The LEAP Program: Quality Improvement Training to Address Team Readiness Gaps Identified by Implementation Science Findings.

BACKGROUND: Integrating evidence-based innovations (EBIs) into sustained use is challenging; most implementations in health systems fail. Increasing frontline teams' quality improvement (QI) capability may increase the implementation readiness and success of EBI implementation. OBJECTIVES: Develop a QI training program ("Learn. Engage. Act. Process." (LEAP)) and evaluate its impact on frontline obesity treatment teams to improve treatment delivered within the Veterans Health Administration (VHA). DESIGN: This was a pre-post evaluation of the LEAP program. MOVE! coordinators (N = 68) were invited to participate in LEAP; 24 were randomly assigned to four starting times. MOVE! coordinators formed teams to work on improvement aims. Pre-post surveys assessed team organizational readiness for implementing change and self-rated QI skills. Program satisfaction, assignment completion, and aim achievement were also evaluated. PARTICIPANTS: VHA facility-based MOVE! teams. INTERVENTIONS: LEAP is a 21-week QI training program. Core components include audit and feedback reports, structured curriculum, coaching and learning community, and online platform. MAIN MEASURES: Organizational readiness for implementing change (ORIC); self-rated QI skills before and after LEAP; assignment completion and aim achievement; program satisfaction. KEY RESULTS: Seventeen of 24 randomized teams participated in LEAP. Participants' self-ratings across six categories of QI skills increased after completing LEAP (p< 0.0001). The ORIC measure showed no statistically significant change overall; the change efficacy subscale marginally improved (p < 0.08), and the change commitment subscale remained the same (p = 0.66). Depending on the assignment, 35 to 100% of teams completed the assignment. Nine teams achieved their aim. Most team members were satisfied or very satisfied (81-89%) with the LEAP components, 74% intended to continue using QI methods, and 81% planned to continue improvement work. CONCLUSIONS: LEAP is scalable and does not require travel or time away from clinical responsibilities. While QI skills improved among participating teams and most completed the work, they struggled to do so amid competing clinical priorities.

Quality Improvement and Personalization for Statins: the QUIPS Quality Improvement Randomized Trial of Veterans' Primary Care Statin Use.

BACKGROUND: Implementation of new practice guidelines for statin use was very poor. OBJECTIVE: To test a multi-component quality improvement intervention to encourage use of new guidelines for statin use. DESIGN: Cluster-randomized, usual-care controlled trial. PARTICIPANTS: The study population was primary care visits for patients who were recommended statins by the 2013 guidelines, but were not receiving them. We excluded patients who were over 75 years old, or had an ICD9 or ICD10 code for end-stage renal disease, muscle pain, pregnancy, or in vitro fertilization in the 2 years prior to the study visit. INTERVENTIONS: A novel quality improvement intervention consisting of a personalized decision support tool, an educational program, a performance measure, and an audit and feedback system. Randomization was at the level of the primary care team. MAIN MEASURES: Our primary outcome was prescription of a medium- or high-strength statin. We studied how receiving the intervention changed care during the quality improvement intervention compared to before it and if that change continued after the intervention. KEY RESULTS: Among 3787 visits to 43 primary care providers, being in the intervention arm tripled the odds of patients being prescribed an appropriate statin (OR 3.0, 95% CI 1.8-4.9), though the effect resolved after the personalized decision support ended (OR 1.7, 95% CI 0.99-2.77). CONCLUSIONS: A simple, personalized quality improvement intervention is promising for enabling the adoption of new guidelines. CLINICALTRIALS. GOV IDENTIFIER: NCT02820870.

Behavioral Treatment for Veterans with Obesity: 24-Month Weight Outcomes from the ASPIRE-VA Small Changes Randomized Trial.

BACKGROUND: Small Changes (SC) is a weight management approach that demonstrated superior 12-month outcomes compared to the existing MOVE!® Weight Management Program at two Veterans Affairs (VA) sites. However, approaches are needed to help graduates of treatment continue to lose or maintain their weight over the longer term. OBJECTIVE: The purpose of the present study was to examine the effectiveness of a second year of low-intensity SC support compared to support offered by the usual care MOVE! programs. DESIGN: Following participation in the year-long Aspiring to Lifelong Health in VA (ASPIRE-VA) randomized controlled trial, participants were invited to extend their participation in their assigned program for another year. Three programs were extended to include six SC sessions delivered via telephone (ASPIRE-Phone) or an in-person group (ASPIRE-Group), or 12 sessions offered by the MOVE! programs. PARTICIPANTS: Three hundred thirty-two overweight/obese veterans who consented to extend their participation in the ASPIRE-VA trial by an additional year. MAIN MEASURES: Twenty-four-month weight change (kg). KEY RESULTS: Twenty-four months after baseline, participants in all three groups had modest weight loss (-1.40 kg [-2.61 to -0.18] in the ASPIRE-Group, -2.13 kg [-3.43 to -0.83] in ASPIRE-Phone, and -1.78 kg [-3.07 to -0.49] in MOVE!), with no significant differences among the three groups. Exploratory post hoc analyses revealed that participants diagnosed with diabetes initially benefited from the ASPIRE-Group program (-2.6 kg [-4.37 to 0.83]), but experienced significant weight regain during the second year (+2.8 kg [0.92-4.69]) compared to those without diabetes. CONCLUSIONS: Participants in all three programs lost weight and maintained a statistically significant, though clinically modest, amount of weight loss over a 24-month period. Although participants in the ASPIRE-Group initially had greater weight loss, treatment was not sufficient to sustain weight loss through the second year, particularly in veterans with diabetes. Consistent, continuous-care treatment is needed to address obesity in the VA.

Implementation strategies in suicide prevention: a scoping review.

BACKGROUND: Implementation strategies can be a vital leveraging point for enhancing the implementation and dissemination of evidence-based suicide prevention interventions and programming. However, much remains unknown about which implementation strategies are commonly used and effective for supporting suicide prevention efforts. METHODS: In light of the limited available literature, a scoping review was conducted to evaluate implementation strategies present in current suicide prevention studies. We identified studies that were published between 2013 and 2022 that focused on suicide prevention and incorporated at least one implementation strategy. Studies were coded by two independent coders who showed strong inter-rater reliability. Data were synthesized using descriptive statistics and a narrative synthesis of findings. RESULTS: Overall, we found that studies most commonly utilized strategies related to iterative evaluation, training, and education. The majority of studies did not include direct measurement of suicide behavior outcomes, and there were few studies that directly tested implementation strategy effectiveness. CONCLUSION: Implementation science strategies remain an important component for improving suicide prevention and intervention implementation. Future research should consider the incorporation of more type 3 hybrid designs as well as increased systematic documentation of implementation strategies. TRIAL REGISTRATION: < de-identified > .

Maintaining Implementation through Dynamic Adaptations (MIDAS): protocol for a cluster-randomized trial of implementation strategies to optimize and sustain use of evidence-based practices in Veteran Health Administration (VHA) patients.

BACKGROUND: The adoption and sustainment of evidence-based practices (EBPs) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. The Veterans Affairs (VA) Maintaining Implementation through Dynamic Adaptations (MIDAS) Quality Enhancement Research Initiative (QUERI) program was funded as a series of trials to test multi-component implementation strategies to sustain optimal use of three EBPs: (1) a deprescribing approach intended to reduce potentially inappropriate polypharmacy; (2) appropriate dosing and drug selection of direct oral anticoagulants (DOACs); and (3) use of cognitive behavioral therapy as first-line treatment for insomnia before pharmacologic treatment. We describe the design and methods for a harmonized series of cluster-randomized control trials comparing two implementation strategies. METHODS: For each trial, we will recruit 8-12 clinics (24-36 total). All will have access to relevant clinical data to identify patients who may benefit from the target EBP at that clinic and provider. For each trial, clinics will be randomized to one of two implementation strategies to improve the use of the EBPs: (1) individual-level academic detailing (AD) or (2) AD plus the team-based Learn. Engage. Act. PROCESS: (LEAP) quality improvement (QI) learning program. The primary outcomes will be operationalized across the three trials as a patient-level dichotomous response (yes/no) indicating patients with potentially inappropriate medications (PIMs) among those who may benefit from the EBP. This outcome will be computed using month-by-month administrative data. Primary comparison between the two implementation strategies will be analyzed using generalized estimating equations (GEE) with clinic-level monthly (13 to 36 months) percent of PIMs as the dependent variable. Primary comparative endpoint will be at 18 months post-baseline. Each trial will also be analyzed independently. DISCUSSION: MIDAS QUERI trials will focus on fostering sustained use of EBPs that previously had targeted but incomplete implementation. Our implementation approaches are designed to engage frontline clinicians in a dynamic optimization process that integrates the use of actional clinical data and making incremental changes, designed to be feasible within busy clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05065502 . Registered October 4, 2021-retrospectively registered.

