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Ear Mould for Congenital Auricular Deformities: a Protocol for Systematic Review and Meta-Analysis

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Ear Mould for Congenital Auricular Deformities: a Protocol for Systematic Review and Meta-Analysis Ear mould for congenital auricular deformities: a protocol for systematic review and meta-analysis Jincheng Huang Sichuan University West China School of Public Health Kun Zou Sichuan University West China School of Public Health Ping Yuan Sichuan University West China School of Public Health Longhao Zhang Sichuan University West China Hospital Min Yang Sichuan University West China School of Public Health Yunqi Miao Sichuan University West China School of Public Health li zhao ( [email protected] ) Sichuan University West China School of Public Health https://orcid.org/0000-0002-6297-528X Yanjun Fan Chinese Center for Disease Control and Prevention Protocol Keywords: congenital auricle deformities, ear mold, non-surgical treatment, systematic review, meta- analysis, protocol Posted Date: July 14th, 2020 DOI: https://doi.org/10.21203/rs.3.rs-40986/v1 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 1/10 Abstract Background: Congenital auricle deformities (CADs) not only affect the appearance, but may also result in social inferiority or diculties, inuence the hearing and mental health of the children. Although some studies have pointed out CADs have a natural improvement trend, there is still a lack of high-quality research to demonstrate the degree of that. Therefore, related studies agree that early treatment are necessary. Ear mold correction is currently main non-surgical treatment for CADs, but the existing research often involves a small sample size, and the research conclusions are inconsistent. More importantly, there is still no systematic review on ear mold correction for CADs. This study aims to systematically evaluate the effectiveness and safety of ear mold correction for CADs, so as to provide an evidence base for further research. Methods: The study has been designed according to the Preferred Reporting program for Systems Evaluation and Meta-analysis Protocol (PRISMA-P). We will search electronic literature databases of PubMed, Embase, Cochrane Library, Web of science, CBM, CNKI, Wanfang and VIP from their initiative to 1 June 2020 for interventional studies on ear mould for children with CADs. The study selection, data extraction and quality assessment will be performed by two authors. Meta-analysis will be conducted on primary outcome effectiveness rate of physician assessment and secondary outcomes of effectiveness rate of parents’ assessment, effectiveness score, hearing assessment, and adverse reactions using relative ratio or mean difference and their 95% condence intervals. The heterogeneity of the included studies will be tested using Chi square test and I2, and random-effects model will be used when signicant heterogeneity was found, otherwise, xed-effects model will be used. Sensitivity analysis will be performed using trials with high quality and using alternative [1]models (xed-effects or random effects model). Publication bias will be tested using funnel plot and Egger’s test. Discussion: This study will be the rst to systematically evaluate the effectiveness and safety of ear mold correction for CADs, to provide evidence base for clinical guideline making, clinical decision and future research. Systematic review registration : CRD42020190982. Background Congenital auricle deformities (CADs) are common among neonates. Tan ST, Leonardi and Eun Woo JE et al. [1–3] have all described their denitions, generally thinking that it had a complete organizational structure, but with morphological abnormalities. Due to the lack of a unied denition and diagnostic criteria, previous studies found that the incidence of CADs in Japan, China, and the United States was 55.20%, 43.46%, and 25.00%, respectively [4–6]. CADs not only affect the appearance, but may also result in social inferiority or diculties, inuence the hearing and mental health of the children [7]. Although Matsuo K et al. [8] in Japan found that different types of CADs have the tendency of natural improvement, there is still a lack of high-quality studies to demonstrate the degree of natural Page 2/10 improvement. Therefore, it is suggested that treatment and correction should be carried out as early as possible [9–11]. The treatments of CADs includes surgical and non-surgical treatments. The former is mainly performed at the age of 6, and its effect is closely related to the type, severity and operation mode of the deformities [12–14]. In addition, surgery, as an invasive method, can bring complications such as suture extrusion, hematoma, wound depravation and skin necrosis, and at the same time, it is expensive and imposes a greater economic