-
Recommendations for optimising pilot and feasibility work in surgery Pilot Feasibility Stud. Pub Date : 2024-04-18 K. Fairhurst, S. Potter, J. M. Blazeby, K. N. L. Avery
Surgical trials are recognised as inherently challenging. Pilot and feasibility studies (PAFS) are increasingly acknowledged as a key method to optimise the design and conduct of randomised trials but remain limited in surgery. We used a mixed methods approach to develop recommendations for how surgical PAFS could be optimised. The findings from a quantitative analysis of funded surgical PAFS over
-
Online compassion-based self-help for depression in people with skin conditions: a feasibility study Pilot Feasibility Stud. Pub Date : 2024-04-16 Elaine N. Clarke, Paul Norman, Andrew R. Thompson
There is a need to develop psychological interventions for depression in people with skin conditions. This study aimed to investigate the acceptability, feasibility, and effects of an online compassion-based self-help intervention for depression in people with skin conditions. Adult participants (n = 34) with skin conditions and mild-moderate depressive symptoms were invited to undertake a six-week
-
A qualitative feasibility study of a prototype patient-centered video intervention to increase uptake of cancer genetic testing among Black Americans Pilot Feasibility Stud. Pub Date : 2024-04-11 Katherine Clegg Smith, Rachel Grob, Michelle McCullough, Betty May, Emily Warne, Amanda Matchette, Avonne E. Connor, Kala Visvanathan
Health advances due to developments in genomic medicine are unequally experienced in the USA; racial differences in the uptake of genetic testing are one factor in this disparity. In collaboration with Black patients and diverse health care providers, we are developing a patient-centered video intervention to increase cancer genetic testing among eligible Black Americans. The objective of the pilot
-
A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD) Pilot Feasibility Stud. Pub Date : 2024-04-10 Stanley Tang, Clare Akers, Hussain Alnajjar, Ben Ayres, Cinzia Baldini, Andrew Embleton-Thirsk, Kurinchi Gurusamy, Paul Hadway, Vivekanandan Kumar, Maurice Lau, Raj Nigam, Karl Pang, Arie Parnham, Elena Pizzo, Veronica Ranieri, Rowland Rees, Vijay Sangar, Anvi Wadke, Norman Williams, Asif Muneer
Penile cancer is a rare male genital malignancy. Surgical excision of the primary tumour is followed by radical inguinal lymphadenectomy if there is metastatic disease detected by biopsy, fine needle aspiration cytology (FNAC) or following sentinel lymph node biopsy in patients with impalpable disease. However, radical inguinal lymphadenectomy is associated with a high morbidity rate, and there is
-
Improving medication prescribing-related outcomes for vulnerable elderly in transitions on high-risk medications (IMPROVE-IT HRM): a pilot randomized trial protocol Pilot Feasibility Stud. Pub Date : 2024-04-10 Anne Holbrook, Dan Perri, Mitch Levine, Lawrence Mbuagbaw, Sarah Jarmain, Lehana Thabane, Jean-Eric Tarride, Lisa Dolovich, Sylvia Hyland, Victoria Telford, Jessyca Silva, Carmine Nieuwstraten
Seniors with recurrent hospitalizations who are taking multiple medications including high-risk medications are at particular risk for serious adverse medication events. We will assess whether an expert Clinical Pharmacology and Toxicology (CPT) medication management intervention during hospitalization with follow-up post-discharge and communication with circle of care is feasible and can decrease
-
Feasibility of diabetes self-management coaching program for individuals with type 2 diabetes in the Ethiopian primary care setting: a protocol for a feasibility mixed-methods parallel-group randomized controlled trial Pilot Feasibility Stud. Pub Date : 2024-04-08 Fikadu Ambaw Yehualashet, Dorothy Kessler, Segenet Bizuneh, Catherine Donnelly
Diabetes mellitus is the third most prevalent chronic metabolic disorder and a significant contributor to disability and impaired quality of life globally. Diabetes self-management coaching is an emerging empowerment strategy for individuals with type 2 diabetes, enabling them to achieve their health and wellness goals. The current study aims to determine the feasibility of a diabetes self-management
-
A feasibility study of mindfulness-based interventions for children Pilot Feasibility Stud. Pub Date : 2024-04-08 Wai Man Sin, Mimi Mun Yee Tse, Joanne Wai Yee Chung, Sandy Pin Pin Choi
Children’s overall psychological well-being is a concern for parents and adults worldwide. Mindfulness appears to be a promising intervention for enhancing children’s psychological well-being, and its effectiveness has been well-documented. However, there is a paucity of data on the feasibility and acceptability of implementing mindfulness-based interventions (MBIs) for children; this is a crucial
-
Consolidated guidance for behavioral intervention pilot and feasibility studies Pilot Feasibility Stud. Pub Date : 2024-04-06 Christopher D. Pfledderer, Lauren von Klinggraeff, Sarah Burkart, Alexsandra da Silva Bandeira, David R. Lubans, Russell Jago, Anthony D. Okely, Esther M. F. van Sluijs, John P. A. Ioannidis, James F. Thrasher, Xiaoming Li, Michael W. Beets
In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus
-
Implementation of an internet-based stress management program in micro- and small-sized enterprises: a study protocol for a pre-post feasibility study of the effectiveness-implementation hybrid type 2 trial Pilot Feasibility Stud. Pub Date : 2024-04-05 Natsu Sasaki, Taichi Shimazu, Hajime Takeno, Sayaka Ogawa, Utako Sawada, Akizumi Tsutsumi, Kotaro Imamura
