A community engagement training program for basic and translational cancer researchers.

PURPOSE: There is an increasing awareness of the importance of patient engagement in cancer research, but many basic and translational researchers have never been trained to do so. To address this unmet need, a 1-year patient engagement training program for researchers was developed. METHODS: Eleven researchers and eleven paired research advocates participated. This program, designed for virtual delivery, included 3 didactic modules focused on (1) Community Outreach and Engagement principles and methods, (2) Communication skills, and (3) Team Science. This was followed by longitudinal projects to be completed by the researcher/advocate pairs, including learning about the research project, and co-authoring abstracts, manuscripts and grant proposals. Monthly group meetings allowed pairs to share their experiences. The program culminated in the pairs creating and presenting oral abstracts for the University of Kansas Cancer Center's Annual Research Symposium. RESULTS: All participants indicated that the modules had a positive impact on their ability to collaborate in research. Both researcher self-evaluations and patient advocate evaluations of their researcher partner showed an improvement in researcher communication competency. Results from the Patient Engagement in Research Scale showed that advocates were highly engaged. Within 1 year after program completion, participating pairs have completed four abstracts and 9 grant proposals. CONCLUSION: The program will be modified based on participant feedback, and can be adapted for future cohorts if an increased number of sessions per month and shortened program duration are desired. The program's virtual format allows scalability across institutions to potentially benefit large cohorts of researchers.

A secondary analysis of PAIN-CONTRoLS: Pain's impact on sleep, fatigue, and activities of daily living.

INTRODUCTION/AIMS: Peripheral neuropathies commonly affect quality of life of patients due to pain, sleep disturbances, and fatigue, although trials have not adequately explored these domains of care. The aim of this study was to assess the impact of nortriptyline, duloxetine, pregabalin, and mexiletine on pain, sleep, and fatigue in patients diagnosed with cryptogenic sensory polyneuropathy (CSPN). METHODS: We implemented a Bayesian adaptive design to perform a 12-wk multisite, randomized, prospective, open-label comparative effectiveness study in 402 CSPN patients. Participants received either nortriptyline (n = 134), duloxetine (n = 126), pregabalin (n = 73), or mexiletine (n = 69). At prespecified analysis timepoints, secondary outcomes, Patient Reported Outcomes Measurement Information System (PROMIS) surveys including Short Form (SF)-12, pain interference, fatigue, and sleep disturbance, were collected. RESULTS: Mexiletine had the highest quit rate (58%) due to gastrointestinal side effects, while nortriptyline (38%) and duloxetine (38%) had the lowest quit rates. If tolerated for the full 12 wk of the study, mexiletine had the highest probability (>90%) of positive outcomes for improvements in pain interference and fatigue. There was no significant difference among the medications for sleep disturbance or SF-12 scores. Adverse events and lack of efficacy were the two most common reasons for cessation of therapy. DISCUSSION: Physicians caring for patients with CSPN should consider mexiletine to address pain and fatigue, although nortriptyline and duloxetine are better medications to trial first since they are better tolerated. Future research should compare other commonly used medications for CSPN to determine evidence-based treatment strategies.

Perceived barriers to the adoption of active surveillance in low-risk prostate cancer: a qualitative analysis of community and academic urologists.

BACKGROUND: Clinical practice guidelines recommend active surveillance as the preferred treatment option for low-risk prostate cancer, but only a minority of eligible men receive active surveillance, and practice variation is substantial. The aim of this study is to describe barriers to urologists' recommendation of active surveillance in low-risk prostate cancer and explore variation of barriers by setting. METHODS: We conducted semi-structured interviews among 22 practicing urologists, evenly distributed between academic and community practice. We coded barriers to active surveillance according to a conceptual model of determinants of treatment quality to identify potential opportunities for intervention. RESULTS: Community and academic urologists were generally in agreement on factors influencing active surveillance. Urologists perceived patient-level factors to have the greatest influence on recommendations, particularly tumor pathology, patient age, and judgements about the patient's ability to adhere to follow-up protocols. They also noted cross-cutting clinical barriers, including concerns about the adequacy of biopsy samples, inconsistent protocols to guide active surveillance, and side effects of biopsy procedures. Urologists had differing opinions on the impact of environmental factors, such as financial disincentives and fear of litigation. CONCLUSIONS: Despite national and international recommendations, both academic and community urologists note a variety of barriers to implementing active surveillance in low risk prostate cancer. These barriers will need to be specifically addressed in efforts to help urologists offer active surveillance more consistently.

