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

Autor:	Andreas Kristian Pedersen, Helene Skjøt-Arkil, Mariana Bichuette Cartuliares, Flemming S Rosenvinge, Thor Aage Skovsted, Christian Backer Mogensen
Rok vydání:	2021
Předmět:	Respiratory Tract Infections/diagnosis Medicine (General) medicine.medical_specialty Statistical analysis plan Forced expiratory technique Respiratory tract infection Medicine (miscellaneous) law.invention Study Protocol R5-920 Randomized controlled trial law Lower respiratory tract infection Internal medicine medicine Humans Induced sputum Pharmacology (medical) Sputum sample Adverse effect Respiratory Tract Infections Protocol (science) business.industry Sputum COVID-19 Reproducibility of Results medicine.disease Hospitalization Pneumonia Gram staining medicine.anatomical_structure medicine.symptom business Tracheal suction Respiratory tract
Zdroj:	Trials Cartuliares, M B, Skjøt-Arkil, H, Rosenvinge, F S, Mogensen, C B, Skovsted, T A & Pedersen, A K 2021, ' 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 ', Trials, vol. 22, 675 . https://doi.org/10.1186/s13063-021-05639-1 Trials, Vol 22, Iss 1, Pp 1-13 (2021)
ISSN:	1745-6215
DOI:	10.1186/s13063-021-05639-1
Popis:	Background Targeted 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. Method The 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 registration Clinicaltrials.gov, NCT04595526. Submitted on October 19, 2020
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8b7d7e14fa96b0d13dd17f79be386c81 https://pubmed.ncbi.nlm.nih.gov/34600559 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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