Digital Storytelling as a Tool to Increase Colorectal Cancer Screening Intention in a Latinx Church Community.

Although colorectal cancer screening (CRCS) rates have improved for all racial groups due to wider availability of screening, Latinx continue to have lower screening rates and are more likely to be diagnosed with later stages of colorectal cancer compared to non-Latinx whites. More culturally tailored educational interventions are needed to reach this population. This study introduced a digital storytelling (DST) intervention in a church community setting and explored its potential to influence CRCS intention and perception among Latinx and the acceptability of the DST intervention. Participants (n=20) between the ages of 50 and 75 who were not up-to-date with CRCS were recruited to view digital stories developed by fellow church members with previous CRCS experience. They completed surveys assessing their intention to complete CRCS before and after the viewing and were asked to participate in focus groups to understand, qualitatively, how the digital stories influenced their perceptions and intentions related to CRCS. Analysis of participant narratives revealed three overarching themes related to their perceptions and intentions of CRCS after the DST intervention: (1) the duality of the faith-health connection and fatalism, (2) willingness to consider other screening methods, and (3) the push-pull of individual barriers and interpersonal facilitators. Participants felt the DST intervention humanized the CRCS process and that it would be acceptable and well received in other church settings. The introduction of a community-based DST intervention within a church setting is a novel strategy with the potential to influence members of the Latinx church population to complete CRCS.

Health care improvement and survivorship priorities of colorectal cancer survivors: findings from the PORTAL colorectal cancer cohort survey.

PURPOSE: Few population-level surveys have explored patient-centered priorities for improving colorectal cancer survivors' care. Working with patients, we designed a survey to identify care improvement and survivorship priorities. METHODS: We surveyed a random sample of 4000 patients from a retrospective, population-based cohort of colorectal cancer survivors diagnosed during 2010-2014. The survey included two multiple response questions: "What would you have changed about your cancer diagnosis and treatment experience?" and "What are your biggest health or lifestyle concerns (other than having cancer) since being diagnosed?" Multivariable regression identified characteristics associated with endorsement of health care experience and survivorship concerns. RESULTS: Survey response rate was 50.2% (2000/3986). Fifty-three percent reported at least one unmet need, most commonly for more information about life after treatment (26.7%). Survivors of rectal cancer reported more needs than respondents with colon cancer; persons of color reported more needs than non-Hispanic whites; individuals without high school diplomas reported more needs than individuals with more education. Fear of recurrence was the most common health/lifestyle concern (58.9%). Respondents under age 65 reported nearly all health/lifestyle concerns more often than respondents over age 74. Rectal cancer survivors reported more concerns about activity limitation, changes, and body function and appearance than colon cancer survivors. Persons of color were more likely to report financial concerns than non-Hispanic whites. CONCLUSIONS: The greatest needs for intervention are among survivors of rectal cancer, survivors of minority racial/ethnic background, and survivors of younger age. Survivors with low educational attainment and those with higher stage disease could also benefit.

Multiple Stakeholder Views on Data Sharing in a Biobank in an Integrated Healthcare Delivery System: Implications for Biobank Governance.

BACKGROUND: Beginning in 2005, researchers at Kaiser Permanente Northern California (KPNC) Division of Research developed the Research Program on Genes, Environment, and Health (RPGEH), a research resource of linked biospecimens, health surveys, and electronic health records on more than 200,000 adult KPNC members. This study examined multiple stakeholders' values and preferences regarding protection of participants' privacy and wide sharing of participant data by RPGEH. METHODS: We conducted 45 semi-structured interviews in person or via phone and two focus groups with seven stakeholder groups, including RPGEH participants and decliners who are KPNC members, KPNC research scientists, external scientists, leadership, Human Subjects Research Protection Program staff, and RPGEH Community Advisory Panel members. RESULTS: Three major themes emerged related to: (1) perceived individual and social harms associated with data sharing; (2) concerns to address when governing access to RPGEH data; and (3) impact of a blurred boundary between research and clinical care in the context of biobanking. CONCLUSIONS: The study results were considered in the development of RPGEH data governance and motivated the inclusion of KPNC Community Advisory Panel members and ELSI experts on committees that evaluate data access proposals. Our findings can help inform other biobanks going through similar processes developing data sharing and access policies.

Increasing Minority Enrollment Onto Clinical Trials: Practical Strategies and Challenges Emerge From the NRG Oncology Accrual Workshop.