A systematic exploration of differences in contextual factors related to implementing the MOVE! weight management program in VA: a mixed methods study.

BACKGROUND: In January 2006, Veterans Affairs (VA) disseminated the MOVE!® Weight Management Program to VA medical centers to address the high prevalence of overweight/obesity. In its second year, MOVE! implementation varied widely across facilities. The objective of this study was to understand contextual factors that facilitated or impeded implementation of MOVE! in VA medical centers in the second year after its dissemination. METHODS: We used an embedded mixed methods cross-sectional study design. Qualitative and quantitative data were collected simultaneously with the primary purpose to explore contextual factors most likely to influence MOVE! implementation effectiveness at five purposively selected facilities. Facilities were selected to maximize variation with respect to participation in MOVE! by candidate Veterans. Semi-structured phone interviews were conducted with 24 staff across the five facilities. Quantitative responses were elicited followed by open-ended questions. The quantitative measures were adapted from a published implementation model. Qualitative analysis was conducted using rigorous content analysis methods. RESULTS: Qualitative and quantitative data converged to strengthen findings that point to several recommendations. Management support can help increase visibility of the program, commit needed resources, and communicate the importance of implementation efforts. Establishing a receptive implementation climate can be accomplished by emphasizing the important role that weight management may have in reducing incidence and severity of obesity-related chronic conditions. Coalescing highly functioning multi-disciplinary teams was an essential step for more effective implementation of MOVE!. In some situations, local champions can overcome challenging barriers in facilities that lack sufficient management support. CONCLUSIONS: Key organizational factors at local VA medical centers were strongly associated with MOVE! implementation. Results pointed to recommendations that can help accelerate large-scale dissemination of complex weight management programs.

Nurse practitioners as primary care providers within the VA.

We examined the perceptions of nurse practitioners (NPs) and physicians regarding NPs' roles as primary care providers within the Department of Veterans Affairs, thus suggesting possible reasons for the variation of NPs use. NPs and physicians from 7 Veterans Affairs hospitals were surveyed regarding perceptions and concerns about NPs' responsibilities. Quality of care was verified through outpatient services, laboratory results, and medications prescribed for 104,226 hypertensive or diabetic patients. Clinical findings suggest primary care for diabetic and hypertensive patients was comparable. Survey findings suggest physicians tended to underestimate what NPs do on their own for acute patients. Both groups expressed some concerns about expectations for NPs. To successfully integrate NPs into the primary care environment, health systems need to pay increased attention to differences in role perceptions among primary care providers.

A quick measure to guide allocation of chaplains' time with hospitalized veterans.

Assessing veterans' desire to see a chaplain can be difficult. Due to alleged personal weakness associated with seeing a chaplain while on active duty, veterans may still be reluctant to admit a need. Additionally chaplains may be challenged with multiple time demands. We devised and correlated with known instruments a single item containing four graded responses. One correlation was strong, suggesting the question's potential for serving as a useful tool for allocation of chaplains' time.

The "State of Implementation" Progress Report (SIPREP): a pilot demonstration of a navigation system for implementation.

