Articles

Measuring skin necrosis in a randomised controlled feasibility trial of heat preconditioning on wound healing after reconstructive breast surgery: study protocol and statistical analysis plan for the PREHEAT trial

Essential strategies are needed to help reduce the number of post-operative complications and associated costs for breast cancer patients undergoing reconstructive breast surgery. Evidence suggests that local ...

Authors: Suzie Cro, Saahil Mehta, Jian Farhadi, Billie Coomber and Victoria Cornelius

A randomised feasibility study to investigate the impact of education and the addition of prompts on the sedentary behaviour of office workers

Office workers have been identified as being at risk of accumulating high amounts of sedentary time in prolonged events during work hours, which has been associated with increased risk of a number of long-term...

Authors: Catriona O’Dolan, Margaret Grant, Maggie Lawrence and Philippa Dall

A feasibility study of a randomised controlled trial to examine the impact of the ABCDE bundle on quality of life in ICU survivors

Early rehabilitation has been found to prevent delirium and weakness that can hamper the recovery of intensive care unit (ICU) survivors. Integrated clinical practice guidelines for managing patient pain, agit...

Authors: Kellie Sosnowski, Marion L. Mitchell, Hayden White, Lynette Morrison, Joanne Sutton, Jessica Sharratt and Frances Lin

Research protocol: investigating the feasibility of a group self-management intervention for stroke (the GUSTO study)

Life after stroke can be an ongoing struggle with over half of all survivors reporting unmet emotional and social needs. In the United Kingdom’s (UK) national clinical guidelines for stroke, self-management is...

Authors: Ella Clark, Nick S. Ward, Gianluca Baio and Fiona Jones

Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson’s disease: a pilot randomised controlled trial (PD COMM pilot)

Speech-related problems are common in Parkinson’s disease (PD), but there is little evidence for the effectiveness of standard speech and language therapy (SLT) or Lee Silverman Voice Treatment (LSVT LOUD®).

Authors: Catherine M. Sackley, Christina H. Smith, Caroline E. Rick, Marian C. Brady, Natalie Ives, Smitaa Patel, Rebecca Woolley, Francis Dowling, Ramilla Patel, Helen Roberts, Sue Jowett, Keith Wheatley, Debbie Kelly, Gina Sands and Carl E. Clarke

Withdrawal of antihypertensive therapy in people with dementia: feasibility study

This study explored the feasibility of a randomised controlled withdrawal trial of antihypertensive medication in normotensive people with dementia. Feasibility aspects included response, recruitment, exclusio...

Authors: Veronika van der Wardt, Jennifer K. Burton, Simon Conroy, Tomas Welsh, Pip Logan, Jaspal Taggar, Lukasz Tanajewski and John Gladman

Preventing stress-related ill health among newly registered nurses by supporting engagement in proactive behaviors: development and feasibility testing of a behavior change intervention

Transitioning into a new professional role is a stressful experience with consequences for mental and physical health, job satisfaction, organizational commitment, and turnover. New registered nurses seem to b...

Authors: Elin Frögéli, Ann Rudman, Brjánn Ljótsson and Petter Gustavsson

Para-aortic lymphadenectomy in advanced stage cervical cancer, a protocol for comparing safety, feasibility and diagnostic accuracy of surgical staging versus PET-CT; PALDISC trial

Currently, a PET-CT is used to assess the need for extended field radiotherapy of para-aortic lymph nodes (PALN) in International Federation of Gynaecology and Obstetrics (FIGO) stage IB2, IIA2–IVA (locally ad...

Authors: Casper Tax, Karin Abbink, Maroeska M. Rovers, Ruud L. M. Bekkers and Petra L. M. Zusterzeel

Epicardial delivery of autologous atrial appendage micrografts during coronary artery bypass surgery—safety and feasibility study

The atrial appendages are a tissue reservoir for cardiac stem cells. During on-pump coronary artery bypass graft (CABG) surgery, part of the right atrial appendage can be excised upon insertion of the right at...

