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Clinical and Experimental Ophthalmology 2015; ••: ••–•• doi: 10.1111/ceo.12524
Original Article Novel system for distant assessment of cataract surgical quality in rural China Lanhua Wang MD,1* Danping Xu MD,2* Bin Liu MD,1 Ling Jin MS,1 Decai Wang MD,1 Mingguang He MD PhD,1,3,4 Nathan G Congdon MD MPH1,5 and Wenyong Huang MD PhD1 1
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, and 2Guangdong Hospital of Traditional Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China; 3University College London Institute of Ophthalmology, London, UK; 4Centre for Eye Research Australia, University of Melbourne, Melbourne, Victoria, Australia; and 5ORBIS International, New York, New York, USA
women and 77.5% completing > 50 training cases). The majority (53.1%, 26/49) had performed ≤ 50 cataract surgeries prior to training. Kappa was 0.57∼0.98 for the steps (mean 0.85). Poorest-rated steps were draping the surgical field (mean ± standard deviation = 3.27 ± 0.78), hydro-dissection (3.88 ± 1.22) and wound closure (3.92 ± 1.03), and top-rated steps were insertion of viscoelastic (4.96 ± 0.20) and anterior chamber entry (4.69 ± 0.74). In linear regression models, higher total score was associated with younger age (P = 0.015) and having performed >50 independent manual small incision cases (P = 0.039).
ABSTRACT Background: This study aims to assess the quality of various steps of manual small incision cataract surgery and predictors of quality, using video recordings. Design: This paper applies a retrospective study. Participants: Fifty-two trainees participated in a hands-on small incision cataract surgery training programme at rural Chinese hospitals. Methods: Trainees provided one video each recorded by a tripod-mounted digital recorder after completing a one-week theoretical course and hands-on training monitored by expert trainers. Videos were graded by two different experts, using a 4-point scale developed by the International Council of Ophthalmology for each of 12 surgical steps and six global factors. Grades ranged from 2 (worst) to 5 (best), with a score of 0 if the step was performed by trainers. Main Outcome Measures: Mean score for the performance of each cataract surgical step rated by trainers. Results: Videos and data were available for 49/52 trainees (94.2%, median age 38 years, 16.3%
Conclusions: More training should be given to preoperative draping, which is poorly performed and crucial in preventing infection. Surgical experience improves ratings. Key words: video.
China, cataract surgery, outcome, rural,
INTRODUCTION China has among the lowest cataract surgical rates (CSR) in Asia, at 900 cases per million populations per year in 2010.1 Factors such as relatively high
■ Correspondence: Professor Wenyong Huang, Department of Preventive Ophthalmology, Zhongshan Ophthalmic Center, ZOC, Sun Yat-sen University, Xianlie S Rd, #54 Yuexiu District, Guangzhou 510060, China. Email:
[email protected] Received 10 January 2015; accepted 4 March 2015. Conflict of interest: None. Funding sources: Starr Foundation (New York, USA) through Helen Keller International (New York, USA). Professor Congdon is supported by a Thousand Man Plan grant from the Chinese government. *Contributed equally to this study. © 2015 Royal Australian and New Zealand College of Ophthalmologists
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surgical fees,2 lack of skilled cataract surgeons3 and unbalanced distribution of medical resources between urban and rural areas largely explain this situation.4 Though 50% of the population dwells in rural areas, only 20% of ophthalmologists reside there.3 The result is that cataract remains the leading cause of blindness in China,5 as it is in the East Asia region6 and globally.7 Thus, programmes of rural cataract surgical training supported by the government and NGOs8 are of great importance in building cataract surgical capacity in China. The advantage of manual small incision cataract surgery (MSICS) is its potential for high-quality visual outcomes8 despite relatively low per-case costs. This makes it more appropriate than phacoemulsification for use in underdeveloped areas of China.9 But it is important to note that some studies have showed that poor surgical outcomes may reduce willingness of rural patients to undergo MSICS surgery.10 Population-based studies have also shown that poor outcomes result after cataract surgery in as many as half of cases in rural China,11 underscoring the need for better training. Since 2007, the hands-on Starr MSICS surgical training programme, carried out in collaboration between Helen Keller International (HKI, New York, USA) and Zhongshan Ophthalmic Center (ZOC, Guangzhou, China), has trained >50 physicians in county and township-level hospitals to the point of performing surgery independently. The purpose of the present study is to assess the quality of each step of MSICS surgery performed by trainees in the Starr programme, to better focus training efforts on more problematic stages of surgery while also identifying risk factors for poor performance.
