1 00:00:00,030 --> 00:00:05,760 I'd like to start this evening's presentation off by welcoming Dr. Helen Ashton, 2 00:00:06,780 --> 00:00:16,710 who is a university clinical lecturer, a practising GP and an actual doctoral fellow. 3 00:00:18,270 --> 00:00:29,459 She has also been a student on this course. So here is one of our success stories and tells that to talk to us today about a project that she devised 4 00:00:29,460 --> 00:00:34,410 and put through to completion and is going to tell us about everything that happened along the road. 5 00:00:34,860 --> 00:00:39,930 Thank you. Thank you very much. And thank you, Emily and Claire, for inviting me to speak today. 6 00:00:39,990 --> 00:00:47,700 It's a great honour. And yet, as class as I was in your seats two years ago, pretty much two years ago today, I think. 7 00:00:49,140 --> 00:00:59,280 And really I wanted to because I realise this is the study design and research methods module focus more than on the research itself, 8 00:00:59,310 --> 00:01:06,360 on the process of kind of what took me from originally having the original idea and taking that all the way through to 9 00:01:06,360 --> 00:01:13,050 publication and the kind of processes that that involves with all the many bumps along the road that go along with that. 10 00:01:13,920 --> 00:01:18,180 So how many people here are doing the empty module at the moment? 11 00:01:18,990 --> 00:01:26,190 The Study Design and Research Methods module. Okay. So most people and how many people are practising clinicians and how many people are surgeons? 12 00:01:26,460 --> 00:01:30,300 Okay. Well, that's just useful for me tonight in terms of how I how I structure. 13 00:01:30,540 --> 00:01:37,559 So most of the talk is made up of pictures. I realise you've been in lectures all day and so I want to try and make this a little bit 14 00:01:37,560 --> 00:01:41,700 more fun and also that some people probably got up really early this morning to be here. 15 00:01:41,970 --> 00:01:50,340 So I don't want you to to fall asleep and do interrupt me if you got anything that isn't obvious as we go along, 16 00:01:50,340 --> 00:01:57,300 although there will be Question Time to ask me questions at the end and also drinks afterwards if you've got anything that you want to to know about. 17 00:01:58,380 --> 00:02:01,680 So first of all, just to give you a little bit bit of background about me. 18 00:02:02,520 --> 00:02:06,599 So as Claire said, I'm a I'm a GP. 19 00:02:06,600 --> 00:02:11,819 I got to this week by doing my medical training at both Cambridge and Oxford, 20 00:02:11,820 --> 00:02:19,400 and these are my lovely colleges that I was at and then did most of my clinical training at the John Ratcliffe Hospital here in Oxford. 21 00:02:19,410 --> 00:02:27,180 After that and since then, I've sort of gradually become more involved in academia and academic work along the way, 22 00:02:27,810 --> 00:02:31,050 and I've really been involved in some very diverse projects, 23 00:02:31,680 --> 00:02:37,890 so ranging for many things, started off with a project on conjunctivitis, sarcoidosis, 24 00:02:38,310 --> 00:02:44,130 a project on breathalysers, childhood immunisation, flu like illness in children. 25 00:02:44,430 --> 00:02:55,380 And then more recently, I've just started a dphil looking at how we can use blood eosinophilia to predict responsiveness to inhaled steroids in COPD. 26 00:02:56,460 --> 00:03:07,590 But what I'm here to talk about today is the Speed Bump Project to say this is a speed bump and talk about, as I say, the process involved in that. 27 00:03:07,980 --> 00:03:09,660 So this is the finished thing. 28 00:03:09,960 --> 00:03:19,800 This is the article which was published in the BMJ coming up for two years ago now, and this is the front cover of the BMJ where it was published. 29 00:03:19,800 --> 00:03:23,310 It was the Christmas edition, which for those of you who don't know, 30 00:03:23,310 --> 00:03:28,620 the UK in the British Medical Journal is very much a kind of fund issue that's published. 31 00:03:28,620 --> 00:03:38,270 That is the final issue that's published before Christmas and often has articles in it which have a slightly a fun element that, 32 00:03:38,290 --> 00:03:44,759 you know, that they have serious research articles but with something more quirky about them than the things that are published weekly. 33 00:03:44,760 --> 00:03:50,250 Obviously, everything published day to day in the BMJ is very interesting, but these are particularly particularly fun articles. 34 00:03:51,390 --> 00:03:58,230 So it really from from that sort of the week before Christmas in 2012 went a bit mad really. 35 00:03:58,500 --> 00:04:05,549 And this is just a flavour of the media attention that this paper got in the week before Christmas. 36 00:04:05,550 --> 00:04:09,510 I mean, I know it's I know this paper's used a lot as a teaching exercise on the courses. 37 00:04:09,780 --> 00:04:13,169 And if you haven't come across it already, you probably will at some point, 38 00:04:13,170 --> 00:04:16,889 particularly if you do the diagnosis and screening module, which I think is great. 39 00:04:16,890 --> 00:04:21,420 So you should definitely do that. And there were a few different things. 40 00:04:21,420 --> 00:04:27,600 So, you know, it ended up in various different newspapers all over the all over the Internet. 41 00:04:27,600 --> 00:04:31,740 And I got to go on a few radio shows as well, which was which was really good fun. 42 00:04:32,130 --> 00:04:36,660 So that's how I ended up. And I'm going to go right back to the beginning now with how it began. 43 00:04:37,350 --> 00:04:46,820 So this is Stoke Mandeville Hospital. The statement of the hospital is now it's in is in Aylesbury, which is about 20 miles from here, 44 00:04:46,830 --> 00:04:52,770 something that I say a bit closer and is known as a spinal rehabilitation hospital. 45 00:04:52,770 --> 00:04:56,280 It was the first one and it's where the first Paralympics were held. 46 00:04:57,480 --> 00:04:59,820 But my attachment, there was nothing. 47 00:04:59,920 --> 00:05:07,690 What's so exciting is that it was just a general surgery attachment in my first, first job as a doctor back in 2009. 48 00:05:08,110 --> 00:05:14,890 And I was what's called a House officer, which is the most junior or one which is the most junior grade of doctor. 49 00:05:15,220 --> 00:05:19,690 And everybody has to do a little bit of medicine and surgery. 50 00:05:19,690 --> 00:05:27,220 And so this was my surgery attachment based pretty much in the emergency Department of State Medical Hospital, which is this delightful building here. 51 00:05:27,760 --> 00:05:39,280 And things really started at about 3 a.m. on a wintry evening back in 2009, when, as is often the case, I would go along with my registrar, 52 00:05:39,280 --> 00:05:47,830 who was a more senior, a more senior surgeon, and make notes while the registrar was was taking the taking the clerk and seeing the patient. 53 00:05:48,100 --> 00:05:54,730 And we saw a young girl who had been admitted with tummy pain, pain on the right side of her tummy. 54 00:05:55,240 --> 00:06:00,310 And she and the registrar was taking the details of the history from the patient. 55 00:06:00,640 --> 00:06:03,790 And then he asked her, how did you get to hospital? 56 00:06:04,600 --> 00:06:09,670 And she immediately said in the car. And we went over the bumps and it was absolutely awful. 57 00:06:10,270 --> 00:06:14,530 And he turned round to me and said, I don't need to ask any more questions. 58 00:06:14,530 --> 00:06:18,249 We're taking her straight to the operating theatre and when asked about this afterwards, 59 00:06:18,250 --> 00:06:23,350 he said he thought that it was a classical sign for knowing whether a patient had appendicitis or not. 60 00:06:23,590 --> 00:06:29,320 Was the fact that the patient complained of having pain when they went over the bumps on the way to hospital. 61 00:06:29,920 --> 00:06:37,700 And it turned out that a few of the other surgeons when when I and also another colleague asked them about this, they said, oh, yeah, you know it. 62 00:06:38,170 --> 00:06:40,479 Everybody knows that. And it wasn't everybody, 63 00:06:40,480 --> 00:06:48,340 but it was certainly something that was known about in that it was something that you could ask about that if patients had paid on the journey, 64 00:06:49,050 --> 00:06:50,770 they may well have appendicitis. 