-
Notifications
You must be signed in to change notification settings - Fork 0
/
project.html
676 lines (665 loc) · 27.9 KB
/
project.html
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
325
326
327
328
329
330
331
332
333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
351
352
353
354
355
356
357
358
359
360
361
362
363
364
365
366
367
368
369
370
371
372
373
374
375
376
377
378
379
380
381
382
383
384
385
386
387
388
389
390
391
392
393
394
395
396
397
398
399
400
401
402
403
404
405
406
407
408
409
410
411
412
413
414
415
416
417
418
419
420
421
422
423
424
425
426
427
428
429
430
431
432
433
434
435
436
437
438
439
440
441
442
443
444
445
446
447
448
449
450
451
452
453
454
455
456
457
458
459
460
461
462
463
464
465
466
467
468
469
470
471
472
473
474
475
476
477
478
479
480
481
482
483
484
485
486
487
488
489
490
491
492
493
494
495
496
497
498
499
500
501
502
503
504
505
506
507
508
509
510
511
512
513
514
515
516
517
518
519
520
521
522
523
524
525
526
527
528
529
530
531
532
533
534
535
536
537
538
539
540
541
542
543
544
545
546
547
548
549
550
551
552
553
554
555
556
557
558
559
560
561
562
563
564
565
566
567
568
569
570
571
572
573
574
575
576
577
578
579
580
581
582
583
584
585
586
587
588
589
590
591
592
593
594
595
596
597
598
599
600
601
602
603
604
605
606
607
608
609
610
611
612
613
614
615
616
617
618
619
620
621
622
623
624
625
626
627
628
629
630
631
632
633
634
635
636
637
638
639
640
641
642
643
644
645
646
647
648
649
650
651
652
653
654
655
656
657
658
659
660
661
662
663
664
665
666
667
668
669
670
671
672
673
674
675
676
<!DOCTYPE html>
<html
lang="en-GB"
xmlns:og="https://ogp.me/ns#"
xmlns:fb="https://ogp.me/ns/fb#"
>
<head>
<meta charset="UTF-8" />
<title>COMPare - Methods</title>
<meta name="robots" content="noodp,noydir" />
<meta name="viewport" content="width=device-width, initial-scale=1" />
<link rel="dns-prefetch" href="https://w.sharethis.com/" />
<link
rel="alternate"
type="application/rss+xml"
title="COMPare » Feed"
href="feed/index.html"
/>
<link
rel="alternate"
type="application/rss+xml"
title="COMPare » Comments Feed"
href="comments/feed/index.html"
/>
<link rel="canonical" href="project.html" />
<link
rel="stylesheet"
id="parallax-pro-theme-css"
href="wp-content/themes/parallax-pro/style.css"
type="text/css"
media="all"
/>
<link
rel="stylesheet"
id="sm-style-css"
href="wp-content/plugins/wp-show-more/wpsm-style.css"
type="text/css"
media="all"
/>
<link
rel="stylesheet"
id="kamn-css-easy-twitter-feed-widget-css"
href="wp-content/plugins/easy-twitter-feed-widget/easy-twitter-feed-widget.css"
type="text/css"
media="all"
/>
<link
rel="stylesheet"
id="dashicons-css"
href="wp-includes/css/dashicons.min.css"
type="text/css"
media="all"
/>
<link rel="preconnect" href="https://fonts.gstatic.com" />
<link
href="https://fonts.googleapis.com/css2?family=Montserrat&family=Sorts+Mill+Goudy&display=swap"
rel="stylesheet"
/>
<link
rel="stylesheet"
id="sccss_style-css"
href="index.css"
type="text/css"
media="all"
/>
<script
type="text/javascript"
src="wp-includes/js/jquery/jquery.js"
></script>
<script
type="text/javascript"
src="wp-includes/js/jquery/jquery-migrate.min.js"
></script>
<script type="text/javascript">
/* <![CDATA[ */
var cssTarget = "img.";
/* ]]> */
</script>
<script
type="text/javascript"
src="wp-content/plugins/svg-support/js/min/svg-inline-min.js"
></script>
