Objectives: The objective of the study was to develop and validate an adequate tool to evaluate the risk of bias of randomized controlled trials, observational studies, and systematic reviews assessing drug adverse events.
Study Design And Setting: We developed a structured risk of bias checklist applicable to randomized trials, cohort, case-control and nested case-control studies, and systematic reviews focusing on drug safety. Face and content validity was judged by three experienced reviewers. Interrater and intrarater reliability were determined using 20 randomly selected studies, assessed by three other independent reviewers including one performing a 3-week retest.
Results: The developed checklist examines eight domains: study design and objectives, selection bias, attrition, adverse events information bias, other information bias, statistical methods to control confounding, other statistical methods, and conflicts of interest. The total number of questions varied from 10 to 32 depending on the study design. Interrater and intrarater agreements were fair with Kendall's W of 0.70 and 0.74, respectively. Median time to complete the checklist was 8.5 minutes.
Conclusion: The developed checklist showed face and content validity and acceptable reliability to assess the risk of bias for studies analyzing drug adverse events. Hence, it might be considered as a novel useful tool for systematic reviews and meta-analyses focusing on drug safety.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.jclinepi.2017.04.023 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Projections of Public Spending on Pharmaceuticals: A Review of Methods.
Pharmacoeconomics
January 2025
Belgian Health Care Knowledge Centre, Brussels, Belgium.
Background: Forecasting future public pharmaceutical expenditure is a challenge for healthcare payers, particularly owing to the unpredictability of new market introductions and their economic impact. No best-practice forecasting methods have been established so far. The literature distinguishes between the top-down approach, based on historical trends, and the bottom-up approach, using a combination of historical and horizon scanning data.
View Article and Find Full Text PDFIndications for the addition of a patellofemoral joint arthroplasty following a previous unicondylar knee arthroplasty- a literature review and Delphi consensus.
Arch Orthop Trauma Surg
January 2025
Institute for Locomotion, Aix-Marseille University, Marseille, France.
Introduction: The aim of this study was to establish an international consensus statement on the indications for the addition of a patellofemoral joint arthroplasty (PFJA) in patients with a unicondylar knee arthroplasty (UKA) and symptomatic progression of patellofemoral compartment osteoarthritis.
Materials And Methods: A systematic review of the literature was conducted, and the results used to inform the development of a statement by an expert working group. This was then evaluated and modified, using a Delphi process, by members of the European Knee Society (EKS).
Functional outcomes after ankle fracture-dislocation: a systematic review.
Arch Orthop Trauma Surg
January 2025
Department of Orthopaedic Surgery, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.
Introduction: Ankle fractures represent a significant portion of orthopedic injuries, with fracture dislocations tending to have worse outcomes. Logsplitter fractures represent a subset of fracture dislocations in which the talus is axially wedged in the tibiofibular joint. We aim to comprehensively investigate and report on the complications and functional outcomes associated with ankle fracture-dislocations.
View Article and Find Full Text PDFPrecision medicine in diagnosis, prognosis, and disease monitoring of bone and soft tissue sarcomas using liquid biopsy: a systematic review.
Arch Orthop Trauma Surg
January 2025
Department of Orthopaedics and Trauma, Medical University of Graz, Auenbruggerplatz 5, 8036, Graz, Austria.
Introduction: Liquid biopsy as a non-invasive method to investigate cancer biology and monitor residual disease has gained significance in clinical practice over the years. Whilst its applicability in carcinomas is well established, the low incidence and heterogeneity of bone and soft tissue sarcomas explains the less well-established knowledge considering liquid biopsy in these highly malignant mesenchymal neoplasms.
Materials And Methods: A systematic literature review adhering to the PRISMA guidelines initially identified 920 studies, of whom 68 original articles could be finally included, all dealing with clinical applicability of liquid biopsy in sarcoma.
Patients with hard-to-heal wounds: a review and synthesis of their experiences and perceptions of maggot debridement.
J Wound Care
January 2025
Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Clinical Research Centre, Singapore.
Objective: There is little use of maggot debridement therapy (MDT) worldwide, albeit there is much literature supporting its benefits and effectiveness for hard-to-heal (chronic) wounds. Hard-to-heal wounds are becoming ever more prevalent and MDT can play a pivotal role in wound care management. This underuse can be associated with patients' perceptions and experiences of MDT.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!