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Pilot and Feasibility Studies

Anne Purcell, Thomas Buckley, Jennie King, Wendy Moyle, Andrea P Marshall
Background: The physical, occupational, social and psychological impact of chronic leg ulcers (CLUs) on an individual is considerable. Wound-related pain (WRP), the most common symptom, is frequently reported as moderate to severe and mostly occurs at dressing change. WRP pain may not be alleviated by oral analgesics alone. Persistent poorly controlled leg ulcer pain can negatively impact wound healing and health-related quality of life (HRQoL). Methods: A pilot, parallel group, non-blinded, randomised controlled trial was conducted in six procedure clinics located in a public community nursing service in New South Wales, Australia to evaluate eutectic mixture of local anaesthetics (EMLA®) on painful CLUs when used as a primary dressing...
2018: Pilot and Feasibility Studies
Karen Cardwell, B Clyne, F Moriarty, E Wallace, T Fahey, F Boland, L McCullagh, S Clarke, K Finnigan, M Daly, M Barry, S M Smith
Background: Prescribing for patients taking multiple medicines (i.e. polypharmacy) is challenging for general practitioners (GPs). Limited evidence suggests that the integration of pharmacists into the general practice team could improve the management of these patients. The aim of this study is to develop and test an intervention involving pharmacists, working within GP practices, to optimise prescribing in Ireland, which has a mixed public and private primary healthcare system. Methods: This non-randomised pilot study will use a mixed-methods approach...
2018: Pilot and Feasibility Studies
Victoria Pile, Patrick Smith, Mary Leamy, Simon E Blackwell, Richard Meiser-Stedman, Dominic Stringer, Elizabeth G Ryan, Barnaby D Dunn, Emily A Holmes, Jennifer Y F Lau
Background: Adolescent depression is common and impairing. There is an urgent need to develop early interventions to prevent depression becoming entrenched. However, current psychological interventions are difficult to access and show limited evidence of effectiveness. Schools offer a promising setting to enhance access to interventions, including reducing common barriers such as time away from education. Distressing negative mental images and a deficit in positive future images, alongside overgeneral autobiographical memories, have been implicated in depression across the lifespan, and interventions targeting them in adults have shown promise...
2018: Pilot and Feasibility Studies
Elizabeth Gibbons, Ray Fitzpatrick
Background: Obtaining patients' views of their health and outcomes of interventions utilising patient-reported outcome measures (PROMs) is a well-established method, but there is still uncertainty about the impact of PROMs on services and patient care. Studies are now needed of alternative ways of implementing PROMs. This paper describes a case study of the introduction of a new PROM to assess musculoskeletal (MSK) problems, known as the Musculoskeletal Health Questionnaire (MSK-HQ). Methods: Following an invitation from the Arthritis Research UK (ARUK), 11 groups and organisations agreed to become 'partners' in piloting the MSK-HQ...
2018: Pilot and Feasibility Studies
Frouke A P Nijhuis, Glyn Elwyn, Bastiaan R Bloem, Bart Post, Marjan J Faber
Background: In advanced stages of Parkinson's disease (PD), patients and neurologists regularly face complex treatment decisions. Shared decision-making (SDM) can support the process where evidence, the clinician's expertise and the patient's preferences jointly contribute to reach an optimal decision. Here, we describe the rationale of our feasibility study protocol.The aim of the study is to test the feasibility of the SDM intervention by (1) analysing the acceptability of the intervention by users (i...
2018: Pilot and Feasibility Studies
Liam G Glynn, Alaa Mustafa, Monica Casey, Janusz Krawczyk, Jeanete Blom, Rose Galvin, Ailish Hannigan, Colum P Dunne, Andrew W Murphy, Christian Mallen
Background: Platelet-rich plasma (PRP) is a concentrate of autologous blood growth factors which has been shown to provide some symptomatic relief in early osteoarthritis (OA) of the knee. The objective of this study was to test the feasibility and efficacy potential of platelet rich plasma (PRP) in primary care. Methods: Feasibility study to assess safety of the intervention procedures and assess primary and secondary outcome measures. Consecutive patients presenting with symptomatic knee OA were recruited in a primary care setting in Ireland...