Racial and ethnic diversity has historically been difficult to achieve in National Cancer Institute-sponsored clinical trials, even while as many as 80% of those trials have faced difficulty in meeting overall recruitment targets. In an attempt to address these issues, NRG Oncology recently convened a comprehensive workshop titled "Clinical Trials Enrollment: Challenges and Opportunities." Discussants at the workshop included representatives of the three legacy groups of the NRG (ie, Gynecologic Oncology Group, National Surgical Adjuvant Breast and Bowel Program, and Radiation Therapy Oncology Group), a minority-based community clinical oncology program, a large integrated health care system, the leadership of the National Cancer Institute, and a large patient advocacy group. This article summarizes the concepts discussed at the workshop, which included: needs assessments, infrastructural support, training of investigators and research staff, specific clinical trial recruitment strategies (both system and community based), and development and mentoring of young investigators. Many new, more specific tactics, including use of diverse cancer care settings, direct-to-consumer communication, and the need for centralized information technology such as the use of software to match trials to special populations, are presented. It was concluded that new, innovative trial designs and the realities of limited funding would require the adoption of effective and efficient recruiting strategies, specialized training, and stakeholder engagement. US clinical research programs must generate and embrace new ideas and pilot test novel recruitment strategies if they are to maintain their historic role as world leaders in cancer care innovation and delivery.

Harms, benefits, and the nature of interventions in pragmatic clinical trials.

To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems.

Characterizing Race/Ethnicity and Genetic Ancestry for 100,000 Subjects in the Genetic Epidemiology Research on Adult Health and Aging (GERA) Cohort.

Using genome-wide genotypes, we characterized the genetic structure of 103,006 participants in the Kaiser Permanente Northern California multi-ethnic Genetic Epidemiology Research on Adult Health and Aging Cohort and analyzed the relationship to self-reported race/ethnicity. Participants endorsed any of 23 race/ethnicity/nationality categories, which were collapsed into seven major race/ethnicity groups. By self-report the cohort is 80.8% white and 19.2% minority; 93.8% endorsed a single race/ethnicity group, while 6.2% endorsed two or more. Principal component (PC) and admixture analyses were generally consistent with prior studies. Approximately 17% of subjects had genetic ancestry from more than one continent, and 12% were genetically admixed, considering only nonadjacent geographical origins. Self-reported whites were spread on a continuum along the first two PCs, indicating extensive mixing among European nationalities. Self-identified East Asian nationalities correlated with genetic clustering, consistent with extensive endogamy. Individuals of mixed East Asian-European genetic ancestry were easily identified; we also observed a modest amount of European genetic ancestry in individuals self-identified as Filipinos. Self-reported African Americans and Latinos showed extensive European and African genetic ancestry, and Native American genetic ancestry for the latter. Among 3741 genetically identified parent-child pairs, 93% were concordant for self-reported race/ethnicity; among 2018 genetically identified full-sib pairs, 96% were concordant; the lower rate for parent-child pairs was largely due to intermarriage. The parent-child pairs revealed a trend toward increasing exogamy over time; the presence in the cohort of individuals endorsing multiple race/ethnicity categories creates interesting challenges and future opportunities for genetic epidemiologic studies.

Automated Assay of Telomere Length Measurement and Informatics for 100,000 Subjects in the Genetic Epidemiology Research on Adult Health and Aging (GERA) Cohort.

The Kaiser Permanente Research Program on Genes, Environment, and Health (RPGEH) Genetic Epidemiology Research on Adult Health and Aging (GERA) cohort includes DNA specimens extracted from saliva samples of 110,266 individuals. Because of its relationship to aging, telomere length measurement was considered an important biomarker to develop on these subjects. To assay relative telomere length (TL) on this large cohort over a short time period, we created a novel high throughput robotic system for TL analysis and informatics. Samples were run in triplicate, along with control samples, in a randomized design. As part of quality control, we determined the within-sample variability and employed thresholds for the elimination of outlying measurements. Of 106,902 samples assayed, 105,539 (98.7%) passed all quality control (QC) measures. As expected, TL in general showed a decline with age and a sex difference. While telomeres showed a negative correlation with age up to 75 years, in those older than 75 years, age positively correlated with longer telomeres, indicative of an association of longer telomeres with more years of survival in those older than 75. Furthermore, while females in general had longer telomeres than males, this difference was significant only for those older than age 50. An additional novel finding was that the variance of TL between individuals increased with age. This study establishes reliable assay and analysis methodologies for measurement of TL in large, population-based human studies. The GERA cohort represents the largest currently available such resource, linked to comprehensive electronic health and genotype data for analysis.

