Shared decision-making and disease management in advanced cancer and chronic kidney disease using patient-reported outcome dashboards.

OBJECTIVES: To assess the use of a co-designed patient-reported outcome (PRO) clinical dashboard and estimate its impact on shared decision-making (SDM) and symptomatology in adults with advanced cancer or chronic kidney disease (CKD). MATERIALS AND METHODS: We developed a clinical PRO dashboard within the Northwestern Medicine Patient-Reported Outcomes system, enhanced through co-design involving 20 diverse constituents. Using a single-group, pretest-posttest design, we evaluated the dashboard's use among patients with advanced cancer or CKD between June 2020 and January 2022. Eligible patients had a visit with a participating clinician, completed at least two dashboard-eligible visits, and consented to follow-up surveys. PROs were collected 72 h prior to visits, including measures for chronic condition management self-efficacy, health-related quality of life (PROMIS measures), and SDM (collaboRATE). Responses were integrated into the EHR dashboard and accessible to clinicians and patients. RESULTS: We recruited 157 participants: 66 with advanced cancer and 91 with CKD. There were significant improvements in SDM from baseline, as assessed by collaboRATE scores. The proportion of participants reporting the highest level of SDM on every collaboRATE item increased by 15 percentage points from baseline to 3 months, and 17 points between baseline and 6-month follow-up. Additionally, there was a clinically meaningful decrease in anxiety levels over study period (T-score baseline: 53; 3-month: 52; 6-month: 50; P < .001), with a standardized response mean (SRM) of -0.38 at 6 months. DISCUSSION: PRO clinical dashboards, developed and shared with patients, may enhance SDM and reduce anxiety among patients with advanced cancer and CKD.

Implementation of a Co-Design Strategy to Develop a Dashboard to Support Shared Decision Making in Advanced Cancer and Chronic Kidney Disease.

Background: Shared decision making (SDM) is the process by which patients and clinicians exchange information and preferences to come to joint healthcare decisions. Clinical dashboards can support SDM by collecting, distilling, and presenting critical information, such as patient-reported outcomes (PROs), to be shared at points of care and in between appointments. We describe the implementation strategies and outcomes of a multistakeholder collaborative process known as "co-design" to develop a PRO-informed clinical dashboard to support SDM for patients with advanced cancer or chronic kidney disease (CKD). Methods: Across 14 sessions, two multidisciplinary teams comprising patients, care partners, clinicians, and other stakeholders iteratively co-designed an SDM dashboard for either advanced cancer (N = 25) or CKD (N = 24). Eligible patients, care partners, and frontline clinicians were identified by six physician champions. The co-design process included four key steps: (1) define "the problem", (2) establish context of use, (3) build a consensus on design, and (4) define and test specifications. We also evaluated our success in implementing the co-design strategy using measures of fidelity, acceptability, adoption, feasibility, and effectiveness which were collected throughout the process. Results: Mean (M) scores across implementation measures of the co-design process were high, including observer-rated fidelity and adoption of co-design practices (M = 19.1 on a 7-21 scale, N = 36 ratings across 9 sessions), as well as acceptability based on the perceived degree of SDM that occurred during the co-design process (M = 10.4 on a 0 to 12 adapted collaboRATE scale). Capturing the feasibility and adoption of convening multistakeholder co-design teams, min-max normalized scores (ranging from 0 to 1) of stakeholder representation demonstrated that, on average, 95% of stakeholder types were represented for cancer sessions (M = 0.95) and 85% for CKD sessions (M = 0.85). The co-design process was rated as either "fully" or "partially" effective by 100% of respondents, in creating a dashboard that met its intended objective. Conclusions: A co-design process was successfully implemented to develop SDM clinical dashboards for advanced cancer and CKD care. We discuss key strategies and learnings from this process that may aid others in the development and uptake of patient-centered healthcare innovations.

Screening for Prediabetes and Diabetes in a National Network of Federally Qualified Health Centers: An Observational Study.

