4,194 research outputs found

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

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    Melanie L Bell,1 Amy L Whitehead,2 Steven A Julious2 1Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA; 2Medical Statistics Group, Design, Trials and Statistics, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK 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 potential. However, estimation is poor because pilot studies are small, so sensitivity analyses for the main trial’s sample size calculations should be undertaken.Methods: We 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.Results: The 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.Conclusion: Pilot 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. Keywords: pilot, feasibility, sample size, power, randomized controlled trial, sensitivity analysi

    FIT Authors Talks: "The Miracles" with Amy Lemmon

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    Professor and Chair of English and Communication Studies Amy Lemmon reads from and talks about her book The Miracles.With lyricism and grace, Amy Lemmon gives us a worldview to live by. The all-too-familiar “wear of sorrow’s rub” is presented alongside the world’s miracles, including the author’s two children. Fearlessly bridging the gap between tradition and artistic innovation, the author moves us forward with her into the unknown, to entertain new relationships with herself, her children, and the world

    American Women Writers: Amy M. Clark

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    A 2011 conversation with the author Amy M. Clark about her life and the inspiration for her work

    Dr. Amy Howard – Faculty Author Interview

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    Amy Howard, executive director of the Bonner Center for Civic Engagement and associated faculty in American studies, discusses her new book, More Than Shelter: Activism and Community in San Francisco Public Housing, published recently by the University of Minnesota Press. Her research and book looks closely at three public housing projects in San Francisco and brings to light the dramatic measures tenants have taken to create communities that mattered to them

    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

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    There is little published guidance as to the sample size required for a pilot or feasibility trial despite the fact that a sample size justification is a key element in the design of a trial. A sample size justification should give the minimum number of participants needed in order to meet the objectives of the trial. This paper seeks to describe the target sample sizes set for pilot and feasibility randomised controlled trials, currently running within the United Kingdom. Data were gathered from the United Kingdom Clinical Research Network (UKCRN) database using the search terms 'pilot' and 'feasibility.' From this search 513 studies were assessed for eligibility of which 79 met the inclusion criteria. Where the data summary on the UKCRN Database was incomplete, data were also gathered from: the International Standardised Randomised Controlled Trial Number (ISRCTN) register; the clinicaltrials.gov website and the website of the funders. For 62 of the trials, it was necessary to contact members of the research team by email to ensure completeness. Of the 79 trials analysed, 50 (63.3%) were labelled as pilot trials, 25 (31.6%) feasibility and 14 were described as both pilot and feasibility trials. The majority had two arms (n = 68, 86.1%) and the two most common endpoints were continuous (n = 45, 57.0%) and dichotomous (n = 31, 39.2%). Pilot trials were found to have a smaller sample size per arm (median = 30, range = 8 to 114 participants) than feasibility trials (median = 36, range = 10 to 300 participants). By type of endpoint, across feasibility and pilot trials, the median sample size per arm was 36 (range = 10 to 300 participants) for trials with a dichotomous endpoint and 30 (range = 8 to 114 participants) for trials with a continuous endpoint. Publicly funded pilot trials appear to be larger than industry funded pilot trials: median sample sizes of 33 (range = 15 to 114 participants) and 25 (range = 8 to 100 participants) respectively. All studies should have a sample size justification. Not all studies however need to have a sample size calculation. For pilot and feasibility trials, while a sample size justification is important, a formal sample size calculation may not be appropriate. The results in this paper describe the observed sample sizes in feasibility and pilot randomised controlled trials on the UKCRN Database

    Do you have to walk it to talk it? The significance on an elite athletic career in becoming a high-performance coach in men’s football and rugby union

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    A book chapter published in ‘Myths of Sport Coaching’ edited by A. Whitehead and J. Coe, published by Sequoia Books on Friday 17.12.2021 - https://www.sequoia-books.com/catalog/whiteheadcoe

    Pilot and feasibility studies: Is there a difference from each other and from a randomised controlled trial?

