COSUTI: a protocol for the development of a core outcome set (COS) for interventions for the treatment of uncomplicated urinary tract infection (UTI) in adults.


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
07 Feb 2019
Historique:
received: 15 08 2018
accepted: 11 01 2019
entrez: 9 2 2019
pubmed: 9 2 2019
medline: 14 6 2019
Statut: epublish

Résumé

Urinary tract infections (UTIs) are the second most common infection presenting in the community. Clinical guidelines and decision aids assist health practitioners to treat a UTI; however, treatment practices vary due to patient needs and context of presentation. Numerous trials have evaluated the effectiveness of treatment interventions for UTI; however, it is difficult to compare the results between trials due to inconsistencies between reported outcomes. Poor choice of outcome measures can lead to impairment of evidence synthesis due to the inability to compare outcomes between trials with similar aims. Transparency in selecting and reporting outcomes can be mitigated through the development of an agreed minimum set of outcomes that should be reported in clinical trials, referred to as a core outcome set (COS). This paper presents the protocol for the development of a COS for interventions in the treatment of uncomplicated UTI in adults. This COS development consists of three phases. Phase 1 is a systematic review, which aims to identify the core outcomes that have been reported in trials and systematic reviews of interventions treating uncomplicated UTI in adults. Phase 2 consists of a three-round online Delphi survey with stakeholders in the area of treatment interventions for UTI. The aim of this online Delphi survey is to achieve consensus on the importance of the outcomes emerging from Phase 1 of this research. Phase 3 is a consensus meeting to finalise the COS that should be reported in trials evaluating the effectiveness of interventions for the treatment of UTI. It is hoped that the development of a COS for interventions for the treatment of uncomplicated UTI in adults will be adopted as a minimum set of outcomes that should be reported and measured within this context. If the findings from clinical trials related to treatment interventions for UTI are to impact on policy and practice, it is important that the findings from different treatment interventions are comparable across trials.

Sections du résumé

BACKGROUND BACKGROUND
Urinary tract infections (UTIs) are the second most common infection presenting in the community. Clinical guidelines and decision aids assist health practitioners to treat a UTI; however, treatment practices vary due to patient needs and context of presentation. Numerous trials have evaluated the effectiveness of treatment interventions for UTI; however, it is difficult to compare the results between trials due to inconsistencies between reported outcomes. Poor choice of outcome measures can lead to impairment of evidence synthesis due to the inability to compare outcomes between trials with similar aims. Transparency in selecting and reporting outcomes can be mitigated through the development of an agreed minimum set of outcomes that should be reported in clinical trials, referred to as a core outcome set (COS). This paper presents the protocol for the development of a COS for interventions in the treatment of uncomplicated UTI in adults.
METHODS METHODS
This COS development consists of three phases. Phase 1 is a systematic review, which aims to identify the core outcomes that have been reported in trials and systematic reviews of interventions treating uncomplicated UTI in adults. Phase 2 consists of a three-round online Delphi survey with stakeholders in the area of treatment interventions for UTI. The aim of this online Delphi survey is to achieve consensus on the importance of the outcomes emerging from Phase 1 of this research. Phase 3 is a consensus meeting to finalise the COS that should be reported in trials evaluating the effectiveness of interventions for the treatment of UTI.
DISCUSSION CONCLUSIONS
It is hoped that the development of a COS for interventions for the treatment of uncomplicated UTI in adults will be adopted as a minimum set of outcomes that should be reported and measured within this context. If the findings from clinical trials related to treatment interventions for UTI are to impact on policy and practice, it is important that the findings from different treatment interventions are comparable across trials.

Identifiants

pubmed: 30732617
doi: 10.1186/s13063-019-3194-x
pii: 10.1186/s13063-019-3194-x
pmc: PMC6367821
doi:

Substances chimiques

Anti-Bacterial Agents 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

106

Subventions

Organisme : Health Research Board
ID : CTN-2014-011
Pays : Ireland

Références

Clin Ther. 1999 Jun;21(6):966-81
pubmed: 10440621
Ann Intern Med. 2001 Jul 3;135(1):41-50
pubmed: 11434731
BMJ. 2003 Sep 6;327(7414):557-60
pubmed: 12958120
Cochrane Database Syst Rev. 2004;(3):CD001209
pubmed: 15266443
BMJ. 2006 Jan 14;332(7533):94-7
pubmed: 16410583
PLoS Med. 2009 Jul 21;6(7):e1000100
pubmed: 19621070
Cochrane Database Syst Rev. 2010 Oct 06;(10):CD007182
pubmed: 20927755
Vital Health Stat 13. 2011 Apr;(169):1-38
pubmed: 21614897
Trials. 2012 Aug 06;13:132
pubmed: 22867278
BMJ. 2013 May 29;346:f3140
pubmed: 23719637
Trials. 2014 Feb 05;15:49
pubmed: 24495582
JAMA. 2014 Oct 22-29;312(16):1677-84
pubmed: 25335150
PLoS Med. 2016 Oct 18;13(10):e1002148
pubmed: 27755541
Trials. 2017 Jun 20;18(Suppl 3):280
pubmed: 28681707
J Clin Epidemiol. 2018 Apr;96:84-92
pubmed: 29288712
Am J Obstet Gynecol. 2018 Jul;219(1):40-51
pubmed: 29305250
Trials. 2018 Mar 1;19(1):147
pubmed: 29490702
Haemophilia. 2018 Jul;24(4):e167-e172
pubmed: 29781145
Am J Med Sci. 1997 Oct;314(4):245-9
pubmed: 9332263

Auteurs

Sinead Duane (S)

HRB Trials Methodology Research Network, College of Medicine, Nursing & Health Sciences, National University of Ireland, Galway, Ireland. sinead.duane@nuigalway.ie.

Akke Vellinga (A)

Discipline of General Practice, School of Medicine, National University of Ireland, Galway, Ireland.
Discipline of Bacteriology, School of Medicine, National University of Ireland, Galway, Ireland.

Andrew W Murphy (AW)

Discipline of General Practice, HRB Primary Care Clinical Trial Network Ireland, College of Medicine, Nursing and Health Sciences, National University of Ireland, Galway, Ireland.

Martin Cormican (M)

Discipline of Bacteriology, School of Medicine, National University of Ireland, Galway, Ireland.

Andrew Smyth (A)

HRB Clinical Research Facility Galway, National University of Ireland, Galway, Ireland.

Patricia Healy (P)

HRB Trials Methodology Research Network, College of Medicine, Nursing & Health Sciences, National University of Ireland, Galway, Ireland.
School of Nursing and Midwifery, National University of Ireland, Galway, Ireland.

Michael Moore (M)

Primary Care and Population Sciences, Primary Care and Population Sciences, University of Southampton Faculty of Medicine, Southampton, UK.

Paul Little (P)

Primary Care and Population Sciences, Primary Care and Population Sciences, University of Southampton Faculty of Medicine, Southampton, UK.

Declan Devane (D)

HRB Trials Methodology Research Network, College of Medicine, Nursing & Health Sciences, National University of Ireland, Galway, Ireland.
School of Nursing and Midwifery, National University of Ireland, Galway, Ireland.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH