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Health and Quality of Life Outcomes

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Open Access 01-12-2010 | Research

Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials

Authors: Christoph Gerlinger, Ulrike Schumacher, Thomas Faustmann, Antje Colligs, Heinz Schmitz, Christian Seitz

Published in: Health and Quality of Life Outcomes | Issue 1/2010

Abstract

Background

When comparing active treatments, a non-inferiority (or one-sided equivalence) study design is often used. This design requires the definition of a non-inferiority margin, the threshold value of clinical relevance. In recent studies, a non-inferiority margin of 15 mm has been used for the change in endometriosis-associated pelvic pain (EAPP) on a visual analog scale (VAS). However, this value was derived from other chronic painful conditions and its validation in EAPP was lacking.

Methods

Data were analyzed from two placebo-controlled studies of active treatments in endometriosis, including 281 patients with laparoscopically-confirmed endometriosis and moderate-to-severe EAPP. Patients recorded EAPP on a VAS at baseline and the end of treatment. Patients also assessed their satisfaction with treatment on a modified Clinical Global Impression scale. Changes in VAS score were compared with patients' self-assessments to derive an empirically validated non-inferiority margin. This anchor-based value was compared to a non-inferiority margin derived using the conventional half standard deviation rule for minimal clinically important difference (MCID) in patient-reported outcomes.

Results

Anchor-based and distribution-based MCIDs were-7.8 mm and-8.6 mm, respectively.

Conclusions

An empirically validated non-inferiority margin of 10 mm for EAPP measured on a VAS is appropriate to compare treatments in endometriosis.

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Title: Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials
Authors: Christoph Gerlinger
Ulrike Schumacher
Thomas Faustmann
Antje Colligs
Heinz Schmitz
Christian Seitz
Publication date: 01-12-2010
Publisher: BioMed Central
Published in: Health and Quality of Life Outcomes / Issue 1/2010
Electronic ISSN: 1477-7525
DOI: https://doi.org/10.1186/1477-7525-8-138

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials

Abstract

Background

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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