ArticleTrials2025
Polysomnographic titration of non-invasive ventilation in motor neurone disease (3TLA): protocol for a process evaluation of a clinical trial.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05136222 (A Multi-centre Randomised Controlled Trial of Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-centre Randomised Controlled Trial of Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease (PSG4NIVinMND; 3, Three Letter Acronyms [3TLA])
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe are undertaking a multicentre randomised controlled trial to determine the effectiveness of including a sleep study (polysomnography (PSG)) to assist the commencement of non-invasive ventilation (NIV) in people with motor neurone disease (MND): the Polysomnographic titration of non-invasive ventilation in motor neurone disease (PSG4NIVinMND; 3-three letter acronym; 3TLA) trial. A process evaluation will be conducted alongside the clinical trial to understand: (1) the implementation of the 3TLA intervention in the trial sites, including barriers and enablers, and (2) the mechanisms through which the 3TLA intervention produces change. This protocol paper describes the rationale, aims and methods of the 3TLA process evaluation.
methodsTo guide the design of the process evaluation, a logic model representing the 3TLA intervention, the likely mechanisms of impact, potential external contextual factors and assumptions, and the anticipated outcomes was developed by the researchers in collaboration with the 3TLA Trial Steering Committee. From this, five key process evaluation research questions were identified, a priori. The mixed-methods design is guided by three implementation frameworks: the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, the Theoretical Domains Framework (TDF), and the Theoretical Framework of Acceptability (TFA). We will conduct semi-structured interviews with approximately 20-30 clinical trial participants (people with MND) and their carers, and focus groups and surveys with approximately 60 health professionals involved in delivering the intervention at each site. Quantitative process data will also be collected from the main clinical trial. Qualitative and quantitative data will be analysed iteratively throughout the trial, independent of the main trial outcome analyses. Process evaluation findings will be triangulated with the results of the clinical trial. DISCUSSION: This process evaluation incorporates a mixed-methods design and is informed by three theoretical frameworks. It will provide insights into how the 3TLA intervention was implemented, for whom and how the 3TLA intervention was (and was not) effective, and what adaptations may be needed to facilitate future implementation into routine clinical practice.
trial registrationClinicalTrials.gov NCT05136222. Registered on November 25, 2021.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.