Building Meaningful Patient Engagement in Research: Case Study From ADVANCE Clinical Data Research Network.

BACKGROUND: Strategies to engage patients to improve and enhance research and clinical care are increasingly being implemented in the United States, yet little is known about best practices for or the impacts of meaningful patient engagement. OBJECTIVE: We describe and reflect on our patient stakeholder groups, engagement framework, experiences, and lessons learned in engaging patients in research, from generating proposal ideas to disseminating findings. SETTING: The ADVANCE (Accelerating Data Value Across a National Community Health Center Network) clinical data research network is the nation's largest clinical dataset on the safety net, with outpatient clinical data from 122 health systems (1109 clinics) in 23 states. RESULTS: Patients stakeholders codeveloped the ADVANCE engagement framework and its implementation in partnership with network leaders. In phase I of ADVANCE, patients were involved with designing studies (input on primary outcome measures and methods) and usability testing (of the patient portal). In phase II, the network is prioritizing research training, dissemination opportunities, an "ambassador" program to pair more experienced patient stakeholders with those less experienced, and evaluation of engagement activities and impacts. DISCUSSION: The ADVANCE framework for patient engagement has successfully involved a diverse group of patients in the design, implementation, and interpretation of comparative effectiveness research. Our experience and framework can be used by other organizations and research networks to support patient engagement activities.

The ADVANCE network: accelerating data value across a national community health center network.

The ADVANCE (Accelerating Data Value Across a National Community Health Center Network) clinical data research network (CDRN) is led by the OCHIN Community Health Information Network in partnership with Health Choice Network and Fenway Health. The ADVANCE CDRN will 'horizontally' integrate outpatient electronic health record data for over one million federally qualified health center patients, and 'vertically' integrate hospital, health plan, and community data for these patients, often under-represented in research studies. Patient investigators, community investigators, and academic investigators with diverse expertise will work together to meet project goals related to data integration, patient engagement and recruitment, and the development of streamlined regulatory policies. By enhancing the data and research infrastructure of participating organizations, the ADVANCE CDRN will serve as a 'community laboratory' for including disadvantaged and vulnerable patients in patient-centered outcomes research that is aligned with the priorities of patients, clinics, and communities in our network.

Behavioral counseling to prevent sexually transmitted infections: a systematic review for the U.S. Preventive Services Task Force.

BACKGROUND: Despite advances in prevention and treatment, sexually transmitted infections (STIs) remain an important cause of morbidity and mortality in the United States. PURPOSE: To systematically review the evidence for behavioral counseling interventions to prevent STIs in adolescents and adults (nonpregnant and pregnant). DATA SOURCES: English-language articles in MEDLINE, PsycINFO, the Centers for Disease Control and Prevention's Prevention Synthesis Research Project database, and Cochrane databases (1988 through December 2007), supplemented with expert recommendations and the bibliographies of previous systematic reviews. STUDY SELECTION: Reviewers included 21 articles representing 15 fair- or good-quality randomized, controlled trials that evaluated behavioral counseling interventions feasible in primary care and 1 fair-quality and 1 good-quality controlled trial with study samples representative of primary care populations in English-speaking countries. Comparative effectiveness trials that did not include a true control group were excluded. DATA EXTRACTION: Investigators abstracted, critically appraised, and synthesized 21 articles that met inclusion criteria. DATA SYNTHESIS: Most evidence suggests a modest reduction in STIs at 12 months among high-risk adults receiving multiple intervention sessions and among sexually active adolescents. Evidence also suggested that these interventions increase adherence to treatment recommendations for women in STI clinics and general contraceptive use in male adolescents and decrease nonsexual risky behavior and pregnancy in sexually active female adolescents. No evidence of substantial behavioral or biological harms for risk reduction counseling was found. LIMITATION: Significant clinical heterogeneity in study populations, interventions, and measurement of outcomes limited the reviewers' ability to meta-analyze trial results and to suggest important intervention components. CONCLUSION: Good-quality evidence suggests that behavioral counseling interventions with multiple sessions conducted in STI clinics and primary care effectively reduces STI incidence in "at-risk" adult and adolescent populations. Additional trial evidence is needed for both lower-intensity behavioral counseling interventions and lower-risk patient populations.