Although internet-based stress management programs are proven effective in improving mental health among workers, micro- and small-sized enterprises (MSEs), lacking in occupational healthcare services, face challenges implementing them. To address this gap, this study will develop the program with stakeholders at MSEs to aim for real-world implementation. This paper describes a study protocol for a
-
Watch Me Play!: protocol for a feasibility study of a remotely delivered intervention to promote mental health resilience for children (ages 0–8) across UK early years and children’s services Pilot Feasibility Stud. Pub Date : 2024-04-04 Elizabeth Randell, Claire Nollett, Josie Henley, Kim Smallman, Sean Johnson, Lena Meister, Rachel McNamara, David Wilkins, Jeremy Segrott, Angela Casbard, Jenifer Wakelyn, Kathy McKay, Ekaterina Bordea, Vaso Totsika, Eilis Kennedy
Half of mental health problems are established by the age of 14 years and 75% by 24 years. Early intervention and prevention of mental ill health are therefore vitally important. However, increased demand over recent years has meant that access to child mental health services is often restricted to those in severest need. Watch Me Play! (WMP) is an early intervention designed to support caregiver attunement
-
Remotely prescribed and monitored home-based gait-and-balance therapeutic exergaming using augmented reality (AR) glasses: protocol for a clinical feasibility study in people with Parkinson’s disease Pilot Feasibility Stud. Pub Date : 2024-03-27 L. E. S. Hardeman, D. J. Geerse, E. M. Hoogendoorn, J. Nonnekes, M. Roerdink
Clinical guidelines for people with Parkinson’s disease (pwPD) stress that, complementary to pharmacological treatment, exercise and physiotherapy should be given a central role in disease management. Adhering to regular exercise of the right type, and with high repetition, remains a challenge for pwPD. Exergaming has the potential to increase adherence through play and personalised interventions,
-
Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK Pilot Feasibility Stud. Pub Date : 2024-03-26 K. Khan, C. L. Hall, C. Babbage, S. Dodzo, C. Greenhalgh, M. Lucassen, S. Merry, K. Sayal, K. Sprange, K. Stasiak, C. R. Tench, E. Townsend, P. Stallard, C. Hollis
A serious game called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), originally developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depression and anxiety in adolescents with mild to moderate depression in studies undertaken in Australasia. However, SPARX has never been trialled in the United Kingdom (UK)
-
Promoting hEalthy Diet and Active Lifestyle (PEDAL): a protocol for the development and feasibility study of a multicomponent intervention among primary school children in Singapore Pilot Feasibility Stud. Pub Date : 2024-03-23 Cindy Mei Jun Chan, Falk Müller-Riemenschneider, Michael Yong Hwa Chia, Zoe Jane-Lara Hildon, Mary Foong-Fong Chong
Setting healthy lifestyle habits during the formative years of childhood is critical as habits can track to adulthood and help prevent obesity and chronic disease risks in later life. While multicomponent interventions have been shown to be effective in changing the lifestyle behaviours of children, there is a limited understanding of the feasibility of such interventions in primary schools in Singapore
-
Developing and testing a produce prescription implementation blueprint to improve food security in a clinical setting: a pilot study protocol Pilot Feasibility Stud. Pub Date : 2024-03-23 Hannah E. Frank, Linda E. Guzman, Shivani Ayalasomayajula, Ariana Albanese, Brady Dunklee, Matthew Harvey, Kelly Bouchard, Maya Vadiveloo, Amy L. Yaroch, Kelli Scott, Alison Tovar
Food insecurity is common in the United States, especially in Rhode Island, where it affects up to 33% of residents. Food insecurity is associated with adverse health outcomes and disproportionally affects people from minoritized backgrounds. Produce prescription programs, in which healthcare providers write “prescriptions” for free or reduced cost vegetables, have been used to address food insecurity
-
Lifestyle counselling as secondary prevention in patients with minor stroke or transient ischemic attack: a randomized controlled pilot study Pilot Feasibility Stud. Pub Date : 2024-03-22 Jacob Liljehult, Stig Molsted, Tom Møller, Dorthe Overgaard, Thomas Christensen
Patients with minor stroke or transient ischemic attacks have an increased risk of future strokes. These patients are often discharged home with limited specialized follow-up, although close to half of them experience cognitive deficits. Simple encouragements to avoid smoking, be physically active, and to take preventive medication are often insufficient to ensure adherence and more comprehensive interventions
-
Feasibility of a physical activity intervention for children and adolescents with anxiety and depression Pilot Feasibility Stud. Pub Date : 2024-03-05 Arne Kodal, Fiona Muirhead, John J. Reilly, Gro Janne Wergeland, Paul Joachim Bloch Thorsen, Lars Peder Bovim, Irene Bircow Elgen
Physical activity is identified as a key modifiable factor towards good short- and long-term mental health and has shown positive effects on anxiety and depression in children and adolescents. However, physical activity-based interventions are not a part of standard mental health care and evidence on the effect of such interventions is still lacking. A transdiagnostic, physical activity-based intervention
