Search

BACKGROUND: There is a paucity of published data regarding the quality of care of inflammatory bowel disease (IBD) in Canada. Clinical quality indicators are quantitative end points used to guide, monitor and improve the quality of patient care. In Canada, where universal health care can vary significantly among provinces, quality indicators can be used to identify potential gaps in the delivery of IBD care and standardize the approach to interprovincial management.METHODS: The Emerging Practice in IBD Collaborative (EPIC) group generated a shortlist of IBD quality indicators based on a comprehensive literature review. An iterative voting process was used to select quality indicators to take forward. In a face-to-face meeting with the EPIC group, available evidence to support each quality indicator was presented by the EPIC member aligned to it, followed by group discussion to agree on the wording of the statements. The selected quality indicators were then ratified in a final vote by all EPIC members.RESULTS: Eleven quality indicators for the management of IBD within the single-payer health care system of Canada were developed. These focus on accurate diagnosis, appropriate and timely management, disease monitoring, and prevention or treatment of complications of IBD or its therapy.CONCLUSIONS: These quality indicators are measurable, reflective of the evidence base and expert opinion, and define a standard of care that is at least a minimum that should be expected for IBD management in Canada. The next steps for the EPIC group involve conducting research to assess current practice across Canada as it pertains to these quality indicators and to measure the impact of each of these indicators on patient outcomes.

Antitumour necrosis factor (anti-TNF) therapy has been a major advance in the treatment of inflammatory bowel disease (IBD) by improving rates of mucosal healing, steroid-free remission, and decreasing rates of hospitalization and surgery. Because IBD affects women in their reproductive years, clinicians have and will continue to be asked in the future about the safety profile of these agents and their potential impact on pregnancy, the developing fetus and newborn. Immunoglobulin G transfer from the mother to fetus begins in the second trimester, with an elevation starting at 22 weeks of gestation and the largest amount transferred in the third trimester. Although research investigating the long-term outcomes of children exposed to anti-TNF therapy in utero is limited, there is no known adverse effect on either pregnancy or newborn outcomes including infectious complications with this class of drugs. The World Congress of Gastroenterology consensus statement on biological therapy for IBD considered infliximab and adalimumab to be low risk and compatible with use during conception and during pregnancy in at least the first two trimesters. Based on a clinical algorithm used at the University of Calgary Pregnancy and IBD clinic (Calgary, Alberta), recommendations have been provided on the management of pregnant patients on anti-TNF therapy, particularly with regard to third-trimester dosing, taking into account disease characteristics of individual patients. When educated about the safety of anti-TNF therapy during pregnancy, patients often choose to continue on therapy during the third trimester.

