Although patient navigation was introduced 2 decades ago, there remains a lack of consensus regarding its definition, the necessary qualifications of patient navigators, and its impact on the continuum of cancer care. This review provides an update to the 2008 review by Wells et al on patient navigation. Since then, there has been a significant increase in the number of published studies dealing with cancer patient navigation. The authors of the current review conducted a search by using the keywords "navigation" or "navigator" and "cancer." Thirty-three articles published from November 2007 through July 2010 met the search criteria. Consistent with the prior review, there is building evidence of some degree of efficacy of patient navigation in terms of increasing cancer screening rates. However, there is less recent evidence concerning the benefit of patient navigation with regard to diagnostic follow-up and in the treatment setting, and a paucity of research focusing on patient navigation in cancer survivorship remains. Methodological limitations were noted in many studies, including small sample sizes and a lack of control groups. As patient navigation programs continue to develop across North America and beyond, further research will be required to determine the efficacy of cancer patient navigation across all aspects of the cancer care continuum.

https://onlinelibrary.wiley.com/doi/pdf/10.3322/caac.20111

Patient navigation: An update on the state of the science

Background Barriers to cancer clinical trial participation have been the subject of frequent study, but the rate of trial participation has not changed substantially over time. Studies often emphasize patient-related barriers, but other types of barriers may have greater impact on trial participation. Our goal was to examine the magnitude of different domains of trial barriers by synthesizing prior research. Methods We conducted a systematic review and meta-analysis of studies that examined the trial decision-making pathway using a uniform framework to characterize and quantify structural (trial availability), clinical (eligibility), and patient/physician barrier domains. The systematic review utilized the PubMed, Google Scholar, Web of Science, and Ovid Medline search engines. We used random effects to estimate rates of different domains across studies, adjusting for academic vs community care settings. Results We identified 13 studies (nine in academic and four in community settings) with 8883 patients. A trial was unavailable for patients at their institution 55.6% of the time (95% confidence interval [CI] = 43.7% to 67.3%). Further, 21.5% (95% CI = 10.9% to 34.6%) of patients were ineligible for an available trial, 14.8% (95% CI = 9.0% to 21.7%) did not enroll, and 8.1% (95% CI = 6.3% to 10.0%) enrolled. Rates of trial enrollment in academic (15.9% [95% CI = 13.8% to 18.2%]) vs community (7.0% [95% CI = 5.1% to 9.1%]) settings differed, but not rates of trial unavailability, ineligibility, or non-enrollment. Conclusions These findings emphasize the enormous need to address structural and clinical barriers to trial participation, which combined make trial participation unachievable for more than three of four cancer patients.

/pdf/systematic-review-and-meta-analysis-of-the-magnitude-of-2u7spbmvgs.pdf

Systematic Review and Meta-Analysis of the Magnitude of Structural, Clinical, and Physician and Patient Barriers to Cancer Clinical Trial Participation.

Strategies addressing barriers to clinical trial enrollment of underrepresented populations: A systematic review

In 2010, the National Cancer Institute and the American Society of Clinical Oncology cosponsored a symposium to examine the state of clinical trial accrual science and identify opportunities to facilitate trial enrollment. The authors provide recommendations for best practices and for future research developed from the symposium.

https://ascopubs.org/doi/pdf/10.1200/JOP.2013.001119

The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and recommendations

Exciting new medical therapies for a number of diseases that disproportionately affect African Americans and Latinos are currently being developed and tested in clinical trials (Robinson & Trochim, 2007). Despite bearing an unequal burden of disease, African Americans and Latinos continue to be underrepresented in clinical trials research, even though the National Institutes of Health Revitalization Act of 1993 (P.L. 103-43) stipulating the participation of women and minority groups in research was created in 1993 and updated in 2001 (Pinsky et al., 2008). Insufficient representation of racially and ethnically diverse groups and women in clinical trials results in inequitable distribution of the risks and benefits of research participation and reduces the generalizability of trial results (Pinsky et al., 2008). Health disparities in the United States could be reduced if targeted therapies were discovered that work equally well in all populations or work especially well in members of affected racial and ethnic groups.

The purpose of this study was to use qualitative data obtained via focus groups with African American and Latino adults ages 50 years and older to elicit potential solutions to the problem of low rates of participation of such populations in clinical trials research. The conceptual framework of the study was based on the Institute of Medicine (IOM) report Unequal Treatment: Confronting Racial and Ethnic Disparities in Healthcare (Smedley & Nelson, 2003), which identified three factors as major sources of racial and ethnic disparities in health outcomes: (1) characteristics of health care systems, (2) perceptions of and actual interactions with health care providers, and (3) preferences and attitudes of patients.

We applied IOM's conceptual framework to the arena of disparities in recruitment of diverse populations to clinical trials research by revising the wording of the IOM framework to refer to clinical trials research instead of to health care disparities. For example, in the framework, we replaced “health care systems” with “health care systems and study processes,” “health care providers” with “researchers,” and “patients” with “potential trial participants.” The revised framework is depicted in Figure ​Figure11 and is described in the following sections. The conceptual framework is related to the systems approach in the field of social work, in which clients and their needs are related to a multilevel model of resources, systems, and institutions (Darnell, 2007; NASW, 2008). 



Figure 1:

Model Framework of Multilevel Factors Affecting Decision to Participate in a Clinical Trial

Unequal Burden of Disease, Unequal Participation in Clinical Trials: Solutions from African American and Latino Community Members

PURPOSE: To assess cancer clinical trial recruitment and reasons for nonaccrual among a rural, medically underserved population served by a community-based cancer care center.