2018: Pilot and Feasibility Studies
Rachel Pozzar, Laura-Mae Baldwin, Barbara A Goff, Donna L Berry
Background: Ovarian cancer is the deadliest gynecologic malignancy and the fifth leading cause of cancer death among women living in the USA. Treatment for ovarian cancer that follows the guidelines published by the National Comprehensive Cancer Network is associated with a 33% decrease in disease-specific mortality, yet fewer than 40% of women with ovarian cancer receive guideline-adherent treatment. Little is known about the process by which women with ovarian cancer, their unpaid caregivers, and physicians make decisions about ovarian cancer treatment...
2018: Pilot and Feasibility Studies
Susan O'Connell, Robert Palmer, Kathleen Withers, Neeleem Saha, Sarah Puntoni, Grace Carolan-Rees
Background: The patient-reported outcome measures (PROMs), patient-reported experience measure (PREMs) and Effectiveness Programme (PPEP) launched with the aim of supporting all National Health Service Wales (NHS Wales) organisations to collect PROMs and PREMs across a range of conditions. The aim is to collect generic and condition-specific PROMs and PREMs electronically from every secondary care patient in Wales to provide a measure that can be used to determine the clinical and cost-effectiveness of treatments and services...
2018: Pilot and Feasibility Studies
Leonor Corsino, Cynthia J Coffman, Catherine Stanwyck, Eugene Z Oddone, Hayden B Bosworth, Ranee Chatterjee, Amy S Jeffreys, Rowena J Dolor, Kelli D Allen
Background: Arthritis affects approximately 50 million adults in the USA. Hispanics/Latinos have a higher prevalence of arthritis-attributed activity limitations primarily related to osteoarthritis (OA). Hispanic/Latinos are less likely to receive hip replacement independent of health care access, and they are less likely to receive knee replacement. There have been few interventions to improve OA treatment among the Hispanic/Latino population in the USA. In our study, we aimed to develop and test a telephone delivered culturally appropriate Spanish behavioral intervention for the management of OA in Hispanic/Latino adults...
2018: Pilot and Feasibility Studies
C L Downey, J Croft, H Buckley, R Randell, J M Brown, D G Jayne
Background: Despite medical advances, major surgery remains high risk. Up to 44% of patients experience postoperative complications, which can have huge impacts for patients and the healthcare system. Early recognition of postoperative complications is crucial in reducing morbidity and preventing long-term disability. The current standard of care is intermittent manual vital signs monitoring, but new wearable remote monitors offer the benefits of continuous vital signs monitoring without limiting the patient's mobility...
2018: Pilot and Feasibility Studies
Patricia Holch, Simon Pini, Ann M Henry, Susan Davidson, Jacki Routledge, Julia Brown, Kate Absolom, Alexandra Gilbert, Kevin Franks, Claire Hulme, Carolyn Morris, Galina Velikova
Background: An estimated 17,000 patients are treated annually in the UK with radical radiotherapy (RT) for pelvic cancer. New treatment approaches in RT have increased survivorship and changed the subjective toxicity profile for patients who experience acute and long-term pelvic-related adverse events (AE). Multi-disciplinary follow-up creates difficulty for monitoring and responding to these events during treatment and beyond. Originally developed for use in systemic oncology therapy eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an online system for patients to report AEs from home...
2018: Pilot and Feasibility Studies
Miriam B Vos, Ran Jin, Juna V Konomi, Rebecca Cleeton, Jessica Cruz, Saul Karpen, Dellys Soler Rodriguez, Jennifer K Frediani, Courtney McCracken, Jean Welsh
Background: Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in children, and currently, there are no FDA-approved therapies. Plasminogen activator inhibitor-1 (PAI-1) is elevated in children with NAFLD and associated with increased disease severity. Losartan potassium (losartan) is an angiotensin II receptor blocker (ARB) that reduces PAI-1 production and improves insulin sensitivity that has been proposed as a treatment for pediatric NAFLD but has not previously been tested...
2018: Pilot and Feasibility Studies
Linda Irvine, Ambrose J Melson, Brian Williams, Falko F Sniehotta, Gerry Humphris, Iain K Crombie
Background: Socially disadvantaged men are at high risk of suffering from alcohol-related harm. Disadvantaged groups are less likely to engage with health promotion. There is a need for interventions that reach large numbers at low cost and which promote high levels of engagement with the behaviour change process. The aim of this study was to design a theoretically and empirically based text message intervention to reduce binge drinking by socially disadvantaged men. Results: Following MRC guidance, the intervention was developed in four stages...
