The evaluation of a musculoskeletal health package intervention to prevent bone toxicity in women with gynaecological malignancies undergoing pelvic radiotherapy. The RadBone randomised controlled feasibility study

Abstract Background Segmental tibial fractures are fractures in two or more areas of the tibial diaphysis resulting in a separate intercalary segment of the bone. Surgical fixation is recommended for patients with segmental tibial fractures as non-operative treatment outcomes are poor. The most common surgical interventions are intramedullary nailing (IMN) and circular frame external fixation (CFEF), but evidence about which is better is of poor quality. An adequately powered randomised controlled trial (RCT) to determine optimum treatment is required. STIFF-F aimed to assess the feasibility of a multicentre RCT comparing IMN with CFEF for segmental tibial fracture. Methods STIFF-F was a mixed-methods feasibility study comprising a pilot RCT conducted at six UK Major Trauma Centres, qualitative interviews drawing on Phenomenology and an online survey of rehabilitation. The primary outcome was recruitment rate. Patients, 16 years and over, with a segmental tibial fracture (open or closed) deemed suitable for IMN or CFEF were eligible to participate. Randomisation was stratified by site using random permuted blocks of varying sizes. Participant or assessor blinding was not possible. Interviews were undertaken with patients about their experience of injury, treatment, recovery and participation. Staff were interviewed to identify contextual factors affecting trial processes, their experience of recruitment and the treatment pathway. An online survey was developed to understand the rehabilitation context of the treatments. Results Eleven patients were screened and three recruited to the pilot RCT. Nineteen staff and four patients participated in interviews, and 11 physiotherapists responded to the survey. This study found the following: (i) segmental tibial fractures were rarer than anticipated, (ii) the complexity of the injury, study setup times and surgeon treatment preferences impeded recruitment, (iii) recovery from a segmental tibial fracture is challenging, and rehabilitation protocols are inconsistent and (iv) despite the difficulty recruiting, staff valued this research question and strived to find a way forward. Conclusion The proposed multicentre RCT comparing IMN with CFEF is not feasible. This study highlighted the difficulty of recruiting patients to an RCT of a complex rare injury over a short time period. Trial registration The study was registered with the International Standard Randomised Controlled Trials Number Registry: ISRCTN11229660

Download Full-text

A randomised controlled clinical trial comparing the effectiveness of bandaging compared to the JuxtaCures™ device in the management of people with venous ulceration: Feasibility study

Phlebology The Journal of Venous Disease ◽

10.1177/0268355520988226 ◽

2021 ◽

pp. 026835552098822

Author(s):

Philip Stather ◽

Carroll Petty ◽

Helen Langthorne ◽

Emma Rayner ◽

Jufen Zhang ◽

...

Keyword(s):

Quality Of Life ◽

Feasibility Study ◽

Multicentre Trial ◽

Compression Therapy ◽

Controlled Clinical Trial ◽

Venous Ulceration ◽

Significant Difference ◽

Potential Benefits ◽

Randomised Controlled

Introduction The mainstay of treatment for venous ulceration remains compression therapy. Velcro Wrap devices are being increasingly used in these patients despite limited evidence. This feasibility study aimed to compare standard bandaging to the JuxtaCures™ Velcro wrap device. Methods A single centre, unblinded RCT compared participants with venous ulceration randomised to either the JuxtaCures™ device or short stretch bandaging. Participants were followed up for 26 weeks. Results 160 participants were screened with 40 randomised. 3 participants in bandaging and 1 in JuxtaCures™ didn’t complete the study. 60% in JuxtaCures™ healed v 55% in bandaging despite larger ulcers in the JuxtaCures™ arm (9.33 cm2 v 6.97 cm2). There was no significant difference in time to healing (12.17 v 13.64 weeks). JuxtaCures™ showed improved ulcer reduction for those that didn’t heal (14.91–5.00 cm2 v 14.20–8.62 cm2; P = 0.06). JuxtaCures™ had more consistent sub-bandage pressure dropping from 39–36 mmHg versus 41–25 mmHg in bandaging between application and removal (P < 0.001). Quality of life (EQ5D) was improved in JuxtaCures at 3 months (mean difference 0.14, p = 0.04), but not at 1 and 6 months, or in disease specific quality of life. Cost was lower in JuxtaCures™ £842.47 v £1064.68. Duration of appointment was significantly shorter in JuxtaCures™ (41 minutes v 53 minutes; P = 0.003). Conclusion This study has shown the feasibility and necessity of running a multicentre trial to evaluate the use of Velcro wrap devices for venous ulceration. It highlights the potential benefits of more consistent pressure, increased self-care, and potential with regards to ulcer healing, cost, nursing resource and quality of life.

