A French multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the “REal world dAta in LYmphoma and survival in adults” (REALYSA) cohort

Abstract Background Age-adjusted lymphoma incidence rates continue to rise in France since the early 80’s, although rates have slowed since 2010 and vary across subtypes. Recent improvements in patient survival in major lymphoma subtypes at population level raise new questions about patient outcomes (i.e. quality of life, long-term sequelae). Epidemiological studies have investigated factors related to lymphoma risk, but few have addressed the extent to which socioeconomic status, social institutional context (i.e. healthcare system), social relationships, environmental context (exposures), individual behaviours (lifestyle) or genetic determinants influence lymphoma outcomes, especially in the general population. Moreover, the knowledge of the disease behaviour mainly obtained from clinical trials data is partly biased because of patient selection. Methods The REALYSA (“REal world dAta in LYmphoma and Survival in Adults”) study is a real-life multicentric cohort set up in French areas covered by population-based cancer registries to study the prognostic value of epidemiological, clinical and biological factors with a prospective 9-year follow-up. We aim to include 6000 patients over 4 to 5 years. Adult patients without lymphoma history and newly diagnosed with one of the following 7 lymphoma subtypes (diffuse large B-cell, follicular, marginal zone, mantle cell, Burkitt, Hodgkin, mature T-cell) are invited to participate during a medical consultation with their hematologist. Exclusion criteria are: having already received anti-lymphoma treatment (except pre-phase) and having a documented HIV infection. Patients are treated according to the standard practice in their center. Clinical data, including treatment received, are extracted from patients’ medical records. Patients’ risk factors exposures and other epidemiological data are obtained at baseline by filling out a questionnaire during an interview led by a clinical research assistant. Biological samples are collected at baseline and during treatment. A virtual tumor biobank is constituted for baseline tumor samples. Follow-up data, both clinical and epidemiological, are collected every 6 months in the first 3 years and every year thereafter. Discussion This cohort constitutes an innovative platform for clinical, biological, epidemiological and socio-economic research projects and provides an opportunity to improve knowledge on factors associated to outcome of lymphoma patients in real life. Trial registration 2018-A01332–53, ClinicalTrials.gov identifier: NCT03869619.

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VP49 Real-world Evidence For Economic Evaluation Of Medical Devices

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462319003167 ◽

2019 ◽

Vol 35 (S1) ◽

pp. 87-88

Author(s):

Benedetta Pongiglione ◽

Aleksandra Torbica

Keyword(s):

Medical Devices ◽

Real World ◽

Epidemiological Data ◽

Evidence Base ◽

National Registry ◽

Economic Research ◽

Data Mapping ◽

Real World Data ◽

World Data

IntroductionRandomized controlled trials (RCTs) are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. The low external validity of RCTs and the general shortage of clinical evidence available to support the use of many medical devices have emphasized the necessity for exploring the use of real-world data (RWD) as a complementary source to RCTs data for establishing a more robust evidence base on the effectiveness of medical devices. The aim of the present project is to assess in a comprehensive way the existing sources of real world data on medical devices in Europe.MethodsThe guidelines to the mapping exercise have been outlined in a research protocol. First, all national relevant sources (e.g. website of Ministry of Health, national institutions, research bodies) are screened, both in local language and English. Second, we perform a systematic search on PubMed using a set of key words for each case study, adapted to each country setting. Finally, we seek advice from key actors in the field of the device and clinical conditions, such as manufacturers or clinicians.ResultsInformation on existing sources of RWD for each case studies are provided in a template including details on the key features of the source (e.g. data producer, data collection period, sample size, study design, geographical coverage) and the main content of the dataset, distinguishing socio-demographic information, clinical and epidemiological data, data on resource use and health outcomes. The data mapping includes all countries of the project participants, i.e. Italy, UK, Netherlands, Switzerland, Germany, Hungary, and we enlarge the scope of our mapping including other countries: Spain, France, Denmark, Finland, Sweden, Poland and Hungary as well as international databases at pan-EU level. The number of available sources of RWD and their quality vary depending on case study and across countries. For example, in the case of orthopaedics, many countries have a national registry and administrative data, such as hospital discharge, contain useful information, although not as detailed. When a registry is not available, it is often the case that more observational studies are available; this occurs for example in France.ConclusionsIn this work we shows the importance of RWE and map in an accurate and comprehensive way which source of RWD are currently available and to what extent they are known and used in medical, epidemiological and economic research.

