Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study

Öz:

Objective: The aim of this study is to assess the prevalence ofpolypharmacy, inappropriate drug use, and drug-drug interactions(DDIs) in elderly patients presenting at outpatient cardiology clinicsin Turkey.Methods: The EPIC (Epidemiology of Polypharmacy and PotentialDrug-Drug Interactions in Elderly Cardiac Outpatients) study willbe an observational, real-world, multicenter study conducted toevaluate DDIs and polypharmacy in elderly cardiac outpatients. Allconsecutive patients (aged ≥65 years) admitted to outpatient cardiologyclinics between July 30, 2018 and July 30, 2019 who providewritten, informed consent will be enrolled. A total of approximately5000 patients are to be enrolled in this non-interventional study. Allof the data will be collected at one point in time and current clinicalpractice will be evaluated (ClinicalTrials.gov NCT03370523).Results: Patient demographics, comorbid disease characteristics,laboratory test results, and details of medication use will be collectedusing self-reports and medical records. The severity of comorbid diseasewill be recorded and scored according to Charlson ComorbidityIndex (CCI) and patients will be divided into 3 groups: mild, thosewith a CCI score of 1–2; moderate, those with a CCI score of 3–4;and severe, those with a CCI score of ≥5. Polypharmacy will be definedas the use of 5 or more medications at one time. DDIs will bedetermined using the Lexicomp Online drug interaction screeningtool and potentially inappropriate medications will be defined basedon the 2015 update of the Beers Criteria for Potentially InappropriateMedication Use in Older Adults. Severe drug interactions will be definedas those in category D or X.Conclusion: EPIC will be the first large-scale study in Turkey toevaluate polypharmacy, potentially inappropriate medications, andDDIs in elderly cardiac outpatients in a real-world clinical setting.

Anahtar Kelime:

EPIC (Yaşlı, Ayaktan Kardiyak Hastalarda Polifarmasi ve Potansiyel İlaç-İlaç Etkileşimlerinin Epidemiyolojisi) çalışmasının temel, tasarım ve metodolojisi

Öz:

Amaç: Türkiye’deki kardiyoloji polikliniklerine başvuran yaşlı hastalarda polifarmasi prevalansını, uygunsuz ilaç kullanımını ve ilaç-ilaç etkileşimlerini (İİE) değerlendirmek. Yöntemler: EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) çalışması kardiyoloji polikliniklerine başvuran yaşlı hastalarda polifarmasi ve İİE’nin değerlendirileceği, gerçek yaşam verilerini aktaran, çok merkezli ve gözlemsel bir çalışma olarak tasarlandı. Çalışmaya; 30 Temmuz 2018 ve 30 Temmuz 2019 tarihleri arasında farklı kardiyoloji polikliniklerine başvuran, aydınlatılmış onam formunu imzalayan, 65 yaş ve üzeri, kadın ve erkek, ardışık 5000 hastanın dahil edilmesi planlandı. Hastalarla ilgili tüm verilerin tek bir ziyarette alınması ve verilerin değerlendirilmesi planlandı (ClinicalTrials.gov numarası NCT03370523). Bulgular: Hastalara ait demografik veriler, komorbid hastalık durumları, laboratuvar test sonuçları ve ilaç bilgileri hasta beyanları ve medikal kayıtlar yoluyla toplanacaktır. Komorbid hastalıklar kaydedilecek ve komorbid hastalıkların ciddiyeti Charlson komorbidite indeksi’ne (CKİ) göre hastalar 3 gruba ayrılacaktır: CKİ skoru 1–2 olanlar hafif, CKİ skoru 3–4 olanlar orta, CKİ skoru ≥5 olanlar ciddi. Polifarmasi aynı hastanın bir kerede 5 ve üzeri ilaç kullanması olarak tanımlanacaktır. İİE Lexicomp® çevrimiçi ilaç etkileşimi tarama aracı ile kontrol edilecek, potansiyel uygunsuz ilaç kullanımı 2015 Beers kriterlerine göre tanımlanacaktır. D ve X kategorisindeki etkileşimler ciddi ilaç etkileşimi olarak sınıflandırılacaktır. Sonuç: EPIC çalışması kardiyoloji polikliniklerine başvuran yaşlı hastalarda polifarmasi, İİE ve potansiyel uygunsuz ilaç kullanımı konularında gerçek yaşam verilerini ayrıntılı olarak aktaran ilk büyük çaplı çalışma olacaktır.

