Achieving Synergy: Linking an Internet-Based Inflammatory Bowel Disease Cohort to a Community-Based Inception Cohort and Multicentered Cohort in Inflammatory Bowel Disease.

BACKGROUND: Traditional cohort studies are important contributors to our understanding of inflammatory bowel diseases, but they are labor intensive and often do not focus on patient-reported outcomes. Internet-based studies provide new opportunities to study patient-reported outcomes and can be efficiently implemented and scaled. If a traditional cohort study was linked to an Internet-based study, both studies could benefit from added synergy. Existing cohort studies provide an opportunity to develop and test processes for cohort linkage. The Crohn's and Colitis Foundation of America's (CCFA) Partners study is an Internet-based cohort of more than 14,000 participants. The Ocean State Crohn's and Colitis Area Registry (OSCCAR) is an inception cohort. The Sinai-Helmsley Alliance for Research Excellence (SHARE) is a multicentered cohort of inflammatory bowel disease patients. Both the later cohorts include medical record abstraction, patient surveys, and biospecimen collection. OBJECTIVE: Given the complementary nature of these existing cohorts, we sought to corecruit and link data. METHODS: Eligible OSCCAR and SHARE participants were invited to join the CCFA Partners study and provide consent for data sharing between the 2 cohorts. After informed consent, participants were directed to the CCFA Partners website to complete enrollment and a baseline Web-based survey. Participants were linked across the 2 cohorts by the matching of an email address. We compared demographic and clinical characteristics between OSCCAR and SHARE participants who did and did not enroll in CCFA Partners and the data linkage. RESULTS: Of 408 participants in the OSCCAR cohort, 320 were eligible for participation in the CCFA Partners cohort. Of these participants, 243 consented to participation; however, only 44 enrolled in CCFA Partners and completed the linkage. OSCCAR participants who enrolled in CCFA Partners were better educated (17% with doctoral degrees) than those who did not (3% with doctoral degrees, P=.01). In the SHARE cohort, 436 participants enrolled and linked to the Partners cohort. More women (60% vs 50%) linked and those who linked were predominantly white (96%; P<.01). Crohn's disease patients who linked had lower mean scores on the Harvey-Bradshaw Index (3.6 vs 4.4, P<.01). Ulcerative colitis patients who linked had less extensive disease than those who did not link (45% vs 60%, P<.01). CONCLUSIONS: Linkage of CCFA Partners with cohorts such as OSCCAR and SHARE may be a cost-effective way to expand the infrastructure for clinical outcomes and translational research. Although linkage is feasible from a technical, legal, and regulatory perspective, participant willingness appears to be a limiting factor. Overcoming this barrier will be needed to generate meaningful sample sizes to conduct studies of biomarkers, natural history, and clinical effectiveness using linked data.

Pouch-Related Symptoms and Quality of Life in Patients with Ileal Pouch-Anal Anastomosis.

BACKGROUND: Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) has become the standard surgical treatment for the majority of patients with inflammatory bowel disease (IBD) who require colectomy. We evaluated the prevalence of pouch-related symptoms among the Crohn's and Colitis Foundation of America Partners cohort and the effect of pouch-related symptoms on Patient-Reported Outcome Measurement Information System measures. METHODS: We performed analyses nested in the Crohn's and Colitis Foundation of America Partners cohort. We used bivariate analyses to compare demographics and medication use among patients with ulcerative colitis or indeterminate colitis and pouch-related symptoms and those with IPAA without symptoms. We also compared Patient-Reported Outcome Measurement Information System domains (measured in T-scores) and short IBD questionnaire quality of life scales between symptomatic pouch patients (over the past 6 mo) and those without symptoms. RESULTS: Among 243 patients reporting a history of IPAA, 199 (82%) reported a history of pouch symptoms. Patients with recent pouch symptoms demonstrated higher mean T-scores in pain interference (53.0 versus 45.3; P < 0.001), depression (51.0 versus 46.4; P = 0.002), and fatigue (56.3 versus 47.0; P < 0.001). Symptomatic pouch patients reported lower mean scores in social role satisfaction (47.4 versus 54.6) and short IBD questionnaire (4.8 versus 5.8) (both P < 0.001). These differences were all clinically meaningful. CONCLUSIONS: In a large sample of patients with IBD, nearly all patients with IPAA reported a history of pouch symptoms. Patients experiencing symptoms within the 6 months before the survey assessment demonstrated clinically meaningful decrements in patient-reported outcomes in multiple domains of physical and psychosocial functioning.

