中国大陆地区发表在SCI期刊上的眼科随机对照试验报告质量评价

背景按照循证医学（EBM）的理念对医学临床研究进行随机对照试验（RCT）能够为医疗决策提供重要证据,国际编辑组织提供的临床试验报告统一标准（CONSORT）是医学临床研究者正确撰写RCT报告的指南。目前中国临床研究人员对RCT的评价和使用方法了解的还不够。目的采用2010版CONSORT对中国大陆地区眼科研究者在SCI期刊上所发表的有关眼科疾病的RCT报告的方法学质量进行评价,为RCT报告的正确撰写提供方法学介绍。方法在PubMed平台检索中国大陆眼科研究者在SCI期刊上发表的眼科RCT研究文章,检索文献截止至2013年3月,由2位评阅者对检索的文献独立评分,统计所纳入文献对于CONSORT各项条目的符合率,根据CONSORT的发表和修订年份对文章进一步分层分析。结果共纳入60篇眼科研究相关的RCT文献,研究中的干预措施以手术类为主（34／60）,共有44篇文献设立了2个研究组,样本量的中位数为76．0。纳入的文献中,仅有22％的文章（13／60）在文题中标注了RCT。绝大多数文章在摘要和背景部分进行了合理描述,仅4篇文章提出了试验的假设,占7％。在方法部分,仅12篇文章报告了如何计算样本量,有41篇报告了资料收集的场所和地点,仅6篇文章提到了中期分析和中止原则。2010版CONSORT声明发表后,中国大陆地区所发表的RCT报告对随机化的描述并未显著改善（RR=1．06,95％CI：0．62～1．82）,对盲法进行描述的报告仅占42％（25／60）。结论中国大陆地区发表在SCI期刊上的RCT报告还存在较多问题。严格按照CONSORT声明设计并报告高质量的RCT有助于真实、客观地反映中国眼科临床研究的现状,提高中国大陆地区眼科临床试验的质量,并为眼科临床工作提供指导。     

重视眼科影像学检查提高临床诊断率

目的 总结分析眼科临床出现的误诊和漏诊病例的原因,应重视影像学检查,弥补临床常规检查诊断的不足.方法 对2007年至2008年两年间门诊和住院病人通过各种影像学检查纠正诊断的37例患者进行分析,年龄6～75岁,男性17例,女性20例.结果 在37例患者中,有8例为颈动脉海绵窦瘘(2例外伤性,6例自发性)被诊断为结膜炎或巩膜炎;6例外伤性眶壁线性骨折的儿童被诊断为眼肌麻痹或肌肉断裂,给予保守治疗10至20d无效;2例淋巴瘤和3例泪腺样囊性癌患者被诊断为眼眶炎性假瘤;2例横纹肌肉瘤诊断为眼眶炎症;2例脉络膜黑色素瘤因延误治疗出现眶内蔓延;2例额窦黏液囊肿和1例下直肌缺如诊断为麻痹性斜视;蝶窦颅底病变和眼内占位各1例诊断为知觉性斜视;视神经脑膜瘤和颅内鞍区蝶窦占位各1例诊断为球后视神经炎;1例泪囊鳞癌诊断为泪囊炎;4例骨内血管瘤患者CT软组织窗扫描考虑为骨瘤;2例外伤眶内异物漏诊.结论 通过分析总结可见,颈动脉海绵窦瘘、外伤性眶壁线性骨折、外伤眶内异物等通过病史询问,仔细检查和临床经验辅之以影像学检查可以得到正确诊断;有些病变则应对诊断治疗过程中出现的不同表现和不典型症状,要及时鉴别诊断,进行各种影像学检查,排除其他疾病的存在,避免误诊和漏诊.总之,影像学检查是一种有效和必要的,特别是对眶内和颅内病变的揭示有重要价值,在临床工作中应给予重视.     