<!--[if lt IE 9]>
<script
type="text/javascript"
src="https://www.compare-trials.org/wp-content/themes/genesis/lib/js/html5shiv.min.js?ver=3.7.3"
></script>
<![endif]-->
<script
type="text/javascript"
src="wp-content/themes/parallax-pro/js/responsive-menu.js"
></script>
<script
id="st_insights_js"
type="text/javascript"
src="https://w.sharethis.com/button/st_insights.js?publisher=eba0f3ba-f9ab-408c-bc68-c28af5afe749&product=feather"
></script>
<link rel="https://api.w.org/" href="wp-json/index.html" />
<link
rel="EditURI"
type="application/rsd+xml"
title="RSD"
href="xmlrpc.php%3Frsd"
/>
<link
rel="alternate"
type="application/json+oembed"
href="https://www.compare-trials.org/wp-json/oembed/1.0/embed?url=http%3A%2F%2Fcompare-trials.org%2Fmethods"
/>
<link
rel="alternate"
type="text/xml+oembed"
href="https://www.compare-trials.org/wp-json/oembed/1.0/embed?url=http%3A%2F%2Fcompare-trials.org%2Fmethods&format=xml"
/>
<style type="text/css"></style>
<style type="text/css"></style>
<style type="text/css">
.synved-social-resolution-single {
display: inline-block;
}
.synved-social-resolution-normal {
display: inline-block;
}
.synved-social-resolution-hidef {
display: none;
}
@media only screen and (min--moz-device-pixel-ratio: 2),
only screen and (-o-min-device-pixel-ratio: 2/1),
only screen and (-webkit-min-device-pixel-ratio: 2),
only screen and (min-device-pixel-ratio: 2),
only screen and (min-resolution: 2dppx),
only screen and (min-resolution: 192dpi) {
.synved-social-resolution-normal {
display: none;
}
.synved-social-resolution-hidef {
display: inline-block;
}
}
</style>
<link
rel="icon"
href="wp-content/uploads/2016/01/cropped-original-32x32.png"
sizes="32x32"
/>
<link
rel="icon"
href="wp-content/uploads/2016/01/cropped-original-192x192.png"
sizes="192x192"
/>
<link
rel="apple-touch-icon-precomposed"
href="wp-content/uploads/2016/01/cropped-original-180x180.png"
/>
<meta
name="msapplication-TileImage"
content="https://www.compare-trials.org/wp-content/uploads/2016/01/cropped-original-270x270.png"
/>
<script
id="plausible"
defer
data-domain="compare-trials.org"
src="https://plausible.io/js/plausible.compat.js"
></script>
<!-- START - Facebook Open Graph, Google+ and Twitter Card Tags 2.0.4 -->
<!-- Facebook Open Graph -->
<meta property="og:locale" content="en_GB" />
<meta property="og:site_name" content="COMPare" />
<meta property="og:title" content="Methods" />
<meta property="og:url" content="https://www.compare-trials.org/methods" />
<meta property="og:type" content="article" />
<meta
property="og:description"
content="The COMPare (CEBM Outcome Monitoring Project) team is monitoring clinical trials for switched outcomes. Through increased awareness of misreported outcomes, individual accountability, and feedback for specific journals, we hope to fix the ongoing problem of outcome switching.
Why outcome switchin"
/>
<meta
property="og:image"
content="https://www.compare-trials.org/wp-content/uploads/2016/01/logo_large-1.png"
/>
<!-- Google+ / Schema.org -->
<meta itemprop="name" content="Methods" />
<meta
itemprop="description"
content="The COMPare (CEBM Outcome Monitoring Project) team is monitoring clinical trials for switched outcomes. Through increased awareness of misreported outcomes, individual accountability, and feedback for specific journals, we hope to fix the ongoing problem of outcome switching.
