04.02.2015 Views

Dictionary of Evidence-based Medicine.pdf

Dictionary of Evidence-based Medicine.pdf

Dictionary of Evidence-based Medicine.pdf

SHOW MORE
SHOW LESS

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.

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!