The rationale for patient-reported outcomes surveillance in cancer and a reproducible method for achieving it.

Patient-reported outcomes (PROs) measure quality of life, symptoms, patient functioning, and patient perceptions of care; they are essential for gaining a full understanding of cancer care and the impact of cancer on people's lives. Repeatedly captured facility-level and/or population-level PROs (PRO surveillance) could play an important role in quality monitoring and improvement, benchmarking, advocacy, policy making, and research. This article describes the rationale for PRO surveillance and the methods of the Patient Reported Outcomes Symptoms and Side Effects Study (PROSSES), which is the first PRO study to use the American College of Surgeons Commission on Cancer's Rapid Quality Reporting System to identify patients and manage study data flow. The American Cancer Society, the National Cancer Institute, the Commission on Cancer, and RTI International collaborated on PROSSES. PROSSES was conducted at 17 cancer programs that participated in the National Cancer Institute Community Cancer Centers Program among patients diagnosed with locoregional breast or colon cancer. The methods piloted in PROSSES were successful as demonstrated by high eligibility (93%) and response (61%) rates. Differences in clinical and demographic characteristics between respondents and nonrespondents were mostly negligible, with the exception that non-white individuals were somewhat less likely to respond. These methods were consistent across cancer centers and reproducible over time. If repeated and expanded, they could provide PRO surveillance data from patients with cancer on a national scale.

Improving the implementation of diabetes self-management: findings from the Alliance to Reduce Disparities in Diabetes.

To enhance the health and well-being of patients managing type 2 diabetes, the five grantees comprising the Alliance to Reduce Disparities in Diabetes implemented evidence-based approaches to patient self-management education as part of their programs. This article describes strategies implemented by the grantees that may help explain program success, defined as improvement in clinical values and patient-reported outcomes. A process evaluation of grantee programs included interviews and document review at the beginning, midpoint, and end of the Alliance initiative. A total of 97 interviews were conducted over time with 65 program representatives. The Alliance programs served 2,328 people from diverse racial and ethnic backgrounds and provided 36,826 diabetes self-management sessions across the intervention sites. Framework analysis of the interviews identified four key themes that emerged across time and program sites that may help account for program success: empowerment, increasing access and support, addressing local needs and barriers, and care coordination. The overall evaluation findings may help other diabetes self-management programs seeking to translate and implement evidence-based approaches to reduce disparities and enhance patient well-being.

Cross-site evaluation of the Alliance to Reduce Disparities in Diabetes: clinical and patient-reported outcomes.

Alliance programs implemented multilevel, multicomponent programs inspired by the chronic care model and aimed at reducing health and health care disparities for program participants. A unique characteristic of the Alliance programs is that they did not use a fixed implementation strategy common to programs using the chronic care model but instead focused on strategies that met local community needs. Using data provided by the five programs involved in the Alliance, this evaluation shows that of the 1,827 participants for which baseline and follow-up data were available, the program participants experienced significant decreases in hemoglobin A1c and blood pressure compared with a comparison group. A significant time by study group interaction was observed for hemoglobin A1c as well. Over time, more program participants met quality indicators for hemoglobin A1c and blood pressure. Those participants who attended self-management classes and experienced more resources and support for self-management attained more benefit. In addition, program participants experienced more diabetes competence, increased quality of life, and improvements in diabetes self-care behaviors. The cost-effectiveness of programs ranged from $23,161 to $61,011 per quality-adjusted life year. In sum, the Alliance programs reduced disparities and health care disparities for program participants.

The efficacy and cost-effectiveness of a community weight management intervention: a randomized controlled trial of the health weight management demonstration.

PURPOSE: The study investigated the efficacy and cost-effectiveness of a cognitive-behavioral weight management program, complemented by an interactive Web site and brief telephone/e-mail coaching. METHODS: In 2006-2007, 1755 overweight, non-active-duty TRICARE beneficiaries were randomized to one of three conditions with increasing intervention intensity: written materials and basic Web access (RCT1), plus an interactive Web site (RCT2), plus brief telephone/e-mail coaching support (RCT3). The study assessed changes in weight, blood pressure, and physical activity from baseline to 6, 12, and 15-18 months. (Study retention was 31% at 12 months.) Average and incremental cost-effectiveness and cost-offset analyses were conducted. RESULTS: Participants experienced significant weight loss (-4.0%, -4.0%, and -5.3%, respectively, in each RCT group after 12 months and -3.5%, -3.8%, and -5.1%, respectively, after 15 to 18 months), increased physical activity, and decreased blood pressure. Cost-effectiveness ratios were $900 to $1100/quality-adjusted life year (QALY) for RCT1 and RCT2 and $1900/QALY for RCT3. The cost recovery period to the government was 3 years for RCTs 1 and 2 and 6 years for RCT3. CONCLUSION: A relatively inexpensive cognitive-behavioral weight management intervention improved patient outcomes. Extrapolation of savings for the entire TRICARE population would significantly reduce direct medical costs.

