Publications by authors named "Theodore G Ganiats"

95 Publications

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

JAMA Netw Open 2020 07 1;3(7):e2010174. Epub 2020 Jul 1.

Center for Healthcare Policy and Research, Division of General Medicine, University of California, Davis, Sacramento.

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.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.10174DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7352152PMC
July 2020

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

J Cardiovasc Nurs 2020 May 8. Epub 2020 May 8.

Sarah C. Haynes, PhD, MPH Department of Pediatrics, University of California Davis, Sacramento, California. Daniel J. Tancredi, PhD Department of Pediatrics and Center for Healthcare Policy and Research, University of California Davis, Sacramento, California. Kathleen Tong, MD Adventist Heart and Vascular Institute, St. Helena, California. Jeffrey S. Hoch, PhD Department of Public Health Sciences and Center for Healthcare Policy and Research, University of California Davis, Sacramento, California. Michael K. Ong, MD, PhD Division of General Internal Medicine and Health Services Research, University of California Los Angeles and VA Greater Los Angeles Healthcare System, California. Theodore G. Ganiats, MD Department of Family Medicine and Public Health, University of California San Diego School of Medicine, La Jolla, California. Lorraine S. Evangelista, PhD, RN Sue and Bill Gross School of Nursing, University of California Irvine, California. Jeanne T. Black, PhD, MBA Department of Orthopaedics, Cedars-Sinai Medical Center, Los Angeles, California. Andrew Auerbach, MD, MPH Department of Medicine, University of California San Francisco School of Medicine. Patrick S. Romano, MD, MPH Division of General Medicine and Center for Healthcare Policy and Research, University of California Davis, Sacramento, California.

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.
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http://dx.doi.org/10.1097/JCN.0000000000000689DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091911PMC
May 2020

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

JNCI Cancer Spectr 2020 Feb 14;4(1):pkz086. Epub 2019 Oct 14.

See the Notes section for the full list of authors' affiliations.

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.
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http://dx.doi.org/10.1093/jncics/pkz086DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6988584PMC
February 2020

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

Qual Life Res 2020 May 28;29(5):1349-1360. Epub 2020 Jan 28.

Division of General Internal Medicine & Health Services Research, UCLA Department of Medicine, 1100 Glendon Avenue, Suite 850, Los Angeles, CA, 90024, USA.

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.
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http://dx.doi.org/10.1007/s11136-020-02422-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7195256PMC
May 2020

Economic analysis in behavioral health: Toward application of standardized methodologies.

Health Psychol 2019 Aug;38(8):672-679

Department of Psychology.

Health care remains the most expensive sector in the U.S. economy, now accounting for nearly 1 in every 5 dollars spent. The purpose of health care is to improve the health of populations. However, formal medical care is one of many alternatives for improving health. In order to make better use of scarce resources, cost-effectiveness methodologies have been developed to evaluate how to produce the most health within the constraints of available resources. Standardized cost-effectiveness methodologies are now commonly used in the evaluation of medical therapies and new technologies. However, these methods have rarely been employed for the evaluation of behavioral interventions. Behavioral interventions often use measures that are not generally applied in other areas of health outcomes research. A consequence of neglecting to employ standardized cost-effectiveness analysis is that behavioral, psychological, and environmental interventions may be left out of resource allocation discussions. The purpose of this paper is to review standardized approaches to cost-effectiveness analysis and to encourage their use for the evaluation of behavioral intervention programs. Application of standardized methods of cost-effectiveness analysis will allow direct comparisons between investing in behavioral interventions programs in comparison to a wide range of other alternatives. The methods are general and can be used to estimate the cost-effectiveness of social and environmental interventions in addition to traditional medical and surgical treatments. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
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http://dx.doi.org/10.1037/hea0000769DOI Listing
August 2019

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

J Gen Intern Med 2019 01 14;34(1):154-158. Epub 2018 Nov 14.

Department of Health and Human Services, Center for Evidence and Practice Improvement of the Agency for Healthcare Research and Quality, Rockville, MD, USA.

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.
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http://dx.doi.org/10.1007/s11606-018-4737-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318165PMC
January 2019

Future Directions for Cost-effectiveness Analyses in Health and Medicine.