Effect of Behavioral Therapy With In-Clinic or Telephone Group Visits vs In-Clinic Individual Visits on Weight Loss Among Patients With Obesity in Rural Clinical Practice: A Randomized Clinical Trial.

Importance: Rural populations have a higher prevalence of obesity and poor access to weight loss programs. Effective models for treating obesity in rural clinical practice are needed. Objective: To compare the Medicare Intensive Behavioral Therapy for Obesity fee-for-service model with 2 alternatives: in-clinic group visits based on a patient-centered medical home model and telephone-based group visits based on a disease management model. Design, Setting, and Participants: Cluster randomized trial conducted in 36 primary care practices in the rural Midwestern US. Inclusion criteria included age 20 to 75 years and body mass index of 30 to 45. Participants were enrolled from February 2016 to October 2017. Final follow-up occurred in December 2019. Interventions: All participants received a lifestyle intervention focused on diet, physical activity, and behavior change strategies. In the fee-for-service intervention (n = 473), practice-employed clinicians provided 15-minute in-clinic individual visits at a frequency similar to that reimbursed by Medicare (weekly for 1 month, biweekly for 5 months, and monthly thereafter). In the in-clinic group intervention (n = 468), practice-employed clinicians delivered group visits that were weekly for 3 months, biweekly for 3 months, and monthly thereafter. In the telephone group intervention (n = 466), patients received the same intervention as the in-clinic group intervention, but sessions were delivered remotely via conference calls by centralized staff. Main Outcomes and Measures: The primary outcome was weight change at 24 months. A minimum clinically important difference was defined as 2.75 kg. Results: Among 1407 participants (mean age, 54.7 [SD, 11.8] years; baseline body mass index, 36.7 [SD, 4.0]; 1081 [77%] women), 1220 (87%) completed the trial. Mean weight loss at 24 months was -4.4 kg (95% CI, -5.5 to -3.4 kg) in the in-clinic group intervention, -3.9 kg (95% CI, -5.0 to -2.9 kg) in the telephone group intervention, and -2.6 kg (95% CI, -3.6 to -1.5 kg) in the in-clinic individual intervention. Compared with the in-clinic individual intervention, the mean difference in weight change was -1.9 kg (97.5% CI, -3.5 to -0.2 kg; P = .01) for the in-clinic group intervention and -1.4 kg (97.5% CI, -3.0 to 0.3 kg; P = .06) for the telephone group intervention. Conclusions and Relevance: Among patients with obesity in rural primary care clinics, in-clinic group visits but not telephone-based group visits, compared with in-clinic individual visits, resulted in statistically significantly greater weight loss at 24 months. However, the differences were small in magnitude and of uncertain clinical importance. Trial Registration: ClinicalTrials.gov Identifier: NCT02456636.

Electronic cigarette use and psychological distress in the Native Hawaiian and Pacific Islander adults compared with other racial/ethnic groups: Data from the National Health Interview Survey, 2014.

Document the prevalence of electronic cigarette (E-cigarette) use among the native Hawaiian and other Pacific Islander (NHPI) adults compared with other racial/ethnic groups, and examine associations between psychological distress and E-cigarette use. 2014 National Health Interview Survey (NHIS) and 2014 NHPI-NHIS were combined for comparisons. Data were analyzed using descriptive statistics, Rao-Scott χ2 test, and multivariable logistic regression. E-cigarette use among NHPI (5.6%) was significantly higher than among Blacks (2.1%), Hispanics (2.2%), and Asians (1.7%; p < .001). NHPI with Kessler 6 (K6) score of 11-24 had greater odds of using E-cigarettes (odds ratio [OR]: 3.90; 95% confidence intervals [CI]: 1.81-8.42) as compared to those with a K6 score of 0. Associations between having a K6 score of 11-24 and using E-cigarettes were also found for Whites (OR: 3.49; CI: 2.44-4.99), Asians (OR: 5.29; CI: 1.29-21.70), and Hispanics (OR: 6.14; CI: 2.72-13.83). E-cigarette use was higher among NHPI relative to other racial/ethnic groups. NHPI with K6 score of 11-24 had greater odds of using E-cigarettes as compared to those with a K6 score of 0. Policies and strategies to reduce E-cigarette use among NHPI should give careful consideration to the associations between E-cigarette use and psychological distress in the NHPI population.