BACKGROUND: In 2021, the U.S. Preventive Services Task Force (USPSTF) recommended screening for prediabetes and diabetes among adults aged 35-70 years with overweight or obesity. Studying dysglycemia screening in federally qualified health centers (FQHCs) that serve vulnerable patient populations is needed to understand health equity implications of this recommendation. OBJECTIVE: To investigate screening practices among FQHC patients who would be eligible according to the 2021 USPSTF recommendation. DESIGN: Retrospective cohort study analyzing electronic health records from a national network of 282 FQHC sites. PARTICIPANTS: We included 183,329 patients without prior evidence of prediabetes or diabetes, who had ≥ 1 office visit from 2018-2020. MAIN MEASURES: Screening eligibility was based on age and measured body mass index (BMI). The primary outcome, screening completion, was ascertained using hemoglobin A1c or fasting plasma glucose results from 2018-2020. KEY RESULTS: Among 89,543 patients who would be eligible according to the 2021 USPSTF recommendation, 53,263 (59.5%) were screened. Those who completed screening had higher BMI values than patients who did not (33.0 ± 6.7 kg/m2 vs. 31.9 ± 6.2 kg/m2, p < 0.001). Adults aged 50-64 years had greater odds of screening completion relative to younger patients (OR 1.13, 95% CI: 1.10-1.17). Patients from racial and ethnic minority groups, as well as those without health insurance, were more likely to complete screening than White patients and insured patients, respectively. Clinical risk factors for diabetes were also associated with dysglycemia screening. Among patients who completed screening, 23,588 (44.3%) had values consistent with prediabetes or diabetes. CONCLUSIONS: Over half of FQHC patients who would be eligible according to the 2021 USPSTF recommendation were screened. Screening completion was higher among middle-aged patients, those with greater BMI values, as well as vulnerable groups with a high risk of developing diabetes. Future research should examine adoption of the 2021 USPSTF screening recommendation and its impact on health equity.

An EHR-automated and theory-based population health management intervention for smoking cessation in diverse low-income patients of safety-net health centers: a pilot randomized controlled trial.

This study tested the preliminary effectiveness of an electronic health record (EHR)-automated population health management (PHM) intervention for smoking cessation among adult patients of a federally qualified health center in Chicago. Participants (N = 190; 64.7% women, 82.1% African American/Black, 8.4% Hispanic/Latino) were self-identified as smokers, as documented in the EHR, who completed the baseline survey of a longitudinal "needs assessment of health behaviors to strengthen health programs and services." Four weeks later, participants were randomly assigned to the PHM intervention (N = 97) or enhanced usual care (EUC; N = 93). PHM participants were mailed a single-page self-determination theory (SDT)-informed letter that encouraged smoking cessation or reduction as an initial step. The letter also addressed low health literacy and low income. PHM participants also received automated text messages on days 1, 5, 8, 11, and 20 after the mailed letter. Two weeks after mailing, participants were called by the Illinois Tobacco Quitline. EUC participants were e-referred following a usual practice. Participants reached by the quitline were offered behavioral counseling and nicotine replacement therapy. Outcome assessments were conducted at weeks 6, 14, and 28 after the mailed letter. Primary outcomes were treatment engagement, utilization, and self-reported smoking cessation. In the PHM arm, 25.8% of participants engaged in treatment, 21.6% used treatment, and 16.3% were abstinent at 28 weeks. This contrasts with no quitline engagement among EUC participants, and a 6.4% abstinence rate. A PHM approach that can reach all patients who smoke and address unique barriers for low-income individuals may be a critical supplement to clinic-based care.

Patient-Reported Outcome Dashboards Within the Electronic Health Record to Support Shared Decision-making: Protocol for Co-design and Clinical Evaluation With Patients With Advanced Cancer and Chronic Kidney Disease.