Why outcome switchin"
/>
<meta
itemprop="image"
content="https://www.compare-trials.org/wp-content/uploads/2016/01/logo_large-1.png"
/>
<!-- Twitter Cards -->
<meta name="twitter:title" content="Methods" />
<meta name="twitter:url" content="https://www.compare-trials.org/methods" />
<meta
name="twitter:description"
content="The COMPare (CEBM Outcome Monitoring Project) team is monitoring clinical trials for switched outcomes. Through increased awareness of misreported outcomes, individual accountability, and feedback for specific journals, we hope to fix the ongoing problem of outcome switching.
Why outcome switchin"
/>
<meta
name="twitter:image"
content="https://www.compare-trials.org/wp-content/uploads/2016/01/logo_large-1.png"
/>
<meta name="twitter:card" content="summary" />
<meta name="twitter:site" content="@compare_trials" />
<!-- SEO -->
<meta
name="description"
content="The COMPare (CEBM Outcome Monitoring Project) team is monitoring clinical trials for switched outcomes. Through increased awareness of misreported outcomes, individual accountability, and feedback for specific journals, we hope to fix the ongoing problem of outcome switching.
Why outcome switchin"
/>
<!-- Misc. tags -->
<!-- END - Facebook Open Graph, Google+ and Twitter Card Tags 2.0.4 -->
</head>
<body
class="page page-id-8 page-template-default full-width-content"
itemscope
itemtype="https://schema.org/WebPage"
>
<aside class="paper-alert" role="alert">
<p>Read the COMPare papers:</p>
<ul>
<li><a href="https://doi.org/10.1186/s13063-019-3173-2">A prospective cohort study correcting and monitoring 58 misreported trials in real time</a></li>
<li><a href="https://doi.org/10.1186/s13063-019-3172-3">Qualitative analysis of researchers’ responses to critical correspondence on a cohort of 58 misreported trials</a></li>
</ul>
</aside>
<div class="site-container">
<header
class="site-header"
itemscope
itemtype="https://schema.org/WPHeader"
>
<div class="wrap">
<div class="title-area">
<h1 class="site-title" itemprop="headline">
<a href="index.html">COMPare</a>
</h1>
<h2 class="site-description" itemprop="description">
Tracking switched outcomes in clinical trials
</h2>
</div>
<div class="widget-area header-widget-area">
<section id="nav_menu-3" class="widget widget_nav_menu">
<div class="widget-wrap">
<nav
class="nav-header"
itemscope
itemtype="https://schema.org/SiteNavigationElement"
>
<ul id="menu-main-menu" class="menu genesis-nav-menu">
<li
id="menu-item-14"
class="menu-item menu-item-type-post_type menu-item-object-page current-menu-item page_item page-item-8 current_page_item menu-item-14"
>
<a href="project.html" itemprop="url"
><span itemprop="name">Methods</span></a
>
</li>
<li
id="menu-item-15"
class="menu-item menu-item-type-post_type menu-item-object-page menu-item-15"
>
<a href="results.html" itemprop="url"
><span itemprop="name">Results</span></a
>
</li>
<li
id="menu-item-13"
class="menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-13"
>
<a href="team.html" itemprop="url"
><span itemprop="name">Team</span></a
>
<ul class="sub-menu">
<li
id="menu-item-633"
class="menu-item menu-item-type-post_type menu-item-object-page menu-item-633"
>
<a href="speaking.html" itemprop="url"
><span itemprop="name">SPEAKING DATES</span></a
>
</li>
</ul>
</li>
<li
id="menu-item-230"
class="menu-item menu-item-type-post_type menu-item-object-page menu-item-230"
>
<a href="faq.html" itemprop="url"
><span itemprop="name">FAQ</span></a
>
</li>
<li
id="menu-item-19"
class="menu-item menu-item-type-post_type menu-item-object-page menu-item-19"
>
<a href="blog/index.html" itemprop="url"
><span itemprop="name">Blog</span></a
>
</li>
</ul>
</nav>
</div>
</section>
</div>
</div>
</header>
<div class="site-inner">
<div class="content-sidebar-wrap">
<main class="content">
<article
class="post-8 page type-page status-publish entry"
itemscope
itemtype="https://schema.org/CreativeWork"
>
<header class="entry-header">
<h1 class="entry-title" itemprop="headline">Methods</h1>
</header>
<div class="entry-content" itemprop="text">
<p>
The COMPare (<a href="https://cebm.net">CEBM</a> Outcome
Monitoring Project) <a href="team.html">team</a> is monitoring
clinical trials for switched outcomes. Through increased
awareness of misreported outcomes, individual accountability,
and feedback for specific journals, we hope to fix the ongoing
problem of outcome switching.