-
Motiv8: a study protocol for a cluster-randomised feasibility trial of a weight management intervention for adults with severe mental illness in secure forensic services Pilot Feasibility Stud. Pub Date : 2024-03-02 Rebekah Carney, Hany El-Metaal, Heather Law, Siobhan Savage, Ingrid Small, Mark Hann, Gemma Shields, David Shiers, Parise Carmichael-Murphy, Richard Jones, Elizabeth Kimber, Andrew McDonald, Sophie Parker
People with severe mental illness have physical comorbidities which result in significant reductions in quality of life and premature mortality. Effective interventions are required that are suitable for people in secure forensic mental health services. We conducted pilot work of a multidisciplinary weight management intervention (Motiv8) which showed improvements in physical and mental health and
-
The Gestational Obesity Weight Management: Implementation of National Guidelines (GLOWING) study: a pilot cluster randomised controlled trial Pilot Feasibility Stud. Pub Date : 2024-03-01 Nicola Heslehurst, Catherine McParlin, Falko F. Sniehotta, Judith Rankin, Lisa Crowe, Elaine McColl
Pregnancy weight management interventions can improve maternal diet, physical activity, gestational weight gain, and postnatal weight retention. UK guidelines were published in 2010 but health professionals report multiple complex barriers to practice. GLOWING used social cognitive theory to address evidence-based barriers to midwives’ implementation of weight management guidelines into routine practice
-
A community-based advanced nurse practitioner-led integrated oncology care model for adults receiving oral anticancer medication: a pilot study Pilot Feasibility Stud. Pub Date : 2024-02-29 Janice P. Richmond, Mary Grace Kelly, Alison Johnston, Patrick J. Murphy, Laura O’Connor, Paddy Gillespie, Anna Hobbins, Alberto Alvarez-Iglesias, Andrew W. Murphy
Oral anti-cancer medications (OAMs) are being used increasingly within cancer care. OAMs offer the potential to improve patient convenience and increase hospital capacity. The clinical assessment for each cycle of OAMs requires specialist patient review often performed in hospital-based oncology units. Consequently, any potential improvement in patient expediency or increased hospital capacity that
-
Flexible bronchoscopy insufflated and high-flow nasal oxygen pilot trial (BUFFALO protocol pilot trial) Pilot Feasibility Stud. Pub Date : 2024-02-29 Susan Humphreys, Andreas Schibler, Tara Williams, Susan Spall, Trang Pham, Tiffany Atkins, Vikas Goyal, David Sommerfield, Aine Sommerfield, Adam Keys, Neil Hauser, Britta S von Ungern-Sternberg
Hypoxaemia occurs in approximately 30% of children during anaesthesia for flexible bronchoscopy. High-flow nasal oxygen (HFNO) can prolong safe apnoea time and be used in children with abnormal airways. During flexible bronchoscopy, there is limited evidence if HFNO confers advantages over current standard practice in avoiding hypoxaemia. The aim is to investigate feasibility of HFNO use during anaesthesia
-
Pragmatic Return to Effective Dental Infection Control through Triage and Testing (PREDICT): an observational, feasibility study to improve dental office safety Pilot Feasibility Stud. Pub Date : 2024-02-28 Janine Fredericks-Younger, Cecile A. Feldman, Veerasathpurush Allareddy, Ellen Funkhouser, MaryAnn McBurnie, Cyril Meyerowitz, Pat Ragusa, Julie Chapman-Greene, Modupe Coker, Daniel Fine, Maria Laura Gennaro, Gayathri Subramanian
During the COVID-19 pandemic, there was a substantial interruption of care, with patients and workers fearful to return to the dental office. As dental practice creates a highly aerosolized environment, the potential for spread of airborne illness is magnified. As a means to increase safety and mitigate risk, pre-visit testing for SARS-CoV-2 has the potential to minimize disease transmission in dental
-
Exercise therapy, education, and cognitive behavioral therapy alone, or in combination with total knee arthroplasty, in patients with knee osteoarthritis: a randomized feasibility study Pilot Feasibility Stud. Pub Date : 2024-02-28 Turid Rognsvåg, Ingvild Buset Bergvad, Ove Furnes, Kari Indrekvam, Anners Lerdal, Maren Falch Lindberg, Søren T Skou, Jan Stubberud, Mona Badawy
One in five patients experience chronic pain 1 year after total knee arthroplasty (TKA), highlighting the need for enhanced treatment strategies to improve outcomes. This feasibility trial aimed to optimize the content and delivery of a complex intervention tailored to osteoarthritis (OA) patients at risk of poor outcome after TKA and assess the feasibility of initiating a full-scale multicenter randomized
-
Protocol for a single-arm, pilot trial of creatine monohydrate supplementation in patients with Alzheimer’s disease Pilot Feasibility Stud. Pub Date : 2024-02-27 Matthew K. Taylor, Jeffrey M. Burns, In-Young Choi, Trent J. Herda, Phil Lee, Aaron N. Smith, Debra K. Sullivan, Russell H. Swerdlow, Heather M. Wilkins
Impaired brain bioenergetics is a pathological hallmark of Alzheimer’s disease (AD) and is a compelling target for AD treatment. Patients with AD exhibit dysfunction in the brain creatine (Cr) system, which is integral in maintaining bioenergetic flux. Recent studies in AD mouse models suggest Cr supplementation improves brain mitochondrial function and may be protective of AD peptide pathology and
-
