The development, assessment, and selection of questionnaires.

Patient-reported outcome measurement has become accepted as an important component of comprehensive outcomes research. Researchers wishing to use a patient-reported measure must either develop their own questionnaire (called an instrument in the research literature) or choose from the myriad of instruments previously reported. This article summarizes how previously developed instruments are best assessed using a systematic process and we propose a system of quality assessment so that clinicians and researchers can determine whether there exists an appropriately developed and validated instrument that matches their particular needs. These quality assessment criteria may also be useful to guide new instrument development and refinement. We welcome debate over the appropriateness of these criteria as this will lead to the evolution of better quality assessment criteria and in turn better assessment of patient-reported outcomes.     

Intensity and complexity index of disease for strabismus surgery.

BACKGROUND: The value of health care must be calculated by weighing quality of care with cost of care, and quality of care must be measured not only by objective clinical outcomes but also by resulting health-related quality of life and patient satisfaction. To date, no validated method allows this determination. In this article, we present results of a survey to determine an intensity and complexity index (ICI) for strabismus surgery and discuss how this information can be used in a larger system of determining treatment outcomes and value. METHODS: We surveyed the membership of the American Association for Pediatric Ophthalmology and Strabismus to determine the ICI for 20 specific surgical procedures on the extraocular muscles and for 17 add-on factors that correct for circumstances altering the difficulty of the surgical procedure. RESULTS: Of the 620 surveys that were sent, 222 (36%) were returned and analyzed. Median ICI ranged from 1.00 for lateral rectus recession and for medial rectus recession to 2.00 for Harada-Ito and for superior oblique lengthening with silicone expander. Median ICI for add-on factors ranged from 0.50 for lateral incomitance, concurrent neurological syndrome, age 70 years or older, and ASA rating III or higher to 2.00 for complicated strabismus operation, eg, lost muscle. CONCLUSIONS: The ICI is a new method of risk-adjusting a patient population undergoing strabismus surgery, thus allowing further evaluation of the outcome and the value of treatment of disease in that patient population.     

葡萄膜炎专业硕士研究生培养的思考

眼科学是研究人类视觉器官疾病的发生、发展及其防治的专门学科,有着很强的专业特点,对从事本专业人员的科研和临床要求高。其中葡萄膜炎专业更为复杂,葡萄膜炎发病率和致盲率高,与全身系统关系密切。传统的“填鸭式”教学已经不适合当今社会对葡萄膜炎专业研究生的
　　培养需求,这就要求硕士研究生导师探索符合培养研究生实践能力和创新能力的新型教学模式。     

Practice patterns of Canadian glaucoma specialists: planning for the next generation

BACKGROUND: To identify practice patterns of Canadian glaucoma specialists in order to begin identifying the needs of the work force to care for the next generation of glaucoma patients. METHODS: Survey of 130 Canadian glaucoma specialists whose names were obtained from the Canadian Ophthalmological Society specialist list. RESULTS: The response rate was 62% (81/130); 77% (62/81) considered themselves glaucoma specialists, but only 77% (48/62) of these had at least 1 year of formal glaucoma training. Specialists had a mean of 6.4 half days per month in the operating room, devoting the majority of their surgical time to glaucoma but performing more cataract surgery than glaucoma surgery. Forty percent of glaucoma specialists do not perform glaucoma drainage implant surgery. All the respondents stated that wait time for emergency care was within hours, but only 21% could perform their nonurgent cases within the benchmark set in this study of 4 weeks, wait times averaging 9.2 (range: 3-24) weeks. Forty-eight percent of the glaucoma specialists were not satisfied with their mix of clinical, laser, surgery, and nonophthalmology activities. Forty-four percent plan to decrease their clinical load over the next 5 years: 23% plan to increase their teaching, 19% their research, and 35% plan to devote less time to ophthalmology over the next 5 years. INTERPRETATION: Forty-eight percent of glaucoma specialists had concerns regarding timely intervention for semiurgent care, in that only 21% of these cases are performed within 1 month of a confirmed need for surgery. With a benchmark that surgery be performed within 1 month in patients whose glaucoma is progressing despite medical, laser, or prior incisional surgical care, we do not have adequate resources to care for current glaucoma needs. With the aging population and ongoing attrition of ophthalmologists, we need to plan for improved access to glaucoma surgery.     

