Articles

Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial

Despite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding. Stress ulcer prophylaxis may have unintended consequences—...

Authors: Mark Duffett, Karen Choong, Jennifer Foster, Elaine Gilfoyle, Jacques Lacroix, Nikhil Pai, Lehana Thabane and Deborah J Cook

A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study)

Chronic tinnitus is a common incurable condition often associated with depression, anxiety, insomnia and reduced quality of life. Within National Health Service (NHS) audiology in the United Kingdom (UK), no s...

Authors: John A. Taylor, Deborah A. Hall, Dawn-Marie Walker, Mary McMurran, Amanda Casey, David Stockdale, Debbie Featherstone, Dean M. Thompson, Carol MacDonald and Derek J. Hoare

On Your Feet to Earn Your Seat: pilot RCT of a theory-based sedentary behaviour reduction intervention for older adults

Of all age groups, older adults spend most of the time sitting and are least physically active. This sequential, mixed-methods feasibility study used a randomised controlled trial design to assess methods for ...

Authors: Isabelle White, Lee Smith, Daniel Aggio, Sahana Shankar, Saima Begum, Raluca Matei, Kenneth R. Fox, Mark Hamer, Steve Iliffe, Barbara J. Jefferis, Nick Tyler and Benjamin Gardner

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam ar...

Authors: Hoa L. Nguyen, Jeroan J. Allison, Duc A. Ha, Germán Chiriboga, Ha N. Ly, Hanh T. Tran, Cuong K. Nguyen, Diem M. Dang, Ngoc T. Phan, Nguyen C. Vu, Quang P. Nguyen and Robert J. Goldberg

Erratum to: Progesterone supplementation for HIV-positive pregnant women on protease inhibitor-based antiretroviral regimens (the ProSPAR study): a study protocol for a pilot randomized controlled trial

Authors: Kaitlin Siou, Sharon L. Walmsley, Kellie E. Murphy, Janet Raboud, Mona Loutfy, Mark H. Yudin, Michael Silverman, Noor N. Ladhani, Eszter Papp and Lena Serghides

Injection versus Decompression for Carpal Tunnel Syndrome-Pilot trial (INDICATE-P)—protocol for a randomised feasibility study

Carpal tunnel syndrome (CTS) is the commonest peripheral nerve disorder in the UK, with over 52,996 carpal tunnel decompressions performed in 2011. By 2030, this figure is estimated to double. Whilst evidence ...

Authors: Will Mason, Daniel Ryan, Asif Khan, Hui-Ling Kerr, David Beard, Jonathan Cook, Ines Rombach and Cushla Cooper

A comparison of earlier and enhanced rehabilitation of mechanically ventilated patients in critical care compared to standard care (REHAB): study protocol for a single-site randomised controlled feasibility trial

Mortality from critical illness is improving, but survivors suffer from prolonged weakness and psychological and cognitive impairments. Maximising the recovery after critical illness has been highlighted as a ...

Authors: Catherine Snelson, Charlotte Jones, Gemma Atkins, James Hodson, Tony Whitehouse, Tonny Veenith, David Thickett, Emma Reeves, Aisling McLaughlin, Lauren Cooper and David McWilliams

Potentially effective therapy of heavy menstrual bleeding with an oestradiol-nomegestrol acetate oral contraceptive: a pilot study

Heavy menstrual bleeding (HMB) exceeding 80 mL per cycle leads to considerable adverse impact on a woman’s iron metabolism, incidence of iron deficiency and anaemia, as well as her functioning in society.

Authors: Edith Weisberg, Kevin McGeehan, Jane Hangan and Ian S Fraser

Feasibility of high-intensity interval training and moderate-intensity continuous training in adults with inactive or mildly active Crohn’s disease: study protocol for a randomised controlled trial

Structured exercise training has been proposed as a useful adjunctive therapy for Crohn’s disease by improving immune function and psychological health, reducing fatigue and promoting gains in muscle and bone ...

