ArticleBMJ (Clinical research ed.)2013
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.
49 registry-linked trialsAbstract read
In one paragraph
Article in BMJ (Clinical research ed.), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 49 registered trials, which are not on this map. Cited by 4,055 papers, 1 of them a synthesis that pooled it.
0numbers the graph read from it
0cells of the map it votes in
4,055citing papers in PubMed, 1 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.
Study of Curative Effect Evaluation of DanLou Tablet on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy
PMID 23173251PMID 20432394PMID 20531008PMID 20681275PMID 22019563PMID 26142341PMID 27480425PMID 27491230PMID 27847338other papers from this trial
Open the trial in the graphStudy of Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy
PMID 27847338PMID 20432394PMID 20531008PMID 20681275PMID 22019563PMID 27480425other papers from this trial
Open the trial in the graphComparison 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 graphA Prospective Observational Study to Determine the Negative Predictive Value of UroMark to Rule Out the Presence of Bladder Cancer in Patients With Haematuria.
Efficacy of a Short-bout Handgrip Exercise Intervention for Smoking Cessation: a Pilot Randomized Controlled Trial
Retroclavicular Approach vs Infraclavicular Approach for Plexic Bloc Anesthesia of the Upper Limb: a Multi-centric Non-inferiority Randomised Controlled Trial
A Prospective Non-randomized Controlled, Multicenter, Multidisciplinary Trial Comparing Appendectomy and Conservative Treatment for Patients With Uncomplicated Acute Appendicitis (the ACTUAA STUDY).
Transforaminal Lumbar Interbody Fusion With Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation: a Multicentre Randomised Controlled Trial
Effectiveness of a Structured Group-Based Intervention "Know Your Medicine - Take It For Health" (KYM-TIFH) in Improving Medication Adherence Among Malay Patients With Underlying Type 2 Diabetes Mellitus in the Sarawak State of Malaysia: A Randomized Controlled Trial
A Randomized Pilot Trial to Evaluate the Preliminary Effect and Safety of Using Spraino® to Prevent Lateral Ankle Sprains in Indoor Sports (The Spraino Pilot Trial)
Effect of Improved "Injera" Baking Stove Intervention on Household Air Pollution and Childhood Acute Respiratory Infection Prevention: A Cluster Randomized Controlled Trial In Northwest Ethiopia
Randomized Controlled Trial of Exercise Therapy in Combination With Central Nervous System-targeted Treatment Compared With Exercise Therapy Alone for Treatment of People With Knee Osteoarthritis
Effectiveness of Long-term Low-frequency High-Intensity Interval Training (HIIT) to Improve Body Adiposity and Liver Fat in Adults With Central Obesity: A Randomized Controlled Trial
A Prospective, Randomized Controlled Trial Comparing Percutaneous Screw Fixation to Non-Operative Management for the Treatment of Sacral Fragility Fractures
Bolus Versus Continuous Enteral Feeding in Critically Ill Patients
Multi-Site Cluster, Randomized Proof of Concept Trial to Study the Effects of the ACT OUT! Social Issue Theater Program on Social-Emotional Competence and Bullying in Youth and Adolescents
Study Protocol of the EMPOWER-SUSTAIN Project: A Pilot Randomised Controlled Trial of e-Health Intervention to Improve Patient Activation and Self-Management Behaviours Among Individuals With Metabolic Syndrome in Primary Care Setting
A Randomized Controlled Trial Comparing the Efficacy of Therapist Guided Internet-delivered Cognitive Therapy (TG-iConquerFear) With Augmented Treatment as Usual in Reducing Fear of Cancer Recurrence in Danish Colorectal Cancer Survivors
Comparison of Phenol and Silver Nitrate Application in the Sacrococcygeal Pilonidal Sinus: A Prospective Randomized Controlled Study
Scandinavian Humeral diAphyseal Fracture Trial - A Pragmatic Randomized Controlled Trial
Recurrent Acute Pancreatitis Prevention by the Elimination of Alcohol and Cigarette Smoking (REAPPEAR): Protocol of a Randomized Controlled Trial and a Cohort Study