Health researchers' experiences, perceptions and barriers related to sharing study results with participants.

BACKGROUND: Although research participants are generally interested in receiving results from studies in which they participate, health researchers rarely communicate study findings to participants. The present study was designed to provide opportunity for a broad group of health researchers to describe their experiences and concerns related to sharing results (i.e. aggregate study findings) with research participants. METHODS: We used a mixed-methods concurrent triangulation design, relying on an online survey to capture health researchers' experiences, perceptions and barriers related to sharing study results with participants. Respondents were health researchers who conduct research that includes the consent of human subjects and hold a current appointment at an accredited academic medical institution within the United States. For quantitative data, the analytic strategy focused on item-level descriptive analyses. For the qualitative data, analyses focused on a priori themes and emergent subthemes. RESULTS: Respondents were 414 researchers from 44 academic medical institutions; 64.5% reported that results should always be shared with participants, yet 60.8% of respondents could identify studies in which they had a leadership role where results were not shared. Emergent subthemes from researchers' reasons why results should be shared included participant ownership of findings and benefits of results sharing to science. Reasons for not sharing included concerns related to participants' health literacy and participants' lack of desire for results. Across all respondents who described barriers to results sharing, the majority described logistical barriers. CONCLUSIONS: Study findings contribute to the literature by documenting researchers' perspectives and experiences about sharing results with research participants, which can inform efforts to improve results sharing. Most respondents indicated that health research results should always be shared with participants, although the extent to which many respondents described barriers to results sharing as well as reported reasons not to share results suggests difficulties with a one-size-fits-all approach to improving results sharing.

Patient vs. Community Engagement: Emerging Issues.

BACKGROUND: The value proposition of including patients at each step of the research process is that patient perspectives and preferences can have a positive impact on both the science and the outcomes of comparative effectiveness research. How to accomplish engagement and the extent to which approaches to community engagement inform strategies for effective patient engagement need to be examined to address conducting and accelerating comparative effectiveness research. OBJECTIVES: To examine how various perspectives and diverse training lead investigators and patients to conflicting positions on how best to advance patient engagement. RESEARCH DESIGN: Qualitative methods were used to collect perspectives and models of engagement from a diverse group of patients, researchers and clinicians. The project culminated with a workshop involving these stakeholders. The workshop used a novel approach, combining World Café and Future Search techniques, to compare and contrast aspects of patient engagement and community engagement. SUBJECTS: Participants included patients, researchers, and clinicians. MEASURES: Group and workshop discussions provided the consensus on topics related to patient and community engagement. RESULTS: Participants developed and refined a framework that compares and contrasts features associated with patient and community engagement. CONCLUSIONS: Although patient and community engagement may share a similar approach to engagement based on trust and mutual benefit, there may be distinctive aspects that require a unique lexicon, strategies, tactics, and activities.

Roadmap to engagement: Bringing patient partners into cancer research and beyond.

The University of Kansas Cancer Center (KU Cancer Center) initiated an engagement program to leverage the lived experience of individuals and families with cancer. KU Cancer Center faculty, staff, and patient partners built an infrastructure to achieve a patient-designed, patient-led, and research-informed engagement program called Patient and Investigator Voices Organizing Together (PIVOT). This special communication offers an engagement roadmap that can be replicated, scaled, and adopted at other cancer centers and academic health systems. PIVOT demonstrates that collaboration among academic leaders, investigators, and people with a lived experience yields a patient-centered, vibrant environment that enriches the research enterprise.

Case example of a jail-based cancer prevention clinical trial: Social determinants of health framework, novel experimental design, and retention strategies to facilitate long-term follow-up of clinical trial participants.

