Carol Somkin, PhD

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Associate Adjunct Professor
Address Postal

3333 California Street, Rm 360
UCSF Box 0646
San Francisco, CA 94118
United States

Navigating the research-clinical interface in genomic medicine: analysis from the CSER Consortium.

Abstract

PurposeThe Clinical Sequencing Exploratory Research (CSER) Consortium encompasses nine National Institutes of Health-funded U-award projects investigating translation of genomic sequencing into clinical care. Previous literature has distinguished norms and rules governing research versus clinical care. This is the first study to explore how genomics investigators describe and navigate the research-clinical interface.MethodsA CSER working group developed a 22-item survey. All nine U-award projects participated. Descriptive data were tabulated and qualitative analysis of text responses identified themes and characterizations of the research-clinical interface.ResultsSurvey responses described how studies approached the research-clinical interface, including in consent practices, recording results, and using a research versus clinical laboratory. Responses revealed four characterizations of the interface: clear separation between research and clinical care, interdigitation of the two with steps to maintain separation, a dynamic interface, and merging of the two. All survey respondents utilized at least two different characterizations. Although research has traditionally been differentiated from clinical care, respondents pointed to factors blurring the distinction and strategies to differentiate the domains.ConclusionThese results illustrate the difficulty in applying the traditional bifurcation of research versus clinical care to translational models of clinical research, including in genomics. Our results suggest new directions for ethics and oversight.Genetics in Medicine advance online publication, 31 August 2017; doi:10.1038/gim.2017.137.

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

Abstract

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.

Abstract

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.

Abstract

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.

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

Abstract

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.

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

Abstract

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.

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

Abstract

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

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.

Oncologists' attitudes toward KRAS testing: a multisite study.

Abstract

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.

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

Abstract

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.

Abstract

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

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

Abstract

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.

Factors influencing time to diagnosis after abnormal mammography in diverse women.

Abstract

BACKGROUND

Abnormal mammograms are common, and the risk of false positives is high. We surveyed women in order to understand the factors influencing the efficiency of the evaluation of an abnormal mammogram.

METHODS

Women aged 40-80 years, identified from lists with Breast Imaging Reporting and Data System (BIRADS) classifications of 0, 3, 4, or 5, were surveyed. Telephone surveys asked about the process of evaluation, and medical records were reviewed for tests and timing of evaluation.

RESULTS

In this study, 970 women were surveyed, and 951 had chart reviews. Overall, 36% were college graduates, 68% were members of a group model health plan, 18% were Latinas, 25% were African Americans, 15% were Asian, and 43% were white. Of the 352 women who underwent biopsies, 151 were diagnosed with cancer (93 invasive). Median time to diagnosis was 183 days for BIRADS 3 compared to 29 days for BIRADS 4/5 and 27 days for BIRADS 0. At 60 days, 84% of BIRADS 4/5 women had a diagnosis. Being African American (hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.49-0.97, p=0.03), income

CONCLUSIONS

Evaluation of BIRADS 0, 4, or 5 abnormal mammograms was completed in most women within the recommended 60 days. Even within effective systems, correctible communication factors may adversely affect time to diagnosis.

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

Abstract

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

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

Abstract

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 

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.

Abstract

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.

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

Abstract

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.

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

Abstract

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="" were="" provided="" with="" a="" fit="" kit="" and="" of="" these="" patients="" completed="" within="" days.="" multivariate="" analyses="" participants="" significantly="" more="" likely="" to="" complete="" fits="" compared="" flu-only="" ratio="2.76" confidence="" interval="" overall="" crcs="" rate="" for="" increased="" from="" percentage="" points="" an="" increase="" lt="" 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.

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

Abstract

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.

Abstract

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

Community engagement in biobanking: Experiences from the eMERGE Network.

Abstract

Advances in genomic technologies and the promise of "personalised medicine" have spurred the interest of researchers, healthcare systems, and the general public. However, the success of population-based genetic studies depends on the willingness of large numbers of individuals and diverse communities to grant researchers access to detailed medical and genetic information. Certain features of this kind of research - such as the establishment of biobanks and prospective data collection from participants' electronic medical records - make the potential risks and benefits to participants difficult to specify in advance. Therefore, community input into biobank processes is essential. In this report, we describe community engagement efforts undertaken by six United States biobanks, various outcomes from these engagements, and lessons learned. Our aim is to provide useful insights and potential strategies for the various disciplines that work with communities involved in biobank-based genomic research.

Considering culture in physician-- patient communication during colorectal cancer screening.

Abstract

Racial and ethnic disparities exist in both incidence and stage detection of colorectal cancer (CRC). We hypothesized that cultural practices (i.e., communication norms and expectations) influence patients' and their physicians' understanding and talk about CRC screening. We examined 44 videotaped observations of clinic visits that included a CRC screening recommendation and transcripts from semistructured interviews that doctors and patients separately completed following the visit. We found that interpersonal relationship themes such as power distance, trust, directness/ indirectness, and an ability to listen, as well as personal health beliefs, emerged as affecting patients' definitions of provider-patient effective communication. In addition, we found that in discordant physician-patient interactions (when each is from a different ethnic group), physicians did not solicit or address cultural barriers to CRC screening and patients did not volunteer culture-related concerns regarding CRC screening.