Authors: Annu Nummi, Tuomo Nieminen, Tommi Pätilä, Milla Lampinen, Miia L. Lehtinen, Sari Kivistö, Miia Holmström, Erika Wilkman, Kari Teittinen, Mika Laine, Juha Sinisalo, Markku Kupari, Esko Kankuri, Tatu Juvonen, Antti Vento, Raili Suojaranta…

Developing Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT): protocol for a pilot randomized controlled trial

There is a lack of evidence-based substance use disorder treatment and services targeting returning inmates. Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT) is a community-driven...

Authors: Dennis P. Watson, Bradley Ray, Lisa Robison, Huiping Xu, Rhiannon Edwards, Michelle P. Salyers, James Hill and Sarah Shue

Protocol for a feasibility randomised controlled trial of the use of Physical ACtivity monitors in an Exercise Referral Setting: the PACERS study

Exercise referral schemes are recommended by the National Institute for Clinical Excellence (NICE) for physical activity promotion among inactive patients with health conditions or risk factors. Whilst there i...

Authors: Jemma Hawkins, Michelle Edwards, Joanna Charles, Russell Jago, Mark Kelson, Kelly Morgan, Simon Murphy, Emily Oliver, Sharon Simpson, Rhiannon Tudor Edwards and Graham Moore

Study protocol for Enhancing Parenting In Cancer (EPIC): development and evaluation of a brief psycho-educational intervention to support parents with cancer who have young children

Parents with cancer have high rates of psychological morbidity, and their children are at risk of poor psychosocial outcomes, particularly in the context of parental distress and poor family communication. Par...

Authors: Lesley Stafford, Michelle Sinclair, Jane Turner, Louise Newman, Claire Wakefield, Mei Krishnasamy, G. Bruce Mann, Leslie Gilham, Kylie Mason, Paula Rauch, Julia Cannell and Penelope Schofield

Study protocol for a phase II dose evaluation randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study)

Clinical research has recently demonstrated that vitamin D deficiency (VDD) is highly prevalent in the pediatric intensive care unit (PICU) and associated with worse clinical course. Multiple adult ICU trials ...

Authors: Dayre McNally, Karin Amrein, Katharine O’Hearn, Dean Fergusson, Pavel Geier, Matt Henderson, Ali Khamessan, Margaret L. Lawson, Lauralyn McIntyre, Stephanie Redpath, Hope A. Weiler and Kusum Menon

The effects of low-intensity blood flow restricted exercise compared with conventional resistance training on the clinical outcomes of active UK military personnel following a 3-week in-patient rehabilitation programme: protocol for a randomized controlled feasibility study

A challenge for rehabilitation practitioners lies in designing optimal exercise programmes that facilitate musculoskeletal (MSK) adaptations whilst simultaneously accommodating biological healing and the safe ...

Authors: Peter Ladlow, Russell J. Coppack, Shreshth Dharm-Datta, Dean Conway, Edward Sellon, Stephen D. Patterson and Alexander N. Bennett

Action 3:30R: protocol for a cluster randomised feasibility study of a revised teaching assistant-led extracurricular physical activity intervention for 8- to 10-year-olds

Approximately half of 7-year-old children do not meet physical activity (PA) recommendations. Interventions targeting primary school children’s afterschool discretionary time could increase PA. Teaching assist...

Authors: Byron Tibbitts, Alice Porter, Simon J. Sebire, Chris Metcalfe, Emma Bird, Jane Powell and Russell Jago

Effects of virtual rehabilitation versus conventional physical therapy on postural control, gait, and cognition of patients with Parkinson’s disease: study protocol for a randomized controlled feasibility trial

There is an association among postural instability, gait dysfunction, and cognitive impairment in subjects with Parkinson’s disease (PD). Difficulty in dividing attention, response inhibition, and visuospatial...

