Abstract
Background/Purpose:
We sought to understand the frequency of contraception documentation for women with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) in a large U.S. electronic health record (EHR)-based registry, and to identify disparities by teratogen prescription and patient race and ethnicity.
Methods:
Contraception documentation from structured data fields within the RISE (Rheumatology Informatics System for Effectiveness) Registry was collected for women of childbearing age (18–45 years) in 2018 who had at least 2 visits with ICD-9/10 diagnosis codes for SLE or RA (at any time). Univariate and multivariate analyses compared the frequency of contraception documentation based on patient characteristics including diagnosis, age, race, and teratogenicity of prescribed anti-rheumatic medications.
Results:
In 2018 there were 9,826 women of childbearing age with SLE and 19,009 with RA, of whom 9.1% had any contraception documented. Rates of contraceptive documentation were significantly lower for women with SLE (adjusted OR 0.84 (0.76, 0.92)). Women of Hispanic ethnicity, Black and Asian race were all less likely than white women to have contraception documentation. Teratogen prescription was associated with higher rates of contraception documentation for women with RA but not SLE (RA adjusted OR 1.31 (1.16, 1.47); SLE adjusted OR 1.08 (0.91, 1.28)).
Conclusion:
There are large gaps in contraception documentation within the RISE registry that are particularly stark among women of color. While these data likely underestimate contraception use, they highlight that most rheumatologists do not have a systematic approach to collecting and recording this information in the EHR.
Introduction:
An unplanned or ill-timed pregnancy in a woman with rheumatic disease places the patient, the pregnancy, and her offspring at risk for health complications. Nearly 50% of all pregnancies in the general U.S. population are unplanned, and while the incidence of unplanned pregnancy is unknown for women with rheumatic diseases, it is unlikely that the risk of unplanned pregnancy is lower in this group. (1) Unplanned pregnancies in the general population are accompanied by fewer of the maternal health behaviors known to be associated with pregnancy success, such as folic acid supplementation, prenatal health care receipt; and smoking cessation. (2) Recent data suggests that unplanned pregnancies in women with SLE are also accompanied by fewer healthy behaviors, more likely to occur when disease is active, and result in frequent severe pregnancy and fetal complications. (3) Active rheumatic disease at the time of conception, particularly when affecting the internal organs, increases the risk of pregnancy loss, preterm birth, and may lead to impaired growth of the developing fetus. (4, 5) Unplanned pregnancies that are conceived while a woman uses a teratogenic disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive agent, such as methotrexate and mycophenolate, increase the risk of pregnancy loss up to 40%, and birth defects by 8 to 26%, respectively. (6)
Contraception is essential for many women with rheumatic diseases to optimize their timing of pregnancy. Without contraception, 90% of women who have sex with men will become pregnant within a year.(7) Across the United States from 2017–2019, 65.3% of women use contraception, with 34% using highly effective contraception (e.g., surgical sterilization, intrauterine device, subdermal implant), 17% using moderately effective contraception (e.g., pill, patch, shot), and 14% using low-efficacy barrier methods. (8) In contrast, studies of women with rheumatic diseases suggest that approximately 50 to 75% of women use contraception, with 8–35% of women prescribed highly effective contraception. (9, 10)
Given the potential benefits of contraception in the health care of women with rheumatic diseases, we sought to understand the frequency of contraception documentation for women with SLE and RA within a national registry of patients with rheumatic disease. We focused specifically on differences in documentation between these two diagnoses, and the extent to which documentation varied by prescription of teratogenic medications and by patient race and ethnicity.
Methods:
The RISE (Rheumatology Informatics System for Effectiveness) Registry is a national electronic health record (EHR)-enabled registry sponsored by the American College of Rheumatology (ACR) that passively collects data from participating rheumatology practices. The RISE Registry has been approved by the Western IRB and the UCSF Committee on Human Research. As of 2018, 1,113 clinicians in 226 practices in the United States contributed data to the Registry, representing about 30% of the entire US clinical rheumatology workforce. The data contained within the RISE Registry is derived from structured variables within the EHR, including medication lists, diagnosis codes, patient-reported measures, CPT-codes, allergies, demographics, and any other discrete variables that providers from a participating rheumatology practice record during the course of clinical care. The data within the RISE Registry is collected as part of routine clinical care and study-specific data is not collected.
