The challenge of equipoise: qualitative interviews exploring the views of health professionals and women with multiple ipsilateral breast cancer in a surgical randomised controlled trial

Abstract Background. A multicentre feasibility trial (MIAMI), comparing outcomes and quality of life of women with multiple ipsilateral breast cancer (MIBC) randomised to therapeutic mammoplasty or mastectomy, has been conducted. The MIAMI feasibility trial aimed to investigate recruitment of sufficient numbers of women to this surgical trial, however only four patients were recruited. A nested qualitative study sought to understand the reasons for this lack of recruitment.Methods. Interviews were conducted from November 2019 to September 2020 with 17 staff from eight hospital-based breast care centres that recruited and attempted to recruit to MIAMI; and seven patients from four centres, comprising all patients who were recruited to the trial and some who declined to take part. Interviews were audio-recorded, anonymised and analysed using thematic methods of building codes into themes and sub-themes using the process of constant comparison.Results. Overarching themes of 1) influences on equipoise and recruitment and 2) effects of a lack of equipoise were generated. Within these themes health professional themes described the barriers to recruitment in ‘the treatment landscape has changed’; staff preferences and beliefs’ which influenced equipoise and patient advice; and how different the treatments were for patients. Patient themes of ‘altruism and timing of trial approach’; ‘influences from consultants and others’; and ‘diagnostic journey doubts’ played a part in whether patients agreed to take part in the trial.Conclusions. Barriers to recruiting to breast cancer surgical trials can be significant, especially where there are substantial differences between the treatments being offered and a lack of equipoise communicated by healthcare professionals to patients. Patients can become overwhelmed by numerous requests for participation in research trials and inappropriate timing of trial discussions. Alternative study designs to the gold standard randomised control trial for surgical interventions may be required to provide the high-quality evidence on which to base practice.Trial registration numbers: ISRCTN (ISRCTN17987569) and ClinicalTrials.gov (NCT03514654).

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The Challenge of Equipoise: Qualitative Interviews Exploring the Views of Health Professionals and Women With Multiple Ipsilateral Breast Cancer in a Surgical Randomised Controlled Trial.

10.21203/rs.3.rs-386168/v2 ◽

2021 ◽

Author(s):

Jenny Ingram ◽

Lucy Beasant ◽

John Benson ◽

Adrian Murray Brunt ◽

Anthony Maxwell ◽

...

Keyword(s):

Breast Cancer ◽

Controlled Trial ◽

Feasibility Trial ◽

Randomised Control Trial ◽

Trial Participation ◽

Multidisciplinary Teams ◽

Ipsilateral Breast ◽

Surgical Interventions ◽

Surgical Trial ◽

Breast Care

Abstract BackgroundA multicentre feasibility trial (MIAMI), comparing outcomes and quality of life of women with multiple ipsilateral breast cancer randomised to therapeutic mammoplasty or mastectomy, was conducted from September 2018 to March 2020. The MIAMI surgical trial aimed to investigate recruitment of sufficient numbers of women. Multidisciplinary teams at 10 breast care centres in the UK identified 190 with MIBC diagnosis; 20 were eligible for trial participation but after being approached only four patients were recruited. A nested qualitative study sought to understand the reasons for this lack of recruitment.MethodsInterviews were conducted from November 2019 to September 2020 with 17 staff from eight hospital-based breast care centres that recruited and attempted to recruit to MIAMI; and seven patients from four centres, comprising all patients who were recruited to the trial and some who declined to take part. Interviews were audio-recorded, anonymised and analysed using thematic methods of building codes into themes and sub-themes using the process of constant comparison.ResultsOverarching themes of 1) influences on equipoise and recruitment and 2) effects of a lack of equipoise were generated. Within these themes health professional themes described the barriers to recruitment as ‘the treatment landscape has changed’; staff preferences and beliefs’ which influenced equipoise and patient advice; and how different the treatments were for patients. Patient themes of ‘altruism and timing of trial approach’; ‘influences from consultants and others’; and ‘diagnostic journey doubts’ all played a part in whether patients agreed to take part in the trial.ConclusionsBarriers to recruiting to breast cancer surgical trials can be significant, especially where there are substantial differences between the treatments being offered and a lack of equipoise communicated by healthcare professionals to patients. Patients can become overwhelmed by numerous requests for participation in research trials and inappropriate timing of trial discussions. Alternative study designs to the gold standard randomised control trial for surgical interventions may be required to provide the high-quality evidence on which to base practice.Trial registration numbers: ISRCTN (ISRCTN17987569) registered 20/04/2018, https://www.isrctn.com/ISRCTN17987569; and ClinicalTrials.gov (NCT03514654).