BACKGROUND: Patient-reported outcomes-symptoms, treatment side effects, and health-related quality of life-are important to consider in chronic illness care. The increasing availability of health IT to collect patient-reported outcomes and integrate results within the electronic health record provides an unprecedented opportunity to support patients' symptom monitoring, shared decision-making, and effective use of the health care system. OBJECTIVE: The objectives of this study are to co-design a dashboard that displays patient-reported outcomes along with other clinical data (eg, laboratory tests, medications, and appointments) within an electronic health record and conduct a longitudinal demonstration trial to evaluate whether the dashboard is associated with improved shared decision-making and disease management outcomes. METHODS: Co-design teams comprising study investigators, patients with advanced cancer or chronic kidney disease, their care partners, and their clinicians will collaborate to develop the dashboard. Investigators will work with clinic staff to implement the co-designed dashboard for clinical testing during a demonstration trial. The primary outcome of the demonstration trial is whether the quality of shared decision-making increases from baseline to the 3-month follow-up. Secondary outcomes include longitudinal changes in satisfaction with care, self-efficacy in managing treatments and symptoms, health-related quality of life, and use of costly and potentially avoidable health care services. Implementation outcomes (ie, fidelity, appropriateness, acceptability, feasibility, reach, adoption, and sustainability) during the co-design process and demonstration trial will also be collected and summarized. RESULTS: The dashboard co-design process was completed in May 2020, and data collection for the demonstration trial is anticipated to be completed by the end of July 2022. The results will be disseminated in at least one manuscript per study objective. CONCLUSIONS: This protocol combines stakeholder engagement, health care coproduction frameworks, and health IT to develop a clinically feasible model of person-centered care delivery. The results will inform our current understanding of how best to integrate patient-reported outcome measures into clinical workflows to improve outcomes and reduce the burden of chronic disease on patients and health care systems. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38461.

Optimization of a technology-supported physical activity promotion intervention for breast cancer survivors: Results from Fit2Thrive.

BACKGROUND: The benefits of moderate to vigorous physical activity (MVPA) for breast cancer survivors are well established. However, most are insufficiently active. Fit2Thrive used the Multiphase Optimization Strategy methodology to determine the effect of 5 intervention components on MVPA in this population. METHODS: Two hundred sixty-nine participants (mean age, 52.5 years; SD, 9.9 years) received a core intervention (the Fit2Thrive self-monitoring app and Fitbit) and were randomly assigned to 5 intervention components set to on/off in a full factorial experiment: support calls, deluxe app, buddy, online gym, and text messages. The intervention was delivered over 12 weeks with a 12-week follow-up. MVPA was measured via accelerometry at the baseline (T1), at 12 weeks (T2), and at 24 weeks (T3). The main effects and interaction effects at each time point were examined for all components. RESULTS: Trial retention was high: 91.8% had valid accelerometer data at T2 or T3. Across all conditions, there were significant increases in MVPA (+53.6 min/wk; P < .001) and in the proportion of survivors meeting MVPA guidelines (+22.3%; P < .001) at T2 that were maintained but attenuated at T3 (MVPA, +24.6 min/wk; P < .001; meeting guidelines, +12.6%; P < .001). No individual components significantly improved MVPA, although increases were greater for the on level versus the off level for support calls, buddy, and text messages at T2 and T3. CONCLUSIONS: The Fit2Thrive core intervention (the self-monitoring app and Fitbit) is promising for increasing MVPA in breast cancer survivors, but the components provided no additional increases in MVPA. Future research should evaluate the core intervention in a randomized trial and determine what components optimize MVPA behaviors in breast cancer survivors.

Breast cancer survivors' preferences for mHealth physical activity interventions: findings from a mixed methods study.

PURPOSE: Despite the benefits of physical activity for breast cancer survivors, the majority remain insufficiently active. Mobile health (mHealth) physical activity interventions may be a more scalable strategy to increase activity among survivors. However, little is known about their preferences for mHealth intervention features. This study explored survivors' preferences for these features. METHODS: Survivors (N = 96; Mage = 55.8 (SD = 10.2)) self-reported demographic and disease characteristics, physical activity. A subset (n = 28) completed a semi-structured phone interview. Transcribed interviews were evaluated using a thematic content analysis approach and consensus review. Following interviews, the full sample self-reported interests and preferences for intervention features via online questionnaires. Quantitative data were analyzed using descriptive statistics. RESULTS: Five themes emerged from interview data: (1) importance of relevance to breast cancer survivors; (2) easy to use; (3) integration with wearable activity trackers; (4) provide sense of accomplishment; and (5) variability in desired level of structure and personalization. The highest ranked intervention features were: daily and weekly progress feedback (87.5%), newsfeed (86.6%), activity challenges (81.3%), and scheduling tool (79.2%). Survivors were interested in receiving progress feedback (80.2%) and motivational (78.1%) and reminder (75.0%) messages. CONCLUSIONS: Breast cancer survivors are interested in mHealth physical activity promotion interventions, but preferences varied around themes of relevance, ease of use, and enhancing personal motivation. IMPLICATIONS FOR CANCER SURVIVORS: Engaging survivors in developing and implementing remotely delivered mHealth activity promotion interventions may enhance their effectiveness.