METHODS Participants Four surgeons from Zhongshan Ophthalmic Center (ZOC, Guangzhou, China), who had performed >1000 MSICS cases and had 3–10 years of experience in MSICS, were selected as trainers in this programme. A letter was sent to every county-level hospital in poorer counties within Guangdong Province whose population was more than 1 000 000 (n = 150), asking whether they wished to nominate an ophthalmologist for cataract surgical training. Among those who agreed, the doctor selected by the hospital was accepted as a trainee regardless of his/ her background. The study was approved by the Ethics Committee at ZOC. Oral informed consent was obtained from all trainees and video-recorded patients, and the tenets of the Declaration of Helsinki were followed throughout. Fifty-two trainees from 43 county-level hospitals, with a varying range of baseline surgical experience,
were recruited into the hands-on MSICS training programme in Guangzhou, China, from July 2008 to December 2010. The large majority of trainees were performing extra-capsular cataract extraction with occasional small incision cases prior to training; very few had any experience with phaco-emulsification. After a one-week training period of wet-lab instruction and lectures on surgical technique at ZOC, trainees returned to their own hospitals for further hands-on training and monitoring of surgical quality by experienced trainers who had performed >1000 MSICS cases. The trainee was deemed to have completed the programme when s/he was able to complete five consecutive MSICSs independently without serious complications such as posterior capsular rupture, irido-dialysis or corneal oedema persisting for >1 week. After completion of didactic and hands-on training, a single case was recorded at random for each trainee using a side-mounted digital recorder, and videos were graded by masked reviewers using a standard system. To reduce variability due to non-physician factors, patients with comorbid ophthalmic disease, poor dilation, hyper-mature cataract, or other risk factors for surgical complication identified at preoperative assessment were excluded.
Surgical technique Surgery was performed after topical and subconjunctival anaesthesia with 2% lidocaine, with retro bulbar anaesthesia added only if poor compliance was anticipated. A half-thickness, superior or superior-temporal corneoscleral tunnel was created after fornix-based peritomy and thermal coagulation. After a can-opener capsulotomy and hydro-dialysis, the lens nucleus was gently prolapsed into the anterior chamber with viscoelastic. The corneoscleral tunnel was widened as needed, and the lens nucleus was delivered intact through the tunnel incision with the help of a lens vectus. Cortical cleanup was carried out via Simcoe cannula, and a rigid polymethylmethacrylate (PMMA) PC IOL (Model OV-55C, 5.5 mm diameter; 66vision Tech Co., Ltd, Suzhou, China) was implanted into the capsular bag. Suturing was carried out with 10.0 nylon only in the event of wound leakage.
Video recording The surgical procedure was recorded through a digital recorder (Nikon Coolpix P90, Nikon Corp, Tokyo, Japan) installed on a tripod beside the operating microscope. All videos were standardized as to magnification and camera settings, and any logos or other characteristics that could identify the surgeon or facility were edited out prior to grading.
© 2015 Royal Australian and New Zealand College of Ophthalmologists
Video assessment of cataract surgery
Video grading The International Council of Ophthalmology has recently made available an assessment tool known as the Ophthalmology Surgical Competency Assessment Rubric: Small Incision Cataract Surgery (OSCAR: SICS) for the purpose of evaluating skill in MSICS surgery among trainees.12 It consists of two parts: 13 step-specific grades, and a set of six global assessments, both anchored by a scoring rubric that exactly defines what is expected to achieve each grade at each step. Each of the global and taskspecific components is rated on a 4-point scale, with scores ranging from 2 (poor performance) to 5 (good performance). A score of 0 is assigned if the step has to be performed by the trainer, and no score of 1 is possible. The sub-score for the global portion ranges from 0–30, and that for task-specific portion is 0–65, for a maximum total score of 95 points. The original assessment tool was created for use during live surgery, and some aspects were not applicable to video-based assessment. The following changes were made to the instrument to accommodate video scoring: First, details more suitable for live assessment, for example, rating stability of the surgical view under the microscope and performance outside of the surgical view, were eliminated. Second, because relatively low quality microscopes and mature cataracts were common in rural hospitals, a can-opener capsulotomy was recommended instead of a continuous curvilinear capsulorhexis (CCC) as used in the OSCAR assessment system. As a result, two separate steps in the assessment of the CCC in the OSCAR system were combined in the current study. An additional step, maintaining the anterior chamber, was added, resulting in the following 13 steps (and therefore no change in total score): (i) draping the surgical field; (ii) thermal coagulation; (iii) construction of the sclera-corneal tunnel; (iv) construction of the corneal entry wound; (v) viscoelastic insertion; (vi) capsulotomy; (vii) hydrodissection; (viii) prolapse of the nucleus into the anterior chamber; (ix) maintenance of the anterior chamber; (x) delivery of the nucleus out of the anterior chamber; (xii) cortical removal; (xii) intra-ocular lens (IOL) insertion; (xiii) wound closure and checking for wound leakage. No changes in the following six global factors in the original OSCAR assessment system were made: (i) wound neutrality and minimizing eye movement and corneal distortion; (ii) eye positioned centrally within microscope view; (iii) handling of conjunctival and corneal tissue; (iv) intraocular spacial awareness; (v) Protection of the iris from damage and maintenance of anterior chamber, (vi) Overall speed and fluidity of procedure.