Med Decis Making 2018 10;38(7):767-777

Duke Clinical Research Institute, Duke University, Durham, NC.

Objectives: In 2016, the Second Panel on Cost-effectiveness in Health and Medicine updated the seminal work of the original panel from 2 decades earlier. The Second Panel had an opportunity to reflect on the evolution of cost-effectiveness analysis (CEA) and to provide guidance for the next generation of practitioners and consumers. In this article, we present key topics for future research and policy.

Methods: During the course of its deliberations, the Second Panel discussed numerous topics for advancing methods and for improving the use of CEA in decision making. We identify and consider 7 areas for which the panel believes that future research would be particularly fruitful. In each of these areas, we highlight outstanding research needs. The list is not intended as an exhaustive inventory but rather a set of key items that surfaced repeatedly in the panel's discussions. In the online Appendix , we also list and expound briefly on 8 other important topics.

Results: We highlight 7 key areas: CEA and perspectives (determining, valuing, and summarizing elements for the analysis), modeling (comparative modeling and model transparency), health outcomes (valuing temporary health and path states, as well as health effects on caregivers), costing (a cost catalogue, valuing household production, and productivity effects), evidence synthesis (developing theory on learning across studies and combining data from clinical trials and observational studies), estimating and using cost-effectiveness thresholds (empirically representing 2 broad concepts: opportunity costs and public willingness to pay), and reporting and communicating CEAs (written protocols and a quality scoring system).

Conclusions: Cost-effectiveness analysis remains a flourishing and evolving field with many opportunities for research. More work is needed on many fronts to understand how best to incorporate CEA into policy and practice.
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http://dx.doi.org/10.1177/0272989X18798833DOI Listing
October 2018

Diagnosis and Management of Mild Traumatic Brain Injury in Children: A Systematic Review.

JAMA Pediatr 2018 11 5;172(11):e182847. Epub 2018 Nov 5.

John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois.

Importance: In recent years, there has been an exponential increase in the research guiding pediatric mild traumatic brain injury (mTBI) clinical management, in large part because of heightened concerns about the consequences of mTBI, also known as concussion, in children. The CDC National Center for Injury Prevention and Control's (NCIPC) Board of Scientific Counselors (BSC), a federal advisory committee, established the Pediatric Mild TBI Guideline workgroup to complete this systematic review summarizing the first 25 years of literature in this field of study.

Objective: To conduct a systematic review of the pediatric mTBI literature to serve as the foundation for an evidence-based guideline with clinical recommendations associated with the diagnosis and management of pediatric mTBI.

Evidence Review: Using a modified Delphi process, the authors selected 6 clinical questions on diagnosis, prognosis, and management or treatment of pediatric mTBI. Two consecutive searches were conducted on PubMed, Embase, ERIC, CINAHL, and SportDiscus. The first included the dates January 1, 1990, to November 30, 2012, and an updated search included December 1, 2012, to July 31, 2015. The initial search was completed from December 2012 to January 2013; the updated search, from July 2015 to August 2015. Two authors worked in pairs to abstract study characteristics independently for each article selected for inclusion. A third author adjudicated disagreements. The risk of bias in each study was determined using the American Academy of Neurology Classification of Evidence Scheme. Conclusion statements were developed regarding the evidence within each clinical question, and a level of confidence in the evidence was assigned to each conclusion using a modified GRADE methodology. Data analysis was completed from October 2014 to May 2015 for the initial search and from November 2015 to April 2016 for the updated search.

Findings: Validated tools are available to assist clinicians in the diagnosis and management of pediatric mTBI. A significant body of research exists to identify features that are associated with more serious TBI-associated intracranial injury, delayed recovery from mTBI, and long-term sequelae. However, high-quality studies of treatments meant to improve mTBI outcomes are currently lacking.

Conclusions And Relevance: This systematic review was used to develop an evidence-based clinical guideline for the diagnosis and management of pediatric mTBI. While an increasing amount of research provides clinically useful information, this systematic review identified key gaps in diagnosis, prognosis, and management.
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http://dx.doi.org/10.1001/jamapediatrics.2018.2847DOI Listing
November 2018

Centers for Disease Control and Prevention Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children.

JAMA Pediatr 2018 11 5;172(11):e182853. Epub 2018 Nov 5.

