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ArticleTrials2021

Effectiveness of expiratory technique and induced sputum in obtaining good quality sputum from patients acutely hospitalized with suspected lower respiratory tract infection: a statistical analysis plan for a randomized controlled trial.

Mariana Bichuette Cartuliares, Helene Skjøt-Arkil, Flemming Schønning Rosenvinge, Christian Backer Mogensen, Thor Aage Skovsted, Andreas Kristian Pedersen

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04595526 (Optimal Collection of Specimens of the Lower Respiratory Tract), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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.

NCT04595526 nacompletednot on this map

Optimal Collection of Specimens of the Lower Respiratory Tract

TypeinterventionalSponsorUniversity of Southern DenmarkRan2020 to 2021Enrolled280ConditionsRespiratory Tract InfectionsArmsForced expiratory technique and induced sputum, Tracheal suction
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
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

6 authors.

Mariana Bichuette CartuliaresEmergency Department, University Hospital of Southern Denmark, Kresten Philipsens vej 15, 6200, Aabenraa, Denmark. mariana.cartuliares@rsyd.dk.ORCID http://orcid.org/0000-0003-0923-6960
Helene Skjøt-ArkilEmergency Department, University Hospital of Southern Denmark, Kresten Philipsens vej 15, 6200, Aabenraa, Denmark.
Flemming Schønning RosenvingeDepartment of Clinical Microbiology, Odense University Hospital, J.B. Winsløwsvej 21-24, 5000, Odense C, Denmark.
Christian Backer MogensenEmergency Department, University Hospital of Southern Denmark, Kresten Philipsens vej 15, 6200, Aabenraa, Denmark.
Thor Aage SkovstedDepartment of Biochemistry and Immunology, University Hospital of Southern Denmark, Kresten Philipsens vej 15, 6200, Aabenraa, Denmark.
Andreas Kristian PedersenDepartment of Regional Health Research, University of Southern Denmark, Aabenraa, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTargeted antimicrobial treatment is essential to avoid unnecessary use of broad-spectrum antibiotics and antimicrobial resistance. Targeted treatment relies on a precise microbiological diagnosis - in pneumonia, this poses a challenge as the usefulness of Gram stains and cultures is highly dependent on the quality of the sputum sample. This study aims to examine adverse effects and quality of sputum samples obtained by expiratory techniques (forced expiratory technique and sputum induction) compared with tracheal suction. The hypothesis is that expiratory techniques are non-inferior to tracheal suction in obtaining samples from the lower respiratory tract. This statistical analysis plan (SAP) describes the study design, method, and data analysis of the trial to increase transparency, avoid reporting bias or data-driven analysis and increase the study's reproducibility.

methodThe design is a pragmatic, non-inferiority, parallel-arm randomized controlled trial including 280 patients admitted with suspected lower respiratory infection to two emergency departments. Patients are randomized to a usual care group, where sputum samples are collected by tracheal suction or to an intervention group where sputum samples are collected by forced expiratory technique and sputum induction. The statistical analysis will follow an intention-to-treat protocol. This SAP is developed and submitted before the end of recruitment, database closure, and statistical analyses. DISCUSSION: The results of this study will provide valuable knowledge to clinical practice by comparing adverse effects and sputum sample quality associated with different sample methods.

trial registrationClinicaltrials.gov , NCT04595526 . Submitted on October 19, 2020.

Indexed as

Respiratory Tract InfectionsEquivalence Trials as TopicHospitalizationHumansPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicReproducibility of ResultsSputumForced expiratory techniqueInduced sputumRandomized controlled trialRespiratory tract infectionSputum sampleStatistical analysis planTracheal suction

Identifiers

PMID34600559
PMCPMC8487344

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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 OpenQuestion graph.