Identifying predictors of COVID-related delays in cancer-specific medical care.

PURPOSE: Evidence of the impact of the COVID-19 pandemic on cancer prevention and control is growing, but little is known about patient-level factors associated with delayed care. We analyzed data from a survey focused on Iowan cancer patients' COVID-19 experiences in the early part of the pandemic. METHODS: Participants were recruited from the University of Iowa Holden Comprehensive Cancer Center's Patients Enhancing Research Collaborations at Holden (PERCH) program. We surveyed respondents on demographic characteristics, COVID-19 experiences and reactions, and delays in any cancer-related health care appointment, or cancer-related treatment appointments. Two-sided significance tests assessed differences in COVID-19 experiences and reactions between those who experienced delays and those who did not. RESULTS: There were 780 respondents (26% response), with breast, prostate, kidney, skin, and colorectal cancers representing the majority of respondents. Delays in cancer care were reported by 29% of respondents. In multivariable-adjusted models, rural residents (OR 1.47; 95% CI 1.03, 2.11) and those experiencing feelings of isolation (OR 2.18; 95% CI 1.37, 3.47) were more likely to report any delay, where experiencing financial difficulties predicted delays in treatment appointments (OR 5.72; 95% CI 1.96, 16.67). Health insurance coverage and concern about the pandemic were not statistically significantly associated with delays. CONCLUSION: These findings may inform cancer care delivery during periods of instability when treatment may be disrupted by informing clinicians about concerns that patients have during the treatment process. Future research should assess whether delays in cancer care impact long-term cancer outcomes and whether delays exacerbate existing disparities in cancer outcomes.

Comparing COVID-19 Response Behaviors between a Cancer Patient Sample and a Population-Based Cancer-Free Sample in a Rural Midwestern State.

INTRODUCTION: The COVID-19 pandemic caused an increase in fear, anxiety, and depressive symptoms globally. For populations at increased risk for adverse outcomes due to illness, such as cancer patients, these worries may have been exacerbated. Understanding how the pandemic impacted cancer patients will inform better preparation for future events that cause disturbances to cancer care delivery. METHODS: This study analyzed data from two surveys to determine whether cancer patients' responses differed from a cancer-free population-based sample in terms of concerns, preventive behaviors, and thoughts on their healthcare provider's communication regarding COVID-19 in a US Midwestern state. In August 2020, a survey was sent to 10,009 Iowans aged 18 and older, randomly selected from the 2018 Iowa voter registration file. In September 2020, a survey was emailed to 2,954 cancer patients aged 18 and older who opted into the University of Iowa Holden Comprehensive Cancer Center's Patients Enhancing Research Collaborations at Holden program. Previously validated and pretested Likert-type and multiple-choice items assessed concern regarding COVID-19, social distancing perception and behaviors, and demographic characteristics of respondents. We used χ2 tests and logistic regression to examine differences between the cancer patient and general population survey responses. RESULTS: We included 3,622 responses from the general population survey and 780 responses from the cancer patient survey in this analysis. Cancer patient survey respondents were more frequently older, lived in urban areas, had Medicare insurance coverage, had a college degree or higher, and were married. Cancer patients were more likely to report engaging in social distancing behaviors and greater concern regarding the pandemic. CONCLUSION: This study suggests differences in the impact of the COVID-19 pandemic on cancer patients compared to cancer-free members of the general population. These results indicate the need for consideration of cancer patients' physical and mental health during large-scale disruptions to cancer care.

Rural and urban differences in perceptions, behaviors, and health care disruptions during the COVID-19 pandemic.

