Zahir is the president of the Syrian American Medical Society, which does amazing work at great personal risk. It's a group of Syrian American physicians going into Syria to provide medical services to Syrians. They provided medical services to around 1.5 million Syrians during the course of this incredibly dangerous conflict. Zahir himself has gone into Syria at great personal risk to do some of this work. He was just in Greece providing medical services to some of the Syrian refugees in Greece. He's also frequently in touch with people within the White House about refugee policy. Suzanne is married to Zahir, and she also is an amazing advocate. She runs an organization that helps Syrian immigrants settle here in the United States. Mona Jundey is an immigration lawyer who is also Syrian American, and she came to a conference here that I saw her speak out, and I thought that you did a brilliant presentation about the necessity of changing the way we're doing business on this issue. Finally, Kutaba is himself a Syrian asylum seeker who came to this country relatively recently. Just to give you, it was almost impossible, by the way, to find a recent Syrian refugee, because we've let in so few people, and it's almost impossible to find one who speaks English, and Kutaba is one of those people. We've got a great panel. We'll start with Zahir. Thank you. Good morning, and thank you very much for having me and my wife. I give credit to New America Foundation to have the first speaking panel from the Syrian American diaspora and also Syrian refugees. I just want to give a credit to the Syrian American diaspora for what they have done over the past four years, and this is something that probably not many of us know. We have at least 18 relief organizations that were founded by the Syrian American diaspora. They spent more than $400 million in Syria, and the neighboring countries to stabilize the situation, provide humanitarian assistance and medical aid to the people in Syria, and also in the neighboring countries, and without their contribution would have seen much more and worse situation for people. I'll leave the heavy lifting to my wife as I usually defer to. What we do in SAMS and the other organizations that we try to keep people inside Syria by providing them health care and education and the humanitarian assistance keep people who are internally displaced from leaving Syria and also provide aid to people who are refugees in Lebanon and Jordan and in Turkey. But Suzan have been trying to take care of them when they come here to United States as refugees, and as you know, many of the refugees in the refugee camps will take them at least 15 to 17 years if the situation in Syria stabilized right now to go back to Syria. So we're talking about long term, and whether we like it or not, we will have to take some of these refugees. The number of the 10,000 is very low, and we're calling for more than 60,000 or 100,000 Syrian refugees to be accepted in the United States. I'm going to start by dispelling some of the myths that Peter and Mary have stressed before, that first of all, there is no Syrian refugee that was implicated in any terrorist act. The media coverage of the Paris attacks that implicated one or two Syrian nationals is wrong, they're now to be wrong. Yesterday there was a Guardian report that the third person who was implicated in the attack was actually a French national who was born in France and not a Syrian refugee. So there's two terrorists who took the pathway of the Syrian refugees, but they are not Syrian refugees. So I want to make sure that this is clear for all of us. The second thing that Syrians who are leaving Syria and going through the Mediterranean trip, and I just came in a couple of weeks ago from the Greek island of Lesbos, they're coming from inside Syria. The majority of them are coming from inside Syria, not from the neighboring countries. These are not people who've been refugees in Turkey or Jordan and Lebanon for some time. These are people who are leaving Syria because of the barrel bombing, because of the Russian attacks, because of the chemical attacks, because of the brutality of the regime. And of course some of them are leaving Syria because of the ISIS attacks, but the supermajority, according to some of the studies that were done in Germany, are leaving because of the brutality of the Assad regime and the barrel bombing. And now with the Russian bombing of some areas in Aleppo and Damascus and other areas, we have seen intensifying of this exodus. Thirdly, Syria is hemorrhaging its human capital. We're talking about doctors and lawyers and businessmen and teachers who are leaving Syria. According to UNHCR, 40% of the people who are leaving Syria through Greece to Europe have college or university degrees. And 40% are high school graduates. So these are people who are educated and Syria is losing its human resources because of this crisis. The supermajority of people who are leaving Syria are Sunni Muslims. They're not Christians. They're not Yazidis. So I want to make sure that this is clear. 85% of people who are reaching Greece, according to UNHCRs, are Sunni Muslims. And 6% of them are only Christians. So this goes against what some of the people in the Republican Party have been talking. If we really need to accept people in proportion to the need, then we need to accept more people who are implicated, which are the Sunni Muslims. And I just want to say that we owe it to the Syrian diaspora because Syrian Americans have contributed to the welfare of this country. 1% of our doctors are of Syrian origin. 1% healing and treating millions of Americans every day and every week and so forth and saving hundreds of thousands of lives every day. Steve Jobs, as you know, is the son of Syrian immigrant. Some of the Republican governors were Syrian immigrants. Mitch Daniels of Indiana was a Syrian immigrant. So I think we have to say that, and I think Anne-Marie mentioned that, that we have to embrace these refugees because they will be the engine of maybe economic recovery in some of these areas. These are people who will contribute to the welfare of our society. I have a few slides to highlight, and some of them are graphic, so I'm going to warn you. And this is a drawing of one of the second grade children in the city of Aleppo. Aleppo is considered the worst or the most dangerous city in the world. It's the largest city in Syria. And this is a second grade student who is drawing bombs, helicopters throwing barrel bombs and amputated children and children who are crying, and instead of what children usually draw, which is skies and rivers and so forth. And many of the Syrian children are traumatized because of the situation. And we don't have that many mental health specialists who are addressing the humanitarian situation and the trauma, psychiatric trauma of Syrian children. This is the impact of barrel bomb. I think the Russian ambassador to the United Nations said that there is no need for no-fly zone because there is no more barrel bomb since the Russian intervention. Since the Russian intervention, 3,800 barrel bombs were thrown on Syrian civilians in the city of Aleppo and city of Idlib and other places in Syria. Only in the last month, we had about 1,000 barrel bombs. So it continued to happen, causing a lot of destruction. And it's the main drive of Syrian exodus outside of Syria. And this is what you see after the barrel bomb. You have children who are pulled from the rubbles. And you have doctors and nurses who are struggling to meet the need of the overwhelming people who are coming with trauma related to barrel bomb. This is a picture that I took myself in the city of Aleppo and look at the desperation. This is Dr. Abdulaziz who's trying to salvage some of the medical supplies in the city of Aleppo in his hospital. It was hit by double barrel bombs. I was in Aleppo at that time. I was planning to visit his hospital. And he called me in the morning. He said, don't come because we had a barrel bomb and we had to evacuate the patients. And I said, well, I mean, there's no more barrel bombs. He said, no, wait. Usually we have after 30 minutes to 40 minutes another one. So if you want to come, come in the afternoon. And I came in the afternoon. I took these pictures for Dr. Abdulaziz. And this is, I'm sorry, a very graphic picture. This is what we see on a daily basis. And the Syrian doctors are saying on a daily basis, children who are killed, 20,000 children were killed in Syria in the crisis. 20,000. It's not only Ilan Kordi who died in Syria because of the crisis. This is one of the children who died every day and dying every day because of the barrel bombing and the Russian attacks lately, unfortunately. And these are some of the children in the city of Douma. Douma is under siege by the government for the past three years, under siege. And in spite of that, they've been bombed every day. And they're trying to heal each other. And these, by the way, are real pictures. And this is a picture and this is very hopeful picture. This is a picture of a child who was born only last week after his mother was killed by what's reported as a Russian attack in the city of Douma. So after she was killed, the doctors in one of the Sam's hospitals were able to deliver her by sea section and the child survived. And this is what we do to try to protect the doctors and the patients in Syria. We have sandbags in the emergency room. And sometimes we have to do hospitals underground. This is a hospital that Sam supported in northern Hama in a cave. And this is a hospital in the city of Aleppo that is four meters underground. Most of the hospitals that we are building right now in Syria are underground. We have Sam's had 102 hospitals inside Syria. Last year, we had 67 of them were targeted by bombs, mostly barrel bombs, compared to 30 hospitals one year before. And we try also to connect the hospitals over there by critical care specialists inside the United States by telemedicine. So we have what we call it electronic ICU. So we have satellite internet that connects ICUs inside Syria to specialists inside United States. This is one of the die-in that we had in New York last month. I think all of us agree that targeting a hospital is a war crime. But unfortunately, it's happening on a daily basis in Syria. This is the refugee camp of Al-Zatari. By the way, 80% or 85% of Syrian refugees are not in camps. This is only one of the Q camps that comes in Jordan. And this is actually I came from Greece a couple of weeks ago. And I took this picture of one Syrian refugee who made it to Lesbos Island. And he had this picture of what to do after you arrived Greece. And I have the whole picture. And it tells in steps when you take a train or when you walk across the border to Macedonia or to Serbia or to Hungary. And how much it will cost you? It will cost about 2,400 euro. By the way, if you're a refugee in Syria going from Turkey to Lesbos Island, you have to pay between 1,000 to 4,000 euros to the smuggler. And there is a weather discount. It was stormy when I was in Lesbos Island. They told me now the rate is 800 euros because the risk of dying or drowning is higher. So 800 euros, there is a stormy weather. And this is one of the capsized boats near the island. I took this picture just two weeks before I arrived. There were about 300 people who were in that boat. And 30 of them drowned. And I talked with some of the doctors who resuscitated them. And most of them were traumatized because they have seen because they could not save the children who drowned in that island. This is a picture that I did not take, but I'm sure that all of you are familiar with. Still about 1,500 people who are arriving to Lesbos Islands every day in the last few months. And this is where they leave. They have all of them life vests. But these life vests do not save them because many of the times when the boat capsized and many times the smugglers stuffed triple or quadruple the number of the refugees that are allowed in these inflatable boats, when these boats capsized in a rocky shore, the children drowned because they stuck under the boat and many of them have hypothermia. And these are what happens to these refugee camps. They are placed in temporary camps in the island for one day before they are moved to the capital of the island and then from there to Athens, where they are kept in holding camps, three holding camps, before they are transported to the border with Macedonia. And these are some of the refugees. 