scholarly journals STEPFORWARD study: a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e045195
Author(s):  
Natalie Vanicek ◽  
Elizabeth Coleman ◽  
Judith Watson ◽  
Kerry Bell ◽  
Catriona McDaid ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Resource Use ◽  
Retention Rate ◽  
Full Scale ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Multiple Time ◽  
Transtibial Amputation ◽  
Community Mobility ◽  
Randomised Controlled

ObjectivesTo determine the feasibility of conducting a full-scale randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard prosthetic ankle-foot.DesignMulticentre parallel group feasibility RCT.SettingFive prosthetics centres in England recruiting from July 2018 to August 2019.ParticipantsAdults aged ≥50 years with a vascular-related or non-traumatic transtibial amputation for 1 year or longer, categorised as having ‘limited community mobility’ and using a non-self-aligning ankle-foot.InterventionParticipants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot.OutcomesFeasibility measures: recruitment, consent and retention rates; and completeness of questionnaire and clinical assessment datasets across multiple time points. Feasibility of collecting daily activity data with wearable technology and health resource use data with a bespoke questionnaire.ResultsFifty-five participants were randomised (61% of the target 90 participants): n=27 self-aligning ankle-foot group, n=28 non-self-aligning ankle-foot group. Fifty-one participants were included in the final analysis (71% of the target number of participants). The consent rate and retention at final follow-up were 86% and 93%, respectively. The average recruitment rate was 1.25 participants/site/month (95% CI 0.39 to 2.1). Completeness of questionnaires ranged from 89%–94%, and clinical assessments were 92%–95%, including the activity monitor data. The average completion rates for the EQ-5D-5L and bespoke resource use questionnaire were 93% and 63%, respectively.ConclusionsThis feasibility trial recruited and retained participants who were categorised as having ‘limited community mobility’ following a transtibial amputation. The high retention rate of 93% indicated the trial was acceptable to participants and feasible to deliver as a full-scale RCT. The findings support a future, fully powered evaluation of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard non-self-aligning version with some adjustments to the trial design and delivery.Trial registration numberISRCTN15043643.

scholarly journals Development and implementation of a nurse-led allergy clinic model in primary care: feasibility trial protocol

2019 ◽  
Vol 29 (1) ◽  
Author(s):  
Margaret Kelman ◽  
Victoria Hammersley ◽  
Marilyn Kendall ◽  
Mome Mukherjee ◽  
Lynn Morrice ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Allergy Clinic ◽  
Randomised Controlled

AbstractIn the United Kingdom, there are acknowledged short comings in allergy care provision for patients seen in primary care. There is a lack of allergy training for healthcare professionals and this leads to inappropriate referrals to the limited number of allergy specialists. The primary aims of this study are to assess the feasibility of delivering and evaluating a new nurse-led allergy service in primary care, measured by recruitment, retention and quality of life. This is a single arm feasibility trial in which up to 250 participants referred to the nurse-led allergy clinic will receive the intervention and complete 6–12 weeks follow-up before being referred back to their usual care. Primary outcomes for this study will be establishment of clinics, recruitment and retention rates, and estimates of change in disease-specific quality of life measures. Secondary outcomes will be acceptability of the new service to participants/carers and healthcare professionals. A sample of participants and professional stakeholders will take part in more in-depth semi-structured qualitative interviews. Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.

scholarly journals P258 Real-world secukinumab retention, response rates and adverse events in the treatment of PsA and axSpA

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Alistair Tindell ◽  
Saira Batool ◽  
Andrew McGucken ◽  
Stefan Siebert
Keyword(s):  
Adverse Events ◽  
Disease Activity ◽  
Real World ◽  
Retention Rate ◽  
Retention Rates ◽  
Hospital Death ◽  
Published Data ◽  
Cerebellar Haemorrhage ◽  
One Year ◽  
Randomised Controlled