</p>
<h2>
<span id="whyitmatters" class="anchorlink"
>Why outcome switching matters</span
>
</h2>
<p>
Before carrying out a clinical trial, all outcomes that will
be measured (e.g. blood pressure after one year of treatment)
should be pre-specified in a
<a href="https://en.wikipedia.org/wiki/Protocol_(science)"
>trial protocol</a
>, and on a
<a
href="https://en.wikipedia.org/wiki/Clinical_trials_registry"
>clinical trial registry</a
>.
</p>
<p>
This is because if researchers measure lots of things, some of
those things are likely to give a positive result by random
chance (a false positive). A pre-specified outcome is much
less likely to give a false-positive result.
</p>
<p>
Once the trial is complete, the trial report should then
report all pre-specified outcomes. Where reported outcomes
differ from those pre-specified, this must be declared in the
report, along with an explanation of the timing and reason for
the change. This ensures a fair picture of the trial results.
</p>
<p>
However, in reality, pre-specified outcomes are often left
unreported, while outcomes that were not pre-specified are
reported, without being declared as novel. This is an
extremely common problem that distorts the evidence we use to
make real-world clinical decisions.
</p>
<h2>
<span id="methodology" class="anchorlink">Our approach</span>
</h2>
<p>
COMPare (CEBM Outcome Monitoring Project) takes a new
approach. We are monitoring all trials published in the top
five medical journals (<a href="https://www.nejm.org/">NEJM</a
>,
<a href="https://jama.jamanetwork.com/journal.aspx">JAMA</a>,
<a href="https://www.thelancet.com/">The Lancet</a>,
<a href="https://annals.org/">Annals of Internal Medicine</a>,
<a href="https://www.bmj.com/theBMJ">BMJ</a>).
</p>
<p>
We are analysing each trial for outcome switching, by
comparing the protocol (or registry entry if a pre-trial
protocol is unavailable) with the trial report. For any trial
where we find that outcomes have been switched, we are writing
letters to the journal to correct the record.
</p>
<h2>Detailed methodology</h2>
<p>
Our <a href="results.html">results table</a> contains a row
for every trial. There are links to our letter, and the
letter’s publication status. We also show the proportion
of pre-specified outcomes correctly reported (for a correctly
reported paper this should be 100%); and the number of novel,
undeclared, non-prespecified outcomes added in the paper (for
a correctly reported paper this should be 0).
</p>
<p>
Each row also contains a link to our full assessment sheet for
that trial, which is filled out by the two coders who audited
that trial, then checked at our weekly project meeting. It
lists the pre-specified outcomes, whether they were reported,
and also lists any new outcomes added.
</p>
<p>
This raw data is shared online to ensure that all our data and
working is fully transparent. We are happy to
<a href="project.html#questions">receive feedback</a> on any
scoring.
</p>
<p>
Some trials have perfect outcome reporting and no letter is
required: these are posted immediately to the table.
Otherwise, we add trials to the table either (i) four weeks
after sending our letter or (ii) when the journal publishes or
refuses to publish the letter (whichever comes first).
