Antibody Kinetics after Three Doses of SARS-CoV-2 mRNA Vaccination in Patients with Inflammatory Bowel Disease.

Background: The emergence of new SARS-CoV-2 variants calls for more data on SARS-CoV-2 mRNA vaccine response. Aims: We aimed to assess the response to a third mRNA vaccine dose against SARS-CoV-2 in inflammatory bowel disease (IBD) patients. Methods: This was a single-center, observational prospective study of IBD patients who received a third mRNA vaccine dose against SARS-CoV-2. Antibody titers were taken post-third-dose at one and three months using the Roche Elecsys anti-SARS-CoV-2-S enzyme immunoassay. Titers less than 0.8 units/mL were considered negative according to the manufactures. Titers between 0.8 units/mL and 250 units/mL were considered non-neutralizing. Titers greater than 250 units/mL were considered neutralizing. Results: Eighty-three patients were included, all of whom had detectable antibodies at 3 months post-third dose. A total of 89% showed neutralizing and 11% non-neutralizing titers. Participants with non-neutralizing titers were more likely to be on systemic corticosteroids (p = 0.04). Two participants seroconverted from negative to positive, whereas 86% with non-neutralizing titers boosted to neutralizing levels. Only one participant with neutralizing titers after a third dose had a decrease to a non-neutralizing level within 3 months. Conclusions: Our findings support the ongoing recommendations for additional doses in immunocompromised individuals. However, longitudinal studies with a greater-sized patient population are needed.

Antibody Response 3 Months After 2-Dose SARS-CoV-2 mRNA Vaccination in Patients With Inflammatory Bowel Disease.

INTRODUCTION: The response to SARS-CoV-2 vaccination of patients with inflammatory bowel disease (IBD) on immune-modifying therapies requires further investigation because previous studies indicate that patients on immune therapy might have decreased antibody concentrations. METHODS: We present the antireceptor binding domain antibody response over a period of 3 months in 217 patients with IBD who completed standard 2-dose SARS-CoV-2 mRNA vaccine series. RESULTS: Almost all (98.6%) IBD vaccine recipients had a positive antireceptor binding domain antibody response at least 3 months after vaccination. Decreased antibody titers at 3 months were seen in a subset of patients on antitumor necrosis factor-alpha. Approximately 10% of the participants with high-titer antibodies at 1 month had a decrease to low-positive titers at 3 months, which was mostly observed in those on combination therapy and antitumor necrosis factor-alpha monotherapy. DISCUSSION: Larger longitudinal studies are required to define the response in IBD population and its clinical impact.

Whole-genome sequencing of African Americans implicates differential genetic architecture in inflammatory bowel disease.

Whether or not populations diverge with respect to the genetic contribution to risk of specific complex diseases is relevant to understanding the evolution of susceptibility and origins of health disparities. Here, we describe a large-scale whole-genome sequencing study of inflammatory bowel disease encompassing 1,774 affected individuals and 1,644 healthy control Americans with African ancestry (African Americans). Although no new loci for inflammatory bowel disease are discovered at genome-wide significance levels, we identify numerous instances of differential effect sizes in combination with divergent allele frequencies. For example, the major effect at PTGER4 fine maps to a single credible interval of 22 SNPs corresponding to one of four independent associations at the locus in European ancestry individuals but with an elevated odds ratio for Crohn disease in African Americans. A rare variant aggregate analysis implicates Ca2+-binding neuro-immunomodulator CALB2 in ulcerative colitis. Highly significant overall overlap of common variant risk for inflammatory bowel disease susceptibility between individuals with African and European ancestries was observed, with 41 of 241 previously known lead variants replicated and overall correlations in effect sizes of 0.68 for combined inflammatory bowel disease. Nevertheless, subtle differences influence the performance of polygenic risk scores, and we show that ancestry-appropriate weights significantly improve polygenic prediction in the highest percentiles of risk. The median amount of variance explained per locus remains the same in African and European cohorts, providing evidence for compensation of effect sizes as allele frequencies diverge, as expected under a highly polygenic model of disease.

Development of an Interdisciplinary Healthcare Team for Pressure Injury Management: A Quality Improvement Project.