Building Toward a Population-Based Approach to Diabetes Screening and Prevention for US Adults.

PURPOSE OF REVIEW: Evidence-based treatments for prediabetes can prevent and delay the development of type 2 diabetes in adults. In this review, we propose a framework for population-based diabetes prevention that links screening and prevention activities across key stakeholders. We also discuss gaps in current practice, while highlighting opportunities to improve diabetes screening and prevention efforts population-wide. RECENT FINDINGS: Awareness of diabetes risk is low, and many adults with prediabetes are not identified through existing screening efforts. Accumulating evidence and policies support expansion of the Diabetes Prevention Program (DPP) into clinical and community settings. However, the infrastructure to facilitate referrals and promote data exchange among patients, clinical settings, and community-based DPP programs is lacking. Development of evidence-driven, scalable processes for assessing diabetes risk, screening eligible adults, and delivering preventive treatments are needed to effectively improve the glycemic health of the US adult population.

Performance of the 2015 US Preventive Services Task Force Screening Criteria for Prediabetes and Undiagnosed Diabetes.

BACKGROUND: In 2015, The US Preventive Services Task Force (USPSTF) recommended screening for prediabetes and undiagnosed diabetes (collectively called dysglycemia) among adults aged 40-70 years with overweight or obesity. The recommendation suggests that clinicians consider screening earlier in people who have other diabetes risk factors. OBJECTIVE: To compare the performance of limited and expanded screening criteria recommended by the USPSTF for detecting dysglycemia among US adults. DESIGN: Cross-sectional analysis of survey and laboratory data collected from nationally representative samples of the civilian, noninstitutionalized US adult population. PARTICIPANTS: A total of 3643 adults without diagnosed diabetes who underwent measurement of hemoglobin A1c (A1c), fasting plasma glucose (FPG), and 2-h plasma glucose (2-h PG). MAIN MEASURES: Screening eligibility according to the limited criteria was based on age 40 to 70 years old and overweight/obesity. Screening eligibility according to the expanded criteria was determined by meeting the limited criteria or having ≥ 1 of the following risk factors: family history of diabetes, history of gestational diabetes or polycystic ovarian syndrome, and non-white race/ethnicity. Dysglycemia was defined by A1c ≥ 5.7%, FPG ≥ 100 mg/dL, and/or 2-h PG ≥ 140 mg/dL. KEY RESULTS: Among the US adult population without diagnosed diabetes, 49.7% had dysglycemia. Screening based on the limited criteria demonstrated a sensitivity of 47.3% (95% CI, 44.7-50.0%) and specificity of 71.4% (95% CI, 67.3-75.2%). The expanded criteria yielded higher sensitivity [76.8% (95% CI, 73.5-79.8%)] and lower specificity [33.8% (95% CI, 30.1-37.7%)]. Point estimates for the sensitivity of the limited criteria were lower in all minority groups and significantly different for Asians compared to non-Hispanic whites [29.9% (95% CI, 23.4-37.2%) vs. 49.8% (95% CI, 45.9-53.7%); P < .001]. CONCLUSIONS: Diabetes screening that follows the limited USPSTF criteria will identify approximately half of US adults with dysglycemia. Screening other high-risk subgroups defined in the USPSTF recommendation would improve detection of dysglycemia and may reduce associated racial/ethnic disparities.

Optimization of a technology-supported physical activity intervention for breast cancer survivors: Fit2Thrive study protocol.

Fit2Thrive is a theory-guided physical activity promotion trial using the Multiphase Optimization Strategy (MOST) to test efficacy for improving physical activity of five technology-supported physical activity promotion intervention components among breast cancer survivors. This trial will recruit 256 inactive breast cancer survivors nationwide. All participants will receive the core intervention which includes a Fitbit and standard self-monitoring Fit2Thrive smartphone application which will be downloaded to their personal phone. Women will be randomized to one of 32 conditions in a factorial design involving five factors with two levels: support calls (No vs. Yes), app type (standard vs. deluxe), text messaging (No vs. Yes), online gym (No vs. Yes) and Fitbit Buddy (No vs. Yes). The proposed trial examines the effects of the components on physical activity at 12 and 24weeks. Results will support the selection of a final package of intervention components that has been optimized to maximize physical activity and is subject to an upper limit of cost. The optimized intervention will be tested in a future trial. Fit2Thrive is the first trial to use the MOST framework to develop and test a physical activity promotion intervention in breast cancer survivors and will lead to an improved understanding of how to effectively change survivors' physical activity. These findings could result in more scalable, effective physical activity interventions for breast cancer survivors, and, ultimately, improve health and disease outcomes.