BACKGROUND: Implementation of new clinical programs across diverse facilities in national healthcare systems like the Veterans Health Administration (VHA) can be extraordinarily complex. Implementation is a dynamic process, influenced heavily by local organizational context and the individual staff at each medical center. It is not always clear in the midst of implementation what issues are most important to whom or how to address them. In recognition of these challenges, implementation researchers within VHA developed a new systemic approach to map the implementation work required at different stages and provide ongoing, detailed, and nuanced feedback about implementation progress. METHODS: This observational pilot demonstration project details how a novel approach to monitoring implementation progress was applied across two different national VHA initiatives. Stage-specific grids organized the implementation work into columns, rows, and cells, identifying specific implementation activities at the site level to be completed along with who was responsible for completing each implementation activity. As implementation advanced, item-level checkboxes were crossed off and cells changed colors, offering a visual representation of implementation progress within and across sites across the various stages of implementation. RESULTS: Applied across two different national initiatives, the SIPREP provided a novel navigation system to guide and inform ongoing implementation within and across facilities. The SIPREP addressed different needs of different audiences, both described and explained how to implement the program, made ample use of visualizations, and revealed both what was happening and not happening within and across sites. The final SIPREP product spanned distinct stages of implementation. CONCLUSIONS: The SIPREP made the work of implementation explicit at the facility level (i.e., who does what, and when) and provided a new common way for all stakeholders to monitor implementation progress and to help keep implementation moving forward. This approach could be adapted to a wide range of settings and interventions and is planned to be integrated into the national deployment of two additional VHA initiatives within the next 12 months.

Prospective analysis of long-term psychosocial outcomes in breast reconstruction: two-year postoperative results from the Michigan Breast Reconstruction Outcomes Study.

OBJECTIVE: To prospectively evaluate the psychosocial outcomes and body image of patients 2 years postmastectomy reconstruction using a multicenter, multisurgeon approach. BACKGROUND: Although breast reconstruction has been shown to confer significant psychosocial benefits in breast cancer patients at year 1 postreconstruction, we considered the possibility that psychosocial outcomes may remain in a state of flux for years after surgery. METHODS: Patients were recruited as part of the Michigan Breast Reconstruction Outcome Study, a 12 center, 23 surgeon prospective cohort study of mastectomy reconstruction patients. Two-sided paired sample t tests were used to compare change scores for the various psychosocial subscales. Multiple regression analysis was used to determine whether the magnitude of the change score varied by procedure type. RESULTS: Preoperative and postoperative year 2 surveys were received from 173 patients; 116 with immediate and 57 with delayed reconstruction. For the immediate reconstruction cohort, significant improvements were observed in all psychosocial subscales except for body image. This occurred essentially independent of procedure type. In the cohort with delayed reconstruction, significant change scores were observed only in body image. Women with transverse rectus abdominis musculocutaneous flaps had significantly greater gains in body image scores (P = 0.003 and P = 0.034, respectively) when compared with expander/implants. CONCLUSIONS: General psychosocial benefits and body image gains continued to manifest at 2 years postmastectomy reconstruction. In addition, procedure type had a surprisingly limited effect on psychosocial well being. With outcomes evolving beyond year 1, these data support the need for additional longitudinal breast reconstruction outcome studies.

The Phased Implementation of a National Telehealth Weight Management Program for Veterans: Mixed-Methods Program Evaluation.

BACKGROUND: The burden of obesity is high among US veterans, yet many face barriers to engaging in in-person, facility-based treatment programs. To improve access to weight-management services, the Veterans Health Administration (VHA) developed TeleMOVE, a home-based, 82-day curriculum that utilizes in-home messaging devices to promote weight loss in VHA patients facing barriers to accessing facility-based services. OBJECTIVE: The primary aim was to establish preliminary evidence for the program by comparing outcomes for TeleMOVE with standard, facility-based MOVE weight-management services (group, individual modalities) over the evaluation period based on the number of patients enrolled per site and the program's clinical effectiveness, as demonstrated by average weight lost per patient. The secondary aim was to understand factors influencing TeleMOVE implementation variability across demonstration sites to develop recommendations to improve national program dissemination. METHODS: We employed a formative mixed-methods design to evaluate the phased implementation of TeleMOVE at 9 demonstration sites and compare patient- and site-level measures of program uptake. Data were collected between October 1, 2009 and September 30, 2011. Patient-level program outcomes were extracted from VHA patient care databases to evaluate program enrollment rates and clinical outcomes. To assess preliminary clinical effectiveness, weight loss outcomes for veterans who enrolled in TeleMOVE were compared with outcomes for veterans enrolled in standard MOVE! at each demonstration site, as well as with national averages during the first 2 years of program implementation. For the secondary aim, we invited program stakeholders to participate in 2 rounds of semistructured interviews about aspects of TeleMOVE implementation processes, site-level contextual factors, and program delivery. Twenty-eight stakeholders participated in audio-recorded interviews. RESULTS: Although stakeholders at 3 sites declined to be interviewed, objective program uptake was high at 2 sites, delayed-high at 2 sites, and low at 5 sites. At 6 months post enrollment, the mean weight loss was comparable for TeleMOVE (n=417) and MOVE! (n=1543) participants at -5.2 lb (SD 14.4) and -5.1 lb (SD 12.2), respectively (P=.91). All sites reported high program complexity because TeleMOVE required more staff time per participant than MOVE! due to logistical and technical assistance issues related to the devices. High-uptake sites overcame implementation challenges by leveraging communication networks with stakeholders, adapting the program to patient needs whenever possible, setting programmatic goals and monitoring feedback of results, and taking time to reflect and evaluate on delivery to foster incremental delivery improvements, whereas low-uptake sites reported less leadership support and effective communication among stakeholders. CONCLUSIONS: This implementation evaluation of a clinical telehealth program demonstrated the value of partnership-based research in which researchers not only provided operational leaders with feedback regarding the effectiveness of a new program but also relevant feedback into contextual factors related to program implementation to enable adaptations for national deployment efforts.

Comprehensive process model of clinical information interaction in primary care: results of a "best-fit" framework synthesis.

Objective: To describe a new, comprehensive process model of clinical information interaction in primary care (Clinical Information Interaction Model, or CIIM) based on a systematic synthesis of published research. Materials and Methods: We used the "best fit" framework synthesis approach. Searches were performed in PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Library and Information Science Abstracts, Library, Information Science and Technology Abstracts, and Engineering Village. Two authors reviewed articles according to inclusion and exclusion criteria. Data abstraction and content analysis of 443 published papers were used to create a model in which every element was supported by empirical research. Results: The CIIM documents how primary care clinicians interact with information as they make point-of-care clinical decisions. The model highlights 3 major process components: (1) context, (2) activity (usual and contingent), and (3) influence. Usual activities include information processing, source-user interaction, information evaluation, selection of information, information use, clinical reasoning, and clinical decisions. Clinician characteristics, patient behaviors, and other professionals influence the process. Discussion: The CIIM depicts the complete process of information interaction, enabling a grasp of relationships previously difficult to discern. The CIIM suggests potentially helpful functionality for clinical decision support systems (CDSSs) to support primary care, including a greater focus on information processing and use. The CIIM also documents the role of influence in clinical information interaction; influencers may affect the success of CDSS implementations. Conclusion: The CIIM offers a new framework for achieving CDSS workflow integration and new directions for CDSS design that can support the work of diverse primary care clinicians.

Does patient satisfaction with breast reconstruction change over time? Two-year results of the Michigan Breast Reconstruction Outcomes Study.

BACKGROUND: Previously, we found patient satisfaction with breast reconstruction at postoperative year 1 significantly higher in the autogenous tissue compared with the expander/implant population. But breast reconstructive procedures have different "aging" processes, and the point at which outcomes stabilize is unclear. So we evaluated patient satisfaction with breast reconstruction at postoperative year 2 and compared the results with those from our previous study. STUDY DESIGN: As part of the Michigan Breast Reconstruction Outcomes Study, women undergoing mastectomy reconstruction (including expander/implants and pedicle and free transverse rectus abdominis musculocutaneous flaps [TRAM]) were prospectively evaluated. Preoperatively and at postoperative years 1 and 2, women completed a questionnaire that collected a variety of validated health status information. The postoperative questionnaire had an additional seven items assessing both general and esthetic satisfaction as separate subscales. To assess the effects of procedure on satisfaction and control for possible confounding, multiple logistic regression was used. RESULTS: At year 2, patients with TRAM flaps (both free and pedicle) continued to have higher levels of esthetic satisfaction compared with expander/implant patients (odds ratio 2.8, p < 0.01). But no significant differences were appreciated in esthetic satisfaction between women with free and pedicle TRAM flaps. In regard to general satisfaction, the type of reconstruction (expander/implant, pedicle TRAM, and free TRAM) had no statistically significant effect. CONCLUSIONS: At postoperative year 2, procedural differences initially found in women's general satisfaction with breast reconstruction diminish. Specifically, women with pedicle TRAM flaps, free TRAM flaps, and expander/implants had similar levels of general satisfaction. But at year 2, patients continue to be more esthetically satisfied with autogenous tissue than with expander/implant reconstructions.

