Evidence mapPaperPMID 15189396Full record

ArticleJournal of evaluation in clinical practice2004

Design and analysis of pilot studies: recommendations for good practice.

Gillian A Lancaster, Susanna Dodd, Paula R Williamson

32 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in Journal of evaluation in clinical practice, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 32 registered trials, which are not on this map. Cited by 1,243 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,243citing papers in PubMed, 1 pooled it
field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT02879409 naactive not recruitingstarted 2016, after this paper: background citation

Does Glycated Hemoglobin Variability in Type 2 Diabetes Differ Depending on the Diabetes Treatment Threshold Used in the Qatari Population: Implication on Diabetes Complication Risk?

Ran2016Enrolled150Registered outcomes4Posted comparisons0ConditionsDiabetes Mellitus Type 2Armsdapagliflozin, Gliclazide, human insulin, liraglutide, Metformin
Open the trial in the graph
NCT04056039 phase2completedstarted 2018, after this paper: background citation

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.

Ran2018Enrolled60Registered outcomes3Posted comparisons0ConditionsArthritis, Rheumatoid, Cardiovascular DiseasesArmsAtorvastatin, Colchicine
Open the trial in the graph
NCT02333240 nacompletednot on this mapstarted 2015, after this paper: background citation

Self-management of Postnatal Anti-hypertensive Treatment: a Trial Development Pilot Study

TypeinterventionalSponsorUniversity of OxfordRan2015 to 2016Enrolled101ConditionsPre-Eclampsia, Hypertension, Pregnancy-InducedArmsSelf-management of postnatal anti-hypertensive treatment
NCT02755753 phase4completednot on this mapstarted 2014, after this paper: background citation

A Multicenter, Randomized, Double-blinded, Placebo-controlled Pilot Study to Evaluate the Efficacy and Safety of Rebamipide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis (REPAIR)

TypeinterventionalSponsorYongChan LeeRan2014 to 2016Enrolled143ConditionsGastroesophageal RefluxArmsLansoprazole, Rebamipide, Rebamipide-placebo
NCT02890576 withdrawnnot on this mapstarted 2019, after this paper: background citation

Organization of Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant.

TypeobservationalSponsorUniversity Hospital, ToulouseRan2019 to 2020Enrolled0ConditionsDeafnessArmstelemedicine
NCT03205514 completednot on this mapstarted 2017, after this paper: background citation

Multimodality Investigation of Intermediate Culprit Lesion With Negative Fractional Flow Reserve in Patients With no ST-segment Elevation Acute Coronary Syndrome.

Typeobservational_patient_registrySponsorUniversity Hospital of FerraraRan2017 to 2021Enrolled35ConditionsMyocardial IschemiaArmsNSTE-ACS with intermediate stenosis and negative FFR
NCT03236558 nawithdrawnnot on this mapstarted 2018, after this paper: background citation

Thymic Generation of Regulatory T Lymphocytes in Type I Diabetes Patients.

TypeinterventionalSponsorUniversity Hospital, ToulouseRan2018 to 2019Enrolled0ConditionsType1 DiabetesArmsBlood collection
NCT03417934 completednot on this mapstarted 2018, after this paper: background citation

Effects of Hip Distraction Without a Perineal Post on Venous Blood Flow and Peripheral Nerve Conduction During Hip Arthroscopic Procedures Clinical Protocol: Prospective Study

Typeobservational_patient_registrySponsorUniversity of Colorado, DenverRan2018 to 2018Enrolled40ConditionsHip DiseaseArmsHip Arthroscopy Procedure
NCT03421054 nacompletednot on this mapstarted 2018, after this paper: background citation

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

TypeinterventionalSponsorRiver Pharma S.r.l.Ran2018 to 2018Enrolled8ConditionsKnee OsteoarthritisArmspatients assuming nutraceutical containing HA
NCT03428373 phase2 / phase3unknown statusnot on this mapstarted 2019, after this paper: background citation

Rivaroxaban for Improvement of Thromboembolism Outcomes in Patients With Multiple Myeloma on Lenalidomide-based Therapy: RithMM Trial

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2019 to 2024Enrolled57ConditionsMultiple Myeloma in Relapse, Multiple Myeloma Progression, Multiple Myeloma Stage II, Multiple Myeloma Stage IArmsRivaroxaban, ASA
NCT03458286 naunknown statusnot on this mapstarted 2018, after this paper: background citation

