Academic Journal
Methodological quality assessment tool for observational studies comparing treatment effectiveness in infectious diseases: a Delphi consensus and application to studies on bloodstream infections due to carbapenem-resistant Enterobacterales.
| Title: | Methodological quality assessment tool for observational studies comparing treatment effectiveness in infectious diseases: a Delphi consensus and application to studies on bloodstream infections due to carbapenem-resistant Enterobacterales. |
|---|---|
| Authors: | Zumbo G; Division of Infectious Diseases and Microbiology, University Hospital Virgen Macarena, Seville, Spain; Department of Medicine, University of Seville, Seville, Spain; Biomedicine Institute of Seville (IBiS)/CSIC, Seville, Spain; Department of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples Federico II, Naples, Italy., Beltrami M; Division of Infectious Diseases and Microbiology, University Hospital Virgen Macarena, Seville, Spain; Department of Medicine, University of Seville, Seville, Spain; Biomedicine Institute of Seville (IBiS)/CSIC, Seville, Spain., Bravo-Ferrer JM; Division of Infectious Diseases and Microbiology, University Hospital Virgen Macarena, Seville, Spain; Department of Medicine, University of Seville, Seville, Spain; Biomedicine Institute of Seville (IBiS)/CSIC, Seville, Spain; Biomedical Research Networking Center in Infectious Diseases (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain., Gutiérrez-Gutiérrez B; Division of Infectious Diseases and Microbiology, University Hospital Virgen Macarena, Seville, Spain; Department of Medicine, University of Seville, Seville, Spain; Biomedicine Institute of Seville (IBiS)/CSIC, Seville, Spain; Biomedical Research Networking Center in Infectious Diseases (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain., Rodríguez-Baño J; Division of Infectious Diseases and Microbiology, University Hospital Virgen Macarena, Seville, Spain; Department of Medicine, University of Seville, Seville, Spain; Biomedicine Institute of Seville (IBiS)/CSIC, Seville, Spain; Biomedical Research Networking Center in Infectious Diseases (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain. Electronic address: jesusrb@us.es. |
| Corporate Authors: | ASSURE-ID group |
| Source: | The Lancet. Infectious diseases [Lancet Infect Dis] 2026 Aug; Vol. 26 (8), pp. e285-e293. Date of Electronic Publication: 2026 Mar 23. |
| Publication Type: | Journal Article; Systematic Review; Review |
| Language: | English |
| Journal Info: | Publisher: Elsevier Science Country of Publication: United States NLM ID: 101130150 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-4457 (Electronic) Linking ISSN: 14733099 NLM ISO Abbreviation: Lancet Infect Dis Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: New York, NY : Elsevier Science ; The Lancet Pub. Group, 2001- |
| MeSH Terms: | Observational Studies as Topic*/standards , Observational Studies as Topic*/methods , Enterobacteriaceae Infections*/drug therapy , Enterobacteriaceae Infections*/microbiology , Anti-Bacterial Agents*/therapeutic use , Bacteremia*/drug therapy , Bacteremia*/microbiology , Carbapenem-Resistant Enterobacteriaceae*/drug effects, Carbapenems/therapeutic use ; Carbapenems/pharmacology ; Enterobacteriaceae/drug effects ; Humans ; Delphi Technique ; Treatment Outcome ; Consensus ; Research Design |
| Abstract: | Observational studies often guide treatment recommendations in infectious diseases when controlled trials are not available. Nevertheless, insufficient methodological rigour can compromise their validity and reproducibility. The Assessment of Methodological Quality and Bias in Observational Studies for Infectious Diseases (ASSURE-ID) questionnaire was created via a Delphi process involving 34 international experts. Three Delphi rounds granted consensus on the assessment tool comprising five domains, 42 items, and 48 assessment questions. A systematic literature review (PROSPERO number CRD420251065957) identified eligible observational studies comparing new drugs for bloodstream infections due to carbapenem-resistant Enterobacterales. After piloting, its final version was applied. Of the 5268 records screened, 14 studies were included. Tool application showed clear reporting of study objectives; however, only one (7%) study documented protocol pre-registration, two (14%) documented adherence to official reporting guidelines, and no studies documented a pre-established statistical analysis plan. Missing data were acknowledged in four (29%) studies and addressed in one (7%). Immortal time bias was addressed in two (14%) studies. Confounders were adjusted in 12 (86%) studies, but causal models and interaction testing were uncommon (in four [29%] studies, and one [7%] study, respectively). ASSURE-ID offers a structured, consensus-based framework to appraise methodological rigour in observational infectious diseases studies comparing treatments. Application to studies on bloodstream infections due to carbapenem-resistant Enterobacterales highlighted substantial limitations in the analysed studies. (Copyright © 2026 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.) |
| Competing Interests: | Declaration of interests We declare no competing interests. |
| Comments: | Erratum in: Lancet Infect Dis. 2026 Jul;26(7):e281. doi: 10.1016/S1473-3099(26)00182-9.. (PMID: 41935531) |
| Contributed Indexing: | Investigator: DL Paterson; SYC Tong; SS Harbarth; MEA de Kraker; EE Tacconelli; LL Scudeller; EE Carrara; MM Paul; LL Leibovici; II Margalit; MM Bonten; PP Naucler; DD Van Duin; PD Tamma; JP Horcajada; PP Retamar-Gentil; TC Lee; AJ Kaasch; MM Guedes; II Gentile; BB Huttner; GG Daikos; MM Giannella; JJ Molina; DD Yahav; JA Schouten; DD Ashiru-Oredope; MN Al-Hasan; MM Akova; JJ Torre-Cisneros; OR Albin; FF Ojo-Benys; SS Kanj; MM Wang |
| Substance Nomenclature: | 0 (Anti-Bacterial Agents) 0 (Carbapenems) |
| Entry Date(s): | Date Created: 20260326 Date Completed: 20260722 Latest Revision: 20260722 |
| Update Code: | 20260723 |
| DOI: | 10.1016/S1473-3099(26)00058-7 |
| PMID: | 41887234 |
| Database: | MEDLINE |
| ISSN: | 1474-4457 |
|---|---|
| DOI: | 10.1016/S1473-3099(26)00058-7 |