Postdischarge Noninvasive Telemonitoring and Nurse Telephone Coaching Improve Outcomes in Heart Failure Patients With High Burden of Comorbidity.

BACKGROUND: Noninvasive telemonitoring and nurse telephone coaching (NTM-NTC) is a promising postdischarge strategy in heart failure (HF). Comorbid conditions and disease burden influence health outcomes in HF, but how comorbidity burden modulates the effectiveness of NTM-NTC is unknown. This study aims to identify patients with HF who may benefit from postdischarge NTM-NTC based on their burden of comorbidity. METHODS AND RESULTS: In the Better Effectiveness After Transition - Heart Failure trial, patients hospitalized for acute decompensated HF were randomized to postdischarge NTM-NTC or usual care. In this secondary analysis of 1313 patients with complete data, comorbidity burden was assessed by scoring complication and coexisting diagnoses from index admissions. Clinical outcomes included 30-day and 180-day readmissions, mortality, days alive, and combined days alive and out of the hospital. Patients had a mean of 5.7 comorbidities and were stratified into low (0-2), moderate (3-8), and high comorbidity (≥9) subgroups. Increased comorbidity burden was associated with worse outcomes. NTM-NTC was not associated with readmission rates in any comorbidity subgroup. Among high comorbidity patients, NTM-NTC was associated with significantly lower mortality at 30 days (hazard ratio 0.25, 95% confidence interval 0.07-0.90) and 180 days (hazard ratio 0.51, 95% confidence interval 0.27-0.98), as well as more days alive (160.1 vs 140.3, P = .029) and days alive out of the hospital (152.0 vs 133.2, P = .044) compared with usual care. CONCLUSIONS: Postdischarge NTM-NTC improved survival among patients with HF with a high comorbidity burden. Comorbidity burden may be useful for identifying patients likely to benefit from this management strategy.

The Effect of Rehospitalization and Emergency Department Visits on Subsequent Adherence to Weight Telemonitoring.

BACKGROUND: Weight telemonitoring may be an effective way to improve patients' ability to manage heart failure and prevent unnecessary utilization of health services. However, the effectiveness of such interventions is dependent upon patient adherence. OBJECTIVE: The purpose of this study was to determine how adherence to weight telemonitoring changes in response to 2 types of events: hospital readmissions and emergency department visits. METHODS: The Better Effectiveness After Transition-Heart Failure trial examined the effectiveness of a remote telemonitoring intervention compared with usual care for patients discharged to home after hospitalization for decompensated heart failure. Participants were followed for 180 days and were instructed to transmit weight readings daily. We used Poisson regression to determine the within-person effects of events on subsequent adherence. RESULTS: A total of 625 events took place during the study period. Most of these events were rehospitalizations (78.7%). After controlling for the number of previous events and discharge to a skilled nursing facility, the rate for adherence decreased by nearly 20% in the 2 weeks after a hospitalization compared with the 2 weeks before (adjusted rate ratio, 0.81; 95% confidence interval: 0.77-0.86; P < .001). CONCLUSIONS: Experiencing a rehospitalization had the effect of diminishing adherence to daily weighing. Providers using telemonitoring to monitor decompensation and manage medications should take advantage of the potential "teachable moment" during hospitalization to reinforce the importance of adherence.

Do the unlabeled response categories of the Minnesota Living with Heart Failure Questionnaire satisfy the monotonicity assumption of simple-summated scoring?

PURPOSE: Half of the 21-item Minnesota Living with Heart Failure Questionnaire (MLHFQ) response categories are labeled (0 = No, 1 = Very little, 5 = Very much) and half are not (2, 3, and 4). We hypothesized that the unlabeled response options would not be more likely to be chosen at some place along the scale continuum than other response options and, therefore, not satisfy the monotonicity assumption of simple-summated scoring. METHODS: We performed exploratory and confirmatory factor analyses of the MLHFQ items in a sample of 1437 adults in the Better Effectiveness After Transition-Heart Failure study. We evaluated the unlabeled response options using item characteristic curves from item response theory-graded response models for MLHFQ physical and emotional health scales. Then, we examined the impact of collapsing response options on correlations of scale scores with other variables. RESULTS: The sample was 46% female; 71% aged 65 or older; 11% Hispanic, 22% Black, 54% White, and 12% other. The unlabeled response options were rarely chosen. The standard approach to scoring and scores obtained by collapsing adjacent response categories yielded similar associations with other variables, indicating that the existing response options are problematic. CONCLUSIONS: The unlabeled MLHFQ response options do not meet the assumptions of simple-summated scoring. Further assessment of the performance of the unlabeled response options and evaluation of alternative scoring approaches is recommended. Adding labels for response options in future administrations of the MLHFQ should be considered.