Our study population included female patients between the ages of 18 and 45 who had at least one clinic visit documented in the RISE Registry in 2018. Each woman was required to have at least two prior visits with ICD 9 or 10 diagnostic codes for either SLE [710.0, 710.00 or M32.x (except M32.0)] or rheumatoid arthritis [714.x (except 714.89 and 714.9) or M05x or M06x (except M06.4)] and at least 30 days apart. Patients who met both criteria were counted as SLE patients.
Contraception documentation was ascertained from structured fields within the EHR. Structured fields included the patient’s medication list, problem list, surgical history list, and procedure fields that included contraceptive information. Our data abstraction methods could not identify free-text documentation of contraception that did not appear in a structured field (e.g., physician notes).
Age and race/ethnicity data were extracted from the EHR. Age was categorized as 18–20 years, 21–25 years, 26–30 years, 31–35 years, 36–40 years and ≥41 years old. Patients were categorized according to the U.S. Census categories of white, Black, Asian, Hispanic, multiracial, or undocumented race/ethnicity.
Disease-modifying anti-rheumatic drugs were categorized by teratogenic risk according to the ACR Reproductive Health Guideline (see Table 1). (6) Patients prescribed any medication with high teratogenic risk were placed in the Teratogen group; patients who were prescribed medications with unknown teratogenicity were placed in the Unknown Risk group; and women who only were prescribed medications that are safe to use in pregnancy were included in the Pregnancy Compatible group. Patients who were not prescribed a disease-modifying anti-rheumatic drug (DMARD) included on these lists were included in the No DMARD group. Contraception was divided into two groups: effective and highly effective (see Table 1) based on their efficacy in real-world use. (11) With typical use of effective contraceptives, 4–10% of women will be pregnant at the end of the year; with typical use of highly effective contraceptives, <1% of women will be pregnant at the end of a year.
Table 1:
Medication risk /and contraceptive effectiveness classification
| Teratogen | Pregnancy-Compatible | Unknown Teratogenicity |
|---|---|---|
| • Methotrexate • Mycophenolate mofetil • Mycophenolic acid • Cyclophosphamide • Leflunomide • Thalidomide • Lenalidomide |
• Hydroxychloroquine • Azathioprine • TNF-α inhibitors |
• Non-TNF biologics • New small molecule medications |
| Highly Effective Contraception Typical use: <1% of women are pregnant after 1 year of use |
Effective Contraception Typical use: 4–10% of women are pregnant after 1 year of use |
|---|---|
| • Tubal ligation • Partner vasectomy • IUD (any type) • Contraceptive implant |
• Oral contraceptives • Depo-medroxyprogesterone • Patch • Ring |
We used multi-level logistic regression models that included age, race/ethnicity, diagnosis (SLE or RA), patients in a single specialty group practice (yes or no) and medication groups (pregnancy compatible, any teratogen, unknown teratogenicity, and no DMARD) to estimate the association between any contraception documentation and patient characteristics, accounting for clustering by practice. Practices reporting on fewer than 20 patients were excluded from this analysis (29 practices with a total of 250 patients), in order to reduce variability in practice-level estimates. We also assessed the association between highly effective contraception documentation and patient characteristics, with the same covariates. In addition, we conducted regression analysis with the same covariates and outcome among SLE patients and RA patients. Odds ratios with 95% confidence intervals (CI) were reported. Analyses were performed using Stata 15 (StataCorp. 2017. College Station, TX: StataCorp LLC.).
Results:
The cohort included 28,835 women, of whom 9,826 women were diagnosed with SLE and 19,009 women were diagnosed with RA. Data from 212 practices were included in the study with an average of 3 providers per practice (range 1–35). The majority of practices were rheumatology-only group practices (53.3%), followed by solo practitioners (27.4%), and multi-specialty group practices (12.3%). The most commonly used EHR vendor was NextGen (35.4%), followed by eClinicalWorks (14.6%).