Download Full-text

Safety in primary care (SAP-C): a randomised, controlled feasibility study in two different healthcare systems

BMC Family Practice ◽

10.1186/s12875-019-0909-8 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Caoimhe Madden ◽

Sinéad Lydon ◽

Margaret E. Cupples ◽

Nigel D. Hart ◽

Ciara Curran ◽

...

Keyword(s):

Primary Care ◽

Feasibility Study ◽

Healthcare Systems ◽

Randomised Controlled

Download Full-text

Feasibility study of an integrated stroke self-management programme: a cluster-randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2015-008900 ◽

2016 ◽

Vol 6 (1) ◽

pp. e008900 ◽

Cited By ~ 18

Author(s):

Fiona Jones ◽

Heather Gage ◽

Avril Drummond ◽

Ajay Bhalla ◽

Robert Grant ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Feasibility Study ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Management Programme ◽

Self Management ◽

Cluster Randomised ◽

Randomised Controlled

Download Full-text

Using personalised avatars as an adjunct to a weight loss management programme: a randomised controlled feasibility study (Preprint)

10.2196/preprints.36275 ◽

2022 ◽

Author(s):

Maria Horne ◽

Maryan Hardy ◽

Trevor Murrells ◽

Hassan Ugail ◽

Andrew Hill

Keyword(s):

Quality Of Life ◽

Weight Loss ◽

Feasibility Study ◽

Self Efficacy ◽

Routine Care ◽

Health Concern ◽

Secondary Outcome ◽

Motivation To Change ◽

Randomised Controlled

BACKGROUND Obesity is a global public health concern. Interventions rely predominantly on managing dietary intake and/or increasing physical activity but sustained adherence to behavioural regimens is often poor. As with all interventions, the lack of sustained motivation, self-efficacy and poor adherence to behavioural regimens are recognized barriers to successful weight loss. Avatar-based interventions have been found to achieve better patient outcomes in the management of chronic conditions by promoting more active engagement and the virtual representations of ‘self’ have been shown to impact real-world behaviour, acting as a catalyst for sustained weight loss behaviour. OBJECTIVE We aimed to evaluate whether a personalised avatar, offered as an adjunct to an established weight loss programme, could increase participant motivation and sustain engagement, optimise service delivery, and improve participant health outcomes. METHODS A feasibility randomised design was used to determine the case for future development and evaluation of avatar-based technology in a randomised controlled trial. Participants were recruited from GP referrals to a 12-week NHS weight improvement programme. The main outcome measure was weight loss. Secondary outcome measures were quality-of-life and self-efficacy. Quantitative data were subjected to descriptive statistical tests and exploratory comparison between intervention and control arms. Feasibility and acceptability were assessed through interviews analysed using the framework approach. HRA ethical approval was granted. RESULTS 10 males (7 intervention; 3 routine care) and 33 females (23 intervention; 10 routine care) were recruited. Initial mean weight of participants was greater in the intervention than routine care arm (126.3 kg vs 122.9 kg); pattern of weight loss was similar across both arms of the study in period T0-T1 but accelerated in period T1-T2 for intervention participants, suggesting that access to the self-resembling avatar may promote greater engagement with weight loss initiatives in the short to medium term. Mean change in weight of participants from T0 to T2 was 4.5kg (95% CI: 2.7-6.3) in routine care arm and 5.3kg (95% CI: 3.9-6.8) in the intervention arm. Quality-of-life and self-efficacy measures demonstrated greater improvement in the intervention arm at both T1 (105.5 routine care; 99.7 intervention arm) and T2 (100.1 routine care; 81.2 intervention arm). 13 participants (11 Female, 2 Male) and two healthcare professionals were interviewed about their experience of using the avatar programme. CONCLUSIONS Overall, participants found using the personalised avatar acceptable and feedback reiterated that seeing a future ‘self’ helped reinforce motivation to change behaviour. This feasibility study demonstrated that avatar-based technology may successfully promote engagement and motivation in weight loss programmes, enabling participants to achieve greater weight loss gains and build self-confidence and belief. CLINICALTRIAL 17953876

