Articles

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

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

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

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

DECADE-pilot: decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases—a protocol of a randomized controlled pilot trial

A healthy lifestyle can reduce cardiovascular risk (CVR) and prevent premature death. Usually most patients at increased CVR have difficulties implementing the necessary health behavior changes, such as smokin...

Authors: Iris Tinsel, Achim Siegel, Claudia Schmoor, Anika Buchholz and Wilhelm Niebling

Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial

Impaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels a...

Authors: H. Gunn, J. Andrade, L. Paul, L. Miller, S. Creanor, C. Green, J. Marsden, P. Ewings, M. Berrow, J. Vickery, A. Barton, B. Marshall, J. Zajicek and J. A. Freeman

ReaDySpeech for people with dysarthria after stroke: protocol for a feasibility randomised controlled trial

Dysarthria, a disordered speech production resulting from neuro-muscular impairment, is a common symptom after stroke. It causes significant problems for patients’ speech intelligibility, communication, psycho...

Authors: Claire Mitchell, Audrey Bowen, Sarah Tyson and Paul Conroy

Study protocol: a mixed methods feasibility study for a loaded self-managed exercise programme for patellofemoral pain

Patellofemoral pain (PFP) is one of the most common forms of knee pain in adults under the age of 40, with a prevalence of 23% in the general population. The long-term prognosis is poor, with only one third of...

Authors: Benjamin E. Smith, Paul Hendrick, Marcus Bateman, Fiona Moffatt, Michael Skovdal Rathleff, James Selfe, Toby O. Smith and Pip Logan

A feasibility study of a theory-based intervention to improve appropriate polypharmacy for older people in primary care

A general practitioner (GP)-targeted intervention aimed at improving the prescribing of appropriate polypharmacy for older people was previously developed using a systematic, theory-based approach based on th...

Authors: Cathal A. Cadogan, Cristín Ryan, Gerard J. Gormley, Jill J. Francis, Peter Passmore, Ngaire Kerse and Carmel M. Hughes

A feasibility study of the Mini-AFTER telephone intervention for the management of fear of recurrence in breast cancer survivors: a mixed-methods study protocol

Fear of recurrence (FoR) is a major concern for patients following treatment for primary breast cancer, affecting 60–99% of breast cancer survivors. Mini-AFTER is a brief intervention developed to address this...

Authors: Susanne Cruickshank, Emma Steel, Deborah Fenlon, Jo Armes, Karen Scanlon, Elspeth Banks and Gerald Humphris

Vaginal progesterone to reduce preterm birth among HIV-infected pregnant women in Zambia: a feasibility study protocol

Women infected with HIV have a risk of preterm birth (PTB) that is twice that among uninfected women, and treatment with antiretroviral therapy (ART) may further increase this risk. Progesterone supplementatio...

Authors: Joan T. Price, Katie R. Mollan, Nurain M. Fuseini, Bethany L. Freeman, Helen B. Mulenga, Amanda H. Corbett, Bellington Vwalika and Jeffrey S. A. Stringer

Development of an implementation intention-based intervention to change children’s and parent-carers’ behaviour

Implementation intentions enable individuals to translate good intentions into action. Parents and children can find maintaining oral health difficult, as evidenced by the presence of tooth decay. This is a co...

Authors: Karen Davies, Christopher J. Armitage, Yin-Ling Lin, James Munro, Tanya Walsh and Peter Callery

Feasibility of the trial procedures for a randomized controlled trial of a community-based peer-led wheelchair training program for older adults

A novel peer-led manual wheelchair (MWC) training program may support the training needs of older adults, but establishing program feasibility is a pragmatic first step. The purpose of this study was to evalua...

Authors: Krista L. Best, William C. Miller, François Routhier and Janice J. Eng

MapMySmoke: feasibility of a new quit cigarette smoking mobile phone application using integrated geo-positioning technology, and motivational messaging within a primary care setting

Approximately 11,000 people die in Scotland each year as a result of smoking-related causes. Quitting smoking is relatively easy; maintaining a quit attempt is a very difficult task with success rates for unai...

Authors: Robert S. Schick, Thomas W. Kelsey, John Marston, Kay Samson and Gerald W. Humphris

Effects of a parallel-arm randomized controlled weight loss pilot study on biological and psychosocial parameters of overweight and obese breast cancer survivors

Weight gain often occurs after breast cancer (BC) diagnosis and obesity along with sedentary behavior are associated with increased risk of BC recurrence and mortality. The primary objective of this study was ...

Authors: Andrea Y. Arikawa, Beth C. Kaufman, Susan K. Raatz and Mindy S. Kurzer

A pilot randomised clinical trial of physiotherapy (manual therapy, exercise, and education) for early-onset hip osteoarthritis post-hip arthroscopy

Despite the increasing use of hip arthroscopy for hip pain, there is no level 1 evidence to support physiotherapy rehabilitation programs following this procedure. The aims of this study were to determine (i) ...

Authors: Joanne Kemp, Kate Moore, Marlene Fransen, Trevor Russell, Matthew Freke and Kay M Crossley

Pilot randomised controlled trial of the ENGAGER collaborative care intervention for prisoners with common mental health problems, near to and after release

Rates of common mental health problems are much higher in prison populations, but access to primary care mental health support falls short of community equivalence. Discontinuity of care on release is the norm...

Authors: Charlotte Lennox, Tim Kirkpatrick, Rod S. Taylor, Roxanne Todd, Clare Greenwood, Mark Haddad, Caroline Stevenson, Amy Stewart, Deborah Shenton, Lauren Carroll, Sarah L. Brand, Cath Quinn, Rob Anderson, Mike Maguire, Tirril Harris, Jennifer Shaw…

Improving the efficiency of trials using innovative pilot designs: the next phase in the conduct and reporting of pilot and feasibility studies

With continuously increasing costs of conducting trials, use of innovative approaches—such as pragmatic trials, registry-based randomised trials, adaptive trials, personalised medicine trials, platform trials,...

Authors: Lehana Thabane and Gillian Lancaster

A mixed methods study to evaluate the feasibility of using the Adolescent Diabetes Needs Assessment Tool App in paediatric diabetes care in preparation for a longitudinal cohort study

An evaluation study was carried out to determine the feasibility of integrating the Adolescent Diabetes Needs Assessment Tool (ADNAT) App into UK paediatric diabetes care, to ascertain best practice standards ...

Authors: Helen Cooper, Gillian A. Lancaster, Phillip Gichuru and Matthew Peak

A study protocol of a three-group randomized feasibility trial of an online yoga intervention for mothers after stillbirth (The Mindful Health Study)

In the USA, stillbirth (in utero fetal death ≥20 weeks gestation) is a major public health issue. Women who experience stillbirth, compared to women with live birth, have a nearly sevenfold increased risk of a...

Authors: Jennifer Huberty, Jeni Matthews, Jenn Leiferman, Joanne Cacciatore and Katherine J. Gold

Feasibility of a randomized single-blind crossover trial to assess the effects of the second-generation slow-release dopamine agonists pramipexole and ropinirole on cued recall memory in idiopathic mild or moderate Parkinson’s disease without cognitive impairment

The aim was to assess the feasibility of a single-centre, single-blind, randomized, crossover design to explore the effects of two slow-release dopamine agonists, ropinirole and pramipexole, on cued recall in ...

Authors: Thomas A. Shepherd, Nicola M. J. Edelstyn, Laura Longshaw, Julius Sim, Keira Watts, Andrew R. Mayes, Michael Murray and Simon J. Ellis

Manual acupuncture plus usual care versus usual care alone in the treatment of endometriosis-related chronic pelvic pain: study protocol for a randomised controlled feasibility study

Endometriosis is the most common cause of chronic pelvic pain worldwide. Non-surgical treatments are effective for only 30–50% of women and have a significant side effect burden that leads to high discontinuat...

Authors: Mike Armour, Caroline A. Smith, Siobhan Schabrun, Genevieve Z. Steiner, Xiaoshu Zhu, Kenny Lawson and Jing Song

Enhancing Knowledge and InterProfessional care for Heart Failure (EKWIP-HF) in long-term care: a pilot study

Heart failure (HF) affects 20% of long-term care (LTC) residents and is associated with significant morbidity, acute care visits, and mortality. Barriers to HF management are staff knowledge gaps and ineffecti...

Authors: George A. Heckman, Veronique M. Boscart, Kelsey Huson, Andrew Costa, Karen Harkness, John P. Hirdes, Paul Stolee and Robert S. McKelvie

The EXPRESS Study: Exercise and Protein Effectiveness Supplementation Study supporting autonomy in community dwelling frail older people‐study protocol for a randomized controlled pilot and feasibility study

Research has repeatedly demonstrated that exercise has a positive impact on physical function and is beneficial in the treatment of physical frailty. However, an even more effective strategy for managing physi...

Authors: Agathe Daria Jadczak, Natalie Luscombe-Marsh, Penelope Taylor, Robert Barnard, Naresh Makwana and Renuka Visvanathan

Assessment of the face validity, feasibility and utility of a patient-completed questionnaire for polymyalgia rheumatica: a postal survey using the QQ-10 questionnaire

The development of a patient-reported outcome measure (PROM) for polymyalgia rheumatica (PMR), a condition that causes pain, stiffness and disability, is necessary as there is no current validated disease-spec...