Clinical trials conducted with incarcerated populations are rare. We present a case example of one such jail-based cancer prevention clinical trial to demonstrate the importance of including a theory-driven approach to intervention framing, novel experimental designs to boost access to low-risk trials, and retention strategies for long-term follow-up of hard-to-reach populations. As such we offer a social determinant of health framework to ensure cancer prevention research is conducted through the lenses of health promotion and health equity. Deviations from the gold-standard randomized control design, transparent systematic allotment, and street-based outreach retention strategies contribute to the feasibility of conducting clinical trials in carceral settings and after people leave jail. Best practices presented can be used in design and conduct of future clinical trials with criminal legal system-involved populations.

Communicating risk and the landscape of cancer prevention - an exploratory study that examines perceptions of cancer-related genetic counseling and testing among African Americans and Latinos in the Midwest.

African American (AA) and Latino populations are impacted disproportionately by cancer incidence and mortality compared to the general US population. Contributing to these rates are multiple inheritable cancers that impact both men and women. Some of these diseases may be detected through genetic counseling and germline DNA testing; however, AA and Latinos are unaware and have limited knowledge and thus significantly underutilize these services and technologies. Research to detect influencing factors to testing uptake has also been slow due to multiple factors. The research team followed a community-based participatory research (CBPR) approach and worked with a Community Advisory Board composed of cancer survivors and co-survivors to design the exploratory study. Six focus groups were held with a pilot sample of African Americans and Latinos who self-reported to be at-risk for cancer (N = 53). The study was held over a 2-month period where attitudes, perceptions, and beliefs about cancer risk and preference regarding cancer-related genetic counseling and testing risk communication were explored. Themes that emerged included (1) the lack of knowledge about cancer-related genetic counseling and testing; (2) cancer is feared often; (3) cancer-related genetic testing was perceived as something that could help but was also perceived as unnecessary testing that exposed individuals to medical harm; and (4) benefits to test were perceived as favorable for medical personnel but not for the patient. Implications of the study provide a unique lens to explore how lived experiences among AA and Latinos may inform strategic risk communication about cancer-related genetic counseling and testing and help advance cancer health equity. Participants viewed cancer genetic testing as important cancer risk prevention strategies. Identification of perceptions of cancer risk and cancer-related genetic counseling and testing in collaboration with members of the community is needed to bolster communication efforts among these populations.

Cross-sectional online survey of clinicians' knowledge, attitudes and challenges to screening and counselling adolescents and young adults for substance use.

OBJECTIVE: To examine adolescent healthcare clinicians' self-reported screening practices as well as their knowledge, attitudes, comfort level and challenges with screening and counselling adolescents and young adults (AYA) for cigarette, e-cigarette, alcohol, marijuana, hookah and blunt use. DESIGN: A 2016 cross-sectional survey. SETTING: Academic departments and community-based internal medicine, family medicine and paediatrics practices. PARTICIPANTS: Adolescent healthcare clinicians (N=771) from 12 US medical schools and respondents to national surveys. Of the participants, 36% indicated male, 64% female, mean age was 44 years (SD=12.3); 12.3% of participants identified as Asian, 73.7% as white, 4.8% as black, 4.2% as Hispanic and 3.8% as other. PRIMARY AND SECONDARY OUTCOME MEASURES: Survey items queried clinicians about knowledge, attitudes, comfort level, self-efficacy and challenges with screening and counselling AYA patients about marijuana, blunts, cigarettes, e-cigarettes, hookah and alcohol. RESULTS: Participants were asked what percentage of their 10-17 years old patients they screened for substance use. The median number of physicians reported screening 100% of their patients for cigarette (1st, 3rd quartiles; 80, 100) and alcohol use (75, 100) and 99.5% for marijuana use (50,100); for e-cigarettes, participants reported screening half of their patients and 0.0% (0, 50), (0, 75)) reported screening for hookah and blunts, respectively. On average (median), clinicians estimated that 15.0% of all 10-17 years old patients smoked cigarettes, 10.0% used e-cigarettes, 20.0% used marijuana, 25.0% drank alcohol and 5.0% used hookah or blunts, respectively; yet they estimated lower than national rates of use of each product for their own patients. Clinicians reported greater comfort discussing cigarettes and alcohol with patients and less comfort discussing e-cigarettes, hookah, marijuana and blunts. CONCLUSIONS: This study identified low rates of screening and counselling AYA patients for use of e-cigarettes, hookahs and blunts by adolescent healthcare clinicians and points to potential missed opportunities to improve prevention efforts.