2018: Pilot and Feasibility Studies
N Courtier, S Gaze, J Armes, A Smith, L Radley, J Armytage, M Simmonds, A Johnson, T Gambling, J Hopkinson
Background: Fatigue is rated as the most distressing side effect of radiotherapy treatment for curable breast cancer. About four in ten women treated experience fatigue, which can last for years after treatment. The impact of this debilitating tiredness is loss of independence and impaired physical and mental function. Our study will take a behavioural intervention with demonstrated effect in treating fatigue in a mixed group of chemotherapy patients and adapt it for women undergoing radiotherapy for early breast cancer...
2018: Pilot and Feasibility Studies
H Waterman, S Bull, M Shaw, C Richardson
Background: Globally, glaucoma is the leading cause of irreversible blindness. However, many patients with glaucoma do not understand their disease which reportedly impacts on their ability to manage their condition successfully. The aim of this feasibility study was to undertake research to inform a future randomised controlled trial of the effectiveness of group-based education for patients to improve adherence to glaucoma eyedrops. Methods: Key objectives were to understand current provision of information during routine nurse-led glaucoma consultations, to investigate if it is possible to deliver patient information in line with a clinical standard by training nurses to deliver group-based education in multiple hospital sites and to explore the acceptability of group-based education to nurses and patients compared with usual information provision in consultations...
2018: Pilot and Feasibility Studies
Jenna P Breckenridge, Carla Gianfrancesco, Nicole de Zoysa, Julia Lawton, David Rankin, Elizabeth Coates
Background: Randomised controlled trials (RCTs) of complex interventions often begin with a pilot phase to test the proposed methods and refine the intervention before it is trialled. Although the Medical Research Council (MRC) recommends regular communication between the practitioners delivering the intervention and the researchers evaluating it during the pilot phase, there is a lack of practical guidance about how to undertake this aspect of pre-trial work. This paper describes a novel structured process for collaborative working, which we developed to iteratively refine a complex intervention prior to an RCT...
2018: Pilot and Feasibility Studies
Patrick J Murphy, Chris Noone, Maureen D'Eath, Dympna Casey, Sally Doherty, Tiny Jaarsma, Andrew W Murphy, Martin O'Donnell, Noeleen Fallon, Paddy Gillespie, Amirhossein Jalali, Jenny Mc Sharry, John Newell, Elaine Toomey, Elaine E Steinke, Molly Byrne
Background: Many people living with cardiovascular disease (CVD) are affected by sexual problems associated with the condition. International guidelines recommend all patients with CVD should receive sexual counselling, yet this is rarely provided by health professionals. The current study piloted the Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention, a complex multi-level intervention designed to increase the implementation of sexual counselling guidelines in hospital-based cardiac rehabilitation (CR) in Ireland...
2018: Pilot and Feasibility Studies
Dorota Juszczyk, Fiona Gillison
Background: Improving diet as a means of reducing the development of disease states and obesity is a public health priority. Although a growing number of countries have adopted policies to improve dietary patterns at the population level, as yet there are no established means of successfully bringing about change, suggesting that new approaches are needed. This study aimed to investigate the feasibility and proof of concept of a theoretically informed healthy eating intervention based on the model of successful month-long alcohol reduction or stop smoking campaigns (i...
2018: Pilot and Feasibility Studies
Fiona Lugg-Widger, Rebecca Cannings-John, Lianna Angel, Gwenllian Moody, Jeremy Segrott, Joyce Kenkre, Michael Robling
Background: Follow-up for public health trials may benefit from greater use of routine data. Our trial of a home-visiting intervention for first-time teenage mothers assessed outcomes to the child's second birthday. To examine its medium-term impact, particularly upon maltreatment outcomes, we designed a study using routine records. Methods: We aimed to establish the feasibility of our study design, which combines trial data with routine health, social care and education data using a dissent-based linkage model...
2018: Pilot and Feasibility Studies
Donna M Evon, Carol E Golin, Rachel Ruffin, Shauna Ayres, Michael W Fried
Background: Patients with chronic hepatitis C virus (HCV) experience reduced quality of life, HCV-associated symptoms, comorbid conditions, and treatment side effects. The Cognitive Behavioral Coping Skills group intervention for HCV (CBCS-HCV) was developed using the Stage Model of Behavioral Therapies Research. Intervention development and initial feasibility testing in wave 1 participants were previously reported. The primary objective of this subsequent pilot with wave 2-3 participants was to investigate the effect sizes and clinical improvements in patient-reported outcomes (PROs) and trial and intervention feasibility...
2018: Pilot and Feasibility Studies
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