Timing of Endoscopic Intervention in Patients With Cirrhosis With Acute Variceal Upper Gastrointestinal Hemorrhage (TEACH Trial): a Randomized Clinical Trial
Proof-of-Concept of the SOAR (Stop OsteoARthritis) Program: A Randomized Delayed-Control Trial
Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID: Study Protocol for a Pragmatic Randomized Controlled SuperiorityTrial
Dietary Sodium Intake and Blood Pressure in Living Kidney Donors: A Pilot Single-Center Crossover Single-Blind Randomized Controlled Trial
Effectiveness of a Psycho-educational Intervention for People With Suicidal Conduct in the Prison Environment. N'VIU Project: a Randomized Control Trial
Defining Decision Thresholds for Judgments on Health Benefits and Harms Using the GRADE Evidence to Decision (EtD) Frameworks: Protocol for a Randomized Methodological Study (GRADE-THRESHOLD)
NCT05259592 phase1 / phase2completednot on this mapstarted 2021, after this paper: background citation
Patient-centered Modular Cognitive Behavioral Therapy for Complex PTSD: A Randomised Controlled Pilot Study
The Effectiveness of a Pain Neuroscience Education Program Compared to Conventional Treatment on Pain, Biopsychosocial Variables, and Functional Capacity in Adults With Cancer Pain
The Effect of Smartphone-Based Virtual Reality Relaxation (S-VR) On the Comfort on Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
a Parallel Assignment Prospective, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression
Effects of VIRTUal reALity on Rehabilitation in Patients With Heart Failure: a Protocol for a Randomized Controlled Trial
NCT06338917 naactive not recruitingnot on this mapstarted 2024, after this paper: background citation
Moderate-to-Vigorous Intensity Physical Activity as a Tool for Severe Mental Illness Recuperation Process: Study Protocol for a Pragmatic Controlled Clinical Trial (+moviMENT)
An Online Home-based Combined Exercise Intervention With Self-selected Intensity for Women With Breast Cancer: The Home-Combo Randomized Controlled Trial.
Effectiveness of an Intervention on Vaccine Hesitancy Among Pediatric Nurses and Pediatricians: A Mixed Methods Study
Effect of Virtual Reality Simulation on Nursing Students' Knowledge and Skill Performance in Respiratory Physical Examination: A Randomized Controlled Trial
Effectiveness of Local Instillation of Antibiotics Compared to Systemic Antibiotics, as Adjunct to Ultrasound Guided Aspiration in the Management of Breast Abscess; a Randomized Controlled Trial
Efficacy of a Digital Health App Five Lives MED to Improve Cognitive Function in Patients With Mild Cognitive Impairment: a Randomised Controlled Trial
Automated Oxygen Control in Preterm Babies on Respiratory Support: A Randomized Cross Over Study
Pilot Study Comparing the HEINE visionPRO HyMac 3 and the GlideScope Hyperangulated S3 Laryngoscope Blade on Time to Intubation
Analgesic Efficacy of Intravenous Ketamine as a Continuous Infusion vs PCA in the Management of Acute Postoperative Pain in Major Orthopedic Surgery: A Randomized Clinical Trial
Effects of Music Intervention on Golf-Specific Skill Performance of Chinese Golfers Under Mental Fatigue
The PAPYRUS Study: Permanent vs. Absorbable Sutures in PrimarY Repair of Umbilical HerniaS: A Multicentre, Single-blind, Non-inferiority, Randomized Controlled Trial
Prone vs Supine Position in Potential Organ Donors: PRODONAR Multicenter Clinical Trial
Heart Rate Variability Guided Optimization of Physical Activity and Exercise Prescription to Enhance Rehabilitation Outcomes in Individuals With Knee Osteoarthritis (HOPE-OA Trial)
Symptoms of Anxiety and/or Depression and the Shared Decision Making (SDM) Process in Older Patients With Critical Limb Threatening Ischaemia (CLTI)
A Prospective, Randomised Controlled Trial Comparing Weight-based Tinzaparin Versus Weight-based Enoxaparin for Peri-operative Thromboprophylaxis in Patients Undergoing Bariatric Surgery: Evaluation of Anti-Xa Levels and Clinical Outcomes.