65 00:06:51,340 --> 00:06:59,049 And a colleague of mine, a chap called Khadar, who I worked very closely with at the time, he he actually had the brainchild for this. 66 00:06:59,050 --> 00:07:06,310 I can't take credit for having the idea of actually abscesses up and the idea of of where we could publish it. 67 00:07:06,310 --> 00:07:12,340 And he said, I bet there's no evidence on that. I bet that would make a really good article for the Christmas BMJ. 68 00:07:13,060 --> 00:07:18,040 And so at that point we decided, great, let's, let's, let's go for that, let's aim for the Christmas BMJ. 69 00:07:19,000 --> 00:07:24,640 And so from from that the study the study was born really. 70 00:07:24,910 --> 00:07:28,300 So that was that was the kind of initial, initial starting point. 71 00:07:29,710 --> 00:07:34,560 I realised that my audience isn't entirely from the UK is it. 72 00:07:35,050 --> 00:07:38,980 Where's the furthest place that anybody's for us. 73 00:07:39,310 --> 00:07:44,620 Anybody beat us. I think you do have speed bumps in the US, but I think they might be called speed humps. 74 00:07:44,810 --> 00:07:47,440 Those they are called speed bumps as well. Okay. 75 00:07:47,590 --> 00:07:51,639 That was one of the criticisms we got from the BMJ was that not everybody would know what speed humps were. 76 00:07:51,640 --> 00:07:56,920 So we had to put a very detailed definition and which is a little bit bizarre, but there we go. 77 00:07:57,640 --> 00:08:03,910 So speed bumps are devices, I suppose, that are put in the road to slow traffic. 78 00:08:03,910 --> 00:08:10,060 And there is evidence that they are associated with a reduction in child deaths and that they slow traffic down, 79 00:08:11,020 --> 00:08:15,610 but they are much hated by drivers as the drivers amongst you will realise. 80 00:08:16,120 --> 00:08:20,290 And also because I realise not everybody is a clinician. I just wanted to say a little bit about appendicitis. 81 00:08:20,290 --> 00:08:24,010 I think appendicitis is one of those conditions that it's very common. 82 00:08:24,220 --> 00:08:26,230 People do have a bit of a general knowledge about them. 83 00:08:26,230 --> 00:08:30,460 I don't think you really need to know much more than the general knowledge that you would have anyway. 84 00:08:30,670 --> 00:08:37,749 But you appendix is part of the guts. It's located here and it can occasionally get inflamed. 85 00:08:37,750 --> 00:08:40,510 And when it gets inflamed that's called appendicitis. 86 00:08:41,080 --> 00:08:46,480 And it had the characteristic symptoms that it gives you is pain on the right side of your tummy, 87 00:08:46,720 --> 00:08:50,020 characteristically pain which actually starts in the middle part of your tummy 88 00:08:50,230 --> 00:08:53,470 and then goes to the right hand side a little bit later on in the course. 89 00:08:54,070 --> 00:09:01,030 And that you can get pain. When doctors assess somebody who might have appendicitis, you get pain in that area. 90 00:09:02,110 --> 00:09:05,169 And then you can also have something called rebound tenderness, 91 00:09:05,170 --> 00:09:09,940 which is when you press in and then take your hand off, it's more painful when you remove your hand. 92 00:09:09,940 --> 00:09:13,030 So that's another test that doctors and surgeons sometimes use. 93 00:09:13,450 --> 00:09:16,060 It also gives you nausea and loss of appetite. 94 00:09:16,840 --> 00:09:23,020 And the definitive treatment traditionally has been an appendix to me, an operation to remove the appendix, 95 00:09:23,020 --> 00:09:28,780 which can be done either by an open root or more commonly now by keyhole surgery. 96 00:09:29,140 --> 00:09:29,920 But actually, 97 00:09:30,610 --> 00:09:39,700 there is also some evidence now for treating particularly mild cases of appendicitis with antibiotics rather than the rather than with with surgery. 98 00:09:40,270 --> 00:09:43,270 And so I think that's probably what I'm going to say about the details of appendicitis. 99 00:09:43,450 --> 00:09:46,840 Oh, no, I can say little bit more about it, which is that, as you know, it's common. 100 00:09:47,890 --> 00:09:52,600 It's important not to miss it, because if you if you miss it, 101 00:09:52,600 --> 00:09:59,620 it can lead to perforation that can cause infection in the tummy and, you know, and sepsis. 102 00:09:59,890 --> 00:10:09,580 And potentially be very serious indeed. But there is also a degree of overdiagnosis and there's associated morbidity with overdiagnosis as well. 103 00:10:09,580 --> 00:10:14,140 And in fact, there's a negative appendage accuracy rate of 5 to 42% in the literature. 104 00:10:14,680 --> 00:10:22,080 So that means that of those that are removed, some of them won't actually, when you look at them under the microscope, show signs of inflammation. 105 00:10:22,090 --> 00:10:29,290 And that's looking at the appendix. Under the microscope is often seen as the gold standard test for whether there is an appendicitis. 106 00:10:29,740 --> 00:10:37,510 And as I say, sometimes it's classical and sometimes everybody has every sign in the textbook, but sometimes it's not quite so easy to diagnose. 107 00:10:38,110 --> 00:10:43,960 And so there are scoring systems which exist, which use a combination of history, 108 00:10:44,200 --> 00:10:52,060 examination and lab findings and also more now things like C.T. and ultrasound as well, too. 109 00:10:52,360 --> 00:10:56,920 And to give more detail about them. Is that all right from the surgeon's perspective? 110 00:10:57,370 --> 00:11:03,339 If I said anything that I disagree with that I realise I'm a GP talking about surgery, which puts me on slightly rocky territory. 111 00:11:03,340 --> 00:11:12,310 But there we go. Okay, so the question that we that we came up with of how good a speed bumps at diagnosing appendicitis. 112 00:11:12,490 --> 00:11:15,250 So I think this week and in the first module, 113 00:11:15,250 --> 00:11:23,110 you will have been talking about Picos and I'm not sure quite how far you've got in terms of diagnostic accuracy studies, but they can be. 114 00:11:23,600 --> 00:11:28,900 And instead of looking at a pico, you can look at a peer to peer support instead. 115 00:11:29,500 --> 00:11:34,149 So instead of having the instead of having the comparison and the outcome, 116 00:11:34,150 --> 00:11:41,230 instead you have the patients or participants exactly the same, the index test, the reference test, and then the target condition. 117 00:11:41,440 --> 00:11:51,250 And then you use that, you compare the results of the index test and the reference standard to to get outcomes such as sensitivity and specificity. 118 00:11:51,460 --> 00:11:56,160 Is that something that people have come across before as a concept? Lots of not good. 119 00:11:56,650 --> 00:12:04,630 Okay. So in terms of our research question we looked at up was patients with possible appendicitis, 120 00:12:04,930 --> 00:12:09,579 the index test pain over speed bumps and that was a worsening of pain from baseline. 121 00:12:09,580 --> 00:12:15,280 So lots of these patients would be in pain already, but it was the idea that their pain would get worse when they went over the bump. 122 00:12:15,850 --> 00:12:18,370 The reference standard, as I said, the gold standard test, 123 00:12:18,370 --> 00:12:27,489 looking at the appendix under the microscope and seeing what it looks like is appendicitis on histology and the target condition, 124 00:12:27,490 --> 00:12:33,460 obviously acute appendicitis. So we set up a surgical audit to answer this question. 125 00:12:34,090 --> 00:12:42,100 So we looked at all the patients who'd been referred to the surgical take, either referred by their general practitioner, their GP, 126 00:12:42,100 --> 00:12:51,610 or that had presented directly to the emergency department over a six week period between April and June 2009, and only was one of the junior doctors. 127 00:12:51,610 --> 00:12:57,940 So it was quite easy to get other doctors to fill in a clerking performer or just to write in the notes as part of their clocking. 128 00:12:58,180 --> 00:13:00,879 As I said, many people were asking about speed bumps anyway, 129 00:13:00,880 --> 00:13:07,000 so I just encourage them to specifically write it down so that they could audit it and to fill in an audit proforma. 