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Real-World Evidence in Clinical Epidemiology and Public Health

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A special issue of International Journal of Environmental Research and Public Health (ISSN 1660-4601). This special issue belongs to the section "Public Health Statistics and Risk Assessment".

Deadline for manuscript submissions: closed (30 September 2022) | Viewed by 34980

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Special Issue Editors

Dr. Matteo Franchi

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Guest Editor

Laboratory of Healthcare Research & Pharmacoepidemiology, Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy
Interests: pharmacoepidemiology; biostatistics; medical statistics

Dr. Anna Cantarutti

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Guest Editor

1. National Centre for Healthcare Research and Pharmacoepidemiology, 20126 Milan, Italy
2. Laboratory of Healthcare Research & Pharmacoepidemiology, Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, 20126 Milan, Italy
Interests: population-based birth cohort study; pharmacoepidemiology and drug safety in pregnancy and breastfeeding; pharmacoepidemiology; healthcare research; real-world data
Special Issues, Collections and Topics in MDPI journals

Dr. Federico Rea

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Guest Editor

1. National Centre for Healthcare Research and Pharmacoepidemiology, 20126 Milan, Italy;
2. Laboratory of Healthcare Research & Pharmacoepidemiology, Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, 20126 Milan, Italy
Interests: healthcare research; cost-effectiveness analysis; epidemiology; meta-analysis; multilevel modelling; pharmacoepidemiology; prognostic score; healthcare utilization database; case-identification algorithms; diagnostic-therapeutic paths

Special Issue Information

Dear Colleagues,

Although randomized clinical trials (RCTs) generate the highest level of evidence on the efficacy of a given treatment, they are insufficient for several reasons: (i) frail individuals, such as children, pregnant women, elderly people and those with comorbidities or co-treatments, are usually excluded from RCTs for both ethical and methodological reasons; (ii) the treatment efficacy is affected by a low rate of adherence and therapeutic inertia in clinical practice with the consequence that guidelines based on RCTs are often disregarded in real life; and (iii) RCTs are not suitable for assessing the efficacy of an integrated healthcare pathway.

Therefore, there is growing interest in observational studies based on real-world data (RWD), i.e., the data relating to patient health status in a non-experimental setting routinely collected from a variety of sources, that could complement the results of RCTs. RWD and real-world evidence (RWE) are playing an increasing role in healthcare decisions, and they are used to monitor post-marketing long-term cost-effectiveness and safety, and to develop guidelines and decision support tools for the use of treatments in clinical practice. According to the Food and Drug Administration, RWE is “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data”. Thus, RWE should generate functional knowledge for the decision-making process, continuously improve the quality of care, and be used to assess the cost-effectiveness profiles of treatments observed in clinical practice.

This Special Issue is dedicated to studies that aim to generate RWE for the decision-making process.

Dr. Matteo Franchi
Dr. Anna Cantarutti
Dr. Federico Rea
Guest Editors

Manuscript Submission Information

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Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. International Journal of Environmental Research and Public Health is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2500 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

real-world evidence
clinical epidemiology
public health
healthcare research
pharmacoepidemiology
frailty
chronic diseases

Published Papers (14 papers)

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Research

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15 pages, 1744 KiB

Open AccessArticle

Prevalence of Anemia among Children and Adolescents of Bangladesh: A Systematic Review and Meta-Analysis

by Shoumik Kundu, Sayeda Sadia Alam, Md Al-Tareq Mia, Tareq Hossan, Phil Hider, Md. Ibrahim Khalil, Kamarul Imran Musa and Md Asiful Islam

Int. J. Environ. Res. Public Health 2023, 20(3), 1786; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph20031786 - 18 Jan 2023