Sources of health information in a multiethnic, underserved, urban community: does ethnicity matter?

The Latino population is the fastest growing minority in the country, and is expected to reach about 30% of the total U.S. population by 2050. Historically, primary care practitioners are not the preferred source of health information for Latinos living in the United States. Latinos are known to rely more on media, family, and friends to get answers to health-related questions. Choosing the appropriate information source is an important component of health information-seeking behavior; it also represents a major challenge for health communicators trying to deliver information to their target audience. This study explores how ethnicity influences health information source selection among Latinos and White non-Latinos living together in an underserved, multiethnic urban community with poor health status and underlying socioeconomic characteristics. The results suggest that this community manifests a high degree of homogeneity in their usage of health information sources. Nevertheless, there are significant differences between ethnic groups and age groups on perceived usefulness of the health information retrieved from common sources. Our results suggest that health information sources that are interactive, native to the community (e.g., the local pharmacist), and promote active engagement are the most useful in delivering health messages that will be listened to by those living in this underserved, multiethnic urban community.

Understanding the role of violence in incarcerated women's cervical cancer screening and history.

In this exploratory study the authors investigated characteristics, including reported experiences of violence, related to incarcerated women's self-report of cervical cancer screening and cancer history and treatment. During a four month period in 2010, 204 women in Kansas City jails were surveyed. Multiple logistic regression models were used to examine the relations of socio-demographic and community characteristics and history of violence among the women to their cervical cancer screening, diagnosis, and treatment histories. Forty percent of the women in the current sample reported abnormal Pap histories, though only 6% of all Pap smears done in the U.S. are abnormal. Women who reported abuse histories in this study were found to be more likely to report having ever had an abnormal Pap smear (for physical abuse Odds Ratio [OR] = 6.05; CI 2.36, 15.54 and for past year intimate partner violence OR = 2.41; CI 1.09, 5.31). Participants who did not fear neighborhood violence were less likely to report an abnormal Pap history (OR = 0.57; CI 0.34, 0.96) and more likely to visit a family doctor for their Pap screenings (OR = 1.91; CI 1.01, 3.60). Women who perceived greater neighborhood violence had increased odds of reporting that they received Pap screenings in a hospital setting (OR = 1.47; CI 1.08, 2.00). Frequency of Pap screening did not differ in women who did and did not have fear of neighborhood violence. This study highlights the heightened cervical cancer risk experienced by women with criminal justice histories and suggests that violence at several levels has implications for cervical cancer prevention for these women.

Loneliness, Burnout, and Other Types of Emotional Distress Among Family Medicine Physicians: Results From a National Survey.

PURPOSE: This study assessed the prevalence of loneliness, burnout, and depressive symptoms from a national sample of family medicine physicians. DISCUSSION: We conducted a cross-sectional survey of 401 physicians who were members of the American Academy of Family Physicians (AAFP) and AAFP National Research Network between December 7, 2019, and January 20, 2020. The study participants completed an anonymous, 30-item survey measuring loneliness, burnout, symptoms of depression, fatigue, in addition to providing demographic information. RESULTS: The response rates were 16.3% (401 of 2456) for all the physicians, 7.0% (113 of 1606) for the AAFP NRN member physicians, and 33.9% (288 of 850) for the AAFP member insight physicians. The prevalence of loneliness, burnout, and depressive symptoms was 44.9% (165 of 367), 45.1% (181 of 401), and 44.3% (163 of 368) respectively. The physicians who experienced a greater feeling of loneliness compared with those who experienced a lesser feeling of loneliness were more likely to report at least 1 manifestation of burnout (69.1% vs 27.4%, P < .01), screen positive for depression (66.0% vs 27.6%, P < .01), and experience a higher degree of fatigue (59.5% vs 32.4%, P < .01). Depressive symptoms (odds ratio [OR] = 5.08; 95% confidence interval [CI], 4.64-7.94; P < .001), overwhelming exhaustion (OR = 7.19; 95% CI, 4.03 to 12.02; P < .001), and burnout (OR = 4.61; 95% CI, 2.96-7.19; P < .001) were associated with loneliness status. CONCLUSION: Our findings demonstrate that loneliness is common in practicing family medicine physicians and is significantly associated with burnout and depression. Future work is needed to understand the various interactions and relationships among loneliness, burnout, and depression to help inform effective interventions.