130 00:13:07,570 --> 00:13:14,020 And then me and a colleague followed these patients through their admission to see what the outcome was, 131 00:13:14,020 --> 00:13:15,850 either whether they were discharged straight home, 132 00:13:16,180 --> 00:13:21,010 whether they were taken to theatre, and if they were taken to theatre, did they have their appendix removed? 133 00:13:21,280 --> 00:13:27,360 And if they did, when they looked, then looked at that under the microscope, did that then confirm appendicitis or not? 134 00:13:27,370 --> 00:13:31,750 And it was only if that confirmed appendicitis that they counted as a positive result. 135 00:13:33,160 --> 00:13:37,270 And these histology details were initially looked at by me, 136 00:13:37,270 --> 00:13:42,309 and then the findings were corroborated by a surgeon who was blinded to all the clinical 137 00:13:42,310 --> 00:13:48,730 details because obviously that that would be quite important to avoid any observer bias, 138 00:13:48,970 --> 00:13:54,430 because I obviously didn't know the clinical details myself. And so it would be possible that I'd be swayed in my result by them. 139 00:13:55,300 --> 00:13:56,800 And the doctors were very obliging. 140 00:13:57,010 --> 00:14:05,110 Lots of people filled them in during this period and 30 we included 32 patients and all of them had travelled over speed bumps, 141 00:14:06,070 --> 00:14:10,420 which was because there was a speed bump on the entry to the hospital site, which was very convenient. 142 00:14:11,380 --> 00:14:16,030 So this is the audit form that we used. 143 00:14:16,780 --> 00:14:18,250 I'm not going to go through it in detail, 144 00:14:18,400 --> 00:14:25,450 but it was just to ask the patients or to ask the doctor that was seeing the patients to particularly make sure they recorded these details. 145 00:14:25,630 --> 00:14:31,720 They often would be recording them anyway. As I said, that these elements of history and examination form up various scores, 146 00:14:31,720 --> 00:14:36,670 and this one particularly called the Alvarado School that we were using at Stoke Mandeville Hospital at that time. 147 00:14:36,670 --> 00:14:45,040 So they were often recording all these details and then they were particularly recording how the patient had given the information, say, 148 00:14:45,040 --> 00:14:48,669 whether they had volunteered that the journey was painful or whether they had to be asked 149 00:14:48,670 --> 00:14:53,080 directly what was the journey like and whether they had to be asked directly about speed bumps. 150 00:14:53,350 --> 00:14:59,260 And the idea was that we could stratify how good the diagnostic test was in relation to. 151 00:14:59,600 --> 00:15:06,499 How strong they how strongly they volunteered the pain in the end with a sample of only 30 to the different number of boxes, 152 00:15:06,500 --> 00:15:10,430 meant that it was it was impossible to do that, but that that was the aim anyway with this. 153 00:15:10,910 --> 00:15:14,030 So I said I talk about a number of bumps along the way. 154 00:15:14,570 --> 00:15:17,330 Does anybody in particular, anybody local to here know where this is? 155 00:15:18,160 --> 00:15:25,580 No, it's Watlington Hill, which is part of the Chilterns is a very pretty area if you ever get to do any exploring while you're down here. 156 00:15:26,420 --> 00:15:31,790 And I used to run I used to be a Brownie leader and Ron Brown, this is related, I promise. 157 00:15:32,030 --> 00:15:43,310 I used to have brownies down in Watlington. And one evening, about two weeks before my wedding, we were doing a campfire on this on this white mark. 158 00:15:43,370 --> 00:15:51,110 It was a good place to have campfires with the brownies. And we all parked our cars just outside along them along the roadside. 159 00:15:51,380 --> 00:15:54,890 And this was my car back then. It was called Leek. And sadly, he's not with me anymore. 160 00:15:55,670 --> 00:16:00,470 But he was a very old car but didn't have a great security mechanism. 161 00:16:01,370 --> 00:16:02,720 You can probably tell where the story is going. 162 00:16:03,590 --> 00:16:11,600 At the time I was collecting all the appendicitis data on these paper audit performers and they didn't have any patient details on them, 163 00:16:11,720 --> 00:16:14,750 but they did have the entirety of the data that was being collected. 164 00:16:15,020 --> 00:16:21,740 And at the end of this, at the end of having finished recruiting with all 32 performers in my car boot, 165 00:16:22,340 --> 00:16:26,180 sadly, Luke was broken into while we were at the well. 166 00:16:26,180 --> 00:16:33,620 We were having the Brownie campfire and I went back to the car and obviously my handbag had gone my wallet, 167 00:16:33,620 --> 00:16:38,629 my phone, my driving licence, and I didn't care about the fact that I'd have to replace all this. 168 00:16:38,630 --> 00:16:43,130 Two weeks before my wedding and honeymoon, all I cared about was the fact that they had taken the appendicitis data, 169 00:16:44,300 --> 00:16:48,620 which, you know, I think the Brownies and the Brownie mums were like, Why are you not worried about the money? 170 00:16:48,620 --> 00:16:55,729 She's worried about a load of sheets of paper, but for some reason, which I don't completely understand now, 171 00:16:55,730 --> 00:17:01,220 instead of doing the sensible thing and calling the police, I decided to give chase to them. 172 00:17:01,820 --> 00:17:05,360 So the guy breaking into the car, the other the other brownie, 173 00:17:05,360 --> 00:17:12,910 the mums of the brownies said that there was a place about five miles away where dodgy things happened in the what like. 174 00:17:12,950 --> 00:17:20,509 So Watlington is a very nice well-to-do area in the chilterns and this was in an area where dodgy things happened. 175 00:17:20,510 --> 00:17:27,800 And so they suggested that this might be a good place to head. So at dusk on this particular evening, I headed to this. 176 00:17:27,860 --> 00:17:31,550 It's a little minor road just behind Junction six of the M40. 177 00:17:31,760 --> 00:17:37,040 So I'd suggest that you don't go down there because it's not a particularly nice place to go particularly late at night. 178 00:17:37,430 --> 00:17:45,200 But as I drove down this little lane, I happened to notice in the hedgerow the Buckinghamshire Hospital Trust Antibiotic Guidelines, 179 00:17:45,530 --> 00:17:50,030 which were on this colourful, you know, these colourful things that they were particularly easy to see. 180 00:17:50,420 --> 00:17:52,700 And so I stopped. And then as I drove along, 181 00:17:52,700 --> 00:17:59,480 I gradually saw more and more things that had been the contents of my wallet until I got to the dead end at the bottom of the road. 182 00:17:59,810 --> 00:18:05,810 And there wasn't anybody, you know, I think by that stage they had gone by the time it takes me to get all my stuff together and follow them. 183 00:18:06,890 --> 00:18:11,210 But in an area of bushes, a little walk away from the road, 184 00:18:11,600 --> 00:18:17,390 I found my bag with all the appendicitis data still in it, which I think is pretty incredible, really. 185 00:18:18,620 --> 00:18:23,899 So that is this is that if I hadn't managed to find this stuff, this probably would have never continued. 186 00:18:23,900 --> 00:18:26,270 I think I probably would've just said, oh, well, it wasn't meant to be. 187 00:18:26,860 --> 00:18:33,500 But anyway, the learning point from that bump is don't leave valuables in your car boot and always keep copies of data. 188 00:18:34,550 --> 00:18:38,560 So there we go. Diagnostic Accuracy studies. 189 00:18:39,550 --> 00:18:44,709 I suspect that you've come across this before a table, a two by two table looking, 190 00:18:44,710 --> 00:18:49,360 comparing index tests to reference tests and using that information to calculate first all 191 00:18:49,390 --> 00:18:54,070 sensitivity and specificity and then positive predictive value and negative predictive value. 192 00:18:54,310 --> 00:18:58,180 If not, I think you'll do it with SU later in the week. Is it so that's doing it. 193 00:18:58,280 --> 00:19:05,760 Yeah. And you may well use this paper as an example and say we did that and this is the results. 