Authors: Garry A. Tew, Roger Carpenter, Michael Seed, Simon Anderson, Louise Langmead, Caroline Fairhurst and Lindsay Bottoms

Aquatic therapy for boys with Duchenne muscular dystrophy (DMD): an external pilot randomised controlled trial

Standard treatment of Duchenne muscular dystrophy (DMD) includes regular physiotherapy. There are no data to show whether adding aquatic therapy (AT) to land-based exercises helps maintain motor function. We a...

Authors: Daniel Hind, James Parkin, Victoria Whitworth, Saleema Rex, Tracey Young, Lisa Hampson, Jennie Sheehan, Chin Maguire, Hannah Cantrill, Elaine Scott, Heather Epps, Marion Main, Michelle Geary, Heather McMurchie, Lindsey Pallant, Daniel Woods…

Improving medication management for patients with multimorbidity in primary care: a qualitative feasibility study of the MY COMRADE implementation intervention

For the majority of patients with multimorbidity, the prescription of multiple long-term medications (polypharmacy) is indicated. However, polypharmacy poses a risk of adverse drug events, drug interactions an...

Authors: Carol Sinnott, Molly Byrne and Colin P. Bradley

Promoting adherence to treatment for latent TB infection through mobile phone text messaging: study protocol for a pilot randomized controlled trial

An estimated two billion people, over one third of the world’s population, have latent infection with Mycobacterium tuberculosis (LTBI). Patient adherence to LTBI treatment is currently poor given that individual...

Authors: Eyal Oren, Melanie L. Bell, Francisco Garcia, Carlos Perez-Velez and Lynn B. Gerald

A protocol for a cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination among girls

Uptake of the human papillomavirus (HPV) vaccine in the UK is good, but there are pockets of the community who remain unprotected. Immunisation teams usually require written parental consent for a girl to rece...

Authors: Alice S. Forster, Victoria Cornelius, Lauren Rockliffe, Laura A. V. Marlow, Helen Bedford and Jo Waller

A protocol for a feasibility randomised controlled trial to assess the difference between functional bracing and plaster cast for the treatment of ankle fractures

UK Hospital Episode Statistics 2013–2014 recorded 57,286 fractures of the lower limb including the ankle. This figure is expected to continue to increase due to a greater population of older adults. Following ...

Authors: Rebecca S. Kearney, Nick Parsons, Dipesh Mistry, Jonathan Young, Jaclyn Brown, Joanne O’Beirne-Elliman and Matthew Costa

The Herts and minds study: evaluating the effectiveness of mentalization-based treatment (MBT) as an intervention for children in foster care with emotional and/or behavioural problems: a phase II, feasibility, randomised controlled trial

A significant proportion of children in the social care system in England present with mental health problems, with the majority experiencing some form of emotional and behavioural difficulties. The most effec...

Authors: Nick Midgley, Sarah Jane Besser, Helen Dye, Pasco Fearon, Tim Gale, Kiri Jefferies-Sewell, Karen Irvine, Joyce Robinson, Solange Wyatt, David Wellsted and Sally Wood

Using brothel leadership to promote condom use among brothel-based female sex workers in Abuja, Nigeria: study protocol for a cluster randomized pilot trial

The HIV prevalence among female populations involved in sex work in Nigeria has heightened interest in HIV prevention programming for this sub-population with brothel-based female sex workers (BB FSWs) having ...

Authors: Uchenna Okafor, Rik Crutzen, Ifeanyi Okekearu, Sylvia Adebajo, Adaora Uzoh, Egbe Aneotah Awo, Chukwuemeka Chima, Ogechukwu Agwagwa and Bart van den Borne

Protocol for the evaluation of a digital storytelling approach to address stigma and improve readiness to seek services among veterans

Research suggests that at least 10% of veterans returning from Iraq and Afghanistan meet criteria for posttraumatic stress disorder (PTSD) related to their military experiences. National dissemination initiati...

