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Tags:
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statistical-analysis-plan
protocols
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source-corpus
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  26. documents/10.1001_jama.2017.19826/protocol.html +0 -0
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  30. documents/10.1001_jama.2018.0899/protocol.html +0 -0
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  34. documents/10.1001_jama.2018.13155/protocol.html +0 -0
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+ # Identical source PDFs
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documents/10.1001_jama.2017.19132/DEDUP_NOTE.md ADDED
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+ # Identical source PDFs
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documents/10.1001_jama.2017.19826/DEDUP_NOTE.md ADDED
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+ # Identical source PDFs
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+ }
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+ .math-block, .math-inline {
323
+ --mmd-highlight-color: rgba(0, 147, 255, 0.25);
324
+ --mmd-highlight-text-color: #1e2029;
325
+ }
326
+ .math-block[data-highlight-color] mjx-container[jax="SVG"] > svg {
327
+ background-color: var(--mmd-highlight-color);
328
+ }
329
+ .math-block[data-highlight-text-color] mjx-container[jax="SVG"] > svg {
330
+ color: var(--mmd-highlight-text-color);
331
+ }
332
+ .math-inline[data-highlight-color] mjx-container[jax="SVG"] {
333
+ background-color: var(--mmd-highlight-color);
334
+ }
335
+ .math-inline[data-highlight-text-color] mjx-container[jax="SVG"] {
336
+ color: var(--mmd-highlight-text-color);
337
+ }
338
+ .math-block p {
339
+ flex-shrink: 1;
340
+ }
341
+ .math-block mjx-container {
342
+ margin: 0 !important;
343
+ }
344
+ .math-error {
345
+ background-color: yellow;
346
+ color: red;
347
+ }
348
+ #preview-content img, #setText img {
349
+ max-width: 100%;
350
+ }
351
+ #preview-content blockquote, #setText blockquote {
352
+ page-break-inside: avoid;
353
+ color: #666;
354
+ margin: 0 0 1em 0;
355
+ padding-left: 3em;
356
+ border-left: .5em solid #eee;
357
+ }
358
+ #preview-content pre, #setText pre {
359
+ border: none;
360
+ padding: 0;
361
+ overflow: auto;
362
+ font-size: 85%;
363
+ line-height: 1.45;
364
+ border-radius: 6px;
365
+ box-sizing: border-box;
366
+ background: #f8f8fa;
367
+ }
368
+ #preview-content pre code, #setText pre code {
369
+ padding: 1rem;
370
+ display: block;
371
+ overflow-x: auto;
372
+ line-height: 24px;
373
+ }
374
+ #preview-content table, #setText table {
375
+ display: table;
376
+ overflow: auto;
377
+ max-width: 100%;
378
+ border-collapse: collapse;
379
+ page-break-inside: avoid;
380
+ margin-bottom: 1em;
381
+ }
382
+ #preview-content table th, #setText table th {
383
+ text-align: center;
384
+ font-weight: bold;
385
+ }
386
+ #preview-content table td, #setText table td,
387
+ #preview-content table th, #setText table th {
388
+ border: 1px solid #dfe2e5;
389
+ padding: 6px 13px;
390
+ }
391
+ #preview-content table tr, #setText table tr {
392
+ background-color: #fff;
393
+ border-top: 1px solid #c6cbd1;
394
+ }
395
+ #preview-content table tr:nth-child(2n), #setText table tr:nth-child(2n) {
396
+ background-color: #f6f8fa;
397
+ }
398
+ .main-title,
399
+ #preview-content .main-title, #setText .main-title {
400
+ text-align: center;
401
+ line-height: 1.2;
402
+ margin: 0 auto 1em auto;
403
+ }
404
+ .author,
405
+ #preview-content .author, #setText .author {
406
+ text-align: center;
407
+ margin: 0 auto;
408
+ display: flex;
409
+ justify-content: center;
410
+ flex-wrap: wrap;
411
+ }
412
+ .author p,
413
+ #preview-content .author p, #setText .author p {
414
+ min-width: 30%;
415
+ max-width: 50%;
416
+ padding: 0 7px;
417
+ }
418
+ .author > p > span,
419
+ #preview-content .author > p > span, #setText .author > p > span {
420
+ display: block;
421
+ text-align: center;
422
+ }
423
+ .section-title,
424
+ #preview-content .section-title, #setText .section-title {
425
+ margin-top: 1.5em;
426
+ }
427
+ .abstract,
428
+ #preview-content .abstract, #setText .abstract {
429
+ text-align: justify;
430
+ margin-bottom: 1em;
431
+ }
432
+ .abstract p,
433
+ #preview-content .abstract p, #setText .abstract p {
434
+ margin-bottom: 0;
435
+ }
436
+ #preview-content sup, #setText sup {
437
+ top: -.5em;
438
+ position: relative;
439
+ font-size: 75%;
440
+ line-height: 0;
441
+ vertical-align: baseline;
442
+ }
443
+ .text-url,
444
+ #preview-content .text-url, #setText .text-url {
445
+ color: #0B93ff;
446
+ cursor: text;
447
+ pointer-events: none;
448
+ }
449
+ .text-url a:hover,
450
+ #preview-content .text-url a:hover, #setText .text-url a:hover {
451
+ color: #0B93ff;
452
+ }
453
+ mark,
454
+ #preview-content mark, #setText mark {
455
+ background-color: #feffe6;
456
+ }
457
+ span[data-underline-type] mark,
458
