Affordable Access

Access to the full text

Should the nail plate be replaced or discarded after nail bed repair in children? Nail bed INJury Analysis (NINJA) randomised controlled trial: a health economic and statistical analysis plan

Authors
  • Stokes, Jamie R.1
  • Png, May Ee2
  • Jain, Abhilash1, 3
  • Greig, Aina V. H.4
  • Shirkey, Beverly A.5
  • Dritsaki, Melina1
  • Cook, Jonathan A.1, 1
  • 1 University of Oxford, Windmill Road, Oxford, OX3 7LD, UK , Oxford (United Kingdom)
  • 2 University of Oxford, Oxford, OX2 6GG, UK , Oxford (United Kingdom)
  • 3 Imperial College Healthcare NHS Trust, London, UK , London (United Kingdom)
  • 4 Guy’s and St Thomas’ NHS Foundation Trust, London, UK , London (United Kingdom)
  • 5 University of Bristol, Canynge Hall, Bristol, UK , Bristol (United Kingdom)
Type
Published Article
Journal
Trials
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Oct 07, 2020
Volume
21
Issue
1
Identifiers
DOI: 10.1186/s13063-020-04724-1
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundNail bed trauma is one of the most common surgically treated paediatric hand injuries in the UK. Despite surgeons generally expressing a preference to replace the nail plate after repairing the nail bed, there is limited evidence to support this practice. We describe a statistical and health economic analysis plan (SHEAP) for the Nail bed INJury Analysis (NINJA) randomised controlled trial.Methods/designNINJA is a multicentre, pragmatic, superiority, parallel group randomised controlled trial of the treatment of nail bed injury in participants 16 years old or younger. The study aims to evaluate the efficacy and cost-effectiveness of replacing the nail plate compared to discarding it following the repair of a nail bed injury. Surgical site infection at 7–10 days post-randomisation and cosmetic appearance of the nail are the co-primary outcomes for NINJA. Surgical site infection at 7–10 days post-randomisation will be evaluated using a logistic regression model adjusting for site as the sole stratification factor and allowing for intra-site correlation. Cosmetic appearance will be assessed via the newly developed Oxford Finger Nail Appearance Score and will be evaluated by use of a Mann-Whitney U test. An ordinal logistic regression model will also be used to assess the Oxford Finger Nail Appearance Score, adjusting for site and allowing for intra-site correlation. Secondary outcomes are measured at 7–10 days and 4 months and include the EQ-5D-Y questionnaire, pain at first dressing change, cost-effectiveness, late surgical site infection, and participant/parent satisfaction with nail healing. Missing primary outcome data will be summarised by treatment arm and investigated through a sensitivity analysis. Full details of the planned methods of analysis and descriptive statistics are described in this paper. The NINJA study protocol has been published previously.DiscussionThe planned analysis strategy for the NINJA trial has been set out here to reduce the risk of reporting bias and data-driven analysis. Any deviations from the SHEAP described in this paper will be detailed and justified fully in the final report of the trial.Trial registrationISRCTN, ISRCTN44551796. Registered on 23 April 2018.

Report this publication

Statistics

Seen <100 times