Methodological Challenges in Web-Based Trials: Update and Insights From the Relatives Education and Coping Toolkit Trial

Robinson, Heather; Appelbe, Duncan; Flowers, Susan; Jones, Steven H.; Mateus, Céu; Mezes, Barbara; Murray, Elizabeth; Rosala-Hallas, Anna; Walker, A. Earl; Williamson, Paula; Lobban, Fiona

doi:10.2196/15878

Cited by 13 publications

(11 citation statements)

References 54 publications

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“…Finally, lack of interest in internet-administered self-help was a common reason for non-participation. Despite well-demonstrated clinical effectiveness of e-MH interventions,78 difficulties with recruitment into trials are common79 and rates of implementation are low 80. Barriers include lack of trust, poor digital health literacy, low levels of confidence in using digital technology, and preferences for face-to-face interventions 17–20.…”

Section: Discussionmentioning

confidence: 99%

Opt-out rates and reasons for non-participation in a single-arm feasibility trial (ENGAGE) of a guided internet-administered CBT-based intervention for parents of children treated for cancer: a nested cross-sectional survey

et al. 2022

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ObjectivesDifficulties with recruitment into clinical trials are common. An opt-out recruitment strategy, whereby potential participants can decline further contact about a study (opt-out), and non-responders are contacted, may facilitate participation. Primary objectives examined opt-out and consent rates, mode and time point of opt-out, and sociodemographic characteristics of those who opted out versus those who chose to participate in a single-arm feasibility trial (ENGAGE) of a guided, internet-administered, cognitive–behavioural therapy-based intervention for parents of children treated for cancer. Secondary objectives examined reasons for non-participation.DesignA cross-sectional survey nested within the ENGAGE feasibility trial.SettingThe intervention was delivered from Uppsala University, with parents located throughout Sweden.ParticipantsPotential participants were recruited 3 months–5 years following their child ending treatment for cancer and were identified via their personal identification number (via the Swedish Childhood Cancer Registry and Swedish Tax Agency) and invited via postal invitation packs and could opt out via post, online, telephone or email. Those who did not opt out or consent, within 4 weeks, received up to five telephone calls and/or one postal reminder.ResultsOf 509 invited, 164 (32.2%) opted out, 78 (47.6%) via post, 53 (32.3%) via telephone, 24 (14.6%) online, and 6 (3.7%) via email, 88 (53.7%) opted out after at least one telephone call and/or postal reminder. There was a trend for parents with lower educational levels to opt out. No need of psychological support, lack of time, and no interest in internet-administered self-help were frequently reported reasons for non-participation.ConclusionsResults emphasise the importance of using different opt-out modes and suggest future research should consider how to widen study participation for parents with lower education levels. Self-identifying a need for psychological support and the acceptability of internet-administered self-help are important factors for participation and should be considered in future research to increase recruitment.Trial registration numberISRCTN57233429.

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Section: Discussionmentioning

confidence: 99%

Opt-out rates and reasons for non-participation in a single-arm feasibility trial (ENGAGE) of a guided internet-administered CBT-based intervention for parents of children treated for cancer: a nested cross-sectional survey

et al. 2022

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“…Studies claimed to have more ethical rigour, 57 as carers highlighted potentially sensitive issues 75 and suggested more appropriate support strategies, 138 wording and methods 65,136 . Their understanding of the participants increased the efficacy of recruitment methods, 65,66,111 and feasibility of participation to improve retention rates 95,105 . Carers helped to interpret ‘the meaning of that experience communicated by the carer’ 89 , .…”

Section: Resultsmentioning

confidence: 99%

Participatory research with carers: A systematic review and narrative synthesis

Bowness,

Henderson,

Akhter Khan

et al. 2023

Health Expectations

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IntroductionAs patient and public involvement (PPI) in research has become increasingly common, research‐based recommendations on its principles and impacts have been established. The specifics of conducting PPI are likely to differ when involving different groups. Family/informal carers for those with health conditions or disabilities have a lot to contribute to research, but instances of their involvement have yet to be reviewed.ObjectiveTo systematically review and synthesize studies where family/informal carers have been involved in the research process, to develop an understanding of the benefits, barriers and facilitating factors.MethodsA search of five electronic databases was conducted using a combination of terms relating to carers, involvement and research. A grey literature search, expert consultation and hand‐searching were also used. Following screening, data extraction and quality assessment, a narrative synthesis incorporating thematic analysis was conducted.FindingsA total of 55 studies met the inclusion criteria, with diverse design and participatory approaches. Four themes were identified, relating to the outcomes, challenges, and practicalities of involving carers: (re) building relationships with carers; carers as equals not afterthoughts; carers have unique experiences; carers create change. Full involvement throughout the research was not always possible, due to barriers from the research world and responsibilities of the caring role. The literature demonstrated ways for carers to contribute in ways that suited them, maximizing their impact, while attending to relationships and power imbalances.ConclusionBy summarizing the reported instances of carer involvement in research, this review brings together different examples of how successful research partnerships can be built with carers, despite various challenges. Carers are a heterogeneous group, and participatory approaches should be tailored to specific situations. Wider understanding of the challenges of conducting empowering research with carers, and the resources required to address these, are needed.Patient and Public InvolvementThe initial findings and themes were presented to a group of carers who had been involved in research and whose reflections informed the final synthesis.