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928-P: Dulaglutide Has Higher Adherence and Persistence than Semaglutide and Exenatide QW: 6-Month Follow-Up from U.S. Real-World Data

Diabetes ◽

10.2337/db20-928-p ◽

2020 ◽

Vol 69 (Supplement 1) ◽

pp. 928-P

Author(s):

REEMA MODY ◽

MARIA YU ◽

BAL K. NEPAL ◽

MANIGE KONIG ◽

MICHAEL GRABNER

Keyword(s):

Real World ◽

Real World Data ◽

World Data ◽

Exenatide Qw

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Prevalence and incidence rates and treatment patterns of non-infectious uveitis in Japan: real-world data using a claims database

Japanese Journal of Ophthalmology ◽

10.1007/s10384-021-00850-8 ◽

2021 ◽

Author(s):

Akihiko Umazume ◽

Nobuyuki Ohguro ◽

Annabelle A. Okada ◽

Kenichi Namba ◽

Koh-Hei Sonoda ◽

...

Keyword(s):

Real World ◽

Incidence Rates ◽

Treatment Patterns ◽

Real World Data ◽

Claims Database ◽

World Data ◽

Infectious Uveitis

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Fuzzy Logic

Handbook of Research on Industrial Informatics and Manufacturing Intelligence - Advances in Civil and Industrial Engineering ◽

10.4018/978-1-4666-0294-6.ch003 ◽

2012 ◽

pp. 33-71 ◽

Cited By ~ 3

Author(s):

Siddhartha Bhattacharyya ◽

Paramartha Dutta

Keyword(s):

Fuzzy Logic ◽

Real World ◽

Fuzzy Inference ◽

Real Life ◽

Real World Data ◽

World Data ◽

Data Intensive ◽

Logic Control ◽

The Subject ◽

Intelligent Management

The field of industrial informatics has emerged as one of the key disciplines for the purpose of intelligent management and dissemination of information in today’s world. With the advent of newer technical know-how, the subject of informative intelligence has assumed increasing importance in the industrial arena, thanks to the evolution of data intensive industry. Real world data exhibit varied amount of unquantifiable uncertainty in the information content. Conventional logic is often unable to explain the associated uncertainty and imprecision therein due to the principles of finiteness of observations and quantifying propositions employed. Fuzzy sets and fuzzy logic provide a logical framework for description of the varied amount of ambiguity, uncertainty and imprecision exhibited in real world data under consideration. The resultant fuzzy inference engine and the fuzzy logic control theory supplement the power of the framework in design of robust failsafe real life systems.

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Application of Health Technology Assessment (HTA) to Evaluate New Laboratory Tests in a Health System: A Case Study of Bladder Cancer Testing

Academic Pathology ◽

10.1177/2374289520968225 ◽

2020 ◽

Vol 7 ◽

pp. 237428952096822

Author(s):

Erik J. Landaas ◽

Ashley M. Eckel ◽

Jonathan L. Wright ◽

Geoffrey S. Baird ◽

Ryan N. Hansen ◽

...

Keyword(s):

Bladder Cancer ◽

Pilot Study ◽

Health Technology Assessment ◽

Technology Assessment ◽

Real World ◽

Health Technology ◽

Test System ◽

Real World Data ◽

World Data

We describe the methods and decision from a health technology assessment of a new molecular test for bladder cancer (Cxbladder), which was proposed for adoption to our send-out test menu by urology providers. The Cxbladder health technology assessment report contained mixed evidence; predominant concerns were related to the test’s low specificity and high cost. The low specificity indicated a high false-positive rate, which our laboratory formulary committee concluded would result in unnecessary confirmatory testing and follow-up. Our committee voted unanimously to not adopt the test system-wide for use for the initial diagnosis of bladder cancer but supported a pilot study for bladder cancer recurrence surveillance. The pilot study used real-world data from patient management in the scenario in which a patient is evaluated for possible recurrent bladder cancer after a finding of atypical cytopathology in the urine. We evaluated the type and number of follow-up tests conducted including urine cytopathology, imaging studies, repeat cystoscopy evaluation, biopsy, and repeat Cxbladder and their test results. The pilot identified ordering challenges and suggested potential use cases in which the results of Cxbladder affected a change in management. Our health technology assessment provided an objective process to efficiently review test performance and guide new test adoption. Based on our pilot, there were real-world data indicating improved clinician decision-making among select patients who underwent Cxbladder testing.

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