SPIRIT 2013 Bildirisi: Klinik Deneyler İçin Standart Protokol Maddelerinin Tanımlanması

Year 2021, , 117 - 127, 31.03.2021

Belgin Akın Deniz Koçoğlu-tanyer

https://doi.org/10.31125/hunhemsire.908072

Cited By: 6

Abstract

Klinik deney protokolü deneyin planlanması, yürütülmesi, raporlanması ve değerlendirilmesinde temel bir dayanak olarak hizmet eder. Ancak deney protokolleri ve mevcut protokol rehberleri, içerik ve kalite yönünden oldukça fazla çeşitlilik göstermektedir. Bu makale klinik deney protokolünün asgari içeriği için bir rehber olan SPIRIT 2013’ün (Standard Protocol Items: Recommendations for Interventional Trials-Standart Protokol Maddeleri: Girişimsel Deneyler için Öneriler) sistematik olarak geliştirilmesini ve kapsamını tanımlamaktadır. 33-maddelik SPIRIT kontrol listesi tüm klinik deney protokollerine uygulanabilir ve şekilden ziyade içeriğe odaklanır. Kontrol listesi, tüm planlananların tarif edilmesini önerir; bir deneyin nasıl tasarlanacağını ya da yürütüleceğini içermez. SPIRIT önerileri, anahtar içerik için rehberlik sağlayarak, yüksek kaliteli protokol taslağı hazırlanmasını kolaylaştırmayı hedefler. SPIRIT’e bağlı kalmak aynı zamanda araştırmacılar, deney katılımcıları, hastalar, sponsorlar, ödenek sağlayanlar, araştırma etik komiteleri ya da kurumsal hakem kurulları, hakemler, dergiler, deney kayıt merkezi, politikacılar, düzenleyiciler ve diğer anahtar paydaşlar için deney protokolünün şeffaflığını ve bütünlüğünü artırır.

Keywords

Deneysel araştırmalar, raporlama, SPIRIT

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

Abstract

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Keywords

Experimental studies, reporting, SPIRIT

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