Cited by 2 | Viewed by 4115

Abstract

The prevalence of anemia is high among children and adolescents in low- and middle-income countries because of undernutrition resulting from their poor socioeconomic status and lack of knowledge on proper nutrition. We conducted a systematic review and meta-analysis to determine the prevalence of anemia among children and adolescents aged between 6 months and 19 years in Bangladesh. Databases such as PubMed, Scopus, and Google Scholar were searched to identify the studies that reported the prevalence of anemia among children and adolescents. A total of 24 studies, including the data of 14,062 cases, were included in the systematic review and meta-analysis of the time period between 1997 and 2019. The random-effects model was used to calculate the summary estimates. The protocol was registered with PROSPERO (CRD42021246960). The pooled prevalence of anemia, iron deficiency anemia (IDA), and non-severe and severe anemia were 46.8% [95% CI: 36.0–57.6], 13.6% [95% CI: 8.0–19.2], 56.4% [95% CI: 39.6–73.1] and 0.7% [95% CI: 0.1–1.4], respectively. Prevalence of anemia exhibited the highest among the children aged ≤2 years. Briefly, 91.67% of the studies were of high quality. No significant publication bias was found; however, two outlier studies were detected. The prevalence of anemia among children and adolescents was estimated as high in Bangladesh. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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12 pages, 632 KiB

Open AccessArticle

Learning the Treatment Impact on Time-to-Event Outcomes: The Transcarotid Artery Revascularization Simulated Cohort

by Pablo Martínez-Camblor

Int. J. Environ. Res. Public Health 2022, 19(19), 12476; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph191912476 - 30 Sep 2022

Cited by 1 | Viewed by 874

Abstract

Proportional hazard Cox regression models are overwhelmingly used for analyzing time-dependent outcomes. Despite their associated hazard ratio is a valuable index for the difference between populations, its strong dependency on the underlying assumptions makes it a source of misinterpretation. Recently, a number of works have dealt with the subtleties and limitations of this interpretation. Besides, a number of alternative indices and different Cox-type models have been proposed. In this work, we use synthetic data, motivated by a real-world problem, for showing the strengths and weaknesses of some of those methods in the analysis of time-dependent outcomes. We use the power of synthetic data for considering observable results but also utopian designs. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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15 pages, 795 KiB

Open AccessArticle

Potentially Inappropriate Prescribing among Elderly Outpatients: Evaluation of Temporal Trends 2012–2018 in Piedmont, Italy

by Federica Galimberti, Manuela Casula, Lorenza Scotti, Elena Olmastroni, Daniela Ferrante, Andrealuna Ucciero, Elena Tragni, Alberico Luigi Catapano and Francesco Barone-Adesi

Int. J. Environ. Res. Public Health 2022, 19(6), 3612; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph19063612 - 18 Mar 2022

Cited by 2 | Viewed by 1689

Abstract

Pharmacological intervention is one of the cornerstones in the treatment and prevention of disease in modern healthcare. However, a large number of drugs are often prescribed and used inappropriately, especially in elderly patients. We aimed at investigating the annual prevalence of potentially inappropriate prescriptions (PIPs) among older outpatients using administrative healthcare databases of the Piedmont Region (Italy) over a seven-year period (2012–2018). We included all Piedmont outpatients aged 65 years or older with at least one drug prescription per year. Polypharmacy and the prevalence of PIPs according to the ERD list explicit tool were measured on an annual basis. A range between 976,398 (in 2012) and 1,066,389 (in 2018) elderly were evaluated. Among them, the number of subjects with at least one PIP decreased from 418,537 in 2012 to 339,764 in 2018; the prevalence significantly reduced by ~25% over the study period. The stratified analyses by age groups and sex also confirmed the downward trend and identified several differences in the most prevalent inappropriately prescribed drugs. Overall, despite a reduction in PIP prevalence, one out of three older outpatients was still exposed to inappropriateness, highlighting the extensive need for intervention to improve prescribing. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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12 pages, 2494 KiB

Open AccessArticle

Retrospective Analysis of the Pharmaco-Utilization of VEGF Inhibitors and Health Care Costs among Patients with Wet Age-Related Macular Degeneration and Other Ocular Diseases in Italy

by Valentina Perrone, Melania Dovizio, Chiara Veronesi, Rita Citraro, Adele De Francesco, Stefania Dell’Orco, Gianluca Di Manno, Arrigo Paciello, Anna Maria Resta, Fabrizio Quarta, Nicola Ferrante, Daniela Ritrovato and Luca Degli Esposti

Int. J. Environ. Res. Public Health 2022, 19(5), 2548; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph19052548 - 23 Feb 2022

