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Pilot and Feasibility Studies

Mara van Beusekom, Josie Cameron, Carolyn Bedi, Elspeth Banks, Tom Kelsey, Gerry Humphris
Background: Many patients who have been treated for breast cancer experience high levels of fear that the cancer will return. The FORECAST pilot study showed that for a third of the patients, fears of cancer recurrence (FCR) increase during radiotherapy treatment and that conversations with their therapeutic radiographer at the weekly review meetings might help patients manage these concerns. This study aims to develop a communication skills training package (KEW, for 'Know', 'Encourage' and 'Warm-up') for therapeutic radiographers based on the findings of the FORECAST pilot study and on active input from patients and radiographers...
2018: Pilot and Feasibility Studies
Respati W Ranakusuma, Amanda R McCullough, Eka D Safitri, Yupitri Pitoyo, Widyaningsih, Christopher B Del Mar, Elaine M Beller
Background: Acute otitis media (AOM) is an acute inflammation of the middle ear commonly found in children, for which antibiotics are frequently prescribed. However, antibiotics are beneficial for only one third of AOM cases, and then, with only modest benefit. Since antibiotic use leads to risk of side effects and resistance, effective alternative treatments are required. Corticosteroids are a candidate because of their anti-inflammatory effects, although evidence of their efficacy and harms is insufficient...
2018: Pilot and Feasibility Studies
André Golla, Tobias Müller, Kai Wohlfarth, Patrick Jahn, Kerstin Mattukat, Wilfried Mau
Background: Several studies have reported that using the Wii™ Balance Board can provide added value regarding balance (re-)training in neurological diseases. However, for the large group of mobile older stroke survivors, there is no evidence regarding the feasibility of an unsupervised Wii™ Balance Board training in the home setting. The aim of this study was to investigate the feasibility of a home-based Wii™ balance training for these patients and to identify methodological challenges for randomised controlled trials in the future...
2018: Pilot and Feasibility Studies
Kenneth S Rankin, Jayasree Ramaskandhan, Michelle Bardgett, Katie Merrie, Rajkumar Gangadharan, Ian Wilson, David Deehan
Background: Total knee arthroplasty (TKA) is an effective procedure for late-stage osteoarthritis (OA) of the knee; however, up to 20% of patients remain dissatisfied. In some patients, this may be due to residual inflammation of the synovium. Our aim was to perform the first randomised controlled trial (RCT) of synovectomy during TKA for patients with macroscopically inflamed synovium. The main objectives were to assess recruitment rates, protocol adherence and outcomes relating to safety such as haemoglobin decrease and adverse events...
2018: Pilot and Feasibility Studies
Carmela Salomon, Jessica Bellamy, Elizabeth Evans, Renae Reid, Michelle Hsu, Scott Teasdale, Julian Trollor
Background: Older adults with intellectual disability have high rates of lifestyle - related illness yet remain poorly engaged in physical activity and nutrition interventions. There is a need to clarify what types of healthy lifestyle interventions are feasible and effective to implement in this population and how outcome measures can best be tracked. This paper describes the pilot feasibility study protocol for implementing a 12-week physical activity and healthy eating program, 'Get Healthy!' with older adults with intellectual disability...
2018: Pilot and Feasibility Studies
Erika Barrett, Dametreea Carr, Melanie L Bell, Kristen Pogreba-Brown
Background: Campylobacter is a leading cause of gastroenteritis across the globe caused by the ingestion of contaminated food, water, or contact with animals carrying Campylobacter bacteria. The resulting disease, campylobacteriosis, is usually self-limiting, but cases may develop post-infectious sequelae (PIS) such as gastrointestinal disorders, neurological disorders, and joint disorders. The objective of this study was to estimate a crude incidence rate for PIS among Campylobacter cases in Maricopa County, Arizona, USA and to determine the feasibility of conducting a larger scale study to understand chronic outcomes from campylobacteriosis and salmonellosis...
2018: Pilot and Feasibility Studies
Laura M Holdsworth, Heather Gage, Peter Williams, Claire Butler
Background: Measuring service use and costs is an important aspect of service delivery evaluation. In end-of-life care, there is heavy reliance on care by family/friends (informal carers) and this should be reflected in the total cost of care alongside formal services. The Ambulatory and Home Care Record, developed in Canada, is both comprehensive in coverage and validated for collecting data on formal and informal caring. This study aimed to adapt and pilot the Ambulatory and Home Care Record questionnaire for use in the UK within a study evaluating a new palliative care service...
