Do clinical trials improve quality of care? A comparison of clinical processes and outcomes in patients in a clinical trial and similar patients outside a trial where both groups are managed according to a strict protocol.

What Was Tested

This randomized controlled trial looks at Magnesium Sulfate.

To test the hypothesis that trial participants receive higher quality care and, as a consequence, have better outcomes than patients receiving guideline driven routine care.

Who Took Part

The abstract describes 408 women taking part.

PubMed tags the participants as women only.

Retrospective comparative study of 408 women with pre-eclampsia all managed according to a strict protocol.

Trial participants were 86 women who participated in a multicentre randomised controlled trial of magnesium sulphate for the treatment of pre-eclampsia (Magpie Trial); 322 non-participants formed the control group.

How the Study Was Run

The design is described as randomized and multicenter.

The women were allocated by chance, so the Magnesium Sulfate group and the comparison group should start out alike.

More than one site took part, so the women came from several places.

Indicators of the process of care and clinical outcomes were compared between the two groups.

What Was Measured

The subject headings attached to it are Clinical Protocols, Drug Monitoring, England, Magnesium Sulfate, Obstetrics, Patient Participation and Patient Selection.

What This Means in Plain Language

The paper is a randomized and multicenter study of Magnesium Sulfate in 408 women.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2005 (Quality & safety in health care), a journal based in England.

More context: all human trials.