 Aravind Murugasen, did I say that right? Aravind's been visiting us from India. You're at the Aravind Institute, right? Yeah. And he's been a visiting plastics fellow, and he's been wonderful to work with. As far as the residents go, he's been great. Yeah, you've been great. Well, enjoy your talk. He's going to talk to us about a high retention rate in clinical studies. Thank you, Bryce, for the introduction. I'm Aravind Murugasen. I know that the second name is a little difficult to pronounce. And I come from the south of India from a small town called Madurai. Madurai is known for its temples, its very ancient culture and heritage for its vivid architecture and very colorful festivals. It is also known for Aravind Eye Hospital, which is arguably one of the largest eye care service providers in the world. It's a network of five branches. The similarity in the name is pure coincidence, and I have no financial interest in the hospital or the talk that I'm going to give. So this was a paper I presented in the National Level Ophthalmology Meeting in January 2011 in Ahmedabad. And this is not path-breaking scientific research. This is not the latest in science technology. But there are some very simple, practical solutions to some of the most pertinent problems that we face while conducting clinical trials in our setup. So I chose this paper because I thought it would give you an insight of where I come from and what we do. The basic facts start with that clinical trials are all based on certain statistical assumptions, and these assumptions are based on maximum follow-up of all the enrolled subjects. The results of the trial earn their validity only when the data for evaluation matches the pre-trial presumptions. So what happens when we have patients lost to follow-up, subjects who don't turn up for the trial follow-up, the validity of the trial is threatened and affects the bias, too, because of the differential dropout among the different comparison groups and the different participants in the group, too. The general relevance of the study is affected and the statistical power loses its significance. Despite all these threats, this is a topic which gets little attention to and maintaining a good follow-up rate for most trials. So this was a typical study which was ongoing in the Aravindra Research Department. This is a long-term follow-up study in which we recruited about 188 eyes of 94 subjects who underwent cataract surgery with different eye-old designs and we followed them up to see the different rates of posterior capture of pacification. After surgery, these patients were followed up at regular intervals in the sixth month, the first, second, third, fourth and fifth years post-operatively. So on analyzing this data, we realized that our follow-up was something like 96% in the first year, 94% in the second, and nearly 90% at the end of the third year. So we started discussing some of the barriers that we encountered and the strategies that we have in place to achieve high retention rates despite the population. So to understand our barriers, you'll have to understand our population. The population base for Madurai is predominantly rural from lower socioeconomic strata with low levels of awareness and literacy. In such a scenario, even identifying a patient or a subject can be quite a challenge because there are very common subject names with very similar sounding names at that. And we do not have a double naming system. It's a single naming system in South India. There are no surnames. And some family customs restrict the wife from mentioning the husband's name themselves. The addresses, too, lack clarity and specificity. There are no house numbers, street names, and even if they do exist, they're sometimes quite similar and sometimes very confounding. A simple male to 65 Mario Kapeki drive will not suffice in such a situation for a patient reminder. So tracing subjects becomes a huge challenge for the field workers who go down to trace those people who are lost to follow-up. Literacy in rural Madurai is something like 68.24%. So the level of understanding and awareness is dismally low. And they do not understand the concept of clinical trials. There is no treatment. The patients on the subjects do not receive any monetary incentive for coming back for follow-ups. And, in fact, they undergo or incur indirect expenses because most of them are daily wage. And so they lose that wage for the day that they arrive at the hospital and they end up paying for the people accompanying them, too. Some of the psychological barriers is that cataract surgery is quite a single-point treatment to come back for regular follow-up like in diabetic retinopathy or glaucoma. And the absence of visual symptoms for surgery also does not give them an incentive to come back. The barriers extend from an entire spectrum of having a fear of being taken advantage of right down to a blind faith on the physicians that they are completely treated in one go. So with all these barriers we started looking at studies and most of them were American studies. We realized that studies which had lower retention rates actually had fewer strategies in place than those with higher retention even though the follow-up duration was pretty low. Some of the strategies that are in place may sound very commonplace and simple but they have a very relevant role in this scenario. One of these is the unique identification system. We do not just take down the patient's name, we try to take down the next of kin and the local nicknames and try to avoid every ambiguity right in the enrollment itself. A follow-up color coded card is issued to these subjects which they carry on every follow-up visit to the hospital so they do not have to keep searching for a department, they are brought in directly. Addresses are noted down in a lot of minute detail and it's not just again street names and numbers but sometimes entire transport details to their place of origin and also a postcard is issued to them so that they can intimate us if there's any change in address. A systematic patient reminder protocol is also in place in where about two weeks prior to a scheduled visit a postcard is issued to them through mail and one week prior to the visit a telephonic reminder is given. A subject fails to turn up despite this again a reminder through a telephone or a postcard goes through and finally after a window period a field worker goes down to trace the subject. One of the most important things in conducting clinical trials is building a one-on-one patient relationship and most of our study staff are very carefully trained in establishing individualized relationships with these trial subjects with their personal incentive to come back for follow-up. Some of the smaller strategies that we try to ensure that their follow-up visits coincide with routine clinical review the study coordinator is always present with the trial subjects to ensure that their questions and concerns get answered and sometimes they help reduce their waiting time which is a big incentive for patients to come and visit the study coordinators. We also want to exclude patients who are unlikely to comply with the trial requirements and we eliminate them at the level of enrollment itself. In conclusion, we were able to achieve significant loss of follow-up in clinical trials and achieve good retention rates by incorporating innovative preventive and retentive strategies into our trials and this involves thorough planning and good organization and committing time and resources to minimizing loss to follow-up. I'll break for a minute to take suggestions and questions before I go in for acknowledgments. I'm very happy you brought down the question because tele-density actually has increased many fold in India and most of the people, even the ones I showed in the photographs have cell phones and telephones with them but the problem is by things like SMSL it's a short messages the literacy just prevents them from reading those messages so it just never gets through and even if you do call them over telephone and remind them there's no personal incentive to actually land up in the hospital. We do not offer that because again it leads into a very vicious cycle of disincentives and there is no compensation for everyone. We usually make up with all the rest they wait less and time in the queues in the hospital and they get through much faster. And we're talking about a daily outpatient load of about 1,500 patients a day in the single center and about 100,000 surgeries every year in Madurai alone. So I'm pretty much at the end of my three month fellowship in the Moran in Oculoplasty and I enjoyed it so I would start my acknowledgements with thanking the person who's responsible for bringing me here today this morning and that is the University bus driver who has consistently punctually and courteously brought me to work every single day of my last three months and who probably represents everything that is really good for my culture so that's off to you. But jokes apart thanks to this man Dr. Tebin who has been very instrumental in getting me through this fellowship and getting me here to the Moran himself. And as you can see from the photograph we've been working really hard last night getting this presentation ready and thanks to all the people I've been interacting with I've learned a lot from you and not just medicine surgery but a lot in life too and it's been a great pleasure and a privilege being the Moran. Special thanks to Tina who's just delivered her fifth baby yesterday who's been very kind to us and who's taken care of most of the international fellows right through these three months. And again I leave you with this image this is the Utah Vision Walk and I was proudly a member of the Moran Momentum and I'll conclude with these words from our founder I'll let you read it I'm not going to repeat that and if anybody is planning to visit India don't forget your sunblock and don't forget to call me on my email id down there. Thank you.