Genotyping Informatics and Quality Control for 100,000 Subjects in the Genetic Epidemiology Research on Adult Health and Aging (GERA) Cohort.

The Kaiser Permanente (KP) Research Program on Genes, Environment and Health (RPGEH), in collaboration with the University of California-San Francisco, undertook genome-wide genotyping of >100,000 subjects that constitute the Genetic Epidemiology Research on Adult Health and Aging (GERA) cohort. The project, which generated >70 billion genotypes, represents the first large-scale use of the Affymetrix Axiom Genotyping Solution. Because genotyping took place over a short 14-month period, creating a near-real-time analysis pipeline for experimental assay quality control and final optimized analyses was critical. Because of the multi-ethnic nature of the cohort, four different ethnic-specific arrays were employed to enhance genome-wide coverage. All assays were performed on DNA extracted from saliva samples. To improve sample call rates and significantly increase genotype concordance, we partitioned the cohort into disjoint packages of plates with similar assay contexts. Using strict QC criteria, the overall genotyping success rate was 103,067 of 109,837 samples assayed (93.8%), with a range of 92.1-95.4% for the four different arrays. Similarly, the SNP genotyping success rate ranged from 98.1 to 99.4% across the four arrays, the variation depending mostly on how many SNPs were included as single copy vs. double copy on a particular array. The high quality and large scale of genotype data created on this cohort, in conjunction with comprehensive longitudinal data from the KP electronic health records of participants, will enable a broad range of highly powered genome-wide association studies on a diversity of traits and conditions.

Effect of medical oncologists' attitudes on accrual to clinical trials in a community setting.

PURPOSE: Oncology clinical trials (OCTs) are crucial in evaluating new cancer treatments, but only 2% to 3% of US adult patients with cancer enter OCTs. This study assessed barriers to participation in clinical trials among oncologists in a large integrated health care delivery system with an active clinical trials program. Although many studies have identified major physician barriers to enrollment, few have examined how these barriers affect actual trial accrual. METHODS: Using information from a mailed survey, we examined the effect of oncologists' attitudes, beliefs, experiences, sociodemographic factors, and practice characteristics on clinical trial accrual in the 2 years following the survey. We identified relationships between these variables and subsequent clinical trial accrual using correlations and mixed effects models. RESULTS: A construct combining questions that assessed oncologist attitudes, beliefs, and experiences substantially influenced OCT enrollment (r = .51; P < .0001). This construct included awareness of open clinical trials and specific eligible patients, as well as the practice of initiating a discussion about OCTs with most eligible patients. This broad concept of awareness had the greatest correlation with enrollment and mediated the effect on enrollment of other values and beliefs, such as welcoming a patient's initiation of a trial discussion and valuing the support of research nurses and coordinators. CONCLUSION: Even in a health care setting with an active clinical trials program, substantial research personnel, infrastructure support, and widespread access to trials among oncologists and patients, oncologists' participation remains quite variable. Oncologist values, beliefs, and awareness of clinical trials play an important role in OCT accrual.

Patients' attitudes about the use of placebo treatments: telephone survey.

OBJECTIVE: To examine the attitudes of US patients about the use of placebo treatments in medical care. DESIGN: One time telephone surveys. SETTING: Northern California. PARTICIPANTS: 853 members of Kaiser Permanente Northern California, aged 18-75, who had been seen by a primary care provider for a chronic health problem at least once in the prior six months. RESULTS: The response rate was 53.4% (853/1598) of all members who were eligible to participate, and 73.2% (853/1165) of all who could be reached by telephone. Most respondents (50-84%) judged it acceptable for doctors to recommend placebo treatments under conditions that varied according to doctors' level of certainty about the benefits and safety of the treatment, the purpose of the treatment, and the transparency with which the treatment was described to patients. Only 21.9% of respondents judged that it was never acceptable for doctors to recommend placebo treatments. Respondents valued honesty by physicians regarding the use of placebos and believed that non-transparent use could undermine the relationship between patients and physicians. CONCLUSIONS: Most patients in this survey seemed favorable to the idea of placebo treatments and valued honesty and transparency in this context, suggesting that physicians should consider engaging with patients to discuss their values and attitudes about the appropriateness of using treatments aimed at promoting placebo responses in the context of clinical decision making.

Patient-physician interaction and quality of life in recently diagnosed breast cancer patients.

