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1.  MyPreventiveCare: implementation and dissemination of an interactive preventive health record in three practice-based research networks serving disadvantaged patients—a randomized cluster trial 
Background
Evidence-based preventive services for early detection of cancer and other health conditions offer profound health benefits, yet Americans receive only half of indicated services. Policy initiatives promote the adoption of information technologies to engage patients in care. We developed a theory-driven interactive preventive health record (IPHR) to engage patients in health promotion. The model defines five levels of functionality: (1) collecting patient information, (2) integrating with electronic health records (EHRs), (3) translating information into lay language, (4) providing individualized, guideline-based clinical recommendations, and (5) facilitating patient action. It is hypothesized that personal health records (PHRs) with these higher levels of functionality will inform and activate patients in ways that simpler PHRs cannot. However, realizing this vision requires both technological advances and effective implementation based upon clinician and practice engagement.
Methods/design
We are starting a two-phase, mixed-method trial to evaluate whether the IPHR is scalable across a large number of practices and how its uptake differs for minority and disadvantaged patients. In phase 1, 40 practices from three practice-based research networks will be randomized to add IPHR functionality to their PHR versus continue to use their existing PHR. Throughout the study, we will engage intervention practices to locally tailor IPHR content and learn how to integrate new functions into their practice workflow. In phase 2, the IPHR to all nonintervention practices to observe whether the IPHR can be implemented more broadly (Scalability). Phase 1 will feature an implementation assessment in intervention practices, based on the RE-AIM model, to measure Reach (creation of IPHR accounts by patients), Adoption (practice decision to use the IPHR), Implementation (consistency, fidelity, barriers, and facilitators of use), and Maintenance (sustained use). The incremental effect of the IPHR on receipt of cancer screening tests and shared decision-making compared to traditional PHRs will assess Effectiveness. In phase 2, we will assess similar outcomes as phase 1 except for effectiveness.
Discussion
This study will yield information about the effectiveness of new health information technologies designed to actively engage patients in their care as well as information about how to effectively implement and disseminate PHRs by engaging clinicians.
Trial registration
ClinicalTrials.gov: NCT02138448
doi:10.1186/s13012-014-0181-1
PMCID: PMC4269965  PMID: 25500097
Health promotion; Information management; Informatics; Primary health care; Patient-centered care
2.  Decision Making in Prostate Cancer Screening Using Decision Aids vs Usual Care 
JAMA internal medicine  2013;173(18):1704-1712.
IMPORTANCE
The conflicting recommendations for prostate cancer (PCa) screening and the mixed messages communicated to the public about screening effectiveness make it critical to assist men in making informed decisions.
OBJECTIVE
To assess the effectiveness of 2 decision aids in helping men make informed PCa screening decisions.
DESIGN, SETTING, AND PARTICIPANTS
A racially diverse group of male outpatients aged 45 to 70 years from 3 sites were interviewed by telephone at baseline, 1 month, and 13 months, from 2007 through 2011. We conducted intention-to-treat univariate analyses and multivariable linear and logistic regression analyses, adjusting for baseline outcome measures.
INTERVENTION
Random assignment to print-based decision aid (n = 628), web-based interactive decision aid (n = 625), or usual care (UC) (n = 626).
MAIN OUTCOMES AND MEASURES
Prostate cancer knowledge, decisional conflict, decisional satisfaction, and whether participants underwent PCa screening.
RESULTS
Of 4794 eligible men approached, 1893 were randomized. At each follow-up assessment, univariate and multivariable analyses indicated that both decision aids resulted in significantly improved PCa knowledge and reduced decisional conflict compared with UC (all P <.001). At 1 month, the standardized mean difference (Cohen’s d) in knowledge for the web group vs UC was 0.74, and in the print group vs UC, 0.73. Decisional conflict was significantly lower for web vs UC (d = 0.33) and print vs UC (d = 0.36). At 13 months, these differences were smaller but remained significant. At 1 month, high satisfaction was reported by significantly more print (60.4%) than web participants (52.2%; P = .009) and significantly more web (P = .001) and print (P = .03) than UC participants (45.5%). At 13 months, differences in the proportion reporting high satisfaction among print (55.7%) compared with UC (49.8%; P = .06) and web participants (50.4%; P = .10) were not significant. Screening rates at 13 months did not differ significantly among groups.