John H. Stroger, Jr Hospital of Cook County (formerly Cook County Hospital), Chicago, Illinois.

Importance: Mild traumatic brain injury (mTBI), or concussion, in children is a rapidly growing public health concern because epidemiologic data indicate a marked increase in the number of emergency department visits for mTBI over the past decade. However, no evidence-based clinical guidelines have been developed to date for diagnosing and managing pediatric mTBI in the United States.

Objective: To provide a guideline based on a previous systematic review of the literature to obtain and assess evidence toward developing clinical recommendations for health care professionals related to the diagnosis, prognosis, and management/treatment of pediatric mTBI.

Evidence Review: The Centers for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control Board of Scientific Counselors, a federal advisory committee, established the Pediatric Mild Traumatic Brain Injury Guideline Workgroup. The workgroup drafted recommendations based on the evidence that was obtained and assessed within the systematic review, as well as related evidence, scientific principles, and expert inference. This information includes selected studies published since the evidence review was conducted that were deemed by the workgroup to be relevant to the recommendations. The dates of the initial literature search were January 1, 1990, to November 30, 2012, and the dates of the updated literature search were December 1, 2012, to July 31, 2015.

Findings: The CDC guideline includes 19 sets of recommendations on the diagnosis, prognosis, and management/treatment of pediatric mTBI that were assigned a level of obligation (ie, must, should, or may) based on confidence in the evidence. Recommendations address imaging, symptom scales, cognitive testing, and standardized assessment for diagnosis; history and risk factor assessment, monitoring, and counseling for prognosis; and patient/family education, rest, support, return to school, and symptom management for treatment.

Conclusions And Relevance: This guideline identifies the best practices for mTBI based on the current evidence; updates should be made as the body of evidence grows. In addition to the development of the guideline, CDC has created user-friendly guideline implementation materials that are concise and actionable. Evaluation of the guideline and implementation materials is crucial in understanding the influence of the recommendations.
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http://dx.doi.org/10.1001/jamapediatrics.2018.2853DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006878PMC
November 2018

Delivery Of Cascade Screening For Hereditary Conditions: A Scoping Review Of The Literature.

Health Aff (Millwood) 2018 05;37(5):801-808

Heather Hampel is associate director of the Division of Human Genetics and of biospecimen research, and a professor of internal medicine, all at the Ohio State University Comprehensive Cancer Center, in Columbus.

Cascade screening is the process of contacting relatives of people who have been diagnosed with certain hereditary conditions. Its purpose is to identify, inform, and manage those who are also at risk. We conducted a scoping review to obtain a broad overview of cascade screening interventions, facilitators and barriers to their use, relevant policy considerations, and future research needs. We searched for relevant peer-reviewed literature in the period 1990-2017 and reviewed 122 studies. Finally, we described 45 statutes and regulations related to the use and release of genetic information across the fifty states. We sought standardized best practices for optimizing cascade screening across various geographic and policy contexts, but we found none. Studies in which trained providers contacted relatives directly, rather than through probands (index patients), showed greater cascade screening uptake; however, policies in some states might limit this approach. Major barriers to cascade screening delivery include suboptimal communication between the proband and family and geographic barriers to obtaining genetic services. Few US studies examined interventions for cascade screening or used rigorous study designs such as randomized controlled trials. Moving forward, there remains an urgent need to conduct rigorous intervention studies on cascade screening in diverse US populations, while accounting for state policy considerations.
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http://dx.doi.org/10.1377/hlthaff.2017.1630DOI Listing
May 2018

Cost analysis of rapid diagnostics for drug-resistant tuberculosis.

BMC Infect Dis 2018 03 2;18(1):102. Epub 2018 Mar 2.

Department of Medicine, University of California, San Diego, CA, USA.

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 .
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http://dx.doi.org/10.1186/s12879-018-3013-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5833048PMC
March 2018

AHRQ's Tools for Better Practice: Helping Family Physicians Manage Today's Challenges.

Am Fam Physician 2017 Nov;96(9):569-570

Agency for Healthcare Research and Quality, Rockville, MD, USA.

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November 2017

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

Gastroenterology 2018 01 28;154(1):105-116.e20. Epub 2017 Sep 28.

Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.