50% of them are from Afghanistan, by the way. About 25% of them are from Syria lately. And many of them are from Iraq and Iran. And this is our clinic that we provide health care to the refugees in there. And I want to end with this picture. The person of the year was chosen by times was Chancellor Merkel, which I agree. And we really thank the German government and the leadership of Germany for embracing the Syrian refugees. I read some reports that the German economy improved actually in the last year because of the refugees and the spending on refugees, which is great. And I think many of the countries will attest to that. But these are the people who need to be recognized, including myself. We have a physician from Norway and a physician from Palestine who went to Lesbos Island because they want to help in the situation. And I've seen 90 different NGOs in the island trying to help the refugees from Syria and Afghanistan from Iraq. They are providing very good help for them right now. And I think without their help, the situation would have been much worse. Thank you very much for having me. Good afternoon, everyone. Thank you, Zahir. It's very difficult to follow him after whenever he gives one of his talks. And thank you to the New America Foundation and to Peter and to David and to Anne-Marie for your kind invitation.  Our organization is Syrian Community Network. And back in 2013, when Sam's national board appointed me to be the refugee resettlement coordinator to understand what the process looks like when refugees come to the United States. And so we kind of took this on as a project. And the Syrian Community Network was born from the Syrian American Medical Society from Sam. So thank you, Sam's. Our vision is to empower Syrian refugees in achieving a seamless transition into their life. I have to say that when we started the organization, I kept having flashbacks of the time when I first came to the United States at the age of 10. My father came in the 1960s to study engineering in Chicago. And he met my mother. And my mother is Canadian. So I only have Syrian. And my mother is the daughter of an Irishman and a Scottish woman. So I'm kind of all over the place, actually. So I started having all these thoughts and memories of how difficult it was to come after my father and mother got married. They went back to Syria. But I was born in Syria. So I came back at 10. And just to have those stories and remembering the difficulties as a child to come in and to acclimate and to assimilate into a new culture and to learn a new language, we were privileged to learn to know English in Syria because my mother is Canadian. So we were always speaking in English to my mom. But now having to jump in and learn a new culture and a new learning style was quite difficult. So those stories, we remember those stories. And so we try to help our families to go through them so that they're not suffering as much as some of the trauma that we went through. And my sisters and I always joke that we never got over our trauma from moving here. But with time, things get better. And so we envision a matured wave. And the reason why we put wave in our vision statement is because we wanted to, we know that Syrians have been coming to the United States for about 100 years now. So we imagine this third wave to be the refugee wave that's coming in, the asylum, asylum wave. So our goals, we work with the Resalma agencies in Chicago. We work with the Resalma agencies on a national level and we work, try to include the families in the larger community so that they don't feel that isolation. So we've done some programs for them, dental hygiene workshops. We do the e-drives after Ramadan. We try to include them in events. And I'm whizzing through them, I'm sorry, because I want to make sure I get through my time. And so, and one of the things that we also do is we try to connect them to the larger community and we try to do a cultural understanding of Syrian culture and what our faith is, whether we're Muslim or we're Christian, a lot of the groups, the church group, this is a Unitarian group that invited us to do a Syrian culture 101. And they wanted to learn about the culture and do's and don'ts and because they were going to be receiving this family the next day at the airport. So they wanted to make sure that they were receiving them very, in a way that is welcoming and to make the family feel secure and safe. So this was a really nice group to be with. And so these are some pictures of some of the families. We had a community event for them. Right now in Chicago, we have about 22 families, which is about 100 individuals. And they're mainly kids, 51% of the families that we have are children.  So we try to help them and include them in the community and make sure that they are supported. We do volunteer trainings as well so that when we have volunteers go into their house to mentor them, we're trying to launch our mentorship program so that our volunteers are trained and ready to go in and so that they can do a great job and mentoring the families. We do back to school drives. And here's a story I wanna share about Widad. Widad is the one in the blue hijab and the blue scarf. And Widad came in, they were part of the first family that we met in January of this year. And Widad came, her father was killed by a sniper in Syria and she's one of six children. And when they were being, they were internally displaced in Syria and her house was bombed and she sustained injury and to this day she still has shrapnel in her body. And we registered her with a summer camp for girls and adolescent refugee girls. And in the summer she got the award for most improved English learner and we're really proud of her and for her to show that smile on her face because when she first came in, she did not smile as much as we tried to talk to her and try to joke with her, anything she was not smiling but to see her smile, it just, it's really heartwarming. And then she drew this picture. I look funny in the picture, but she said the organization asked her to draw a picture of someone who has helped you or has impacted you and she put our organization's name but me because I'm the one who goes and visits her and all the time but it's nice to feel that you've helped someone. Oh, I'm sorry. And part of our advocacy, one of the things that we'd like to focus on is advocacy with everything that's going on with the rhetoric that's been coming, whether it's from our lawmakers or our governors. Advocacy plays a key role in getting the stories out and we're proud to work with SAMS and all these other organizations MPAC and some of our faith partners and to help bring the stories of their Syrian refugees. So this was an event that was organized by MPAC and SAMS where we brought in fluent refugees to Washington DC and they got a chance to stand in front of the White House to speak on their own behalf and asking President Obama to increase the numbers of refugees. So it was really a proud moment to see them speak and to take leadership and to experience American civic engagement. So I thought we think that was very powerful for them and they really remember and cherish their memories. So this is them in front of the White House. This is Mayada, Fatima, the Daughters Widad, Shahad and Sheyma and they're standing. So they were excited because in Syria, you don't get to stand in front of the White House. The White House is usually on top of a mountain, there's many guards and so for them to stand in front of the White House was nice and it was empowering for them. And then also part of our advocacy efforts as the local in Chicago, Senator Dick Durbin wanted to visit with refugee families. And so these are my board members of Syrian Community Network.  And then also in Chicago itself with the governor making those statements that refugees are not welcomed in Illinois, the Chicago City Council came up with a resolution to welcome refugees. So Alderman Ed Burke wrote a resolution with Alderman too and they recognized Syrian refugees in the city council meeting.  And it was really a powerful moment, a symbolic moment for the refugees to feel welcome because they were feeling very anxious and upset that they were feeling unwanted. And another with our advocacy also with the city is this is Mayor Rahm Emanuel. They hosted Thanksgiving dinner for the refugees. So this is him serving, he went to every person and he served them turkey and stuffing and you know it was really him and the other Alderman as well. And here's Alderman Ed Burke also serving Brad and it was really a beautiful moment and these are the refugees, the refugee families. So we had about over 90 people in the room and with everybody, all the children were there and enjoyed and they all got gifts from the city and they all was very nice. So and also another organization, MOVON has been also hosting small dinners for community members and inviting refugees all over the United States. So this was a dinner that they hosted also just before Thanksgiving. So this is Anna, the director of the Chicago chapter and representative Jan Shikowsky was there and she, we invited the refugees with us. Fatima and the girls were there and my colleague Hadya also was there and she and representative Shikowsky was talking about the story of how the St. Louis in 1939 came to drop off the refugees and they were pushed back. So she was really adamant about welcoming the refugees and here she was asking them to speak as well. And this is part of the dinner and more advocacy efforts with civic and religious groups that we help in engaging and getting the refugees to get the word out and to speak on their own behalf. Again, more pictures of the dinner. And so here, these two boys, this is Usama and Abid Hakim and yesterday on Wednesday we were at a dinner with MOVON also and Senator Dick Durbin was there and Senator Al Franken and another Syrian refugee was there, her name is Mariela Shaker. She's a violinist and she got to play for everyone in the dinner and this picture was blown up in their living room. This was from the Chicago dinner and Senator Dick Durbin said, are we afraid of these two boys?  