Cost Effectiveness of Age-Specific Screening Intervals for People With Family Histories of Colorectal Cancer.

BACKGROUND & AIMS: Relative risk of colorectal cancer (CRC) decreases with age among individuals with a family history of CRC. However, no screening recommendations specify less frequent screening with increasing age. We aimed to determine whether such a refinement would be cost effective. METHODS: We determined the relative risk for CRC for individuals based on age and number of affected first-degree relatives (FDRs) using data from publications. For each number of affected FDRs, we used the Microsimulation Screening Analysis model to estimate costs and effects of colonoscopy screening strategies with different age ranges and intervals. Screening was then optimized sequentially, starting with the youngest age group, and allowing the interval of screening to change at certain ages. Strategies with an incremental cost effectiveness ratio below $100,000 per quality-adjusted life year were considered cost effective. RESULTS: For people with 1 affected FDR (92% of those with a family history), screening every 3 years beginning at an age of 40 years is most cost effective. If no adenomas are found, the screening interval can gradually be extended to 5 and 7 years, at ages 45 and 55 years, respectively. From a cost-effectiveness perspective, individuals with more affected FDRs should start screening earlier and at shorter intervals. However, frequency can be reduced if no abnormalities are found. CONCLUSIONS: Using a microsimulation model, we found that for individuals with a family history of CRC, it is cost effective to gradually increase the screening interval if several subsequent screening colonoscopies have negative results and no new cases of CRC are found in family members.

The Care and Learn Model: a Practice and Research Model for Improving Healthcare Quality and Outcomes.

The Agency for Healthcare Research and Quality conducted internal work to formulate a model that could be used to analyze the Agency's research portfolio, identify gaps, develop and prioritize its research agenda, and evaluate its performance. Existing models described the structure and components of the healthcare system. Instead, we produced a model of two functions: caring and learning. Central to this model is the commitment to and participation of people-patients, communities, and health professionals-and the organization of systems to respond to people's problems using evidence. As a product of caring, the system produces evidence that is then used to adapt and continuously improve this response, closely integrating caring and learning. The Agency and the health services research and improvement communities can use this Care and Learn Model to frame an evidence-based understanding of vexing clinical, healthcare delivery, and population health problems and to identify targets for investment, innovation, and investigation.

Cost analysis of rapid diagnostics for drug-resistant tuberculosis.

BACKGROUND: Growth-based drug susceptibility testing (DST) is the reference standard for diagnosing drug-resistant tuberculosis (TB), but standard time to result (TTR) is typically ≥ 3 weeks. Rapid tests can reduce that TTR to days or hours, but accuracy may be lowered. In addition to the TTR and test accuracy, the cost of a diagnostic test may affect whether it is adopted in clinical settings. We examine the cost-effectiveness of rapid diagnostics for extremely drug-resistant TB (XDR-TB) in three different high-prevalence settings. METHODS: 1128 patients with confirmed TB were enrolled at clinics in Mumbai, India; Chisinau, Moldova; and Port Elizabeth, South Africa. Patient sputum samples underwent DST for first and second line TB drugs using 2 growth-based (MGIT, MODS) and 2 molecular (Pyrosequencing [PSQ], line-probe assays [LPA]) assays. TTR was the primary measure of effectiveness. Sensitivity and specificity were also evaluated. The cost to perform each test at each site was recorded and included test-specific materials, personnel, and equipment costs. Incremental cost-effectiveness ratios were calculated in terms of $/day saved. Sensitivity analyses examine the impact of batch size, equipment, and personnel costs. RESULTS: Our prior results indicated that the LPA and PSQ returned results in a little over 1 day. Mean cost per sample without equipment or overhead was $23, $28, $33, and $41 for the MODS, MGIT, PSQ, and LPA, respectively. For diagnosing XDR-TB, MODS was the most accurate, followed by PSQ, and LPA. MODS was quicker and less costly than MGIT. PSQ and LPA were considerably faster but cost more than MODS. Batch size and personnel costs were the main drivers of cost variation. CONCLUSIONS: Multiple factors must be weighed when selecting a test for diagnosis of XDR-TB. Rapid tests can greatly improve the time required to diagnose drug-resistant TB, potentially improving treatment success, and preventing the spread of XDR-TB. Faster time to result must be weighed against the potential for reduced accuracy, and increased costs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02170441 .

Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine.

IMPORTANCE: Since publication of the report by the Panel on Cost-Effectiveness in Health and Medicine in 1996, researchers have advanced the methods of cost-effectiveness analysis, and policy makers have experimented with its application. The need to deliver health care efficiently and the importance of using analytic techniques to understand the clinical and economic consequences of strategies to improve health have increased in recent years. OBJECTIVE: To review the state of the field and provide recommendations to improve the quality of cost-effectiveness analyses. The intended audiences include researchers, government policy makers, public health officials, health care administrators, payers, businesses, clinicians, patients, and consumers. DESIGN: In 2012, the Second Panel on Cost-Effectiveness in Health and Medicine was formed and included 2 co-chairs, 13 members, and 3 additional members of a leadership group. These members were selected on the basis of their experience in the field to provide broad expertise in the design, conduct, and use of cost-effectiveness analyses. Over the next 3.5 years, the panel developed recommendations by consensus. These recommendations were then reviewed by invited external reviewers and through a public posting process. FINDINGS: The concept of a "reference case" and a set of standard methodological practices that all cost-effectiveness analyses should follow to improve quality and comparability are recommended. All cost-effectiveness analyses should report 2 reference case analyses: one based on a health care sector perspective and another based on a societal perspective. The use of an "impact inventory," which is a structured table that contains consequences (both inside and outside the formal health care sector), intended to clarify the scope and boundaries of the 2 reference case analyses is also recommended. This special communication reviews these recommendations and others concerning the estimation of the consequences of interventions, the valuation of health outcomes, and the reporting of cost-effectiveness analyses. CONCLUSIONS AND RELEVANCE: The Second Panel reviewed the current status of the field of cost-effectiveness analysis and developed a new set of recommendations. Major changes include the recommendation to perform analyses from 2 reference case perspectives and to provide an impact inventory to clarify included consequences.

A systematic review and meta-analysis on the association between quality of hospital care and readmission rates in patients with heart failure.

UNLABELLED: In recent years, readmission rates have been increasingly used as a measure of quality of hospital care for patients with heart failure. The aim of this systematic review is to assess the scientific evidence regarding the relation between hospital readmission rates and quality of hospital care for patients with heart failure. METHODS: We defined quality of hospital care for patients with heart failure by adhering to the performance measures developed by the American College of Cardiology (ACC)/American Heart Association (AHA). Relevant articles published in English and indexed in the bibliographic databases Embase, Medline OvidSP, Web of Science, Cochrane Central, and PubMed were reviewed. RESULTS: Of the 2,638 studies identified, 18 were included. They varied widely in their methodology, data sources used, and study populations. We found mixed but rather limited evidence that there is a relationship between the ACC/AHA process measures and the rate of readmission. Four of 10 studies showed a significant correlation of readmission rate with "angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use." Three of 9 studies showed a significant correlation between readmission rates and "evaluation of left ventricular systolic function." One of 7 studies showed a significant correlation with "smoking cessation counseling," and 2 of 8 showed a significant correlation with "providing discharge instructions." No evidence was found for a relationship between readmission rates and the performance measure "warfarin for atrial fibrillation." CONCLUSIONS: Readmission rates after heart failure are mostly not related to the evidence-based ACC/AHA in-hospital process indicators for heart failure. It is unclear whether in-hospital quality of care is the key determinate of the readmission rate or whether readmissions are likely influenced more by postdischarge care. Further research is needed to clarify whether the readmission rate is a reflection of hospital care or quality of care on a larger level, especially when it is used for a pay-for-performance scheme to measure quality of hospital care.