Authors: Keyte Guedes Silva, Tatiana Beline De Freitas, Flávia Doná, Fernando Freitas Ganança, Henrique Ballalai Ferraz, Camila Torriani-Pasin and José Eduardo Pompeu

Understanding muscle-immune interactions in adolescent idiopathic scoliosis: a feasibility study

Adolescent idiopathic scoliosis (AIS) is the most common form of scoliosis in children, and its cause remains unknown. The Immune-metabolic CONnections to Scoliosis (ICONS) Study was designed to elucidate the ...

Authors: Srikesh Rudrapatna, Devin Peterson, Paul Missiuna, Ishan Aditya, Brian Drew, Nicola Sahar, Lehana Thabane and M. Constantine Samaan

Ketogenic diets as an adjuvant therapy in glioblastoma (the KEATING trial): study protocol for a randomised pilot study

Glioblastoma is the commonest form of malignant brain tumour in adults, affecting 2–3 people per 100,000 per year. Despite current treatment options including surgical resection, radiotherapy and temozolomide ...

Authors: Kirsty J. Martin-McGill, Anthony G. Marson, Catrin Tudur Smith and Michael D. Jenkinson

The ReSiT study (reducing sitting time): rationale and protocol for an exploratory pilot study of an intervention to reduce sitting time among office workers

Desk-based workers engage in long periods of uninterrupted sitting time, which has been associated with morbidity and premature mortality. Previous workplace intervention trials have demonstrated the potential...

Authors: Benjamin Gardner, Stephen Dewitt, Lee Smith, John P. Buckley, Stuart J. H. Biddle and Louise Mansfield

Fish oil supplementation in chronic obstructive pulmonary disease: feasibility of conducting a randomised controlled trial

Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFAs) may act as an effective adjunct therapy for chronic obstructive pulmonary disease (COPD), a condition characterised by persistent airflow limitation ...

Authors: Ashley S. Fulton, Alison M. Coates, Marie T Williams, Peter R. C. Howe, Manohar L. Garg, Lisa G. Wood, Peter Frith and Alison M. Hill

Can we predict necrosis intra-operatively? Real-time optical quantitative perfusion imaging in surgery: study protocol for a prospective, observational, in vivo pilot study

Compromised perfusion as a result of surgical intervention causes a reduction of oxygen and nutrients in tissue and therefore decreased tissue vitality. Quantitative imaging of tissue perfusion during reconstr...

Authors: Sanne M. Jansen, Daniel M. de Bruin, Mark I. van Berge Henegouwen, Simon D. Strackee, Denise P. Veelo, Ton G. van Leeuwen and Suzanne S. Gisbertz

Validity, reliability and feasibility of commercially available activity trackers in physical therapy for people with a chronic disease: a study protocol of a mixed methods research

For older people and people with a chronic disease, physical activity provides health benefits. Patients and healthcare professionals can use commercially available activity trackers to objectively monitor (al...

Authors: Emmylou Beekman, Susy M. Braun, Darcy Ummels, Kim van Vijven, Albine Moser and Anna J. Beurskens

The feasibility of assessing swallowing physiology following prolonged intubation after cardiovascular surgery

Dysphagia following prolonged intubation after cardiovascular (CV) surgery is common occurring in 67% of patients; however, this population’s swallowing physiology has never been prospectively evaluated using ...

Authors: Stacey A. Skoretz, Terrence M. Yau, John T. Granton and Rosemary Martino

Evaluating the feasibility of conducting a trial using a patient decision aid in implantable cardioverter defibrillator candidates: a randomized controlled feasibility trial

Patient decision aids (PtDA) support quality decision-making. The aim of this research was to evaluate the feasibility of conducting a randomized controlled trial delivering an implantable cardioverter defibri...