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    BackgroundA crucial part in the development of any intervention is the preliminary work carried out prior to a large-scale definitive trial. However, the definitions of these terms are not clear cut and many authors redefine them. Because of this, the terms feasibility and pilot are often misused.AimTo provide an introduction to the topic area of pilot and feasibility trials and draw together the work of others in the area on defining what is a pilot or feasibility study.MethodsThis study used a review of definitions and advice from the published literature and from funders' websites. Examples are used to show evidence of good practice and poor practice.ResultsWe found that researchers use different terms to describe the various stages of the research process. Some define the terms feasibility and pilot as being different whereas others argue that these terms are synonymous. All reflective papers agree that feasibility/pilot studies should not test treatment comparisons nor estimate feasible effect sizes. However, this is not universally observed in practice.SummaryWe believe that the term ‘feasibility’ should be used as an overarching term for preliminary studies and the term ‘pilot’ refers to a specific type of study which resembles the intended trial in aspects such as, having a control group and randomisation. However, studies labelled ‘pilot’ should have different aims and objectives to main trials and also should include an intention for future work. Researchers should not use the title ‘pilot’ for a trial which evaluates a treatment effect.<br/

    Payton, Amy Louise. "Looking Back" radio show on Paytons book on Georgina Stirling.

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    CBC freelance broadcaster Cathy Porter talking to author Amy Louise Payton about the life of Georgina Stirling, Soprano Premadonna from Twillingate. Payton talks about her interest in the singer and her book on Stirling; Hiram Silk interviews Amy Louise Payton on the program Looking Back about her book Nightingale of the North about Georgina Stirling. Payton talks about Stirling and the history of the Twillingate area

    Sparrows can't sing : East End kith and kinship in the 1960s

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    Sparrows Can’t Sing (1963) was the only feature film directed by the late and much lamented Joan Littlewood. Set and filmed in the East End, where she worked for many years, the film deserves more attention than it has hitherto received. Littlewood’s career spanned documentary (radio recordings made with Ewan MacColl in the North of England in the 1930s) to directing for the stage and the running of the Theatre Royal in London’s Stratford East, often selecting material which aroused memories in local audiences (Leach 2006: 142). Many of the actors trained in her Theatre Workshop subsequently became better known for their appearances on film and television. Littlewood herself directed hardly any material for the screen: Sparrows Can’t Sing and a 1964 series of television commercials for the British Egg Marketing Board, starring Theatre Workshop’s Avis Bunnage, were rare excursions into an area of practice which she found constraining and unamenable (Gable 1980: 32). The hybridity and singularity of Littlewood’s feature may answer, in some degree, for its subsequent neglect. However, Sparrows Can’t Sing makes a significant contribution to a group of films made in Britain in the 1960s which comment generally on changes in the urban and social fabric. It is especially worthy of consideration, I shall argue, for the use which Littlewood made of a particular community’s attitudes – sentimental and critical – to such changes and for its amalgamation of an attachment to documentary techniques (recording an aural landscape on location) with a preference for nonnaturalistic delivery in performance

    Letter from Amy Narawaki to Mr. and Mrs. A.W. Thomas, December 15, 1971

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    A holiday letter of greetings on Christmas from Amy Nakawaki [=Emiko Amy Terada] in Stanton, California to Mr. and Mrs. A.W. Thomas in Lawndale, California, which contains basic correspondence.The James H. Osborne Nisei Collection contains mainly correspondence between Emiko and Usami Terada, incarcerees in the Rohwer incarceration camp, McGehee Arkansas, and the Thomas family in Lawndale, California, and photographs of the Teradas and the Thomases. The letters describe the trip from the Santa Anita Temporary Assembly Center to the Rohwer incarceration camp, their lives and conditions in the camp, and their concerns about their properties in Lawndale, California. Also included are photographs taken in the camp, some issues of "The Rohwer outpost," and fliers published during wartime
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