Randomized trial of a whole-system ayurvedic protocol for type 2 diabetes.

CONTEXT: Though complementary and alternative medicine (CAM) treatments are popular, evidence to support their application to diabetes care is scarce. Previous CAM diabetes research has generally focused on single modalities, but CAM practitioners more commonly prescribe complex, multimodality interventions. OBJECTIVES: The aims of this study were to determine the feasibility and clinical impact of a whole-system, Ayurvedic intervention for newly diagnosed people with type 2 diabetes. DESIGN: Patients were randomly assigned to either an experimental or control arm. SETTING: Group model health maintenance organization. PARTICIPANTS: We recruited 60 adult patients with baseline glycosylated hemoglobin (HbA1c) values between 6.0 and 8.0. INTERVENTION: Treatment for the experimental group included exercise, an Ayurvedic diet, meditation instruction, and an Ayurvedic herb supplement (MA 471). Control patients attended standard diabetes education classes with primary care clinician follow-up. MEASUREMENTS: Clinical outcomes were assessed at 3 and 6 months and included HbA1c, fasting glucose, lipids, blood pressure, and weight. RESULTS: Ninety-two percent of randomized patients completed the study, and there were no significant adverse study-related events. Using analysis of co-variance (ANCOVA), we found no significant differences for clinical outcomes at 6 months between on-study patient groups, though trends favored the Ayurvedic group. When we included a factor measuring how much baseline HbA1c exceeded the mean (6.5%), however, we found statistically significant improvements in the Ayurvedic group for HbA1c (P = .006), fasting glucose (P = .001), total cholesterol (P = .05), low-density lipoprotein (LDL) cholesterol (P = .04), and weight (P = .035). CONCLUSIONS: These results suggest that the Ayurvedic intervention may benefit patients with higher baseline HbA1c values, warranting further research.

The circadian basis of winter depression.

The following test of the circadian phase-shift hypothesis for patients with winter depression (seasonal affective disorder, or SAD) uses low-dose melatonin administration in the morning or afternoon/evening to induce phase delays or phase advances, respectively, without causing sleepiness. Correlations between depression ratings and circadian phase revealed a therapeutic window for optimal alignment of circadian rhythms that also appears to be useful for phase-typing SAD patients for the purpose of administering treatment at the correct time. These analyses also provide estimates of the circadian component of SAD that may apply to the antidepressant mechanism of action of appropriately timed bright light exposure, the treatment of choice. SAD may be the first psychiatric disorder in which a physiological marker correlates with symptom severity before, and in the course of, treatment in the same patients. The findings support the phase-shift hypothesis for SAD, as well as suggest a way to assess the circadian component of other psychiatric, sleep, and chronobiologic disorders.

The Oregon Center for Complementary and Alternative Medicine career development program: innovation in research training for complementary and alternative medicine.

BACKGROUND: The burgeoning use of complementary and alternative medicine (CAM) highlights the need for high-quality research to discriminate between those approaches based on positive anecdotes or polished marketing and those that are consistently effective and safe. DESCRIPTION: To help meet this need, the Oregon Center for Complementary and Alternative Medicine has developed an innovative program to train researchers. The training program includes an individual mentoring and training plan, group mentoring, a clinical research class, proposal development, completion of an actual study, and journal club participation. EVALUATION: After 2 years the fellows have submitted 18 grants, presented 4 posters, submitted 7 articles, developed 2 treatment protocols, and earned 1 master of public health degree and 1 graduate certificate. CONCLUSIONS: This program helps experienced CAM practitioners quickly adopt a research perspective. We encourage other career development programs to extend training in research methods to individuals possessing a profound understanding of CAM.