"The medications are the decision-makers " Making reproductive and medication use decisions among female patients with rheumatoid arthritis: a constructivist grounded theory.

OBJECTIVE: To examine how female patients with RA form decisions about having children, pregnancy, and medication use. METHODS: We employed a constructivist grounded theory design and recruited female participants who are 18 years or older, have a rheumatologist-confirmed RA diagnosis, live in Canada, and are able to communicate in English or French. We collected data through semi-structured individual and focus group interviews using telephone or video conferencing technology. Data collection and analysis were iterative, employed theoretical sampling, reflexive journaling, and peer debriefing, and culminated in a theoretical model. RESULTS: We recruited 21 participants with a mean age of 34 years and median 10 years since RA diagnosis. Overall, 33% had never been pregnant, 57% had previously been pregnant, and 10% were pregnant at the time of interview. Of those who had experienced pregnancy, 64% had at least one pregnancy while diagnosed with RA and of those, 56% used DMARD(s) during a pregnancy. We constructed a patient-centred framework depicting the dynamic relationships between 4 decision-making processes-(1) using medications, (2) having children, (3) planning pregnancy, and (4) parenting-and the substantial impact of healthcare providers on patients' experiences making these decisions. These processes were further influenced by participants' intersecting identities and contextual factors, particularly attitudes towards health and medications, disease onset and severity, familial support system, and experiences interacting with the healthcare system. CONCLUSION: Our framework provides insight into how patients make reproductive decisions in the context of managing RA and the opportunities for providers to support them at each decision-making process. A patient-centred care approach is suggested to support female patients with RA in making reproductive and medication choices aligning with their individual desires, needs, and values.

Partners of female patients with rheumatoid arthritis and reproductive decision-making: a constructivist grounded theory study.

OBJECTIVE: Partners of patients with RA often take on supportive roles given the debilitating nature of RA. Our objective was to explore the perspectives, attitudes and experiences of partners of female patients with RA regarding reproductive experiences and decision-making. METHODS: We conducted a qualitative study involving semi-structured interviews with partners of female patients with RA. We defined a partner as an individual within a romantic relationship. Constructivist grounded theory was applied to interview transcripts to identify and conceptualize themes. RESULTS: We interviewed 10 partners of female patients with RA (10 males; mean age, 35 [23-56] years), of whom 40% had at least one child with a female patient with RA and did not desire additional children. We identified four themes representing stages of reproductive decision-making: (1) developing an understanding of RA, (2) contemplating future family decision-making, (3) initiating reproductive decision-making with partner, and (4) reflecting on past reproductive experiences. Participants contemplated their attitudes and perspectives regarding pregnancy and used available information to support their partner's medication decisions. When reflecting on their reproductive experiences, participants shared the impacts of past reproductive decisions on their romantic relationship and their mental health and wellbeing. CONCLUSION: Our study highlights the need for comprehensive support for both female patients with RA and their partners at all stages of reproductive decision-making. Health-care providers can identify opportunities for intervention that involves female patients with RA and their partners to minimize stress and its negative impacts on the family.

Management of Inflammatory Arthritis in pregnancy: a National Cross-Sectional Survey of Canadian rheumatologists.

BACKGROUND: With improved therapies and management, more women with inflammatory arthritides (IA) are considering pregnancy. Our objective was to survey rheumatologists across Canada about their IA management in pregnancy to identify practice patterns and knowledge gaps. METHODS: We administered an online survey with questions regarding medications for IA treatment including conventional synthetic disease modifying antirheumatic drugs (csDMARDs) and biologics/small molecules in planned and unplanned pregnancies. Email invitations were sent to members of the Canadian Rheumatology Association. We calculated responses frequencies and a priori set a cut-off of ≥75% to define consensus. RESULTS: Ninety rheumatologists participated in the survey (20% participation rate); 57% have been practicing for > 10 years, 32% for ≤10 years, and 11% in training. There was consensus on discontinuation of 4 csDMARDs - cyclophosphamide (100%), leflunomide (98%), methotrexate (96%), and mycophenolate mofetil (89%) - in planned pregnancies but varied responses on when to discontinue them or what to do in unplanned pregnancies. Respondents agreed that 3 csDMARDs - azathioprine (84%), hydroxychloroquine (95%), and sulfasalazine (77%) - were safe to continue in planned and unplanned pregnancies. There was consensus with use of 4 biologics - adalimumab (81%), certolizumab (80%), etanercept (83%), and infliximab (76%) - in planned pregnancies but uncertainty on when they should be discontinued and their use in unplanned pregnancies. CONCLUSIONS: This national survey shows consensus among rheumatologists on the use of some csDMARDs and biologics/small molecules in IA patients planning pregnancy but varied knowledge on when to discontinue and what to do in unplanned pregnancies.

