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General practice / Family practice
Protocol
Strategies to reduce antibiotic use in women with uncomplicated urinary tract infection in primary care: protocol of a systematic review and meta-analysis including individual patient data
  1. Judith Heinz1,
  2. Christian Röver1,
  3. Ghefar Furaijat2,3,
  4. Yvonne Kaußner4,
  5. Eva Hummers2,
  6. Thomas Debray5,
  7. Alastair D Hay6,
  8. Stefan Heytens7,
  9. Ingvild Vik8,9,
  10. Paul Little10,
  11. Michael Moore10,
  12. Beth Stuart10,
  13. Florian Wagenlehner11,
  14. Andreas Kronenberg12,
  15. Sven Ferry13,
  16. Tor Monsen13,
  17. Morten Lindbaek8,
  18. Tim Friede1,
  19. Ildiko Gagyor4
  1. 1Department of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany
  2. 2Department of General Practice, University Medical Center Goettingen, Goettingen, Germany
  3. 3Department of Emergency Medicine, University Medical Center Goettingen, Goettingen, Germany
  4. 4Department of General Practice, Julius Maximilians University Wuerzburg Faculty of Medicine, Wuerzburg, Germany
  5. 5Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
  6. 6Centre for Academic Primary Care, University of Bristol, Bristol, UK
  7. 7Department of Public Health and Primary Care, University of Ghent, Gent, Belgium
  8. 8Department of General Practice, The Antibiotic Centre of Primary Care, Institute of Health and Society, University of Oslo, Oslo, Norway
  9. 9Department of Emergency General Practice, Oslo Accident and Emergency Outpatient Clinic, Oslo, Norway
  10. 10Primary Care Population Sciences and Medical Education Unit, University of Southampton School of Medicine, Southampton, UK
  11. 11Clinic for Urology, Pediatric Urology and Andrology, Justus Liebig University Giessen Faculty of Medicine, Giessen, Germany
  12. 12Institute for Infectious Diseases, University of Bern, Bern, Switzerland
  13. 13Department of Clinical Microbiology, Bacteriology, Umea University, Umea, Sweden
  1. Correspondence to Dr Judith Heinz; judith.heinz{at}med.uni-goettingen.de

Abstract

Introduction Uncomplicated urinary tract infection (UTI) in women is a common reason to present in general practice and is usually treated with antibiotics to reduce symptom severity and duration. Results of recent clinical trials indicate that non-antibiotic treatment approaches can also be effective. However, it remains unclear which patients would benefit from antibiotic treatment and which can effectively and safely be treated without antibiotics. This systematic review and meta-analysis aims to estimate the effect of treatment strategies to reduce antibiotic use in comparison with immediate antibiotic treatment and to identify prognostic factors and moderators of treatment effects. A further aim is to identify subgroups of patients benefiting from a specific therapy.

Methods and analysis A systematic literature search will be performed to identify randomised controlled trials which investigated the effect of treatment strategies to reduce antibiotic use in female adults with uncomplicated UTI compared with immediate antibiotic treatment. Therefore, the primary outcome of the meta-analysis is incomplete recovery. Anonymised individual patient data (IPD) will be collected. Aggregate data will be used for pairwise comparisons of treatment strategies using meta-analysis models with random effects accounting for potential between-study heterogeneity. Potential effect moderators will be explored in meta-regressions. For IPD, generalised linear mixed models will be used, which may be adjusted for baseline characteristics. Interactions of baseline variables with treatment effects will be explored. These models will be used to assess direct comparisons of treatment, but might be extended to networks.

Ethics and dissemination The local institutional review and ethics board judged the project a secondary analysis of existing anonymous data which meet the criteria for waiver of ethics review. Dissemination of the results will be via published scientific papers and presentations. Key messages will be promoted for example, via social media or press releases.

PROSPERO registration number CRD42019125804.

  • urinary tract infections
  • general medicine (see internal medicine)
  • adult urology
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-035883

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    Footnotes

    • Twitter @TPA_Debray, @Sven Ferry, @tim_friede

    • JH and CR contributed equally.

    • Contributors IG, TF, EH, ADH, MM, IV, PL, ML, SH, TM, SF, AK, BS and FW: conception of the study. TF, CR and TD: statistical concept. GF, YK, IG and JH: contact to possible cooperation partners. CR and JH: drafting the manuscript. CR and JH: developing search strategy. All authors: revising the manuscript critically for important intellectual content and approval of the final version of the manuscript. IG: guarantor of the review.

    • Funding This work is funded by the Federal Ministry of Education and Research (BMBF), research grant number KS2017-047. TPAD is funded by The Netherlands Organisation for Health Research and Development (grant 91617050).

    • Disclaimer The funders were not involved in developing the protocol.

    • Competing interests IG, GF, TF, EH, MM are involved in the following studies: ‘REGATTA—reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with uva-ursi’. Afshar K, Fleischmann N, Schmiemann G, Bleidorn J, Hummers-Pradier E, Friede T, Wegscheider K, Moore M, Gagyor I. 'Reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with uva-ursi (REGATTA)—a double-blind, randomised, controlled comparative effectiveness trial'. BMC Complement Altern Med. 2018 Jul 3;18(1):203. doi: 10.1186/s12906-018-2266-x). IV was involved in the study: ‘Vik I, Bollestad M, Grude N, Bærheim A, Damsgaard E, Neumark T, Bjerrum L, Cordoba G, Olsen IC, Lindbæk M. Ibuprofen versus pivmecillinam for uncomplicated urinary tract infection in women—a double-blind, randomised non-inferiority trial'. PLoS Med 15;5:e1002569. Doi.org/10.1371/journal.pmed.1002569. MM, ADH and PL are coauthors of the study: ‘Moore M, Trill J, Simpson C, Webley F, Radford M, Stanton L, Maishman T, Glanopoulou A, Flower A, Eyles C, Willcox M, Hay AD, van der Werf E, Gibbons S, Lewith G, Little P, Griffiths G. Uva-ursi extract and ibuprofen as alternative treatments for uncomplicated urinary tract infection in women (ATAFUTI): a factorial randomised trial. Clinical Microbiology and Infection'. Doi.org/10.1016/j.cmi.2019.01.011. SH was involved in the study with the reference number 11. PL and MM were involved in the study with the reference number 12. SF and TM were involved in the study with the reference number 13. IG, EH were involved in the studies with the reference numbers 14 and 15. AK was involved in the study with the reference number 16.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.