Few studies have explored how patient-physician interactions influence patients' quality of life (QOL). In a prospective cohort study of 1,855 women diagnosed with invasive breast cancer in the Kaiser Permanente Northern California Medical Care Program from 2006 to 2011, we examined associations between patient-physician interactions during cancer treatment and QOL, overall and by racial/ethnic group. Participants completed the interpersonal processes of care (IPC) survey at approximately 8 months post-diagnosis to assess specific domains of the patient-physician interaction during the months after cancer diagnosis. Domains included: compassion, elicited concerns, explained results, decided together, lack of clarity, discrimination due to race/ethnicity, and disrespectful office staff. The functional assessment of cancer therapy-breast cancer was completed concurrently to measure QOL. Linear regression models examined the association of IPC with QOL, first adjusting for patient covariates including age, race, clinical factors, and psychosocial measures and then for physician characteristics such as age, sex, race/ethnicity, and specialty. For all participants (n = 1,855), IPC scores suggesting greater lack of clarity, discrimination due to race/ethnicity, and disrespectful office staff in patient-physician interactions were associated with lower QOL (P< 0.01). IPC scores suggesting physicians demonstrating compassion, eliciting concerns, or explaining results were associated with higher QOL (P< 0.01). Among Whites (n = 1,306), only the associations with higher QOL remained. African Americans (n = 110) who reported higher scores on physician compassion and elicited concerns had higher QOL, whereas higher scores for disrespectful office staff had lower QOL. No associations were observed among Asians (n = 201) and Hispanics (n = 186). After further adjustment for physician factors, the associations among Whites remained, whereas those among African Americans disappeared. In the breast cancer treatment setting, characteristics of the patient-physician interaction as perceived by the patient are associated with QOL, yet were not specific to patient race/ethnicity.

Effectiveness and reach of the FLU-FIT program in an integrated health care system: a multisite randomized trial.

OBJECTIVES: We tested the effectiveness of offering home fecal immunochemical tests (FITs) during influenza vaccination clinics to increase colorectal cancer screening (CRCS). METHODS: In a clinical trial at Kaiser Permanente Northern California influenza clinics in Redwood City, Richmond, South San Francisco, Union City, and Fresno, we randomly assigned influenza clinic dates to intervention (FIT offered) or control (FIT not offered) and compared subsequent CRCS activity. RESULTS: Clinic staff provided FITs to 53.9% (1805/3351) of intervention patients aged 50 to 75 years. In the intent-to-treat analysis, 26.9% (900/3351) and 11.7% (336/2884) of intervention and control patients completed an FIT, respectively, within 90 days of vaccination (P ≤ .001). The adjusted odds ratio for completing FIT in the intervention versus the control arm was 2.75 (95% confidence interval = 2.40, 3.16). In the per protocol analysis, 35.4% (648/1830) of patients given FIT and 13.3% (588/4405) of patients not given FIT completed FIT within 90 days of vaccination (P ≤ .001). CONCLUSIONS: This intervention may increase CRCS among those not reached by other forms of CRCS outreach. Future research should include the extent to which these programs can be disseminated and implemented nationally.

Oncologists' attitudes toward KRAS testing: a multisite study.

Recent discoveries promise increasingly to help oncologists individually tailor anticancer therapy to their patients' molecular tumor characteristics. One such promising molecular diagnostic is Kirsten ras (KRAS) tumor mutation testing for metastatic colorectal cancer (mCRC) patients. In the current study, we examined how and why physicians adopt KRAS testing and how they subsequently utilize the information when discussing treatment strategies with patients. We conducted 34 semi-structured in-person or telephone interviews with oncologists from seven different health plans. Each interview was audiotaped, transcribed, and coded using qualitative research methods. Information and salient themes relating to the research questions were summarized for each interview. All of the oncologists in this study reported using the KRAS test at the time of the interview. Most appeared to have adopted the test rapidly, within 6 months of the publication of National Clinical Guidelines. Oncologists chose to administer the test at various time points, although the majority ordered the test at the time their patient was diagnosed with mCRC. While oncologists expressed a range of opinions about the KRAS test, there was a general consensus that the test was useful and provided benefits to mCRC patients. The rapid adoption and enthusiasm for KRAS suggests that these types of tests may be filling an important informational need for oncologists when making treatment decisions. Future research should focus on the informational needs of patients around this test and whether patients feel informed or confident with their physicians' use of these tests to determine treatment access.

Patient awareness and knowledge of breast cancer-related lymphedema in a large, integrated health care delivery system.