194 00:19:05,770 --> 00:19:13,960 So you can see that this shows this positive column here shows all of those who were had a confirmed diagnosis of appendicitis. 195 00:19:14,290 --> 00:19:18,450 So nine out of 11 people and that gave a sensitivity of 8 to 2%. 196 00:19:18,760 --> 00:19:26,500 And then this specificity, which is the number, the number of two true negatives over the total in this column, gives the specificity. 197 00:19:27,070 --> 00:19:33,640 And so you can see that this showed that the test had a relatively good sensitivity and a slightly less good specificity. 198 00:19:34,120 --> 00:19:35,530 One of the major problems, though, 199 00:19:35,710 --> 00:19:42,850 is these confidence intervals that our sample size of 32 meant that we had incredibly wide confidence intervals, so ranging from 48. 200 00:19:42,850 --> 00:19:50,260 So a pretty poor test in terms of sensitivity all the way up to 98%, which would be a fantastic test in terms of in terms of sensitivity. 201 00:19:51,100 --> 00:19:55,210 But we did show even with these results, with the the estimate, as we as we have them, 202 00:19:55,930 --> 00:20:02,770 that this was comparable to or better than other diagnostic tests used in appendicitis diagnosis. 203 00:20:03,010 --> 00:20:10,690 So comparing it to things like the migration of pain or rebound tenderness or nausea and vomiting, this looked better. 204 00:20:10,990 --> 00:20:19,780 So this made us think this is this is obviously know this backs up what we thought in that it is a fairly decent, decent test. 205 00:20:20,560 --> 00:20:27,490 So we presented it to the surgical audit meeting at statement of the hospital and planned to submitted for publication. 206 00:20:28,120 --> 00:20:35,079 And then nothing happened for two years. So this is the second bump, which is just basically with these things. 207 00:20:35,080 --> 00:20:43,450 It's just so easy for other things in life to take over, particularly if you don't have anybody to prompt you and say, get on with this. 208 00:20:43,470 --> 00:20:46,780 You know, it's been six months and I've not heard anything from you. 209 00:20:47,020 --> 00:20:50,799 And the problem with this project is that there wasn't really anybody like that. 210 00:20:50,800 --> 00:20:55,930 It was kind of us that had started it. And so nothing more happened. 211 00:20:55,930 --> 00:20:58,870 So I did lots more lots more medical jobs. 212 00:20:58,870 --> 00:21:06,040 Both the John Ratcliffe and the Churchill bought a house, got married, had very busy uncle incubators, did various medical exams. 213 00:21:06,460 --> 00:21:10,190 And it was only when I then came for my interviews, for my GP, 214 00:21:10,190 --> 00:21:17,200 for the GP academic clinical fellowships that I think they asked at the interview something like Describe a project that you've done. 215 00:21:17,500 --> 00:21:23,290 And I just thought, well, I'll mention the speed bumps for them and the interview panel were really excited by it. 216 00:21:23,290 --> 00:21:26,889 They thought they said, That's fantastic. You know, have you not written this up for publication? 217 00:21:26,890 --> 00:21:28,330 This is wonderful. 218 00:21:28,570 --> 00:21:35,380 And I think I was really surprised that somebody outside of me who'd done the study and, you know, surgeons would be interested in it. 219 00:21:36,010 --> 00:21:41,020 So when I started my my ECF and I had a little bit of academic time to do something, 220 00:21:41,020 --> 00:21:45,579 I said to my supervisor, Anthony Harnden, you know, what do you think about this? 221 00:21:45,580 --> 00:21:49,330 And he was equally very, very excited and said we should you know, yes, 222 00:21:49,330 --> 00:21:53,049 you should definitely, definitely write this up and submitting it to Christmas. 223 00:21:53,050 --> 00:21:56,380 BMJ sounds like a fantastic idea, so we went for it. 224 00:21:57,400 --> 00:22:01,300 The learning point is don't let good potential projects fall to the wayside. 225 00:22:03,190 --> 00:22:09,040 So we set about assembling a team of co-authors to write to submit to the BMJ. 226 00:22:09,250 --> 00:22:15,399 So the surgical colleague that I had been involved in in the beginning was now a radiology trainee, 227 00:22:15,400 --> 00:22:20,139 but wanted to but wanted to stay stay involved here. 228 00:22:20,140 --> 00:22:25,150 And we involved a consultant surgeon so as to have a sort of content expert on the team, 229 00:22:26,080 --> 00:22:29,530 found a medical statistician by wandering around the department. 230 00:22:29,530 --> 00:22:34,660 And I've done a lot of work with Richard Stephens, who will be talking to you later in the later in the course. 231 00:22:35,500 --> 00:22:36,909 I've done a lot of work with him since. 232 00:22:36,910 --> 00:22:43,090 And actually the reason I started working at working with him was that he was the only statistician around on the day the Anthony Hunt. 233 00:22:43,090 --> 00:22:49,300 And then I happened to be wandering around around the department looking for some help with with calculating confidence intervals. 234 00:22:49,630 --> 00:22:53,350 So that's the way that's the way to get get involved in things, I guess. 235 00:22:54,040 --> 00:23:03,040 And he had the unenviable task of trying to retrospectively calculate something resembling a sample size calculation for 32 patients, 236 00:23:03,040 --> 00:23:09,040 which I think is pretty impossible, to be honest with hindsight. But he did a really good job of having a go. 237 00:23:09,910 --> 00:23:16,150 And then also Anthony Harnden stayed involved as a as a sort of GP primary care research expertise person. 238 00:23:16,900 --> 00:23:26,560 The third bump when we came to submit, there's a question on when you try and submit any research, was ethical approval obtained and if not, why not? 239 00:23:27,010 --> 00:23:33,219 So some of you might have noticed that when we had done this originally, we called this an audit and we very much thought of it as an audit. 240 00:23:33,220 --> 00:23:36,640 This was something that lots of the doctors in the hospital were doing already and. 241 00:23:36,700 --> 00:23:42,610 We were just trying to find out whether it linked to whether, you know, what the diagnostic accuracy was. 242 00:23:42,910 --> 00:23:46,330 And we weren't doing anything that kind of involved the patients directly. 243 00:23:47,020 --> 00:23:52,629 However, the research ethics committees didn't necessarily agree with our logic on that, 244 00:23:52,630 --> 00:23:56,500 and that guidance is very clear that any research proposal involving patients and 245 00:23:56,500 --> 00:24:01,540 users of the NHS should go through ethics or should go through ethical approval. 246 00:24:02,060 --> 00:24:11,380 Then there are kind of get out things in terms of surveys and service improvement and ways that you could not get ethics. 247 00:24:11,650 --> 00:24:17,440 And we actually I have a friend who's a medical lawyer and we consulted her because she sits on lots of ethics committees. 248 00:24:17,440 --> 00:24:22,329 And she did think it very much sat on the borderline and that it wasn't a problem to submit it. 249 00:24:22,330 --> 00:24:27,580 You know, clearly we hadn't done anything morally wrong. We hadn't been doing stuff to patients without their consent. 250 00:24:27,850 --> 00:24:34,210 But that probably it would be something which with with hindsight it would have been better to get ethical approval, 251 00:24:34,690 --> 00:24:40,450 say, on the wording for submission. We, we wrote the study protocol was reviewed by a senior member of the Buckinghamshire 252 00:24:40,450 --> 00:24:44,889 Healthcare NHS Trust who ruled that the study was a survey and under NHS research, 253 00:24:44,890 --> 00:24:47,980 governance arrangements did not require formal ethical approval. 254 00:24:48,310 --> 00:24:49,810 Now we never got picked up on that, 255 00:24:50,050 --> 00:24:58,540 but I do wonder if it had got further at that stage we whether it might have sort of caused a problem when it came to publication. 256 00:24:59,260 --> 00:25:04,540 So my learning point from that was always check ethical approval situation before embarking on any project. 