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1.  An Opportunity for Improving Osteoporosis Treatment in Home Health Care 
Purpose: To examine osteoporosis prevention and treatment among home health care (HHC) patients at risk of fragility fracture in a large, Midwestern integrated HHC system. Methods: All patients who received HHC services in 2006 were identified. International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes and pharmaceutical data were examined between January 1, 2004 and December 31, 2005 to determine risk status (high vs average) for fragility fracture. Patients with a documented diagnosis of osteoporosis, osteopenia, previous fragility fracture, stroke, or those taking a glucocorticoid were categorized as high risk. Pharmaceutical data (eg, estrogen, bisphosphonates) were obtained during the same 2-year period to determine treatment status. Descriptive statistics documented the proportion at high risk and treatment status. Inferential statistics tested differences in characteristics (age, gender, race, number of comorbidities) among high-risk patients with and without treatment. Results: 2798 patients were seen in HHC during 2006 and had utilization data available in 2004 and 2005. Of these, 754 were categorized as high risk and 2044 as average risk. Approximately one third (34%) of high-risk patients received osteoporosis medication compared to 4% of average risk (P < .0001). We found no treatment differences based on age. Those with higher comorbidity profiles were less likely to receive treatment (P < .0001). Conclusion: Only 34% of HHC patients at high risk for fracture received adequate treatment. Patients with more comorbidities were least likely to receive treatment. Since these individuals are receiving medical and nursing care, an opportunity exists to increase treatment rates for those at greatest risk.
doi:10.1177/2151458510386950
PMCID: PMC3597295  PMID: 23569662
Aged; bone density conservation agents; home care services; osteoporosis; risk factors
2.  Focus Groups Inform a Web-Based Program to Increase Fruit and Vegetable Intake 
Patient education and counseling  2009;77(2):314-318.
Objective
To use focus groups to inform a web-based educational intervention for increased fruit and vegetable (FV) consumption.
Methods
Twelve groups (participants =137, aged 21–65) were recruited from four geographically diverse health systems. Four groups were stratified by gender and eight by race (white and African American) and gender. Questions included perceptions of healthy eating, factors that encourage or serve as barriers to FV consumption and features preferred for a web-based educational intervention.
Results
Though knowledgeable about healthy eating, participants did not know how to achieve or always care about healthy nutritional choices. Motivators for FV consumption included being role models and health concerns. Barriers included: lack of time, expense and FV availability. Website preferences included: visuals, links, tailored materials, menu suggestions, goal setting assistance, printable summaries and built in motivation. The developers incorporated nearly all suggestions.
Conclusion
Focus groups provided needs-based tactical strategies for an online, education intervention targeting factors to improve FV consumption.
Practice Implications
Focus groups can provide valuable input to inform interventions. Further, web-based programs’ abilities to offer information without time or geographic constraints, with capacity for tailoring and tracking progress makes them a valuable addition in the arsenal of efforts to promote healthy behaviors.
doi:10.1016/j.pec.2009.03.032
PMCID: PMC2767451  PMID: 19409750
Fruit and Vegetable Consumption; Patient education; Internet; Focus Groups; Web-based interventions; Health Maintenance Organization
3.  CARDIOLOGY CLINICAL TRIAL PARTICIPATION IN COMMUNITY-BASED HEALTHCARE SYSTEMS: OBSTACLES AND OPPORTUNITIES 
Contemporary clinical trials  2008;29(5):646-653.
Background
The objective of our study was to examine cardiologists’ and organizational leaders’ interest in clinical trial participation and perceived barriers and facilitators to participation within ten diverse non-profit healthcare delivery systems. Trials play a pivotal role in advancing knowledge about the safety and efficacy of cardiovascular interventions and tests. Although cardiovascular trials successfully enroll patients, recruitment challenges persist. Community-based health systems could be an important source of participants and investigators, but little is known about community cardiologists’ experiences with trials.
Methods
We interviewed 25 cardiology and administrative leaders and mailed questionnaires to all 280 cardiologists at 10 U.S. healthcare organizations.
Results
The survey received a 73% response rate. While 60% of respondents had not participated in any trials in the past year, nearly 75% wanted greater participation. Cardiologists reported positive attitudes toward trial participation; more than half agreed that trials were their first choice of therapy for patients, if available. Almost all leaders described their organizations as valuing research but not necessarily trials. Major barriers to participation were lack of physician time and insufficient skilled research nurses.
Conclusions
Cardiologists have considerable interest in trial participation. Major obstacles to increased participation are lack of time and effective infrastructure to support trials. These results suggest that community-based health systems are a rich source for cardiovascular research but additional funding and infrastructure are needed to leverage this resource.
doi:10.1016/j.cct.2008.02.003
PMCID: PMC2615791  PMID: 18397842
clinical trials; clinical trials recruitment; barriers to clinical trial participation; clinician participation in clinical trials
4.  Specificity of Clinical Breast Examination in Community Practice 
Background
Millions of women receive clinical breast examination (CBE) each year, as either a breast cancer screening test or a diagnostic test for breast symptoms. While screening CBE had moderately high specificity (∼94%) in clinical trials, community clinicians may be comparatively inexperienced and may conduct relatively brief examinations, resulting in even higher specificity but lower sensitivity.