Family history and the natural history of colorectal cancer: systematic review.

PURPOSE: Family history of colorectal cancer (CRC) is a known risk factor for CRC and encompasses both genetic and shared environmental risks. METHODS: We conducted a systematic review to estimate the impact of family history on the natural history of CRC and adherence to screening. RESULTS: We found high heterogeneity in family-history definitions, the most common definition being one or more first-degree relatives. The prevalence of family history may be lower than the commonly cited 10%, and confirms evidence for increasing levels of risk associated with increasing family-history burden. There is evidence for higher prevalence of adenomas and of multiple adenomas in people with family history of CRC but no evidence for differential adenoma location or adenoma progression by family history. Limited data regarding the natural history of CRC by family history suggest a differential age or stage at cancer diagnosis and mixed evidence with respect to tumor location. Adherence to recommended colonoscopy screening was higher in people with a family history of CRC. CONCLUSION: Stratification based on polygenic and/or multifactorial risk assessment may mature to the point of displacing family history-based approaches, but for the foreseeable future, family history may remain a valuable clinical tool for identifying individuals at increased risk for CRC.

The "Other E" in ELSI: The Use of Economic Evaluation to Inform the Expansion of Newborn Screening.

The utilization and application of genomic information generated from precision medicine continues to increase with the goal of improving health outcomes. Increasingly researchers, health care professionals, and public health teams include an examination of the ethical, legal, and social issues (ELSI) in their consideration of the use of precision medicine for newborn and pediatric health. In addition to ELSI considerations, stakeholders could benefit from an understanding of economics, the other "E" in ELSI. The use of an economic evaluation could aid decision-making on whether to screen newborns who may be at risk for disease, to diagnose newborns and children who present with symptoms, to inform the treatment and management of diagnosed individuals. In this manuscript we review the core concepts of economic evaluation, the framework of decision-analysis, and key parameters for consideration in assessing the economics of NBS program(s). We describe the common language used in the economic evaluation and provide a practical overview of health economic evaluations including 1) their purpose, 2) different types and components, 3) evaluation of the different types and components of economic evaluations (i.e., cost-effectiveness vs. cost-benefit analysis), 4) impact of societal or healthcare perspectives on the analysis, 5) health outcomes, 6) time horizon for the analysis, 7) identification of appropriate comparators, and 8) resources for economic data. We conclude with a use case to demonstrate the application and understanding of economic considerations for in the advancement and expansion of NBS.

Measuring the impact of cataract surgery on generic and vision-specific quality of life.

PURPOSE: Cataracts are the leading cause of blindness worldwide and cause visual impairment for millions of adults in the United States. We compared the sensitivity of a vision-specific health-related quality of life (HRQOL) measure to that of multiple generic measures of HRQOL before and at 2 time points after cataract surgery. METHODS: Participants completed 1 vision-specific and 5 generic quality of life measures before cataract surgery, and again 1 and 6 months after surgery. Random effects modeling was used to measure changes over the three assessment points. RESULTS: The NEI-VFQ25 total score and all 11 subscales showed significant improvements during the first interval (baseline and 1 month). During the second interval (1-6 months post-surgery), significant improvements were observed on the total score and 5 of 11 NEI-VFQ25 subscales. There were significant increases in HRQOL during the first interval on some preference-based generic HRQOL measures, though changes during the second interval were mostly non-significant. None of the SF-36v2™ or SF6D scales changed significantly between any of the assessment periods. CONCLUSIONS: The NEI-VFQ25 was sensitive to changes in vision-specific domains of QOL. Some preference-based generic HRQOL measures were also sensitive to change and showed convergence with the NEI-VFQ25, but the effects were small. The SF-36v2™ and SF-6D did not change in a similar manner, possibly reflecting a lack of vision-related content. Studies seeking to document both the vision-specific and generic HRQOL improvements of cataract surgery should consider these results when selecting measures.