PURPOSE: The objective of this study was to assess perceptions, health behaviors, and disruptions related to the COVID-19 pandemic in a largely rural, Midwestern state, and to examine differences between rural and urban respondents. METHODS: A questionnaire was mailed August 2020 to a sample of 10,009 registered voters in Iowa ages 18-100 years, with oversampling from 6 select rural counties. Previously validated and tested items assessed COVID-19 precautions, health care disruptions, emotional reactions, health behavior changes, telehealth and experiences with the internet, and demographic characteristics. FINDINGS: There were 4,048 respondents (40% response rate); 65% were rural and 35% were urban residents. The average age of respondents was 58.3 years and 45% of respondents identified as female. Rural respondents reported less concern about COVID-19 in their community (29% vs 40%, P<.001) and lower perceived importance of social distancing (51% vs 64%, P<.001). Urban respondents more often reported experiencing disruption to daily living, stronger negative emotional reactions, and displayed more pronounced behavior change compared to their rural counterparts. For example, urban respondents reported more pandemic-related job losses (6% vs 4%, P = .05), disruptions to daily activities (48% vs 35%, P<.001), and use of telehealth services during the pandemic (24% vs 16%, P<.001). CONCLUSIONS: The majority of respondents reported disruptions to normal activities, medical appointment cancellations, and emotional distress during the first 6 months of the pandemic. The impact of the pandemic on urban residents appeared to be greater than for rural respondents. Timing of pandemic spread and varying beliefs are potential explanations.

Exploration of PCORnet Data Resources for Assessing Use of Molecular-Guided Cancer Treatment.

PURPOSE: Examine the ability of PCORnet data resources to investigate molecular-guided cancer treatment. PATIENTS AND METHODS: Patients (N = 86,154) had single primary solid tumors (diagnosed 2013-2017) from hospital oncology registries linked to the PCORnet Common Data Model (CDM) at 11 medical institutions. Molecular and anatomic test procedures and oral and infused therapies were identified with Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes, RxNorm Concept Unique Identifier, and National Drug Codes from CDM tables. Chart review (2 institutions, n = 213) for advanced colorectal cancer and Medicare claims linkages (7 institutions, n = 1,731) for breast cancer explored options for increasing electronic data capture. RESULTS: Molecular testing prevalence detected via analyte-specific molecular CPT/HCPCS codes was 5.5% (n = 4,784); for the nonspecific anatomic pathology codes, for which only some testing is performed to guide therapy selection, it was an additional 44.8% (n = 38,610). Molecular-guided therapy prevalence was 5% (n = 4,289). Testing and treatment were most common with stage IV disease and varied across cancer types and study institutions (testing, 0%-10.4%; treatment, 0.8%-8.4%). Therapy-concordant test results were found in charts for all 36 treated patients with colorectal cancer at the 2 institutions, 3 (8.3%) of whom received treatment outside the institution. Breast cancer Medicare claims linkage increased rates of identified testing from 62.7%-98.9% and treatment from 3.9%-8.2%. CONCLUSION: Although a minority of patients received molecular-guided therapies, the majority had testing that could guide cancer treatment. Claims data extended electronic data capture for therapies and test orders but often was uninformative for types of test ordered. Test results continue to require text data curation from narrative pathology reports.

Impact of programs to reduce antipsychotic and anticholinergic use in nursing homes.

INTRODUCTION: Antipsychotics are used for managing behavioral and psychological symptoms of dementia (BPSD) but have risks. Anticholinergics can worsen outcomes in dementia. The Improving Antipsychotic Appropriateness in Dementia Patients educational program (IA-ADAPT) and Centers for Medicare and Medicaid Services Partnership to Improve Dementia Care (CMS Partnership) promote improved care for BPSD. The purpose of this study was to evaluate the impact of these programs on medication use and BPSD among nursing home residents. METHODS: This quasi-experimental longitudinal study used Medicare and assessment data for Iowa nursing home residents from April 2011 to December 2012. Residents were required to be eligible for six continuous months for inclusion. Antipsychotic use and anticholinergic use were evaluated on a monthly basis, and changes in BPSD were tracked using assessment data. Results are presented as odds ratios (ORs) per month after exposure to the IA-ADAPT or the start of the CMS Partnership. RESULTS: Of 426 eligible Iowa nursing homes, 114 were exposed to the IA-ADAPT in 2012. Nursing home exposure to the IA-ADAPT was associated with reduced antipsychotic use (OR [95% CI] = 0.92 [0.89-0.95]) and anticholinergic use (OR [95% CI] = 0.95 [0.92-0.98]), reduced use of excessive antipsychotic doses per CMS guidance (OR [95% CI] = 0.80 [0.75-0.86]), increased odds of a potentially appropriate indication among antipsychotic users (OR [95% CI] = 1.04 [1.00-1.09]), and decreased documentation of verbal aggression (OR [95% CI] = 0.96 [0.94-0.99]). Facilities with two or more IA-ADAPT exposures had greater reductions in antipsychotic and anticholinergic use than those with only one. The CMS Partnership was associated with reduced antipsychotic use (OR [95% CI] = 0.96 [0.94-0.98]) and decreased documentation of any measured BPSD (OR [95% CI] = 0.98 [0.97-0.99]) as well as delirium specifically (OR [95% CI] = 0.98 [0.96-0.99]). DISCUSSION: This study suggests that the IA-ADAPT and the CMS Partnership improved medication use with no adverse impact on BPSD.