Harnessing person-generated health data to accelerate patient-centered outcomes research: the Crohn's and Colitis Foundation of America PCORnet Patient Powered Research Network (CCFA Partners).

The Crohn's and Colitis Foundation of America Partners Patient-Powered Research Network (PPRN) seeks to advance and accelerate comparative effectiveness and translational research in inflammatory bowel diseases (IBDs). Our IBD-focused PCORnet PPRN has been designed to overcome the major obstacles that have limited patient-centered outcomes research in IBD by providing the technical infrastructure, patient governance, and patient-driven functionality needed to: 1) identify, prioritize, and undertake a patient-centered research agenda through sharing person-generated health data; 2) develop and test patient and provider-focused tools that utilize individual patient data to improve health behaviors and inform health care decisions and, ultimately, outcomes; and 3) rapidly disseminate new knowledge to patients, enabling them to improve their health. The Crohn's and Colitis Foundation of America Partners PPRN has fostered the development of a community of citizen scientists in IBD; created a portal that will recruit, retain, and engage members and encourage partnerships with external scientists; and produced an efficient infrastructure for identifying, screening, and contacting network members for participation in research.

Collecting Biospecimens From an Internet-Based Prospective Cohort Study of Inflammatory Bowel Disease (CCFA Partners): A Feasibility Study.

BACKGROUND: The Internet has successfully been used for patient-oriented survey research. Internet-based translational research may also be possible. OBJECTIVE: Our aim was to study the feasibility of collecting biospecimens from CCFA Partners, an Internet-based inflammatory bowel disease (IBD) cohort. METHODS: From August 20, 2013, to January 4, 2014, we randomly sampled 412 participants, plus 179 from a prior validation study, and invited them to contribute a biospecimen. Participants were randomized to type (blood, saliva), incentive (none, US $20, or US $50), and collection method for blood. The first 82 contributors were also invited to contribute stool. We used descriptive statistics and t tests for comparisons. RESULTS: Of the 591 participants, 239 (40.4%) indicated interest and 171 (28.9%) contributed a biospecimen. Validation study participants were more likely to contribute than randomly selected participants (44% versus 23%, P<.001). The return rate for saliva was higher than blood collected by mobile phlebotomist and at doctors' offices (38%, 31%, and 17% respectively, P<.001). For saliva, incentives were associated with higher return rates (43-44% versus 26%, P=.04); 61% contributed stool. Fourteen IBD-associated single nucleotide polymorphisms were genotyped, and risk allele frequencies were comparable to other large IBD populations. Bacterial DNA was successfully extracted from stool samples and was of sufficient quality to permit quantitative polymerase chain reaction for total bacteria. CONCLUSIONS: Participants are willing to contribute and it is feasible to collect biospecimens from an Internet-based IBD cohort. Home saliva kits yielded the highest return rate, though mobile phlebotomy was also effective. All samples were sufficient for genetic testing. These data support the feasibility of developing a centralized collection of biospecimens from this cohort to facilitate IBD translational studies.

Studying the effects of early child care experiences on the development of children of color in the United States: toward a more inclusive research agenda.

Evidence is presented of the different cultural and ecological contexts affecting early child care for families of color. It is argued that improvements on previous research require a fundamental shift in how race, ethnicity, and culture as psychological variables are examined. Furthermore, to avoid the pitfalls and failures of previous research, new research must incorporate expanded models of child care and development in childhood. The integrative model of development for children of color proposed by Garcia Coll et al. (1996) is presented as a basis for developing more specific ecological models relevant to addressing child care issues in ethnic minority families. Finally, priority areas for future research are recommended to stimulate and enable child care researchers to adopt a more inclusive view of child care and its effects.