Adverse events among high-risk participants in a home-based walking study: a descriptive study.

BACKGROUND: For high-risk individuals and their healthcare providers, finding the right balance between promoting physical activity and minimizing the risk of adverse events can be difficult. More information on the prevalence and influence of adverse events is needed to improve providers' ability to prescribe effective and safe exercise programs for their patients. METHODS: This study describes the type and severity of adverse events reported by participants with cardiovascular disease or at-risk for cardiovascular disease that occurred during an unsupervised, home-based walking study. This multi-site, randomized controlled trial tested the feasibility of a diet and lifestyle activity intervention over 1.5 years. At month 13, 274 eligible participants (male veterans) were recruited who were ambulatory, BMI > 28, and reporting one or more cardiovascular disease risk factors. All participants attended five, face-to-face dietitian-delivered counseling sessions during the six-month intervention. Participants were randomized to three study arms: 1) time-based walking goals, 2) simple pedometer-based walking goals, and 3) enhanced pedometer-based walking goals with Internet-mediated feedback. Two physicians verified adverse event symptom coding. RESULTS: Enrolled participants had an average of five medical comorbidities. During 1110 person months of observation, 87 of 274 participants reported 121 adverse events. One serious study-related adverse event (atrial fibrillation) was reported; the individual resumed study participation within three days. Non-serious, study related adverse events made up 12% of all symptoms - predominantly minor musculoskeletal events. Serious, non-study related adverse events represented 32% of all symptoms while non-serious, non-study related adverse events made up 56% of symptoms. Cardiovascular disease events represented over half of the non-study related adverse event symptoms followed by musculoskeletal complaints. Adverse events caused 50 temporary suspensions averaging 26 days in duration before physician medical clearance was obtained to resume walking. CONCLUSION: Men at high risk for adverse cardiovascular events can safely be advised to start a progressive walking program. Results suggest that minor to serious medical problems unrelated to exercise are a major barrier to walking adherence. Helping individuals with chronic illness return to physical activity quickly but safely after an adverse event is an important component of any physical activity intervention targeting this population.

Impact of institutional review board practice variation on observational health services research.

OBJECTIVE: To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study. DATA SOURCE AND SETTING: Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics. DESIGN: Explanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence. DATA COLLECTION AND ABSTRACTION METHODS: Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data. PRINCIPAL FINDINGS: Approximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed: (1) Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites. (2) Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants. (3) Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document. (4) Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site. CONCLUSIONS: Several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects.

Impact of an educational video on patient decision making in early breast cancer treatment.

Previous research suggests that patient education programs promoting shared decision making (SDM) may improve patient satisfaction and outcomes, yet controlled clinical trials are lacking. The authors evaluate the impact of an early breast cancer treatment educational video on patients' decisional preferences and behavior. Newly diagnosed stage I/stage II breast cancer patients were assigned to SDM video program or control groups in alternating months. Surveys were administered prior to the provider visit and 1 week following the treatment decision. Variables assessed included autonomy preferences, perceived involvement in care, satisfaction, and treatment choice. There were no significant intervention effects on informational/decisional preferences, anxiety, knowledge, or satisfaction. Although 25% of SDM patients chose mastectomy compared to 14% of controls, this difference was not statistically significant. Eventhough enthusiasm for SDM programs remains high among some patients and providers, this study found only modest benefits.

A Comparative Effectiveness Trial of Three Walking Self-monitoring Strategies.