中国大陆地区在SCI期刊上发表的眼科随机对照试验论文统计

背景 近年来中国发表在国际期刊上的眼科随机对照试验(RCT)论文逐渐增多,目前尚缺乏系统的整理和归纳. 目的 系统检索并统计分析中国大陆地区截止2012年11月1日在SCI期刊上发表的有关眼科疾病的RCT论文.方法 在Pubmed检索平台,以Ophthalmology、Eye及其所有下位主题词、文献类型限定为randomized controlled trial、国家限定为China进行检索.对于检索到的文献进行筛选、数据提取和分析.结果 中国大陆地区自1989年以来共发表68篇眼科疾病方面的RCT论文,其中2005年后数量迅速增长,2006年7篇,2009年11篇,2011年15篇.68篇RCT论文集中在白内障、眼视光、青光眼、角膜结膜病、眼免疫/药理和眼底病等领域,共发表在35种SCI期刊上,覆盖了大多数的SCI眼科期刊,如Ophthalmology和IOVS等,以及少量其他专业期刊,其中发表论文最多的期刊为Clin Experiment Ophthalmol(8篇).68篇RCT论文来自中国26家单位,主要为广州、北京、上海、温州和杭州等地的医学院校附属医院. 结论 中国大陆地区在SCI期刊上所发表的眼科疾病相关的RCT论文数量持续增多,主要集中在白内障、眼视光和青光眼等领域,RCT论文的总体数量仍较少,且存在地区间分布不均衡.     

The reporting quality of parallel randomised controlled trials in ophthalmic surgery in 2011: a systematic review

Purpose

Randomised controlled trials (RCTs) represent a gold standard for evaluating therapeutic interventions. However, poor reporting clarity can prevent readers from assessing potential bias that can arise from a lack of methodological rigour. The Consolidated Standards of Reporting Trials statement for non-pharmacological interventions 2008 (CONSORT NPT) was developed to aid reporting. RCTs in ophthalmic surgery pose particular challenges in study design and implementation. We aim to provide the first assessment of the compliance of RCTs in ophthalmic surgery to the CONSORT NPT statement.

Method

In August 2012, the Medline database was searched for RCTs in ophthalmic surgery reported between 1 January 2011 and 31 December 2011. Results were searched by two authors and relevant papers selected. Papers were scored against the 23-item CONSORT NPT checklist and compared against surrogate markers of paper quality. The CONSORT score was also compared between different RCT designs.

Results

In all, 186 papers were retrieved. Sixty-five RCTs, involving 5803 patients, met the inclusion criteria. The mean CONSORT score was 8.9 out of 23 (39%, range 3.0–14.7, SD 2.49). The least reported items related to the title and abstract (1.6%), reporting intervention adherence (3.1%), and interpretation of results (4.7%). No significant correlation was found between CONSORT score and journal impact factor (R=0.14, P=0.29), number of authors (R=0.01, P=0.93), or whether the RCT used paired-eye, one-eye, or two-eye designs in their randomisation (P=0.97).

Conclusions

The reporting of RCTs in ophthalmic surgery is suboptimal. Further work is needed by trial groups, funding agencies, authors, and journals to improve reporting clarity.     

Pattern of publication of ophthalmic abstracts in peer-reviewed journals

Presentation of research work at scientific meetings and professional societies is an important first step toward effective scientific communication of research results. To determine the current publication patterns of abstracts, a computerized MEDLINE literature search was performed on 175 randomly selected ophthalmic clinical and basic science abstracts published in conjunction with two ophthalmic national meetings. This search revealed that 105 abstracts (60%) led to full-length articles in peer-reviewed journals within 50 to 56 months of the meeting date. A median interval of 13 months occurred from date of abstract publication to acceptance of the corresponding article. Most articles appeared within 3 years of abstract presentation. Sixty-four percent (48 of 75) of the posters and free papers presented at the annual meeting of the American Academy of Ophthalmology in November 1984 led to full-length articles, as did 57% (57 of 100) of the abstracts presented at the annual meeting of the Association for Research in Vision and Ophthalmology in May 1985. These findings emphasize the preliminary nature of abstracts. The fact that nearly 60% of abstracts are published reflects favorably on the review process of both meetings.     