Cited by 3 | Viewed by 1947

Abstract

This Italian retrospective study aimed to analyze the pharmaco-utilization of anti-VEGF drugs and health care costs among patients with wet age-related macular degeneration (wAMD) or other ocular diseases. A retrospective analysis was performed on administrative databases of Italian entities covering approximately six million individuals. Across January 2010–December 2017, patients aged ≥50 years with a prescription of intravitreal anti-VEGFs were included as “wAMD” patients [by wAMD hospitalization or intravitreal injections] or as “other ocular diseases” patients [by hospitalization for other ocular disorders or intravitreal injections, with concomitant diabetes diagnosis or dexamethasone treatment]. The date of first matching of inclusion criteria was index-date. wAMD-cohort. Overall, 3879 patients were included; at index-date, 82.2% were treated with Ranibizumab, 15.8% with Aflibercept, and 2% with Pegaptanib. During the follow-up, the mean/annual anti-VEGF prescription [3.6 (first-year)–0.8 (third-year)] and the total expenditure [5799.84 € (first-year)–3212.84 € (third-year)] decreased. Other ocular diseases-cohort. Overall, 2646 patients were enclosed; 85.9% were treated with Ranibizumab, 13.5% with Aflibercept, and 0.6% with Pegaptanib. During the follow-up, the mean/annual anti-VEGF prescription [3.3 (first-year)–0.5 (third-year)] and the total cost [7196.83 € (first-year)–5162.68 € (third-year)] decreased. This observational study highlighted a decline in anti-VEGF prescriptions over time in both cohorts, suggesting a trend of under-treatment that could worsen the patients’ clinical outcomes and increase health care resource consumption. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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10 pages, 824 KiB

Open AccessArticle

Occurrence of Idiopathic Pulmonary Fibrosis in Italy: Latest Evidence from Real-World Data

by Marica Iommi, Martina Bonifazi, Andrea Faragalli, Lara Letizia Latini, Federico Mei, Liana Spazzafumo, Edlira Skrami, Luigi Ferrante, Flavia Carle and Rosaria Gesuita

Int. J. Environ. Res. Public Health 2022, 19(5), 2510; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph19052510 - 22 Feb 2022

Cited by 2 | Viewed by 1890

Abstract

The aim of the study was to evaluate the trend in the incidence of idiopathic pulmonary fibrosis (IPF) in a real-world setting of the Marche region, a region of Central Italy, between 2014 and 2019. This observational prospective study was based on administrative databases of hospital discharges and drug prescriptions. All adult residents in the Marche Region with a first prescription of antifibrotic drugs, or a first hospitalization with a diagnosis of IPF during the study period, were identified as incident cases of IPF. A multiple Poisson regression analysis was used to estimate the IPF incidence trend, adjusted for age, sex, and health conditions. The mean incidence rate was 9.8 cases per 100,000 person-years. A significant increasing trend of 6% per year was observed. The incidence rates were significantly higher in males than females, older subjects, and those with poorer health conditions. To our knowledge, this is the first study evaluating incidences of IPF over a 6-year period in Italy, combining hospital discharge and drug prescription databases. The study highlights that the combined use of two secondary sources is a reliable strategy to accurately identify new cases of IPF when the appropriate disease registry is lacking. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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15 pages, 2323 KiB

Open AccessArticle

Eight Good Reasons for Careful Monitoring and Evaluation of the Vaccine Campaign against COVID-19: Lessons Learned through the Lombardy Experience for Dealing with Next Challenges

by Giovanni Corrao, Guido Bertolaso, Giovanni Pavesi and Letizia Moratti

Int. J. Environ. Res. Public Health 2022, 19(3), 1073; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph19031073 - 19 Jan 2022

Cited by 4 | Viewed by 2148

Abstract

Background: Using the knowledge gained during the first eleven months of the vaccine campaign in Lombardy, Italy, we provide an overview of the benefits of using reliable, complete, and rapidly available observational data to monitor the progress of the vaccine strategy. Methods: A population-based platform was implemented by linking four registries reporting individual data on: (i) date, type, and dose of vaccine dispensed; (ii) SARS-CoV-2 infections and hospital admissions and deaths due to COVID-19; (iii) inpatient diagnoses and outpatient services supplied by the Regional Health Services (RHS); and the (iv) health registry reporting and updating data on patient status. Background, methods, findings, and implications of eight COVID-19 relevant questions are reported. Results: Before starting the vaccine campaign, we identified high-risk individuals who need to be prioritized. During the vaccine campaign, we: (i) monitored the trend in the speed of the vaccine campaign progression and the number of prevented clinical outcomes; (ii) verified that available vaccines work in real-life, assessed their effectiveness-harm profile, and measured their reduced effectiveness against the delta variant. Finally, we studied the reduced effectiveness of the vaccine over time and identified risk factors of post-vaccine infection and severe illness. Conclusions: The correct use of rapidly available observational data of good quality and completeness generates reliable evidence to promptly inform patients and policymakers. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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9 pages, 1043 KiB