Development and validation of a mental health subscale from the Quality of Well-Being Self-Administered.

PURPOSE: The purpose of this study was to create and validate a mental health subscale for the Quality of Well-Being Self-Administered (QWB-SA). METHODS: The QWB-SA and other measures such as the Profile of Mood States (POMS), Medical Outcomes Study 36 Item Short Form (SF-36), EuroQOL 5D (EQ-5D), and Health Utilities Index Mark 2 (HUI) were administered to three samples: a general population (N = 3,844), a non-psychiatric medical population (N = 535), and a psychiatric population (N = 915). Independent expert ratings of which items represented the construct of mental health were used along with psychometric methods to develop and validate a 10-item QWB-SA mental health scale. RESULTS: The mental health scale demonstrated high internal consistency (Cronbach's alpha = 0.827-0.842) and strong correlations with other measures of mental health, such as the POMS (r = -0.77), mental health scale from the SF-36 (r = 0.72), EQ-5D mood item (r = 0.61), and HUI Emotion Scale (r = 0.59). It was not highly correlated with measures of physical health. Among the psychiatric population, the new mental health scale was moderately correlated with indicators of psychiatric problem severity. CONCLUSIONS: It is now possible to report outcomes and relationships with mental health in studies that use the QWB-SA. This new mental health subscale can also be used with the large volume of previously collected data using the QWB-SA to examine the impact of illnesses and interventions on mental health-related quality of life.

Racial differences in self-rated health diminishing from 1972 to 2008.

In addition to higher morbidity and mortality, Black adults have reported lower self-rated health than White adults. The purpose of this study was to evaluate the diminishing difference in self-rated health between races from 1972 to 2008. Data from 37,936 participants over a 36-year span of the General Social Survey were used to evaluate the effects of race and time on self-rated health. Results confirmed that Black adults reported significantly worse health than White adults. Overall health was rated slightly better across both groups as time went on ([Formula: see text] = .002, P < .0005). However, this increase in health ratings has slowed, even reversing with a decline in health ratings as of late ([Formula: see text] = -.014, P = .001). Significant interactions between race and time indicated that the racial difference on this self-rated health measure has changed over time. The rate of change in the difference has slowed over time ([Formula: see text] = -.010, P = .021), suggesting that the reduction in the racial difference in self-rated health may be decelerating.

Cost-effectiveness of a mailed educational reminder to increase colorectal cancer screening.

BACKGROUND: Colorectal cancer (CRC) screening rates are low in many areas and cost-effective interventions to promote CRC screening are needed. Recently in a randomized controlled trial, a mailed educational reminder increased CRC screening rates by 16.2% among U.S. Veterans. The aim of our study was to assess the costs and cost-effectiveness of a mailed educational reminder on fecal occult blood test (FOBT) adherence. METHODS: In a blinded, randomized, controlled trial, 769 patients were randomly assigned to the usual care group (FOBT alone, n = 382) or the intervention group (FOBT plus a mailed reminder, n = 387). Ten days after picking up the FOBT cards, a 1-page reminder with information related to CRC screening was mailed to the intervention group. Primary outcome was number of returned FOBT cards after 6 months. The costs and incremental cost-effectiveness ratio (ICER) of the intervention were assessed and calculated respectively. Sensitivity analyses were based on varying costs of labor and supplies. RESULTS: At 6 months after card distribution, 64.6% patients in the intervention group returned FOBT cards compared with 48.4% in the control group (P < 0.001). The total cost of the intervention was $962 or $2.49 per patient, and the ICER was $15 per additional person screened for CRC. Sensitivity analysis based on a 10% cost variation was $13.50 to $16.50 per additional patient screened for CRC. CONCLUSIONS: A simple mailed educational reminder increases FOBT card return rate at a cost many health care systems can afford. Compared to other patient-directed interventions (telephone, letters from physicians, mailed reminders) for CRC screening, our intervention was more effective and cost-effective.