PURPOSE: The purpose of this quality improvement project was to create an interdisciplinary healthcare team for the management of patients with stage 3, stage 4, and unstageable pressure injuries (PIs), improve the communication among the interdisciplinary healthcare team, test the educational level of the nursing staff regarding PI management, and conduct quarterly PI prevalence surveys to decrease the rate of the hospital-acquired pressure injuries (HAPIs). PARTICIPANTS AND SETTING: Patients with stage 3, stage 4, and unstageable PIs in medical adult inpatient units of a private tertiary hospital located in the eastern province of Saudi Arabia were included in the study. APPROACH: During the project period (February 21, 2017, to May 23, 2017), a healthcare team was formed consisting of a hospitalist, a plastic surgeon, a case manager, a dietitian, a physiotherapist, and wound and home health nurses. The team communication and staff adherence to the care plan were measured through an audit tool. Nurses' educational level was measured by pre- and posttest assessments. In addition, a quarterly PI survey day was conducted twice to monitor the occurrence of HAPIs and to reevaluate nursing staff knowledge of management of HAPIs. OUTCOMES: Results showed improvement in communication within the interdisciplinary team regarding care of patients with HAPIs, with 100% staff adherence to the plan of care. In addition, unit-based educational sessions conducted to measure staff knowledge showed a statistically significant increase (P < .000). Although small, the HAPI rate decreased from 5.9% to 5% during this short 3-month study.

Symptoms among emerging adults with inflammatory bowel disease: a descriptive study.

Individuals with inflammatory bowel disease (IBD) are commonly diagnosed when they are between the ages of 18-29, a developmental period known as emerging adulthood. Typically, emerging adults are subsumed into the category of adults even though emerging adults have unique developmental needs. In this descriptive study of IBD in emerging adults, the aims were to (a) determine the prevalence of symptoms; (b) describe the severity of symptoms and their interference with daily activities; and (c) examine the association between individual symptom severity and presence of fatigue. Emerging adults with IBD were recruited using web-based convenience sampling. Sixty-one individuals met the inclusion criteria. They had a mean age of 24.7 and a disease duration of 6.4 years. The most prevalent symptoms reported were: fatigue (n = 44, 72.1%), abdominal cramps (n = 39, 63.9%), abdominal pain (n = 39, 63.9%), and diarrhea (n = 38, 62.3%). The symptom with the greatest severity and interference with daily activities was fatigue. Abdominal cramps, abdominal pain, diarrhea, passing gas, and abdominal tenderness were associated with fatigue when controlling for age, emerging adulthood, gender, time since diagnosis, and current steroid use. Among emerging adults with IBD, fatigue is the most prevalent symptom and is the symptom with the greatest severity and interference with daily activities. These results suggest a need for interventions aimed at reducing both fatigue and gastrointestinal symptoms among emerging adults with IBD.

Healthcare Providers' Perceived Communication Barriers to Offering Palliative Care to Patients With Heart Failure: An Integrative Review.

CONTEXT: Heart failure is a chronic complex syndrome that is common and burdensome. International clinical practice guidelines recommend that healthcare providers communicate palliative care options with patients with heart failure. OBJECTIVES: The aim of this study was to conduct an integrative review to evaluate how healthcare providers perceived communication barriers to offering information to individuals in the palliative phase of heart failure. METHODS: Four databases and the gray literature were searched from January 1987 to February 2017. Inclusion and exclusion criteria were applied. Studies were graded for strength and quality using a critical appraisal tool, and key themes were extracted and synthesized. RESULTS: Ten articles met the full inclusion criteria. Most studies were qualitative or nonexperimental studies of good quality. Authors of several studies found that healthcare providers lacked basic knowledge about palliative care or did not possess sufficient knowledge to effectively provide care. Poor knowledge of palliative care created a barrier between the provider and the patient. Inadequate education or inexperience in palliative care led to the resistance of health providers to implementing a palliative approach. CONCLUSIONS: The results of this review emphasize a lack of knowledge as a barrier to delivering palliative care. Healthcare providers caring for individuals with heart failure need palliative care knowledge, skills, and competencies to ensure that this vulnerable population receives holistic patient-centered care.

Using cognitive interviewing to improve questionnaires: An exemplar study focusing on individual and condition-specific factors.