Open AccessArticle

Trends of Total Knee Arthroplasty According to Age Structural Changes in Korea from 2011 to 2018

by Yong-Beom Kim, Hyung-Suk Choi, Eun Myeong Kang, Suyeon Park, Gi-Won Seo, Dong-Il Chun and Tae-Hong Min

Int. J. Environ. Res. Public Health 2021, 18(24), 13397; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph182413397 - 20 Dec 2021

Cited by 7 | Viewed by 1817

Abstract

Total Knee Arthroplasty (TKA) is one of the most commonly performed surgeries worldwide since it can improve pain, quality of life, and functional outcome. Due to the expansion of hospitals specialized in joint surgery, the topography of TKA implementation in Korea is changing. This study analyzed longitudinal trends of TKA based on changes in age distribution, sex, hospital, and region based on the Health Insurance Review and Assessment Service (HIRA) of Korea database. Data were collected from the National Health Insurance Service (NHIS), the Korean Statistical Information Service (KOSIS), and the Health Insurance Review and Assessment Service (HIRA) in Korea for the period 2011–2018. Results show the total number of surgeries increased and the number of patients by age decreased in those under the age of 70, while the number of patients over 70 years of age increased. A remarkable increase in women was found, and there was no significant difference between regions. TKA is spreading in a more universal and easily accessible form in Korea and has increased more in other relatively small medical institutions compared to tertiary referral medical centers. Due to the increase of orthopedics’ specialized hospitals and clinics, TKA is becoming more prominent in those hospitals. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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12 pages, 1272 KiB

Open AccessArticle

Drug–Drug Interactions in Italian Patients with Chronic Hepatitis C Treated with Pangenotypic Direct Acting Agents: Insights from a Real-World Study

by Alessandra Mangia, Francesco Scaglione, Pierluigi Toniutto, Mario Pirisi, Nicola Coppola, Giovanni Di Perri, Gema Alvarez Nieto, Stefano Calabrese, Candido Hernandez, Valentina Perrone, Luca Degli Esposti and Stefano Fagiuoli

Int. J. Environ. Res. Public Health 2021, 18(13), 7144; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph18137144 - 03 Jul 2021

Cited by 9 | Viewed by 2394

Abstract

This Italian observational real-world study aims to assess in chronic hepatitis C virus (HCV) patients treated with pangenotypic direct acting agents (pDAAs) glecaprevir/pibrentasvir (GLE/PIB) or sofosbuvir/velpatasvir (SOF/VEL) the potential drug–drug interactions (DDIs) with concomitant medications prescribed, with a focus on cardiovascular and system nervous (CNS) co-medications. Data were collected from administrative databases covering 6.9 million health-assisted individuals. All patients prescribed SOF/VEL or GLE/PIB between 11/2017 and 12/2018 were included. Patients were analyzed while on DAA. DDIs were identified according to the Liverpool University tool. Overall, 3181 HCV patients were included: 1619 in the GLE/PIB cohort and 1562 in the SOF/VEL cohort. SOF/VEL patients were generally older than GLE/PIB ones (mean age 58.4 vs. 53.1, p < 0.001) and had more cardiovascular and CNS comorbidities (58% vs. 42%, p < 0.001 and 33% vs. 28%, p = 0.002, respectively). Contraindications due to DDIs in the GLE/PIB cohort affected 9.3% and 3.2% of patients before and on DAA, respectively, while the percentages in the SOF/VEL cohort were 3.2% before and 0.4% after pDAAs initiation. Among GLE/PIB patients, 2.7% had cardiovascular drugs (all statins) contraindicated while on DAA. The potential DDIs between cardiovascular drugs and SOF/VEL were mainly with statins (5%). SOF/VEL was prescribed in patients with older age and with more cardiovascular and CNS comorbidities. Despite this, a proportion of contraindicated drugs lower than that of GLE/PIB was registered. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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10 pages, 2247 KiB

