Evidence map›Paper›PMID 33292770›Full record

ArticlePilot and feasibility studies2020

Guidance for conducting feasibility and pilot studies for implementation trials.

Nicole Pearson, Patti-Jean Naylor, Maureen C Ashe, Maria Fernandez, Sze Lin Yoong, Luke Wolfenden

9 registry-linked trialsAbstract readLetter
In one paragraph

Article in Pilot and feasibility studies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 9 registered trials, which are not on this map. Cited by 262 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
262citing papers in PubMed, 4 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.

NCT06164119 naunknown statusnot on this mapstarted 2023, after this paper: background citation

A Randomised Effectiveness-implementation Trial for Evaluating Dietary and Manual Treatment With Osteopathic Techniques on Quality of Life and on Modulation of the Inflammatory State of Patients Diagnosed With Breast Cancer Undergoing Antiestrogenic Hormonal Treatment.

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2023 to 2025Enrolled600ConditionsBreast CancerArmsmanual treatment with osteopathic techniques and nutritional treatment, manual treatment with osteopathic techniques, nutritional treatment
NCT06248203 narecruitingnot on this mapstarted 2024, after this paper: background citation

Teachers Delivering Task-Shifted Mental Health Care to Adolescents in India

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2024 to 2027Enrolled216ConditionsAdolescent Behavior, Adolescent - Emotional Problem, Mental Health Issue, Psychosocial FunctioningArmsTealeaf-Mansik Swasta (Tealeaf) as adapted for Adolescents, Enhanced Usual Care (EUC)
NCT06471595 nacompletednot on this mapstarted 2024, after this paper: background citation

Peau o le Vasa: Accelerating the Currents of Health Equity for Pasifika People

TypeinterventionalSponsorUniversity of HawaiiRan2024 to 2025Enrolled242ConditionsWeight Loss Trial, Cardiometabolic Syndrome, Hypertension, DyslipidemiaArmsPartnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) Component
NCT06587230 narecruitingnot on this mapstarted 2024, after this paper: background citation

Building Teachers Mental Health Skills to Support Students With Mental Health Needs in Elementary and Middle Schools in North Carolina: Program Implementation and Prospective Data Collection

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2024 to 2027Enrolled312ConditionsChild Behavior, Mental Health Issue, Psychosocial Functioning, DepressionArmsTeachers Leading the Frontlines, Responding to Students' Emotions Through Education
NCT07035106 narecruitingnot on this mapstarted 2025, after this paper: background citation

I-WEAR: From ICU to Recovery - Evaluating the Feasibility and Usability of Bi-Weekly Health Summaries Using Wearables in Patients After Intensive Care Unit Treatment - A Pilot Study

TypeinterventionalSponsorLudwig Boltzmann GesellschaftRan2025 to 2026Enrolled60ConditionsPost-Intensive Care Syndrome (PICS), Critical Illness Recovery, Coronary Artery DiseaseArmsWearable Health Monitoring, Digital Health Summary and Lifestyle Counseling
NCT07102914 naenrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Building Effective Evidence-Based Services at New Haven Adult Education

TypeinterventionalSponsorYale UniversityRan2025 to 2028Enrolled340ConditionsBehavioral Health ChallengesArmsScreening, Brief Intervention and Referral for Treatment (SBIRT)
NCT07554677 narecruitingnot on this mapstarted 2026, after this paper: background citation

Feasibility of a Co-designed PRe-radiotherapy Exercise Programme for People With Stage I-III Non-small Cell Lung cAnCEr: A Single-centre, Single Arm Pilot Study

TypeinterventionalSponsorQueen's University, BelfastRan2026 to 2026Enrolled30ConditionsLung CancerArmsExercise, radiotherapy
NCT07712978 nacompletednot on this mapstarted 2024, after this paper: background citation

Mothers' Heartbeat Intervention in Newborn's Phototherapy Treatment at Maternity Ward: A Mixed Methods Feasibility Study

TypeinterventionalSponsorMervi HakalaRan2024 to 2025Enrolled40ConditionsAnxiety, Stress, ExperienceArmsMothers' Heartbeat Intervention
NCT07790991 nanot yet recruitingnot on this mapstarted 2027, after this paper: background citation

Low-cost Negative Pressure Wound Therapy Versus Standard Wound Dressings for Gustilo-Anderson Type IIIb Open Tibial Fractures in a Low-resource Setting: Protocol for a Pilot Randomised Controlled Trial in Bukavu,Democratic Republic of Congo

TypeinterventionalSponsorUniversité Catholique de BukavuRan2027 to 2028Enrolled66ConditionsOpen Tibia FractureArmsintervention2: standard wound dressing, Intervention1: Low-cost NPWT
3 · Its place in the literature

Who cites it

262 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  12. Mechanisms of change in a randomized control pilot study of partner-involved financial incentive treatments for dual-smoking couples.Health psychology : official journal of the Division of Health Psychology, American Psychological Association · 2025
    Trial
  13. Trial
  14. Acceptance and Commitment Therapy Eczema Management Program for Children With Eczema: A Pilot Randomised Controlled Trial.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2025
    Trial
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202 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

6 authors.

Nicole PearsonSchool of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Nicole.Pond@health.nsw.gov.au.ORCID http://orcid.org/0000-0003-2677-2327
Patti-Jean NaylorSchool of Exercise Science, Physical and Health Education, Faculty of Education, University of Victoria, PO Box 3015 STN CSC, Victoria, BC, V8W 3P1, Canada.
Maureen C AsheDepartment of Family Practice, University of British Columbia (UBC) and Centre for Hip Health and Mobility, University Boulevard, Vancouver, BC, V6T 1Z3, Canada.
Maria FernandezCenter for Health Promotion and Prevention Research, University of Texas Health Science Center at Houston School of Public Health, Houston, TX, 77204, USA.
Sze Lin YoongSchool of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.
Luke WolfendenSchool of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.

Funding

National Health and Medical Research Council APP1128348National Heart Foundation of Australia 101175
6 · The paper itself

Abstract

backgroundImplementation trials aim to test the effects of implementation strategies on the adoption, integration or uptake of an evidence-based intervention within organisations or settings. Feasibility and pilot studies can assist with building and testing effective implementation strategies by helping to address uncertainties around design and methods, assessing potential implementation strategy effects and identifying potential causal mechanisms. This paper aims to provide broad guidance for the conduct of feasibility and pilot studies for implementation trials.

methodsWe convened a group with a mutual interest in the use of feasibility and pilot trials in implementation science including implementation and behavioural science experts and public health researchers. We conducted a literature review to identify existing recommendations for feasibility and pilot studies, as well as publications describing formative processes for implementation trials. In the absence of previous explicit guidance for the conduct of feasibility or pilot implementation trials specifically, we used the effectiveness-implementation hybrid trial design typology proposed by Curran and colleagues as a framework for conceptualising the application of feasibility and pilot testing of implementation interventions. We discuss and offer guidance regarding the aims, methods, design, measures, progression criteria and reporting for implementation feasibility and pilot studies.

conclusionsThis paper provides a resource for those undertaking preliminary work to enrich and inform larger scale implementation trials.

Indexed as

FeasibilityHybrid trial designsImplementation sciencePilot

Identifiers

PMID33292770
PMCPMC7603668

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

and 3 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.