Exploratory studies to inform full-scale evaluations of complex public health interventions: the need for guidance

Moore, Laurence; Hallingberg, Britt; Wight, Daniel; Turley, Ruth; Segrott, Jeremy; Craig, Peter; Robling, Michael; Murphy, Simon; Simpson, Sharon Anne; Moore, Graham

doi:10.1136/jech-2017-210414

Cited by 64 publications

(13 citation statements)

References 9 publications

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“…However, there is serious inconsistency concerning the design, execution and evaluation of pilot studies, which are even interchangeably termed as exploratory or feasibility trails [38]. More specific guidelines concerning the design, execution, analysis and reporting of pilot studies are therefore needed, and might be published shortly [51,52].…”

Section: Methodological Considerationsmentioning

confidence: 99%

The MiLES intervention targeting employers to promote successful return to work of employees with cancer: design of a pilot randomised controlled trial

Greidanus

Boer

Rijk

et al. 2020

Trials

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Background: Employers express a need for support to facilitate the return to work (RTW) process of employees with cancer. We have developed the MiLES intervention, an online toolbox targeting employers during the RTW of employees with cancer. To evaluate the MiLES intervention, we propose the design of a pilot randomised controlled trial (RCT). The aim of this pilot is to determine whether a future RCT to study the effectiveness of this intervention on successful RTW of employees with cancer is feasible. Secondary aims are to obtain preliminary results on the effectiveness of the intervention and to determine the sample size needed in a future definitive RCT. Methods: A pilot RCT with a 6-month follow-up will be conducted. Using medical specialists at Dutch hospitals, we aim to enrol 90 participants diagnosed with cancer (<2 years earlier) aged 18-63 years who are in paid employment with an employer and who are currently sick-listed or partly sick-listed for <1 year. Participants randomised to the intervention group will be asked to inform their employer about the online toolbox supporting employers during the RTW process of employees with cancer. Participants in the control group will receive 'care as usual' from their employer. All measures will be assessed at the level of the employee using questionnaires at baseline and after 3 and 6 months of follow-up. The feasibility of a future RCT will be determined using criteria concerning methodrelated uncertainties and acceptability of the study protocol. The primary effect measure will be successful RTW (that is, RTW perceived as being successful by the cancer survivor themselves). This effect measure will be used to perform the sample size calculation for a future definitive RCT. Discussion: The design is proposed to determine the feasibility to study the effectiveness of the MiLES intervention targeting employers on the successful RTW of employees diagnosed with cancer. This pilot RCT can increase the probability of a successful future definitive RCT on the effectiveness of the intervention and potentially obviate the need to carry out an unfeasible and resource-intensive study.

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Section: Methodological Considerationsmentioning

confidence: 99%

The MiLES intervention targeting employers to promote successful return to work of employees with cancer: design of a pilot randomised controlled trial

Greidanus

Boer

Rijk

et al. 2020

Trials

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“…A decision not to proceed to full evaluation may be made for example due to failure to demonstrate that recruitment can be achieved in particular settings, such as lower socio-economic status schools or neighbourhoods. New MRC-NIHR funded guidance on feasibility studies is in development (Hallingberg et al, 2018; Moore et al, 2018), and will likely stimulate further debate and changes in practice around some of the issues identified in this article.…”

Section: What Does a Systems Lens Mean For Intervention Development Amentioning

confidence: 99%

From complex social interventions to interventions in complex social systems: Future directions and unresolved questions for intervention development and evaluation

et al. 2018

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Complex systems approaches to social intervention research are increasingly advocated. However, there have been few attempts to consider how models of intervention science, such as the UK’s Medical Research Council complex interventions framework, might be reframed through a complex systems lens. This article identifies some key areas in which this framework might be reconceptualized, and a number of priority areas where further development is needed if alignment with a systems perspective is to be achieved. We argue that a complex systems perspective broadens the parameters of ‘relevant’ evidence and theory for intervention development, before discussing challenges in defining feasibility in dynamic terms. We argue that whole systems evaluations may be neither attainable, nor necessary; acknowledgment of complexity does not mean that evaluations must be complex, or investigate all facets of complexity. However, a systems lens may add value to evaluation design through guiding identification of key uncertainties, and informing decisions such as timings of follow-up assessments.

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“…Findings were further considered in relation to wider theoretical and methodological debates, and their potential relationship to existing methodological recommendations in population health. [3][4][5] The meeting was audio-recorded and transcribed verbatim by a professional transcription service. Three members of the study team (GM, RE and AM) analysed the data to identify key themes.…”

Section: Adapt Study Panel Meetingmentioning

confidence: 99%

How can we adapt complex population health interventions for new contexts? Progressing debates and research priorities

Evans

Moore

Movsisyan

et al. 2020

J Epidemiol Community Health

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IntroductionThe UK Medical Research Council and National Institute for Health Research have funded the ADAPT study (2018–2020), to develop methodological guidance for the adaptation of complex population health interventions for new contexts. While there have been advances in frameworks, there are key theoretical and methodological debates to progress. The ADAPT study convened a panel meeting to identify and enrich these debates. This paper presents the panel’s discussions and suggests directions for future research.MethodsSixteen researchers and one policymaker convened for a 1-day meeting in July 2019. The aim was to reflect on emerging study findings (systematic review of adaptation guidance; scoping review of case examples; and qualitative interviews with funders, journal editors, researchers and policymakers), progress theoretical and methodological debates, and consider where innovation may be required to address research gaps.DiscussionDespite the proliferation of adaptation frameworks, questions remain over the definition of basic concepts (eg, adaptation). The rationale for adaptation, which often focuses on differences between contexts, may lead to adaptation hyperactivity. Equal emphasis should be placed on similarities. Decision-making about intervention modification currently privileges the concept of ‘core components’, and work is needed to progress the use and operationalisation of ‘functional fidelity’. Language and methods must advance to ensure meaningful engagement with diverse stakeholders in adaptation processes. Further guidance is required to assess the extent of re-evaluation required in the new context. A better understanding of different theoretical perspectives, notably complex systems thinking, implementation science and realist evaluation may help in enhancing research on adaptation.

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Exploratory studies to inform full-scale evaluations of complex public health interventions: the need for guidance

Cited by 64 publications

References 9 publications

The MiLES intervention targeting employers to promote successful return to work of employees with cancer: design of a pilot randomised controlled trial

The MiLES intervention targeting employers to promote successful return to work of employees with cancer: design of a pilot randomised controlled trial

From complex social interventions to interventions in complex social systems: Future directions and unresolved questions for intervention development and evaluation

How can we adapt complex population health interventions for new contexts? Progressing debates and research priorities

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