Authors: Sandra L. Carroll, Dawn Stacey, Michael McGillion, Jeff S. Healey, Gary Foster, Sarah Hutchings, Heather M. Arthur, Gina Browne and Lehana Thabane

Caring for Caregivers (C4C): study protocol for a pilot feasibility randomised control trial of Positive Written Disclosure for older adult caregivers of people with psychosis

The caregivers of people who experience psychosis are themselves at risk of developing physical and mental health problems. This risk is increased for older adult caregivers who also have to manage the lifesty...

Authors: Cassie M. Hazell, Christina J. Jones, Mark Hayward, Stephen A. Bremner, Daryl B. O’Connor, Vanessa Pinfold and Helen E. Smith

A pilot investigation to optimise methods for a future satiety preload study

Preload studies are used to investigate the satiating effects of foods and food ingredients. However, the design of preload studies is complex, with many methodological considerations influencing appetite resp...

Authors: Mark R. Hobden, Laetitia Guérin-Deremaux, Daniel M. Commane, Ian Rowland, Glenn R. Gibson and Orla B. Kennedy

Evaluation of neurological changes in secondary progressive multiple sclerosis patients treated with immune modulator MIS416: results from a feasibility study

While disease progression can be readily monitored in early stage relapsing multiple sclerosis (MS), it is more challenging for secondary progressive multiple sclerosis (SPMS). This advanced stage of disease h...

Authors: Gill A. Webster, Dalice A. Sim, Anne C. La Flamme and Nancy E. Mayo

The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study

Both obesity and congenital heart disease (CHD) are risk factors for the long-term cardiovascular health of children and adolescents. The addition of smart mobile technology to conventional lifestyle counselin...

Authors: Meghan Rombeek, Stefanie De Jesus, Luis Altamirano-Diaz, Eva Welisch, Harry Prapavessis, Jamie A. Seabrook and Kambiz Norozi

Differences in early risk factors for obesity between African American formula-fed infants and White breastfed controls

Previous RCTs to prevent early rapid weight gain were conducted in predominantly White, well-educated, middle-income mother-infants at low risk for obesity. To inform the design of an RCT in a higher-risk samp...

Authors: Paige K. Berger, Justin A. Lavner, Jessica J. Smith and Leann L. Birch

A comparison of isometric, isotonic concentric and isotonic eccentric exercises in the physiotherapy management of subacromial pain syndrome/rotator cuff tendinopathy: study protocol for a pilot randomised controlled trial

Subacromial pain syndrome (SPS) involving rotator cuff tendinopathy is a common cause of shoulder pain and disability. Evidence suggests that structured physiotherapy may be as effective as surgery in this con...

Authors: Rita Kinsella, Sallie M. Cowan, Lyn Watson and Tania Pizzari

Feasibility of an incentive scheme to promote active travel to school: a pilot cluster randomised trial

In Great Britain, 19% of trips to primary school within 1 mile, and 62% within 1–2 miles, are by car. Active travel to school (ATS) offers a potential source of moderate-to-vigorous physical activity (MVPA). T...

Authors: Samuel Ginja, Bronia Arnott, Vera Araujo-Soares, Anil Namdeo and Elaine McColl

An implementation-effectiveness hybrid trial of video-based family therapy for peripartum depression in home visited mothers: a protocol for a pilot trial

The Federal Maternal, Infant, and Early Childhood Home Visiting (HV) Program serves over 100,000 vulnerable families at risk for child abuse in the USA and aims to improve many outcomes, including maternal men...

Authors: Fallon Cluxton-Keller, Craig L. Donnelly, Melony Williams, Jennifer Buteau, Patricia Stolte, Maggie Monroe-Cassel and Martha L. Bruce

Unsupervised progressive elastic band exercises for frail geriatric inpatients objectively monitored by new exercise-integrated technology—a feasibility trial with an embedded qualitative study

Frailty is a serious condition frequently present in geriatric inpatients that potentially causes serious adverse events. Strength training is acknowledged as a means of preventing or delaying frailty and loss...

