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NL888 Posted 12 years ago
Grammar
What does "who did not cross over" mean?
Context:
The 6-month period from baseline to ascertainment of the primary end point might be too short if a placebo effect declined with time, though prior studies showed a large effect by 6 months (which was sustained through 3 years); the patients in our study will be followed for up to 5 years, including those who did not cross over. The trial was not powered to detect small differences in systolic or diastolic blood pressure or any potential effects in subgroups. An operator learning curve can affect the success of interventional procedures, though all procedures were proctored. We observed no significant difference in outcomes between operators performing five or more procedures and those performing fewer than five procedures, and we found no evidence of a learning curve for high-volume operators when earlier procedures were compared with later ones. There was no direct measurement to confirm that the renal nerves were in fact denervated by the procedure, because there is no test that can be easily performed in a large trial. However, the Symplicity catheter system allowed confirmation of energy delivery, and the presence of angiographic notching indicated a biologic effect of energy delivery on the artery. Finally, the results of this trial are specific to the catheter tested and cannot necessarily be generalized to other denervation systems.
MOre:
http://www.nejm.org/doi/full/10.1056/NEJMoa1402670?query=featured_home#t=article
The 6-month period from baseline to ascertainment of the primary end point might be too short if a placebo effect declined with time, though prior studies showed a large effect by 6 months (which was sustained through 3 years); the patients in our study will be followed for up to 5 years, including those who did not cross over. The trial was not powered to detect small differences in systolic or diastolic blood pressure or any potential effects in subgroups. An operator learning curve can affect the success of interventional procedures, though all procedures were proctored. We observed no significant difference in outcomes between operators performing five or more procedures and those performing fewer than five procedures, and we found no evidence of a learning curve for high-volume operators when earlier procedures were compared with later ones. There was no direct measurement to confirm that the renal nerves were in fact denervated by the procedure, because there is no test that can be easily performed in a large trial. However, the Symplicity catheter system allowed confirmation of energy delivery, and the presence of angiographic notching indicated a biologic effect of energy delivery on the artery. Finally, the results of this trial are specific to the catheter tested and cannot necessarily be generalized to other denervation systems.
MOre:
http://www.nejm.org/doi/full/10.1056/NEJMoa1402670?query=featured_home#t=article
Top answer
NL888 What does "who did not cross over" mean? In the same text: Patients underwent renal angiography before randomization. At 6 months, patients in the control group were allowed to cross over to undergo denervation if they still met the inclusion criteria for the study.
- NL888 What does "who did not cross over" mean?
- In the same text: Patients underwent renal angiography before randomization.
- At 6 months, patients in the control group were allowed to cross over to undergo denervation if they still met the inclusion criteria for the study.
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1 Answers
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NL888 What does "who did not cross over" mean?In the same text:
Patients underwent renal angiography before randomization. At 6 months, patients in the control group were allowed to cross over to undergo denervation if they still met the inclusion criteria for the study.
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