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Recruitment And Retention Of Participants From Socioeconomically Deprived Communities: Lessons From The Awareness And Beliefs About Cancer (ABACus3) Randomised Controlled Trial

10.21203/rs.3.rs-33953/v1 ◽

2020 ◽

Author(s):

Vasiliki Kolovou ◽

Yvonne Moriarty ◽

Stephanie Gilbert ◽

Harriet Quinn-Scoggins ◽

Julia Townson ◽

...

Keyword(s):

Financial Incentives ◽

Controlled Trial ◽

Qualitative Interviews ◽

Randomised Control Trial ◽

Trial Participant ◽

Community Settings ◽

Research Strategies ◽

Healthcare Settings ◽

Randomised Controlled ◽

Deprived Areas

Abstract Background Recruitment of research participants poses challenges in socioeconomically deprived areas. The Awareness and Beliefs About Cancer (ABACus) phase 3 Randomised Control Trial recruited adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model. We report the strategies used to successfully recruit and retain our trial participant sample. Methods Community and healthcare settings in areas of high socioeconomic deprivation were identified by lay advisors who recruited participants opportunistically or by appointment. Follow-up was done by telephone or post at 2-weeks and 6-months after recruitment, and all participants were offered financial incentives. Qualitative interviews were conducted with lay advisors regarding their experience and reflections. Results The lay advisors identified and contacted 107 potential recruitment venues across South and West Yorkshire and South East Wales of which 41.1% (n = 42) were opened for recruitment. A total of 234 participants were recruited, with 91% (n = 212) retention at 2-weeks and 85% (n = 199) at 6-months. Community settings yielded 75% (n = 176) of participants. Participants had a mean age of 61.3 years and 63.3% (n = 148) were female, with 66% (n = 154) resident in the most deprived geographical areas. Lay advisors described recruitment as intensive, although engaging participants was easier in community settings. Conclusions The ABACus3 trial achieved recruitment and high retention with a population that is often “hard to reach” or entirely missed in health research. Strategies were specifically tailored to engage the venues and adult residents of highly deprived areas. Future studies recruiting adults living in the most deprived areas might benefit from community recruitment and from collaborating with local gatekeepers who are key to engagement.

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

npj Primary Care Respiratory Medicine ◽

10.1038/s41533-019-0155-5 ◽

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.

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Recruitment And Retention Of Participants From Socioeconomically Deprived Communities: Lessons From The Awareness And Beliefs About Cancer (ABACus3) Randomised Controlled Trial.

10.21203/rs.3.rs-33953/v3 ◽

2020 ◽

Author(s):

Vasiliki Kolovou ◽

Yvonne Moriarty ◽

Stephanie Gilbert ◽

Harriet Quinn-Scoggins ◽

Julia Townson ◽

...

Keyword(s):

Financial Incentives ◽

Controlled Trial ◽

Qualitative Interviews ◽

Randomised Control Trial ◽

Trial Participant ◽

Community Settings ◽

Research Strategies ◽

Healthcare Settings ◽

Randomised Controlled ◽

Deprived Areas

Abstract Background: Recruitment of research participants poses challenges in socioeconomically deprived areas. The Awareness and Beliefs About Cancer (ABACus) phase 3 Randomised Control Trial recruited adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model. We report the strategies used to successfully recruit and retain our trial participant sample.Methods: Community and healthcare settings in areas of high socioeconomic deprivation were identified by lay advisors who recruited participants opportunistically or by appointment. Follow-up was done by telephone or post at 2-weeks and 6-months after recruitment, and all participants were offered financial incentives. Qualitative interviews were conducted with lay advisors regarding their experience and reflections.Results: The lay advisors identified and contacted 107 potential recruitment venues across South and West Yorkshire and South East Wales of which 41.1% (n= 42) were opened for recruitment. A total of 234 participants were recruited, with 91% (n= 212) retention at 2-weeks and 85% (n= 199) at 6-months. Community settings yielded 75% (n= 176) of participants. Participants had a mean age of 61.3 years and 63.3% (n= 148) were female, with 66% (n= 154) resident in the most deprived geographical areas. Lay advisors described recruitment as intensive, although engaging participants was easier in community settings.Conclusions: The ABACus3 trial achieved recruitment and high retention with a population that is often “hard to reach” or entirely missed in health research. Strategies were specifically tailored to engage the venues and adult residents of highly deprived areas. Future studies recruiting adults living in the most deprived areas might benefit from community recruitment and from collaborating with local gatekeepers who are key to engagement.This study adheres to CONSORT guidelines.Trial Registration: Retrospectively registered with ISRCTN (http://www.isrctn.com/ISRCTN16872545) on 12.01.2018.