Abstract Background Secukinumab, an IL-17A inhibitor, has been licensed for use in the United Kingdom for both axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) for several years. Despite this there is minimal published data on its use out with randomised controlled trials. We present here the collated real-world rheumatology experience of secukinumab use in Glasgow. Methods Patients who have ever received secukinumab for any rheumatology indication were identified using available medical records (from 14/05/2012 to 18/09/2019). Diagnosis, baseline demographics, disease activity at baseline and at 6 months, and whether patients are still currently on secukinumab was recorded. Primary inefficacy was defined as stopping treatment due to inefficacy ≤6 months. Reasons for discontinuation were also recorded. As disease activity scores were variably recorded, the primary outcome was retention rate as a surrogate for efficacy and lack of adverse event. Patients only included in disease scores if scores available both at baseline and 6 months. Results 352 patients (with 530 patient-years of exposure) identified. 251 (71.3%) patients currently remain on secukinumab. 301 of 336 (89.6%) patients remained on drug at six-month review (16 await review). Characteristics and response of two main diagnostic groups listed in Table 1 (Note: 3 patients had SAPHO, 5 had Juvenile Idiopathic Arthritis, 1 had reactive arthritis). Common adverse events were infections (11 patients), rash and/or pruritis (6 patients), mood change and/or fatigue (4 patients). Three patients developed inflammatory bowel disease (IBD) subsequent to starting secukinumab. Five patients had pre-existing IBD, none of which flared on secukinumab. Two patients required hospitalisation for abscesses whilst on secukinumab. One patient had a stroke and one patient had a myocardial infarction whilst on secukinumab - both patients had multiple risk factors for cardiovascular disease. No malignancies identified. Three patients died, with none felt related to secukinumab (cerebellar haemorrhage in warfarinised patient with high INR; pneumonia six months after switching from secukinumab to tocilizumab; one out of hospital death over one year after stopping secukinumab). Conclusion In this real world cohort of patients with axSpA and PsA, secukinumab retention rates at 6 months are high with no new safety signals identified. Disclosures A. Tindell None. S. Batool None. A. McGucken None. S. Siebert Consultancies; S.S. has received speaker or consultation fees or honoraria from AbbVie, UCB, Janssen, Boehringer Ingelheim, Novartis, Celgene. Honoraria: S.S. has received speaker or consultation fees or honoraria from AbbVie, UCB, Janssen, Boehringer Ingelheim, Novartis, Celgene. Grants/research support; S.S has received funding for research/ grants from Pfizer, Janssen, BMS, Celgene, UCB, Boehringer Ingelheim, Novartis, GSK.

scholarly journals Cost-effectiveness of a community-delivered multicomponent intervention compared with enhanced standard care of obese adolescents: cost-utility analysis alongside a randomised controlled trial (the HELP trial)

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e018640 ◽  
Author(s):  
Monica Panca ◽  
Deborah Christie ◽  
Tim J Cole ◽  
Silvia Costa ◽  
John Gregson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Resource Use ◽  
Standard Care ◽  
Controlled Trial ◽  
Cost Effective ◽  
Cost Utility ◽  
Cost Utility Analysis ◽  
Community Settings ◽  
Utility Analysis ◽  
Randomised Controlled

ObjectiveTo undertake a cost-utility analysis of a motivational multicomponent lifestyle-modification intervention in a community setting (the Healthy Eating Lifestyle Programme (HELP)) compared with enhanced standard care.DesignCost-utility analysis alongside a randomised controlled trial.SettingCommunity settings in Greater London, England.Participants174 young people with obesity aged 12–19 years.InterventionsIntervention participants received 12 one-to-one sessions across 6 months, addressing lifestyle behaviours and focusing on motivation to change and self-esteem rather than weight change, delivered by trained graduate health workers in community settings. Control participants received a single 1-hour one-to-one nurse-delivered session providing didactic weight-management advice.Main outcome measuresMean costs and quality-adjusted life years (QALYs) per participant over a 1-year period using resource use data and utility values collected during the trial. Incremental cost-effectiveness ratio (ICER) was calculated and non-parametric bootstrapping was conducted to generate a cost-effectiveness acceptability curve (CEAC).ResultsMean intervention costs per participant were £918 for HELP and £68 for enhanced standard care. There were no significant differences between the two groups in mean resource use per participant for any type of healthcare contact. Adjusted costs were significantly higher in the intervention group (mean incremental costs for HELP vs enhanced standard care £1003 (95% CI £837 to £1168)). There were no differences in adjusted QALYs between groups (mean QALYs gained 0.008 (95% CI −0.031 to 0.046)). The ICER of the HELP versus enhanced standard care was £120 630 per QALY gained. The CEAC shows that the probability that HELP was cost-effective relative to the enhanced standard care was 0.002 or 0.046, at a threshold of £20 000 or £30 000 per QALY gained.ConclusionsWe did not find evidence that HELP was more effective than a single educational session in improving quality of life in a sample of adolescents with obesity. HELP was associated with higher costs, mainly due to the extra costs of delivering the intervention and therefore is not cost-effective.Trial registration numberISRCTN99840111.

