Abbott Penelope, Gunasekera Hasantha, Leach Amanda Jane, Askew Deborah, Walsh Robyn, Kong Kelvin, Girosi Federico, Bond Chelsea, Morris Peter, Lujic Sanja, Hu Wendy, Usherwood Tim, Tyson Sissy, Spurling Geoffrey, Douglas Markeeta, Schubert Kira, Chapman Shavaun, Siddiqui Nadeem, Murray Reeion, Rabbitt Keitha, Porykali Bobby, Woodall Cheryl, Newman Tina, Reath Jennifer
School of Medicine, Western Sydney University, Sydney, NSW, Australia.
University of Sydney, Sydney, NSW, Australia.
Trials. 2016 Mar 3;17(1):119. doi: 10.1186/s13063-016-1247-y.
Treatment guidelines recommend watchful waiting for children older than 2 years with acute otitis media (AOM) without perforation, unless they are at high risk of complications. The high prevalence of chronic suppurative otitis media (CSOM) in remote Aboriginal and Torres Strait Islander communities leads these children to be classified as high risk. Urban Aboriginal and Torres Strait Islander children are at lower risk of complications, but evidence to support the subsequent recommendation for watchful waiting in this population is lacking.
METHODS/DESIGN: This non-inferiority multi-centre randomised controlled trial will determine whether watchful waiting is non-inferior to immediate antibiotics for urban Aboriginal and Torres Strait Islander children with AOM without perforation. Children aged 2 - 16 years with AOM who are considered at low risk for complications will be recruited from six participating urban primary health care services across Australia. We will obtain informed consent from each participant or their guardian. The primary outcome is clinical resolution on day 7 (no pain, no fever of at least 38 °C, no bulging eardrum and no complications of AOM such as perforation or mastoiditis) as assessed by general practitioners or nurse practitioners. Participants and outcome assessors will not be blinded to treatment. With a sample size of 198 children in each arm, we have 80 % power to detect a non-inferiority margin of up to 10 % at a significance level of 5 %, assuming clinical improvement of at least 80 % in both groups. Allowing for a 20 % dropout rate, we aim to recruit 495 children. We will analyse both by intention-to-treat and per protocol. We will assess the cost- effectiveness of watchful waiting compared to immediate antibiotic prescription. We will also report on the implementation of the trial from the perspectives of parents/carers, health professionals and researchers.
The trial will provide evidence for the safety and effectiveness of watchful waiting for the management of AOM in Aboriginal and Torres Strait Islander children living in urban settings who are considered to be at low risk of complications.
The trial is registered with Australia New Zealand Clinical Trials Registry ( ACTRN12613001068752 ). Date of registration: 24 September 2013.
治疗指南建议，对于2岁以上无鼓膜穿孔的急性中耳炎（AOM）患儿，除非他们有并发症的高风险，否则应进行观察等待。偏远地区原住民和托雷斯海峡岛民社区慢性化脓性中耳炎（CSOM）的高患病率导致这些儿童被归类为高风险。城市原住民和托雷斯海峡岛民儿童出现并发症的风险较低，但缺乏支持对该人群后续进行观察等待建议的证据。
方法/设计：这项非劣效性多中心随机对照试验将确定，对于无鼓膜穿孔的城市原住民和托雷斯海峡岛民AOM患儿，观察等待是否不劣于立即使用抗生素治疗。将从澳大利亚各地六个参与研究的城市初级卫生保健服务机构招募2至16岁、被认为并发症风险较低的AOM患儿。我们将从每位参与者或其监护人处获得知情同意。主要结局是由全科医生或执业护士评估的第7天临床治愈情况（无疼痛、无至少38°C的发热、无鼓膜膨出且无AOM的并发症，如穿孔或乳突炎）。参与者和结局评估者不会对治疗设盲。每组有198名儿童的样本量，假设两组临床改善率至少为80%，我们有80%的把握在5%的显著性水平上检测到高达10%的非劣效性界值。考虑到20%的失访率，我们的目标是招募495名儿童。我们将采用意向性分析和符合方案分析。我们将评估观察等待与立即开具抗生素处方相比的成本效益。我们还将从父母/照顾者、卫生专业人员和研究人员的角度报告试验的实施情况。
该试验将为对居住在城市环境中、被认为并发症风险较低的原住民和托雷斯海峡岛民儿童进行AOM观察等待管理的安全性和有效性提供证据。
该试验已在澳大利亚新西兰临床试验注册中心注册（ACTRN12613001068752）。注册日期：2013年9月24日。