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.
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http://dx.doi.org/10.1053/j.gastro.2017.09.021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6104831PMC
January 2018

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

JAMA 2016 Sep;316(10):1093-103

Department of Family Medicine and Community Health, Miller School of Medicine, University of Miami, Miami, Florida.

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.
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http://dx.doi.org/10.1001/jama.2016.12195DOI Listing
September 2016

Cost-Effectiveness of the Hepatitis C Self-Management Program.

Health Educ Behav 2017 02 9;44(1):113-122. Epub 2016 Jul 9.

1 VA San Diego Healthcare System, San Diego, CA, USA.

Background: Despite the emergence of new hepatitis C virus (HCV) antiviral medications, many people with chronic HCV know little about their disease, are at risk for transmitting HCV to others, and/or are not considered good treatment candidates. Self-management interventions can educate HCV-infected persons, improve their quality of life, and prepare them for treatment.

Purpose: A cost-effectiveness analysis of the HCV Self-Management Program is presented.

Method: Effectiveness data in quality-adjusted life years (QALYs) were derived from the previously published prospective, randomized controlled trial ( n = 134). Health care utilization was abstracted from medical records in 2011 for the 12 months before and after study enrollment. Intervention costs were tracked from the payer's perspective and combined with health care costs. Sensitivity analyses were used to examine assumptions. Data were analyzed in 2014.

Results: Estimated intervention costs including organizational overhead were $1,760 per 6-week workshop, or $229/person. Health care costs were $815 lower/person for self-management participants, resulting in a cost savings of $586/person. Self-management participants had an average net gain of 0.02975 QALYs after 1 year. When removing inpatient substance use treatment days from analyses, costs were similar between groups, producing an incremental cost-effectiveness ratio of $6,218/QALY. Sensitivity analyses showed that the results and conclusions change little when assumptions were varied.

Conclusions: When compared to information-only, the HCV Self-Management Program led to more QALYs and cost savings in the randomized controlled trial. Independent of health care costs, the intervention is low-cost and educates HCV-infected individuals about antiviral treatment and avoiding viral transmission. Low-cost interventions that can enhance the outcomes derived from expensive antiviral treatments should be studied further.
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http://dx.doi.org/10.1177/1090198116639239DOI Listing
February 2017

Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial.

JAMA Intern Med 2016 Mar;176(3):310-8

Department of Medicine, University of California, Los Angeles.

Importance: It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure (HF) after hospitalization.

Objective: To evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF.

Design, Setting, And Participants: We randomized 1437 patients hospitalized for HF between October 12, 2011, and September 30, 2013, to the intervention arm (715 patients) or to the usual care arm (722 patients) of the Better Effectiveness After Transition-Heart Failure (BEAT-HF) study and observed them for 180 days. The dates of our study analysis were March 30, 2014, to October 1, 2015. The setting was 6 academic medical centers in California. Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF.

Interventions: The intervention combined health coaching telephone calls and telemonitoring. Telemonitoring used electronic equipment that collected daily information about blood pressure, heart rate, symptoms, and weight. Centralized registered nurses conducted telemonitoring reviews, protocolized actions, and telephone calls.

Main Outcomes And Measures: The primary outcome was readmission for any cause within 180 days after discharge. Secondary outcomes were all-cause readmission within 30 days, all-cause mortality at 30 and 180 days, and quality of life at 30 and 180 days.

Results: Among 1437 participants, the median age was 73 years. Overall, 46.2% (664 of 1437) were female, and 22.0% (316 of 1437) were African American. The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge, which occurred in 50.8% (363 of 715) and 49.2% (355 of 722) of patients, respectively (adjusted hazard ratio, 1.03; 95% CI, 0.88-1.20; P = .74). In secondary analyses, there were no significant differences in 30-day readmission or 180-day mortality, but there was a significant difference in 180-day quality of life between the intervention and usual care groups. No adverse events were reported.

Conclusions And Relevance: Among patients hospitalized for HF, combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions.

Trial Registration: clinicaltrials.gov Identifier: NCT01360203.
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http://dx.doi.org/10.1001/jamainternmed.2015.7712DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4827701PMC
March 2016

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

Am Heart J 2015 Nov 18;170(5):1005-1017.e2. Epub 2015 Jul 18.

