Pragmatic trial design elements showed a different impact on trial interpretation and feasibility than explanatory elements

Nieuwenhuis, Joost B.; Irving, Elaine; Rengerink, Katrien Oude; Lloyd, E. L.; Goetz, Iris; Grobbee, Diederick E.; Stolk, Pieter; Zuidgeest, Mira G. P.

doi:10.1016/j.jclinepi.2016.04.010

Cited by 10 publications

(10 citation statements)

References 25 publications

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“…Given that EAM is targeted in OA prevention programs, 35 , 37 , 39 perhaps pre-emptive reductions may help protect prosthesis users from OA development and subsequent progression. 10 , 24 However, this is currently speculative: this study was neither longitudinal nor with individuals with diagnosed OA. This suggestion needs to be supported by appropriate high-quality longitudinal studies.…”

Section: Discussionmentioning

confidence: 94%

“…This study was a pragmatic randomized controlled cross-over trial (RCT; Pan African Clinical Trials Registry number: PACTR202006792038036). 24 We chose a cross-over design so that each participant served as their own control, minimizing intergroup variation. Wherever possible, we sought to introduce blinding into this study by using measures to conceal prosthetic componentry from both the testing team and participants.…”

Section: Methodsmentioning

confidence: 99%

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A novel pivot ankle/foot prosthesis reduces sound side loading and risk for osteoarthritis: a pragmatic randomized controlled trial

Runciman

Cockcroft

Derman

2022

Prosthetics &Amp; Orthotics International

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Background:Individuals with unilateral transtibial amputation are at risk of abnormal mechanical joint loading and development of osteoarthritis on sound side joint structures.Objectives:This study describes the spatiotemporal and kinetic and kinematic parameters related to osteoarthritis in participants while using (A) a solid-ankle cushioned-heel prosthesis (SACH), (B) a conventional energy storage and return (ESAR) foot prosthesis, and (C) a novel ESAR (N-ESAR) foot prosthesis.Study design:A pragmatic randomized controlled trial.Methods:K3–K4 ambulators used three feet in a 2-week randomized cross-over order. Kinetics of vertical ground reaction forces (vGRFs) and 3D kinematics of joint angles were integrated to provide normalized parameters. Data were analyzed using one way and mixed model Analysis of variance (ANOVAs) (p < 0.05) and Cohen d statistic.Results:Twenty participants, aged 40 ± 16 years with body mass index of 24.7 ± 3.6 kg/m2, experienced minimal change in the spatiotemporal parameters between feet. Participants using the N-ESAR foot prosthesis experienced reduced peak knee external adduction moment (p = 0.030), peak vGRFs (p < 0.001), and peak loading rate of vGRFs (p = 0.030). Peak knee flexion moments only changed when using the solid-ankle cushioned-heel prosthesis, in a positive direction (p = 0.014). Using the N-ESAR prosthesis also increased peak distal shank power during late stance phase (p < 0.001).Conclusions:A novel ankle/foot ESAR prosthesis reduces loading on the sound side. With extended use of the N-ESAR foot prosthesis, these findings may provide the prosthesis user with improved outcomes related to sound side loading and development of osteoarthritis.

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Section: Discussionmentioning

confidence: 94%

Section: Methodsmentioning

confidence: 99%

A novel pivot ankle/foot prosthesis reduces sound side loading and risk for osteoarthritis: a pragmatic randomized controlled trial

Runciman

Cockcroft

Derman

2022

Prosthetics &Amp; Orthotics International

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“…To gain the benefit of the full potential of a pragmatic trial, there is a need for guidance and tools in designing the trial while ensuring operational feasibility [44,45]. The consequences of design choices should be clarified, including the possible impact on feasibility, ethical acceptability, stakeholder preferences, validity, precision, and generalizability (see Box 1).…”

Section: Resultsmentioning

confidence: 99%

Series: Pragmatic trials and real world evidence: Paper 1. Introduction

Zuidgeest

Goetz

Groenwold

et al. 2017

Journal of Clinical Epidemiology

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163

139

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This is the introductory paper in a series of eight papers. In this series, we integrate the theoretical design options with the practice of conducting pragmatic trials. For most new market-approved treatments, the clinical evidence is insufficient to fully guide physicians and policy makers in choosing the optimal treatment for their patients. Pragmatic trials can fill this gap, by providing evidence on the relative effectiveness of a treatment strategy in routine clinical practice, already in an early phase of development, while maintaining the strength of randomized controlled trials. Selecting the setting, study population, mode of intervention, comparator, and outcome are crucial in designing pragmatic trials. In combination with monitoring and data collection that does not change routine care, this will enable appropriate generalization to the target patient group in clinical practice. To benefit from the full potential of pragmatic trials, there is a need for guidance and tools in designing these studies while ensuring operational feasibility. This paper introduces the concept of pragmatic trial design. The complex interplay between pragmatic design options, feasibility, stakeholder acceptability, validity, precision, and generalizability will be clarified. In this way, balanced design choices can be made in pragmatic trials with an optimal chance of success in practice.

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“…In general, it should be considered that design choices towards a more pragmatic or explanatory study design may affect validity, generalizability, precision, and feasibility [ 51 ]. Currently, the PRECIS-2 tool, which was developed to support researchers in designing trials, would be a helpful instrument to make informed decisions about the trials’ position on the pragmatic-explanatory continuum [ 52 ].…”

Section: Discussionmentioning

confidence: 99%

Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT)

Ammann-Reiffer

Bastiaenen

Meyer-Heim

et al. 2020

PRM

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PURPOSE: To investigate the effectiveness of outpatient robot-assisted gait training (RAGT) in ambulatory children with spastic cerebral palsy. METHODS: Children were randomized to two different intervention sequences within a pragmatic crossover design. They performed five weeks of RAGT (3 sessions per week) and five weeks of usual care (UC). Dimension E of the Gross Motor Function Measure-88 (GMFM E) as the primary outcome as well as Dimension D (GMFM D), and timed walking tests were assessed before and after each treatment sequence and after a 5-week follow-up. RESULTS: The trial was stopped early because of recruitment problems. We included 16 children with a mean age of 11.3 years (6.0-15.3 years). GMFM E median (IQR) change scores were −0.7 (−2.8 to 3.5) after RAGT and 0 (−2.4 to 2.4) after UC. Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow-up, or carry-over effects observable. CONCLUSIONS: RAGT as a single intervention was not effective in improving walking abilities in the included children. It should be embedded in a holistic treatment approach, as it cannot cover all aspects relevant to gait. Furthermore, children's personalized rehabilitation goals should be carefully monitored with individualized measurement instruments.

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Pragmatic trial design elements showed a different impact on trial interpretation and feasibility than explanatory elements

Cited by 10 publications

References 25 publications

A novel pivot ankle/foot prosthesis reduces sound side loading and risk for osteoarthritis: a pragmatic randomized controlled trial

A novel pivot ankle/foot prosthesis reduces sound side loading and risk for osteoarthritis: a pragmatic randomized controlled trial

Series: Pragmatic trials and real world evidence: Paper 1. Introduction

Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT)

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