A Roadmap to Patient Engagement: Facioscapulohumeral Muscular Dystrophy and the ReSolve Clinical Trial.

We describe our efforts to overcome barriers to patient engagement in facioscapulohumeral muscular dystrophy (FSHD) and offer a roadmap that can be replicated in other rare neurologic disorders. We implemented an engagement plan during Clinical Trial Readiness to Solve Barriers to Drug Development for FSHD (ReSolve), an 18-month, multisite, observational study of individuals with FSHD. Elements of our engagement plan included conducting focus groups during protocol development, patient involvement on the ReSolve external advisory committee, creation of a patient advisory committee, and collaboration with patient advocacy groups. Patient feedback led to adaptations in the study protocol and to changes in recruitment and retention methods. Patient engagement ensures that the patient voice contributes to multiple aspects of trial design and implementation. Our engagement efforts exemplify how collaboration with patients and families can be accomplished in FSHD and the resultant roadmap process may be replicable in other rare neurologic diseases.

Non-cancer clinical trials start-up metrics at an academic medical center: Implications for advancing research.

The primary goal for any clinical trial after it receives a funding notification is to receive regulatory approval and initiate the trial for recruitment. Every trial must go through documentation and regulatory process before it can start recruiting participants and collecting data; this initial process of review and approval is known as the study start-up process (SSU). We evaluated the average time taken for studies to receive approvals. Using data from clinical trials conducted at the University of Kansas Medical Center, various times to reach the start of the study were calculated based on the dates of individual study. The results of this analysis showed that chart review studies and investigator-initiated trials had a shorter time to activation than other types of studies. Additionally, single-center studies had a shorter activation time than multi-center studies. The analysis also demonstrated that the overall processing time consistently had been reduced over time.

Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS): Bayesian Adaptive Comparative Effectiveness Randomized Trial.

Importance: Cryptogenic sensory polyneuropathy (CSPN) is a common generalized slowly progressive neuropathy, second in prevalence only to diabetic neuropathy. Most patients with CSPN have significant pain. Many medications have been tried for pain reduction in CSPN, including antiepileptics, antidepressants, and sodium channel blockers. There are no comparative studies that identify the most effective medication for pain reduction in CSPN. Objective: To determine which medication (pregabalin, duloxetine, nortriptyline, or mexiletine) is most effective for reducing neuropathic pain and best tolerated in patients with CSPN. Design, Setting, and Participants: From December 1, 2014, through October 20, 2017, a bayesian adaptive, open-label randomized clinical comparative effectiveness study of pain in 402 participants with CSPN was conducted at 40 neurology care clinics. The trial included response adaptive randomization. Participants were patients with CSPN who were 30 years or older, with a pain score of 4 or greater on a numerical rating scale (range, 0-10, with higher scores indicating a higher level of pain). Participant allocation to 1 of 4 drug groups used the utility function and treatment's sample size for response adaptation randomization. At each interim analysis, a decision was made to continue enrolling (up to 400 participants) or stop the whole trial for success (80% power). Patient engagement was maintained throughout the trial, which helped guide the study and identify ways to communicate and disseminate information. Analysis was performed from December 11, 2015, to January 19, 2018. Interventions: Participants were randomized to receive nortriptyline (n = 134), duloxetine (n = 126), pregabalin (n = 73), or mexiletine (n = 69). Main Outcomes and Measures: The primary outcome was a utility function that was a composite of the efficacy (participant reported pain reduction of ≥50% from baseline to week 12) and quit (participants who discontinued medication) rates. Results: Among the 402 participants (213 men [53.0%]; mean [SD] age, 60.1 [13.4] years; 343 White [85.3%]), the utility function of nortriptyline was 0.81 (95% bayesian credible interval [CrI], 0.69-0.93; 34 of 134 [25.4%] efficacious; and 51 of 134 [38.1%] quit), of duloxetine was 0.80 (95% CrI, 0.68-0.92; 29 of 126 [23.0%] efficacious; and 47 of 126 [37.3%] quit), pregabalin was 0.69 (95% CrI, 0.55-0.84; 11 of 73 [15.1%] efficacious; and 31 of 73 [42.5%] quit), and mexiletine was 0.58 (95% CrI, 0.42-0.75; 14 of 69 [20.3%] efficacious; and 40 of 69 [58.0%] quit). The probability each medication yielded the highest utility was 0.52 for nortriptyline, 0.43 for duloxetine, 0.05 for pregabalin, and 0.00 for mexiletine. Conclusions and Relevance: This study found that, although there was no clearly superior medication, nortriptyline and duloxetine outperformed pregabalin and mexiletine when pain reduction and undesirable adverse effects are combined to a single end point. Trial Registration: ClinicalTrials.gov Identifier: NCT02260388.