257 00:25:04,720 --> 00:25:10,990 And it's kind of made me a little bit obsessional about it with subsequent projects of just making absolutely sure that I've been through all 258 00:25:10,990 --> 00:25:19,390 the hoops and I've got stuff in writing from the from the people that be to absolutely make sure that I don't need to get ethical approval. 259 00:25:19,930 --> 00:25:28,450 However, it was not to be. I had on the 6th of October 2011, thank you for sending us this paper we sent. 260 00:25:28,450 --> 00:25:33,640 It was for peer review, but we're sorry to say that we cannot publish it in the BMJ at this time. 261 00:25:34,510 --> 00:25:39,459 Now, it would be would have been easy to think of this as the mother of all speed bumps. 262 00:25:39,460 --> 00:25:49,270 I think this must be in the States. But we didn't the the reasons for rejection were kind of predictable. 263 00:25:49,270 --> 00:25:54,280 And I don't remember being bitterly disappointed because I think I was sort of half expecting it. 264 00:25:55,450 --> 00:25:58,630 They said we didn't have any specific criticism of the design or methods. 265 00:25:58,840 --> 00:26:04,479 The main problem is the small sample size, which I think, you know, anybody looking at this could say, well, what did you expect? 266 00:26:04,480 --> 00:26:12,580 It wasn't getting it into the BMJ with a sample size of 32 patients, but they said, we suggest that you might gather more data prospectively, 267 00:26:12,760 --> 00:26:15,639 perhaps collaborating with clinicians from another centre to build up a bigger 268 00:26:15,640 --> 00:26:19,300 sample so that a future analysis might not suffer from being underpowered. 269 00:26:19,960 --> 00:26:25,030 If you can do this, we may be interested in seeing a resubmission for next year's Christmas BMJ, 270 00:26:25,570 --> 00:26:32,380 so I'm sure that some people would have seen that and said, oh well that's, you know, it's that's only in a year's time. 271 00:26:32,710 --> 00:26:40,480 This was on the sixth of 6th of October 2011 and getting a whole study together in time for December 2012. 272 00:26:40,750 --> 00:26:46,450 Time for the submission deadline, September 2012, that that might be a bit impossible, 273 00:26:46,450 --> 00:26:51,519 but I think I saw it as a challenge and the other people saw it as a challenge because these were 274 00:26:51,520 --> 00:26:56,190 the comments that I immediately had backed by return from Anthony and Richard Anthony said, 275 00:26:56,200 --> 00:27:00,010 Comments are excellent. Let's discuss extending the study with poor ethics approval. 276 00:27:00,250 --> 00:27:06,580 That was because of the whole problem that we've had with the ethics. And in fact, since BMJ 2012, we may even be able to secure a small grant. 277 00:27:06,970 --> 00:27:11,320 And Richard said this looks like a good opportunity to seek funding and do the study on a larger scale. 278 00:27:11,530 --> 00:27:16,959 You could be really onto something here. So I felt like from the rest of my team that there was lots of positive feeling about it. 279 00:27:16,960 --> 00:27:18,850 And so I thought, let's go for it. 280 00:27:19,090 --> 00:27:25,569 So I think I've put a question mark by the fourth bump because I think actually it wasn't so much as a bump as an opportunity. 281 00:27:25,570 --> 00:27:31,120 So I think seeing opportunity and failure and I think nobody gets anywhere without having failures along the way. 282 00:27:31,120 --> 00:27:36,730 And you know, when this did come out and Christmas and Christmas, everyone was, you know, kind of like, wow, this is amazing. 283 00:27:36,880 --> 00:27:39,790 But actually, it really wasn't a completely smooth pathway. 284 00:27:39,790 --> 00:27:44,890 And, you know, the fact that it didn't get in the year before was very much a major thing along the way. 285 00:27:45,460 --> 00:27:52,810 So as I say, a new challenge. First of all, we had to redesign the study to take account of the criticisms that we'd had, 286 00:27:53,290 --> 00:27:56,290 that we'd had and things that we would have wanted to change anyway. 287 00:27:56,290 --> 00:28:01,870 Doing it on a larger scale, going through ethical approval, and I'd never done a clinical study before. 288 00:28:02,110 --> 00:28:08,560 So suddenly coming across all these ridiculous number of acronyms that you have to get your head around when designing a study. 289 00:28:08,770 --> 00:28:11,559 And I only had about a month in which to get my head around all of it. 290 00:28:11,560 --> 00:28:16,870 So I did my GCP training, which is good clinical practice filled in the IRS form. 291 00:28:17,230 --> 00:28:23,770 I don't even know what that stands for. Some sort of form you fill in. It takes ages. 292 00:28:23,770 --> 00:28:32,140 So yeah, leave more than a month to do it. The there's the research ethics committee, the local trust research and development. 293 00:28:32,350 --> 00:28:36,550 There's this site specific form that needs to be filled in. You also need to get sponsorship. 294 00:28:36,730 --> 00:28:46,080 The university that provides kind of legal cover and general support from a university point of view that clinical trials and research, 295 00:28:46,080 --> 00:28:53,880 governance and then PR is the IS stands for proportionate proportionate review, 296 00:28:54,120 --> 00:28:57,630 I think, which was something that had just come in a few weeks before, 297 00:28:57,810 --> 00:29:02,010 which was really handy and was a two week fast track process for getting things to ethical approval. 298 00:29:02,220 --> 00:29:06,120 Because I think for many things it does take several months and this was part of 299 00:29:06,120 --> 00:29:09,930 a scheme to recognise that for studies that really weren't too controversial, 300 00:29:10,200 --> 00:29:14,100 we could, you know, it could go through a lot more quickly. 301 00:29:15,390 --> 00:29:20,790 We had to design a new protocol, come up with study packs, consent forms, think about funding. 302 00:29:20,790 --> 00:29:25,740 In the end, we didn't actually get any funding. Everybody did it through goodwill and wanting to be involved in the study. 303 00:29:26,370 --> 00:29:32,310 And I got a little bit of funding to pay for the cost of printing all the consent forms from an organisation called UK, 304 00:29:32,640 --> 00:29:38,820 which is the programme that funds the Oxford ECF had to recruit staff because obviously I was 305 00:29:38,820 --> 00:29:42,210 no longer working at Stoke Mandeville Hospital and I didn't have any contacts there anymore, 306 00:29:44,010 --> 00:29:45,870 have the other people that we needed on the team. 307 00:29:45,870 --> 00:29:53,429 So we asked Richard to still be involved as the statistician, and we were aware that we needed somebody to actually do the work, 308 00:29:53,430 --> 00:29:58,530 so to get a research assistant as well, but without having anything to pay that research assistant with, 309 00:29:58,530 --> 00:30:07,919 which was a little bit interesting, we had to get review of the protocol and Donald Sadiq Dick We did a review of the protocol for us, 310 00:30:07,920 --> 00:30:11,520 which was really helpful and we really improved it as a result of getting their input. 311 00:30:12,060 --> 00:30:17,610 And then we had to recruit a lot more patients compared to previously to try and get three to try 312 00:30:17,610 --> 00:30:22,920 and get through the process in order to then submit in time for the Christmas BMJ the year after. 313 00:30:24,880 --> 00:30:34,700 So the study redesign. This time we had some pilot data to go on for the from the first the first study that we've done, 314 00:30:35,690 --> 00:30:39,830 although because of the wide confidence intervals, it again wasn't completely perfect. 315 00:30:40,100 --> 00:30:45,050 But Richard came up with a great sample size calculation so such that we could 316 00:30:45,290 --> 00:30:50,240 say that we needed to recruit between 100 and 150 patients to the study. 317 00:30:50,510 --> 00:30:58,040 And that that was to show a significant difference in likelihood ratio compared 318 00:30:58,040 --> 00:31:01,460 to rebound tenderness so that we were going to outperform rebound tenderness. 