PURPOSE: Walking programs improve health outcomes in adults at risk for cardiovascular disease and self-monitoring strategies can improve adherence to such programs. The objective of this study was to determine if a six-month internet-based walking program using web-enhanced pedometers results in more weight loss than walking programs based on time or simple pedometer-step count goals in adults with or at risk for cardiovascular disease (CVD). METHODS: This was a multi-site, randomized controlled trial of 255 male Veterans who were ambulatory, insufficiently active, BMI ≥ 28, and who reported 1 ≥ CVD risk factors. Participants were randomized to one of three self-monitoring strategies to increase walking: (1) time-based walking goals; (2) simple pedometer-based walking goals; and (3) web-enhanced pedometer feedback goals with Internet-mediated feedback. All participants also attended five individual weight loss sessions with a dietitian. The main outcome measure was change in weight at six months (kg) and secondary outcomes were change in accelerometer-measured physical activity (min) and change in health-related quality of life at six months. RESULTS: The 255 participants had a mean age of 56.3 years (SD = 10.0), BMI=36.3 (SD = 5.3) with a mean of 5.2 (SD = 2.3) medical comorbidities. Dropouts were distributed evenly across the three groups and 72% of participants completed the program. At six months, participants in the web-enhanced pedometer arm lost significantly more weight (-1.9 kg, 95% CI=-2.7, -1.1) than those in the time-based group (-0.7 kg, 95% CI=-1.5, 0.0; p = 0.04) and simple pedometer group (-0.6 kg, 95% CI=-1.4, 0.2; p = 0.02). CONCLUSION: Internet-enhanced pedometers result in greater weight loss in Veterans than walking programs using time-based walking goals or simple pedometers.

Patient-physician concordance: preferences, perceptions, and factors influencing the breast cancer surgical decision.

PURPOSE: This study explored patient preferences for involvement in the breast cancer treatment decision and concordance between patients' and physicians' views on decisional role. The impact of demographic and psychosocial characteristics on patients' decisional role was also examined. PATIENTS AND METHODS: Women with stage I or II breast cancer who were candidates for either mastectomy or lumpectomy were recruited from a university breast cancer treatment center. Patient interviews were obtained before meeting the surgical oncologist and again after the treatment decision was made but before surgical intervention. Clinician responses were obtained after the consultation. RESULTS: The 101 participants were generally white (97%), married (80%), and well-educated. They reported moderate levels of depression and anxiety but good social support and self-efficacy in communicating with their physician. Before the consultation, 47% of women reported a preference for shared decision making; afterwards, 61% felt they had primary responsibility for the decision. Only 38% of patients agreed with the physician's assessment of how the treatment decision was made. In regression analyses, higher education was significantly associated with patients' preferred level of control (P = .01). There was a trend toward women with greater self-efficacy desiring more active decisional roles (P = .08). Patient preference for decision making did not impact time in the patient-physician encounter, but more influence did increase satisfaction. CONCLUSION: Limited concordance between patient preference and patient perception and between patient and physician perception in how the treatment decision was made suggests the need for better communication between patient and clinician during a critical treatment encounter for breast cancer patients.

Feasibility of adding enhanced pedometer feedback to nutritional counseling for weight loss.

BACKGROUND: Intensive interventions targeting diet and physical activity are effective for weight reduction but are costly. Tailored, computer-generated, step-count feedback may provide an intensive and affordable way to increase the physical activity of people at high risk for cardiovascular disease. OBJECTIVE: The objective was to test the feasibility of adding tailored, computer-generated, step-count feedback to a face-to-face nutritional counseling weight loss intervention. METHODS: We recruited 12 participants, 4 from each of three Department of Veterans Affairs medical centers. There were 11 male participants and 1 female participant. Each had a body mass index of 30 or greater and at least one of the following cardiovascular disease risk factors: diabetes, hypertension, hypercholesterolemia, obesity, or coronary artery disease. Participants attended one-on-one counseling sessions with a registered dietitian for four sessions over three weeks. At the initial session, each participant received an enhanced pedometer to record time-stamped, step-count data. Participants wore the device daily throughout the intervention. At the three follow-up sessions, the dietitian uploaded the computer data, reviewed a Web-based graphical display of step-count feedback, and helped set new walking goals. RESULTS: All 12 participants completed the program (100% attendance). Initial mean weight was 255 lbs (SD = 49 lbs), and weight loss was just over 4 lbs (n = 12, paired t test, P = .004). Mean daily step counts during the first week averaged 6019 steps per day, increasing to an average of 7358 per day after the third week (average increase of 1339 steps per day, or 0.6 miles, or 12 minutes of walking, n = 10, paired t test, P = .04). CONCLUSIONS: Enhanced pedometer feedback in conjunction with nutritional counseling is feasible and results in significant weight loss and increased walking among individuals at high risk for cardiovascular disease.