Reeves Barnaby C, Scott Lauren J, Taylor Jodi, Harding Simon P, Peto Tunde, Muldrew Alyson, Hogg Ruth E, Wordsworth Sarah, Mills Nicola, O'Reilly Dermot, Rogers Chris A, Chakravarthy Usha
Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
BMJ Open. 2016 Jul 8;6(7):e010685. doi: 10.1136/bmjopen-2015-010685.
To compare the ability of ophthalmologists versus optometrists to correctly classify retinal lesions due to neovascular age-related macular degeneration (nAMD).
Randomised balanced incomplete block trial. Optometrists in the community and ophthalmologists in the Hospital Eye Service classified lesions from vignettes comprising clinical information, colour fundus photographs and optical coherence tomographic images. Participants' classifications were validated against experts' classifications (reference standard).
Internet-based application.
Ophthalmologists with experience in the age-related macular degeneration service; fully qualified optometrists not participating in nAMD shared care.
The trial emulated a conventional trial comparing optometrists' and ophthalmologists' decision-making, but vignettes, not patients, were assessed. Therefore, there were no interventions and the trial was virtual. Participants received training before assessing vignettes.
Primary outcome-correct classification of the activity status of a lesion based on a vignette, compared with a reference standard. Secondary outcomes-potentially sight-threatening errors, judgements about specific lesion components and participants' confidence in their decisions.
In total, 155 participants registered for the trial; 96 (48 in each group) completed all assessments and formed the analysis population. Optometrists and ophthalmologists achieved 1702/2016 (84.4%) and 1722/2016 (85.4%) correct classifications, respectively (OR 0.91, 95% CI 0.66 to 1.25; p=0.543). Optometrists' decision-making was non-inferior to ophthalmologists' with respect to the prespecified limit of 10% absolute difference (0.298 on the odds scale). Optometrists and ophthalmologists made similar numbers of sight-threatening errors (57/994 (5.7%) vs 62/994 (6.2%), OR 0.93, 95% CI 0.55 to 1.57; p=0.789). Ophthalmologists assessed lesion components as present less often than optometrists and were more confident about their classifications than optometrists.
Optometrists' ability to make nAMD retreatment decisions from vignettes is not inferior to ophthalmologists' ability. Shared care with optometrists monitoring quiescent nAMD lesions has the potential to reduce workload in hospitals.
ISRCTN07479761; pre-results registration.
比较眼科医生和验光师正确分类新生血管性年龄相关性黄斑变性(nAMD)所致视网膜病变的能力。
随机平衡不完全区组试验。社区验光师和医院眼科服务部门的眼科医生根据包含临床信息、彩色眼底照片和光学相干断层扫描图像的病例 vignette 对病变进行分类。将参与者的分类与专家分类(参考标准)进行验证。
基于互联网的应用程序。
有年龄相关性黄斑变性服务经验的眼科医生;未参与 nAMD 共享护理的完全合格验光师。
该试验模拟了一项比较验光师和眼科医生决策的传统试验,但评估的是病例 vignette,而非患者。因此,没有干预措施,该试验是虚拟的。参与者在评估病例 vignette 之前接受了培训。
主要结局——根据病例 vignette 对病变活动状态进行正确分类,并与参考标准进行比较。次要结局——潜在的视力威胁性错误、对特定病变成分的判断以及参与者对其决策的信心。
共有 155 名参与者注册参加试验;96 名(每组 48 名)完成了所有评估并构成分析人群。验光师和眼科医生的正确分类分别为 1702/2016(84.4%)和 1722/2016(85.4%)(比值比 0.91,95%可信区间 0.66 至 1.25;p = 0.543)。在预先设定的 10%绝对差异(比值尺度上为 0.298)限制内,验光师的决策不劣于眼科医生。验光师和眼科医生做出的视力威胁性错误数量相似(57/994(5.7%)对 62/994(6.2%),比值比 0.93,95%可信区间 0.55 至 1.57;p = 0.789)。眼科医生对病变成分存在的评估频率低于验光师,且对其分类比验光师更有信心。
验光师从病例 vignette 做出 nAMD 再治疗决策的能力不劣于眼科医生。由验光师监测静止的 nAMD 病变进行共享护理有可能减轻医院的工作量。
ISRCTN07479761;结果前注册。