Vitreoretinal Society of India practice pattern survey 2020: Medical retina

Purpose:The aim of this study was to present the outcomes of the Vitreo-retinal Society of India (VRSI) Practice Pattern Survey 2020 in medical retina.Methods:An online survey of members of VRSI was conducted in April 2020 regarding their practice-patterns on varied medical and surgical retina topics concerning imaging and management approach. The results were evaluated by two independent experts in this field and compared with the evidence and other practice patterns in the world.Results:A total of 107 VRSI members participated in the online survey. Responses were obtained on management of wide-ranging chorioretinal disorders such as Central Serous Chorioretinopathy (CSCR), Polypoidal Choroidal Vasculopathy (PCV), Neovascular age related macular degeneration (n-AMD), Retinal Vein Occlusions (RVO), and Diabetic Retinopathy (DR). Participants were also surveyed regarding their attitudes and perceptions about anti-VEGF practice patterns and role of imaging in their current practice. Each of the survey question responses were then compared to contemporary literature, including evidence-based guidelines, randomized controlled trials (RCTs), real-world evidence and analogous international surveys. Comprehensive analysis related to this has been put forward in the article.Conclusion:This survey represents the contemporary practice patterns amongst vitreoretinal specialists in India. The survey results are vital for fellow practitioners to understand the ''standard of care’ practice in medical retina. This will guide them to devise the best possible individualized treatment strategy for most favorable clinical outcomes.     

重视《中国青光眼指南(2020年)》发布后的推广和评价

青光眼是全球首位不可逆性致盲眼病。《中国青光眼指南(2020年)》(以下简称《指南》)基于我国基本国情,结合了国内外最新研究进展,可为我国青光眼临床诊疗工作提供重要参考和建议。眼科界应对《指南》加大宣传和推广力度,拓展其传播渠道和覆盖范围,以期充分发挥《指南》对临床工作的指导作用;还应注重对《指南》进行质量评价和后效评价,在临床工作中检验《指南》的可靠性和适用性,推动青光眼循证实践;同时应不断积累和反馈证据,以促进《指南》更新和完善,从而构建良好的证据生态系统,以期不断有效助力我国青光眼临床诊疗水平提高。(中华眼科杂志,2021,57:161-165)     

Vitreoretinal Society of India practice pattern survey 2020: Surgical retina

Purpose:To present the outcomes of the Vitreo-retinal Society of India (VRSI) Practice Pattern Survey 2020 in surgical retina.Methods:An online survey of members of VRSI was conducted in April 2020 regarding their practice patterns on varied medical and surgical retina topics concerning imaging and management approach. The results were evaluated by two independent experts in this field and compared with the evidence and other practice patterns in the world.Results:A total of 107 VRSI members participated in the online survey. Responses were obtained on management of wide-ranging surgical retina topics such as diabetic retinopathy, retinal detachments, Macular Hole, and Epiretinal membranes. Participants were also surveyed regarding their attitudes and perceptions about microscopes with the heads-up display system. Each of the survey question responses were then compared to contemporary literature, including evidence-based guidelines, randomized controlled trials, real-world evidence, and analogous international surveys. Comprehensive analysis related to this has been put forward in the article.Conclusion:This survey represents the contemporary practice patterns among vitreoretinal specialists in India. The survey results are vital for fellow practitioners to understand the “standard of care” practice in surgical retina. This will guide them to devise the best possible individualized treatment strategy for most favorable clinical outcomes.     

National audit of the outcome of primary surgery for rhegmatogenous retinal detachment. II. Clinical outcomes

PURPOSE: This national study was designed to audit anatomical outcome and complications relating to primary surgery for rhegmatogenous retinal detachments. This paper presents success and complication rates, and examines variations in outcome. METHODS: Sampling and recruitment details of this nationwide cross-sectional survey of 768 patients of 167 consultant ophthalmologists having their first operation for rhegmatogenous retinal detachment have been described. The main clinical outcomes detailed here are anatomical reattachment at 3 months after surgery and complications related to surgery. Consultants with a declared special interest in retinal surgery and able to perform pars plana vitrectomy were designated specialists for the analyses. RESULTS: Overall reattachment rate with a single procedure was 77% (95% CI 73.9-80.2). There were significant differences in reattachment rates between specialists and non-specialists. Without allowing for case-mix, specialists had a reattachment rate of 82% (95% CI 77.9-85.7) with a single procedure and non-specialists 71% (95% CI 65.9-76.0). Allowing for case-mix, there was a significant difference between specialists and non-specialists for grade 2 detachments of 87% and 70% respectively (P < 0.0001). Analysing detachments by break type, the largest difference between specialists and non-specialists was observed for retinal detachments secondary to horseshoe tears, 80% and 68% respectively (P < 0.003). Specialists met the standards set for primary reattachment rates, while non-specialists did not. Over a third of patients had at least one complication reported at some point during the audit period. CONCLUSIONS: Significant differences were seen in reattachment rates between specialists and non-specialists, overall and for specific subgroups of patients. This study provides relevant, robust and valid standards to enable all surgeons to audit their own surgical outcomes for primary retinal detachment repair in rhegmatogenous retinal detachments, identify common categories of failure and aim to improve results.     