+ #preview-content span[data-underline-type] mark,
459
+ #setText span[data-underline-type] mark {
460
+ background: inherit;
461
+ background-color: #feffe6;
462
+ padding-top: 0;
463
+ padding-bottom: 0;
464
+ }
465
+ *[data-has-dotfill] {
466
+ position: relative;
467
+ overflow: hidden;
468
+ }
469
+ *[data-has-dotfill] .dotfill::after {
470
+ position: absolute;
471
+ padding-left: .25ch;
472
+ content: " . . . . . . . . . . . . . . . . . . . "
473
+ ". . . . . . . . . . . . . . . . . . . . . . . "
474
+ ". . . . . . . . . . . . . . . . . . . . . . . "
475
+ ". . . . . . . . . . . . . . . . . . . . . . . "
476
+ ". . . . . . . . . . . . . . . . . . . . . . . "
477
+ ". . . . . . . . . . . . . . . . . . . . . . . "
478
+ ". . . . . . . . . . . . . . . . . . . . . . . ";
479
+ text-align: right;
480
+ }
481
+ .smiles,
482
+ #preview-content .smiles, #setText .smiles {
483
+ text-align: center;
484
+ }
485
+ div.svg-container,
486
+ #preview-content > div.svg-container,
487
+ #setText > div.svg-container {
488
+ display: flex;
489
+ justify-content: center;
490
+ }
491
+ @media print {
492
+ #preview {
493
+ font-size: 10pt !important;
494
+ }
495
+ .math-block svg, .math-inline svg {
496
+ shape-rendering: crispEdges;
497
+ margin-top: 1px;
498
+ }
499
+ #preview-content img, #setText img {
500
+ display: block;
501
+ }
502
+ #preview-content .figure_img img, #setText .figure_img img {
503
+ display: inline;
504
+ }
505
+ #preview-content h1, #preview-content h2, #preview-content h3,
506
+ #preview-content h4, #preview-content h5, #preview-content h6,
507
+ #setText h1, #setText h2, #setText h3,
508
+ #setText h4, #setText h5, #setText h6 {
509
+ page-break-inside: avoid;
510
+ position: relative;
511
+ border: 2px solid transparent;
512
+ }
513
+ #preview-content h1::after, #preview-content h2::after, #preview-content h3::after,
514
+ #preview-content h4::after, #preview-content h5::after, #preview-content h6::after,
515
+ #setText h1::after, #setText h2::after, #setText h3::after,
516
+ #setText h4::after, #setText h5::after, #setText h6::after {
517
+ content: "";
518
+ display: block;
519
+ height: 100px;
520
+ margin-bottom: -100px;
521
+ position: relative;
522
+ }
523
+ }
524
+ #preview-content code, #setText code {
525
+ font-family: Inconsolata;
526
+ font-size: inherit;
527
+ display: initial;
528
+ background: #f8f8fa;
529
+ }
530
+ #preview-content .mmd-highlight code, #setText .mmd-highlight code,
531
+ #preview-content pre.mmd-highlight code, #setText pre.mmd-highlight code {
532
+ background-color: transparent;
533
+ }
534
+ #preview-content pre code, #setText pre code {
535
+ font-family: 'DM Mono', Inconsolata, monospace;
536
+ color: #333;
537
+ font-size: 15px;
538
+ }
539
+ .hljs-comment, .hljs-quote,
540
+ #preview-content .hljs-comment, #setText .hljs-comment,
541
+ #preview-content .hljs-quote, #setText .hljs-quote {
542
+ color: #998;
543
+ font-style: italic;
544
+ }
545
+ .hljs-command,
546
+ #preview-content .hljs-command, #setText .hljs-command {
547
+ color: #005cc5;
548
+ }
549
+ .hljs-keyword, .hljs-selector-tag, .hljs-subst,
550
+ #preview-content .hljs-keyword, #setText .hljs-keyword,
551
+ #preview-content .hljs-selector-tag, #setText .hljs-selector-tag,
552
+ #preview-content .hljs-subst, #setText .hljs-subst {
553
+ color: #d73a49;
554
+ font-weight: bold;
555
+ }
556
+ .hljs-number, .hljs-literal, .hljs-variable,
557
+ .hljs-template-variable, .hljs-tag .hljs-attr,
558
+ #preview-content .hljs-number, #setText .hljs-number,
559
+ #preview-content .hljs-literal, #setText .hljs-literal,
560
+ #preview-content .hljs-variable, #setText .hljs-variable,
561
+ #preview-content .hljs-template-variable, #setText .hljs-template-variable,
562
+ #preview-content .hljs-tag .hljs-attr, #setText .hljs-tag .hljs-attr {
563
+ color: #005cc5;
564
+ }
565
+ .hljs-string, .hljs-doctag,
566
+ #preview-content .hljs-string, #setText .hljs-string,
567
+ #preview-content .hljs-doctag, #setText .hljs-doctag {
568
+ color: #24292e;
569
+ }
570
+ .hljs-title, .hljs-section, .hljs-selector-id,
571
+ #preview-content .hljs-title, #setText .hljs-title,
572
+ #preview-content .hljs-section, #setText .hljs-section,
573
+ #preview-content .hljs-selector-id, #setText .hljs-selector-id {
574
+ color: #6f42c1;
575
+ font-weight: bold;
576
+ }
577
+ .hljs-subst,
578
+ #preview-content .hljs-subst, #setText .hljs-subst {
579
+ font-weight: normal;
580
+ }
581
+ .hljs-type, .hljs-class .hljs-title,
582
+ #preview-content .hljs-type, #setText .hljs-type,
583
+ #preview-content .hljs-class .hljs-title, #setText .hljs-class .hljs-title {
584
+ color: #458;
585
+ font-weight: bold;
586
+ }
587
+ .hljs-tag, .hljs-name, .hljs-attribute,
588
+ #preview-content .hljs-tag, #setText .hljs-tag,
589
+ #preview-content .hljs-name, #setText .hljs-name,
590
+ #preview-content .hljs-attribute, #setText .hljs-attribute {
591
+ color: #000080;
592
+ font-weight: normal;
593
+ }
594
+ .hljs-regexp, .hljs-link,
595
