Müdahalenin daha iyi sunumu: Müdahale Tanımlama ve Tekrarlama Şablonu (Template for Intervention Description and Replication, TIDieR) kontrol listesi ve rehberi

Year 2020, Volume: 7 Issue: 3, 302 - 320, 06.01.2021

Yavuz Yakut , Özge Özalp , Aida Habibzadeh Ceren Gürşen , Gözde Yagcı

Abstract

Müdahalelerin yayınlanmış ayrıntılı açıklaması olmadan, klinisyenler ve hastalar, yararlı olduğu gösterilen müdahaleleri güvenilir bir şekilde uygulayamaz ve diğer araştırmacılar araştırma bulgularını tekrar edemez veya bu bulgulara güvenemez. Bununla birlikte, yayınlardaki müdahalelerin tanımlanmasının kalitesi oldukça düşüktür. Müdahalelerin raporlanmasının eksiksizliğini ve nihayetinde tekrarlanabilirliğini iyileştirmek için, uluslararası uzmanlar ve paydaşlar grubu Müdahale Tanımlama ve Tekrarlama Şablonu (TIDieR) kontrol listesi ve rehberini geliştirdi. Bu süreç, ilgili kontrol listeleri ve araştırmaların literatür incelemesini, madde seçimine rehberlik etmek için uzmanların katıldığı uluslararası panelin Delphi anketini ve yüz yüze panel toplantısını içeriyordu. Ortaya çıkan 12 maddelik TIDieR kontrol listesi [kısa adı, neden, ne (malzemeler), ne (prosedür), kim sağladı, nasıl, nerede, ne zaman ve ne kadar, uyarlama, değişiklikler, ne kadar iyi (planlanan), ne kadar iyi (gerçekte)] CONSORT 2010 (madde 5) ve SPIRIT 2013 bildiriminin (madde 11) bir uzantısıdır. Kontrol listesi özellikle çalışmalar üzerine odaklanırken, kılavuz ise değerlendirme içeren tüm araştırma tasarımlarına uygulanması hedef alınarak hazırlanmıştır. Bu makale, TIDieR kontrol listesini ve kılavuzunu, her maddeyi açıklayıp detaylandırarak iyi raporlama örnekleri ile birlikte sunmaktadır. TIDieR kontrol listesi ve kılavuzu, müdahalelerin raporlanmasının kalitesini arttırmakla beraber araştırmacıların müdahalelerini yapılandırmasını, hakemlerin ve editörlerin açıklamaları değerlendirmesini ve okuyucuların bu bilgileri kullanmasını kolaylaştıracaktır.

Keywords

Araştırma raporu, Metod, Rehber, Kontrol listesi

Better Reporting of Interventions: Template for Intervention Description and Replication (TIDieR) Checklist and Guide

Abstract

Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.

References

• 1. Duff J, Leather H, Walden E, LaPlant K, George T. Adequacy of published oncology randomised controlled trials to provide therapeutic details needed for clinical application. J Natl Cancer Inst 2010;102:702-5.
• 2. Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from descriptions of treatment in trials and reviews? BMJ 2008;336:1472-4.
• 3. Hoffmann T, Erueti C, Glasziou P. Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials. BMJ 2013;347:f3755.
• 4. Schulz K, Altman D, Moher D, CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
• 5. Schroter S, Glasziou P, Heneghan C. Quality of descriptions of treatments: a review of published randomised controlled trials. BMJ Open 2012;2:e001978.
• 6. Boutron I, Moher D, Altman D, Schulz K, Ravaud P. Extending the CONSORT statement to randomised trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008;148:295-310.
• 7. MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, et al. Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement. PLoS Med 2010;7:e1000261.
• 8. Gagnier J, Boon H, Rochon P, Moher D, Barnes J, Bombardier C, et al. Reporting randomised, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006;144:364-7.
• 9. Chan A, Tetzlaff J, Gøtzsche P, Altman D, Mann H, Berlin J, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.
• 10. Moher D, Schulz K, Simera I, Altman D. Guidance for developers of health research reporting guidelines. PLoS Med 2010;7:e1000217.
• 11. Murphy M, Black N, Lamping D, McKee C, Sanderson C, Askham J, et al. Consensus development methods, and their use in clinical guideline development. Health Technol Assess 1998;2:1-88.
• 12. Von Elm E, Altman D, Egger M, Pocock S, Gøtzsche P, Vandenbroucke J, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ 2007;335:806-8.
• 13. De Bruin M, Viechtbauer W, Hospers H, Schaalma H, Kok G. Standard care quality determines treatment outcomes in control groups of HAART-adherence intervention studies: implications for the interpretation and comparison of intervention effects. Health Psychol 2009;28:668-74.
• 14. Thorpe K, Zwarenstein M, Oxman AD, Treweek S, Furberg C, Altman D, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol 2009;62:464-75.
• 15. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008;337:a1655.
• 16. McCleary N, Duncan E, Stewart F, Francis J. Active ingredients are reported more often for pharmacologic than non-pharmacologic interventions: an illustrative review of reporting practices in titles and abstracts. Trials 2013;14:146.
• 17. Michie S, West R. Behaviour change theory and evidence: a presentation to Government. Health Psychol Rev 2013;7:1-22.
• 18. Dixon-Woods M, Leslie M, Tarrant C, Bion J. Explaining Matching Michigan: an ethnographic study of a patient safety program. Implement Sci 2013;8:70.
• 19. Dixon-Woods M, Bosk C, Aveling E, Goeschel C, Pronovost P. Explaining Michigan: developing an ex post theory of a quality improvement program. Milbank Q 2011;89:167-205.
• 20. Carroll C, Patterson M, Wood S, Booth A, Rick J, Ba lain S. A conceptual framework for implementation fidelity. Implement Sci 2007;2:40.
• 21. Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci D, Ory M, et al. Enhancing treatment fidelity in health behaviour change studies: best practices and recommendations from the NIH Behaviour Change Consortium. Health Psychol 2004;23:443-51.
• 22. Hardeman W, Michie S, Fanshawe T, Prevost T, McLoughlin K, Kinmonth AL. Fidelity of delivery of a physical activity intervention: predictors and consequences. Psychol Health 2008;23:11-24.
• 23. Spillane V, Byrne M, Byrne M, Leathem C, O’Malley M, Cupples M. Monitoring treatment fidelity in a randomised controlled trial of a complex intervention. J Adv Nursing 2007;60:343-52.
• 24. Hopewell S, Ravaud P, Baron G, Boutron I. Effect of editors’ implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis. BMJ 2012;344:e4178.
• 25. Hoffmann T, English T, Glasziou P. Reporting of interventions in randomised trials: an audit of journal Instructions to Authors. Trials 2014;15:20.
• 26. Michie S, Fixsen D, Grimshaw JM, Eccles MP. Specifying and reporting complex behaviour change interventions: the need for a scientific method. Implement Sci 2009;4:40.
• 27. Nature. For authors: manuscript formatting guide [Internet]. www.nature.com/nature/ authors/gta/index.html#a5.3.
• 28. Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev 2012;1:60.
• 29. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009;374:86-9.
• 30. Glasziou P, Altman D, Bossuyt P, Boutron I, Clarke M, Julious S, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet 2014;383:267-76.