BACKGROUND: There is no validated case definition for @entity1 @entity465 virus-associated immune reconstitution @entity32 (IRIS). We measured the level of agreement of 2 published case definitions (hereafter referred to as @entity4897 and @entity3138 ) with expert opinion in a prospective cohort of @entity1 who were starting antiretroviral therapy in South Africa. METHODS: A total of 498 adult @entity1 were monitored for the first 6 months of antiretroviral therapy. All new or worsening clinical events were reviewed by 2 investigators and classified on the basis of expert opinion, @entity4897 , and @entity3138 . Events were categorized according to whether they were paradoxical or unmasking in presentation. We measured positive, negative, and chance-corrected agreement (kappa) with expert opinion for @entity4897 and @entity3138 , and reviewed areas of disagreement. RESULTS: A total of 620 clinical events were recorded, of which, on the basis of expert opinion, 144 (23.2%) were defined as probable IRIS and 112 (18.1%) were defined as possible IRIS. Of the 144 probable IRIS events, 93 (64.6%) were unmasking in presentation, 99 (68.8%) were associated with @entity66 , and 45 (31.3%) were associated with @entity378 or major @entity1292 . Of the 620 clinical events recorded, 41 (6.6%) were classified as IRIS on the basis of @entity4897 , and 156 (25.2%) were classified as IRIS on the basis of @entity3138 . Positive agreement between @entity4897 and expert opinion was low for both unmasking (17.2%; kappa = 0.24) and paradoxical events (37.3%; kappa = 0.43), mainly because 1 major criterion requires IRIS to be atypical and either an @entity1292 or a @entity5 , although negative agreement was >98%. In contrast, @entity3138 had good positive agreement (>75% for most event types), with a kappa value of 0.75 for paradoxical and 0.62 for unmasking. CONCLUSIONS: @entity3138 agreed well with expert opinion, with additional clinical events, such as @entity2720 and inflammatory dermatoses, being classified as IRIS and added to @entity3138 . We propose revised case definitions for both paradoxical and unmasking IRIS.

Defining immune reconstitution XXXX : evaluation of expert opinion versus 2 case definitions in a South African cohort.

@entity1 :: ('9606', 'Species') :: ['human', 'patients'] @entity32 :: ('MESH:D007249', 'Disease') :: ['inflammatory syndrome'] @entity66 :: ('MESH:D004194', 'Disease') :: ['dermatological or orogenital disease'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity4897 :: ('911', 'Gene') :: ['CD1'] @entity3138 :: ('914', 'Gene') :: ['CD2'] @entity465 :: ('MESH:D007153', 'Disease') :: ['immunodeficiency'] @entity2720 :: ('MESH:D007592', 'Disease') :: ['arthropathy'] @entity1292 :: ('MESH:D009894', 'Disease') :: ['opportunistic infection', 'opportunistic infections'] @entity378 :: ('MESH:D014376', 'Disease') :: ['tuberculosis']
@entity32 :: (MESH:D007249,Disease) :: ['inflammatory syndrome']
