ArticleJournal of clinical epidemiology2021
Pilot and feasibility studies for pragmatic trials have unique considerations and areas of uncertainty.
Article in Journal of clinical epidemiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06909279 (The More Than Words® Program for Parents of Young Children With Social Communication Challenges), which is not on this map. Cited by 27 papers.
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.
The More Than Words® Program for Parents of Young Children With Social Communication Challenges: A Pilot Pragmatic Randomized Waitlist-Control Trial
Who cites it
27 citing papers in PubMed, 27 citations in OpenAlex.
- Feasibility Pilot Trial for the Trajectories of Recovery after Intravenous Propofol versus Inhaled Volatile Anesthesia (THRIVE) Pragmatic Randomized Clinical Trial.Anesthesiology · 2026Trial
- From Intensive Care to Recovery: Feasibility of a Randomised Controlled Study Design Evaluating a Cognitive Rehabilitation Intervention for Critically Ill Patients.Nursing in critical care · 2026Trial
- Trial
- Prescribing for the patient and the planet: a pragmatic feasibility study of a behaviour change intervention to reduce liquid amoxicillin prescribing in primary care.Exploratory research in clinical and social pharmacy · 2026Article
- Hearing screening outcomes and otoscopic findings among primary school children in Southwest Ethiopia: A cross-sectional study.The South African journal of communication disorders = Die Suid-Afrikaanse tydskrif vir Kommunikasieafwykings · 2026Article
- Article
- Lessons Learned From the Implementation of a Pragmatic Trial Evaluating Non-Pharmacological Approaches to Dementia Care in US Nursing Homes.Journal of evaluation in clinical practice · 2026Article
- Tobacco cessation intervention for individuals with severe mental illness in Bangladesh, India, and Pakistan: protocol for a multi-country feasibility randomised controlled trial (SCIMITAR-SA).Contemporary clinical trials communications · 2026Article
- Aquatic Therapy as a Programmable Multisensory Environment for Arousal and Postural Control After Severe Acquired Brain Injury: A Perspective.Brain sciences · 2026Article
- A feasibility randomised trial of remotely delivered Video Interaction Guidance for parents of children with intellectual disability referred to specialist mental health services.Pilot and feasibility studies · 2026Article
- The More Than Words® parent-delivered program for autistic children and those with social communication challenges: a single-arm pragmatic feasibility trial.Pilot and feasibility studies · 2026Article
- Patient-centred outcomes of a rheumatology podiatry service for people with foot-specific symptoms: protocol for a randomised feasibility trial.Rheumatology international · 2026Article
- Prehabilitation for patients undergoing neoadjuvant treatment: results of a single-center pilot study using an integrative medicine day clinic.Frontiers in oncology · 2026Article
- A feasibility study of a co-designed intervention to manage benzodiazepine dependence and high-risk use in those receiving opioid agonist treatment.Pilot and feasibility studies · 2025Article
- Clinical decision-making frameworks for pandemic preparedness and response: A scoping review.Health promotion perspectives · 2025Review
- Developing an Inclusive Dance Guide for Children With Cerebral Palsy: A Co-Design Process and Initial Feasibility Study.Health expectations : an international journal of public participation in health care and health policy · 2025Article
- Improving Trial Informativeness: A Rapid Review of Global Research on How to Ensure Trials Are Useful.Journal of evaluation in clinical practice · 2025Review
- Evaluation of a Curriculum-Based Nutrition Education Intervention Protocol in Elementary Schools: Nonrandomized Feasibility Study.JMIR formative research · 2025Article
- Living Well With Uncertainty in Advanced, Metastatic or Incurable Cancers: A Pragmatic Feasibility Study of the Adapting to Life With Cancer Cognitive ExisteNtial Therapy (ACCENT).Psycho-oncology · 2025Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
Abstract
BACKGROUND AND
objectiveFeasibility studies are increasingly being used to support the development of, and investigate uncertainties around, future large-scale trials. The future trial can be designed with either a pragmatic or explanatory mindset. Whereas pragmatic trials aim to inform the choice between different care options and thus, are designed to resemble conditions outside of a clinical trial environment, explanatory trials examine the benefit of a treatment under more controlled conditions. There is existing guidance for designing feasibility studies, but none that explicitly considers the goals of pragmatic designs. We aimed to identify unique areas of uncertainty that are relevant to planning a pragmatic trial.
resultsWe identified ten relevant domains, partly based on the pragmatic-explanatory continuum indicator summary-2 (PRECIS-2) framework, and describe potential questions of uncertainty within each: intervention development, research ethics, participant identification and eligibility, recruitment of individuals, setting, organization, flexibility of delivery, flexibility of adherence, follow-up, and importance of primary outcome to patients and decision-makers. We present examples to illustrate how uncertainty in these domains might be addressed within a feasibility study.
conclusionResearchers planning a feasibility study in advance of a pragmatic trial should consider feasibility objectives specifically relevant to areas of uncertainty for pragmatic trials.
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What OpenQuestion holds
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.