Open AccessArticle

Treatment Patterns and Pharmacoutilization in Patients Affected by Rheumatoid Arthritis in Italian Settings

by Valentina Perrone, Serena Losi, Veronica Rogai, Silvia Antonelli, Walid Fakhouri, Massimo Giovannitti, Elisa Giacomini, Diego Sangiorgi and Luca Degli Esposti

Int. J. Environ. Res. Public Health 2021, 18(11), 5679; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph18115679 - 26 May 2021

Cited by 4 | Viewed by 3224

Abstract

This study aimed to evaluate the treatment patterns and pharmacoutilization of patients with rheumatoid arthritis (RA) in real-world settings in Italy. This retrospective observational analysis was based on administrative databases of selected Italian entities. All adult patients with RA diagnosis confirmed by ≥1 discharge diagnosis of RA (ICD-9-CM code = 714.0) or an active exemption code (006.714.0) were enrolled in 2019. Two cohorts were created: one included patients prescribed baricitinib, the other those prescribed biological disease-modifying antirheumatic drugs (bDMARDs). Overall, 47,711 RA patients were identified, most of them without DMARD prescription. As a first-line prescription, 43.2% of patients were prescribed conventional synthetic DMARDs (csDMARDs), 5.2% bDMARDs and 0.3% baricitinib. In 2019, 82.6% of csDMARD users continued with the same DMARD category, 15.9% had a bDMARD, while 1.5% had baricitinib as second-line therapy. Overall, 445 patients used baricitinib during 2019. During follow-up, baricitinib was prescribed as monotherapy to 31% of patients, as cotreatment with csDMARDs and corticosteroids to 27% of patients, with corticosteroids to 28% of patients and with csDMARDs to 14% of patients. In line with previous findings, a trend of bDMARD undertreatment was observed. The treatment patterns of baricitinib patients could help to better characterize patients eligible for new therapeutic options that will be available in the future. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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10 pages, 2546 KiB

Open AccessArticle

Significantly Reduced Alanine Aminotransferase Level Increases All-Cause Mortality Rate in the Elderly after Ischemic Stroke

by Sang Joon An, Yun-Jung Yang, Na-mo Jeon, Yeon-Pyo Hong, Yeong In Kim and Doo-Young Kim

Int. J. Environ. Res. Public Health 2021, 18(9), 4915; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph18094915 - 05 May 2021

Cited by 6 | Viewed by 2016

Abstract

(1) Background: A significantly reduced alanine aminotransferase (ALT) level is being recognized as a risk factor of increasing mortality in the elderly in relation to frailty. In the elderly, both frailty and ischemic stroke are not only common, but are also associated with mortality. The aim of this research was to investigate whether a significantly reduced ALT level increases the all-cause mortality rate in the elderly with ischemic stroke. (2) Methods: Between February 2014 and April 2019, a retrospective study of 901 patients with ischemic stroke admitted to a university-affiliated hospital was conducted. Cox proportional hazard regression was used to determine whether a significantly reduced ALT level is an independent risk factor for mortality in elderly patients after an ischemic stroke. (3) Results: This study enrolled 323 older adults (age ≥ 65 years) who were first diagnosed with ischemic stroke. The mean age of the participants was 76.5 ± 6.6 years, the mean survival time was 37.1 ± 20.4 months, and the number of deaths was 96 (29.7%). Our results showed that reduced ALT level (less than 10 U/L) increased the risk of all-cause mortality in the elderly after ischemic stroke (adjusted HR: 3.24, 95% CI: 1.95–5.41; p < 0.001). (4) Conclusions: A significantly reduced ALT level at the time of diagnosis (less than 10 U/L) is an independent risk factor that increases the mortality rate in the elderly after ischemic stroke. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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13 pages, 1315 KiB

Open AccessArticle

Associated Factors and Survival Outcomes for Breast Conserving Surgery versus Mastectomy among New Zealand Women with Early-Stage Breast Cancer

by Mohammad Shoaib Abrahimi, Mark Elwood, Ross Lawrenson, Ian Campbell and Sandar Tin Tin