319 00:31:01,580 --> 00:31:09,620 That was the goal. This time we were going to get written consent from patients and we couldn't get we couldn't ask the doctors on the 320 00:31:09,620 --> 00:31:14,419 wards to actually take consent because otherwise they would all have had to have gone through good clinical practice, 321 00:31:14,420 --> 00:31:15,620 training and things like that. 322 00:31:15,710 --> 00:31:22,940 So we wanted it to be an entirely written process so that the patients could read all the information and sort of effectively consent themselves, 323 00:31:23,090 --> 00:31:25,700 which is fine for a low intervention study. 324 00:31:26,360 --> 00:31:34,010 We wanted to standardise the index test, so we designed a questionnaire that they had to complete within 12 hours of their arrival in the hospital. 325 00:31:34,610 --> 00:31:39,530 And that was just because we were worried that a longer time than that and there'd be a degree of recall bias. 326 00:31:40,700 --> 00:31:46,729 And then we also arranged a telephone follow up after discharge for those without appendicitis. 327 00:31:46,730 --> 00:31:51,799 And the reason for that was because there was the possibility that patients might have 328 00:31:51,800 --> 00:31:56,870 been readmitted elsewhere with appendicitis that we didn't know about in in that hospital, 329 00:31:56,870 --> 00:32:01,910 because obviously we only had had access to the medical records within the hospital. 330 00:32:02,330 --> 00:32:10,790 So I actually brought along some of the study paperwork because I'm aware that not everybody perhaps, you know, been through study recruitment. 331 00:32:10,910 --> 00:32:17,120 So if you do want to either pass this around or come and have a look afterwards, then I'm very happy for, you know, have a leaf, have a leaflet. 332 00:32:17,720 --> 00:32:26,960 So it's made up of participant information sheets, which patients had a read of beforehand, a consent form, 333 00:32:28,610 --> 00:32:33,320 the patient questionnaire where we asked various details about their demographics, about their symptoms, 334 00:32:33,530 --> 00:32:37,760 and then quite a lot of detail about their pain, whether they were in pain already, 335 00:32:38,030 --> 00:32:43,850 whether the pain got worse when they went over a bump, and also how they got to the how they'd got to the hospital. 336 00:32:44,450 --> 00:32:48,379 Plus, getting their contact details just for the purposes of cooling them, cooling them. 337 00:32:48,380 --> 00:32:52,580 Afterwards, we asked the doctors to complete the data collection form. 338 00:32:52,820 --> 00:32:55,549 As it happens, none of the doctors actually filled in the data collection form, 339 00:32:55,550 --> 00:33:01,490 but the research assistant filled us in afterwards and then recruitment guidance for the clinical staff on the ward. 340 00:33:02,180 --> 00:33:07,190 So Christmas 2011, I've tried to give a slightly Christmas flavour to this, given that it's the 1st of December. 341 00:33:08,690 --> 00:33:14,960 I was saying to Claire beforehand that looking back in preparation for this talk, I went back through my emails in relation to speed bumps, 342 00:33:15,140 --> 00:33:20,930 which I hadn't looked at in over a year, and the amount of email correspondence that went went round. 343 00:33:20,930 --> 00:33:24,670 And at this time I was doing a really busy paediatrics job. And so I must have been, you know, 344 00:33:24,740 --> 00:33:29,149 lots of them were sort of sent three or 4 a.m. and looking back I think what on 345 00:33:29,150 --> 00:33:32,240 earth did I get the energy from to do would have to do all of that at the time. 346 00:33:32,450 --> 00:33:42,400 But this was a I actually sent all the documents off to the university CTG, which was the first stage of getting ethics approval on Christmas Day, 347 00:33:42,410 --> 00:33:47,959 a 7:48 p.m., which I was just amazed at looking back at, I think what on earth was I doing on Christmas Day? 348 00:33:47,960 --> 00:33:54,770 Sending the sending ethics documents? But I think what happened was that we decided to delay Christmas because I was in the middle 349 00:33:54,770 --> 00:33:59,180 of a horrible set of nights and celebrate Christmas several days later when I came off night. 350 00:33:59,190 --> 00:34:04,310 So I'm trying to think that I wasn't being too overly keen and that actually it did it did make sense. 351 00:34:05,570 --> 00:34:12,410 But part of getting this together so quickly was the fact that was the fact 352 00:34:12,410 --> 00:34:18,290 that I had a really great team that was able to reply to emails within a few 353 00:34:18,290 --> 00:34:21,859 minutes of me sending them and were willing to go to great lengths to get all 354 00:34:21,860 --> 00:34:25,070 this ethical stuff in so that we could start recruitment as soon as possible. 355 00:34:25,340 --> 00:34:33,520 So within about six weeks of having had the rejection, we'd already got all the documents ready for sending out to ethics, which, you know, 356 00:34:33,560 --> 00:34:40,400 looking back on it was pretty phenomenal that we managed to do that because now, you know, the pace of research often does go a lot slower than that. 357 00:34:40,400 --> 00:34:44,660 And people don't reply to your emails for ten days and things like that, and nobody did that. 358 00:34:44,660 --> 00:34:48,379 Everybody was just really quick and realised that to get this going and to make a go of this, 359 00:34:48,380 --> 00:34:52,430 we needed to be really quick, really prompt and a particular example of that. 360 00:34:52,430 --> 00:34:59,180 The reason I've got a map of Africa which might seem rather odd is that at the time when I submitted to ethics, 361 00:35:00,050 --> 00:35:06,500 they needed to have hard copy signatures or a real life signature within 24 hours of me submitting the forms. 362 00:35:06,800 --> 00:35:12,200 And it happened that that coincided with Antony Holland and being in Uganda, Nigel, 363 00:35:12,200 --> 00:35:20,810 who was the lead that I had and the surgeon who I'd recruited in Stoke Mandeville to lead the study kind of on the ground. 364 00:35:21,410 --> 00:35:27,379 He was a senior house officer then he was in Egypt and then the other surgeon was somewhere in Europe. 365 00:35:27,380 --> 00:35:30,310 And they were all. They went to the business centres at their hotels, 366 00:35:30,310 --> 00:35:34,810 they scanned in their signatures and they just went to great lengths to kind of sort that out for me. 367 00:35:34,810 --> 00:35:40,780 And I just, you know, I think that was actually amazing. And so, you know, the hard work and dedication from all the team really made this happen. 368 00:35:40,960 --> 00:35:44,890 You know, I did work hard on it, but it really was, you know, it was it was really a team effort. 369 00:35:45,490 --> 00:35:51,400 So in February 2012, recruitment started, we got ethical approval through on the 25th of January, 370 00:35:51,760 --> 00:35:57,250 got all the documents printed within a few days, and I had the printing company primed to get it all done as quickly as possible. 371 00:35:57,370 --> 00:36:03,760 And the idea was to get this so that it was already so that we could start recruitment at doctor changeover at the beginning of February. 372 00:36:04,030 --> 00:36:08,590 Because for those of you that don't know, doctors change over on Wednesdays, which is a little odd. 373 00:36:09,850 --> 00:36:15,340 And the people who were starting the six month jobs, it meant that we could catch them right at the beginning. 374 00:36:15,940 --> 00:36:18,400 And that unfortunately coincided with snow. 375 00:36:19,630 --> 00:36:27,070 And I had to I met with Nigel, who, as I say, is the guy who was running the study on the ground halfway between Aylesbury and Oxford. 376 00:36:27,070 --> 00:36:34,300 And both of us braved the snow. And I met him at about 11:00 at night with all the roads closed, closed due to snow, 377 00:36:34,510 --> 00:36:39,879 just to get all these study packs out state manageable in time for for the new doctors starting 378 00:36:39,880 --> 00:36:44,830 but we did it I always like to put pictures of cats in my presentations so these are my cats, 379 00:36:44,830 --> 00:36:49,180 Agnes and Pippa. And this was the first time that ever experienced the snow. 380 00:36:49,390 --> 00:36:54,840 I think this is an eye garden and I'm not sure quite what they thought of it, but okay. 381 00:36:55,540 --> 00:37:05,529 So the fist bump, I think this is the final bump. So the first four weeks of the study, we sadly only recruited ten patients, which was rather a blow, 382 00:37:05,530 --> 00:37:11,830 given that in the pilot or the audit or whatever you want to call it, we recruited 32 patients in six weeks. 