Design and Development of a Community-Based, Interdisciplinary, Collaborative Dementia Care Program.

OBJECTIVE: To describe the design, development, and baseline characteristics of enrollees of a home-based, interdisciplinary, dyadic, pilot dementia care program. DESIGN: Single-arm, dementia care intervention in partnership with primary care providers delivered by Health Coaches to persons with dementia and caregiver "dyads" and supervised by an interdisciplinary team. SETTING: Home- and virtual-based dyad support. PARTICIPANTS: Persons with mild cognitive impairment or dementia diagnosis and/or who were prescribed antidementia medications; had an identified caregiver willing to participate; were under the care of a partner primary care provider; and had health insurance through the affiliated accountable care organization (Banner Health Network). INTERVENTION: Provision of personalized dementia education and support in the home or virtually by Health Coaches supported by an interdisciplinary team. MEASUREMENTS: Cognition, function, mood, and behavior of persons with dementia; caregiver stress and program satisfaction; primary care provider satisfaction. RESULTS: Served dyads from three primary care clinics with a total of 87 dyads enrolled between December 2018 and June 2020. CONCLUSION: A pilot Dementia Care Partners demonstrated feasibility and suggested acceptability, and high satisfaction among primary care providers and caregivers.

Defining, Estimating, and Communicating Overdiagnosis in Cancer Screening.

The toll of inadequate health care is well-substantiated, but recognition is mounting that "too much" is also possible. Overdiagnosis represents one harm of too much medicine, but the concept can be confusing: It is often conflated with related harms (such as overtreatment, misclassification, false-positive results, and overdetection) and is difficult to measure because it cannot be directly observed. Because the U.S. Preventive Services Task Force (USPSTF) issues screening recommendations aimed largely at healthy persons, it has a particular interest in understanding harms related to screening, especially but not limited to overdiagnosis. In support of the USPSTF, the authors summarize the knowledge and provide guidance on defining, estimating, and communicating overdiagnosis in cancer screening. To improve consistency, thinking, and reporting about overdiagnosis, they suggest a specific definition. The authors articulate how variation in estimates of overdiagnosis can arise, identify approaches to estimating overdiagnosis, and describe best practices for communicating the potential for harm due to overdiagnosis.

Evaluation of immunization data completeness within a large community health care system exchanging data with a state immunization information system.

CONTEXT: Information systems are used by most states to maintain registries of immunization data both for monitoring population-level adherence and for use in clinical practice and research. Direct data exchange between such systems and electronic health record systems presents an opportunity to improve the completeness and quality of information available. OBJECTIVE: Our goals were to describe and compare the completeness of the Arizona State Immunization System, the electronic health record at a large community health provider in Arizona exchanging electronic data with the Arizona system, and personal immunization records in an effort to contribute to the discussion on the completeness of state-run immunization registries and data exchange with these registries. DESIGN: Immunization histories from these sources were collected and reviewed sequentially. Unique dates of vaccination administrations were counted for each patient and tagged on the basis of comparisons across sources. RESULTS: We quantified completeness by combining information from all 3 sources and comparing each source with the complete set. We determined that the state registry was 71.8% complete, the hospital electronic health record was 81.9% complete, and personal records were 87.8% complete. Of the 2017 unique vaccination administrations, 65% were present in all 3 sources, 24.6% in 2 of the 3 sources, and 10.4% in only 1 source. Only 11% of patients had records in complete agreement across the 3 sources. CONCLUSION: This study highlights issues related to data completeness, exchange, and reporting of immunization information to state registries and suggests that there is some degree of deficiency in completeness of immunization registries and other sources. This study indicates that there is a need to strengthen links between electronic data sources with immunization information and describes potential improvements in completeness that such efforts could provide, enabling providers to better rely on state immunization registries and to improve research utilization of immunization information systems.

Isoflavone soy protein supplementation and atherosclerosis progression in healthy postmenopausal women: a randomized controlled trial.

