GuidelineAnnals of internal medicine2013
SPIRIT 2013 statement: defining standard protocol items for clinical trials.
46 registry-linked trialsAbstract readConsensus StatementPractice Guideline
In one paragraph
Guideline in Annals of internal medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 46 registered trials, which are not on this map. Cited by 4,697 papers, 2 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
4,697citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.
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.
Comparison of Atorvastatin and Pitavastatin on the Effect of HbA1c in Acute Myocardial Infarction (AMI) Patients With Abnormal Glucose Metabolism: a Multicenter Prospective Randomized Clinical Trial
PMID 21812889PMID 24998014PMID 25575403PMID 26084792PMID 22878405PMID 18981652PMID 23352266PMID 21028996PMID 27181110PMID 25109606PMID 25312577PMID 21693744other papers from this trial
Open the trial in the graphFissure Caries Inhibition Study With Solea CO2-9.3μm Short-pulsed Laser - A Randomized, Single Blind, Prospective, Split Mouth Controlled, Clinical Trial
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Auricular Acupuncture as Adjunct for Pain Management During First Trimester Uterine Aspiration.
Testing the Efficacy of the ENCOURAGE App in Decreasing Sedentary Behaviour: A Time Series Quasi-Experimental Study
Southern Medical University Clinical Research Project Initiative：Efficacy and Safety of a Multicomponent Physical Therapy Program in Mechanically Ventilated Patient With Sepsis
Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women: a Study Protocol for a Randomized Controlled Trial
Multicenter, Randomised, Open-label Phase III-IV Study to Evaluate the Efficacy of Cloxacillin and Fosfomycin Combination Versus Cloxacillin Monotherapy in Patients With Methicillin-susceptible Staphylococcus Aureus Bacteraemia: SAFO Trial
The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU: A Pilot Study
Dosing of Extracorporeal Cytokine Removal In Septic Shock (DECRISS): a Prospective, Randomized, Multicenter Clinical Trial
Timing of Endoscopic Intervention in Patients With Cirrhosis With Acute Variceal Upper Gastrointestinal Hemorrhage (TEACH Trial): a Randomized Clinical Trial
NanaBis™ an Oro-buccal Administered Equimolar d9-THC & CBD Formulation as Monotherapy for Management of Opioid Requiring Bone Pain Due to Metastatic Cancer: Phase 3 Multi Centre Blinded Randomized Withdrawal Active & Placebo Controlled Trial
Effect of Taurine on Glycemic, Lipid and Inflammatory Profile in Individuals With Type 2 Diabetes: a Randomized Clinical Trial
BeaRberry in the Treatment of Acute UncoMplIcated Cystitis (BRUMI)- Protocol of a Multicentre, Randomized Double-Blind Clinical Trial
The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION Trial): Protocol of a Multicentre Randomized Controlled Clinical Trial
Efficacy of mHealth and Education-led Peer Counseling of Patients With Hypertension and Coronary Artery Disease: a Double-blinded Pragmatic Randomized Control Trial With Factorial Design, Pakistan
Electroacupuncture for Bladder Pain Syndrome: An Randomized Controlled Trial and Study for Central Mechanism
Feasibility Study of the Medication Review With Follow up Service for Patients With Polypharmacy in Swiss Community Pharmacies
Double-blind Randomized Controlled Clinical Trial for Evaluating the Effects of Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis
Improving and Evaluation of a New Cross-sectoral Hospital at Home Model for Elderly Acute Ill Patients
Evaluation of Post-discharge Surveillance Mobile Application for Surgical Site Infection as a Clinical Decision Support System
CBT-E vs CBT-F+Metacognitive Interpersonal Therapy for Non-underweight Adults With Eating Disorders: Study Protocol for a Pilot Randomised Controlled Trial
Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy (BioSteP): a Randomized Controlled Study
Pain Informed Movement for People With Knee Osteoarthritis: A Pilot and Feasibility Randomized Controlled Trial
Motivational to Weight Loss Version 1 (MWL v.1): Protocol for a Feasibility Single-arm, Open-label Clinical Trial of a Motivational Interviewing, Stages and Processes of Change-based Intervention for Weight Loss in Adults
The Effect of 3D Modeling on Family Quality of Life, Surgical Success and Patient Outcomes in Congenital Heart Diseases: A Randomized Controlled Trial Protocol
A Pilot Study of Perioperative Application of Sivelestat Sodium in Acute Type A Aortic Dissection Patients With Preoperative Moderate to Severe Hypoxemia to Shorten the Duration of Postoperative Invasive Mechanical Ventilation
Non-invasive Neurostimulation and Rehabilitation in the Treatment of Patients With Respiratory Disorders: Randomized Controlled Clinical Trial
Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel- a Single-blinded Randomized Controlled Trial.
