A. What evidence are you proposing to translate into practice?
From: Systematic Review of the Literature Informing the Systemic Lupus Erythematosus Indicators Project: Reproductive Health Care Quality Indicators
Arthritis Care & Research. Vol. 63, No. 1, January 2011, pp 17–30
IF a woman between 18 and 45 years of age is started on a medication for SLE (e.g., chloroquine, quinacrine, methotrexate, azathioprine, leflunomide, mycophenolate mofetil, cyclosporine, cyclophosphamide, or thalidomide), THEN a discussion with the patient about the potential teratogenic risks of therapy and about contraception should be documented prior to drug initiation, unless the patient is unable to conceive (e.g., the patient had a hysterectomy, oophorectomy, or tubal ligation, or is postmenopausal), BECAUSE these drugs either have teratogenic potential or pose an unknown risk to the developing fetus.
I actually believe as a pediatric rheumatologist, that this age group should be extended down to any post-menarchal female.
- Justify that this evidence is “ready for translation.” Though this is not a practice guideline, it is a systematic review that was done with the purpose of developing quality indicators pertaining to reproductive health in SLE.
- Identify a single, key behavior change target for your translational activity. To document discussion of teratogenic risk at initiation (100%) and medication reconciliation of all of the following females: post-menarchal, able to conceive, on any of the following medications: Chloroquine/quinacrine, methotrexate, leflunomide, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, thalidomide.
- Conduct a “gap analysis” of your target behavior. Look to diverse sources for “best guess” estimates if specific measures are not available.
Yazdany. Arthritis Care & Research. Vol. 63, No. 3, March 2011, pp 358 –365: Most women at risk for unplanned pregnancy reported no contraceptive counseling in the past year, despite common use of potentially teratogenic medications. Many relied upon contraceptive methods with high failure rates; few used IUDs. Some were inappropriately using estrogen-containing contraceptives. These findings suggest the need to improve the provision of contraceptive services to women with SLE.
Schwarz. Ann Intern Med 2007;147:370–6: 1 of 6 women had filled a prescription for a Food and Drug Administration (FDA) class D or X drug within the previous year. The incidence of filled prescriptions followed by a documented positive pregnancy test was similar among women taking FDA class A and B medications as compared with women taking class D or X medications.
Weisman. Womens Health Issues 2002;12:79–95: 898 women of childbearing age without SLE were interviews and they found that a history of contraceptive counseling correlated with a decrease in unintended pregnancy and a higher likelihood of contraception use.
Ronis. Arthritis Care & Research Vol. 66, No. 4, April 2014, pp 631–635: 90 females in a pediatric rheumatology clinic (stanford) were surveyed if HEADSS assessment was performed on patient in clinic. Almost all patients (99%) agreed that reproductive health was discussed; 71% reported that pregnancy risks were discussed, 42% had recent concerns about reproductive health, and 33% reported their provider recommended that they seek further reproductive health care. Eighty-four patients completed followup phone surveys, with 25% reporting seeking further information on reproductive health concerns, but with only 9.5% actually seeking further care. Only 18% of patients reported having ever asked their rheumatology provider for guidance regarding reproductive health care concerns.
B. What is the quality (performance) gap? Contraceptive counseling/preconception health care for patients with lupus on teratogenic medications and adherence to contraception for these patients.
C. What is the outcome gap? Unintended pregnancy.
D. Is there evidence that changing performance will improve health (clinical outcomes)?
Not eaxctly, but this can be extrapolated from: Weisman. Womens Health Issues 2002;12:79–95: 898 women of childbearing age without SLE were interviews and they found that a history of contraceptive counseling correlated with a decrease in unintended pregnancy and a higher likelihood of contraception use.