Breast cancer patients have voiced dissatisfaction regarding their education on breast cancer-related lymphedema risk and risk reduction strategies from their clinicians. Informing patients about lymphedema can contribute to decrease their risk of developing the condition, or among those already affected, prevent it from progressing further. In this cross-sectional study, a lymphedema awareness score was calculated based on responses to a brief telephone interview conducted among 389 women diagnosed with invasive breast cancer at Kaiser Permanente Northern California from 2000 to 2008 and had a previous record of a lymphedema-related diagnosis or procedure in their electronic medical record. During the telephone interview, women self-reported a lymphedema clinical diagnosis, lymphedema symptoms but no lymphedema diagnosis, or neither a diagnosis nor symptoms, and responded to questions on lymphedema education and support services as well as health knowledge. Multivariable logistic regression [odds ratio (OR) and 95 % confidence interval (CI)] was used to determine the associations of selected sociodemographic and clinical factors with the odds of having lymphedema awareness (adequate vs. inadequate). The median (range) of the lymphedema awareness score was 4 (0-7). Compared with patients <50 years of age, patients 70+ years of age at breast cancer diagnosis had lower odds of adequate lymphedema awareness (OR 0.25; 95 % CI 0.07, 0.89), while patients 50-59 and 60-69 years had greater odds of adequate awareness although not statistically significant (OR 2.05; 95 % CI 0.88, 4.78 and OR 1.55; 95 % CI 0.60, 4.02, respectively; p for trend = 0.09). Higher educational level and greater health literacy were suggestive of adequate awareness yet were not significant. These results can help inform educational interventions to strengthen patient knowledge of lymphedema risk and risk reduction practices, particularly in an integrated health care delivery setting. With the growing population of breast cancer survivors, increasing patient awareness and education about lymphedema risk reduction and care after cancer diagnosis is warranted.

Clinician awareness and knowledge of breast cancer-related lymphedema in a large, integrated health care delivery setting.

Breast cancer survivors have reported dissatisfaction regarding their education on risk of breast cancer-related lymphedema (BCRL) from clinicians. We describe clinician knowledge and treatment referral of patients with BCRL among active oncologists, surgeons, and primary care physicians in the Kaiser Permanente Northern California Medical Care Program. A total of 887 oncologists, surgeons, and primary care clinicians completed a 10-minute web survey from May 2, 2010 to December 31, 2010 on BCRL knowledge, education, and referral patterns. A knowledge score of BCRL was calculated based on clinician responses. Multivariable regression models were used to determine the associations of selected covariates with BCRL knowledge score and clinician referral, respectively. Compared with primary care clinicians, oncologists had the highest mean score followed closely by surgeons (P < 0.0001). In multivariable analyses, being female, an oncologist or surgeon, and recently receiving BCRL materials were each significantly associated with higher BCRL knowledge scores. About 44% of clinicians (n = 381) indicated they had ever made a BCRL referral (100% oncologists, 79% surgeons, and 36% primary care clinicians). Clinicians with a higher knowledge score were more likely to make referrals. In stratified analyses by specialty, the significant associated factors remained for primary care but became non-significant for oncology and surgery. These results can inform educational interventions to strengthen clinician knowledge of the clinical management of BCRL, especially among primary care clinicians. With the growing number of breast cancer survivors, increasing clinician education about BCRL across all specialties is warranted.

Design and coverage of high throughput genotyping arrays optimized for individuals of East Asian, African American, and Latino race/ethnicity using imputation and a novel hybrid SNP selection algorithm.

Four custom Axiom genotyping arrays were designed for a genome-wide association (GWA) study of 100,000 participants from the Kaiser Permanente Research Program on Genes, Environment and Health. The array optimized for individuals of European race/ethnicity was previously described. Here we detail the development of three additional microarrays optimized for individuals of East Asian, African American, and Latino race/ethnicity. For these arrays, we decreased redundancy of high-performing SNPs to increase SNP capacity. The East Asian array was designed using greedy pairwise SNP selection. However, removing SNPs from the target set based on imputation coverage is more efficient than pairwise tagging. Therefore, we developed a novel hybrid SNP selection method for the African American and Latino arrays utilizing rounds of greedy pairwise SNP selection, followed by removal from the target set of SNPs covered by imputation. The arrays provide excellent genome-wide coverage and are valuable additions for large-scale GWA studies.

The FLU-FIT program: an effective colorectal cancer screening program for high volume flu shot clinics.