The Pathways Study: a prospective study of breast cancer survivorship within Kaiser Permanente Northern California.

Abstract

OBJECTIVE

With 2.3 million breast cancer survivors in the US today, identification of modifiable factors associated with breast cancer recurrence and survival is increasingly important. Only recently new studies have been designed to examine the impact of lifestyle factors on prognosis, including Pathways, a prospective study of women with breast cancer in Kaiser Permanente Northern California (KPNC).

METHODS

Pathways aims to examine the effect on recurrence and survival of (1) lifestyle factors such as diet, physical activity, quality of life, and use of alternative therapies and (2) molecular factors such as genetic polymorphisms involved in metabolism of chemotherapeutic agents. Eligibility includes any woman diagnosed with invasive breast cancer within KPNC, no previous diagnosis of other invasive cancer, age 21 years or older, and ability to speak English, Spanish, Cantonese, or Mandarin. Newly diagnosed patients are identified daily from electronic pathology records and are enrolled within two months of diagnosis. An extensive baseline interview is conducted, blood and saliva samples are collected, and body measurements are taken. Women are followed for lifestyle updates, treatment, and outcomes by self-report and query of KPNC databases.

RESULTS

Recruitment began in 9 January, 2006, and as of 16 January, 2008, 1,539 women have been enrolled along with collection of 1,323 blood samples (86%) and 1,398 saliva samples (91%).

CONCLUSIONS

The Pathways Study will become a rich resource to examine behavioral and molecular factors and breast cancer prognosis.

Cardiology clinical trial participation in community-based healthcare systems: obstacles and opportunities.

Abstract

BACKGROUND

The objective of our study was to examine cardiologists' and organizational leaders' interest in clinical trial participation and perceived barriers and facilitators to participation within ten diverse non-profit healthcare delivery systems. Trials play a pivotal role in advancing knowledge about the safety and efficacy of cardiovascular interventions and tests. Although cardiovascular trials successfully enroll patients, recruitment challenges persist. Community-based health systems could be an important source of participants and investigators, but little is known about community cardiologists' experiences with trials.

METHODS

We interviewed 25 cardiology and administrative leaders and mailed questionnaires to all 280 cardiologists at 10 U.S. healthcare organizations.

RESULTS

The survey received a 73% response rate. While 60% of respondents had not participated in any trials in the past year, nearly 75% wanted greater participation. Cardiologists reported positive attitudes toward trial participation; more than half agreed that trials were their first choice of therapy for patients, if available. Almost all leaders described their organizations as valuing research but not necessarily trials. Major barriers to participation were lack of physician time and insufficient skilled research nurses.

CONCLUSIONS

Cardiologists have considerable interest in trial participation. Major obstacles to increased participation are lack of time and effective infrastructure to support trials. These results suggest that community-based health systems are a rich source for cardiovascular research but additional funding and infrastructure are needed to leverage this resource.

Breast cancer risk reduction options: awareness, discussion, and use among women from four ethnic groups.

Abstract

BACKGROUND

With recent advances in breast cancer risk reduction practices, it is increasingly important to assess both the breadth of and disparities in use across different racial/ethnic groups.

METHODS

We conducted telephone interviews with 1,700 women ages 40 to 74, from four racial/ethnic groups, without prior history of breast cancer, who received mammograms at one of five mammography facilities in San Francisco. Main outcomes measured included recognition of tamoxifen, raloxifene, genetic testing, and prophylactic surgery. Global indicators (recognition of any therapy, discussion of breast cancer risk) were developed from original outcome measures and analyzed using logistic regression.

RESULTS

Multivariate analyses indicate that race/ethnicity and interview language affected recognition of therapies and discussion of risk. White women were more likely than all other women to recognize any therapy and more likely than Asian-Americans to discuss risk. Women at high risk, who had a prior abnormal mammogram, who perceived themselves to be at high risk, or who were exposed to breast health information were more likely to discuss risk.

CONCLUSIONS

Women are aware of preventive therapies, although discussion and use is limited. Interventions to increase use of therapies should focus on those at high risk.

Shared decision making and the experience of partnership in primary care.

Abstract

PURPOSE

Communication has been researched either as a set of behaviors or as a facet of the patient-physician relationship, often leading to conflicting results. To determine the relationship between these perspectives, we examined shared decision making (SDM) and the subjective experience of partnership for patients and physicians in primary care.