Adoption of cardiovascular risk reduction guidelines: a cluster-randomized trial.

BACKGROUND AND OBJECTIVES: Cardiovascular disease (CVD) and underlying atherosclerosis begin in childhood and are related to CVD risk factors. This study evaluates tools and strategies to enhance adoption of new CVD risk reduction guidelines for children. METHODS: Thirty-two practices, recruited and supported by 2 primary care research networks, were cluster randomized to a multifaceted controlled intervention. Practices were compared with guideline-based individual and composite measures for BMI, blood pressure (BP), and tobacco. Composite measures were constructed by summing the numerators and denominators of individual measures. Preintervention and postintervention measures were assessed by medical record review of children ages 3 to 11 years. Changes in measures (pre-post and intervention versus control) were compared. RESULTS: The intervention group BP composite improved by 29.5%, increasing from 49.7% to 79.2%, compared with the control group (49.5% to 49.6%; P < .001). Intervention group BP interpretation improved by 61.1% (from 0.2% to 61.3%), compared with the control group (0.4% to 0.6%; P < .001). The assessment of tobacco exposure or use for 5- to 11-year-olds in the intervention group improved by 30.3% (from 3.4% to 49.1%) versus the control group (0.6% to 21.4%) (P = .042). No significant change was seen in the BMI or tobacco composites measures. The overall composite of 9 measures improved by 13.4% (from 48.2% to 69.8%) for the intervention group versus the control group (47.4% to 55.2%) (P = .01). CONCLUSIONS: Significant improvement was demonstrated in the overall composite measure, the composite measure of BP, and tobacco assessment and advice for children aged 5 to 11 years.

Implementation of the NHLBI integrated guidelines for cardiovascular health and risk reduction in children and adolescents: rationale and study design for young hearts, strong starts, a cluster-randomized trial targeting body mass index, blood pressure, and tobacco.

BACKGROUND: Cardiovascular disease (CVD) and the underlying atherosclerosis begin in childhood, and their presence and intensity are related to known cardiovascular disease risk factors. Attention to risk factor control in childhood has the potential to reduce subsequent risk of CVD. OBJECTIVE: The Young Hearts Strong Starts Study was designed to test strategies facilitating adoption of the National, Heart, Lung and Blood Institute supported Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents. This study compares guideline-based quality measures for body mass index, blood pressure, and tobacco using two strategies: a multifaceted, practice-directed intervention versus standard dissemination. STUDY DESIGN: Two primary care research networks recruited practices and provided support for the intervention and outcome evaluations. Individual practices were randomly assigned to the intervention or control groups using a cluster randomized design based on network affiliation, number of clinicians per practice, urban versus nonurban location, and practice type. The units of observation are individual children because measure adherence is abstracted from individual patient's medical records. The units of randomization are physician practices. This results in a multilevel design in which patients are nested within practices. The intervention practices received toolkits and supported guideline implementation including academic detailing, an ongoing e-learning group. This project is aligned with the American Board of Pediatrics Maintenance of Certification requirements including monthly physician self-abstraction, webinars, and other elements of the trial. SIGNIFICANCE: This trial will provide an opportunity to demonstrate tools and strategies to enhance CV prevention in children by guideline-based interventions.

Project IMPACT: results from a pilot validity study of a new observational database.

OBJECTIVE: The objective of this study was to evaluate the accuracy of the information contained in the Project IMPACT database. Project IMPACT is a comprehensive database system developed to measure and describe the care of intensive care patients. This database is being used by a large group of hospitals to help clinicians improve the care of these patients. Data on patient demographics, diagnoses, treatment, and outcomes are entered into the Project IMPACT database by staff at participating hospitals. This pilot study was a first step in assessing the accuracy of these data to determine the usefulness of the Project IMPACT database for measuring intensive care unit (ICU) performance and patient outcomes. DESIGN: The design of the pilot study was the independent abstraction of selected data items from a random sample of ICU patient records from two hospitals participating in Project IMPACT. The abstracted data were compared with the data existing in the Project IMPACT database for agreement. SETTING: Abstraction was performed onsite at the two pilot hospitals by a trained abstractor who was not affiliated with either hospital. PATIENTS: Patients whose records were abstracted included 45 randomly selected ICU patients at each of the two pilot hospitals. MEASUREMENTS AND MAIN RESULTS: Comparison of the Project IMPACT data with the independently abstracted data indicated good agreement (80% or above) on discrete items, such as type of ICU patient. Poorer agreement (under 80%) was seen for continuous items (e.g., 24-hr urine output) and coded items requiring judgment (e.g., reason for ICU admission). CONCLUSIONS: The pilot study showed good internal validity for most of the abstracted variables. High agreement rates were observed, regardless of method of original data capture (electronic download or manual entry), although agreement was higher for some data items that had been electronically downloaded into the Project IMPACT database. The results suggest that Project IMPACT is a valuable resource for ICUs to collect and evaluate information about treatment and patient outcomes.