Canadian Rheumatology Association Recommendations for the Assessment and Monitoring of Systemic Lupus Erythematosus.

OBJECTIVE: To develop recommendations for the assessment of people with systemic lupus erythematosus (SLE) in Canada. METHODS: Recommendations were developed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. The Canadian SLE Working Group (panel of Canadian rheumatologists and a patient representative from Canadian Arthritis Patient Alliance) was created. Questions for recommendation development were identified based on the results of a previous survey of SLE practice patterns of members of the Canadian Rheumatology Association. Systematic literature reviews of randomized trials and observational studies were conducted. Evidence to Decision tables were prepared and presented to the panel at 2 face-to-face meetings and online. RESULTS: There are 15 recommendations for assessing and monitoring SLE, with varying applicability to adult and pediatric patients. Three recommendations focus on diagnosis, disease activity, and damage assessment, suggesting the use of a validated disease activity score per visit and annual damage score. Strong recommendations were made for cardiovascular risk assessment and measuring anti-Ro and anti-La antibodies in the peripartum period and conditional recommendations for osteoporosis and osteonecrosis. Two conditional recommendations were made for peripartum assessments, 1 for cervical cancer screening and 2 for hepatitis B and C screening. A strong recommendation was made for annual influenza vaccination. CONCLUSION: These are considered the first guidelines using the GRADE method for the monitoring of SLE. Existing evidence is largely of low to moderate quality, resulting in more conditional than strong recommendations. Additional rigorous studies and special attention to pediatric SLE populations and patient preferences are needed.

Monitoring of Systemic Lupus Erythematosus Pregnancies: A Systematic Literature Review.

OBJECTIVE: Few data exist to guide the frequency and type of monitoring in systemic lupus erythematosus (SLE) pregnancies. A systematic literature review was performed to address this gap in the literature. METHODS: A systematic review of original articles (1975-2015) was performed using Medline, Embase, and Cochrane Library. We included search terms for SLE, pregnancy, and monitoring. We also hand-searched reference lists, review articles, and grey literature for additional relevant articles. RESULTS: The search yielded a total of 1106 articles. After removing 117 duplicates, 929 articles that were evidently unrelated to our topic based on title and/or abstract, and 7 that were in a language other than English or French, 53 articles were included for full-text review. Following a more in-depth review, 15 were excluded: 6 did not use any measure of SLE activity and 6 did not specifically address SLE monitoring in pregnancy; 1 case series, 1 review, and 1 metaanalysis were removed. Among the 38 included studies, presence of active disease, antiphospholipid (aPL) antibodies positivity, and abnormal uterine and umbilical artery Doppler studies predicted poor pregnancy outcomes. No studies evaluated an evidence-based approach to the frequency of monitoring. CONCLUSION: Few existing studies address monitoring for optimal care during SLE pregnancies. The available data imply roles for aPL antibodies measurement (prior to pregnancy and/or during the first trimester), uterine and umbilical artery Doppler studies in the second trimester, and following disease activity. Optimal frequency of monitoring is not addressed in the existing literature.

Cancer risk in systemic lupus: an updated international multi-centre cohort study.