3 Two expert reviewers (trainers in the programme, each averaging 100–200 cataract surgeries per month) independently reviewed the recordings and assigned grades as above. In view of the high level of agreement between graders, a single grade for each step by each trainee was selected at random for analysis using a simple coin flip. Trainees were provided feedback on their grades for each step of their videotaped surgery, and encouraged to review all steps receiving marks 50cases
5.72 6.53 13.0
Median 38 12 12 8 (16.3)
Min
Max
27 1 1
51 25 72
11 (22.5) 38 (77.5) 26 (53.1) 23 (46.9)
MSICS, manual small incision cataract surgery; SD, standard deviation. Table 2. Inter-rater reliability for each step of surgery as rated by two experienced trainers Step Draping Thermal coagulation Sclerocorneal tunnel Corneal entry Viscoelastic insertion Hydrodissection Nuclear prolapse Nuclear extraction Cortical removal IOL implant Wound closure Wound neutrality and minimizing eye rolling and corneal distortion Intraocular spacial awareness Conjunctival and corneal tissue handling Eye positioned centrally within microscope view Overall speed and fluidity of procedure Maintenance of anterior chamber Capsulotomy Iris protection Mean (range)
Weighted Kappa 0.84 0.81 0.98 0.90 0.74 0.90 0.96 0.90 0.93 0.85 0.87 0.81
training and total previous number of cataract operations were unassociated with the score for draping (Table 4). In linear regression models for total score, younger age (P = 0.015) and having performed more than 50 independent MSICS cases during training (P = 0.039) were associated with higher score, though no association was present with sex, years of experience in an eye department, surgical time or number of cataract operations performed prior to training (Table 5).
DISCUSSION
0.90 0.82 0.92 0.75 0.79 0.57 0.86 0.85 (0.57∼0.98)
Draping the surgical field (mean score ± standard deviation ([SD] = 3.27 ± 0.78), hydro-dissection (3.88 ± 1.22) and wound closure (3.92 ± 1.03) were rated the most poorly performed steps, while insertion of the viscoelastic (4.96 ± 0.20), construction of the corneal entry (4.69 ± 0.74) and the construction of the sclerocorneal tunnel (4.63 ± 0.67) were the best-performed ones (Table 3). In ordinal logistic regression models of score for draping, younger trainees (OR = 0.74 per year of age, 95% CI 0.58, 0.95, P < 0.05) were more likely achieve higher ratings, and sex, years of experience in an eye department, surgical time (including incision time, cortical-removal time and total surgical time), number of independent MSICS cases during
Draping the surgical field was the most poorly performed step in the current study, with a mean score of only slightly >3. According to the published criteria of the OSCAR system for MSICS, a score of three for surgical draping indicates: ‘Drapes with minimal verbal instruction, incomplete lash coverage’.12 Previous studies have showed that the patient’s ocular adnexal flora are the most common infectious agents in postoperative endophthalmitis.13 It has been reported that careful draping to isolate the lashes from the field can reduce the risk of postoperative endophthalmitis.14 Though the incidence of post-cataract endophthalmitis is relatively low (between 0.06% and 0.32%)15,16 in series from developed countries, rates are largely unreported in rural Asia, and outcomes where they have been assessed