So it just doesn't make sense. And I just want to end with a story and I wish I had her picture. Her name is one of the refugees. She's a Syrian Kurdish refugee. Her name is Helwa. She doesn't want to be photographed but she used to work as a seamstress and we were trying to get her, we want to get her up in her project going where we buy her a sewing machine and get her to start, you know, having her own business at home because her mother's 80 years old she needs to take care of her and her brother has leukemia and she can't leave them. And so today we were scrambling to think how what are we gonna do? How are we gonna help her? And today I got a phone call from a woman and who lives in Evanston in the north side of Chicago told me I'll do anything, just tell me what you want. I'm a marketing specialist and I told her would you like to market Helwa's business, a sewing business and she said yes. So a lot of times we try to reach and we scramble to see how we can help people but then there's people reaching out to us and asking for help. So for everyone negative Donald Trump comment that we receive, we get hundreds of comments of support and love. So thank you all for inviting me. Thank you to New America for inviting us, myself and other panel members. Oftentimes we're listening to pundits talk about Syrians and Syrian refugees are they ISIS, are they not? And we feel that they're talking around us. So it's nice that today you're talking to us or more importantly you're listening to us. So thank you for that opportunity. My name is Munal Jendi and I am chair of government relations for United for Free Syria. We are one of six organizations that are the coalition, a part of the coalition for a democratic Syria. And our focus is on advocacy here in Washington DC to try to get what we think is a better policy on Syria and so far that's not happening. So first the Syrians wondered why the world had abandoned them and then they wondered why the world hated them. Our motto in terms of our advocacy work is treat the symptoms, stop the cause. So we understand that right now there's a refugee crisis. There's a refugee crisis in Europe. There's been a refugee crisis for a long time in the regional countries. And we are now sort of learning about it here in the US. The rhetoric is about security and who should we let in and who should we not let in. And really what's missing from this discourse is what is the cause of this refugee crisis. One listening to this might think that there was an earthquake that happened or there's a hurricane. When in fact there is an intentional displacement and killing of Syrian people by the Syrian regime. And this is something that I think that we really need to focus on because Congress scrambled very quickly to say let's block Syrian refugees. Well where have we been for four years to scramble to say let us keep them in their homes. Yes, there is a crisis. Yes, as Americans it is our responsibility. It's part of our heritage. We take in refugees. We have to take our responsibility in that. What we also need to do is help people stay in their homes. Help them stop having to leave Syria. Dr. Sahdoul pointed out that most of the refugees that are going to Europe are not the ones that are sitting in camps. Which oddly enough for the US the few that have come in so far are the ones that are actually sitting in the camps. They're basically the ones that have been sitting in the camps even before ISIS existed in Syria. But the ones that are showing up to Europe are the ones that are literally still fleeing. So why are we not talking about why are Syrians still fleeing Syria? So we have 4.1 million refugees. But we have half the country is displaced internally. And they are under siege. They're besieged. They're being bombed by Assad. And they're being bombed by Russia. They're being attacked by Iran. They're being attacked by Hezbollah. They have all of these forces against them. And the main focus is on civilians. So what is happening in Syria? I'm sure many of you know Dr. Sahdoul mentioned barrel bombs. Barrel bombs are the great tool that the Assad regime uses. They're literally big metal barrels that are filled with TNT and explosives. The advantage to the regime is simple. One, they're cheap. Two, they're easy to make. And three, they can be dropped from non-military aircraft.  They obviously have no ability to be targeted. So they just drop and wherever they land, they land. And the regime is focusing, of course, on civilians. Over 90% of those killed by barrel bombs are civilians. And of course, as well, we knew about the chemical weapons that the regime used. And these same barrel bombs, the regime has used to drop chlorine bombs. So they turned in their sarin gas and replaced it with chlorine. Chlorine is easier to use. And of course, after the UN security resolution, security council resolution, saying that chlorine bombs can't be used, chlorine bombs were, again, used. Surprise. So what happens? Basically when a group of the rebels take over an area, the regime comes and barrel bombs them. And that's a good thing to do for them because one, it attacks civilians and makes them feel that those that are defending Syria are now somehow the culprits. It also knocks out basic supply, so water, electricity. And of course, as Dr. Sahoon mentioned, they target hospitals, regularly targeting hospitals, field hospitals and ambulances. And once they, if they can, the regime then tries to surround an area. And when it surrounds an area, then it does not allow any humanitarian aid in. Again, UN security council resolution said humanitarian aid can go in without the permission of the regime, but then the regime still has blocked overwhelmingly the majority of the humanitarian aid convoy. You have areas like Eastern Ruta, which is just outside of Damascus that have upwards of two to 700,000 people that have been under siege for years now. And this means they don't have food. They don't, they can't get food. They only can eat that which they grow, which obviously is seasonal. And so there's a lot of hunger that happens. And what happens is they try to, it's a systematic use of starvation to force local populations into submission. So then they say, let's do the regime says, let's do these local ceasefires. And these local ceasefires say, okay, hand us over your weapons and get out. And get out means civilian populations. There is an intentional displacement of Syrian populations from within Syria. And I can give you an example of my mom's family, for example, they are from the camp of Yarmouk, which is overwhelmingly Palestinian refugees from 1948, who are in an area in Damascus that was under siege for about 18 months. Finally, when they negotiated a ceasefire, they were basically told, if this door is only being opened for a very limited time, we're going to reshut the door.  And my aunt, my uncles, all of them ended up fleeing camp Yarmouk, and many of them made it to, actually to Lebanon. And I have several of my cousins now who made it to Germany in these death boats. And they have horrendous, horrendous stories. So there's these local ceasefires that are also an intentional way to displace Syrian populations. This is a form of collective punishment. And we know, I don't even know if I should talk about international law, because there are so many violations, whether recent or historic of our international law that just keep happening and the regime is empowered to continue its violations. And of course, now Russia's intervention only further emboldened and empowered the regime. So I'm going to conclude with this. There is no solution to the refugee crisis without a primary focus on civilian protection, civilian protection, civilian protection. That means a nose fly zone, a safe zone, some area where civilians can stay within Syria and be protected from the constant aerial bombardment of the regime and of Russia. There has to be a political transition. With Assad in power, there is no, he cannot reclaim legitimacy. He cannot have created the chaos and destruction and death, missing persons and torture and reclaim legitimacy in Syria. That is a non-starter. There has to be a political transition, Assad has to go. We feel right now, the international community feels that our solution is let's give more money to the regional countries to keep hosting these refugees. Let's go through these peace talks that really are stalled peace talks. Nobody really knows where they're going, where they're coming, what's going to happen tomorrow, what does it mean at the end? And we're also talking about resettling minuscule, minuscule numbers of refugees. We're not trying to minimize the fact that we need to do this, but that is not going to be a solution. Unless we focus on civilian protection, there will be no solution to the refugee crisis. I do have the Coalition for Democratic Syria. We have put together a policy paper called Syrian Refugees, an intentional product of Assad's war. Our policy director, Tyler Thompson and Erika Hannachek, Congressional Affairs coordinator are here. If anybody wants a copy, please feel free to take one. Thank you so much. Hello. My name is Puteba, Puteba Adilby. I want to thank Peter and David, New America for having me here. As Peter said, I'm Syrian, been raised in Syria almost all my life. I got the good English because I was fortunate to know Taylor Swift when I was 15 years old, when many Americans didn't know about it. And Backstreet Boys also helped. I was, I had like me like, yeah, the normal life for like a kid kind of, but I was kind of politically involved since I was 12. My dad was one of the leaders of the non-violent movement in Syria since the 60s, so it kind of runs in the blood. When the revolution started back in 2011, I was senior in college doing finance and banking, but I mean like with everything going on in the Middle East and the Arab Spring, there was no question what to do at that time. Because of my good English, I was the only English correspondent at that time talking to BBC, Sky News, Fox News, CNN, telling them what is going on, why the people are out on the streets, why they are risking their lives, which led at some point for me to be detained by the government. I survived the first time. It's really hard to describe being in Assad's prisons, but it's just something inhuman. And then the second time came and I also barely survived it. Then there was the question, whether should I stay or should I leave? The government didn't give me a choice back then for a long time. 10 days later, they tried to arrest me a third time, so I managed to escape. And when I escaped, they tried to kidnap my 17 years old little brother. So at that point, I felt like this is not only about myself, but it's also about affecting my family. For some time, we hid in some place out of the city of Damascus, and then we decided to leave because the government kept asking, the intelligence kept asking about us. So we left first to Lebanon. It was only me and my 17 years old brother. Lebanon was different. Relatively, it's safer than Syria, although you still have the risk of having Hezbollah militia or thugs all around. And also, the Syrian government invaded Lebanon for 30 years. So even the people who support the revolution in Syria, they got enough of 30 years with Syrians, so it wasn't really helpful. So we stayed there for six months, or like, relatively five months, and then we had to leave to Egypt because I wanted to get my brother back to high school at that time because we left when it was his graduation from high school. So I had to do his high school. So we left to Egypt where I could put him in high school, but at the same time, the Egyptian government didn't allow me to have residency, even tourist residency because I'm a youth Syrian, politically involved back in Syria.  At that time, my mom would come and go to Egypt to take care of my brother when I'm not there. And then later on in January, 2013, the government went to our house. They wanted to arrest my other brother. My mom was in Egypt at the time, so there was no choice really for her to get back. My brother escaped to the suburbs of Damascus. And then, I mean, at that time, still at that time, when I was in Lebanon or in Egypt with my family, we were only thinking it's gonna be this year or the next and then we'll be back home. It will be different. Everything will change. But at that point, especially at the beginning of 2013, politically, everything was starting to get really depressing. Nothing is really changing. International community for us as Syrians was not really helping. So I was invited to a program with the State Department called Leaders for Democracy. And I managed to get here. When I first got to the program, I was still deciding whether I should stay or not. And the question kept in my mind was the same question the asylum officer asked me when I did my asylum interview.  