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“…Key user statements and interview observations generated the first iteration of user needs [ 18 ], including needs being met by current means of evaluating DHIs and needs that remained unmet or were causing difficulty and frustration in evaluation efforts. Identified user needs were articulated using an accepted UCD template called Jobs To Be Done (JTBD), which identifies the type of user, their need, when the need arises, and the outcome they are trying to achieve [ 25 ].…”

Section: Resultsmentioning

confidence: 99%

“…As a public health body with a finite budget and responsibility for improving population health, Public Health England (PHE) was at the forefront of considering how best to use DHIs to improve health outcomes and evaluate their value (measured as an improvement to public health). Multiple biomedical and digital approaches to the evaluation of DHIs exist and are described and critiqued elsewhere [ 2 , 11 , 15 - 18 ]. This paper reports on a project by PHE to develop and operationalize an evaluation framework that combines these approaches with the goal of demonstrating the impact, cost-effectiveness, and benefit of DHIs on public health.…”

Section: Introductionmentioning

confidence: 99%

An Evaluation Service for Digital Public Health Interventions: User-Centered Design Approach

Karpathakis¹,

Libow²,

Potts³

et al. 2021

J Med Internet Res

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Background Digital health interventions (DHIs) have the potential to improve public health by combining effective interventions and population reach. However, what biomedical researchers and digital developers consider an effective intervention differs, thereby creating an ongoing challenge to integrating their respective approaches when evaluating DHIs. Objective This study aims to report on the Public Health England (PHE) initiative set out to operationalize an evaluation framework that combines biomedical and digital approaches and demonstrates the impact, cost-effectiveness, and benefit of DHIs on public health. Methods We comprised a multidisciplinary project team including service designers, academics, and public health professionals and used user-centered design methods, such as qualitative research, engagement with end users and stakeholders, and iterative learning. The iterative approach enabled the team to sequentially define the problem, understand user needs, identify opportunity areas, develop concepts, test prototypes, and plan service implementation. Stakeholders, senior leaders from PHE, and a working group critiqued the outputs. Results We identified 26 themes and 82 user needs from semistructured interviews (N=15), expressed as 46 Jobs To Be Done, which were then validated across the journey of evaluation design for a DHI. We identified seven essential concepts for evaluating DHIs: evaluation thinking, evaluation canvas, contract assistant, testing toolkit, development history, data hub, and publish health outcomes. Of these, three concepts were prioritized for further testing and development, and subsequently refined into the proposed PHE Evaluation Service for public health DHIs. Testing with PHE’s Couch-to-5K app digital team confirmed the viability, desirability, and feasibility of both the evaluation approach and the Evaluation Service. Conclusions An iterative, user-centered design approach enabled PHE to combine the strengths of academic and biomedical disciplines with the expertise of nonacademic and digital developers for evaluating DHIs. Design-led methodologies can add value to public health settings. The subsequent service, now known as Evaluating Digital Health Products, is currently in use by health bodies in the United Kingdom and is available to others for tackling the problem of evaluating DHIs pragmatically and responsively.

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Methodological Challenges in Web-Based Trials: Update and Insights From the Relatives Education and Coping Toolkit Trial

Abstract: International Registered Report Identifier (IRRID) RR2-10.1136/bmjopen-2017-016965

Cited by 13 publications

References 54 publications

Opt-out rates and reasons for non-participation in a single-arm feasibility trial (ENGAGE) of a guided internet-administered CBT-based intervention for parents of children treated for cancer: a nested cross-sectional survey

Opt-out rates and reasons for non-participation in a single-arm feasibility trial (ENGAGE) of a guided internet-administered CBT-based intervention for parents of children treated for cancer: a nested cross-sectional survey

Participatory research with carers: A systematic review and narrative synthesis

An Evaluation Service for Digital Public Health Interventions: User-Centered Design Approach

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