Authors: C. R. Rathleff, T. Bandholm, E. G. Spaich, M. Jorgensen and J. Andreasen

A phase 2 quasi-experimental trial evaluating the feasibility, acceptability, and potential effectiveness of complex nursing intervention focused on QoL assessment on advanced cancer patients with palliative care needs: study protocol

Palliative care (PC) is an approach that improves the quality of life (QoL) of patients and their families facing the problem associated with incurable terminal disease. A number of QoL assessment tools have b...

Authors: Gianluca Catania, Annamaria Bagnasco, Alessio Signori, Paola Pilastri, Marta Bottino, Claudia Cervetti, Milko Zanini, Giuseppe Aleo and Loredana Sasso

Development of a communication aid for explaining hypertrophic cardiomyopathy genetic test results

Large gene panels are now commonplace for hypertrophic cardiomyopathy (HCM), increasing the yield of uncertain genetic findings. Few resources exist which aim to facilitate communication of HCM genetic test re...

Authors: Yana Smagarinsky, Charlotte Burns, Catherine Spinks, Christopher Semsarian and Jodie Ingles

Changes of intestinal microbiota composition and diversity in very low birth weight infants related to strategies of NEC prophylaxis: protocol for an observational multicentre pilot study

At the Division of Neonatology, Department of Paediatrics, Medical University Graz, a unique regimen of necrotizing enterocolitis (NEC) prophylaxis in preterm infants showing a < 1500 g birth weight (i.e. very...

Authors: Stefan Kurath-Koller, Christine Moissl-Eichinger, Gregor Gorkiewicz, Raimund Kraschl, Claudia Kanduth, Barbara Hopfer, Berndt Urlesberger and Bernhard Resch

Ethnic differences in patients’ perceptions towards isolated orthopedic injuries: a pilot study

Patients’ perceptions of their healthcare have been reported to influence clinical outcomes following orthopedic trauma. Findings across clinical outcomes have demonstrated significant differences in perceptio...

Authors: Boris A. Zelle, Gurpreet Singh, Deanna L. Kitchen, Roberto J. Fajardo, Mohit Bhandari and Melissa A. Valerio

Alpha test results for a Housing First eLearning strategy: the value of multiple qualitative methods for intervention design

Detailed descriptions of implementation strategies are lacking, and there is a corresponding dearth of information regarding methods employed in implementation strategy development. This paper describes method...

Authors: Emily Q. Ahonen, Dennis P. Watson, Erin L. Adams and Alan McGuire

Danish translation of a physical function item bank from the Patient-Reported Outcome Measurement Information System (PROMIS)

The Patient-Reported Outcome Measurement Information System (PROMIS) is an assessment system that aims to provide more valid, reliable, responsive, and precise patient-reported outcome (PRO) measures than has ...

Authors: Christina W. Schnohr, Charlotte L. Rasmussen, Henning Langberg and Jakob B. Bjørner

Erratum to: Pilot and Feasibility Studies, Vol. 4

Authors:

Feasibility, safety, acceptability, and functional outcomes of playing Nintendo Wii Fit Plus™ for frail elderly: study protocol for a feasibility trial

Frailty can be defined as a medical syndrome with multiple causes and contributors, characterized by diminished strength and endurance and reduced physiological function that increases the vulnerability to dev...

Authors: Gisele Cristine Vieira Gomes, Jéssica Maria Ribeiro Bacha, Maria do Socorro Simões, Sumika Mori Lin, Larissa Alamino Pereira Viveiro, Eliana Maria Varise, Wilson Jacob Filho and José Eduardo Pompeu

Pilot parallel randomised controlled trial of protective socks against usual care to reduce skin tears in high risk people: ‘STOPCUTS’

Skin tears are common in older adults and those taking steroids and warfarin. They are traumatic, often blunt injuries caused by oblique knocks to the extremities. The epidermis may separate from the dermis or...

