Practical Guidance for Involving Stakeholders in Health Research.

Stakeholder engagement is increasingly common in health research, with protocols for engaging multiple stakeholder groups becoming normative in patient-centered outcomes research. Previous work has focused on identifying relevant stakeholder groups with whom to work and on working with stakeholders in evidence implementation. This paper draws on the expertise of a team from four countries-Canada, Australia, the UK, and the USA-to provide researchers with practical guidance for carrying out multi-stakeholder-engaged projects: we present a list of questions to assist in selecting appropriate roles and modes of engagement; we introduce a matrix to help summarize engagement activities; and we provide a list of online resources. This guidance, matrix, and list of resources can assist researchers to consider more systematically which stakeholder groups to involve, in what study roles, and by what modes of engagement. By documenting how stakeholders are paired up with specific roles, the matrix also provides a potential structure for evaluating the impact of stakeholder engagement.

PCORI at 3 years--progress, lessons, and plans.

The Patient-Centered Outcomes Research Institute (PCORI) has established distinctive pathways for funding and conducting practical research and has awarded over $318 million for studies covering a wide range of conditions, locations, and socioeconomic characteristics.

Engaging patients and stakeholders in research proposal review: the patient-centered outcomes research institute.

The inaugural round of merit review for the Patient-Centered Outcomes Research Institute (PCORI) in November 2012 included patients and other stakeholders, as well as scientists. This article examines relationships among scores of the 3 reviewer types, changes in scoring after in-person discussion, and the effect of inclusion of patient and stakeholder reviewers on the review process. In the first phase, 363 scientists scored 480 applications. In the second phase, 59 scientists, 21 patients, and 31 stakeholders provided a "prediscussion" score and a final "postdiscussion" score after an in-person meeting for applications. Bland-Altman plots were used to characterize levels of agreement among and within reviewer types before and after discussion. Before discussion, there was little agreement among average scores given by the 4 lead scientific reviewers and patient and stakeholder reviewers. After discussion, the 4 primary reviewers showed mild convergence in their scores, and the 21-member panel came to a much stronger agreement. Of the 25 awards with the best (and lowest) scores after phase 2, only 13 had ranked in the top 25 after the phase 1 review by scientists. Five percent of the 480 proposals submitted were funded. The authors conclude that patient and stakeholder reviewers brought different perspectives to the review process but that in-person discussion led to closer agreement among reviewer types. It is not yet known whether these conclusions are generalizable to future rounds of peer review. Future work would benefit from additional data collection for evaluation purposes and from long-term evaluation of the effect on the funded research.

Population trends in the incidence and outcomes of acute myocardial infarction.

BACKGROUND: Few studies have characterized recent population trends in the incidence and outcomes of myocardial infarction. METHODS: We identified patients 30 years of age or older in a large, diverse, community-based population who were hospitalized for incident myocardial infarction between 1999 and 2008. Age- and sex-adjusted incidence rates were calculated for myocardial infarction overall and separately for ST-segment elevation and non-ST-segment elevation myocardial infarction. Patient characteristics, outpatient medications, and cardiac biomarker levels during hospitalization were identified from health plan databases, and 30-day mortality was ascertained from administrative databases, state death data, and Social Security Administration files. RESULTS: We identified 46,086 hospitalizations for myocardial infarctions during 18,691,131 person-years of follow-up from 1999 to 2008. The age- and sex-adjusted incidence of myocardial infarction increased from 274 cases per 100,000 person-years in 1999 to 287 cases per 100,000 person-years in 2000, and it decreased each year thereafter, to 208 cases per 100,000 person-years in 2008, representing a 24% relative decrease over the study period. The age- and sex-adjusted incidence of ST-segment elevation myocardial infarction decreased throughout the study period (from 133 cases per 100,000 person-years in 1999 to 50 cases per 100,000 person-years in 2008, P<0.001 for linear trend). Thirty-day mortality was significantly lower in 2008 than in 1999 (adjusted odds ratio, 0.76; 95% confidence interval, 0.65 to 0.89). CONCLUSIONS: Within a large community-based population, the incidence of myocardial infarction decreased significantly after 2000, and the incidence of ST-segment elevation myocardial infarction decreased markedly after 1999. Reductions in short-term case fatality rates for myocardial infarction appear to be driven, in part, by a decrease in the incidence of ST-segment elevation myocardial infarction and a lower rate of death after non-ST-segment elevation myocardial infarction.