Rural Family Medicine Clinicians' Motivations to Participate in a Pragmatic Obesity Trial.

PURPOSE: To understand the motivations of rural-practicing primary care clinicians who participate in an intensive multiyear pragmatic randomized behavioral obesity intervention trial, Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER). METHODS: Structured interviews were conducted with 21 family medicine clinicians who were study leads at participating rural practices. Themes emerged through an analysis of transcripts and interview notes by using the constant comparative method. RESULTS: The analysis revealed 3 main themes. First, primary care clinicians participated in RE-POWER because it provided a concrete plan to address their recurring clinical care need for effective obesity treatment and management. Second, participation offered help to frustrated physicians who felt a deep professional duty to care for all their patients' problems but were dissatisfied with current obesity management. Third, participation was also attractive to rural primary care clinicians because it provided a visible and sustainable way to demonstrate their commitment to improving the health of patients and the broader community. CONCLUSIONS: Our findings show that clinicians are motivated to try solutions for a clinical problem-in this case obesity-when that clinical problem is also closely connected to a particularly frustrating area of clinical care that challenges their professional identity. Our data suggest that a motivation to close the gap between ideal and real practice can become such a high priority that clinicians are sometimes willing to try potential solutions, such as engagement in research, that they otherwise would not consider.

Characterizing health researcher barriers to sharing results with study participants.

INTRODUCTION: Research participants want to receive results from studies in which they participate. However, health researchers rarely share the results of their studies beyond scientific publication. Little is known about the barriers researchers face in returning study results to participants. METHODS: Using a mixed-methods design, health researchers (N = 414) from more than 40 US universities were asked about barriers to providing results to participants. Respondents were recruited from universities with Clinical and Translational Science Award programs and Prevention Research Centers. RESULTS: Respondents reported the percent of their research where they experienced each of the four barriers to disseminating results to participants: logistical/methodological, financial, systems, and regulatory. A fifth barrier, investigator capacity, emerged from data analysis. Training for research faculty and staff, promotion and tenure incentives, and funding agencies supporting dissemination of results to participants were solutions offered to overcoming barriers. CONCLUSIONS: Study findings add to literature on research dissemination by documenting health researchers' perceived barriers to sharing study results with participants. Implications for policy and practice suggest that additional resources and training could help reduce dissemination barriers and increase the return of results to participants.

Measuring quality and outcomes of research collaborations: An integrative review.

INTRODUCTION: Although the science of team science is no longer a new field, the measurement of team science and its standardization remain in relatively early stages of development. To describe the current state of team science assessment, we conducted an integrative review of measures of research collaboration quality and outcomes. METHODS: Collaboration measures were identified using both a literature review based on specific keywords and an environmental scan. Raters abstracted details about the measures using a standard tool. Measures related to collaborations with clinical care, education, and program delivery were excluded from this review. RESULTS: We identified 44 measures of research collaboration quality, which included 35 measures with reliability and some form of statistical validity reported. Most scales focused on group dynamics. We identified 89 measures of research collaboration outcomes; 16 had reliability and 15 had a validity statistic. Outcome measures often only included simple counts of products; publications rarely defined how counts were delimited, obtained, or assessed for reliability. Most measures were tested in only one venue. CONCLUSIONS: Although models of collaboration have been developed, in general, strong, reliable, and valid measurements of such collaborations have not been conducted or accepted into practice. This limitation makes it difficult to compare the characteristics and impacts of research teams across studies or to identify the most important areas for intervention. To advance the science of team science, we provide recommendations regarding the development and psychometric testing of measures of collaboration quality and outcomes that can be replicated and broadly applied across studies.