And I remember I was the youngest in that room and that day I was like, simply because the international community would not allow this to happen. The international community would not allow innocent youth coming out of the streets demanding for freedom and democracy to be just killed without pressuring Assad to step down or without pressuring Assad at that time to make reforms. And that's why I decided that my mission is actually to talk to the media to bring that image. I mean, so no one would say that we don't know what is going on in Syria and like we didn't know what happened. But back then mean like when, two years after I realized it's not happening. I wanna go back to my country. I wanted to get back as it was, but I don't see it in the future. And I mean, wherever you go, it's like part of the process for like when I start applying for asylum, it's like any refugee actually applying for resettlement back in the region. The only difference is I'm here. I'm allowed to work after seven months of like applying for asylum, but nothing else is different really. I'm still appending as Siley. Whenever I ask mean, some people are too polite to tell me, they told me like the process and number of refugees.  Any Syrian Arab Sunni is a potential terrorist threat. I'm a single male with relatives back in Syria.  But mean the main reason for me to come here is like, yeah, I don't wanna be labeled. I don't wanna be labeled like that just because I hold this passport because this is who I am. I'm still Syrian. I mean, this is, I cannot change that. And I will still be, but yeah, I didn't want to be labeled wherever I go just because of this item, just because this is how people think about Syrians. I remember the asylum officer asked me also like, like why did you choose to come here?  And as silly as honestly this question is, mean for 50 years here in this country we're born like, we born and live like in this atmosphere. We don't really feel what freedom means. We don't really feel being able to walk around, express yourself, express what you believe and tell who you are without actually looking back or like watching your back or like watching around and seeing like if anyone is listening to you, if anyone from the intelligence like, you know, would try to or like would they arrest you? This is, this means a lot. And for us, I mean, for me and as Syrian, like for many when the revolution started, we started this because we wanted the same thing. We wanted the American dream, not the American dream to have, you know, the fancy cars, the fancy houses. I mean, a lot of, I mean, in Syria before 2005 at least, economically things were really good.  But what was so horrible is like, you're not able, able to breathe. You cannot, you're not able to express yourself. You express yourself. You're not able to have what you have here. This is the American dream was for me.  In some, in Egypt, probably, yeah, you're not, you're allowed to work. It's still under the table, considered by me like no one is watching. In Jordan, you're not allowed to work. If you're, if you get caught in Jordan working, you will be sent back, not to the refugee camp, but they will actually put you on the Syrian borders, on the borders from the Syrian side. It's like you have to go back to where like all the killing, all the barrel bombs are happening. And this is as a Syrian is like coming here and like and living all of that. It was, it was hard at the beginning, like feeling like legally it's like, it felt the same as being in the Middle East. I'm still in the process. I'm still like those thousands of refugees waiting for them to get a pass to a safe heaven where they can think about their future, where they can think that they can attend college, actually. They can get a small, they can start a small business or get a small job or do things, do something for their kids in the future, where they can actually, I mean, even get married and have kids. But when you're like in a limpo and the refugee camps or either for asylum seekers here, it's like you don't know even if you're gonna be accepted. You don't know if you're like able to live your life here. But still I had the feeling that when I got here that these things doesn't really matter because I'm living and doesn't matter as much because I'm living the things that I dreamt for, that I can come here and speak to you about what is happening. Come here to speak to you about what I feel. And a lot of people, I don't know about that, a lot of people when I first come here, I was speaking at Princeton University and someone came to me after the panel and asked me like, you kept saying our American history, our government. And at the time I was speaking the obvious. I was telling about our history as a nation, as a nation of refugees about who we are and what made us a great nation. And he asked me, he was like, you're still Syrian, you're not even American. And at the time I felt it might not have the passport, might not have the green card or the ID that tells I'm an American. But actually being an American, it's not about only about having this paper that says that you're American. Being an American is being able to live this freedom, to be able to express yourself, to be able to speak here, to be able to live freely without any interference. That's what being American is for me. Thank you. Thank you all for those brilliant presentations. If you have a question, raise your hand if you could wait for the mic and also identify yourself because we'll need that for the C-SPAN audience as well. So if anybody has a question, raise their hands. They have questions. Okay. Thank you very much. I'm Ali Dodd-Mafinez on with the West Asia Council. The question has to do with the parallel goals of the removal of Bashar al-Assad on the one hand and looking after the needs, the vast needs of millions of refugees on the other. Which one do you think takes precedence? Which one do you think is more important and should one wait for one to happen for the other to be possible? Thank you. Well, maybe I can maybe address a little bit. The UNSCR had a study and I think there was another study about the Syrian refugees in Europe and they asked them, would you go back to Syria now if Assad stays in power? And the majority said no. So for the starting of the process of resettling the Syrian refugees in Syria, you have to have a political resolution of the conflict without Assad being in the picture. Of course, as we know, based on historic backgrounds, most of the refugees, even if the crisis stopped now, we're gonna take them 15 to 20 years to go back to Syria. Many of the villages and the neighborhoods were completely destroyed. So you have to couple that with a process that is based focus on developing the neighboring countries, integrating refugees, providing them with healthcare, with work, with education. More than 80% of Syrian children in Lebanon and Jordan and Turkey are not getting secular education. So 10 years from now, we're gonna have a generation of Syrians in many of the areas that are prone for extremism. They have no education. They're not gonna be participant in the economy of their countries. So this is a huge problem that will be facing us 10 years from now if we don't address it right now. So developing the countries around Syria should be a priority. There is an initiative by Middle East Investment Initiative that called Middle East Recovery Plan. I think they have a plan to redeveloping the countries and integrating Syrian refugees, providing them with jobs and education. I think that should go hand in hand with the political resolution. Slava here. Natalia Pineda, Survival of the World Organization. I'm originally from Ukraine, but I'm Ukrainian-American or American-Ukrainian. And what you're saying about refugees, very close to me because the same things happen in Ukraine. And suddenly, we are living in a danger world. Russia, I'm speaking fluently Russian, so I can see watching news and all the brainwash what they're putting in use. That they're actually helping Syrians, not the ones who are killing Syrians, which is horrible. Tell me, all of this situation is terribly affecting all the people, but I'd like to ask you about the children. What are you doing to help children because psychologically it's, I don't know if there is a way to overcome this. How are you focusing on children and how are you actually helping the Syrian children in this situation, thank you. Well, I mean, many of the NGOs that are working, international NGOs and Syrian diaspora NGOs are providing healthcare and trying to provide education to Syrian children. Unfortunately, mental health is something that there's not enough emphasis on it. The priority is to provide housing and food and less education. But this is something that the international community has to pay more attention to. There's not enough resources or expertise in the region to provide mental health to Syrian refugees. I mean, the picture that I've shown in the first picture, that's only one example of tens of thousands or hundreds of thousands of Syrian children who are completely traumatized because of the situation, because of the violence. Not only Syrian children, by the way, Syrian women, Syrian elderly, Syrian disabled, Syrian doctors and nurses are traumatized because of what they're seeing and the apathy that they are witnessing by the international community. This is something that has to be addressed. Great, well, we're sort of running a little bit over time and we need to move on to the next panel. Thank you, all of you, for a brilliant presentation.


We have Jack Culver, visiting from Berkeley, and just so that I can announce, Peter Houghton is here at 3 o'clock getting a talk and then having a conversation in Global Health at 4 o'clock. And that's in the All-Way 106 building. So there's quite a lot of activities today for some reason. We have a concatenation of stars that are visiting Samford. So my introduction to Jack is Jack is a triple degree person. He has an MD, an MPH and a PhD. His MD is from Houghton's and his MPH and PhD is from Berkeley. He did his training at UCSF, but then he came here to do his chief residency. He's actually a chief resident at Samford and then went back and did his ID training at UCSF. He now is a professor of epidemiology at UC Berkeley where he teaches methods and designs of large field trials. He has done at least four triple blindment randomized studies of water sanitation and hygiene and how it affects child health in Bolivia that has also worked in at least five or six other countries. He's worked for the WHO and the World Bank giving them expert advice on how water quality can actually be improved. Today, I actually looked at his CV and was amazed that he's in the midst of now randomizing 22,000 children in Bolivia, in Bangladesh to a water sanitation intervention to see if it affects their health. He's going to share with us today some of the challenges of doing field studies in large populations, so thank you. Great. Well, it's great to be back and I spent many hours on... I don't know how you came back as chief resident. Okay, sure. I spent many year hours sitting where you're sitting listening to various speakers and wondering if I wanted to be a lab jockey or someone doing procedures all the time or what and kind of stumbled into this career that I have which is sort of a mix of infectious disease. I still practice at the VA in San Francisco in the ID clinic or teaching. I teach quite a lot. I teach intensively in the fall each year and then not the rest of the year when I do the rest of my traveling and teaching and writing. And then I do a lot of field trials of different public health interventions. So if you have interest in international health or infectious diseases or these