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Study protocol for the ‘HelpMeDoIt!’ randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity

BMJ Open ◽

10.1136/bmjopen-2017-017159 ◽

2017 ◽

Vol 7 (10) ◽

pp. e017159 ◽

Cited By ~ 11

Author(s):

Lynsay Matthews ◽

Juliana Pugmire ◽

Laurence Moore ◽

Mark Kelson ◽

Alex McConnachie ◽

...

Keyword(s):

Social Support ◽

Weight Loss ◽

Controlled Trial ◽

Qualitative Interviews ◽

Intervention Group ◽

Ethics Committee ◽

Feasibility Trial ◽

Control Group ◽

Weight Loss Intervention ◽

Randomised Controlled

IntroductionHelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite ‘helpers’ from their social circle to help them achieve their goal(s).AimTo test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals.Methods and analysis12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI)>30 kg/m2and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual factors influencing the intervention.Ethics and disseminationThe protocol has been approved by the West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108). Findings will be disseminated widely through peer-reviewed publication and conference presentations.Trial registration numberISRCTN85615983.

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Evaluating Palin Stammering Therapy for School Children (Palin STSC 8-14): Protocol for a Feasibility Randomised Control Trial Comparing Palin STSC(8-14) with Usual Treatment

10.21203/rs.3.rs-1144678/v1 ◽

2021 ◽

Author(s):

Sharon K Millard ◽

Suzanne Murphy ◽

Garry Barton ◽

Maria Lethersich ◽

Lorna Rixon ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Peer Relations ◽

School Children ◽

Controlled Trial ◽

Feasibility Trial ◽

Randomised Control Trial ◽

Treatment As Usual ◽

Children And Parents ◽

Randomised Controlled ◽

The Impact

Abstract Background: Having a stammer can have a significant effect on a child’s social, emotional and educational development. With approximately 66,000 children in the UK having a stammer, there is a need to establish an adequate evidence base to inform clinical practise. We describe a feasibility trial to explore the effectiveness of a new therapy programme for children aged 8-14: Palin Stammering Therapy for School Children (Palin STSC(8-14)). Preliminary data from the Michael Palin Centre, where the programme was developed, indicate that Palin STSC(8-14) is effective in reducing stammering frequency and impact for children, with beneficial effects for parents too. We will investigate the feasibility of the methods required for a definitive randomised control trial to investigate the application of this therapy by NHS speech and language therapists (SLTs), compared with ‘treatment as usual’ (TAU), beyond the specialist context in which it was developed.Methods: This is a two-arm feasibility cluster-randomised controlled trial of Palin STSC(8-14) with TAU control arm, and randomisation at the level of the SLT. Quantitative and qualitative data will be collected to examine: the recruitment and retention of therapists and families; the acceptability of the research processes and the therapeutic intervention; the appropriateness of the therapy outcome measures. Assessments will be completed by children and parents at baseline and six months later, including measures of: stammering severity; the impact of child’s stammering on both children and parents; child temperament, behaviour, peer relations, anxiety; quality of life; and, economic outcomes. There will also be a qualitative process evaluation, including interviews with parents, children, SLTs and SLT managers to explore the acceptability of both the research and therapy methods. Treatment fidelity will be examined through analysis of therapy session records and recordings. Discussion: The findings of this feasibility trial will inform the decision as to whether to progress to a full-scale randomised controlled trial to explore the effectiveness of Palin STSC(8-14) when compared to Treatment as Usual in NHS SLT services. There is a strong need for an evidence based intervention for school age children who stammer. Trial registration: ISRCTN. ISRCTN17058884. Registered 18th December 2019. https://www.isrctn.com/ISRCTN17058884

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

BMJ Open ◽

10.1136/bmjopen-2019-035787 ◽

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

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Recruitment And Retention Of Participants From Socioeconomically Deprived Communities: Lessons From The Awareness And Beliefs About Cancer (ABACus3) Randomised Controlled Trial.