Use of Real-World Data in Population Science to Improve the Prevention and Care of Diabetes-Related Outcomes.

The past decade of population research for diabetes has seen a dramatic proliferation of the use of real-world data (RWD) and real-world evidence (RWE) generation from non-research settings, including both health and non-health sources, to influence decisions related to optimal diabetes care. A common attribute of these new data is that they were not collected for research purposes yet have the potential to enrich the information around the characteristics of individuals, risk factors, interventions, and health effects. This has expanded the role of subdisciplines like comparative effectiveness research and precision medicine, new quasi-experimental study designs, new research platforms like distributed data networks, and new analytic approaches for clinical prediction of prognosis or treatment response. The result of these developments is a greater potential to progress diabetes treatment and prevention through the increasing range of populations, interventions, outcomes, and settings that can be efficiently examined. However, this proliferation also carries an increased threat of bias and misleading findings. The level of evidence that may be derived from RWD is ultimately a function of the data quality and the rigorous application of study design and analysis. This report reviews the current landscape and applications of RWD in clinical effectiveness and population health research for diabetes and summarizes opportunities and best practices in the conduct, reporting, and dissemination of RWD to optimize its value and limit its drawbacks.

Construction of a multisite DataLink using electronic health records for the identification, surveillance, prevention, and management of diabetes mellitus: the SUPREME-DM project.

INTRODUCTION: Electronic health record (EHR) data enhance opportunities for conducting surveillance of diabetes. The objective of this study was to identify the number of people with diabetes from a diabetes DataLink developed as part of the SUPREME-DM (SUrveillance, PREvention, and ManagEment of Diabetes Mellitus) project, a consortium of 11 integrated health systems that use comprehensive EHR data for research. METHODS: We identified all members of 11 health care systems who had any enrollment from January 2005 through December 2009. For these members, we searched inpatient and outpatient diagnosis codes, laboratory test results, and pharmaceutical dispensings from January 2000 through December 2009 to create indicator variables that could potentially identify a person with diabetes. Using this information, we estimated the number of people with diabetes and among them, the number of incident cases, defined as indication of diabetes after at least 2 years of continuous health system enrollment. RESULTS: The 11 health systems contributed 15,765,529 unique members, of whom 1,085,947 (6.9%) met 1 or more study criteria for diabetes. The nonstandardized proportion meeting study criteria for diabetes ranged from 4.2% to 12.4% across sites. Most members with diabetes (88%) met multiple criteria. Of the members with diabetes, 428,349 (39.4%) were incident cases. CONCLUSION: The SUPREME-DM DataLink is a unique resource that provides an opportunity to conduct comparative effectiveness research, epidemiologic surveillance including longitudinal analyses, and population-based care management studies of people with diabetes. It also provides a useful data source for pragmatic clinical trials of prevention or treatment interventions.

Study of Women, Infant Feeding, and Type 2 diabetes mellitus after GDM pregnancy (SWIFT), a prospective cohort study: methodology and design.

BACKGROUND: Women with history of gestational diabetes mellitus (GDM) are at higher risk of developing type 2 diabetes within 5 years after delivery. Evidence that lactation duration influences incident type 2 diabetes after GDM pregnancy is based on one retrospective study reporting a null association. The Study of Women, Infant Feeding and Type 2 Diabetes after GDM pregnancy (SWIFT) is a prospective cohort study of postpartum women with recent GDM within the Kaiser Permanente Northern California (KPNC) integrated health care system. The primary goal of SWIFT is to assess whether prolonged, intensive lactation as compared to formula feeding reduces the 2-year incidence of type 2 diabetes mellitus among women with GDM. The study also examines whether lactation intensity and duration have persistent favorable effects on blood glucose, insulin resistance, and adiposity during the 2-year postpartum period. This report describes the design and methods implemented for this study to obtain the clinical, biochemical, anthropometric, and behavioral measurements during the recruitment and follow-up phases. METHODS: SWIFT is a prospective, observational cohort study enrolling and following over 1, 000 postpartum women diagnosed with GDM during pregnancy within KPNC. The study enrolled women at 6-9 weeks postpartum (baseline) who had been diagnosed by standard GDM criteria, aged 20-45 years, delivered a singleton, term (greater than or equal to 35 weeks gestation) live birth, were not using medications affecting glucose tolerance, and not planning another pregnancy or moving out of the area within the next 2 years. Participants who are free of type 2 diabetes and other serious medical conditions at baseline are screened for type 2 diabetes annually within the first 2 years after delivery. Recruitment began in September 2008 and ends in December 2011. Data are being collected through pregnancy and early postpartum telephone interviews, self-administered monthly mailed questionnaires (3-11 months postpartum), a telephone interview at 6 months, and annual in-person examinations at which a 75 g 2-hour OGTT is conducted, anthropometric measurements are obtained, and self- and interviewer-administered questionnaires are completed. DISCUSSION: This is the first, large prospective, community-based study involving a racially and ethnically diverse cohort of women with recent GDM that rigorously assesses lactation intensity and duration and examines their relationship to incident type 2 diabetes while accounting for numerous potential confounders not assessed previously.