Anahtar Kelime:

Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık

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APA	ÖZLEK E, ÇEKİÇ E, ÖZLEK B, ÇİL C, ÇELİK O, doğan v, basaran o, TANIK V, ÖZDEMİR H, ÇELİK Y, KAÇMAZ C, Simsek Z, GÜNEŞ H, ŞAFAK Ö, ÖZKAN B, Tasar O, ÖNAL Ç, BEKAR L, BİTEKER M (2019). Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study. , 391 - 398. 10.5543/tkda.2019.27724
Chicago	ÖZLEK EDA,ÇEKİÇ EDİP GÜVENÇ,ÖZLEK BÜLENT,ÇİL CEM,ÇELİK OĞUZHAN,doğan volkan,basaran ozcan,TANIK VEYSEL OZAN,ÖZDEMİR Halil İbrahim,ÇELİK Yunus,KAÇMAZ Caner,Simsek Zeki,GÜNEŞ Hacı Murat,ŞAFAK Özgen,ÖZKAN Buğra,Tasar Onur,ÖNAL ÇAĞATAY,BEKAR Lütfü,BİTEKER MURAT Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study. (2019): 391 - 398. 10.5543/tkda.2019.27724
MLA	ÖZLEK EDA,ÇEKİÇ EDİP GÜVENÇ,ÖZLEK BÜLENT,ÇİL CEM,ÇELİK OĞUZHAN,doğan volkan,basaran ozcan,TANIK VEYSEL OZAN,ÖZDEMİR Halil İbrahim,ÇELİK Yunus,KAÇMAZ Caner,Simsek Zeki,GÜNEŞ Hacı Murat,ŞAFAK Özgen,ÖZKAN Buğra,Tasar Onur,ÖNAL ÇAĞATAY,BEKAR Lütfü,BİTEKER MURAT Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study. , 2019, ss.391 - 398. 10.5543/tkda.2019.27724
AMA	ÖZLEK E,ÇEKİÇ E,ÖZLEK B,ÇİL C,ÇELİK O,doğan v,basaran o,TANIK V,ÖZDEMİR H,ÇELİK Y,KAÇMAZ C,Simsek Z,GÜNEŞ H,ŞAFAK Ö,ÖZKAN B,Tasar O,ÖNAL Ç,BEKAR L,BİTEKER M Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study. . 2019; 391 - 398. 10.5543/tkda.2019.27724
Vancouver	ÖZLEK E,ÇEKİÇ E,ÖZLEK B,ÇİL C,ÇELİK O,doğan v,basaran o,TANIK V,ÖZDEMİR H,ÇELİK Y,KAÇMAZ C,Simsek Z,GÜNEŞ H,ŞAFAK Ö,ÖZKAN B,Tasar O,ÖNAL Ç,BEKAR L,BİTEKER M Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study. . 2019; 391 - 398. 10.5543/tkda.2019.27724
IEEE	ÖZLEK E,ÇEKİÇ E,ÖZLEK B,ÇİL C,ÇELİK O,doğan v,basaran o,TANIK V,ÖZDEMİR H,ÇELİK Y,KAÇMAZ C,Simsek Z,GÜNEŞ H,ŞAFAK Ö,ÖZKAN B,Tasar O,ÖNAL Ç,BEKAR L,BİTEKER M "Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study." , ss.391 - 398, 2019. 10.5543/tkda.2019.27724
ISNAD	ÖZLEK, EDA vd. "Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study". (2019), 391-398. https://doi.org/10.5543/tkda.2019.27724