A Pilot Randomised Control Trial to Measure the Effectiveness of Combined Modulated Ultrasound and Electric Current Stimulation in Treating Diabetic Foot Ulcers

TypeinterventionalSponsorRoyal College of Surgeons, IrelandRan2018 to 2018Enrolled50ConditionsDiabetic Foot UlcerArmsBRH-A2 wound healing device
NCT03612986 nacompletednot on this mapstarted 2018, after this paper: background citation

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

TypeinterventionalSponsorRiver Pharma S.r.l.Ran2018 to 2019Enrolled72ConditionsKnee OsteoarthritisArmsSYALOX® 300 Plus, Placebo
NCT03786315 completednot on this mapstarted 2021, after this paper: background citation

Exploring 'VOLITION' in Context - a Study to Inform the Implementation of a New Intervention

TypeobservationalSponsorUniversity of ExeterRan2021 to 2022Enrolled72ConditionsDecision Making, Aged, Multimorbidity, General Practice
NCT03821896 naterminatednot on this mapstarted 2019, after this paper: background citation

Feasibility, User Experiences, and Preliminary Effectiveness of Conversation Cards for Adolescents, a Patient-centered Communication and Behavior Change Tool: a Pragmatic, Pilot Randomized Controlled Trial

TypeinterventionalSponsorUniversity of AlbertaRan2019 to 2022Enrolled31ConditionsAdolescent Obesity, Life Style, Health Behavior, Health CommunicationArmsConversation Cards for Adolescents and Goal-Setting, Goal-Setting
NCT03823456 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Self-acupressure for Cancer-related Symptom Cluster of Insomnia, Depression, and Anxiety in Cancer Patients: a Feasibility Randomized Controlled Trial

TypeinterventionalSponsorThe Hong Kong Polytechnic UniversityRan2018 to 2019Enrolled114ConditionsInsomnia, Anxiety, DepressionArmsSelf-acupressure, Sham Self-acupressure
NCT04589169 unknown statusnot on this mapstarted 2020, after this paper: background citation

Continuous Non-Invasive Eye Tracking for the Early Detection of Delirium on the Intensive Care Unit

TypeobservationalSponsorChelsea and Westminster NHS Foundation TrustRan2020 to 2021Enrolled30ConditionsDelirium
NCT04720014 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Enhancing Resilience in Senior Living Community Residents

TypeinterventionalSponsorMassachusetts General HospitalRan2021 to 2021Enrolled80ConditionsStress, Psychological, Coping SkillsArmsSMART-3RP Group Intervention
NCT04736251 unknown statusnot on this mapstarted 2019, after this paper: background citation

A Prospective Intra-patient Single-blinded Randomised Trial to Examine the Mechanistic Basis of fractiOnal Ablative carbOn Dioxide Laser Therapy in Treating Adult Burns and/or Trauma Patients With Hypertrophic Scarring

TypeobservationalSponsorNaiem MoiemenRan2019 to 2023Enrolled60ConditionsBurn Scar, Scar
NCT04921176 completednot on this mapstarted 2020, after this paper: background citation

Evaluating Quality of Life of AF Patients Following a Bleed

Typeobservational_patient_registrySponsorSwansea UniversityRan2020 to 2022Enrolled32ConditionsAtrial Fibrillation
NCT05180656 nacompletednot on this mapstarted 2021, after this paper: background citation

The Impact of a Remotely-Delivered Yoga Intervention on Cognitive Function in Breast Cancer Survivors: A Feasibility Study

TypeinterventionalSponsorUniversity of TorontoRan2021 to 2022Enrolled18ConditionsBreast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage IIIArmsYoga Intervention
NCT05416879 recruitingnot on this mapstarted 2022, after this paper: background citation

Lifestyle Behaviours of Women Newly Diagnosed With Heart Failure: A Quantitative and Qualitative Approach

TypeobservationalSponsorNewcastle UniversityRan2022 to 2026Enrolled40ConditionsHeart FailureArmsActigraph GT3X+BT
NCT05438134 nacompletednot on this mapstarted 2022, after this paper: background citation

Enhancing Resilience in Senior Living Community Residents: A Randomized Controlled Trial

TypeinterventionalSponsorMassachusetts General HospitalRan2022 to 2023Enrolled288ConditionsQuality of Life, Stress, PsychologicalArmsSMART-3RP Group Intervention
NCT05507385 nawithdrawnnot on this mapstarted 2022, after this paper: background citation

