Evidence map›Paper›PMID 39621215›Full record

ReviewInternational urology and nephrology2025

The cornerstones of randomized clinical trials.

Mercedes Gori, Domenico Abelardo, Annalisa Pitino, Eleni Stamellou, Adamantia Bratsiakou, Carmela Marino, Giovanni Tripepi, Stefanos Roumeliotis, Graziella D'Arrigo

Abstract readReview
PubMed Publisher
In one paragraph

Review in International urology and nephrology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Mercedes GoriCNR-IFC, Institute of Clinical Physiology, Section of Rome, 00185, Rome, Italy.
Domenico AbelardoDepartment of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Italy and Regional Epilepsy Centre, Great Metropolitan "Bianchi-Melacrino-Morelli" Hospital, Reggio Calabria, Italy.
Annalisa PitinoCNR-IFC, Institute of Clinical Physiology, Section of Rome, 00185, Rome, Italy.
Eleni StamellouDivision of Nephrology and Clinical Immunology, RWTH Aachen University, 52074, Aachen, Germany.
Adamantia BratsiakouDepartment of Nephrology and Kidney Transplantation, University Hospital of Patras, Patras, Greece.
Carmela MarinoCNR-IFC, Institute of Clinical Physiology of Reggio Calabria, Reggio Calabria, Italy.
Giovanni TripepiCNR-IFC, Institute of Clinical Physiology of Reggio Calabria, Reggio Calabria, Italy.
Stefanos Roumeliotis *Second Department of Nephrology, School of Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, 1 St. Kyriakidi street, 54636, Thessaloniki, Greece. st_roumeliotis@hotmail.com.
Graziella D'Arrigo *CNR-IFC, Institute of Clinical Physiology of Reggio Calabria, Reggio Calabria, Italy. graziella.darrigo@cnr.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Randomized clinical trials (RCTs) are pivotal in medical research, offering critical evidence on the efficacy and safety of treatments. This paper explores the distinct purposes and designs of superiority, non-inferiority, equivalence, and pragmatic trials, each addressing unique research questions. Superiority trials aim to demonstrate a new treatment's effectiveness over existing standards, while non-inferiority and equivalence trials focus on ensuring new treatments are not significantly worse or are similar to existing ones, respectively. Pragmatic trials assess interventions in real-world settings. A fundamental ethical principle in RCTs is clinical equipoise, ensuring unbiased treatment allocation. The CONSORT statement provides guidelines for transparent reporting of RCTs, enhancing the reliability of findings. Key methodological considerations include sample size calculation, randomization, blinding, and the choice between intention-to-treat and per-protocol analyses. Stratified analysis and forest plots further aid in understanding treatment effects across diverse populations. By adhering to these principles, RCTs remain a cornerstone of evidence-based medical practice, advancing patient care and outcomes.

Indexed as

Randomized Controlled Trials as TopicResearch DesignHumansCONSORTEquipoiseEquivalence trialIntention to treat analysisNon-inferiority trialsPer protocol analysisPragmatic trialsRandomizationRandomized clinical trialsSuperiority trials

Identifiers

PMID39621215

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.