Questionnaires are a standard component of quantitative research, but seldom do researchers consider the importance of item clarity and participant comprehension. This is particularly true among the often overlooked individual and condition-specific items which characterize the patient and disease process. Cognitive interviewing is one approach to assess item clarity and identify how participants understand and respond to questions. The purpose of this paper is to describe the process of cognitive interviewing used to identify questions that are unclear or challenging to answer for a unique population, emerging adults (age 18-29) with inflammatory bowel disease (IBD). Through cognitive interviewing four areas were identified as needing improvement among individual and condition-specific items: 1) clarity - describing terms and adding details to item directions; 2) cognitive recall burden - rewording questions to avoid the need for mental math, 3) timeframe - adding phrases like 'in the past 2 weeks,' and 4) question relevance - including items on disease remission. Analysis of these four areas may guide other researchers working with IBD patients to obtain high quality data, as well as stimulate questionnaire adaption using cognitive interviewing with other populations. Cognitive interviewing can be useful when drafting a new questionnaire or when adapting an established questionnaire; in either case, it can enhance item clarity and participant comprehension.

Low Incidence of Dysplasia and Colorectal Cancer Observed among Inflammatory Bowel Disease Patients with Prolonged Colonic Diversion.

Background: In inflammatory bowel disease (IBD), many scenarios call for fecal diversion, leaving behind defunctionalized bowel. The theoretical risk of colorectal cancer (CRC) in this segment is frequently cited as a reason for resection. To date, no studies have characterized the incidence of neoplasia in the diverted colorectal segments of IBD patients. Methods: A retrospective cohort analysis was conducted for IBD patients identified through a tertiary care center pathology database. Patients that had undergone colorectal diversion and were diverted for ≥ 1 year were included. Incidence of diverted dysplasia/CRC was calculated for Crohn's disease (CD) and ulcerative colitis (UC) with respect to diverted patient-years (dpy) and patient-years of disease (pyd). Results: In total, 154 patients comprising 754 dpy and 1984 pyd were analyzed. Only 2 cases of diverted colorectal dysplasia (CD 1, UC 1) and 1 case of diverted CRC (UC) were observed. In the UC cohort (n = 75), the rate of diversion-associated CRC was 4.5 cases/1000 dpy (95% CI 0.11-25/1000) or 1.5 cases/1000 pyd (95% CI 0.04-8.2/1000). In the CD cohort (n = 79), no patients developed CRC, although a dysplasia rate of 1.9 cases/1000 dpy (95% CI 0.05-11/1000) or 0.77 cases/1000 pyd (95% CI 0.02-4.3/1000) was observed. All patients developing neoplasia had disease duration > 10 years and microscopic inflammation. Conclusions: Diverted dysplasia occurred infrequently with rates overlapping those reported in registries for IBD-based rectal cancers. Neoplasia was undetected in patients with < 10 pyd, regardless of diversion duration, suggesting low yield for endoscopic surveillance before this time.

Routine Pouchoscopy Prior to Ileostomy Takedown May Not Be Necessary in Patients with Chronic Ulcerative Colitis.

BACKGROUND: Creation of a J pouch is the gold standard surgical intervention in the treatment of chronic ulcerative colitis (UC). Pouchoscopy prior to ileostomy takedown is commonly performed. We describe the frequency, indication, and findings on pouchoscopy, and determine if pouchoscopy affects rates of complications after takedown. METHODS: All UC or indeterminate inflammatory bowel disease patients with a J pouch were retrospectively evaluated from January 1994 to December 2014. Cases were defined as having routine (asymptomatic) pouchoscopy after pouch creation but before ileostomy takedown. Controls were defined as having no pouchoscopy or pouchoscopy on the same day as that of takedown. RESULTS: The study included 178 patients (81.5% cases, 18.5% controls). Fifty two percent of pouchoscopies were reported as normal. Common abnormal endoscopy findings included stricture (35%), pouchitis (7%), and cuffitis (0.7%). Length of stay during takedown hospitalization was shorter for cases than controls (3 vs. 5 days; p = 0.001), but neither short- nor long-term complications were statistically different between cases and controls. Abnormalities on pouchoscopy were not predictive for short-term complications (p = 0.73) or long-term complications (p = 0.55). Routine pouchoscopy did not delay takedown surgery in any of the included patients. CONCLUSIONS: Routine pouchoscopy may not be necessary prior to ileostomy takedown; its greatest utility is in patients with suspected pouch complications.

