Introducing the CONSORT extension to pilot trials: enhancing the design, conduct and reporting of pilot or feasibility trials

IntroductionEndotracheal intubation and invasive mechanical ventilation are lifesaving interventions that are commonly performed in the intensive care unit (ICU). Laryngeal oedema is a known complication of intubation that may cause airway obstruction in a patient on extubation. To date, the only test available to predict this complication is the cuff leak test (CLT); however, its diagnostic accuracy and utility remains uncertain. Herein, we report the protocol for the CuffLeak and AirwayObstruction in MechanicallyVentilated ICU Patients (COMIC) pilottrial.Methods and analysisThis will be a multicentred, pragmatic, pilot randomised controlled trial (RCT). We will enrol 100 mechanically ventilated patients in the ICU who are deemed ready for extubation. We will exclude patients at a high risk of laryngeal oedema. All enrolled patients will have a CLT done before extubation. In the intervention arm, the results of the CLT will be communicated to the bedside physician, and decision to extubate will be left to the treating team. In the control arm, respiratory therapist will not communicate the results of the CLT to the treating physician, and the patient will be extubated regardless of the CLT result. Randomisation will be done in a 1:1 allocation ratio, stratified by size of the endotracheal tube and duration of invasive mechanical ventilation.Although we will examine all clinical outcomes relevant for the future COMIC RCT, the primary outcomes of the COMIC pilottrial will be feasibility outcomes including: consent rate, recruitment rate and protocol adherence. Clinical outcomes include postextubation stridor, reintubation, emergency surgical airway, ICU mortality, in hospital mortality, duration of mechanical ventilation and ICU length of stay in days.Ethics and disseminationThe Hamilton Integrated Research Ethics Board, Imam Abdulrahman Bin Faisal University Institutional Review Board and Bioethical Commission of the Jagiellonian University approved this study. The trial results will be disseminated via publication in peer-reviewed journals.Trial registration numberNCT03372707.

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“…We plan to enrol 100 patients for the pilot trial to ensure feasibility criteria will be appropriately examined 21 22…”

Section: Discussionmentioning

confidence: 99%

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COMIC): a pilot randomised controlled trial protocol

et al. 2019

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“…As this was a pilot feasibility study [ 23 ], a convenience sample of 38 older adults was recruited and no sample size calculations were performed [ 24 ]. All baseline and follow-up data are presented as means ± SDs and all change data are reported as means with 95% confidence intervals (CIs) unless otherwise stated.…”

Section: Methodsmentioning

confidence: 99%

Feasibility and acceptability of a remotely delivered, home-based, pragmatic resistance ‘exercise snacking’ intervention in community-dwelling older adults: a pilot randomised controlled trial

et al. 2022

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Background Very few older adults meet current muscle strengthening exercise guidelines, and several barriers exist to supervised, community-based resistance exercise programs. Older adults therefore require access to feasible resistance exercise modalities that may be performed remotely. This pilot study assessed the feasibility and acceptability of undertaking a four-week home-based resistance ‘exercise snacking’ intervention (performed either once, twice, or thrice daily) when delivered and monitored remotely in older adults. Methods Thirty-eight community-dwelling older adults [mean ± SD age 69.8 ± 3.8 y, 63% female] were randomised to complete resistance ‘exercise snacks’ (9-minute sessions) either once (n = 9), twice (n = 10), or thrice (n = 9) daily, or allocated to usual-activity control (n = 10). Exercise adherence and adverse events were assessed using an exercise diary, and acceptability of the intervention was explored using an online questionnaire. Physical function [balance, 5-times sit-to-stand (STS), and 30-second STS tests] was assessed remotely at baseline and follow-up using videoconferencing. Results The intervention was feasible and safe, with 100% participant retention, high adherence (97, 82, and 81% for once, twice, and thrice daily, respectively), and only two adverse events from a total of 1317 ‘exercise snacking’ sessions. The exercise intervention was rated as enjoyable (75% reported their enjoyment as ≥4 on a 5-point Likert scale), easy to perform, and most (82%) planned to continue similar exercise at home. We also found it was feasible to assess measures of physical function via videoconferencing, although effect sizes for 4-week changes in both 5-STS (d range, 0.4–1.4) and 30-STS (d range, 0.7–0.9) following the exercise intervention were similar to controls (d = 1.1 and 1.0 for 5-STS and 30-STS, respectively). Conclusions Resistance ‘exercise snacking’ may be a feasible strategy for engaging older adults in home-based resistance exercise when delivered and monitored remotely. The findings of this pilot feasibility trial support the need for longer-term studies in larger cohorts to determine the effectiveness of resistance ‘exercise snacking’ approaches for improving physical function in older adults. Trial registration The trial was retrospectively registered on 10/11/2021 with the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12621001538831).

