Dictionary of Evidence-based Medicine.pdf
Dictionary of Evidence-based Medicine.pdf
Dictionary of Evidence-based Medicine.pdf
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
32 <strong>Dictionary</strong> <strong>of</strong> <strong>Evidence</strong>-<strong>based</strong> <strong>Medicine</strong><br />
Masking (blinding)<br />
Describe:<br />
(i) mechanism (e.g. capsules, tablets)<br />
(ii) similarity <strong>of</strong> treatment characteristics (e.g.<br />
appearance, taste)<br />
(iii) allocation schedule control (location <strong>of</strong><br />
code during trial and when broken)<br />
(iv) evidence for successful blinding among<br />
participants, persons doing intervention, outcome<br />
assessors, and data analysts.<br />
Results Participants Provide a trial pr<strong>of</strong>ile (Figure 4) summarizing<br />
participant flow and number and timing <strong>of</strong><br />
randomization assignment, intervention followup<br />
measurements for each randomized group.<br />
Analysis<br />
(i) State estimated effect <strong>of</strong> intervention on<br />
primary and secondary outcome measures,<br />
including point estimates and measures <strong>of</strong><br />
precision (confidence interval).<br />
(ii) State results in absolute numbers when<br />
feasible (e.g. 10/20, not 50%).<br />
(iii) Present summary data and appropriate<br />
descriptive and inferential statistics in sufficient<br />
detail to permit alternative analyses and<br />
replication.<br />
(iv) Describe prognostic variables by treatment<br />
group and any attempt to adjust for them.<br />
(v) Describe protocol violations from the study<br />
as planned, together with the reasons.<br />
Discussion<br />
(i) State specific interpretation <strong>of</strong> study findings,<br />
including sources <strong>of</strong> bias and imprecision<br />
(internal validity) and discussion <strong>of</strong> external<br />
validity, including appropriate quantitative<br />
measures when possible.<br />
(ii) State general interpretation <strong>of</strong> the data in<br />
light <strong>of</strong> totality <strong>of</strong> the available evidence.