A System-Level Approach to Overweight and Obesity in the Veterans Health Administration.

Healthcare systems are challenged by steady increases in the number of patients who are overweight and obese. Large-scale, evidence-based behavioral approaches for addressing overweight and obesity have been successfully implemented in systems such as the Veterans Health Administration (VHA). These population-based interventions target reduction in risk for obesity-associated conditions through lifestyle change and weight loss, and are associated with modest weight loss. Despite the fact that VHA has increased the overall reach of these behavioral interventions, the number of high-risk overweight and obese patients continues to rise. Recommendations for weight loss medications and bariatric surgery are included in clinical practice guidelines for the management of overweight and obesity, but these interventions are underutilized. During a recent state of the art conference on weight management held by VHA, subject matter experts identified challenges and gaps, as well as potential solutions and overarching policy recommendations, for implementing an integrated system-wide approach for improving population-based weight management.

Detecting Dysglycemia Using the 2015 United States Preventive Services Task Force Screening Criteria: A Cohort Analysis of Community Health Center Patients.

BACKGROUND: In 2015, the United States Preventive Services Task Force (USPSTF) recommended targeted screening for prediabetes and diabetes (dysglycemia) in adults who are aged 40 to 70 y old and overweight or obese. Given increasing prevalence of dysglycemia at younger ages and lower body weight, particularly among racial/ethnic minorities, we sought to determine whether the current screening criteria may fail to identify some high-risk population subgroups. METHODS AND FINDINGS: We investigated the performance of the 2015 USPSTF screening recommendation in detecting dysglycemia among US community health center patients. A retrospective analysis of electronic health record (EHR) data from 50,515 adult primary care patients was conducted. Longitudinal EHR data were collected in six health centers in the Midwest and Southwest. Patients with a first office visit between 2008 and 2010 were identified and followed for up to 3 y through 2013. We excluded patients who had dysglycemia at baseline and those with fewer than two office visits during the follow-up period. The exposure of interest was eligibility for screening according to the 2015 USPSTF criteria. The primary outcome was development of dysglycemia during follow-up, determined by: (1) laboratory results (fasting/2-h postload/random glucose ≥ 100/140/200 mg/dL [5.55/7.77/11.10 mmol/L] or hemoglobin A1C ≥ 5.7% [39 mmol/mol]); (2) diagnosis codes for prediabetes or type 2 diabetes; or (3) antidiabetic medication order. At baseline, 18,846 (37.3%) participants were aged ≥40 y, 33,537 (66.4%) were overweight or obese, and 39,061 (77.3%) were racial/ethnic minorities (34.6% Black, 33.9% Hispanic/Latino, and 8.7% Other). Overall, 29,946 (59.3%) patients had a glycemic test within 3 y of follow-up, and 8,478 of them developed dysglycemia. Only 12,679 (25.1%) patients were eligible for screening according to the 2015 USPSTF criteria, which demonstrated the following sensitivity and specificity (95% CI): 45.0% (43.9%-46.1%) and 71.9% (71.3%-72.5%), respectively. Racial/ethnic minorities were significantly less likely to be eligible for screening yet had higher odds of developing dysglycemia than whites (odds ratio [95% CI]: Blacks 1.24 [1.09-1.40]; Hispanics 1.46 [1.30-1.64]; and Other 1.33 [1.16-1.54]). In addition, the screening criteria had lower sensitivity in all racial/ethnic minority groups compared to whites. Limitations of this study include the ascertainment of dysglycemia only among patients with available test results and findings that may not be generalizable at the population level. CONCLUSIONS: Targeted diabetes screening based on new USPSTF criteria may detect approximately half of adult community health center patients with undiagnosed dysglycemia and proportionately fewer racial/ethnic minorities than whites. Future research is needed to estimate the performance of these screening criteria in population-based samples.

Design and participant characteristics for a randomized effectiveness trial of an intensive lifestyle intervention to reduce cardiovascular risk in adults with type 2 diabetes: The I-D-HEALTH study.

