torsdag 5 juni 2008

Surrogatvariabler istället för patientnytta

En artikel i the heart kommenterar att man i läkemedelsförsök på diabetiker koncentrerar sig på surrogatvariabler snarare än hårda ändpunkter och patientnytta

- Too many randomized controlled trials of diabetes drugs are designed with surrogate end points and not with the kinds of end points that actually matter to patients.
Resumé: Alltför många studier av diabetespreparat designas med surrogatändpunkter istället för vad som faktiskt tjänar patientens behov.

They found that "patient-important" outcomes—including cardiovascular events, death, pain, function, and quality of life—were chosen as primary outcomes in just 18% of trials and as primary or secondary outcomes in less than half of the studies.
Resumé: Utfall som är viktiga för patienter väljs som första variabel i endast 18% av studierna.

...the bulk of trials used either surrogate outcomes, such as glycated hemoglobin or cholesterol levels, or physiological/laboratory outcomes (eg, insulin levels, C-peptide levels, etc). Of note, trials of patients with type 2 diabetes were significantly less likely than trials of type 1 diabetes or type 1 and 2 combined to report outcomes important to patients.
Resumé: I studier på diabetiker typ 2 (sockersjuka) var patientnyttiga ändpunkter signifikant mer underrepresenterade.

...there are two likely reasons why trials are continually designed with surrogate end points. ... The second is that trials are designed primarily to gain market approval or new market indications. "These tend to be brief, and they tend to focus on surrogate markers that then are sold as being important," he said.
Resumé: En orsak är att studier fokuserar på surrogatvariabler för att få erkännande på marknaden.
Se även: MatFrisk Blogg på Passagen

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