Tough Choices: Exploring Medication Decision-Making During Pregnancy and Lactation Among Women With Inflammatory Arthritis.

OBJECTIVE: This study explored how women's beliefs about drug safety and interactions with their health care providers influenced their decisions to continue arthritis medications during pregnancy and lactation. METHODS: We collaborated with ArthritisPower, a patient-powered research network, and CreakyJoints, its partner online community, to develop and disseminate a survey among members with inflammatory arthritis who had at least one pregnancy after diagnosis. Participants' free-text responses were evaluated by using thematic analysis. RESULTS: Women in the sample were 40 years old on average (N = 66). Nineteen of their pregnancies had ended in fetal loss. Fifteen percent of all pregnancies were exposed to methotrexate. Among women who used safe arthritis medications, up to 80% discontinued treatment either in preparation for pregnancy or during pregnancy or lactation. Women's decisions to continue medications during pregnancy were influenced by their perceptions of safety and advisement from health care providers, although they often described that advice about medication safety was inconsistent between providers. CONCLUSION: Women often chose to endure active inflammatory arthritis rather than to use disease-modifying antirheumatic drugs because of concerns about medication safety during pregnancy and lactation. Conflicting medical advice from health care providers undermined patients' trust in their providers and in the safety of their medications. The high rate of peripartum exposure to methotrexate, a fetotoxic drug, underscores the need for better family planning care for women with childbearing potential.

2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases

To develop an evidence-based guideline on contraception, assisted reproductive technologies (ART), fertility preservation with gonadotoxic therapy, use of menopausal hormone replacement therapy (HRT), pregnancyassessment and management, and medication use in patients with rheumatic and musculoskeletal disease (RMD). We conducted a systematic review of evidence relating to contraception, ART, fertility preservation,HRT, pregnancy and lactation, and medication use in RMD populations, using Grading of Recommendations Assessment, Development and Evaluation methodology to rate the quality of evidence and a group consensus process todetermine final recommendations and grade their strength (conditional or strong). Good practice statements wereagreed upon when indirect evidence was sufficiently compelling that a formal vote was unnecessary.. This American College of Rheumatology guideline provides 12 ungraded good practice statements and131 graded recommendations for reproductive health care in RMD patients. These recommendations are intended toguide care for all patients with RMD, except where indicated as being specific for patients with systemic lupus erythematosus, those positive for antiphospholipid antibody, and/or those positive for anti-Ro/SSA and/or anti-La/SSBantibodies. Recommendations and good practice statements support several guiding principles: use of safe andeffective contraception to prevent unplanned pregnancy, pre-pregnancy counseling to encourage conception during periods of disease quiescence and while receiving pregnancy-compatible medications, and ongoing physicianpatient discussion with obstetrics/gynecology collaboration for all reproductive health issues, given the overall low level of available evidence that relates specifically to RMD. Guidelines and recommendations developed and/or endorsed by the American College of Rheumatology (ACR) are intended to provide guidance for patterns of practice and not to dictate the care of a particular patient. The ACR considers adherence to the recommendations within this guideline to be voluntary, with the ultimate determination regarding their application to be made by the clinician in light of each patient's individual circumstances. Guidelines and recommendations are intended to promote beneficial or desirable outcomes, but cannot guarantee any specific outcome. Guidelines and recommendations developed and endorsed by the ACR are subject to periodic revision, as warranted by the evolution of medical knowledge, technology, and practice. ACR recommendations are not intended to dictate payment or insurance decisions. These recommendations cannot adequately convey all uncertainties and nuances of patient care. The American College of Rheumatology is an independent, professional, medical and scientific society that does not guarantee, warrant, or endorse any commercial product or service. This guideline provides evidence-based recommendations developed and reviewed by panels of experts and RMD patients. Many recommendations are conditional, reflecting a lack of data or low-level data. We intend that this guideline be used to inform a shared decision-making process between patients and their physicians on issues related to reproductive health that incorporates patients' values, preferences, and comorbidities.

2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases.

