China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      This is a prospective, investigator-masked randomised controlled education-intervention trial
      of intense simulation-based surgical education plus conventional training versus a current
      six-week standard training course. The aim is to investigate whether the addition of
      simulation-based surgical education to standard training improves competence and surgical
      outcomes. All participants in the study will receive the educational intervention of the
      six-week Orbis-COS course. The intervention groups will receive this training and an
      additional element of learning and sustained deliberate practice using model eyes and
      simulation.
    

Detailed description: 
      Project Description:

      The leading cause of blindness in China and the world is un-operated cataract. Despite
      notable efforts on the part of the Chinese government, China's cataract surgical rate
      (1400/million/year in 2015) remains behind that of many of its poorer neighbours, such as
      India (6500) and Vietnam (2250). An important reason is the unavailability of trained
      surgeons: though China has over 36,000 ophthalmologists, only a third are capable of
      performing independent cataract surgery. This shortfall is due in large part to lack of
      hands-on training opportunities. A recent survey of residents at China's top-ranked resident
      training programs found that the median number of independent cataract surgeries performed
      was actually zero. The problem persists after formal training is completed: <5% of cataract
      surgeries are performed by doctors aged 24-43 years. The problem is particularly acute in
      rural areas, where hands-on training opportunities for young ophthalmic surgeons are even
      rarer. One reason is safety concerns on the part of patients and senior doctors in entrusting
      operations to young surgeons.

      New training models for cataract surgery are needed which can safely and efficiently support
      trainees during the transition from novice to competent surgeon. Simulation-based surgical
      training, using high-fidelity, inexpensive, re-usable model eyes have been successfully
      piloted. The investigators now propose to carry out a randomized trial comparing training
      using these model eyes with traditional techniques, to study the impact on quality of surgery
      (assessed by masked grading of videos using the ICO OSCAR system), visual acuity and
      cost-utility outcomes.

      The investigators research will reduce expenses by piggybacking on an on-going collaborative
      program between Orbis International, the Chinese MOH, Chinese National Blindness Prevention
      Committee and Tongren Hosptal (one of China's largest and best-respected eye hospitals),
      which will train 120 rural cataract surgeons at 60 county hospitals in 6 provinces. The
      study's collaboration involves internationally-respected vision research teams at ICEH,
      Queen's University Belfast and Tongren, while offering opportunities for scale-up and
      engagement with Chinese policy makers at the highest level.

      A successful trial proving the training benefits of inexpensive model eyes will make a unique
      contribution to building the capacity to manage China's leading cause of blindness, thus
      furthering the aims of SightFirst and the Chinese Ministry of Health, while improving the
      lives of Chinese people dwelling in low-resource areas.
    

Intervention name(s): Simulation-based surgical training; Standard surgical training
Intervention type(s): Other; Other
Intervention description(s): Those in the intervention group will be introduced to a variety of simulation-based surgical training techniques. Specifically, this will involve breaking down the SICS cataract surgery procedure into stages, and practicing each stage repeatedly using simulation. This sustained deliberate practice will be integrated into the six-week course, as an enhancement to the course, and not as a replacement of any part of the educational content. Within the last three weeks of the course, 'intervention' arm participants will be introduced to the artificial eyes, the Simulation-OSSCAR rubric, and be provided with ongoing feedback.
All participants in both intervention and control arms will undertake the six-week Orbis-COS training course.; Standard surgical training (without bespoke training scheme using simulation and model eye). All participants in both intervention and control arms will undertake the existing six-week Orbis-COS training course, which includes 2-4 weeks of didactic lectures, surgical observation, and wet lab training with a minimum of 50 pig eye wet lab simulations per trainee. After observed mastery of wet lab pig eyes, trainees then perform hands-on training in county level hospitals. The hands-on training pairs a surgeon from the training centre to mentor the trainee through a minimum of 30 assisted surgeries and 50 independent surgeries under supervision.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: education; developing country; developing countries; low-and middle-income country; low-and middle-income countries; surgical training; blindness; china; simulation; model