BACKGROUND AND PURPOSE: Although epidemiological and experimental studies suggest that dietary intake of soy may be cardioprotective, use of isoflavone soy protein (ISP) supplementation as a primary preventive therapy remains unexplored. We determined whether ISP reduces subclinical atherosclerosis assessed as carotid artery intima-media thickness progression. METHODS: In a double-blind, placebo-controlled trial, 350 postmenopausal women 45 to 92 years of age without diabetes and cardiovascular disease were randomized to 2 evenly divided daily doses of 25 g soy protein containing 91 mg aglycon isoflavone equivalents or placebo for 2.7 years. RESULTS: Overall, mean (95% CI) carotid artery intima-media thickness progression rate was 4.77 (3.39-6.16) µm/year in the ISP group and 5.68 (4.30-7.06) µm/year in the placebo group. Although carotid artery intima-media thickness progression was reduced on average by 16% in the ISP group relative to the placebo group, this treatment effect was not statistically significant (P=0.36). Among the subgroup of women who were randomized within 5 years of menopause, ISP participants had on average a 68% lower carotid artery intima-media thickness progression rate than placebo participants 2.16 (-1.10 to 5.43) versus 6.79 (3.56-10.01) µm/year (P=0.05). ISP supplementation had a null effect on women who were >5 years beyond menopause when randomized. There were no major adverse events from ISP supplementation. CONCLUSIONS: ISP supplementation did not significantly reduce subclinical atherosclerosis progression in postmenopausal women. Subgroup analysis suggests that ISP supplementation may reduce subclinical atherosclerosis in healthy young (median age, 53 years) women at low-risk for cardiovascular disease who were <5 years postmenopausal. These first trial results of their kind warrant further investigation.

Reconsidering the approach to prevention recommendations for older adults.

The U.S. Preventive Services Task Force (USPSTF) bases its recommendations on an evidence-based model of clinical prevention that focuses on specific diseases, well-defined preventive interventions, and evidence of improved health outcomes. Applying this model to prevention for very old patients has been problematic for several reasons: Many geriatric disorders have multiple risk factors, interventions, and expected outcomes; older adults are not often represented in clinical trials; and important outcomes may not be measured and reported in ways that are conducive to evidence synthesis and interpretation. In 2005, the USPSTF convened a geriatrics workgroup to refine USPSTF methodology and processes to better address the preventive needs of older adults. The USPSTF has begun to apply these new approaches to the review and recommendation on interventions to prevent falls in older adults.

Overlooked Shortcomings of Observational Studies of Interventions in Coronavirus Disease 2019: An Illustrated Review for the Clinician.

The rapid spread of severe acute respiratory syndrome coronavirus 2 infection across the globe triggered an unprecedented increase in research activities that resulted in an astronomical publication output of observational studies. However, most studies failed to apply fully the necessary methodological techniques that systematically deal with different biases and confounding, which not only limits their scientific merit but may result in harm through misleading information. In this article, we address a few important biases that can seriously threaten the validity of observational studies of coronavirus disease 2019 (COVID-19). We focus on treatment selection bias due to patients' preference on goals of care, medical futility and disability bias, survivor bias, competing risks, and the misuse of propensity score analysis. We attempt to raise awareness and to help readers assess shortcomings of observational studies of interventions in COVID-19.

The development and validation of a simulation tool for health policy decision making.

Computer simulations have been used to model infectious diseases to examine the outcomes of alternative strategies for managing their spread. Methicillin resistant Staphylococcus aureus (MRSA) skin and soft tissue infections have become prominent in many communities and efforts are underway to reduce the spread of this organism both in hospitals and communities. Currently, there are few tools for policy makers to use to examine the outcome of various choices when making decisions about MRSA. Using the example of MRSA, we describe, in this paper, a rigorous approach for development and validation of a tool that simulates the spread of MRSA infections. We used sensitivity analyses in a novel way and validated the simulation results against local data over time. Our approach for simulation development and validation is generalizeable to simulations of other diseases.

Update on the methods of the U.S. Preventive Services Task Force: insufficient evidence.

The U.S. Preventive Services Task Force (USPSTF) seeks to provide reliable and accurate evidence-based recommendations to primary care clinicians. However, clinicians indicate frustration with the lack of guidance provided by the USPSTF when the evidence is insufficient to make a recommendation. This article describes a new USPSTF plan to commission its Evidence-based Practice Centers to collect information in 4 domains pertinent to clinical decisions about prevention and to report this information routinely. The 4 domains are potential preventable burden, potential harm of the intervention, costs (both monetary and opportunity), and current practice. The process and rationale used to select these domains are presented, along with examples of how clinicians might use the information to guide clinical decision making when evidence is insufficient.