Objective
To estimate the specificity of screening and diagnostic CBE in clinical practice and identify patient factors associated with specificity.
Design
Retrospective cohort study.
Subjects
Breast-cancer-free female health plan enrollees in 5 states (WA, OR, CA, MA, and MN) who received CBE (N = 1,484).
Measurements
Medical charts were abstracted to ascertain breast cancer risk factors, examination purpose (screening vs diagnostic), and results (true-negative vs false-positive). Women were considered “average-risk” if they had neither a family history of breast cancer nor a prior breast biopsy and “increased-risk” otherwise.
Results
Among average- and increased-risk women, respectively, the specificity (true-negative proportion) of screening CBE was 99.4% [95% confidence interval (CI): 98.8–99.7%] and 97.1% (95% CI: 95.7–98.0%), and the specificity of diagnostic CBE was 68.7% (95% CI: 59.7–76.5%) and 57.1% (95% CI: 51.1–63.0%). The odds of a true-negative screening CBE (specificity) were significantly lower among women at increased risk of breast cancer (adjusted odds ratio 0.21; 95% CI: 0.10–0.46).
Conclusions
Screening CBE likely has higher specificity among community clinicians compared to examiners in clinical trials of breast cancer screening, even among women at increased breast cancer risk. Highly specific examinations, however, may have relatively low sensitivity for breast cancer. Diagnostic CBE, meanwhile, is relatively nonspecific.
doi:10.1007/s11606-006-0062-7
PMCID: PMC1824753  PMID: 17356964
breast cancer; sensitivity and specificity; screening; physical examination
5.  Specificity of Clinical Breast Examination in Community Practice 
Background
Millions of women receive clinical breast examination (CBE) each year, as either a breast cancer screening test or a diagnostic test for breast symptoms. While screening CBE had moderately high specificity (∼94%) in clinical trials, community clinicians may be comparatively inexperienced and may conduct relatively brief examinations, resulting in even higher specificity but lower sensitivity.
Objective
To estimate the specificity of screening and diagnostic CBE in clinical practice and identify patient factors associated with specificity.
Design
Retrospective cohort study.
Subjects
Breast-cancer-free female health plan enrollees in 5 states (WA, OR, CA, MA, and MN) who received CBE (N = 1,484).
Measurements
Medical charts were abstracted to ascertain breast cancer risk factors, examination purpose (screening vs diagnostic), and results (true-negative vs false-positive). Women were considered “average-risk” if they had neither a family history of breast cancer nor a prior breast biopsy and “increased-risk” otherwise.
Results
Among average- and increased-risk women, respectively, the specificity (true-negative proportion) of screening CBE was 99.4% [95% confidence interval (CI): 98.8–99.7%] and 97.1% (95% CI: 95.7–98.0%), and the specificity of diagnostic CBE was 68.7% (95% CI: 59.7–76.5%) and 57.1% (95% CI: 51.1–63.0%). The odds of a true-negative screening CBE (specificity) were significantly lower among women at increased risk of breast cancer (adjusted odds ratio 0.21; 95% CI: 0.10–0.46).
Conclusions
Screening CBE likely has higher specificity among community clinicians compared to examiners in clinical trials of breast cancer screening, even among women at increased breast cancer risk. Highly specific examinations, however, may have relatively low sensitivity for breast cancer. Diagnostic CBE, meanwhile, is relatively nonspecific.
doi:10.1007/s11606-006-0062-7
PMCID: PMC1824753  PMID: 17356964
breast cancer; sensitivity and specificity; screening; physical examination
6.  A Randomized Clinical Trial Evaluating Online Interventions to Improve Fruit and Vegetable Consumption 
American journal of public health  2009;100(2):319-326.
Objectives
We assessed change in fruit and vegetable intake in a population-based sample, comparing an online untailored program (arm 1) with a tailored behavioral intervention (arm 2) and with a tailored behavioral intervention plus motivational interviewing–based counseling via e-mail (arm 3).
Methods
We conducted a randomized controlled intervention trial, enrolling members aged 21 to 65 years from 5 health plans in Seattle, Washington; Denver, Colorado; Minneapolis, Minnesota; Detroit, Michigan; and Atlanta, Georgia. Participants reported fruit and vegetable intake at baseline and at 3, 6, and 12 months. We assessed mean change in fruit and vegetable servings per day at 12 months after baseline, using a validated self-report fruit and vegetable food frequency questionnaire.
Results
Of 2540 trial participants, 80% were followed up at 12 months. Overall baseline mean fruit and vegetable intake was 4.4 servings per day. Average servings increased by more than 2 servings across all study arms (P<.001), with the greatest increase (+2.8 servings) among participants of arm 3 (P=.05, compared with control). Overall program satisfaction was high.
