Die TIDieR Checkliste und Anleitung – ein Instrument für eine verbesserte Interventionsbeschreibung und Replikation

Zusammenfassung

Nur wenn Interventionsbeschreibungen vollständig veröffentlicht sind, können Kliniker und Patienten Interventionen, die sich als nützlich erwiesen haben, verlässlich umsetzen und andere Forscher die Studienergebnisse replizieren oder darauf aufbauen. Die Qualität von Interventionsbeschreibungen in wissenschaftlichen Publikationen ist bemerkenswert gering. Um die Vollständigkeit der Berichterstattung und damit die Replizierbarkeit von Interventionen zu verbessern, entwickelte eine internationale Gruppe von Experten und Interessensvertretern die Checkliste zur Interventionsbeschreibung und Replikation (TIDieR). Der Prozess beinhaltete eine Literaturrecherche zu relevanten Checklisten und wissenschaftlichen Untersuchungen, eine Delphi-Umfrage mit internationalen Experten zur Steuerung der Item-Auswahl und eine Expertenkonferenz. Die daraus resultierende 12-Item-TIDieR Checkliste (Bezeichnung, Warum, Was (Materialien), Was (Verfahren), Wer intervenierte, Wie, Wo, Wann und Wieviel, Anpassungen, Modifikationen, Wie gut (geplante Durchführungskontrolle), Wie gut (tatsächliche Durchführung)) ist eine Erweiterung des CONSORT 2010 Statements (Item 5) und des SPIRIT 2013 Statements (Item 11). Während der Fokus der Checkliste auf klinischen Studien liegt, kann die erweiterte Anleitung bei allen evaluativen Studiendesigns herangezogen werden. Dieser Artikel präsentiert die TIDieR Checkliste und Anleitung mit Erklärung und Erläuterung jedes einzelnen Items sowie Beispielen guter Berichterstattung. Die TIDieR Checkliste und Anleitung sollen das Berichten von Interventionen verbessern und Autoren eine Hilfe bieten, die Berichterstattung ihrer Interventionen zu strukturieren, Gutachtern und Herausgebern, die Beschreibungen zu beurteilen und Lesern, die Informationen zu nutzen.

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 intervened, how, where, when and how much, tailoring, modifications, how well (planned), how well (actually carried out)) 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 a detailed explanation of 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 the accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.

Schlüsselwörter

Leitlinien zur Forschungsberichterstattung - Interventionsbeschreibung - Replizierbarkeit

Key words

reporting guidelines - intervention description - replicability

• Literatur

• 1 Duff J, Leather H, Walden E. et al. Adequacy of published oncology randomised controlled trials to provide therapeutic details needed for clinical application. J Natl Cancer Inst 2010; 102: 702-705
• 2 Glasziou P, Meats E, Heneghan C. et al. What is missing from descriptions of treatment in trials and reviews?. BMJ 2008; 336: 1472-1474
• 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. et al. 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. 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. et al. Reporting randomised, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006; 144: 364-367
• 9 Chan A, Tetzlaff J, Gøtzsche P. et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013; 346: e7586
• 10 Moher D, Schulz K, Simera I. et al. Guidance for developers of health research reporting guidelines. PLoS Med 2010; 7: e1000217
• 11 Murphy M, Black N, Lamping D. 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. et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ 2007; 335: 806-808
• 13 De Bruin M, Viechtbauer W, Hospers H. et al. 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: 668-674
• 14 Thorpe K, Zwarenstein M, Oxman AD. et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol 2009; 62: 464-475
• 15 Craig P, Dieppe P, Macintyre S. et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008; 337: a1655
• 16 McCleary N, Duncan E, Stewart F. et al. 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. et al. Explaining Matching Michigan: an ethnographic study of a patient safety program. Implement Sci 2013; 8: 70
• 19 Dixon-Woods M, Bosk C, Aveling E. et al. 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. et al. A conceptual framework for implementation fidelity. Implement Sci 2007; 2: 40
• 21 Bellg AJ, Borrelli B, Resnick B. et al. Enhancing treatment fidelity in health behaviour change studies: best practices and recommendations from the NIH Behaviour Change Consortium. Health Psychol 2004; 23: 443-451
• 22 Hardeman W, Michie S, Fanshawe T. et 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. et al. Monitoring treatment fidelity in a randomised controlled trial of a complex intervention. J Adv Nursing 2007; 60: 343-352
• 24 Hopewell S, Ravaud P, Baron G. et al. 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. et al. 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/uthors/gta/index.html#a5.3.
• 28 Turner L, Shamseer L, Altman DG. et al. 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: 86-89
• 30 Glasziou P, Altman D, Bossuyt P. et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet 2014; 383: 267-276