The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study)

Crawley, Esther; Mills, Nicola; Beasant, Lucy; Johnson, Debbie; Collin, Simon M.; Deans, Zuzana; White, Kate; Montgomery, Alan

doi:10.1186/1745-6215-14-415

Cited by 19 publications

(36 citation statements)

References 26 publications

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“…- Example “Allocation…was implemented using an automated telephone randomization service provided by the Bristol Randomized Trials Collaboration to ensure concealment from clinical staff undertaking recruitment [62]. ”…”

Section: Methodsmentioning

confidence: 99%

“…If the child and his or her family were willing to find out more about the study a researcher contacted the family and arranged to visit them at a convenient location (usually at home)…Those willing to take part were randomized to receive either specialist medical care or to specialist medical care plus the Phil Parker Lightning Process (LP). Allocation…was implemented…by the Bristol Randomized Trials Collaboration…” [62] …”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Eldridge

Chan

Campbell

et al. 2016

Pilot Feasibility Stud

1,724

1,227

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The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply.The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist.The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number.This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials.Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.Electronic supplementary materialThe online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Eldridge

Chan

Campbell

et al. 2016

Pilot Feasibility Stud

1,724

1,227

View full text Add to dashboard Cite

show abstract

“…Children (aged 12–18 years) and their parents were interviewed as part of the SMILE trial about whether PROMs used were suitable to assess the impact of CFS/ME and measure important outcomes. 24 25 Children and their mothers were interviewed at three possible time points using a checklist of topics 24 25 usually at the participants’ homes. Purposive sampling ensured interviews included a range of informants, in terms of age, sex and families from both intervention arms (maximum variation sampling).…”

Section: Methodsmentioning

confidence: 99%

What matters to children with CFS/ME? A conceptual model as the first stage in developing a PROM

et al. 2015

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BackgroundPaediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) is relatively common and disabling. Research is hampered because current patient-reported outcome measures (PROMs) do not capture outcomes that are important to children with CFS/ME.AimThe aim of this study was to explore the aspects of life and health outcomes that matter to children with CFS/ME.MethodsTwenty-five children with CFS/ME were interviewed (11 males, 14 females; mean age 12.9 years (SD 2.2), range 8–17). Twelve were trial participants interviewed during the trial and 13 were recruited as part of a follow-up qualitative study. Parents were present in 19 interviews with their children. Three mothers participated in a focus group. All the interviews and the focus group were audio-recorded and transcribed. Data were analysed thematically using techniques of constant comparison. NVivo was used to structure and categorise data in a systematic way.ResultsChildren identified four key themes (health outcome domains): ‘symptoms’ that fluctuated, which caused an unpredictable reduction in both ‘physical activity’ and ‘social participation’ all of which impacted on ‘emotional well-being’. These domains were influenced by both ‘management’ and ‘contextual factors’, which could be positive and negative. The relationship between healthcare and school was considered pivotal.ConclusionsChildren's descriptions helped to inform a conceptual model that is necessary to develop a new paediatric CFS/ME PROM. Doctors need to be aware of how children conceptualise CFS/ME; the relationship between healthcare and school is fundamental to ameliorate the impact of CFS/ME.Trial registration numberISRCTN81456207.

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“…Qualitative reports may also neglect underlying contexts or describe only limited areas of variation (for example, between individuals rather than over time) (e.g. Crawley et al, 2013;Gafos et al, 2017). Given the ethical importance of acceptability and its ambiguity, further work to clarify this concept may support more nuanced investigation of participant perceptions to inform responsive trial design.…”

Section: A N U S C R I P Tmentioning

confidence: 99%

Six dimensions of research trial acceptability: how much, what, when, in what circumstances, to whom and why?

Gooding

Phiri

Peterson

et al. 2018

Social Science & Medicine

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Ethics guidelines emphasise that research should be acceptable to the people invited to take part. However, acceptability is subjective and dependent on context, complicating its assessment and use as an ethical standard. This paper examines the concept of acceptability in relation to parents' perspectives on a paediatric vaccine trial in Malawi. We examined decisions on participation and experiences of the trial through interviews with parents in 41 households invited to enrol their children and participant observation of trial processes. Fieldwork took place in Chikwawa, Southern Malawi from February-October 2016. Parents were not neatly split between those who saw the trial as acceptable and those who did not; instead there were mixed and changing feelings among parents who enrolled their children, and among those who withdrew or did not take part. Some parents agreed to participate but had concerns about the trial, while others expressed satisfaction with the trial but still did not take part. These experiences indicate substantial variation in the nature of acceptance. We describe these variations in relation to six dimensions of acceptability: how acceptable the trial is, what aspects are acceptable, changes over time, circumstances affecting acceptability, variations between people, and reasons for participation or non-participation. The findings illustrate the difficulty of determining whether a trial is sufficiently acceptable to potential participants. We suggest that clarifying definitions of acceptability and examining how acceptability varies in degree, between trial components, over time, and between people and contexts may help researchers generate more nuanced descriptions of acceptability that support responsive and ethical trial design.

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The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study)

Cited by 19 publications

References 26 publications

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

What matters to children with CFS/ME? A conceptual model as the first stage in developing a PROM

Six dimensions of research trial acceptability: how much, what, when, in what circumstances, to whom and why?

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