OBJECTIVE: To update estimates of cancer risk in SLE relative to the general population. METHODS: A multisite international SLE cohort was linked with regional tumor registries. Standardized incidence ratios (SIRs) were calculated as the ratio of observed to expected cancers. RESULTS: Across 30 centres, 16,409 patients were observed for 121,283 (average 7.4) person-years. In total, 644 cancers occurred. Some cancers, notably hematologic malignancies, were substantially increased (SIR 3.02, 95% confidence interval, CI, 2.48, 3.63), particularly non-Hodgkin's lymphoma, NHL (SIR 4.39, 95% CI 3.46, 5.49) and leukemia. In addition, increased risks of cancer of the vulva (SIR 3.78, 95% CI 1.52, 7.78), lung (SIR 1.30, 95% CI 1.04, 1.60), thyroid (SIR 1.76, 95% CI 1.13, 2.61) and possibly liver (SIR 1.87, 95% CI 0.97, 3.27) were suggested. However, a decreased risk was estimated for breast (SIR 0.73, 95% CI 0.61-0.88), endometrial (SIR 0.44, 95% CI 0.23-0.77), and possibly ovarian cancers (0.64, 95% CI 0.34-1.10). The variability of comparative rates across different cancers meant that only a small increased risk was estimated across all cancers (SIR 1.14, 95% CI 1.05, 1.23). CONCLUSION: These data estimate only a small increased risk in SLE (versus the general population) for cancer over-all. However, there is clearly an increased risk of NHL, and cancers of the vulva, lung, thyroid, and possibly liver. It remains unclear to what extent the association with NHL is mediated by innate versus exogenous factors. Similarly, the etiology of the decreased breast, endometrial, and possibly ovarian cancer risk is uncertain, though investigations are ongoing.

Minimal clinically important difference for 7 measures of fatigue in patients with systemic lupus erythematosus.

OBJECTIVE: To determine the minimal clinically important difference (MCID) for 7 measures of fatigue in patients with systemic lupus erythematosus (SLE). METHODS: Study subjects completed 7 fatigue instruments [Fatigue Severity Scale (FSS), Multidimensional Assessment of Fatigue (MAF), Multidimensional Fatigue Inventory (MFI), Vitality scale of the MOS-SF-36, Chalder Fatigue Scale (CFS), Functional Assessment of Chronic Illness Therapy-Fatigue, and a global Rating Scale (RS)] and then participated in a series of interviews with other study participants comparing their fatigue with one another. Each interview participant rated the difference in their fatigue levels on a 7-point transition scale. The MCID was estimated from the mean difference in fatigue scores between each pair of interview participants based on their subjective rating of fatigue contrast. The MCID was also estimated using linear regression modeling. RESULTS: Eighty patients with SLE participated. Patients reported significant levels of fatigue [mean normalized (0 = none, 100 = maximum) fatigue scores for the 7 instruments ranged from 49.8 (CFS) to 71.1 (FSS)]. The MCID of "a little more" fatigue tended to be greater than the MCID for a "little less fatigue" and differed significantly for FSS and MAF. The MCID of normalized scores estimated by linear regression ranged from 7.0 (CFS) to 14.3 (MFI). CONCLUSION: Fatigue is a common and debilitating component of SLE. Estimates of MCID will help to interpret changes observed in a fatigue score and will be critical in estimating sample size requirements for clinical trials including fatigue as an outcome.

Determination of the minimal clinically important difference for seven fatigue measures in rheumatoid arthritis.

OBJECTIVE: To estimate the minimal clinically important difference (MCID) of seven measures of fatigue in rheumatoid arthritis. STUDY DESIGN AND SETTING: A cross-sectional study design based on interindividual comparisons was used. Six to eight subjects participated in a single meeting and completed seven fatigue questionnaires (nine sessions were organized and 61 subjects participated). After completion of the questionnaires, the subjects had five one-on-one 10-minute conversations with different people in the group to discuss their fatigue. After each conversation, each patient compared their fatigue to their conversational partners on a global rating. Ratings were compared to the scores of the fatigue measures to estimate the MCID. Both nonparametric and linear regression analyses were used. RESULTS: Nonparametric estimates for the MCID relative to "little more fatigue" tended to be smaller than those for "little less fatigue." The global MCIDs estimated by linear regression were: Fatigue Severity Scale, 20.2; Vitality scale of the MOS-SF36, 14.8; Multidimensional Assessment of Fatigue, 18.7; Multidimensional Fatigue Inventory, 16.6; Functional Assessment of Chronic Illness Therapy-Fatigue, 15.9; Chalder Fatigue Scale, 9.9; 10-point numerical Rating Scale, 19.7, for normalized scores (0-100). The standardized MCIDs for the seven measures were roughly similar (0.67-0.76). CONCLUSION: These estimates of MCID will help to interpret changes observed in a fatigue score and will be critical in estimating sample size requirements.

