background We have little systematic information about the extent to which standard processes involved in health care — a key element of quality — are delivered in the United States. methods We telephoned a random sample of adults living in 12 metropolitan areas in the United States and asked them about selected health care experiences. We also received written consent to copy their medical records for the most recent two-year period and used this information to evaluate performance on 439 indicators of quality of care for 30 acute and chronic conditions as well as preventive care. We then constructed aggregate scores. results Participants received 54.9 percent (95 percent confidence interval, 54.3 to 55.5) of recommended care. We found little difference among the proportion of recommended preventive care provided (54.9 percent), the proportion of recommended acute care provided (53.5 percent), and the proportion of recommended care provided for chronic conditions (56.1 percent). Among different medical functions, adherence to the processes involved in care ranged from 52.2 percent for screening to 58.5 percent for follow-up care. Quality varied substantially according to the particular medical condition, ranging from 78.7 percent of recommended care (95 percent confidence interval, 73.3 to 84.2) for senile cataract to 10.5 percent of recommended care (95 percent confidence interval, 6.8 to 14.6) for alcohol dependence. conclusions The deficits we have identified in adherence to recommended processes for basic care pose serious threats to the health of the American public. Strategies to reduce these deficits in care are warranted.

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The quality of health care delivered to adults in the United States.

Background: Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus The quality of the scientific evidence supporting the use of these assays varies substantially

Approach: An expert committee drafted evidence-based recommendations for the use of laboratory analysis in patients with diabetes An external panel of experts reviewed a draft of the guidelines, which were modified in response to the reviewers’ suggestions A revised draft was posted on the Internet and was presented at the AACC Annual Meeting in July, 2000 The recommendations were modified again in response to oral and written comments The guidelines were reviewed by the Professional Practice Committee of the American Diabetes Association

Content: Measurement of plasma glucose remains the sole diagnostic criterion for diabetes Monitoring of glycemic control is performed by the patients, who measure their own plasma or blood glucose with meters, and by laboratory analysis of glycated hemoglobin The potential roles of noninvasive glucose monitoring, genetic testing, autoantibodies, microalbumin, proinsulin, C-peptide, and other analytes are addressed

Summary: The guidelines provide specific recommendations based on published data or derived from expert consensus Several analytes are of minimal clinical value at the present time, and measurement of them is not recommended

/pdf/guidelines-and-recommendations-for-laboratory-analysis-in-547km3houz.pdf

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

Background: Inadequate functional health literacy is common, but its impact on patients with chronic diseases is not well described. Objective: To examine among patients with hypertension or diabetes the relationship between their functional health literacy level and their knowledge of their chronic disease and treatment. Methods: We conducted a cross-sectional survey of patients with hypertension and diabetes presenting to the general medicine clinics at 2 urban public hospitals. Literacy was measured by the Test of Functional Health Literacy in Adults. Knowledge of their illness was assessed in patients with diabetes or hypertension using 21 hypertension and 10 diabetes questions based on key elements in educational materials used in our clinics.

https://jamanetwork.com/journals/jamainternalmedicine/articlepdf/191123/ioi70066.pdf

Relationship of Functional Health Literacy to Patients' Knowledge of Their Chronic Disease A Study of Patients With Hypertension and Diabetes

Socioeconomic and racial/ethnic disparities in health care quality have been extensively documented. Recently, the elimination of disparities in health care has become the focus of a national initiative. Yet, there is little effort to monitor and address disparities in health care through organizational quality improvement. After reviewing literature on disparities in health care, we discuss the limitations in existing quality assessment for identifying and addressing these disparities. We propose 5 principles to address these disparities through modifications in quality performance measures: disparities represent a significant quality problem; current data collection efforts are inadequate to identify and address disparities; clinical performance measures should be stratified by race/ethnicity and socioeconomic position for public reporting; population-wide monitoring should incorporate adjustment for race/ethnicity and socioeconomic position; and strategies to adjust payment for race/ethnicity and socioeconomic position should be considered to reflect the known effects of both on morbidity. JAMA. 2000;283:2579-2584

Inequality in quality : Addressing socioeconomic, racial, and ethnic disparities in health care

Monitoring of glycemic status, as performed by patients and health care providers, is considered a cornerstone of diabetes care. Results of monitoring are used to assess the efficacy of therapy and to make adjustments in diet, exercise, and medications in order to achieve the best possible blood glucose control.

