Yıl: 2020 Cilt: 8 Sayı: 2 Sayfa Aralığı: 196 - 205 Metin Dili: İngilizce DOI: 10.14235/bas.galenos.2019.3390 İndeks Tarihi: 11-10-2020

Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording

Öz:
The World Health Organization (WHO) considers the registration of the study protocol as the publication of an internationally recognized set of information on the design, conduct, and management of clinical trials. Writing a detailed study protocol with all the correct and necessary steps is an important step before starting randomized controlled trials. WHO says that study protocols should be included in a standardized registration system and published on a publicly accessible website. From an ethical point of view, the Helsinki Declaration emphasizes that study protocols should be registered in a public database. In addition, before the implementation process of the RCTs has started, obtaining the registration number (protocol ID) in public databases has become an important necessity for the studies to be published in quality journals. The purpose of this review is to review, consider recommendations and provide guidance for protocol registration during protocol preparation, which is the most important stage of a correctly planned RCT process. It is seen that the culture of planning and adhering to this protocol has not yet become widespread in the researchers in our country as they begin the RCT process, according to the principles of the study protocol preparation. It is thought that the information in this review will guide the researchers at this point.
Anahtar Kelime:

Randomize Kontrollü Çalışmalar için Protokol Hazırlama: Öneriler ve Protokol Kaydı

Öz:
Dünya Sağlık Örgütü (DSÖ), çalışma protokolü kaydını, klinik çalışmaların tasarımı, yürütülmesi ve yönetimi ile ilgili uluslararası kabul görmüş bir bilgi dizisinin yayınlanması olarak kabul etmektedir. Doğru ve gerekli tüm basamakları içeren ayrıntılı bir çalışma protokolü yazmak, randomize kontrollü çalışmalara (RKÇ) başlamadan önce önemli bir adımdır. DSÖ çalışma protokollerini standartlara uygun bir kayıt sisteminde yer alması ve bu bilgilerin herkes tarafından erişilebilen bir web sitesinde yayınlanması gerektiğini söylemektedir. Etik açıdan bakıldığında Helsinki Bildirgesi’de çalışma protokollerinin halka açık bir veri tabanında kayıtlı olması gerektiğini vurgulamaktadır. Ayrıca hazırlanan protokollerin RKÇ’nin uygulama süreci başlamadan önce uluslararası veri tabanlarında kayıt edilmesi ve kayıt numarasının (protokol ID) alınması, çalışmaların kaliteli dergilerde yayına dönüşmesi için oldukça önemli bir zorunluluk haline gelmiştir. Bu derlemenin amacı, kanıt değeri yüksek, doğru planlanmış bir RKÇ sürecinin en önemli aşaması olan protokol hazırlama sırasında, dikkate edilmesi gereken noktaları gözden geçirmek, öneriler vermek ve protokol kaydı için rehberlik sağlamaktır. Ülkemizdeki araştırmacılarda RKÇ sürecine başlarken, çalışma protokolü hazırlama ilkelerine göre çalışmalarını planlama ve bu protokole bağlı kalarak sürdürme kültürünün henüz yaygınlaşmadığı görülmektedir. Bu derlemede yer alan bilgilerin araştırmacılara bu noktada rehberlik ederek yol göstereceği düşünülmektedir.
Anahtar Kelime:

