Worauf kommt es beim Lesen von Therapiestudien an?

Zusammenfassung

Das Lesen und kritische Verstehen von Publika­tionen, die über die Ergebnisse von klinischen Studien berichten, ist oftmals schwierig. Klinische Studien lassen sich grundsätzlich 2 Kategorien zuordnen: Beobachtungsstudien und experimentelle Studien abhängig von einer spezifischen Intervention, die untersucht werden soll. Beobachtungsstudien umfassen Fall-Studien/Fallserien, Fall-/Kontrollstudien und Kohortenstudien. Experimentelle Studien lassen sich in randomisierte und nicht-randomisierte Studien unterteilen. Die randomisierte kontrollierte klinische Studie stellt dabei den „Gold-Standard“ zur Evaluation einer Intervention dar. In diesem kurzen Artikel soll ein systematischer Ansatz, basierend auf den CONSORT-Kriterien, als Leitfaden für das Lesen von Arbeiten zu klinischen Studien vorgestellt werden.

Abstract

To read and understand the reports of clinical trials can often be tedious and difficult. Clinical research falls into 2 categories: observational and experimental studies, depending on whether the investigator assigns the exposures or not. Experimental trials can be subdivided into randomised and non-randomised studies. The controlled randomised clinical trial marks the “gold standard” to evaluate the effects of a therapeutic intervention. In this article we provide a short guide, based on the CONSORT criteria, about how to read and understand the results of clinical trials.

Schlüsselwörter

klinische Studie - Beobachtungsstudie - CONSORT

Keywords

clinical trial - observational trial - CONSORT

• Literatur

• 1 Olatunbosun OA, Edouard L, Pierson RA. Physicians’ attitudes toward evidence based obstetric practice: a questionnaire survey. BMJ 1998; 316: 365-366
• 2 Koretz RL. Considerations of study design. Nutr Clin Pract 2007; 22: 593-598
• 3 Schumacher M, Schulgen G. Methodik klinischer Studien. Berlin, Heidelberg, New York: Springer; 2002
• 4 Deeks JJ, Dinnes J, D’Amico R et al. Evaluating non-randomised intervention studies. Health Technol Assess 2003; 7 iii–x, 1-173
• 5 Windeler J, Antes G, Behrens J et al. Randomised controlled trials (RCTs). Z Evid Fortbild Qual Gesundhwes 2008; 102: 321-325
• 6 Silverman SL. From randomized controlled trials to observational studies. Am J Med 2009; 122: 114-120
• 7 Olivo SA, Macedo LG, Gadotti IC et al. Scales to assess the quality of randomized controlled trials: a systematic review. Phys Ther 2008; 88: 156-175
• 8 Dechartres A, Charles P, Hopewell S et al. Reviews assessing the quality or the reporting of randomized controlled trials are increasing over time but raised questions about how quality is assessed. J Clin Epidemiol 2011; 64: 136-144
• 9 Moher D, Cook DJ, Jadad AR et al. Assessing the quality of reports of randomised trials: implications for the conduct of meta-analyses. Health Technol Assess. 1999; 3: i–iv 1-98
• 10 Mohe D, Jadad AR, Tugwell P. Assessing the quality of randomized controlled trials. Current issues and future directions. Int J Technol Assess Health Care 1996; 12: 195-208
• 11 Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 152. 726-732
• 12 Stampfer MJ, Buring JE, Willett W et al. The 2×2 factorial design: its application to a randomized trial of aspirin and carotene in U.S. physicians. Stat Med 1985; 4: 111-116
• 13 Peterson AV, Mann SL, Kealey KA et al. Experimental design and methods for school-based randomized trials. Experience from the Hutchinson Smoking Prevention Project (HSPP). Control Clin Trials 2000; 21: 144-165
• 14 Cohen JStatistical power analysis for the behavioral sciences . Psychology Press. New York: Taylor&Francis; 1998
• 15 Ellis C, Hall JL, Khalil A et al. Evolution of methodological standards in surgical trials. ANZ J Surg 2005; 75: 874-877
• 16 Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care 2005; 20: 187-191 discussion 183–191
• 17 Gilmore SJ. Evaluating statistics in clinical trials: making the unintelligible intelligible. Australas J Dermatol 2008; 49: 177-184 quiz 176–185
• 18 Gotzsche PC. Believability of relative risks and odds ratios in abstracts: cross sectional study. BMJ 2006; 333: 231-234
• 19 Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 1999; 319: 670-674
• 20 Starzl TE, Donner A, Eliasziw M et al. Randomised trialomania? The multicentre liver transplant trials of tacrolimus. Lancet 1995; 346: 1346-1350
• 21 Loscalzo J. Clinical trials in cardiovascular medicine in an era of marginal benefit, bias, and hyperbole. Circulation 2005; 112: 3026-3029
• 22 Jadad AR, Moore RA, Carroll D et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 1996; 17: 1-12
• 23 Noordzij M, Dekker FW, Zoccali C et al. Study designs in clinical research. Nephron Clin Pract 2009; 113: c218-c221
• 24 Fisher CG, Wood KB. Introduction to and techniques of evidence-based medicine. Spine (Phila Pa 1976). 2007 32. S66-S72
• 25 Jessen F, Spottke A, Kopp I et al. Methodenreport und Evidenztabellen zur S3 Leitlinie Demenzen. Ort Berlin: DGPPN und DGN; 2009
• 26 Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet 2002; 359: 57-61