重视和加强我国的眼科临床研究

多年来,虽然我国的临床病例资源明显多于国际上的先进国家,但由于我国对临床研究的重视程度和资金投入不足,我国的临床医学研究工作一直比较滞后,大大影响了我国临床规范化医疗的开展.近年来,随着我国政府对临床医学研究在医学科技创新中的作用认识的加深和对临床科研支持力度的加大,基于临床的研究将面临新的机遇.眼科医生既是疾病的诊治者,也是临床研究的实施者,应当注重在一线临床工作中发现临床问题,通过开展临床研究工作来更新和完善新的知识体系,指导和规范医疗行为,提高眼病诊疗水平,把握医学发展的客观趋势,开展高质量的临床试验研究.目前,要在眼科领域开展临床研究,我们还面临一些挑战,如临床研究项目立项困难、临床研究的伦理学审批困难、前瞻性研究方案设计需规范、多学科合作的研究方式有待加强等.希望有关管理部门和国内同道重视眼科的临床研究,期待更多有分量的临床研究结果展现在世人面前.     

Moving from PROMs to POEMs for Glaucoma Care: A Qualitative Scoping Exercise

Purpose. Patient-reported outcome measures (PROMs) are accepted widely as important outcomes in comparative effectiveness research. Over 30 PROMs have been described for use in glaucoma research, but their role in routine care is undefined. Our study explores the views of patients with glaucoma and their carers on the feasibility and content of a glaucoma PROM for use in day-to-day clinical practice. Methods. Focus groups were held with 71 participants facilitated by 23 staff working in the field of ophthalmology. Comparisons were made among themes derived from this exercise using simple thematic analysis and currently available health-related quality of life (HRQoL) instruments. Results. Participants were supportive of reporting their outcomes if the instrument was short, practical, and useful. Potential barriers to the use of PROMs, including bureaucratic overload and accessibility issues, were identified. Measuring health outcome and patient experience was important to participants. No freely available instrument covers all the domains identified, particularly knowledge and understanding. A novel instrument, a glaucoma patient-reported outcome and experience measure (POEM) is proposed. This addresses three aspects of outcome (fear of blindness, acceptability of treatment/side effects, and impact on daily life), and three aspects of experience (safety, respect, and understanding). Conclusions. Using PROMs routinely in the management of glaucoma presents significant challenges. Although current instruments (questionnaires) cover many of the participants' key domains, no single instrument covered them all. Further research is required to determine the feasibility (resources required), and validity and reliability of the proposed glaucoma POEM in clinical care.     

Attitudes of consultant ophthalmologists in the UK to initial management of glaucoma patients presenting with severe visual field loss: a national survey

Background: Recent National Institute of Clinical Excellence guidance suggests primary surgery should be offered to patients presenting with glaucoma with severe visual field loss. We undertook a survey of UK consultant ophthalmologists to determine if this represents current practice and explore attitudes towards managing patients with advanced glaucoma at presentation. Design: Questionnaire evaluation study. Participants: All consultant ophthalmologists currently practicing in the UK. Methods: A single‐page questionnaire was posted to all consultants (n = 910) currently practicing in the UK along with a pre‐paid return envelope. A second questionnaire was sent to non‐responders (n = 459). Main Outcome Measures: Questionnaire responses. Results: 626 responses were received representing 68.8% of the population surveyed. 152 (24%) volunteered a specialist interest in glaucoma. Consensus opinion for both glaucoma specialists (64.9%) and non‐glaucoma specialists (62.4%) was to start with primary medical therapy, most commonly citing surgical risk as the primary reason (23% and 22%, respectively) for this approach. Most felt the highest intraocular pressure measurement during follow up (measured in clinic) was the most important variable for prevention of further visual loss (60% of glaucoma specialists and 55% of non‐glaucoma specialists). Eighty‐three per cent of all responders suggested they would change their practice if evidence supporting primary surgery as a safe and more effective approach existed. Conclusions: Recent National Institute of Clinical Excellence guidance does not reflect the current management approach of UK ophthalmologists. The primary concern was related to potential complications of surgery although most practitioners would be willing to change their practice if evidence existed supporting primary surgery in patients presenting with advanced glaucoma.     

