Interventions to mitigate cancer-related medical financial hardship: A systematic review and meta-analysis.

BACKGROUND: This study systematically reviewed interventions mitigating financial hardship in patients with cancer and assessed effectiveness using a meta-analytic method. METHODS: PubMed, Cochrane, Scopus, CINAHL, and Web of Science were searched for articles published in English during January 2000-April 2023. Two independent reviewers selected prospective clinical trials with an intervention targeting and an outcome measuring financial hardship. Quality appraisal and data extraction were performed independently by two reviewers using a quality assessment tool. A random-effects model meta-analysis was performed. Reporting followed the preferred reporting items for systematic review and meta-analyses guidelines. RESULTS: Eleven studies (2211 participants; 55% male; mean age, 59.29 years) testing interventions including financial navigation, financial education, and cost discussion were included. Financial worry improved in only 27.3% of 11 studies. Material hardship and cost-related care nonadherence remained unchanged in the two studies measuring these outcomes. Four studies (373 participants; 37% male, mean age, 55.88 years) assessed the impact of financial navigation on financial worry using the comprehensive score of financial toxicity (COST) measure (score range, 0-44; higher score = lower financial worry) and were used for meta-analysis. There was no significant change in the mean of pooled COST score between post- and pre-intervention (1.21; 95% confidence interval, -6.54 to 8.96; p = .65). Adjusting for pre-intervention COST, mean change of COST significantly decreased by 0.88 with every 1-unit increase in pre-intervention COST (p = .02). The intervention significantly changed COST score when pre-intervention COST was ≤14.5. CONCLUSION: A variety of interventions have been tested to mitigate financial hardship. Financial navigation can mitigate financial worry among high-risk patients.

Psychological stress and cortisol during pregnancy: An ecological momentary assessment (EMA)-Based within- and between-person analysis.

BACKGROUND: Although the linkage between psychological stress and cortisol is believed to mediate the association of stress with health outcomes, several studies have been unable to demonstrate this association. We suggest this inability may be a consequence of limitations in the measurement approach and/or reliance on analytic strategies that focus on associations across, rather than within individuals. The link between psychological stress and cortisol is of particular interest in the context of pregnancy and fetal development. Using an ecological momentary assessment (EMA) design, we examined the association between psychological stress and cortisol at the between- and the within-person level. METHODS: 152 participants completed a 4-day long EMA protocol serially in early, mid and late pregnancy to provide momentary stress appraisals (average of 150 measures/subject) and saliva samples (average of 55 samples/subject) for quantification of cortisol. The association between stress and cortisol was estimated using linear mixed models. RESULTS: After accounting for the effects of key determinants of variation in cortisol, momentary stress was significantly and positively associated with cortisol at the within-person level (B = .030, p = .031), but not at the between-person level. No association was evident for traditional retrospective measures of stress with cortisol at either the between- or the within-person level. CONCLUSIONS: Our study highlights the value of EMA methods and linear mixed-modeling approaches in linking maternal psychological and physiological states across pregnancy. These findings may have important implications for the development of personalized risk identification and "just-in-time" intervention strategies to optimize maternal and child health.

Longitudinal assessment of air conduction audiograms in a phase III clinical trial of difluoromethylornithine and sulindac for prevention of sporadic colorectal adenomas.

A phase III clinical trial assessed the recurrence of adenomatous polyps after treatment for 36 months with difluoromethylornithine (DFMO) plus sulindac or matched placebos. Temporary hearing loss is a known toxicity of treatment with DFMO, thus a comprehensive approach was developed to analyze serial air conduction audiograms. The generalized estimating equation method estimated the mean difference between treatment arms with regard to change in air conduction pure tone thresholds while accounting for within-subject correlation due to repeated measurements at frequencies. Based on 290 subjects, there was an average difference of 0.50 dB between subjects treated with DFMO plus sulindac compared with those treated with placebo (95% confidence interval, -0.64 to 1.63 dB; P = 0.39), adjusted for baseline values, age, and frequencies. In the normal speech range of 500 to 3,000 Hz, an estimated difference of 0.99 dB (-0.17 to 2.14 dB; P = 0.09) was detected. Dose intensity did not add information to models. There were 14 of 151 (9.3%) in the DFMO plus sulindac group and 4 of 139 (2.9%) in the placebo group who experienced at least 15 dB hearing reduction from baseline in 2 or more consecutive frequencies across the entire range tested (P = 0.02). Follow-up air conduction done at least 6 months after end of treatment showed an adjusted mean difference in hearing thresholds of 1.08 dB (-0.81 to 2.96 dB; P = 0.26) between treatment arms. There was no significant difference in the proportion of subjects in the DFMO plus sulindac group who experienced clinically significant hearing loss compared with the placebo group. The estimated attributable risk of ototoxicity from exposure to the drug is 8.4% (95% confidence interval, -2.0% to 18.8%; P = 0.12). There is a <2 dB difference in mean threshold for patients treated with DFMO plus sulindac compared with those treated with placebo.

Does concordance between data sources vary by medical organization type?