Nearly a Third of High-Grade Dysplasia and Colorectal Cancer Is Undetected in Patients with Inflammatory Bowel Disease.

BACKGROUND: It is unclear whether intensive surveillance protocols have resulted in a decreased incidence of colorectal cancer (CRC) in inflammatory bowel disease (IBD). AIMS: To determine the prevalence and characteristics of IBD associated high-grade dysplasia (HGD) or CRC that was undetected on prior colonoscopy. METHODS: This is a single-center, retrospective study from 1994 to 2013. All participants had a confirmed IBD diagnosis and underwent a colectomy with either HGD or CRC found in the colectomy specimen.The undetected group had no HGD or CRC on prior colonoscopies. The detected group had HGD or CRC identified on previous biopsies. RESULTS: Of 70 participants, with ulcerative colitis (UC) (n = 47), Crohn's disease (CD) (n = 21), and indeterminate colitis (n = 2), 29% (n = 20) had undetected HGD/CRC at colectomy (15 HGD and 5 CRC). In the undetected group, 75% had prior LGD, 15% had indefinite dysplasia, and 10% had no dysplasia (HGD was found in colonic strictures). Patients in the undetected group were more likely to have pancolitis (55 vs. 20%) and multifocal dysplasia (35 vs. 8%). The undetected group was less likely to have CRC at colectomy (25 vs. 62%). There was a trend toward right-sided HGD/CRC at colectomy (40 vs. 20%; p = 0.08). In addition, 84% of the lesions found in the rectum at colectomy were not seen on prior colonoscopy in the undetected group. CONCLUSIONS: The prevalence of previously undetected HGD/CRC in IBD found at colectomy was 29%. The high proportion of undetected rectal and right-sided HGD/CRC suggests that these areas may need greater attention during surveillance.

Genome-Wide Association Study Identifies African-Specific Susceptibility Loci in African Americans With Inflammatory Bowel Disease.

BACKGROUND & AIMS: The inflammatory bowel diseases (IBD) ulcerative colitis (UC) and Crohn's disease (CD) cause significant morbidity and are increasing in prevalence among all populations, including African Americans. More than 200 susceptibility loci have been identified in populations of predominantly European ancestry, but few loci have been associated with IBD in other ethnicities. METHODS: We performed 2 high-density, genome-wide scans comprising 2345 cases of African Americans with IBD (1646 with CD, 583 with UC, and 116 inflammatory bowel disease unclassified) and 5002 individuals without IBD (controls, identified from the Health Retirement Study and Kaiser Permanente database). Single-nucleotide polymorphisms (SNPs) associated at P < 5.0 × 10-8 in meta-analysis with a nominal evidence (P < .05) in each scan were considered to have genome-wide significance. RESULTS: We detected SNPs at HLA-DRB1, and African-specific SNPs at ZNF649 and LSAMP, with associations of genome-wide significance for UC. We detected SNPs at USP25 with associations of genome-wide significance for IBD. No associations of genome-wide significance were detected for CD. In addition, 9 genes previously associated with IBD contained SNPs with significant evidence for replication (P < 1.6 × 10-6): ADCY3, CXCR6, HLA-DRB1 to HLA-DQA1 (genome-wide significance on conditioning), IL12B,PTGER4, and TNC for IBD; IL23R, PTGER4, and SNX20 (in strong linkage disequilibrium with NOD2) for CD; and KCNQ2 (near TNFRSF6B) for UC. Several of these genes, such as TNC (near TNFSF15), CXCR6, and genes associated with IBD at the HLA locus, contained SNPs with unique association patterns with African-specific alleles. CONCLUSIONS: We performed a genome-wide association study of African Americans with IBD and identified loci associated with UC in only this population; we also replicated IBD, CD, and UC loci identified in European populations. The detection of variants associated with IBD risk in only people of African descent demonstrates the importance of studying the genetics of IBD and other complex diseases in populations beyond those of European ancestry.