An Overview of the Korean Intermittent Exotropia Multicenter Study by the Korean Association for Pediatric Ophthalmology and Strabismus

The Korean Intermittent Exotropia Multicenter Study (KIEMS), which was initiated by the Korean Association of Pediatric Ophthalmology and Strabismus, is a collaborative multicenter study on intermittent exotropia in Korea. The KIEMS was designed to provide comprehensive information, including subjective and objective findings of intermittent exotropia in a large study population. A total of 65 strabismus specialists in 53 institutions contributed to this study, which, to date, is one of the largest clinical studies on intermittent exotropia. In this article, we provide a detailed methodology of the KIEMS to help future investigations that may use the KIEMS data.     

Prophylaxis for retinal detachment: evidence or eminence based?

PURPOSE: Prophylactic laser treatment of peripheral retinal lesions to prevent retinal detachment enjoys widespread use. However, clinical and scientific evidence for such treatment only exists for a few particular clinical situations. The aim of the present study was to delineate the current practice patterns for such prophylaxis among some European retinal specialists. METHODS: A postal survey was conducted among all members of BEAVRS (British and Eire Association of Vitreoretinal Surgeons; n = 236), all members of the German Retinological Society (n = 396), and Swiss retinal surgeons (n = 12) using a questionnaire with 6 case scenarios. The retinal specialists were asked to choose between three different options for each case: treat retinal lesion prophylactically, clinical follow-up, and other options. RESULTS: The return rates of the questionnaire were 36% in the United Kingdom, 42% in Germany, and 83% in Switzerland. There was a general tendency to apply laser prophylaxis to peripheral retinal lesions despite the absence of evidence in the medical literature. CONCLUSIONS: Nonevidence-based prophylactic laser treatment of peripheral retinal lesions remains a clinical and economic issue that must be addressed, and more evidence-based data are needed to establish clear clinical guidelines. Swiss retinal specialists are particularly conscientious in sending back a medical questionnaire.     

Glaucoma management trends in Australia and New Zealand

BACKGROUND: To describe self-reported patterns of care for glaucoma of ophthalmologists in Australia and New Zealand and summarize current practice styles and patterns associated with glaucoma management. METHODS: A questionnaire of glaucoma management practices was mailed to all ophthalmologists registered with the Royal Australian and New Zealand College of Ophthalmologists in June 2003. The questionnaire assessed practice preferences for medical management, examination techniques and indications for surgery. The results were cross-tabulated by age, country and subspecialty training in glaucoma. RESULTS: Fifty-one per cent of 761 surveys were returned, 14% being from glaucoma specialists. New Zealand ophthalmologists proceeded to surgical management of glaucoma earlier than did their Australian colleagues. Australian ophthalmologists tended to use argon laser trabeculoplasty more frequently. Ninety-six per cent of ophthalmologists routinely use gonioscopy in diagnosing glaucoma. Disc drawings and recording cup:disc ratios were the most commonly used methods of documenting disc morphology; glaucoma specialists were more likely to use imaging technologies. SITA-Standard 24-2 was the most commonly used modality of perimetry, and was favoured by glaucoma specialists. CONCLUSIONS: This survey represents the first Australian and New Zealand effort to identify glaucoma management practices. Although a substantial consensus was found in most areas of treatment, a few areas showed diversity. The information gathered will enable ophthalmologists to compare their own practices with those of their colleagues. In addition, this survey provides a baseline allowing future trends in management to be determined.     