Authors: Brian E. Bunnell, Tatiana M. Davidson, Jessica L. Hamblen, Danna L. Cook, Anouk L. Grubaugh, Brian E. Lozano, Peter W. Tuerk and Kenneth J. Ruggiero

Development and refinement of a complex intervention within cardiac rehabilitation services: experiences from the CADENCE feasibility study

Patients who experience a cardiac event are at higher risk of developing depression than the general population. Despite this, cardiac rehabilitation (CR) programmes do not provide a systematic approach to psy...

Authors: Rachel Winder, Suzanne H. Richards, John L. Campbell, David A. Richards, Chris Dickens, Manish Gandhi, Christine Wright and Katrina Turner

Evaluating the feasibility of a web-based weight loss programme for naval service personnel with excess body weight

Overweight and obesity are a major concern that may influence the operational capacity of the UK Naval Service (NS). This study was conducted to evaluate the feasibility of trialling and implementing a modifie...

Authors: Gulcan Garip, Kate Morton, Robert Bridger and Lucy Yardley

Developing and testing an electronic medication administration monitoring device for community dwelling seniors: a feasibility study

Medication non-adherence, polypharmacy, and adverse drug events are major healthcare issues leading to significant morbidity, mortality, and healthcare expenditures. Currently, there are no methods to systemat...

Authors: Henry Yu-Hin Siu, Dee Mangin, Michelle Howard, David Price and David Chan

How much will older adults exercise? A feasibility study of aerobic training combined with resistance training

Both aerobic training (AT) and resistance training (RT) have multidimensional health benefits for older adults including increased life expectancy and decreased risk of chronic diseases. However, the volume (i...

Authors: Ryan S. Falck, Jennifer C. Davis, Elizabeth Milosevic and Teresa Liu-Ambrose

Rapid analgesia for prehospital hip disruption (RAPID): protocol for feasibility study of randomised controlled trial

Adequate pain relief at the point of injury and during transport to hospital is a major challenge in all acute traumas, especially for those with hip fractures, whose injuries are difficult to immobilise and w...

Authors: Jenna K. Bulger, Alan Brown, Bridie A. Evans, Greg Fegan, Simon Ford, Katy Guy, Sian Jones, Leigh Keen, Ashrafunnesa Khanom, Ian Pallister, Nigel Rees, Ian T. Russell, Anne C. Seagrove and Helen A. Snooks

Comparing counselling alone versus counselling supplemented with guided use of a well-being app for university students experiencing anxiety or depression (CASELOAD): protocol for a feasibility trial

University counselling services face a unique challenge to offer short-term therapeutic support to students presenting with complex mental health needs and in a setting which suits the academic timetable. The ...

Authors: Emma Broglia, Abigail Millings and Michael Barkham

Distant delivery of a mindfulness-based intervention for people with Parkinson’s disease: the study protocol of a randomised pilot trial

Psychological difficulties, especially depression and anxiety, are the most prevalent non-motor symptoms in Parkinson’s disease. Pharmacological treatments for these conditions appear relatively ineffective in...

Authors: A. Bogosian, C. S. Hurt, D. Vasconcelos e Sa, J. V. Hindle, L. McCracken and P. Cubi-Molla

Smoking treatment optimisation in pharmacies (STOP): a cluster randomised pilot trial of a training intervention

UK government policy aims to strengthen the role of community pharmacies in health promotion. Thus, we conducted feasibility studies for an intervention to enhance delivery of the NHS Smoking Cessation Service.

Authors: V. W. Madurasinghe, Ratna Sohanpal, Wai James, Liz Steed, Sandra Eldridge, SJC Taylor, C. Griffiths and Robert Walton

Lifestyle intervention in BRCA1/2 mutation carriers: study protocol for a prospective, randomized, controlled clinical feasibility trial (LIBRE-1 study)

Women with highly penetrant BRCA mutations have a 55–60% lifetime risk for breast cancer and a 16–59% lifetime risk for ovarian cancer. However, penetrance differs interindividually, indicating that environmen...