10.21203/rs.3.rs-33953/v2 ◽

2020 ◽

Author(s):

Vasiliki Kolovou ◽

Yvonne Moriarty ◽

Stephanie Gilbert ◽

Harriet Quinn-Scoggins ◽

Julia Townson ◽

...

Keyword(s):

Financial Incentives ◽

Controlled Trial ◽

Qualitative Interviews ◽

Randomised Control Trial ◽

Trial Participant ◽

Community Settings ◽

Research Strategies ◽

Healthcare Settings ◽

Randomised Controlled ◽

Deprived Areas

Abstract Background: Recruitment of research participants poses challenges in socioeconomically deprived areas. The Awareness and Beliefs About Cancer (ABACus) phase 3 Randomised Control Trial recruited adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model. We report the strategies used to successfully recruit and retain our trial participant sample.Methods: Community and healthcare settings in areas of high socioeconomic deprivation were identified by lay advisors who recruited participants opportunistically or by appointment. Follow-up was done by telephone or post at 2-weeks and 6-months after recruitment, and all participants were offered financial incentives. Qualitative interviews were conducted with lay advisors regarding their experience and reflections.Results: The lay advisors identified and contacted 107 potential recruitment venues across South and West Yorkshire and South East Wales of which 41.1% (n= 42) were opened for recruitment. A total of 234 participants were recruited, with 91% (n= 212) retention at 2-weeks and 85% (n= 199) at 6-months. Community settings yielded 75% (n= 176) of participants. Participants had a mean age of 61.3 years and 63.3% (n= 148) were female, with 66% (n= 154) resident in the most deprived geographical areas. Lay advisors described recruitment as intensive, although engaging participants was easier in community settings.Conclusions: The ABACus3 trial achieved recruitment and high retention with a population that is often “hard to reach” or entirely missed in health research. Strategies were specifically tailored to engage the venues and adult residents of highly deprived areas. Future studies recruiting adults living in the most deprived areas might benefit from community recruitment and from collaborating with local gatekeepers who are key to engagement.This study adheres to CONSORT guidelines.Trial RegistrationRetrospectively registered with ISRCTN (http://www.isrctn.com/ISRCTN16872545) on 12.01.2018.

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Recruitment and retention of participants from socioeconomically deprived communities: lessons from the Awareness and Beliefs About Cancer (ABACus3) Randomised Controlled Trial

BMC Medical Research Methodology ◽

10.1186/s12874-020-01149-x ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Vasiliki Kolovou ◽

Yvonne Moriarty ◽

Stephanie Gilbert ◽

Harriet Quinn-Scoggins ◽

Julia Townson ◽

...

Keyword(s):

Financial Incentives ◽

Controlled Trial ◽

Qualitative Interviews ◽

Randomised Control Trial ◽

Trial Participant ◽

Community Settings ◽

Research Strategies ◽

Healthcare Settings ◽

Randomised Controlled ◽

Deprived Areas

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The Kick-Smart Program: A Randomised Feasibility Trial Evaluating the Feasibility and Efficacy of a Primary-School Based Martial Arts Program Integrating Mathematics, Physical Fitness and Well-Being

Journal of Education and Training Studies ◽

10.11114/jets.v9i3.5142 ◽

2021 ◽

Vol 9 (3) ◽

pp. 47

Author(s):

Louis David Burt ◽

Nicholas Riley ◽

Robert John Parkes ◽

Narelle Eather

Keyword(s):

Primary School ◽

Martial Arts ◽

Controlled Trial ◽

School Setting ◽

Well Being ◽

Feasibility Trial ◽

Randomised Control Trial ◽

Significant Treatment ◽

And Mathematics ◽

Randomised Controlled

The objective of this study was to evaluate the feasibility and efficacy of the ‘Kick-Smart’ martial arts programme using a randomised controlled-trial conducted in one Australian primary school. Kick-Smart involved children 9-11yrs (n= 46) randomised into treatment or wait-list control conditions. Kick-Smart consisted of 2x60min curriculum sessions/week for 6-weeks during school hours. Positive feedback was received from students and teachers regarding program enjoyment, perceived benefits and future plans. Significant treatment effects favouring the Kick-Smart group for muscular fitness and mathematics achievement demonstrates preliminary efficacy. Findings indicate Kick-Smart is feasible for delivery in a primary school setting and effective for improving selected fitness and academic outcomes. Further evidence for the effectiveness of Kick-Smart via a larger randomised control trial is recommended.

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