+ #preview-content .hljs-regexp, #setText .hljs-regexp,
596
+ #preview-content .hljs-link, #setText .hljs-link {
597
+ color: #009926;
598
+ }
599
+ .hljs-symbol, .hljs-bullet,
600
+ #preview-content .hljs-symbol, #setText .hljs-symbol,
601
+ #preview-content .hljs-bullet, #setText .hljs-bullet {
602
+ color: #990073;
603
+ }
604
+ .hljs-built_in, .hljs-builtin-name,
605
+ #preview-content .hljs-built_in, #setText .hljs-built_in,
606
+ #preview-content .hljs-builtin-name, #setText .hljs-builtin-name {
607
+ color: #24292e;
608
+ }
609
+ .hljs-meta,
610
+ #preview-content .hljs-meta, #setText .hljs-meta {
611
+ color: #999;
612
+ font-weight: bold;
613
+ }
614
+ .hljs-meta-keyword,
615
+ #preview-content .hljs-meta-keyword, #setText .hljs-meta-keyword {
616
+ color: #d73a49;
617
+ }
618
+ .hljs-meta-string,
619
+ #preview-content .hljs-meta-string, #setText .hljs-meta-string {
620
+ color: #032f62;
621
+ }
622
+ .hljs-deletion,
623
+ #preview-content .hljs-deletion, #setText .hljs-deletion {
624
+ background: #fdd;
625
+ }
626
+ .hljs-addition,
627
+ #preview-content .hljs-addition, #setText .hljs-addition {
628
+ background: #dfd;
629
+ }
630
+ .hljs-emphasis,
631
+ #preview-content .hljs-emphasis, #setText .hljs-emphasis {
632
+ font-style: italic;
633
+ }
634
+ .hljs-strong,
635
+ #preview-content .hljs-strong, #setText .hljs-strong {
636
+ font-weight: bold;
637
+ }
638
+ .table_tabular,
639
+ #preview-content .table_tabular, #setText .table_tabular {
640
+ overflow-x: auto;
641
+ padding: 0 2px 0.5em 2px;
642
+ }
643
+ .tabular,
644
+ #preview-content .tabular, #setText .tabular {
645
+ display: inline-table !important;
646
+ width: auto;
647
+ table-layout: auto;
648
+ border-collapse: collapse;
649
+ border-spacing: 0;
650
+ margin: 0 0 1em;
651
+ font-size: inherit;
652
+ height: fit-content;
653
+ }
654
+ .tabular th,
655
+ #preview-content .tabular th, #setText .tabular th {
656
+ border: none !important;
657
+ padding: 6px 13px;
658
+ background-color: transparent;
659
+ font-weight: bold;
660
+ }
661
+ .tabular tr,
662
+ #preview-content .tabular tr, #setText .tabular tr {
663
+ border-top: none !important;
664
+ border-bottom: none !important;
665
+ background-color: transparent;
666
+ }
667
+ .tabular td,
668
+ #preview-content .tabular td, #setText .tabular td {
669
+ border-style: none !important;
670
+ background-color: #fff;
671
+ border-color: #000 !important;
672
+ word-break: keep-all;
673
+ padding: 0.1em 0.5em !important;
674
+ }
675
+ .tabular td > p,
676
+ #preview-content .tabular td > p, #setText .tabular td > p {
677
+ margin-bottom: 0;
678
+ margin-top: 0;
679
+ }
680
+ .tabular td._empty,
681
+ #preview-content .tabular td._empty, #setText .tabular td._empty {
682
+ height: 1.3em;
683
+ }
684
+ .tabular td .f,
685
+ #preview-content .tabular td .f, #setText .tabular td .f {
686
+ opacity: 0;
687
+ }
688
+ #preview-content .sub-table table, #setText .sub-table table {
689
+ margin-bottom: 0;
690
+ }
691
+ html[data-theme="dark"] .tabular tr,
692
+ html[data-theme="dark"] #preview-content .tabular tr, html[data-theme="dark"] #setText .tabular tr,
693
+ html[data-theme="dark"] .tabular td,
694
+ html[data-theme="dark"] #preview-content .tabular td, html[data-theme="dark"] #setText .tabular td {
695
+ background-color: #202226;
696
+ border-color: #fff !important;
697
+ }
698
+ .figure_img,
699
+ #preview-content .figure_img, #setText .figure_img {
700
+ margin-bottom: 0.5em;
701
+ overflow-x: auto;
702
+ }
703
+ div.figure_img img,
704
+ #preview-content div.figure_img img, #setText div.figure_img img {
705
+ display: inline;
706
+ margin: 0;
707
+ }
708
+ ol.enumerate, ul.itemize,
709
+ #preview-content ol.enumerate, #setText ol.enumerate,
710
+ #preview-content ul.itemize, #setText ul.itemize {
711
+ padding-inline-start: 40px;
712
+ margin: 0 0 1em 0;
713
+ }
714
+ li > ol.enumerate, li > ul.itemize,
715
+ #preview-content li > ol.enumerate, #setText li > ol.enumerate,
716
+ #preview-content li > ul.itemize, #setText li > ul.itemize {
717
+ margin: 0;
718
+ }
719
+ ul.itemize > li,
720
+ #preview-content ul.itemize > li, #setText ul.itemize > li {
721
+ position: relative;
722
+ min-height: 1.4em;
723
+ margin-bottom: 0;
724
+ }
725
+ .enumerate > .li_enumerate,
726
+ #preview-content .enumerate > .li_enumerate, #setText .enumerate > .li_enumerate {
727
+ margin-bottom: 0;
728
+ }
729
+ .itemize > li > span.li_level, .li_enumerate.not_number > span.li_level,
730
+ #preview-content .itemize > li > span.li_level, #setText .itemize > li > span.li_level,
731
+ #preview-content .li_enumerate.not_number > span.li_level, #setText .li_enumerate.not_number > span.li_level {
732
+ position: absolute;
733
+ right: 100%;
734
+ white-space: nowrap;
735
+ width: max-content;
736
+ display: flex;
737
+ justify-content: flex-end;
738
+ padding-right: 10px;
739
+ box-sizing: border-box;
740
+ }
741
+ .li_enumerate.not_number,
742
+ #preview-content .li_enumerate.not_number, #setText .li_enumerate.not_number {