Int. J. Environ. Res. Public Health 2021, 18(5), 2738; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph18052738 - 08 Mar 2021

Cited by 5 | Viewed by 2426

Abstract

This study aimed to investigate type of loco-regional treatment received, associated treatment factors and mortality outcomes in New Zealand women with early-stage breast cancer who were eligible for breast conserving surgery (BCS). This is a retrospective analysis of prospectively collected data from the Auckland and Waikato Breast Cancer Registers and involves 6972 women who were diagnosed with early-stage primary breast cancer (I-IIIa) between 1 January 2000 and 31 July 2015, were eligible for BCS and had received one of four loco-regional treatments: breast conserving surgery (BCS), BCS followed by radiotherapy (BCS + RT), mastectomy (MTX) or MTX followed by radiotherapy (MTX + RT), as their primary cancer treatment. About 66.1% of women received BCS + RT, 8.4% received BCS only, 21.6% received MTX alone and 3.9% received MTX + RT. Logistic regression analysis was used to identify demographic and clinical factors associated with the receipt of the BCS + RT (standard treatment). Differences in the uptake of BCS + RT were present across patient demographic and clinical factors. BCS + RT was less likely amongst patients who were older (75+ years old), were of Asian ethnicity, resided in impoverished areas or areas within the Auckland region and were treated in a public healthcare facility. Additionally, BCS + RT was less likely among patients diagnosed symptomatically, diagnosed during 2000–2004, had an unknown tumour grade, negative/unknown oestrogen and progesterone receptor status or tumour sizes ≥ 20 mm, ≤50 mm and had nodal involvement. Competing risk regression analysis was undertaken to estimate the breast cancer-specific mortality associated with each of the four loco-regional treatments received. Over a median follow-up of 8.8 years, women who received MTX alone had a higher risk of breast cancer-specific mortality (adjusted hazard ratio: 1.38, 95% confidence interval (CI): 1.05–1.82) compared to women who received BCS + RT. MTX + RT and BCS alone did not have any statistically different risk of mortality when compared to BCS + RT. Further inquiry is needed as to any advantages BCS + RT may have over MTX alternatives. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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14 pages, 1549 KiB

Open AccessArticle

Association between Adherence with Recommended Antenatal Care in Low-Risk, Uncomplicated Pregnancy, and Maternal and Neonatal Adverse Outcomes: Evidence from Italy

by Giovanni Corrao, Anna Cantarutti, Anna Locatelli, Gloria Porcu, Luca Merlino, Simona Carbone, Flavia Carle and Rinaldo Zanini

Int. J. Environ. Res. Public Health 2021, 18(1), 173; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph18010173 - 29 Dec 2020

Cited by 1 | Viewed by 2385

Abstract

Antenatal care (ANC) aims of monitoring wellbeing of mother and foetus during pregnancy. We validate a set of indicators aimed of measuring the quality of ANC of women on low-risk, uncomplicated pregnancy through their relationship with maternal and neonatal outcomes. We conducted a population-based cohort study including 122,563 deliveries that occurred between 2015 and 2017 in the Lombardy Region, Italy. Promptness and appropriateness of number and timing of gynaecological visits, ultrasounds and laboratory tests were evaluated. We assessed several maternal and neonatal outcomes. Log-binomial regression models were used to estimate prevalence ratio (PR), and corresponding 95% confidence interval (95% CI), for the exposure→outcome association. Compared with women who adhered with recommendations, those who were no adherent had a significant higher prevalence of maternal intensive care units admission (PR: 3.1, 95%CI: 1.2–7.9; and 2.7, 1.1–7.0 respectively for promptness of gynaecological visits, and appropriateness of ultrasound examinations), low Apgar score (1.6, 1.1–1.2; 1.9, 1.3–2.7; and 2.1, 1.5–2.8 respectively for appropriateness and promptness of gynaecological visits, and appropriateness of ultrasound examinations), and low birth weight (1.8, 1.5–2.3 for appropriateness of laboratory test examinations). Benefits for mothers and newborn are expected from improving adherence to guidelines-driven recommendations regarding antenatal care even for low-risk, uncomplicated pregnancies. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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21 pages, 4119 KiB