Project P.E.A.C.H. (Pathway and Education Toward Adherence and Completion in Hepatitis C Therapy): A Nurse-Driven Evidence-Based Protocol.

Chronic hepatitis C virus (HCV) remains a major healthcare concern. The 24-48 week treatment of pegylated interferon and ribavirin therapy requires a tremendous amount of commitment from patients and providers. Thus, there has been a huge focus on health-related quality of life and various measures to support patient adherence and completion of the recommended HCV treatment regimen. This quality improvement project aimed to develop and test a nurse-driven evidence-based pathway that supports the care of patients receiving hepatitis C medication therapy in a tertiary, academic hepatology practice. All adult patients, 18 years and older, who were started on HCV treatment from January 20 to February 15, 2011, were included in the testing of a nurse-driven HCV pathway for the first 12 weeks of treatment. The majority of the patients treated were male (71.8% prepathway and 83.3% postpathway), of White ethnic background (61.5% prepathway and 58.3% postpathway), genotype 1 (69% prepathway and 91.7% postpathway), and had comorbid conditions classified as "other" (38.5% prepathway and 33.3% postpathway). As for treatment status, the majority of the patients were "treatment naive" in prepathway or had never received prior HCV treatment (59.0%) or "had recurrent HCV after liver transplantation" (41.7%). The 4-week treatment completion rate was 94.9% for the prepathway group and 100.0% for the postpathway group; 12-week completion rate was 87.2% (prepathway) and 58.3% for the postpathway group. The mean 4-week adherence score for the prepathway group was 2.46 and the postpathway group was 2.92. Mean lag time to treatment was decreased with 26 days in the postpathway and 43 in the prepathway. Providers and nurses expressed overall satisfaction with the nurse-driven pathway.

Quality indicators for inflammatory bowel disease: development of process and outcome measures.

INTRODUCTION: Variation in adherence to management guidelines for inflammatory bowel disease (IBD) suggests variable quality of care. Quality indicators (QIs) can be developed to measure the structure, processes, and outcomes of health care delivery. The RAND/UCLA appropriateness method was used to develop a set of process and outcome QIs to define quality of care for IBD. METHODS: Guidelines and position papers for IBD published from 2006 to 2011 were reviewed for potential QIs, which were rated by a multidisciplinary panel. Potential process and outcome QIs were discussed at 3 moderated in-person meetings, with pre-meeting and post-meeting confidential electronic voting. Panelists rated the validity and feasibility of QIs on a 1 through 9 scale; disagreement was assessed using a validated index. QIs rated above 8 were selected for the final set. RESULTS: More than 500 potential process QIs were extracted from guidelines. Following ratings and discussion by the first panel, 35 process QIs were selected for literature review. After the second panel, 10 process QIs were included in the final set. Candidate outcome QIs were then derived from physician, nurse, and patient input and ratings, in addition to outcomes associated with candidate process QIs. None of the top QIs exhibited disagreement. CONCLUSIONS: A set of QIs for IBD was developed with expert interpretation of the literature and multidisciplinary input. Outcome QIs focused largely on remission and quality of life, whereas process QIs were aimed at therapeutic optimization and patient safety. Evaluation of these QIs in clinical practice is needed to assess the correlation of performance on process QIs with performance on outcome QIs.

Adherence and completion in hepatitis C management: a systematic review.

The complexity and challenge of Hepatitis C virus (HCV) medication therapy call for a comprehensive and integrated approach in management. This article includes an appraisal of the current state of the science in HCV management and the various models that support treatment completion and adherence. The patient undergoing HCV therapy may experience a wide range of symptoms such as anemia, depression, fatigue, and flu-like symptoms. These can constantly confront the patient's adherence and compliance with treatment. The article includes an analysis of the strengths, weaknesses, and limitations of the evidence. Future directions in research were also identified.

Patient perspectives on the impact of Crohn's disease: results from group interviews.