Testing the feasibility of the QuitAid smoking cessation intervention in a randomized factorial design in an independent, rural community pharmacy Pilot Feasibility Stud. Pub Date : 2024-02-26 Melissa A. Little, Taylor Reid, Matthew Moncrief, Wendy Cohn, Kara P. Wiseman, Candace H. Wood, Wen You, Roger T. Anderson, Rebecca A. Krukowski
Adult smoking rates in the USA are highest in economically depressed rural Appalachia. Pharmacist-delivered tobacco cessation support that incorporates medication therapy management (such as the QuitAid intervention) is a promising approach to address this need. Twenty-four adult smokers recruited between September and November 2021 through an independent pharmacy in rural Appalachia were randomized
-
Physical activity self-efficacy online intervention for adults with obesity: protocol for a feasibility study Pilot Feasibility Stud. Pub Date : 2024-02-26 Seungmin Lee, Kevin Lahoda, Nicholas D. Myers, Andrew Horowitz, Kenneth Chiu, Lina Begdache, Eldad Einav
Even without weight loss, adults with obesity can greatly benefit from regular physical activity. The Physical Activity Self-efficacy (PAS) intervention is an online behavioral intervention newly developed to promote physical activity in adults with obesity by providing capability-enhancing learning opportunities. The objective of this manuscript is to describe the protocol for a feasibility study
-
Robot-assisted partial knee replacement versus standard total knee replacement (RoboKnees): a protocol for a pilot randomized controlled trial Pilot Feasibility Stud. Pub Date : 2024-02-21 Kim Madden, Breanne Flood, Monica Malek, Vincent Milantoni, Janie L. Astephen Wilson, Jean-Eric Tarride, Vickas Khanna, Anthony Adili
Total knee arthroplasty is a common surgery for end-stage knee osteoarthritis. Partial knee arthroplasty is also a treatment option for patients with arthritis present in only one or two knee compartments. Partial knee arthroplasty can preserve the natural knee biomechanics, but these replacements may not last as long as total knee replacements. Robotic-assisted orthopedic techniques can help facilitate
-
Group-based positive psychotherapy for people living with acquired brain injury: a protocol for a feasibility study Pilot Feasibility Stud. Pub Date : 2024-02-21 Zoe Fisher, Susannah Field, Deb Fitzsimmons, Hayley Hutchings, Kym Carter, Daniel Tod, Fergus Gracey, Alec Knight, Andrew H. Kemp
Acquired brain injury (ABI) and other chronic conditions are placing unprecedented pressure on healthcare systems. In the UK, 1.3 million people live with the effects of brain injury, costing the UK economy approximately £15 billion per year. As a result, there is an urgent need to adapt existing healthcare delivery to meet increasing current and future demands. A focus on wellbeing may provide an
-
A 10-week intergenerational program bringing together community-living older adults and preschool children (INTERACTION): a pilot feasibility non-randomised clinical trial Pilot Feasibility Stud. Pub Date : 2024-02-21 Mei Ling Lim, Christine Zammit, Ebony Lewis, Nicole Ee, Genevieve Maiden, Micah Goldwater, Eva Kimonis, Gail Kenning, Kenneth Rockwood, Anneke Fitzgerald, Katrina Radford, Hiroko Dodge, Stephanie A. Ward, Kim Delbaere, Ruth Peters
Social isolation and low levels of physical activity are strong drivers for frailty, which is linked to poor health outcomes and transition to long-term care. Frailty is multifactorial, and thus an integrated approach is needed to maintain older adults’ health and well-being. Intergenerational programs represent a novel multifactorial approach to target frailty, social isolation and physical decline
-
Feasibility study of Glucagon-like peptide-1 analogues for the optimization of Outcomes in obese patients undergoing AbLation for Atrial Fibrillation (GOAL-AF) protocol Pilot Feasibility Stud. Pub Date : 2024-02-21 Kyaw Z. Win, Matthew Armstrong, Richard P. Steeds, Manish Kalla
Catheter ablation for atrial fibrillation is recommended for symptomatic patients after failed medical therapy. Ablation has a higher failure rate in obese patients, and both the prevalence of atrial fibrillation and obesity are increasingly globally. The outcome of ablation can be improved if obese patients can achieve goal-oriented weight reduction prior to ablation. Conventional weight loss strategies
-
A crisis planning and monitoring intervention to reduce compulsory hospital readmissions (FINCH study): protocol for a randomised controlled feasibility study Pilot Feasibility Stud. Pub Date : 2024-02-20 Sonia Johnson, Mary Birken, Patrick Nyikavaranda, Ariana Kular, Rafael Gafoor, Jordan Parkinson, Chloe Hutchings-Hay, Thomas Gant, Jazmin Molai, Jessica Rivera, James Fenwick, Caroline Bendall, Louise Blakley, Theresa Bacarese-Hamilton, Valerie Christina White, Mark Keith Holden, Janet Seale, Jackie Hardy, Kathleen Lindsay Fraser, Lizzie Mitchell, Barbara Lay, Henrietta Mbeah-Bankas, Paul McCrone,
Rates of compulsory (also known as involuntary) detention under mental health legislation have been rising over several decades in countries including England. Avoiding such detentions should be a high priority given their potentially traumatic nature and departure from usual ethical principles of consent and collaboration. Those who have been detained previously are at high risk of being detained
-
A smartphone application to reduce problematic drinking: a feasibility trial Pilot Feasibility Stud. Pub Date : 2024-02-20 Christian Aljoscha Lukas, Jens Blechert, Matthias Berking