Predictors of insulin regimens and impact on outcomes in youth with type 1 diabetes: the SEARCH for Diabetes in Youth study.

OBJECTIVES: To describe the insulin regimens used to treat type 1 diabetes mellitus (T1DM) in youth in the United States, to explore factors related to insulin regimen, and to describe the associations between insulin regimen and clinical outcomes, particularly glycemic control. STUDY DESIGN: A total of 2743 subjects participated in the SEARCH for Diabetes in Youth study, an observational population-based study of youth diagnosed with T1DM, conducted at 6 centers. Data collected during a study visit included clinical and sociodemographic information, body mass index, laboratory measures, and insulin regimen. RESULTS: Sociodemographic characteristics were associated with insulin regimen. Insulin pump therapy was more frequently used by older youth, females, non-Hispanic whites, and families with higher income and education (P = .02 for females, P < .001 for others). Insulin pump use was associated with the lowest hemoglobin A1C levels in all age groups. A1C levels were >7.5% in >70% of adolescents, regardless of regimen. CONCLUSIONS: Youth using insulin pumps had the lowest A1C; A1C was unacceptably high in adolescents. There is a need to more fully assess and understand factors associated with insulin regimens recommended by providers and the influence of race/ethnicity, education, and socioeconomic status on these treatment recommendations and to develop more effective treatment strategies, particularly for adolescents.

Glycemic control in youth with diabetes: the SEARCH for diabetes in Youth Study.

OBJECTIVE: To assess correlates of glycemic control in a diverse population of children and youth with diabetes. STUDY DESIGN: This was a cross-sectional analysis of data from a 6-center US study of diabetes in youth, including 3947 individuals with type 1 diabetes (T1D) and 552 with type 2 diabetes (T2D), using hemoglobin A(1c) (HbA(1c)) levels to assess glycemic control. RESULTS: HbA(1c) levels reflecting poor glycemic control (HbA(1c) >or= 9.5%) were found in 17% of youth with T1D and in 27% of those with T2D. African-American, American Indian, Hispanic, and Asian/Pacific Islander youth with T1D were significantly more likely to have higher HbA(1c) levels compared with non-Hispanic white youth (with respective rates for poor glycemic control of 36%, 52%, 27%, and 26% vs 12%). Similarly poor control in these 4 racial/ethnic groups was found in youth with T2D. Longer duration of diabetes was significantly associated with poorer glycemic control in youth with T1D and T2D. CONCLUSIONS: The high percentage of US youth with HbA(1c) levels above the target value and with poor glycemic control indicates an urgent need for effective treatment strategies to improve metabolic status in youth with diabetes.

Prevalence and determinants of elevated apolipoprotein B and dense low-density lipoprotein in youths with type 1 and type 2 diabetes.

OBJECTIVE: The objective of the study was to assess the prevalence and determinants of elevated apolipoprotein B (apoB) and dense low-density lipoprotein (LDL) in United States youth with type 1 or type 2 diabetes. METHODS: We conducted cross-sectional analyses of apoB concentrations, LDL density, and prevalence of elevated apoB levels and dense LDL from the SEARCH for Diabetes in Youth study, a six-center U.S.-based study of youth with diabetes onset younger than 20 years of age (2657 with type 1 and 345 with type 2). RESULTS: Among youth with type 1 diabetes, 11% had elevated apoB (>or=100 mg/dl, 1.95 mm/liter), 8% had dense LDL (relative flotation rateor=130 mg/dl, 3.36 mm/liter). In contrast, among youth with type 2 diabetes, 36% had elevated apoB, 36% had dense LDL, but only 23% had elevated LDL-cholesterol. Dense LDL and apoB each increased with hemoglobin A1c in both types. Among type 1 diabetics in poor glycemic control (hemoglobin A1c>or=9.5%), 28% had elevated apoB, and 18% had dense LDL, whereas 72% of poorly controlled type 2 diabetics had elevated apoB and 62% had dense LDL. CONCLUSIONS: In youth with type 1 diabetes, elevated apoB and dense LDL were not highly prevalent, whereas elevated apoB and dense LDL were common lipoprotein abnormalities in youth with type 2 diabetes. The prevalence of these risk factors substantially increased with poor glycemic control in both groups, stressing the importance of achieving and maintaining an optimal glucose control.