743
+ position: relative;
744
+ display: inline-block;
745
+ list-style-type: none;
746
+ min-height: 1.4em;
747
+ }
748
+ .itemize > li > span.li_level .math-inline,
749
+ .enumerate > li > span.li_level .math-inline,
750
+ #preview-content .itemize > li > span.li_level .math-inline,
751
+ #setText .itemize > li > span.li_level .math-inline,
752
+ #preview-content .enumerate > li > span.li_level .math-inline,
753
+ #setText .enumerate > li > span.li_level .math-inline {
754
+ display: inline-block;
755
+ }
756
+ #preview {
757
+ font-family: 'CMU Serif', 'Georgia', Helvetica, Arial, sans-serif;
758
+ font-size: 17px;
759
+ visibility: visible;
760
+ word-break: break-word;
761
+ padding: 2.5em;
762
+ max-width: 800px;
763
+ margin: auto;
764
+ box-sizing: content-box;
765
+ }
766
+ #preview h1, #preview h2, #preview h3, #preview h4, #preview h5, #preview strong {
767
+ font-family: 'CMU Serif Bold', 'Georgia', Helvetica, Arial, sans-serif;
768
+ }
769
+ #preview i, #preview em {
770
+ font-family: 'CMU Serif Italic', 'Georgia', Helvetica, Arial, sans-serif;
771
+ }
772
+ .mmd-menu {
773
+ max-width: 320px;
774
+ position: absolute;
775
+ background-color: white;
776
+ color: black;
777
+ width: auto;
778
+ padding: 5px 0;
779
+ border: 1px solid #E5E6EB;
780
+ margin: 0;
781
+ cursor: default;
782
+ font: menu;
783
+ text-align: left;
784
+ text-indent: 0;
785
+ text-transform: none;
786
+ line-height: normal;
787
+ letter-spacing: normal;
788
+ word-spacing: normal;
789
+ word-wrap: normal;
790
+ white-space: nowrap;
791
+ float: none;
792
+ z-index: 201;
793
+ border-radius: 5px;
794
+ -webkit-border-radius: 5px;
795
+ -moz-border-radius: 5px;
796
+ -khtml-border-radius: 5px;
797
+ box-shadow: 0 10px 20px #808080;
798
+ -webkit-box-shadow: 0 10px 20px #808080;
799
+ -moz-box-shadow: 0 10px 20px #808080;
800
+ -khtml-box-shadow: 0 10px 20px #808080;
801
+ }
802
+ .mmd-menu:focus { outline: none; }
803
+ .mmd-menu.mmd-menu-sm {
804
+ max-width: 100vw;
805
+ padding-bottom: 34px;
806
+ border-radius: 0;
807
+ -webkit-border-radius: 0;
808
+ -moz-border-radius: 0;
809
+ -khtml-border-radius: 0;
810
+ }
811
+ .mmd-menu-item-icon {
812
+ color: #1E2029;
813
+ margin-left: auto;
814
+ align-items: center;
815
+ display: none;
816
+ flex-shrink: 0;
817
+ }
818
+ .mmd-menu-item {
819
+ padding: 8px 1.25rem;
820
+ display: flex;
821
+ background: transparent;
822
+ height: 52px;
823
+ max-height: 52px;
824
+ }
825
+ .mmd-menu-item:focus { outline: none; }
826
+ .mmd-menu-item.active {
827
+ background-color: #e1e0e5;
828
+ }
829
+ .mmd-menu-item.active .mmd-menu-item-icon {
830
+ display: flex;
831
+ }
832
+ .mmd-menu-item-container {
833
+ overflow: hidden;
834
+ }
835
+ .mmd-menu-item-title {
836
+ color: #1E2029;
837
+ white-space: nowrap;
838
+ text-overflow: ellipsis;
839
+ overflow: hidden;
840
+ font-size: 14px;
841
+ line-height: 20px;
842
+ }
843
+ .mmd-menu-item-value {
844
+ color: #7d829c;
845
+ white-space: nowrap;
846
+ text-overflow: ellipsis;
847
+ overflow: hidden;
848
+ font-size: 12px;
849
+ line-height: 16px;
850
+ }
851
+ html[data-theme="dark"] .mmd-menu-item-title {
852
+ color: #ebefe7;
853
+ }
854
+ html[data-theme="dark"] .mmd-menu-item.active .mmd-menu-item-title {
855
+ color: #1E2029;
856
+ }
857
+ html[data-theme="dark"] .mmd-menu {
858
+ background-color: #33363a;
859
+ }
860
+ .mmd-context-menu-overlay {
861
+ background: rgba(0, 0, 0, 0.56);
862
+ }
863
+ .ClipboardButton {
864
+ padding: 0;
865
+ margin: 0.5rem;
866
+ display: inline-block;
867
+ cursor: pointer;
868
+ color: rgb(36, 41, 47);
869
+ background: rgb(246, 248, 250);
870
+ border-radius: 6px;
871
+ border: 1px solid rgba(31, 35, 40, 0.15);
872
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+ <div id="preview" class="preview scrollEditor">
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+ <div id="container-ruller" />
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+ <div id="preview-content">
966
+ <div>Title: Long-term treatment outcome on symptomatic osteoarthritis in patients with a meniscal tear: Statistical analysis plan for the 5-year follow-up of the ESCAPE trial</div>
967
+ <div>NCT01850719<br>
968
+ Date: May <span class="math-inline ">
969
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+ <div>This statistical analysis plan was developed and published online a priori of the 5 year data analyses. With this document we aim to provide insight and transparency for our statistical analyses and reporting of our results.</div>
971
+ <h2 type="section" data-unnumbered="true" class="section-title" id="statistical-analysis-plan-of-the-5-year-follow-up">
972
+ Statistical analysis plan of the 5 year follow up</h2>
973
+ <div>We will analyze the 5 -year follow up data following the intention-to-treat principle. To test for robustness of the results, we will also perform an as-treated analysis. In the intention-to-treat analysis, participants will be analyzed in two groups, according to their allocated treatment.</div>
