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Haematology (incl blood transfusion)
Protocol
Risk of infection associated with intravenous iron preparations: protocol for updating a systematic review
  1. Akshay Shah1,
  2. Anita Sugavanam2,
  3. Jack Reid2,
  4. Antony J Palmer3,
  5. Edward Dickson4,
  6. Susan Brunskill5,
  7. Carolyn Doree6,
  8. Charles M Oliver7,
  9. Austin Acheson8,
  10. Ravi Rao Baikady9,
  11. Sohail Bampoe10,
  12. Edward Litton11,
  13. Simon Stanworth12
  1. 1 Radcliffe Department of Medicine, University of Oxford, Oxford, UK
  2. 2 Department of Anaesthetics, Brighton and Sussex University Hospitals NHS Trust, Brighton and Hove, UK
  3. 3 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
  4. 4 Department of Colorectal Surgery, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
  5. 5 Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK
  6. 6 NHS Blood and Transplant, John Radcliffe Hospital, Oxford, UK
  7. 7 Division of Biosciences, University College London, London, UK
  8. 8 Department of Colorectal Surgery and NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases, Queen’s Medical Centre, Nottingham, UK
  9. 9 Department of Anaesthetics, Perioperative Medicine and Pain, Royal Marsden NHS Foundation Trust, London, UK
  10. 10 Department of Anaesthesia and Perioperative Medicine, University College London Hospitals NHS Foundation Trust, London, UK
  11. 11 Intensive Care Unit, St John of God Hospital, Perth, Western Australia, Australia
  12. 12 Department of Haematology/Transfusion Medicine, Oxford Radcliffe Hospitals Trust, Oxford, UK
  1. Correspondence to Dr Akshay Shah; akshay.shah{at}ndcls.ox.ac.uk

Abstract

Introduction The benefits and risk of intravenous iron have been documented in previous systematic reviews and continue to be the subject of randomised controlled trials (RCTs). An ongoing issue that continues to be raised is the relationship between administering iron and developing infection. This is supported by biological plausibility from animal models. We propose an update of a previously published systematic review and meta-analysis with the primary focus being infection.

Methods and analysis We will include RCTs and non-randomised studies (NRS) in this review update. We will search the relevant electronic databases. Two reviewers will independently extract data. Risk of bias for RCTs and NRS will be assessed using the relevant tools recommended by The Cochrane Collaboration. Data extracted from RCTs and NRS will be analysed and reported separately. Pooled data from RCTs will be analysed using a random effects model. We will also conduct subgroup analyses to identify any patient populations that may be at increased risk of developing infection. We will provide a narrative synthesis on the definitions, sources and responsible pathogens for infection in the included studies. Overall quality of evidence on the safety outcomes of mortality and infection will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach.

Ethics and dissemination This systematic review will only investigate published studies and therefore ethical approval is not required. The results will be broadly distributed through conference presentations and peer-reviewed publications.

Trial registration number PROSPERO (CRD42018096023).

  • Intravenous Iron
  • Infection
  • Mortality
  • Systematic review
  • Meta-analysis

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-2018-024618

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    Footnotes

    • Contributors AS, AS, SS and EL conceived the idea for the review update. AS prepared the initial protocol draft with input from SB and SS who contributed to the revision of the manuscript. CD will perform the search and AS, JR, AJP and ED will screen and extract data. All listed authors, including CMO, AA, RRB and SB, contributed to the development of the idea and drafting and revisions of the manuscript.

    • Funding AS is funded by an NIHR Doctoral Research Fellowship (DRF-2017-10-094). This research received no specific grant from any funding agency in the public, commercial or not-forprofit sectors.

    • Competing interests RRB has received educational grants/honorarium from Pharmacosmos UK and Vifor Pharma. AA’s research department has received grant support from Syner-Med, UK, Pharmacosmos, Denmark and Vifor Pharma, Switzerland. Honoraria or travel support received for lecturing from the following companies: Ethicon Endosurgery; Johnson and Johnson, UK; Olympus, Essex, UK; Vifor Pharma, Glattbrugg, Switzerland and Pharmacosmos, Denmark.

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

    • Patient consent for publication Not required.