A Brief Intervention Targeting Anhedonia in Adolescents: a Feasibility Randomised Controlled Trial

TypeinterventionalSponsorKing's College LondonRan2022 to 2024Enrolled0ConditionsDepression, AnhedoniaArmsIMAGINE-POSITIVE, Control
NCT05571761 nawithdrawnnot on this mapstarted 2022, after this paper: background citation

Feasibility and Usefulness of a Neuropsychological Telerehabilitation Program in Asymptomatic HIV Patients: Pilot Randomized Controlled Trial

TypeinterventionalSponsorUniversidad Nacional Autonoma de MexicoRan2022 to 2024Enrolled0ConditionsTelerehabilitation, Neuropsychology, HIV DementiaArmsCognitive stimulation program
NCT05849259 nacompletednot on this mapstarted 2023, after this paper: background citation

Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care

TypeinterventionalSponsorMassachusetts General HospitalRan2023 to 2024Enrolled50ConditionsDementia, Quality of Life, Caregiver StressArmsDementia Care Quality at Home
NCT06048068 nacompletednot on this mapstarted 2023, after this paper: background citation

Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events (RESURFACE): A Randomized Pilot Intervention Study

TypeinterventionalSponsorColumbia UniversityRan2023 to 2024Enrolled53ConditionsCardiac ArrestArmsEducational Informational Platform
NCT06358976 naunknown statusnot on this mapstarted 2024, after this paper: background citation

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

TypeinterventionalSponsorArab American University (Palestine)Ran2024 to 2024Enrolled48ConditionsSpasticity as Sequela of StrokeArmsVibration plus anti-spastic hand splint, Anti-spastic hand splint, Vibration
NCT06596031 naenrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Health Coaching in Addition to a Digital Resource to Promote Self-management for Patients Waiting for Total Hip or Knee Replacements: A Randomised Feasibility Trial

TypeinterventionalSponsorSheffield Hallam UniversityRan2025 to 2025Enrolled36ConditionsArthritis Knee, Arthritis of HipArmsHealth coaching, Digital toolkit
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

TypeinterventionalSponsorInstituto Mexicano del Seguro SocialRan2025 to 2026Enrolled40ConditionsPostoperative Pain Management, Laparoscopic Cholecystectomy, Ondansetron, Postoperative Nausea and VomitingArmsOndansetron Intraperitoneal Lavage, Saline Intraperitoneal Lavage
NCT06828003 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

A Remotely-Delivered Resistance Training Program for Cognitive Function in Men Living With and Beyond Prostate Cancer: A Feasibility Study

TypeinterventionalSponsorUniversity of TorontoRan2025 to 2026Enrolled30ConditionsProstate Cancer, Resistance TrainingArmsResistance Training
NCT07385183 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

CARE: Comprehensive Assessment of Real-world Effectiveness of F/TAF in Persons Who Use Drugs (PWUD)

TypeobservationalSponsorHeather HendersonRan2026 to 2027Enrolled200ConditionsPeople Who Inject Drugs, PrEP AdherenceArmsPrEP adherence, PrEP perspectives
NCT07742137 nacompletednot on this mapstarted 2026, after this paper: background citation

Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality

TypeinterventionalSponsorUniversidad de AlmeriaRan2026 to 2026Enrolled18ConditionsPsychological Well Being, Healthy Volunteers, Aging, Long-Term CareArmsActive IVR, Passive IVR
3 · Its place in the literature

Who cites it

1,243 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  20. The Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention: A Pilot Randomized Controlled Trial.Transplant international : official journal of the European Society for Organ Transplantation · 2026
    Trial

1,183 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Gillian A LancasterDepartment of Mathematical Sciences, University of Liverpool, UK. g.lancaster@liv.ac.uk
Susanna Dodd
Paula R Williamson

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pilot studies play an important role in health research, but they can be misused, mistreated and misrepresented. In this paper we focus on pilot studies that are used specifically to plan a randomized controlled trial (RCT). Citing examples from the literature, we provide a methodological framework in which to work, and discuss reasons why a pilot study might be undertaken. A well-conducted pilot study, giving a clear list of aims and objectives within a formal framework will encourage methodological rigour, ensure that the work is scientifically valid and publishable, and will lead to higher quality RCTs. It will also safeguard against pilot studies being conducted simply because of small numbers of available patients.

Indexed as

Randomized Controlled Trials as TopicResearch DesignPilot ProjectsUnited Kingdom

Identifiers

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

and 26 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.