Authors: Marion Kiechle, Christoph Engel, Anika Berling, Katrin Hebestreit, Stephan Bischoff, Ricarda Dukatz, Wolf-Dieter Gerber, Michael Siniatchkin, Katharina Pfeifer, Sabine Grill, Maryam Yahiaoui-Doktor, Ellen Kirsch, Uwe Niederberger, Nicole Marter, Ute Enders, Markus Löffler…

The curious case of an internal pilot in a multicentre randomised trial—time for a rethink?

Multicentre randomised trials are complex projects with many operational uncertainties. The embedding of a formal check upon study progress and viability at a pre-specified time point (sometimes referred to as...

Authors: Jonathan Alistair Cook, David John Beard, Johanna Rosemary Cook and Graeme Stewart MacLennan

Evaluating acupuncture and standard care for pregnant women with back pain: the EASE Back pilot randomised controlled trial (ISRCTN49955124)

Low back pain (LBP) and pelvic girdle pain (PGP) during pregnancy are common and often accepted as a ‘normal’ part of pregnancy. Many women receive little in the way of treatment, and yet pain interferes with ...

Authors: Annette Bishop, Reuben Ogollah, Bernadette Bartlam, Panos Barlas, Melanie A. Holden, Khaled M. Ismail, Sue Jowett, Martyn Lewis, Alison Lloyd, Christine Kettle, Jesse Kigozi and Nadine E. Foster

Investigating the differential impact of school and community-based integrated control programmes for soil-transmitted helminths in Timor-Leste: the (S)WASH-D for Worms pilot study protocol

Water, sanitation and hygiene (WASH) interventions represent an important component of soil-transmitted helminth (STH) infection control, alongside the administration of anthelmintic drugs, which are generally...

Authors: Naomi E. Clarke, Archie C. A. Clements, Stuart Bryan, John McGown, Darren Gray and Susana V. Nery

Assessing the feasibility of injectable growth-promoting therapy in Crohn’s disease

Despite optimal therapy, many children with Crohn’s disease (CD) experience growth retardation.

Authors: Mabrouka A. Altowati, Ashley P. Jones, Helen Hickey, Paula R. Williamson, Farah M. Barakat, Nicolene C. Plaatjies, Ben Hardwick, Richard K. Russell, Thomas Jaki, S. Faisal Ahmed and Ian R. Sanderson

Update to a protocol for a feasibility cluster randomised controlled trial of a peer-led school-based intervention to increase the physical activity of adolescent girls (PLAN-A)

Physical activity levels are low amongst adolescent girls, and this population faces specific barriers to being active. Peer influences on health behaviours are important in adolescence, and peer-led intervent...

Authors: Simon J. Sebire, Mark J. Edwards, Rona Campbell, Russell Jago, Ruth Kipping, Kathryn Banfield, Bryar Kadir, Kirsty Garfield, Ronan A. Lyons, Peter S. Blair and William Hollingworth

Evaluation of the effectiveness of music therapy in improving the quality of life of palliative care patients: a randomised controlled pilot and feasibility study

Music therapy is frequently used as a palliative therapy. In consonance with the goals of palliative care, the primary aim of music therapy is to improve people’s quality of life by addressing their psychologi...

Authors: Tracey McConnell, Lisa Graham-Wisener, Joan Regan, Miriam McKeown, Jenny Kirkwood, Naomi Hughes, Mike Clarke, Janet Leitch, Kerry McGrillen and Sam Porter

Trial of Optimal Personalised Care After Treatment for Gynaecological cancer (TOPCAT-G): a study protocol for a randomised feasibility trial

Gynaecological cancers are diagnosed in over 1000 women in Wales every year. We estimate that this is costing the National Health Service (NHS) in excess of £1 million per annum for routine follow-up appointme...

Authors: Kirstie Pye, Nicola Totton, Nicholas Stuart, Rhiannon Whitaker, Val Morrison, Rhiannon Tudor Edwards, Seow Tien Yeo, Laura J. Timmis, Caryl Butterworth, Liz Hall, Tekendra Rai, Zoe Hoare, Richard D. Neal, Clare Wilkinson and Simon Leeson

Development and feasibility testing of an intervention to support active lifestyles in youths with type 1 diabetes—the ActivPals programme: a study protocol

The global incidence of type 1 diabetes is rising, and youths with type 1 diabetes continue to suffer poorer health than peers without diabetes. Evidence suggests youths with type 1 diabetes have physical acti...