</p>
<p>
This procedure is specified in detail in our
<a
href="wp-content/uploads/2016/01/COMPare-Protocol-18.5.2016.pdf"
>full protocol</a
>
(PDF).
</p>
<div class="content-box-red">
Please note that we do not think that pre-specified outcomes
are set in stone: consistent with the
<a href="https://www.consort-statement.org/"
>CONSORT guidelines</a
>, where a pre-specified outcome has been switched,
<em
>but this fact has been discussed or explained in the trial
report</em
>, we do not regard that as undisclosed outcome switching, and
it is not scored as such. For more details on the criteria we
are using for correct reporting of outcomes, see our
<a
href="wp-content/uploads/2016/01/COMPare-Protocol-18.5.2016.pdf"
>full protocol</a
>.
</div>
<h2>Questions and feedback</h2>
<p>
If you have any questions about our methodology, please read
our
<a
href="wp-content/uploads/2016/01/COMPare-Protocol-18.5.2016.pdf"
>full protocol</a
>
first, as your question may be answered there. We are happy to
receive feedback:
<a href="mailto:[email protected]"
>.
</p>
<div class="social">
<a
class="synved-social-button synved-social-button-share synved-social-size-48 synved-social-resolution-normal synved-social-provider-facebook nolightbox"
data-provider="facebook"
target="_blank"
rel="nofollow"
title="Share on Facebook"
href="https://www.facebook.com/sharer.php?u=http%3A%2F%2Fcompare-trials.org%2Fmethods&t=Methods&s=100&p[url]=http%3A%2F%2Fcompare-trials.org%2Fmethods&p[images][0]=&p[title]=Methods"
style="
font-size: 0px;
width: 48px;
height: 48px;
margin: 0;
margin-bottom: 5px;
margin-right: 5px;
"
><img
alt="Facebook"
title="Share on Facebook"
class="synved-share-image synved-social-image synved-social-image-share"
width="48"
height="48"
style="
display: inline;
width: 48px;
height: 48px;
margin: 0;
padding: 0;
border: none;
box-shadow: none;
"
src="wp-content/plugins/social-media-feather/synved-social/image/social/regular/48x48/facebook.png" /></a
><a
class="synved-social-button synved-social-button-share synved-social-size-48 synved-social-resolution-normal synved-social-provider-twitter nolightbox"
data-provider="twitter"
target="_blank"
rel="nofollow"
title="Share on Twitter"
href="https://twitter.com/intent/tweet?url=http%3A%2F%2Fcompare-trials.org%2Fmethods&text=COMPare%3A%20Tracking%20switched%20outcomes%20in%20clinical%20trials"
style="
font-size: 0px;
width: 48px;
height: 48px;
margin: 0;
margin-bottom: 5px;
"
><img
alt="twitter"
title="Share on Twitter"
class="synved-share-image synved-social-image synved-social-image-share"
width="48"
height="48"
style="
display: inline;
width: 48px;
height: 48px;
margin: 0;
padding: 0;
border: none;
box-shadow: none;
"
src="wp-content/plugins/social-media-feather/synved-social/image/social/regular/48x48/twitter.png" /></a
><a
class="synved-social-button synved-social-button-share synved-social-size-48 synved-social-resolution-hidef synved-social-provider-facebook nolightbox"
data-provider="facebook"
target="_blank"
rel="nofollow"
title="Share on Facebook"
href="https://www.facebook.com/sharer.php?u=http%3A%2F%2Fcompare-trials.org%2Fmethods&t=Methods&s=100&p[url]=http%3A%2F%2Fcompare-trials.org%2Fmethods&p[images][0]=&p[title]=Methods"
style="
font-size: 0px;
width: 48px;
height: 48px;
margin: 0;
margin-bottom: 5px;
margin-right: 5px;
"
><img
alt="Facebook"