METHODS

From a convenience sample of experienced primary care physicians in 3 clinics, we recruited a stratified sample of 18 English- or Spanish-speaking patients. Direct observation of visits was followed by videotape-triggered stimulated recall sessions with patients and physicians. We coded decision moments for objective evidence of SDM, using a structured instrument. We classified patients' and physicians' subjective experience of partnership as positive or negative by a consensus analysis of stimulated recall sessions. We combined results from these 2 analyses to generate 4 archetypes of engagements and used grounded theory to identify themes associated with each archetype.

RESULTS

The 18 visits yielded 125 decisions, 62 (50%) of which demonstrated SDM. Eighty-two decisions were discussed in stimulated recall and available for combined analysis, resulting in 4 archetypes of engagement in decision making: full engagement (SDM present, subjective experience positive)--22%; simulated engagement (SDM present, subjective experience negative)--38%; assumed engagement (SDM absent, subjective experience positive)--21%; and nonengagement (SDM absent, subjective experience negative)--19%. Thematic analysis revealed that both relationship factors (eg, trust, power) and communication behavior influenced subjective experience of partnership.

CONCLUSIONS

Combining direct observation and assessment of the subjective experience of partnership suggests that communication behavior does not ensure an experience of collaboration, and a positive subjective experience of partnership does not reflect full communication. Attempts to enhance patient-physician partnership must attend to both effective communication style and affective relationship dynamics.

Participation of Asian-American women in cancer chemoprevention research: physician perspectives.

Abstract

To the authors' knowledge, little is known regarding the participation of Asian Americans in cancer prevention research. In 2002, the authors mailed surveys to primary care physicians in Northern California to assess their knowledge, attitudes, behaviors, and barriers concerning the participation of Asian-American women in breast cancer chemoprevention research. The response rate was 52.3% (n=306 physicians). For physician barriers, most respondents selected lack of study knowledge (73%) and effort required to establish eligibility (75%) and to explain risks and benefits (68%). For patient barriers, most physicians chose the following: physicians did not inform patients about trials (76%), limited English proficiency (78%), researcher-participant language discordance (74%), and complex protocols (69%). Significantly more Asian-American physicians than non-Asian-American physicians (but a majority of each) selected as patient barriers a lack of culturally relevant information on breast cancer, a lack of knowledge about research concepts, and fear of experimentation. A majority of Asian-American physicians also selected the following patient barriers: lack of knowledge of preventive care or breast cancer, work concern, misperception that experimental treatment is inferior, personal modesty, and lack of personal benefit. In multivariate analyses, physicians who were in practice longer, who spent more time with patients, or who knew of tools to estimate breast cancer risk were more likely to discuss such trials with Asian-American women; whereas male physicians and those who believed that Asian-American women's deference to physicians was a barrier were less likely to have discussed such trials with Asian-American women. Efforts to increase research participation among Asian Americans should include physician education and linguistically appropriate recruitment efforts.

Effects of obesity and race on prognosis in lymph node-negative, estrogen receptor-negative breast cancer.

Abstract

BACKGROUND

Several factors may contribute to poorer prognosis for obese breast cancer patients, including unfavorable disease features, the influence of fat on estrogen availability, co-morbidity, and socio-demographic factors. Both obesity and estrogen receptor negative (ER-) tumors are more prevalent in black women than in whites in North America. We evaluated obesity and race in relation to outcomes in women with ER-breast cancer.

METHODS

Among 4,077 women from National Surgical Adjuvant Breast and Bowel Project clinical trials for node-negative, ER-breast cancer, we evaluated disease-free survival (DFS) and its constituents (tumor recurrence, contralateral breast cancer (CBC), second primary cancers, deaths prior to these events) and mortality in relation to body mass index (BMI) and race, using statistical modeling to account for other prognostic factors.

RESULTS

Compared to those of normal weight (BMI or = 30) women [hazard ratio (HR)=1.16, 95% confidence interval (CI)=1.01-1.33]. Obesity did not increase recurrence hazard, but did influence CBC (HR=2.08, 95% CI=1.22-3.55 in postmenopausal women) and second cancers (HR=1.49, 95% CI=1.06-2.10). Mortality increased with obesity; when partitioned by likely cause, those with BMI > or = 35.0 had greater risk of non-breast cancer mortality (HR=1.86, 95% CI=1.21-2.84). Relative to whites and adjusted for BMI, black women had greater hazard for DFS (HR=1.17, 95% CI=1.00-1.38), CBC (HR=1.37, 95% CI=0.94-1.99), and non-breast cancer deaths (HR=2.10, 95% CI=1.45-3.03); risk for deaths likely due to breast cancer was closer to that in whites (HR=1.18; 95% CI=0.93-1.50).

CONCLUSIONS

For women with node-negative, ER-breast cancer from clinical trials, obesity did not increase recurrence risk, but was associated with greater risk for second cancers, CBC, and mortality, particularly non-breast cancer deaths. Less favorable prognosis for black women persists in clinical trials, and is in part attributable to non-breast cancer outcomes.

Sex and racial/ethnic disparities in outcomes after acute myocardial infarction: a cohort study among members of a large integrated health care delivery system in northern California.