Authors: Fiona Mitchell, Alison Kirk, Kenneth Robertson and John J. Reilly

Lifestyle change in the cancer setting using ‘the teachable moment’: protocol for a proof-of-concept pilot in a urology service

Previous research has shown diagnosis or screening for cancer may be a ‘teachable moment’ for prevention through lifestyle change. Previous trials have been successful but have been delivered via national prog...

Authors: Alyssa Sara Lee, Gozde Ozakinci, Steve Leung, Gerry Humphris, Hannah Dale and Neil Hamlet

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we pr...

Authors: Sandra M. Eldridge, Claire L. Chan, Michael J. Campbell, Christine M. Bond, Sally Hopewell, Lehana Thabane and Gillian A. Lancaster

Revie ⊕: the influence of a life review intervention including a positive, patient-centered approach towards enhancing the personal dignity of patients with advanced cancer—a study protocol for a feasibility study using a mixed method investigation

It is generally recognized that existential concerns must be addressed to promote the dignity of patients with advanced cancer. A number of interventions have been developed in this regard, such as dignity the...

Authors: Maria Goreti Da Rocha Rodrigues, Sophie Pautex and Maya Shaha

Survivors of intensive care with type 2 diabetes and the effect of shared care follow-up clinics: study protocol for the SWEET-AS randomised controlled feasibility study

Many patients who survive the intensive care unit (ICU) experience long-term complications such as peripheral neuropathy and nephropathy which represent a major source of morbidity and affect quality of life a...

Authors: Yasmine Ali Abdelhamid, Liza Phillips, Michael Horowitz and Adam Deane

Implementing resilience engineering for healthcare quality improvement using the CARE model: a feasibility study protocol

Resilience engineering (RE) is an emerging perspective on safety in complex adaptive systems that emphasises how outcomes emerge from the complexity of the clinical environment. Complexity creates the need for...

Authors: J. E. Anderson, A. J. Ross, J. Back, M. Duncan, P. Snell, K. Walsh and P. Jaye

Developing the ‘gripes’ tool for junior doctors to report concerns: a pilot study

Junior doctors often have concerns about quality and safety but show low levels of engagement with incident reporting systems. We aimed to develop and pilot a web-based reporting tool for junior doctors to pro...

Authors: S. Carr, T Mukherjee, A. Montgomery, M. Durbridge and C. Tarrant

Measuring prefrontal cortical activity during dual task walking in patients with Parkinson’s disease: feasibility of using a new portable fNIRS device

Many patients with Parkinson’s disease (PD) have difficulties in performing a second task during walking (i.e., dual task walking). Functional near-infrared spectroscopy (fNIRS) is a promising approach to stud...

Authors: Freek Nieuwhof, Miriam F. Reelick, Inbal Maidan, Anat Mirelman, Jeffrey M. Hausdorff, Marcel G.M. Olde Rikkert, Bastiaan R. Bloem, Makii Muthalib and Jurgen A.H.R. Claassen

Can a mindfulness-informed intervention reduce aggressive behaviour in people with intellectual disabilities? Protocol for a feasibility study

Approximately 10–20 % of adults with intellectual disabilities engage in challenging behaviours such as aggression, destructiveness, and self-injury, which are often accompanied by feelings of anger. The inabi...

Authors: Gemma Maria Griffith, Robert Jones, Richard Patrick Hastings, Rebecca S. Crane, Judith Roberts, Jonathan Williams, Lucy Bryning, Zoe Hoare and Rhiannon Tudor Edwards

Using mobile health technology to improve behavioral skill implementation through homework in evidence-based parenting intervention for disruptive behavior disorders in youth: study protocol for intervention development and evaluation

Disruptive behavior disorders (DBDs) (oppositional defiant disorder (ODD) and conduct disorder (CD)) are prevalent, costly, and oftentimes chronic psychiatric disorders of childhood. Evidence-based interventio...