CONCLUSIONS AND RELEVANCE
Both decision aids improved participants’ informed decision making about PCa screening up to 13 months later but did not affect actual screening rates. Dissemination of these decision aids may be a valuable public health tool.
doi:10.1001/jamainternmed.2013.9253
PMCID: PMC3992617  PMID: 23896732
3.  How patients want to engage with their personal health record: a qualitative study 
BMJ Open  2013;3(7):e002931.
Objective
To assess factors related to use and non-use of a sophisticated interactive preventive health record (IPHR) designed to promote uptake of 18 recommended clinical preventive services; little is known about how patients want to use or be engaged by such advanced information tools.
Design
Descriptive and interpretive qualitative analysis of transcripts and field notes from focus groups of the IPHR users and of patients who were invited but did not use the IPHR (non-users). Grounded theory techniques were then applied via an editing approach for key emergent themes.
Setting
Primary care patients in eight practices of the Virginia Ambulatory Care Outcomes Research Network (ACORN).
Participants
Three focus groups involved a total of 14 IPHR users and two groups of non-users totalled 14 participants.
Outcomes/results
For themes identified (relevance, trust and functionality) participants indicated that endorsement and use of the IPHR by their personal clinician was vital. In particular, participants’ comments linked the IPHR use to: (1) integrating the IPHR into current care, (2) promoting effective patient–clinician encounters and communication and (3) their confidence in the accuracy, security and privacy of the information.
Conclusions
In addition to patients’ stated desires for advanced functionality and information accuracy and privacy, successful adoption of the IPHRs by primary care patients depends on such technology's relevance, and on its promotion via integration with primary care practices’ processes and the patient–clinician relationship. Accordingly, models of technological success and adoption, when applied to primary care, may need to include the patient–clinician relationship and practice workflow. These findings are important for healthcare providers, the information technology industry and policymakers who share an interest in encouraging patients to use personal health records.
Trial Registration
Clinicaltrials.gov identifier: NCT00589173
doi:10.1136/bmjopen-2013-002931
PMCID: PMC3731712  PMID: 23901027
Primary Care; Preventive Medicine; Qualitative Research
4.  Developing clinical practice guidelines: types of evidence and outcomes; values and economics, synthesis, grading, and presentation and deriving recommendations 
Clinical practice guidelines are one of the foundations of efforts to improve healthcare. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearinghouses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this second paper, we discuss issues of identifying and synthesizing evidence: deciding what type of evidence and outcomes to include in guidelines; integrating values into a guideline; incorporating economic considerations; synthesis, grading, and presentation of evidence; and moving from evidence to recommendations.
doi:10.1186/1748-5908-7-61
PMCID: PMC3436711  PMID: 22762158
5.  Developing clinical practice guidelines: reviewing, reporting, and publishing guidelines; updating guidelines; and the emerging issues of enhancing guideline implementability and accounting for comorbid conditions in guideline development 
Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this third paper we discuss the issues of: reviewing, reporting, and publishing guidelines; updating guidelines; and the two emerging issues of enhancing guideline implementability and how guideline developers should approach dealing with the issue of patients who will be the subject of guidelines having co-morbid conditions.
doi:10.1186/1748-5908-7-62
PMCID: PMC3503794  PMID: 22762242
6.  Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest 
Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development.
doi:10.1186/1748-5908-7-60
PMCID: PMC3523009  PMID: 22762776
7.  Designing a patient-centered personal health record to promote preventive care 
Background
Evidence-based preventive services offer profound health benefits, yet Americans receive only half of indicated care. A variety of government and specialty society policy initiatives are promoting the adoption of information technologies to engage patients in their care, such as personal health records, but current systems may not utilize the technology's full potential.
Methods
Using a previously described model to make information technology more patient-centered, we developed an interactive preventive health record (IPHR) designed to more deeply engage patients in preventive care and health promotion. We recruited 14 primary care practices to promote the IPHR to all adult patients and sought practice and patient input in designing the IPHR to ensure its usability, salience, and generalizability. The input involved patient usability tests, practice workflow observations, learning collaboratives, and patient feedback. Use of the IPHR was measured using practice appointment and IPHR databases.