On average, women with SLE were younger than those with RA (35.7±6.9 vs 37.0±6.7, p<0.001). The cohort was diverse: among women with SLE with documented race and/or ethnicity, 51% were white, 27% black, 17% Hispanic and 4% Asian; among women with RA with documented race and/or ethnicity, 74% were white, 10% black, 14% Hispanic, and 3% Asian. Black race was significantly more common among women with SLE than RA (p<0.001). No race was recorded for 22–23% of all women with SLE or RA.
Overall, 9.1% of women with SLE or RA had a contraception method documented within a structured field in 2018. There was significant variability in documentation between clinics, with 22.2% of clinics having no contraception documentation in any women, and 7.1% of clinics having 20% or more women with documentation of a contraception method. No clinic had contraception documentation for more than 30% of women with RA or SLE.
Contraception documentation varied by rheumatic diagnosis. In both univariate and multivariate analysis, contraceptive documentation was significantly less common in women with SLE than RA (SLE 8.1%, RA: 9.6% p<0.001; adjusted OR 0.84; 95% CI: 0.76, 0.92).
Contraception documentation varied by the age of the woman, with documentation most common among women age 21–25 and least common among women over 40 years old. Among both women with SLE and RA, the average age of women with contraceptive documentation was younger compared to those without contraceptive documentation (SLE 32.9 (SD: 7.2) vs 36 (SD: 6.9), p<0.001; RA 34.4 (SD: 7.3) vs 37.3 (SD: 6.6) p<0.001). Contraception documentation was highest among women with RA between the ages of 21–25 years who were prescribed a teratogen (22%).
Contraception documentation also varied by race. In univariate and multivariate analyses, white women were more likely to have contraception documented than women of other races and ethnicities (tables 2 and 3). Hispanic women had contraception documented half as often as white women. Black women with RA had about half the documentation of white women, and Black women with SLE had two-thirds the documentation of white women. Asian women with RA did not have significantly less contraception documentation, but Asian women with SLE had half the documentation of white women.
Table 2:
The percentage of women of reproductive age with contraception documented within the RISE Registry in 2018 in each of the medication-risk groups by patient characteristics.
| Systemic Lupus Erythematosus | All women 18–45 with SLE | Pregnancy Compatible Medications (n=4,499) | Teratogens (n=2,903) | Unknown Teratogenic Risk (n=892) | No DMARDs (n=1,532) |
|---|---|---|---|---|---|
| All women with SLE (n=9,826) | 7.9% | 7.9% | 8.4% | 9.4% | 6.3%2 |
| Race | |||||
| White (n=3,933) | 9.4% | 9.5% | 9.7% | 10.9% | 7.5% |
| Hispanic (n=1,297) | 5.7%1 | 4.9%3 | 6.2%3 | 8.7% | 5.4% |
| Black (n=2,066) | 7.0%1 | 6.7%3 | 7.8% | 7.8% | 5.0% |
| Asian (n=332) | 6.9% | 8.2% | 5.4% | 11.8% | 4.4% |
| Other/Mixed (n=35) | 8.6% | 0% | 20% | 0% | 0% |
