The task force chairs designed a 14-question needs assessment survey, emailed to 13 members in August 2014. The survey response rate was 100%; responses were analyzed anonymously in a descriptive fashion that revealed consensus regarding the need for new APS Classification Criteria [28]. Ninety-two percent of those queried reported the need for new APS Classification Criteria; 100% agreed that all disease domains are not sampled by current criteria; 85% reported scenarios in which current criteria disagree with expert diagnoses, for instance, “non-criteria” manifestations only with or without aPL, non-criteria obstetrical findings with aPL, and high suspicion for APS in patients without persistent or low titer aPL; and 62% agreed that other aPL tests should be considered. Thus, the task force decided to proceed with efforts to prepare new classification criteria.

Under the leadership of Dr. Stephane Zuily, four different teams have been working on the meta-analyses of the selected non-criteria manifestations of aPL, i.e., livedo reticularis, thrombocytopenia, hemolytic anemia, and aPL nephropathy [38–41]. These four meta-analyses, together with others [33–35, 42–45], will guide physician-scientists during the new classification criteria development efforts.

During the 2014–2016 ACR Annual Scientific Meetings , as part of a study group, our classification criteria update efforts have been presented to other task force members, APS researchers, and interested physicians. These sessions share our plans with others and demonstrate inclusiveness. The results of the needs assessment survey were presented at the ACR Annual Scientific Meeting and discussed in detail with worldwide physicians interested in APS. During the 15th International Congress on aPL (www.​apsistanbul2016.​org), the task force organized a session together with the Scientific Planning Committee of the congress; discussions included the historical aspects, limitations, and strengths of the Sapporo Classification Criteria, the methodology to develop classification criteria, and the accomplishments and future plans of the task force.

During phase I, our goal was to identify candidate criteria for the new classification criteria [46–48]. Fifty-four physician-scientists from our master list were asked three questions via e-mail:

We encouraged respondents to consider their real-life experiences with aPL-positive patients, rather than focusing on current APS Classification Criteria. Responses were systematically clustered by the task force members by organ system to avoid duplication and for ease of interpretability.

The phase I response rate was 76% (41/54 respondents), of whom 18 were rheumatologists, five clinical immunologists, five hematologists, five nephrologists/cardiologists/neurologists, four internists, two pediatric rheumatologists, and two obstetricians. One hundred and fifty-two candidate criteria, displayed by organ systems, were generated (Table 15.2, laboratory variables and family history are also included). The distribution of non-obstetrical candidate criteria with potential negative weight generated is shown in Table 15.3. Additional obstetrical candidate criteria with potential negative weight were late reproductive age, early/very early (recurrent) miscarriage, normal placental pathology, and concomitant causes of recurrent miscarriage, such as uterine/cervical abnormality, thyroid diseases, or genetic abnormalities. The reported subpopulations of APS patients, grouped based on age, clinical manifestations, aPL profile, and risk level, are shown in Table 15.4.