Authors: Helen Twohig, Georgina Jones, Sarah Mackie, Christian Mallen and Caroline Mitchell

Facilitating access to health research through a participatory research register: a feasibility study in outpatient clinics

A research register (Reach West) has been established to facilitate recruitment of people and patients to health-related research. We conducted a prospective feasibility study to investigate the practicality o...

Authors: Verity A. Leach, John D. McGeagh, Ruta Margelyte, Niamh M. Redmond, Axel Walther, Sabi Redwood, Richard M. Martin and Jenny L. Donovan

Pilot study of a randomized trial to evaluate a Web-based intervention targeting adolescents presenting to the emergency department with acute asthma

Low-income African-American adolescents use preventive medical services less frequently than their White counterparts, indicating a need for effective interventions targeting this group. Puff City is a Web-bas...

Authors: Christine L. M. Joseph, Prashant Mahajan, Stephanie Stokes-Buzzelli, Dayna A. Johnson, Elizabeth Duffy, Renee Williams, Talan Zhang, Dennis R. Ownby, Shannon Considine and Mei Lu

Educational intervention to reduce disease related to sub-optimal basic hygiene in Rwanda: initial evaluation and feasibility study

Despite a global reduction in morbidity related to sub-optimal water, sanitation and hygiene, the incidence of such diseases remains a significant problem in sub-Saharan Africa. This study aimed to initially a...

Authors: Margaret A. Stone and Hormisdas Ndagijimana

Raising the profile of pilot and feasibility studies in relation to the development, evaluation and implementation of patient-reported outcome measures

This editorial introduces a new special series on the pilot and feasibility testing of patient-reported outcome measures (PROMs) in the on-line open access journal Pilot and Feasibility Studies. Pilot and feasibi...

Authors: Georgina Jones

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

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

Physical micro-environment interventions for healthier eating in the workplace: protocol for a stepped wedge randomised controlled pilot trial

An estimated one third of energy is consumed in the workplace. The workplace is therefore an important context in which to reduce energy consumption to tackle the high rates of overweight and obesity in the ge...

Authors: Milica Vasiljevic, Emma Cartwright, Rachel Pechey, Gareth J. Hollands, Dominique-Laurent Couturier, Susan A. Jebb and Theresa M. Marteau

Important considerations for feasibility studies in physical activity research involving persons with multiple sclerosis: a scoping systematic review and case study

Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis (MS). There is disagreement regarding the strength of this research, perhaps becaus...

Authors: Yvonne C. Learmonth and Robert W. Motl

Assessing the usefulness and acceptability of a low health literacy online decision aid about reproductive choices for younger women with breast cancer: the aLLIAnCE pilot study protocol

Young women diagnosed with breast cancer may be confronted by many difficult decisions, especially around fertility preservation prior to commencing cancer treatment. The information to be conveyed is complex,...

Authors: Michelle Peate, Sian Karen Smith, Victoria Pye, Alice Hucker, Catharyn Stern, Lesley Stafford, Catherine Oakman, Laura Chin-Lenn, Kerry Shanahan, Nipuni Ratnayake Gamage and Martha Hickey

Managing challenging behaviour in preschool children post-traumatic brain injury with online clinician support: protocol for a pilot study

Traumatic brain injury (TBI) in children is associated with a range of poor long-term outcomes, including behavioural disturbances. Parents can experience high levels of stress and injury-related burden, and e...

Authors: Kaitlyn Taylor, Cathy Catroppa, Celia Godfrey, Audrey McKinlay, Jennie Ponsford, Jan Matthews and Vicki Anderson

Mindfulness-Based Cognitive Therapy (MBCT) programme for depression in people with early stages of dementia: study protocol for a randomised controlled feasibility study

Depression and dementia are major public health problems in the UK. Depression in early-stage dementia is very common and significantly reduces quality of life, speeds cognitive decline and increases functiona...

Authors: Elisa Aguirre, Josh Stott, Georgina Charlesworth, Deirdre Noone, Jacob Payne, Mina Patel and Aimee Spector

Supporting Looked After Children and Care Leavers In Decreasing Drugs, and alcohol (SOLID): protocol for a pilot feasibility randomised controlled trial of interventions to decrease risky substance use (drugs and alcohol) and improve mental health of looked after children and care leavers aged 12–20 years

Looked after children (LAC) and care leavers are young people who have been placed under the legal care of local authorities, in many instances due to a history of abuse and/or neglect. These young people have...

Authors: Hayley Alderson, Ruth McGovern, Rebecca Brown, Denise Howel, Frauke Becker, Louise Carr, Alex Copello, Tony Fouweather, Eileen Kaner, Paul McArdle, Elaine McColl, Janet Shucksmith, Alison Steele, Luke Vale and Raghu Lingam