A National Survey of Glaucoma Specialists on the Preoperative (Trabeculectomy) Management of the Ocular Surface*

Background: Preserved anti-glaucoma drops cause ocular surface disease (OSD), which is increasingly being recognized as a likely cause of trabeculectomy failure. Aim: To determine the routine pre-trabeculectomy management of the ocular surface by glaucoma specialists. Methods: A questionnaire consisting of 11 questions was posted to 146 UK glaucoma specialists. Results: The first-time response rate was 43.8%. Regarding routine pre-operative management, 40.6% of specialists use preservative-free drops, 29.7% commence a drop holiday, and 53% advise lid hygiene. 42.1% prescribe lubricants, 50% prescribe topical steroids, 7.8% topical NSAIDs, and 34.4% systemic tetracyclines. 84.4% of specialists change their routine management if OSD is present. Pre-operative optimization of the ocular surface is viewed “necessary” by 48.4% and “beneficial” by 85.9%. Conclusion: A wide variation exists in the routine pre-operative management of the ocular surface. Research to determine the impact of different pre-operative interventions upon trabeculectomy outcomes is required.     

Professor Jules Fran?ois Memorial Lecture. Code of ethics and its practice in ophthalmology

Several Articles are shown from the code of ophthalmological ethics written by late Professor Jules Fran?ois. Some examples found in the history of ophthalmological practice that complied with these articles are demonstrated. In the modern society with aging population, ophthalmic surgery must be done with great care; long-term prognosis should always be taken into consideration for the patients to be able to maintain high quality of life throughout their life-span. To achieve this, meticulous and continuous care of patients by means of best possible noninvasive techniques must be exercised and this is a conscience of ophthalmologists.     

马来西亚综合医院后囊破裂的诱发因素与相关性及结果分析

目的：：观察后囊破裂的诱发因素、相关性及结果。方法：回顾性研究。研究对象为2007~2014年我院出现后囊破裂患者。研究后囊破裂与眼部合并症、晶状体相关并发症、手术水平、手术类型、独立手术或联合手术的相关性,及患者最终视力情况。结果：在12846名患者中,后囊破裂是最常见的术中并发症(n=623,4.8%)。眼部合并症和晶状体状态不会引起后囊破裂。手术者的经验和资历与后囊破裂发生的相关性显著。基层医务人员手术时出现后囊破裂比知名专家多(P=0.0000),而知名专家手术时出现后囊破裂情况反而比一般专家多(P=0.000)。白内障手术中出现后囊破裂与下列手术方式显著相关：超声乳化术、超乳转囊外摘除术及囊内摘除术(P=0.000),晶状体吸出术(P=0.020)和白内障囊外摘除术( P=0.003)。术中发生( P=0.013)与未发生(P=0.001)后囊破裂时,专家均比学员的手术结果好。尽管如此,在复杂病例中,专家与学员术中出现后囊破裂无显著差异。后囊破裂致视力损害的主要原因是散光。视力丧失(P=0.000)和低视力(P=0.000)出现较多。相对于其它并发症,后囊破裂更易致低视力。结论：后囊破裂会发生在所有类型的白内障手术中,且是引起术后低视力的主要术中并发症。专家在处理后囊破裂的手术结果优于学员。因而初级外科医生应加强手术练习。     

The effect on pediatric ophthalmologists of the randomized trial of patching regimens for treatment of moderate amblyopia.

PURPOSE: To investigate the implementation of the recommendations of the randomized trial of patching regimens for treatment of moderate amblyopia in children. METHODS: A questionnaire was e-mailed to 380 members of the American Association for Pediatric Ophthalmology and Strabismus. RESULTS: Ninety responses were received. The majority of questionnaire respondents did not alter their clinical practice of patching subsequent to publication of the results of the patching trial. Thirty-nine percent made no modification whatsoever; an additional 33% made rare adjustments, and only 12% claimed to have adapted the amount of patching hours to the recommendations of the study. CONCLUSIONS: It is evident from the questionnaire results that the majority of pediatric ophthalmologists that replied to the questionnaire did not alter their clinical practice of patching subsequent to publication of the results of the patching trial.     

History of the evaluation of medicines aiming for marketing authorization

The European Directive on Medicines Evaluation and Marketing Authorization were issued in 1975. For more than 30 years, Marketing Authorization criteria have been defined as pharmaceutical and biological quality, therapeutic efficacy, and safety. The application comes from the pharmaceutical company and must include the full data on drug development. French procedures have always included practical assessment of the drug by health practitioners: clinicians, pharmacists, biologists, and specialists in biostatistics.