OBJECTIVE: Little is known about how concordance between patient self-report and medical record data varies with medical organization type. Given discrepancies in quality of care received across patient cohorts and organizations, it is important to understand the degree to which concordance metrics are robust across organization types. We tested whether concordance between patient selfreport and medical record data would vary with medical organization type, controlling for patient demographic characteristics, health status, and domain of medical care. STUDY DESIGN: This observational study included 1270 patients sampled from 39 West Coast medical organizations with at least 1 of the following conditions: diabetes, ischemic heart disease, asthma or chronic obstructive pulmonary disease, or low back pain. METHODS: Medical records and patient self-report were used to measure 50 items grouped into 4 conceptual domains: diagnosis, clinical services delivered, counseling and referral, and medication use. We evaluated the concordance between ambulatory medical record and patient survey data. We conducted multivariate logistic regressions to test the impact of medical organization type (medical groups vs independent practice associations), controlling for patient characteristics and domain of care, on 5 concordance measures. RESULTS: Independent practice associations were associated with worse agreement, survey specificity, and medical record sensitivity, and better medical record specificity compared with medical groups. CONCLUSIONS: The medical record and patient survey do not measure quality comparably across organization types. We recommend continued efforts to improve survey data collection across different patient populations and to improve the quality of clinical data.

Does ambulatory process of care predict health-related quality of life outcomes for patients with chronic disease?

OBJECTIVE: The validity of quality of care measurement has important implications for practicing clinicians, their patients, and all involved with health care delivery. We used empirical data from managed care patients enrolled in west coast physician organizations to test the hypothesis that observed changes in health-related quality of life across a 2.5-year window reflecting process of care. DATA SOURCES/STUDY SETTING: Patient self-report data as well as clinically detailed medical record review regarding 963 patients with chronic disease associated with managed care from three west coast states. STUDY DESIGN: Prospective cohort study of change in health-related quality of life scores across 30 months as measured by change in SF-12 physical component scores. DATA COLLECTION/EXTRACTION METHODS: Patient self-report and medical record abstraction. PRINCIPAL FINDINGS: We found a positive relationship between better process scores and higher burden of illness (p<.05). After adjustment for burden of illness, using an instrumental variables approach revealed better process is associated with smaller declines in SF-12 scores across a 30-month observation window (p=.014). The application of the best quartile of process of care to patients currently receiving poor process is associated with a 4.24 increment in delta SF-12-physical component summary scores. CONCLUSIONS: The use of instrumental variables allowed us to demonstrate a significant relationship between better ambulatory process of care and better health-related quality of life. This finding underscores the importance of efforts to improve the process of care.

What is the concordance between the medical record and patient self-report as data sources for ambulatory care?

BACKGROUND: The validity of quality of care assessments relies upon data quality, yet little is known about the relative completeness and validity of data sources for evaluating the quality of care. OBJECTIVES: We evaluated concordance between ambulatory medical record and patient survey data. Levels of concordance, variations by type of item, sources of disagreement between data sources, and implications for quality of care assessment efforts are discussed. DESIGN AND SUBJECTS: This was an observational study that included 1270 patients sampled from 39 West Coast medical organizations with at least 1 of the following: diabetes, ischemic heart disease, asthma or chronic obstructive pulmonary disease, or low back pain. MEASURES: Items from both data sources were grouped into 4 conceptual domains: diagnosis, clinical services delivered, counseling and referral, and medication use. We present total agreement, kappa, sensitivity, and specificity at the item and domain-levels and for all items combined. RESULTS: We found good concordance between survey and medical records overall, but there was substantial variation within and across domains. The worst concordance was in the counseling and referrals domain, the best in the medication use domain. Patients were able to report with good sensitivity on memorable items. CONCLUSIONS: Quality ratings are likely to vary in differing directions, depending on the data source used. The most appropriate data source for analyses of components of and overall quality of care must be considered in light of study objectives and resources. We recommend data collection from multiple sources to most accurately portray the patient and provider experience of medical care.

Imputation of SF-12 health scores for respondents with partially missing data.

OBJECTIVE: To create an efficient imputation algorithm for imputing the SF-12 physical component summary (PCS) and mental component summary (MCS) scores when patients have one to eleven SF-12 items missing. STUDY SETTING: Primary data collection was performed between 1996 and 1998. STUDY DESIGN: Multi-pattern regression was conducted to impute the scores using only available SF-12 items (simple model), and then supplemented by demographics, smoking status and comorbidity (enhanced model) to increase the accuracy. A cut point of missing SF-12 items was determined for using the simple or the enhanced model. The algorithm was validated through simulation. DATA COLLECTION: Thirty-thousand-three-hundred and eight patients from 63 physician groups were surveyed for a quality of care study in 1996, which collected the SF-12 and other information. The patients were classified as "chronic" patients if they reported that they had diabetes, heart disease, asthma/chronic obstructive pulmonary disease, or low back pain. A follow-up survey was conducted in 1998. PRINCIPAL FINDINGS: Thirty-one percent of the patients missed at least one SF-12 item. Means of variance of prediction and standard errors of the mean imputed scores increased with the number of missing SF-12 items. Correlations between the observed and the imputed scores derived from the enhanced models were consistently higher than those derived from the simple model and the increments were significant for patients with > or =6 missing SF-12 items (p<.03). CONCLUSION: Missing SF-12 items are prevalent and lead to reduced analytical power. Regression-based multi-pattern imputation using the available SF-12 items is efficient and can produce good estimates of the scores. The enhancement from the additional patient information can significantly improve the accuracy of the imputed scores for patients with > or =6 items missing, leading to estimated scores that are as accurate as that of patients with <6 missing items.