Abstract

BACKGROUND

Previous studies have documented sex and racial/ethnic disparities in outcomes after acute myocardial infarction (AMI), but the explanation of these disparities remains limited. In a setting that controls for access to medical care, we evaluated whether sex and racial/ethnic disparities in prognosis after AMI persist after consideration of socioeconomic background, personal medical history, and medical management.

METHODS

We conducted a prospective cohort study of the members (20,263 men and 10,061 women) of an integrated health care delivery system in northern California who had experienced an AMI between January 1, 1995, and December 31, 2002, and were followed up for a median of 3.5 years (maximum, 8 years). Main outcome measures included AMI recurrence and all-cause mortality.

RESULTS

In age-adjusted analyses relative to white men, black men (hazard ratio [HR], 1.44; 95% confidence interval [CI], 1.26-1.65), black women (HR, 1.47; 95% CI, 1.26-1.72), and Asian women (HR, 1.37; 95% CI, 1.13-1.65) were at increased risk of AMI recurrence. However, multivariate adjustment for sociodemographic background, comorbidities, medication use, angiography, and revascularization procedures effectively removed the excess risk of AMI recurrence in these 3 groups. Similarly, the increased age-adjusted risk of all-cause mortality seen in black men (HR, 1.55; 95% CI, 1.37-1.75) and black women (HR, 1.45; 95% CI, 1.27-1.66) was greatly attenuated in black men and reversed in black women after full multivariate adjustment.

CONCLUSION

In a population with equal access to medical care, comprehensive consideration of social, personal, and medical factors could explain sex and racial/ethnic disparities in prognosis after AMI.

Recommendations for care related to follow-up of abnormal cancer screening tests: accuracy of patient report.

Abstract

When using patient self-report of processes of care as part of measuring quality performance, validity and reliability are important considerations. In this study, the congruence of patient report of recommendations of screening follow-up care was compared with record audit data. Survey data were collected from a random sample of patients with abnormal breast (n = 230) or cervical (n = 219) cancer screening tests from four health centers. With patient consent, record audits were conducted to validate self-report. Measures of congruence for recommendations for follow-up were calculated along with sensitivity and specificity for procedure-specific recommendations. Overall congruence was higher in the mammography sample (81%) as compared to the Pap sample (61%). Predictors of overall congruence for the abnormal Pap test sample included health plan, self-reported health status, and test result. There were no significant predictors of congruence for the abnormal mammogram test sample from the potential variables collected. Raw agreement rates support using patient self-report in assessing abnormal test follow-up recommendations.

Organizational barriers to physician participation in cancer clinical trials.

Abstract

OBJECTIVE

To assess barriers to physician participation in cancer clinical trials among oncologists, oncology leaders, and health plan leaders.

STUDY DESIGN

Mail survey of 221 oncologists combined with semistructured telephone interviews with oncology and plan leaders at 10 integrated healthcare systems.

METHODS

The survey instrument examined physicians' involvement in clinical trials; their perception of the value of trials to them, their patients, and their organization; and the presence of infrastructure support for trials and associated resource constraints. The interviews investigated similar issues from the leaders' perspective. We used linear regression to model trial enrollment and standard qualitative techniques to analyze the interviews.

RESULTS

Oncologists estimated they enrolled 7% of patients in trials. They expressed extremely favorable attitudes toward trials as a source of high-quality patient care and a benefit to themselves professionally. While positive attitudes toward trials were common, and were significant bivariate predictors of enrollment, organizational factors were the predominant predictors in multivariate analysis. The best combination of factors independently predicting enrollment related to organizational support for trials, subspecialty of the oncologist, and limitations of trial eligibility requirements.

CONCLUSIONS

To increase trial participation, there is a critical need for infrastructure to support trials, especially additional support staff and research nurses. In addition, there is a need for better intra-organizational communication and consideration of the impact of trial design on internal health plan resources. This research supports the need to continue a national dialogue about the broadly defined benefits and costs of clinical trials to patients, physicians, and health plans.

Are risk factors for breast cancer associated with follow-up procedures in diverse women with abnormal mammography?

Abstract

OBJECTIVE

We evaluated the association of risk factors for breast cancer with reported follow-up procedures after abnormal mammography among diverse women.

METHODS

Women ages 40--80 years were recruited from four clinical sites after receiving a screening mammography result that was classified as abnormal but probably benign, suspicious or highly suspicious, or indeterminate using standard criteria. A telephone-administered survey asked about breast cancer risk factors (family history, estrogen use, physical inactivity, age of menarche, age at birth of first child, parity, alcohol use), and self-reported use of diagnostic tests (follow-up mammogram, breast ultrasound, or biopsy).