title="Share on Facebook"
class="synved-share-image synved-social-image synved-social-image-share"
width="48"
height="48"
style="
display: inline;
width: 48px;
height: 48px;
margin: 0;
padding: 0;
border: none;
box-shadow: none;
"
src="wp-content/plugins/social-media-feather/synved-social/image/social/regular/96x96/facebook.png" /></a
><a
class="synved-social-button synved-social-button-share synved-social-size-48 synved-social-resolution-hidef synved-social-provider-twitter nolightbox"
data-provider="twitter"
target="_blank"
rel="nofollow"
title="Share on Twitter"
href="https://twitter.com/intent/tweet?url=http%3A%2F%2Fcompare-trials.org%2Fmethods&text=COMPare%3A%20Tracking%20switched%20outcomes%20in%20clinical%20trials"
style="
font-size: 0px;
width: 48px;
height: 48px;
margin: 0;
margin-bottom: 5px;
"
><img
alt="twitter"
title="Share on Twitter"
class="synved-share-image synved-social-image synved-social-image-share"
width="48"
height="48"
style="
display: inline;
width: 48px;
height: 48px;
margin: 0;
padding: 0;
border: none;
box-shadow: none;
"
src="wp-content/plugins/social-media-feather/synved-social/image/social/regular/96x96/twitter.png"
/></a>
</div>
</div>
</article>
</main>
</div>
</div>
<div class="footer-widgets">
<div class="wrap">
<div class="footer-widgets-1 widget-area">
<section id="text-2" class="widget widget_text">
<div class="widget-wrap">
<h4 class="widget-title widgettitle">How to cite us</h4>
<div class="textwidget">
<p>
Prior to publication of the first paper on COMPare, please
cite this project as:
</p>
<p>
<em>The COMPare Trials Project.</em> Goldacre B, Drysdale H,
Powell-Smith A, et al. www.COMPare-trials.org, 2016.
</p>
<p>Or alternatively:</p>
<p>
<em>The COMPare Trials Project.</em> Ben Goldacre, Henry
Drysdale, Anna Powell-Smith, Aaron Dale, Ioan Milosevic,
Eirion Slade, Philip Hartley, Cicely Marston, Kamal Mahtani,
Carl Heneghan. www.COMPare-trials.org, 2016.
</p>
</div>
</div>
</section>
</div>
</div>
</div>
<footer
class="site-footer"
itemscope
itemtype="https://schema.org/WPFooter"
>
<div class="wrap">
<span class="logos">
<a href="https://www.ox.ac.uk"
><img
src="wp-content/uploads/2016/01/oxford_logo.png"
alt="University of Oxford logo"
height="40"
/></a>
<a href="https://www.phc.ox.ac.uk"
><img
src="wp-content/uploads/2016/01/nuffield_logo.png"
alt="Nuffield Department of Primary Care Health Sciences logo"
height="40"
/></a>
<a href="https://www.cebm.net/"
><img
src="wp-content/uploads/2016/01/cebm_logo.png"
alt="Centre for Evidence-Based Medicine logo"
height="40"
/></a>
</span>
<p>
Copyright © 2019 ·
<a href="https://www.bennett.ox.ac.uk/">Bennett Institute for Applied Data Science</a>
</p>
</div>
</footer>
</div>
<script
type="text/javascript"
src="https://cdn.datatables.net/s/dt/dt-1.10.10,fh-3.1.0,r-2.0.0/datatables.min.js"
></script>
<script src="wp-content/uploads/2016/01/tabletop.js"></script>
<script src="wp-content/uploads/2016/01/countUp.js"></script>
<script src="wp-content/uploads/2016/01/all.js"></script>
<script
type="text/javascript"
src="wp-content/plugins/wp-show-more/wpsm-script.js"
></script>
<script
type="text/javascript"
src="wp-content/plugins/easy-twitter-feed-widget/lib/js/widget-easy-twitter-feed-widget.js"
></script>
<script
type="text/javascript"
src="wp-includes/js/wp-embed.min.js"
></script>
</body>
</html>