974
+ <div>For the as-treated analysis, participants will be divided into three groups: 1) patients allocated to partial meniscectomy who indeed underwent surgery; 2) patients allocated to physical therapy who indeed completed 16 (or more) physical therapy sessions; and 3) patients allocated to physical therapy who underwent surgery during the study period. Participants who did not undergo their allocated treatment (either APM or completion of physical therapy) will be discarded from the as-treated analysis. Their 5 year outcomes will be reported descriptively.</div>
975
+ <div>We will analyze binary outcomes with generalized estimating equation (GEE) with exchangeable structure. We will perform GEE analyses to evaluate symptomatic knee OA from baseline to 5 year follow up. Interaction effects of treatment (APM vs physical therapy) and time (baseline, 2 years and 5 years follow-up) will be calculated to test between-group differences in changes over time. The adjusted between-group difference will be assessed by adding potential confounders to the models. These potential confounders are BMI, age, baseline KL score, baseline pain during activities and frequency of pain.</div>
976
+ <div>Continuous outcome measures will be analyzed using linear mixed model analysis with random intercept. We will define the overall crude intervention effects by a model with only treatment group and the baseline value of the outcome as independent variables. We will add time and time-bytreatment interaction terms to specify crude intervention effects for each follow-up time point. Adjusted intervention effects will be calculated using similar models, expanded with the following potential confounders as independent variables: level of OA at baseline using the Kellgren and Lawrence<br>
977
+ classification[7], baseline pain during weight bearing, BMI at baseline (three categories: <span class="math-inline ">
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In all models, physical therapy will be defined as the reference treatment. All analyses will be performed using IBM SPSS version 27 (IBM, Armonk, NY), and statistical significance will be assessed at the 0.05 level.</div>
980
+
981
+ </div>
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+ </div>
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+ </body>
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+ </html>
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+ {"pages":[{"image_id":"bbffe277-e94d-471a-8395-80abee113530-1","page":1,"lines":[{"cnt":[[236,245],[1833,245],[1833,296],[236,296]],"region":{"top_left_x":236,"top_left_y":244,"width":1597,"height":53},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fcb0052aa81b44be854457a0e2adbbaa","type":"text","conversion_output":true,"text":"Title: Long-term treatment outcome on symptomatic osteoarthritis in patients with a meniscal tear:","text_display":"Title: Long-term treatment outcome on symptomatic osteoarthritis in patients with a meniscal tear:","confidence":1,"confidence_rate":1},{"cnt":[[236,296],[1313,296],[1313,350],[236,350]],"region":{"top_left_x":236,"top_left_y":296,"width":1077,"height":55},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7beb29dc93374f2f88b28fa899035de0","type":"text","conversion_output":true,"text":"Statistical analysis plan for the 5-year follow-up of the ESCAPE trial","text_display":" Statistical analysis plan for the 5-year follow-up of the ESCAPE trial","confidence":0.51513671875,"confidence_rate":0.9911946899548226},{"cnt":[[236,389],[468,389],[468,432],[236,432]],"region":{"top_left_x":236,"top_left_y":388,"width":233,"height":44},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5cc8887e225043ee8117dd41b467e478","type":"text","conversion_output":true,"text":"NCT01850719","text_display":"\n\nNCT01850719","confidence":1,"confidence_rate":1},{"cnt":[[236,473],[565,473],[565,522],[236,522]],"region":{"top_left_x":236,"top_left_y":472,"width":330,"height":51},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5d1cc3232c1f4343b524329af26a14d5","type":"text","conversion_output":true,"text":"Date: May \\(15{ }^{\\text {th }} 2021\\)","text_display":"\nDate: May \\(15{ }^{\\text {th }} 2021\\)","confidence":0.9681507863247971,"confidence_rate":0.9990484696735403},{"cnt":[[236,653],[1798,653],[1798,703],[236,703]],"region":{"top_left_x":236,"top_left_y":653,"width":1563,"height":50},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"57d1192925a84922bbb200e6f9b7baae","type":"text","conversion_output":true,"text":"This statistical analysis plan was developed and published online a priori of the 5 year data analyses.","text_display":"\n\nThis statistical analysis plan was developed and published online a priori of the 5 year data analyses.","confidence":1,"confidence_rate":1},{"cnt":[[236,705],[1869,705],[1869,758],[236,758]],"region":{"top_left_x":236,"top_left_y":704,"width":1634,"height":55},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"08027db3a54c4899825e4d2260c374ba","type":"text","conversion_output":true,"text":"With