383 00:37:12,430 --> 00:37:13,690 So this is quite a lot slower. 384 00:37:14,320 --> 00:37:22,330 And the reasons for this were that, you know, I was I was probably the most enthusiastic and the keenest and I was based in Oxford. 385 00:37:23,440 --> 00:37:32,860 Nigel who was the CHB running the study was based in High Wickham and all the other study staff were based in High Wickham or Oxford or elsewhere. 386 00:37:33,640 --> 00:37:39,430 And we had recruited we had recruited a research assistant who was somebody who said that they were keen to be involved. 387 00:37:39,430 --> 00:37:45,610 And we said, you know, you can be a co-author if you're the research, but, you know, it's just a bit unreliable, really. 388 00:37:46,660 --> 00:37:50,920 You know, obviously it's very busy when you have, you know, hospital raters, 389 00:37:51,130 --> 00:37:59,860 but just didn't have the kind of impetus to really get involved and go after work and fill in forms and encourage other people to recruit, 390 00:37:59,860 --> 00:38:07,180 which was what we really, really needed. And the ones the the House offices that we wanted to go up to patients and say, there's this study going on. 391 00:38:07,510 --> 00:38:11,680 I won't tell you much about it, but here's a study pack for you to read about and see if you want to fill. 392 00:38:11,680 --> 00:38:19,660 And they just weren't really doing that. We tried to give them you know, we said that they could keep the pen if they wanted afterwards. 393 00:38:19,990 --> 00:38:23,110 Whereas, you know, we we I thought that was great. 394 00:38:23,110 --> 00:38:24,400 You know, you're always looking for a pen. 395 00:38:24,610 --> 00:38:31,600 And in fact, we I kept topping up the pens that we had in the sort of study box that we kept in the emergency department. 396 00:38:31,930 --> 00:38:35,110 And, I mean, we recruited in the end 101 patients. 397 00:38:35,320 --> 00:38:38,860 But the number of pens I'd got through was about three times that. 398 00:38:39,130 --> 00:38:42,520 So I think people were just using it for the whole emergency department must have 399 00:38:42,520 --> 00:38:46,749 been using this box as a source of pens without actually recruiting patients, 400 00:38:46,750 --> 00:38:53,200 which wasn't the idea. But never mind if I could have given pens to St Mary's Hospital then that's great though. 401 00:38:53,200 --> 00:38:57,970 It was also. One of the other major problems was that in the meantime, in the sort of intervening two years, 402 00:38:58,330 --> 00:39:01,510 there'd been a redevelopment of the hospital site so that the speedbump, 403 00:39:01,510 --> 00:39:07,749 which guaranteed that everybody went over a speed bump, was no longer there, which was really, really sad. 404 00:39:07,750 --> 00:39:11,799 So it meant that we'd gone from 100% of patients having gone over a speed bump to only about 405 00:39:11,800 --> 00:39:15,129 two thirds of patients because statement was in quite a residential area in Aylesbury. 406 00:39:15,130 --> 00:39:20,740 So still most patients had gone over a speed bump, but not all of them, which as I say, is just absolutely tragic. 407 00:39:21,970 --> 00:39:28,510 How did we get around that? We recruited a new fantastic research assistant called Diyala, who was just wonderful. 408 00:39:28,510 --> 00:39:34,299 She just had so much enthusiasm and she went off to work each day and recruited patients. 409 00:39:34,300 --> 00:39:38,590 She'd be, you know, she yeah. She's the reason that the study was successful. 410 00:39:39,460 --> 00:39:45,190 The plan Nigel called from Wickham every day to the on call staff because state manual and 411 00:39:45,190 --> 00:39:48,790 Wickham on separate sites which is a little bit inconvenient and so it meant that he was actually 412 00:39:48,790 --> 00:39:53,529 based on the other side most of the time we got the consultant who was meant to be kind of 413 00:39:53,530 --> 00:39:59,350 overseeing the study to send repeated emails to junior staff saying this is absolutely compulsory. 414 00:39:59,980 --> 00:40:07,809 We applied for a major amendment from the Ethics Committee to increase the time window of recruitment to 24 hours. 415 00:40:07,810 --> 00:40:11,290 I thought this would be a minor amendment, but it had to go back through the ethics. 416 00:40:11,410 --> 00:40:14,860 But luckily we didn't have to stop recruitment while we were getting that amendment. 417 00:40:15,850 --> 00:40:22,839 So that increased to 24 hours and we looked at other ways to increase recruitment as well. 418 00:40:22,840 --> 00:40:27,820 So things like chocolate certificates for participation, even more pens. 419 00:40:29,830 --> 00:40:35,920 And so I think my learning point here that the local staff really have to be on board and interested and you have to 420 00:40:36,400 --> 00:40:41,950 think about paying people to take part in your study or they have to have some sort of personal gain to want to do it. 421 00:40:42,400 --> 00:40:45,549 And we reached our recruitment target in July 2012. 422 00:40:45,550 --> 00:40:50,110 This is my data entry spreadsheet, which was very colourful and I was very proud of it. 423 00:40:50,140 --> 00:40:52,840 I think I've done such a colourful data entry spreadsheet since. 424 00:40:54,610 --> 00:41:03,069 So the final decisions after we've gathered all the data, we're chasing up the histology, which there's a kind of month lag on getting that, 425 00:41:03,070 --> 00:41:07,870 which was a bit of an issue given that we were so tight to the publication deadline deciding on 426 00:41:07,870 --> 00:41:11,270 how we were going to deal with the things like patients that had said they were unsure about, 427 00:41:11,440 --> 00:41:16,120 about whether they'd gone over speed bumps, patients who'd been treated with antibiotics instead. 428 00:41:16,600 --> 00:41:20,139 One of the other issues was that everybody was on holiday at the time that we were trying to write it up. 429 00:41:20,140 --> 00:41:25,810 So I think if the deadline for submitting for Christmas BMJ was the 14th of September, 430 00:41:26,020 --> 00:41:31,600 which meant that trying to write it up during August and August and beginning part of September was a bit of a nightmare. 431 00:41:32,050 --> 00:41:33,850 So this is a picture of Castle Drogo, 432 00:41:34,180 --> 00:41:42,159 which is in Devon and is where I was mildly trying to get a Wi-Fi connection to do some statistical analysis and correspond with Richard about things, 433 00:41:42,160 --> 00:41:47,799 which was a bit of a challenge. So I was also I'm really not into it very much about the results because you can read 434 00:41:47,800 --> 00:41:50,980 it in the paper and I wanted to focus on the process rather than the actual results. 435 00:41:51,250 --> 00:41:54,010 But as I say, we recruited 101 patients. 436 00:41:54,880 --> 00:42:02,500 43 of them had confirmed appendicitis, which gave a negative open secondary rate of 20%, which is about average and 68. 437 00:42:02,500 --> 00:42:06,160 So about two thirds had travelled over speed bumps and we excluded four of them. 438 00:42:07,450 --> 00:42:11,109 These are all the results. So you can see the two by two table. 439 00:42:11,110 --> 00:42:21,120 Again, 33 out of 34 patients who were positive for appendicitis had been were positive, also positive for speed bumps. 440 00:42:21,130 --> 00:42:23,710 So that gave us a sensitivity of 97%. 441 00:42:24,100 --> 00:42:29,740 And what that means is that when a test has a really high sensitivity, it means that it's a really good rule out test. 442 00:42:29,950 --> 00:42:37,810 So that means that if you if you don't have pain when you go over speed bumps, it's means it's very unlikely that you will have appendicitis. 443 00:42:38,770 --> 00:42:46,479 The specificity, however, was really low. That's what you'd expect and is because the majority of patients did have pain when they went over bumps. 444 00:42:46,480 --> 00:42:50,020 Most patients who were pain in pain anyway said yes, the bumps are more painful. 