Download Full-text

Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study

BMJ Open ◽

10.1136/bmjopen-2018-022233 ◽

2018 ◽

Vol 8 (9) ◽

pp. e022233 ◽

Cited By ~ 27

Author(s):

Amanda Jane Blatch-Jones ◽

Wei Pek ◽

Emma Kirkpatrick ◽

Martin Ashton-Key

Keyword(s):

Feasibility Study ◽

Randomised Controlled Trials ◽

Feasibility Studies ◽

Cross Sectional Study ◽

Sectional Study ◽

Cross Sectional ◽

Group 2 ◽

Randomised Controlled ◽

Pilot Feasibility Study ◽

Group 1

ObjectivesTo assess the value of pilot and feasibility studies to randomised controlled trials (RCTs) funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. To explore the methodological components of pilot/feasibility studies and how they inform full RCTs.Study designCross-sectional study.SettingBoth groups included NIHR HTA programme funded studies in the period 1 January 2010–31 December 2014 (decision date). Group 1: stand-alone pilot/feasibility studies published in the HTA Journal or accepted for publication. Group 2: all funded RCT applications funded by the HTA programme, including reference to an internal and/or external pilot/feasibility study. The methodological components were assessed using an adapted framework from a previous study.Main outcome measuresThe proportion of stand-alone pilot and feasibility studies which recommended proceeding to full trial and what study elements were assessed. The proportion of ‘HTA funded’ trials which used internal and external pilot and feasibility studies to inform the design of the trial.ResultsGroup 1 identified 15 stand-alone pilot/feasibility studies. Study elements most commonly assessed weretesting recruitment(100% in both groups),feasibility(83%, 100%) andsuggestions for further study/investigation(83%, 100%). Group 2 identified 161 ‘HTA funded’ applications: 59 cited an external pilot/feasibility study wheretesting recruitment(50%, 73%) andfeasibility(42%, 73%) were the most commonly reported study elements: 92 reported an internal pilot/feasibility study wheretesting recruitment(93%, 100%) andfeasibility(44%, 92%) were the most common study elements reported.Conclusions‘HTA funded’ research which includes pilot and feasibility studies assesses a variety of study elements. Pilot and feasibility studies serve an important role when determining the most appropriate trial design. However, how they are reported and in what context requires caution when interpreting the findings and delivering a definitive trial.

Download Full-text

The effect of targeted treatment on people with patellofemoral pain: a pragmatic, randomised controlled feasibility study

BMC Musculoskeletal Disorders ◽

10.1186/s12891-017-1698-7 ◽

2017 ◽

Vol 18 (1) ◽

Cited By ~ 6

Author(s):

Benjamin T. Drew ◽

Philip G. Conaghan ◽

Toby O. Smith ◽

James Selfe ◽

Anthony C. Redmond

Keyword(s):

Feasibility Study ◽

Patellofemoral Pain ◽

Targeted Treatment ◽

Randomised Controlled

Download Full-text

Investigating the effects of 6 months extended duration, in-centre nocturnal versus conventional haemodialysis treatment: a non-randomised, controlled feasibility study

BMJ Open ◽

10.1136/bmjopen-2016-012583 ◽

2016 ◽

Vol 6 (9) ◽

pp. e012583 ◽

Cited By ~ 1

Author(s):

Darren R Churchward ◽

Matthew P M Graham-Brown ◽

Robert Preston ◽

Warren Pickering ◽

Gerry P McCann ◽

...

Keyword(s):

Feasibility Study ◽

Extended Duration ◽

Randomised Controlled ◽

Haemodialysis Treatment

Download Full-text

Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

BMJ Open ◽

10.1136/bmjopen-2017-019142 ◽

2018 ◽

Vol 8 (1) ◽

pp. e019142 ◽

Cited By ~ 7

Author(s):

Kate Jolly ◽

Jenny Ingram ◽

Joanne Clarke ◽

Debbie Johnson ◽

Heather Trickey ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Infant Feeding ◽

Feasibility Study ◽

Breast Feeding ◽

Controlled Trial ◽

Feasibility Trial ◽

Study Results ◽

Service Staff ◽

Before And After ◽

Randomised Controlled

IntroductionBreast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman’s feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care.Methods and analysisA two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper–women interactions to assess intervention fidelity.Ethics and disseminationStudy results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN14760978; Pre-results.

Download Full-text