Checklist completion

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6 # - A pilot study testing the feasibility of skin temperature monitoring to reduce recurrent foot ulcers in patients with diabetes– a randomized controlled trial

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5 # - Are appropriate definitions included for the terms “ulcer”, “healing”, and all other required aspects of the population and the outcomes?

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6 # - Was the choice of study population appropriate for the chosen intervention and the stated conclusions?

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7 # - Was there a control population that was managed at the same time as those in the intervention group or groups?

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8 # - Is the intervention sufficiently well described to enable another researcher to replicate the study?

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9 # - Are the components of other aspects of care described for the intervention and comparator groups?

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10 # - Were the participants randomised into intervention and comparator groups?

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11 # - Were the participants randomised by an independent person or agency?

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12 # - Was the number of participants studied in the trial based on an appropriate sample size calculation?

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13 # - Was the chosen primary outcome of direct clinical relevance?

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14 # - Was the person who assessed the primary outcome or outcomes blinded to group allocation?

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15 # - Were the clinical researcher who cared for the wound at research visits and the participants blinded to group allocation?

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16 # - Did the study complete recruitment?

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17 # - Was it possible to document the primary outcome in 75% or more of those recruited?

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18 # - Were the results analysed primarily by intention-to-treat analysis?

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19 # - Were appropriate statistical methods used throughout?

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20 # - Was the performance in the control group of the order that would be expected in routine clinical practice?

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21 # - Are the results from all participating centres comparable? Answer “yes” if the study was done in only one centre

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22 # - Is the report free from errors of reporting—eg, discrepancies between data reported in different parts of the report?

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23 # - Are the important strengths and weaknesses of the study discussed in a balanced way?

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24 # - Are the conclusions supported by the findings?

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25 # - Is the report free from any suggestion that the analysis or the conclusions could have been substantially influenced by people with commercial or other personal interests in the findings?

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