Intervening in Diabetes with Healthy Eating, Activity and Linkages To Healthcare (I-D-HEALTH) is a community-based randomized trial evaluating the effectiveness of a group-based adaption of the Look AHEAD intensive lifestyle intervention. Most potentially eligible patients were identified through electronic medical record queries or referral to a diabetes resource hub. Trial enrollees had a usual source of primary care, elevated body mass index (BMI) and type 2 diabetes. I-D-HEALTH participants were randomized to either standard care alone or standard care plus free-of-charge access to a group-based lifestyle intervention (GLI) offered by the YMCA. GLI participation was encouraged, but not required, for the latter group. The primary outcome is percent weight change over 6, 12 and 24months. Secondary outcomes include direct intervention costs and direct medical and non-medical expenditures, as well as changes in systolic blood pressure, hemoglobin A1c and cholesterol. Among 331 I-D-HEALTH participants, 167 were randomized to standard care and 164 to GLI. The mean age (±standard deviation) in each group was 57.1years (±12.2) and 57.6years (±10.5), respectively. Mean BMI was 34.9kg/m(2) (±7.3) among standard care participants and 36.2kg/m(2) (±7.8) among GLI participants. In both groups, approximately one third of participants were non-Hispanic Whites. We detected no significant differences between groups in mean systolic blood pressure, hemoglobin A1c or total cholesterol (P >0.05 for all characteristics above). The I-D-HEALTH study enrolled a diverse sample of adults with diabetes and offers a unique opportunity to evaluate the effectiveness of offering a community-based intensive lifestyle intervention.

Medical costs associated with type 2 diabetes complications and comorbidities.

OBJECTIVES: To estimate the direct medical costs associated with type 2 diabetes, its complications, and its comorbidities among U.S. managed care patients. STUDY DESIGN: Data were from patient surveys, chart reviews, and health insurance claims for 7109 people with type 2 diabetes from 8 health plans participating in the Translating Research Into Action for Diabetes (TRIAD) study between 1999 and 2002. METHODS: A generalized linear regression model was developed to estimate the association of patients' demographic characteristics, tobacco use status, treatments, related complications, and comorbidities with medical costs. RESULTS: The mean annualized direct medical cost was $2465 for a white man with type 2 diabetes who had been diagnosed fewer than 15 years earlier, was treated with oral medication or diet alone, and had no complications or comorbidities. We found annualized medical costs to be 10% to 50% higher for women and for patients whose diabetes had been diagnosed 15 or more years earlier, who used tobacco, who were being treated with insulin, or who had several other complications. Coronary heart disease, congestive heart failure, hemiplegia, and amputation were each associated with 70% to 150% higher costs. Costs were approximately 300% higher for end-stage renal disease treated with dialysis and approximately 500% higher for end-stage renal disease with kidney transplantation. CONCLUSIONS: Most medical costs incurred by patients with type 2 diabetes are related to complications and comorbidities. Our cost estimates can help when determining the most cost-effective interventions to prevent complications and comorbidities.

Health utility scores for people with type 2 diabetes in U.S. managed care health plans: results from Translating Research Into Action for Diabetes (TRIAD).

OBJECTIVE: To estimate the health utility scores associated with type 2 diabetes, its treatments, complications, and comorbidities. RESEARCH DESIGN AND METHODS: We analyzed health-related quality-of-life data, collected at baseline during Translating Research Into Action for Diabetes, a multicenter, prospective, observational study of diabetes care in managed care, for 7,327 individuals with type 2 diabetes. We measured quality-of-life using the EuroQol (EQ)-5D, a standardized instrument for which 1.00 indicates perfect health. We used multivariable regression to estimate the independent impact of demographic characteristics, diabetes treatments, complications, and comorbidities on health-related quality-of-life. RESULTS: The mean EQ-5D-derived health utility score for those individuals with diabetes was 0.80. The modeled utility score for a nonobese, non-insulin-treated, non-Asian, non-Hispanic man with type 2 diabetes, with an annual household income of more than $40,000, and with no diabetes complications, risk factors for cardiovascular disease, or comorbidities, was 0.92. Being a woman, being obese, smoking, and having a lower household income were associated with lower utility scores. Arranging complications from least to most severe according to the reduction in health utility scores resulted in the following order: peripheral vascular disease, other heart diseases, transient ischemic attack, cerebral vascular accident, nonpainful diabetic neuropathy, congestive heart failure, dialysis, hemiplegia, painful neuropathy, and amputation. CONCLUSIONS: Major diabetes complications and comorbidities are associated with decreased health-related quality-of-life. Utility estimates from our study can be used to assess the impact of diabetes on quality-of-life and conduct cost-utility analyses.

