Trial 41 Assessment Sheet AD

	A	B	H	I	J	K	L	M
1	Trial Info
2	Week	4
3	Study ID	41
4	Journal name	JAMA
5	Trial Title	Endovascular Revascularization and Supervised Exercise for Peripheral Artery Disease and Intermittent Claudication
6	Trial Link	http://jama.jamanetwork.com/article.aspx?articleid=2468892
7	Publication date	10/11/2015
8	Registry link	http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2249
9	Registry ID	NTR2249 (Netherlands)
10	Protocol link, if available	http://jama.jamanetwork.com/article.aspx?articleid=2468892
11
12
13	Prespecified Primary Outcome			Correctly reported?	Incorrectly reported in main trial results table or figure?	Not reported in tables, but reported elswhere in paper?	Not reported in journal publication	Outcome measure not sufficiently pre-specified
14	1	Maximum walking distance [1 month]		Yes
15	2	Maximum walking distance [6 months]		Yes
16	3	Maximum walking distance [12 months]		Yes
17	4
18	5
19
20	Total	3	TOTALS	3
21
22	Prespecified Secondary Outcome			Correctly reported?	Incorrectly reported in main trial results table or figure?	Not reported in tables, but reported elswhere in paper?	Not reported in journal publication	Outcome measure not sufficiently pre-specified
23	1	Preference-based ultilities (Rating Scale) [1 month]		Yes
24	2	Preference-based ultilities (Rating Scale) [6 months]		Yes
25	3	Preference-based ultilities (Rating Scale) [12 months]		Yes
26	4	EQ-5D [1 month]					Yes
27	5	EQ-5D [6 months]					Yes
28	6	EQ-5D [12 months]					Yes
29	7	SF-36 Physical functioning [1 month]		Yes
30	8	SF-36 Physical functioning [6 months]		Yes
31	9	SF-36 Physical functioning [12 months]		Yes
32	10	SF-36 Physical-role functioning [1 month]		Yes
33	11	SF-36 Physical-role functioning [6 months]		Yes
34	12	SF-36 Physical-role functioning [12 months]		Yes
35	13	SF-36 Social functioning [1 month]					Yes
36	14	SF-36 Social functioning [6 months]					Yes
37	15	SF-36 Social functioning [12 months]					Yes
38	16	VascuQoL score [1 month]		Yes
39	17	VascuQoL score [6 month]		Yes
40	18	VascuQoL score [12 month]		Yes
41	19	Maximum painless walking distance [1 month]		Yes
42	20	Maximum painless walking distance [6 months]		Yes
43	21	Maximum painless walking distance [12 months]		Yes
44	22	ABI at rest [1 month]		Yes
45	23	ABI at rest [6 months]		Yes
46	24	ABI at rest [12 months]		Yes
47	25	ABI after exercise [1 month]		Yes
48	26	ABI after exercise [6 months]		Yes
49	27	ABI after exercise [12 months]		Yes
50	28	Clinical success measured by improvement in Rutherford scale [1 month]					Yes
51	29	Clinical success measured by improvement in Rutherford scale [6 months]					Yes
52	30	Clinical success measured by improvement in Rutherford scale [12 months]					Yes
53	31	CVD risk factor score [6 months]					Yes
54	32	CVD risk factor score [12 months]					Yes
55	33	Medication use [6 months]					Yes
56	34	Medication use [12 months]					Yes
57	35	Number of adverse events [1 month]					Yes
58	36	Number of adverse events [6 months]					Yes
59	37	Number of adverse events [12 months]					Yes
60
61
62
63
64
65
66
67	Total	37	TOTALS	21			16
68
69	Non-prespecified outcome in publication			Correctly reported as non-pre-specified?			Not declared as non-prespecified
70	1	SF-36 Bodily pain [1 month]		No			Yes
71	2	SF-36 Bodily pain [6 months]		No			Yes
72	3	SF-36 Bodily pain [12 months]		No			Yes
73	4	SF-36 General health [1 month]		No			Yes
74	5	SF-36 General health [6 months]		No			Yes
75	6	SF-36 General health [12 months]		No			Yes
76	7
77	8
78	9
79	10
80	11
81	12
82
83	Total	6	TOTALS	0			6
84
85	Complications to trial and issues arising in free text
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100