Problematic drinking is common among college students and associated with various somatic and mental health problems. Given significant evidence for the efficacy of smartphone-based interventions and the frequent use of smartphones among college students, it can be assumed that such interventions have great potential to facilitate access to evidence-based interventions for students suffering from problematic
-
Study protocol for the Screen-Free Time with Friends Feasibility Trial Pilot Feasibility Stud. Pub Date : 2024-02-19 Sarah Overgaard Sørensen, Kristian Traberg Larsen, Teresa Victoria Høy, Anders Blædel Gottlieb Hansen, Russell Jago, Peter Lund Kristensen, Mette Toftager, Anders Grøntved, Anne Kær Gejl
Children are spending less leisure time with their friends in person and an increasing amount of time with digital screens. These changes may negatively affect children’s physical and mental health. The Screen-Free Time with Friends Feasibility Trial will test the feasibility, including acceptability and compliance, of an intervention designed to reduce screen media usage and encourage physical interaction
-
Supporting physical activity through co-production in people with severe mental ill health (SPACES): protocol for a randomised controlled feasibility trial Pilot Feasibility Stud. Pub Date : 2024-02-17 Gareth Jones, Laura Bailey, Rebecca J. Beeken, Samantha Brady, Cindy Cooper, Robert J. Copeland, Suzanne Crosland, Sam Dawson, Matthew Faires, Simon Gilbody, Holly Haynes, Andrew Hill, Emily Hillison, Michelle Horspool, Ellen Lee, Jinshuo Li, Katarzyna K. Machaczek, Steve Parrott, Helen Quirk, Brendon Stubbs, Garry A. Tew, Gemma Traviss-Turner, Emily Turton, Lauren Walker, Stephen Walters, Scott Weich
Severe mental ill health (SMI) includes schizophrenia, bipolar disorder and schizoaffective disorder and is associated with premature deaths when compared to people without SMI. Over 70% of those deaths are attributed to preventable health conditions, which have the potential to be positively affected by the adoption of healthy behaviours, such as physical activity. People with SMI are generally less
-
Strong culture, healthy lifestyles: a mixed methods feasibility study for a co-created afterschool cultural programme for Australian Aboriginal children Pilot Feasibility Stud. Pub Date : 2024-02-15 Rebecca M. Stanley, Anthony McKnight, Yasmine Probst, Gabrielle O’Flynn, Sarah Tillott
Having a strong connection to culture and Country is fundamental to the health and wellbeing of Australian Aboriginal children. The aim of the research was to evaluate the feasibility of study methods and programme implementation of a co-created afterschool cultural programme, and identify areas for improvement. Aboriginal Relational Research Methodology and mixed methods were applied to evaluate the
-
Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): a protocol for a feasibility randomised controlled trial in patients undergoing total knee arthroplasty Pilot Feasibility Stud. Pub Date : 2024-02-15 Kim Madden, Sushmitha Pallapothu, Darren Young Shing, Anthony Adili, Mohit Bhandari, Lisa Carlesso, Moin Khan, Ydo V. Kleinlugtenbelt, Adrijana Krsmanovic, Matilda Nowakowski, Tara Packham, Eric Romeril, Jean-Eric Tarride, Lehana Thabane, Daniel M. Tushinski, Christine Wallace, Mitchell Winemaker, Harsha Shanthanna
Knee arthritis is a leading cause of limited function and long-term disability in older adults. Despite a technically successful total knee arthroplasty (TKA), around 20% of patients continue to have persisting pain with reduced function, and low quality of life. Many of them continue using opioids for pain control, which puts them at risk for potential long-term adverse effects such as dependence
-
PAM trial protocol: a randomised feasibility study of psychedelic microdosing–assisted meaning-centred psychotherapy in advanced stage cancer patients Pilot Feasibility Stud. Pub Date : 2024-02-12 Alesha Wells, A. P. Suresh Muthukumaraswamy, Eva Morunga, Will Evans, Alana Cavadino, Mahima Bansal, Nicola J. Lawrence, Amanda Ashley, Nicholas R. Hoeh, Frederick Sundram, Allison J. Applebaum, Hineatua Parkinson, Lisa Reynolds
An advanced cancer diagnosis can be associated with a significant profile of distress. Psychedelic compounds have shown clinically significant effects in the treatment of psychological distress in patients with advanced-stage cancer. Given the challenges of delivering timely and effective intervention in the advanced cancer context, it is possible that an alternative, more pragmatic, approach lies
-
Caring for caregivers and persons living with dementia under home-based primary care: protocol for an interventional clinical trial Pilot Feasibility Stud. Pub Date : 2024-02-09 Maimouna Sy, Ayush Thacker, Orla C. Sheehan, Bruce Leff, Christine Seel Ritchie
Approximately 7.5 million older adults are homebound, who have difficulty and/or need assistance to leave their homes. In this growing population, the prevalence of people living with dementia (PLWD) is approximately 50%. Current dementia care models in the USA were developed for traditional office-based primary care and have not been tailored to home-based primary care (HBPC) delivery models. Literature
-
Transcutaneous auricular vagus nerve stimulation for the treatment of myoarthropatic symptoms in patients with craniomandibular dysfunction – a protocol for a randomized and controlled pilot trial Pilot Feasibility Stud. Pub Date : 2024-02-08 Lea S. Prott, Frank A. Spitznagel, Alfons Hugger, Robert Langner, Petra C. Gierthmühlen, Mortimer Gierthmühlen