are generally very poor due to delays in referral.17 If rural surgeons in China are in fact failing to properly perform this crucial step, they are exposing their patients to potentially devastating visual consequences. Our previous work in rural cataract training programmes in fact showed that surgeons rated the step of draping as being the easiest of all in SICS.18 It seems likely that the importance of properly isolating the adnexa from the surgical field has been under-rated by trainees, and needs to be further emphasized in training. Our training materials in the
© 2015 Royal Australian and New Zealand College of Ophthalmologists
Video assessment of cataract surgery
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Table 3. Mean scores (scale of 2 [poorest] to 5 [best], 0 score for steps done by trainer) assigned to the steps of cataract surgery for 49 ophthalmologists participating in a training course in rural China Steps
Score
Draping Hydrodissection* Wound closure* Cortical removal* IOL implant* Iris protection* Capsulotomy* Nuclear prolapse* Intraocular spacial awareness* Maintenance of anterior chamber* Conjunctival and corneal tissue handling* Thermal coagulation* Wound neutrality and minimizing eye rolling and corneal distortion* Nucleus extraction* Eye positioned centrally within microscope view* Sclerocorneal tunnel* Overall speed and fluidity of procedure* Corneal entry* Viscoelastic insertion*
0
2
3
4
5
Median score
1 (2.04) 3 (6.12) 2 (4.17) 2 (4.08) 2 (4.08)
1 (2.04) 1 (2.04) 1 (2.08)
33(67.4) 6 (12.2) 4 (8.33) 6 (12.2) 6 (12.2) 8 (16.7) 4 (8.16) 7 (14.6) 7 (14.6) 2 (4.17) 2 (4.17) 3 (6.12) 2 (4.17)
11 (22.5) 25 (51.0) 31 (64.6) 25 (51.0) 20 (40.8) 1 (27.1) 26 (53.1) 12 (25.1) 14 (29.2) 20 (41.7) 20 (41.7) 18 (36.7) 19 (39.6)
3 (6.12) 14 (28.6) 10 (20.8) 16 (32.7) 21 (48.9) 22 (52.1) 19 (38.8) 28 (58.3) 28 (56.3) 26 (54.2) 26 (54.2) 28 (57.1) 27 (56.3)
3 4 4 4 4 5 4 5 5 5 5 5 5
3.27 ± 0.78 3.88 ± 1.22 3.92 ± 1.03 4.04 ± 1.06 4.14 ± 1.10 4.27 ± 0.89 4.31 ± 0.62 4.40 ± 0.82 4.42 ± 0.74 4.50 ± 0.58 4.50 ± 0.58 4.51 ± 0.61 4.52 ± 0.58
2 (4.16)
13 (27.1) 18 (37.5) 11 (22.6) 13 (27.1) 5 (10.2) 2 (4.08)
32 (66.7) 30 (62.5) 35 (71.4) 33 (68.8) 40 (81.6) 47 (95.9)
5 5 5 5 5 5
4.54 ± 0.87 4.63 ± 0.50 4.63 ± 0.67 4.65 ± 0.56 4.69 ± 0.74 4.96 ± 0.20
2 (4.17) 1 (2.08)
1 (2.08) 1 (2.04) 2 (4.08)
2 (4.08) 2 (4.17) 2 (4.08)
Mean score (± SD)
*Wilcoxon signed-rank test for difference between the various steps and draping (the worst-performed step) P < 0.001. Table 4.
Ordinal logistic regression models of potential predictors score for the step of draping (rated as the worst-performed step)
Potential predictor
Model for draping score Univariate analysis OR
Trainee age (years) 0.92 Sex (Male) 0.40 Years in an eye department 0.98 Total numbers of independent MSICS completed during training – ≤50 cases‡ >50 cases 1.0 Numbers of cataract surgeries before training – ≤50 cases‡ >50 cases 1.68 Incision time 1.02 Irrigation–aspiration time 1.04 Total surgical time 0.96
Multivariate analysis
95% CI
OR
95% CI
[0.82, 1.03] [0.09, 1.68] [0.90, 1.08]
0.74* 0.38 1.17
[0.58, 0.95] [0.08, 1.89] [0.94, 1.46]
– [0.26, 3.92]
– 0.78
– [0.15, 3.96]
– [0.51, 5.49] [0.63, 1.67] [0.88, 1.23] [0.88, 1.04]
– 2.72
– [0.69, 10.6]
0.96
[0.89, 1.05]
*P < 0.05. ‡Reference category. 95% CI, 95% confidence interval; MSICS, manual small incision cataract surgery; OR, odds ratio.
