ArticleBMC medical research methodology2010
A tutorial on pilot studies: the what, why and how.
Erratum issued 45 registry-linked trialsAbstract read
In one paragraph
Article in BMC medical research methodology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 45 registered trials, which are not on this map. Cited by 1,397 papers, 2 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
1,397citing 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.
Efficacy of Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity as a Biomarker of Myocardial Damage in Patients With Rheumatoid Arthritis With Severe Activity.
PMID 25662717PMID 27580061PMID 27965879PMID 28610589PMID 29322198PMID 29331272PMID 29352092PMID 29353098PMID 29417936PMID 29554376PMID 24093840PMID 23265346other papers from this trial
Open the trial in the graphA Pragmatic Randomized Trial to Investigate the Effectiveness of BehaviouRal ActiVation Group Therapy in Reducing dEpressive Symptoms and Improving Quality of Life in Patients With Depression: BRAVE Pilot Study
Evaluating Agreement Between USCOM and 2D-echocardiographic Hemodynamic Measurements in Pediatric Patients
Self-management of Postnatal Anti-hypertensive Treatment: a Trial Development Pilot Study
Do Inflammatory Arthritis Inpatients Receiving Group Music Therapy Improve Pain Compared to Music Listening Over the 4 Weeks Using a Randomised Control Trial?
A Randomised Controlled Trial of Multimodal Physiotherapy for Patients With Acute / Sub-acute Cervical Radiculopathy
Quality Of LIfe Tool for IBD (QOLITI): Pilot Testing of a Self-administered Intervention to Target Psychological Distress in Inflammatory Bowel Disease
My Cardiac Recovery (MyCaRe): A Pilot RCT to Examine the Effect of MyCaRe Android Application on Recovery Outcomes and Enrolment in Cardiac Rehab Post Cardiac Surgery.
Organization of Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant.
Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges
Training Therapists in Motivational Interviewing to Enhance Rehabilitation Participation for Spinal Cord Injury (SCI)
Pilot, Open Non-controled Trial to Assess the Feasibility of Implementing Objective Parameters as Primary Endpoints in a Clinical Trial With Patients Affected by Knee Osteoarthritis
The BEACON Study: Protocol for a Pilot Randomized Controlled Trial of Smartphone-assisted Problem Solving Therapy in Men Who Present With Intentional Self-harm to Emergency Departments in Ontario
Double Blind, Placebo Controlled Trial to Evaluate the Effects of a Nutraceutical Containing High-Molecular-Weight Hyaluronic Acid (HA) and Acetyl-11-Keto-Beta-Boswellic Acid (AKBA) in Patients Affected by Knee Osteoarthritis
Investigating Music Care Intervention On Palliative Care Patients
Exploring 'VOLITION' in Context - a Study to Inform the Implementation of a New Intervention
Premenstrual Hormonal and Affective State Evaluation (PHASE) Project
Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Elevated Depression Symptoms
Planning Advance Care Together (PACT) to Improve Engagement in Advance Care Planning
Proof-of-Concept of the SOAR (Stop OsteoARthritis) Program: A Randomized Delayed-Control Trial
The Effectiveness of the Protection Motivation Theory in Reducing Vaping Behaviour in a Student Population
Achieving Greater Value for Veterans Through Full Cost Transparency
Evaluating an Educational Intervention for Improving Residents' Recognition and Response to Child Maltreatment - A Mixed Method Acceptability and Feasibility Study With a Pilot Randomized Trial
DELIRE-ICU: A Randomised Controlled Feasibility Trial of Melatonin vs Placebo in the Treatment of Delirium in the Intensive Care Unit
Pain Informed Movement for People With Knee Osteoarthritis: A Pilot and Feasibility Randomized Controlled Trial
Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges, Australia Cohort
Evaluating an Online Interprofessional Chronic Pain Management Group for Survivors of Breast Cancer: A Feasibility Study of a Randomized Controlled Trial
The Stop Osteoarthritis (SOAR) Hybrid Effectiveness-Implementation Type 1 Randomized Controlled Trial for Young People At-High-Risk of Early Onset Knee Osteoarthritis
Support for Cancer Patients Awaiting News (SCAN Study): Pilot Testing a Stress Management Program
Combining Transcranial Direct Current Stimulation and Yoga for Improved Pain Management for Knee Osteoarthritis: A Pilot and Feasibility Trial
Teachers Delivering Task-Shifted Mental Health Care to Adolescents in India
Implementing a Digital Telerehabilitation Protocol and Non-motor Outcomes, and Quality of Life in Patients With Functional Motor Disorders: a Feasibility 2-arm Parallel Randomized Controlled Clinical Trial
The Effectiveness of Anti-spastic Splint With Added Focal Muscle Vibration (FMV) in Decreasing Hand Spasticity and Improving Hand Functionality Among Individuals With Chronic Stroke: a Pilot Randomized Control Trial
Intramedullary Screw Versus Kirschner Wire Fixation of Extraarticular Proximal and Middle Phalanx Fractures: Pilot Study for a Randomized Controlled Trial
Evaluating the Physiological Impact of Pain Neuroscience Education Versus Standard Education for Older Adults With Osteoarthritis
Evaluating the Feasibility of a Future Trial-based Economic Evaluation of a Multistage Shared Decision-making Program for the Treatment of Type 2 Diabetes Mellitus: a Pilot Study
NCT06632184 phase4active not recruitingnot on this mapstarted 2025, after this paper: background citation
Pilot Comparative Study on the Efficacy of Multimodal Management With Peritoneal Lavage Using Saline Solution Versus Saline Solution With Ondansetron in Laparoscopic Cholecystectomy