scholarly journals A randomised controlled trial of energetic activity for depression in young people (READY): a multi-site feasibility trial protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
N. Howlett ◽  
L. Bottoms ◽  
A. Chater ◽  
A. B. Clark ◽  
T. Clarke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Large Scale ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Exercise Session ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Prevalence of depression is increasing in young people, and there is a need to develop and evaluate behavioural interventions which may provide benefits equal to or greater than talking therapies or pharmacological alternatives. Exercise could be beneficial for young people living with depression, but robust, large-scale trials of effectiveness and the impact of exercise intensity are lacking. This study aims to test whether a randomised controlled trial (RCT) of an intervention targeting young people living with depression is feasible by determining whether it is possible to recruit and retain young people, develop and deliver the intervention as planned, and evaluate training and delivery. Methods The design is a three-arm cluster randomised controlled feasibility trial with embedded process evaluation. Participants will be help-seeking young people, aged 13–17 years experiencing mild to moderate low mood or depression, referred from three counties in England. The intervention will be delivered by registered exercise professionals, supported by mental health support workers, twice a week for 12 weeks. The three arms will be high-intensity exercise, low-intensity exercise, and a social activity control. All arms will receive a ‘healthy living’ behaviour change session prior to each exercise session and the two exercise groups are energy matched. The outcomes are referral, recruitment, and retention rates; attendance at exercise sessions; adherence to and ability to reach intensity during exercise sessions; proportions of missing data; adverse events, all measured at baseline, 3, and 6 months; resource use; and reach and representativeness. Discussion UK National Health Service (NHS) policy is to provide young people with advice about using exercise to help depression but there is no evidence-based exercise intervention to either complement or as an alternative to medication or talking therapies. UK National Institute for Health and Care Excellence (NICE) guidelines suggest that exercise can be an effective treatment, but the evidence base is relatively weak. This feasibility trial will provide evidence about whether it is feasible to recruit and retain young people to a full RCT to assess the effectiveness and cost-effectiveness of an exercise intervention for depression. Trial registration ISRCTN, ISRCTN66452702. Registered 9 April 2020.

scholarly journals Psychological therapy for mood instability within bipolar spectrum disorder: a randomised, controlled feasibility trial of a dialectical behaviour therapy-informed approach (the ThrIVe-B programme)

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Kim Wright ◽  
Alyson L. Dodd ◽  
Fiona C. Warren ◽  
Antonieta Medina-Lara ◽  
Barnaby Dunn ◽  
...  
Keyword(s):  
Recruitment Rate ◽  
Spectrum Disorder ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Bipolar Spectrum ◽  
Behaviour Therapy ◽  
Treatment As Usual ◽  
Bipolar Spectrum Disorder ◽  
Randomised Controlled

Abstract Background A subgroup of those with bipolar spectrum disorders experience ongoing mood fluctuations outside of full episodes. We conducted a randomised, controlled feasibility study of a Dialectical Behavioural Therapy-informed approach for bipolar mood fluctuations (Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). Our study aimed to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost effectiveness of the ThrIVe-B programme. Participants were required to meet diagnostic criteria for a bipolar spectrum disorder and report frequent mood swings outside of acute episodes. They were randomised to treatment as usual (control arm) or the ThrIVe-B intervention plus treatment as usual (intervention arm). Follow-up points were at 3, 6, 9 and 15 months after baseline, with 9 months as the primary end point. To evaluate feasibility and acceptability we examined recruitment and retention rates, completion rates for study measures, adverse events and feedback from participants on their experience of study participation and therapy. Results Of the target 48 participants, 43 were recruited (22 in the intervention arm; 21 in the control arm), with a recruitment rate of 3.9 participants per month. At 9 months 74% of participants engaged in research follow-up assessment, exceeding the pre-specified criterion of 60%. There were no serious concerns about the safety of the research procedures or the intervention. On one of the four candidate primary outcome measures, the 95% CI for the between-group mean difference score excluded the null effect and included the minimal clinically important difference, favouring the intervention arm, whilst on no measure was there evidence of deterioration in the intervention arm relative to the control arm. Attendance of the intervention (50% attending at least half of the mandatory sessions) was below the pre-specified continuation criterion of 60%, and qualitative feedback from participants indicated areas that may have hampered or facilitated engagement. Conclusions It is broadly feasible to conduct a trial of this design within the population of people with frequent bipolar mood swings. Changes should be made to the therapy to increase uptake, such as simplifying content and considering individual rather than group delivery. Trial registration ISRCTN: ISRCTN54234300. Registered 14th July 2017, http://www.isrctn.com/ISRCTN54234300