Evaluating Artificial Intelligence for Language Translation of Health-related Knowledge Mobilization Resources: A Randomized Controlled Trial and Qualitative Study
The Impact of Body Composition on Setup Errors in Patients Undergoing Radiotherapy With Thermoplastic Mask Immobilization: A Single-Center Prospective Cohort Study
Who cites it
4,055 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effectiveness of Digital Health Interventions on Body Weight and Dietary Intake Outcomes Among Culturally and Linguistically Diverse (CALD) and Indigenous Populations: A Systematic Review.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2026Pooled it
- Catecholaminergic Contributions to Inhibitory Control Following Physical Fatigue: Behavioral and Neurophysiological Findings.European journal of sport science · 2026Trial
- Trial
- Physiotherapist-led treatment for femoroacetabular impingement syndrome (the PhysioFIRST study): an assessor-blinded, limited disclosure randomised controlled trial.British journal of sports medicine · 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
- Early vs Late Initiation of Extracorporeal Membrane Oxygenation: Protocol for a Prospective, Randomized, Multicenter Study.JMIR research protocols · 2026Trial
- Trial
- Evaluation of a transdiagnostic mental health intervention in German primary care: a parallel-group, two-arm, cluster randomised controlled pilot study.BMC primary care · 2026Trial
- Trial
- Trial
- Trial
- Trial
- Virtual Reality for the Management of Postoperative Pain and Anxiety in Children and Adolescents Undergoing Nuss Repair of Pectus Excavatum: Randomized Controlled Trial.JMIR perioperative medicine · 2026Trial
- Evaluating the efficacy of dual-task training in older patients with chronic heart failure and comorbid cognitive frailty: a protocol for a randomized controlled trial.BMC geriatrics · 2026Trial
- Assisted infant toilet training and the prevalence of functional gastrointestinal disorders up to the age of 9 months: a randomised, controlled trial.Archives of disease in childhood · 2026Trial
- Trial
- Effect of Cervical Epidural STimulation After Neurological Damage: protocol for phase I/II open label controlled CE-STAND trial.BMJ open · 2026Trial
- Effectiveness of a Theory-Based Intervention in Improving Bacillus Calmette-Guérin Uptake and Preventive Practices of Childhood Tuberculosis Among Pregnant Women: Protocol for a Randomized Control Trial.JMIR research protocols · 2026Trial
- Trial
- Article
3,995 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
13 authors.
An-Wen ChanWomen's College Research Institute at Women's College Hospital, Department of Medicine, University of Toronto, Toronto, Canada M5G 1N8.
Jennifer M Tetzlaff
Peter C Gøtzsche
Douglas G Altman
Howard Mann
Jesse A Berlin
Kay Dickersin
Asbjørn Hróbjartsson
Kenneth F Schulz
Wendy R Parulekar
Karmela Krleza-Jeric
Andreas Laupacis
David Moher
Funding
CIHR 106068-1CIHR 78874-1CIHR DET - 106068CIHR MET-117434
Abstract
High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
Indexed as
Practice Guidelines as TopicChecklistClinical ProtocolsClinical Trials as TopicClinical Trials Data Monitoring CommitteesComputer SecurityData CollectionEthics, MedicalHumansMedical AuditPatient SelectionProfessional RoleQuality ControlRandom AllocationResearch DesignResearch Personnel
Identifiers
What OpenQuestion holds
Textmetadata
Read underepoch 390
Registered trials
NCT03072082ClinicalTrials.gov
NCT03072121ClinicalTrials.gov
NCT04945122ClinicalTrials.gov
NCT02676180ClinicalTrials.gov
NCT02844296ClinicalTrials.gov
NCT02913625ClinicalTrials.gov
and 43 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.