Association of Adherence to Weight Telemonitoring With Health Care Use and Death: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Adherence to telemonitoring may be associated with heart failure exacerbation but is not included in telemonitoring algorithms. Objective: To assess whether telemonitoring adherence is associated with a patient's risk of hospitalization, emergency department visit, or death. Design, Setting, and Participants: This post hoc secondary analysis of the Better Effectiveness After Transition-Heart Failure randomized clinical trial included patients from 6 academic medical centers in California who were eligible if they were hospitalized for decompensated heart failure and excluded if they were discharged to a skilled nursing facility, were expected to improve because of a medical procedure, or did not have the cognitive or physical ability to participate. The trial compared a telemonitoring intervention with usual care for patients with heart failure after hospital discharge from October 12, 2011, to September 30, 2013. Data analysis was performed from November 8, 2016, to May 10, 2019. Interventions: The intervention group (n = 722) received heart failure education, telephone check-ins, and a wireless telemonitoring system that allowed the patient to transmit weight, blood pressure, heart rate, and selected symptoms. The control group (n = 715) received usual care. Patients were followed up for 180 days after discharge. Main Outcomes and Measures: The main outcome was within-person risk of hospitalization, emergency department visit, or death by week during the study period. Poisson regression was used to determine the within-person association of adherence to daily weighing with the risk of experiencing these events in the following week. Results: Among the 538 participants (mean [SD] age, 70.9 [14.1] years; 287 [53.8%] male; 269 [50.7%] white) in the present analysis, adherence was lowest during the first week after enrollment but steadily increased, peaking between days 26 and 60 at 69%, or 371 transmissions. Adherence to weight telemonitoring was associated with events in the following week; an increase in adherence by 1 day was associated with a 19% decrease in the rate of death in the following week (incidence rate ratio, 0.81; 95% CI, 0.73-0.90) and an 11% decrease in the rate of hospitalization (incidence rate ratio, 0.89; 95% CI, 0.86-0.91). Adherence in the previous week was not associated with reduced rates of emergency department visits (incidence rate ratio, 0.95; 95% CI, 0.90-1.02). Conclusions and Relevance: In this study, lower adherence to weight telemonitoring in a given week was associated with an increased risk of subsequent hospitalization or death in the following week. It is unlikely that this is a result of the telemonitoring intervention; rather, adherence may be an important factor associated with a patient's health status.

Cost-Effectiveness of Risk-Stratified Colorectal Cancer Screening Based on Polygenic Risk: Current Status and Future Potential.

BACKGROUND: Although uniform colonoscopy screening reduces colorectal cancer (CRC) mortality, risk-based screening may be more efficient. We investigated whether CRC screening based on polygenic risk is a cost-effective alternative to current uniform screening, and if not, under what conditions it would be. METHODS: The MISCAN-Colon model was used to simulate a hypothetical cohort of US 40-year-olds. Uniform screening was modeled as colonoscopy screening at ages 50, 60, and 70 years. For risk-stratified screening, individuals underwent polygenic testing with current and potential future discriminatory performance (area under the receiver-operating curve [AUC] of 0.60 and 0.65-0.80, respectively). Polygenic testing results were used to create risk groups, for which colonoscopy screening was optimized by varying the start age (40-60 years), end age (70-85 years), and interval (1-20 years). RESULTS: With current discriminatory performance, optimal screening ranged from once-only colonoscopy at age 60 years for the lowest-risk group to six colonoscopies at ages 40-80 years for the highest-risk group. While maintaining the same health benefits, risk-stratified screening increased costs by $59 per person. Risk-stratified screening could become cost-effective if the AUC value would increase beyond 0.65, the price per polygenic test would drop to less than $141, or risk-stratified screening would lead to a 5% increase in screening participation. CONCLUSIONS: Currently, CRC screening based on polygenic risk is unlikely to be cost-effective compared with uniform screening. This is expected to change with a greater than 0.05 increase in AUC value, a greater than 30% reduction in polygenic testing costs, or a greater than 5% increase in adherence with screening.