445 00:42:50,020 --> 00:42:58,629 So it wasn't very specific. And actually lots of the patients who had pain went onto went on to be diagnosed with something else, 446 00:42:58,630 --> 00:43:04,570 either another serious abdominal problem or didn't you didn't have anything wrong with them at all. 447 00:43:05,890 --> 00:43:14,170 And when we compared the speed bumps to other diagnostic variables, we found that we had set out to prove what we wanted to, 448 00:43:14,230 --> 00:43:20,139 which is that the sensitivity for the pain over speed bumps was better than these three other sensitivity. 449 00:43:20,140 --> 00:43:23,200 So migratory pain, nausea, vomiting and rebound tenderness. 450 00:43:23,500 --> 00:43:28,960 And also in terms of negative likelihood ratio, it was a better negative likelihood ratio than for all these things. 451 00:43:29,140 --> 00:43:37,450 So in terms of proving that, it's making it less likely that you have appendicitis if you don't have that sign and we it was accepted. 452 00:43:37,510 --> 00:43:43,900 So we submitted and we then had a very nice email back saying we were please say we would like to publish the paper in the Christmas BMJ. 453 00:43:44,230 --> 00:43:48,940 We had quite a lot of they have quite a lot of comments and things they wanted to add detail on. 454 00:43:49,180 --> 00:43:56,500 So making it more suitable for the US audience, as I said, some extra sensitivity analyses, more details in the methods. 455 00:43:56,790 --> 00:43:59,769 We'd also got a comment at the end which we thought was quite amusing for Christmas. 456 00:43:59,770 --> 00:44:06,190 BMJ saying that further studies would involve seeing if there was a difference between male and female drivers. 457 00:44:06,700 --> 00:44:10,659 And we, you know, we thought this Christmas BMJ they'll go for it. 458 00:44:10,660 --> 00:44:15,280 But we had several test comments back saying please remove the comment about male and female drivers. 459 00:44:15,280 --> 00:44:19,089 It is unnecessary and not related to the research. And we were like, Yes, but that's the point. 460 00:44:19,090 --> 00:44:23,020 But anyway, they, I think our humour didn't quite match their humour. 461 00:44:23,350 --> 00:44:30,370 And the reason for the picture of Oxford Crown Crown Court is that I was on jury duty at the time and so was trying 462 00:44:30,370 --> 00:44:36,160 to do all these re-editing at the same time as trying to decide whether somebody was guilty of blackmail or not. 463 00:44:37,060 --> 00:44:40,000 And after we submit, after we sent in the revised comments, 464 00:44:40,000 --> 00:44:44,710 we then had a lovely email back saying We are very pleased to be able to publish it this year, which was really exciting. 465 00:44:45,490 --> 00:44:52,209 So this is Christmas 2012 when, as I say, all went it all went very, very chaotic. 466 00:44:52,210 --> 00:45:00,040 So I was doing the MBTI two course two years ago. And during during the course, that was when I heard that they wanted to make a podcast. 467 00:45:00,040 --> 00:45:04,720 And so I had loads of feedback from everyone else in the course about how we could write this podcast. 468 00:45:04,960 --> 00:45:11,590 And, you know, particularly the surgeons in the course, you know, how we could make it relevant to lots of different people and recruited some, 469 00:45:11,620 --> 00:45:16,840 some willing volunteers, particularly from the department, to be in the, in the podcast. 470 00:45:17,320 --> 00:45:21,220 And so we made that a week or so later they they press released it. 471 00:45:21,460 --> 00:45:25,990 And unfortunately the timing of the press releases when I had a full day in GP surgery. 472 00:45:26,710 --> 00:45:33,000 So the reception. S were put on guard to put any reporters through, you need to put them on hold while I finish with my patient x my patient, 473 00:45:33,000 --> 00:45:39,000 and then I try and slot them in between patients and things. So again, that's something that if that if you ever do anything, which is press release, 474 00:45:39,180 --> 00:45:44,370 make sure you clear the day after it's going to be press release because it's not going to be have a full surgery full of patients. 475 00:45:44,970 --> 00:45:48,630 But the university media team and the department media team were absolutely great. 476 00:45:49,080 --> 00:45:52,979 And then I was on several radio shows, as I mentioned, one of them, 477 00:45:52,980 --> 00:45:58,020 I had to come up with a Christmas joke and I managed to put it on Facebook saying, Does anyone have a joke? 478 00:45:58,020 --> 00:46:01,500 And you've managed to find an appendicitis related joke, which was really good. 479 00:46:02,700 --> 00:46:06,239 And there are two sort of good podcasts. 480 00:46:06,240 --> 00:46:14,610 I'm not going to play you that. The BMJ, as I say, made a podcast which featured several people in the department and is very I think is good. 481 00:46:14,610 --> 00:46:18,230 It doesn't just fit to me. It features lots of other people as well and is very, very funny. 482 00:46:18,240 --> 00:46:20,760 I'm just going to pay you the naked scientists one, 483 00:46:20,760 --> 00:46:28,710 just to give you a flavour of the sort of things that I had to talk alongside in the run up to Christmas. 484 00:46:29,820 --> 00:46:35,040 And so Happy Christmas and welcome to the final episode of The Naked Scientists of 2012. 485 00:46:35,310 --> 00:46:38,550 It's Christmas Eve. And so and only here with you. 486 00:46:39,030 --> 00:46:43,379 And to celebrate this festive period, we're going to be taking a look at the lighter side of science this week, 487 00:46:43,380 --> 00:46:48,210 including finding out why speed bumps are the best way to diagnose appendicitis, potentially. 488 00:46:48,780 --> 00:46:51,209 Also, why reindeer have red nose. 489 00:46:51,210 --> 00:46:58,410 This will speak to some of these animals on treadmills to find out is a real physiology experiment and we'll be meeting Cliff, 490 00:46:58,590 --> 00:47:02,140 the dog that can sniff for sea do catch the one. 491 00:47:02,460 --> 00:47:05,960 We also need you to send in your science questions first to us. 492 00:47:05,970 --> 00:47:10,410 That's all I'll play. But it was kind of it was this bizarre thing because there was a kind of serious 493 00:47:10,410 --> 00:47:13,170 aspect to our research and that this is a sign that you can use in practice. 494 00:47:13,170 --> 00:47:20,100 But because it came out in the week before Christmas, it was you know, there were lots of things like the Christmas joke. 495 00:47:20,100 --> 00:47:25,110 And everywhere that it was, it was presented it was presented as alongside this other article, 496 00:47:25,110 --> 00:47:28,620 which was how Rudolph has his red nose, which was just quite, quite funny. 497 00:47:30,390 --> 00:47:37,020 So I think that's all I'm specifically going to say. I've got a huge list of acknowledgements that I'm not going to go through specifically. 498 00:47:38,160 --> 00:47:43,139 But, you know, as I said before, it was really, really very much a team effort. 499 00:47:43,140 --> 00:47:45,390 And although I did work hard, you know, 500 00:47:45,420 --> 00:47:51,180 everybody else played a really key role and I couldn't have done it without everybody else helping me, helping me along. 501 00:47:51,840 --> 00:47:55,050 And lastly, I just wanted to thank my poor longsuffering husband, Michael. 502 00:47:55,470 --> 00:48:04,950 This is a picture of him on the 23rd of December 2012, which was when I had promised to make a batch of sausage rolls for 20 people. 503 00:48:05,700 --> 00:48:09,509 And unfortunately, I wasn't able to do it because of all the press release stuff. 504 00:48:09,510 --> 00:48:14,640 And I ended up having to go on the Naked Scientist Show while at the time of making the sausage rolls. 505 00:48:14,820 --> 00:48:20,820 And so this is him downstairs in the kitchen making it very meticulously making sausage rolls, 506 00:48:20,820 --> 00:48:27,299 because I think the I think there was a I think you had to make them two and a half centimetres or an inch thick or something. 507 00:48:27,300 --> 00:48:30,300 And well, normal people would just have guessed it. He did it with a tape measure. 508 00:48:31,590 --> 00:48:36,000 But anyway, that's him while I was on them, while I was on the radio. 509 00:48:37,140 --> 00:48:40,480 And so, yeah, I think that's all I have to say. And Merry Christmas and.