Effectiveness of an Evidence-based Multi-component Intervention Programme to Reduce Medication-related Problems Among Polymedicated Home-dwelling Older Adults: Protocol for a Multi-site Pilot Study of the OptiMed Clinical Trial
Comparison of Two Strategies to Allow Mechanical Ventilation Separation Using Biphasic Airway Pressure Ventilation Without Any Synchronization (BIPAP) or Pressure Support Ventilation (PSV): a Randomized Feasibility Trial
Designing a Spatial Navigation Intervention Protocol Informed by Region-specific Brain Activation for Mild Cognitive Impairment
Pilot Feasibility Trial of a Peer Support Program for Trauma Survivors
Eating Fruits and Vegetables With Pleasure! A Pilot Randomized Controlled Feasibility and Acceptability Assessment of a Nutritional Intervention Integrating Eating Pleasure to Promote Healthy Eating in Higher-Weight Adults
Feasibility And Acceptability of a Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F): Pilot Study
Pain Reprocessing Therapy for Chronic Low Back Pain: A Pilot Randomized Controlled Trial
Comparing Two Moral Injury Treatments: Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury
Who cites it
1,397 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Metacognitive interventions for adolescents with mental disorders: a scoping review.Pediatric research · 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
- The Safety, Efficacy, and Feasibility of Fecal Microbiota Transplantation in a Population With Bipolar Disorder During Depressive Episodes: A Pilot Parallel Arm Randomized Controlled Trial: Sécurité, efficacité et faisabilité de la transplantation de microbiote fécal chez une population atteinte de troubles bipolaires, au cours d'épisodes dépressifs : essai pilote contrôlé à répartition aléatoire et à groupes parallèles.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2026Trial
- Optimizing Health for Canadian Youth at Clinical High Risk for Psychosis: A Feasibility Study: Optimiser la santé des jeunes Canadiens présentant un risque clinique élevé de psychose : Une étude de faisabilité.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2026Trial
- Diffractive optical element (D.O.E) spectacle lenses for myopia prevention and control: a small-scale pilot study among younger Chinese children.BMJ open ophthalmology · 2026Trial
- A Randomised Feasibility Trial of a Service-Coordinated Exercise Intervention in First-Episode Psychosis: Challenges in Implementation and Outcome Assessment.Early intervention in psychiatry · 2026Trial
- Low Molecular Weight Heparin Thromboprophylaxis or No Treatment following Cesarean Delivery: A Pilot Randomized Controlled Trial.American journal of perinatology · 2026Trial
- The Effects of Short-Term Post-Exposure to 3.6 GHz 5G Mobile Phone Electromagnetic Exposure on Static and Dynamic Postural Control in Healthy Adults: A Randomized Sham-Controlled Pilot Study.Sensors (Basel, Switzerland) · 2026Trial
- Acceptability, Feasibility, and Outcome Responsiveness of the Joint Effort Mobile App for Promoting Lower-Risk Cannabis Use Among Young Adults: Pilot Randomized Controlled Trial.JMIR mHealth and uHealth · 2026Trial
- An international randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP trial).Antimicrobial resistance and infection control · 2026Trial
- Trial
- Suppression of microbial burden to reduce pneumonia in critical illness: the SMURF feasibility pilot study.Critical care (London, England) · 2026Trial
- A Mobile Self-Assessment and Referral Platform for Family Caregivers of Individuals With Alzheimer Disease and Related Dementias: Protocol for a Pilot Randomized Controlled Trial.JMIR research protocols · 2026Trial
- Physical activity coaching programme for people with Long COVID: a pilot randomised clinical trial.Scientific reports · 2026Trial
- Feasibility and potential effectiveness of an exergame program for people with moderate to advanced Parkinson's disease: A pilot randomized controlled trial.Journal of Parkinson's disease · 2026Trial
- Feasibility of a randomized trial comparing exercise-based rehabilitation to no exercise-based rehabilitation after total knee arthroplasty: DRAW-TKA hybrid 1 RCT.Osteoarthritis and cartilage open · 2026Trial
- Intensive community care services for adolescents with acute psychiatric emergencies: trial feasibility findings from the pilot phase of a multi-centre randomised controlled trial.BMC psychiatry · 2026Trial
- A pilot randomized controlled trial comparing the feasibility and preliminary effects of different forms of exercise-related social support for older adult survivors of cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Trial
- A Neonatal Nurse-Controlled Model of Analgesia to Manage Post-Operative Pain in the Surgical Neonate: A Pilot Randomised Controlled Trial.Journal of advanced nursing · 2026Trial
- Evaluating the Cultural Adaptation of Evidence-Based HIV Prevention Interventions for African Immigrant Women: Exploratory Pilot Mixed-Methods Study.Journal of immigrant and minority health · 2026Trial
1,337 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
10 authors.
Lehana ThabaneDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton ON, Canada. thabanl@mcmaster.ca
Jinhui Ma
Rong Chu
Ji Cheng
Afisi Ismaila
Lorena P Rios
Reid Robson
Marroon Thabane
Lora Giangregorio
Charles H Goldsmith
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format.
Indexed as
Pilot ProjectsResearch DesignClinical Trials, Phase III as TopicHumansRandomized Controlled Trials as Topic
Identifiers
What Socratic holds
Textmetadata
LicenceCC BY
Read underepoch 390
Registered trials
NCT04056039ClinicalTrials.gov
NCT02045771ClinicalTrials.gov
NCT02083172ClinicalTrials.gov
NCT02333240ClinicalTrials.gov
NCT02436785ClinicalTrials.gov
NCT02449200ClinicalTrials.gov
and 39 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 Socratic graph.