| Unknown (n=2,163) | 7.8% | 7.8% | 8.8% | 8.0% | 5.9% |
| Age | |||||
| 18–20 | 12% | 12% | 13% | 19% | 8% |
| 21–25 | 15% | 16% | 15% | 15% | 12% |
| 26–30 | 13% | 13% | 11% | 18% | 11% |
| 31–35 | 9% | 9% | 8% | 11% | 7% |
| 36–40 | 6% | 6% | 8% | 8% | 5% |
| >=41 | 5% | 5% | 5% | 4% | 5% |
| Rheumatoid Arthritis | All women 18–45 with RA | Pregnancy Compatible Medications (n=5,429) | Teratogens (n=8,466) | Unknown Teratogenic Risk (n=1,881) | No DMARDs (n=3,233) |
|---|---|---|---|---|---|
| All women with RA (n=19,009) | 9.4% | 9.1%2 | 10.3% | 10.1% | 7.3%2 |
| Race | |||||
| White (n=10,719) | 10.9% | 10.3% | 12.1% | 11.3% | 8.7% |
| Hispanic (n=2,037) | 5.4%1 | 6.3%3 | 5.4%3 | 6.3% | 3.8% |
| Black (n=1,388) | 6.3%1 | 5.1%3 | 7.9%3 | 3.4% | 5.0% |
| Asian (n=384) | 7.8% | 5.6% | 9.4% | 5.4% | 8.5% |
| Other/Mixed (n=53) | 3.8% | 6.3% | 0% | 12.5% | 0% |
| Unknown (n=4,428) | 8.9% | 8.8% | 9.7% | 10.6% | 5.9% |
| Age | |||||
| 18–20 | 15% | 14% | 15% | 26% | 13% |
| 21–25 | 18% | 15% | 22% | 14% | 15% |
| 26–30 | 16% | 15% | 20% | 16% | 10% |
| 31–35 | 12% | 11% | 14% | 14% | 8% |
| 36–40 | 8% | 7% | 9% | 9% | 7% |
| >=41 | 7% | 6% | 7% | 7% | 5% |
p<0.001 comparing contraception documentation white women to women of different race/ethnicity.
p<0.05 comparing contraception documentation in women prescribed a teratogen to other medication risk groups.
p<0.05 comparing contraception documentation in white women to women of different race/ethnicity within the medication risk group.
Table 3:
Patient and medication factors associated with contraception documentation stratified by diagnosis. Prescription of a teratogen increased contraception documentation in women with RA but not SLE.
| SLE | RA | |||
|---|---|---|---|---|
|
| ||||
| Contraception documentation | Adjusted Odds Ratio (95% CI) | Contraception documentation | Adjusted Odds Ratio (95% CI) | |
| Age | ||||
| 18–20 | 12% | REF | 15% | REF |
| 21–25 | 15% | 1.21 (0.77, 1.91) | 18% | 1.17 (0.84, 1.63) |
| 26–30 | 13% | 1.01 (0.65, 1.57) | 16% | 1.00 (0.73, 1.38) |
| 31–35 | 9% | 0.66 (0.42, 1.02) | 12% | 0.71 (0.52, 0.98) |
| 36–40 | 6% | 0.47 (0.30, 0.73) | 8% | 0.44 (0.32, 0.60) |
| >=41 | 5% | 0.34 (0.22, 0.53) | 7% | 0.35 (0.26, 0.49) |
| Race | ||||
| White | 9% | REF | 11% | REF |
| Hispanic | 6% | 0.58 (0.44, 0.76) | 5% | 0.55 (0.44, 0.68) |
| African American | 7% | 0.70 (0.57, 0.86) | 6% | 0.59 (0.07, 0.74) |
| Asian | 7% | 0.63 (0.40, 0.99) | 8% | 0.69 (0.14, 1.02) |
| Other/Mixed | 9% | 0.78 (0.23, 2.68) | 4% | 0.24 (0.20, 1.20) |
| Unknown/Declined | 8% | 0.78 (0.64, 0.95) | 9% | 0.82 (0.06, 0.95) |
| Medication | ||||
| Pregnancy compatible | 8% | REF | 9% | REF |
| Teratogen | 8% | 1.08 (0.91, 1.28) | 10% | 1.31 (1.16, 1.47) |
| Unknown Teratogenicity | 9% | 1.15 (0.89, 1.49) | 10% | 1.16 (0.97, 1.39) |
| No DMARD | 6% | 0.84 (0.67, 1.06) | 7% | 0.94 (0.80, 1.10) |
| Clinic Type | ||||
| Single specialty group practice | 9% | 1.31 (1.07, 1.60) | 11% | 1.35 (1.11, 1.64) |
Practices with >=20 patients were included, N=183.