Impact of lifestyle intervention and metformin on health-related quality of life: the diabetes prevention program randomized trial.

BACKGROUND: Adults at high risk for diabetes may have reduced health-related quality of life (HRQoL). OBJECTIVE: To assess changes in HRQoL after interventions aimed at diabetes risk reduction. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial, the Diabetes Prevention Program, was conducted in 27 centers in the United States, in 3,234 non-diabetic persons with elevated fasting and post-load plasma glucose, mean age 51 years, mean BMI 34 Kg/m(2); 68 % women, and 45 % members of minority groups. INTERVENTIONS: Intensive lifestyle (ILS) program with the goals of at least 7 % weight loss and 150 min of physical activity per week, metformin (MET) 850 mg twice daily, or placebo (PLB). MEASUREMENTS: HRQoL using the 36-Item Short-Form (SF-36) health survey to evaluate health utility index (SF-6D), physical component summaries (PCS) and mental component summaries (MCS). A minimally important difference (MID) was met when the mean of HRQoL scores between groups differed by at least 3 %. RESULTS: After a mean follow-up of 3.2 years, there were significant improvements in the SF-6D (+0.008, p=0.04) and PCS (+1.57, p<0.0001) scores in ILS but not in MET participants (+0.002 and +0.15, respectively, p=0.6) compared to the PLB group. ILS participants showed improvements in general health (+3.2, p<0.001), physical function (+3.6, p<0.001), bodily pain (+1.9, p=0.01), and vitality (+2.1, p=0.01) domain scores. Treatment effects remained significant after adjusting sequentially for baseline demographic factors, and for medical and psychological comorbidities. Increased physical activity and weight reduction mediated these ILS treatment effects. Participants who experienced weight gain had significant worsening on the same HRQoL specific domains when compared to those that had treatment-related (ILS or MET) weight loss. No benefits with ILS or MET were observed in the MCS score. CONCLUSION: Overweight/obese adults at high risk for diabetes show small improvement in most physical HRQoL and vitality scores through the weight loss and increased physical activity achieved with an ILS intervention.

Understanding the gap between good processes of diabetes care and poor intermediate outcomes: Translating Research into Action for Diabetes (TRIAD).

BACKGROUND: Performance of diabetes clinical care processes has improved recently, but control of hemoglobin A1c (A1c) and other vascular disease risk factors has improved more slowly. OBJECTIVES: To identify patient factors associated with control of vascular disease risk factors among diabetes patients receiving recommended care processes. POPULATION: Managed care enrollees who participated in the TRIAD (Translating Research into Action for Diabetes) Study and received at least 5 of 7 recommended care processes during the 12 months before the second survey (2002-2003). METHODS: Comparison of 1003 patients with good control of A1c (<8%), systolic blood pressure (<140 mm Hg) and LDL-cholesterol (<130 mg/dL) versus 812 patients with poor control for at least 2 of these factors. RESULTS: Poorly controlled patients were younger, more frequently female, African American, with lower education and income (P < 0.001 for each). General health status was lower, body mass index higher, and insulin treatment more frequent; history of prior coronary heart disease was less frequent. They were more likely to indicate depression and hopelessness and to identify costs as a barrier to self-care; less likely to report trust in their regular physician; and more likely to smoke cigarettes and be physically inactive. Adjusting for demographic and clinical variables, concerns about costs, low trust in one's physician, current smoking, and physical inactivity remained associated with poor control. However, inclusion of these 4 variables in a single model did not diminish associations of race/ethnicity or education with control. CONCLUSIONS: Clinical, socioeconomic, psychosocial, and behavioral factors were independently associated with poor control. However, these factors did not fully explain observed racial and socioeconomic disparities in control.

Cost-effectiveness of screening for pre-diabetes among overweight and obese U.S. adults.