Selection bias and subject refusal in a cluster-randomized controlled trial.

BACKGROUND: Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial. METHODS: The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE) study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site's allocation prior to consent. Patients who consented or declined to participate were compared across control and intervention arms for differing characteristics. Statistical significance was determined using a two-tailed, equal variance t-test and a chi-square test with adjusted Bonferroni p-values. Results were adjusted for random cluster variation. RESULTS: There were 2749 completed screening forms returned to research staff with 461 subjects who had either consented or declined participation. Patients with poorly controlled diabetes were found to be significantly more likely to decline participation in intervention sites compared to those in control sites. A higher mean diastolic blood pressure was seen in patients with uncontrolled hypertension who declined in the control sites compared to those who declined in the intervention sites. However, these findings were no longer significant after adjustment for random variation among the sites. After this adjustment, females were now found to be significantly more likely to consent than males (odds ratio = 1.41; 95% confidence interval = 1.03, 1.92). CONCLUSIONS: Though there appeared to be a higher consent rate for females than for males, the overall impact of potential selection bias and refusal to participate was minimal. Without rigorous methodology, selection bias may be a threat to external validity in cluster-randomized trials. TRIAL REGISTRATION: NCT01983813 . Date of registration: Oct. 28, 2013.

Efficacy and safety of nighttime dosing of antihypertensives: review of the literature and design of a pragmatic clinical trial.

Blood pressure exhibits circadian variability, and nighttime blood pressure is one of the best predictors of cardiovascular (CV) events. Adults with hypertension who lack a nighttime dipping pattern are at particularly high risk. Several studies have found that bedtime dosing of antihypertensive agents reduces sleep blood pressure and improves the dipping pattern in nondippers. One small study and 2 substudies of diabetes and chronic kidney disease suggest that bedtime dosing of ≥ 1 antihypertensives significantly reduced CV events. A Cochrane review of 5 studies found no difference in adverse events between morning and evening dosing. However, several evaluations in ophthalmology have found that nocturnal arterial hypotension precipitated ocular vascular disorders such as ischemic optic neuropathy. Some authors have suggested that additional studies of nighttime dosing of antihypertensive agents that evaluate CV events need to be conducted. The authors describe a randomized controlled pragmatic trial that is being planned at the University of Iowa and Duke University. Patients with hypertension and other comorbid conditions will be randomized to either continue morning dosing of all antihypertensive agents or to switch their nondiuretic medications to bedtime dosing. Patients will be followed for 36 to 42 months. This study will determine whether nighttime dosing reduces CV risk when compared with traditional morning dosing of antihypertensive agents.

Dietary supplement polypharmacy: an unrecognized public health problem?

Excessive and inappropriate use of medications, or 'polypharmacy', has been recognized as a public health problem. In addition, there is growing use of dietary supplements in the United States; however, little is known about the patterns of supplement use. Recent reports in the literature of cases of excessive or inappropriate use of herbal dietary supplements leading to the term 'polyherbacy'. The clinical vignettes described in this article highlight the need for further research on the nature and extent of multiple and inappropriate dietary supplement use or 'dietary supplement polypharmacy'. Clinical interviewing and population surveys both address this issue in complementary ways, and provide a further understanding of dietary supplement use patterns.

Application of FDA adverse event report data to the surveillance of dietary botanical supplements.

