Strengths and limitations
Strengths of this study include the large sample size, prospective nature, consistent evidence-informed follow-up assessments by trained nurses, and large number and range of characteristics that could be examined. Study limitations include the reduced sample size for the follow up analysis due to missing data on some of the baseline characteristics. In particular, some of the pain characteristics were not captured at baseline, possibly because pain was not the primary
outcome in the original RCT. If those without pain were less likely to record pain scores, then our findings overestimate the prevalence of pain at healing by up to 3% (29% vs. 32%). Finally, it is possible that the tissue at the site of the ulcer may have remained tender due to nociceptive processes because the assessment was done at time of healing.
Strengths and limitations
Strengths of this study include the large sample size, prospective nature, consistent evidence-informed follow-up assessments by trained nurses, and large number and range of characteristics that could be examined. Study limitations include the reduced sample size for the follow up analysis due to missing data on some of the baseline characteristics. In particular, some of the pain characteristics were not captured at baseline, possibly because pain was not the primary
outcome in the original RCT. If those without pain were less likely to record pain scores, then our findings overestimate the prevalence of pain at healing by up to 3% (29% vs. 32%). Finally, it is possible that the tissue at the site of the ulcer may have remained tender due to nociceptive processes because the assessment was done at time of healing.
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