Conclusions
This online nutritional intervention was well received, convenient, easy to disseminate, and associated with sustained dietary change. Such programs have promise as population-based dietary interventions.
doi:10.2105/AJPH.2008.154468
PMCID: PMC2804654  PMID: 20019315
7.  Engagement and Retention: Measuring Breadth and Depth of Participant Use of an Online Intervention 
Background
The Internet provides us with tools (user metrics or paradata) to evaluate how users interact with online interventions. Analysis of these paradata can lead to design improvements.
Objective
The objective was to explore the qualities of online participant engagement in an online intervention. We analyzed the paradata in a randomized controlled trial of alternative versions of an online intervention designed to promote consumption of fruit and vegetables.
Methods
Volunteers were randomized to 1 of 3 study arms involving several online sessions. We created 2 indirect measures of breadth and depth to measure different dimensions and dynamics of program engagement based on factor analysis of paradata measures of Web pages visited and time spent online with the intervention materials. Multiple regression was used to assess influence of engagement on retention and change in dietary intake.
Results
Baseline surveys were completed by 2513 enrolled participants. Of these, 86.3% (n = 2168) completed the follow-up surveys at 3 months, 79.6% (n = 2027) at 6 months, and 79.4% (n = 1995) at 12 months. The 2 tailored intervention arms exhibited significantly more engagement than the untailored arm (P < .01). Breadth and depth measures of engagement were significantly associated with completion of follow-up surveys (odds ratios [OR] = 4.11 and 2.12, respectively, both P values < .001). The breadth measure of engagement was also significantly positively associated with a key study outcome, the mean increase in fruit and vegetable consumption (P < .001).
Conclusions
By exploring participants’ exposures to online interventions, paradata are valuable in explaining the effects of tailoring in increasing participant engagement in the intervention. Controlling for intervention arm, greater engagement is also associated with retention of participants and positive change in a key outcome of the intervention, dietary change. This paper demonstrates the utility of paradata capture and analysis for evaluating online health interventions.
Trial Registration
NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5u8sSr0Ty)
doi:10.2196/jmir.1430
PMCID: PMC3056524  PMID: 21087922
Methodological studies; Internet; process metrics; tailored intervention
8.  Recruitment to a Randomized Web-Based Nutritional Intervention Trial: Characteristics of Participants Compared to Non-Participants 
Background
Web-based behavioral programs efficiently disseminate health information to a broad population, and online tailoring may increase their effectiveness. While the number of Internet-based behavioral interventions has grown in the last several years, additional information is needed to understand the characteristics of subjects who enroll in these interventions, relative to those subjects who are invited to enroll.
Objective
The aim of the study was to compare the characteristics of participants who enrolled in an online dietary intervention trial (MENU) with those who were invited but chose not to participate, in order to better understand how these groups differ.
Methods
The MENU trial was conducted among five health plans participating in the HMO Cancer Research Network in collaboration with the University of Michigan Center for Health Communication Research. Approximately 6000 health plan members per site, between the ages of 21 and 65, and stratified by gender with oversampling of minority populations, were randomly selected for recruitment and were mailed an invitation letter containing website information and a US$2 bill with the promise of US$20 for completing follow-up surveys. Administrative and area-based data using geocoding along with baseline survey data were used to compare invitees (HMO members sent the introductory letter), responders (those who entered a study ID on the website), and enrollees (those who completed the enrollment process). Generalized estimating equation multivariate and logistic regression models were used to assess predictors of response and enrollment.
Results
Of 28,460 members invited to participate, 4270 (15.0%) accessed the website. Of the eligible responders, 2540 (8.9%) completed the consent form and baseline survey and were enrolled and randomized. The odds of responding were 10% lower for every decade of increased age (P < .001), while the likelihood of enrolling was 10% higher for every decade increase in age (P < .001). Women were more likely to respond and to enroll (P < .001). Those living in a census tract associated with higher education levels were more likely to respond and enroll, as well as those residing in tracts with higher income (P < .001). With a 22% (n = 566) enrollment rate for African Americans and 8% (n = 192) for Hispanics, the enrolled sample was more racially and ethnically diverse than the background sampling frame.
Conclusions
Relative to members invited to participate in the Internet-based intervention, those who enrolled were more likely to be older and live in census tracts associated with higher socioeconomic status. While oversampling of minority health plan members generated an enrolled sample that was more racially and ethnically diverse than the overall health plan population, additional research is needed to better understand methods that will expand the penetration of Internet interventions into more socioeconomically diverse populations.
Trial Registration
Clinicaltrials.gov NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5jB50xSfU)
doi:10.2196/jmir.1086
PMCID: PMC2762858  PMID: 19709990
Recruitment; Web-based interventions; making effective nutritional choices; Cancer Research Network; CRN; fruits and vegetables; research subject selection; selection; patient; mass screening; Internet; motivation; cultural diversity; health maintenance organizations

Results 1-8 (8)