BACKGROUND: Concerns have been raised about the sufficiency of dietary botanical supplement (DBS) surveillance in the US. The Food and Drug Administration's Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS) represents one of the few existing surveillance mechanisms, but it has not been well characterized with respect to DBS adverse effects. OBJECTIVE: To characterize data on DBSs associated with adverse event reports submitted to CAERS. METHODS: We requested and obtained CAERS data from 1999 to 2003 involving adverse effects associated with the 6 most frequently used DBSs: Echinacea, ginseng, garlic, Ginkgo biloba, St. John's wort, and peppermint. We summarized and characterized the adverse event reports received, focusing on the composition of the DBSs and the nature of associated adverse events. We also cross-referenced reported single-ingredient DBSs with corresponding available product information. A sample of CAERS cases associated with signal DBSs was also characterized in detail. RESULTS: CAERS reports involving ginseng DBSs were most frequently reported during the study period, whereas reports involving St. John's wort were the least frequently reported. Most CAERS reports involved multiple-ingredient DBSs, and 3-13% of reports involved multiple DBSs. Gastrointestinal and neurologic problems were the most common clinical outcomes among single-ingredient DBS-associated adverse events. CONCLUSIONS: CAERS surveillance of DBS adverse effects is potentially as effective as other passive surveillance methods, but the number of reports is relatively small, validation is incomplete, and some inconsistencies within reports were found. Reports in CAERS may underrepresent DBS adverse events associated with DBS consumption.

Patterns of natural herb use by Asian and Pacific Islanders.

OBJECTIVE: Previous studies have noted the role of race/ethnicity in use of complementary and alternative medicine (CAM). Asian and Pacific Islanders (APIs) in particular have been found to use herbs more frequently, although the patterns of use among this population have not been described. The goal of this study was to characterize the rates and patterns of herb use among the API population of the United States. DESIGN: Data from the 2002 US National Health Interview Survey, including the supplement on CAM, were analyzed using SAS. Cross-tabulation and logistical regression were used to determine the association between herb use and race/ethnicity, while adjusting for demographic factors. RESULTS: After adjusting for age, gender and educational attainment, we found that APIs were more likely to use herbs than non-Hispanic Whites (OR=1.3; 95% CI: 1.1, 1.5; p=0.013), with the difference being most prominent in those 60 years old or older (OR=2.9; 95% CI: 1.8, 4.5; p<0.0001). Herb use among APIs was more common among women, those with higher education and income, and those in older age groups. Patterns of use also varied among API subgroups, with Chinese Americans reporting the highest rates of herb use in their lifetimes (44%) and in the previous 12 months (33%). CONCLUSION: Considerable diversity exists within API subgroups with regard to the prevalence and demographic and health correlates of natural herb use. Herb use is more common among APIs than non-Hispanic Whites, particularly among the elderly. The disaggregation of APIs by racial/ethnic subgroups may be important for patient-health care professional interactions, and when designing studies of racial/ethnic minority populations.

National surveillance of herbal dietary supplement exposures: the poison control center experience.

PURPOSE: The purpose of this report is to characterize reports to poison control centers (PCCs) involving two widely used herbal dietary supplements (HDSs), Echinacea, and St. John's wort (SJW). METHODS: We purchased data from the American Association of Poison Control Center's (AAPCC) toxic exposure surveillance system (TESS(R)) on reports made to PCCs in 2001 involving Echinacea or SJW. Analyses were limited to those cases in which Echinacea or SJW were the only associated products, and in which these HDSs were deemed primary to observed adverse effects. Descriptive statistics were generated for selected demographic and exposure-related variables. RESULTS: During 2001, PCCs were contacted regarding 406 exposures involving Echinacea and 356 exposures involving SJW. Most of the reported exposures for both HDSs occurred among children 5 years and younger, and the majority of exposures were coded as unintentional. For both HDSs, exposures among patients >/=20 years old were more likely to be associated with adverse effects. Intentional exposures accounted for 21% of SJW cases and 3% of Echinacea cases, with 13% of SJW exposures reported as 'suspected suicidal'. CONCLUSIONS: TESS represents a potentially important means of assessing and characterizing HDS-related adverse effects. Detailed studies validating the clinical events and outcomes of a sample of exposures reported to TESS(R) might offer substantial insights into adverse events (AEs) that could be systematically studied with other, established pharmacoepidemiological study designs.

Use of herbs among adults based on evidence-based indications: findings from the National Health Interview Survey.

