Cargando…

Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes

BACKGROUND: A 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 po...

Descripción completa

Detalles Bibliográficos
Autores principales:	Bell, Melanie L, Whitehead, Amy L, Julious, Steven A
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Dove Medical Press 2018
Materias:	Methodology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5779280/ https://www.ncbi.nlm.nih.gov/pubmed/29403314 http://dx.doi.org/10.2147/CLEP.S146397

Ejemplares similares

Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable
por: Whitehead, Amy L, et al.
Publicado: (2015)

A retrospective analysis of conditional power assumptions in clinical trials with continuous or binary endpoints
por: Edwards, Julia M., et al.
Publicado: (2023)

Applying mixed methods to pilot feasibility studies to inform intervention trials
por: Aschbrenner, Kelly A., et al.
Publicado: (2022)

An investigation of the impact of futility analysis in publicly funded trials
por: Sully, Benjamin GO, et al.
Publicado: (2014)

The mixed model for repeated measures for cluster randomized trials: a simulation study investigating bias and type I error with missing continuous data
por: Bell, Melanie L., et al.
Publicado: (2020)

DELTA(2) guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial
por: Cook, Jonathan A., et al.
Publicado: (2018)

The statistical interpretation of pilot trials: should significance thresholds be reconsidered?
por: Lee, Ellen C, et al.
Publicado: (2014)

Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials
por: Cooper, Cindy L, et al.
Publicado: (2018)

CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials
por: Grant, Sean, et al.
Publicado: (2018)

An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database
por: Billingham, Sophie AM, et al.
Publicado: (2013)

Using discrete choice experiments to inform the design of complex interventions
por: Terris-Prestholt, Fern, et al.
Publicado: (2019)

Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice
por: Dawson, Shoba, et al.
Publicado: (2022)

Do pilot trials reliably predict recruitment and retention rates for full trial? A review of HTA funded trials
por: Whitehead, Amy, et al.
Publicado: (2015)

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
por: Dimairo, Munyaradzi, et al.
Publicado: (2020)

Data sharing in clinical trials – practical guidance on anonymising trial datasets
por: Keerie, Catriona, et al.
Publicado: (2018)

An internal pilot design for prospective cancer screening trials with unknown disease prevalence
por: Brinton, John T., et al.
Publicado: (2015)

Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units
por: Love, Sharon B., et al.
Publicado: (2022)

Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document
por: Witt, Claudia M, et al.
Publicado: (2014)

Statistical design of personalized medicine interventions: The Clarification of Optimal Anticoagulation through Genetics (COAG) trial
por: French, Benjamin, et al.
Publicado: (2010)

Dichotomisation of a continuous outcome and effect on meta-analyses: illustration of the distributional approach using the outcome birthweight
por: Ofuya, Mercy, et al.
Publicado: (2014)

Whose knowledge counts? Involving communities in intervention and trial design using community conversations
por: Burgess, Rochelle A., et al.
Publicado: (2023)

Expected Value of Sample Information to Guide the Design of Group Sequential Clinical Trials
por: Flight, Laura, et al.
Publicado: (2021)

Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed
por: Treweek, Shaun, et al.
Publicado: (2020)

A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials
por: Rosala-Hallas, Anna, et al.
Publicado: (2019)

Sample sizes for cluster-randomised trials with continuous outcomes: Accounting for uncertainty in a single intra-cluster correlation estimate
por: Lewis, Jen, et al.
Publicado: (2021)

A novel preference-informed complementary trial (PICT) design for clinical trial research influenced by strong patient preferences
por: Ali, Samina, et al.
Publicado: (2021)

Improving analysis practice of continuous adverse event outcomes in randomised controlled trials - a distributional approach
por: Chis Ster, Anca, et al.
Publicado: (2021)

Using a technology-based intervention to promote weight loss in sedentary overweight or obese adults: a randomized controlled trial study design
por: Barry, Vaughn W, et al.
Publicado: (2011)

An imbalance in cluster sizes does not lead to notable loss of power in cross-sectional, stepped-wedge cluster randomised trials with a continuous outcome
por: Kristunas, Caroline A., et al.
Publicado: (2017)

Optimising recruitment into trials using an internal pilot
por: Bertram, W., et al.
Publicado: (2019)

Guidance to best tools and practices for systematic reviews
por: Kolaski, Kat, et al.
Publicado: (2023)

The use of qualitative methods to inform Delphi surveys in core outcome set development
por: Keeley, T., et al.
Publicado: (2016)

Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting
por: Grant, Aileen, et al.
Publicado: (2013)

Practical guidance for the use of indirect calorimetry during COVID 19 pandemic
por: Singer, Pierre, et al.
Publicado: (2020)

A flexible dose-response modeling framework based on continuous toxicity outcomes in phase I cancer clinical trials
por: Lee, Se Yoon
Publicado: (2023)

Sample size determination for external pilot cluster randomised trials with binary feasibility outcomes: a tutorial
por: Hemming, K., et al.
Publicado: (2023)

Series: Practical guidance to qualitative research. Part 2: Context, research questions and designs
por: Korstjens, Irene, et al.
Publicado: (2017)

Sample size requirements for pilot randomised controlled trials with continuous outcomes: a simulation study
por: Teare, Marion, et al.
Publicado: (2013)

Publishing descriptions of non-public clinical datasets: proposed guidance for researchers, repositories, editors and funding organisations
por: Hrynaszkiewicz, Iain, et al.
Publicado: (2016)

Retraining function in people with Parkinson’s disease using the Microsoft kinect: game design and pilot testing
por: Galna, Brook, et al.
Publicado: (2014)

Cannot write session to /tmp/vufind_sessions/sess_oekmr8s4f6r8pvjttb0j027104