Authors: Anil Chacko, Andrew Isham, Andrew F. Cleek and Mary M. McKay

The safety climate in primary care (SAP-C) study: study protocol for a randomised controlled feasibility study

Research on patient safety has focused largely on secondary care settings, and there is a dearth of knowledge relating to safety culture or climate, and safety climate improvement strategies, in the context of...

Authors: Sinéad Lydon, Margaret E. Cupples, Nigel Hart, Andrew W. Murphy, Aileen Faherty and Paul O’Connor

Using Specialist Screening Practitioners (SSPs) to increase uptake of the Bowel Scope (Flexible Sigmoidoscopy) Screening Programme: a study protocol for a feasibility single-stage phase II trial

The NHS Bowel Scope Screening (BSS) programme offers men and women aged 55 years a once-only flexible sigmoidoscopy (FS), a test that can help reduce colorectal cancer (CRC) incidence and mortality. However, t...

Authors: Lesley M. McGregor, Hanna Skrobanski, Hayley Miller, Mary Ritchie, Lindy Berkman, Stephen Morris, Colin Rees and Christian von Wagner

Erratum to: The SABRTooth feasibility trial protocol: a study to determine the feasibility and acceptability of conducting a phase III randomised controlled trial comparing stereotactic ablative radiotherapy (SABR) with surgery in patients with peripheral stage I non-small cell lung cancer (NSCLC) considered to be at higher risk of complications from surgical resection

Authors: M. P. Snee, L. McParland, F. Collinson, C. M. Lowe, A. Striha, D. R. Baldwin, B. Naidu, D. Sebag-Montefiore, W. M. Gregory, J. Bestall, J. Hewison, S. Hinsley and K. N. Franks

Protecting children from secondhand smoke: a mixed-methods feasibility study of a novel smoke-free home intervention

Globally, 40 % of children under 14 years are regularly exposed to secondhand smoke (SHS), typically in their homes. There is limited evidence of the effectiveness of interventions to reduce children’s SHS exp...

Authors: John Marsh, Ann McNeill, Sarah Lewis, Tim Coleman, Manpreet Bains, Alexandra Larwood, Jacqueline Purdy and Laura L Jones

Feasibility and acceptance of exercise recommendations (10,000 steps a day) within routine German health check (Check-Up 35/GOÄ29)—study protocol

Benefits of exercise to prevent non-communicable diseases are well-documented. Limited data exists to promote physical activity in healthy but sedentary and/or overweight people. Brief interventions within rou...

Authors: Christine Graf, Stefanie Schlepper, Carina Bauer, Nina Ferrari, Stefan Frank, Lena Gartner, Svenja Gehring, Rudolf Henke, Walter Lehmacher, Hans-Michael Steffen, Sabine Schindler-Marlow and Katharina Sternal

The feasibility and acceptability of trial procedures for a pragmatic randomised controlled trial of a structured physical activity intervention for people diagnosed with colorectal cancer: findings from a pilot trial of cardiac rehabilitation versus usual care (no rehabilitation) with an embedded qualitative study

Pilot and feasibility work is conducted to evaluate the operational feasibility and acceptability of the intervention itself and the feasibility and acceptability of a trials’ protocol design. The Cardiac Reha...

Authors: Gill Hubbard, Ronan O’Carroll, Julie Munro, Nanette Mutrie, Sally Haw, Helen Mason and Shaun Treweek

Repetitive arm functional tasks after stroke (RAFTAS): a pilot randomised controlled trial

Repetitive functional task practise (RFTP) is a promising treatment to improve upper limb recovery following stroke. We report the findings of a study to determine the feasibility of a multi-centre randomised ...

Authors: Lianne Brkic, Lisa Shaw, Frederike van Wijck, Richard Francis, Christopher Price, Anne Forster, Peter Langhorne, Caroline Watkins and Helen Rodgers