Temporomandibular disorders (TMD) are a collective term for pain and dysfunction of the masticatory muscles and the temporomandibular joints. The most common types of TMD are pain-related, which may impact the psychological behavior and quality of life. Currently, the most popular methods for the treatment of TMD patients are occlusal splint therapy, often in combination with physical- and/or pharmacotherapy
-
A feasibility (pilot) mixed methods study of an innovative non-pharmacological breath-based yoga and social-emotional intervention program in an at-risk youth sample in London, Canada Pilot Feasibility Stud. Pub Date : 2024-02-07 Akshya Vasudev, Emily Ionson, Janani Sathiaselan, Anurag Thatipalli, Aman Chauhan, Christine Hassan, Javeed Sukhera, Mark Speechley, Cheryl Forchuk
Various service provision models for youth at risk of homelessness have been researched and implemented, including access to housing and physical and mental health resources. However, even with these interventions, we remain unaware of how best to manage symptoms of depression and anxiety and the rate of drug use in these populations primarily because of a lack of feasibility data. This paper presents
-
Randomised controlled feasibility study protocol of the Carers-ID online intervention to support the mental health of family carers of people with intellectual disabilities Pilot Feasibility Stud. Pub Date : 2024-02-06 Mark A. Linden, Rachel Leonard, Trisha Forbes, Michael Brown, Lynne Marsh, Stuart Todd, Nathan Hughes, Maria Truesdale
Family carers play a crucial role in supporting the health and well-being of people with intellectual disabilities. Given their role and responsibilities, many family carers experience significant and ongoing stress and mental health difficulties. Programmes and interventions which provide training and support to family carers have been shown to have a positive impact on levels of stress and quality
-
Feasibility of a breath robot intervention to reduce sleep problems in posttraumatic stress disorder: protocol for a randomized controlled study Pilot Feasibility Stud. Pub Date : 2024-02-05 Annett Lotzin, Isabelle Laskowsky
Many patients with posttraumatic stress disorder (PTSD) suffer from sleep problems. Robot-based interventions might be an innovative approach to reduce sleep problems and hyperarousal in PTSD. However, the feasibility and effectiveness of a breath robot in patients with PTSD have never been empirically tested. The aim of this study is to investigate the feasibility of a breath robot to reduce sleep
-
Protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work IGLOo intervention Pilot Feasibility Stud. Pub Date : 2024-02-03 Oliver Davis, Jeremy Dawson, Lizzie Degerdon, Jaime Delgadillo, Umesh Kadam, Karina Nielsen, Alice Sinclair, Jo Yarker, Fehmidah Munir
Long-term sickness costs businesses in the United Kingdom (UK) approximately £7 billion per annum. Most long-term sickness absences are attributed to common mental health conditions, which are also highly prevalent in people with acute or musculoskeletal health conditions. This study will pilot the IGLOo (Individual, Group, Leaders, Organisation, overarching context) intervention which aims to support
-
Feasibility and acceptability of a contextualized physical activity and diet intervention for the control of hypertension in adults from a rural subdistrict: a study protocol (HYPHEN) Pilot Feasibility Stud. Pub Date : 2024-02-03 Kganetso Sekome, Francesc Xavier Gómez-Olivé, Lauren B. Sherar, Dale W. Esliger, Hellen Myezwa
In rural and remote South Africa, most strokes and ischaemic heart diseases are as a consequence of hypertension, which is a modifiable risk factor. The widely recommended therapeutic approaches to control hypertension are through physical activity and diet modifications. However, there is a lack of culturally sensitive community-based, lifestyle interventions to control hypertension among rural African
-
Lessons learned about development and assessment of feasibility of tools for health and rehabilitation services Pilot Feasibility Stud. Pub Date : 2024-02-02 Harsha Kathard, Rizwana Mallick, Tracey-lee Cloete, Anthea Hansen, Lehana Thabane
Given the dire need for health and rehabilitation services internationally, exacerbated during the COVID-19 pandemic, there is a critical need to develop tools to support service delivery. This need is palpable in the Global South where tools developed in Eurocentric contexts are not always adaptable, applicable, or relevant. It is for this reason that the researchers present three case studies of
-
A randomized trial evaluating the utility of non-targeted biopsies for colorectal neoplasia detection in adults with inflammatory bowel disease: a pilot study protocol Pilot Feasibility Stud. Pub Date : 2024-02-01 Sanjay K. Murthy, Luba Marderfeld, Dean Fergusson, Tim Ramsay, Charles N. Bernstein, Geoffrey C. Nguyen, Vipul Jairath, Robert Riddell
Persons with inflammatory bowel diseases are at increased risk of developing colorectal cancer and require frequent colonoscopy surveillance. Guidelines recommend taking 30 to 40 non-targeted biopsies throughout the colorectum to detect “invisible” neoplasia in this setting, despite a lack of evidence supporting this practice. We sought to assess the utility of this practice through a randomized controlled
-