Incidence of dementia in long-term hormone users.

Results from epidemiologic studies of postmenopausal hormone use and dementia have been conflicting. Investigators from the Women's Health Initiative Memory Study reported that the incidence of dementia in women aged >/=65 years assigned to hormone use was increased. Here the authors report results from a prospective cohort study of 2,906 dementia-free women (1,519 hormone users and 1,387 hormone nonusers) aged > or =75 years who were recruited from a Southern California health plan in 1999 and followed through 2003. Cognitive status was assessed annually using the Telephone Interview of Cognitive Status-modified, supplemented by the Telephone Dementia Questionnaire and medical record review. The mean self-reported age at initiation of hormone use was 48.3 years for users of estrogen alone (n = 1,072) and 54.9 years for users of estrogen plus progestin (n = 447); self-reported mean durations of hormone use were 30.5 years and 23.2 years, respectively. There were 283 incident dementia cases identified during follow-up. After adjustment for age, education, and medical history, hazard ratios for incident dementia were 1.34 (95% confidence interval: 0.95, 1.89) in estrogen/progestin users and 1.23 (95% confidence interval: 0.94, 1.59) in estrogen users. These findings do not provide support for an effect of estrogen or estrogen/progestin use in preventing dementia.

Social network, cognitive function, and dementia incidence among elderly women.

OBJECTIVES: We examined whether social networks had a protective association with incidence of dementia among elderly women. METHODS: We prospectively studied 2249 members of a health maintenance organization who were 78 years or older, were classified as free of dementia in 2001, and had completed at least 1 follow-up interview in 2002 through 2005. We used the Telephone Interview for Cognitive Status-modified, the Telephone Dementia Questionnaire, and medical record review to assess cognitive status. We used the Lubben Social Network Scale-6 to assess social network. We estimated hazard ratios for incident dementia with Cox proportional hazards models, adjusting for age at entry, education, hormone use, cognitive status scores, and health conditions. RESULTS: We identified 268 incident cases of dementia during follow-up. Compared with women with smaller social networks, the adjusted hazard ratio for incident dementia in women with larger social networks was 0.74 (95% confidence interval=0.57, 0.97). CONCLUSIONS: Our findings suggest that larger social networks have a protective influence on cognitive function among elderly women. Future studies should explore which aspects of social networks are associated with dementia risk and maintenance of cognitive health.

Update on the methods of the U.S. Preventive Services Task Force: estimating certainty and magnitude of net benefit.

The major goal of the U.S. Preventive Services Task Force (USPSTF) is to provide a reliable and accurate source of evidence-based recommendations on a wide range of preventive services. In this article, the USPSTF updates and reviews the process by which it evaluates evidence, determines the certainty and magnitude of net benefit, and gives a final letter grade to recommendations. Because direct evidence about prevention is often unavailable, the Task Force usually considers indirect evidence. To guide its selection of indirect evidence, a "chain of evidence" is constructed within an analytic framework. The Task Force examines evidence of various research designs that addresses the key questions within the framework. New terms have been added to describe the USPSTF's judgment about the evidence for each key question: "convincing," "adequate," or "inadequate." For increased clarity, the USPSTF has changed its description of overall evidence of net benefit for the preventive service from "good," "fair," or "poor" quality to "high," "moderate," or "low" certainty. This rating considers the extent to which an uninterrupted chain of evidence exists across the analytic framework. Individual studies will continue to be judged as being of "good," "fair," or "poor" quality. Using outcomes tables, the USPSTF estimates the magnitude of benefits and the magnitude of harms, and synthesizes them into an estimate of the magnitude of net benefit. Although some judgment is required at all steps, the USPSTF strives to make the process as explicit and transparent as possible. The USPSTF anticipates that its methods for making evidence-based recommendations will continue to evolve.