scholarly journals Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design—a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e035787
Author(s):  
Dumbor Ngaage ◽  
Natasha Mitchell ◽  
Alexandra Dean ◽  
Claire Hirst ◽  
Enoch Akowuah ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Cardiac Rehabilitation ◽  
Hospital Discharge ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Median Sternotomy ◽  
Retention Rates ◽  
Upper Body ◽  
Feasibility Trial ◽  
Randomised Controlled

IntroductionFollowing cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier.Methods and analysesThis is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18–80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial.Ethics and disseminationEthics approval was granted by East Midlands—Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders.Trial registration numberISRCTN80441309

scholarly journals Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study)

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e032924
Author(s):  
Natasha Mitchell ◽  
Elizabeth Coleman ◽  
Judith Watson ◽  
Kerry Bell ◽  
Catriona McDaid ◽  
...  
Keyword(s):  
Sample Size ◽  
Older Patients ◽  
Large Scale ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Cochrane Review ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Advisory Group ◽  
Transtibial Amputation

IntroductionThe majority of older patients with a transtibial amputation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any individual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related amputations and other health issues compared with a standard prosthesis.Methods and analysisThis feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target sample size is 90 patients, who are aged 50 years and over, and have a transtibial amputation, where amputation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future sample size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT.Ethics and disseminationEthical approval was granted by Yorkshire and the Humber—Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group.Trial registration numberISRCTN15043643.

scholarly journals A randomised controlled feasibility trial of music-assisted language telehealth intervention for minimally verbal autistic children—the MAP study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Tim I. Williams ◽  
Tom Loucas ◽  
Jacqueline Sin ◽  
Mirjana Jeremic ◽  
Georgia Aslett ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Educational Interventions ◽  
Autism Spectrum ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Language Therapy ◽  
Minimally Verbal ◽  
Children With Asd ◽  
Wide Range ◽  
Randomised Controlled

Abstract Background About 30% of children with autism spectrum disorder (ASD) do not develop functional speech and remain non-verbal or minimally verbal even after years of speech, language and educational interventions. A wide range of interventions have been developed for improving communication in ASD, but none have proved effective in eliciting functional language in ASD children. Research has found that people with ASD are more likely to have perfect pitch and prefer music to language. Further, it seems that language delay tends to co-occur with better musical skills. Brain imaging research has found that music alongside words increases the attention that people with ASD pay to spoken words. Methods In this protocol, we describe our music-assisted programmes (MAP) that will use music to attract the attention of people with ASD to speech. MAP may open the brain pathways to language and therefore help improve communication skills for people with ASD more than standard communication protocols. In particular, we aim to develop and test whether individualised, easily used MAP would increase spoken language in 24–60-month-old, nonverbal or minimally verbal children with ASD. We will develop a structured training method, delivered through naturalistic, interactive activities (e.g. songs) to teach language to ASD children. We will test this by comparing two groups: one undertaking music-assisted programmes, and the other receiving speech and language therapy in the way that is recommended in NHS clinics. Participants will be allocated to groups randomly. The feasibility of MAP will be assessed through estimations of recruitment and retention rates, the sensitivity and reliability of the outcome measures, the intensity and frequency of the trial, the usability of the MAP app (beta version), and the burden of the assessments for the children and parents. Discussion This feasibility randomised controlled trial will establish the acceptability and estimate the power of the MAP intervention to improve early word learning in children with ASD. In the longer term, this research will help us develop an app for parents or carers of children with ASD to design their own songs and implement their own individualised MAP. Trial registration ISRCTN, ISRCTN12536062. Registered on 26 June 2019.

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