Is it feasible to nest a Trial within a Cohort Study (TwiCS) to evaluate an early years parenting programme? A Born in Bradford’s Better Start study protocol Pilot Feasibility Stud. Pub Date : 2024-01-30 Kate E. Mooney, Charlie Welch, Kirsty Crossley, Tracey Bywater, John Wright, Josie Dickerson, Sarah Blower
Evaluating the effectiveness of early years parenting interventions provides evidence to improve the development and wellbeing of children. This protocol paper describes a study to explore the feasibility of evaluating the Incredible Years Toddler early life intervention programme, which is offered to parents of 1–3-year-olds via the Better Start Bradford programme. The study aims to use a Trial within
-
Correction: Development and testing the feasibility of a sports‑based mental health promotion intervention in Nepal: a protocol for a pilot cluster‑randomised controlled trial Pilot Feasibility Stud. Pub Date : 2024-01-29 Kelly Rose‑Clarke, Damodar Rimal, Joanna Morrison, Indira Pradhan, John Hodsoll, Gerard Abou Jaoude, Brian Moore, Louise Banham, Justin Richards, Mark Jordans, Audrey Prost, Nabin Lamichhane, Jaya Regmee, Kamal Gautam, Nagendra P. Luitel
Correction: Pilot Feasibility Stud 9, 149 (2023) https://doi.org/10.1186/s40814-023-01324-z Following publication of the original article [1], the authors wish to update the author list to include John Hodsoll, identified as JH in the original article. The original article [1] has been updated. Rose-Clarke K, Rimal D, Morrison J, et al. Development and testing the feasibility of a sports-based mental
-
Improving cardiovascular health in patients with an abdominal aortic aneurysm: development of the cardiovascular risk reduction in patients with aneurysms (CRISP) behaviour change intervention Pilot Feasibility Stud. Pub Date : 2024-01-29 Tom M. Withers, Colin J. Greaves, Matt J. Bown, Athanasios Saratzis
Abdominal aortic aneurysm (AAA) is an important cardiovascular health problem. Ultrasound screening is proven to reduce AAA mortality and programmes have been implemented in some healthcare systems. Those who are identified as having a small AAA in screening enter into a surveillance programme to monitor AAA size. Individuals in AAA surveillance are at elevated risk of cardiovascular events, which
-
Get Back, a person-centred digital programme targeting physical activity for patients undergoing spinal stenosis surgery—a study protocol of a randomized feasibility study Pilot Feasibility Stud. Pub Date : 2024-01-26 Emelie Karlsson, Rikard Hanafi, Helena Brisby, Andreas Fors, Mike Kemani, Håkan Hedman, Jo Nijs, Mari Lundberg
Spinal stenosis is the most common reason for elective spine surgery, and the cardinal symptom is leg pain and discomfort when walking. Patients with spinal stenosis have a decreased level of physical activity and thereby an increased risk of poor health. Get Back is a person-centred digital programme that strives to support patients being physically active after surgery. The aim is to explore if Get
-
Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D pilot): results of a feasibility randomised trial Pilot Feasibility Stud. Pub Date : 2024-01-25 Andrew J. Farmer, Julie Allen, Y. Kiera Bartlett, Peter Bower, Yuan Chi, David P. French, Bernard Gudgin, Emily Holmes, Robert Horne, Dyfrig A. Hughes, Louise Jones, Cassandra Kenning, Louise Locock, Jennifer McSharry, Lisa Miles, Nicola Newhouse, Rustam Rea, Stephanie Robinson, Lionel Tarassenko, Carmelo Velardo, Nicola Williams, Ly-Mee Yu
The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up
-
Doing research in non-specialist mental health services for children and young people: lessons learnt from a process evaluation of the ICALM (Interpersonal Counselling for Adolescent Low Mood) feasibility randomised controlled trial Pilot Feasibility Stud. Pub Date : 2024-01-23 Thando Katangwe-Chigamba, Jamie Murdoch, Paul Wilkinson, Viktoria Cestaro, Carys Seeley, Eirini Charami-Roupa, Tim Clarke, Aoife Dunne, Brioney Gee, Sharon Jarrett, Andrew Laphan, Susie McIvor, Richard Meiser-Stedman, Thomas Rhodes, Lee Shepstone, David A. Turner, Jon Wilson
The rising prevalence of adolescent mild depression in the UK and the paucity of evidence-based interventions in non-specialist sectors where most cases present, creates an urgent need for early psychological interventions. Randomised controlled trials (RCTs) are considered the gold standard for obtaining unbiased estimates of intervention effectiveness. However, the complexity of mental health settings
-
Characterising concurrent pain experience and dietary patterns in people with chronic musculoskeletal pain: a feasibility study protocol Pilot Feasibility Stud. Pub Date : 2024-01-22 Susan J. Ward, Alison M. Coates, Katherine L. Baldock, Carolyn Berryman, Alison M. Hill
Nutrition-related factors linked to pain chronicity and disability include weight status and dietary behaviours. Dietary patterns associated with concurrent pain episodes, however, remain poorly characterised. This paper outlines the protocol for a feasibility study that aims to characterise pain-related dietary and lifestyle behaviours in people experiencing chronic musculoskeletal pain. The study
-
The feasibility of an exercise intervention after robotic-assisted radical cystectomy for urinary bladder cancer, prior to the CanMoRe trial Pilot Feasibility Stud. Pub Date : 2024-01-22 Andrea Porserud, Patrik Karlsson, Malin Nygren-Bonnier, Markus Aly, Maria Hagströmer