Models adjusted for all variables shown.
p<0.05
Among women who were prescribed a teratogen versus those who were not, contraception documentation was higher for women with RA but not for women with SLE. Prescription of medications of unknown teratogenic risk was not associated with an increase in contraceptive documentation.
Differences in contraception documentation persisted by race among women prescribed teratogens: among women with SLE who were prescribed a teratogen, Hispanic but not Black women were significantly less likely to have contraception documented than white women (table 2). Among women with RA prescribed a teratogen, both Hispanic and Black women were significantly less likely to have contraception documentation than white women.
The specific type of contraception was recorded in the majority of patients with contraceptive documentation. Of these, the majority used effective contraception (SLE: 5%, RA: 5.6%) and the minority used highly effective contraception (SLE: 1.5%, RA: 1.7%). The documentation of highly effective contraception followed a similar pattern to overall contraception documentation when adjusted for patient characteristics, with more documentation among younger, white women (supplemental table). Compared to women on pregnancy-compatible medications, women with RA, but not SLE, prescribed a teratogen were more likely to have documentation of highly effective contraception.
Estrogen-containing contraceptives can be associated with thrombotic events, leading to concerns about use in women with SLE. Among women with documented contraceptive type significantly fewer with SLE than RA were using an estrogen-containing contraceptive (SLE: 46%, RA: 53%; p=0.001)
Discussion:
This study found large gaps in contraceptive documentation within the RISE Registry. In 2018, none of the rheumatology clinics within the RISE Registry consistently recorded patients’ contraception use within their EHR using structured fields. In addition, we found significant racial disparities in contraceptive documentation, as white women had significantly more documentation than Hispanic and Black women. Women with SLE also had lower rates of contraception documentation than women with RA, although the consequences of ill-timed pregnancy may be higher among women with SLE due to higher rates of pregnancy complications related to active disease and more common use of mycophenolate. Our data underscore the need for better contraception documentation in the rheumatology context.
One of the clearest indications for contraception documentation for women with rheumatic diseases is the prescription of a teratogen, most commonly methotrexate in women with RA or mycophenolate in women with SLE. While these medications are both associated with a 40% risk for pregnancy loss, mycophenolate results in more major birth defects (26%) than methotrexate (7%) among liveborn babies. (6) Among women with RA, teratogen prescription was associated with higher rates of contraception documentation, likely reflecting physicians’ concerns about the risks of pregnancy on methotrexate. Among women with SLE, however, teratogen prescription did not increase contraception documentation. As more women with SLE are prescribed mycophenolate, it is particularly important that women with SLE on a teratogen receive contraception counseling and have their contraception method documented. Our data suggest that the mycophenolate Risk Evaluation and Mitigation Strategy (REMS) is currently inadequate in ensuring the documentation of effective contraception (https://www.mycophenolaterems.com/).
The risks of poor pregnancy outcomes, including pregnancy loss, preterm birth, and preeclampsia, are significantly higher among women with SLE than with RA. These risks are exacerbated when pregnancies are unplanned and/or conceived when SLE is active or when the woman is taking a teratogen. (3) Therefore, we would have expected to see increased attention to contraception documentation among women SLE than with RA; instead, we observed the opposite in the RISE Registry. A number of studies have reported that contraception counseling or care rarely occurs in the rheumatology setting, which may explain the low rates of contraception documentation in this study.(12, 13) Rheumatologists should initiate conversations about contraception with all patients with childbearing potential, help patients who wish to prevent pregnancy to access contraception, and document contraception use or non-use. In one quality improvement project, providers in an academic rheumatology clinic successfully modified EHR templates to augment documentation of and referrals for contraception; contraception documentation may serve as an important first step in advancing contraception care for women with rheumatic diseases. (10)
It is unclear why contraception documentation was lower among Black and Hispanic women than white women in the RISE registry. As lupus nephritis and adverse pregnancy outcomes occur more frequently among women of color, we would expect to see an emphasis on optimal pregnancy timing and increased contraception documentation in these groups. Instead, we see that when compared to white women, women of color have significantly less contraception documentation. In the general U.S. population, Black and Hispanic women are significantly more likely than white women to receive contraception counseling from their providers (14). However, Black and Hispanic women also are more likely to perceive implicit pressure from their providers to select contraception methods with higher efficacy, and to rate the quality of their family planning care as poor or inadequate (15) (16). Gaps in patient-centered and equitable contraception care among minority women may contribute to low contraception usage, and may partially explain the low rates of contraception documentation among these women in the current study.