RESULTS

Nine hundred and seventy women completed the interview, mean age was 56, 42% were White, 19% Latina, 25% African American, and 15% Asian. White women were more likely to have a positive family history (20%), use estrogen (32%), be nulliparous (17%) and drink alcohol (62%). Latinas were more likely to be physically inactive (93%), African Americans to have early onset of menarche (53%) and Asians first child after age 30 (21%). White women were more likely to have suspicious mammograms (40%) and to undergo biopsy (45%). In multivariate models, Latinas were more likely to report breast ultrasound, physical inactive women reported fewer follow-up mammograms, and care outside the academic health center was associated with fewer biopsies. Indeterminate and suspicious mammography interpretations were significantly associated with more biopsy procedures (OR=8.4; 95% CI=3.8-18.5 and OR=59; 95% CI=35-100, respectively).

CONCLUSIONS

Demographic profile and breast cancer risk factors have little effect on self-reported use of diagnostic procedures following an abnormal mammography examination. Level of mammography abnormality determines diagnostic evaluation but variance by site of care was observed.

Women's decision making about whether or not to use breast cancer chemoprevention.

Abstract

BACKGROUND

Minimal research is available that examines how women at high risk for breast cancer make choices about chemoprevention. We examined how women decide whether to use chemoprevention within the Study of Tamoxifen and Raloxifene (STAR), a non-placebo arm prevention trial.

DESIGN

We used in-depth, semi-structured interviews and qualitative analysis. We interviewed 28 participants who chose to take chemoprevention and 23 STAR eligible women who declined participation and chemoprevention.

RESULTS

Most participants perceived themselves at heightened risk for and anxious about developing breast cancer and believed taking either trial medication was a reasonable way to reduce risk. More than half of non-participants did not perceive themselves at heightened risk for and felt little anxiety about breast cancer. More than half of non-participants felt at greater risk for developing other diseases.

CONCLUSIONS

While breast cancer risk can be calculated with a fair degree of accuracy, its impact on women's choices about chemoprevention is likely best assessed in tandem with women's feelings about developing breast cancer, whether within the context of a clinical trial or not.

Participation of Asian-American women in cancer treatment research: a pilot study.

Abstract

Few Asian-American women participate in cancer treatment trials. In a pilot study to assess barriers to participation, we mailed surveys to 132 oncologists and interviewed 19 Asian-American women with cancer from Northern California. Forty-four oncologists responded. They reported as barriers language problems, lack of culturally relevant cancer information, and complex protocols. Most stated that they informed Asian-American women about treatment trials. Only four women interviewed knew about trials. Other patient-identified barriers were fear of side effects, language problems, competing needs, and fear of experimentation. Family decision making was a barrier for both oncologists and patients. Compared to non-Asian oncologists, more Asian oncologists have referred Asian-American women to industry trials and identified barriers similar to patients' reports. Our findings indicate that Asian-American women need to be informed about cancer treatment trials, linguistic barriers should be addressed, and future research should evaluate cultural barriers such as family decision making.

Breast and cervical cancer screening: clinicians' views on health plan guidelines and implementation efforts.

Abstract

BACKGROUND

Optimizing breast and cervical cancer screening rates within health plans requires clinician support for screening guidelines, an awareness of whether there are tools available and functioning to aid screening implementation, and a perception of collegial and leadership support for quality screening services. This study investigated clinicians' perceptions of guidelines, reminders for screening, and plan and practice commitment in order to assess where opportunities exist to improve the screening process.

METHODS

A stratified sample of 761 primary care clinicians from three comprehensive health plans were surveyed to assess awareness of and agreement with guideline elements, perception of guidelines' usefulness, awareness of plan strategies to promote guideline adherence, perception of support for high-quality screening services, and ratings of plan efforts to maximize members' access.

RESULTS

Clinician awareness of and agreement with guideline elements was high (98% breast, 94% cervical). Across guideline elements, agreement was lower for mammography than cervical screening, notably for upper age limit recommendations (58% breast, 79% cervical). Knowledge of systems that cue patients and clinicians that screening is due varied by cancer test, and clinician report and plan report data about the existence of systems were, at times, not congruent. Views about consistent operation of systems differed by test (mammograms, 74%-92%; Pap, 66%-84%). Clinicians rated local colleagues and local and plan medical leadership as very committed to high-quality screening, albeit with somewhat lower ratings for cervical testing. Although the majority rated overall plan efforts to maximize screening as very good or excellent, perceived consistency of systems to cue a woman that she is due for testing and perception of collegial support were independently and significantly related to ratings of plan efforts.

CONCLUSIONS

Improvements in knowledge of systems that support guideline implementation varied, and action to ensure accurate perception of reminders, as well as consistent implementation of systems, may be important for improving screening rates and outcomes. Plan efforts and clinician efforts at the practice level are closely linked and need to be aligned to maximize screening rates. This requires plan and practice-level analyses of structures and processes that could be improved.

Local services and amenities, neighborhood social capital, and health.