Belge Türü: Makale Makale Türü: Derleme Erişim Türü: Erişime Açık
  • 1. Senyuva E. Hemşirelik Eğitimi ve Kanıta Dayalı Uygulamalar. Florence Nightingale Hemşirelik Dergisi 2016;24:59-65.
  • 2. Closs S, Cheater F. Evidence for nursing practice: a clarification of the issues. Journal of Advanced Nursing 1999;30:10-7.
  • 3. Arslan S, Şener DK, Küçük Ö. Pediatri kliniğinde çalişan hemşirelerin kanita dayali uygulamalara ilişkin görüşleri. Yildirim Beyazit Üniversitesi Hemşirelik E-Dergisi. 2016;3.
  • 4. Kocaman G. Hemşirelikte Kanıta Dayalı Uygulama. Hemşirelikte Araştırma Geliştirme Dergisi 2006;2:61-9.
  • 5. Scott K, McSherry R. Evidence-based nursing: clarifying the concepts for nurses in practice. Journal of clinical nursing 2009;18:1085-95.
  • 6. Ingersoll GL. Evidence-based nursing: what it is and what it isn’t. Nursing outlook 2000;48:151-2.
  • 7. Baldi I, Dal Lago E, De Bardi S, Sartor G, Soriani N, Zanotti R, et al. Trends in RCT nursing research over 20 years: mind the gap. British journal of nursing (Mark Allen Publishing) 2014;23:895-9.
  • 8. WHO. International Clinical Trials Registry Platform (ICTRP) 2018 [cited 2018 December 15].
  • 9. Boden C, Bidonde J, Busch A. Gaps exist in the current guidance on the use of randomized controlled trial study protocols in systematic reviews. Journal of Clinical Epidemiology 2017;85:59-69.
  • 10. Closs SJ, Cheater FM. Evidence for nursing practice: a clarification of the issues. J Adv Nurs 1999;30:10-7.
  • 11. Kocaman G. Hemşirelikte Kanıta Dayalı Uygulama. Hemşirelikte Araştırma Geliştirme Dergisi 2003;2:61-9.
  • 12. Gray J, Chambers LW. Evidence-based healthcare: how to make health policy & management decisions. Canadian Medical Association Journal 1997;157:1598.
  • 13. Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schunemann HJ. What is “quality of evidence” and why is it important to clinicians? Bmj 2008;336:995-8.
  • 14. Donaldson L. Evidence-based health care, by J A Muir Gray1997. 615- p.
  • 15. Burns PB, Rohrich RJ, Chung KC. The levels of evidence and their role in evidence-based medicine. Plastic and reconstructive surgery 2011;128:305-10.
  • 16. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS medicine 2009;6:e1000097.
  • 17. Grove SK, Burns N, Gray J. The practice of nursing research: Appraisal, synthesis, and generation of evidence: Elsevier Health Sciences; 2012.
  • 18. Association WM. Declaration of Helsinki. Ethical principles for medical research involving human subjects. http://www wma net/e/ policy/b3 htm. 2008.
  • 19. Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
  • 20. Cameli M, Novo G, Tusa M, Mandoli GE, Corrado G, Benedetto F, et al. How to Write a Research Protocol: Tips and Tricks. Journal of cardiovascular echography 2018;28:151-3.
  • 21. Chow S-C, Liu J-p. Design and analysis of clinical trials: concepts and methodologies: John Wiley & Sons;2008.
  • 22. ECCRT(European Centre For Clinical Research Training). Writing Clinical Research Protocols 2016 [cited 2018 December 10].
  • 23. DeRenzo E, Moss J. Writing clinical research protocols: Ethical considerations: Elsevier; 2005.
  • 24. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Bmj 2013;346:e7586.
  • 25. O’Brien K, Wright J. How to write a protocol. Journal of orthodontics 2002;29:58-61.
  • 26. wiki.ecdc.europa. Writing a Study Protocol 2016 [cited 2018 December, 6].
  • 27. Gonzalez CD, Bolaños R, de Sereday M. Editorial on hypothesis and objectives in clinical trials: superiority, equivalence and noninferiority. Thrombosis journal 2009;7:3.
  • 28. Gray R, Badnapurkar A, Thomas D. Reporting of clinical trials in nursing journals: how are we doing? Journal of Advanced Nursing 2017;73:2782-4.
  • 29. WHO. Trial Registration 2018 [cited 2018 December, 15
  • 30. Zarin DA, Keselman A. Registering a clinical trial in ClinicalTrials. gov. Chest 2007;131:909-12.
  • 31. Al-JunDi A, Sakka S. Protocol writing in clinical research. Journal of clinical and diagnostic research: JCDR 2016;10:ZE10.