APA	ÖZLEK E, ÇEKİÇ E, ÖZLEK B, ÇİL C, ÇELİK O, doğan v, basaran o, TANIK V, ÖZDEMİR H, ÇELİK Y, KAÇMAZ C, Simsek Z, GÜNEŞ H, ŞAFAK Ö, ÖZKAN B, Tasar O, ÖNAL Ç, BEKAR L, BİTEKER M (2019). Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study. Türk Kardiyoloji Derneği Arşivi, 47(5), 391 - 398. 10.5543/tkda.2019.27724
Chicago	ÖZLEK EDA,ÇEKİÇ EDİP GÜVENÇ,ÖZLEK BÜLENT,ÇİL CEM,ÇELİK OĞUZHAN,doğan volkan,basaran ozcan,TANIK VEYSEL OZAN,ÖZDEMİR Halil İbrahim,ÇELİK Yunus,KAÇMAZ Caner,Simsek Zeki,GÜNEŞ Hacı Murat,ŞAFAK Özgen,ÖZKAN Buğra,Tasar Onur,ÖNAL ÇAĞATAY,BEKAR Lütfü,BİTEKER MURAT Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study. Türk Kardiyoloji Derneği Arşivi 47, no.5 (2019): 391 - 398. 10.5543/tkda.2019.27724
MLA	ÖZLEK EDA,ÇEKİÇ EDİP GÜVENÇ,ÖZLEK BÜLENT,ÇİL CEM,ÇELİK OĞUZHAN,doğan volkan,basaran ozcan,TANIK VEYSEL OZAN,ÖZDEMİR Halil İbrahim,ÇELİK Yunus,KAÇMAZ Caner,Simsek Zeki,GÜNEŞ Hacı Murat,ŞAFAK Özgen,ÖZKAN Buğra,Tasar Onur,ÖNAL ÇAĞATAY,BEKAR Lütfü,BİTEKER MURAT Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study. Türk Kardiyoloji Derneği Arşivi, vol.47, no.5, 2019, ss.391 - 398. 10.5543/tkda.2019.27724
AMA	ÖZLEK E,ÇEKİÇ E,ÖZLEK B,ÇİL C,ÇELİK O,doğan v,basaran o,TANIK V,ÖZDEMİR H,ÇELİK Y,KAÇMAZ C,Simsek Z,GÜNEŞ H,ŞAFAK Ö,ÖZKAN B,Tasar O,ÖNAL Ç,BEKAR L,BİTEKER M Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study. Türk Kardiyoloji Derneği Arşivi. 2019; 47(5): 391 - 398. 10.5543/tkda.2019.27724
Vancouver	ÖZLEK E,ÇEKİÇ E,ÖZLEK B,ÇİL C,ÇELİK O,doğan v,basaran o,TANIK V,ÖZDEMİR H,ÇELİK Y,KAÇMAZ C,Simsek Z,GÜNEŞ H,ŞAFAK Ö,ÖZKAN B,Tasar O,ÖNAL Ç,BEKAR L,BİTEKER M Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study. Türk Kardiyoloji Derneği Arşivi. 2019; 47(5): 391 - 398. 10.5543/tkda.2019.27724
IEEE	ÖZLEK E,ÇEKİÇ E,ÖZLEK B,ÇİL C,ÇELİK O,doğan v,basaran o,TANIK V,ÖZDEMİR H,ÇELİK Y,KAÇMAZ C,Simsek Z,GÜNEŞ H,ŞAFAK Ö,ÖZKAN B,Tasar O,ÖNAL Ç,BEKAR L,BİTEKER M "Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study." Türk Kardiyoloji Derneği Arşivi, 47, ss.391 - 398, 2019. 10.5543/tkda.2019.27724
ISNAD	ÖZLEK, EDA vd. "Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study". Türk Kardiyoloji Derneği Arşivi 47/5 (2019), 391-398. https://doi.org/10.5543/tkda.2019.27724