Inflammatory bowel disease (IBD) affects patients in their adolescent and adult years of life, during a time when they may be contemplating pregnancy or are pregnant. Maternal IBD and, specifically, active IBD during pregnancy are associated with an increased risk of adverse maternal and fetal outcomes including prematurity, low birth weight, and cesarean delivery [1]. Thus optimization and management of IBD before and during pregnancy are important in improving maternal and fetal outcomes. Nevertheless, patients and physicians are challenged on balancing the benefits of therapy for active maternal IBD with the potential risks of these therapies to the fetus. The medical literature has demonstrated that significant gaps in knowledge about the management of IBD during pregnancy exist in both patients and their physicians, resulting in misperceptions about IBD therapies during pregnancy [2–4]; “voluntary childlessness” as a consequence of fear of infertility, the ability to cope with the pregnancy in the presence of disease, heritability of the disease, and adverse fetal outcomes [2–4]; medication nonadherence [3–7]; and misdirected physician-led modification or cessation of therapies in this cohort [7–9]. Further, in a recent Canadian survey of physicians, less than 50% of surveyed physicians felt comfortable managing IBD during pregnancy [10]. In Canada, family physicians and nurses are often the primary initial contact for the IBD patient in their journey from preconception to pregnancy. Once pregnant, women in the Canadian healthcare system are cared for by a multidisciplinary team that includes family physicians, obstetricians, nurses, and midwives. Acknowledging the knowledge gap and changing landscape of IBD management, “The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy” were developed, integrating up-to-date evidence vetted by the GRADE approach and tailored to North American clinical practice [11]. “The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy” [11] consist of 29 recommendations (27 statements, of which two statements have two parts, i.e., 4A, 4B, 10A, and 10B) spanning preconception, pregnancy, and postpartum care. The recommendations can be viewed in Table 1 or within the hyperlink provided: https://www.cag-acg.org/images/publications/PIIS0016508515017734.pdf. The working group comprised experts from multiple disciplines which included (1) gastroenterologists with expertise in the management of IBD; (2) obstetricians; (3) specialists in maternal-fetal medicine; (4) pharmacologists; and (5) female IBD patient representation. The consensus panel was also well represented by Motherisk, an internationally recognized program that provides information and advice to pregnant women and their healthcare providers on the safety of medications during pregnancy and breastfeeding. As adverse events such as preterm delivery can lead to higher rates of infant mortality, appropriate and timely diagnostic and treatment interventions during pregnancy can be considered lifesaving measures. Taking this into consideration and the highly favorable benefit-harm profile, the working group designated 21 of the 29 recommendations as strong despite the very low quality of evidence presented. Table 1 Summary of consensus recommendations for the management of IBD in pregnancy. In contrast to previously published guidelines, the Toronto consensus is very explicit in its recommendations for management of flares during pregnancy. These recommendations are stratified by disease phenotype and current medication(s) at the time of the flare. Statements 14–16 emphasize the use of induction agents that include corticosteroid therapy or anti-TNF therapy. Additionally, the consensus statements help to guide care providers on the use of concomitant thiopurine therapy, making the distinction between a patient who is naive to thiopurine therapy in the event of a flare (Statement 16) and the scenario of a patient already on combination therapy (Statement 11). Recognizing that controversy surrounds the use of anti-TNF therapy, the Toronto consensus provides clear recommendations that anti-TNF therapy is to be continued throughout pregnancy (Statement 10A). This differs from various editorials, guidelines, and review articles that have focused on discontinuation of anti-TNF in the late second trimester or early third trimester [12–14]. There is no doubt that the current Toronto guidelines place disease remission as top priority based on solid evidence that inactive disease portends the best prognosis for both maternal and fetal health. Further, consensus members discussed that the common practice of modifying the dosing schedule during the third trimester (e.g., providing an infusion of infliximab at weeks 30–32 and adalimumab at weeks 34–36 and then resuming therapy postpartum) to minimize drug hiatus may help minimize disease flare in the mother but does not minimize fetal exposure, as transplacental drug transfer is very efficient in the second and third trimesters. There is, however, little evidence of an increased risk of infection or developmental delay (at least in the short-term) with continued anti-TNF therapy. However, recognizing a variety of individual factors such as theoretical concerns or strong patient preference, Statement 10B makes the conditional recommendation that, in order to minimize fetal exposure, one could administer the last dose at 22 to 24 weeks of gestation in patients who are at low risk for relapse. Strict criteria for determining patients who are at low risk for relapse are explicitly stated and include sustained symptomatic remission during the 12 months before conception, no active disease on endoscopy or imaging during the preconception period, no prior secondary loss of response to anti-TNF therapy or dose escalation, demonstrated therapeutic levels of anti-TNF therapy, no prior intestinal resections, and no hospitalizations in the past 36 months [15]. These statements make strong recommendations for objective assessments before conception and close monitoring during pregnancy, though it is recognized that some jurisdictions may have limited access to endoscopy, specialized gastroenterology care, or high-risk obstetrical consultation. However, these guidelines provide a framework from which healthcare providers can make decisions regarding the management of IBD during pregnancy and provide a common algorithm that can be followed by the multidisciplinary care team that manages the pregnant woman with IBD. V. Huang Y. Leung G. C. Nguyen C. H. Seow