JMIR Publications

ABSTRACT

Background:

Enrollment into pregnancy registries is often challenging, despite substantial awareness-raising activities, generally resulting in low recruitment due to lack of safety data. Understanding patient and physician awareness of and attitudes towards pregnancy registries are needed to facilitate enrollment.

Objective:

To use online crowdsourcing platforms to evaluate awareness among patients and physicians, and identify potential barriers to enrollment in a pregnancy registry, using the Belimumab Pregnancy Registry (BPR) as a case study.

Methods:

Two surveys were designed and conducted using two separate online crowdsourcing platforms: Amazon Mechanical Turk (14-question patient survey) and SERMO RealTime (11-question rheumatologist survey). Eligible patients were female, 18–55 years of age, diagnosed with systemic lupus erythematosus (SLE), and either pregnant, recently pregnant (within 2 years), or planning pregnancy. Eligible rheumatologists were required to have prescribed belimumab treatment and treated pregnant women. Responses were analyzed descriptively.

Results:

Of 151 patient respondents (58% aged 26–35 years; 99% with mild or moderate SLE; 98% from the USA), 51% were currently or recently pregnant. Overall, 169 rheumatologists completed the survey; 59% were US-based. Belimumab exposure was reported by 63/151 (42%) patients, with rheumatologists continuing to prescribe belimumab during their careers to fewer than 5 (75/145 [52%]), 5–10 (37/145 [26%]), or greater than 10 (33/145 [23%]) patients who were either pregnant or planning pregnancy. Of patients exposed to belimumab, 32/63 (51%) were BPR-aware, as were 77/169 (46%) rheumatologists. Overall, 38/63 (60%) patients reported belimumab discontinuation due to pregnancy or planned pregnancy. Among 77 BPR-aware rheumatologists, 70 (91%) would refer patients to the registry. Concerns among rheumatologists who did not prescribe belimumab during pregnancy included the unknown pregnancy safety profile (119/169 [70%]); 104/169 (62%) reported their patients’ concerns about the unknown pregnancy safety profile. Belimumab exposure during or recently after pregnancy or while trying to conceive was reported in patients with mild (6/64 [9%]), moderate (22/85 [26%]), or severe (1/2 [50%]) SLE. Rheumatologists more commonly recommended belimumab for moderate (84/169 [50%]) and severe (123/169 [73%]) SLE than mild SLE (36/169 [21%]) for patients trying to conceive, recently or currently pregnant. Overall, 138/169 (82%) rheumatologists would suggest a belimumab washout period prior to pregnancy of 0–30 days (44/138 [32%]), 30–60 days (64/138 [46%]), or >60 days (30/138 [22%]).

Conclusions:

Online crowdsourcing is a viable approach for obtaining patient and physician input regarding pregnancy registries and gathering information from difficult to recruit populations. Several rheumatologists and patients reported belimumab treatment continuation during pregnancy or while trying to conceive and rheumatologists’ willingness to refer patients to the registry; however, BPR enrollment remains low. Overall, the data highlighted several barriers to BPR enrollment including lack of awareness, voluntary nature, lack of benefit to participants, and limited belimumab safety data in pregnancy.