ArticlePLoS medicine2025
SPIRIT 2025 statement: Updated guideline for protocols of randomised trials.
Article in PLoS medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 59 papers.
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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.
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.
Effectiveness of Low-Level Laser Auriculotherapy in the Treatment of Myogenic Temporomandibular Disorders and Anxiety: A Randomized Clinical Trial
Effects of Ultra-processed Food Reduction Intervention on Postprandial Glucose and Glycemic Variability in Korean Young Adults: Study Protocol for the ULTRA-CGM Randomized Controlled Trial
Reducing Filth Fly Populations and Transmission of Diarrhoeal Pathogens in Harsh Settings: a Cross-over Trial in South Sudan
Who cites it
59 citing papers in PubMed.
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- Sealant retention, patient satisfaction, and operator preference: a split-mouth randomised controlled trial comparing EasyPrepEuropean archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry · 2026Trial
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- Plaque removal using powered and manual toothbrushes in children with and without attention deficit hyperactivity disorder: a randomized controlled trial.BMC oral health · 2026Trial
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- WIse CHoices in the ICU (WICH-ICU): Protocol and Statistical Analysis Plan for a Stepped-Wedge Cluster Randomized Trial of Choosing Wisely Interventions in Swedish Intensive Care Units.Acta anaesthesiologica Scandinavica · 2026Article
- Fascial Manipulation Compared to Stretching for Rehabilitation of Children With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial.JMIR research protocols · 2026Article
- A study protocol for a randomised controlled trial of two stepwise pharmacological treatment approaches to adult asthma: inhaled corticosteroid/formoterol reliever-ERJ open research · 2026Article
- FREquency of strength home exercises for knee osteoarthritis pain: Protocol for the FRESH non-inferiority randomised controlled trial.Osteoarthritis and cartilage open · 2026Article
- Nurse-led care model to overcome migration-related language barriers in people with cancer (BMJ open · 2026Article
- Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion for Adolescents With Posttraumatic Stress Disorder: Protocol for a Pilot Randomized Controlled Trial in Northern Sweden.JMIR research protocols · 2026Article
- Article
- Article
- Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration.BMJ (Clinical research ed.) · 2026Article
- Phenobarbital as an Adjuvant to benzodiazepines when compared to Single-agent benzodiazepine Treatment (usual care) for Alcohol withdrawal syndrome in the intensive care unit (PASTA): a study protocol.Pilot and feasibility studies · 2026Article
- Empowering Older Adults Through Values-Informed Solutions for Technology Adoption: Protocol for a Feasibility and Acceptability Randomized Controlled Pilot Trial.JMIR research protocols · 2026Article
- An Explainable AI Tool (FibroX) for Detecting Advanced Liver Fibrosis in Adults With Type 2 Diabetes: Protocol for a Pilot Crossover Trial.JMIR research protocols · 2026Article
- Guidance for protocol content and reporting of dog-assisted interventions in randomised controlled trials: explanation and elaboration of the SPIRIT 2025 and CONSORT 2025 extensions.BMC medical research methodology · 2026Article
- The Flourishing Child: Study Protocol for an Acceptability and Feasibility Trial of a Digital Early Childhood Flourishing Intervention.Children (Basel, Switzerland) · 2026Article
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Authors and funding
39 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
importanceThe protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users.
objectiveTo systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial.
designWe completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting.
findingsOverall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.
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Registered trials
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 Socratic graph.