OBJECTIVE: To determine whether offering home fecal immunochemical tests (FITs) to eligible patients during a high volume influenza vaccination clinic could lead to increased colorectal cancer screening (CRCS) rates in a managed care setting. STUDY DESIGN: Observational study. METHODS: During influenza vaccination clinics in 2008, trained staff provided FITs to patients who were eligible for CRCS (FLU-FIT group) (FLU indicates influenza vaccine). Screening outcomes for this cohort of patients were compared with those of a similar group of influenza clinic attendees who were not exposed to the intervention (FLUonly group). RESULTS: Among eligible participants in the FLU-only group (N = 4653), 13.7% completed FIT within 90 days of their influenza vaccine, and in the FLU-FIT group (N = 2812), 30.3% completed FIT (P <.0001). In the FLU-FIT group, 1447 (51.4%) were provided with a FIT kit, and 653 (45.1%) of these patients completed a FIT kit within 90 days. In multivariate analyses, FLU-FIT group participants were significantly more likely to complete FITs compared with FLU-only group participants (Odds Ratio = 2.76 [95% confidence interval, 2.45-3.11]). Overall, the CRCS rate for the FLU-only group increased from 51.5% to 56.3% (increase of 4.8 percentage points), compared with an increase from 49.2% to 63.2% (increase of 14.0 percentage points) in the FLU-FIT group (P lt;.0001 for change difference). CONCLUSIONS: The FLU-FIT Program is feasible to implement in a high volume influenza vaccination clinic conducted in a managed care setting and increases colorectal cancer screening activity among eligible influenza vaccination recipients who are reached with the intervention.

Ethical and practical challenges of sharing data from genome-wide association studies: the eMERGE Consortium experience.

In 2007, the National Human Genome Research Institute (NHGRI) established the Electronic MEdical Records and GEnomics (eMERGE) Consortium (www.gwas.net) to develop, disseminate, and apply approaches to research that combine DNA biorepositories with electronic medical record (EMR) systems for large-scale, high-throughput genetic research. One of the major ethical and administrative challenges for the eMERGE Consortium has been complying with existing data-sharing policies. This paper discusses the challenges of sharing genomic data linked to health information in the electronic medical record (EMR) and explores the issues as they relate to sharing both within a large consortium and in compliance with the National Institutes of Health (NIH) data-sharing policy. We use the eMERGE Consortium experience to explore data-sharing challenges from the perspective of multiple stakeholders (i.e., research participants, investigators, and research institutions), provide recommendations for researchers and institutions, and call for clearer guidance from the NIH regarding ethical implementation of its data-sharing policy.

Physicians' approaches to recommending colorectal cancer screening: a qualitative study.

Little is known about strategies that physicians use to encourage receipt of colorectal cancer screening (CRCS). This study conducted focus groups with physicians. Twenty-seven physicians participated in four focus groups. Physicians described four categories of approaches: (1) why screening is important, (2) providing test information, (3) motivational strategies, and (4) tailoring strategies. Participants reported tailoring based on their relationship with a patient, as well as to patient gender, education, and language. Tailoring to cultural background or ethnicity was not prominent. Most physicians reported a typical approach to CRCS and reported some tailoring based on gender, education, and language, but not on ethnicity.

Quality of life among women recently diagnosed with invasive breast cancer: the Pathways Study.

Few studies have assessed quality of life (QOL) of women diagnosed with breast cancer within the first few weeks of their initial diagnosis. We describe QOL among 950 women recently diagnosed with invasive breast cancer. Starting in January 2006, we invited women aged > or =21 years who were diagnosed with first primary invasive breast cancer within Kaiser Permanente Northern California (KPNC) to enroll in the Pathways Study, a prospective study of breast cancer survivorship. QOL was measured using the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B), along with sociodemographic and social support information. Clinical characteristics were obtained from the KPNC cancer registry and electronic medical record. We used multivariable linear regression models to identify factors associated with QOL scores calculated from the FACT-B. The mean age +/- SD of the sample was 59.6 years (+/-11.9 years), and the mean time +/-SD from diagnosis until interview was 8.0 weeks (+/-3.2 weeks). Younger age at diagnosis was associated with lower scores in all QOL domains (P < 0.01), and later stage at diagnosis was associated with lower scores in all domains (P < 0.05) except for social well-being. Higher levels of social support were associated with higher QOL except for physical well-being (P < 0.05). These associations were stronger within 2 months of breast cancer diagnosis. Quality of life as influenced by a diagnosis of breast cancer is an important factor in cancer survivorship. Age, stage at diagnosis, and social support are key factors in this important variable.