Development and initial content validation of a new version of the damage index in thrombotic antiphospholipid syndrome (DIAPSV2)

Abstract

Background

Antiphospholipid syndrome (APS) is the most common acquired hypercoagulable disorder characterized mainly by thrombotic events and obstetric morbidity. Quantifying chronic damage caused by APS is crucial for patient management. The original Damage Index for Thrombotic APS (DIAPS) was developed to address this need, but required updates to improve its comprehensiveness and specificity.

Objective

To report the initial content validation process of a new version of the damage index: DIAPSv2.

Methods

A modified Delphi panel was conducted in two stages. Stage 1 involved a systematic scoping review of DIAPS studies, with data extracted from questionnaires and confirmed by the leading committee. These questionnaires identified items from the original instrument that needed modification, elimination, or replacement with new candidate items. Stage 2 employed the modified Delphi method over three rounds, considering expert panelists’ opinions to select concepts for inclusion in DIAPSv2.

Results

In Stage 1, evidence supported the validity of the original DIAPS but highlighted missing conditions reflecting chronic damage, such as alveolar hemorrhage and significant bleeding due to anticoagulation therapy. In Stage 2, participants from different working groups reached a consensus to evaluate 41 of the 67 items that the leading committee proposed for accurately measuring chronic damage in APS. A final consensus included 32 items. Definitions of all items were updated according to specialists’ input and international recommendations for each domain.

Conclusions

A collaborative and multidisciplinary consensus-based approach developed a new version of the damage index, comprising 11 domains and 32 items (an update from 10 domains and 38 items in the original version). DIAPSv2 offers a more specific tool for evaluating irreversible damage in patients with thrombotic APS.