this document we aim to provide insight and transparency for our statistical analyses and reporting","text_display":" With this document we aim to provide insight and transparency for our statistical analyses and reporting","confidence":1,"confidence_rate":1},{"cnt":[[236,761],[466,761],[466,810],[236,810]],"region":{"top_left_x":236,"top_left_y":760,"width":231,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e517a9e3f7714c94ad7abc9f4ab33af1","type":"text","conversion_output":true,"text":"of our results.","text_display":" of our results.","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"bbffe277-e94d-471a-8395-80abee113530-2","page":2,"lines":[{"cnt":[[236,331],[990,331],[990,389],[236,389]],"region":{"top_left_x":236,"top_left_y":330,"width":755,"height":59},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d5342e59eea46f8bcae38926a10a281","type":"section_header","conversion_output":false,"children_ids":["e4de95ef596146f3aa913dfef1bb6b98"],"text":"","text_display":""},{"cnt":[[241,337],[986,337],[986,382],[241,382]],"region":{"top_left_x":240,"top_left_y":337,"width":747,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4de95ef596146f3aa913dfef1bb6b98","type":"text","conversion_output":true,"parent_id":"2d5342e59eea46f8bcae38926a10a281","text":"Statistical analysis plan of the 5 year follow up","text_display":"\n\n\\section*{Statistical analysis plan of the 5 year follow up}","confidence":0.9487795829772949,"confidence_rate":0.9990779907548722},{"cnt":[[361,425],[1835,425],[1835,471],[361,471]],"region":{"top_left_x":360,"top_left_y":425,"width":1475,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d6ca7fce6214ca89f00dc71eae0e461","type":"text","conversion_output":true,"text":"We will analyze the 5 -year follow up data following the intention-to-treat principle. To test for","text_display":"\n\nWe will analyze the 5 -year follow up data following the intention-to-treat principle. To test for","confidence":0.974609375,"confidence_rate":0.9997574017969119},{"cnt":[[241,520],[1846,520],[1846,565],[241,565]],"region":{"top_left_x":240,"top_left_y":519,"width":1606,"height":47},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"820dc7bcf750404f8e3b79e8fb5f21f3","type":"text","conversion_output":true,"text":"robustness of the results, we will also perform an as-treated analysis. In the intention-to-treat analysis,","text_display":" robustness of the results, we will also perform an as-treated analysis. In the intention-to-treat analysis,","confidence":1,"confidence_rate":1},{"cnt":[[241,612],[1532,612],[1532,660],[241,660]],"region":{"top_left_x":240,"top_left_y":612,"width":1292,"height":48},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"da59c173b1244890a43bf2fd1113dfc5","type":"text","conversion_output":true,"text":"participants will be analyzed in two groups, according to their allocated treatment.","text_display":" participants will be analyzed in two groups, according to their allocated treatment.","confidence":1,"confidence_rate":1},{"cnt":[[365,705],[1876,705],[1876,750],[365,750]],"region":{"top_left_x":365,"top_left_y":704,"width":1511,"height":46},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9cfd1ede05494f578b9d447305a776de","type":"text","conversion_output":true,"text":"For the as-treated analysis, participants will be divided into three groups: 1) patients allocated to","text_display":"\n\nFor the as-treated analysis, participants will be divided into three groups: 1) patients allocated to","confidence":0.9810137218009913,"confidence_rate":0.9998191783129493},{"cnt":[[241,799],[1798,799],[1798,846],[241,846]],"region":{"top_left_x":240,"top_left_y":799,"width":1559,"height":48},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6335d5001a81408882f9a8a2267ed01d","type":"text","conversion_output":true,"text":"partial meniscectomy who indeed underwent surgery; 2) patients allocated to physical therapy who","text_display":" partial meniscectomy who indeed underwent surgery; 2) patients allocated to physical therapy who","confidence":0.9775390625,"confidence_rate":0.9997751042405244},{"cnt":[[241,889],[1846,889],[1846,939],[241,939]],"region":{"top_left_x":240,"top_left_y":889,"width":1606,"height":50},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"58bff6aa7a7a4d218d9f894d44c7ecce","type":"text","conversion_output":true,"text":"indeed completed 16 (or more) physical therapy sessions; and 3) patients allocated to physical therapy","text_display":" indeed completed 16 (or more) physical therapy sessions; and 3) patients allocated to physical therapy","confidence":0.9072265625,"confidence_rate":0.9991152728131285},{"cnt":[[241,984],[1768,984],[1768,1033],[241,1033]],"region":{"top_left_x":240,"top_left_y":983,"width":1529,"height":51},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e2a1f1637d73483c92273b5007087907","type":"text","conversion_output":true,"text":"who underwent