PANDREAS. Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy: a Multicentre Clinical Trial
Combining Transcranial Direct Current Stimulation and Yoga for Improved Pain Management for Knee Osteoarthritis: A Pilot and Feasibility Trial
Tushirikiane-4-Uthabiti (Supporting Each Other For Resilience)
Can Preoperative Information Via Virtual Reality Affect Patient's Anxiety? A Randomized Controlled Trial and Patient Interviews
One-on-one and Group-based Physical Activity Intervention Compared to a Wait-list Control for Post-secondary Student Mental Health and Well-being: A 3-arm Parallel Randomized Controlled Trial
Evaluating the Physiological Impact of Pain Neuroscience Education Versus Standard Education for Older Adults With Osteoarthritis
Early Prednisolone for Suspected Community-acquired Acute Respiratory Tract Infection (PREDICATE): A Double-blind, Randomised, Multi-centre, Adaptive Platform, Controlled Trial
Continuous GLUCOse Monitoring System With a SENSor Compared to Fingerstick Glucose Monitoring in Surgical Wards (GLUCOSENS)
Rationale and Design of a Cardiac Rehabilitation Program on the Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Treatment With Anthracyclines and/or Trastuzumab: A Randomized, Active Control Group, Open-Label Trial
Effects of Music Intervention on Golf-Specific Skill Performance of Chinese Golfers Under Mental Fatigue
The Safety and Feasibility of Transauricular Vagus Nerve Stimulation Therapy in Chronic Whiplash-Associated Disorders: A Randomized Pilot Trial
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Whole-Body Photobiomodulation Use in Professional Soccer Players During a State Championship
NCT07357909 phase1not yet recruitingnot on this mapstarted 2026, after this paper: background citation
A First-in-Human, Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravenous Hydrogen-Oxygen Ultrafine Bubbles in Adults
The Impact of Body Composition on Setup Errors in Patients Undergoing Radiotherapy With Thermoplastic Mask Immobilization: A Single-Center Prospective Cohort Study
EmpowerHer: Protocol for a Multicentre Randomized Controlled Trial Evaluating a Hybrid Digital Exercise and Education Intervention for Breast Cancer Survivors Across Five European Countries
THRIVE-Belize: A Single-School Mixed-Methods Feasibility Trial of a Multi-Component Life-Skills Curriculum for Adolescent Health Promotion at Toledo Community College, Belize
Who cites it
4,697 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Physical education-embedded fitness-oriented exercise interventions for youth physical fitness: a systematic review and meta-analysis.BMC public health · 2026Pooled it
- Preoperative low-energy diets for patients with a body mass index >30 kg/m2 undergoing non-bariatric surgery: pilot feasibility randomized clinical trial and a systematic review and meta-analysis of efficacy data.The British journal of surgery · 2026Pooled it
- A Conversation Tool to Enhance Care for People With Type 2 Diabetes: The QBSafe Cluster Randomized Clinical Trial.JAMA network open · 2026Trial
- Trial
- Internet Attachment-Based Compassion Therapy for Adults With Chronic Medical Conditions: Randomized Controlled Trial.Journal of medical Internet research · 2026Trial
- Efficacy and safety of GS1-144, a novel neurokinin 3 receptor antagonist, for moderate-to-severe vasomotor symptoms associated with menopause in Chinese women: a randomized, double-blind, placebo-controlled phase 2 trial.Menopause (New York, N.Y.) · 2026Trial