kinds of things, global health, that's something I'm happy to talk with you outside of today's lecture about. So I'd like to describe, to create a framework today, I'll sort of make a Christmas tree on which we'll hang some ornaments about different issues that come up in study designs. But I want you to think more broadly. I mean, if you're not passionate about diarrhea like I am, which is sort of a key outcome I work with, then you have some other outcome that you'd like to measure rigorously. So the designs we're going to talk about today are transportable to many other both field and hospital type questions. So I think you'll see as we go what I mean and feel free to interrupt me because I'll stop and ask questions. So let me articulate some of these challenges first in my next slide and then I'll illustrate these with a study that we did in Bolivia. I'll go through a bit, talk about some of the design and analysis challenges caused by working with big populations. And then time permitting, I can talk a little bit about some of our group's current work in these other countries. All right, so let me, this slide is just to remind me to bring up a couple of issues that should permeate the whole talk. One is on one of my trips to Bolivia, going out to see one of the farmers whose family was a participant in the trial I'm about to tell you about. Who wanted to show me a new latrine that his family had. An NGO, a non-governmental organization, had come through and built thousands of latrines in this section outside Cochabamba where we were working. So, you know, as is often the case, an NGO can put up on its website, built our latrines, health is better and so forth. So we're walking out to the latrine, the farmer opens the door and it's filled with potatoes from the bottom of the pit to the top of the roof. So it was never going to be used as the way you might think a latrine was going to be used, but it was a great place to store potatoes. But nonetheless, the NGO can come through and build its latrines and leave its mark and people can do what they do. I've had other similar experiences coming on the heels of CDC interventions done a year or two before I arrived to do my work where drinking water storage containers that were built for safe storage of water now serve as the soccer goalposts for the village. So we do lots of things in public health and we assume that kind of the process outcome of having done them and checking them off is enough. And in fact, what I and a number of other people, actually a lot of economists are really getting into are things called impact evaluations where we really try to see, have these big programs made any measurable difference with respect to health. Now, of course, measuring meaningful outcomes, diarrhea, child growth, cognitive development children is much more difficult than counting latrines. I'm going to talk a little bit about the issues that arise from whether or not people participate in your studies because compliance, as you'll see in the study I'll present, is a really important and big issue. You should challenge me, as you should any speaker, on the ethics of what we've done in this trial. Was it ethical to do the trial we did it? What do you think about our comparison group? Was that in violation of a number of guidelines you've probably studied about performing studies in the developing world or not? What's it like to work with multiple disciplines? This work involved engineers, anthropologists, economists, behavioral scientists, and you can just imagine what that's, I mean, you know it's like to work with surgeons and radiologists, right? So this whole mix of people with different disciplines creates its own kind of microculture. Another generic topic that applies to any sort of work that involves cluster, that involves cluster design. So in the work I'm going to describe today we're going to talk about randomizing villages. You might be randomizing wards, or you might in large scale studies be randomizing hospitals. And when you use a design such as this it creates methodologic issues about contamination and spillover. Nothing to do with water contamination, but a spillover of the effect of your intervention and its effect on potential outcomes in the different units that represent the clusters that you're studying. It creates sorts of difficult issues for sample size estimation, sampling, and analysis. What happens when you go on your happy way in your dissertation or your project and you carry out a big intervention and then the government comes along with some other co-intervention that you have nothing to do with, but it totally addresses the outcome you're interested in and sort of swamps the area. You're doing a water sanitation intervention and some other organization comes along and builds its latrines in the same village. How do you take care of that? Lots of behavioral science lurking in what we're doing today. You may or may not have interest in that. We can certainly talk about it. The study I'm going to describe today was not a blinded study, so that should raise some methodologic issues for you. I do do blinded studies as well. Those are more difficult. We can talk about what one might do to aviate the need for intensive blinding in a cluster randomized trial such as this. Another theme I'd like to leave you with today or have you think about is that when you do studies such as this that the people who are measuring the outcomes of the study are different, should be different, from the people who are delivering the intervention. There's just a natural human bias built in. If I tell a health promoter to go and promote solar water disinfection as we did, there's a natural bias if that person is recording the data to want to think that the people who got the solar water disinfection treatment are better. So they're going to shade unintentionally usually, but shade their recording of the data in ways that may influence the truth about what you're trying to find. So separating the implementers from the promoters is an important theme. And then the need for hard outcomes. So although the study I'm going to talk about today was powered and measured on diarrhea, we should talk about other outcomes that are possible in this sort of field and in others. Alright, so let's talk about a specific trial to illustrate some of these points. So the technique or technology I'm going to talk about is called solar water disinfection or sodas. And it's almost achieved status as a religion. So people in the field of water and sanitation believe deeply in solar water disinfection. Because as you're going to see, how could this not be a good thing? It's so sensible, sustainable, all those other S's. Sexy, you know, it just works. It has to work. And it does work. In the laboratory, if you treat water with enough sunlight in clear bottles, it will eliminate most of the pathogens. Now, not all. Can you think of a particular pathogen that's a waterborne pathogen that might be difficult to eliminate? It's really difficult to eliminate in municipal systems too. Cryptosporidine is tough. So cousin of Giardia, really tough cyst, etc. So it's not great for cryptosporidine, which is something we deal with enough, but it's not the key issue. So it does leave a few holes in the coverage, but it's free and it's widely available. And the technique is to expose bottles of water to sunlight for a day. I'll show a little bit more about that in a minute. And then the family usually has two sets of bottles. They put one up on the roof one day and then bring it down and drink it. And then the next day the other bottle goes up. And it's not just the radiation itself, the UV radiation that's treating the water. It's also the heat. So at higher temperatures, it requires less radiation. So this synergy goes on between the two treatment modalities. All right. So here's a study you've probably seen, I think from BMJ, about whether we need to do randomized studies to study everything. So a lot of people in our field have the view that, you know, we know that good drinking water is a good thing. Why do a randomized trial? That's kind of a silly thing to go out and spend, in this case, $3 million doing. So this study was called Parachute Use to Prevent Death and Major Trauma Related to Gravitational Challenge. And it's a systematic review. You're all familiar with systematic reviews. And the expensive conclusion reached was that parachutes reduce the risk of injury after gravitational challenge, but their effectiveness has not been proved with randomized controlled trials. So lots of things in life aren't going to be subjected to randomized controlled trials. We're not going to take residents' post-call and assign half of them to go driving in a dangerous situation and half not and then see whether or not there's more traffic accidents, right? There's just certain things that must be common sense. But the issue here, looking in the solar water disinfection issue, is whether or not people actually use water treatments the way they're supposed to use them. And that results in better health or not. So things can work well in the lab. We all know this from drug trials and everything else. And then you take them out into a population and not so much. Okay. One common problem in international development is this thing I alluded to earlier about this mismatch between implementation outcomes. Some people call these process outcomes. The economists call these first stage outcomes. That in some causal sequence, one has an idea about the different steps that should happen in the intermediate steps of a process. So if I provide solar treatment to water, I should see an improvement in water. And then I should see downstream from that the improvement in health. We're coping with a big World Bank study at the moment where we got some amazing improvements in health in a big campaign in seven million people in six different countries. Big improvements in health, but we couldn't show any improvement in the intermediate steps of the water getting better. And then as we look more deeply into the data, we saw that many outcomes other than diarrhea got better for things that shouldn't have improved with a water intervention like bruising and abrasions and things. Anybody know what those alternate outcomes are called? You ought to think about these in studies you do or read. So you have your main outcome in a study, but you're also interested in other outcomes that might have nothing to do with the intervention. And if those got better in your intervention group, you have a problem. So what are those other outcomes called? Important term to know. Those are called falsification outcomes. Have you heard that term? Some people call that negative control outcomes and so forth, but falsification outcomes is a term I think is most descriptive. So again, not just in the issue of diarrhea, but if you're studying malaria, I work with a lot of people who spend their careers counting bed nets, but the measurement of malaria is really where it's at, but again, it's much more expensive, harder. People who work on HIV infection count condoms distributed, but we really want to see changes in HIV rates. All right, here's the sodas process. So clean bottles which are widely available anywhere in the world, and I know there's a pointer here. Bottles are cleaned out, filled with water, put up on the roof. Where we worked at in Bolivia, we often had people with kind of tin corrugated roofs. So if you have a reflective surface behind the water, all the better, it works faster. It'll work without that as well. Water goes up for four to six hours, again, depending on how warm it is, and then it's ready for consumption. Just to mention that a common and very effective way to treat water in much of the developing world is through boiling. Boiling is extremely effective, and it