Our study had several strengths. Our data were derived from a large registry of women with rheumatic disease across the United States who were cared for within community rheumatology practices—a population of patients that is understudied. In 2018, the RISE Registry did not include data from any academic centers, ensuring that the data recorded is most consistent with the care provided within communities. As the RISE Registry is primarily a quality improvement dataset, patients did not need to consent or to enroll prospectively to be included in the study, eliminating the selection biases inherent in many studies of women with SLE and RA. Our study population was also more reflective of a real-world cohort of women with SLE and RA, as nearly 20% with RA and 35% of women with SLE were Hispanic or Black.The frequency of racial and ethnic minorities within this RISE study population is similar to that expected across the United States. A recent meta-analysis of the prevalence of SLE across the United States in 2018 by race found that 31% of women with SLE are Black, 6% are Asian, and 20% are Hispanic.(17)
Our study has several limitations. Our data are likely to underestimate the actual rates of contraception use among women with rheumatic diseases in the U.S. Data were limited to the structured fields in the EHR, and we were unable to abstract notes in the registry. Thus, contraception may have been mentioned in free-text provider notes but not captured in our methodology. Furthermore, some women may prefer the use of low-efficacy contraception methods (e.g., condoms) that are rarely captured in the EHR. Male partner vasectomy may also not have been captured in a woman’s EHR.
In order to limit the tragedies of pregnancy loss, very early deliveries and birth defects, it is essential that rheumatologists and patients collaborate to time pregnancy carefully. Important components of this collaboration include ascertaining a woman’s plans for pregnancy and assessing whether teratogenic medication prescription is appropriate in the context of her plans, discussing optimal timing for pregnancy, documenting contraception use or nonuse, and facilitating appropriate contraception prescription. This study highlights a critical need for improved contraception documentation by rheumatologist across the United States. Contraception documentation was particularly low among women with SLE and Hispanic and Black women. This study emphasizes the importance of improving contraception documentation and education in accordance with our patients’ goals for preventing pregnancy or planning the safest possible pregnancy.
Supplementary Material
Significance:
Fewer than 10% of women of reproductive age with SLE and RA have contraception documented within their rheumatologist’s electronic medical record.
Only women with RA, but not women with SLE, who are prescribed a teratogen have a higher rate of contraception documentation.
Black and Hispanic women with both diseases have less contraceptive documentation than white women.
To decrease the frequency of unplanned pregnancies among women with rheumatic disease it is essential that rheumatologists become more effective in documenting effective and highly effective contraception.
Acknowledgments
Funding:
Data collection was supported by the ACR’s RISE Registry. However, the views expressed represent those of the authors, not necessarily those of the ACR.
Dr. Schmajuk is supported by the Russell/ Engleman Medical Research Center for Arthritis.
Dr. Eudy is supported by the NIH National Center for Advancing Translational Sciences Award 1KL2TR002554.
Dr. Birru Talabi is supported by Robert Wood Johnson Foundation Harold Amos Medical Faculty Development Program and NIAMS K23AR075057.
Footnotes
Conflicts of Interest: Dr. Clowse is supported by an independent medical education grant from GlaxoSmithKline to Duke University. Dr. Clowse is a consultant for UCB.
Contributor Information
Megan E. B. Clowse, Duke University.
Jing Li, UC San Francisco.
Mehret Birru Talabi, University of Pittsburgh Medical Center.
Amanda M. Eudy, Duke University.
Gabriela Schmajuk, UC San Francisco and the San Francisco VAMC.
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