The purpose of this review is to summarize current knowledge about the tests used most widely in monitoring the glycemic status of people with diabetes. The review addresses both patient- and physician/laboratory-based testing, and it includes tests of urine glucose and ketones and tests of blood glucose and glycated proteins (hemoglobin and serum proteins). The major emphasis is on the advantages and limitations of each test for routine clinical practice. Use of these tests for diabetes screening and diagnosis will not be addressed in this review. Since this review was first published in 1995, there have been many advances in the field, most notably standardization of glycated hemoglobin testing and new approaches to self-monitoring of blood glucose (SMBG), including minimally invasive continuous glucose monitoring over hours to days at a time. These and other advances are presented in detail in a recent report that was prepared by the National Academy of Clinical Biochemistry (NACB) and published as an American Diabetes Association (ADA) position statement (1). This review will attempt to complement, rather than duplicate, the material in the NACB report.

If there was an ideal method of monitoring glycemic status, it might be a small noninvasive device, perhaps similar to a wristwatch that people with diabetes could wear to continuously monitor their blood glucose level. The device would warn of impending hypoglycemia. It also would store blood glucose data and perform a variety of calculations such as hourly, daily, weekly, or monthly blood glucose averages. Unfortunately, such a monitoring device is …

https://care.diabetesjournals.org/content/diacare/27/7/1761.full.pdf

Tests of Glycemia in Diabetes

Objective.-To assess whether adults with diagnosed diabetes in the United States are receiving recommended eye examinations for detection of diabetic retinopathy and what factors are associated with receiving them. Design, Setting, and Participants.-The design was a cross-sectional survey of the civilian, noninstitutionalized US population 18 years of age or older, based on the 1989 National Health Interview Survey. A multistage probability sampling strategy was used to identify a representative sample of 84 572 persons. A questionnaire on diabetes was administered to all subjects with diagnosed diabetes (n=2405). Main Outcome Measure.-A dilated eye examination in the past year

Ophthalmic examination among adults with diagnosed diabetes mellitus

Objective. —To assess whether adults with diagnosed diabetes in the United States are receiving recommended eye examinations for detection of diabetic retinopathy and what factors are associated with receiving them. Design, Setting, and Participants. —The design was a cross-sectional survey of the civilian, noninstitutionalized US population 18 years of age or older, based on the 1989 National Health Interview Survey. A multistage probability sampling strategy was used to identify a representative sample of 84572 persons. A questionnaire on diabetes was administered to all subjects with diagnosed diabetes (n=2405). Main Outcome Measure. —A dilated eye examination in the past year. Main Results. —Of all adults with diagnosed diabetes in the United States, only 49% had a dilated eye examination in the past year. This included 57% of people with insulin-dependent diabetes mellitus (IDDM), 55% with insulin-treated non— insulin-dependent diabetes mellitus (NIDDM), and 44% with NIDDM not treated with insulin. Even among diabetics at high risk of vision loss because of retinopathy or long duration of diabetes, the proportion with a dilated eye examination was only 61% and 57%, respectively. By logistic regression, the probability of a dilated eye examination among persons with NIDDM increased with older age, higher socioeconomic status, and having attended a diabetes education class. The probability of a dilated eye examination was not independently related to race, duration of diabetes, frequency of physician visits for diabetes, or health insurance. Conclusions. —About half of adults with diabetes in the United States are not receiving timely and recommended eye care to detect and treat retinopathy. Widespread interventions, including patient and professional education, are needed to ensure that diabetic patients who are not receiving appropriate eye care have an annual dilated eye examination to detect retinopathy and prevent vision loss. (JAMA. 1993;270:1714-1718)

Ophthalmic examination among adults with diagnosed diabetes mellitus.

OBJECTIVE To evaluate self-monitoring of blood glucose, which is considered an important practice for patients with diabetes. However, little is known about the frequency or determinants of this technique. RESEARCH DESIGN AND METHODS A detailed questionnaire on diabetes was administered to a representative sample of 2405 diabetic subjects ≥ 18 yr of age in the U.S. population in the 1989 National Health Interview Survey. RESULTS Among subjects with IDDM, 40% monitored their blood glucose at least 1 time/day. Among subjects with NIDDM treated with insulin, 26% monitored at least 1 time/day and among NIDDM subjects not treated with insulin, the percentage was 5%. When stratified by age, little difference was observed between IDDM subjects and insulin-treated NIDDM subjects in the percentage testing at least 1 time/day. By multivariate analysis, age and insulin use were the major determinants of whether diabetic subjects tested their blood glucose. Race and education were also independently related to self-monitoring of blood glucose. Blacks were 60% less likely to test their blood glucose at least 1 time/day compared with non-Hispanic whites and Mexican Americans. Those with college education were 80% more likely to test their blood glucose compared with those with lower education levels. Having had a patient education class in diabetes management and frequent physician visits for diabetes care were positively related to self-testing. Self-monitoring was not related to higher income or having health insurance. CONCLUSIONS A large proportion of patients with diabetes do not test their blood glucose. Financial barriers associated with income and health insurance do not appear to impede the practice of self-monitoring. Because of the importance of blood glucose control in the prevention of diabetes complications and the role of self-monitoring in achieving blood glucose control, it may be prudent for physicians and their patients to make greater use of this technique. Special attention should be directed to the subgroups of patients (blacks, patients not treated with insulin, those with less education, and those with no education in diabetes) in which the frequency of self-monitoring is particularly low.