OBJECTIVE: To examine the extent to which US adults use herbs (herbal supplements) in accordance with evidence-based indications. PATIENTS AND METHODS: The Alternative Health supplement of the 2002 National Health Interview Survey (NHIS) is part of an annual, nationally representative survey of US adults. It contains data on adults' use of the 10 herbs most commonly taken to treat a specific health condition in the past year (January 1 to December 31, 2002). The Natural Standard database was used to formulate evidence-based standards for herb use. These standards were applied to the NHIS data to identify groups of people who used herbs appropriately and inappropriately, using a multivariable logistic regression model. RESULTS: Of the 30,617 adults surveyed, 5787 (18.9%) consumed herbs in the past 12 months; of those, 3315 (57.3%) used herbs to treat a specific health condition. Among people who used only 1 herb (except echinacea and ginseng), approximately one third used it consonant with evidence-based indications. Women and people with a college education were more likely to use herbs (with the exception of echinacea) concordant with scientific evidence. Adults younger than 60 years and black adults were significantly less likely to use herbs (with the exception of echinacea) based on evidentiary referents than their counterparts. However, for echinacea users, no significant differences were detected. CONCLUSION: Roughly two thirds of adults using commonly consumed herbs (except echinacea) did not do so in accordance with evidence-based indications. Health care professionals should take a proactive role, and public health policies should disseminate evidence-based information regarding consumption of herbal products.

Difficulties after leaving TANF: inner-city women talk about reasons for returning to welfare.

People who leave welfare commonly return, and this phenomenon has become more pressing in the time-limited TANF program. Fostering stable TANF exits may be particularly difficult in poor inner-city areas because of job shortages and neighborhood deterioration. Perspectives of TANF leavers from five focus groups in Chicago about problems leading to welfare returns are presented. Participants indicated that low wages and unstable jobs were most often responsible for TANF returns. Obtaining health care and child care and inconsistent performance of TANF caseworkers were stressed as contributing factors. Participants also focused on strengths helpful in sustaining exits from TANF, particularly psychological benefits associated with working and informal supports received from family members and friends. The implications of recipient-identified problems and strengths are discussed, including balancing "work first" employment policies with substantive educational and job development policies. Strategies for improving the performance of TANF case planning are discussed.

Changing safety net of last resort: downsizing general assistance for employable adults.

General assistance (GA) has served as an income support program of last resort for people not eligible for other programs. Because each state has complete discretion to design its program, the GA services model parallels Temporary Assistance for Needy Families (TANF) in its reliance on decentralized government decision making. Thus, GA programs can provide lessons about services variability and common program features that have arisen in a decentralized income support system. This study examined the characteristics of state GA programs across several program dimensions--eligibility criteria, work requirements, time limits, administrative arrangements, and caseloads. The authors show that GA programs have changed from 1989 to 1998. Although most states retained GA programs in some form, caseloads declined as a result of tightening eligibility requirements for people considered employable. This casts doubt on the viability of GA as a safety net program for economically vulnerable people, including those who do not qualify for or exceed time limits under TANF.

Social work advocacy in the post-TANF environment: lessons from early TANF research studies.

This study examined early research findings concerning the well-being of people who leave Temporary Assistance for Needy Families (TANF) programs and then applies these findings in the development of TANF-related advocacy strategies. Based on secondary data analysis of TANF leaver studies from 12 states with large TANF caseloads, the authors focus on the employment and earnings experiences of leavers; TANF recidivism and its relationship to job stability; and the use of support services. State studies typically have found employment levels among leavers in the 55 percent to 65 percent range, but average earnings fall below the poverty level. Although those who remain employed can expect earnings growth, job instability is a significant problem and contributes to TANF recidivism rates of 21 percent to 35 percent within the first year. Available support services such as Medicaid, food stamps, and child care subsidies are underused, often because leavers do not understand that they are eligible. Recommended advocacy strategies include policy interventions to improve the economic well-being of low-income working people, as well as administrative and direct practice strategies to improve the implementation of existing policies. The authors argue that attention to such advocacy efforts is both critical and opportune for social work, given the profession's historical mission, impending federal TANF reauthorization, and unspent TANF allocations.