Improving the reporting of randomised pilot and feasibility studies: a consort statement extension

Eldridge, Sandra; Bond, Christine; Campbell, Mike; Hopewell, Sally; Thabane, Lehana; Lancaster, Gill; Coleman, Claire L.

doi:10.1186/1745-6215-16-s2-p16

Cited by 6 publications

(5 citation statements)

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“…Results will be reported according to CONSORT guidance [ 56 ] following the conclusion of this study. Feasibility findings as described above will be reported as primary outcomes.…”

Section: Resultsmentioning

confidence: 99%

Coaching While Waiting for Autism Spectrum Disorder Assessment: Protocol of a Pilot Feasibility Study for a Randomized Controlled Trial on Occupational Performance Coaching and Service Navigation Support

Bernie¹,

Williams²,

Graham³

et al. 2021

JMIR Res Protoc

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Background In Australia, the average time between a first concern of autism spectrum disorder (ASD) and diagnosis is over 2 years. After referral for assessment, families often wait 6-12 months before their appointment. This can be a time of uncertainty and stress for families. For some families, other forms of assistance are not accessible and thus timely intervention opportunities are missed. There is little evidence about how to provide the best support for children or caregivers while on assessment waiting lists. Objective The aim of this study is to determine whether use of a coaching intervention called Occupational Performance Coaching (OPC) combined with service navigation support is feasible for families waiting for ASD assessment, as a crucial first step in planning a randomized controlled trial. Methods A pilot and feasibility study will be conducted using recommended constructs and associated measures, which will be reported using CONSORT (Consolidated Standards or Reporting Trials) guidance. Participants will be child and caregiver dyads or triads, recruited within 4 months of their child (aged 1-7 years) being referred to one of two services for an ASD assessment in Victoria, Australia. A blinded randomization procedure will be used to allocate participants to one of three trial arms: (1) coaching and support intervention delivered face to face, (2) coaching and support intervention via videoconference, and (3) usual care. Descriptive statistics will be used to describe the sample characteristics of parents and children, inclusive of service access at baseline and follow up. Recruitment rates will be reported, and retention rates will be evaluated against a predicted rate of 70%-80% in each intervention arm. Goal attainment, using the Canadian Occupational Performance Measure, will indicate preliminary evidence for efficacy within the intervention arms, with an increase of 2 or more points on a 10-point performance and satisfaction scale considered clinically significant. Results The study was approved by The Royal Children’s Hospital Research Ethics and Governance Department in September 2018. As of October 2020, 16 families have been recruited to the study. Data analysis is ongoing and results are expected to be published in 2021. Conclusions Study findings will support planning for a future randomized controlled trial to assess the efficacy of OPC and service navigation support for caregivers of children awaiting ASD assessment. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12620000164998; www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378793&isReview=true International Registered Report Identifier (IRRID) DERR1-10.2196/20011

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“…Results will be reported according to CONSORT guidance [ 56 ] following the conclusion of this study. Feasibility findings as described above will be reported as primary outcomes.…”

Section: Resultsmentioning

confidence: 99%

Coaching While Waiting for Autism Spectrum Disorder Assessment: Protocol of a Pilot Feasibility Study for a Randomized Controlled Trial on Occupational Performance Coaching and Service Navigation Support

Bernie¹,

Williams²,

Graham³

et al. 2021

JMIR Res Protoc

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“…Furthermore, there were only two items (7a and 20) found with significant improved guideline adherence in FDT compared with NFT, implying that more endeavours were requried even in those pilots trials with specified feasibility objective(s). Therefore all these findings suggested further dissemination of the guidline to help clarify the definition of feasibility and pilot trials [2] and to enhance the guildeline adherence [3].…”

Section: Discussionmentioning

confidence: 96%

“…Pilot trials are significantly important for the design of a future main trial (or definitive trial) by providing evidence of feasibility issues and aoviding wasted recourses [1]. In 2016, Eldridge et al published two critical publications aiming to reduce the misunderstanding and improve the reporting quality of pilot trials: the first providing a conceptual framework to define a pilot trial [2], and the second developing a CONSORT (Consolidated Standards of Reporting Trials) extension for pilot trials with a 26-item checklist included [3]. While the two publications may help with the design, implementation, reporting and dissemination of pilot trials, it remained largely unkonwn about their impact on the pilot trials published in the literature.…”

Section: Introductionmentioning

confidence: 99%

Pilot and feasibility trials in traditional Chinese medicine: a literature survey

Chen

et al. 2020

Preprint

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Background The guidelines for pilot and feasibility studies were published in 2016. Little is known about the guideline adherence of TCM (Traditional Chinese Medicine) pilot trials or whether the guidelines can significantly enhance the quality of implementation and reporting of TCM pilot trials. We aimed to investigate the guideline adherence, assess the impact of guidelines on TCM pilot trials, and discuss potentially undetected challenges for TCM pilot trials, by conducting a liteature survey.Methods We systematically searched MEDLINE, EMBASE and CNKI to retreive TCM pilot trials. We randomly chose 50 pilot trials from the eligible studies for analyses. The CONSORT extension to pilot and feasibility studies was used as a framework to assess the methodology and reporting quality of the studies.Results The included stuides had a guideline adherence level ranging from 4% to 96%, where the lowest adherence was found in the item 6c (prespecified criteria used to judge progression to future definitive trial). The guidance published in 2016 seemed to exert minimal effect on guideline adherence in TCM pilot trials. The unidentified issues related to TCM pilot trials from the guidelines included blinding, lack of standard formula of interventions, difficulty in comparison for effect assessment of interventions, and difficulty in bias control.Conclusions The current practice in TCM pilot trials requried substantial improvement in the literature. Further endeavors are needed for training and dissemination of guideline adherence, and development of more detailed methodology in the field of TCM pilot trials.

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“…Factors associated with the context of a complex intervention should also be considered at the earliest stage in the evaluation process, using theoretically informed feasibility and pilot studies. 74 Theoretical frameworks should be used more prospectively as part of the trial design process for complex interventions (or other ex-post methodologies). 75,76 Equally, process evaluations should be run in parallel alongside empirical evaluations of complex interventions in order to help understand 'the causal assumptions underpinning the intervention and … how interventions work in practice'.…”

Section: Discussionmentioning

confidence: 99%

How Should We Evaluate and Use Evidence to Improve Population Oral Health?

Brocklehurst

Baker

Listl

et al. 2019

Dental Clinics of North America

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Improving the reporting of randomised pilot and feasibility studies: a consort statement extension

Cited by 6 publications

References 0 publications

Coaching While Waiting for Autism Spectrum Disorder Assessment: Protocol of a Pilot Feasibility Study for a Randomized Controlled Trial on Occupational Performance Coaching and Service Navigation Support

Coaching While Waiting for Autism Spectrum Disorder Assessment: Protocol of a Pilot Feasibility Study for a Randomized Controlled Trial on Occupational Performance Coaching and Service Navigation Support

Pilot and feasibility trials in traditional Chinese medicine: a literature survey

How Should We Evaluate and Use Evidence to Improve Population Oral Health?

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