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

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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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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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 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/v1 ◽

2021 ◽

Author(s):

Jenny Ingram ◽

Lucy Beasant ◽

John Benson ◽

Adrian Murray Brunt ◽

Anthony Maxwell ◽

...

Keyword(s):

Breast Cancer ◽

Controlled Trial ◽

Qualitative Interviews ◽

Feasibility Trial ◽

Randomised Control Trial ◽

Ipsilateral Breast ◽

Surgical Interventions ◽

Surgical Trial ◽

Patient Advice ◽

Randomised Controlled

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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Text messaging and financial incentives to encourage weight loss in men with obesity: the Game of Stones feasibility RCT

Public Health Research ◽

10.3310/phr08110 ◽

2020 ◽

Vol 8 (11) ◽

pp. 1-224

Author(s):

Stephan U Dombrowski ◽

Matthew McDonald ◽

Marjon van der Pol ◽

Mark Grindle ◽

Alison Avenell ◽

...

Keyword(s):

Weight Loss ◽

Health Research ◽

Financial Incentives ◽

Controlled Trial ◽

Phase 1 ◽

Qualitative Interviews ◽

Public Health Research ◽

Management Intervention ◽

Randomised Controlled ◽

Weight Management Intervention

Background In 2016, 26% of UK men were estimated to be obese. Systematic reviews suggest that few men engage in formal weight loss interventions that support weight reduction and improve health. Objective To co-produce, with patient and public involvement, an acceptable and feasible randomised controlled trial design to test a men-only weight management intervention. Design This was a two-phase feasibility study. Phase 1 was the development of intervention components, study procedures and materials including a discrete choice experiment with survey questions. Phase 2 was an individually randomised three-arm feasibility trial over 12 months. Qualitative interviews were conducted at 3 and 12 months. Setting The setting was two sites in Scotland that had disadvantaged urban and rural areas and differed in employment levels and ethnic groups. Participants In phase 1, 1045 men with obesity were recruited by Ipsos MORI (London, UK; www.ipsos.com/ipsos-mori/en-uk) to represent the UK population. In phase 2, 105 men with obesity were recruited in the community or through general practice obesity registers. Qualitative interviews were conducted with 50 men at 3 months and with 33 men at 12 months. Interventions The trial arms were narrative short message service (SMS) for 12 months (SMS only), financial endowment incentive informed by loss aversion and linked to achievement of weight loss targets plus narrative SMS for 12 months (SMS + I), and waiting list control group for 12 months followed by 3 months of an alternative SMS style developed based on feedback from men who had received the narrative SMS (control). Main outcome measures The main outcome measures were acceptability and feasibility of recruitment, retention, engagement, intervention components and trial procedures. Outcomes were assessed by examining procedural, quantitative and qualitative data at 3, 6 and 12 months. Results The most acceptable incentive strategy, based on the discrete choice experiment results, was to verify weight loss of 5% at 3 months, verify weight loss of 10% at 6 months and maintain weight loss of 10% at 12 months. Overall, 105 men with obesity from across the socioeconomic spectrum were successfully recruited to target, 59% of whom lived in more disadvantaged areas. Retention at 12 months was acceptable (74%) and was higher among individuals from disadvantaged areas. Narrative SMS were acceptable to many men, with a minority reporting negative reactions. Incentives were acceptable but were not the primary motivation for behaviour change. Twelve men in the incentive arm (33%) secured at least some money and three (8%) secured the full amount. Both intervention arms lost some weight, with greater weight loss in the arm that received SMS and incentives. The alternative SMS based on men’s feedback received no strong negative reactions. Limitations Fewer participants from the SMS + I arm (64%) completed the study at 12 months than did those in the SMS-only (79%) and control (83%) arms. The reasons for this difference were complex. Conclusions The men-only weight management intervention consisting of narrative SMS and financial incentives was acceptable and feasible, meeting the progression criteria for a full trial. Tailoring of SMS may improve acceptability and retention. Future work Minor refinements to the intervention components based on the study findings will be made prior to testing in a multisite definitive randomised controlled trial. Trial registration ClinicalTrials.gov NCT03040518. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 11. See the NIHR Journals Library website for further project information.

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Faculty Opinions recommendation of A randomised controlled trial of active chronic otitis media comparing courses of eardrops versus one-off topical treatments suitable for primary, secondary and tertiary healthcare settings.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.717955853.793460754 ◽

2012 ◽

Author(s):

Marc Bennett

Keyword(s):

Randomised Controlled Trial ◽

Otitis Media ◽

Controlled Trial ◽

Chronic Otitis Media ◽

Healthcare Settings ◽

Tertiary Healthcare ◽

Topical Treatments ◽

Randomised Controlled

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Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol

BMJ Open ◽

10.1136/bmjopen-2018-026086 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026086

Author(s):

Yasutake Tomata ◽

Fumiya Tanji ◽

Dieta Nurrika ◽

Yingxu Liu ◽

Saho Abe ◽

...

Keyword(s):

Financial Incentives ◽

Primary Outcome ◽

Financial Incentive ◽

Controlled Trial ◽

Intervention Group ◽

Sample Size Calculation ◽

Community Dwelling ◽

Control Group ◽

Modifiable Factors ◽

Randomised Controlled

IntroductionPhysical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan.Methods and analysisThis study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4–6 weeks and 7–9 weeks) relative to the average number of daily steps at the baseline (1–3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps.Ethics and disseminationThis study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal.Trial registration numberUMIN000033276; Pre-results.

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A novel ACT-based video game to support mental health through embedded learning: a mixed-methods feasibility study protocol

BMJ Open ◽

10.1136/bmjopen-2020-041667 ◽

2020 ◽

Vol 10 (11) ◽

pp. e041667

Author(s):

Darren J Edwards ◽

Andrew H Kemp

Keyword(s):

Mental Health ◽

Mixed Methods ◽

Video Game ◽

Emotional Regulation ◽

Cognitive Skills ◽

Controlled Trial ◽

Qualitative Interviews ◽

Mental Health Disorder ◽

Acceptance And Commitment ◽

Randomised Controlled

IntroductionIn recent years, serious video games have been used to promote emotional regulation in individuals with mental health issues. Although these therapeutic strategies are innovative, they are limited with respect to scope of treatment, often focusing on specific cognitive skills, to help remediate a specific mental health disorder.ObjectiveHere, we propose a protocol for assessing the feasibility of a novel acceptance and commitment therapy (ACT)-based video game for young adults.Methods and analysisThe Medical Research Council (MRC) framework will be used for developing a complex intervention to design and test the feasibility of an ACT-based video game intervention using a mixed-methods approach involving qualitative and quantitative data. The primary outcomes will include feasibility testing of recruitment processes and the acceptability of the intervention through qualitative interviews, attendance and rates of attrition. Secondary outcomes will involve a series of quantitative questionnaires to obtain effect sizes for power analysis, allowing for the ideal sample size for an appropriately powered, randomised controlled trial to be determined.Ethics and disseminationThis study has been approved by the Psychology Department Research Ethics Committee (2020-4929-3923) at Swansea University in the UK. Dissemination activities will involve publications in peer-reviewed journals, presentations at local and national conferences and promotion through social media.Trial registration numberNCT04566042.

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