Evidence mapPaperPMID 41849488Full record

ArticleCritical care science2026

Statistical analysis plan for a cluster stepped-wedge randomized clinical trial assessing the effects of a multicomponent telemedicine-based intervention on quality of life in adults with respiratory failure requiring mechanical ventilation (Tele-Rehab MV Trial).

Yasmin Ferreira Cavaliere, Rafael Barberena Moraes, Geraldine Trott, Maura Cristina Dos Santos, Gabriela Soares Rech, Andrea de Carvalho, Ivan Ramos Maia, Fernando Godinho Zampieri, Adriano José Pereira, Regis Goulart Rosa

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Critical care science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06343545 (Evaluation of an Integrated Multicomponent Telemedicine-Based Intervention on Health-Related Quality of Life in Adults With Acute Respiratory Failure Requiring Mechanical Ventilation), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

NCT06343545 nacompletednot on this map

Evaluation of an Integrated Multicomponent Telemedicine-Based Intervention on Health-Related Quality of Life in Adults With Acute Respiratory Failure Requiring Mechanical Ventilation (Tele-Rehab MV Trial)

TypeinterventionalSponsorHospital Israelita Albert EinsteinRan2024 to 2025Enrolled1,916ConditionsAcute Respiratory FailureArmsStandard of Care, Disability Prevention and Rehabilitation
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Yasmin Ferreira CavaliereHospital Israelita Albert Einstein - São Paulo (SP), Brazil.
Rafael Barberena MoraesHospital Moinhos de Vento - Porto Alegre (RS), Brazil.ORCID http://orcid.org/0000-0001-6631-7260
Geraldine TrottHospital Moinhos de Vento - Porto Alegre (RS), Brazil.ORCID http://orcid.org/0000-0002-1374-6595
Maura Cristina Dos SantosHospital Israelita Albert Einstein - São Paulo (SP), Brazil.
Gabriela Soares RechHospital Moinhos de Vento - Porto Alegre (RS), Brazil.ORCID http://orcid.org/0000-0001-5122-8820
Andrea de CarvalhoHospital Israelita Albert Einstein - São Paulo (SP), Brazil.
Ivan Ramos MaiaHospital Israelita Albert Einstein - São Paulo (SP), Brazil.
Fernando Godinho ZampieriHospital Israelita Albert Einstein - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0001-9315-6386
Adriano José PereiraHospital Israelita Albert Einstein - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-3528-3800
Regis Goulart RosaHospital Moinhos de Vento - Porto Alegre (RS), Brazil.ORCID http://orcid.org/0000-0001-7881-9866

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo describe the analytical objectives and procedures of the Tele-Rehab MV Trial prior to database lock.

methodsThe Tele-Rehab MV Trial is a cluster stepped-wedge randomized clinical trial comparing a telemedicine-based quality improvement program focused on disability prevention and rehabilitation strategies with usual care. The intervention is implemented during the patient's intensive care unit stay, continued through ward admission, and extends up to 2 months post-hospital discharge. The trial targets adult patients with acute hypoxemic respiratory failure requiring invasive mechanical ventilation, in whom SARS-CoV-2 infection is part of the differential diagnosis. The protocol was approved by the Research Ethics Committee of the coordinating center and by the ethics committees of each of the 20 participating intensive care units, in accordance with Brazilian regulations. The primary outcome is health-related quality of life, assessed 90 days after hospital discharge using the EuroQol 5-Dimension 3-Level (EQ-5D-3L) scale. Secondary outcomes include 30-day rehospitalization, all-cause mortality, anxiety, depression, cognitive impairment, new disabilities in instrumental activities of daily living, and return to work or study 90 days after discharge. This report outlines the primary statistical procedures to be used for evaluating results and conducting sensitivity analyses.

conclusionWe anticipate that this reporting approach will minimize analysis bias and enhance the interpretation of the Tele-Rehab MV Trial results.

Indexed as

Quality of LifeRespiration, ArtificialRespiratory InsufficiencyTelemedicineActivities of Daily LivingAdultBrazilCluster AnalysisCOVID-19HumansIntensive Care UnitsQuality ImprovementRandomized Controlled Trials as Topic

Identifiers

PMID41849488
PMCPMC13124108

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.