Results
The IPHR that emerged from this process generates tailored patient recommendations based on guidelines from the U.S. Preventive Services Task Force and other organizations. It extracts clinical data from the practices' electronic medical record and obtains health risk assessment information from patients. Clinical content is translated and explained in lay language. Recommendations review the benefits and uncertainties of services and possible actions for patients and clinicians. Embedded in recommendations are self management tools, risk calculators, decision aids, and community resources - selected to match patient's clinical circumstances. Within six months, practices had encouraged 14.4% of patients to use the IPHR (ranging from 1.5% to 28.3% across the 14 practices). Practices successfully incorporated the IPHR into workflow, using it to prepare patients for visits, augment health behavior counseling, explain test results, automatically issue patient reminders for overdue services, prompt clinicians about needed services, and formulate personalized prevention plans.
Conclusions
The IPHR demonstrates that a patient-centered personal health record that interfaces with the electronic medical record can give patients a high level of individualized guidance and be successfully adopted by busy primary care practices. Further study and refinement are necessary to make information systems even more patient-centered and to demonstrate their impact on care.
Trial Registration
Clinicaltrials.gov identifier: NCT00589173
doi:10.1186/1472-6947-11-73
PMCID: PMC3250934  PMID: 22115059
8.  Is discussion of colorectal cancer screening options associated with heightened patient confusion? 
Background
Clinical guidelines recommend offering patients options for colorectal cancer (CRC) screening, but the modalities vary by frequency, accuracy, preparations, discomfort and cost, which may cause confusion and reduce screening rates. We examined whether patients reported confusion about the options and whether confusion was associated with socio-demographic characteristics, number of options discussed, and adherence.
Methods
Patients aged 50–75 who had visited a clinician within two years were randomly selected for a cross-sectional study (n=6,100). A questionnaire mailed in 2007 asked: whether a clinician had ever discussed CRC screening options; which of four recommended tests (i.e., FOBT, flexible sigmoidoscopy, colonoscopy, and barium enema) were presented; and whether the options were confusing. Analyses were restricted to respondents who reported discussing ≥1 screening option (n=1,707). Weighted frequencies were calculated and multivariate logistic regression was performed.
Results
The sample was: 55.5% female, 15.6% African American, 83.2% adherent to screening recommendations, and 56.0% had discussed ≥2 screening options. In adjusted analyses, non-adherent patients reported greater confusion than adherent patients (P<0.01). Adults who discussed ≥2 options were 1.6 times more likely to be confused than those who discussed one option (95% CI: 1.08–2.26). Patients who reported being confused were 1.8 times more likely to be non-adherent to screening than those who did not (95% CI: 1.14–2.75).
Conclusions
Our study provides the first empiric evidence linking multiple options with confusion and confusion with screening adherence.
Impact
Confusion may act as a barrier to screening and should be considered in public health messages and interventions.
doi:10.1158/1055-9965.EPI-10-0695
PMCID: PMC2976781  PMID: 20852010
Colorectal cancer screening; Confusion; Physician-patient communication; Multiple screening options
9.  The Relative Importance of Patient-Reported Barriers to Colorectal Cancer Screening 
Background
Colorectal cancer (CRC) screening rates are suboptimal. The most important barriers identified by patients are poorly understood. A comprehensive assessment of barriers to all recommended modalities is needed.
Methods
In 2007, a questionnaire was mailed to 6,100 patients, aged 50–75 years, from 12 family medicine practices in the Virginia Ambulatory Care Outcomes Research Network. People aged 65–75 years and African Americans were oversampled. Patients were asked to rate 19–21 barriers to each of four recommended tests. In 2008, responses were coded on a 5-point scale; higher scores reflected stronger barrier endorsement.
Results
The response rate was 55% (n=3,357). Approximately 40% of respondents were aged ≥65 years, 30% were African-American, and 73% were adherent to screening. A clinician's failure to suggest screening and not knowing testing was necessary received the highest mean scores as barriers. Financial concerns and misconceptions were also cited. Barrier scores differed depending on whether respondents were never-screened, overdue for screening, or adherent to guidelines. The top five barriers for each modality included test-specific barriers (e.g., handling stool, bowel preparation), which often outranked generic barriers to screening. Not knowing testing was necessary was a top barrier for all tests but colonoscopy.