surgery during the study period. Participants who did not undergo their allocated","text_display":" who underwent surgery during the study period. Participants who did not undergo their allocated","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[238,1079],[1869,1079],[1869,1124],[238,1124]],"region":{"top_left_x":238,"top_left_y":1078,"width":1632,"height":46},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"beb86220b25d4fccbcb8450fd091d650","type":"text","conversion_output":true,"text":"treatment (either APM or completion of physical therapy) will be discarded from the as-treated analysis.","text_display":" treatment (either APM or completion of physical therapy) will be discarded from the as-treated analysis.","confidence":1,"confidence_rate":1},{"cnt":[[236,1171],[1068,1171],[1068,1218],[236,1218]],"region":{"top_left_x":236,"top_left_y":1170,"width":832,"height":49},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f7a1b6e5f84f4e0b89d34b89898c1991","type":"text","conversion_output":true,"text":"Their 5 year outcomes will be reported descriptively.","text_display":" Their 5 year outcomes will be reported descriptively.","confidence":0.9990236759185791,"confidence_rate":0.999983986997124},{"cnt":[[361,1263],[1863,1263],[1863,1313],[361,1313]],"region":{"top_left_x":360,"top_left_y":1263,"width":1503,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f02cbe8af4344190b648c56a14ca0e34","type":"text","conversion_output":true,"text":"We will analyze binary outcomes with generalized estimating equation (GEE) with exchangeable","text_display":"\n\nWe will analyze binary outcomes with generalized estimating equation (GEE) with exchangeable","confidence":1,"confidence_rate":1},{"cnt":[[241,1358],[1882,1358],[1882,1405],[241,1405]],"region":{"top_left_x":240,"top_left_y":1357,"width":1643,"height":49},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d812424568914a1daaa914ed45073f5c","type":"text","conversion_output":true,"text":"structure. We will perform GEE analyses to evaluate symptomatic knee OA from baseline to 5 year follow","text_display":" structure. We will perform GEE analyses to evaluate symptomatic knee OA from baseline to 5 year follow","confidence":0.9814541339874268,"confidence_rate":0.9998298326902371},{"cnt":[[241,1450],[1824,1450],[1824,1497],[241,1497]],"region":{"top_left_x":240,"top_left_y":1450,"width":1585,"height":48},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a933360e3744b919883f5772cf2b5c2","type":"text","conversion_output":true,"text":"up. Interaction effects of treatment (APM vs physical therapy) and time (baseline, 2 years and 5 years","text_display":" up. Interaction effects of treatment (APM vs physical therapy) and time (baseline, 2 years and 5 years","confidence":0.99951171875,"confidence_rate":0.9999956778810385},{"cnt":[[236,1543],[1779,1543],[1779,1592],[236,1592]],"region":{"top_left_x":236,"top_left_y":1542,"width":1543,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb7f3b73ade2418f9548a8d3b396fa3b","type":"text","conversion_output":true,"text":"follow-up) will be calculated to test between-group differences in changes over time. The adjusted","text_display":" follow-up) will be calculated to test between-group differences in changes over time. The adjusted","confidence":0.9985356330871582,"confidence_rate":0.9999857725269791},{"cnt":[[241,1637],[1762,1637],[1762,1687],[241,1687]],"region":{"top_left_x":240,"top_left_y":1637,"width":1522,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38bacd93a1ba4816ac96913a0e7de944","type":"text","conversion_output":true,"text":"between-group difference will be assessed by adding potential confounders to the models. These","text_display":" between-group difference will be assessed by adding potential confounders to the models. These","confidence":1,"confidence_rate":1},{"cnt":[[241,1732],[1837,1732],[1837,1779],[241,1779]],"region":{"top_left_x":240,"top_left_y":1731,"width":1597,"height":48},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50fd92f56b084382ae24e2258744bfdf","type":"text","conversion_output":true,"text":"potential confounders are BMI, age, baseline KL score, baseline pain during activities and frequency of","text_display":" potential confounders are BMI, age, baseline KL score, baseline pain during activities and frequency of","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[241,1826],[329,1826],[329,1871],[241,1871]],"region":{"top_left_x":240,"top_left_y":1826,"width":89,"height":46},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42722ee4032c44369cf709d404c437e2","type":"text","conversion_output":true,"text":"pain.","text_display":" pain.","confidence":1,"confidence_rate":1},{"cnt":[[363,1916],[1850,1916],[1850,1966],[363,1966]],"region":{"top_left_x":363,"top_left_y":1916,"width":1487,"height":50},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f61b225aaa44e2c8cd9c968a40012cc","type":"text","conversion_output":true,"text":"Continuous outcome measures will be