Authors: Roy J. Powell, Christopher J. Hayward, Caroline L. Snelgrove, Kathleen Polverino, Linda Park, Rohan Chauhan, Philip H. Evans, Rachel Byford, Carolyn Charman, Christopher J. W. Foy, Colin Pritchard and Andrew Kingsley

Interpersonal art psychotherapy for the treatment of aggression in people with learning disabilities in secure care: a protocol for a randomised controlled feasibility study

Art psychotherapy has greater potential for use with adults with mild to moderate learning disabilities as it places less of a burden on verbal interaction to achieve positive therapeutic, psychological, and b...

Authors: Simon S. Hackett, John L. Taylor, Mark Freeston, Andrew Jahoda, Elaine McColl, Lindsay Pennington and Eileen Kaner

Optimising the acceptability and feasibility of novel complex interventions: an iterative, person-based approach to developing the UK Morita therapy outpatient protocol

The aim of this paper is to showcase best practice in intervention development by illustrating a systematic, iterative, person-based approach to optimising intervention acceptability and feasibility, as applie...

Authors: Holly Victoria Rose Sugg, David A. Richards and Julia Frost

Small volume plasma exchange for Guillain-Barré syndrome in resource poor settings: a safety and feasibility study

In Bangladesh, most patients with Guillain-Barré syndrome (GBS) cannot afford standard treatment with intravenous immunoglobulin (IVIG) or a standard plasma exchange (PE) course, which partly explains the high...

Authors: Md. Badrul Islam, Zhahirul Islam, Shafiqur Rahman, Hubert P. Endtz, Margreet C. Vos, Mathieu van der Jagt, Pieter A. van Doorn, Bart C. Jacobs and Quazi D. Mohammad

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol

Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support br...

Authors: Friederike Barbara Haslbeck, Hans-Ulrich Bucher, Dirk Bassler and Cornelia Hagmann

HOPE: Help fOr People with money, employment, benefit or housing problems: study protocol for a randomised controlled trial

Self-harm and suicide increase in times of economic recession. Factors including job loss, austerity measures, financial difficulties and house repossession contribute to the risk. Vulnerable individuals commo...

Authors: M. C. Barnes, A. M. Haase, A. M. Bard, J. L. Donovan, R. Davies, S. Dursley, J. Potokar, N. Kapur, K. Hawton, R. C. O’Connor, W. Hollingworth, C. Metcalfe and D. Gunnell

A nurse-delivered mental health intervention for obstetric fistula patients in Tanzania: results of a pilot randomized controlled trial

Obstetric fistula has severe psychological consequences, but no evidence-based interventions exist to improve mental health in this population. This pilot trial evaluated a psychological intervention for women...

Authors: Melissa H. Watt, Mary V. Mosha, Alyssa C. Platt, Kathleen J. Sikkema, Sarah M. Wilson, Elizabeth L. Turner and Gileard G. Masenga

Research protocol for a complex intervention to support hearing and vision function to improve the lives of people with dementia

Hearing and vision impairments are among the most common and disabling comorbidities in people living with dementia. Intervening to improve sensory function could be a means by which the lives of people living...

Authors: Iracema Leroi, Annie Pye, Christopher J. Armitage, Anna Pavlina Charalambous, Fofi Constantinidou, Catherine Helmer, Ines Himmelsbach, Sarah Marié, Jahanara Miah, Suzanne Parsons, Jemma Regan, Chryssoula Thodi, Lucas Wolski, Abebaw Mengistu Yohannes and Piers Dawes

DIAMOND (DIgital Alcohol Management ON Demand): a mixed methods feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use

Alcohol is a major risk factor for preventable illness, with huge cost to healthcare economies. There is a role for alcohol-specific digital health interventions (DHI), but there have been few randomised contr...

Authors: Fiona L. Hamilton, Jo Hornby, Jessica Sheringham, Stuart Linke, Charlotte Ashton, Kevin Moore, Fiona Stevenson and Elizabeth Murray