Trial 41 Assessment Sheet AD
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Trial Info
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Week4
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Study ID41
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Journal nameJAMA
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Trial Title
Endovascular Revascularization and Supervised Exercise for Peripheral Artery Disease and Intermittent Claudication
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Trial Linkhttp://jama.jamanetwork.com/article.aspx?articleid=2468892
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Publication date10/11/2015
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Registry linkhttp://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2249
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Registry IDNTR2249 (Netherlands)
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Protocol link, if availablehttp://jama.jamanetwork.com/article.aspx?articleid=2468892
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Prespecified Primary OutcomeCorrectly reported?Incorrectly reported in main trial results table or figure?Not reported in tables, but reported elswhere in paper?Not reported in journal publicationOutcome measure not sufficiently pre-specified
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1Maximum walking distance [1 month]Yes
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2Maximum walking distance [6 months]Yes
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3Maximum walking distance [12 months]Yes
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Total3TOTALS3
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Prespecified Secondary OutcomeCorrectly reported?Incorrectly reported in main trial results table or figure?Not reported in tables, but reported elswhere in paper?Not reported in journal publicationOutcome measure not sufficiently pre-specified
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1Preference-based ultilities (Rating Scale) [1 month]Yes
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2Preference-based ultilities (Rating Scale) [6 months]Yes
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3Preference-based ultilities (Rating Scale) [12 months]Yes
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4EQ-5D [1 month]Yes
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5EQ-5D [6 months]Yes
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6EQ-5D [12 months]Yes
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7SF-36 Physical functioning [1 month]Yes
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8SF-36 Physical functioning [6 months]Yes
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9SF-36 Physical functioning [12 months]Yes
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10SF-36 Physical-role functioning [1 month]Yes
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11SF-36 Physical-role functioning [6 months]Yes
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12SF-36 Physical-role functioning [12 months]Yes
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13SF-36 Social functioning [1 month]Yes
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14SF-36 Social functioning [6 months]Yes
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15SF-36 Social functioning [12 months]Yes
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16VascuQoL score [1 month]Yes
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17VascuQoL score [6 month]Yes
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18VascuQoL score [12 month]Yes
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19Maximum painless walking distance [1 month]Yes
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20Maximum painless walking distance [6 months]Yes
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21Maximum painless walking distance [12 months]Yes
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22ABI at rest [1 month]Yes
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23ABI at rest [6 months]Yes
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24ABI at rest [12 months]Yes
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25ABI after exercise [1 month]Yes
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26ABI after exercise [6 months]Yes
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27ABI after exercise [12 months]Yes
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28Clinical success measured by improvement in Rutherford scale [1 month]Yes
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29Clinical success measured by improvement in Rutherford scale [6 months]Yes
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30Clinical success measured by improvement in Rutherford scale [12 months]Yes
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31CVD risk factor score [6 months]Yes
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32CVD risk factor score [12 months]Yes
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33Medication use [6 months]Yes
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34Medication use [12 months]Yes
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35Number of adverse events [1 month]Yes
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36Number of adverse events [6 months]Yes
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37Number of adverse events [12 months]Yes
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Total37TOTALS2116
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Non-prespecified outcome in publicationCorrectly reported as non-pre-specified?Not declared as non-prespecified
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1SF-36 Bodily pain [1 month]NoYes
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2SF-36 Bodily pain [6 months]NoYes
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3SF-36 Bodily pain [12 months]NoYes
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4SF-36 General health [1 month]NoYes
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5SF-36 General health [6 months]NoYes
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6SF-36 General health [12 months]NoYes
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Total6TOTALS06
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Complications to trial and issues arising in free text
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