No new Insights
Introducing, the authors explain that based on evidence from studies, theophylline is of little benefit in COPD and associated with risks. At the same time, they state that the interesting question cannot be clarified “conclusively” with their study so that “further ... studies of routine data are needed”. Even if one does not follow the obvious conclusion that the interesting question was already answered before this study, this analysis has at least not helped to resolve the uncertainty. One wonders why this analysis was performed at all. It does no produce any new insights and, according to the authors, has significant limitations. Therefore, the “causal interpretation … is limited” and the “effectiveness ... und adverse effects ... could only be conclusively assessed in RCTs“. Consequently, further studies with the same known limitations will not clarify the matter. These are a waste of resources (1–3) and ethically problematic as they attempt to answer an apparently relevant question with insufficient means, according to the authors’ evaluation, and thus delay the answering of the question. Why “it is hard to imagine” that ethics committees would approve RCTs is hard to understand. Either the question is open and can only be answered “conclusively” by means of RCTs—in which case ethics committees would certainly be sensible enough to realize this—or the question is no longer open. In that case, the question of ethics would not even arise and further studies would not be required.
RCTs are certainly not needed to answer each and every question, but where they are needed they should be conducted. We certainly do not need analyses where it is foreseeable that the results will not add to our knowledge – even if they make use of routine data.
Prof. Dr. med. Jürgen Windeler
Conflict of interest statement
The author declares that no conflict of interest exists.
|1.||Kleinert S, Horton R: How should medical science change? Lancet 2014; 383: 197–8 CrossRef MEDLINE|
|2.||Ioannidis JP, Greenland S, Hlatky MA, et al.: Increasing value and reducing waste in research design, conduct, and analysis. Lancet 2014; 383: 166–75 CrossRef MEDLINE|
|3.||Chalmers I, Glazsiou P: Avoidable waste in the production and reporting of research evidence. Lancet 2009; 374: 86–9 CrossRef MEDLINE|
|4.||Fexer J, Donnachie E, Schneider A, et al.:The effects of theophylline on hospital admissions and exacerbations in COPD patients: audit data from the bavarian disease management program. Dtsch Arztebl Int 2014; 111: 293–300 VOLLTEXT|