Abstract

Recent work on health and place has examined the impact of the environment on health. At the local level, research has followed several strands, such as contextual effects of neighborhoods, the impact of differential access to services and amenities, effects of a neighborhood's collective efficacy, and the relationship between social capital and health. Of these four approaches, social capital has generated the most debate; some scholars discuss social capital as a key epidemiological variable, while others discount or dismiss its utility. We undertook this research to assess whether the concept of social capital could increase our understanding of the impact of neighborhoods on residents' health. We utilized key informant interviews and focus groups to understand ways in which residents of diverse neighborhoods in one large California city perceived that their local communities were affecting health. We argue in this paper that using the term "social capital" to discuss social resources and their mobilization in a particular neighborhood highlights the ways in which social resources can vary in relation to economic resources, and that residents of neighborhoods with differing levels of services and amenities face different issues when mobilizing to improve their neighborhoods. Additionally, the projects that people invest in vary by neighborhood socioeconomic status. We draw on the paired concepts of "bridging" and "bonding" social capital, and discuss that while stores of bonding social capital may be more uniform across neighborhoods of varying SES, bridging social capital tends to be found in greater amounts in neighborhoods of higher SES which allows them greater success when mobilizing to improve their neighborhoods.

The effect of access and satisfaction on regular mammogram and Papanicolaou test screening in a multiethnic population.

Abstract

BACKGROUND

Access and satisfaction are determinants of preventive service use, but few studies have evaluated their role in breast and cervical cancer screening in multiethnic populations.

OBJECTIVES

We sought to investigate the relationship between race/ethnicity, access, satisfaction, and regular mammogram and Papanicolaou test receipt in 5 racial/ethnic groups.

RESEARCH DESIGN

We conducted a telephone survey in 4 languages.

SUBJECTS

Our subjects were black, Chinese, Filipino, Latino, or white women aged 40 to 74 residing in Alameda County, California.

MEASURES

Our subjects were black, Chinese, Filipino, Latino, or white women aged 40 to 74 residing in Alameda County, California.

OUTCOME

regular mammograms (last test within 15 months and another within 2 years prior) and Papanicolaou tests (36 months and 3 years, respectively). Independent: race/ethnicity, sociodemographic variables, access (health insurance, usual site of care, regular doctor, check-up within 12 months, knowing where to go, copayment for tests), and satisfaction (overall satisfaction scale, waiting times, test-related pain and embarrassment, test satisfaction).

RESULTS

Among women who had ever had a mammogram or Papanicolaou test, 54% and 77%, respectively, received regular screening. In multivariate analyses, regular mammography was positively associated with increased age (odds ratio [OR] 1.05 per year), private insurance (OR 1.7), check-up in the past year (OR 2.3), knowing where to go for mammography (OR 3.0), and greater satisfaction with processes of care (OR 1.04 per unit), and negatively with not knowing copayment amount (OR 0.4), too many forms to fill out (OR 0.5), embarrassment at the last mammogram (OR 0.6), and Filipino race/ethnicity. Similar results were found for regular Papanicolaou tests.

CONCLUSIONS

Access and satisfaction are important predictors of screening but do little to explain racial/ethnic variation. Tailored interventions to improve regular mammography and Papanicolaou test screening in multiethnic populations are needed.

Processes of care in cervical and breast cancer screening and follow-up--the importance of communication.

Abstract

BACKGROUND

Given limited research, we investigated patient reports of processes of care related to screening follow-up, timing of result notification, communication issues, and adherence following an abnormal mammogram or Pap test.

METHODS

Women age 50 and over with an abnormal screening mammogram and women age 18 and above with an abnormal Pap test result completed surveys. The mammogram and Pap survey instruments had similar items except pertaining to measures specific to mammography or Pap tests. Bivariate associations between processes of care variables (test results, result receipt, recommendation adherence, receipt of confusing/conflicting information) and global satisfaction were explored using chi-square contingency table analysis. Multivariable logistic regression modeling was conducted.

RESULTS

One thousand one hundred thirty-four women (79.1%) completed the mammogram survey and 1087 women (69.7%) completed the Pap survey. The majority of women received test results quickly. High compliance was reported with recommendations for short-term follow-up. Conflicting/confusing information was reported by a minority of women, but was significantly and positively related to reporting that "care could be better". Patient's lack of understanding about equivocal findings was evident.

CONCLUSIONS

This study confirms that patients need clear messages about recommendations, especially when findings are equivocal and where multiple providers are involved in the process of making clinical decisions.

Acceptance of flexible sigmoidoscopy screening for colorectal cancer.

Abstract

This study was conducted in the Kaiser Permanente Medical Care Program of Northern California to identify patient characteristics that explain interest in flexible sigmoidoscopy (FS) screening. A mailed screening invitation to 6837 age-eligible patients elicited responses from 49%. Efforts to reach and interview both eligible respondents and non-respondents resulted in 2728 computer-assisted telephone interviews (CATI), with 60% indicating interest in FS screening. Five components of the Integrated Behavioral Model were measured with respect to FS screening: attitude, affect, social influence, facilitators/barriers, and perceived risk of colorectal cancer. All five model components were significantly and independently associated with interest in FS, with patient attitude being the strongest predictor. Of the 32 items comprising the model components, nine items having the highest correlations with FS interest were identified as potentially important issues to address by efforts to increase interest in screening. Six of these were attitudinal beliefs. The findings from this theory-driven study provide specific targets for the design of interventions to increase FS interest and screening rates.