OBJECTIVE: To develop an evidence-based guideline on contraception, assisted reproductive technologies (ART), fertility preservation with gonadotoxic therapy, use of menopausal hormone replacement therapy (HRT), pregnancy assessment and management, and medication use in patients with rheumatic and musculoskeletal disease (RMD). METHODS: We conducted a systematic review of evidence relating to contraception, ART, fertility preservation, HRT, pregnancy and lactation, and medication use in RMD populations, using Grading of Recommendations Assessment, Development and Evaluation methodology to rate the quality of evidence and a group consensus process to determine final recommendations and grade their strength (conditional or strong). Good practice statements were agreed upon when indirect evidence was sufficiently compelling that a formal vote was unnecessary. RESULTS: This American College of Rheumatology guideline provides 12 ungraded good practice statements and 131 graded recommendations for reproductive health care in RMD patients. These recommendations are intended to guide care for all patients with RMD, except where indicated as being specific for patients with systemic lupus erythematosus, those positive for antiphospholipid antibody, and/or those positive for anti-Ro/SSA and/or anti-La/SSB antibodies. Recommendations and good practice statements support several guiding principles: use of safe and effective contraception to prevent unplanned pregnancy, pre-pregnancy counseling to encourage conception during periods of disease quiescence and while receiving pregnancy-compatible medications, and ongoing physician-patient discussion with obstetrics/gynecology collaboration for all reproductive health issues, given the overall low level of available evidence that relates specifically to RMD. CONCLUSION: This guideline provides evidence-based recommendations developed and reviewed by panels of experts and RMD patients. Many recommendations are conditional, reflecting a lack of data or low-level data. We intend that this guideline be used to inform a shared decision-making process between patients and their physicians on issues related to reproductive health that incorporates patients' values, preferences, and comorbidities.

2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases.

OBJECTIVE: To develop an evidence-based guideline on contraception, assisted reproductive technologies (ART), fertility preservation with gonadotoxic therapy, use of menopausal hormone replacement therapy (HRT), pregnancy assessment and management, and medication use in patients with rheumatic and musculoskeletal disease (RMD). METHODS: We conducted a systematic review of evidence relating to contraception, ART, fertility preservation, HRT, pregnancy and lactation, and medication use in RMD populations, using Grading of Recommendations Assessment, Development and Evaluation methodology to rate the quality of evidence and a group consensus process to determine final recommendations and grade their strength (conditional or strong). Good practice statements were agreed upon when indirect evidence was sufficiently compelling that a formal vote was unnecessary. RESULTS: This American College of Rheumatology guideline provides 12 ungraded good practice statements and 131 graded recommendations for reproductive health care in RMD patients. These recommendations are intended to guide care for all patients with RMD, except where indicated as being specific for patients with systemic lupus erythematosus, those positive for antiphospholipid antibody, and/or those positive for anti-Ro/SSA and/or anti-La/SSB antibodies. Recommendations and good practice statements support several guiding principles: use of safe and effective contraception to prevent unplanned pregnancy, pre-pregnancy counseling to encourage conception during periods of disease quiescence and while receiving pregnancy-compatible medications, and ongoing physician-patient discussion with obstetrics/gynecology collaboration for all reproductive health issues, given the overall low level of available evidence that relates specifically to RMD. CONCLUSION: This guideline provides evidence-based recommendations developed and reviewed by panels of experts and RMD patients. Many recommendations are conditional, reflecting a lack of data or low-level data. We intend that this guideline be used to inform a shared decision-making process between patients and their physicians on issues related to reproductive health that incorporates patients' values, preferences, and comorbidities.

Pregnancy, Periods, and "The Pill": Exploring the Reproductive Experiences of Women with Inflammatory Arthritis.

OBJECTIVE: Women with inflammatory arthritis appear to have fewer children as compared with healthy women, but few studies have assessed how patients' attitudes and decision making influence their family sizes. Little is also known about how patients experience other aspects of their reproductive lives, such as menstruation and contraception. METHODS: We partnered with ArthritisPower, a patient-powered research network, and its associated online patient community, CreakyJoints, to create and disseminate a survey among female members aged 18-50 years with inflammatory arthritis. RESULTS: Women in the final sample (n = 267) were 40 years old on average; most had rheumatoid arthritis (79%) and were predominantly white and college educated. Many women chose to limit childbearing because of their arthritis (58%); they feared that their arthritis was heritable, their diseases and medications could directly harm a fetus, they would be incapable of physically caring for a child, and arthritis could cause premature death, preventing them from raising their children. Infertility affected 40% of the sample. Half of women experienced subjective arthritis flares around the time of menstruation. Oral contraceptive pills (OCPs) did not worsen disease activity for most women and even prevented menstrual-associated arthritis flares for a subset of women. CONCLUSION: Our findings suggest that infertility, but also potentially outsized fear and anxiety related to their diagnoses, may affect the family sizes of women with inflammatory arthritis. The observation that menstruation worsens disease activity for some women requires additional study, and OCP use should be explored as a possible treatment for menstrual-associated arthritis. Clinicians may wish to consider how they communicate patients' individual pregnancy-associated risks, reassure patients when appropriate, and help to guide and support patients to make well-informed reproductive decisions.

Contraception methods used by women with rheumatoid arthritis and psoriatic arthritis.

Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are common in women of childbearing age and are often treated with teratogenic medications. In this study, we assessed contraceptive methods in young women with RA or PsA and correlated contraceptive method efficacy with use of concomitant rheumatic medications. We combined the data from several cross-sectional surveys of women under the age of 40 with RA or PsA. Two surveys recruited participants from a clinic setting (RA and PsA Clinic Surveys), and the third survey recruited participants from CreakyJoints.org , an online forum for patients with inflammatory arthritis (CreakyJoints Survey). Of the 164 women included, 138 had RA (67 in RA Clinic Survey, 71 in CreakyJoints Survey) and 26 had PsA (19 in PsA Clinic Survey, 7 in CreakyJoints Survey). Use of specific contraceptive and rheumatic medications were similar between the clinic and online surveys. In the pooled analysis of the Clinic and CreakyJoints survey data, women with RA and PsA reported similar utilization of highly effective contraception methods (31.9% RA, 34.6% PsA) and effective methods (31.2% RA, 30.8% PsA), but different utilization of ineffective methods (35.5% RA, 11.5% PsA) and no methods (1.5% RA, 23.1% PsA), p = 0.0002. These proportions remained similar across subgroups taking methotrexate, anti-TNF biologics, and novel medications. Approximately two thirds of women with RA and PsA reported using effective or highly effective methods of contraception, though women with PsA were more likely to report no methods of contraception.

Patient Governance in a Patient-Powered Research Network for Adult Rheumatologic Conditions.

BACKGROUND: Patient-Powered Research Networks (PPRNs) are a unique type of patient-powered patient registry for patient-centered outcomes research requiring that stakeholder engagement play a key role in governance (eg, research guidance and decision making). The purpose of this report is to describe the governance structure of a newly formed PPRN and the activities undertaken prelaunch and postlaunch to evaluate and improve the engagement of patient stakeholders in governance. METHODS: During the 18-month start-up period of ArthritisPower, a PPRN for adult rheumatologic conditions, 12 members of the patient body of the PPRN governance completed a 12-item preassessment and postassessment based on the Patient-Centered Outcomes Research Institute (PCORI) Engagement Rubric. The assessment was intended to measure Patient Governor (PG) perceptions of their engagement in governance within the first 3 months of their involvement at an in-person orientation. Six months later, the PG Chair initiated a mid-year evaluation with the same group to identify areas for improvement. Semistructured phone interviews were conducted with 11 PGs who were asked to rate and explain their perceptions about their participation in PPRN governance, the progress of the PPRN toward conducting research, the support they receive from staff, and the support they receive from other PGs. Results were compiled and interpreted by the Chair with help from the coprincipal investigator. RESULTS: Preassessment/postassessments indicated that PGs understood their governance role and decision-making authority after in-person orientation and felt that major PPRN decisions were being made with their input. Feedback and scores from the PG-led mid-year evaluation coalesced around 3 themes: a preference for receiving news and updates via email to allow more discussion and decision making during conference calls, a desire for guidance about how best to help advance the PPRN toward the conduct of research, and a need to communicate with each other as a group outside of monthly conference calls. Suggested activities to support patient engagement in PPRN governance include communicating clear expectations, providing well-prepared tools for engagement, and conducting regular assessments. CONCLUSIONS: Members of an online patient community are willing to share their expertise to participate in and shape research governance and bring both their professional and lived health experience to the development and improvement of PPRN governance structure. A patient-initiated and patient-led evaluation of governance communication procedures within the PPRN provided more specific recommendations for improvement than did an investigator-led preevaluation/postevaluation based on the PCORI Engagement Rubric.

When Patients Write the Guidelines: Patient Panel Recommendations for the Treatment of Rheumatoid Arthritis.

OBJECTIVE: How best to involve patients in the development of clinical practice guideline (CPG) recommendations is not known. We sought to determine the feasibility and value of developing CPG recommendations based on a voting panel composed entirely of patients, with the ultimate goal of comparing the patients' recommendations to ones developed by a physician-dominated voting panel on the same clinical questions. METHODS: Ten patients with rheumatoid arthritis completed 8 hours of training on evidence-based medicine and guideline development. They constituted a voting panel and, with 2 American College of Rheumatology staff with expertise in CPG development and a physician facilitator, subsequently met at a face-to-face meeting to develop recommendations. They applied the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology to formulate recommendations on 18 questions for which there was evidence warranting moderate or high confidence. RESULTS: The patient panel developed recommendations for 16 of the 18 questions; for the other 2, the panel thought there were insufficient data to support a recommendation. For 13 of the 16 questions, the patient panel recommended the same course of action as did the physician-dominated panel. Differences were due to how the 2 panels valued the balance between benefits and harms. CONCLUSION: Patient and physician-dominated panels developed the same recommendations for most questions for which there was evidence warranting moderate to high confidence. Additional experiences are necessary to advance the evidence necessary to determine what panel composition is optimal to produce the best guidelines.