Suboptimal Vaccination Administration in Mothers With Inflammatory Bowel Disease and Their Biologic-Exposed Infants.

BACKGROUND: Pregnant women with inflammatory bowel disease (IBD) are at increased risk of developing complications from vaccine-preventable infections. We investigated the factors influencing vaccine administration in pregnant women with IBD and their infants, in addition to the safety of vaccination in the infants. METHODS: This retrospective cohort study identified individuals from a tertiary referral clinic whose records were linked to a provincial vaccine database. We conducted χ 2 tests, Fisher exact tests, and logistic regression adjusting for age and disease duration to compare vaccine administration by medication class. Potential rotavirus vaccine adverse events were determined in infants of women with IBD. RESULTS: We included 303 pregnant women and 262 infants. Vaccines were administered to women on biologic therapy as follows: hepatitis B virus (82.9%), diphtheria-tetanus-pertussis (82.1%), and hepatitis A virus (49.3%). The influenza vaccination was provided peripartum in 50.7% of patients. The measles-mumps-rubella-varicella vaccine was provided to 89.3% of women before biologic initiation. Women treated with a biologic (adjusted odds ratio, 2.50; 95% confidence interval, 1.39-4.35) or immunomodulator (adjusted odds ratio, 4.00; 95% confidence interval, 2.22-7.69) were more likely to receive the Prevnar 13 and Pneumovax 23 vaccines than were unexposed individuals, but the overall proportion vaccinated was low (Prevnar 13, 35.7%; Pneumovax 23, 39.3%). At least 90% of infants received the measles-mumps-rubella-varicella vaccine and inactivated vaccines. Fourteen biologic-exposed children (19.2%) received the live rotavirus vaccine with no significant differences in adverse events compared with biologic-unexposed infants (7.1% vs 8.2%, P = 0.99). CONCLUSIONS: Better education surrounding vaccine recommendations is required for both health care providers and individuals with IBD given poor pneumococcal, hepatitis A virus, and influenza vaccination rates. Inadvertent administration of the rotavirus vaccine in biologic-exposed infants did not result in more adverse events, raising the possibility of safety.

Universal Testing to Identify Lynch Syndrome Among Women With Newly Diagnosed Endometrial Carcinoma.

BACKGROUND: Lynch syndrome (LS) is an autosomal dominant cancer syndrome caused by a germline mutation in the mismatch repair (MMR) genes. Protocols based on immunohistochemical expression of MMR proteins in cancer are used to identify patients with LS. METHODS: The universal LS screening protocol of the Tom Baker Cancer Centre (Calgary, AB) of all patients diagnosed between April 1, 2013 and April 1, 2015 with endometrioid carcinoma of the endometrium was audited through a retrospective chart review. LS status and frequency of protocol compliance at each of the key steps were calculated (Canadian Task Force Classification II-2). RESULTS: The cohort consisted of 375 patients. MMR immunohistochemical testing was requested for 321 (85.6%). Expression of at least one protein was lost in 86 (26.8%). Twenty-one (6.5%) patients were eligible for genetic counselling because PMS2, MSH2, or MSH6 protein expression was lost in 19, and two patients had a family history of LS. Eleven (91.7%) of 12 (57.1%) who attended had germline testing, and six (54.5%) showed a mutation diagnostic of LS. LS status among the cohort of 375 patients was positive in six (1.6%), negative in 294 (78.4%), and unknown in 75 (20%) because of protocol non-compliance. LS was confirmed in six (2%) of the 321 women who completed the protocol. CONCLUSION: This is the first audit of a Canadian-based universal LS screening protocol of patients with endometrial cancer. The success of the protocol is endorsed by the 80% compliance and by the 2% prevalence of LS, which is within the published range.

Post-colposcopy Management of ASC-US and LSIL Pap Tests (PALS Trial): Pilot RCT.

OBJECTIVE: Evidence supporting optimal follow-up of women with atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion cytology found to have low-grade disease or normal findings at initial colposcopy is weak. Surveillance options include continued colposcopy, discharge with Pap testing, or HPV testing at 12 months. This study was a pilot RCT comparing these three follow-up policies. The objectives were to determine the feasibility of an RCT and to compare the incidence of greater than or equal to high-grade squamous intraepithelial lesion (≥HSIL) in each of the follow-up policies. METHODS: A total of 133 women referred with ASC-US or low-grade squamous intraepithelial lesion cytology between June and August 2012 underwent initial colposcopy where incident ≥HSIL histology was ruled out. Of these women, 125 were randomly assigned to colposcopic surveillance, Pap testing, or HPV testing. Patients with high-risk results at any point were treated according to standard of care. Patient recruitment and adherence to follow-up were calculated using descriptive statistics. Accuracy of the three follow-up arms was calculated (Canadian Task Force Classification: IC). RESULTS: Recruitment rates were 80%, and adherence to protocol was 85% to 100%. Nine of 125 (7.2%) patients overall were found to have ≥HSIL histology at exit: one of 43 in the reference colposcopy group, and six of 41 and three of 41 in Pap and HPV arms, respectively. One early cancer was detected in the HPV arm. Sensitivity and specificity (CI) for each arm, respectively, were as follows: colposcopy N/A, 100% (88.1%-100%); Pap, 100% (47.8%-100%) and 85.7% (63.7%-97%); and HPV, 66.7% (9.4%-99.2%) and 68% (46.5%-85.1%). CONCLUSION: This pilot study demonstrated the operational and safety feasibility of an RCT in this patient population. Validation of clinical findings is necessary.