Meaningful variation in performance: what does variation in quality tell us about improving quality?

BACKGROUND: Variance reduction is sometimes considered as a goal of clinical quality improvement. Variance among physicians, hospitals, or health plans has been evaluated as the proportion of total variance (or intraclass correlation, ICC) in a quality measure; low ICCs have been interpreted to indicate low potential for quality improvement at that level. However, the absolute amount of variation, expressed in clinically meaningful units, is less frequently reported. Moreover, changes in variance components have not been studied as quality improves. OBJECTIVES: To examine changes in variance components at primary care physician and medical facility levels as performance improved for 4 quality indicators: systolic blood pressure levels in hypertension; low-density lipoprotein-cholesterol levels in hyperlipidemia; patient-reported care experience scores after primary care visits; and mammography screening rates. POPULATION: Adult members (n = 62,596-410,976) of Kaiser Permanente in Northern California, served by more than 1000 primary care physicians in 35 facilities, from 2001 to 2006. METHODS: Multilevel linear and logistic regression to examine the interphysician and interfacility variances in 4 quality indicators over 6 years, after case-mix adjustment. RESULTS: ICCs were low for all 4 indicators at both levels (0.0021-0.086). Nevertheless, variances at both levels were statistically and clinically significant. For systolic blood pressure and the care experience score, interfacility and interphysician variance as well as ICCs decreased further as quality improved; declines were greater at the facility level. For low-density lipoprotein-cholesterol, variability at both levels increased with quality improvement; and for screening mammography, small declines were not statistically significant for either physicians or facilities. CONCLUSIONS: Low proportions of variance do not predict low potential for quality improvement. Despite low ICCs for facilities, quality improvement efforts directed primarily at facilities improved quality for all 4 indicators.

Meaningful variation in performance: a systematic literature review.

BACKGROUND: Recommendations for directing quality improvement initiatives at particular levels (eg, patients, physicians, provider groups) have been made on the basis of empirical components of variance analyses of performance. OBJECTIVE: To review the literature on use of multilevel analyses of variability in quality. RESEARCH DESIGN: Systematic literature review of English-language articles (n = 39) examining variability and reliability of performance measures in Medline using PubMed (1949-November 2008). RESULTS: Variation was most commonly assessed at facility (eg, hospital, medical center) (n = 19) and physician (n = 18) levels; most articles reported variability as the proportion of total variation attributable to given levels (n = 22). Proportions of variability explained by aggregated levels were generally low (eg, <19% for physicians), and numerous authors concluded that the proportion of variability at a specific level did not justify targeting quality interventions to that level. Few articles based their recommendations on absolute differences among physicians, hospitals, or other levels. Seven of 12 articles that assessed reliability found that reliability was poor at the physician or hospital level due to low proportional variability and small sample sizes per unit, and cautioned that public reporting or incentives based on these measures may be inappropriate. CONCLUSIONS: The proportion of variability at levels higher than patients is often found to be "low." Although low proportional variability may lead to poor measurement reliability, a number of authors further suggested that it also indicates a lack of potential for quality improvement. Few studies provided additional information to help determine whether variation was, nevertheless, clinically meaningful.

Validation of an algorithm for categorizing the severity of hospital emergency department visits.

