Responsiveness of the SF-36 and the Health Assessment Questionnaire Disability Index in a systemic sclerosis clinical trial.

What Was Tested

Researchers studied Relaxin in this randomized controlled trial publication.

This study compares the responsiveness to change of the Medical Outcomes Study Short Form Health Survey (SF-36), a measure of health related quality of life (HRQOL), and the Health Assessment Questionnaire Disability Index (HAQ-DI), a function instrument, in a randomized clinical trial for treatment of systemic sclerosis (SSc).

Responsiveness indices were computed and Cohen's effect size criteria were used to assess the magnitude of change.

Who Took Part

The age groups tagged for this paper are adults, middle-aged adults and older adults, both men and women.

How the Study Was Run

The researchers set it up as a randomized, placebo-controlled and multicenter study.

The participants were allocated by chance, so the Relaxin group and the comparison group should start out alike.

The comparison arm used a placebo, so changes seen with Relaxin could be set against what happens without it.

Running at several centres spread the Relaxin study over different clinics and patient groups.

Internal consistency reliability of multi-item scales was estimated using Cronbach's alpha.

Responsiveness to change of the SF-36 and HAQ-DI was computed between Weeks 0 and 24.

What Was Measured

PubMed files the paper under topics including Disability Evaluation, Health Status Indicators, Outcome Assessment, Health Care, Quality of Life, Relaxin, Reproducibility of Results and Scleroderma, Systemic.

What This Means in Plain Language

The paper is a randomized, placebo-controlled and multicenter study of Relaxin.

Its findings take up roughly 4 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2005 (The Journal of rheumatology), a journal based in Canada.

More context: the related Relaxin (Serelaxin) library page, all human trials.