonacept and etanercept. Data on the use of tocilizumab, infliximab and adalimumab in these conditions were limited; thus, further research is warranted.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Alan Brnabic ◽  
Lisa M. Hess

Abstract Background Machine learning is a broad term encompassing a number of methods that allow the investigator to learn from the data. These methods may permit large real-world databases to be more rapidly translated to applications to inform patient-provider decision making. Methods This systematic literature review was conducted to identify published observational research of employed machine learning to inform decision making at the patient-provider level. The search strategy was implemented and studies meeting eligibility criteria were evaluated by two independent reviewers. Relevant data related to study design, statistical methods and strengths and limitations were identified; study quality was assessed using a modified version of the Luo checklist. Results A total of 34 publications from January 2014 to September 2020 were identified and evaluated for this review. There were diverse methods, statistical packages and approaches used across identified studies. The most common methods included decision tree and random forest approaches. Most studies applied internal validation but only two conducted external validation. Most studies utilized one algorithm, and only eight studies applied multiple machine learning algorithms to the data. Seven items on the Luo checklist failed to be met by more than 50% of published studies. Conclusions A wide variety of approaches, algorithms, statistical software, and validation strategies were employed in the application of machine learning methods to inform patient-provider decision making. There is a need to ensure that multiple machine learning approaches are used, the model selection strategy is clearly defined, and both internal and external validation are necessary to be sure that decisions for patient care are being made with the highest quality evidence. Future work should routinely employ ensemble methods incorporating multiple machine learning algorithms.


2021 ◽  
Vol 54 (5) ◽  
pp. 1-34
Author(s):  
Vimal Dwivedi ◽  
Vishwajeet Pattanaik ◽  
Vipin Deval ◽  
Abhishek Dixit ◽  
Alex Norta ◽  
...  

Smart contracts are a key component of today’s blockchains. They are critical in controlling decentralized autonomous organizations (DAO). However, smart contracts are not yet legally binding nor enforceable; this makes it difficult for businesses to adopt the DAO paradigm. Therefore, this study reviews existing Smart Contract Languages (SCL) and identifies properties that are critical to any future SCL for drafting legally binding contracts. This is achieved by conducting a Systematic Literature Review (SLR) of white- and grey literature published between 2015 and 2019. Using the SLR methodology, 45 Selected and 28 Supporting Studies detailing 45 state-of-the-art SCLs are selected. Finally, 10 SCL properties that enable legally compliant DAOs are discovered, and specifications for developing SCLs are explored.


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Monika Jedynak ◽  
Wojciech Czakon ◽  
Aneta Kuźniarska ◽  
Karolina Mania

PurposeThe purpose of this paper is to identify the development of the digital transformation literature and to the systematic literature review methodology.Design/methodology/approachThe authors run a systematic literature review, followed by a rigorous thematic analysis of both academic and grey literature dataset, in order to develop a conceptual map of organizations' digital transformation. The authors aggregate the concepts and topics identified across the literature to find that they overwhelmingly tackle digital business models. At the same time, the authors identify a major blind spot resulting from ignoring the organization itself as a unit of analysis.FindingsThe findings show that developing a digital theory of the organization or the theory of digitally transformed organization is a major challenge to management researchers. The analysis exposed numerous research gaps that can be helpful for future research directions.Originality/valueDigital transformation research enjoys an increasingly rapid rise to recognition across many academic disciplines and strongly impacts the management domain. adopt the view that published documents reflect the collective understanding of a phenomenon. This paper contributes to filtering the digital transformation literature, clarify complex relation between digital transformations of organizations and identify the key blind points.


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