BACKGROUND: Differentiating between appropriate and inappropriate resource use represents a critical challenge in health services research. The New York University Emergency Department (NYU ED) visit severity algorithm attempts to classify visits to the ED based on diagnosis, but it has not been formally validated. OBJECTIVE: To assess the validity of the NYU algorithm. RESEARCH DESIGN: A longitudinal study in a single integrated delivery system from January 1999 to December 2001. SUBJECTS: A total of 2,257,445 commercial and 261,091 Medicare members of an integrated delivery system. MEASURES: ED visits were classified as emergent, nonemergent, or intermediate severity, using the NYU ED algorithm. We examined the relationship between visit-severity and the probability of future hospitalizations and death using a logistic model with a general estimating equation approach. RESULTS: Among commercially insured subjects, ED visits categorized as emergent were significantly more likely to result in a hospitalization within 1-day (odds ratio = 3.37, 95% CI: 3.31-3.44) or death within 30-days (odds ratio = 2.81, 95% CI: 2.62-3.00) than visits categorized as nonemergent. We found similar results in Medicare patients and in sensitivity analyses using different probability thresholds. ED overuse for nonemergent conditions was not related to socio-economic status or insurance type. CONCLUSIONS: The evidence presented supports the validity of the NYU ED visit severity algorithm for differentiating ED visits based on need for hospitalization and/or mortality risk; therefore, it can contribute to evidence-based policies aimed at reducing the use of the ED for nonemergencies.

Characteristics of insured patients with persistent gaps in diabetes care services: the Translating Research into Action for Diabetes (TRIAD) study.

BACKGROUND: Although preventing diabetes complications requires long-term management, little is known about which patients persistently fail to get recommended care. OBJECTIVE: To determine the frequency and correlates of persistent, long-term gaps in diabetes care. METHOD: : The study population included 8392 patients with diabetes. Patient surveys and medical records from 10 health plans over 3 years provided data on socioeconomic characteristics, access to care, social support, and mental and physical health, and diabetes preventive care services. We defined a "persistent gap" as a participant's missing a preventive care service for the entire 3 years. Services considered included hemoglobin A1c, cholesterol, and albuminuria tests, and foot and dilated eye examinations. RESULTS: Thirty percent of participants had at least 1 persistent gap. The most common gaps were lipid testing (11.6%), microalbuminuria testing (9.7%), and eye examinations (9.0%). Persistent gaps were 18% to 42% higher for young patients, lean persons, those with low income, employed persons, smokers, those with diabetes less than 5 years, and patients with none or 1 comorbid conditions. Sex, education, marital status, family demands, transportation, trust in physicians, and mental health were not associated with gaps in care. CONCLUSIONS: Persistent gaps in diabetes care are common even among insured patients. Patients with lower income, younger age, fewer years of diabetes, having fewer comorbidities, taking fewer medications, and poor health behaviors are vulnerable to persistent gaps in care and a group who warrant targeted interventions to improve preventive diabetes care.

Unintended consequences of caps on Medicare drug benefits.

BACKGROUND: Little information exists about the consequences of limits on prescription-drug benefits for Medicare beneficiaries. METHODS: We compared the clinical and economic outcomes in 2003 among 157,275 Medicare+Choice beneficiaries whose annual drug benefits were capped at 1,000 dollars and 41,904 beneficiaries whose drug benefits were unlimited because of employer supplements. RESULTS: After adjusting for individual characteristics, we found that subjects whose benefits were capped had pharmacy costs for drugs applicable to the cap that were lower by 31 percent than subjects whose benefits were not capped (95 percent confidence interval, 29 to 33 percent) but had total medical costs that were only 1 percent lower (95 percent confidence interval, -4 to 6 percent). Subjects whose benefits were capped had higher relative rates of visits to the emergency department (relative rate, 1.09 [95 percent confidence interval, 1.04 to 1.14]), nonelective hospitalizations (relative rate, 1.13 [1.05 to 1.21]), and death (relative rate, 1.22 [1.07 to 1.38]; difference, 0.68 per 100 person-years [0.30 to 1.07]). Among subjects who used drugs for hypertension, hyperlipidemia, or diabetes in 2002, those whose benefits were capped were more likely to be nonadherent to long-term drug therapy in 2003; the respective odds ratios were 1.30 (95 percent confidence interval, 1.23 to 1.38), 1.27 (1.19 to 1.34), and 1.33 (1.18 to 1.48) for subjects using drugs for hypertension, hyperlipidemia, and diabetes. In each subgroup, the physiological outcomes were worse for subjects whose drug benefits were capped than for those whose benefits were not capped; the odds ratios were 1.05 (95 percent confidence interval, 1.00 to 1.09), 1.13 (1.03 to 1.25), and 1.23 (1.03 to 1.46), respectively, for subjects with a systolic blood pressure of 140 mm Hg or more, a serum low-density-lipoprotein cholesterol level of 130 mg per deciliter or more, and a glycated hemoglobin level of 8 percent or more. CONCLUSIONS: A cap on drug benefits was associated with lower drug consumption and unfavorable clinical outcomes. In patients with chronic disease, the cap was associated with poorer adherence to drug therapy and poorer control of blood pressure, lipid levels, and glucose levels. The savings in drug costs from the cap were offset by increases in the costs of hospitalization and emergency department care.