2018: Pilot and Feasibility Studies
Christopher Snowden, Ellen Lynch, Leah Avery, Craig Gerrand, Eilish Gilvarry, Nicola Goudie, Catherine Haighton, Lesley Hall, Nicola Howe, Denise Howel, Elaine McColl, James Prentis, Elaine Stamp, Eileen Kaner
Background: Evidence suggests that increased preoperative alcohol consumption increases the risk of postoperative complications; therefore, a reduction or cessation in alcohol intake before surgery may reduce perioperative risk. Preoperative assessment presents an opportunity to intervene to optimise patients for surgery. This multicentre, two-arm, parallel group, individually randomised controlled trial will investigate whether a definitive trial of a brief behavioural intervention aimed at reducing preoperative alcohol consumption is feasible and acceptable to healthcare professionals responsible for its delivery and the preoperative elective orthopaedic patient population...
2018: Pilot and Feasibility Studies
Ho-Yan Yvonne Chun, Alan J Carson, Martin S Dennis, Gillian E Mead, William N Whiteley
Background: Anxiety affects a quarter of strokes. It can be disabling even after mild stroke and transient ischaemic attack (TIA). It is not feasible to deliver conventional psychological therapies to the large population of anxious stroke and TIA patients. We are testing the feasibility of a web-enabled randomised controlled trial (RCT) to compare an individualised telemedicine cognitive behavioural therapy (CBT)-based intervention with a self-guided web-based relaxation programme. This study aims to evaluate the feasibility of novel trial procedures and the delivery of the TASK interventions in stroke and TIA patients...
2018: Pilot and Feasibility Studies
Parvati R Perman-Howe, Emma L Davies, David R Foxcroft
Background: Effective interventions are required to reduce alcohol consumption and its associated harms at the population level. Reducing the alcohol content of beverages has the potential to reduce alcohol consumption through non-conscious processes. Before implementing a randomised controlled trial (RCT) to assess the effect of alcohol strength on alcohol consumption, its feasibility needs to be established. This study aims to pilot a RCT and obtain data to estimate key parameters required when designing a RCT...
2018: Pilot and Feasibility Studies
Rasha El-Kotob, Lora M Giangregorio
Background: Clinical trials of physical activity and rehabilitation interventions can be challenging. Pilot or feasibility studies can be conducted prior to a definitive randomized controlled trial (RCT), to improve the chances of conducting a high-quality RCT of a physical activity intervention. Main body: Physical activity interventions or trials present unique challenges at the population, intervention, comparator and outcome levels. At each level, we present guidance for researchers on the design considerations for pilot or feasibility studies of physical activity interventions...
2018: Pilot and Feasibility Studies
Siyang Yuan, Gerry Humphris, Al Ross, Lorna MacPherson, Yuefang Zhou, Ruth Freeman
Background: The promotion of twice yearly application of fluoride varnish (FVA) to the teeth of pre-school children in the dental practice is one component of Scotland's child oral health improvement programme (Childsmile). Nevertheless, evidence shows that application rates of FVA are variable and below optimal levels. The reasons are complex, with many contextual factors influencing activity. However, we propose that one possible reason may be related to the communication challenges when interacting with younger children...
2018: Pilot and Feasibility Studies
M M Husted, A M Beck, L K Ulrikkeholm
Background: Community-dwelling older adults receiving support at home such as meals-on-wheels may lose the ability to preserve social, cognitive, and functional abilities, when becoming accustomed to and dependent of community aged care. When still able to cook older adults often hold some control over the foods that are prepared and which they eat, and which helps to foster identity. The purpose of this study is to assess feasibility of outcome measurements and sample size when conducting a pilot cluster randomized trial to evaluate community-dwelling older adults being involved in activities in relation to meals in a rehabilitation program...
2018: Pilot and Feasibility Studies
Simon E Blackwell, Katharina Westermann, Marcella L Woud, Jan C Cwik, Torsten Neher, Christian Graz, Peter W Nyhuis, Jürgen Margraf
Background: Enhancing the capacity to experience positive affect could help improve recovery across a range of areas of mental health. Experimental psychopathology research indicates that a computerized cognitive training paradigm involving generation of positive mental imagery can increase state positive affect, and more recent clinical studies have suggested that this training could be used as an adjunct treatment module to target symptoms related to positive affect deficits, specifically anhedonia...