The application of a computerised diagnostic index for ophthalmic practice

All 2792 patients seen in my private practice between July 1989 and September 1992 and receiving a diagnosis were coded according to the International Classification of Diseases-9 (Clinical Modification), 1979. Any procedures performed were coded according to the American Medical Association Current Procedural Terminology. Patient details and codes were filed by computer using a customised database in Foxpro 2.0 software. Those with minor refractive error or presbyopia alone and those who had no abnormality were excluded from the database. The set-up and maintenance of this diagnostic index is described and the database structure is specified. A modification of the glaucoma section of ICD-9, which better suited my needs, is presented. Examples of the potential information available from such a database is described, including some analysis of this general ophthalmic practice.     

Sample size in studies on diagnostic accuracy in ophthalmology: a literature survey

AIM: To assess the sample sizes used in studies on diagnostic accuracy in ophthalmology. Design and sources: A survey literature published in 2005. METHODS: The frequency of reporting calculations of sample sizes and the samples' sizes were extracted from the published literature. A manual search of five leading clinical journals in ophthalmology with the highest impact (Investigative Ophthalmology and Visual Science, Ophthalmology, Archives of Ophthalmology, American Journal of Ophthalmology and British Journal of Ophthalmology) was conducted by two independent investigators. RESULTS: A total of 1698 articles were identified, of which 40 studies were on diagnostic accuracy. One study reported that sample size was calculated before initiating the study. Another study reported consideration of sample size without calculation. The mean (SD) sample size of all diagnostic studies was 172.6 (218.9). The median prevalence of the target condition was 50.5%. CONCLUSION: Only a few studies consider sample size in their methods. Inadequate sample sizes in diagnostic accuracy studies may result in misleading estimates of test accuracy. An improvement over the current standards on the design and reporting of diagnostic studies is warranted.     

Immunohistochemistry in diagnostic ophthalmic pathology: a review

Immunohistochemistry (IHC) is a powerful laboratory technique that employs antibodies to identify cellular components. IHC has revolutionized histopathological diagnosis in the past several decades. This review of IHC in diagnostic ophthalmic pathology will concentrate on common lesions and diagnostic scenarios that frequently are evaluated by IHC in a busy ophthalmic pathology laboratory. Antibodies and markers that are used in the evaluation of ophthalmic lesions will be emphasized.     

The accuracy of the Edinburgh visual loss diagnostic algorithm

Purpose

To assess the diagnostic accuracy of the Edinburgh visual loss algorithm.

Methods

This was a prospective study. Patients referred to the Edinburgh Eye Pavilion with visual loss were assessed using the Edinburgh Visual Loss Algorithm by either a medical student, an inexperienced ophthalmology trainee or an optometrist in the Lothian Optometry Treat and Teach clinic. Accuracy of this ‘algorithm-assisted'' diagnosis was then compared with the ‘gold-standard'' diagnosis, made by an experienced ophthalmologist. Accuracy of the pre-algorithm diagnosis, made by the referrer, was also compared with the algorithm-assisted diagnosis.

Results

All patients referred with visual loss were eligible for inclusion. Seventy patients were assessed; two were excluded. Pre-algorithm accuracy of referral of patients with visual loss was 51% (30/59). Overall, the algorithm-assisted diagnosis was correct 84% (57/68) of the time. The algorithm correctly diagnosed: retina in 71% of cases (5/7), macula in 86% (25/29), peripheral retina in 100% (2/2), optic nerve in 71% (5/7), media opacity in 89% (16/18), post chiasmal in 100% (4/4), and refractive error in 0% (0/1). Accuracy of diagnosis was similar for each algorithm user; medical student 81%, inexperienced ophthalmology trainee 84% and optometrist 92%.

Discussion

The baseline diagnostic accuracy of clinicians who are inexperienced in ophthalmology rose from 51 to 84% when patients were assessed using the algorithm. This algorithm significantly improves the diagnostic accuracy of referrals to the hospital eye service, regardless of the user''s previous ophthalmic experience. We hope we have demonstrated its potential as a learning tool for inexperienced clinicians.