METHODS: We prospectively tracked clinical trial enrollment incidence among all new patients presenting at the Rapid City Regional Cancer Care Institute. Evaluating physicians completed questionnaires for each patient regarding clinical trial enrollment status and primary reasons for nonenrollment. Patients who identified as American Indian were referred to a program where patients were assisted in navigating the medical system by trained, culturally competent staff.

RESULTS: Between September 2006 and January 2008, 891 new cancer patients were evaluated. Seventy-eight patients (9%; 95% confidence intervals, 7-11%) were enrolled on a clinical treatment trial. For 73% (95% confidence intervals, 69-75%) of patients (646 of 891) lack of relevant protocol availability or protocol inclusion criteria restrictiveness was the reason for nonenrollment. Only 45 (5%; 95% confidence intervals, 4-7%) patients refused enrollment on a trial. Of the 78 enrolled on a trial, 6 (8%; 95% confidence intervals, 3-16%) were American Indian. Three additional American Indian patients were enrolled under a nontreatment cancer control trial, bringing the total percentage enrolled of the 94 American Indians who presented to the clinic to 10% (95% confidence intervals, 5-17%).

LIMITATIONS: Eligibility rates were unable to be calculated and cross validation of the number in the cohort via registries or ICD-9 codes was not performed.

CONCLUSION: Clinical trial participation in this medically underserved population was low overall, but approximately 3-fold higher than reported national accrual rates. Lack of availability of protocols for common cancer sites as well as stringent protocol inclusion criteria were the primary obstacles to clinical trial enrollment. Targeted interventions using a Patient Navigation program were used to engage AI patients and may have resulted in higher clinical trial enrollment among this racial/ethnic group.

/pdf/involving-american-indians-and-medically-underserved-rural-5ez2myphg5.pdf

Involving American Indians and medically underserved rural populations in cancer clinical trials

https://doi.org/10.1016/j.clim.2022.109027

SARS-CoV-2/COVID-19 and its relationship with NOD2 and ubiquitination

Intravenous immunoglobulin (IVIG) is a therapeutic preparation used in the treatment of multiple diseases. Autoimmune testing with antinuclear antibody (ANA) screening is often obtained for some of these conditions, but only after initiation of IVIG treatment. This can present a diagnostic dilemma in hospitalized patients and may trigger a rheumatology consultation. We describe our consultative inpatient two-year experience with five such patients and review the pertinent literature. A retrospective chart review of rheumatology inpatient consultations between 6-2018 and 6-2020 at our academic tertiary care hospital for post-IVIG positive serologies was performed. A pertinent literature review was performed. Five patients had a positive ANA and other autoantibodies detected in their serum after they received IVIG for non-rheumatological conditions. None of these patients met the criteria for a connective tissue disease. The literature review identified a total of 58 patients from case reports and case series, several of whom tested positive for ANA and other antibodies after receiving IVIG. Studies assessing specific IVIG products detected multiple autoantibodies in the donor pool. Autoimmune testing is initiated on inpatients receiving IVIG for non-rheumatological conditions. If an autoantibody ANA screen is positive, a rheumatology consultation may be requested. In the absence of pre-IVIG antibody tests it is difficult to interpret post-IVIG-positive antibodies. Whether such positive antibodies are of clinicopathological significance is determined by clinical judgment and time.

/pdf/inpatient-rheumatology-consultation-prompted-by-positive-3h3ihdqt.pdf

Inpatient Rheumatology Consultation Prompted by Positive Autoantibodies in Patients Receiving Intravenous Immunoglobulin Therapy: A Case Series and Literature Review

OBJECTIVES
Whipple's disease (WD) results from infection of the bacteria Tropheryma whipplei (TW). This disease is characterized by macrophage infiltration of intestinal mucosa and primarily affects Caucasian males. Genetic studies of host susceptibility are scarce. Nucleotide-binding oligomerization domain containing protein 2 (NOD2) is an innate immune sensor, resides mainly in monocytes/macrophages and contributes to defense against infection and inflammatory regulation. NOD2 mutations are associated with autoinflammatory diseases. We report the association of NOD2 mutations with TW and WD for the first time.


METHODS
A multicenter, retrospective study of three patients with WD was conducted. Patients received extensive multidisciplinary evaluations and were cared for by the authors. NOD2 and its association with infection and inflammation were schematically represented.


RESULTS
All patients were Caucasian men and presented with years of autoinflammatory phenotypes, including recurrent fever, rash, inflammatory arthritis, gastrointestinal symptoms, and elevated inflammatory markers. All patients underwent molecular testing using a gene panel for periodic fever syndromes and were identified to carry NOD2 mutations associated with NOD2-associated autoinflammatory disease. Despite initially negative gastrointestinal evaluations, repeat endoscopy with duodenal tissue biopsy ultimately confirmed WD. After initial ceftriaxone and maintenance with doxycycline and/or hydroxychloroquine, symptoms were largely controlled, though mild relapses occurred in follow up.


CONCLUSION
Both NOD2 and TW/WD are intensively involved in monocytes/macrophages. WD is regarded as a macrophage disease. NOD2 leucin rich repeat-associated mutations in monocytes/macrophages cause functional impairment of these cells and consequently may make the host susceptible for TW infection and WD, especially in the setting of immunosuppression.

Asha Patnaik

Papers

Involving American Indians and medically underserved rural populations in cancer clinical trials

SARS-CoV-2/COVID-19 and its relationship with NOD2 and ubiquitination

Inpatient Rheumatology Consultation Prompted by Positive Autoantibodies in Patients Receiving Intravenous Immunoglobulin Therapy: A Case Series and Literature Review

Susceptibility of nucleotide-binding oligomerization domain 2 mutations to Whipple's disease.