Stokes Jamie R, Png May Ee, Jain Abhilash, Greig Aina V H, Shirkey Beverly A, Dritsaki Melina, Cook Jonathan A
Oxford Clinical Trials Research Unit, Botnar Research Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Windmill Road, Oxford, OX3 7LD, UK.
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.
Trials. 2020 Oct 7;21(1):833. doi: 10.1186/s13063-020-04724-1.
Nail 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/DESIGN: NINJA 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.
The 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.
ISRCTN, ISRCTN44551796 . Registered on 23 April 2018.
在英国，甲床创伤是最常见的需手术治疗的儿童手部损伤之一。尽管外科医生普遍倾向于在修复甲床后更换甲板，但支持这种做法的证据有限。我们描述了一项针对甲床损伤分析（NINJA）随机对照试验的统计与卫生经济学分析计划（SHEAP）。
方法/设计：NINJA是一项多中心、务实、优效性、平行组随机对照试验，针对16岁及以下的甲床损伤参与者。该研究旨在评估修复甲床损伤后更换甲板与丢弃甲板相比的疗效和成本效益。随机分组后7 - 10天的手术部位感染和指甲的外观是NINJA的共同主要结局。随机分组后7 - 10天的手术部位感染将使用逻辑回归模型进行评估，以手术部位作为唯一分层因素并考虑部位内相关性。外观将通过新开发的牛津指甲外观评分进行评估，并使用曼-惠特尼U检验进行评价。还将使用有序逻辑回归模型评估牛津指甲外观评分，对手术部位进行调整并考虑部位内相关性。次要结局在7 - 10天和4个月时进行测量，包括EQ - 5D - Y问卷、首次换药时的疼痛、成本效益、晚期手术部位感染以及参与者/家长对指甲愈合的满意度。缺失的主要结局数据将按治疗组进行汇总，并通过敏感性分析进行研究。本文描述了计划的分析方法和描述性统计的详细信息。NINJA研究方案先前已发表。
此处阐述了NINJA试验的计划分析策略，以降低报告偏倚和数据驱动分析的风险。与本文所述SHEAP的任何偏差将在试验的最终报告中详细说明并充分论证。
ISRCTN，ISRCTN44551796。于2018年4月23日注册。