Guidelines for breast and ovarian cancer genetic counseling referral: adoption and implementation in HMOs.

Abstract

PURPOSE

To describe referral guidelines for hereditary breast and ovarian cancer (HBOC) counseling among a group of Health Maintenance Organizations (HMOs) and awareness of such among primary care clinicians.

METHODS

An organizational assessment of plan policies and a primary care clinician survey.

RESULTS

Five of the 7 HMOs reported having HBOC referral guidelines. Differences between plan's criteria included age of breast cancer onset, inclusion of male breast cancer, and second-degree relatives. Of the 91% clinicians responding, only half were aware of the HBOC guidelines. Awareness was higher in the plan with the most intense implementation effort (OR=3.0, 1.5-5.9) and among gynecologists (OR=2.8, 1.5-5.4).

CONCLUSIONS

Although HBOC counseling guidelines within participating HMOs identify persons for referral that can be easily incorporated into routine practice, continued work is needed to better understand how to help primary care providers identify high-risk persons, and new models of providing genetic services may need to be considered.

Implementation of systems strategies for breast and cervical cancer screening services in health maintenance organizations.

Abstract

OBJECTIVE

To describe the systems strategies used to reduce failures in delivery of breast and cervical cancer screening services in HMOs with high performance rates for these services.

STUDY DESIGN

Multiple case study.

PARTICIPANTS AND METHODS

Seven HMOs participated in an assessment of their breast and cervical cancer screening policies and procedures. Current clinical practice guidelines were analyzed, and key informants were interviewed about organizational policies and procedures that ensure initial screening and follow-up of abnormal results. Data were analyzed across plans for several theoretically relevant domains, including leadership and policies, clinical decision support, delivery system design, clinical information systems, and patient self-management support.

RESULTS

Practice guidelines were fundamentally similar across plans for both cancer screenings, although operationalization of risk and formatting of the written documents differed. These plans adopted a wide array of strategies, particularly in the clinical decision support, clinical information systems, and patient self-management support domains, but there is room for improvement. Differences among plans and between strategies for breast and cervical cancer screening provide new understanding of how to approach this problem.

CONCLUSIONS

Organizations seeking to improve performance of breast and cervical cancer screening should consider multiple strategies aimed at multiple targets and should ensure that strategies used for one type of cancer are considered for others.

Validation of recall of breast and cervical cancer screening by women in an ethnically diverse population.

Abstract

BACKGROUND

Screening mammogram and Pap smear rates are lower for women in underserved racial and ethnic groups, yet may be overestimated due to reliance on patients' self-reports. The purpose of this study was to determine accuracy of self-reports of mammograms and Pap smears in a multiethnic, multilingual population of African American, Latina, Chinese, Filipina, and White women residing in low-income census tracts of Alameda County, California.

METHODS

Following a baseline telephone survey of 1,464 women regarding receipt of mammograms and Pap smears, we examined computerized and written medical records to validate the dates and locations of tests reported by women.

RESULTS

Of 1,464 subjects, 94.9% reported having had a Pap smear, and 87% reported having had a mammogram. For Pap smears, in a subsample of 448 cases, we validated only 69.4% of the women's self-reports, and for mammography, in a subsample of 846 women, we validated only 75.4% of the self-reports. Validation rates differed significantly by ethnicity and site of care for both Pap smears and mammograms.

CONCLUSIONS

Population estimates of breast and cervical cancer screening rates based upon patient self-reports need to be adjusted downward, by as much as one-quarter to one-third, for low-income, ethnic women.

Caffeine, cajoling, and other strategies to maximize clinician survey response rates.

Abstract

An ongoing objective in health services research is to increase response rates to clinician surveys to ensure generalizability of findings. Three HMOs in the Cancer Research Network participated in a primary care clinician survey to better understand organizational characteristics affecting adoption and implementation of breast and cervical cancer screening guidelines. A four-stage data collection strategy was implemented to maximize response. This included careful attention to survey design and layout, extensive piloting, choice of token incentive, use of "local champions," and denominator management. An overall response rate of 91% was attained, ranging from 83 to 100% among the plans (N = 621). Although the response rate after the second stage of data collection met commonly used standards, the authors argue for the four-stage method due to the possibility of differences when comparing early and late responders. This is important when multiple plans with differing structure and internal characteristics are surveyed.

Correlates of breast cancer screening among low-income, low-education Latinas.

Abstract

INTRODUCTION

This paper discusses the factors associated with breast cancer screening among low-education, low-income Latinas.

BACKGROUND

These data were collected as part of a breast cancer educational intervention study aimed at this population. The objective of the larger study was to evaluate multimedia methods as an appropriate medium for educating this population of Latinas about breast cancer.