Department of Public Health, Centre for Medical Decision Making, Erasmus MC, Rotterdam, the Netherlands. Electronic address:

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.
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http://dx.doi.org/10.1016/j.ahj.2015.06.026DOI Listing
November 2015

Redefining the chronic fatigue syndrome.

Ann Intern Med 2015 May;162(9):653-4

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http://dx.doi.org/10.7326/M15-0357DOI Listing
May 2015

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

Genet Med 2015 Sep 15;17(9):702-12. Epub 2015 Jan 15.

Kaiser Permanente Center for Health Research, Portland, Oregon, USA.

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.
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http://dx.doi.org/10.1038/gim.2014.188DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4955831PMC
September 2015

Our Choice/Nuestra Opción: the Imperial County, California, Childhood Obesity Research Demonstration study (CA-CORD).

Child Obes 2015 Feb 13;11(1):37-47. Epub 2015 Jan 13.

1 Division of Health Promotion and Behavioral Science, Graduate School of Public Health, San Diego State University , and the Institute for Behavioral and Community Health, San Diego, CA.

Background: Despite recent declines among young children, obesity remains a public health burden in the United States, including among Latino/Hispanic children. The determining factors are many and are too complex to fully address with interventions that focus on single factors, such as parenting behaviors or school policies. In this article, we describe a multisector, multilevel intervention to prevent and control childhood obesity in predominantly Mexican-origin communities in Southern California, one of three sites of the CDC-funded Childhood Obesity Research Demonstration (CA-CORD) study.

Methods: CA-CORD is a partnership between a university-affiliated research institute, a federally qualified health center, and a county public health department. We used formative research, advisory committee members' recommendations, and previous research to inform the development of the CA-CORD project. Our theory-informed multisector, multilevel intervention targets improvements in four health behaviors: fruit, vegetable, and water consumption; physical activity; and quality sleep. Intervention partners include 1200 families, a federally qualified health center (including three clinics), 26 early care and education centers, two elementary school districts (and 20 elementary schools), three community recreation centers, and three restaurants. Intervention components in these sectors target changes in behaviors, policies, systems, and the social and physical environment. Evaluation activities include assessment of the primary outcome, BMI z-score, at baseline, 12-, and 18-months post-baseline, and sector evaluations at baseline, 12, and 24 months.

Conclusions: Identifying feasible and effective strategies to prevent and control childhood obesity has the potential to effect real changes in children's current and future health status.
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http://dx.doi.org/10.1089/chi.2014.0080DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4323021PMC
February 2015

The Global Consortium for Drug-resistant Tuberculosis Diagnostics (GCDD): design of a multi-site, head-to-head study of three rapid tests to detect extensively drug-resistant tuberculosis.

Trials 2014 Nov 6;15:434. Epub 2014 Nov 6.

Department of Family & Preventive Medicine, University of California, San Diego, CA, USA.

Background: Drug-resistant tuberculosis (DR-TB) remains a threat to global public health, owing to the complexity and delay of diagnosis and treatment. The Global Consortium for Drug-resistant Tuberculosis Diagnostics (GCDD) was formed to develop and evaluate assays designed to rapidly detect DR-TB, so that appropriate treatment might begin more quickly. This paper describes the methodology employed in a prospective cohort study for head-to-head assessment of three different rapid diagnostic tools.

Methods: Subjects at risk of DR-TB were enrolled from three countries. Data were gathered from a combination of patient interviews, chart reviews, and laboratory testing from each site's reference laboratory. The primary outcome of interest was reduction in time from specimen arrival in the laboratory to results of rapid drug susceptibility tests, as compared with current standard mycobacterial growth indicator tube (MGIT) drug susceptibility tests.

Results: Successful implementation of the trial in diverse multinational populations is explained, in addition to challenges encountered and recommendations for future studies with similar aims or populations.

Conclusions: The GCDD study was a head-to-head study of multiple rapid diagnostic assays aimed at improving accuracy and precision of diagnostics and reducing overall time to detection of DR-TB. By conducting a large prospective study, which captured epidemiological, clinical, and biological data, we have produced a high-quality unique dataset, which will be beneficial for analyzing study aims as well as answering future DR-TB research questions. Reduction in detection time for XDR-TB would be a major public health success as it would allow for improved treatment and more successful patient outcomes. Executing successful trials is critical in assessment of these reductions in highly variable populations.