also gets our friend cryptosporidium. It's really quite a powerful, effective technique. In urban settings, I work with colleagues in DACA. They show me lots of gas lines out in the slum areas of the town where people, you know, pirate gas supplies in order to boil their water. So this is widely known. But out in rural areas, there's often not enough wood or fuel to supply the fuel to boil the water, so it's not such an easy thing to always do, even though it's very effective. But we also have this plague of soft drink bottles around the world, so these soft drink bottles we're all very familiar with can be used for the sodas treatment. So I'm thinking, of course, why not harness these? This is from that church of sodas that I mentioned, this foundation that works worldwide to promote solar water disinfection. And these are just some different kill curves to show what degree of either heat and or sunlight and radiation and heat combined that's necessary to capture some of the more important organisms we care about in contaminated drinking water. And here, just a reflection of this issue about synergy that at higher temperatures things kill off quickly. I'll make the point that it's very expensive to measure all the individual pathogens we care about in drinking water so the field has pretty much resorted to using indicator organisms and then, of course, like any field, there's debates about the best indicator organisms, whether you use fecal coliforms or total coliforms or E. coli. All of them have advantages and disadvantages. Some of the disadvantages, for example, total coliforms, lots of animals shed coliforms, so you're never certain if it's animal waste contamination. It doesn't sound too tasty to drink either, but it's really human waste contamination that causes the main problem for humans developing illness from drinking water. So, again, the promotional campaign, what could be wrong? When we started this study eight or nine years ago, when we first put in the first proposal, the program had spread throughout the world. Many countries were doing it. Based on the results of a couple of small studies, one in particular in Africa among the Maasai that had shown about a third reduction in GI illness in tribal members who use the sodas technique. So, the elders were taught how to teach their people the sodas technique. They went out and taught the technique. Diarrhea went down in young children under five by about 33%. And several facts I just mentioned there are going to be relevant as we come to some sample size and other issues. I think I've hit on most of the technology advantages of sodas so far, so let me skip over to the... I'll just make one other one though is that the big push in much of the water and sanitation field is towards providing people with individual control of household level drinking water treatment because you're familiar with the Millennium Development Goals, for example. We've heard these that by 2015 all these great things were going to happen. One of them was that in the drinking water field that there would be a 50% reduction in the number of people receiving unimproved water in the world. And even that statement has a lot of problem because what counts for the joint monitoring program at the UN that follows water, what counts as improved water is delivery through pipes. So you can deliver sewage water through pipes and that would count towards those MGG goals. So obviously a little silly back to this issue of what are we really measuring, what do we really care about is causing an improvement. Some other limitations of sodas. It doesn't treat chemical problems with the water. I work in a lot of areas, for example, in India and Bangladesh where arsenic is a problem, other areas where fluoride is a problem. So this does not do anything for that. In those settings, sometimes people combine sodas with a physical filter filtration type thing. This isn't useful for treating large volumes of water. It's meant for household level treatment. It requires relatively clear water because the sunlight needs to penetrate the column of water and get to the organisms. And if it's very turbid, the organisms either never feel the sunlight or they cling to the solutes that are in the water and escape treatment essentially. All right, so here's the study I'd like to motivate our discussion with. This was an NIH-funded project we did in Bolivia, in children under the age of five. Obviously choosing one's target population is critical. Obvious question, why would one want to work with children under five in studies such as this? I mean, diarrhea is a problem for lots of people. Yeah, so mortality is higher. Now, one important point is it's really hard, even in large studies, even in my largest studies, it's hard to use mortality as a primary outcome because the study has to be so big to power it properly. So in addition to mortality being higher, incidence is quite high in children under five. And that's why you always go look for an outcome with a really high incidence, regardless of what the study is you're doing. We picked rural over urban Bolivia just because we didn't want to create this kind of stratified sense of if we saw different results in rural versus urban, we wouldn't know what that meant. This is an issue for everybody doing urban studies in urban populations around the world. There's intense migration, so it's really hard to do urban studies and know in a long study that you're going to have the same population after you've enrolled them, you know, a year or two years later and so forth. We had 22 communities with 660 children. They were randomized equally to sodas versus current practice. Who's going to challenge me on the ethics? Current practice is they're going to keep doing what they're doing. You should have a problem with that. Is that an ethical thing to do? You've heard of the HIV trials where pregnant mothers were treated and another group was randomized to current care, which was no treatment. Those trials were stopped, created a huge ethical debate. I hope you've been engaged in at some point. Anybody see an ethical problem? I'm okay with ethical problems. This is my life here. So what's wrong with this study? I can tell when I'm talking to clinical audiences. Yes, in the back. So that's a great side question. After we did the study, another study was published unrelated to ours dealing with the polypropylene phthalate that is the coating of the bottles. It does leach in fact, and in lab rats exposed to 10,000 times of human dose for a year, you can get a mesothelioma kind of thing. That wasn't an issue for us at the point, but that's a good question. Is the treatment itself a risk? Let's assume we're cleared of that because that was nowhere in the literature when we started. That's a great methodologic problem. Current practices could vary in the different clusters. Fortunately in this study they didn't. We weren't too concerned about that, but certainly you do worry when people are just doing whatever as opposed to giving them, you know, we're not giving them a placebo to take. So the ethical challenge that we would often face here, anybody? Yes. That's right. So we have these people doing current practice which is to consume their water, literally. I don't make this up. I mean they go outside their dwelling and they reach into the ditch and they take water out and then take it back and feed it to their children. Hard to believe that that's a safe practice, but that is current practice. That's what they do. So can you think of a way, then how could you do a controlled study? If we agree that that's an unsafe practice and if we agree that investigators shouldn't be promoting or encouraging or enrolling people engaging in unsafe practices, what's the out here? So here's the way we did this dance and I feel okay about it, but it's certainly open for discussion and challenge. The NGO we were working with, Project Concern International, was not able to do all the villages they wanted to do in the year we were going to do the study. So they could do about 10 to 15 villages a year. What we did decide to do, and I think this has application to lots of programs in the developing world, we asked them to introduce randomization into the villages they were going to enroll in their first two years. So they were going to take essentially 10 villages one year and 10 villages the next year in the program. We asked them to do that rather than the way that it's normally done, which is, you know, my cousin is the alcohol day of this district or whatever. We go first to do it with randomization and in fact we found that people actually preferred to get an NGO program through randomization process. We had a big public randomization process. We had bingo balls where we had the communities paired into treatment control and it was randomly drawn who was going to be treatment, who was going to be controlled. So we found that people actually preferred randomization to just assignment in the way it was typically done as these kind of programs would usually come through. The reason I say I think this has broader applicability is a lot of work we do with other organizations that are rolling out big campaigns, there's the potential to introduce randomization into what they're doing with just a little bit of thought and scientific presence. So a large part of what my group does now is try to convince NGOs that are rolling things out that hey, you could introduce randomization in this, cover the same number of people and yet then have a study that has some scientific inference from which you can draw perhaps some valid conclusions. Okay, another methodologic technique we used here that's widely applicable to any kind of work you might do on award if you're doing individual studies or cluster studies is we pair matched the villages on baseline diarrhea. So pair matching is a kind of a whole separate side village or side thought. Let's step over to that thought for a moment. Why might one want to pair match clusters or pair match the units of randomization even in a clinical trial? What's the disadvantage of pair matching? What's randomization supposed to achieve on its own? Decrease in bias of what causes bias when you don't randomize? Sorry? Confounders? Yeah, so here's an extreme example. I do a study of some drug for prostate cancer and I get a group of 1,000 men in their 30s and 1,000 men in their 60s and I give one group the 30-year-olds I give the drug to and just prevent prostate cancer the 60-year-olds I don't and then I report, well, there was no difference and it didn't work, whatever. But what's unbalanced there? Of course it's the age. So if I didn't have randomization to equalize the age and all other factors that I care to be importantly different between the groups then I've created a group that really can't be compared to the other. So randomization is really critical in studies that are going to be doomed if there's an imbalance and an important variable it's critical to try to balance those variables of a baseline even beyond randomization and pair matching is one way to do that. So if you know your key outcome by, you know, if I flip a coin a thousand times no one's going to be surprised and I get 400 heads and 600 tails but that might be too imbalanced even though it's random that might be too imbalanced to do the study I want to do so I add something extra to ensure this balance beyond randomization and that one way to do that is with pair matching we matched on baseline diarrhea could you think of other things one might match on in a study such as this solar water treatment for reducing diarrhea or why match on diarrhea obviously we thought that was important enough covariate to mention what other variables might be of interest here also, okay, so you could match on environmental factors you could match on differences