How to read the new recommendation statement: methods update from the U.S. Preventive Services Task Force.

Since 2001, the U.S. Preventive Services Task Force (USPSTF) has worked to refine its methods of evidence review and assessment and to create more usable documents in response to clinicians' needs. These changes have resulted in a revised grading system, as well as a new format and new language for the recommendation statement. This paper focuses on the changes to and the new look of the USPSTF recommendation statement. The new recommendation statement comprises 9 sections. Important changes include standardization of the format of the summary statement to specify what service is being recommended in what population; standardization of the headings in the rationale section; a change in the wording of the grade C recommendation and the I statement; and a new section, called "Other Considerations," in which salient issues related to cost-effectiveness, mandates, and other implementation issues are described.

Collaborative Modeling: Experience of the U.S. Preventive Services Task Force.

Models can be valuable tools to address uncertainty, trade-offs, and preferences when trying to understand the effects of interventions. Availability of results from two or more independently developed models that examine the same question (comparative modeling) allows systematic exploration of differences between models and the effect of these differences on model findings. Guideline groups sometimes commission comparative modeling to support their recommendation process. In this commissioned collaborative modeling, modelers work with the people who are developing a recommendation or policy not only to define the questions to be addressed but ideally, work side-by-side with each other and with systematic reviewers to standardize selected inputs and incorporate selected common assumptions. This paper describes the use of commissioned collaborative modeling by the U.S. Preventive Services Task Force (USPSTF), highlighting the general challenges and opportunities encountered and specific challenges for some topics. It delineates other approaches to use modeling to support evidence-based recommendations and the many strengths of collaborative modeling compared with other approaches. Unlike systematic reviews prepared for the USPSTF, the commissioned collaborative modeling reports used by the USPSTF in making recommendations about screening have not been required to follow a common format, sometimes making it challenging to understand key model features. This paper presents a checklist developed to critically appraise commissioned collaborative modeling reports about cancer screening topics prepared for the USPSTF.

Serum lipids and glucose control: the SEARCH for Diabetes in Youth study.

OBJECTIVE: To assess the relationship of serum lipid concentrations with glucose control in youth with diabetes mellitus. DESIGN: Cross-sectional analyses of data from the SEARCH for Diabetes in Youth study. SETTING: Multicenter study of youth with diabetes onset at younger than 20 years. PATIENTS/ PARTICIPANTS: Nineteen hundred seventy-three SEARCH participants aged 10 years or older with hemoglobin A(1c) and fasting total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride measured at the SEARCH study examination. MAIN EXPOSURE: Hemoglobin A(1c). OUTCOME MEASURE: Lipid concentrations. RESULTS: There were significant trends of higher levels of TC, LDL-C, triglyceride, and non-HDL-C (but not HDL-C) with higher hemoglobin A(1c) concentrations for both diabetes types. The slopes of TC increase were 7.8 mg/dL (0.20 mmol/L) per unit increase in hemoglobin A(1c) for type 1 and 8.1 mg/dL (0.21 mmol/L) for type 2. Levels of TC, LDL-C, triglyceride, and non-HDL-C were all significantly higher (all P values <.001) in type 2 than in type 1 diabetes (mean differences in milligrams per deciliter [millimoles per liter], +13.6 [+0.35] for TC; +8.3 [+0.22] for LDL-C; +66.3 [+0.75] for triglyceride; +25.5 [+0.66] for non-HDL-C). Levels of HDL-C were lower in youth with type 2 diabetes (mean difference, -11.9 mg/dL [-0.31 mmol/L]). Among those with type 1 diabetes in poor glycemic control, 35%, 27%, and 12% had high concentrations of TC (>or=200 mg/dL [5.17 mmol/L]), LDL-C (>or=130 mg/dL [3.36 mmol/L]), and triglyceride (>or=200 mg/dL [2.26 mmol/L]), respectively. In youth with type 2 diabetes in poor glycemic control, percentages with high levels of TC, LDL-C, and triglycerides were 65%, 43%, and 40%, respectively. CONCLUSIONS: Glycemic control and lipid levels are independently associated in youth with both type 1 and type 2 diabetes.