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Short report
Use of scratchcards for allocation concealment in a prehospital randomised controlled trial
  1. Leigh Keen1,
  2. Jenna Katherine Bulger2,
  3. Nigel Rees1,
  4. Helen Snooks2,
  5. Greg Fegan2,
  6. Simon Ford3,
  7. Bridie Angela Evans2,
  8. Mirella Longo4
  1. 1 Central and West Region, The Welsh Ambulance Services NHS Trust, Swansea, UK
  2. 2 Swansea University Medical School, Swansea, UK
  3. 3 Abertawe Bro Morgannwg University Health Board, Port Talbot, UK
  4. 4 Cardiff University, Cardiff, UK
  1. Correspondence to Dr Leigh Keen, The Welsh Ambulance Services NHS Trust, Swansea, SA2 0GP, UK; leigh.keen{at}wales.nhs.uk

Abstract

Background Rapid Analgesia for Prehospital Hip Disruption was a small study designed to determine the feasibility of undertaking a randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics administering Fascia Iliaca Compartment Block as early prehospital pain relief to patients with a fractured hip. The objective was to devise a simple and effective method of random allocation concealment suitable for use by paramedics while in the emergency prehospital setting.

Methods Scratchcards were produced using scratch-off silver stickers which concealed the trial arm allocation. Paramedics were each allocated a unique range of consecutive numbers, used as both the scratchcard number and the patient’s study ID. The cards were designed to allow the paramedic to write on the incident number, date and signature. A small envelope holding the cards was prepared for each paramedic. The study took place between 28 June 2016 and 31 July 2017 in the Swansea area.

Results Nineteen trial paramedics used 71 scratchcards throughout the study and reported no problems randomly allocating patients using the scratchcards. Five protocol deviations were reported in relation to scratchcard use. On auditing the scratchcards, all unused cards were located, and no evidence of tampering with the silver panel was found.

Conclusion Paramedics can use scratchcards as a method of randomly allocating patients in trials in prehospital care. In the future, a method that allows only the top card to be selected and a more protective method of storing the cards should be used. Scratchcards can be considered for wider use in RCTs in the emergency prehospital setting.

Trial registration number ISRCTN60065373; Post-results.

  • research, methods
  • paramedics, extended roles
  • paramedics, clinical management
  • anaesthesia - local
  • fractures and dislocations

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/emermed-2018-207881

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    Footnotes

    • Contributors LK drafted the manuscript with editorial input from all authors. The research idea was conceived and developed by NR and SF, with methodological advice from GF and HS. JKB and GF undertook the statistical analysis. BAE led the qualitative analysis with JKB and LK. All authors read and approved the final manuscript.

    • Funding This study was funded by Health and Care Research Wales (1003).

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval Wales Research Ethics Committee 6.

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