OBJECTIVE: To estimate the cost-effectiveness of screening overweight and obese individuals for pre-diabetes and then modifying their lifestyle based on the Diabetes Prevention Program (DPP). RESEARCH DESIGN AND METHODS: A Markov simulation model was used to estimate disease progression, costs, and quality of life. Cost-effectiveness was evaluated from a health care system perspective. We considered two screening/treatment strategies for pre-diabetes. Strategy 1 included screening overweight subjects and giving them the lifestyle intervention included in the DPP if they were diagnosed with both impaired glucose tolerance (IGT) and impaired fasting glucose (IFG). Strategy 2 included screening followed by lifestyle intervention for subjects diagnosed with either IGT or IFG or both. Each strategy was compared with a program of no screening. RESULTS: Screening for pre-diabetes and treating those identified as having both IGT and IFG with the DPP lifestyle intervention had a cost-effectiveness ratio of $8,181 per quality-adjusted life-year (QALY) relative to no screening. If treatment was also provided to subjects with only IGT or only IFG (strategy 2), the cost-effectiveness ratio increased to $9,511 per QALY. Changes in screening-related parameters had small effects on the cost-effectiveness ratios; the results were more sensitive to changes in intervention-related parameters. CONCLUSIONS: Screening for pre-diabetes in the overweight and obese U.S. population followed by the DPP lifestyle intervention has a relatively attractive cost-effectiveness ratio.

An evaluation of cost sharing to finance a diet and physical activity intervention to prevent diabetes.

OBJECTIVE: The Diabetes Prevention Program (DPP) lifestyle intervention is a cost-effective strategy to prevent type 2 diabetes, but it is unclear how this intervention could be financed. We explored whether this intervention could be offered in a way that allows return on investment for private health insurers while remaining attractive for consumers, employers, and Medicare. RESEARCH DESIGN AND METHODS: We used the DPP and other published reports to build a Markov simulation model to estimate the lifetime progression of disease, costs, and quality of life for adults with impaired glucose tolerance. The model assumed a health-payer perspective and compared DPP lifestyle and placebo interventions. Primary outcomes included cumulative incidence of diabetes, direct medical costs, quality-adjusted life-years (QALYs), and cost per QALY gained. RESULTS: Compared with placebo, providing the lifestyle intervention at age 50 years could prevent 37% of new cases of diabetes before age 65, at a cost of $1,288 per QALY gained. A private payer could reimburse $655 (24%) of the $2,715 in total discounted intervention costs during the first 3 intervention years and still recover all of these costs in the form of medical costs avoided. If Medicare paid up to $2,136 in intervention costs over the 15-year period before participants reached age 65, it could recover those costs in the form of future medical costs avoided beginning at age 65. CONCLUSIONS: Cost-sharing strategies to offer the DPP lifestyle intervention for eligible people between ages 50 and 64 could provide financial return on investment for private payers and long-term benefits for Medicare.

Prompting primary providers to increase community exercise referrals for older adults: a randomized trial.

OBJECTIVES: To determine whether a clinic-based physical activity promotion intervention can lead to more community-based exercise referrals by providers and higher exercise motivation in patients. DESIGN: Cluster randomized, controlled trial. SETTING: Seattle Veterans Affairs General Internal Medicine Clinic. PARTICIPANTS: Thirty-one physicians and nurse practitioners were randomized to a physical activity counseling intervention or control condition (counseling about tobacco cessation). Three hundred thirty-six patients aged 50 and older and visiting a study provider were enrolled. INTERVENTION: Intervention providers were trained to offer referrals to community exercise programs for patients who reported before their clinic visit that they were "contemplative" about regular exercise. MEASUREMENTS: Process measures of health behavior assessment and provider advice, exercise stage-of-change, proportion of participants reporting regular physical activity. RESULTS: At baseline, 172 intervention patients and 164 controls were similar with respect to sex, age, comorbidity score, and exercise motivation level. Forty-five percent of all intervention patients and 35% of controls reported receiving exercise advice (P=.07). Intervention patients who were contemplative about exercise were even more likely to receive exercise advice than contemplative controls (59% vs 38%; P=.02). After 4 months, 35% of all intervention patients reported regular exercise, compared with 28% of controls (P=.06). CONCLUSION: Primary providers are more likely to offer exercise advice when informed whether patients are contemplative about exercise. Patients may be more likely to start regular exercise as a result of this advice.