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“…As this was a pilot feasibility study [ 23 ], a convenience sample of 20 older adults was recruited with no formal sample size calculations [ 24 ]. However, the observed effect sizes (Cohen d ) for the functional and physical activity measures were calculated using the following formula: mean posttest minus mean baseline divided by baseline standard deviation.…”

Section: Methodsmentioning

confidence: 99%

Feasibility, Usability, and Enjoyment of a Home-Based Exercise Program Delivered via an Exercise App for Musculoskeletal Health in Community-Dwelling Older Adults: Short-term Prospective Pilot Study

Daly

Gianoudis

Hall

et al. 2021

JMIR Mhealth Uhealth

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Background Many older adults choose and prefer to exercise at home, but to attain the greatest benefits, the correct type and dose of exercise should be prescribed and adherence maintained. Advances in digital health technologies now provide the opportunity for exercise professionals to deliver and monitor personalized, evidence-based exercise programs to anyone at any time. Objective The aim of this study was to evaluate the feasibility, usability, and enjoyment of a web-based exercise prescription app as a platform for exercise professionals to remotely deliver and monitor an individually tailored, home-based multicomponent exercise program (delivered through tablet computers) to older adults living independently in the community. Methods This was an 8-week, prospective single-arm pilot study in 20 adults aged ≥65 years living independently in the community: 10 owned a tablet computer (tablet owners) and 10 did not own tablets (tablet nonowners). All participants were prescribed a home-based, muscle strengthening, weight-bearing impact and challenging balance/mobility program (3 days/week) using a commercial exercise prescription app on a tablet computer. Study endpoints were feasibility (retention, adherence, adverse events), usability (System Usability Scale), physical activity enjoyment (Physical Activity Enjoyment Scale), changes in lower extremity function (Short Physical Performance Battery [SPPB]), and level of physical activity (questionnaire). Process measures related to the participants' experiences and perceptions of the exercise program and web-based app were also included. Results A total of 19 participants (mean age, 70 years) completed the study (19/20, 95%), and mean adherence to the exercise program was 84% (95% CI 70%-97%). There were 2 minor adverse events in 2 participants from 401 completed sessions. Mean weekly walking time increased by 78 minutes (95% CI 0-156, P =.049) and moderate-to-vigorous physical activity time by 41 minutes (95% CI –8 to 90, P =.09). For SPPB scores, there was a 0.3 point (95% CI –0.1 to 0.7, P =.17) modest sized (effect size, d =0.42) improvement after 8 weeks. Mean (SD) system usability was high (86 [10] with 100 best imaginable). There was no change in the overall physical activity enjoyment scores after 8 weeks, but participants reported that they enjoyed using the web-based exercise app and the exercise program (median score 4 on a 5-point Likert scale). For all measures, there were no differences between previous tablet owners and nonowners. Conclusions This pilot feasibility study indicates that it is safe and feasible for community-dwelling older adults to participate in a home-based, multicomponent exercise program targeting musculoskeletal health and function that was delivered and monitored remotely by exercise profes...

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Introducing the CONSORT extension to pilot trials: enhancing the design, conduct and reporting of pilot or feasibility trials

Cited by 12 publications

References 16 publications

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COMIC): a pilot randomised controlled trial protocol

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COMIC): a pilot randomised controlled trial protocol

Feasibility and acceptability of a remotely delivered, home-based, pragmatic resistance ‘exercise snacking’ intervention in community-dwelling older adults: a pilot randomised controlled trial

Feasibility, Usability, and Enjoyment of a Home-Based Exercise Program Delivered via an Exercise App for Musculoskeletal Health in Community-Dwelling Older Adults: Short-term Prospective Pilot Study

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