Open AccessArticle

Real World Use of Antidiabetic Drugs in the Years 2011–2017: A Population-Based Study from Southern Italy

by Ylenia Ingrasciotta, Maria Paola Bertuccio, Salvatore Crisafulli, Valentina Ientile, Marco Muscianisi, Luca L’Abbate, Maurizio Pastorello, Vincenzo Provenzano, Alessandro Scorsone, Salvatore Scondotto and Gianluca Trifirò

Int. J. Environ. Res. Public Health 2020, 17(24), 9514; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17249514 - 18 Dec 2020

Cited by 6 | Viewed by 2448

Abstract

Diabetes mellitus is a metabolic disease characterized by chronic hyperglycemia. The availability of new antidiabetic drugs (ADs) has led to complex treatment patterns and to changes in the patterns of specific drug utilization. The aim of this population-based study was to describe the pattern of antidiabetic drugs (ADs) use in Southern Italy in the years 2011–2017, in relation to the updated type 2 diabetes mellitus (T2DM) therapy guidelines. A retrospective cohort study was conducted on T2DM patients using data from the Palermo Local Health Unit (LHU) claims database and diabetologist registry. The first-line treatment was investigated and incident treatments were identified and characterized at baseline in terms of demographics, complications, comorbidities, concomitant drugs and clinical parameters. Persistence to AD treatment was also evaluated. During the study period, one-third of first ever ADs users started the treatment with ADs other than metformin, in contrast to guideline recommendations. Among 151,711 incident AD treatments, the male to female ratio was 1.0 and the median age was 66 (57–75) years. More than half (55.0%) of incident treatments discontinued the therapy during the first year of treatment. In Italy, general practitioners (GPs) can only prescribe first-generation ADs, while the prescription of more recently marketed ADs, such as GLP-1RA, DPP4i and SGLT2i, is restricted to diabetologists only, based on a therapeutic plan. The role of GPs in the management of T2DM in Italy should be re-evaluated. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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Review

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16 pages, 2027 KiB

Open AccessReview

The Risk of Gastrointestinal Bleeding between Non-Vitamin K Antagonist Oral Anticoagulants and Vitamin K Antagonists in the Asian Atrial Fibrillation Patients: A Meta-Analysis

by Kuang-Tsu Yang, Wei-Chih Sun, Tzung-Jiun Tsai, Feng-Woei Tsay, Wen-Chi Chen and Jin-Shiung Cheng

Int. J. Environ. Res. Public Health 2021, 18(1), 137; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph18010137 - 27 Dec 2020

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Abstract

Background: Non-vitamin K antagonist oral anticoagulants (NOACs) are more commonly used to prevent atrial fibrillation (AF) patients from thromboembolic events than vitamin K antagonists (VKAs). However, the gastrointestinal bleeding (GIB) risk in the Asian AF patients associated with NOACs in comparison with VKAs remained unaddressed. Materials and Methods: A systematic search of studies on NOACs and VKAs in the Asian AF patients was conducted in PubMed, Cochrane Library, and ClinicalTrials.gov. The primary outcome was the hazard ratio (HR) of any GIB associated with NOACs versus VKAs. The secondary outcome was the GIB risks in different kinds of NOACs compared with VKAs. Results: This meta-analysis included two randomized controlled trials (RCTs) and four retrospective studies, comprising at least 200,000 patients in total. A significantly lower HR of GIB risks was found in all kinds of NOACs than VKAs in the Asian AF patients (HR: 0.633; 95% confidence interval: 0.535–0.748; p < 0.001). Additionally, the GIB risks of different NOACs were apixaban (HR: 0.392), edoxaban (HR: 0.603), dabigatran (HR: 0.685), and rivaroxaban (HR: 0.794), respectively. Conclusions: NOACs significantly reduced the risk of GIB in the Asian AF patients compared with VKAs. In the four NOACs compared with VKAs, apixaban probably had a trend of the least GIB risk. We need further head-to-head studies of different NOACs to confirm which NOAC is the most suitable for Asian AF patients and to know the optimal dosage regimen of different NOACs. Full article

(This article belongs to the Special Issue Real-World Evidence in Clinical Epidemiology and Public Health)

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