There has been a recent increase in research evaluating treatment-based subgroups of non-specific low back pain. The aim of these sub-classification schemes is to identify subgroups of patients who will respond preferentially to one treatment as opposed to another. Our article provides accessible guidance on to how to interpret this research and determine its implications for clinical practice. We propose that studies evaluating treatment-based subgroups can be interpreted in the context of a three-stage process: (1) hypothesis generation-proposal of clinical features to define subgroups; (2) hypothesis testing-a randomised controlled trial (RCT) to test that subgroup membership modifies the effect of a treatment; and (3) replication-another RCT to confirm the results of stage 2 and ensure that findings hold beyond the specific original conditions. At this point, the bulk of research evidence in defining subgroups of patients with low back pain is in the hypothesis generation stage; no classification system is supported by sufficient evidence to recommend implementation into clinical practice.
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http://dx.doi.org/10.1016/j.berh.2009.11.003 | DOI Listing |
Stat Methods Med Res
January 2025
Institute for Statistics and Competence Center for Clinical Trials, University of Bremen, Bremen, Germany.
The population-wise error rate is a type I error rate for clinical trials with multiple target populations. In such trials, a treatment is tested for its efficacy in each population. The population-wise error rate is defined as the probability that a randomly selected, future patient will be exposed to an inefficient treatment based on the study results.
View Article and Find Full Text PDFInflamm Bowel Dis
January 2025
Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University, Abeno-ku, Osaka, Japan.
Background: The efficacy of 5-aminosalicylic acid (5-ASA) in combination with advanced therapies (ADTs), particularly ustekinumab (UST), for the treatment of inflammatory bowel disease (IBD) remains unclear.
Methods: This retrospective cohort analysis used data from the Medical Data Vision database, including patients with ulcerative colitis (UC) and Crohn's disease (CD) who had initiated UST therapy. Cumulative UST continuation rates and factors associated with UST failure were analyzed, and post hoc subgroup analyses based on prior ADT use were conducted.
Front Immunol
December 2024
School of Medical Information and Engineering, Xuzhou Medical University, Xuzhou, Jiangsu, China.
BMC Cancer
November 2024
Medical University Department, Kantonsspital Aarau, Aarau, Switzerland.
Background: Use of serum procalcitonin (PCT), an inflammatory biomarker for bacterial infections, has shown promising results for early stopping antibiotic treatment among patients with respiratory infections and sepsis. There is need for additional data regarding effectiveness and safety of this concept among patients with cancer.
Methods: Individual data of patients with a documented diagnosis of cancer and proven or suspected respiratory infection and/or sepsis were extracted from previous trials where adult patients were randomized to receive antibiotic treatment based on a PCT protocol or usual care (control group).
Neuro Oncol
November 2024
Department of Neurosurgery, LMU University Hospital of the Ludwig-Maximilians-University Munich, Munich, Germany.
Background: Following surgery, patients with newly diagnosed glioblastoma frequently enter clinical trials. Nuanced risk assessment is warranted to reduce imbalances between study arms. Here, we aimed (I) to analyze the interactive effects of residual tumor with clinical and molecular factors on outcome and (II) to define a postoperative risk assessment tool.
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