in the village structure differences in temperature whatever however we knew that diarrhea was one of the things that most strongly predicted future diarrhea so by matching on diarrhea it's an attempt to make the baseline conditions which is what you want in the trial make the baseline conditions as equal as possible we chose a sample size that I showed you earlier to detect with 80% power a reduction of 33% in diarrhea between the group so if the rate of diarrhea and the groups before any intervention is 10 cases per child per year we'd be able to see something at 6.7 or lower per year 33% reduction now why 33% reduction where do you think that comes from how do you make sample size estimations in studies before you start prior studies so I had told you earlier that the prior study in the Messiah in Kenya showed a 33% reduction remember that so turns out that's about the the largest reduction smallest reduction we could afford to power the study for too for our budget the NIH has a fixed budget for studies such as this so you have to find and out you know you have to shoehorn your outcome and your sample size and your effect size all together in this magical mix that makes your study fundable so if we couldn't afford to do a 33% reduction we might have had to pick a different outcome with a larger reduction what do you think is it harder or easier to do a study to detect a larger effect so if we had wanted to detect a 50% reduction would that have required more participants or fewer fewer it's easier to see large differences right if I'm looking if I wanted to declare a heavy person different than a light person the greater the discrepancy between the two the easier it is to pick that up if they're you know 16 ounces different pick that up easily it's the same thing in these large studies the larger the difference you're looking for an effect size the easier it is to power the study to see the difference okay so we enrolled the 920 children on average there were about 37 children in each of our village units that's another important point we randomly sampled the children to be in the study in each village we couldn't afford to enroll all the children so the clusters create this sampling frame in which we sample randomly the children to participate in each in each thing I mentioned that we pair matched people on baseline diarrhea that baseline diarrhea was gotten from a eight week study before the study started to measure what diarrhea was in each of the villages and our process created very good you know kind of table one balance of of covariates of the villages you'd like to see in a randomized trial that all the things you can think to measure because you're hoping that all the things you didn't think to measure also are balanced in a randomized trial so we worked in an area called Tatora right outside Cochabamba right smack dab in the middle of the cocaine trail that whole industry was a big part of the area in which we were working so that created all sorts of other secondary issues in conducting the study I talked about spillover and contamination earlier I can tell you these are quite far apart quite isolated we had really no concerns about common markets or common shinnering of water supplies and so forth so we weren't too worried about contamination spillover here's this pair matching process at the beginning these are the community cluster numbers and so for instance these two communities are paired because their baseline diarrhea is the closest so on the intervention group so it's random who becomes the intervention group in each pair so the ramization is done at the pair level lots of different things are collected during the course of the study one important point I'll make is that while sodas as it's being rolled out worldwide now is basically back to the parachute idea sodas is parachuted into these villages in most parts of the world people are trained once left alone we didn't do that we were trying to conduct an efficacy trial here as opposed to an effectiveness trial so we had our promoters going every two weeks to the villages throughout the course of the year that term efficacy effectiveness a common parlance for you what's the difference how is this efficacy not effectiveness or it's a spectrum you know efficacy anybody what's efficacy is like in the lab if I control all the conditions and it works I've shown that something's efficacious whereas if I take it out into the real world and sort of stilted I mean sorry in non stilted or in real conditions we call that effectiveness but there's a spectrum between it so you could argue our study sodas in the lab that was kind of an efficacy study but not of health our study was we think the best you can do for promotion of sodas in the wild so we view it on the study simplified down so diary incidents let me first tell you what these outcome measures meaning diarrhea incidents refers to the number of episodes of diarrhea per child per year and the way WHO defines diarrhea as three loose stools in a 24-hour period and the way we define episode which is common in literature is an episode is a new occurrence of diarrhea that's more than three days separate from the original occurrence in a row our presumption is that's the same pathogen we're not treating that as a different episode so episodes are separated by three days of no symptoms as opposed to prevalence or in this case term would be longitudinal prevalence where we're measuring the number of days a child is ill in the year divided by the number of days they were observed so as expected you would see more the number the absolute number of longitudinal prevalence would be higher because you count up days there's going to be the business of needing to be separated by disease-free days this is a plot of the longitudinal prevalence over time in the study and I'll make a point that in many human health population studies you see this dramatic fall in incidence of disease early in the study in both the control and intervention groups lots is being written about that now our group is working on some of this methodological underpinning of this but we think it's kind of a type of Hawthorne effect so let's look at the results and interpret those together so in terms of episodes of disease the control group went from 4.3 to 3.6 and that ratio of those is a 0.81 with this confidence interval anybody want to interpret that give up on SOTUS continue SOTUS promote it globally sorry but it seems like no effect okay and you say no effect because the confidence because the confidence crosses the null which is right okay so let's work this through so if the confidence interval crosses the null we say that we don't have evidence at the level of evidence we'd like to see that the treatment worked now we're talking about big states here right global childhood diarrhea what's our I mean in our gut what's our best estimate of the effect of SOTUS forget confidence intervals and p-values and if you had to pick a single number to represent its effect its reduction or increase in diarrhea what would you say it is yeah 0.81 now clinically would that be meaningful or not if I could get a 19% reduction in childhood diarrhea in the world do I have to argue with you that that's meaningful that's huge 4% reduction diarrhea would be huge in terms of life saved and growth promoted so we're left with this bit of a dilemma that we went through this big study came to a conclusion we can't prove it with the kind of level of trial certainty that we'd like to have say for a new drug but we're not talking about a new drug so as you can perhaps imagine what came about after article was people who believed in SOTUS believed in it even more strongly and they said at Colford group what they did wrong in their study was what because 0.81 were to be the true estimate let's just in a different parallel universe 0.81 what would turn the confidence interval into a significant finding more power what would I need for more power I need more people you can't but who can guess at how much larger the study and the budget would have had to have been if 0.8 if we had powered the study for 0.81 instead of what we powered for remember click click back the earlier slides what did we power 33% reduction so that would have meant 6.7 here or lower but let's say we went into the NIH and said we're looking for a 0.81 19-20% reduction what does that mean how much larger would have had to have been 2.5 times larger so now it's a 10 million study so this is tricky because if someone else is going to go out and replicate this now they're going to need a study that much larger to do this and let's just look at the consistency or not of the longitudinal prevalence measure that happens interval crossing 1 some reduction so hard to know for sure yes could you argue per child year in 17 prevalence you know on one hand you can argue that's not a lot yeah that's a very that's a very sophisticated question and let me make a point do you remember what we thought the baseline prevalence was going to be when we did our baseline calculations I talked about what did we think diarrhea in the wild was anybody remember it was about 6% so this is a 30% this is already so if you want a 33% reduction what you want to do is get my group to come and do a study because then diarrhea is going to go down by 33% before the study even starts and this happens all the time in lots of human health studies when you go out into a population to do a study all of your assumptions and even pre-measurements often change now whether this is because the people who are in a study are different like the kind of Mr. Fit Lore and this sort of thing or just bad luck that's it that's great let's do it yep that's going to be on a list of what could have gone wrong here that's great that's the next slide good question other questions about the results what's this p-value of .19 are you all sick of interpreting p-values or the statisticians beat this into your heads already anybody what's a p-value of .19 how does that relate to that .81 right it has nothing to do with the .81 it's going to just lead you it's often a good first-year epi question on a test but what's that p-value telling us what's the .20% chance that you see this yeah so I'd say a little differently there's a .19% chance that if we did this study over and over again we could see a result this extreme extremely different but the null would still be true as you started off that's here alright so somebody asked about compliance and whether people were using it and by compliance there's an issue not just with the group that got the solar water treatment there's also concern about whether the group that didn't get the solar water treatment started doing solar water treatment because they were watching people get solar water treatment so luckily I don't have any of that up here about the control group but we have it in the paper and I know that number 20% of the households in the control groups were using sodas at points during the study so quite quite low but now these data all reflect the active group the treatment group so let's talk about human nature so we measured sodas use in a couple of different ways we went to the people right after they had gotten trained all excited lots of community campaign energy you're going to be and a couple of weeks into it we asked them are you using it how's it going you like sodas so here's their response about 78% of the people reported were using sodas so that's a little disappointing but it's not 100 but it's there and just jumping to the end of the study the same amount reported at the end of the study and this was a question framed as did you use it in the last I think two weeks were using sodas but sly investigators that we are as we were in their houses the promoters were trained to do a number of different things they were trained