Anesthetic management of the parturient with relapsing polychondritis.

PURPOSE: To present the anesthetic management of a parturient with relapsing polychondritis (RP) and to discuss the anesthetic implications of RP. CLINICAL FEATURES: A 28-yr-old primiparous woman with known RP, spondyloarthropathy and fibromyalgia presented for urgent Cesarean delivery for breech presentation and prodromal labour. Her pregnancy had been complicated by a hospital admission for an exacerbation of her RP as manifested by hoarseness, increased pain and tenderness of her left ear and nasal bridge cartilages, sinusitis with bloody nasal discharge and increased pain and tenderness of the anterior tracheal rings. Epidural anesthesia was administered for the Cesarean delivery. Her intraoperative and postoperative course was uneventful. Close cooperation among obstetricians, anesthesiologists and rheumatologists resulted in a successful outcome. CONCLUSION: Relapsing polychondritis is a syndrome with important anesthetic implications. Multidisciplinary cooperation is essential in managing these high risk parturients.

Treatment of antiphospholipid antibody syndrome (APS) in pregnancy: a randomized pilot trial comparing low molecular weight heparin to unfractionated heparin.

OBJECTIVE: To compare low molecular weight heparin (LMWH), specifically dalteparin, to unfractionated heparin (UFH) for the treatment of antiphospholipid antibody syndrome (APS) in pregnancy. METHODS: In a tertiary referral centre, 28 women met the 1999 International Consensus Criteria for APS, based on their obstetrical history and APS serology. The women were randomized, using a random numbers table with blocks of 12, to receive either prophylactic dosing of dalteparin or UFH starting either preconceptionally or early in pregnancy. All women also received low-dose acetylsalicylic acid, started preconceptionally. The primary outcome was a live birth. The secondary outcomes were maternal and fetal complications. RESULTS: Of the 14 women who received the LMWH, dalteparin, and the 14 women who received UFH, 1 woman in each group did not conceive. Nine of the 13 women (69%) given dalteparin had a successful pregnancy (95% confidence interval [CI], 39-91%), compared to 4 out of the 13 women (31%) in the UFH group (95% CI, 9-61%). Nine women in total had spinal or epidural anaesthesia, and there were no complications overall. CONCLUSION: Dalteparin may be an effective alternative to UFH for treatment of APS in pregnancy. A multicentre randomized trial is needed to determine benefit-to-risk ratios for the use of dalteparin and UFH to treat this high-risk obstetrical condition. Pharmacokinetic and pharmacodynamic studies are also recommended to maximize therapeutic response and minimize toxicity.

Gender and ethnic origin have no effect on longterm outcome of childhood-onset systemic lupus erythematosus.

OBJECTIVE: To investigate the associations of gender and ethnic origin with longterm outcome in childhood-onset systemic lupus erythematosus (SLE). METHODS: The study cohort consisted of 51 patients (13 males and 38 females) with childhood-onset SLE followed for > or = 5 years at the British Columbia Children's Hospital in Vancouver. Fifteen patients were Caucasian, 14 Chinese, 9 East Indian, and 13 patients were of other ethnic backgrounds: none was African-American or Hispanic. Outcome measures assessed retrospectively included Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index score (SDI), SLE-related death, need for dialysis or renal transplantation, and use of intensive immunosuppressive therapy. A SDI > or = 2 was assigned as poor outcome. RESULTS: The median age at diagnosis was 10.8 years and the median duration of followup was 7.2 years. Five-year survival was 100%; 10-year survival was 85.7% (12/14 patients). The median SDI score at last followup was 2.0 (range 0-9); 2.0 for male, 1.5 for female; 2.0 for Caucasian and 2.03 for non-Caucasian patients. Twenty-six out of 51 patients (51%) had poor outcome (SDI score > 2). Three female patients required dialysis: 2 had subsequent renal transplants. Thirty patients received intensive immunosuppressive therapy. The SDI scores, mortality, and need for intensive immunosuppressive therapy were not influenced by either gender or ethnic origin. CONCLUSION: The median SDI score was high for this cohort with childhood-onset SLE. In contrast to other published data, no association of male gender and/or non-Caucasian ethnicity with poor outcome was found in our study cohort.

