ArticleClinical epidemiology2018
Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes.
Article in Clinical epidemiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 13 registered trials, which are not on this map. Cited by 140 papers, 1 of them a synthesis that pooled 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.
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.
Giving Information Systematically and Transparently in Lung and GI Cancer
Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2
The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual (SADL-eM): Study Protocol for a Randomized Clinical Trial
Multiphasic Neuroplasticity Based Training Protocol With Shock Wave Therapy For Post Stroke Spasticity
Evaluating TESLA-G, a Gamified, Telegram-delivered, Quizzing Platform for Surgical Education in Medical Students: a Protocol for a Pilot Randomised Controlled Trial
Using Data to Achieve Surgical Health Equity in the Community
"Effects of a Decision Support Intervention on End-of-life Care Planning in Chinese Older Adults With Advanced Disease and Their Family Members: A Feasibility Trial"
Effects of Myofascial Reorganization on Running Performance, and Lower Limb Biomechanical, Viscoelastic, and Thermographic Properties of Triathletes: a Randomized Clinical Trial.
AI-Enhanced App-based Intervention for Adolescent E-cigarette Cessation
Early Ketamine Plus Midazolam Versus Ketamine Plus Midazolam for the Treatment of Refractory Status Epilepticus
A Pilot Randomized Controlled Trial of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion
Rural Initiative for Inflammatory Screening & Engagement for Women
CanCOG® - Cognitive Rehabilitation in Cancer: A Protocol for a Multicenter Pilot Randomized Controlled Trial With Non-central Nervous System Cancer Survivors
Who cites it
140 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Vibrational Spectroscopy Saliva Profiling as Biometric Tool for Disease Diagnostics: A Systematic Literature.Molecules (Basel, Switzerland) · 2020Pooled it
- Feasibility of a Virtual Mindfulness-Based Stress Reduction Intervention for Individuals With Chronic Pain: Pilot Randomized Controlled Trial.JMIR formative research · 2026Trial
- Web-Based Cognitive Rehabilitation for Patients With Aggressive Lymphoma With Perceived Cognitive Impairment: A Randomised Pilot Study.Psycho-oncology · 2026Trial
- Feasibility of glycated haemoglobin target-setting in adults with diabetes: A mixed-methods study.PloS one · 2026Trial
- Feasibility Trial of a Tailored Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer.Pediatric blood & cancer · 2026Trial
- Feasibility of a randomised controlled trial of Healthier Wealthier Families in Sweden: results from the Ameliorating Child poverty through Connecting Economic Services with child health Services (ACCESS) pilot study.BMC health services research · 2025Trial
- Brief Versions of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Spanish Primary Care Service: Results of a Feasibility Pilot Study.Journal of clinical psychology · 2025Trial
- The addition of interpectoral and pectoserratus fascial plane blocks to paravertebral blocks for analgesia after total mastectomy and immediate breast reconstruction: a pilot feasibility randomized controlled trial.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2025Trial
- Trial
- Evaluation of a Novel eHealth Tool for Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease: Randomized Controlled Pilot and Feasibility Trial.JMIR formative research · 2025Trial
- Digital mindfulness-based intervention for people with COPD - a multicentre pilot and feasibility RCT.Respiratory research · 2025Trial
- Trial
- Results of a Feasibility Pilot Pragmatic Trial Implementing Palliative Care in Skilled Nursing Facilities.Journal of palliative medicine · 2025Trial
- Leveraging Mobile Health to Improve Capecitabine Adherence Among Women With Breast Cancer: A Pilot Randomized Controlled Trial.JCO oncology practice · 2024Trial
- Feasibility and acceptability of a nurse-led telehealth intervention (BOLSTER) to support patients with peritoneal carcinomatosis and their caregivers: A pilot randomized clinical trial.Gynecologic oncology · 2024Trial
- Effect of early weight bearing program with conventional physiotherapy on functional outcomes in surgically treated proximal tibia fracture: a pilot randomized controlled trial.Archives of orthopaedic and trauma surgery · 2024Trial
- Feasibility, Acceptability, and Safety of Faecal Microbiota Transplantation in the Treatment of Major Depressive Disorder: A Pilot Randomized Controlled Trial.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2023Trial
- A Randomised Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Palovarotene Ophthalmic Solution.Drugs in R&D · 2023Trial
- Randomized Trial on the Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: A Path Analytic and Supervised Machine-Learning Study.International journal of environmental research and public health · 2022Trial
- Effects of non-invasive respiratory supports on inspiratory effort in moderate-severe COVID-19 patients. A randomized physiological study.European journal of internal medicine · 2022Trial
80 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
3 authors.
Funding
Abstract
backgroundA pilot study can be an important step in the assessment of an intervention by providing information to design the future definitive trial. Pilot studies can be used to estimate the recruitment and retention rates and population variance and to provide preliminary evidence of efficacy potential. However, estimation is poor because pilot studies are small, so sensitivity analyses for the main trial's sample size calculations should be undertaken.
methodsWe demonstrate how to carry out easy-to-perform sensitivity analysis for designing trials based on pilot data using an example. Furthermore, we introduce rules of thumb for the size of the pilot study so that the overall sample size, for both pilot and main trials, is minimized.
resultsThe example illustrates how sample size estimates for the main trial can alter dramatically by plausibly varying assumptions. Required sample size for 90% power varied from 392 to 692 depending on assumptions. Some scenarios were not feasible based on the pilot study recruitment and retention rates.
conclusionPilot studies can be used to help design the main trial, but caution should be exercised. We recommend the use of sensitivity analyses to assess the robustness of the design assumptions for a main trial.
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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 OpenQuestion graph.