burden on families and society [15–16]. Non-surgical correction of CADs has been increasingly used since its rst introduced by Matsuo et al. [8] and Kurozumi et al. [17] in the 1980s, initially by splint and later evolved to ear (ear mold) orthotics. This method is non-invasive, simple, effective and has achieved good results at the beginning of its use, which has been unanimously recognized by the academic circle [18]. It has been reported that the clinical effect on early non-surgical correction for CADs is signicant [19–20]. Therefore, it has been popularized successively in Japan, European and American countries, and different types of ear orthotics have appeared one after another In 2009, van Wijk MP et al. [21] reviewed the non-surgical treatment for CADs, and concluded that the clinical effect on early non-surgical correction for CADs by earmold was signicant. However, only the splint correction was included in this review, and its data source was limited to Pubmed. Existing studies of ear mould for CADs often involved a small sample size, and there is still controversy on the effectiveness, safety, intervention time, and intervention duration of ear mould correction for CADs [22– 23]. To our best knowledge, no systematic evaluation of ear mould for CADs has been made. Therefore, this study aims to systematically evaluate the effectiveness and safety of the ear model correction for CADs. Methods Research design and methodology The review has been registered in the PROSPERO International Systematic Review Prospective Register (ID:CRD42020190982). This protocol has been prepared in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) statement, as provided in Additional le. Eligibility criteria The inclusion and exclusion criteria for this systematic review were formulated following the PICOS principle: 1. Participants: children who was diagnosed as congenital CADs. 2. Interventions: ear mould correction for children with CADs. Page 3/10 3. Control: surgical treatment, other non-surgical treatment, placebo, no intervention, or before after comparison. 4. Study designs: randomized controlled trials (RCTs), quasi-RCTs or non-RCTs. Only publications using English and Chinese will be included as we lack of resources to review research in other languages. Search strategy We will search the following databases: PubMed, Embase, Cochrane Library, CBM, CNKI, Wanfang and VIP, Web of science from their initiative to 1 june 2020. Key words and MeSH will be used including: congenital ear/auricular abnormalities, deformity, malformation, non-surgical treatment, ear mould/mold, Earwell. Reference lists of included studies will also be scanned for eligible studies. Preliminary Pubmed search strategy is showed in Table 1. Outcome measures The effectiveness rate according to physician assessment will be the main outcome. The following secondary outcomes will be considered: (1) Effectiveness rate according to parents’assessment. (2) Hearing assessment. (3) Adverse reactions including: redness or swelling of the skin, dermatitis, allergy, eczema, local infection, tissue necrosis, ear mould loss, recurrence of CAD, or other unexpected mild or severe adverse reactions. Study selection The two authors (JCH, YQM) will jointly lter the headings and abstracts of all checked records, and full- text search will be conducted on the qualied records screened, then these full-texts will be reviewed by using the above eligibility/exclusion criteria. Any differences arising will be resolved by a separate author's decision (LZ, KZ). Comprehensive information extraction of eligible articles will be carried out. The consistency between the evaluators will be evaluated using the kappa value [24]. Data extraction The data will be independently extracted by two authors (JCH, YQM). Any disagreement will be resolved by discussion until consensus is reached or by consulting a third senior reviewer. The following data will be extracted: author, year of publication, language, study design, participants characteristics (gender, age, type of congenital deafness shape deformity sample size), intervention characteristics (start time, duration), control characteristics, and outcomes. Risk of bias (quality) assessment The risk bias of the included studies will be independently assessed by two authors (JCH, YQM), and the controversial opinions will be resolved after discussion with a senior author (LZ, KZ). The following Page 4/10 dimensions of bias will be assessed according to the Cochrane Collaboration Bias Risk Assessment Tool [25]: selection bias, implementation bias, measurement bias, follow-up bias, reporting bias, and other biases of the included studies. The quality of evidence for each outcome will be appraised using the Grading of Recommendations Assessment Development and Evaluation (GRADE) approach. RevMan will
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