Starr programme have now been modified to further emphasize the importance of careful draping. It is difficult to compare our study with other reports due to differences in design, methods of evaluation and selection of surgeons. Much published literature focuses on phacoemulsification surgery, with nuclear emulsification,19,20 capsulorhexis19 and loading the foldable intraocular lens20 having been rated as especially difficult and/or poorly performed steps. By contrast, the capsulotomy was rated by graders in the current report as having been per-
formed relatively well by trainees (mean score 4.31 +/− 0.62), presumably due to the comparative ease of the can opener compared to the continuous curvilinear capsulotomy technique. Our finding of improved total scores with greater surgical experience was consistent with a previous study showing that key stages of phacoemulsification were easier for third-year trainees than second-year ones,20 and with our own previous results relating to self-rated difficulty of various surgical steps.18 The number of cases which
© 2015 Royal Australian and New Zealand College of Ophthalmologists
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Table 5. Linear regression models of potential predictors for total score Potential predictor
Model for total score Univariate analysis Beta
Trainee age (years) −0.10 Sex (male) −0.41 Years in an eye department −0.01 total numbers of independent MSICS completed during training – ≤50 cases‡ >50 cases 1.65 Numbers of cataract surgeries before training – ≤50 cases‡ >50 cases 0.83 Incision time 0.19 Irrigation–aspiration Time 0.06 Total surgical time −0.09
Multivariate analysis
95% CI
Beta
95% CI
[−0.24, 0.04] [−2.58, 1.75] [−0.14, 0.12]
−0.19* −0.52
[−0.33, −0.05] [−2.51, 1.47]
– [−0.28, 3.58]
– 1.95*
– [0.06, 3.84]
– [−0.77, 2.44] [−0.60, 0.97] [−0.18, 0.31] [−0.19, 0.01]
– 1.13
– [−0.46, 2.71]
−0.09
[−0.18, 0.01]
*P < 0.05. ‡Reference category; 95% CI, 95% confidence interval; MSICS, manual small incision cataract surgery.
distinguished between higher and lower total scores was 50, similar to the number recommended as a minimum numbers of surgeries by the Royal College of Ophthalmology Training Committee,21 and more in line with the surgical cases recommended by American Council for Graduate Medical Education (86)22 than 15 cases suggested by the Chinese Ophthalmologic Society.23 Our study found that younger trainees tended to perform better, which is consistent with Neumayer et al.,24 who reported that surgical skills and outcomes declined above the age of 45 years. Reports from other surgical fields also suggest that physicians’ ability to learn and perform new skills may be compromised by aging.25 This result may have implications for selection of future candidates for surgical training in rural areas. In ophthalmic surgery training programmes, the goals of quality monitoring are specifically to assess surgical skill transfer, improve the learning curve and identify factors that affect residents’ surgical performance. Traditional surgical assessment has generally consisted of retrospective performance analysis conducted by the trainee’s supervisor, which is potentially subjective and unreliable.26 We relied on video-based assessment with specific behavioral narrative anchors and objective benchmarks as provided by the OSCAR rating system. Our results suggest that this approach generally produced reliable results, in that the mean kappa value over all surgical steps was high, and the value for only one step fell below 0.60. This system may also be more convenient for ongoing assessment of skills within networks covering a large area, as it relies on user-provided videos rather than on-site assessment.27 Some limitations of this approach include inability to assess patient selection and actions outside of the operating
field. High-quality videos are necessary, which may pose a particular challenge in some settings. Strengths of this study include the relatively large number of rural trainees included, use of a standardized and validated assessment system, and generally good agreement between masked reviewers. Limitations must also be acknowledged: all participants in the current study were drawn from the same programme in one region, as trained by a relatively small number of experts (four in this case). Broader application of these results may only be made with caution. It should also be acknowledged that rating surgeons on only a single case is a limitation. Unfortunately, recording multiple cases for each surgeon was not practical, and the point of the current study is less to rate individual surgeons than to bring out critical trends in terms of weaknesses or strengths apparent across all trainees in this programme. For this purpose, a single case for each surgeon was adequate. It is also possible that cases submitted on behalf of trainees were not actually performed by them; in most hospitals, the trainees were the only surgeons capable of performing independent cataract surgery, so this possibility is relatively remote, but it does remain an inherent weakness of this videobased approach. Finally, it would have been valuable to assess the correlation between surgical grade and vision outcomes. Unfortunately, we did not collect these data, though our previous publication has demonstrated generally good surgical results among trainees in this programme using this instruction technique.28 While important technical shortcomings such as poor preoperative prepping and draping increase the chances of postoperative infection and consequent visual loss, but such events remain rare, and thus the impact on vision of low grades on this important step
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Video assessment of cataract surgery would likely not have been ascertainable in this setting. In part due to these practical considerations, previous papers validating the OSCAR system29 have also followed the approach used here of comparing results between graders rather than attempting to correlate them with vision outcomes. In conclusion, when learning MSICS, more attention in training should be given to preoperative draping, which may be poorly performed and is crucial in preventing postoperative infection. Increasing numbers of surgeries is the most important predictors of improved performance on key steps. Our method of combining the OSCAR system with videos in evaluating surgical performance was stable and reliable, and may be a valuable training tool in other similar settings where high-quality training is needed to overcome the burden of cataract blindness.
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