METHODS

The study was designed as a field experiment with a pre and posttest design. A total of 1,197 individuals participated in the study, and these were all self-identified Latinas above the age of 40 years who fit the screening criteria of low income and education levels. Of these, 583 individuals provided the baseline (pretest) data on mammogram attitudes, knowledge, and intentions analyzed in this paper.

RESULTS

Our results indicate that breast cancer screening knowledge and having a regular doctor were significant factors in ever having had a mammogram and having had a recent mammogram in this sample of low-income, low-education Latinas. Age affected the odds of ever having had a mammogram, but not a recent mammogram.

CONCLUSION

Attitudes toward mammography, insurance status, and demographic factors such as foreign birth were not significant predictors of mammography screening in this study.

Screening mammography in an integrated health care system: the Kaiser permanente experience.

Abstract

In this paper, we describe the attributes of a comprehensive approach to breast cancer screening possible in an integrated health care system. We define an integrated health care system as one in which comprehensive preventive and medical care is provided to a defined population, by a defined panel of providers, and in which this care can be tracked using automated electronic data systems. Guided by the Pathways Conceptual Framework, it is possible to identify and systematically address (through research and interventions) the multiple predisposing, enabling, and reinforcing factors at the individual and organizational level associated with each step along the screening process. This framework is helpful as both a planning and an evaluation tool, in identifying places in the screening and follow-up process that could benefit from concerted quality improvement efforts and in guiding an evaluation of those efforts. We describe examples from research and organizational programmatic efforts, and use the framework to point to additional areas for further investigation and potential organizational intervention. These examples use a variety of research methods, impact the breast cancer screening pathway in different places, and therefore show how it is possible to approach the broad issue of reduction of breast cancer mortality from multiple perspectives. Integrated health care systems, unlike more traditional academic settings, are well suited to supporting this full spectrum of research while also providing the context for its application.

The effect of patient and provider reminders on mammography and Papanicolaou smear screening in a large health maintenance organization.

Abstract

BACKGROUND

We evaluated the effectiveness of 2 reminder interventions to increase the use of screening mammograms and Papanicolaou (Pap) smears among female members of a large health maintenance organization.

METHODS

Seven thousand seventy-seven female health maintenance organization members (aged 50-74 years with no prior mammogram in the previous 30 months or aged 20-64 years with no prior Pap smear in the previous 36 months) were randomized to receive one of the following: a letter inviting them to make an appointment for a mammogram or a Pap smear; in addition to the letter, a reminder manually placed in the patient's medical chart alerting providers of that member's need for screening; or their usual care.

RESULTS

Compared with women who did not receive the reminder letter, women who did receive the letter were more likely to obtain mammograms (16.0% vs 25.5%, respectively; P

CONCLUSIONS

We recommend the use of patient reminder letters as a first step in a mammography or Pap smear screening outreach program. Further research is needed to evaluate a cost-effective provider reminder system and additional outreach strategies directed to women who do not use health care services.

Cost of care for cancer in a health maintenance organization.

Abstract

The direct costs of medical care for cancer are examined at Kaiser Permanente (KP) in Northern California. Use data from July 1987 through June 1991 were obtained from KP automated files for all 21,977 KP patients in the Bay Area SEER registry with cancer at one of seven cancer sites. Medical charts were reviewed for a stratified sample of 886 patients. Costs were estimated for initial, continuing, and terminal care, and for all person time within 15 years of diagnosis, by stage at diagnosis. From diagnosis until death or 15 years, long-term costs attributable to cancer were as follows: breast, $35,000; colon, $42,000; rectum, $51,000; lung, $33,000; ovarian, $64,000; prostate, $29,000; and Non-Hodgkin's Lymphoma (NHL), $48,000. The utilization and cost results reported here may be useful in assessing the cost-effectiveness of cancer prevention and control programs, in adjusting capitation rates and budgets, and in estimating the aggregate medical care costs attributable to cancer.

Breast self-examination: improving competence and frequency in a classroom setting.

Abstract

We conducted a prospective study of 459 women to determine if a one-session class in breast self-examination (BSE) can improve competence and frequency. Women who attended the class were randomly assigned to one of two groups. We assessed three areas of competence of BSE in one group immediately before the class, in the other group immediately after the class, and in both groups at follow-up one year later. Of the 459 women who attended the class, 286 returned for the one-year follow-up. All three areas of competence measured showed significant improvement in the group tested immediately after the class compared with the group tested just before the class. Competence scores at the one-year follow-up remained twice as high as those before the class although there was a decrease in competence from just after the class. Younger women proved more competent in performing BSE than did older women. At one year, participants further reported performing BSE nearly twice as often as before the class. We conclude that competent BSE can be learned and frequency of BSE can be increased from a one-session class.

Clinical Trials As Topic
Colorectal Neoplasms
Mammography
Medical Oncology
Patient Selection