- Trial
- Community-Based High-Intensity Multimodal Training: A Mixed-Method Evaluation of a Randomised Control Trial.European journal of sport science · 2026Trial
- Effect of Ultrasound-Guided Lateral Infraclavicular Brachial Plexus Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures: A Randomized Controlled Noninferiority Trial.Acta anaesthesiologica Scandinavica · 2026Trial
- Anxiety-metabolism networks in human anorexia nervosa: Responses to caloric and non-caloric meals in the Networks Integrating Anxiety and Metabolism in Anorexia Nervosa (NAMA) randomized trial.The British journal of nutrition · 2026Trial
- Strengthening cancer prevention in european schools: a randomized controlled trial of digital interventions in adolescents: the SUNRISE program.BMC public health · 2026Trial
- High-intensity interval training differentially modulates acute BDNF and cognitive responses in young adult males: a randomized crossover trial.Scientific reports · 2026Trial
- Therapeutic contact intensity as an adjunct to a cognitive behavioral smoking cessation app: protocol for a randomized controlled trial.Addiction science & clinical practice · 2026Trial
- Bowel Stimulation Before Loop Ileostomy Closure Using Probiotics: Study Protocol for a Randomized Controlled Trial at a Single Center.JMIR research protocols · 2026Trial
- Nitrous oxide for pain and anxiety management in elderly patients after THA rehabilitation: a study protocol for a randomized controlled trial.BMC geriatrics · 2026Trial
- Neoadjuvant Pembrolizumab in Stages I-III Deficient Mismatch Repair Colon Cancer: A Clinical Trial.Annals of surgery · 2026Trial
- Trial
- Chemoradiotherapy and transanal endoscopic surgery versus transanal endoscopic surgery alone in T1N0M0 rectal cancer: a multicenter, randomized, controlled, phase III clinical trial (TAUTEM-T1 study).International journal of colorectal disease · 2026Trial
- DIALOG+ for service users with chronic depression: a cluster-randomised controlled feasibility trial and qualitative evaluation.BMC psychiatry · 2026Trial
- Maternal facilitated tucking versus nurse facilitated tucking for alleviation of pain during neonatal heel lancing: A randomised, two-period, cross-over trial.The Indian journal of medical research · 2026Trial
4,637 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
An-Wen ChanWomen’s College Research Institute, Women’s College Hospital, University of Toronto, 790 Bay Street, Toronto, Ontario M5G 1N8, Canada. anwen.chan@utoronto.ca
Jennifer M Tetzlaff
Douglas G Altman
Andreas Laupacis
Peter C Gøtzsche
Karmela Krleža-Jerić
Asbjørn Hróbjartsson
Howard Mann
Kay Dickersin
Jesse A Berlin
Caroline J Doré
Wendy R Parulekar
William S M Summerskill
Trish Groves
Kenneth F Schulz
Harold C Sox
Frank W Rockhold
Drummond Rennie
David Moher
Funding
CIHR 106068-1CIHR 78874-1Medical Research Council MC_EX_G0800814
Abstract
The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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ChecklistClinical ProtocolsClinical Trials as TopicHumans
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Read underepoch 390
Registered trials
NCT04945122ClinicalTrials.gov
NCT02357979ClinicalTrials.gov
NCT02676180ClinicalTrials.gov
NCT03391986ClinicalTrials.gov
NCT03403270ClinicalTrials.gov
NCT03406494ClinicalTrials.gov
and 40 more above
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.