Conclusions
Although physician advice and awareness of the need for screening are important, barriers to screening are not homogenous across tests, and test-specific barriers warrant consideration in designing strategies to improve screening rates. Barrier scores differ by screening status, highlighting the need to address prior screening experience. Evidence that patients are more familiar with colonoscopy than with other modalities suggests an opportunity to improve screening rates by educating patients about alternative tests.
doi:10.1016/j.amepre.2010.01.020
PMCID: PMC2946819  PMID: 20347555
10.  Patient-Reported Barriers to Colorectal Cancer Screening 
Background
Barriers experienced by patients influence the uptake of colorectal cancer (CRC) screening. Prior research has quantified how often patients encounter these challenges but has generally not revealed their complex perspective and experience with barriers.
Methods
A two-part, mixed-methods study was conducted of primary care patients recruited from Virginia Ambulatory Care Outcome Research Network practices. First, in June–July 2005 a survey was mailed to 660 patients aged 50–75 years posing an open-ended question about “the most important barrier” to CRC screening. Second, beginning in October 2005 seven gender- and largely race-specific focus groups involving 40 patients aged 45–75 years were conducted. Beginning in October 2005, survey verbatim responses were coded and quantitatively analyzed and focus group transcripts were qualitatively analyzed.
Results
Responses to the open-ended survey question, answered by 74% of respondents, identified fear and the bowel preparation as the most important barriers to screening. Only 1.6% of responses cited the absence of physician advice. Focus group participants cited similar issues and other previously reported barriers, but their remarks exposed the intricacies of complex barriers, such as fear, lack of information, time, the role of physicians, and access to care. Participants also cited barriers that have little documentation in the literature, such as low self-worth, “para-sexual” sensitivities, fatalism, negative past experiences with testing, and skepticism about the financial motivation behind screening recommendations.
Conclusions
Mixed-methods analysis helps to disaggregate the complex nuances that influence patient behavior. In this study, patients explained the web of influences on knowledge, motivation, and ability to undergo CRC screening, which clinicians and policymakers should consider in designing interventions to increase the level of screening.
doi:10.1016/j.amepre.2010.01.021
PMCID: PMC2946825  PMID: 20409499
11.  The development of a web- and a print-based decision aid for prostate cancer screening 
Background
Whether early detection and treatment of prostate cancer (PCa) will reduce disease-related mortality remains uncertain. As a result, tools are needed to facilitate informed decision making. While there have been several decision aids (DAs) developed and tested, very few have included an exercise to help men clarify their values and preferences about PCa screening. Further, only one DA has utilized an interactive web-based format, which allows for an expansion and customization of the material. We describe the development of two DAs, a booklet and an interactive website, each with a values clarification component and designed for use in diverse settings.
Methods
We conducted two feasibility studies to assess men's (45-70 years) Internet access and their willingness to use a web- vs. a print-based tool. The booklet was adapted from two previous versions evaluated in randomized controlled trials (RCTs) and the website was created to closely match the content of the revised booklet. Usability testing was conducted to obtain feedback regarding draft versions of the materials. The tools were also reviewed by a plain language expert and the interdisciplinary research team. Feedback on the content and presentation led to iterative modifications of the tools.
Results
The feasibility studies confirmed that the Internet was a viable medium, as the majority of men used a computer, had access to the Internet, and Internet use increased over time. Feedback from the usability testing on the length, presentation, and content of the materials was incorporated into the final versions of the booklet and website. Both the feasibility studies and the usability testing highlighted the need to address men's informed decision making regarding screening.
Conclusions
Informed decision making for PCa screening is crucial at present and may be important for some time, particularly if a definitive recommendation either for or against screening does not emerge from ongoing prostate cancer screening trials. We have detailed our efforts at developing print- and web-based DAs to assist men in determining how to best meet their PCa screening preferences. Following completion of our ongoing RCT designed to test these materials, our goal will be to develop a dissemination project for the more effective tool.
Trial Registration
NCT00623090
doi:10.1186/1472-6947-10-12
PMCID: PMC2845091  PMID: 20199680
14.  Developing clinical guidelines 
Western Journal of Medicine  1999;170(6):348-351.
The methods of guideline development should ensure that treating patients according to guidelines will achieve the outcomes that are desired. This article presents a combination of the literature about guideline development and the results of our combined experience in guideline development in North America and Britain. It considers the 5 steps in the initial development of an evidence-based guideline.
Images
PMCID: PMC1305691  PMID: 18751155
15.  Developing guidelines 
BMJ : British Medical Journal  1999;318(7183):593-596.
PMCID: PMC1115034  PMID: 10037645

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