  • 32. Huang GD, Bull J, Johnston McKee K, Mahon E, Harper B, Roberts JN. Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative. Contemporary Clinical Trials 2018;66:74-9.
  • 33. WHO ICTRP. International Clinical Trials Registry Platform Searh Portal 2018 [cited 2018 December, 22]. Available from: http://apps. who.int/trialsearch/.
  • 34. WHO. Recommended format for a Research Protocol 2018 [cited 2018 December, 15].
  • 35. Eaton KA, Santini A. An Introduction to Research for Primary Dental Care Clinicians Part 3: Stage 5. Writing a Protocol. Primary Dental Care 2011;18:91.
  • 36. Bhandari M, Devereaux PJ, Montori V, Cina C, Tandan V, Guyatt GH. Users’ guide to the surgical literature: how to use a systematic literature review and meta-analysis. Canadian journal of surgery Journal canadien de chirurgie 2004;47:60-7.
  • 37. Smith BA, Lee HJ, Lee JH, Choi M, Jones DE, Bausell RB, et al. Quality of reporting randomized controlled trials (RCTs) in the nursing literature: application of the consolidated standards of reporting trials (CONSORT). Nursing outlook 2008;56:31-7.
  • 38. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC medicine 2010;8:18.
  • 39. equator network. Enhancing the QUAlity and Transparency Of health Research 2019 [cited 2019 5 May,].
  • 40. Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta analysis protocols (PRISMA-P) 2015 statement. Systematic reviews 2015;4:1.
  • 41. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, KrlezaJeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Annals of internal medicine 2013;158:200-7.
  • 42. ClinicalTrials.gov. ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world 2018 [cited 2018 December,13].
  • 43. ANZCTR. The Australian New Zealand Clinical Trials Registry 2019.
  • 44. BMC Part of Springer Nature. ISRCTN registry 2019.
APA Dağıstan Akgöz A, Ozer Z (2020). Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording. , 196 - 205. 10.14235/bas.galenos.2019.3390
Chicago Dağıstan Akgöz Ayşe,Ozer Zeynep Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording. (2020): 196 - 205. 10.14235/bas.galenos.2019.3390
MLA Dağıstan Akgöz Ayşe,Ozer Zeynep Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording. , 2020, ss.196 - 205. 10.14235/bas.galenos.2019.3390
AMA Dağıstan Akgöz A,Ozer Z Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording. . 2020; 196 - 205. 10.14235/bas.galenos.2019.3390
Vancouver Dağıstan Akgöz A,Ozer Z Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording. . 2020; 196 - 205. 10.14235/bas.galenos.2019.3390
IEEE Dağıstan Akgöz A,Ozer Z "Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording." , ss.196 - 205, 2020. 10.14235/bas.galenos.2019.3390
ISNAD Dağıstan Akgöz, Ayşe - Ozer, Zeynep. "Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording". (2020), 196-205. https://doi.org/10.14235/bas.galenos.2019.3390
APA Dağıstan Akgöz A, Ozer Z (2020). Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording. Bezmiâlem Science, 8(2), 196 - 205. 10.14235/bas.galenos.2019.3390
Chicago Dağıstan Akgöz Ayşe,Ozer Zeynep Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording. Bezmiâlem Science 8, no.2 (2020): 196 - 205. 10.14235/bas.galenos.2019.3390
MLA Dağıstan Akgöz Ayşe,Ozer Zeynep Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording. Bezmiâlem Science, vol.8, no.2, 2020, ss.196 - 205. 10.14235/bas.galenos.2019.3390
AMA Dağıstan Akgöz A,Ozer Z Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording. Bezmiâlem Science. 2020; 8(2): 196 - 205. 10.14235/bas.galenos.2019.3390
Vancouver Dağıstan Akgöz A,Ozer Z Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording. Bezmiâlem Science. 2020; 8(2): 196 - 205. 10.14235/bas.galenos.2019.3390
IEEE Dağıstan Akgöz A,Ozer Z "Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording." Bezmiâlem Science, 8, ss.196 - 205, 2020. 10.14235/bas.galenos.2019.3390
ISNAD Dağıstan Akgöz, Ayşe - Ozer, Zeynep. "Study Protocol Preparation for Randomized Controlled Trials: Recommendations and Protocol Recording". Bezmiâlem Science 8/2 (2020), 196-205. https://doi.org/10.14235/bas.galenos.2019.3390