2018: Pilot and Feasibility Studies
Samuel M Brown, Sarah J Beesley, Michael J Lanspa, Colin K Grissom, Emily L Wilson, Samir M Parikh, Todd Sarge, Daniel Talmor, Valerie Banner-Goodspeed, Victor Novack, B Taylor Thompson, Sajid Shahul
Background: High adrenergic tone appears to be associated with mortality in septic shock, while adrenergic antagonism may improve survival. In preparation for a randomized trial, we conducted a prospective, single-arm pilot study of esmolol infusion for patients with septic shock and tachycardia that persists after adequate volume expansion. Methods: From April 2016 to March 2017, we enrolled patients admitted to an intensive care unit with sepsis who were receiving vasopressor infusion and were tachycardic despite adequate volume expansion...
2018: Pilot and Feasibility Studies
Lauren Albrecht, Shannon D Scott, Lisa Hartling
Background: Pediatric acute gastroenteritis (AGE) is a common childhood illness with substantial health, family, and system impacts. Connecting parents to evidence-based patient education is key to effective decision-making and therapeutic management of AGE. Digital knowledge translation (KT) tools offer a promising approach to communicate complex health information to parents; therefore, we developed a whiteboard animation video for parents about AGE. To optimize future effectiveness evaluation of this video, the purpose of this pilot study is to assess feasibility of effectiveness outcomes and specific trial methods in four key trial domains...
2018: Pilot and Feasibility Studies
Juthaporn Cowan, Sunita Mulpuru, Shawn Aaron, Gonzalo Alvarez, Antonio Giulivi, Vicente Corrales-Medina, Venkatesh Thiruganasambandamoorthy, Kednapa Thavorn, Ranjeeta Mallick, D William Cameron
Background: Chronic obstructive pulmonary disease (COPD) is a chronic progressive inflammatory disease of the airways, associated with frailty, disability, co-morbidity, and mortality. Individuals with COPD experience increased risk and rates of acute exacerbation as their lung disease worsens. Current treatments to prevent acute exacerbation of COPD (AECOPD) are only modestly effective. New therapies are needed to improve the quality of life and clinical outcomes for individuals living with COPD and especially for those prone to frequent recurrent AECOPD...
2018: Pilot and Feasibility Studies
M J Campbell, G A Lancaster, S M Eldridge
Background: It has been argued that true endpoints (or 'hard' endpoints) for clinical trials, which are meaningful to clinicians, researchers and patients alike, are limited to those that measure health status, survival and cost. Other endpoints are termed 'surrogate' endpoints and are intended to substitute and predict the true endpoint.  A number of trials that describe using surrogate endpoints use the term 'pilot' in the title of the paper but the reason for this, as related by the authors, is the use of these surrogate endpoints in the trial...
2018: Pilot and Feasibility Studies
Blakely Brown, Kari Jo Harris, Daniel Heil, Michael Tryon, Aric Cooksley, Erin Semmens, James Davis, Krupa Gandhi
Background: Children living in rural areas are at higher risk for obesity compared to urban children, and Native American (NA) children have the highest prevalence of overweight/obesity for all races combined. Out-of-school programs (OOSPs) are a promising setting to improve children's health. Parents are important in supporting their child's obesity-related behaviors, yet it remains unclear what combination and dose of parent engagement strategies is feasible and optimal. This study's primary objective was to assess the feasibility of an OOSP and home-based obesity prevention intervention for rural NA and non-NA children...
2018: Pilot and Feasibility Studies
Paula Anne Newman-Casey, Leslie M Niziol, Chamisa K Mackenzie, Kenneth Resnicow, Paul P Lee, David C Musch, Michele Heisler
Background: About half of people with glaucoma do not adhere to their recommended medications. Interventions for other chronic conditions have successfully utilized reminder systems and motivational interviewing (MI)-based counseling. This study was designed to pilot a personalized intervention that leverages these strategies to assess their impact on medication adherence in glaucoma patients. Methods: Glaucoma patients taking ≥ 1 medication will be pre-screened by telephone survey for adherence to their medication(s)...
2018: Pilot and Feasibility Studies
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