Identifying risk factors for racial disparities in diabetes outcomes: the translating research into action for diabetes study.

BACKGROUND: Versus whites, blacks with diabetes have poorer control of hemoglobin A1c (HbA1c), higher systolic blood pressure (SBP), and higher low-density lipoprotein (LDL) cholesterol as well as higher rates of morbidity and microvascular complications. OBJECTIVE: To examine whether several mutable risk factors were more strongly associated with poor control of multiple intermediate outcomes among blacks with diabetes than among similar whites. DESIGN: Case-control study. SUBJECTS: A total of 764 blacks and whites with diabetes receiving care within 8 managed care health plans. MEASURES: Cases were patients with poor control of at least 2 of 3 intermediate outcomes (HbA1c > or =8.0%, SBP > or =140 mmHg, LDL cholesterol > or =130 mg/dL) and controls were patients with good control of all 3 (HbA1c <8.0%, SBP <140 mmHg, LDL cholesterol <130 mg/dL). In multivariate analyses, we determined whether each of several potentially mutable risk factors, including depression, poor adherence to medications, low self-efficacy for reducing cardiovascular risk, and poor patient-provider communication, predicted case or control status. RESULTS: Among blacks but not whites, in multivariate analyses depression (odds ratio: 2.28; 95% confidence interval: 1.09-4.75) and having missed medication doses (odds ratio: 1.96; 95% confidence interval: 1.01-3.81) were associated with greater odds of being a case rather than a control. None of the other risk factors were associated for either blacks or whites. CONCLUSIONS: Depression and missing medication doses are more strongly associated with poor diabetes control among blacks than in whites. These 2 risk factors may represent important targets for patient-level interventions to address racial disparities in diabetes outcomes.

Treatment intensification and risk factor control: toward more clinically relevant quality measures.

BACKGROUND: Intensification of pharmacotherapy in persons with poorly controlled chronic conditions has been proposed as a clinically meaningful process measure of quality. OBJECTIVE: To validate measures of treatment intensification by evaluating their associations with subsequent control in hypertension, hyperlipidemia, and diabetes mellitus across 35 medical facility populations in Kaiser Permanente, Northern California. DESIGN: Hierarchical analyses of associations of improvements in facility-level treatment intensification rates from 2001 to 2003 with patient-level risk factor levels at the end of 2003. PATIENTS: Members (515,072 and 626,130; age >20 years) with hypertension, hyperlipidemia, and/or diabetes mellitus in 2001 and 2003, respectively. MEASUREMENTS: Treatment intensification for each risk factor defined as an increase in number of drug classes prescribed, of dosage for at least 1 drug, or switching to a drug from another class within 3 months of observed poor risk factor control. RESULTS: Facility-level improvements in treatment intensification rates between 2001 and 2003 were strongly associated with greater likelihood of being in control at the end of 2003 (P < or = 0.05 for each risk factor) after adjustment for patient- and facility-level covariates. Compared with facility rankings based solely on control, addition of percentages of poorly controlled patients who received treatment intensification changed 2003 rankings substantially: 14%, 51%, and 29% of the facilities changed ranks by 5 or more positions for hypertension, hyperlipidemia, and diabetes, respectively. CONCLUSIONS: Treatment intensification is tightly linked to improved control. Thus, it deserves consideration as a process measure for motivating quality improvement and possibly for measuring clinical performance.

Hypoglycemic episodes and risk of dementia in older patients with type 2 diabetes mellitus.

