Response to the publication by Ueberall and Mueller-Schwefe

Abstract

Gonçalo S Duarte,1–3 João Santos,3 João Costa1–41Clinical Pharmacology and Therapeutics Laboratory, Faculdade de Medicina, Universidade de Lisboa, 2Clinical Pharmacology Unit, Instituto de Medicina Molecular, 3Center for Evidence Based Medicine, Faculdade de Medicina, Universidade de Lisboa, 4Cochrane Portugal, Lisboa, PortugalWhile updating our Cochrane review on tapentadol for chronic musculoskeletal pain,1 we found a study by Ueberall and Mueller-Schwefe.2 It passed the initial screening phase by using words such as “blinded” and “randomly”, methodologically positive characteristics most often seen in randomized controlled trials (RCTs). On further analysis, we found that it is not an RCT and therefore not eligible for our Cochrane review. We nonetheless remained interested, since the authors clearly made methodological options that, despite sounding pondered, rigorous, and methodologically desirable, in fact add little to nothing in terms of quality or rigor. In fact, this quasi-rigor can be fully appreciated when assessing the study using the Cochrane model for risk of bias in non-randomized studies of interventions.3View the original paper by Ueberall and Mueller-Schwefe.

Keywords

• non-interventional study
• oxycodone/naloxone
• tapentadol
• chronic low back pain