Group psychotherapy reduces illness intrusiveness in systemic lupus erythematosus.

OBJECTIVE: We investigated whether brief supportive-expressive group psychotherapy might reduce illness-induced interference with valued activities and interests (i.e., illness intrusiveness) among women with systemic lupus erythematosus (SLE) in relation to 3 life domains: (1) relationships and personal development (family relationships, other social relationships, self-expression), (2) intimacy (relationship with spouse, sex life), and/or (3) instrumental life (work, finances, active recreation). METHODS: Women with SLE recruited from 9 rheumatology centers were randomly assigned to receive either usual care (n = 66) or a 12 week brief supportive-expressive group psychotherapy followed by 3 monthly booster sessions (n = 58). Standard instruments assessed disease activity and damage, illness intrusiveness, and psychological distress at 4 measurement occasions: (1) pretreatment, (2) posttreatment, (3) 6 month followup, and (4) 12 month followup. RESULTS: Analysis of covariance, controlling for disease activity and household income, indicated that women who received brief supportive-expressive group psychotherapy experienced significant reductions in illness intrusiveness for 2 of 3 domains: (1) relationships and personal development and (2) intimacy. Benefits were evident at 6 and 12 month followups. CONCLUSION: Brief supportive-expressive group psychotherapy facilitates adaptation to SLE by assisting women in reducing illness-induced disruptions into important domains of life experience.

Cardiovascular risk factor screening in systemic lupus erythematosus.

OBJECTIVE: To evaluate the frequency of cardiovascular (CV) disease risk factor screening in systemic lupus erythematosus (SLE). METHODS: Medical records of patients from a lupus clinic and 5 private practices were assessed for CV disease risk factors, including hyperlipidemia, hypertension, diabetes mellitus, smoking, family history of CV disease, antiphospholipid antibodies, hyperhomocysteinemia, postmenopausal status, obesity, and nephrotic syndrome. RESULTS: A total of 183 records were included: 60 (33%) from the lupus clinic and 123 (67%) from private practices. Serum lipid profiles were measured in 56/183 (31%): 37/60 (62%) in the lupus clinic vs 19/123 (15%) private practice. Of the 56 with lipids measured, the individual tests obtained were as follows: total cholesterol in 56 (100%), HDL in 50 (89%), triglycerides in 49 (88%), LDL in 48 (86%), and VLDL in 33 (59%). Thirty-one of 56 patients (55%) had elevated lipids. Only 9/25 (36%) with hyperlipidemia who had a subsequent visit had a response to the hyperlipidemia charted. Of 9 nonlipid risk factors, a median of 8 were assessed in the lupus clinic vs 3 in private practices. The most frequent risk factors screened were nephrotic syndrome (91%), hypertension (74%), and smoking (59%). CONCLUSION: Despite an inordinately high risk of CV disease in SLE, assessment of CV risk factors was surprisingly uncommon among the practices assessed. Greater attention needs to be paid to CV disease risk factor screening in patients with lupus.

Counterbalancing patient demands with evidence: results from a pan-Canadian randomized clinical trial of brief supportive-expressive group psychotherapy for women with systemic lupus erythematosus.

OBJECTIVE: To evaluate the effect of Brief Supportive-Expressive Group Psychotherapy as an adjunct to standard medical care in reducing psychological distress, medical symptoms, and health care costs and improving quality of life in women with systemic lupus erythematosus (SLE). METHODS: A randomized clinical trial was conducted with 133 SLE female patients from 9 clinics across Canada. Clinical and psychosocial measures were taken at baseline, posttreatment, and 6 and 12 months posttreatment. Outcomes assessed were psychological distress, quality of life, disease activity, health service utilization, and diminished productivity. RESULTS: Intention-to-treat analyses revealed that there were no clinically important group differences on any of the outcome measures. CONCLUSION: Although both groups improved over time on several measures (e.g., decreases in psychological distress, stress, and emotion-oriented coping), these changes could not be attributed to the psychotherapeutic intervention. Thus, evidence does not support the referral of these patients to this type of intervention.