CONTEXT: Although acute hypoglycemia may be associated with cognitive impairment in children with type 1 diabetes, no studies to date have evaluated whether hypoglycemia is a risk factor for dementia in older patients with type 2 diabetes. OBJECTIVE: To determine if hypoglycemic episodes severe enough to require hospitalization are associated with an increased risk of dementia in a population of older patients with type 2 diabetes followed up for 27 years. DESIGN, SETTING, AND PATIENTS: A longitudinal cohort study from 1980-2007 of 16,667 patients with a mean age of 65 years and type 2 diabetes who are members of an integrated health care delivery system in northern California. MAIN OUTCOME MEASURE: Hypoglycemic events from 1980-2002 were collected and reviewed using hospital discharge and emergency department diagnoses. Cohort members with no prior diagnoses of dementia, mild cognitive impairment, or general memory complaints as of January 1, 2003, were followed up for a dementia diagnosis through January 15, 2007. Dementia risk was examined using Cox proportional hazard regression models, adjusted for age, sex, race/ethnicity, education, body mass index, duration of diabetes, 7-year mean glycated hemoglobin, diabetes treatment, duration of insulin use, hyperlipidemia, hypertension, cardiovascular disease, stroke, transient cerebral ischemia, and end-stage renal disease. RESULTS: At least 1 episode of hypoglycemia was diagnosed in 1465 patients (8.8%) and dementia was diagnosed in 1822 patients (11%) during follow-up; 250 patients had both dementia and at least 1 episode of hypoglycemia (16.95%). Compared with patients with no hypoglycemia, patients with single or multiple episodes had a graded increase in risk with fully adjusted hazard ratios (HRs): for 1 episode (HR, 1.26; 95% confidence interval [CI], 1.10-1.49); 2 episodes (HR, 1.80; 95% CI, 1.37-2.36); and 3 or more episodes (HR, 1.94; 95% CI, 1.42-2.64). The attributable risk of dementia between individuals with and without a history of hypoglycemia was 2.39% per year (95% CI, 1.72%-3.01%). Results were not attenuated when medical utilization rates, length of health plan membership, or time since initial diabetes diagnosis were added to the model. When examining emergency department admissions for hypoglycemia for association with risk of dementia (535 episodes), results were similar (compared with patients with 0 episodes) with fully adjusted HRs: for 1 episode (HR, 1.42; 95% CI, 1.12-1.78) and for 2 or more episodes (HR, 2.36; 95% CI, 1.57-3.55). CONCLUSIONS: Among older patients with type 2 diabetes, a history of severe hypoglycemic episodes was associated with a greater risk of dementia. Whether minor hypoglycemic episodes increase risk of dementia is unknown.

Partnerships in translation: advancing research and clinical care. The 14th Annual HMO Research Network Conference, April 13-16, 2008, Minneapolis, Minnesota.

The Health Maintenance Organization Research Network held its annual meeting in Minneapolis in April of 2008, with more than 300 investigators, research staff, clinical leaders, and academic partners gathering in conjunction with the conference theme 'Partnerships in Translation: Advancing Research and Clinical Care.' This article provides some background on the network, its research activities, and the annual conference. Also featured is an article by Coleman and colleagues summarizing the conference's first plenary session, where operational leaders of health care organizations discussed the optimization of health care through research. This issue of Clinical Medicine & Research also includes a selection of scientific abstracts presented at the meeting on a wide range of clinical and population health topics.

Is the number of documented diabetes process-of-care indicators associated with cardiometabolic risk factor levels, patient satisfaction, or self-rated quality of diabetes care? The Translating Research into Action for Diabetes (TRIAD) study.

OBJECTIVE: Simple process-of-care indicators are commonly recommended to assess and compare quality of diabetes care across health plans. We sought to determine whether variation in the number of simple diabetes processes of care across provider groups is associated with variation in other quality indicators, including cardiometabolic risk factor levels, patient satisfaction with care, or patient-rated quality of care. RESEARCH DESIGN AND METHODS: We used cross-sectional survey and chart audit data for 8,733 patients with diabetes who received care from 68 provider groups nested in 10 health plans that participated in the Translating Research Into Action for Diabetes study. Analyses using hierarchical regression models assessed associations of the mean number of seven simple process measures with each of the following: HbA(1c) (A1C), systolic blood pressure (SBP), HDL and LDL cholesterol levels, patient satisfaction with care, and patient-rated quality of care. RESULTS: After adjusting for case-mix differences across groups and plans, an average of one additional documented process of care for each patient in a group or plan was associated with significantly lower mean LDL cholesterol levels (-4.51 mg/dl [95% CI 1.46-7.58]) but not with A1C, SBP, or HDL cholesterol levels. The number of care processes documented was associated with patient satisfaction measures and self-rated quality of diabetes care. CONCLUSIONS: Variation in the number of simple process-of-care indicators across provider groups or health plans is associated with differences in patient-centered measures of quality, but assessment of the quality of cardiometabolic risk factor control will require more advanced clinical performance indicators.