Self-Monitoring of Blood Glucose by Adults With Diabetes in the United States Population


 Objectives: Real-world data (RWD) from the routine care of patients with cancer captured through EHRs is a valuable resource for research. Understanding the relationship between characteristics and outcomes of patients treated in the real world and those treated in clinical trials is essential to produce evaluable trial-like populations using RWD in oncology for research and regulatory purposes. Methods: This study used: a) RWD from the Flatiron Health EHR-derived, de-identified, longitudinal database (comprising patient-level structured and unstructured data, curated via technology-enabled abstraction selected from approximately 280 US cancer clinics [~800 sites of care]) and b) patient-level data from three completed RCTs (PALOMA-2, MONALEESA-2, and MONARCH-3) including patients with previously untreated hormone receptor positive (HR+), HER2/neu negative (HER2-) mBC, then separately pooled across the trials into two treatment groups, patients who received aromatase inhibitor monotherapy (AI) or a CDK4/6 inhibitor + AI. Key eligibility criteria were similar across the RCTs and were used to select a real world external cohort (rwEC) initiating AI monotherapy on or prior to 11 Nov 2015 (end of MONARCH-3 enrollment period). Patients from the rwEC were matched separately to the control arm and experimental arm patients from the pooled RCT using propensity score method (PSM). The propensity score was estimated by a logistic regression using baseline covariates of age, race, site of disease (visceral, non-visceral), Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0, 1), and metastatic disease (recurrent, new). The matching ratio was 1:1 without replacement with calipers. Covariate balance was measured by the absolute standardized mean difference (ASMD). Due to the high percentage of missing ECOG PS data, matching was repeated 100 times with imputed ECOG PS. The impact of including additional key covariates for propensity matching such as number of disease sites, bone-only disease, and prior endocrine therapy was assessed. Results: There were 1326 patients with HR+, HER2- mBC selected from the EHR-derived database who received first-line AI therapy and 1827 patients randomized in the RCTs (1106 and 721 patients for experimental and control arms, respectively). With 100 matching iterations, 563 rwEC patients on average (range, 547-572) were matched to the RCTs control arm, and 753 rwEC patients on average (range: 741-761) were matched to the RCTs experimental arm. Prior to matching, the ASMD varied widely across all prespecified baseline covariates (4.3 for the rwEC vs. RCTs control arm, 2.6 for the rwEC vs. RCTs experimental arm). After matching was performed, across all baseline covariates used in the PSM, the ASMD was reduced to be under 0.12 for the rwEC vs. RCTs control arm, and under 0.2 for the rwEC vs. RCTs experimental arm in more than 90% of the matching iterations. Analyses looking at the additional baseline covariates to the propensity matching resulted in similar ASMDs. Conclusions: EHR-derived RWD can be used to generate a cohort of patients with similar baseline characteristics to those treated on RCT. The next step in our trial emulation framework is to analyze the comparability of outcomes between these two matched cohorts.
 Citation Format: Laleh Amiri-Kordestani, Xin Gao, Shrujal Baxi, Erik Bloomquist, Jonathan Bryan, Lynn Howie, Catherine Keane, Paul G. Kluetz, Christy Osgood, Prashni Paliwal, Donna R. Rivera, James Roose, Julie Schneider, Harpreet Singh, Shenghui Tang, Lijun Zhang, Julia A. Beaver. Generating real-world external comparators for randomized clinical trials (RCTs) in metastatic breast cancer (mBC) using electronic health records (EHRs) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P2-11-05.

Abstract P2-11-05: Generating real-world external comparators for randomized clinical trials (RCTs) in metastatic breast cancer (mBC) using electronic health records (EHRs)

L J Howie

Papers

Ophthalmic examination among adults with diagnosed diabetes mellitus

Ophthalmic examination among adults with diagnosed diabetes mellitus.

Self-Monitoring of Blood Glucose by Adults With Diabetes in the United States Population

Abstract P2-11-05: Generating real-world external comparators for randomized clinical trials (RCTs) in metastatic breast cancer (mBC) using electronic health records (EHRs)