to ask for a cup of water and they watched where that cup of water came from often they declined that cup of water when they saw where it came from because often it didn't come from the sodas bottles they also went and looked for sodas bottles and recorded where they were so there were a number of kind of passive measurements about whether or not sodas was being used compliance let's look at how that compliance compared to self-reported compliance and I'll just make the point I can guarantee you this if you go to more often than not self-reported data are used but if you don't leave the talk today fearful of self-reported data then I have failed so here are the sodas bottles in the kitchen that's down in the 20% range so on average over the whole study over all the weeks of the study it worked out that we had about a 31% compliance rate in terms of weeks that the bottle should have been in use versus weeks that the bottles were in use so one third of what happened so now the story gets even more complicated so if this 19% reduction is true and it comes from such low compliance is this a compliance phenomenon so can you think methodologically or more analytically how could I take the data that you know I have and look at whether or not compliance is related to effect what's the effect reduction in diarrhea so what am I going to correlate here what two variables am I going to divide plot what could I do yeah so I could plot compliance in diarrhea I could do that as a continuous measure or I could divide the groups which is what we did to have enough to analyze I could divide the groups into levels of compliance and then look within each group to see whether or not are the people this is very commonly done are the people with really high compliance was the reduction in diarrhea greater among that group than it was in the people with very low compliance slopes were the same no difference in the mean so does use and the outcome in the different groups based on compliance yeah yes was there a different number of bottles given to each household depending on number of children that's right that's right so that was all calibrated based on the number of children in the house and so forth right okay so any other questions about compliance anybody give people drugs where compliance is an issue yeah so just think about self-report think about compliance very generic okay um lost track of time there so you have 10 minutes I think yeah so I I'm going to pause for a moment just open it for any conversation about the Bolivia study and then I'll I'll talk about some other work we're doing and some of the other challenges that raises yes oh that's a great that's a great question there is variation in the seasonality of the water in that here in the Bay Area maybe much to your surprise when there are lots of rains water quality can change because there's lots of flushing that occurs from sources on the ground that get into the water system so yes in in times of heavy rain there's a change in the water quality luckily in our randomized trial we had controls throughout all the various seasons so that wasn't an issue for us here other other questions about Bolivia compliance ethics yes were the villagers enrolled encouraged to find some the reason I asked yeah why if it's so cheap and easy all the villagers knew about it because of the randomization that didn't go yeah why didn't they just do it have you ever tried to give somebody cholesterol drugs or daily aspirin or pathology oh hopefully not but it's too late when it gets to you human nature is just tough in that there are lots of things that should be easy and should be doable but ours is not the first in fact it's one in a line of ten thousand studies to show that people often don't do what they know to be potentially good for them so the behavioral scientists on our team work on these issues about how do you promote more now what I will say is that our promotion of sodas that I alluded to with that earlier cartoon our promotion of sodas was you know I'm gonna say ten times more than the way the sodas campaign is traditionally done which is to drop off so we could not humanly have done any more than every other week I mean well you couldn't tell I showed you how remote those communities were so getting to those 22 communities in these little valleys and mountains you know this was not an easy task for the promoters to get out there so I don't think we could have done any more on that on that thought but it was certainly something we thought of other questions yeah Michelle it's hand washing so hand washing was not part of this study it's part of other studies we do so with a variable like that in a trial you assume that there isn't an interaction between the intervention you give like clean water isn't changing people's washing with their hands I mean the causal path would go something like that like this what if they got clean water and now they're more attentive to these issues so they also wash their hands or reduction a greater health benefit which we didn't see so either it didn't happen or it didn't matter you wouldn't necessarily think that the people doing what they were currently doing would change their hand washing at all so this is we call this a conservative bias in the sense that we are we are likely underestimating the effect which is what you tend to want to do when you're trying to prove something new works or doesn't yes sure boy this is tough this is a big dilemma in our field because certainly because of the human behavior issues centralized structured systematic I should say systematic interventions generally work better you know for instance in the US there's someone here on the Stanford campus Grant Miller who's tracked how typhoid plunged as sewer systems were built public sewer systems were built across the US you could just and they didn't all come online at the same time so you could see this nice sort of time series so ideally system interventions are better but they're expensive they're hard they're hard to get to that last mile to the people out there so that's why in the past several years this household level focus has been kind of where the action's been at because no one there's really I don't think there's much scientific debate about whether a pipe system can be better this is like Milwaukee where they have a pipe system and someone flips a switch the wrong way and the system gets loaded with cryptosporidium and you have 10,000 cases of cryptosporidium back in the early part of this century so it's a tough dilemma so this is meant to give people who care to do something about it household level individual control are there questions? yes was there anything on how that comes with so this and the other ones so just published recently a group from Ireland that we've now written a letter of discussion with them in the journal about but they are claiming to show an improvement in child growth in a group that got sodas in a completely another study that just finished they did that though it was a randomized trial but they did it with modeled data and they don't show us what the actual results were so this is always kind of for an epidemiologist makes us a little twitchy that if I can't see the raw results I don't really know whether the model is doing something that the real data aren't and it's just kind of bizarre not to show your raw outcome so that's a active debate our group is having in the literature now with this other team that just came out that's Ronan Conroy and Duprize is the first author other questions things we're going to measure in upcoming studies I'll just say a little bit about maybe well let me talk about another set of studies that I'm working on with would I use sodas? I think if I if it personally if it were the only water treatment technology I had available to me in a situation I would use sodas would I recommend it for promulgation around the world I'd have to say honestly the evidence doesn't yet support that because these things come with a cost should sodas be done in preference to boiling should it be done in preference to other you know should be done in preference to vaccine if you're a health policy planner people like to use how do I as a minister in the government make a decision between my water people asking me to do something versus my vaccine people asking me to do something versus my nutrition people asking me to do something and so forth so in other studies we're doing we're combining water interventions with other health interventions as well to see whether there's synergistic effects you know there's a lot written in the HIV literature about there's a fellow at at UNC who works on this who's on the NIH study section for HIV Blinken and his name but big push about drinking water in HIV patients in Africa improving their response to antiretrovirals so that that sort of I think that's the next generation of water and sanitation studies is how does water and sanitation relate to relate to other synergies with other diseases so forth in our work in Kenya in Bangladesh that Michelle alluded to we're actually doing not just diarrhea we're also doing child growth child growth is actually much harder to measure than you might like to think we like to call it a hard outcome but measuring squirmy children with these stadiumeters you have to use to measure them is not an easy task that's really difficult so that's another outcome we're also measuring cognitive development two and three years after the intervention a little side story I have a colleague who's now a professor at Berkeley who has his dissertation work wow 20 years ago did a cluster-randomized deworming trial in Kenya and they had the foresight to gather very good this would be four cell phones to gather very good follow-up information on how to find these people so now with the NIH's help they've gone back and interviewed I don't know like 85% of the people who were in that study so all these people had that we know was different they were randomized to a school program for deworming you know just mass albendazol whatever the anti-parasite dejures versus the school clusters that got nothing and now 20 years later there's a striking difference of economic gain in the group that got treated and they've tracked these people down to the UK and all the places people from Kenya have gone so one of the tough things about these long-term outcomes that we all care about like school attendance and so forth and educational attainment economic attainment they're so hard to measure and they take so long to measure that people's careers have often moved along for the measure even now we're just getting head start data that's quite interesting you know from years ago when head start happened and the educational people are quite excited about in some cases some of the longer term findings were things that didn't work initially with head start that now look like they may have worked later and the only thing that was different in some of the children was the head start intervention other questions I think that's enough time to do two more sites so I'll stop there oh I think so Rebecca is being chief resident here? most do more do more the preceding program is copyrighted by the board of trustees of the Leland Stanford Junior University please visit us at med.stanford.edu


Start working, start working. All right, the sun is just peeking above the horizon here, and it's time for morning exercises. Mm, looks soaking wet outside still. No running on the trail this morning. So I think I'm gonna swim a lap around the island. All right, I got my eyeballs, and I got my weaponry in case something tries to kill me. All right, I'm gonna go for it. What are you gonna do this morning? Whatever it is, get your heart rate up a little, get yourself moving, give yourself a good start to the day. All right, I'm going.