Trial Registration: ClinicalTrials.gov NCT02170441.
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http://dx.doi.org/10.1186/1745-6215-15-434DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4232628PMC
November 2014

Re: counterpoint: rationing on the fly: the opportunity cost of clinical guidelines.

J Am Board Fam Med 2014 Jul-Aug;27(4):443

From Department of Family and Preventive Medicine, University of California-San Diego, La Jolla.

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http://dx.doi.org/10.3122/jabfm.2014.04.140138DOI Listing
April 2015

Rationing on the fly: the opportunity cost of clinical guidelines.

J Am Board Fam Med 2014 Jul-Aug;27(4):439-41

From the Department of Family and Preventive Medicine, University of California-San Diego, La Jolla.

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http://dx.doi.org/10.3122/jabfm.2014.04.120282DOI Listing
April 2015

A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial.

Trials 2014 Apr 13;15:124. Epub 2014 Apr 13.

Resource and Outcomes Management Department, Cedars-Sinai Health System, Los Angeles, CA 90048, USA.

Background: Heart failure is a prevalent health problem associated with costly hospital readmissions. Transitional care programs have been shown to reduce readmissions but are costly to implement. Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed. The objective of this randomized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight, blood pressure, heart rate, and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure.

Methods/design: A multi-center, randomized controlled trial is being conducted at six academic health systems in California. A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure. Patients in the intervention group will receive intensive patient education using the 'teach-back' method and receive instruction in using the telemonitoring equipment. Following hospital discharge, they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a centralized call center. The nurses also will call patients and patients' physicians in response to alerts generated by the telemonitoring system, based on predetermined parameters. The primary outcome is readmission for any cause within 180 days. Secondary outcomes include 30-day readmission, mortality, hospital days, emergency department (ED) visits, hospital cost, and health-related quality of life.

Discussion: BEAT-HF is one of the largest randomized controlled trials of telemonitoring in patients with heart failure, and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring. The study population also includes patients with a wide range of demographic and socioeconomic characteristics. Once completed, the study will be a rich resource of information on how best to use remote technology in the care management of patients with chronic heart failure.

Trial Registration: ClinicalTrials.gov # NCT01360203.
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http://dx.doi.org/10.1186/1745-6215-15-124DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3990010PMC
April 2014

The diagnosis and management of acute otitis media.

Pediatrics 2013 Mar 25;131(3):e964-99. Epub 2013 Feb 25.

American Academy of Pediatrics and American Academy of Family Physicians

This evidence-based clinical practice guideline is a revision of the 2004 acute otitis media (AOM) guideline from the American Academy of Pediatrics (AAP) and American Academy of Family Physicians. It provides recommendations to primary care clinicians for the management of children from 6 months through 12 years of age with uncomplicated AOM. In 2009, the AAP convened a committee composed of primary care physicians and experts in the fields of pediatrics, family practice, otolaryngology, epidemiology, infectious disease, emergency medicine, and guideline methodology. The subcommittee partnered with the Agency for Healthcare Research and Quality and the Southern California Evidence-Based Practice Center to develop a comprehensive review of the new literature related to AOM since the initial evidence report of 2000. The resulting evidence report and other sources of data were used to formulate the practice guideline recommendations. The focus of this practice guideline is the appropriate diagnosis and initial treatment of a child presenting with AOM. The guideline provides a specific, stringent definition of AOM. It addresses pain management, initial observation versus antibiotic treatment, appropriate choices of antibiotic agents, and preventive measures. It also addresses recurrent AOM, which was not included in the 2004 guideline. Decisions were made on the basis of a systematic grading of the quality of evidence and benefit-harm relationships. The practice guideline underwent comprehensive peer review before formal approval by the AAP. This clinical practice guideline is not intended as a sole source of guidance in the management of children with AOM. Rather, it is intended to assist primary care clinicians by providing a framework for clinical decision-making. It is not intended to replace clinical judgment or establish a protocol for all children with this condition. These recommendations may not provide the only appropriate approach to the management of this problem.
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http://dx.doi.org/10.1542/peds.2012-3488DOI Listing
March 2013