AIM: To understand the impact of Crohn's disease (CD) on various aspects of daily life from the perspective of patients living with CD. Awareness of the disease and biologic therapies, patient satisfaction and adherence, and physician (provider) relationships were also assessed. BACKGROUND: CD is a chronic, inflammatory, autoimmune disorder of the gastrointestinal tract that substantially impacts patients' physical and emotional well-being. For patients eligible for biologic therapy, anti-tumor necrosis factor agents represent an important addition to the available therapies for CD. METHODS: The study sample included biologic-naïve and biologic-experienced patients who had self-reported moderate to severe CD, were under the care of a specialist, and agreed to film a video diary and participate in a focus group. Data from the videos and group interviews were collected from May to June of 2009 and summarized qualitatively by grouping similar answers and quotations. RESULTS: Of the 44 participants who submitted video diaries, 23 were biologic-experienced and 21 were biologic-naïve. Participants stated that CD caused fear and embarrassment, that they were reluctant to share the full impact of CD with family and providers, and that they relied on their provider for treatment decisions. Many participants accepted a new state of normalcy if their current medication helped their most bothersome symptoms without providing sustained remission. Participants receiving biologic therapy generally were more informed, more satisfied, and more likely to adhere to treatment regimens. CONCLUSION: Participants' responses suggest a need for more patient education and more collaborative relationships between patients and providers (physicians) regarding treatment decisions.

Ulcerative colitis from patients' viewpoint: a review of two Internet surveys.

Ulcerative colitis negatively impacts patients' quality of life, but little is known about which aspects of patients' lives are affected, how patients' perceptions compare with patients with other chronic conditions, and how these perceptions compare with those of gastroenterologists. This review discusses two recent Internet surveys: (1) the Ulcerative Colitis: New Observations on Remission Management And Lifestyle (UC:NORMAL) and (2) the Crohn's and Colitis Foundation of America studies. The surveys revealed that the major impact ulcerative colitis has on patients includes frequent disease manifestations, a substantial psychological burden, and disruption to daily activities. This was more evident in patients with ulcerative colitis than those with migraine, asthma, or rheumatoid arthritis. Physicians' perceptions were considerably different from those of patients, as physicians believed that the disease had a lesser impact on patient quality of life. Furthermore, patients and physicians also identified nonadherence to prescribed medication as a major concern in the treatment of ulcerative colitis. Improved communication and education is needed to address nonadherence and poor health related quality of life in patients living with ulcerative colitis. The influence of Advanced Practice Registered Nurses on physicians, nurses, and patients may help improve adherence and long-term disease outcomes, including patients' health related quality of life. The nurse practitioner, working with both patients who have ulcerative colitis and the physicians who care for these patients, is uniquely placed to address these needs.

Validation of the Dudley Inflammatory Bowel Symptom Questionnaire for the assessment of bowel symptoms in axial SpA: prevalence of clinically relevant bowel symptoms and association with disease activity.

OBJECTIVES: To validate the Dudley Inflammatory Bowel Disease Questionnaire (DISQ) for determining the presence and severity of bowel symptoms in axial SpA. METHODS: Seventy-seven SpA patients were assessed for disease activity using the BASDAI. All participants, including 32 healthy controls and 29 patients with Crohn's Disease (CD), completed the DISQ and an assessment of stool form and frequency. Validation of the DISQ was undertaken in accordance with OMERACT criteria. RESULTS: Validity of the DISQ for measuring bowel symptoms in SpA was confirmed (Cronbach's α 0.79). Mean DISQ scores (s.d.) were: controls 2.6 (2.6), SpA 8.7 (6.1) and CD 17.1 (10.2). Differences were significant between controls and SpA, and SpA and CD, and correlated with disease activity (ρ 0.27, P = 0.02). In SpA, DISQ scores of those taking NSAIDs (n = 59) did not differ from those not taking NSAIDs (n = 18) (P = 0.31). Stool form and frequency differed significantly between SpA patients and healthy controls (P < 0.001). Using the DISQ the prevalence of clinically relevant bowel symptoms in SpA is 31%, and 7.8% experience bowel symptoms equivalent to active CD. CONCLUSION: The DISQ is a valid measure of bowel symptoms in SpA. Bowel symptoms are prevalent in SpA and correlate with disease activity. Symptoms do not relate to treatment with NSAIDs. We conclude that bowel symptoms should be included as a domain in the clinical assessment of patients with SpA and that the DISQ has potential as an outcome measure in clinical trials.