Complications after radical cystectomy for urinary bladder cancer are common. Physical activity after surgery is thought to reduce complications. However, patients with urinary bladder cancer have low levels of physical activity, and interventions supporting physical exercise are needed. This study aimed to evaluate the feasibility of a physical exercise intervention in primary health care. One of
-
Protocol for evaluation of the feasibility and preliminary efficacy of a targeted transition readiness workshop intervention for pediatric brain tumor survivors Pilot Feasibility Stud. Pub Date : 2024-01-19 Marco Bonanno, Leandra Desjardins, Tziona Lugasi, Julie Carrier, Nathalie Labonté, Serge Sultan, Hallie Coltin, Sébastien Perrault, Carole Provost, Caroline Laverdière, Nancy Cloutier, Andrea Saragosti, Émilie Régnier-Trudeau, Benedicte Koukoui
Pediatric brain tumor survivors (PBTS) are at risk of physical, cognitive, and psychosocial challenges related to their diagnosis and treatment. Routine follow-up care as adults is therefore essential to their long-term health and quality of life. In order to successfully navigate to adult healthcare, it is recommended that youth develop transition readiness skills. Existing transition readiness interventions
-
Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study Pilot Feasibility Stud. Pub Date : 2024-01-17 Amy Corneli, Summer Starling, Yujung Choi, Jurgis Vosylius, Leanne Madre, Andrew Mackinnon, Pamela Tenaerts
The use of electronic informed consent (eIC) in decentralized trials offers a pragmatic approach to enrolling participants across multiple geographic areas. Using a randomized, cross-over study design, we conducted a qualitative descriptive evaluation of two eIC approaches—text-only eIC and enhanced eIC—in a mock hypertension Phase III clinical trial. We assessed participant comprehension and acceptability
-
SPiRIT study protocol (Shoulder Pain: Randomised trial of Injectable Treatments): a randomised feasibility and pilot study of autologous protein solution (APS) vs corticosteroids for treating subacromial shoulder pain Pilot Feasibility Stud. Pub Date : 2024-01-17 A. Howard, A. Woods, I. Rombach, J. Achten, D. Appelbe, A. Athwal, E. Jones, K. Draper, S. Gwilym
The management of subacromial shoulder pain represents a significant challenge and is typically managed through either physiotherapy, joint injection or surgical intervention. Recent surgical trials have questioned the efficacy and there is a need to improve the evidence base for the non-surgical management of this condition. The study aims to provide evidence of the feasibility of conducting a randomised
-
A single-subject research design evaluating a co-created yoga program for adults with gynecologic cancer: feasibility study protocol Pilot Feasibility Stud. Pub Date : 2024-01-16 Jenson Price, Jennifer Brunet
Worldwide, > 1.3 million adults are diagnosed with a gynecologic cancer each year, affecting their wellbeing and quality of life. This manuscript describes the protocol for a study that sought to assess the feasibility, acceptability, and fidelity of a community-based co-created yoga program and proposed evaluative methods, and estimate program effects on self-reported outcomes. Using a multiple baseline
-
Home-based cognitive bias modification training for reducing maladaptive fear in patients with suspected acute coronary syndrome: a pilot randomized clinical trial Pilot Feasibility Stud. Pub Date : 2024-01-11 David Lopez-Veneros, Robin Cumella, Ian M. Kronish, Amit Lazarov, Jeffrey L. Birk
Patients evaluated in an emergency department for suspected acute coronary syndromes (ACS; e.g., myocardial infarction) often experience a lingering fear of recurrence, which may adversely affect their mental health and adherence to recommended health behaviors. Cognitive bias modification training (CBMT) is an acceptable, easy-to-use intervention that reduces fear of recurrence in cancer patients
-
Describing skin health and disease in urban-living Aboriginal children: co-design, development and feasibility testing of the Koolungar Moorditj Healthy Skin pilot project Pilot Feasibility Stud. Pub Date : 2024-01-11 Bernadette M. Ricciardo, Heather-Lynn Kessaris, Noel Nannup, Dale Tilbrook, Brad Farrant, Carol Michie, Lorraine Hansen, Richelle Douglas, Jacinta Walton, Ainslie Poore, Alexandra Whelan, Timothy C. Barnett, Prasad S. Kumarasinghe, Jonathan R. Carapetis, Asha C. Bowen
Indigenous children in colonised nations experience high rates of health disparities linked to historical trauma resulting from displacement and dispossession, as well as ongoing systemic racism. Skin infections and their complications are one such health inequity, with the highest global burden described in remote-living Australian Aboriginal and/or Torres Strait Islander (hereafter respectfully referred
-
Correction: The feasibility of Technology, Application, Self-Management for Kidney (TASK) intervention in post-kidney transplant recipients using a pre/posttest design Pilot Feasibility Stud. Pub Date : 2024-01-10 Tara O’Brien, Karen Rose, Brian Focht, Noor Al Kahlout, Tad Jensen, Kenzie Heareth, Uday Nori, Reem Daloul
Correction: Pilot Feasibility Stud 9, 190 (2023) https://doi.org/10.1186/s40814-023-01417-9 Following publication of the original article [1], the authors identified an error in the author name of Uday Nori. The incorrect author name is: Uday Noir The correct author name is: Uday Nori The author group has been updated above and the original article [1] has been corrected. O’Brien T, Rose K, Focht B