analyzed using linear mixed model analysis with random","text_display":"\n\nContinuous outcome measures will be analyzed using linear mixed model analysis with random","confidence":1,"confidence_rate":1},{"cnt":[[241,2011],[1820,2011],[1820,2058],[241,2058]],"region":{"top_left_x":240,"top_left_y":2010,"width":1580,"height":49},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea5a60c52e024a949beff730ff89918e","type":"text","conversion_output":true,"text":"intercept. We will define the overall crude intervention effects by a model with only treatment group","text_display":" intercept. We will define the overall crude intervention effects by a model with only treatment group","confidence":1,"confidence_rate":1},{"cnt":[[241,2103],[1734,2103],[1734,2151],[241,2151]],"region":{"top_left_x":240,"top_left_y":2103,"width":1494,"height":48},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb1aff601bf34f5dac767ff9e823e90d","type":"text","conversion_output":true,"text":"and the baseline value of the outcome as independent variables. We will add time and time-by-","text_display":" and the baseline value of the outcome as independent variables. We will add time and time-by","confidence":1,"confidence_rate":1},{"cnt":[[236,2196],[1878,2196],[1878,2245],[236,2245]],"region":{"top_left_x":236,"top_left_y":2195,"width":1642,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c645bd61e21345bc926e7250d1fa2b9c","type":"text","conversion_output":true,"text":"treatment interaction terms to specify crude intervention effects for each follow-up time point. Adjusted","text_display":"treatment interaction terms to specify crude intervention effects for each follow-up time point. Adjusted","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[241,2290],[1772,2290],[1772,2340],[241,2340]],"region":{"top_left_x":240,"top_left_y":2290,"width":1533,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6163826fa0de49bcad604eeacf7acc4c","type":"text","conversion_output":true,"text":"intervention effects will be calculated using similar models, expanded with the following potential","text_display":" intervention effects will be calculated using similar models, expanded with the following potential","confidence":1,"confidence_rate":1},{"cnt":[[241,2385],[1721,2385],[1721,2432],[241,2432]],"region":{"top_left_x":240,"top_left_y":2384,"width":1481,"height":49},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d7479b1167e4808b5c6aedaf09c51a0","type":"text","conversion_output":true,"text":"confounders as independent variables: level of OA at baseline using the Kellgren and Lawrence","text_display":" confounders as independent variables: level of OA at baseline using the Kellgren and Lawrence","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"bbffe277-e94d-471a-8395-80abee113530-3","page":3,"lines":[{"cnt":[[236,245],[1837,245],[1837,299],[236,299]],"region":{"top_left_x":236,"top_left_y":244,"width":1601,"height":55},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"651782749fe44bf0b167281fa29b59b7","type":"text","conversion_output":true,"text":"classification[7], baseline pain during weight bearing, BMI at baseline (three categories: \\(<25,25-30\\), or","text_display":"\nclassification[7], baseline pain during weight bearing, BMI at baseline (three categories: \\(<25,25-30\\), or","confidence":0.968040581792593,"confidence_rate":0.9997270854055713},{"cnt":[[236,335],[1858,335],[1858,391],[236,391]],"region":{"top_left_x":236,"top_left_y":335,"width":1623,"height":57},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"68af1a3ce5374591b96940ed3f643b7c","type":"text","conversion_output":true,"text":"\\(30-35 kg / m 2)\\) and gender. In all models, physical therapy will be defined as the reference treatment. All","text_display":" \\(30-35 kg / m 2)\\) and gender. In all models, physical therapy will be defined as the reference treatment. All","confidence":0.993659496307373,"confidence_rate":0.999943712291653},{"cnt":[[236,430],[1863,430],[1863,483],[236,483]],"region":{"top_left_x":236,"top_left_y":429,"width":1627,"height":55},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"90edc912818745ab856dec1f4e2a63d3","type":"text","conversion_output":true,"text":"analyses will be performed using IBM SPSS version 27 (IBM, Armonk, NY), and statistical significance will","text_display":" analyses will be performed using IBM SPSS version 27 (IBM, Armonk, NY), and statistical significance will","confidence":1,"confidence_rate":1},{"cnt":[[236,524],[703,524],[703,574],[236,574]],"region":{"top_left_x":236,"top_left_y":524,"width":467,"height":50},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fec2307786e04862b48951a642b30d69","type":"text","conversion_output":true,"text":"be assessed at the 0.05 level.","text_display":" be assessed at the 0.05 level.","confidence":0.99951171875,"confidence_rate":0.9999871474379078}],"page_height":2750,"page_width":2125,"languages_detected":[]}]}
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